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NCT06307496

Not yet recruiting

VIDeOS for Smoking Cessation

The purpose of the current study is to pilot the efficacy, feasibility, and acceptability of an evidence-based smoking cessation intervention adapted for cancer patients and delivered via video. Investigators aim to assess if this intervention is considered acceptable by participants, feasible to implement, and effective at increasing knowledge about smoking cessation before conducting a fully powered clinical trial.

- EligibilityCriteria: Inclusion Criteria: Age 18 or older Diagnosed with cancer (any type) Receiving care at Medical University of South Carolina Reads and understands English language Currently smoking cigarettes (any amount) Exclusion Criteria: - Unstable or poorly managed medical or psychiatric conditions that impair cognition and ability to provide informed consent (e.g., dementia, active psychosis). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06307470

Not yet recruiting

Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors

The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are: What is the feasibility of this intervention in an online, private setting? What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image? Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 8 - 10 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time.

- EligibilityCriteria: Inclusion Criteria: Diagnosed with breast cancer (stages I - III) between ages 18 - 50 Completed active treatment (chemotherapy and/or radiation) within the last five years Can read/speak English Access to talk in quiet, safe environment for privacy On hormonal therapies (aromatase inhibitors, tamoxifen) Currently partnered (i.e., in a relationship) Exclusion Criteria: Currently undergoing active treatment (chemotherapy and/or radiation) More than five years have passed since completing active treatment (chemotherapy and/or radiation) History of advanced breast cancer (stage IV) or a breast cancer recurrence Women without access to the internet Cannot read/speak in English - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Participant eligibility is based on gender at birth. - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06307457

Not yet recruiting

A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.

The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer. The study will consider participants who: have advanced or metastatic breast cancer that is spread to other parts of the body. have HR+/HER2- (hormone receptor positive* / human epidermal growth factor receptor 2 negative**) breast cancer types. Hormone receptor positive (HR+): are cells that have a group of proteins that bind to a specific hormone. For example, some breast cancer cells have receptors for the hormones estrogen or progesterone. These cells are hormone receptor positive, and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Knowing if the cancer is hormone receptor positive may help plan treatment. Human epidermal growth factor receptor 2 negative (HER2-): cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface. Checking to see if a cancer is HER2 negative may help plan treatment. have started treatment in the period between January 2017 and December 2021. The study will describe the treatment effect for different patient groups in terms of age and comorbidities. Comorbidity is the condition of having two or more diseases at the same time. The data is collected by the Danish Breast Cancer Group in the period between 2017 to 2023.

- EligibilityCriteria: Inclusion Criteria: Patients with breast cancer (ICD-10: C50) A diagnosis of HR+/HER2- locally advanced or metastatic breast cancer Endocrine sensitive, endocrine resistant, or de novo mBC patient Inclusion date: Date of relapse/stage IV disease/progression leading to initiation of palbociclib+AI Exclusion Criteria: There are no exclusion criteria for this study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The full dataset consists of endocrine sensitive, endocrine resistant and de novo HR+/HER2- mBC patients treated with palbociclib as first-line treatment (01 January 2017- 31 December 2021). Patients will be censored for OS and PFS by 31 December 2023. - SamplingMethod: Non-Probability Sample

NCT06307444

Not yet recruiting

Ultrasound-Guided Erectro Spinae Plane Block Versus Stellate Ganglion Block for Patients With Upper Limb Acute Herpes Zoster Pain.

Herpes zoster (HZ) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.

- EligibilityCriteria: Inclusion Criteria: patients over the age of 21 with upper limb herpetic eruption lasting shorter than a week along with moderate to severe pain who got adequate antiviral medications Exclusion Criteria: We will exclude patients who refuse to participate, those who are taking anticoagulant medications, have secondary bacterial infections of the dermatome, those who have an allergy to local anesthetics or serious disease of the heart ( e.g. heart block), lung, kidneys and those who had a history of neck surgery, such as thyroid cancer. - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult

NCT06307431

Not yet recruiting

A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)

The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.

- EligibilityCriteria: Inclusion Criteria: Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell or papillary histology. Has intermediate-high-risk, high-risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading: Intermediate-high-risk RCC: pT2 Gr4, N0, M0; pT3 Gr3/4, N0, M0 High-risk RCC: pT4, N0, M0; pT any stage, N1, M0 M1 NED RCC participants who present not only with the primary kidney tumor, but also solid, isolated, soft tissue metastases that can be completely resected at 1 of the following: the time of nephrectomy (synchronous), or ≤2 years from nephrectomy (metachronous) Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants. Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization and recovered from surgery and any post-operative complications before randomization. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization. Exclusion Criteria: Has had a major surgery other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization. Has residual thrombus post nephrectomy in the vena renalis or vena cava. Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. Received prior treatment with a cancer vaccine. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Has a history of brain or bone metastatic lesions. Has severe hypersensitivity to study medication or any of the substances used to prepare the study medication. Has an active autoimmune disease that has required systemic treatment in the past 2 years. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. Has an active infection requiring systemic therapy. History of allogeneic tissue/solid organ transplant. Has not adequately recovered from major surgery or has ongoing surgical complications. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06307418

Not yet recruiting

Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport

The aim of this randomized controlled trial is to investigate the effects of internet-based support (Carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer. The main question[s] it aims to answer are: What are the effects of internet-based support on informal caregivers preparedness for caregiving? What are the effects of internet-based support on informal caregivers burden and wellbeing? Informal caregivers who are randomized to Carer eSupport will have access to Carer eSupport for 18 weeks and they will be asked to complete questionnaires (outcome measures) at: baseline (before randomization) 18 weeks (post-intervention) and at 3 months after the intervention is completed (long term follow-up). Informal caregivers in the intervention group will be compared to informal caregivers who receive standard care support regarding preparedness for caregiving, caregiver burden and wellbeing.

- EligibilityCriteria: Inclusion Criteria: Informal caregivers who have been identified as an informal caregiver by a patient who have consented to that the informal caregivers is approached. Informal caregivers of patients with head and neck cancer who are about to start radiotherapy or have undergone at most five radiotherapy treatment session. Radiotherapy may be combined with surgery and/or medical oncological treatment. Exclusion Criteria: Informal caregivers who do not understand and read Swedish or suffer from cognitive impairment, and informal caregivers with who need support or treatment that cannot be provided by Carer eSupport. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06307405

Not yet recruiting

The Value of mNGS in Diagnosis of Pulmonary Infection

Retrospective analysis of clinical data from 50 hospital-admitted patients with suspected pulmonary infection (as judged by clinical manifestations and imaging findings) was performed on study participants who had collected two different samples of alveolar lavage fluid (BALF) and sputum and underwent metagenomic next generation sequencing (mNGS) and routine pathogen detection, respectively. The positive rate of pathogen detection and the consistency of pathogen detection results of the two detection methods were compared to evaluate the clinical manifestation and role of mNGS in pathogen diagnosis.

- EligibilityCriteria: Inclusion Criteria: Inclusion criteria: Patients meeting diagnostic criteria for pulmonary infection between January 1, 2020 and October 31, 2023. Patients with pulmonary infection were diagnosed with new or worsening focal or diffuse infiltrating lesions on chest CT accompanied by at least one of the following four pneumonic-related clinical manifestations: (1) Recent cough, sputum, or aggravation of existing respiratory symptoms with or without purulent sputum, chest pain, dyspnea, and hemoptysis; ② Heat, T≥38℃; ③ Signs of lung consolidation and/or smell and moist rales; ④ Peripheral blood white blood cell count > 10*109/L or < 4*109/L. Exclusion criteria: ① The patient did not undergo bronchoscopy; Absence of clinical or laboratory data. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients whose symptoms, signs, imaging, and infection indicators met the diagnostic criteria for pulmonary infection while routine etiological detection of sputum and pulmonary alveolar lavage fluid mNGS were performed. - SamplingMethod: Probability Sample

NCT06307392

Not yet recruiting

Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial)

Emergency intubation is routinely performed in the prehospital setting. Airway management in the prehospital setting has substantial challenges, such as hostile environment or lack of technical support in case of first attempt intubation failure, and inherent risk of complications, such as hypoxemia, aspiration or oesophageal intubation. This risk is higher when several attempts are needed to succeed endotracheal intubation. Thus, a successful first attempt intubation is highly desirable to avoid adverse intubation-related events. Noteworthy, prehospital emergency intubation is associated with a lower rate of first attempt intubation success when compared to emergency intubation in the emergency department (ED). Research is needed to overcome the specific challenges of airway management in the prehospital setting, and to improve the safety and efficiency of prehospital emergency intubation. Literature reports that the use of assistive devices such as bougie may increase the rate of first-attempt intubation success in the ED. To date, no randomized trial has ever studied this device in the prehospital setting. Thus, the aim of the BETA trial is to compare first attempt intubation success facilitated by the bougie versus the endotracheal tube alone in the prehospital setting.

- EligibilityCriteria: Inclusion Criteria: Managed by a physician staffed mobile intensive care unit (MICU). With an indication of emergency prehospital endotracheal intubation. Exclusion Criteria: Pregnant women Patients with a "not to be resuscitated" indication. Patients with predictors of difficult intubation (that can be collected in the prehospital setting, including previous history of face, neck, throat surgery or pathology, limited mandibular protrusion, cervical spine trauma, facial trauma, ear-nose-throat malignancy, head or neck burns, history of previous difficult airways) for whom the use of a bougie is indicated on first intubation attempt. Patients under guardianship, trusteeship or safeguard of justice and patients with no health insurance. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06307379

Recruiting

Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures

'Patient-reported outcomes' (PROMS) and 'patient-reported experiences' (PREMS) are increasingly important parameters in evaluating and adjusting clinical procedures and strategies in healthcare. Validated disease-specific PROMS related to bronchoscopic procedures are not available and examples in the medical literature are very scarce.

- EligibilityCriteria: Inclusion Criteria: Age above 18 years Patient referred for diagnostic flexible bronchoscopy Procedure performed in outpatient setting Exclusion Criteria: Patient unable to adequately respond to the contents of the patient questionnaire. Procedure performed in hospitalised setting Patient with active pregnancy - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Out-of-hospital care - SamplingMethod: Non-Probability Sample

NCT06307366

Not yet recruiting

Perceptions and Experiences of (Family Members of) People With Mental Illness About the Chance for Mental Illness in (Future) Children, and Needs for Care and Research

Despite consistent evidence that mental illness runs in families, intergenerational transmission of risk of mental illness is rarely considered in clinical practice. Neither preventive programs for children of parents with mental illness are usually implemented in care, nor supportive programs for parenting. Furthermore, parents with mental illness are not always aware of how their disorder may impact the well-being of their children. To date, the needs for counseling, care and research in parents with mental illness and family members of people with mental illness are unclear. Therefore, this prospective qualitative interview study aims to gain insights into the perceptions and experiences of (future) parents with mental illness, partners and family members of people with mental illness about risk for and resilience against mental illness in (future) children, as well as their needs for counseling, care and research.

- EligibilityCriteria: Inclusion Criteria: Having (a partner or relative with) a diagnosis of a mental illness in the mood-psychosis spectrum, i.e., psychotic disorder, bipolar disorder, or severe depression At least 18 years old Exclusion Criteria: Insufficient proficiency of the Dutch language No demonstration of adequate understanding of the purpose, procedures, risks, benefits, emergency contacts, and payment issues (in accordance with criteria to assess capacities to consent from Appelbaum & Grisso, 1988). Unable to give consent to all aspects of the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The following participants will be included: (Future) parents with (a partner with) mental illness in the mood-psychosis spectrum (psychotic disorder, bipolar disorder, severe depression); ≥ 18 years old. If including (future) parents with mental illness and their partners will turn out to be difficult given our timeframe, we will mitigate this by additionally including family members of people with mental illness, e.g. siblings or grandparents. - SamplingMethod: Non-Probability Sample

NCT06307353

Not yet recruiting

Trends of Contraception Methods in Urban Medical Center in el_Balyana

family planning is avital primary Health care intervention that saves lives of mothers and infants empowers women and support their choices regarding their health public life and additional education .In addition family planning is considered as a short term intervention to limit population growth and manage overpopulation problems.Globally the contraception prevalance rate an indicator for family planning programs continue to face challenges in developing countries.

- EligibilityCriteria: Inclusion Criteria: - currently married woman in the child bearing period (15_49) years old attending El_Balyana urban medical Center Exclusion Criteria: women who are divorced or widowed or beyond age of fertility will be excluded - - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 15 Years - MaximumAge: 49 Years - StdAgeList: Child, Adult - StudyPopulation: currently married woman in the child bearing period (15_49) years old attending El_Balyana urban medical Center Exclusion Criteria: women who are divorced or widowed or beyond age of fertility will be excluded - - SamplingMethod: Probability Sample

NCT06307340

Not yet recruiting

Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors.

- EligibilityCriteria: Inclusion Criteria: must be 18 years or older, be a patient at the START clinic receiving methadone for treatment of opioid use disorder, self-report 10+ days of co-use of cocaine and illicit opioids in the past 30-days, meet the criteria for stimulant use disorder (cocaine type; mild, moderate or severe) and a score of 3≥ on the PC-PTSD-5. Exclusion Criteria: cognitive impairment that would interfere with their ability to understand study participation as assessed by the researcher, does not speak/understand English at a conversational level, plans to leave the START clinic in the next 60 days, patients who missed methadone doses (inactive) for 30 days or more, or having received clinical care from the interventionist(s) in the past 30 days - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06307327

Recruiting

Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis

Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. To solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) Scattered erosion type; (3) Fusion erosion type; (4) Ulcer type. We intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples.

- EligibilityCriteria: Inclusion Criteria: Voluntarily sign informed consent; Age 18 or older on the date of signing the informed consent; Histologically confirmed head and neck tumor, radiotherapy or chemoradiotherapy. Exclusion Criteria: They also have other uncontrolled serious medical conditions, such as unstable heart disease requiring treatment, poorly controlled diabetes (fasting blood glucose > 1.5× the upper limit of normal), mental illness, and a history of severe allergies - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The subjects in this study were head and neck tumor patients receiving radiotherapy - SamplingMethod: Probability Sample

NCT06307314

Recruiting

Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis

Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients.

- EligibilityCriteria: Inclusion Criteria: Over 18 years of age. Voluntarily sign informed consent. The pathological diagnosis was nasopharyngeal carcinoma, head and neck tumor. Need to be treated with radiotherapy. ECOG PS Score: 0/1. Exclusion Criteria: There are contraindications to radiotherapy. Combined with other tumors. Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), and mental illness. At the investigator's discretion, those who was not considered to be suitable for participation in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with nasopharyngeal carcinoma and head and neck tumors requiring radiotherapy. - SamplingMethod: Probability Sample

NCT06307275

Recruiting

Intermittent Fasting on Body Fat and Quality of Life

The purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life.

- EligibilityCriteria: Inclusion Criteria: • In good health Exclusion Criteria: • Diabetes or Metabolic Syndrome - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06307262

Recruiting

European Registry of Transcatheter Repair for Tricuspid Regurgitation

To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.

- EligibilityCriteria: Inclusion Criteria: Patients treated with one of the following transcatheter devices for TV repair or replacement (e.g. PASCAL, TriClip, TricValve, Evoque, LuX-Valve) Exclusion Criteria: Age < 18 years - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients treated with one of the following transcatheter devices for TV repair or replacement (e.g. PASCAL, TriClip, TricValve, Evoque, LuX-Valve) - SamplingMethod: Non-Probability Sample

NCT06307249

Recruiting

Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA

Solid tumors pose significant challenges in current therapeutic approaches. Targeted therapy has emerged as a promising avenue, aiming to enhance treatment efficacy while minimizing adverse effects. This clinical trial focuses on an innovative combination of two targeted inhibitors, Palbociclib and Bevacizumab, for their potential synergistic effects in addressing these challenging malignancies. Moreover, this study incorporates a molecular approach by considering Long Non-Coding RNAs (LncRNAs) as biomarkers. Initiating with a focus on colorectal cancer, the study aims to expand its scope to other solid tumors, including lung, breast, ovarian and other cancers. Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, disrupts the cell cycle progression, particularly in cancer cells with specific molecular characteristics. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, targets angiogenesis-a critical process for tumor growth and metastasis. The rationale behind combining these agents lies in their complementary mechanisms of action, potentially leading to enhanced antitumor effects. LncRNAs have shown promise in predicting treatment response and prognosis in various cancers, providing an additional layer of precision to the treatment strategy. By elucidating the molecular basis through LncRNA analysis, the trial aims to tailor the treatment to the specific molecular profile of each patient, ultimately striving for better outcomes and improved survival rates. This novel combination therapy, coupled with a personalized biomarker-driven approach, represents a cutting-edge strategy in the pursuit of more effective and individualized treatment for solid tumors.

- EligibilityCriteria: Inclusion Criteria: Individuals of white ethnicity. Age between > 18 Both males and females. Diagnosis of selected cancer type (e.g., colorectal cancer, lung cancer, genitourinary cancers, breast cancer). Cancer stage III/ IV with or without metastasis or lymph node dissemination at the time of enrollment. Unrelated patients. Exclusion Criteria: History of hematological cancer types or previous cancers, recurrent or relapse. Diagnosis of inflammatory bowel diseases. Pre-existing cardiovascular diseases or coronary artery diseases. Confirmed treated or untreated autoimmune diseases. Metabolic disorders, diabetes, or hypertension. Neurological diseases. Evidence of cardiac, renal, bone, or cerebral damage. Presence of more than one type of malignancies. Active infections or myositis. Familial polyposis. Alcohol or smoking habits. Body mass index (BMI) >30. Significant weight loss within the last 2 years. History of surgeries. Pregnancy. Related patients. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06307197

Recruiting

HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia

HAAL project aims to test several technological devices in order to improve the quality of life of older people with dementia and their informal and formal caregiver.

- EligibilityCriteria: Inclusion Criteria: being the caregiver of a person with cognitive impairment or dementia; availability of time to participate; visit the assisted person at least two times at week or live with him/her. Exclusion Criteria: Lack of written informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult

NCT06307184

Recruiting

Assessing the Convenience of Natural Proliferative Phase Frozen Embryo Transfer

This study will assess the convenience of the natural proliferative phase frozen embryo transfer (NPP-FET) in terms of number of number of appointments needed before cycle scheduling.

- EligibilityCriteria: Inclusion Criteria: Endometrial thickness ≥ 7 mm on the day of starting progesterone-based luteal phase support (LPS) Serum progesterone levels <1.5 ng/ml on the day of starting progesterone-based LPS LPS with micronized progesterone 400mg b.i.d. Regular cycles (>24 days, ≤ 38 days) IVF/ICSI with donated oocytes Single blastocyst stage embryo transfer First or second embryo transfer from the same cohort Exclusion Criteria: Use of exogenous ovarian stimulation during FET Untreated hydrosalpinx, polyp, submucous myomas or severe adenomyosis Recurrent pregnancy loss (≥ 3 previous pregnancy losses) Recurrent implantation failure with embryos from oocyte donation (≥ 3 previous failed embryo transfers) Personalized initiation of exogenous progesterone according to a previous endometrial receptivity assay test - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 49 Years - StdAgeList: Adult - StudyPopulation: The study group will include a prospectively recruited cohort of ovulatory patients undergoing their first or second FET attempt following oocyte donation in a natural proliferative phase protocol. The control group will include a retrospective cohort of ovulatory patients undergoing a natural cycle frozen embryo transfer following oocyte donation. - SamplingMethod: Probability Sample

NCT06307171

Recruiting

Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers

This is an exploratory experimental multicentre study on archived serum samples and on prospectively collected serum samples and blood samples. General objectives of the study are: to identify specific biomarkers in order to develop more accurate serological tests for the screening of Leishmania infections that does not present cross-reaction with other infectious diseases; to unveil the Antigen Recognition Patterns (ARPs) of Leishmania infection in humans; to verify whether the ARPs and the new biomarkers are common to different Leishmania infantum strains isolated in Italy as well as in other part of the World and to different strains of L. donovani isolated in Sudan as well as in other part of the World and discard any possible cross reaction with other infectious diseases such as Chagas, TB, leprosy or malaria.

- EligibilityCriteria: CASES: Inclusion criteria: Leishmania positive patient from Italy (n=30) and from Sudan (n=30); patient with a clinically or laboratory confirmed diagnosis of leishmaniasis; signed informed consent (criteria not applied in case of samples stored at the Tropica Biobank at the DITM) being clinically classified as leishmaniasis patient by an experienced clinician or being laboratory confirmed as leishmaniasis patients, giving positive to at least two different serological tests or to a molecular test for Leishmania sp. adult subjects (equal or older than 18 years) Exclusion criteria: lack of the necessary data and/or of biological samples subjects younger than 18 years COMMUNITY CONTROLS: Inclusion criteria: Cryo-preserved serum samples stored at the Tropica Biobank at the DITM , IRCCS Sacro Cuore Don Calabria Hospital, Negrar (Vr), from subject from Italy (n=30) and from Africa (n=30) with no infection due by Leishmania spp. signed informed consent to Tropica Biobank adult subjects (equal or older than 18 years) being negative to two different serological tests for leishmaniasis Exclusion criteria: subjects younger than 18 years being positive to one serological tests for leishmaniasis. VALIDATION CONTROLS (VC): Inclusion criteria: serum samples stored in Tropica Biobank at the DITM from subjects that have been clinically diagnosed with Chagas's disease, or TB, or malaria or leprosy. informed consent signed to Tropical Biobank adult subjects (equal or older than 18 years) being negative to two different serological tests for leishmaniasis. being clinically diagnosed with Chagas disease or TB, or malaria or leprosy Exclusion criteria: younger than 18 years positive result to one serological test for leishmaniasis. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06307080

Recruiting

Clinical Study of Multi-mode Thermal Ablation for the Treatment of Pancreatic Cancer With Liver Metastasis

Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies. Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy. Transformation and clinical application of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.

- EligibilityCriteria: Inclusion Criteria: age 18-70 years old, gender is not limited; Newly diagnosed pancreatic cancer with liver metastasis confirmed by pathology or consistent with clinical diagnosis, and no metastases to organs other than the liver; Imaging evaluable tumors with safe access to puncture; The number of half liver tumors ≤3 and the size of each tumor ≤3 cm; ECOG PS score ≤2 points, expected survival > 3 months. Exclusion Criteria: Liver function Child-Pugh grade C, severe jaundice, especially obstructive jaundice; The liver is significantly atrophy, the tumor is too large, and the ablation range needs to reach one-third of the liver volume; Expected survival < 3 months; serious heart, lung, liver and kidney dysfunction and coagulation dysfunction; Uncontrolled co-morbidities, including poorly controlled hypertension or diabetes, persistent active infections, or mental illness or social conditions that may affect participants' compliance with the study; refractory ascites, pleural fluid or bad fluid; Pregnancy or breastfeeding; The researcher considers that there are any other factors that are not suitable for inclusion or affect the participant's participation in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06307067

Not yet recruiting

Improving Care for Uncomplicated URinary Tract Infection-associated Symptoms in Primary Healthcare Settings in INDOnesia

In the present study, we aim to analyze the impact of the introduction of a urinary dipstick test for patients presenting with uncomplicated UTI-associated symptoms on antibiotic prescription in primary health care in Indonesia. In addition, the knowledge of HCW regarding antibiotics and prudent use of antibiotics in the community setting will be investigated. Specific aims of the study: To analyze the quality of antibiotic prescriptions for uncomplicated UTI in the primary health care settings in Indonesia, before introduction of urinary dipstick testing compared to after introduction of urinary dipstick testing. To analyze the knowledge level of healthcare workers on uncomplicated UTI and prudent antibiotic use in primary health care settings in Indonesia.

- EligibilityCriteria: Inclusion Criteria: All adult patients with uncomplicated urinary tract infection Exclusion Criteria: patients who have recurrent episodes of uncomplicated UTI, pregnant women, and patients with recent antibiotic use (any antibiotic use within 3 months before visit) - HealthyVolunteers: No - Gender: All - GenderBased: Yes - GenderDescription: Female and male patients will be included, but women suffer more from uncomplicated UTI. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients that come to a public health center with symptoms of an uncomplicated urinary tract infection - SamplingMethod: Non-Probability Sample

NCT06307054

Recruiting

CLL-1 CAR-NK Cells for Relapsed/Refractory AML

This study is a single-arm, open-label, dose-escalation clinical trial aimed at exploring the safety, tolerability, and pharmacokinetic characteristics of the CLL-1 CAR NK cells, as well as providing preliminary observations on its efficacy in subjects with relapsed/refractory acute myeloid leukemia.

- EligibilityCriteria: Inclusion Criteria: Age 18-70 years, gender unrestricted; Expected survival time exceeds 12 weeks; ECOG score 0-2; Meets the 2022 WHO criteria for acute myeloid leukemia and flow cytometry shows ≥70% expression of CLL1 in leukemia cells; or immunohistochemistry shows CLL1 expression ≥50% and meets the following criteria for relapse and refractory: Relapse criteria: Bone marrow shows primitive cells ≥5% after hematological remission (excluding post-chemotherapy hematopoietic recovery); or at least two peripheral blood samples taken at least one week apart show primitive cells; or extramedullary lesions are present. Early relapse (relapse within 12 months after initial remission) patients can be directly included, while late relapse (relapse after 12 months of initial remission) patients must have undergone salvage chemotherapy according to standard protocols without achieving complete remission. Salvage treatment for all relapsed patients should include at least one course of targeted therapy without achieving remission. Patients who relapse after allogeneic hematopoietic stem cell transplantation, have no other effective treatment options, and have no active grade 2 or higher acute GVHD. Refractory criteria: No complete remission after two courses of standard intensive chemotherapy based on the 3+7 regimen, and no complete remission after second-line salvage chemotherapy or treatment including targeted therapy; or no complete remission after one course of purine analog induction chemotherapy (such as FLAG-Ida, CLIA, or similar regimens), and no complete remission after salvage treatment or treatment including targeted therapy; or no complete remission after three cycles of low-intensity treatment based on HMA, including low-intensity regimens containing venetoclax; relapse within 12 months after remission (early relapse); patients for whom the original induction is ineffective after relapse. Able to establish the required venous access for collection, and no contraindications for leukapheresis; Liver and kidney function, cardiac and pulmonary function meet the following requirements: Creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 mL/min or creatinine ≤ 2.5×ULN; Ejection fraction >50%, no clinically significant electrocardiogram changes; baseline blood oxygen saturation >92%; total bilirubin ≤ 3×ULN; ALT and AST ≤ 3×ULN; Able to understand and sign the informed consent form. Exclusion Criteria: Any of the following conditions disqualify a subject from participation in the trial: Confirmed AML with PML-RARA fusion gene; History of malignancies other than acute myeloid leukemia within 5 years before screening, except adequately treated carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin, or prostate cancer after radical surgery, or thyroid cancer after radical surgery; Uncontrolled active bacterial, viral, or fungal infections requiring treatment; HBsAg or HBcAb positive, with peripheral blood HBV DNA ≥ lower limit of detection; HCV RNA positive in the presence of hepatitis C virus antibodies; positive TRUST test for syphilis; HIV antibody positive; Significant organ (cardiovascular, pulmonary) dysfunction; active gastrointestinal bleeding within the past 3 months; uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy; significant history or evidence of major cardiovascular risk, including congestive heart failure, unstable angina, clinically significant arrhythmias (such as ventricular fibrillation, ventricular tachycardia, etc.); history of arterial thrombosis within the past 3 months (such as stroke, transient ischemic attack); symptomatic deep vein thrombosis within the past 6 months, history of pulmonary embolism, or history of coronary angioplasty, defibrillation, or any clinical significant complications or diseases that may pose a risk to the subject's safety or interfere with the study evaluation, procedures, or completion; Any uncontrolled active disease that hinders participation in the trial; Active, uncontrolled central nervous system involvement, or a history of central nervous system disease requiring treatment (such as epilepsy); Subjects receiving systemic corticosteroid therapy before screening and deemed by the investigator to require long-term systemic corticosteroid therapy during the study period (excluding inhalation or local use); and subjects who have received systemic corticosteroid therapy within 72 hours before cell infusion (excluding inhalation or local use); Subjects who have used PD-1 or PD-L1 monoclonal antibodies within 3 months before enrollment Pregnant or lactating women; and subjects planning to become pregnant within 1 year after infusion, during or after the treatment period; Uncontrolled active infections (excluding simple urinary tract infections or upper respiratory tract infections); Subjects who have received CAR-T therapy or other gene-modified cell therapy in the past; Patients after allogeneic transplantation, with no significant acute or chronic GVHD, and have discontinued immunosuppressive drugs for at least 1 month; Known allergy to any component of anti-CLL-1 CAR-NK cell infusion or chemotherapy regimen (cyclophosphamide and fludarabine); Any situation deemed by the investigator to compromise the safety of the subject or interfere with the purpose of the study, or deemed unsuitable for participation by the investigator; Afflicted with a condition that affects the ability to sign the informed consent form in writing or to comply with the study procedures; unwilling or unable to comply with the study requirements. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06307028

Recruiting

Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P)

In this project, the investigators will provide a new HIV prevention training and empowerment sessions to Black women in Washington D.C. who are at high risk for getting HIV. This training is tailored to the experience of Black women and seeks to reduce the high HIV transmission rates in the Black community.

- EligibilityCriteria: Inclusion Criteria: Black women are eligible if you: Have sex with men Are age 18+ Live in Washington D.C. Are not HIV+ Exclusion Criteria: HIV+ - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Black women are eligible for this study. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06307015

Not yet recruiting

De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE)

The goal of this prospective clinical trial is to determine if HPV-associated oropharyngeal squamous cell carcinoma that is non-hypoxic on FMISO PET can be successfully treated with a lower dose of radiation therapy. The main questions it aims to answer are: What is the pathologic complete response rate in patients selected for radiation dose de-escalation and neck dissection? What is the correlation between MRI and FMISO PET assessment of hypoxia before and during RT? What are the acute and late toxicities in patients selected for radiation dose de-escalation? What are the quality of life scores in patients selected for radiation dose de-escalation? What are the local, regional and distant failure rates of patients selected for radiation dose de-escalation? Patients with cT1-2N1-2b (AJCC 7th edition) oropharyngeal tumours will undergo surgical resection of the primary tumour. Following this, they will be allocated to standard radiation therapy (70Gy with concurrent cisplatin chemotherapy) or de-escalation radiation therapy (30Gy with concurrent cisplatin chemotherapy) based on the results of FMISO PET. Patients with non-hypoxic tumours at baseline OR after two weeks of radiation therapy will be allocated to the de-escalated group. 3-4 months after completion of radiation therapy, all patients in the de-escalated group will undergo mandatory neck dissection to assess pathologic response. Researchers will assess the pathologic response rate after surgery in the de-escalation group. They will also compare the outcomes (oncological outcomes and quality of life) between the group receiving the standard treatment (70Gy) and the group receiving de-escalated radiation therapy (30Gy).

- EligibilityCriteria: Inclusion Criteria: Age > 18 years Histologically confirmed cT1-2N1-2b oropharyngeal squamous cell carcinoma or cTxN1-2 carcinoma of unknown primary p16 positive (70% nuclear and cytoplasmic staining) and HPV positive (genotyping via PCR) tumours of the tonsil, base of tongue, glossotonsillar sulcus, or unknown primary site (suspected mucosal origin). No contraindications to radiotherapy, platinum-based chemotherapy or surgery No contraindications to PET/CT or MRI Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (KPS > 70%) Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: Women lactating, pregnant or of childbearing potential who are not willing to avoid pregnancy during the study Patients with a history of severe renal disease(s) (eGFR <20) than cannot tolerate gadolinium chelate contrast agents.) ECOG ≥ 3 Previous high dose radiation therapy to the head or neck Patients unwilling or unable to have PET/CT or MRI Geographically remote patients unable to agree to imaging schedule Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study. Patients with significant cardiac or pulmonary disease including cardiac arrythmias or Chronic Obstructive Pulmonary Disease (COPD) that are unable to tolerate high flow O2 for oxygen contrast. Patients taking carbonic anhydrase inhibitors (acetazolamide) History of glaucoma Any implant, foreign body, 3T MRI incompatible device, or other contraindication to MRI imaging - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06307002

Not yet recruiting

Evaluating What's My Method? in Barbados

The purpose of this study is to measure the impact of the What's My Method game on participants' sense of agency, education, and empowerment around contraceptive decision-making. Patients receiving standard of care contraceptive counseling will be compared to those who play the game in addition to counseling.

- EligibilityCriteria: Inclusion Criteria: - English-speaking Capable of using a tablet Childbearing individuals Individuals/Couples seeking family planning counseling (one response collected per couple) Exclusion Criteria: Unable to provide informed consent due to intellectual or physical impairment - Under the age of 18 unless accompanied by a parent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Persons who can become pregnant - MinimumAge: 18 Years - MaximumAge: 48 Years - StdAgeList: Adult

NCT06306989

Recruiting

Observational Clinical Study of Letermovir for Preventing CMV Infection After Allo-HSCT

The goal of this observational study is to get a series of clinical data related to the prevention of CMV infection after allo-HSCT with letemovir. The main question it aims to answer are: Efficacy and safety of letemovir for the prevention of CMV infection after allo-HSCT. Optimal initiation of letemovir to prevent CMV infection. Participants will be categorized into high-risk and intermediate-risk groups based on risk factors for CMV infection.Initiate letemovir prophylaxis on day +1 in high-risk patients and on days +7 to +14 in non-high-risk patients.(240 mg, qd in patients with concomitant cyclosporine; 480 mg, qd in patients with concomitant tacrolimus) to +100 days. For patients with comorbid GVHD who require intensive immunosuppression, consider extending the regimen to +200 days.Treatments they will be given and use bullets.

- EligibilityCriteria: Inclusion Criteria: Biological age not less than 14 years. Positive CMV serology. No detectable CMV-DNA from plasma samples taken 5 days prior to randomization into groups. Exclusion Criteria: severe hepatic impairment; estimated creatinine clearance of less than 10 ml/min; current or recent recipients of antiviral medications with anti-CMV activity; and any other factor that affects the impact of obtaining data. - HealthyVolunteers: No - Gender: All - MinimumAge: 14 Years - MaximumAge: 100 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients who underwent hematopoietic stem cell transplantation at the Department of Hematology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China - SamplingMethod: Non-Probability Sample

NCT06306963

Not yet recruiting

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in GAVE

The researchers are trying to find out more about Gastric Antral Vascular Ectasia (GAVE). This is a condition that affects the blood vessels in the stomach, leading to their enlargement and possible bleeding. It can also cause symptoms such as abdominal pain and nausea. By participating in this study, you will help us learn how often these symptoms occur and how they relate to stomach functioning.

- EligibilityCriteria: Inclusion Criteria: Patients >18 years of age with endoscopic evidence of Gastric Antral Vascular Ectasia. Willingness to participate in the study Capacity to provide informed consent. No evidence of organic, systemic, or metabolic disease (e.g. diabetes mellitus) to explain the symptoms on routine investigations Exclusion Criteria: Patients with active bleeding. Patients with severe decompensated liver disease. Patients with chronic kidney disease. Presence of other diseases (structural or metabolic) which could interfere with interpretation of the study results. Pregnant or lactating women due to radiation exposure. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who have undergone an endoscopy and found to have GAVE will be included. Patients with underlying cirrhosis and GAVE in comparison to control patients with cirrhosis and no GAVE. - SamplingMethod: Probability Sample

NCT06306924

Not yet recruiting

UNC Metastatic Cancer Radiation Therapy Registry

The purpose of this registry is to collect clinical data from participants attending UNC Hospitals who present with metastatic cancer and are evaluated to receive radiation therapy as part of their standard of care treatment. The goal of this study is to provide a foundation for studies designed to identify projects across the translational continuum related to metastatic cancer and radiation therapy treatment. The relevant clinical data will be linked to patient-reported outcomes (PROs) thus allowing for a unique and robust dataset. Ultimately, this registry will provide current and future studies with the ability to analyze the correlation of radiation therapy regimens with metastatic cancer outcomes.

- EligibilityCriteria: Inclusion Criteria: 1. Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. Ability to understand and willingness to sign informed consent 3. Has been diagnosed with or is suspected to have metastatic cancer. 4. Age ≥ 18 years at the time of consent. 5. Evaluated to receive radiation therapy as part of their standard of care treatment plan. Exclusion Criteria: All participants must not meet any of the following exclusion criteria prior to enrollment to participate in this study: 1. Any serious medical or psychiatric disorder that would interfere with the participant's ability to give informed consent. - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects with metastatic cancer receiving palliative radiation therapy at the University of North Carolina Chapel Hill. - SamplingMethod: Non-Probability Sample

NCT06306911

Recruiting

Bioavailability of Aronia Melanocarpa

The main objective of this study is to study the bioavailability and kinetics of acute Aronia Melanocarpa supplementation in healthy young (18-35 years) and older adults (55-75 years) adults. During the test day, participants will ingest a drink consisting of Aronia Melanocarpa extract (AME). The bioavailability and kinetics of AME will be assessed via frequent blood sampling, urine collection, and faecal sampling, in which AME and metabolite profiles will be quantified.

- EligibilityCriteria: Inclusion Criteria: BMI between 18-35 kg/m2 Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg Stable body weight (weight gain or loss < 3 kg in the past three months) Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study Exclusion Criteria: Smoking or smoking cessation < 12 months Severe medical conditions, including asthma, kidney failure, auto-inflammatory diseases, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, gastrointestinal disorders such as Crohn's disease, colitis Use of dietary supplements or medication affecting the main outcomes of the study (e.g. affecting gut metabolism, blood pressure medication) Use of an investigational product within another biomedical intervention trial within the previous month Abuse of drugs More than 3 alcoholic consumptions per day Known pregnancy or lactation Known allergy to study product Difficult venepuncture - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06306898

Not yet recruiting

Intra-Arrest-Ventilation in Human Cadavers

The study investigates the influence of non-synchronized, intermittent positive pressure ventilation (IPPV), as recommended in the current resuscitation guidelines of the European Resuscitation Concil (tidal Volume (Vt) = 5-6 mL/kg body weight, respiratory rate = 10 min-1) and Chest Compression Synchronized Ventilation (pInsp = 40 mbar; respiratory rate = chest compression rate) with regard to achieving a sufficient tidal volume and the tightness of various supraglottic airway devices (laryngeal mask, i-Gel-laryngeal mask, laryngeal tube) and endotracheal intubation.

- EligibilityCriteria: Inclusion Criteria: > 17 Years of Age Exclusion Criteria: Adult respiratory distress syndrome (ARDS) Severe lung or thoracic injuries pneumothorax Abnormal airways Tracheostoma severe aspirations - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult

NCT06306885

Not yet recruiting

Effects of Early Sleep After Action Observation and Motor Imagery After Metacarpal Fracture Surgery

The study aimed to investigate the effects of early sleep after action observation and motor imagery (AOMI) training sessions on manual dexterity in patients with hand immobilization after surgical fixation for metacarpals and phalanges fractures. Fifty-one patients with hand immobilization for surgical fixation of IV or V metacarpals or first phalanges fractures will be randomized into AOMI-sleep (n=17), AOMI-control (n=17), and Control (n=17) group. AOMI-sleep and AOMI-control groups will perform an AOMI-training before sleeping or in the morning respectively, while Control group will be asked to observe landscape video-clips. Participants will be assessed for manual dexterity, hand range of motion, hand disability and quality of life at baseline before and after the training and at 1 month after the training end.

- EligibilityCriteria: Inclusion Criteria: Surgical fixation for IV or V MTC or P1 fracture at the level of the right hand Age 18-40 years old Right-hand dominance Exclusion Criteria: Damage to additional hand structure requiring surgery (e.g. tendons, ligaments and nerves) Occurrence of left upper limb injuries Post-surgical complications (e.g. CPRS) Immobilization <12 or >30 days Diagnosis of neurological/musculoskeletal conditions Sports or activities requiring advanced manual skills or sleep deprivation History of psychiatric disorders Sleep disorders (e.g. insomnia, OSAS, REN or Non-REM behavioural disorders) Medication affecting the physiological sleep pattern - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06306872

Recruiting

A Clinical Trial to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules

The main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose

- EligibilityCriteria: Inclusion Criteria: Healthy subjects aged between 18 and 45 years (including 18 and 45 years) at the time of screening; Male ≥50 kg, female ≥45kg, body mass index (BMI) between 19 and 28 (including 19 and 28), BMI= weight (kg)/height (m) 2; Physical examination, laboratory examination and other relevant examination results before the first medication are normal or abnormal but meet the following requirements, or other abnormal results but not clinically significant determined by the investigator: 35.9℃≤ ear temperature ≤37.5℃; pulse rate ≥55 times/min and ≤100 times/min; Systolic blood pressure ≥90 mmHg and < 140 mmHg, diastolic blood pressure ≥60mmHg and < 90 mmHg; Total bilirubin (TBIL) ≤1.5×ULN; Fertile male or female subjects must consent to the use of an effective contraceptive method during the study period and for 6 months after the last dose of the investigational drug is administered (And male subjects do not donate sperm during this period, and female subjects do not donate eggs during this period; Female subjects must be non-pregnant and non-lactating female subjects, defined as women in a state of pregnancy from conception to termination of pregnancy, as determined by laboratory human chorionic gonadotropin (hCG) test within 7 days before the start of the study; Voluntarily participate in this clinical trial, understand the study procedure and sign the informed consent before screening; Good compliance, willing to follow study procedures. Exclusion Criteria: Patients with medical history or existing diseases of motor system, neuropsychiatric system, endocrine system, blood circulatory system, respiratory system, digestive system, urinary system, reproductive system, and other abnormalities, and those determined by the investigator to be clinically significant ; A known or persistent mental disorder that may interfere with the participant's participation in the study, as determined by the investigator; Known allergic history to food, environment, experimental drug ABSK-011 or other drugs; Participants who have participated in other clinical trials and used other clinical trial drugs or test devices within 3 months before or during the screening period, or plan to participate in other clinical trials during the study period, or participants who do not participate in clinical trials themselves;\ have previously participated in this study or any other study related to ABSK-011 as a subject and have taken ABSK-011; Patients who had used proton pump inhibitors (including omeprazole, Lansoprazole, Rabeprazole, pantoprazole, etc.) within 14 days before the first dose; Those who have used strong inhibitors or inducers of CYP3A4 (including grapefruit juice, grapefruit hybrids, pomegranates, star fruits, grapefruits, Seville oranges and fruit juices or other processed products) within 14 days before the first dose, or have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products; For those who have used CYP2C19 inhibitors or inducers (including fluoxetine, fluvoxamine, ticlopidine, rifamepine) within 14 days before the first dose, (Part C only); There are factors that significantly affect drug absorption, distribution, metabolism and excretion, such as inability to take oral experimental drugs (dysphagia), significant nausea, vomiting and malabsorption, history of gastric or intestinal surgery, or other surgical history that affects drug absorption, distribution, metabolism and excretion (except appendicitis surgery); Patients with needle fainting, blood fainting history, or inability to tolerate venipunction, or difficulty in blood collection; Blood donation or heavy blood loss (≥400ml) within 3 months before or during screening (except female menstrual period); Have special dietary requirements, can not comply with the unified diet (such as the standard meal food intolerance, lactose intolerance, etc.) and the corresponding regulations, or have swallowing difficulties; Those who do not wish to comply with the dietary requirements/restrictions during the study period, which are: (i) only dietary supplements provided by the study center during hospitalization, (ii) avoiding CYP3A4 strong inhibitor or inducer during the study, and (iii) avoiding other CYP2C19 strong inhibitor or inducer during the study ( (iii) Only Part C); Those who consumed more than 14 units of alcohol per week in the 3 months prior to screening (1 unit of alcohol is about 360mL beer or 45mL spirits with 40% alcohol or 150mL wine), or whose alcohol breath test results were > 0mg/100ml, or those who cannot abstain from alcohol during the study; Smokers who smoked more than 5 cigarettes per day (or a corresponding amount of tobacco or nicotine products) in the 3 months prior to screening; Or unable to stop using any tobacco products during the trial; People who had excessive methylxanthine/caffeine consumption in the past 6 months (excess consumption was defined as consuming more than 6 units of caffeine per day, with 1 unit of caffeine equivalent to 177 ml of coffee, 355 ml of tea, 355 ml of cola, or 85 grams of chocolate), Or were unwilling to comply with the methylxanthine/caffeine use restrictions in 5.3.3 during the study period, or had a known history of substance abuse or screened positive for substance abuse; Hepatitis B surface antigen, treponema pallidum antibody, antibody to human immunodeficiency virus, antibody to hepatitis C antibody were abnormal and were clinically significant determined by the investigator; Patients with a history of bacterial, fungal, parasitic, viral (excluding nasopharyngitis) or mycobacterium infection within 45 days prior to the first administration, or imaging findings (chest radiograph) supporting related infections (as determined by the investigator); had been vaccinated within 2 months prior to the first dose, or intended to be vaccinated throughout the study period; Any other factors that the investigator considers inappropriate for participation in this trial, which may affect the participant's adherence to the protocol, interfere with the interpretation of the study results, or expose the participant to risk. Or subjects withdraw from the experiment for their own reasons. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06306859

Not yet recruiting

Development of Health Monitoring System on Patient's Well Being in Dialysis Context

One of the goals in the Sustainable Development Goals (SDGs) is the availability of a healthy and prosperous life for all ages. This goal mentions health priorities i.e. non-communicable diseases. Chronic kidney failure (CRF) is one of the non-communicable diseases that is the main cause of death and disability both in the world and in Indonesia. The prevalence of CRF in Indonesia is 0.5% with 83.2% of patients being of productive age and the highest number of CRF patients in North Kalimantan, Southeast Sulawesi, DKI Jakarta and Yogyakarta. Monitoring and evaluation of patients with CRF is currently mostly carried out conventionally not using health technology that is integrated with hospital information systems. This study aims to design and provide a health information system for patients with CRF, hereinafter referred to as SIKIDI, which integrates mobile-health applications used independently by patients with existing information systems in hospitals.

- EligibilityCriteria: Inclusion Criteria: >18 years old has been undergoing hemodialysis >3 months has smartphone Exclusion Criteria: emergency hemodialysis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06306846

Recruiting

Neoadjuvant SBRT in Localized Advanced HNSCC

The response rate of HNSCC to immune checkpoint blockade was not satisfied. Improving the mPR rate of neoadjuvant immunotherapy through the combination with other treatment methods is an important way to further improve the prognosis of such patients. This study aims to explore the efficacy and safety of PD-1 monoclonal antibody with neoadjvant SBRT and chemotherapy. The triple mode not only can Increase the effectiveness of neoadjuvant therapy，meanwhile，the in situ tumor vaccine inoculation effect generated by enhancing the release of specific antigens after tumor radiotherapy with PD-1 monoclonal antibody achieves a sustained anti-tumor immune effect throughout the body， reducing postoperative adjuvant radiotherapy and chemotherapy. The triple mode has important exploratory value in achieving high quality and long-term survival for patients, and may provides a more efficient mode for locally advanced HNSCC.

- EligibilityCriteria: Inclusion Criteria: Pathologically confirmed initially resectable Localized advanced head and neck squamous cell carcinoma，and plan for surgical resection. Immunohistochemical confirmed the HPV status through P16 immunostaining. Male or female, Between the aged from 18 to 70 years, Able to provide informed consent, comply with agreements, and sign research specific consent documents. ZPS is less than 2. Adequate bone marrow, liver and kidney, heart , lung and other physiological function determined by Researchers, able to tolerate neoadjuvant anti-PD-1, anti-EGFR, and radiation therapy. Subjects are willing and able to comply with visits, treatment regimens, laboratory tests, and other requirements of the study as spe. Exclusion Criteria: Any clinical illness, such as hemorrhage, active infection, or mental illness, that can hinder safe participation or adherence of research procedures. Patients who cannot accept radiotherapy in standard treatment. Long term maintenance of oral steroids (≥ 20mg prednisone equivalent per day) is required, excluding patients with inhaled, local, or non absorbable steroids. Autoimmune diseases, including but not limited to inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathy (such as Guillain Barre syndrome), etc. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06306833

Recruiting

The Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain

The prevalence of chronic low back pain (CLBP) among the Pakistani population is reported to be as high as 78% leading towards different physiological and psychosocial alterations with the worst cases suffering from disabilities. CLBP is a multifactorial phenomenon in which age, gender, comorbidities, lifestyle conditions, profession, working hours, and different stressors play their roles in its causation. However, different therapeutic techniques have been determined to reduce CLBP. Thus, this study aimed to assess the effectiveness of the biofeedback surface EMG (sEMG) technique in reducing chronic low back pain among sufferers in the long run.

- EligibilityCriteria: Inclusion Criteria: Individuals who constantly experience low back pain for the last three months. Individuals who seek care from healthcare provider due to low back pain Individuals with average pain intensity, were assessed using the Brief Pain Inventory (BPI) over the past week ≥ 2 on a 0-10 scale. Individuals with an average Oswestry Disability Index (ODI) score ≥ 4. Individuals with State-Trait Anxiety Inventory (STAI) score ≥ 20. Exclusion Criteria: Age below or above 25 and 75 years, respectively. Females who are pregnant, lactating, or that they anticipate becoming pregnant in the next 3-6 months will be excluded. Individuals having any diagnosed chronic disease. Individuals having any diagnosed neurological disorder including Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke Individuals having any diagnosed motor disorder or had pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis. Including a history of spine surgery or a hip arthroplasty Individuals with an active cancer Blind individuals Individuals having a body mass index greater than 35 kg/m2 Individuals with clinical depression, that is having a score of 24 or higher on the Center for Epidemiology Depression Scale. Individuals who have used narcotics or muscle relaxants within 30 days before study enrollment. - HealthyVolunteers: No - Gender: All - MinimumAge: 25 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06306820

Not yet recruiting

Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery

The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries.

- EligibilityCriteria: Inclusion Criteria: Age from 3 to 8 years. Both sexes. American Society of Anesthesiologists (ASA) physical status I-II. Children scheduled for elective laparoscopic abdominal surgeries. Exclusion Criteria: Parental refusal. Bronchial asthma or any preexisting chest disease. Congenital deformity of the thoracic cage. Patients with a history of thoracic surgery. Cardiac, hepatic, or renal failure. Obese children with BMI at or above 95th percentile of the same age and sex. - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 8 Years - StdAgeList: Child

NCT06306794

Not yet recruiting

Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration

The aim of this study was to investigate the effect of using amigurumi octopus on the pain and comfort of the newborn in premature infants undergoing endotracheal aspiration. It is a randomized controlled quasi-experimental design. The study will be conducted in the neonatal intensive care unit of Health Sciences University Bursa High Specialization Training and Research Hospital. The population of the study will consist of preterm hospitalized in the neonatal intensive care unit during the period of the conducted study. In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups. PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used as a case report form for the collection of the study data. All the patients included in the study will be intervened by the nurse having a neonatal nursing experience by paying attention to aseptic conditions in accordance with the routine aspiration criteria of the unit. Standardization will be ensured by intervening in all patients with the same application by the same nurse. During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. Babies will be allowed to touch the octopus for 10 minutes during and after the procedure. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study. The routine aspiration application steps of the unit will be applied to the control group without any intervention.

- EligibilityCriteria: Inclusion Criteria: Gestational age range of 26-36 weeks The baby should be between postnatal day 0 and 5 (Postnatal day of baby should be between 0 and 5 days.) Need for invasive mechanical ventilator support Need for endotracheal aspiration No analgesic, opioid and sedative medication was applied within the 4 hours before the endotracheal aspiration At least 2 hours passed since the last painful procedure Exclusion Criteria: Receiving analgesic medication Major congenital anomaly Having a pneumothorax tube Stage III and intraparenchymal hemorrhage Receiving a sedative medication - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Day - MaximumAge: 5 Days - StdAgeList: Child

NCT06306781

Not yet recruiting

A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection (Homologous Allogeneic Hepatocytes) in Patients With Decompensated Cirrhosis

This study protocol is designed to evaluate the clinical efficacy, safety, and tolerability of HCL001 cell injection in the treatment of decompensated cirrhosis. The aim is to provide stronger evidence for the clinical application of HCL001 cell injection in the treatment of decompensated cirrhosis, thereby attempting to improve patients' survival and quality of life to meet the clinical needs for treating decompensated liver cirrhosis.

- EligibilityCriteria: Inclusion Criteria: When signing the informed consent form, individuals between the ages of 18 to 75 years (inclusive, including the boundary values) are eligible, and there are no restrictions based on gender. According to the "Guidelines for the Diagnosis and Treatment of Cirrhosis (2019 Edition)", a diagnosis of decompensated cirrhosis is made. A Child-Pugh score of 7-12 points (including the threshold) is classified as [insert the corresponding classification as per the provided appendix]. An ECOG performance status score of 0-2 or a Karnofsky Performance Status (KPS) score greater than 60 is considered [insert the corresponding classification or interpretation]. A safe vascular access that allows for hepatic intra-arterial catheterization and angiography If screening for patients with hepatitis B or C-related cirrhosis, the viral load should be ≤1000 IU/mL for HBV-DNA and ≤15 IU/mL for HCV-RNA. For patients with alcoholic cirrhosis, the abstinence period should be ≥6 months. During screening, the serum ALT level should be ≤3 times the upper limit of normal (ULN). Understand and adhere to the research process, voluntarily participate, and sign the informed consent form (the informed consent form is to be voluntarily signed by myself or a legally authorized representative). Exclusion Criteria: Allergic individuals, especially those allergic to any component of HCL001 cell injection or its excipients. Individuals with concurrent liver cancer or other malignant tumors. Patients who are unable or unwilling to cooperate or comply with the requirements of the research protocol. International Normalized Ratio (INR) >2.5 and platelet count (PLT) less than 30 x 10^9/L. Patients who have used anticoagulant or antiplatelet medications within the past week prior to screening. Patients with a history of upper gastrointestinal bleeding or spontaneous peritonitis within the past four weeks prior to screening. Patients who have experienced grade 3 or higher hepatic encephalopathy within the past three months prior to administering the medication. Patients with severe dysfunction in vital organs such as the heart, lungs, brain, or kidneys, including: History of severe lung diseases such as severe emphysema, pulmonary embolism, or other lung conditions that significantly impact lung function. Significant history of heart disease that meets either of the following conditions: a. Decompensated heart failure (New York Heart Association [NYHA] class III-IV). b. Unstable angina. Chronic kidney disease, such as chronic nephritis, renal insufficiency, or uremia. For patients with diabetes mellitus that is being treated but not effectively controlled, it typically refers to those with a glycated hemoglobin (HbA1c) level of ≥8%. Patients with severe coagulation dysfunction or bleeding disorders, such as hemophilia, as well as those with severe jaundice indicated by a serum total bilirubin level of ≥171 μmol/L. This includes pregnant or lactating women, as well as individuals who are unable or unwilling to follow the researcher's guidance in using the approved contraceptive measures during the study period and for 6 months after the study ends. Those who have received stem cell therapy in the past, or who are currently participating in another interventional clinical trial or have been enrolled in one within the past 3 months, are excluded from screening. HIV positive Presence of active infection during screening The researchers consider any other factors that are not suitable for trial inclusion. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06306768

Not yet recruiting

Remote Therapeutic Monitoring Exercise Tracking

The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform.

- EligibilityCriteria: Inclusion Criteria: Are ambulatory as their primary means of mobility without an assistive device except for single point cane or walking sticks in community Have a diagnosis of Parkinson's disease (Hoehn and Yahr 1-3), Parkinsonism, or Multiple Sclerosis Personal goal and willingness to address physical activity Have a smart phone (Datos Health app is compatible with any Smart phone device) Willing to accept Datos' Terms and Conditions Exclusion Criteria: Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 89 Years - StdAgeList: Adult, Older Adult

NCT06306755

Not yet recruiting

Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer

To evaluate the feasibility, applicability, effectiveness, and health-economic value of the risk-based sequential screening modality for esophageal and gastric cancers, the investigators aim to initiate a community-based randomized controlled trial in Xun County, Henan Province, which is a high-risk region of upper gastrointestinal cancer (UGIC) in northern China. A total of 258 target villages from all the 11 communities (townships and streets) in Xun County will be randomly selected and assigned to the sequential screening group and the universal screening group at a ratio of 2:1 and the total sample size will be 21,000. In the sequential screening group, participants in the top 50% risk level (i.e., stratified as the high-risk subgroup) will be offered a standard upper gastrointestinal endoscopic screening. In contrast, all participants in the universal screening group will receive the endoscopic examination. The surveillance strategy for participants with screening-detected premalignant lesions in the sequential screening group will be tailored based on individualized risk assessment using endoscopic characteristics, pathological diagnosis, and biomarkers. Surveillance for participants in the universal screening group will adhere to current guidelines for UGIC screening and clinical treatment. Detection rates of upper gastrointestinal malignant lesions, early-stage malignant lesions and premalignant lesions, and health-economic indicators such as the unit cost per detected malignant lesions will be compared between the two groups.

- EligibilityCriteria: Inclusion Criteria: Permanent residency in the target villages in Xun County, Henan Province, China; Aged 50 to 69 at the enrollment; Voluntarily participate in this study and provide informed consent. Exclusion Criteria: Had a history of endoscopic examination within 5 years prior to the initial interview; Had a history of cancer; Had a history of mental disorder; Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV); Had severe cardiovascular and cerebrovascular diseases; Had severe respiratory disease, dyspnea, or asthmaticus status; Had retropharyngeal abscess, severe spinal deformity, or aortic aneurysm; With physical debility unable to tolerate endoscopic examination, or with difficulty in achieving sedation and self-control; In the acute phase of corrosive inflammation of the upper gastrointestinal tract, or with suspected perforation of the upper gastrointestinal tract; Had massive ascites, severe abdominal distension, or severe esophageal varices; Pregnancy; Had severe history of allergies; Had propensity for bleeding (coagulopathy); Others unable to tolerate the clinical examinations involved in this study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 50 Years - MaximumAge: 69 Years - StdAgeList: Adult, Older Adult

NCT06306742

Recruiting

Open-label Placebo in Manual Therapy

to investigate the effects of placebo in patients affected by low-back pain.

- EligibilityCriteria: Inclusion Criteria: Adult patients (+18 years) who complain of chronic non-specific low back pain for at least 3 months with or without pain exacerbations at the time of recruitment, will be included. -Patients will need to have a diagnosis of low back pain made by a physician Exclusion Criteria: pathologies such as ankylosing spondylitis, infections, fractures, tumors or metastases. Pregnant women patients with previous spinal surgery or undergoing cortisone therapy in the 6 months prior to the trial diseases that may affect the interpretation of results such as fibromyalgia patients currently being treated by other specialists or other manual therapists - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06306729

Not yet recruiting

Computational Assessment of Bioprosthetic Aortic Valve Function

Bioprosthetic valves are usually made of biological tissue that are mounted to a frame and are designed to function similarly to a healthy natural valve. Edwards Magna Ease and Intuity Elite bioprosthetic valves have similar leaflets and mounting designs. However, the valves are implanted in the patient in different ways (one is stitched to the wall of the left ventricular outflow tract, and the other is held in place by the radial force of the valve skirt). The study aims to understand in more detail how the different valves interact with the left ventricular outflow tract and aortic root.

- EligibilityCriteria: Inclusion Criteria: Male and female patients aged 18 years or over. Patients diagnosed with aortic valve disease, and scheduled to undergo Edwards Magna Ease or Intuity Elite and free of exclusion criteria below. The patient is willing and able to understand the Patient Information Sheet and provide written informed consent. The patient must agree to comply with the study imaging protocol as required at prespecified times. Exclusion Criteria: Inability to provide valid informed consent. Male and female patients aged < 18 years of age. Contraindications for CT angiography: renal failure (Cr>250 μmol/L or eGFR<30 mL/min) due to the additional risk of contrast medium nephrotoxicity or allergy to iodine. Women of childbearing age who have not had a hysterectomy and/or who may be breastfeeding. History of cardiac pacing device insertion, or any other MRI incompatible device implants. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 20 informed and consented patients who undergo the Intuity Elite (n=10) and Magna EASE (n=10) valves will be prospectively enrolled. The patients will be evaluated at 3- and 12-months post valve replacement. - SamplingMethod: Non-Probability Sample

NCT06306716

Not yet recruiting

Single Center Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds

The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds.

- EligibilityCriteria: Inclusion Criteria: Subject has provided written informed consent. Subject is 18 years of age or over. Subject is able and willing to comply with study requirements. Subject is suitable to participate in the study in the opinion of the Investigator. Subject is an inpatient at time of enrollment and will be able to attend follow-up visits in clinic following discharge. Subject has a wound that, per Instructions for Use (IFU), is indicated and suitable for management with NPWT and fits one of the following wound types: a. Chronic* (this may include Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers but this is not an exhaustive list) b. Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns) *Chronic wound in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause Subject's wound to be treated is of a size that can be managed with one of the available sizes of the study device Exclusion Criteria: Subject has hypersensitivity to the use of the RENASYS NPWT System or its components, or a contraindication per the IFU such as: a. exposed arteries, veins, organs, or nerves b. necrotic tissue with eschar present (unless adequately debrided) c. non-enteric and unexplored fistulas d. exposed anastomotic site e. malignancy in the wound Subject participation in the treatment period of another clinical trial within thirty (30) days of baseline visit or during the study. Subject has skin features (e.g., tattoos, pre-existing scarring, etc.) which in the opinion of the investigator will interfere with the study assessments. For lower extremity wounds, any subject with a wound on a limb with an Ankle Brachial Index (ABI) <0.7 Any subject that meets the definition of a Vulnerable Subject per ISO 14155 (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response). Ethnic minorities will be included providing they meet other inclusion criteria. Subject has had the target wound for greater than three months. Subject has a target wound that measures <3 millimeters (mm) in maximum depth. Subject has untreated osteomyelitis Subject has active, untreated soft tissue infection. Subject has wounds that has previously been managed with NPWT in the previous four (4) weeks Subject has participated previously in this clinical trial. Subject has a history of poor compliance with medical treatment. Pregnancy at time of enrolment. Subject has a medical or physical condition that in the opinion of the Investigator would preclude safe subject participation in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: This study aims to enroll up to 23 subjects from one clinical site in Canada with appropriate wound types including: Chronic* (this may include DFUs, VLUs, Pressure Ulcers but this is not an exhaustive list) Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns, but this is not an exhaustive list) *Chronic wound in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause. As this is a pilot study, there are no limits to inclusion of any one particular wound type, however a minimum of 5 acute and 5 chronic wounds is required. - SamplingMethod: Probability Sample

NCT06306703

Not yet recruiting

Comparison of Teaching Methods of Pelvic Floor Muscle Contraction in Women

The aim of our study; To evaluate the effectiveness of different teaching methods on correct pelvic floor muscle contraction in women who have not received pelvic floor muscle training (PFMT) before. Women who come to the gynecology and obstetrics clinic for examination and volunteer for the study will be randomized with a computer-aided randomization program and divided into 3 groups. First of all, the pelvic floor muscles will be evaluated by ultrasonographic method and perineometer. The first group will be taught pelvic floor muscle contraction with verbal explanation, the second group will be taught with digital vaginal palpation, and the third group will be taught pelvic floor muscle contraction with the help of a perineometer. After the training, the same evaluations will be made again. The number of individuals to be included in the study will be determined by power analysis. As a result of this study, it will be decided which method can be used to teach pelvic floor muscle contraction to women accurately and effectively in clinics. The results of our study will guide clinicians in their preferences for using different teaching methods.

- EligibilityCriteria: Inclusion Criteria: volunteering to participate in the study, getting a score of 25 or more from the "Mini mental Test", having pelvic floor muscle contraction ability, not having received pelvic floor muscle training before, vaginal examination and volunteering for education. Exclusion Criteria: Pregnancy, presence of symptomatic pelvic organ prolapse over stage 2, cooperation problem, presence of urinary infection, epilepsy, and accompanying neurological disease. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 20 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06306690

Recruiting

Biomarkers in Retinitis Pigmentosa

The objective of this study is to discover biomarkers that demonstrate a correlation between the severity of retinitis pigmentosa (RP) and the thickness of the retinal pigment epithelium (RPE). These biomarkers will serve as prognostic indicators for various kinds of retinitis pigmentosa. The objective of this study is to find biomarkers that establish a correlation between the severity of retinitis pigmentosa and the thickness of the retinal pigment epithelium (RPE), which can serve as a prognostic indicator for Retinitis Pigmentosa.

- EligibilityCriteria: Inclusion Criteria: Patients who are able to read and sign informed consent Patients with Retinitis pigmentosa confirmed by genetic test. Patients older than or equal to 18 years of age Exclusion Criteria: Other retinal diseases such as macular hole, retinal detachment, macular neovascularization. Corneal surgery in the last 12 months Glaucoma with pressure above 25 mmHg in the last three months. Best Correct Visual Acuity below 1/10 in at least one eye. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The patients will be enrolled at the Ophthalmology department of Fondazione Policlinico Universitario A. Gemelli IRCCS. Patients with diverse kinds of RP with genetic confirmation, no other retinal disorders, pressure under 25 mmHg for three months, and no corneal surgery in the past year are included. - SamplingMethod: Non-Probability Sample

NCT06306677

Not yet recruiting

Accuracy of an AI-clinical Knowledge-based Hybrid System for Detecting Periodontitis in OPG Images

Periodontitis is highly prevalent and rarely detected and treated in the earlier stages of the disease. Orthopantomography (OPG) is the most frequently taken dental radiograph around the world, and its systematic screening may contribute to early detection of periodontitis and access to the needed level of care. The investigators' recent study initially developed an AI-clinical knowledge-based system for automatic periodontitis diagnosis and indicated good performance for differentiating stage II-IV periodontitis. This cross-sectional diagnostic study aims to compare the diagnostic accuracy of this AI-clinical knowledge-based hybrid system (Index test) with human experts (reference test) for differentiating stage II-IV periodontitis using the OPG images obtained from different 4 centers around the world.

- EligibilityCriteria: Inclusion Criteria: Aged 18 and above Having taken the OPG image Exclusion Criteria: Edentulous mouth - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients seeking care at Shanghai Ninth People's Hospital Pudong Clinics; Patients seeking care at Shanghai Ninth People's Hospital South Clinics; Patients seeking care at Prince Philip Dental Hospital in Hong Kong; Patients seeking care at The University of Rome La Sapienza in Italy; - SamplingMethod: Non-Probability Sample

NCT06306651

Not yet recruiting

High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea

This study aims to compare the effectiveness of conventional oxygen therapy oxygen and high-flow nasal cannula therapy on oxygen saturation (SpO2), measuring number of SpO2 drop >4% of base line oxygen saturation (o2 desaturation index), length of the ICU stay, and the need of use supplemental continuous positive airway pressure (CPAP) support in any of the study groups in the postoperative ICU setting.

- EligibilityCriteria: Inclusion Criteria: Age group from 21 - 40 years old. Both sexes. Mild to moderate obstructive sleep apnea (OSA) patients with STOP-BANG score less than 5. OSA patients undergoing non cardiac surgeries. Patients who will undergo scheduled elective surgeries under general anesthesia. Exclusion Criteria: Patient refusal of procedure or participation in the study. Patients with severe OSA, STOP-BANG score more than or equal 5. Patients dependent on home ventilation CPAP or bilevel devices. Pregnant females. Post cardiac or thoracic surgery patients. More than American Society of Anesthesiologists (ASA) II patients. Head and face trauma patients. - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06306638

Not yet recruiting

Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction

This phase I/II trial studies the side effects of interstitial photodynamic therapy following palliative radiotherapy and how well it works in treating patients with inoperable malignant central airway obstruction. Patients who have advanced stage cancer tumors in the lung can often have the breathing passages to the lung partially or completely blocked. These tumors could be due to lung cancer or other cancers (e.g., renal, breast, kidney, etc.) that spread to the lung. This blockage puts the patient at a higher risk for respiratory failure, post-obstructive pneumonia, and prolonged hospitalizations. Treatment for these patients may include bronchoscopic intervention (such as mechanical removal, stenting, laser cauterization, or ballooning), radiation therapy with and without chemotherapy. While palliative x-ray radiotherapy may help in shrinking the tumor, high dose curative radiotherapy that can ablate (a localized, nonsurgical destruction) the tumor also has high risk to cause significant toxicity, including bleeding, abnormal connections or passageways between organs or vessels and abnormal scar tissue that can also produce airway obstruction. Photodynamic therapy (PDT) is another possible treatment that can provide local control of the tumor. PDT consists of injecting a light sensitive drug (photosensitizer, PS) into the vein, waiting for the PS to accumulate in the tumor, and then activating it with a red laser light. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving interstitial photodynamic therapy following palliative radiotherapy may improve tumor response and survival without the serious side effects that are associated with the typical high dose curative x-ray radiotherapy alone in patients with malignant central airway obstruction.

- EligibilityCriteria: Inclusion Criteria: Age >= 18 years of age Eligibility checklist before registration requires review of case by the interventional pulmonologist/s and radiation oncologist/s to approve anatomic feasibility of an airway intervention and palliative radiotherapy Patients with pathologic diagnosis of inoperable solid malignancy involving extrabronchial tumor growth that causes airway obstruction and not amenable to curative radiotherapy. All patients will have tumors requiring bronchoscopic intervention with endobronchial ultrasound (EBUS) at the time of I-PDT Participants have at least one measurable lesion which is also the target lesion for Response Evaluation Criteria in Solid Tumors (RECIST) measurement Patients amenable to receive standard of care palliative radiotherapy to the target tumor, as determined by the radiation oncologist/s Amenable to high resolution chest CT (with or without contrast due to known allergy) with 0.625-1.25 mm slice thickness and slice interval 0.5-1 mm Tumor is accessible and amenable to I-PDT, as determined by the interventional pulmonologist/s Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3 Platelets ≥ 100,000 cells/mm^3 (International System of Units [SI] units 100 x 10^9/L) International normalized ratio (INR) < 1.5 and activated partial thromboplastin time (aPTT) < 1.5 x ULN. PTT or aPTT per institutional standards for participating external sites Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 3 months after receiving the study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: Pregnant or nursing female participants Co-existing ophthalmic disease likely to require slit-lamp examination within the next 30 days following I-PDT treatment Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the I-PDT CT imaging suggestive of target tumor invasion into a major blood vessel (typically proximal to segmental vessels) Known hypersensitivity/allergy to porphyrin Patients who are not cleared by the anesthesiologist to undergo an advanced bronchoscopy procedure under general anesthesia Patients diagnosed with porphyria Patients with known allergy to eggs Patients unwilling or unable to follow protocol requirements - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06306625

Not yet recruiting

REmote COnditioning in Out-of-Hospital Cardiac Arrest

Out-of-Hospital Cardiac Arrest remains a major public health problem, resulting in high mortality largely related to multiple organ failure and poor neurological outcomes due to brain anoxia. The pathophysiology of organ dysfunction after resuscitated out-of-hospital cardiac arrest involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy used to protect organs against the detrimental effects of ischemia-reperfusion injury. The objective of the present trial is to determine whether remote ischemic conditioning performed early after out-of-hospital cardiac arrest can decrease mortality, or multiple organ failure and/or severe neurological failure.

- EligibilityCriteria: Inclusion Criteria: Age between 18 and 80 years old Out-of-hospital cardiac arrest, whatever the initial cardiac rhythm (shockable or non-shockable) or the duration of no-flow and low-flow, Presence of a witness who may or may not have started cardiopulmonary resuscitation, or patient seen alive in the 30 minutes prior to the cardiac arrest, Hospitalisation in critical care (intensive care unit or cardiac intensive care unit) for less than 3 hours, Informed consent obtained from a close relative (exceptionally from the patient himself if his condition permits) or, failing this, use of the emergency procedure by the investigator. Exclusion Criteria: Traumatic cardiac arrest Patient on extracorporeal circulatory assistance Cardiac arrest for which continuation of resuscitation does not appear justified (unavoidable death, terminal stage of an irreversible disease, etc.) Contraindication of the use of brachial cuff on both arms (arteriovenous fistula, lymphoedema or severe peripheral vascular pathology, unstable humeral fracture, continuous infusion into an upper limb vein of an essential drug such as a catecholamine, radial arterial catheter for continuous invasive measurement of blood pressure) Pregnant, parturient, or breast-feeding women Patients deprived of their liberty by a judicial or administrative decision, Patients under legal protection (guardianship, curatorship), Patient not affiliated to a social security scheme or beneficiary of a similar scheme, Previous inclusion in the study, Subject participating in another interventional study with an exclusion period still in progress at pre-inclusion. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06306612

Recruiting

CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer

The goal of this clinical trial is to compare systemic therapy combined with cytoreductive prostatectomy with standard of care (SOC) in de novo poly-metastatic hormone sensitive prostate cancer (de novo pmHSPC). The main questions it aims to answer are: To explore the clinical benefit and safety of systemic therapy combined with cytoreductive prostatectomy for patients with de novo pmHSPC. To explore the characteristics of the subgroup of patients who could benefit more from the above treatment. To explore the relationship between stage efficacy and clinical prognosis. To explore the correlation between molecular imaging such as PSMA-PET/CT and its changes with treatment efficacy. Participants will undergo systemic therapy combined with cytoreductive prostatectomy. Researchers will compare systemic therapy combined with cytoreductive prostatectomy with SOC to see the pros and cons of the two strategies.

- EligibilityCriteria: Inclusion Criteria: Fully understand the purpose of this trial and sign a written informed consent; Men aged 18-85 years; have histologically or cytologically confirmed adenocarcinoma of the prostate; Have multiple metastatic disease, defined as follows: according to RECIST v1.1, metastatic disease was defined as metastatic foci detected on bone scans or measurable lymph nodes or soft tissue or visceral lesions above the aortic bifurcation. Lymph nodes were defined as measurable if their short-axis diameter was ≥15 mm; soft tissue/visceral lesions were defined as measurable if their long-axis diameter was ≥10 mm. and total number of metastatic lesions ≥ 5. Patients with only regional lymph node metastases (N1, below the aortic bifurcation) were not eligible for the study. At the investigator's discretion, patients must meet the indications for ADT and docetaxel; Patients have not received any prior local or systemic therapy for prostate cancer primary or metastasis. Eastern Cooperative Oncology Group (ECOG) score of 0-1; Blood count at screening: hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5 x 10^9/L, and platelet count ≥ 100 x 10^9/L (patient has not received any colony-stimulating factor within 4 weeks or a transfusion or blood product within 7 days prior to blood collection) Serum alanine aminotransferase and/or aspartate aminotransferase ≤ 1.5 x Upper limit of normal (ULN), total bilirubin ≤ ULN, creatinine ≤ 2.0 x ULN. Exclusion Criteria: Prior therapy: ADT, second-generation androgen receptor inhibitors, CYP17 enzyme inhibitors, any chemotherapy or immunotherapy for prostate cancer, radiotherapy (external radiation radiotherapy, brachytherapy, or radiopharmaceuticals); Known hypersensitivity to any of the investigational drugs, or excipients in the preparations; Contraindication to CT/MRI examination; Any of the following conditions within 6 months prior to randomization: stroke, myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, or congestive heart failure (New York Heart Association cardiac function class III or IV); uncontrolled hypertension as evidenced by a resting systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg after treatment History of prior malignancy, except basal cell or cutaneous squamous cell carcinoma in complete remission; History of gastrointestinal disorders or surgery expected to significantly interfere with the absorption of study drug(s); Active acute and chronic viral hepatitis, known HIV infection; Prior (28 days prior to initiation of study drug or 5 half-lives of investigational therapy from a prior study, whichever is longer) or concurrent participation in another clinical study of study drug; Any other serious or unstable medical condition or condition that may interfere with their participation in the study or the evaluation of study results or may jeopardize the safety of the trial and other conditions; Inability to swallow oral medications; A close interest in the research center. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06306586

Not yet recruiting

A Digital Treatment for Adolescents With Eating Disorders

The goal of this feasibility study is to evaluate the feasibility and preliminary clinical outcomes of a personalized digital treatment for adolescents with eating disorders. The main objectives are to: i) Evaluate whether a personalized digital treatment for adolescents with eating disorders are feasible in a child and adolescent psychiatric outpatient clinic. ii) Evaluate who benefits from a personalized digital treatment for adolescents with eating disorders (what works for whom?) iii) Evaluate the cost-benefit of a personalized digital treatment for adolescents with eating disorders. Participants will be enrolled in a 10-week digital treatment including weekly therapist contact. They will be asked to complete self-report questionnaires at pre-, during, post- and 3- and 6-months follow-up.

- EligibilityCriteria: Inclusion Criteria: A. Diagnosed with F50.1 Atypical anorexia nervosa, F50.3 Atypical bulimia nervosa, F50.8 Other eating disorders, F50.9 Eating disorder, unspecified B. Age between 16 and 18 years. C. Stable dose of medication for a co-morbid psychiatric treatment for six weeks and who continue to meet study entry criteria. D. Internet access. E. Speaks and write Norwegian. Exclusion Criteria: A. Diagnosed with F50.0 Anorexia nervosa or F50.2 Bulimia nervosa B. Disorders of psychological development (F80-F89). C. Patients with avoidant restrictive food intake disorders (F50.82) D. Participants with a co-morbid medical condition or disorder known to influence eating or weight (i.e., pregnancy, cancer), psychotic disorders, acute suicidality, or substance abuse and/or substance dependence and severe depressive episode. E. Receiving inpatient- or face to face psychological treatment. - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06306560

Not yet recruiting

A Study of Adebrelimab Combined With Famitinib and Chemotherapy in the Treatment of ES-SCLC.

This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer.

- EligibilityCriteria: Inclusion Criteria: Age: 18-80 years old, male or female Patients with pathologically confirmed extensive stage small cell lung cancer (according to the Veterans Administration Lung Study Group, VALG staging) Never received prior systemic therapy for extensive stage small cell lung cancer Have a measurable tumour target lesion (meeting RECIST 1.1 criteria) Expected survival > 3 months ECOG PS: 0-1 points Normal function of major organs Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior to initiation of treatment, and women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose Patients voluntarily enrolled in this study by signing an informed consent form Exclusion Criteria: Previous or concurrent other malignant tumours within 5 years, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial or non-invasive bladder cancer Active tuberculosis infection, or a history of previous tuberculosis infection Uncontrolled, symptomatic brain metastases that are not effectively controlled or a history of psychiatric illness that cannot be easily controlled or severe intellectual or cognitive dysfunction Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage Subjects with the presence of any severe and/or uncontrolled disease Imaging showing tumour invasion of large vessels or poor demarcation from large vessels Susceptibility to bleeding, risk of hemoptysis, and history of significant coagulation disorders History of psychotropic substance abuse, alcoholism or drug addiction Active hepatitis (Hepatitis B reference: HBsAg positive with HBV DNA test value exceeding the upper limit of normal value Hepatitis C reference HCV antibody positive with HCV viral titre test value exceeding the upper limit of normal value) Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive Patients who are unable to comply with the trial protocol or who are unable to cooperate with follow-up visits Patients who, in the opinion of the investigator, should not be enrolled in the trial - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06306547

Not yet recruiting

Clinical Study Cohort of Idiopathic Inflammatory Myositis

Idiopathic inflammatory myositis (IIM), also known as myositis, are a heterogeneous group of diseases characterized by chronic inflammation of striated muscles and skin, with different clinical manifestations, treatment responses, and prognosis. This project will build a clinical follow-up cohort for idiopathic inflammatory myositis (IIM) centered on Renji Hospital, Shanghai Jiao Tong University School of Medicine, to promote the clinical and pathogenesis of this group of diseases.

- EligibilityCriteria: Inclusion Criteria:Subjects must meet the following criteria for inclusion in this study: meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (IIM) or the 2018 ENMC-DM classification criteria (see above), plus: Age≥ 18 years old and ≤ 75 years old Meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (IIM), the above score ≥ 5.5 points if there is no muscle biopsy, and 6.7 points ≥ if there is muscle biopsy Cooperate with follow-up, examination and treatment and voluntarily sign the informed consent form. - Exclusion Criteria:Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria: a. IIM with other connective tissue diseases; b. Negative myositis antibody test; c. Those who are in the period of acute infection, or have a history of active tuberculosis in the past; d. People with allergies or allergies to multiple drugs; e. Those who have mental illness or other reasons and cannot cooperate with examination, follow-up or treatment; f. Women who are pregnant, or are trying to become pregnant; g. Those who are participating in or have participated in clinical trials within the specified time. - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Aged 18-75 years and eligible for the 2017 European League Against Rheumatism/American College of Rheumatology. - SamplingMethod: Probability Sample

NCT06306534

Recruiting

Auditory Intranerve Stimulation Study

This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.

- EligibilityCriteria: Inclusion Criteria: Written informed consent Patients who will undergo an acoustic neuroma removal surgery and are functional deaf Age ≥ 18 years Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists Exclusion Criteria: Disabilities in addition to hearing impairment which might interfere with the study procedure Pregnant and breast feeding woman or other vulnerable population - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06306521

Recruiting

An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing

The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Parents will be approached to provide informed consent to enroll their newborns in prenatal, postnatal, and outpatient settings. The main questions this study aims to answer are: What is the utility of BeginNGS as compared to state newborn screening? What is the acceptability and feasibility of BeginNGS as compared to state newborn screening? What is the cost effectiveness of BeginNGS as compared to state newborn screening? Enrolled newborns will have a blood sample taken and will receive the BeginNGS test. Newborns will have also had the state newborn screening test.

- EligibilityCriteria: Inclusion Criteria: Neonates (<28 days old) at enrollment sites. Parents must have identified a primary care provider (or group). Exclusion Criteria: Neonates whose mother is less than 18 years of age. Neonates who are wards of the state. Neonates whose parent/legal guardian is unable to provide consent. Parents with a home address outside the US or jurisdiction of the enrollment sites. Neonates or fetuses who are ill and in whom enrollment or sampling is anticipated to interfere with healthcare provision at delivery. For example, fetuses or neonates who are likely to require transfer to a higher level of care, such as to a Level IV NICU upon delivery. Neonates who are under consideration for a rapid diagnostic genome sequence or other diagnostic genetic testing. Neonates who are not expected to survive the neonatal period. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 1 Day - MaximumAge: 28 Days - StdAgeList: Child

NCT06306508

Recruiting

Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis

Some parents may be more protective of children with CF due to concerns about worsening of the disease due to infection, which can affect their functional level. The goal of this observational study is to learn about the family's protective approach to the functioning and disease course of children with cystic fibrosis (CF) to determine whether there are possible negative effects. There will be an alternative viewpoint offered to clinicians regarding the management of CF with outputs of this study.

- EligibilityCriteria: Inclusion Criteria: For a child To be between 7-17 years old, Living with family or caregiver. For the parent Being the mother, father or other caregiver of the child, Voluntarily agreeing to participate in the study on behalf of both the child and oneself. Exclusion Criteria: For the child Having cognitive impairment that would prevent participation in the study or being able to cooperate with the measurements and not being able to adapt, History of previous lung or liver transplantation, History of hospitalization within the last 1 month, Having a neurological or orthopedic comorbidity that affects mobility. For the parent Having cognitive impairment at a level that prevents participation in the study Not living in the same household with the child. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: Children with cystic fibrosis and their parents who visited a private hospital's Pediatric Chest Diseases Outpatient Clinic made up the study's population. 37 parents of children with cystic fibrosis and their 37 offspring who match the inclusion and exclusion criteria and willingly consent to take part in the study will make up the sample. - SamplingMethod: Non-Probability Sample

NCT06306482

Not yet recruiting

Determination of Posture in Patients With Restrictive and Obstructive Lung Disease

The aim of this study is to determine posture and posture related factors in patients with restrictive and obstructive lung disease.

- EligibilityCriteria: Inclusion Criteria: Chronic Obstructive Pulmonary Disease Group Inclusion Criteria: Over 55 years old, Stage 1-2-3-4 according to the GOLD, Being clinically stable for the last 4 weeks. Chronic Obstructive Pulmonary Disease Group Exclusion Criteria: Receiving long-term oxygen therapy, Having central and peripheral vestibular disease, Communication problems, known mental and cognitive problems, Having undergone any surgical intervention related to the spine within the last six months, Inclusion Criteria for the Cystic Fibrosis Group: Being diagnosed with CF as a result of two sweat tests, Being over 18 years old. Cystic Fibrosis Group Exclusion Criteria: Being in acute pulmonary exacerbation period, Receiving long-term oxygen therapy, Having undergone any surgical intervention related to the spine within the last six months, Inclusion Criteria for the Asthma Group: Diagnosed with asthma according to the Global Strategy for the Prevention and Treatment of Asthma (GINA), Clinically stable for the last 1 month Being over 18 years old. Asthma Group Exclusion Criteria: Change in medication for the last 1 month. Having undergone any surgical intervention related to the spine in the last six months, Inclusion Criteria for Bronchiectasis Group: Being over 18 years old, Being diagnosed with bronchiectasis other than cystic fibrosis, Being clinically stable for the last 1 month. Bronchiectasis Group Exclusion Criteria: Receiving long-term oxygen therapy, Having undergone any surgical intervention related to the spine in the last six months. Diffuse Parenchymal Lung Diseases Inclusion Criteria: Being diagnosed with diffuse parenchymal lung according to American Thoracic Society/European Respiratory Society (ATS/ERS) criteria, Being over 18 years old, Having volunteered to participate in the research, To be clinically stable and to have comorbid conditions (such as hypertension, diabetes) under control, Diffuse Parenchymal Lung Diseases Exclusion Criteria: Having undergone any surgical intervention related to the spine within the last six months, Having exacerbation in the last 3 months - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Obstructive and restrictive lung disease and healthy controls will be included in this study according to the inclusion and exclusion criteria. - SamplingMethod: Non-Probability Sample

NCT06306456

Recruiting

A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC

This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations.

- EligibilityCriteria: Inclusion Criteria: Subjects or their legal representatives can understand and voluntarily sign the written ICF (before the start of screening and any study procedures); Male or female subjects aged ≥18 years; Advanced NSCLC patients with EGFR mutations confirmed by cytological or histological assessments, and meet the following requirement: Phase Ib： patients with disease progression previously at least treated with third-generation EGFR-TKIs and platinum-containing chemotherapy; Phase IIa and IIb：patients with disease progression previously at least treated with a third-generation EGFR-TKIs (Osimertinib, Furmonertinib Almonertinib etc.). Patients have at least one measurable lesion as defined by RECIST v1.1 (a tumor lesion in the area that has undergone radiotherapy or other loco-regional therapies, is generally not considered as measurable unless there is a disease progression in the lesion); Consent to provide samples for genetic testing; Life expectancy of ≥ 3 months; ECOG PS score of 0-1; The subjects must have adequate organ functions; Male and female of reproductive potential must agree to take reliable contraceptive measures (hormone or barrier methods or abstinence) from signing the ICF until 30 days after the last dose. Pregnancy test results must be negative for female of reproductive potential within 7 days prior to the first dose of the investigational product. Exclusion Criteria: Subjects who receive any chemotherapy or antitumor biologics within 3 weeks, or antitumor therapies such as radiotherapy and endocrine therapy within 4 weeks prior to the first dose of the investigational product, except for the following: Use of nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational product; Oral administration of fluorouracils, small molecule targeted drugs, and Chinese herbal medicines or Chinese patent medicines with antitumor indications within 5 half-lives or 2 weeks before the first dose of the investigational product (whichever is shorter); Small molecule TKI inhibitors within 5 half-lives or 2 weeks prior to the first dose of the investigational product (whichever is shorter); Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational product; Subjects who have had another investigational new drug or therapy within 4 weeks prior to the first dose of the investigational product; Subjects who have had a major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of the investigational product, or require an elective surgery during the study; Subjects who have received strong CYP3A4 inhibitors or inducers and strong P-gp inhibitors or inducers within 2 weeks or within 5 half-lives (whichever is longer) prior to the first dose of the investigational product; Subjects with evidence of the following heart conditions: Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months prior to the first dose of the investigational product; Grade III-IV heart failure diagnosed according to the cardiac function classification of the New York Heart Association at screening; Echocardiography (ECHO) shows the left ventricular ejection fraction (LVEF) ≤ 50% at screening; QT interval corrected by Fridericia method (QTcF) is ≥ 450 ms (male) or ≥ 470 ms (female) at screening; Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) despite of medication treatment at screening; Subjects with dysphagia, gastrointestinal disorders that affect drug absorption, or other malabsorption conditions, such as intestinal obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome, delayed gastric emptying, or severe gastrointestinal toxicities that have not resolved to Grade 2 or lower prior to the first dose of the investigational product; or subjects are diagnosed with a clinically significant or acute gastrointestinal disease; Subjects with poorly controlled clinical pleural ascites assessed by the investigator; Subjects with active central nervous system metastasis and/or carcinomatous meningitis (e.g., brain metastases accompanied by central nervous system symptoms, including headache, vomiting and dizziness, etc.); Subjects with interstitial pneumonia, or any evidence of clinically active interstitial lung disease within 6 months before the first dose of the investigational product; Subjects with a history of other malignancies (excluding those deemed eligible by the investigator, such as skin squamous cell carcinoma in situ, basal cell carcinoma, and cervical cancer in situ that have been cured and have not relapsed for 5 years; or subjects deemed eligible by the investigator in Phase Ib); Subjects with a history of severe allergies, a history of allergies to Osimertinib, or to multiple drugs; Subjects with hepatitis B virus infection (HBsAg positivity and DNA copies < 100 IU/mL); or hepatitis C virus infection (HCV antibody positivity, and HCV RNA > ULN); or human immunodeficiency virus infection (HIV antibody positivity); Subjects with active infections requiring anti-infective treatment (Grade ≥ 2) or fever > 38°C of unknown etiology within 28 days prior to the first dose of the investigational product; Subjects with any toxicity caused by a previous antitumor therapy that has not resolved to Grade ≤ 1 according to CTCAE 5.0 (except for alopecia, Grade 2 peripheral neuropathy, and/or other Grade ≤ 2 AEs of insignificant safety risks) before the first dose of the investigational product; Female subjects who are pregnant or breastfeeding; Subjects who are not suitable for this study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06306443

Not yet recruiting

Buprenorphine for Individuals in Jail

This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.

- EligibilityCriteria: Inclusion Criteria: Adult male or female inmates at participating jail who are eligible for release within 120 days (sentenced and/or pretrial [note: individuals who might be sentenced to state/federal prison will be excluded]); Those individuals who are pre-trial and/or sentenced who are completing their sentence in the community (probation, parole, home detention, electronic monitoring, drug or other treatment court [or equivalent]) will be eligible to participate; History of opioid use disorder (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration); Suitability for XR-B and/or SL-B treatment as determined by medical evaluation; Willingness to enroll in XR-B or SL-B treatment in jail and continue in the community; Planning to live in Baltimore City or the Baltimore Region; Exclusion Criteria: Liver function test levels greater than 5 times normal (if we are unable to obtain labs, a determination by the study physician will be made to allow inclusion); Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; moderate to severe renal impairment; adequately treated medical conditions are acceptable); Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrythmics, antipsychotics and antidepressant); Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania; adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed); History of allergic reaction to buprenorphine; Suicidal ideation (within the past 6 months); Inability to pass a study enrollment quiz; and Currently receiving non-buprenorphine MOUD in jail (methadone, naltrexone). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06306430

Not yet recruiting

Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis

Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU).

- EligibilityCriteria: Inclusion Criteria: Inclusion criteria for PTB, PNTM and extraPTB: Adult subjects with documented active pulmonary TB, pulmonary NTM or extrapulmonary TB Subjects who have signed informed consent Aged ≥18 years Inclusion criteria for HC: healthy donors who have signed informed consent aged ≥ 18 years no TB or NTM risk factors or exposure Exclusion Criteria: Exclusion criteria for PTB, PNTM and extraPTB: Do not have active pulmonary TB, NTM or extrapulmonary TB Do not sign the informed consent Are aged < 18 years Exclusion criteria for HC: Have active pulmonary TB or NTM Do not sign the informed consent Are aged < 18 years - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects attending the Infectious Diseases Ward of the participating centers with a pulmonary TB, pulmonary NTM or extrapulmonary TB. Healthy controls, - SamplingMethod: Probability Sample

NCT06306417

Recruiting

A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome

To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients.

- EligibilityCriteria: Inclusion Criteria: For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL Exclusion Criteria: Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L) thyroid dysfunction and hyperprolactinemia. Type I diabetes or not well controlled type II diabetes Stage 2 hypertension (resting blood pressure ≥160/100mmHg) Psychiatric diagnoses or using psychiatric medications including antidepressants Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06306404

Not yet recruiting

Improving Sleep and Mood in the Peri-menopause

The perimenopause is known as a vulnerable period for some women, with noticeable somatic and psychological issues. Aside from climacteric symptoms, insomnia and depression are common. About half of women during the peri-menopausal period experience sleep problems like problems falling asleep, awakening during the night and being unable to return to sleep. This is often attributed to vasomotor symptoms, but this is not the only reason of poor sleep (Joffe et al., 2010). Also, the peri-menopausal period is a critical time for the occurrence of new onset and recurrent depressions (Cohen et al., 2006). It has been suggested that fluctuations in estradiol may increase the risk for depression by altering neuronal functions in the brain. But there are also indications that the risk for depression increases by indirect effects, such as the increase in insomnia. Poor sleep has increasingly been recognized as the key modifiable factor affecting mental issues like depression (Van Someren, 2021). While antidepressants and psychotherapies continue to be the treatments of choice for depression, and Cognitive Behavioral Therapy for sleep (CBTi) for insomnia, preclinical and clinical data support the benefits of estrogen-based therapies to improve mood, sleep and other menopause-related symptoms (Gordon et al. 2018). Transdermal estradiol patches, which provide a stable release of estradiol and lead to more stable blood levels, have been suggested to have a positive effect on sleep (Joffe et al., 2020) and depressive symptoms (Gordon et al., 2018) in randomized controlled trials. However, it is currently unclear if the relation between improvement in mood and estradiol patches is mediated by improvement in sleep problems, and if the effect of estradiol patches on sleep problems is more effective during peri-menopause than the current evidence-based sleep interventions of CBTi, preferably in combination with Circadian Rhythm Support (CRS). The aim of the study is to pinpoint the determinants of complaints about sleep and mood and how they respond to Menopausal Hormone Treatment (MHT) with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS. Measurements will be conducted at baseline (T0), 2 months (T1) and 4 months (T3), with questionnaires, sleep measurements (EEG sleepband and actigraph) and skin conductance (to measure hot flushes). Participants will be recruited via www.slaapregister.nl and via OLVG outpatient clinic population of peri-menopausal women seeking help for climacteric complaints (like hot flushes, feeling bloated, increase in weight), including sleep problems. The participants are adults between 40-55 years old, with an Insomnia Severity Index score ≥10 and Climacteric Green Scale score ≥ 13.They have the self-considered capability to complete online questionnaires and diaries in Dutch. The intervention will be MHT (estradiol transdermal patches 50 mcg (Systen), in combination with 200 mg progesterone (Utrogestan tablets for 2 weeks, adjusted to the menstrual cycle to prevent endometrium carcinoma according to the international MHT guidelines), with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS.

- EligibilityCriteria: Inclusion Criteria: Age between 40-55 years old Insomnia severity index score =>10 Green Climacteric Score =>13 Self-considered capability of completing online questionnaires and diaries in Dutch Exclusion Criteria: CBTi treatment in past 3 months Bipolar disorder or psychotic disorder Contra-indication for Menopausal Hormonal Therapy Use of hormonal anti-conception - HealthyVolunteers: No - Gender: Female - MinimumAge: 40 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06306391

Recruiting

Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers.

This is a phase I interventional clinical trial and the aim will be to characterize the PK and PD of two formulations of naloxone (intranasal and intravenous) in healthy subjects, which will be used to verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing.

- EligibilityCriteria: Inclusion Criteria: Healthy male or female volunteers according to physical examination, vital signs (blood pressure, heart rate and body temperature), ECG and safety laboratory parameters and results should be within normal ranges or considered as non-clinically relevant by the investigator. Age ≥ 18 and ≤ 55 years. Body mass index (BMI) ≥ 18 and ≤ 30. Able/willing to be compliant with the study restrictions. Able to read Spanish and adhere to study requirements. Signed informed consent prior to any study-mandated procedure. Exclusion Criteria: Life-time substance use disorders (SUD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Consumption of prescribed opiates (in the last 6 months). Smoking. History of or ongoing clinically relevant diseases or conditions. Being under any administrative or legal supervision. Pregnancy and breastfeeding Positive blood or urine test for drugs of abuse or alcohol breath test prior to study drug administration. Life-time history of mental diseases. History of anxiety or depression not completely recovered within 12 months prior to study drug administration, as assessed by the Dual Diagnosis Screening Interview (DDSI). Any other clinically relevant disease or condition that in the judgment of the investigator might interfere with the subject's ability to comply with study procedures or requirements and/or bias the interpretation of the study results and/or jeopardize the subject's safety. Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption. Subjects with a clinically significant disease within one month prior to study drug administration. Any clinically relevant findings in physical examination, vital signs, 12-lead ECG and safety laboratory parameters. Positive hepatitis or HIV test. Known hypersensitivity to any drug or drug excipients. Use of drugs known to induce or inhibit hepatic drug metabolism (e.g., cimetidine) within one month prior to study administration or during the study and use of citrus juice during the study. Any prescription or over-the-counter (OTC) product including herbal, homeopathic, vitamins, minerals and nutritional supplements within one week prior to study drug administration. Intake of foods or beverages containing xanthine (more than 5 units of coffee, tea or cola drinks per day). Donation of blood or plasma within one month prior to study drug administration or transfusion of blood or plasma for medical/surgical reasons or intention to donate blood or plasma within one month after study drug administration. History of inadequate venous access and/or experience of difficulty donating blood. Subject included in a clinical study within 3 months prior to study drug administration. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06306378

Recruiting

The Relationship Between Social Memory Disorders and Sleep Spindles in Children With Autism Spectrum Disorder

Research background and project basis Autism spectrum disorder (ASD) is a lifelong neurodevelopmental disorder characterized by social disorders and repetitive stereotypical behavior. Social memory impairment is a significant feature of ASD patients, and the specific pathogenesis of social memory impairment in ASD patients is currently unclear, and there are no objective indicators to measure social memory levels. Sleep spindle wave is a special brain wave in sleep that is closely related to memory consolidation. However, no one has yet studied the impact of sleep spindles on social memory. Research purpose Exploring the correlation between sleep spindles and social memory in the population, providing reference for the auxiliary diagnosis of social memory disorders in children with ASD.

- EligibilityCriteria: Inclusion Criteria: Children with ASD diagnosed through DSM-V (Healthy controls do not have this requirement) IQ score ≥ 75（WISC-IV，Wechsler Intelligence Scale for Children） Age: 6-18 Not receiving psychotropic medication (Or stopping medication for at least 2 weeks before the experiment) Exclusion Criteria: In addition to ASD, other mental illnesses are also combined Presence of a sleep disorder, sleep apnea, periodic leg movements during sleep, or atypical EEG patterns Left handed - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: It is expected to recruit 60 participants aged 6-18, of which 30 in the case group are all inpatient and outpatient cases from Xi'an Traditional Chinese Medicine Brain Disease Hospital, and are designated as ASD according to unified diagnostic standards; The healthy control group consists of 30 individuals from nearby community kindergartens and primary schools at Xi'an Traditional Chinese Medicine Brain Disease Hospital, who have not suffered from ASD or other diseases related to ASD research factors. - SamplingMethod: Non-Probability Sample

NCT06306365

Recruiting

Effects of Modern Board Games on Well Being in Older Adults

The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being.

- EligibilityCriteria: Inclusion criteria: Be residents of the Centro Doctor Villacián (Valladolid). Willing to commit to the study. Have literacy skills. Exclusion criteria: · Presentation of advanced dementia case. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 65 Years - MaximumAge: 120 Years - StdAgeList: Older Adult

NCT06306339

Not yet recruiting

A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug)

The goal of this clinical trial is to evaluate the efficacy and safety of intravenous infusions of burfiralimab (hzVSF-v13) when added to Disease-Modifying Antirheumatic Drug (DMARD) treatment as Standard of Care (SOC) in participants with moderate to severe Rheumatoid Arthritis (RA).

- EligibilityCriteria: Inclusion Criteria: Participant has a diagnosis of adult-onset RA for at least 3 months prior to Screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria. Participant has moderate to severe RA at Screening and Baseline. Participant has had an inadequate response to, loss of response, or intolerance to at least 2 bDMARDs or tsDMARDs. Participant is positive for anti-citrullinated protein antibodies (ACPA). Participant has a C-reactive protein (CRP) > upper limit normal (ULN) (5.0 g/L). Participant has a negative tuberculosis test at Screening, defined as either negative QuantiFERON® test or purified protein derivative <5 mm of induration at 48 to 72 hours after the test was placed. Exclusion Criteria: Participant has Class IV RA according to ACR revised response criteria. Participant has 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to the following: Poorly controlled diabetes or hypertension, Chronic kidney disease stage IIIb, IV, or V, Symptomatic heart failure according to New York Heart Association Classes II, III, or IV, Myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack, within the past 12 months before randomization, Severe chronic pulmonary disease, for example, requiring oxygen therapy, Clinically significant hepatic diseases (i.e., hemochromatosis, Wilson's disease, alcoholic hepatitis, autoimmune liver disease, nonalcoholic steatohepatitis, or α-1-antitrypsin deficiency, Participant has known history of prosthetic or native joint infection or human immunodeficiency virus or neurologic symptoms suggestive of central nervous system demyelinating disease. Participant has a chronic inflammatory disease or connective tissue disease other than RA, including but not limited to; systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non radiographic axial spondylarthritis, reactive arthritis, gout, scleroderma, polymyositis, dermatomyositis and/or active fibromyalgia and/or multiple sclerosis. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06306326

Not yet recruiting

3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities

Treatment of craniofacial deformities is a significant topic in oral and maxillofacial surgery, and autologous fat grafting has become one of the main methods for treating facial concave deformities. However, the instability of its treatment effect has always been a bottleneck in this field, mainly due to the uncertain absorption rate of transplanted fat. This project aims to use advanced the 3dMD face system (3dMD) (3dMD Inc, Atlanta, Ga) technology to precisely measure the facial volume changes before and after autologous fat grafting to address this issue. By performing autologous fat grafting surgery on 100 patients with craniofacial deformities that meet the research criteria, 3dMD technology will be used for facial three-dimensional scanning preoperatively, immediately postoperatively, and at six months postoperatively to obtain facial volume data. Then, through precise data analysis, we will calculate the fat absorption rate and study the effects of individual factors on treatment outcomes through correlation regression analysis.

- EligibilityCriteria: Inclusion Criteria: Facial soft tissue volume deficiency deformity caused by congenital/acquired factors, meeting the indications for autologous fat grafting surgery. Good physical health, without severe systemic diseases or infectious diseases. Not pregnant and without plans for pregnancy. Signed informed consent form. Exclusion Criteria: Contraindications to general anesthesia. Patient refusal to participate in this study. Significant contour changes in non-filled facial areas during follow-up period leading to inability to register data. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 3 Years - MaximumAge: 80 Years - StdAgeList: Child, Adult, Older Adult

NCT06306313

Not yet recruiting

Effects of Robot-Assisted Rehabilitation on Upper Extremity Functions in Chronic Stroke

The most common problem caused by stroke is motor activity limitation that reduces muscle movement and mobility. But stroke can also lead to sensory and cognitive impairment. Additionally, the ability to independently carry out activities of daily living and participate in social and community life is greatly reduced. Up to 85% of stroke patients experience hemiparesis immediately after stroke, while 55% to 75% of survivors continue to experience reduced quality of life with motor impairments. It requires long-term physical rehabilitation to achieve functional recovery in the upper extremity, maximum independence and the highest possible quality of life. Different methods can be used to achieve these results, but there is no clear evidence yet as to which treatment method gives the best results. Scientific evidence shows that a multifactorial approach and high-intensity treatment accelerates the motor recovery of the upper extremities in stroke rehabilitation. Passive and active upper extremity movements appear to increase motor recovery due to their effects on somatosensory input, motor planning, soft tissue properties and spasticity. In recent years, robotic devices have emerged that have been proven to improve the motor performance of the upper extremity in chronic stroke patients. There are also studies showing that robotic device-assisted upper extremity therapy can contribute to the development of sensorimotor skills in plegic patients. However, in the current literature, there is still a need for randomized controlled studies in this field. The aim of this study is to investigate the effects of robot-assisted therapy on upper extremity functions and daily living activities in the rehabilitation of chronic stroke patients. After the demographic data of the cases in both groups are obtained, evaluations will be made before the study. Then, the study group will receive conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks, and in addition robot-assisted therapy with the ReoGo Upper Extremity Exoskeleton Robot in a single session of 60 minutes a day, 5 days a week for 4 weeks. The control group will receive only conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks. The initial evaluations will be repeated after the end of the treatment period.

- EligibilityCriteria: Inclusion Criteria: Having had a single stroke Having had at least 6 months since the stroke Having hemiparesis/hemiplegia following the stroke Having mental health sufficient to meet all evaluation and treatment procedures in the study Exclusion Criteria: Having a history of disease other than stroke that affects the use of the upper extremity - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - StdAgeList: Adult, Older Adult

NCT06306300

Recruiting

Randomized Open-label and Non-inferiority Clinical Trial

Up to 650,000 people in Brazil are living with chronic hepatitis c virus (HCV) infection. Hepatitis C is a silent disease, and up to 20% of cases can progress to liver cirrhosis and its complications. Rapid tests for diagnosis of HCV infection and non-invasive methods for detecting liver cirrhosis are available in the Brazilian Public Health System. Additionally, safe and highly effective drugs (direct-acting antivirals, DAAs) have been delivered for free for hepatitis C treatment by the Brazilian Unified Health System (Sistema Único de Saúde, SUS) since 2015. Sustained virological response (SVR) rates with DAAs in studies conducted in Brazil and Latin America were higher than 90%. Despite the availability of rapid tests for early diagnosis and effective drugs, the HCV continuum of care remains deficient in Brazil. It is estimated that only 10% of individuals known to have hepatitis C achieve HCV cure (SVR). This is explained by multiple barriers from diagnosis to treatment access, such as low rates of population screening (HCVST are not available in Brazil) and few available slots in tertiary centers for hepatitis C treatment by specialists. International studies have described that SVR rates by simplified hepatitis C treatment performed by non-specialists in the Primary Care System were similar to those treated in tertiary centers by specialists (standard-of-care). However, the optimal strategy for managing hepatitis C within the Brazilian-SUS remains unclear.This project aims to evaluate the improve of the HCV continuum of care by a implementation of a test-and-treat strategy in the Primary Care System in Brazil. The project consists of two parallel studies (and a sub-study). The project consists of two parallel studies (and a sub-study). Study I is a population-based cross-sectional screening study using rapid tests to determine the prevalence of HCV infection in people attending a Basic Health Care Unit. The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (participants included in Study I). Study II is a phase IV open-label randomized clinical trial to evaluate the non-inferiority of simplified and decentralized hepatitis C treatment ("Simplified-and-Decentralized (SD) HCV treatment"; experimental arm) compared to specialist reference treatment ("Standard-of-Care (SC) HCV treatment"; control arm) within the SUS.

- EligibilityCriteria: Study I and Sub-Study Inclusion Criteria: - Age between 18-79 years-old Exclusion Criteria: Presence of a disease that need urgent/emergency treatment and/or acute febrile illness, such as COVID-19, Dengue, Zyca virus infection or Chikungunya Lack of capacity to sign the informed consent or refuse to participate Study II Inclusion Criteria: Age between 18 and 79 years old. Presence of active/chronic hepatitis C, defined by a positive HCVab test and detectable HCV-RNA Exclusion Criteria: Children and adolescents (< 18 years old) Pregnancy, defined by a positive β-HCG urinary test Lactating individuals Co-infection with HBV or HIV Regular use of medications with potential drug interactions or contraindication for co-administration with SOF/VEL Presence of severe acute illness, active neoplasia, solid organ transplant, or use of immunosuppressive medications Presence of clinical signs of decompensated liver cirrhosis (ascites, hepatic encephalopathy, report of a recent episode of gastrointestinal bleeding within the last 12 weeks) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 79 Years - StdAgeList: Adult, Older Adult

NCT06306287

Recruiting

Adolescent Screening and Personalized Intervention Resource for Enhancement of Behavioral Health and Substance Use

Only a small fraction of youth who are beginning to experience behavioral health problems and use alcohol or illicit drugs receive needed treatment services due to the lack of accessible, effective early intervention resources. The goal of this clinical trial is to compare a personalized brief web-based early intervention, eHealth Personalized Approach for Change Efficacy (ePACE), in which youth are offered choices regarding intervention content and desired level of engagement, to a "fixed", non-tailored brief intervention, eHealth Fixed Approach for Change Efficacy (eFACE) for adolescents with mild/moderate substance use and common co-occurring problems. Both ePACE and eFACE include a multi-problem screener that guides youths through a set of key integrated behavior change and counseling modules providing a cohesive focus on these four problem domains: drug abuse, interpersonal relations, negative emotions and stress. The main questions the trial aims to answer are: Are substance use and co-occurring problem outcomes for ePACE and eFACE are superior to those for a waitlist comparison group (WC) Are outcomes for ePACE are superior to those for eFACE Are the direct effects of ePACE and eFACE (i.e., the improvements in substance use and co-occurring problem outcomes) associated with improvements in areas of functioning and new skills that are hypothesized to produce change -- that is, are the improvements shown in the ePACE and eFACE groups due to the mechanisms by which change is hypothesized to occur Participants in ePACE and eFACE will complete a baseline assessment prior to engaging in the intervention to which they are assigned and will complete post-intervention assessments 3 months and 6 months later. Participants in the WC group will complete three assessments: at baseline, 3-months, and 6-months.

- EligibilityCriteria: Inclusion Criteria: 12-17-years old live at home with at least one parent or parent figure reporting mild/moderate substance use reporting mental health issues sufficient English language skills for assessments and intervention Exclusion Criteria: a sibling has already participated in the study evidence of psychotic or organic state high problem severity indicating possible need for higher level of care - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - GenderBased: Yes - MinimumAge: 12 Years - MaximumAge: 17 Years - StdAgeList: Child

NCT06306274

Not yet recruiting

Topical Tacrolimus for Breast Cancer-related Lymphedema

The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are: How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life). If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months.

- EligibilityCriteria: Inclusion Criteria: Age over 18 years BCRL ISL stage I or II Pitting edema Postmenopausal or use of Contraceptive drugs Healthy opposite arm L-Dex score over 10 Exclusion Criteria: Pregnant, breast-feeding, or aiming to conceive within the next year Bilateral breast cancer Contralateral lymphadenectomy Allergy to tacrolimus, macrolides, or iodine Pacemaker Known kidney or liver disease - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06306261

Not yet recruiting

Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis

The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists.

- EligibilityCriteria: Inclusion Criteria: - Patients in whom the ulcerative colitis has been diagnosed and eligible for advanced therapies Patients will be asked to sign an informed consensus before filling out the questionnaire. Exclusion Criteria: - Patients in whom the ulcerative colitis has not been diagnosed. All those who have not signed previously informed consensus. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 150 patients affected by UC under the standard of care protocols at OSR, will be subjected to a questionnaire each 30 days about their habits. - SamplingMethod: Probability Sample

NCT06306248

Recruiting

Immune Activation, Neural Plasticity and Depression

Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.Increasing evidence indicates a clear link between immune dysfunction and MDD.Moreover, an activation of inflammatory pathways is associated to a lack of clinical response to antidepressants. Thus, the regulation of inflammation represents a potential approach to modulate the link between the living environment and antidepressant outcome. Light therapy combined with sleep deprivation hastens recovery, with benefits that can be perceived by patients during the first week of treatment. Alteration of the sleep-wake cycle and of sleep structure are core symptoms of MDD.The aims of the present project are (i) to show that neural plasticity and the environmental context are moderating factors of the therapeutic outcome of immune modulation and (ii) to exploit their interplay to set up novel and effective therapeutic strategies for MDD.This is a observational prospective study with non-invasive add-on procedures (Magnetic Resonance without contrast). In this study, 60 patients with a depressive episode in course of MDD and treated with a chronobiological intervention including total sleep deprivation (TSD) + light therapy (LT), as performed in clinical practice, will be studied. All participants enrolled in the study will receive Treatment As Usual (TAU), i.e., pharmacotherapy, chronobiological intervention plus clinical management. Drug prescription will be performed during the clinical management sessions.The study will have a total duration of 24 months. Each subject will participate in the study for 6 months, will undergo Magnetic Resonance Imaging (MRI) and clinical evaluation at baseline, after one week of chronobiological treatment and at 6 months follow-up.

- EligibilityCriteria: Inclusion Criteria: A depressive episode according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria in the course of MDD with: HDRS score > 17 Age 18-65 years; In treatment with TSD+LT Signed informed consent, able to understand, speak and write the national language Exclusion Criteria: History of bipolar disorder, schizophrenia, schizoaffective disorder, psychosis not otherwise specified; anorexia or bulimia nervosa; Taking following medications: antipsychotics, anticonvulsants, mood stabilizers; stimulants Active infection requiring antibiotics therapy; Immunosuppressed patient or other chronic diseases Signs of active infection requiring treatment Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder. Forbidden treatment: corticosteroids, Non Steroidal Anti-inflammatory Drugs, immunosuppressant IV-Ig based treatment Ongoing fever, infection treated by antibiotics or uncontrolled diabetes type I or II; Existing cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer); Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), Parkinson's or Alzheimer's disease, or any other serious condition likely to interfere e with the conduct of the trial; Abuse of drugs or alcohol in the past 6 months Other exclusion criteria related to the MRI procedure include Aneurysm clip Implanted neural stimulator Implanted cardiac pacemaker or auto-defibrillator Cochlear implant Ocular foreign body (e.g., metal shavings) Any implanted device (pumps, infusion devices, etc) Shrapnel injuries - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients diagnosed with major depressive disorder - SamplingMethod: Non-Probability Sample

NCT06306222

Recruiting

Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease

This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL.

- EligibilityCriteria: Inclusion Criteria: Renal/ureteral stones > 4 mm Exclusion Criteria: Anatomical abnormalities - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult

NCT06306209

Recruiting

Inflammatory Control of Antidepressant Efficacy: a Pharmaco-epigenetic Approach

Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.It posits that the increase in serotonin levels induced by Selective Serotonin Reuptake Inhibitors (SSRIs) does not affect mood per se, but enhances brain plasticity and thus amplifies the influence of the environment on the individual. Thus, SSRI treatment has not a univocal effect but, in a favorable environment, it would lead to a reduction of symptoms while in a stressful environment might lead to a worse prognosis.Such innovative view opens new perspectives on how to improve SSRI efficacy by controlling the environment. However, often it is not possible to act on the quality of the living environment because of constraints due to patient's personal history and unchangeable life circumstances. In these cases, the pharmacological modulation of the factors underlying the link between living environment and SSRI efficacy represents a novel and desirable strategy to improve treatment outcome even in patients living in adverse conditions, which are very common in depressed patients. Inflammatory levels are markedly affected by the socioeconomic status and thus by the quality of the living environment. The hypothesis of the present project is that inflammation mediates the influence of the environment on SSRI outcome.Therefore, the control of inflammatory levels is a promising strategy to improve treatment efficacy and overcome the limited SSRI efficacy, especially when administered in patients living in adverse conditions. A further hypothesis is that the influence of the environment on inflammation, in turn affecting SSRI efficacy, occurs through epigenetic modifications. Therefore, the project aims at developing a pharmaco-epigenetic approach as effective treatment for MDD. In addition, through neuroimaging investigations, it will provide important information about functional and structural brain modifications associated to SSRI efficacy in patients. Both males and females will be considered because MDD is twice as common in women than men, suggesting that different mechanisms may underlie the psychopathology in the two sexes.

- EligibilityCriteria: Inclusion Criteria: A depressive episode according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria in the course of MDD with: HDRS score > 17 Age 18-65 years; In treatment with SSRIs Signed informed consent, able to understand, speak and write the national language Exclusion Criteria: History of bipolar disorder, schizophrenia, schizoaffective disorder, psychosis not otherwise specified; anorexia or bulimia nervosa; Taking following medications: antipsychotics, anticonvulsants, mood stabilizers; stimulants Active infection requiring antibiotics therapy; Immunosuppressed patient Other chronic diseases Signs of active infection requiring treatment Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder. Forbidden treatment: corticosteroids, Non Steroidal Anti-inflammatory Drugs, immunosuppressant IV-Ig based treatment Ongoing fever, infection treated by antibiotics or uncontrolled diabetes type I or II; Existing cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer); Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), Parkinson's or Alzheimer's disease, or any other serious condition likely to interfere e with the conduct of the trial; Abuse of drugs or alcohol in the past 6 months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients are always informed on currently ongoing and upcoming (clinical) duties during their regular outpatient clinic visits and at the first interview during hospitalization - SamplingMethod: Non-Probability Sample

NCT06306196

Not yet recruiting

Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children

The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals

- EligibilityCriteria: Inclusion Criteria (healthy participants only): Healthy participants 2 to 45 years of age at enrollment, Participants/Parent(s)/LAR who have voluntarily given informed consent/assent, Participants/Parent(s)/LAR willing to follow the study procedures and available for the entire duration of the study and agrees to the collection of all biospecimens, HIV negative, Not pregnant, Agreement to practice effective contraception for female participants of childbearing potential and non-sterile males until at least 8 months after the first vaccination. Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose of vaccine, and Female participant not currently breastfeeding. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Has received any hepatitis E vaccine in the past, Febrile illness (body temperature ≥ 38°C) or acute illness within 3 days prior to the study vaccination, Known history or allergy to study vaccine components and/or excipients or other medications, or any other allergies or medical history deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial (e.g., Guillain-Barre Syndrome), Major congenital abnormalities which in the opinion of the investigator may affect the participant's participation in the study, Known history of immune function disorders including immunodeficiency diseases (known HIV infection or other immune function disorders) and lupus, Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs within the past 6 weeks, Any abnormality or chronic disease which in the opinion of the investigator might be detrimental to the safety of the participant and interfere with the assessment of the study objectives, Behavioral or cognitive impairment, chronic substance abuse, or psychiatric disease or neural disorders, that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial, History of splenectomy, History of thrombocytopenia and/or thrombosis, myocarditis or pericarditis or any other significant cardiac condition, With a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections/blood extractions., Receipt of blood or blood-derived products in the past 3 months, Receipt of other vaccines from 4 weeks prior to test vaccination or planned to receive any vaccine within 4 weeks of last dose of study vaccine, Concomitantly enrolled or scheduled to be enrolled in another trial, Research staff involved with the clinical study or family/household members of research staff, Body mass index (BMI) of ≥ 40 in adults and for children a BMI- index-for-age is ≥95th percentile, at the time of the screening visit, or As per the Investigator's medical judgement, an individual could be excluded from the study despite meeting all inclusion/exclusion criteria mentioned above. Inclusion criteria for HIV-positive arm: Adults 18-45 years living with HIV on anti-retroviral (ARV) treatment and willing to have CD4 and viral load measured as per protocol, Able to provide a voluntary signed informed consent, Participants willing to follow the study procedures of the study and available for the entire duration of the study and agrees to the collection of all biospecimens, Agreement to practice effective contraception for female participants of childbearing potential and non-sterile males until at least 3 months after the last vaccination. Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the last dose of vaccine, and Female participant is currently not breastfeeding. Exclusion Criteria for HIV-positive arm: An individual who meets any of the following criteria will be excluded from participation in this study: Has received any hepatitis E vaccine in the past, Newly diagnosed HIV-positive (diagnosed on screening) on ARVs for 0-4 weeks (Note: These participants can be re-screened and enrolled once they have been on ARVs for 4 weeks), Febrile illness (body temperature ≥ 38°C) or acute illness within 3 days prior to the study vaccination, Serious adverse reaction to any vaccine, or any component of the investigational vaccine, including a history of anaphylaxis and symptoms of a severe allergic reaction and history of allergies in the past, Current hospitalization, History of inherited blood disorders, heparin-induced thrombocytopenia, or thromboembolic disorders, History of any blood product transfusion up to 6 months before enrolment, Receipt of other vaccines from 4 weeks prior to test vaccination or planned to receive any vaccine within 4 weeks of last dose of study vaccine Currently taking anti-coagulation therapy, or chronic aspirin in the past 3 months, Pregnant or breastfeeding women throughout the study period, Extreme obesity (defined as BMI of 40 kg/m2 or higher), Chronic kidney disease requiring dialysis, Liver disease (Note mild chronic liver disease is not an exclusion criterion), Participants with acquired or hereditary immunodeficiencies other than HIV, History of hereditary, idiopathic, or acquired angioedema, No spleen or functional asplenia, Platelet disorder or other bleeding disorder that may cause injection contraindication, Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, or immunomodulators. The use of low dose topical, ophthalmic, inhaled, and intranasal steroid preparations will be permitted, According to the judgement of the investigator, the participant has any other factors that might interfere with the results of the clinical trial or pose additional risk due to participation in the study, Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 2 Years - MaximumAge: 45 Years - StdAgeList: Child, Adult

NCT06306183

Not yet recruiting

Effect of Vitamin C on Pain Reduction After an Emergency Department Visit

Emergency department (ED) clinicians often prescribe anti-inflammatory drugs (NSAIDs) to manage acute musculoskeletal (MSK) pain (e.g.: fracture, sprain, back pain). However, even short-term NSAIDs use can have significant gastrointestinal, cardiovascular, MSK and renal adverse effects. For this reason, some patients cannot take or tolerate NSAIDs. Recent evidence has shown that vitamin C has some analgesic and anti-inflammatory properties particularly in postoperative context and prevent specific types of chronic pain. Furthermore, vitamin C is safe and associated with very few adverse events. The primary objective of this study is to determine whether vitamin C can reduce pain intensity during a seven-day period following an ED visit for acute MSK pain. The investigators propose to compare two groups of patients, one receiving 900 mg of vitamin C to another receiving a placebo, twice a day for seven days. Both groups will consume acetaminophen slow release 650 mg two pills every eight hours regularly. Naproxen 500 mg (NSAID) will be used as a rescue medication if the patient's pain is not relieved. Participants will be ≥18 years of age, treated in ED for acute MSK pain present for less than 48 hours with pain intensity at triage of ≥ 4 on a 0-10 numeric rating scale, and discharged by an ED clinician with an NSAIDs prescription without opioids. The level of pain intensity during a seven-day period will be assessed daily using an electronic or paper diary, as well as pain relief, pain medication consumption, and adverse events. Three months after the injury, participants will also be contacted to assess the presence of chronic pain. The investigators hypothesized that vitamin C will reduce pain intensity and chronic pain development at three months. This research could provide a safe alternative to patients who are unable to take NSAIDs. It may also contribute to the reduction of the burden associated with chronic pain development.

- EligibilityCriteria: Inclusion Criteria: Age ≥ 18 years old Treated in the ED for acute MSK pain present ≤ 48 hours at triage (time to presentation for most acute MSK pain in our previous study) Numerical rating scale (NRS) pain intensity at triage of ≥ 4 on a 0-10 scale Discharged with instructions to take an NSAID for pain (need determined by treating clinicians) French or English-speaking Exclusion Criteria: Received an opioid prescription at ED discharge Currently using vitamin C supplements Active cancer Currently treated for chronic pain Unable to fill out a diary or unavailable for follow-up Allergy, to milk (lactose in the placebo), vitamin C, acetaminophen or NSAIDs Treated with cyclosporine or warfarin (interaction with vitamin C) Pre-existing oxalate nephropathy, liver cirrhosis or hemochromatosis Pregnant ≥ 20 weeks. - HealthyVolunteers: No - Gender: All - GenderBased: Yes - GenderDescription: Gender is self identified by participants. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06306170

Recruiting

Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)

This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed.

- EligibilityCriteria: Inclusion Criteria: gynecologic cancer patients >18 years old treated with advanced radiotherapy techniques (IGRT, IMRT, SBRT) Exclusion Criteria: other tumors > 90 years old - Gender: Female - GenderBased: Yes - GenderDescription: Gynecologic tumor patients - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Gynecologic cancer patients, > 18 years old, treated with IGRT, IMRT, SBRT - SamplingMethod: Probability Sample

NCT06306157

Not yet recruiting

Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome

Complex Regional Pain Syndrome (CRPS) is a rare and often debilitating chronic pain condition whereby individuals may experience extreme sensitivity, discoloration, and swelling of the affected area -- along with numerous other painful symptoms. There are currently a limited number of treatment options available to those suffering with the condition, with various treatments including nerve blocks, neuropathic medications, and desensitization physical therapy modules. There is budding interesting in the role naltrexone, an opiate antagonist, may play in the pain management of CRPS when prescribed in very low doses. This study aims to collect preliminary data on pain scores, symptom severity, and side-effects in patients with Complex Regional Pain Syndrome randomized to receive low dose naltrexone or placebo capsules. Enrollment of 40 patients total will occur over two years from study start to study end. Each patient will be randomized to receive placebo capsules or active low dose naltrexone capsules, with both the patient and treating clinician blind to the randomization. Each patient will be actively enrolled in the study for six months and will take the medication daily at the instructed dose for the respective duration of time. Following the initial visit and study enrollment, the investigators are asking each patient to return for three (3) in-person follow-up office visits. These office visits will occur 1 month after the patient starts the medication, 3 months afterwards, and 6 months afterwards. The final 6-month office visit will mark the conclusion of the patient's active participation in the study.

- EligibilityCriteria: Inclusion Criteria: Between 18 and 65 years old Meeting CRPS diagnostic criteria using the Budapest Clinical Diagnostic Criteria CRPS patients with severe pain (NRS>3) that affects their daily life. CRPS patients with pain and other symptoms for more than 3 months. Exclusion Criteria: Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (MRI, CT). Systemic or local infection Malignancy Current or planned pregnancy within the study period. Uncontrolled medical and psychiatric condition Patients with known liver issues, including but not limited to end-stage liver disease, severe cirrhosis or an acute hepatic state. Patients who are currently using opioid drugs Patients who are currently using alcohol or considering using alcohol during the study period. Allergy to naltrexone or naloxone - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06306144

Not yet recruiting

Early-phase Telecare Programs for Minor Stroke

Minor strokes (few acute neurological symptoms ; NIHSS score <5), represent almost 65% of cerebrovascular ischemic events. The increasing incidence of stroke in people under 65, together with advances in diagnostic and revascularization techniques, mean that post-stroke life expectancy is now in the order of decades. Most patients with minor stroke are rapidly discharged from hospital, with follow-up focused on secondary prevention and they are offered little or no rehabilitation. However, up to 70% of patients with minor stroke experience difficulties resuming their social or professional activities, which can lead to social and economic disruption (delayed/compromised return to work) and an increased risk of depression. While some care recommendations exist for this population, in France there is no consensus nor identified care pathway for follow-up assessment or management of these patients. Furthermore, existing services are unevenly distributed across the country, and research into the effectiveness of rehabilitation is still scarce, leading to uncertainty as to which interventions should be prioritized to decrease difficulties related to cognitive impairment. Since there are currently no rehabilitation proposals in France for patients with mild cognitive impairment after mild stroke, in this trial the investigaror will investigate the effectiveness of two six-week telerehabilitation programs each consisting of a weekly session supervised by a therapist and a self-rehabilitation session. The aim of this multicenter randomized controlled trial is the evaluate the relevance and feasibility of early identification of patients eligible for a cognition-focused management proposal and the efficacy of two telecare programs, (a) psychoeducation and (b) computerized cognitive rehabilitation.

- EligibilityCriteria: Inclusion Criteria: Minor cerebrovascular accident (CVA): NIHSS score < 5 upon discharge from the neurovascular unit Hospitalization for a first stroke Patient over 18 years old and under 65 years old Post-stroke time < 8 weeks Living at home (not institutionalized) Affiliated with social security or benefiting from such a scheme French language Presence of a cognitive complaint (Score on the "perceived cognitive impairments" subscale of the FACT-Cog < 55) and absence of major cognitive disorder Signature of informed consent Exclusion Criteria: History of stroke Uncorrected hearing or visual deficit Neurological pathology other than stroke or disabling psychiatric disorder Unstabilized epilepsy Patient following cognitive rehabilitation in another context or having integrated a post-stroke ETP program Patient residing in a white zone that does not allow the implementation of remote rehabilitation Patient unable to connect to the internet Pregnant, parturient or breastfeeding women* (interview data) Persons deprived of liberty by a judicial or administrative decision Persons admitted to a health or social establishment for purposes other than research Adults subject to a legal protection measure (guardianship, curatorship) Subject participating in another interventional research including an exclusion period still ongoing at pre-inclusion,… - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06306131

Recruiting

Phase II Study of Ovulation in Obese Women

The goal of this clinical trial is to compare the delay in ovulation between placebo to levonorgestrel plus meloxicam in obese women with normal menses. The main questions it aims to answer are: Ovulation will be delayed by ≥7 days following the first dose of levonorgestrel plus meloxicam compared to ovulation within 3 days following the first dose of placebo. There will be no difference in unscheduled vaginal bleeding or adverse events between the two treatments [placebo versus levonorgestrel plus meloxicam]. Participants will: undergo two treatment cycles the 1st uses placebo and the 2nd is levonorgestrel plus meloxicam, maintain daily diary logs for adverse events, unscheduled bleeding, and onset, cessation, and amount of menstrual bleeding, collect daily first morning voided urine from menstrual day 9 to 24, undergo transvaginal ultrasound for ovarian follicle development on menstrual days 9, 11,13 and 14. allow a blood sample to be drawn on days with ultrasound scans. Take 1st placebo and levonorgestrel plus meloxicam under observation when dominant ovarian follicle is 17 ±1.0 millimeters (mm) in diameter and 2nd dose 48 hours later. Researchers will compare the placebo cycle to levonorgestrel plus meloxicam to see if ovulation is delayed, there is unscheduled vaginal bleeding, menstrual onset is delayed or there is an abnormal amount or duration of menses, there is any difference in treatment emergent side effects and any change in vital signs

- EligibilityCriteria: Inclusion Criteria: Female in good general health with no chronic medical conditions that result in periodic exacerbations that require significant medical care. Age between 18 to 40 years inclusive at time of enrollment. BMI ≥30 kg/m² and no recent rapid weight loss or gain. Intact uterus with both ovaries intact. Papanicolaou test within American Society for Colposcopy and Cervical Pathology (ASCCP), or American College of Obstetricians and Gynecologists (ACOG) guidelines such that additional testing or evaluation will not be required during the study period. If there is no copy of a recent Papanicolaou test and the subject is 21 years or older a Papanicolaou test should be done during the screening visit. Regular menstrual cycles with an interval of 24 to 32 days: If postpartum or post-second trimester abortion, she must have 2 spontaneous menses prior to enrollment. If the subject has had a first trimester pregnancy loss or abortion, she must have one spontaneous menses prior to enrollment. Have a negative urine pregnancy test on menstrual cycle day 9 pre-treatment visit. Not at risk of pregnancy for the duration of the study defined as heterosexually abstinent, prior female or male permanent contraception, non-hormonal intrauterine device or willing to use a non-hormonal barrier contraceptive method with each act of intercourse until study exit. Subject is willing and able in the Investigators opinion of complying with protocol requirements. Subject is willing to collect daily first morning urines and store them until brought to the study site. Lives within the study catchment area or a reasonable distance from the study site. Understands and signs the IRB approved informed consent prior to undergoing any screening assessment. Agrees not to participate in any other clinical trials during the course of this study. Screening serum progesterone level greater than 3 ng/ml.- Exclusion Criteria: Known hypersensitivity or contraindications to progestins. Abnormal transvaginal ultrasound or safety laboratory results evaluated during the screening period recognized as clinically significant by the investigator or medically qualified designee. Known or suspected alcohol or marijuana abuse. Undiagnosed abnormal genital bleeding. Undiagnosed vaginal discharge, lesions or abnormalities. Women with a history of genital herpes can be included if the outbreaks are infrequent. Antiviral prophylaxis is allowed. Uncontrolled Thyroid disorder. Current use of hormonal contraception or a levonorgestrel releasing intrauterine device. Use of a long-acting injectable hormonal contraceptive within the past 6 months unless has had at least one spontaneous menstrual cycle (two menstrual bleeding episodes) since the last injection. Breastfeeding women or those who have not had a spontaneous menstrual bleed since discontinuing breastfeeding. Women who plan a major surgical procedure during the study. Women who plan to become pregnant during their participation in the study. Women who smoke >15 cigarettes per day or who use >1 mL/day of nicotine-containing liquid for electronic cigarettes. Current or history of ischemic heart disease or stroke while pregnant or during use of hormonal contraception. Current or past deep vein thrombosis or thromboembolic disorder. Personal or family history of thrombophilia History of retinal vascular lesions or partial or complete loss of vision. Known or suspected carcinoma of the breast, endometrium, or other suspected progestin sensitive neoplasia. History of other carcinomas excluding basal cell cancers unless in remission for > 5 years. Current or past medically diagnosed severe depression unless the potential participant is on stable medication or in the opinion of the Principal Investigator could be exacerbated using a hormonal contraceptive. History of headaches with focal neurologic symptoms. Have a current need for exogenous hormones or therapeutic anticoagulants. History of cholestatic jaundice of pregnancy or jaundice with prior steroid hormone use. Other benign or malignant liver tumors or active liver disease. Systolic BP ≥145 mm Hg and/or diastolic BP ≥96 mm Hg after 5 -10 minutes of rest in a sitting position. If the initial BP values are above these cut-offs, a total of 3 measurements may be taken and the results averaged. If the averaged BP is below the cut-off levels, the participant may be allowed into the study. Hypertension that is treated and controlled may be allowed based on the Investigator's discretion. Clinically significant abnormal serum chemistry value based on the Investigator's judgement. Participation in another clinical trial involving an investigational drug or device within the past two months before anticipated enrollment or is planning to participate in another clinical study during this study. Use of any liver enzyme inducers or plans to use such medication during the study. Known HIV infection. History of a gastrointestinal ulcer or bleeding. Women who are using medication on the Exclusionary medication list (See Appendix). Have issues or concerns, in the opinion of the Investigator, that may compromise the study or confound the reliability of compliance and information that is required in this study. Have a known hypersensitivity to either levonorgestrel or a non-steroidal anti-inflammatory drug. Use of any medication that could interfere with the metabolism of a hormonal contraceptive or the non-steroidal anti-inflammatory drugs or any drug that falls in FDA Pregnancy and Lactation narrative subsections (Formerly Category D or X medications). Be a site member with delegated study responsibilities or a family member of, or have a close relationship with, a site staff member who will be delegated study responsibilities. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Designated as female at birth. - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06306118

Recruiting

Autoguide Positioning Device for Multiple Stereotactic Biopsies

The purpose of this clinical study should be that, in the context of planned resections of glial brain tumors, pieces of tissue (biopsies) are removed from the tumor at several specific locations before the actual tumor resection takes place. The aim of these biopsies in advance to the actual tumor resection will be to receive tumor tissue samples not altered in such a way that it is no longer adequate for further treatment. If not adequate, a so-called "undergrading" could occur, which means that the biological structure of the tumor is misjudged and further therapy does not achieve the desired effect in the patient. On the one hand, certain tumor regions can drift due to a "brain shift" which leads to inaccurate tissue removal, and on the other hand samples are not altered by pressure or bleeding. To carry out these biopsies, a robot positioning device (AutoGuide®) will be used that has already been approved and tested for this type of intervention. The use of the AutoGuide® is intended to ensure that the tumor sample is taken with the greatest possible precision.

- EligibilityCriteria: Inclusion Criteria: Age 18-80 years Diagnosis of a cerebral lesion with the indication for surgical resection Written informed consent to participate in the present study MRI and CT scanner compatibility Exclusion Criteria: Pregnancy, breast feeding Patients not able to reason Age <18 or >80 years Claustrophobia - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with a preoperative suspected low grade glioma, in whom a tumor resection is planned. - SamplingMethod: Probability Sample

NCT06306105

Recruiting

Assessment of Anti-aging Efficacy of Marine Collagen Peptides

To assess the anti-aging efficacy of Marine Collagen Peptides on skin, hair and finger nails for human

- EligibilityCriteria: Inclusion Criteria: Healthy adults aged above 18 years old Exclusion Criteria: Subjects who are not volunteers Subjects who have been diagnosed with dermatitis, cirrhosis, and chronic kidney failure Subjects who have known cosmetic, drug or food allergies. Patients are taking medicine for chronic diseases Subjects receiving treaments for scalp, hair transplant, and other scalp medical care in past 12 weeks. Subjects getting a manicure and perm in past 12 weeks. Female who is pregnant or nursing or planning to become pregnant during the course of the study. Subjects receiving facial laser therapy, chemical peeling or UV overexposure (> 3 hr/week) in the past 12 weeks. Students who are currently taking courses taught by the principal investigator of this trial. Subjects are not willing to reveal the results of pictures after taking the product Vegetarian. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06306092

Not yet recruiting

Promoting Teenage Sleep for Improved Mental Health and School Performance

The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group).

- EligibilityCriteria: Inclusion Criteria: Students in Swedish high schools and upper secondary schools. Exclusion Criteria: - - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 13 Years - MaximumAge: 19 Years - StdAgeList: Child, Adult

NCT06306053

Not yet recruiting

A New Treatment for Chronic Pain Combining Neuromodulation, Computer Assisted Training and Telemonitoring

Chronic pain (CP) is a leading cause of medical disability, healthcare expenditure, and reduced psychological well-being. Given the limited mobility, travel burden, and cost, access to care can be problematic for patients suffering from this disease, driving the recent shift toward care through telehealth programs. Given the complex interrelationship of physical and psychosocial aspects related to chronic pain, in this project the investigators propose to validate and investigate the effectiveness of new integrated health interventions by combining the technique of transcranial direct current stimulation (tDCS), complementary therapies and telemonitoring. The investigators hypothesize that this novel combined approach will provide a more effective strategy to overcome the classic barriers of pharmacological treatments and access to healthcare due to lack of mobility. To do this, the investigators will rely on a previously developed integrated platform that enables effective delivery of non-pharmacological interventions and outcome assessment. Many patients do not benefit from pharmacological and invasive treatments, leading to the development of alternative therapeutic options such as non-invasive brain stimulation (e.g. tDCS) and complementary interventions to improve physical and psychological well-being. These complementary interventions reduced pain intensity and psychological distress by improving individuals' ability to manage and cope with their pain. However, due to the multiple co-occurring factors associated with chronic pain, a multidisciplinary and integrated treatment approach is challenging. Technology ecosystems can be a reliable tool to achieve such a diverse personalized approach and evaluate their results. In a previous project, the investigators developed PainRE-Life, a dynamic and integrated technology ecosystem to enable continuity of care for CP patients, including personalized applications, training tools and telemonitoring tools for outcome assessment.

- EligibilityCriteria: Inclusion Criteria: patients with chronic pain (Fibromyalgia, Headache, Oncological Pain) Age > 18; Cognitive and motor skills sufficient to support a rehabilitation process mediated by an electronic device on a signed declaration by the clinician; -Having completed and signed the informed consent form, after a detailed explanation of the task and the tools used in the study. Exclusion Criteria: Have started new pharmacological treatments or have changed therapies that act on pain for less than a month; Have a brain stimulator, heart marrow stimulator or pumps for intrathecal drug delivery; Respiratory, cardiac, metabolic or other conditions incompatible with at least 30 minutes of light or moderate intensity exercise therapy; Aphasia, dementia, or psychiatric comorbidity interfering with communication or rehabilitation program compliance; Severe cognitive deficits; Blindness or severe vision problems which may interfere with the use of the tablet; Presence of cranial bone breaches; Recurrent seizures not being treated; Insufficient knowledge of the Italian language and/or inability to understand verbal and written instructions; Concomitant participation in another study or clinical trial involving rehabilitation therapy (recreational therapy, occupational therapy, physiotherapy) or administration of an investigational drug - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06306040

Not yet recruiting

Effect of Intravenous Nalbuphine and Magnesium Sulfate on Emergence Agitation in Pediatric

• Primary outcome: Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales. • Secondary outcome: Therefore, we designed a prospective, randomized, double-blind, single center study to investigate whether nalbuphine and/or magnesium sulphate can prevent EA after hypospadias repair in children under general anesthesia. In addition, the characteristics of anesthesia recovery and the incidence of adverse effects will also be evaluated in this study. Post-operative extubating time, interaction time, open eye time and emergence time. incidence of post-operative vomiting (PONV), laryngospasm, breath-holding, coughing, oxygen desaturation, and cardiac arrhythmias. Face, Legs, Activity, Cry and Consola Bility (FLACC) scale is used to determine post-operative pain score Parental satisfaction scores

- EligibilityCriteria: Inclusion Criteria: • Weight: 10 - 38 kg. Age: 3-7 years. ASA physical status: I-II. Operation: elective hypospadias repair under general anesthesia Exclusion Criteria: • Parent's refusal. Anticipated difficult airway. Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia. History of developmental delay or mental retardation or any neurological disease. Known hypersensitivity to any drug used in this study. Children with co-morbid conditions like congenital heart disease, respiratory pathology, central nervous system disorders or renal pathology - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - GenderDescription: name of patient gender exposure on surgery only male participants are being due to surgery is hypospadias repair. - MinimumAge: 3 Years - MaximumAge: 7 Years - StdAgeList: Child

NCT06306027

Recruiting

The Impact of Web-Based Education on Self-Care Power, Self-Efficacy, and Quality of Life in Knee Arthroplasty Patients.

The knee joint, which we use actively every day, is the largest joint in our body that bears the weight, allowing various movements such as walking, running, squatting, and standing. It involves the largest load-bearing structures in the body, including bones, cartilage, surrounding muscles, and ligaments, facilitating the mobilization of the joint. Due to constant use, the knee joint is susceptible to injuries and wear. Total knee arthroplasty (TKA) surgery involves replacing a degenerated joint surface, often due to conditions like osteoarthritis or rheumatoid arthritis, with a metal or polyethylene prosthesis. TKA, a widely used and highly successful surgical intervention in recent years, reduces pain, enhances functional range of motion, and improves independence and quality of life. Severe pain following TKA surgery restricts the movement of the knee joint and daily life activities, leading to the patient's inadequacy in self-care. Patients undergoing TKA surgery often face a lack of information after discharge. This lack of knowledge, coupled with uncertainty about the disease, limits the patient's self-efficacy. As the self-care power diminishes for patients struggling with daily life activities, their self-efficacy is negatively affected. The continuity of education becomes crucial since the verbal and written instructions given after surgery may not be sustained, causing a gradual decline in an individual's self-efficacy. As seen in the literature, studies have shown that postoperative pain, swelling, joint stiffness, fear, and movement limitations negatively impact the quality of life for patients undergoing TKA. Consequently, the self-care capacity, self-efficacy levels, and quality of life for individuals who have undergone TKA are adversely affected, as indicated in the literature.Ensuring continuity of care at home is crucial not only during the early postoperative period in the clinic but also after discharge. The nurse plays a significant role as an educator/advisor after discharge. The nurse provides counseling to patients discharged after Total Knee Arthroplasty (TKA) on pain management, disease progression, rehabilitation process, exercises, and considerations during daily activities (such as walking, bathing, toileting). Additionally, the nurse offers guidance on late-stage complications that may arise at home due to surgery and situations requiring hospitalization. While web-based educational interventions have been conducted for various patient groups, a web-based education program specifically for TKA surgery has not been identified. Having web-based post-TKA patient education allows continuous monitoring, assesses attendance and effectiveness remotely, and enables individuals to convey requests and questions to researchers through live support, ultimately enhancing the effectiveness of education. This approach is believed to prevent complications, reduce patient care costs and readmissions, increase patients' self-sufficiency in self-care, and consequently elevate their self-efficacy levels and quality of life. Close monitoring of postoperative patients is expected to improve their quality of life and self-care abilities, leading to increased satisfaction with healthcare services.

- EligibilityCriteria: Inclusion Criteria: Being 18 years or older First time performing Total Knee Arthroplasty Ability to access the internet via smart phone, tablet, computer Must have the ability to use smart phones and tablets Ability to read and understand Turkish No mental, psychiatric or neurological disability Exclusion Criteria: Complications develop in the patient during the research. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06306014

Not yet recruiting

Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients

Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in Europe, with over 120,000 cases and almost 3,700 deaths per year. This infection is characterized by a high risk of recurrence after cure, ranging from almost 20% after a first episode to over 60% after 2 recurrences, or in the case of specific risk factors. Currently, first-line treatment of CDI is based on oral antibiotics such as fidaxomicin or vancomycin. These antibiotic treatments, which are effective in 89% and 86% of first-episode cases respectively, do not correct the microbiological imbalance underlying the onset of CDI and may, on the contrary, encourage recurrence by contributing to the maintenance of a deleterious change in the microbiota (dysbiosis) through the elimination of bacteria other than C. difficile, due to their spectrum of activity. In a number of patients, this ecological imbalance can no longer be restored after antibiotic treatment, leading to multiple recurrences of CDI. In this context, fecal microbiota transplantation (FMT) has been validated for over 10 years for the prevention of recurrence in multi-recurrent CDI. The principle of FMT is based on the use of a pharmaceutical preparation made from the stool of a healthy donor, administered within the digestive tract of a patient for therapeutic purposes. Currently, in the case of multiple recurrences, it is the recommended first-line treatment (from 2 recurrences) and the most effective, with a clinical efficacy preventing recurrence of CDI in 69% to 89% of cases at 8 weeks post-treatment, with a good safety profile. Among the microbial factors promoting CDI, the loss of the bacterial species Faecalibacterium prausnitzii constitutes a specific therapeutic target. F. prausnitzii is a commensal bacterium of the human gut, making up nearly 5% of the fecal microbiota, and has been shown to be associated with an individual's state of health. A drop in its relative abundance is associated with an increased risk of numerous diseases, such as Crohn's disease and colorectal cancer. In CDI, F prausnitzii is greatly diminished. Moreover, low abundance of F. prausnitzii is predictive of C. difficile recurrence. Its abundance in stools is increased after FMT and is also predictive of response to treatment. From a pathophysiological point of view, one of the preventive effects of F. prausnitzii on recurrence would be mediated by its ability to hydrolyze the bile acids involved in the germination of C. difficile spores. The aim of this Phase I/II trial is to assess the efficacy and safety of oral administration of EXL01, a single isolated unmodified strain of F. prausnitzii, in preventing CDI recurrence in high-risk patients at W8. The study will be conducted in 2 parts. The phase I (Part A) is planned to include 6 patients. The phase II (Part B) will include 50 patients in two arms (25 patients respectively in the placebo and EXL01 arm).

- EligibilityCriteria: Inclusion Criteria: Adult patient ≥18 years of age ≥3rd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in stool by PCR or enzyme-linked immunosorbent assay or immunochromatography or toxigenic culture) within 6 months with an interval ≤ 12 weeks since the end of treatment of the previous episode of resolved CDI On current or planned vancomycin treatment per os Patient able to give free, informed and written consent Enrolled in compulsory national social security scheme Exclusion Criteria: Currently participating or has participated in a study with an investigational compound or device within 3 months prior to the first dose of the study intervention. Severe and/or complicated C. difficile infection Cirrhosis with Child C score Hospitalization in continuing care unit or intensive care unit Immunosuppression including : Malignant hemopathy under treatment (excluding CLL) HIV AIDS stage Stem cell allograft ≤ 12 months Aplasia (<500 PNN/mm3) at inclusion Treatment with >20mg prednisone equivalent within 14 days prior to inclusion (excluding inhaled or topical treatment). Personal history of gastrointestinal resection other than appendectomy (gastrectomy, esophagectomy, colonic or small bowel resection, short small bowel syndrome). Personal history of small intestinal microbial overgrowth Inflammatory bowel disease Proven celiac disease Current stoma (ileostomy or colostomy) or within the last 6 months, or any other intra-abdominal surgery within the 3 months prior to treatment major surgery or trauma ≤ 4 weeks before the start of treatment Antibiotic therapy in progress or planned during the study for an infection other than CDI Surgery scheduled during the study requiring perioperative antibiotics. -Women without contraception*, pregnant or breastfeeding women History of hypersensitivity to EXL01 and/or to any of its excipients (D-mannitol, sucrose, maltodextrin, L-cysteine, L-cysteine hydrochloride, magnesium stearate and hydroxypropylmethylcellulose), and/or to soy or soy-containing products. History of hypersensitivity to vancomycin as mentioned in local prescribing information. Personal history of fecal microbiota transplantation < 12 months Persons deprived of liberty by judicial or administrative decision Adults under legal protection or unable to give consent Swallowing disorders making oral treatment impossible Participation in another interventional study Expected life expectancy of less than 6 months Presents a known psychiatric disorder that would interfere with adequate cooperation with study requirements. Regular use of illicit or recreational drugs Anticipated administration during the study of treatment that is expected to cause diarrhea (chemotherapy, colonic preparation prior to colonoscopy) History of chronic diarrhea (> 3 watery stools per day for > 4 weeks) not related to gastrointestinal infection. Clinically significant medical or surgical condition not mentioned in the above criteria which, in the opinion of the investigator, could interfere with the administration of study drug, the interpretation of study safety or efficacy data, or compromise the safety or well-being of the subject. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06306001

Not yet recruiting

Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock

Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is: Whether MB treatment reduces death to any cause as compared to no MB treatment. Whether treatment with MB reduces the time to achieve normal blood pressure Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline. Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours.

- EligibilityCriteria: Screening Criteria: preterm infants (<37 weeks, <28 days) clinically diagnosed to have septic shock will be screened for inclusion Inclusion criteria: Subjects must fulfill all the following Definite/probable sepsis :Clinical syndrome of sepsis for which bedside neonatologist starts intravenous antibiotics AND either a positive culture of otherwise sterile body fluid OR presence of any 2 or more of the following five markers of sepsis: (a) C-reactive protein >10 mg/dL; (b) procalcitonin as per age-appropriate cut-off (c) total leukocyte count and absolute neutrophilic count beyond acceptable range (d) chest X-ray adjudged as pneumonia by two independent Neonatologists. Shock: adapted from the definition given by Davis et al 2017 Either SBP < age and gestation appropriate cut-off OR Presence of any 2 of the following 6 parameters i. HR >205/min ii. Central pulses either week OR bounding iii. CRT >3 sec OR flash refill (<1 sec) iv. skin mottled/cool OR flushed v. urine output <0.5 ml/kg/h in the preceding 6 hours vi. DBP < age and gestation appropriate cut-off Fluid and catecholamine-resistant shock: received fluid boluses up to a maximum of 40 ml/kg followed by catecholamine infusion titrated up to the maximum dose. The catecholamine infusion could be either dopamine (maximum dose 20 µg/kg/min) or epinephrine (maximum dose 0.4 µg/kg/min) or norepinephrine (maximum dose 0.4 µg/kg/min). Exclusion Criteria: excluded if ≥1 criterion positive: G6PD deficient or family history of G6PD deficiency Potentially lethal malformation Congenital heart disease Severe acute kidney injury Family history of allergy to methylene blue or food dyes - HealthyVolunteers: No - Gender: All - MinimumAge: 0 Days - MaximumAge: 28 Days - StdAgeList: Child

NCT06305988

Recruiting

Effect and Mechanism of tDCS on Anterior Cingulate Nerve Regulation in ASD

In this proposed study, a transcranial direct current stimulator is used to intervene in the anterior cingulate gyrus of children with autism, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of Autism Spectrum Disorders' intervention is discussed.

- EligibilityCriteria: Inclusion Criteria: Age 3-24 years old; Clinically diagnosed by a psychiatrist with autism spectrum disorder; Confirmed by researchers (pediatric psychiatrists) that they meet the diagnostic criteria for autism spectrum disorders in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) of the United States; Evaluated by researchers (pediatric psychiatrists) using the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS), it is consistent with the diagnosis of autism spectrum disorders; Capable of cooperating with magnetic resonance spectroscopy and transcranial direct current stimulation. Exclusion Criteria: a) Existence of serious physical diseases and conditions, such as significant intracranial lesions, thyroid diseases, epilepsy, congenital heart disease, severe hematological diseases, systemic lupus erythematosus, visual and auditory impairments, etc; b) Imaging examination showed significant brain structural abnormalities; c) Having serious neurological diseases, a clear family history, or potential risks; d) Metal or pacemaker implantation in the body, holes or cracks in the skull; e) Taking benzodiazepines or anticonvulsants; f) The existence of clear or suspicious genetic diseases; g) Conforming to the diagnosis of other serious mental illnesses, such as schizophrenia and bipolar disorder. - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 24 Years - StdAgeList: Child, Adult

NCT06305975

Not yet recruiting

Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery

This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. Patients will be randomized to either blunt fascial or veress needle peritoneal entry. Insufflation times, failed entries, complications and post-operative pain scores will be collected. The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique. Primary Objective: To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique. Secondary Objectives: To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique.

- EligibilityCriteria: Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study 18 years of age or older Undergoing conventional laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division. Exclusion Criteria: Pregnancy Urgent/non-scheduled surgery Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure) Baseline opioid use Planned post-operative admission Non-eligible for umbilical entry - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305962

Recruiting

177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer

This is a first-in-human, open-label study consisting of a Screening Period, an Imaging Period, and a Treatment Period in eligible non-small lung cancer patients who are positive for the biomarker PDL-1. The Screening period lasts up to 4 weeks. The Phase 0 (Imaging Period) is used to determine if patient's tumor(s) are still positive for the biomarker, as well as radiation dosimetry with low dose 177Lu-RAD204im (for a period of up to 2 weeks following the first injection of 177Lu-RAD204im), to assess the safety of the drug. Following the 2 week safety assessment, the subject is eligible to enter Phase I (Treatment Period) with gradual dose increases of 177Lu-RAD204tr. The Treatment Period lasts up to 3 cycles every 6 weeks, with additional extension to a maximum study dose interval of 12 weeks to be approved on a case-by-case basis in discussion with study Sponsor. During the Treatment Period, subjects will be assessed for both safety and treatment response using conventional images and clinical laboratory tests.

- EligibilityCriteria: Inclusion Criteria: Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures. Adult participants ≥ 18 years of age. Participants with a documented history of histopathological confirmed metastatic NSCLC that is unresectable, progressive and for which standard treatment measures are no longer effective. Participants with a documented history of PD-L1 positive NSCLC. Any number of prior treatment lines are allowed in this study, however at least one of the treatment line(s) must include an anti-PD(L)-1 antibody. Participants with any documented PD-L1 positivity by immunohistochemistry (IHC) without prior treatment with anti-PD(L)-1 antibody may be allowed on a case-by-case basis in discussion with study Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Participants must have a life expectancy of >4 months in the opinion of the Investigator. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP are defined as those who are not surgically sterile or post-menopausal. Female subjects will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Female subjects < 50 years old who meet the criteria for post-menopausal status without previous surgical sterilization should be considered for further investigation with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status. WOCBP must agree to use a highly effective method of contraception during the study and for 14 days after the last injection of 177Lu-RAD204im and/or 6 months after the last dose of 177Lu-RAD204tr, whichever occurs later. Acceptable methods of contraception are described the Protocol. Male subjects who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 14 days after the last injection of 177Lu-RAD204im and/or 6 months after the last dose of 177Lu-RAD204tr, whichever occurs later. All male subjects must agree to not donate sperm during the study and for 14 days after the last injection of 177Lu-RAD204im and/or 4 months after the last dose of Lu-RAD204tr, whichever occurs later. Acceptable methods of contraception are described in the Protocol. Subjects with previously treated brain metastases are eligible to participate if: they are clinically and radiologically stable (no evidence of progression by imaging; same imaging modality [magnetic resonance imaging (MRI) or computed tomography (CT) scan] must be used for each assessment) for at least 28 days prior to the first dose of 177Lu-RAD204; and any neurologic symptoms returned to baseline. Note: Subjects with a history of leptomeningeal disease may not participate even if stable clinically. For Phase I: Participants must have positive lesion(s) by 177Lu-RAD204im SPECT/CT as described in Image Review Manual. Estimated total radiation dose to healthy organs derived from phase 0 dosimetry must not exceed dose constraints according to the American Association of Physicists in Medicine Quantitative Analysis of Normal Tissue Effect in the Clinic (QUANTEC) and International Commission on Radiological Protection (ICRP), in discussion with study Sponsor. Exclusion Criteria: History of prior organ transplant. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer. Patients with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with study Sponsor, if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome. Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures, etc. Residual toxicity > Grade 1 from prior anti-cancer therapy (except alopecia). Participants with > Grade 1 toxicity from prior anti-cancer therapy may be approved on a case-by-case basis in discussion with study Sponsor, if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome. History of uncontrolled allergic reactions and/or known or expected hypersensitivity to protein therapeutics, 177Lu-RAD204 or any of its excipients. Inadequate organ functions as reflected in laboratory parameters: Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x upper limit of normal (ULN) Platelet count of < 75 x 109/L Absolute neutrophil count (ANC) < 1.0 x 109/L Haemoglobin < 9 g/dL Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x ULN, or > 5 x ULN for patients with known liver metastases Total bilirubin > 1.5 x ULN, except for patients with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 x ULN For participants not taking warfarin or other anticoagulants: international normalized ratio (INR) ≤1.5 or prothrombin time (PT) ≤1.5 x ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ≤1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR <3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant. Patients requiring blood product transfusion within 4 weeks of first dose of 177Lu-RAD204tr are not eligible to participate. Clinically significant cardiovascular disease including but not limited to: Unstable angina or acute myocardial infarction within 6 months prior to screening Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association (NYHA) grade ≥ 2) Uncontrolled arterial hypertension or unstable clinically significant arrhythmia Known LVEF < 50% QTcF > 470 msec for females and QTcF > 450 msec for males on screening electrocardiogram (ECG) or congenital long QT syndrome. Participation in any other investigational trial at the time of informed consent signature. Pregnant or lactating women. The following exclusion criteria apply to participants in Phase I: Major surgery within 4 weeks prior to first dose of 177Lu-RAD204tr. Exceptions may be approved on a case-by-case basis in discussion with study Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, within 28 days (or 5 half-lives for biologic/noncytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-RAD204tr. Focal palliative radiotherapy given within 28 days prior to the first dose of 177Lu-RAD204tr may be approved on a case-by-case basis in discussion with the Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome. For participants who received radiotherapy more than 28 days prior to the first dose of 177Lu-RAD204tr, efforts should be made to calculate the prior radiation absorbed dose to each critical organ such as the kidneys, liver, lungs, and bone marrow. The absorbed dose limits for critical organs should not exceed the cumulative absorbed dose from the prior radiopharmaceutical and/or external beam radiation therapy (EBRT) treatment(s) and the planned course of treatment in this study. Participants who would have cumulative absorbed dose to critical organs exceeded will not be enrolled in the study. Has had or is scheduled to have major surgery < 28 days prior to the first dose of 177Lu-RAD204tr. Elective surgical procedures not considered to put participants at higher risk of AEs may be allowed on a case-by-case basis in discussion with the Sponsor. Positive status for human immunodeficiency virus (HIV). Active or chronic hepatitis B or C. Chronic hepatitis B or hepatitis C with undetectable viral loads on stable suppression therapy may be allowed on a case-by-case basis in discussion with study Sponsor. Any medical condition which, in the opinion of the Investigator, places the participant at an unacceptably high risk for toxicities. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305949

Not yet recruiting

Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia

The goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia.

- EligibilityCriteria: Inclusion Criteria: men and women >19 years old patients with stroke confirmed by neuroimaging first-time stroke patients patients in subacute or chronic phases of stroke with 3 weeks or more after onset stroke patients with confirmed dysphagia through Videofluoroscopic Swallowing Study (VFSS). Exclusion Criteria: patients with recurrent stoke, traumatic brain injury, spine cord injury, and degenerative brain disease, such as Parkinson's disease, etc. patients with deteriorated cognitive function unable to perform the clinical trial as instructed patients with evidence of delirium, confusion, or other impairment of consciousness patients with uncontrolled medical disease or surgical conditions patients ineligible for Transcranial direct current stimulation (due to scalp condition, metallic material at the electrode attachment area, presence of a pacemaker or cochlear implant) patients with previous experience within the last year using a stimulation device similar to the one use in this clinical trial or who have participated in related clinical trials patients with severe neurologic disorder with concomitant major psychiatric disorder such as major depressive disorder and dementia patients with history of uncontrolled epilepsy within 6 months patients with medical contraindications for neuroimaging test, such as MRI; patients who are taken contraindicated medications or require medication changes during the trial period that could influence cognitive/motor function changes via brain activation changes patients who are pregnant, breastfeeding, or planning pregnancy during the trial period patients considered medically ineligible for participation in the present trial beyond the criteria listened above. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult

NCT06305936

Recruiting

Feasibility Study: Plant Based Diet to Patients With Rheumatoid Arthritis

In this feasibility study, our primary goal is to assess the practicality of implementing a plant-based food diet intervention for individuals with rheumatoid arthritis (RA). The intervention consists of three key components: 1) Educational materials (videos), 2) Participation in a cooking workshop introducing plant-based meals, complete with recipes, and 3) Daily delivery of plant-based dinner meals over a four-week period. This comprehensive investigation covers the testing of recruitment procedures, randomization, intervention elements, outcome assessments, and participant retention. Adopting a daily plant-based diet involves introducing several new plant-based foods and making adjustments to the existing diets of patients with RA. Consequently, the feasibility study will also aim to explore the acceptability of the intervention and whether a full-scale RCT is practically possible.

- EligibilityCriteria: Inclusion Criteria: Disease Activity Score with 28 Joint Counts (DAS28) between 2.0-3.2 A rheumatoid arthritis diagnosis of minimum 1 year Under stable pharmaceutical treatment for at least 4 months and with no planned change in treatment within 8 weeks Exclusion Criteria: Daily smokers Diabetes Mellitus Pregnancy / planned pregnancy Lactation Prednisolone treatment DAS28 below 2.0 and above 3.2 Current dietary habits resembling intervention diet (e.g., 100% plant based diets) Participation in other intervention studies or clinical trials via the rheumatology outpatient clinic that will affect their adherence to plant based diets Not able to eat ad libitum meals because of e.g., allergy Unable to understand the informed consent and study procedures Alcohol and/or drug abuse - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305910

Recruiting

CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults

This is a single center Phase I study of a new adjuvant CD200 activation receptor ligand, CD200AR-L, in combination with imiquimod and GBM6-AD vaccine to treat malignant glioma in children and young adults. The primary objective of this study is to determine the maximum tolerated dose (MTD) of CD200AR-L when given with a fixed dose of GBM6-AD vaccine, imiquimod, and a single dose of radiation for patients with recurrent High Grade Glioma (HGG) or following standard of care therapy radiation therapy for newly diagnosed Newly Diagnosed Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma (DIPG/DMG).

- EligibilityCriteria: Inclusion Criteria: Histologically confirmed newly diagnosed DIPG/DMG with documented H3K27M alteration (based on IHC or DNA sequencing performed in a CLIA-certified laboratory) or recurrent HGG. Patients cannot enroll until they are a minimum of 14 days and preferably within 30 days from the last dose of radiation. Diagnosis of recurrent HGG based on MRI findings. Recurrent HGG must have received standard of care radiation at diagnosis. Prior biopsy material will be required to confirm diagnosis of HGG; however, biopsy of the recurrent/progressive lesion will not be required for study enrollment. Maximal safe resection is preferred prior to clinical trial enrollment if indicated and feasible. Clinically stable on a dose of corticosteroids not to exceed an equivalent of dexamethasone 0.1 mg/kg/day (maximum 4 mg) for at least 2 weeks prior to study enrollment. Prior therapy wash-out is required Minimum of 28 days since last dose of any targeted therapy (including bevacizumab), immunotherapy, investigational agents. Minimum of 10 days since any anti-cancer intervention: cytoreductive surgery/laser ablation and a minimum of 28 days since any viral therapy Voluntary written consent obtained by patient if ≥18 years of age or a parent or guardian if <18 years of age before the performance of any study-related procedure not part of standard medical care Able to comply with follow-up visit schedule (i.e., return to clinic for follow-up visits). Willing to allow for collection of pre-treatment research related blood collection [1-5 mL red top tube and 2-10 mL green top tubes (or to a max of 2 ml/kg of body weight)] for immune characterization. If a patient does not subsequently enroll in the study, the samples will be destroyed according to institutional protocol. Lansky play performance score ≥60 (<16 years) or Karnofsky (≥16 years) performance score of ≥60 Sexually active persons of child-bearing potential or with partners of childbearing potential must agree to use a highly effective form of contraception during the 2-year treatment period. Urine pregnancy tests will be obtained at defined time points during protocol therapy. Adequate bone marrow reserve: Absolute neutrophil (segmented and bands) count (ANC) ≥1.0 x 10E9/L, platelets ≥75 x 10E9/L; Hemoglobin ≥8 g/dL Hepatic: Bilirubin ≤1.3 mg/dL and SGPT (ALT) ≤2.5 x upper limit of normal (ULN) for age Renal: Normal serum creatinine for age or creatinine clearance >60 ml/min/1.73 mE2 Exclusion Criteria: Known sensitivity to the GBM6-AD tumor lysate vaccine, CD200AR-L, or imiquimod. Unable to complete a standard upfront course of radiotherapy due to disease progression or intolerance of therapy. Radiographic evidence of diffuse leptomeningeal disease. Prior history of malignancy within 5 years of enrollment. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements. Concurrent use of tumor treatment field devices (e.g., Optune) - permitted until the time of consent. History of any laboratory findings consistent with any uncontrolled immune system abnormalities such as hyper-immunity (e.g., autoimmune diseases, thyroid dysfunction, lupus, scleroderma, etc.) and hypo-immunity [e.g., myelodysplastic disorders, marrow failures, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), transplant immune-suppression, etc.]. Any known autoimmune disease must be clinically silent and without associated laboratory abnormalities for at least 1 year in the absence of any disease directed therapy or systemic steroids. Any conditions that could potentially alter immune function (e.g., HIV/AIDS, hepatitis B, untreated hepatitis C, multiple sclerosis, renal failure). Receiving ongoing treatment with any immunosuppressive drug for any reason, excluding those patients requiring a low dose of corticosteroids equivalent to dexamethasone 0.1 mg/kg/day (maximum 4 mg) or less for treatment of tumor-related edema. Not able to tolerate an MRI or radiation therapy even with reasonable accommodations or sedation. Known pregnancy or anticipated conception during the 1-year study period - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Years - MaximumAge: 25 Years - StdAgeList: Child, Adult

NCT06305897

Not yet recruiting

Evaluation of the Tolerance (Main Objective) and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-inflammatory Hyperpigmentation) on the Face

The goal of this clinical trial is to compare the 3 different prototype of cyto-selective cryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are: the tolerance of 3 prototypes of cyto-selective cryotherapy treatments the performance of 3 prototypes of cyto-selective cryotherapy treatments Participants will be treated for each spots with a definied prototype during 6 treatment visits. Researchers will compare the tolerance and performance of the 3 prototypes.

- EligibilityCriteria: Inclusion Criteria: Subject having signed a written informed consent form (ICF) to participate in the investigation obtained according to ISO 14155:2020 - Good Clinical Practice (GCP); Healthy male and female subjects, 18 to 75 years old (inclusive), and Fitzpatrick's skin type (II-VI) (1); Subject of Caucasian and or melanin-rich ethnicity skins; Subject presenting at least two brown spots on the face with ≥ 3 and ≤ 6 mm in diameter; Female subject of non-childbearing potential, defined as woman without uterus and/or both ovaries, surgically sterile (at least 6 months prior to Screening visit) or post-menopausal (at least one year post cessation of menses); Female subject of childbearing potential who has been, in the opinion of the Investigator, using an approved method of birth control for at least 1 month prior to Screening visit and agreeing to continue adequate contraception during the entire study period; Reliable methods of contraception are: hormonal methods or intrauterine device in use since at least 1 month prior to Screening visit and during the investigation period; bilateral tubal ligation since at least 3 months prior to Screening visit and during the investigation period; barrier methods in use at least 14 days prior to Screening visit; vasectomized partner; sexual abstinence defined as refraining from heterosexual intercourse for at least 3 months prior to Screening visit and during the entire period of risk associated with the study products. Subject who has not been exposed to UV within at least two months prior to the screening visit and agreeing to avoid exposure to UV radiation (tanning beds, phototherapy and sunlight) for the whole study duration; Subject able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on Investigator's judgement; Subject affiliated to a health social security system (according to French Law). Exclusion Criteria: Female subject who is pregnant, parturient or breast feeding; Female subject of childbearing potential having a positive urinary pregnancy test at Day 0; Subject having performed cosmetic treatments (e.g., exfoliants, scrubs or selftanners, facial UV) in the month before the start of the study on the face (see restrictions paragraph); Subject having performed cosmetic or aesthetic treatments by a dermatologist (e.g., laser, IPL, peeling, creams, cryotherapy) in the last 6 months on the face; Subject receiving systemic or local treatment (e.g., dermocorticoids, corticosteroids, diuretics) likely to interfere with the evaluation of the parameter studied; Subject affected by dermatosis, autoimmune disease, systemic, chronic or acute disease, or any other pathology that may interfere with treatment or influence the results of the study (e.g., people with diabetes or circulatory problems, allergic to cold, Raynaud's syndrome); Subject with clinically significant skin condition on the tested area (e.g., active eczema, psoriasis, rosacea, scleroderma, acne, dermatitis) or presence on the tested area of skin lesions, scars, tattoos; Concomitant participation in other clinical trials/investigations or participation in the evaluation of any IMD/IP during 2 months before this study; Protected subject as defined in the Articles of the French Public Health Code: Article 1121-7: person deprived of liberty by a judicial or administrative decision, or subject to psychiatric care or person admitted to a health or social institution for purposes other than the research. Article 1121-8: adult person subject to a legal protection measure or unable to express his/her consent; Subject unable to communicate or cooperate with the Investigator due to poor mental development, language problems or impaired cerebral function; Subject currently participating in another clinical study or being in an exclusion period of another clinical study; Subject having received 6000 euros indemnities for participation in clinical trials/investigations in the 12 previous months, including participation in the present study (according to French Law). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06305884

Not yet recruiting

Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study

This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home.

- EligibilityCriteria: Inclusion Criteria: COHORT A: Healthy participants COHORT B: Participants with pre-existing lymphedema COHORT B: A history of cancer therapy with surgery or radiation involving the axillary basin COHORT B: Unilateral upper extremity swelling that requires compression or pneumatic therapy or a >= 2-centimeter difference in contralateral arm circumference Exclusion Criteria: Patients with active malignancy or ongoing cancer therapy will be excluded, though breast cancer patients currently on endocrine monotherapy will be included - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult

NCT06305858

Recruiting

Partial Versus Total Knee Replacement in Bicompartmental Gonarthrosis (Medial and Patellofemoral): Prospective Functional Assessment Study

The study is, in accordance with current legislation, definable as a prospective single-center interventional randomized study. The aim of the study is to evaluate the post-operative recovery of the group A patient undergoing the partial knee replacement surgical procedure compared to the group B patient undergoing the total knee replacement surgical procedure through clinical/functional scores. The primary outcome is evaluate the difference in score of the KSS questionnaire, at 1 month after surgery, completed by the patient of group A compared to the patient of group B. The population consists of 48 adult patients with gonarthrosis divided into two groups: 24 patients Group A experimental group: partial denture surgical procedure 24 patients Group B control group: total denture surgical procedure with patellar resurfacing

- EligibilityCriteria: Inclusion Criteria: Grade 3-4 sec Kellgren-Lawrence medial gonarthrosis Patellar symptoms Primary gonarthrosis Patients with ligament integrity Age between 40 and 85 years inclusive Signing of the Informed Consent and consent to cooperate in all study procedures. Exclusion Criteria: Cognitive impairment Psychiatric disorders Neuromuscular disorders Age > 85 years and <40 years Lateral gonarthrosis grade 4 sec Kellgren-Lawrence Secondary medial gonarthrosis Revisions Minors Pregnant women self-declaration - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06305832

Recruiting

Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer

To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or SRT combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).

- EligibilityCriteria: Inclusion Criteria: 1. ≥40 years old, male; 2. Postoperative pathology showed prostate adenocarcinoma; 3. Postoperative pathological stage pN0 or pNx; 4. PSA decline &lt; 0.1ng/ml within 8 weeks after radical prostate cancer surgery for at least 6 months 5. Biochemical recurrence (PSA rose twice in a row, with an interval of ≥2 weeks and absolute value &gt; 0.2ng/ml), and traditional imaging (bone scan and CT/MRI scan) did not show local recurrence and distant metastasis. 6. Have one or more of the following risk factors: Postoperative CAPRA-S score ≥6 points; The pathological score of radical surgery for prostate cancer was Gleason 8-10; The highest postoperative biochemical recurrence PSA &gt; 0.5ng/ml; Postoperative pathological stage PT3/T4; PSADT &lt; 10 months; 7. ECOG status is 0-1; 8. Life expectancy greater than 10 years; 9. Adequate hematological and organ function tests within 4 weeks prior to the first study treatment, as defined below: Neutrophil count (ANC)≥1.5×10^9/L (no granulocyte colony-stimulating factor for 2 weeks prior to cycle 1, day 1); Platelet count (PLT)≥100×10^9/L (no transfusion within 2 weeks prior to day 1 of cycle 1); Hemoglobin (Hb) ≥90g/L Serum creatinine (Cr)≤1.5×ULN or creatinine clearance &gt; 50ml/min; Total bilirubin (BIL)≤1.5×ULN; Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) level ≤2.5×ULN; International Standardized ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN; Left ventricular ejection fraction (LVEF) ≥50%; 10. The subject is willing and understands to sign the informed consent and is able to comply with the agreement. Exclusion Criteria: 1. Previously received endocrine therapy for prostate cancer (including but not limited to goserrelin, levoprorelin, digarek, bicalutamide, abiraterone acetate, darotamine, apatamide, enzalutamide, etc.) or pelvic radiotherapy; 2. Postoperative biochemical recurrence, but PSA more than 2 ng/ml; 3. Postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features; 4. Is currently participating in or has participated in an investigational drug study; 5. Known or suspected allergy to reverumide and reverumide excipients; 6. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect drug use and absorption; 7. Have a history of epilepsy, or a medical condition that can induce seizures within the 12 months prior to C1D1 (including a history of transient ischemic attacks, cerebral stroke, traumatic brain injury with disturbance of consciousness requiring hospitalization); 8. Active heart disease in the 6 months prior to C1D1, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and medically treatable ventricular arrhythmias; 9. Have had any other malignancies within the 3 years prior to C1D1 (except for carcinoma in situ that has been in complete remission and malignancies that the investigator determined to be slowly progressing); 10. Granulocyte colony-stimulating factor was used for support 2 weeks before C1D1; 11. Blood transfusion within 2 weeks before C1D1; 12. Active HBV and HCV infected persons (HBV copy number ≥10^4 copies /mL, HCV copy number ≥10^3 copies /mL); 13. A history of immunodeficiency (including HIV positive, other acquired, congenital immunodeficiency diseases) or a history of organ transplantation; 14. Male subjects whose partner is a fertile woman refuse surgical sterilization or use of effective contraception during the trial period and for 3 months after the last dose of riverutamide. 15. The investigator determines subjects who may affect the conduct of clinical studies, who may not be able to comply with the protocol or cooperate with the protocol, and who pose research risks. - HealthyVolunteers: No - Gender: Male - MinimumAge: 40 Years - StdAgeList: Adult, Older Adult