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NCT06300957

Recruiting

Help Wanted: Evaluating a Prevention Intervention for People With Sexual Interest in Children

This project aims to evaluate the Help Wanted Prevention Intervention, an online program to provide people with a sexual attraction to children the skills and resources to support their commitment to keep children safe and to improve the participants well-being. In phase one, ten men with a sexual attraction to children who have never had a contact offense with a child will be asked to go through an abbreviated version of the participant procedures that will be used in study phase two (described next). Specifically, the ten participants will complete one of the online surveys, review the Help Wanted program, and participate in a 30-60 minute anonymous audio call with a member of the study team to provide feedback on the study procedures and materials (e.g., consent form, recruitment form). Feedback from phase one will inform changes to study procedures for phase two. Phase two consists of a large-scale evaluation of the Help Wanted program. Three hundred men with a sexual attraction to children who have never had a contact offense with a child or accessed the Help Wanted Program will be randomly selected to be part of one of two groups: the program group (N = 200) or the control group (N = 100). Both groups will be asked to complete an online survey before reviewing the Help Wanted Program, provide feedback on the program over a one-month period, and complete another online survey immediately after reviewing the program and three months after reviewing the program. Participants in the control group will have a one month waiting period after the first online survey, during which the participants will receive alternative resources and supports for mental health and sexual attraction to children. After the one month waiting period, participants in the control group will complete one additional online survey before reviewing the Help Wanted program and completing the two final online surveys (one immediately after reviewing the program, one three months after reviewing the program). Survey questions will ask about participants thoughts, feelings, and behaviors, including questions about the participants overall well-being and sexual attraction to children. All study materials and resources are in English. Resources provided to participants are also in English, but provide services in over 30 countries to include participants who may reside in countries outside of the United States. Participation is anonymous and all data will be kept confidential.

- EligibilityCriteria: Inclusion Criteria: Men (cis-gender and transgender) Age 18 and older (no upper age limit) Self-identified sexual attraction to prepubescent or early pubescent children No prior contact offense with a child Never accessed the Help Wanted intervention. Exclusion Criteria: Women (cis-gender and transgender) Under age 18 No sexual attraction to prepubescent or early pubescent children Any prior contact offense with a child Previously accessed the Help Wanted intervention - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - GenderDescription: Cisgender and transgender men are eligible - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300944

Recruiting

The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery

The purpose of this study is to investigate whether continuous intraoperative infusion of esketamine combined with the addition of esketamine to postoperative PCIA can improve postoperative pain and sleep quality in patients undergoing laparoscopic uterine surgery under general anesthesia.

- EligibilityCriteria: Inclusion Criteria: Patient Undergoing laparoscopic uterine surgery under general anesthesia (total hysterectomy, myomectomy); Patients gave the informed consent and signed the informed consent form. The ASA is Ⅰ-Ⅱ Exclusion Criteria: Patients allergic to anesthetics, ropivacaine, and esketamine or with contraindications to use; Patients with cognitive dysfunction or an inability to communicate; Transfer to the ICU after surgery; Patients with hyperthyroidism, tachyarrhythmia, or severe hypertension; Unwilling to use PCIA or refuse to participate in this trial; Patients with liver and kidney dysfunction - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06300931

Not yet recruiting

KAP for Use of SDF Among Dental Interns Before vs After Educational Intervention

This study is a KAP questionnaire to assess Egyptian intern dentists' knowledge, attitudes and practices regarding use of SDF before and after an educational intervention.

- EligibilityCriteria: Inclusion Criteria: - Dental Interns who are enrolled in the pediatric dental department, Faculty of Dentistry, Cairo University who are willing to participate. Exclusion Criteria: Dental Interns who are enrolled in the pediatric dental department , Faculty of Dentistry, Cairo University who are unwilling to participate. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Interns who graduated dental school and are currently enrolled in the pediatric dental department, Faculty of Dentistry, Cairo University - SamplingMethod: Probability Sample

NCT06300918

Not yet recruiting

A Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA

The goal of this prospective randomized controlled study is to compare the therapeutic effect of injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy at different time points. At present, studies have confirmed that anti-VEGF drugs are effective in inhibiting fundus neovascularization in proliferative diabetic retinopathy. The main question it aims to answer is which time point is better to injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy. Participants will be randomly divided into three groups. And time points of injecting anti-VEGF drugs before surgery for each group will be 3 days, 7 days, 14 days. And we have a new technology that can have fluorescein fundus angiography during operation, so it can reflect the condition of fundus neovascularization immediately and precisely. In that case, we can compare the Inhibitory effect of anti-VEGF drugs on fundus neovascularization at different time points.

- EligibilityCriteria: Inclusion Criteria: PDR is diagnosed in people 18 years of age or older with type 1 or type 2 diabetes， Hemoglobin A1c (HbA1c) ≤10% Persistent vitreous hemorrhage for more than one month or recurrent vitreous hemorrhage (within six months) Did not undergo retintis photocoagulation (PRP) Vitreous hemorrhage disease course within six months Exclusion Criteria: Patients who have had previous vitreoretinal surgery Intravitreal drug injection within 3 months Eye diseases other than PDR that may hinder vision improvement, such as optic atrophy or macular hole Thromboembolic events (including cerebrovascular or myocardial infarction) or clotting system disorders or receiving anticoagulation or antiplatelet therapy B-ultrasound or indirect fundus microscopy showing retina detachment (pull or hole origin) Vitrectomy, FFA contraindicated patients, patients with severe abnormality of cardiopulmonary, liver and kidney function - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300892

Not yet recruiting

Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections

This is a prospective, observational study of patients undergoing open GI surgery. At the time of operation, samples will be collected from the incision site and GI tract. The study will follow patients up to 30 days postoperatively, monitoring for signs of SSI. Samples will be taken from all patients who develop SSI. Sequencing will be performed on a subset of samples based on our specific aims. Aim 1: conduct a case-control study of patients with SSI and age-, sex-, diagnosis-, and wound class-matched control patients without SSI, comparing microbiome alpha diversity and community composition with 16S RNA sequencing to determine the association with SSI. Aim 2: identify the strain of bacteria isolated from SSIs using shotgun metagenomic sequencing and determine whether the specific strain was present in the skin and gut at the time of operation.

- EligibilityCriteria: Inclusion Criteria: We will include adult patients (age ≥ 18 years) Undergoing open abdominal surgery during the study period. Open abdominal surgery will include any abdominal procedure entering the peritoneal cavity through a midline incision with a skin incision that is 5cm or greater. Exclusion Criteria: Patients with planned minimally invasive surgery including laparoscopic or robotic surgery as these patients have lower rates of surgical site infections (SSIs). Patients who have a laparoscopic or robotic surgery converted to open surgery will be excluded. Appendectomy and cholecystectomy as these patients have lower risk of SSI. Vascular, gynecological, obstetric, urological or transplantation. Trauma patients. Patients without source control at the index operation including those with an open abdomen, no fascial closure, or temporary abdominal closure device (such as abthera dressing). Pediatric patients (age<18 years). Patients who decline swab/specimen collection. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: adults over the age of 18 years, who are undergoing open abdominal surgery with a midline incision. - SamplingMethod: Non-Probability Sample

NCT06300879

Recruiting

A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III). The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.

- EligibilityCriteria: Inclusion Criteria: Age between 18 and 75 years old; Pathologically confirmed as adenocarcinoma; Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III); If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met. For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach. Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved. No history of upper abdominal surgery (excluding laparoscopic cholecystectomy). No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. Preoperative ECOG (Eastern Cooperative Oncology Group) score of 0/1. Preoperative ASA (American Society of Anesthesiologists) score I-III. Good function of important organs. Signed informed consent. Exclusion Criteria: Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis; Pregnant or lactating women; Patients with severe mental illness; Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment; Severe respiratory diseases, with FEV1 < 50% of predicted value; History of other malignant tumors in the past 5 years; Severe liver or kidney dysfunction; Unstable angina or myocardial infarction within the last 6 months; History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts); Systemic use of glucocorticoids within the last 1 month; Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction); Patient has participated in or is currently participating in other clinical trials (within the last 6 months). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06300853

Recruiting

Understanding Adaptive Immune Response After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups.

This is an experimental study without drug and device, non-profit, single-center. The general objective of the project is to study how the adaptive immune response evolves against SARS-CoV-2 with repeated vaccination boosters and infections also in relation to the evolution of variations. This study will be relevant to frail populations who are the main targets of repeated vaccinations. Our project will benefit from the availability of a highly cohort characterized of vaccinated people, including cancer patients and elderly people, with prospective collection of samples for an in-depth evaluation of the evolution of the immune response with repeated exposure to doses of infection or vaccine. As part of the study, analyzes will be carried out on samples of patients enrolled in a manner prospective at the oncology departments of the IRCCS (Medical Oncology, Department of Radiotherapy advanced oncology and nuclear medicine) and elderly patients residing in retirement homes of the IRCCS. Patients will also be asked for consent to store any residual samples in the Tropica DITM Biobank.

- EligibilityCriteria: Cancer patients Inclusion criteria: Age> 18 years. Solid tumor diagnosis [I, II, III, IV stage,]. Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections. Signed informed consent. Exclusion criteria Age < 18 years. Absence of signed informed consent. Elderly subjects Inclusion criteria: Age> 70 years. Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections. Signed informed consent. Exclusion criteria Age < 70 years. Absence of signed informed consent. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300840

Not yet recruiting

Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH)

The goal of this clinical trial is to study the impact of a continuous vibrotactile feedback belt on balance, (fear of) falling, fatigue and overall functioning in participants with chronic disabling unilateral vestibular hypofunction. The main questions it aims to answer are: • does wearing a vibrotactile feedback belt during waking hours for a week improve sense of balance and mobility, fear of falling, fatigue and overall functioning • does wearing a vibrotactile feedback belt influence static and dynamic balance and gait performance during balance and gait testing. Participants will goes through different phases in an randomized order; a baseline phase, a sham phase (i.e., wearing the BalanceBelt while it is switched off) and an intervention phase (i.e., wearing the BalanceBelt while it is switched on). It is expected that, just as with patients with bilateral loss of the balance organ, patients with a unilateral loss will also benefit from the BalanceBelt.

- EligibilityCriteria: Inclusion Criteria: Diagnosed with severe unilateral vestibular dysfunction (i.e., a gain below 0.6 of the affected side and a gain between 0.8 and 1.1 of the contralateral side measured by the video-Head Impulse Test (vHIIT)). Duration of dizziness complaints >3 months (i.e. chronic dizziness). Self-reported imbalance with a fear of falling and/or actual falls. Is able to walk (with or without a walking aid). Self-reported overall Mobility and Balance Score (MBS) of 3-5 points Motivated to try the BalanceBelt. Provides written informed consent. Exclusion Criteria: Age < 18 years Presence of neurological, psychiatric or orthopaedic disorders, Persistent postural-perceptual dizziness (PPPD), reduced proprioceptive sensitivity or impaired vision which influences the postural stability. Not able to understand instructions and questionnaires in Dutch Not able/willing to visit Gelre Hospital Apeldoorn for necessary visits. Wheelchair bound at home - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300827

Recruiting

The Effect of Structured Digital-Based Education Given to Nursing Students

Turkey is a risky country in terms of disasters. Preparedness and awareness for all disasters affecting the whole world gain value. Disaster literacy is an important approach to evaluating disaster preparedness and awareness processes. Disaster literacy is defined as the ability of an individual to access, read, understand, and use the information necessary to make informed decisions and follow instructions in the context of mitigation, preparation, response, and recovery during a disaster Disaster literacy needs to be increased to raise awareness among individuals and minimize disaster risk. Along with the awareness studies, it is also important to identify the disaster preparedness belief in order to encourage individuals to change potentially harmful behavior. Belief in disaster preparedness; It may vary according to the perception of experiencing a disaster, the perceived severity of the disaster, the benefits of being prepared for a disaster, the perceived barriers to being prepared for a disaster, being prepared, and the individual's belief in his or her ability to cope with a disaster. It may be useful to determine both disaster preparedness beliefs and disaster literacy levels of individuals at the social level. It is predicted that when multiple interventions are brought together in the learning process, there will be a faster and more lasting effect. In this study, which aims to use education and information technology together, a structured digital-based educational intervention is planned. The intervention program was structured by taking advantage of both the advantages of the digital world and active learning methods in order to keep the student active. The program is eight weeks and consists of seven dimensions and the purpose of the program is based on accessing information, understanding, information, making decisions, and applying information. The planned study aimed to determine the effect of structured digital-based education given to university students studying in the nursing department on their disaster literacy and disaster preparedness belief levels.

- EligibilityCriteria: Inclusion criteria To be enrolled in the nursing programme Ability to speak and understand Turkish Speak English at least at beginner level To have signed the informed consent form Exclusion criteria Having previously participated in any disaster training programme Failure to attend the eight-week digital-based disaster training programme twice in a row - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300814

Recruiting

The Effect of Exercise and Music on Sleep, Quality of Life and Emotional State in Children With Epilepsy

This study was planned as a randomized controlled experimental study with a pretest-posttest design to determine the effect of parental supervision and video-guided progressive relaxation exercise (PRE) and music recital on sleep, quality of life and emotional states in children with epilepsy aged 9-16 years. The main questions it aims to answer are as follows: According to the evaluation of children with epilepsy, does the progressive relaxation exercise applied to children have an effect on sleep, quality of life and emotional states? According to the evaluation of children with epilepsy, does music recital applied to children have an effect on sleep quality of life and emotional states? The study consisted of 45 children (15 children in the progressive relaxation exercise group, 15 children in the music recital group and 15 children in the control group). Ethics committee approval, permission from the institutions and informed consent of the children were obtained for the conduct of the study. A value of p<0.05 was considered statistically significant in data analysis.

- EligibilityCriteria: Inclusion Criteria: Between the ages of 9-16, Does not have a chronic or genetic disease other than epilepsy, No mental, visual or hearing impairment, Having a mother who is at least a primary school graduate, Both he and his mother are open to communication and cooperation, Children who both themselves and their mothers volunteer to participate in the research and give verbal and written consent. Exclusion Criteria: Not between the ages of 9-16, Having a chronic or genetic disease other than epilepsy, Mentally, visually or hearing impaired, Mothers who are not primary school graduates, Both he and his mother are not open to communication and cooperation, Neither they nor their mothers volunteered to participate in the research, Children and mothers without smart phones - HealthyVolunteers: No - Gender: All - MinimumAge: 9 Years - MaximumAge: 16 Years - StdAgeList: Child

NCT06300788

Not yet recruiting

Inorganic Pyrophosphate Homeostasis (PPi) in Pediatric Chronic Kidney Disease

The investigator aim to identify the role of inorganic pyrophosphate and other anti-calcifying molecules in vascular disease in children with chronic kidney disease, with a view to developing therapeutic approaches aimed at limiting the onset of vasculopathy.

- EligibilityCriteria: Inclusion Criteria: All groups : Minor patients (<18 years) Patients of both sexes Informed patients and parents who have signed the informed consent form Patients affiliated to social security Control group : - Patients with no particular pathology undergoing surgery and receiving a preoperative check-up CKD groups : Patients on dialysis for more than 3 months, regardless of technique Kidney transplant patients Patients with CKD, whatever the cause Exclusion Criteria: Progressive cancer or kidney disease Treatments that may modify PPi concentration (e.g. bisphosphonates) - HealthyVolunteers: No - Gender: All - MinimumAge: 0 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06300775

Recruiting

Evaluation of Modified Hyrax Versus Quad Helix in Treatment of Posterior Cross Bite

This study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax & Quad helix appliances and to compare which one will provide better results in relation to chewing difficulty in children with posterior cross- bite in mixed dentition

- EligibilityCriteria: Inclusion Criteria: Children with posterior cross-bite in mixed dentition stage. Children with normal and mild growth pattern. Children with completely erupted upper first molars. Exclusion Criteria: Children with advanced periodontal diseases. Children having general diseases, syndromes. Children with previous orthodontic. Children with severe horizontal growth patterns. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06300762

Not yet recruiting

RCT Exudate Management Cutimed Sorbion Product Range

The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. The aim of the current study is to determine whether there is a difference in the clinical performance of exudate absorption with two commonly used CE-marked superabsorbent dressings when used on VLUs in routine wound care. As primary objective the dressing´s absorption performance and its ability to prevent skin maceration and leakage of the wound dressing will be investigated.

- EligibilityCriteria: Inclusion Criteria: Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment Participant is mentally and physically able to participate in this study Men, women, diverse ≥ 18 years Participant complies with study visit schedule Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy) Participant suffers from lower leg ulcer* (including the ankle but not the feet) indicated to be treated with the study deviceinvestigational devices, requiring compression and fulfilling the following: Ulcer is not younger than 4 weeks and not older than 1 year Ulcer is ranging between 2 cm2 and 800 cm2 One side of the ulcer is not extending 40 cm Depth of ulcer < 2 cm Ankle-brachial pressure index (ABPI) of >0.8 and ≤1.3, measurement not older than 12 months * Participants with more than one ulcer are eligible for inclusion, however only one ulcer per patient will be included in the study. Exclusion Criteria: Participant already participates in this study with one ulcer (only one ulcer per participant is allowed) Participant is expected not to be willing or able to follow the study outlines and requirements Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and/or systemic corticosteroids Participant uses any medication that could potentially delay the wound healing ability Participant is an employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site or sponsor staff, e.g. child, spouse etc. Participant is pregnant or currently breastfeeding Participant reporting (and/or suspected by investigator) addiction from alcohol or drugs or is substituted e.g., by Methadone 8. Participant suffers from alcohol or drug addiction or is substituted e.g., by Methadone 9. Participant is or has been included in another clinical investigation with medical devices or pharmaceutical drugs at present or during the past 30 days 10. Participant with a history of sensitivity to any of the components of the study product 11. Participant whose leg ulcers are clinically infected (e.g., erysipelas) or malignant 12. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the trial 13. The ulcer has exposed bone, tendon, ligaments and/or joint 14. History of radiation at the study ulcer site 15. Participant's lesion is a primary skin cancer 16. Participant's lesion is the manifestation of a metastasis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300723

Not yet recruiting

Clinical Study of BRL-101 in Severe SCD

This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101).

- EligibilityCriteria: Inclusion Criteria: - Subjects must meet all the following inclusion criteria to be eligible for enrolment into the study: Subject (or their legally authorized representative or guardian) will sign and date an informed consent form (ICF) and, where applicable, an assent form. Subjects 3 to 35 years of age, inclusive, on the date of informed consent. Clinically confirmed severe SCD, genotypes include: βS/βS, βS/β + or βS/β0. Severe SCD is defined as having at least 2 VOC events per year during the 2 years prior to screening and requiring appropriate supportive care, including a pain management program, HU therapy (if indicated). Karnofsky performance status of ≥80% for subjects ≥16 years of age. Lansky performance status of ≥80% for subjects <16 years of age (see Appendix 1 and 2). Eligible for autologous stem cell transplant as per investigator's judgment. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures. Willing to participate in an additional long-term follow-up study after completion of this study (Study 2022-LTF-BRL-101). Subjects of childbearing potential must use effective contraception for at least 6 months after BRL-101 infusion during the study. Exclusion Criteria: - Subjects meeting any of the following criteria are not eligible for enrolment in the study: Known contraindications, intolerance, or hypersensitivity to hematopoietic stem cell mobilizers, busulfan injection, or dimethyl sulfoxide (DMSO) or study drug-related components. Eligible for allogeneic hematopoietic stem cell transplantation and have found HLA-identical donors. Prior allo-HSCT, gene therapy or gene editing therapy. Clinically significant and active bacterial, viral, fungal, or parasitic infection as determined by the investigator. HbF level >15.0%, irrespective of concomitant treatment with HbF inducing treatments such as HU. Treatment with regular RBC transfusions that, in the opinion of the investigator, cannot be interrupted after engraftment. More than 10 unplanned hospitalizations or emergency department visits related to SCD in the 1 year before screening and the investigator considered this to be a significant chronic pain rather than an acute pain crisis. A history of clinically significant transcranial Doppler (TCD) test abnormalities or test abnormalities in the opinion of the investigator. History of untreated Moyamoya disease or presence of Moyamoya disease at Screening that in the opinion of the investigator puts the subjects at the risk of bleeding. the subject has participated in other clinical studies and used drugs within 3 months before screening. White blood cell count < 3 × 109/L and/or platelet count < 100 × 109/L not due to hypersplenism as judged by the investigator. INR > 1.5×ULN, APTT > 1.5×ULN. Creatinine > 1.5 × ULN or endogenous creatinine clearance < 60 ml/min (calculated according to the Cockcroft-Gault formula, see Appendix 3). ALT or AST> 3×ULN, or direct bilirubin value > 2.5×ULN. Severe iron overload with serum ferritin ≥ 5000 ng/ml, liver iron > 15 mg Fe/g dry weight (or liver MRIT2* < 1.4 ms or > 588 Hz), or heart MRI-T2* < 10 ms. LVEF < 50%. DLco < 50% predicted (corrected haemoglobin or/and alveolar volume) or forced vital capacity (FVC) (measured/predicted) < 60% (For children for whom DLco could not be determined), or abnormal blood gas analysis (for younger children with undetectable ventilatory function only). Hepatitis B virus surface antigen (HBsAg) positive or HBV-DNA positive; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; syphilis (TP) -specific antibody positive; Epstein-Barr virus EBV-DNA positive; cytomegalovirus CMV-DNA positive. History of a significant bleeding disorder. History or family history of malignancy or myeloproliferative disorder. Any prior or current cardiovascular system diseases, such as congestive heart failure, arrhythmia, myocardial disease, valvular heart disease or pulmonary hypertension; cirrhosis, liver fibrosis or active hepatitis; central nervous system diseases or mental illness. Presence of immune dysfunction or endocrine disorders, such as insulin-dependent diabetes mellitus, hyperthyroidism, or insufficiency. Pregnant or breastfeeding females. Any condition that, in the opinion of the investigator, would make participation in this clinical study inappropriate. - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 35 Years - StdAgeList: Child, Adult

NCT06300710

Not yet recruiting

Outcomes and Risk Factors of CPR in PICU

To detect the frequency and the underlying causes of cardiopulmonary arrest . To detect outcome of CPR To identify the associated risk factors for the different outcomes after CPR among those patients

- EligibilityCriteria: Inclusion Criteria: Including Children aged 1 month to 18 years who received at least 1 minute of CPR Exclusion Criteria: Exclusion of 1-Children aged below1 month and older than 18 years . terminal disease patients, such as malignancy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 1 Month - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: Children aged from 1 month to 18 years who suffered in-PICU CA between March 2024 to February 2025 will be included. Cardiopulmonary arrest was defined as the presence of unresponsiveness, apnea, absence of signs of life, and absence of a palpable central pulse or bradycardia of <60 bpm with poor perfusion in infants, requiring external cardiac compressions and assisted ventilation - SamplingMethod: Non-Probability Sample

NCT06300697

Recruiting

Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project

This study will explore potential links between atopic dermatitis and food allergy. This information will be useful to determine atopic dermatitis and food allergy share unique biochemical or genetic identifiers useful for diagnosing and treatments in the future. This is a mechanistic study consisting of obtaining blood and skin samples from participants at baseline. Individuals may also undergo a clinically indicated oral food challenge and have blood and skin samples collected at various times during the oral food challenge. This study will create a molecular map of the pathology of atopic dermatitis and food allergy. This information will be deployed to evaluate the hypothesis that atopic dermatitis and food allergy share unique genetic transcriptional signals in which the study team can then further analyze pathological pathways and cell types.

- EligibilityCriteria: Food allergy-only group Inclusion Criteria: Have a known history of food anaphylaxis to peanut, tree nut, egg, milk, or sesame confirmed by an allergist. Have had skin and blood food allergy testing to the food allergen in question within the past 6 months. Meet the 80% likelihood positive predictive value threshold for allergy based on at least 1 of either the skin or blood immunoglobulin E (IgE) tests per current literature corrected for age. See protocol for more details. No history of atopic dermatitis Food allergy plus atopic dermatitis group Inclusion Criteria: - Meet the "food allergy only group" inclusion criteria except this group must also have atopic dermatitis. Atopic dermatitis without food allergy Inclusion Criteria: Have a present diagnosis of atopic dermatitis by an allergist and/or dermatologist. Have no history of food allergy, past or present. Control Group Inclusion Criteria: - No history of food allergy or atopic dermatitis, past or present. Exclusion Criteria for all groups: People younger than age 10 or older than age 55 Any active cardiovascular disease, cancer, pulmonary disease except well-controlled asthma, or other condition that would preclude an OFC otherwise. Mild conditions that would not preclude an OFC are allowed (i.e., controlled hypertension or a surgically removed skin cancer that is resolved would not be exclusionary for this study, for example). Any medication use that cannot be stopped temporarily for the OFC that would interfere with the OFC result. Medications in this category include antihistamines (first or second generation) within 1 week. Any skin condition aside from atopic dermatitis per inclusion criteria groups that might impact the study, including such conditions as autoimmune skin conditions (such as psoriasis), congenital ichthyoses, hyper-IgE syndromes. Any recent change (within 6 months) of starting or stopping a biologic medication, such as dupilumab, tezepelumab, or others that might interfere with atopic dermatitis or food allergy. Any past or present history of oral immunotherapy (OIT) for any food allergen. Pregnancy - females of childbearing age will be asked and self-report pregnancy status. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 10 Years - MaximumAge: 55 Years - StdAgeList: Child, Adult

NCT06300684

Recruiting

Exploring CBTi's Dual Effect on Sleep, Diet, & Chrononutrition

This study aims to investigate the effects of Cognitive Behavioral Therapy for Insomnia (CBTi) on both sleep patterns and dietary habits in Lebanese adults with insomnia. Sleep patterns and dietary habits are intricately linked, with dysregulated sleep associated with poor diet quality and increased snacking. Conversely, the types of nutrients consumed can affect hormonal balance and circadian rhythm. Insomnia and obesity are interrelated public health concerns, with CBTi showing efficacy in improving sleep. This study will recruit participants with insomnia and randomly assign them to receive either CBTi or basic sleep hygiene education. Baseline assessments will include validated questionnaires about insomnia, dietary habits, and physical activity and a 7-day 24-hour diet recall sheets, as well as actigraphy for sleep parameters, and physical activity assessments. The intervention will last for four weeks, with post-intervention assessments conducted similarly to baseline.

- EligibilityCriteria: Inclusion Criteria: English literate adult men and women participants aged 18 to 65 years with a complaint of insomnia. Exclusion Criteria: Participants under 18 years old or above 65 years old. Participants with a known sleep disorder other than insomnia (sleep apnea, narcolepsy, or restless leg syndrome). Participants with a history of neurological disease including epilepsy/seizures and traumatic brain injury. Participants with active psychosis. Participants with hearing impairment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06300671

Recruiting

The Effect of Subtalar Joint Pronation Amount on Lower Extremity Alignment and Performance

The lower extremity consists of segments that can be affected by the relative position of each other. Deviation of one segment from its normal alignment in the lower extremity also affects the alignment of other segments. The hip joint can affect the frontal plane alignment from proximal to distal, while the foot and ankle complex can also affect it from distal to proximal. Increased subtalar joint pronation in the kinetic chain from distal to proximal; is associated with decreased dorsiflexion angle and increased frontal plane projection angle. It has been shown that ankle dorsiflexion limitation causes changes in the biomechanics and kinematics of landing after jumping, but no study examining the effect of foot pronation on jump tests has been found in the literature. Since the foot is located at the most distal point and acts as a support base for the kinematic chain, the smallest dynamic change in the foot affects the balance of the whole body. Due to foot pronation, changes in the sole contact surface may make it difficult for the foot to adapt to the ground, balance and postural stabilization may be adversely affected, and an increase in the workload of the muscles around the joint may be observed. In another study, it is mentioned that there is limited evidence about the effect of foot posture on postural stability. Although there are studies in the literature examining the effects of subtalar joint pronation on lower extremity alignment and postural stability, studies need to examine the effects of different subtalar joint pronation amounts on lower extremity alignment, jumping performance, and postural stability. Our study will contribute to the literature with this aspect.

- EligibilityCriteria: Inclusion Criteria: - Being between the ages of 18-40 Pain, difficulty in walking and loss of function, etc. not having complaints Foot posture index value should be between 6-12 Not having any orthopedic disease Not having visual or hearing impairment Not having been involved in any physical therapy program in the last 6 months. Not having undergone any surgical procedure on the lower extremity Not using analgesic medication within the specified treatment days throughout the research period. Exclusion Criteria: Having a lower extremity congenital anomaly Having a history of lower extremity surgery or planned lower extremity surgery within the next 12 months Having any signs of pain in the lower extremities Having ligament hyperlaxity Having a history of tendon or cartilage injury Having serious illnesses Predominant knee pain from other knee structures, hip or lumbar spine Having a history of using any shoe insert-orthosis-insoles or knee injection in the last 3 months Having any neurological or systemic inflammatory arthritis disorder (neurological involvement that affects movement) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06300658

Recruiting

Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery

The aim of this study is to evaluate the role of stellate ganglion blockade (SGB) for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgery.

- EligibilityCriteria: Inclusion Criteria: Age 21 to 75 years. Both sexes. American Society of Anesthesiologists (ASA) physical status III. Chronic renal failure (CRF) patients. Undergoing major lower limb orthopedic surgery. Exclusion Criteria: Psychiatric disorders. History of substance abuse. Ipsilateral brachial and radial artery stenosis. Allergy to local anesthetics. Cardiovascular and respiratory disorders. Coagulopathy. Use of vasoactive medications. Obesity (body mass index >30 kg/m2). Smoking. - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06300632

Recruiting

Geriatric Locomotive Syndrome and Related Factors in Older Adults

It has been stated that the results of physical function and physical performance affecting locomotive syndrome in elderly individuals are controversial and studies are still needed. However, no studies have been found examining its relationship with the decrease in physical activity level, decline in cognitive functions, kinesiophobia (fear of movement) and fatigue seen in old age. Early detection of locomotive syndrome risk factors in elderly individuals will help prevent this condition, detect the risk of falling in elderly individuals and increase their quality of life. Based on these deficiencies, it is aimed to examine the relationship between locomotive syndrome and kinesiophobia, physical activity level, physical performance, fatigue and cognitive functions in elderly individuals.

- EligibilityCriteria: Inclusion Criteria: Individuals aged 65 and over, Volunteering to participate in research No cooperation and communication problems (Mini Mental State Test score above 24) Exclusion Criteria: Individuals with neurological and orthopedic problems Uncontrolled hypertension Those with cardiac disease Those with cooperation and communication problems - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - MaximumAge: 85 Years - StdAgeList: Older Adult - StudyPopulation: At Kırıkkale University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, all elderly individuals aged 65 and over who meet the inclusion and exclusion criteria and who volunteer to participate in the study will be collected by face-to-face interview using evaluation forms. - SamplingMethod: Non-Probability Sample

NCT06300606

Recruiting

Nociception Index Level (NOL) Perioperative Monitoring During Regional Anesthesia

This prospective observational study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb. We included 50 consecutive adult patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia. The locoregional anesthesia was performed under ultrasound, with or without neurostimulation. Intraoperative pain is assessed using NOL index monitoring, ALGISCORE and Numerical Scale, and second point study is the midazolam and propofol requirement.

- EligibilityCriteria: Inclusion Criteria: scheduled upper limb orthopedic surgery under regional anesthesia Exclusion Criteria: Patient less than 18 years old emergency surgery patient refusal of regional anesthesia chronic neurocognitive disease - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: all the patients scheduled to undergo an upper limb orthopedic surgery under regional anesthesia - SamplingMethod: Non-Probability Sample

NCT06300593

Recruiting

Activity of Chronic Inflammation in PCOS

Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes.

- EligibilityCriteria: Inclusion Criteria: age 18-45 years PCOS syndrome confirmed by the Rotterdam criteria Exclusion Criteria: absence of at least one ovary diagnosed and/or treated other metabolic disease diagnosed and/or treated other endocrine disease - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult - StudyPopulation: Women aged 18-45, treated at the University Hospital in Krakow, diagnosed with PCOS confirmed by the Rotterdam criteria, phenotypes A, B, C, D, without other metabolic and endocrine diseases. - SamplingMethod: Non-Probability Sample

NCT06300580

Not yet recruiting

Study of Oral ABBV-932 Capsules to Evaluate Dopamine D2 and D3 Receptor Occupancy in Brain in Adult Healthy Volunteers

The main objective of this study is to evaluate the dopamine D2 and D3 receptor occupancy in the brain as measured by PET with radiotracer [11C]-(+)-PHNO up to 14 days of once-daily oral doses of ABBV-932 in healthy subjects. ABBV-932 is a prodrug of DCAR (desmethyl-cariprazine), which is a dopamine D3 receptor-preferring D3/D2 receptor partial agonist. Approximately 12 adult healthy volunteers will be enrolled in the United Kingdom. Participants will receive ABBV-932 oral capsules once daily for 2 weeks and followed for 60 days. Participants will be confined for approximately 15 days. Participants will receive 3 [11C]-(+)-PHNO PET scans during the study. Adverse Events and blood tests will be performed.

- EligibilityCriteria: Inclusion Criteria: Body Mass Index (BMI) is >= 18.0 to <= 35.0 kg/m2. Supine pulse rate >= 50 bpm and <= 100 bpm obtained after a 5-minute rest at Screening. Supine systolic blood pressure (SBP) <= 160 mm Hg and >= 90 mm Hg and supine diastolic blood pressure (DBP) <= 90 mm Hg and obtained after a 5-minute rest at Screening. Exclusion Criteria: Orthostatic (SBP decrease of >= 30 mmHg, DBP decrease of >= 20 mmHg, or pulse increase of >= 30 bpm) as determined after standing for 5 minutes. Current or history of suicidal ideation as indicated by answering "Yes" answer to Suicidal Ideation Questions #4 or #5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening in the past 3 months or any "Yes" answer to Suicidal Behavior Questions #1-5 in the past year. Non-suicidal self-injurious behavior is not exclusionary. History of suicide attempt(s) within 1 year prior to study drug administration as evidenced by answering "Yes" to any Suicidal Behavior Questions (a "Yes" to Non-Suicidal Self-Injurious Behavior is not exclusionary). Contraindications to MRIs (metal implants, paramagnetic objects contained within the body, claustrophobia, etc.) Clinically significant findings as determined from screening brain MRI. History of previous radiation exposure for research purposes such that participation in this study will result in cumulative ionizing radiation exposure >10 mSv in the past 12 months, in additional to normal background exposure. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 23 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06300567

Not yet recruiting

Assessment of Patients Not Concluded After Neonatal Screening of Cystic Fibrosis.

Assessment of the outcome of patients not concluded fir cystic fibrosis, either symptomatic patients or asymptomatic children detected by newborn screening for cystic fibrosis. The aim is to identify patients potentially at risk of progressing to the clinical spectrum of cystic fibrosis

- EligibilityCriteria: Inclusion Criteria: patients not concluded for the diagnosis of Cystic fibrosis either because of intermediate sweat test or because extensive genetic study has identified 2 vrainats at least 1 being not CF causing - Exclusion Criteria: patients carrying 2 CF causing variants of the CFTR gene patients carrying only 1 or no variants of CFTR - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: children of adults not concluded for the diagnosis of Cystic fibrosis - SamplingMethod: Non-Probability Sample

NCT06300554

Not yet recruiting

10th Mountain Healthy Minds Program App Study

The purpose of the study is to evaluate the acceptability, feasibility, and preliminary effects of the Healthy Minds Program (HMP) App in approximately 150 active duty military members.

- EligibilityCriteria: Inclusion Criteria: Active duty military at the 10th Mountain Division Exclusion Criteria: N/A - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300541

Recruiting

Prevalence and Impact of Sarcopenia in Patients With Inflammatory Bowel Disease

Sarcopenia is a condition characterized by significant muscle loss resulting in impaired muscle function. This condition is likely associated with a biological deviation leading to reduced reserves to withstand stressors, resulting in a poorer prognosis. The incidence of sarcopenia among patients with inflammatory bowel diseases (Ulcerative Colitis and Crohn's disease) is currently approximately 40-60%. This is likely a consequence of the preference for drug treatment over surgery, while many patients have continuous inflammation in their intestines leading to muscle loss and subsequently increased morbidity and mortality. The purpose of the study is to identify the prevalence of sarcopenia among patients experiencing a severe flare-up of their bowel disease and to evaluate whether the removal of the colon results in improved nutritional status. Furthermore, the investigators aim to investigate whether there is a specific microbiota composition related to an unfavorable course. The participants are longitudinally monitored with measurements taken at the flare-up/before surgery and one year afterward, including body composition, function, dietary recording, quality of life, blood tests, fecal samples, and intestinal biopsies that will be analyzed. The investigators plan to correlate body composition with a biological profile and then evaluate if there is an association. Additionally, the investigators aim to analyze if these markers are linked to different outcomes after colectomy. This study will contribute to an enhanced understanding of patients with advanced IBD and possibly change the perspective on how the clinicians should prioritize these patients for surgery. The investigators believe this study will lead to an improvement in healthcare quality and an enhanced understanding of how these disease processes function.

- EligibilityCriteria: Inclusion Criteria: All adult patients experiencing an acute flare-up of their bowel disease (ulcerative colitis or Crohn's disease) admitted to a hospital in the Region Västra Götaland and Stockholm are invited to participate in the study. Exclusion Criteria: Not wishing to participate in the study Inability to understand the language or study procedures - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adults with severe IBD. - SamplingMethod: Probability Sample

NCT06300528

Not yet recruiting

Pemigatinib for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma or Marginal Zone Lymphoma

This phase II trial tests how well pemigatinib works in treating patients with mantle cell lymphoma (MCL) or marginal zone lymphoma (MZL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Pemigatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

- EligibilityCriteria: Inclusion Criteria: Age ≥ 18 years Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 Histologically documented MCL or MZL, including extranodal marginal zone lymphoma (EMZL)/mucosa-associated lymphoid tissue (MALT) lymphoma, splenic marginal zone lymphoma (SMZL), and nodal marginal zone lymphoma (NMZL) Patients with gastric MALT lymphoma and those who are Helicobacter (H.) pylori positive need to have failed a trial of H. pylori eradication and are either ineligible, refused, or failed gastric radiation therapy At least two prior lines of systemic therapy and patients do not have Food and Drug Administration (FDA) approved available therapies or refuse them Prior autologous hematopoietic cell transplantation (auto-HCT) and chimeric antigen receptor (CAR)-T cell therapy are eligible. Patients with prior auto-HCT may be eligible if treatment completed after at least 3 months prior to first treatment Patients with CAR T-cell therapy may be eligible if treatment completed after at least 1 month prior to first treatment Patients must have an indication for systemic treatment Radiographically measurable disease by computed tomography (CT) scan, defined as at least one lesion > 1.5 cm in size or assessable disease in the opinion of the investigator Life expectancy of > 3 months, in the opinion of the investigator Willingness to avoid pregnancy or fathering children based on the criteria below: Woman of nonchildbearing potential (i.e., surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea) A woman of childbearing potential who has a negative pregnancy test at screening and before the first dose on day 1 and who agrees to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the subject and their understanding confirmed. A follow-up pregnancy test will be performed at end of treatment (EOT) visit Men who agrees to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after last day of treatment (1 sperm cycle). Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the subject and their understanding confirmed Absolute neutrophil count (ANC) ≥ 1000 cells/mm^3 (≥ 1.0 x 10^9/L) independent of granulocyte colony stimulating factor (G-CSF) support (i.e., no G-CSF within the past 3 days), unless there is documented bone marrow involvement or splenomegaly with ensuing cytopenia in which case ANC of 750 cells/mm^3 (0.75 x 10^9/L) is permissible. Also, there should be no evidence of myelodysplasia or hypoplastic bone marrow Platelet count ≥ 75,000 cells/mm^3 (≥ 75 x 10^9/L) independent of transfusion support (i.e., no transfusion within the past 3 days) unless there is documented bone marrow involvement in which case platelet count of 50,000 cells/mm^3 (0.5 x 10^9/L) is permissible. Patients must be responsive to transfusion support if given for thrombocytopenia and patients refractory to transfusion support are not eligible. Also, there should be no evidence of myelodysplasia or hypoplastic bone marrow Hemoglobin of ≥ 8 g/dL (≥ 80 g/L) independent of transfusion support (i.e., no transfusion within the past 3 days) unless there is documented bone marrow involvement or splenomegaly with ensuing cytopenia in which case hemoglobin of 7 g/dL (70 g/L) is permissible. Patients must be responsive to transfusion support if given for anemia and patients refractory to transfusion support are not eligible. Also, there should be no evidence of myelodysplasia or hypoplastic bone marrow Total bilirubin < 1.5 x upper limit of normal (ULN) or < 2.5 x ULN with document liver involvement and/ or Gilbert's disease Transaminases (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) ≤ 2.5 x ULN or ≤ 5 x ULN with documented liver involvement Calculated creatinine clearance > 30 mL/min according to Cockcroft/Gault Formula Ability to swallow oral tablets Patients or their legal representatives must be able to read, understand, and provide informed consent to participate in the trial Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol Exclusion Criteria: Prior receipt of FGFR inhibitor Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug Major surgery within 4 weeks prior to enrollment Received prior radiation therapy administered within 4 weeks of first dose of study drug. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have radiation pneumonitis. A 2-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease A 4 week wash out from the prior cytotoxic chemotherapy, a 3 week wash out from prior monoclonal antibody and a 2 week wash out from prior BTK inhibitor. The wash out interval is based on the last day of the prior therapy to the start of the study drug (cycle 1 day 1 [C1D1]) Concurrent anticancer therapy except as listed for prostate and breast cancer Significant cardiovascular disease defined as: Unstable angina or acute coronary syndrome within the past 2 months prior to study enrollment History of myocardial infarction within 3 months prior to study enrollment or Documented left ventricular ejection fraction (LVEF) by any method of ≤ 40% in the 12 months prior to study enrollment ≥ grade 3 New York Heart Association (NYHA) functional classification system of heart failure, uncontrolled or symptomatic arrhythmias Patients with CNS involvement Prolongation of the QT interval corrected for heart rate (QTcF) > 470 msec. QTcF is calculated using Fridericia's Formula (QTcF) Correction of suspected drug induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation Correction for underlying bundle branch block (BBB) allowed Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker Patients who have tested positive for human immunodeficiency virus (HIV). For patients with unknown HIV status, HIV testing will be performed at screening and result should be negative for enrollment Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below: Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before enrollment. Patients who are HBV deoxyribonucleic acid (DNA) PCR positive will be excluded. Patients with positive anti-HBc and negative HBV DNA should be on prophylactic nucleo(t)side analogue therapy to prevent reactivation with serial HBV DNA PCR monitoring Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment. Patients who are hepatitis C RNA positive will be excluded. Patients with SMZL who have chronic HCV will need to have undergone antiviral treatment to participate Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and medical monitor may pose a risk for patient participation. Screening for chronic conditions is not required Active second malignancy unless in remission and with life expectancy > 2 years Are pregnant and breast feeding Pregnancy or nursing women or subjects expecting to conceive or father children within the projected duration of the study, starting with the screening visit through completion of safety follow-up visit (90 days from date of last dose for male subjects) History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Moderate CYP3A4 inhibitors are not prohibited but should be avoided Subject with history of hypovitaminosis D requiring supraphysiologic dose (such as 50,000 IU of vitamin D3) to replenish the deficiency. Subjects receiving vitamin D food supplements are allowed Have a known hypersensitivity to any of the excipients of pemigatinib Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to macular/retinal degeneration, diabetic retinopathy, and retinal detachment) as confirmed by ophthalmologic examination Patients with ongoing grade ≥ 2 toxicity from prior therapy, with exceptions such as alopecia - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300515

Not yet recruiting

Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation

Thanks to medical advances, survival rates >5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. These patients also tend to spend too much time inactive, which further accelerates functional decline in addition to producing fatigue and impairing quality of life. Therefore, new strategies are needed to minimize the morbidity associated with HSCT. In this effect, although physical exercise represents an interesting adjuvant treatment option for HSCT, scientific evidence in this area is still scarce. Implementation of physical exercise intervention in pediatric HSCT units is challenging due to the lack of research on the effectiveness, affordability and accessibility of this type of intervention. Therefore, establishing the effectiveness of physical exercise under controlled conditions is an important step. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on physical-functional, behavioral, psycho-cognitive and clinical outcomes, and blood biomarkers. The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the feasibility of implementing the proposed intervention in a real clinical situation in 3 different pediatric HSCT units.

- EligibilityCriteria: Inclusion Criteria: Age between 4 and 21 years. Undergoing hematopoietic stem cell transplantation (HSCT) for cancer diagnosis in complete remission or without remission, in 3 recruiting Hospitals in Madrid Undergoing treatment and follow-up in the same hospital. Speaking Spanish. Providing signed informed consent. Exclusion Criteria: Not being able to participate in the trial according to protocol. Comorbidity or acute condition not associated with the diagnosis and that contraindicates the practice of physical exercise, such as severe deficiencies in the locomotor, neurological, cardiovascular and pulmonary systems. Serious or chronic medical or psychiatric condition that may increase the risk associated with participation in the trial or that may interfere with the interpretation of the results and, in the opinion of the investigator in discussion with the team, makes having such condition inappropriate for entry to this study; inability to understand the study requirements. Not being able to attend hospital visits to perform assessment tests, nor participate in the physical exercise and health counseling program as stipulated in the protocol. Inability to understand the requirements of the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 21 Years - StdAgeList: Child, Adult

NCT06300502

Not yet recruiting

Assessing the Efficacy of Repeat, Monthly Treatments of Cutaneous Neurofibromas (cNFs)

This study will evaluate the tolerability and effectiveness of four FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and Kybella and Polidocanol injections. Each patient will have a treatment and a control site. This study is designed with the goal of improved efficacy/tumor reduction via multiple treatment visits. If there is minimal to no clinical improvement in tumor size with one treatment after three treatment visits, the subject will be given the option of crossover treatment with the most effective of the four treatments. Three treatment visits with the crossover treatment will then take place.

- EligibilityCriteria: Inclusion Criteria: Adult ≥18 years of age Have a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria: Family history of NF1 Six or more light brown ("cafe-au-lait") spots on the skin Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas Freckling under the arms or in the groin area Two or more pigmented, benign bumps on the eye's iris (Lisch nodules) A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg Tumor on the optic nerve that may interfere with vision Patients must be seeking treatment for cNF Patients must have ≥ 6 paired cNF (3 to be treated and 3 untreated) that are visible and measure between 2-8mm in size. These must be in areas amenable to treatment and surveillance with digital photography cNF must be located on the trunk, arms or legs of the patient Able and willing to comply with all visit, treatment and evaluation schedules and requirements Able to understand and provide written informed consent Exclusion Criteria: Individuals who cannot give informed consent or adhere to study schedule. Actively tanning during the course of the study. Known allergy to deoxycholic acid or polidocanol. Women who are pregnant. Those with acute thromboembolic diseases. Those with bleeding abnormalities or those who are currently being treated with antiplatelet or anticoagulant therapy. Any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06300489

Recruiting

Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer

This study is a multicenter, open, and phase I dose increasing clinical study. Based on the UGT1A1 * 28 and * 6 genotypes of patients with locally advanced rectal cancer, determine the dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of weekly irinotecan liposomes in concurrent chemoradiotherapy with capecitabine, investigate the tolerance of irinotecan liposome combined with capecitabine in concurrent chemoradiotherapy with locally advanced rectal cancer, and recommend the dosage for Phase II clinical study，and explore the pharmacokinetic characteristics of irinotecan liposomes combined with capecitabine.At the same time，Preliminary observe the efficacy and safety of irinotecan liposomes combined with capecitabine in chemoradiotherapy.The study plans to recruit 30 patients with advanced rectal cancer who have not received any therapy.

- EligibilityCriteria: Inclusion Criteria: Diagnosed as rectal adenocarcinoma by histopathology, immunohistochemical pMMR or MSI-L, MSS; The baseline clinical stage is T2-4 and/or N+, which is not suitable for initial local resection to achieve curative effect; The distance between the tumor and the anus is<=10cm; No distant metastasis; Age range from 18 to 70 years old, regardless of gender; ECOG PS score 0-1 points; The UGT1A1 * 6 and UGT1A1 * 28 gene phenotypes are all wild-type (GG+6/6), unit point mutant (GG+6/7 or GA+6/6), and dual site mutant (GG+7/7 or AA+6/6 or GA+6/7); Not receiving chemotherapy or any other anti-tumor treatment before enrollment; Able to comply with the protocol during the research period; Sign written informed consent. Exclusion Criteria: Diagnosed as rectal adenocarcinoma by pathological histology, and immunohistochemical dMMR or MSI-H; UGT1A1 * 6, UGT1A1 * 28 gene phenotype three site mutations (AA+7/7 or AA+6/7 or GA+7/7); Pregnant or lactating women Individuals with a history of other malignant diseases in the past 5 years, excluding cured skin cancer and cervical cancer in situ Individuals with a history of uncontrolled epilepsy, central nervous system disease, or mental disorders, whose clinical severity may be assessed by the researcher as hindering the signing of informed consent forms or affecting the patient's adherence to oral medication Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, NYHA grade II or more severe congestive heart failure, or severe arrhythmia requiring medication intervention (see Appendix 12), or a history of myocardial infarction within the past 12 months Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections or other serious uncontrolled comorbidities The baseline blood routine and biochemical indicators of the subjects do not meet the following criteria: hemoglobin ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; ALT and AST ≤ 2.5 times the normal upper limit value; ALP ≤ 2.5 times the normal upper limit value; Serum total bilirubin<1.5 times the upper normal limit value; Serum creatinine<1 times the upper normal limit value; Serum albumin ≥ 30g/L Known individuals with dihydropyrimidine dehydrogenase (DPD) deficiency Individuals who are allergic to any research medication - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06300463

Not yet recruiting

Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are: whether these combinations of immunotherapy change the tumor microenvironment in the liver whether these combinations of immunotherapy are safe and effective when used in colorectal cancer with liver metastases Participants will be randomly assigned to one of the following: Botensilimab and balstilimab Botensilimab, balstilimab, and AGEN1423 Botensilimab, balstilimab, and radiation Participants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years.

- EligibilityCriteria: Inclusion Criteria: Diagnosis of metastatic colorectal adenocarcinoma with liver metastases Participant must be planning to undergo a surgical resection of their liver metastases. Tumor is non-MSI-H/dMMR Presence of measurable disease Participants must be willing to consent to additional molecular analyses of tumor samples removed during surgery for research purposes Women of childbearing potential (WOCBP), or anyone with a uterus, must not be pregnant or breastfeeding. All participants of childbearing potential must agree to use highly effective contraception during this study Participants may not receive chemotherapy, growth factor support, transfusions, or albumin administration within 14 days of start of study treatment. Exclusion Criteria: Not eligible for surgery Any medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. Previous allogeneic tissue/organ transplant Previously received PD-1, PD-L1, or CTLA-4 therapy including experimental immunologic agents Participants must not have any contraindications to immune checkpoint inhibitors Participants must not have active autoimmune disease that has required systemic treatment within 2 years prior to registration. Some exceptions are allowed - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300450

Recruiting

Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy

This single-center, 400-patient, randomized controlled trial assesses the impact of a patient- and provider-facing EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase guideline-directed utilization of statin and statin-alternative oral LDL-C lowering therapies in patients with PAD who are not being prescribed LDL-C-lowering therapy.

- EligibilityCriteria: Inclusion Criteria: All patients ≥ 18 years old Seen in Cardiovascular Medicine Clinic, Primary Care, Podiatry, Vascular Surgery, and Diabetology Medical history entry, visit diagnosis, or problem list entry of PAD Not prescribed LDL-C-lowering therapy Exclusion Criteria: Patients taking a statin, ezetimibe, bempedoic acid, a PCSK9 inhibitor, inclisiran or a combination will be excluded - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300437

Recruiting

The Effects of Jaw Thrust on the Time to Successful Fiberoptic Pediatric Orotracheal Intubation During Residents Training Program

In this study, the authors aim to investigate the effect of adding jaw thrust maneuver on time to successful orotracheal fiberoptic intubation of pediatrics during resident training program.

- EligibilityCriteria: Inclusion Criteria: Children more than 1-year of age American Society of Anesthesiologists physical status I-II scheduled for elective surgery under general anesthesia. Exclusion Criteria: Patients known or suspected difficult intubation. Patients with syndrome known to be associated with difficult intubation. Patients with severe pulmonary or cardiac diseases. Patients at risk of aspiration (patients with lower esophageal disease such as Hiatus hernia, or GERD and DM). Body mass index (BMI) greater than 35 kg/m2. Refusal of the patient guardians. - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Year - MaximumAge: 15 Years - StdAgeList: Child

NCT06300424

Not yet recruiting

Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC

Phase II, single-arm, open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery, adjuvant treatment was upon investigators' decisions.

- EligibilityCriteria: Inclusion Criteria: Male or female，Age: 18 Years and older, Subjects voluntarily joined the study and signed informed consent, pathological proven resectable stage II-IIIB non small cell lung cancer (AJCC 8th edition), ECOG PS=0 or 1, resectable or potentially resectable, or resectability discussed by MDT, harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or L861Q measurable lesion as per RECIST1.1. Exclusion Criteria: pathologica or cytological proven small cell lung cancer, mixed small cell lung cancer or other than non small cell lung cancer, non small cell lung cancer harboring other driver gene alteration with approved targeted drugs, with malignant plural effusion, previous treatment to non small cell lung cancer other than this regimen, received thoracic radiotherapy, currently enrolled in other clinical trial, active or known or suspected autoimmune disease. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300411

Not yet recruiting

SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery

This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts.

- EligibilityCriteria: Inclusion Criteria: Aged 18 years or older Body weight >50kg Have a history of histologically confirmed diagnosis of breast carcinoma or ductal carcinoma in situ, except inflammatory breast cancer. Plan to undergo breast-conserving surgical treatment of breast cancer with curative intent. Adjuvant or neoadjuvant chemotherapy is allowed. Have Eastern Cooperative Oncology Group (ECOG) Performance Status <2 Have adequate organ and bone marrow function at screening Exclusion Criteria: Any known contraindication to ketorolac or other non-steroidal anti-inflammatory drugs (NSAIDs) Patients anticipated to require the use of a drain after breast-conserving surgery (BCS) Patients undergoing immediate reconstruction surgery, intraoperative radiation therapy (IORT) or brachytherapy requiring the placement of balloons or catheters during the lumpectomy procedure. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300398

Recruiting

IAMA-6 Oral Dose Study in Healthy Adults

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA-6 administered orally to healthy adults.

- EligibilityCriteria: Inclusion Criteria: Healthy male and female subjects. Aged between 18 and 55 years. Written informed consent; willing and able to comply with procedures. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception. Body mass index of 18.0 to 30.0 kg/m2, inclusive; and a total body weight >50 kg up to a maximum of 110 kg. The subject must be willing to return to the study centre for study treatment and study-related follow-up procedures as required by the protocol. Exclusion Criteria: Current or past history of a clinically significant (as judged by the Investigator) cardiovascular, cerebrovascular, respiratory, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease/condition, as determined by the Principal Investigator or Designee. Any history of central nervous system problems (e.g. epilepsy, head injury, loss of consciousness). Any history of malignancy in the previous 5 years involving any organ system (other than localised basal cell carcinoma of the skin). Body Mass Index: <18 kg/m2 , or >30 kg/m2. Abnormal vital signs, including known history of hypertension, resting oxygen saturation <95% by pulse oximetry. ECG at screening or on Day -1 showing QTcF interval >450 msec in males or >470 msec in females, or presence of any clinically significant dysrhythmia. History of hypersensitivity to any medicinal product(s) or severe hypersensitivity/anaphylaxis with unclear aetiology. Any clinically significant abnormal chemistry values. Any clinically significant abnormal haematology values. Blood donation within the past 3 months. Seropositivity for HBsAg, HCV, HIV 1, or HIV 2. Has a positive nasopharyngeal test for SARS-CoV-2 within 48h before unit admission. If female, has a positive highly sensitive urine pregnancy test at Screening or Day 1. If female and of child-bearing potential, and not meeting the approved criteria for highly effective methods of birth control. Receipt of any Investigational Drug within the past 6 months. Use of prescription medication within 14 days prior to dosing and antibiotics within 30 days prior to dosing. Intake of OTC preparations, vitamins, minerals, herbal remedies within 48h prior to dosing. Current smokers or history of smoking in previous 6 months. Current or history of drug, alcohol, nicotine abuse, or excessive coffee (>5 cups/day) or tea drinking (>5 cups/day). Inadequate comprehension of study risks and requirements. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06300385

Not yet recruiting

Effect of Electromyostimulation and Strengthening Exercises on Pain, Fatigue and Physical Performance in Motocross Athletes

Motocross, a popular sport, involves riding motorized vehicles on rugged tracks with obstacles. It's physically demanding, with high speeds and a risk of accidents. Grip strength is crucial, especially in the arms and forearms, which are prone to injury. Physiotherapy often employs strength exercises, including electromyostimulation. However, there's little research on their effectiveness for motocross athletes. This study aims to compare electromyostimulation combined with strength training versus strength training alone in relieving pain, fatigue, and improving strength in motocross athletes.

- EligibilityCriteria: Inclusion Criteria: Having at least 5 years of professional motocross training experience Being between 18 and 30 years old Volunteering to participate in the study Exclusion Criteria: To be absent from the 6-week EMS and strengthening program for more than 2 consecutive sessions Having suffered any injury that prevents you from training in the last 6 months Being receiving a physiotherapy program other than the protocol to be used in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult

NCT06300372

Not yet recruiting

Modified Thoracoabdominal Nerve Plane Block In Living Liver Donors

Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed deep into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. As there are studies showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery.

- EligibilityCriteria: Inclusion Criteria: Patients American Society of Anesthesiologists (ASA) classification I- II Scheduled for living liver donation surgery for liver transplantation under general anesthesia Exclusion Criteria: Patients with history of bleeding diathesis, receiving anticoagulant treatment, with allergies or sensitivity to drugs used, with an infection on the puncture site who do not accept the procedure or participate in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06300359

Not yet recruiting

Prognostic Indicators of Gullian-Barre Syndrome

Prognostic indicators of Gullian-Barre syndrome and the predictive factors associated with worse prognosis in the Guillain-Barré syndrome (GBS), which can be helpful to fully evaluate the disease progression and provide proper treatments.

- EligibilityCriteria: Inclusion Criteria: Patients 2 - 18 years old with guillian barrie syndrome admitted at Assiut university children hospital. Acceptance to participate in this study . Exclusion Criteria: Patients aged less than 2 years and more than 18 years old . Children or Parents who refused to participate in this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: children with GBS, presenting with weakness, diagnosed on clinical and/or electrophysiological grounds, were enrolled. The enrolled children underwent a detailed clinical-assessment followed by nerve conduction studies. - SamplingMethod: Non-Probability Sample

NCT06300346

Not yet recruiting

Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery

Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative nausea and vomiting/retching (NVR) may be experienced by 20% to 80% of women undergoing cesarean section (CS) with subarachnoid anesthesia (SA) in the absence of antiemetic prophylaxis. Different treatment options are available to reduce post operative nausea and vomiting (PONV) so we will make a Comparison between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks during Caesarean Delivery with Spinal Anesthesia

- EligibilityCriteria: Inclusion Criteria: Age: 21-40 years old. Physical status American Society of Anesthesiologists (ASA)I&II. Body mass index (BMI) < 35&>20 kg/m2. Elective uncomplicated cesarean section under spinal anesthesia. Exclusion Criteria: Patient refusal. Patients with known history of allergy to study drugs. Advanced hepatic, renal and respiratory diseases. Psychological and mental disorders. Patient with reduced level of consciousness. Hypertensive, cardiac, and diabetic patients. Patients receiving anticoagulants therapy or suspected coagulopathy. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 21 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06300333

Not yet recruiting

Treatment of Ectopic Pregnancy by Low Dose of Methotrexate

Evaluate the efficacy and safety of the use of low dose regimen of methotrexate in treatment of tubal undisturbed tubal ectopic pregnancy

- EligibilityCriteria: Inclusion Criteria: undisturbed ectopic tubal pregnancy Bhcg < 5000 Haemodynamicaly stable Normal liver and kidney functions Commitment for fullow up untill ectopic pregnancy resolvede Exclusion Criteria: disturbed ectopic pregnancy Bhcg >5000 Persistent abdominal pain Lactating women women with abnormal liver and kidney functions - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult - StudyPopulation: the study will include women with undisturbed ectopic tubal pregnancy Bhcg < 5000 Haemodynamicaly stable Normal liver and kidney functions Commitment for fullow up untill ectopic pregnancy resolved - SamplingMethod: Non-Probability Sample

NCT06300320

Not yet recruiting

A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease

This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease

- EligibilityCriteria: Inclusion Criteria: Voluntary and signed informed consent, good compliance; Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months. Received allogeneic hematopoietic stem cell transplantation; Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD) Received systemic therapies for cGVHD; Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening; Absolute Neutrophil Count (ANC) ≥ 1.0×10 9/L ；platelet count (PLT) ≥30×10 9 /L; Hemoglobin ≥80g/L; There were no obvious abnormalities in liver and kidney function and coagulation function; Men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study Exclusion Criteria: Currently present or occured other malignancies within 3 years prior to first administration; Known or suspected active acute graft versus host disease (aGVHD); Presence of infection requiring treatment within 7 days prior to randomization; Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants; Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization; Has a variety of factors that affect oral medications (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc; Those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder; Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment; Have any severe or uncontrolled serious illness, including but not limited to，uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment; Those who are allergic to the study drug or its components; Participation in other clinical trials or major surgery within 4 weeks prior to the first dose; Subjects judged by the investigator to be unsuitable for enrollment; - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06300307

Not yet recruiting

Study of ATX-01 in Participants With DM1

The goal of this clinical trial is to test ATX-01 in participants with myotonic dystrophy type 1 (DM1). The main question it aims to answer is if ATX-01 is safe and well tolerated. The trial will compare the safety and tolerability of ATX-01 and a matching placebo. There will be a single-ascending dose part of the trial and a multiple-ascending dose part. In the single-ascending dose, participants will receive one dose of ATX-01 or placebo. In the multiple-ascending dose part, participants will receive three doses of ATX-01 or placebo. ATX-01 is a novel anti-miR (synthetic single stranded oligonucleotide) that inhibits a microRNA called miR-23b.

- EligibilityCriteria: Key Inclusion Criteria: Participants with a documented clinical diagnosis of DM1 (CTG expansion of >150 repeats in DMPK gene measured in peripheral blood mononuclear cells) Ambulatory, defined as able to complete a 10-meter walk/run test at screening without the use of assistive devices such as canes, walkers, or orthoses, except for ankle-foot orthoses Presence for >3 seconds of grip myotonia as confirmed by a central reader Key Exclusion Criteria: Participants with congenital DM1 Medical Research Council Muscle Scale score of less than 4 on ankle dorsiflexion or significant tibialis anterior atrophy that prevents a muscle biopsy Use of mexiletine or other agent for within 21 days or 5 half-lives, whichever is longer, prior to screening - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 64 Years - StdAgeList: Adult

NCT06300294

Not yet recruiting

Acute Coronary Syndrome and Acupressure

This study aims to examine the effect of acupressure on physiological parameters and anxiety levels in individuals diagnosed with Acute Coronary Syndrome (ACS). H1-1: Acupressure applied to individuals diagnosed with ACS has an effect on the level of anxiety. H1-2: Acupressure applied to individuals diagnosed with ACS has an effect on blood pressure. H1-3: Acupressure applied to individuals diagnosed with ACS has an effect on heart rate. H1-4: Acupressure applied to individuals diagnosed with ACS has an effect on respiratory rate. H1-5: Acupressure applied to individuals diagnosed with ACS has an effect on the pain level. H1-6: Acupressure applied to individuals diagnosed with ACS has an effect on cortisol levels.

- EligibilityCriteria: Inclusion Criteria: Volunteer to participate in the study, Those aged 18 and over Able to speak Turkish Diagnosed with ACS for the first time Cardiopulmonary resuscitation not applied No orientation problems (those who score 15 on the Glasgow Coma Scale) Not diagnosed with psychiatric disease No amputation, fistula, lymphedema, neuropathy or hemiplegia in any of the Upper Extremities Those who underwent femoral intervention for CAG procedure Those who have not used any integrative practices based on pressure and stimulation such as acupressure, acupuncture and reflexology in the last month. Vital signs (28) are within normal range: Blood pressure: 90/60-120/80 mmHg Heart rate: 60-100 min Respiratory rate: 12-18 min Exclusion Criteria: Those with arrhythmia (AF, VT etc.) Patients who have previously undergone Coronary Angiography Diagnosed with myocarditis, pericarditis Those who do not take any speed-breaking drugs (beloc, arlec, etc.). Patients who underwent radial intervention for CAG procedure - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300281

Not yet recruiting

Comparison of Neuromuscular and Aquatic Exercise Programs on Fall Risk and Physical Function in Geriatrics

Objective: The aim of this study is to compare neuromuscular and aquatic Exercise programs on fall risk and physical function in geriatrics. Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2 groups, each with at least 18 participants: Group 1 (NE Group) and Group 2 (AE Group) (Randomizer.org). NE (Neuromuscular Exercise) group will participate in a 12-week exercise program consisting of sensorimotor system training, postural stability and control, global and local joint stabilization, balance training, muscle strength, breathing, and functional movement patterns.AE (Aqıuatic Exercise) Group will participate in an aquatic exercise program, which includes warm-up, mobility and strength, stretching, and cooling exercises in a 140 cm deep pool with a water temperature of 32 °. Data will be collected using the International Physical Activity Survey Short Form (IPAQ-SF), Montreal Cognitive Assessment Scale (MoCA), Geriatric Pain Measure, Optojump-next (Microgate, Bolzano, Italy), 6-minute Walk Test, 30-second-Sit-to-Stand Test, Four Step Square Test, Berg Balance Scale, Fear of Falling Avoidance Behavior Questionnaire. Practice Implications: This current study will contribute to the understanding of how neuromuscular exercises affect falls and physical function in geriatrics.

- EligibilityCriteria: Inclusion Criteria: Being able to speak and understand Turkish, Getting a score at least 21 points on the Montreal Cognitive Assessment Scale (MoCA), Being able to walk without using any assistive device, Being able to adapt to the training program and wanting to participate in the study voluntarily Exclusion Criteria: Presence of neurological, musculoskeletal, inner ear or eye diseases that will cause functional disability and impaired standing balance, Those who have had changes in their medical treatments in the last 6 months, Those with a history of lower extremity surgery as it may affect balance tests, Volunteers who do not attend at least one of the training and evaluations for any reason. Volunteers who want to leave the study voluntarily. Volunteers who cannot continue working due to any additional disease that develops. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 65 Years - MaximumAge: 85 Years - StdAgeList: Older Adult

NCT06300268

Not yet recruiting

Advapro Coronary Stent System in Coronary Artery Diseased Patients.

A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population. To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months. Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population. QCA is applicable for only in sub-strategy participants at baseline and 9 month follow-up visit. A QCA Analysis will be performed on minimum 48 patients in Indian population only. Interval(Days) for patients visit at Day 0, Day 30±6, Day 180±8, Day 270±10 and Day 360±14.

- EligibilityCriteria: Inclusion Criteria: Age >18 years Gender : All (Males, Females, Transgenders, Non-binary) ICF : Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form. Condition - Clinical : Patient with coronary artery disease Eligible for percutaneous coronary intervention (PCI) Condition - Angiographic : Patient with coronary artery disease having one or more de novo stenosis lesion in two native coronary artery with a visually estimated diameter stenosis ≥70% Condition - Angiographic : Patients with Reference vessel diameter of 2.5 ~ 3.50 mm Condition - Angiographic : Patients with lesion length ≤ 36 mm Exclusion Criteria: Ethical : Pregnant and lactating females Patients requiring staged procedure Condition : Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) <30% Condition : Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media Condition : Current medical condition with a life expectancy of less than 12 months Condition : Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure Condition : Patient has current unstable arrhythmias Procedural : Patients previously treated with PCI or CABG for any coronary artery lesion revascularization Procedural : Patients with Chronic Total Occlusion in two or more vessels Procedural : Patients with Ostial lesions (within 5.0mm of vessel origin). Procedural : Patients with Bifurcation lesions that include a side branch >2.0 mm diameter Procedural : Unprotected Left Main Coronary Artery lesion Condition : Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist Condition : Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function (serum creatinine >2.0mg/dl or 150 µmol/L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure Condition : Patients with platelet count <100.000 cells/mm3 or >700.000 cells/mm3 or a WBC <3.000 cells/mm3 - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300255

Not yet recruiting

Evaluation of the H.O.O.V.E.S. Healing Intensives Program

The aim of this study is to measure the impact of these H.O.O.V.E.S. healing intensives on Veteran participants using several psychological instruments. The investigators are planning to administer the demographic questionnaires and psychological instruments to Veteran participants before the healing intensives. Psychological instruments will be administered immediately pre-intervention, pre- and post-session for each session, post-intervention, 90, 120 and 360 days post-intervention. The primary aim is to assess for statistically significant changes pre- to post session and pre- to post-intervention.

- EligibilityCriteria: Inclusion Criteria: Veterans who have served in the military Must be enrolled in a H.O.O.V.E.S. Healing Intensives Program English speakers - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 120 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Veterans enrolled in a H.O.O.V.E.S. healing intensives program and must have served in the military. - SamplingMethod: Non-Probability Sample

NCT06300229

Not yet recruiting

NAPO - Novel Approach for Oligospermia

This randomized controlled trial aims to assess whether treatment with denosumab can improve semen quality in infertile men selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker, and with severely impaired semen quality (concentrations between 0.01 million/mL to 2 million/mL).

- EligibilityCriteria: Inclusion Criteria: Infertile men ≥ 18 years and < 60 years of age Sperm concentration ≤ 2 million pr. mL Serum AMH levels ≥28 pmol/L. The participants must have appropriate Danish or English language skills and give written informed consent. Exclusion Criteria: Chronic diseases, defined as diagnosis where signs, symptoms, and treatment imply an expected long duration and lack of a cure, such as diabetes mellitus, metabolism disorders, osteoporosis, colitis, etc. Sperm concentration <0.01 million pr. mL Men with current or previous malignancies, or at potential risk of testicular cancer after baseline examination and ultrasound will be excluded. Men with hypocalcemia at baseline, defined as albumin corrected calcium < 2,17 mmol/L or total calcium < 2.14 mmol/L Serum vitamin D (25OHD) levels < 25 nmol/L estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1,73 m2 Insufficient dental status Vasectomy Hypersensitivity to latex, Denosumab, or to any of the excipients (acetic acid, sodium hydroxide, Sorbitol (E420), Polysorbate 20) will be excluded. Serum FSH <3 IU/L Testis size > 17 mL BMI ≥ 35 kg/m2 - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06300216

Not yet recruiting

A Real-world Study of Octreotide Microspheres in Chinese Patients With Neuroendocrine Tumors

The aim of this multicenter, open-label, observational study is to evaluate the safety and efficacy of octreotide microspheres in the treatment of advanced neuroendocrine tumors in real clinical practice, especially to evaluate the treatment of octreotide microspheres in various subgroups of neuroendocrine tumor patients.

- EligibilityCriteria: Inclusion Criteria: Sign an informed consent form and voluntarily participate in this study; Patients with unresectable or metastatic neuroendocrine tumors confirmed by histopathology. Patients with recurrence and progression after surgery or local treatment can also be included in the study; Age ≥ 18 years old; Treatment with octreotide microspheres. Exclusion Criteria: Confirmed pregnant or lactating women; Participating in any research with intervention measures outside of routine clinical practice; Other situations unsuitable for inclusion in the study determined by the researcher. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with advanced neuroendocrine tumors treated with octreotide microspheres will be eligible to participate in the study. - SamplingMethod: Probability Sample

NCT06300203

Not yet recruiting

Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis

Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.

- EligibilityCriteria: Inclusion Criteria: Voluntarily sign the informed consent form. Exclusion Criteria: Have any condition that are not suitable for participating in this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06300190

Not yet recruiting

Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV

Aim of this study is comparing results Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV

- EligibilityCriteria: Inclusion Criteria: Traumatic and degenerative etiology. No shoulder deformity . No inflammatory joint disorders. Type of the SLAP is SLAP type IV. Exclusion Criteria: History of the disease. Bilateral shoulder. DM . Epilepsy . psychological disturbance. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06300177

Not yet recruiting

D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure

The purpose of this project is to evaluate progression-free survival (PFS) of D-1553 Tablet versus Docetaxel Injection in subjects with prior standard therapy failure kirsten rat sarcoma viral oncogene (KRAS) G12C mutation positive locally advanced or metastatic non small cell lung cancer (NSCLC), progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) based on RECIST 1.1 was used as the primary endpoint.

- EligibilityCriteria: Inclusion Criteria: Voluntary participation in the study and sign of written informed consent after full informed consent, willing and able to comply with the study procedures and requirements specified in the protocol; Age greater than or equal to 18 years old; male and female; eastern cooperative oncology group performance status (ECOG) score 0-1; expected survival period greater than or equal to 3 months; Pathologically confirmed locally advanced, unresectable and / or metastatic non-small cell lung cancer (stage III b / III c / IV of american joint committee on cancer (AJCC) 8th); Subjects must provide adequate and qualified tumor tissue specimens (surgical resection samples or puncture / biopsy tissue samples within 2 years prior to screening) for confirmation of the KRAS G12C mutation in the central laboratory; Disease progression or toxicity after previous treatment with first-line anti-PD-1 / PD-L1 and platinum-containing chemotherapy is not tolerated.Subjects who have clear medical reasons and can not tolerate anti-PD-1 / PD-L1 therapy or platinum-containing chemotherapy; Having at least one target lesion according to RECIST 1.1; Good function of the major organs; Female subjects of childbearing age should agree that contraception must be used during the study and within 6 months after the end of the study; the serum pregnancy test is negative within 7 days before study enrollment and must be non-lactating subjects; male subjects should agree that contraception must be used during the study and within 6 months after the end of the study period. Exclusion Criteria: Treatment with a KRAS G12C mutation inhibitor or docetaxel at any previous time; NSCLC with mutations of other driver genes; Symptomatic or progressive aggravation of central nervous system metastasis or cancerous meningitis. Subjects with a history of brain metastasis may be considered to be selected if they are clinically stable; Patients with a previous history of epilepsy；presence of superior vena cava syndrome; Cardiovascular system meets any condition: New York Heart Association (NYHA) Heart Function Grade II and above congestive heart failure; Severe cardiac arrhythmias requiring medical treatment; Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass surgery within 6 months prior to enrollment; Left ventricular ejection fraction (LVEF) <50%; QT interval (QTcF) at prolonged; Hypertension that is not effectively controlled; Subjects with stroke or other severe cerebrovascular disease within 6 months before enrollment; History of deep vein thrombosis or any other serious thromboembolism within 3 months prior to enrollment; History of interstitial lung disease, radiation pneumonitis, and immune-associated pneumonia previously treated with steroids, Or active non-infectious pneumonia with interstitial lung disease, radiation pneumonia, and immune-related pneumonia during the screening period, Presence of active tuberculosis, pneumoconiosis or grade 2 other type of pneumonia, or pulmonary function tests confirming severely impaired pulmonary function; Severe bone damage due to tumor bone metastasis may occur at present or after randomization; Active or uncontrolled serious infection (≥grade 2 infection of common toxicity criteria for adverse events (CTC AE)) or fever of unknown origin > 38.5°C; The third space effusion (including pleural effusion, abdominal effusion or pericardial effusion), poor clinical control or the need for local symptomatic treatment such as puncture and drainage; Known impaired gastrointestinal (GI) function or known GI diseases that may significantly affect the absorption or metabolism of oral drugs. Previous history of major surgery in the digestive tract (esophagus, gastrointestinal tract) that may alter the absorption or inability to swallow drugs in the study treatment; Toxicity of previous antitumor therapy, except alopecia, pigmentation, clinically insignificant laboratory abnormalities) has not recovered to grade 1, and peripheral nerve toxicity has not recovered to grade 2 ( CTCAE v5.0); Human immunodeficiency virus (HIV) antibody positive, liver cirrhosis or active viral hepatitis; Active syphilis; Patients with renal failure requiring hemodialysis or peritoneal dialysis; Poor diabetes control [fasting blood glucose (FBG)> 10 mmol/L]; Previous history of organ transplantation or readiness to undergo organ transplantation; Weight of <40 kg and BMI of <18.5 kg/m2, or weight loss of> 5% within 3 months before enrollment; Major surgical treatment or significant traumatic injury within 4 weeks prior to the first dose of this study; Receiving palliative radiotherapy with local lesions within 2 weeks before the first dose of this study; Pregnant or lactating subjects; With the combination of other primary malignancies Serious mental or mental illness or history of substance abuse or serious alcohol abuse; Known allergy to the investigational medicinal product or any ingredient in the formulation; Any other significant clinical abnormality or disease that the investigator considers poses a risk to subject safety or interferes with the medication and evaluation of the clinical study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300164

Not yet recruiting

The Effect of Unripe Carob Fruit in Celiac Patients

The aim of this study was to investigate the effects of the consumption of cookies produced by adding the unripe part of carob fruit, which has high insoluble fiber, polyphenol and antioxidant content, on the oxidative parameters (TAS and MDA), intestinal permeability (zonulin, GIP) and microbiota of celiac patients and to develop new products containing unripe carob fruit for celiac patients in this direction.

- EligibilityCriteria: Inclusion Criteria: Have been diagnosed with celiac disease within a maximum period of 1 year, Have not received dietary treatment by a dietitian before Body Mass Index value between 18.5-25.0 kg/m2, Who have consumed carob fruit and have not had any allergies, Signed the Informed Consent Form, Between the ages of 19 and 64, Who has not had gastrointestinal tract surgery, Without mental disorder, Without inflammatory disease, No antibiotics or probiotics for the last 1 month, Not taking prescription drugs and/or fiber supplements, Not taking vitamin, mineral supplements, Not during pregnancy and lactation, Without excessive alcohol consumption (>2 drinks/day) Exclusion Criteria: Diagnosed with celiac disease for more than 1 year, Have gastrointestinal diseases other than celiac disease, Have previously received dietary treatment by a dietitian, following a diet other than a gluten-free diet, Body Mass Index values below 18.5 kg/m2 and above 25.0 kg/m2, Who have consumed carob fruit and have had any allergies, Not signing the Informed Volunteer Consent Form, Not between the ages of 19-64, Gastrointestinal tract surgery, With a mental disorder, With inflammatory disease, Taking antibiotics or probiotics for the last 1 month, Taking prescription medication and/or fiber supplements, Taking vitamin and mineral supplements, During pregnancy and lactation, Excessive alcohol consumption (>2 drinks/day) - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - MaximumAge: 64 Years - StdAgeList: Adult

NCT06300151

Recruiting

The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia

Ultrasound real-time guidance technology has great advantages over traditional blind exploration technology in terms of accuracy, success rate, and reduction of puncture damage in intervertebral space positioning through operational visualization, greatly improving the effectiveness and safety of spinal block. At present, Doppler ultrasound is rarely used for spinal block, especially for real-time ultrasound guidance technology, which has not been widely applied in clinical practice due to its high equipment requirements, lack of mature puncture plans, complex operation, and high learning curve. If a comprehensive diagnosis and treatment plan can be developed, it will greatly improve the delivery experience of mothers.

- EligibilityCriteria: Inclusion Criteria: American Society of Anesthesiologists (ASA) Class I or II; Single healthy pregnancy; Head showing first; 37 to 41 weeks; The labor process is active, and the cervix dilates<5cm; Require epidural labor analgesia; Volunteer to participate in this study and sign an informed consent form. Exclusion Criteria: Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes; Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction; Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture; Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate. Patients with long-term use of opioids, steroids, and chronic pain. - HealthyVolunteers: No - Gender: Female - MinimumAge: 20 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06300138

Not yet recruiting

Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis

Sporotrichosis is a chronic granulomatous mycosis caused by sporothrix complex. The course of sporotrichosis is always prolonged and even life-threatening, the treatment of this disease in an important scientific problem to be solved. The investigators previously found the predominance of subtype M2 macrophage which play an anti-inflammatory role in the lesions of sporotrichosis, the predominance of M2 macrophage may be responsible for the persistence of sporotrichosis; the investigators also found that local hyperthermia is effective in the treatment of sporotrichosis and hyperthermia treatment can activate the CRAC calcium channel in macrophages which triggers pro-inflammatory type M1 polarization and subsequent killing of sporothrix, however, the mechanism still calls for further investigation. The investigators hypothesize that hyperthermia leads to the activation of CRAC channels resulting in profound Ca2+ influx and Ca2+ upregulates NLRP3 inflammasome expression through inducing Nrf2 activation, then NLRP3 overexpression triggers M1 polarization and subsequent killing of sporothrix. Furthermore, the activation of Nrf2 upregulates STIM1 expression which forms a positive feedback for M1 type polarization of macrophages and further subsequent killing of sporothrix. The purpose of this project is to identify the hypothesis that hyperthermia could treat sporotrichosis by promoting pro-inflammatory type M1 polarization in macrophages, the mechanism by which hyperthermia could treat sporotrichosis is local hyperthermia could led to STIM1/CRAC calcium channel activation mediated calcium ions/Nrf2/NLRP3 induced M1 macrophages polarization and subsequent killing of sporothrix. The hypothesis will be identified at the cellular level, at the animal model level and at the clinical specimens level. The investigators believe that the project will guide the application of hyperthermia in the treatment of sporotrichosis and provide a new basis of theory and practice after the investigators achieving these goals.

- EligibilityCriteria: Inclusion Criteria: The results of pathology and fungal culture were all patients with sporotrichosis. Informed consent to the purpose and content of the study, and follow-up as required The physical condition and self-condition can cooperate with the treatment. Exclusion Criteria: Subjects who are unable to maintain a relatively stable posture during treatment. Those who are sensitive or allergic to this experimental drug. Systemic antifungal or KI therapy within 12 months Local antifungal therapy within 1 month. Previous history of immunodeficiency virus (HIV) infection, or positive HIV antibody in screening period. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06300125

Not yet recruiting

Percutaneous Cryoablation of Low-risk Early Breast Cancer

Expand the current evidence base regarding percutaneous cryoablation of early-stage, low-risk breast tumors, integrated into the standard therapeutic pathway with well-defined follow-up data, as well as data on quality of life. Demonstrate, therefore, that the use of percutaneous cryoablation in the treatment of low-risk breast carcinoma is not inferior to surgery when combined with adjuvant radiotherapy and chemotherapy (when necessary). The hypothesis is that cryoablation, being simple and oncologically effective, ensures a better quality of life for the patient (reduced morbidity, no need for general anesthesia, improved cosmetic outcomes) and consequently has a lesser psychological impact, as well as a better cost-benefit ratio compared to the standard surgical approach.

- EligibilityCriteria: Inclusion Criteria: Tumour, Node, Metastasis stage (TNM) = dimension up to 15 mm as measured by breast ultrasound, MRI, Mammography, Node negative, absence of distant metastasis Unifocality All invasive cancer, except lobular Biology= luminal A and luminal B* (Estrogen Receptor (ER) positive/human epidermal growth factor receptor-2 (HER2)negative) (Documented estrogen receptor (ER)-positive tumor assessed locally and defined as ≥10% of tumor cells stained positive. Documented HER2-negative tumor (in accordance to 2018 American Society of Clinical Oncology guidelines, as determined per local assessment) Any grade (G) Radiological detection= breast ultrasound, MRI, Mammography Tumor site= not located superficially (≥1 cm from the skin plane) Breast size= any, appropriate for the procedure in relation to ultrasound examination Referral to breast cryoablation by a multidisciplinary tumor board Planned treatment with cryoablation using IceCure (TM-trade mark) system Informed consent *Luminal B and G3 BC: previous specific patients' selection and Oncotype Dx [31] on cancer tissue from needle biopsy before procedure and eventual Prediction Analysis of Microarray 50 (PAM50) test. Exclusion Criteria: Plurifocality Invasive lobular breast cancer HER2 overexpressed or Triple Negative Breast Cancer (TNBC) tumor dimension >15 mm Node positive post NeoAdjuvant ChemoTherapy (NACT) breast cancer <50 years Presence of intraductal component (DCIS) Absence of psychological compliance in understanding and adhering to rationale of the study Inability to perform MRI Breast augmentation with implants - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients undergone percutaneous cryoablation of early stage breast cancer - SamplingMethod: Probability Sample

NCT06300112

Not yet recruiting

Prenatal Yoga on Stress, Quality of Sexual Life and Sleep Level

The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns.

- EligibilityCriteria: Inclusion Criteria: Pregnancy week between 24 and 34, Able to read and write Turkish, No communication problems, Those who voluntarily agreed to participate in the research Exclusion Criteria: Those who have risky pregnancies, Those with diagnosed psychiatric problems, Participating in a different training program (meditation, relaxation, etc.) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Pregnant women - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06300099

Not yet recruiting

Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block

Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results. The present randomized study aims to compare the postoperative analgesic effects of dexamethasone and dexmedetomidine as adjuncts to serratus anterior plane block in women undergoing modified radical mastectomy.

- EligibilityCriteria: Inclusion Criteria: Consecutive American Society of Anesthesiologists (ASA) class I-II female patients with breast cancer indicated for modified radical mastectomy Exclusion Criteria: Allergy to the study medications . Patients will also be excluded if they have history of chronic pain conditions, opioid dependence or if they received prolonged analgesic therapy prior to surgery. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06300086

Not yet recruiting

Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease

Kidney Disease Improving Global Outcomes (KDIGO) has recently updated the Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD). This update follows large placebo-controlled randomized trials, which established sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an additional treatment option to reduce the risk of progression to kidney failure and cardiovascular disease in patients with CKD, both with and without diabetes or albuminuria. As a result, SGLT2i is now recommended to a broad range of CKD patients by KDIGO, along with established medical therapies such as renin-angiotensin system inhibition (RASi). Despite the significant adverse consequences of CKD and substantial evidence supporting guideline-directed medical therapy (GDMT) to improve patient outcomes, awareness of CKD among patients and providers remains disproportionately low. Innovative solutions are needed to increase awareness of CKD. Such a solution could potentially be the use of electronic nudge letters delivered to patients with CKD and their general practitioners (GPs) that highlight the importance of GDMT and inform them of updated guidelines. This study will investigate whether digital nudge letters delivered via the official Danish electronic letter system directly to patients with CKD and their associated GPs will improve GDMT in patients with CKD when compared to no letters.

- EligibilityCriteria: Inclusion Criteria: Age ≥18 years Diagnosis of CKD defined as at least one hospital encounter with the following ICD-10 codes in the primary diagnostic positions ≤ 5 years before intervention delivery: N18- N19, I12, E102, E112, E132, E142 Access to the official, mandatory Danish electronic mailbox system Exclusion Criteria: None - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06300060

Not yet recruiting

Synbiotic Supplementation in Cyclists

The goal of this clinical trial is to assess the efficacy of a synbiotic blend on exercise performance and other exercise parameters in trained adult cyclists. It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance. The primary objective is to assess the impact of a synbiotic on 20km distance trial performance in 36 cyclists. Secondary objectives include assessing the impact of the synbiotic on exercise metabolism, body composition, gastrointestinal and immune health.

- EligibilityCriteria: Inclusion Criteria: Male or female between the ages of 18-45 Currently cycling for at least 3 hours per week for the past 3 months Free of any contraindications to exercise and any medical condition that could interfere with or influence metabolic or cardiovascular responses to exercise Have a resting heart rate <100 bpm and resting systolic and diastolic blood pressures <160 mmHg and <90 mmHg, respectively. Exclusion Criteria: Use of antibiotics or probiotic products within 4 weeks prior to study enrollment (note: participants will be eligible after a 2-week washout period) Current laxative use Are a smoker or use tobacco products Consume >21 units of alcohol per week Have donated blood in the previous 3 months Have a BMI ≥30kg/m2 Are pregnant or lactating or planning to become pregnant for the duration of the study Are dieting for weight loss or are following a low carbohydrate diet Have participated in another clinical trial within the 30 days preceding study enrollment Are taking medications known to affect cardiovascular or metabolic responses to exercise Have a medical condition that could interfere with study intervention and assessment Have current musculoskeletal injuries that limit exercise capacity Are non-English speaking - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06300008

Recruiting

Cetylated Fatty Acid for Reducing Pain After TKA

To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA.

- EligibilityCriteria: Inclusion Criteria: Age 50-80 years Osteoarthritic knee patients underwent unilateral primary TKA Participants understand and consent to the protocol of the trial Exclusion Criteria: Inflammatory knee arthritis Previous knee surgery or trauma Previous knee infection Skin problem around the knee such as eczema, psoriasis, wound infection Allergy to studied drug - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06299982

Not yet recruiting

An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO

The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.

- EligibilityCriteria: Inclusion Criteria: Age ≥18 years old, both male and female. Diagnosis of plaque psoriasis according to the Chinese Guideline for the Diagnosis and Treatment of Psoriasis (2018). Exclusion Criteria: Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) . Other inflammatory diseases. Active autoimmune diseases. Pregnant or lactating women. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299969

Recruiting

Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest

The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA).

- EligibilityCriteria: Inclusion Criteria: Patients after cardiac arrest Exclusion Criteria: refused register participation by patient or legal representative - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients treated after out-of-hospital cardiac arrest - SamplingMethod: Probability Sample

NCT06299956

Recruiting

Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark

The goal of this project is to implement a protocol for a supervised exercise therapy intervention including smoking cessation in the municipalities in region Zealand in Denmark. The participants are adults with intermittent claudication. The objective of this project is to describe: The development and design of the implementation process of a rehabilitative intervention including SET and smoking cessation in Region Zealand with a 6-month follow-up period after completion of the SET. The ongoing quality monitoring process of the implementation in terms of referral, recruitment, retention, data completeness, intervention delivery and attendance and to collect feedback that will guide refinements of the intervention delivery and data collection. Outcomes available for assessment of benefits and harms from the SET intervention. Participants will be asked to do supervised exercise therapy by walking on a treadmill for 3 times a week for 12 weeks, and engage in smoking cessation, if they are smoking.

- EligibilityCriteria: Inclusion criteria: Relevant symptoms of intermittent claudication; leg pain when walking due to arteriosclerosis and relieve of symptoms during rest. Distal blood pressure with an ankle-brachial index (ABI) > 50 mmHg for non-diabetics or toe brachial index (TBI) > 40 mmHg for diabetics. Exclusion criteria: • Evaluated by a vascular surgeon: patients with contraindications e.g. medical issues or comorbidity that enables a participation in SET are not referred. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299943

Recruiting

Biofeedback Gait Training by Target Biomechanical Parameters in the Early Recovery Period of Stroke

Single-blinded controlled clinical trial. Biofeedback training courses based on target biomechanical gait parameters are being studied. For targeted biofeedback training, various biomechanical parameters are used: parameters of the gait cycle, EMG or kinematics of joint movements. The number of sessions is 8-11 for each patient. Clinical gain analysis is carried out before and after a course of training. Changes in biomechanical parameters that occurred at the end of the training course are assessed in comparison with those before training, and both statuses (before and after training) are compared with similar gait parameters in a group of healthy adults.

- EligibilityCriteria: Inclusion Criteria: Age - < 75 years; type of stroke - ischemic; structure of the lesion - cerebral hemisphere; disease type - primary; functional ability to walk for at least 5 minutes without using external means of support; absence of reduced higher mental functions, sensorimotor aphasia, muscle tone in the limbs above 2 points according to Ashworth (Modified Ashworth Scale); no history of orthopedic and neurological pathology; absence of pronounced pain syndrome Exclusion Criteria: Signs of orthostatic hypotension during training, patient desire to withdraw from the study, neurological deficit worsening. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06299917

Not yet recruiting

WORK-ON Vocational Rehabilitation

People with chronic inflammatory arthritis (IA) (rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis), often have a reduced work ability. Up to 40% lose their job in the first years after diagnosis. Consequently, they are at high risk of losing their jobs and being permanently excluded from the labour market. Therefore, a new context-specific vocational rehabilitation (VR) for people with IA was developed, based on the Medical Research Council's framework for complex interventions. The 6-months VR is called WORK-ON and consists of three parts: 1) a coordinating occupational therapist who performs an initial assessment and goalsetting process and supports cooperation between relevant partners and navigation between sectors, 2) Four group sessions with peers and if needed, 3) Individual sessions with a social worker, nurse, or physiotherapist. The objective of the WORK-ON trial is to test the overall efficacy on work ability compared to a control group who receives usual care and pamphlets for their employer and colleagues. Based on the experiences from a feasibility study, WORK-ON will be conducted as a randomised controlled trial. Patients with IA, aged 18 years or older, experiencing job insecurity will be randomised to one of two groups: the WORK-ON VR group or usual care (control group). The primary outcome; work ability measured is measured by Work Ability Index single item, at baseline, 6, 12, 18 and 30 months after baseline. Secondary outcomes are absenteeism, presenteeism, overall work impairment, activity impairment, job loss, quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain. Secondary outcomes are measured at baseline, 6 and 12 months after baseline. In addition, work ability, working hours per week and job loss are measured at 18 and 30 months after baseline.

- EligibilityCriteria: Inclusion Criteria: ≥18 years Diagnosed with RA, PsA or ax-SpA by a rheumatologist. Undertakes paid work (full or part-time work or studying) Answers "unlikely" or "not certain" to question #6 from the Work Ability Questionnaire (WAI): "Do you believe, according to your present state of health, that you will be able to do your current job two years from now?" Willing to participate in a trial of the modified WORK-ON intervention. Exclusion Criteria: Planned adjustment or change in pharmacological anti-rheumatic treatment. Morbidities other than IA that may explain reduced work ability. Under examination for comorbidities influencing their work ability. Had major surgery within the past six months or if future surgery is planned Unable to understand or speak Danish at a sufficient level to participate. Cognitive or psychological impairments that may affect participation. Involved in another rehabilitation program (apart from physiotherapy). An ongoing retirement application process or do not plan a retirement within the next three years. On long-term sick leave (> 4 weeks). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06299904

Recruiting

Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke

To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients.

- EligibilityCriteria: Inclusion Criteria: patients who met the diagnostic criteria for stroke formulated in the 4th National Academic Conference on Cerebrovascular disease; patients with relatively stable vital signs, with a NIHSS score of 21 points; patients with tracheotomy accompanied by dysphagia; no previous history of dysphagia; age ≥ 30 years and ≤80 years; informed consent signed by the patient and his family. Exclusion Criteria: patients with medullary haemorrhage/infarction; patients that experienced cerebral hernia and recurrent stroke; patients with unstable arrhythmia, fever, infection, severe restlessness and inability to cooperate with treatment; patients with gastro-oesophageal reflux, bilateral paralysis of the vocal cord, laryngopharyngeal stenosis/haemorrhage/tumour; patients in which there was an inability to accurately locate epiglottis and arytenoid cartilage due to throat disease; patients with a history of epilepsy or risk of seizures. - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06299891

Not yet recruiting

Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity

Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to otherwise healthy children with similar obesity, and later experience excess mortality related to cardiometabolic disease. In this pilot trial, our objective is to gather key preliminary data about phentermine/topiramate (Ph/T) that is FDA-approved for "common" obesity but has never been tested in HO. The subset of individuals with HO who experience hyperphagia or excess daytime sleepiness may benefit from the Ph/T-induced decrease in appetite and increase in alertness. Preliminary assessments of safety, adverse events, dosing (Aim 1), as well as of efficacy (% BMI loss, Aim 2) will be made in a 28-week parallel-arm double-blinded Phase 2 placebo-controlled clinical trial in 12-28-year-old individuals with HO.

- EligibilityCriteria: Inclusion Criteria: Males and Females; Ages 12-28 years (inclusive) History of rapid weight gain related to tumor onset or treatment, as assessed by an experienced endocrinologist (for example, change in BMI z-score > 0.2 and/or BMI +5% during the first 6 months following tumor treatment) Obesity (BMI > 95th%ile for age/sex using CDC 2000 reference for under 18; BMI > 30 kg/m2 for 18+ years) Recent evidence of hypothalamic injury by brain MRI with central review; >6 months status-post definitive therapy (surgery, chemotherapy, or radiation); no major operations/surgeries planned during the study period. Stable on pituitary replacement* and/or appetite-modulating medications (including stimulants) for at least 2 months. *Adjustments of less than 25% (<25%) are permitted to hydrocortisone, growth hormone or thyroid hormone. Sex steroids and DDAVP are exempt. Post-menarchal females must use a highly effective form of contraception, unless hypogonadotropic hypogonadism is documented. All participating females will have pregnancy testing as outlined in the protocol. Participants must be able to communicate well with the investigative team, must comply with requirements of the study, and be able to provide written informed consent and/or assent for individuals less than 18y with consent of a parent/legal guardian. Exclusion Criteria: Contraindication to Phentermine or Topiramate, as assessed using current package inserts. Including: History of glaucoma and known hyperthyroidism. Known history of metabolic acidosis, low bicarbonate on screening laboratory (below lower limit of normal), or clinically significant bone disease requiring medication (not calcium or vitamin D). Current or recent (<14 days) use of monoamine oxidase inhibitor. Known hypersensitivity to sympathomimetic amines. Clinically significant cardiovascular conditions, as defined as any of the following: i) elevated blood pressure, defined as >97%ile for age, sex and height for adult participants abnormal blood pressure is defined as Stage 2 hypertension (systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg); ii) history of cardiac arrhythmia or arrhythmia detected on screening ECG; iii) history of heart failure and/or cardiomyopathy; iv) prolonged QTc interval (QTc > 460 msec), and/or long QT syndrome phenotype and/or positive genotype for long QT syndrome pathogenic; v) history of cardiac disease including coronary artery disease. Females who are pregnant, breastfeeding, or planning to become pregnant during the trial. "Brittle" diabetes insipidus (in the opinion of the referring endocrinologist, e.g. requiring frequent hospitalizations and/or frequent abnormal sodium values). Diabetes mellitus requiring insulin/secretagogue. HbA1c > 8.5% at Screening. Clinically significant liver disease and/or known severe hepatic impairment. ALT > 3 x Upper Limit of Normal (ULN) AST > 3 x ULN Clinically significant kidney disease. GFR<60 ml/min/1.73m2 History of seizure in the 12 months prior to Screening. History of substance abuse, depression of moderate or greater severity, psychiatric disorder and/or suicidality. History of abdominal surgery including gastric bypass. Current use of supra-physiologic steroids. History of allergy or sensitivity to test agents. Including individuals with known aspirin allergy or hypersensitivity and/or known allergy to FD&C Yellow No. 5 (tartrazine). Concurrent use carbonic anhydrase inhibitor. New weight management medication (or more than 5% decrease in weight over prior 2 months on any current, stable regimen), new stimulant, and/or investigational medication within 2 months prior to Screening, and/or plans to initiate new weight management regimen. Cognitive impairment that, in the opinion of the investigator, precludes participation in the study. Individuals considered, in the Investigator's opinion, otherwise not suitable to participate in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 28 Years - StdAgeList: Child, Adult

NCT06299878

Recruiting

MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns]

The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are: radiological and pathological response rate to three doses of antiPD1 agents; do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery. After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years.

- EligibilityCriteria: Inclusion Criteria: Patients aged 18 years and older. Performance status according to the Eastern Cooperative Oncology Group (ECOG) of 0-1. Patients who have not previously received immunotherapy with anti-PD1, anti-PDL1, or anti-CTLA4 agents. Clinical stage III (B-D), i.e., with clinically or radiologically determined metastatic changes in lymph nodes. Histologically confirmed involvement of regional lymph nodes. Lesions assessable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Exclusion Criteria: Patients with melanoma of non-skin localizations. Patients with active autoimmune diseases. Patients with active infectious diseases. Patients with severe concomitant diseases with an ECOG status &gt;1. Pregnant or lactating patients. Patients requiring the intake of glucocorticoids at a dose greater than 10 mg of prednisone (or equivalent) per day. Patients requiring the use of, or having received, systemic antibiotics within 4 weeks prior to the start of the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: No specific requurements to study population - SamplingMethod: Probability Sample

NCT06299865

Not yet recruiting

Comparison of Detection Rates Between Two Commonly Used Bone Density Measurement Methods

72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient. Record the patient's age, gender, height, and weight; Review the patient's past medical history (especially whether there is a history of brittle fractures, whether there is a history of using drugs that affect bone metabolism, etc.). Retrieve the bone density values of the anterior lumbar vertebrae 1 to 4 measured by GE Healthcare Lunar Prodigy dual energy X-ray absorptiometry from the database, and take the average (DXA bone density value). According to the diagnostic criteria of the Diagnosis and Treatment Guidelines for Primary Osteoporosis (2022), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis. Identify the lumbar spine bone density values (QCT bone density values) measured by the GE Gemstone CTHD750 CT instrument from the database. According to the diagnostic criteria of the Chinese Quantitative CT (QCT) Diagnosis Guidelines for Osteoporosis (2018), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis. Statistical analysis was conducted on the normal bone density, bone loss, and number of osteoporosis diagnosed by DXA and QCT respectively, in order to explore the differences in the detection rates of osteoporosis between these two monitoring methods. The data was analyzed and processed using SPSS 21.0 statistical software, and the count data was expressed as a rate (%) χ 2-test, P<0.05 indicates statistically significant difference; Explore whether the difference in detection rates between the two is related to factors such as weight; Calculate the detection rates of osteoporosis using two detection methods in patients who have experienced brittle fractures, and preliminarily determine which detection method is more accurate in determining osteoporosis.

- EligibilityCriteria: Inclusion Criteria: Adults aged 18 and above, regardless of gender The interval between DXA and QCT examinations shall not exceed 3 months. Exclusion Criteria: Individuals with other metabolic and bone diseases causing focal bone destruction of the vertebral body Incomplete key information - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient. - SamplingMethod: Non-Probability Sample

NCT06299852

Recruiting

Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer

This study involves two non-randomized groups of patients: the observation group and the comparison group. The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who received treatment with trastuzumab-emtansine and had a history of SRT. The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer. These patients will undergo SRT followed by the administration of trastuzumab emtansine 24 hours after the SRT. The combined effect of stereotactic radiation therapy on a metastatic lesion followed by anti-HER2 therapy in the 2nd line - trastuzumab emtansine, remains unexplored. This study plans to evaluate the effectiveness of combining systemic therapy and local control methods (SRT) in patients with oligometastatic HER2-positive breast cancer. It will be the first time the efficacy and toxic profile of this new combined treatment method in this patient population will be studied. This basket trial evaluates trastuzumab emtansine for oligo-metastatic breast cancer with the aim of inducing deep responses, long-lasting disease remissions, and potentially cure.

- EligibilityCriteria: Inclusion Criteria: Patients must be at least 18 years of age and able to give written informed consent and comply with study procedures; Clinical diagnosis: breast cancer, metastatic form; Oligo-metastatic disease as determined by standard of care diagnostics, limited to 5 total individual distant metastases, either in one organ or in 2-3 organ systems. Clustered lymph nodes that can be irradiated with curative intent in a single field are defined as single lesion; Possibility of complete elimination of all foci; HER2 expression level of 3+ points according to immunohistochemical analysis (IHC) and/or degree of amplification ≥2.0 according to the results of in situ hybridization (ISH); Patients with stable metastatic brain foci for at least 4-6 weeks (according to MRI); Patients with HER2+ inoperable locally advanced or metastatic breast cancer who previously received taxanes and trastuzumab; ECOG 0-1 status; Life expectancy of more than 6 months. Exclusion Criteria: T-DM1 therapy in the medical history; Autoimmune diseases in the medical history or treatment of exacerbations during the last three months; Uncontrolled brain metastases and/or carcinomatous meningitis, causing neurological symptoms; Primary multiple malignant tumors: other malignant neoplasms requiring active treatment; Acute myocardial infarction, acute cerebrovascular accident, uncorrectable coagulopathy, decompensated concomitant pathology, infectious diseases in the active phase, ECOG status > 2; Pregnancy, lactation. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299839

Recruiting

PAS-004 in Patients With Advanced Solid Tumors

The main purpose of this clinical trial is to test PAS-004 in people with advanced solid tumors with rat sarcoma virus (RAS), neurofibromatosis type I (NF1), or rapidly accelerated fibrosarcoma (RAF) mutations. The main questions it aims to answer are: How well participants are able tolerate different doses of PAS-004, and What side effects PAS-004 might have. Study participants will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety. Everyone participating in the study will take PAS-004 by mouth as a single dose, followed by one week observation, then once a day during the study, in 28-day cycles. Participants will continue on daily PAS-004 for up to 2 years, or until: They decide to withdraw from the study, or They experience unacceptable side effects, or Their disease progresses, or another illness interferes with taking the study drug, or The sponsors stops the study.

- EligibilityCriteria: Inclusion Criteria: Capable of giving signed informed consent which includes compliance with the requirements, prohibitions and restrictions listed in the informed consent form (ICF). Patient has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits, the potential risks, and the discomfort to which they may be exposed and has given written consent to participation in the study prior to study start and any study-related procedure. Patient must be at least 18 years of age at the time of signing the ICF. Patient must be able to swallow oral medication. Patient with histologically or cytologically diagnosed mitogen-activated protein kinase (MAPK) pathway driven advanced solid tumors with all of the following characteristics: Tumor cannot be surgically resected Patient has failed or is ineligible for standard of care therapy Patient has no available treatment options with known clinical benefit Documented evidence of rat sarcoma virus (RAS), neurofibromatosis type I (NF1), and/or rapidly accelerated fibrosarcoma (RAF) mutations. Patients with RAF mutations must have previously failed v-Raf murine sarcoma viral oncogene homolog B (BRAF) / MEK inhibition. Prior to enrollment, patients must agree to provide tumor tissue via biopsy (paraffin section or fresh tissue specimens) that will be sent for analysis to confirm eligibility, if no genetic test data or an adequate tumor tissue sample is available from within the 12 months prior to ICF signature. Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix B). Patient must have an estimated life expectancy of at least 12 weeks in the opinion of the Investigator at the time of informed consent. Patient must have adequate organ function at screening as indicated by the following laboratory value ranges: Serum total bilirubin ≤ 1.5 × upper limit normal (ULN) (Serum total bilirubin can be ≤ 3.0 × ULN if patients have hemolysis or congenital hemolytic diseases) Aspartate aminotransferase (AST) ≤ 2.5 × ULN or 5 × ULN for patient with liver metastases Alanine aminotransferase (ALT) ≤ 2.5 × ULN or 5 × ULN for patient with liver metastases Albumin ≥2 mg/dL Creatinine clearance ≥ 45 mL/min (as calculated per Cockcroft-Gault) Absolute neutrophil count (ANC) ≥ 1.5×109/L Platelets ≥ 100×109/L Hemoglobin ≥ 90 g/L (Note: Criteria must be met without a transfusion within 2 weeks of obtaining the sample) Patient must agree to maintain abstinence (no heterosexual intercourse) or use a highly effective form of contraception during study treatment and for at least 90 days after the last dose of IP. Male patients must agree not to donate sperm while receiving IP and for at least 90 days after the last dose of IP. Exclusion Criteria: Participation in another therapeutic clinical trial within 4 weeks of enrollment. Having received chemotherapy, radiotherapy, major surgery, targeted therapy, immunotherapy, or other antitumor treatment within 4 weeks of enrollment. Known or active central nervous system metastases. Patients with untreated brain metastases ≤ 30 mm that are asymptomatic, do not have significant edema, and do not require steroids or anti-seizure medications are eligible after discussion with the Medical Monitor. Patients with previously treated brain metastases may participate provided they are stable after treatment and without evidence of progression by imaging for at least 4 weeks prior to the first dose of IP administration and are not using corticosteroids for at least 7 days prior to IP administration. Patients with confirmed leptomeningeal disease are to be excluded. Unresolved toxicity from prior antitumor therapy defined as AEs > Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for alopecia; neurotoxicity AEs of patients who have received prior chemotherapy needs to be restored to Grade 2 or below. Patients with ≥ Grade 3 bleeding within 4 weeks of first study treatment dose should be excluded. Taken a medication that is a strong cytochrome P450 (CYP3A) inhibitor or inducer within 14 days of initiation of study therapy dosing. Taken a corrected QT (QTc) interval prolongating medication within 7days of initiation or longer if the half-life of the QTc prolonging medication is such that the drug is not cleared from the body within 7 days (5 half-lives) of initiation of study therapy dosing. Active dysphagia, digestive system disease, malabsorption syndrome, or other conditions affecting PAS-004 absorption. Previous or current retinal vein stenosis, retinal detachment, central retinal vein occlusion, or glaucoma. Active interstitial pneumonia, including clinically significant radiation pneumonitis. Impaired cardiac function or cardiac disease as indicated by: Average QTc interval > 470 ms as calculated according to the QTc formula of the instrument at the research center where electrocardiogram (ECG) measurements are performed. Grade ≥ 3 congestive heart failure per New York Heart Association (NYHA) guidelines. Clinically significant arrhythmias, including but not limited to, complete left bundle branch conduction abnormalities and 2nd degree atrioventricular block. Pregnant or lactating female patients. Known allergy or hypersensitivity to the investigational product (IP), including excipients, or history of severe adverse reaction to any drug, or sensitivity to components of the IP. Clinically active bacterial, fungal, or viral infections, hepatitis B (hepatitis B virus surface antigen positive and hepatitis B virus DNA over 1000 IU/ml) or hepatitis C (hepatitis C virus RNA positive), human immunodeficiency virus infection (HIV positive). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299826

Not yet recruiting

A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure

The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF).

- EligibilityCriteria: Inclusion Criteria: Participants must have a pre-existing diagnosis of HF NYHA FC II to IV. Participants must be on stable HF standard of care medication for at least 4 weeks prior to Screening. Minimum body mass index (BMI) of 18 kilograms per meter square (kg/m^2) at Screening. For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential. All male participants should refrain from fathering a child or donating sperm until 3 months after the final study Follow-up Visit. Non-sterilised male participants should avoid fathering a child either by true abstinence or use of a condom for all sexual intercourse with a female partner of childbearing potential from the first dose until 3 months after the final Follow-up Visit. Exclusion Criteria: Historical or current evidence of a clinically significant disease or disorder including, but not limited to: Myocardial infarction, stroke, transient ischaemic attack, coronary artery bypass grafting, or percutaneous coronary intervention within 12 weeks prior to Screening or transcatheter structural heart interventions or cardiac valve surgery within 6 months prior to Screening. Sarcoidosis, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic (obstructive) cardiomyopathy. History of untreated clinically significant valve disease or a Screening confirmation of severe aortic stenosis, severe mitral stenosis, moderate or severe aortic insufficiency or severe mitral insufficiency. Amyloidosis, Fabry disease, or haemochromatosis. Pericardial disease (i.e., visually significant white pericardium on echocardiogram). Known coagulation disorders. Current diagnosis of active hepatitis. Severe pulmonary disease that is not expected to improve over time, as assessed by the investigator. Decompensated HF or any cardiopulmonary hospitalisation within 4 weeks prior to Screening. History of active malignancy within 2 years, except for fully excised or treated basal cell carcinoma, or ≤ 2 squamous cell carcinomas of the skin and participants who are under investigation for breast or cervical cancer, including participants with a pap smear of grade ≥ 3. History of hypersensitivity to drugs with a similar chemical structure or class to AZD5462 or any component of AZD5462 drug product. Known history of drug or alcohol abuse within 24 months of Screening. Congenital long QT syndrome or history of QT prolongation associated with other medications that required discontinuation of that medication. Cardiac ventricular arrhythmia that requires treatment. History of or anticipated heart transplant. Current or planned bi-ventricular assist device implantation. Any planned highly invasive cardiovascular procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter etc). Positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody at Screening. Known to have historically tested positive for Human immunodeficiency virus. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06299813

Not yet recruiting

Effectiveness of a Single Dose of Betamethasone in Children With Symptomatic Adenovirus Infection

The goal of this double-blind, Placebo-controlled Randomized Study is to assess if a single dose of betamethasone in children with febrile adenoviral infection works well in achieving an early fever regulation. The experimentation is conducted to answer this question: "Can betamethasone help reduce fever more quickly in a child with viral adenovirus infection? "The secondary objective is to assess if the child's overall clinical conditions improve more rapidly (reduced sore throat, quicker return to regular eating) and a reduction in the incidence and duration of hospitalizations.

- EligibilityCriteria: Inclusion Criteria: Body Temperature measured with an axillary or ear thermometer >= n 37.5°C, persisting for a minimum of 6 hours and a maximum of 5 days. Clinical presentation consistent with pharyngo-tonsillar infection by Adenovirus, including At least one of the following symptoms: pharyngodonidae /asthenia/nausea/vomiting/diarrhea/cough/rhinorrhea/abdominal pain/otalgia and at least one of the following signs: pharyngeal hyperemia with or without pharyngo-tonsillar exudate/inflammation of the upper or lower airways/lymphadenopathy/skin rash.- Positive result on the antigen test for Adenovirus performed with the "Biosensor" rapid swab. Negative result on the swab for Group A Streptococcus (SBEGA), if deemed necessary following McIsaac criteria Informed consent form for participation in the study signed by the parent(s) or legal guardian. Exclusion Criteria: Adequate dosage of betamethasone in the 48 hours prior. Underlying chronic illness associated with an increased risk of unusual or severe adenoviral infection. Inability to tolerate oral medications. Documented allergy or any other known contraindication to Bentelan 0.5mg® medication.-Patients on chronic therapy with anticholinesterases, salicylates, nonsteroidal anti-inflammatory drugs, thiazides, furosemide, amphotericin, xanthines (theophylline), antidiabetic drugs, insulin, cyclosporine, ritonavir, ketoconazole, acetylsalicylic acid, phenytoin, phenobarbital, ephedrine, rifampicin, anticoagulants. Subacute or chronic conditions requiring a higher equivalent dose of betamethasone or known primary or secondary adrenal insufficiency. Transfer to another hospital for any reason. Parents who are unable to understand the proposed study or cannot reliably participate in phone follow-up due to significant language barriers. Participation in another study involving an experimental drug within the 30 days prior to and during the current study. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Months - MaximumAge: 6 Years - StdAgeList: Child

NCT06299800

Recruiting

Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer

Recent research has highlighted the significant relationship between type 2 diabetes mellitus and cancer, both prevalent and impactful on global health. The intrinsic correlation arises from shared metabolic processes, particularly a systemic and chronic inflammatory state driven by factors like obesity, dyslipidemia, and hyperglycemia. This leads to the creation of a self-sustaining microenvironment known as meta-inflammation, promoting cancer development through DNA damage, oxidative stress, and the influence of hormones like leptin. The hyperglycemic environment in diabetes contributes to cancer development, supporting the Warburg effect and insulin-related mechanisms. This study aims to identify risk factors associated with diabetes that impact tumor development and progression, crucial for guiding effective preventive strategies in clinical practice. Primary objective of the study: - identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus; Secondary objectives of the study: description of the demographic, clinical and first-line therapy characteristics of patients diagnosed with type 2 diabetes mellitus; assess risk factors for recurrence, presence of a second tumour not related to the first and the presence of both events in patients who have had a tumor within 10 years of diagnosis of diabetes; assess the relationship between the characteristics of patients and the time to the onset of cancer.

- EligibilityCriteria: Inclusion Criteria: Legal age Diagnosis of type 2 diabetes mellitus Exclusion Criteria: Diagnosis of cancer before diagnosis of type 2 diabetes Diagnosis of diabetes secondary to other diseases Diagnosis of diabetes secondary to other drugs Diagnosis of diabetes following surgery - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 779 patients with diabetes mellitus type 2 and with at least 18 years old. - SamplingMethod: Probability Sample

NCT06299787

Recruiting

Cognitive Dysfunction in the Addictions Study - Project 4 (P4)

The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder.

- EligibilityCriteria: Inclusion Criteria: are outpatients; are voluntary and competent to consent to treatment; have a Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) diagnosis of AUD based on the MINI; do not exhibit problematic use of any substances (excluding nicotine and caffeine), including alcohol, for >1 month; are male or female between the ages of 18 - 59; screened positive for an MDE based on the MINI without psychotic symptoms are agreeable to keeping their current antidepressant medications and medications for alcohol use disorder constant during the study; are reliably taking SUD agonist therapies if appropriate and managed by their clinical team; are able to adhere to the study schedule; meet the TMS safety criteria. Exclusion Criteria: have a concomitant major unstable medical illness; are pregnant or intend to get pregnant during the study; have possible or probable dementia (based on the Informant Questionnaire on Cognitive Decline in the Elderly that will be administered to any participant with a baseline total score of < 26 on the Montreal Cognitive Assessment (MoCA); have failed a course of ECT, due to the lower likelihood of response to rTMS; have any significant neurological disorder (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant history of head trauma with radiological evidence of intracranial trauma at the time of injury due to risk of possible seizure foci from prior intracranial lesions. present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, Cushing's disease); have an intracranial implant (e.g., aneurysm clips, shunts, cochlear implants) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; require a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of rTMS [79]; have an inability to communicate in English fluently enough to complete the clinical assessments. have a MINI diagnosis or active symptoms of Bipolar Disorder - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 59 Years - StdAgeList: Adult

NCT06299774

Recruiting

Emergency Care at Home

This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department.

- EligibilityCriteria: Inclusion Criteria: Age >= 18 years Resides within Home Hospital geographic area Lives in permanent housing (i.e., not in temporary housing such as a shelter) Patient of a Mass General Brigham primary care provider Primary care provider attests that their triage recommendation is the emergency department Emergency care at home nurse triages the participant to the emergency department or urgent care Patient attests that they intend to go to the emergency department Exclusion Criteria: Insurance: workers compensation and motor vehicle accident Lives in a healthcare facility (Skilled Nursing, Rehab, long term acute care) Patient/caregiver cannot answer phone or door Active substance use Acute psychiatric concerns (e.g., suicidal ideation, even if passive) Home safety concerns (e.g., intimate partner violence) High-risk features: oHigh Risk Signs, if available: Heart rate > 120 Systolic blood pressure < 90 Shock Index (heart rate divided by systolic blood pressure) > 1 Oxygen < 93% on ambient air Increase in oxygen requirement new or > 2 liters Respiratory rate > 28 Diaphoresis oHigh Risk Symptoms: Active chest pain Severe work of breathing Syncope Hemoptysis Seizure Other concerning symptom per nurse triage Requires inpatient-level care Requires specialty consultation Requires physical, occupational, or speech therapy Requires blood transfusion Requires internal physical exam maneuver (e.g. rectal exam, genitourinary exam) Requires imaging that is not available at home Requires monitoring that is not available at home Troubleshooting wound vacs - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299761

Not yet recruiting

Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications

BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies.

- EligibilityCriteria: Inclusion Criteria: Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists, Availability of FFPE tumor tissue, archival or newly obtained, Measurable disease as defined by RECIST Version 1.1, Adequate hematologic function, Adequate hepatic and renal function, Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1, Other inclusion criteria per study protocol. Exclusion Criteria: Prior exposure to a selective RNR inhibitor (Note: Prior exposure to chemotherapies with nonselective RNR inhibitory activity e.g., gemcitabine is permitted), Receipt of any approved or considered standard of care anticancer drug(s) or biological product(s) within 4 weeks or 5 half-lives, Hematologic malignancies, Primary CNS malignancy, leptomeningeal disease, or symptomatic active CNS metastases, with exceptions per study protocol, Prior or concurrent malignancies, with exceptions per study protocol, History of HBV, HCV, or HIV infection, Clinically significant cardiac condition, Active or history of interstitial lung disease (ILD) or pneumonitis, or history of ILD or pneumonitis requiring steroids or other immunosuppressive medications, QTcF > 470 msec, Concurrent use of strong inhibitors or inducers of CYP3A, CYP2C8, CYP2C9, or CYP2C19, Other exclusion criteria per study protocol. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult

NCT06299748

Not yet recruiting

A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.

This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the VYVGART IV or SC-exposed pregnancies were reported.

- EligibilityCriteria: Inclusion Criteria: Women with exposure to efgartigimod any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days. Written informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written informed assent or eConsent by the pregnant minor (where applicable) and written informed consent or eConsent by the parent/legal guardian). Exclusion Criteria: None - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Pregnant women or women no longer pregnant at the time of study enrollment but exposed to efgartigimod any time within 25 days prior to conception or any time during the pregnancy. - SamplingMethod: Non-Probability Sample

NCT06299735

Recruiting

Comparison of Airway Management With Bronchial Blocker and Double-Lumen Tube in Single-Lung Ventilation

In this study, the primary aim is to compare the impact of using a double-lumen tube and bronchial blocker for single-lung ventilation in patients undergoing minimal invasive cardiac surgeries on postoperative pulmonary functions. Secondary objectives include the comparison of application duration, success in lung collapse, and the number of repositioning attempts for both techniques.

- EligibilityCriteria: Inclusion Criteria: Patients planned for on-pump minimal invasive cardiac surgical procedures requiring single-lung ventilation Female and male patients aged 18 and above Patients with ASA scores of 1-2-3 Patients with signed informed consent to participate in the study Patients with a Body Mass Index (BMI) less than 40 Exclusion Criteria: Emergency surgeries Patients with ASA scores greater than 3 Advanced-stage organ (heart, kidney, liver, lung) failure Advanced lung diseases (COPD, FEV1<50%, restrictive lung diseases, history of chest surgery, Pulmonary Hypertension, PAB>30mmHg) Patients with anticipated difficult intubation Pregnant individuals Patients with a BMI greater than 40 Patients lacking the ability to read, understand, sign the informed consent form, and those who do not wish to participate in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299722

Not yet recruiting

Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents

We aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. Based on randomization, they will either 1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training. STEEL training involves exercises for major muscle groups using free weights, body weight, or tailored machines. Circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. The training takes place in local centers either with friends or with other participants in the project. Before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. The effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and blood analysis).

- EligibilityCriteria: Inclusion Criteria: Ten to 19 years of age at the point of inclusion A minimum of 12 months since the last chemotherapy with no upper limit Ability to understand the physical intervention and general participant advice Exclusion Criteria: Participation in another research study that includes similar treatment Pregnancy Cardiac arrhythmia during exercise Psychological disorders interfering with treatment Presence of a clinical condition that needs immediate treatment Planned surgeries within the subsequent 12 months that may interfere with performing exercises Any contraindications to performing physical exercise as evaluated by the recruiting medical doctor - HealthyVolunteers: No - Gender: All - MinimumAge: 10 Years - MaximumAge: 19 Years - StdAgeList: Child, Adult

NCT06299709

Not yet recruiting

A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)

The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.

- EligibilityCriteria: Key Inclusion Criteria: Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m^2), both inclusive A total body weight greater than (>)50 kg Key Exclusion Criteria: History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug Any condition possibly affecting drug absorption Female participants who are pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug Other protocol defined Inclusion/Exclusion criteria may apply. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06299696

Not yet recruiting

A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists

The purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of VNZ/TEZ/D-IVA fixed dose combination (FDC) granules.

- EligibilityCriteria: Key Inclusion Criteria: Panelists are trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations. Key Exclusion Criteria: History of any illness or clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant. Sensitivity to VNZ, TEZ, or D-IVA. Pregnant, nursing, or planning to become pregnant during the study Other protocol defined Inclusion/Exclusion criteria may apply. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 25 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06299683

Not yet recruiting

Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS.

- EligibilityCriteria: Inclusion Criteria: 18 years of age or older; Diagnosis of IC/BPS as indicated by structured assessments; Capable of giving written informed consent; Able to enroll for the duration of the study period; Exclusion Criteria: Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke; Current or history of diagnosis of primary psychotic or major thought disorder within the past five years; Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD (within the past 5 years); Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, active suicidal ideation, homicidal ideation, substance abuse dependency) reported within the past six months; Non-English speaking; Presenting symptoms at time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking; Difficulties or limitations communicating over the telephone or via teleconferencing systems; Any planned life events that would interfere with participating in the key elements of the study; Any major active medical issues that could preclude participation; Currently being treated for cancer; Cancer-related pain; Recently or actively participating in treatment similar to those being investigated (e.g. individual psychotherapy or pelvic floor pt). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299670

Recruiting

Efficacy of Combination of Hdroxyurea and Thalidomide Over Either Hydroxyurea or Thalidomide Alone in the Treatment of Transfusion Dependent Thalassemia in Children: A Quasi-Randomised Clinical Trial

Transfusion Dependent Thalassemia (TDT) is an emerging global public health concern. Hemopoietic stem cell transplantation (HSCT) is the only curative treatment. But its adoption is limited due to lack of HLA matched donor, experienced centers and high initial cost. So, researches are going on in search of an effective, safe, easily available treatment option. Use of fetal haemoglobin inducing agents shows promising effects in treatment of TDT patients. Thalidomide an immunomodulating and anti-angiogenic drug has been shown to induce γ-globin gene expression and increase the proliferation of erythroid cells. Furthermore Hydroxyurea (HU) is known to increase haemoglobin (Hb) by HbF induction and reduction of inflammation and hypercoagulability. Recent studies with combination of HU and Thalidomide have shown promising results in treatment of Thalassemia patients. However, most of those studies are retrospective or single arm nonrandomized trials & The study population includes both adult and children age group . So the effectiveness of combination therapy of Thalidomide and HU needs to be established through randomized trials. This single centered non blinded quasi randomized clinical trial will be conducted at the Department of Pediatric Hematology and Oncology in Bangabandhu Sheikh Mujib Medical University (BSMMU), Bangladesh for one year of period. Thirty transfusion dependent thalassemia children of 3-18 years old will be included in each group. The objective of this study is to assess the effectiveness of combination of Thalidomide and Hydroxyurea in TDT children. It will play an important role in planning a cost effective and affordable treatment option for TDT children.This study will involve minimum physical risk to the patient. Written informed consent will be taken from parents or study subjects after brief explanation of the purpose and procedure. They will also be informed about the freedom to participate or not to participate at any time. Privacy and confidentiality will be safe guarded. History regarding age, sex, height, weight of these patients will be taken. Thorough physical examinations and laboratory investigations including CBC, Hb electrophoresis, serum Ferritin, serum creatinine, SGPT will be done. Data will be collected in a predesigned questionnaire and will be kept confidential. Statistical analysis will be done using the statistical software SPSS.

- EligibilityCriteria: Inclusion Criteria: Patients diagnosed as transfusion dependent thalassemia Age ranged from 3-18 years Blood transfusion more than 1 year. no bleeding disorder Exclusion Criteria: Active systemic co-morbidity, Past personal or family history of thrombophilia, Recent fracture or recent major surgery Use of drugs that might affect Hb levels 15 days before enrollment - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06299657

Not yet recruiting

Intervention for Managing Physical Reactions to Overwhelming Emotions

The clinical trial aims to conduct a feasibility, acceptability, and usability clinical trial of a modular CBT-based and technologically enhanced intervention for people with an SUD and recently enrolled in IOP, probe target engagement and change in clinical outcomes, and examine attrition rates in IOP. This study will enroll 40 adults who are currently enrolled in IOP, have a substance use disorder, and experience elevated anxiety. 20 individuals will be randomized to the experimental intervention, "Intervention for Managing Physical Reactions to Overwhelming Emotions" (IMPROVE), and 20 individuals will be randomized to the active control group, "Physical Health Education Treatment" (PHET). Participants will be asked to complete a baseline assessment of mood, substance use, and psychophysiology. Participants will then completed ecological momentary assessments (EMA) via smartphone technology 4 times a day for ~ 28 days (the day following the baseline assessment until the 3rd intervention session). Participants will complete one 45 minute - 1 hour intervention each week for 3 weeks (either the IMPROVE or PHET intervention, pending randomization). Following the last intervention session, participants will return to the lab to complete a post-intervention assessment that mirrors the baseline assessment and then complete follow-up surveys 1- and 3-months post intervention.

- EligibilityCriteria: Inclusionary Criteria: Participants will be eligible for enrollment if they: recently enrolled in the Talbot Hall IOP >18 years old PROMIS Anxiety Short Form total score is 13 or greater Exclusionary Criteria: do not pass the Informed Decision-Making Capacity (IDMC) screener, suggesting severe cognitive impairment presence of a psychiatric or medical condition that would prevent them from providing informed consent or from participating in the treatments (e.g., psychosis, mania, acute intoxication) no or limited access to a smartphone that is compatible with the EMA application - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299644

Not yet recruiting

Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.

- EligibilityCriteria: Inclusion Criteria: Patients with 18-65 years of age BMI ≥ 30 kg/m2 Capable of giving informed consent and available to return for follow-up visit Exclusion Criteria: Untreated H. pylori infection Active gastric or duodenal ulceration Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST)) Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D) Esophageal or gastric varices and/or portal hypertensive gastropathy Gastroparesis History of gastric surgery/endoscopic procedure Active psychological issues preventing participation in a lifestyle modification program Known history of endocrine disorders affecting weight (uncontrolled hypothyroidism) Severe coagulopathy Active smoking Substance abuse Serious health condition that increased risk of anesthesia and/or endoscopic procedure Pregnancy or lactation Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06299618

Not yet recruiting

Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism

The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism.

- EligibilityCriteria: Inclusion Criteria: Autistic Adolescents Must be able to interact verbally Parental consent and participants must be able and willing to give written informed assent and to comply with the requirements of the study protocol Must be willing to return for all study visits and wear the study device at home Must have access to and be able to operate a smartphone. Exclusion Criteria: Adolescents with severe motor impairments or schizophrenia Complex medical conditions, which would interfere with ability to take part in the study visits or outcomes. Intellectual disability, not capable to attend mainstream school - HealthyVolunteers: No - Gender: All - MinimumAge: 11 Years - MaximumAge: 15 Years - StdAgeList: Child - StudyPopulation: Participants will be recruited from paediatric and community paediatric clinics. Participants may also be identified through open invitations on websites, social media pages, and through a study specific social media page. - SamplingMethod: Non-Probability Sample

NCT06299605

Not yet recruiting

Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori

The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.

- EligibilityCriteria: Inclusion Criteria: Patients aged 18-70 years old; Patients with H.pylori infection (positive rapid urease test, 13C/14C-urea breath test); Patients without previous treatment for H. pylori eradication. Exclusion Criteria: Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%; Patients with active gastrointestinal bleeding; Patients with a history of upper gastrointestinal surgery; Patients allergic to treatment drugs; Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks; Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial; Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse; Patients who are unwilling or incapable to provide informed consents. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06299592

Recruiting

Comparison of Microglial Activation in Severe Asthma and Healthy Controls

The goal of this clinical trial is to learn about how asthma influences brain function. The main questions it aims to answer are: How airway inflammation in asthma affects the brain; and, Whether airway inflammation in asthma is related to symptoms of depression and anxiety Over the course of 3 visits, participants will: Complete questionnaires Complete computer tasks Undergo allergy skin test and breathing tests Give two blood samples Give a sputum sample Complete brain imaging scans Researchers will compare results between participants with asthma, and participants who do not have asthma.

- EligibilityCriteria: Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document Individuals with no health concerns that might affect the outcome of the study Age 18-75 years of age Ability to tolerate a simulated MRI brain scanning session In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements High-affinity TSPO-binding genotype. Mixed (high/low) binding-affinity genotype may be included at PIs discretion For participants with severe asthma: Physician diagnosis of asthma for at least six months prior to screening (can be determined at the discretion of an asthma/allergy physician member of the study team) Severe asthmatics must meet the ATS definition of severe asthma and/or be currently receiving a GINA 5 therapy (or greater), which may include ongoing use of currently approved biologic immunomodulators Exclusion Criteria: Current smoker (defined as more than 0.5 pack per week for the past 6 months and any smoking within two weeks of study procedures) or has a smoking history exceeding 5 pack years within the last 10 years Currently receiving immunotherapy Use of psychotropic medication that might affect function of neurocircuitry implicated in our hypotheses (at the discretion of the PI/Co-I) Inability to hold medications detailed in the medication hold schedule Needle phobia or claustrophobia Major health problems such as autoimmune disease, history of carotid stenosis, heart disease, uncontrolled hypertension, or lung diseases other than asthma, history of significant arrhythmias, and any of the following in the last 6 months: stroke/TIA, myocardial infarction, stent placement, or acute coronary syndrome. The listed health problems are definitively exclusionary, but decisions regarding major health problems not listed will be based upon the judgment of the investigator Use of biologic medication that might affect signaling pathways under investigation (at the discretion of the PI/Co-I) Pre-existing chronic infectious disease Scheduled use of non-selective beta-blockers prior to each study visit. Use of an investigational drug within 30 days of entering the study. This criterion will be reviewed on a case by case basis by the PI/Co-I to determine appropriate washout period. Appropriate wash out period may be greater than 30 days depending on the half-life of the investigational drug. Participants may be eligible for study participation after completing the washout period designated by the PI or Co-I (physician only). Any MRI incompatibility as determined by most current MRI screening form History of a diagnosed bipolar disorder, schizophrenia, or schizoaffective disorder History of serious head trauma or seizure disorder (can be included at the discretion of the PI or Co-I) Unable, in the judgement of the investigator, to comply with directions and/or tolerate the procedures required for participation in this study Pregnant or breast-feeding or has a planned pregnancy during the course of the study Any other medical condition or disease that would impact participant safety or data integrity in the opinion of the PI/CO-I - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adults (age 18-75) with or without severe asthma. - SamplingMethod: Non-Probability Sample

NCT06299579

Recruiting

Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke

Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke - A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Studywith the primary objective of evaluation of the efficacy and safety of GD-11 for injection in the treatment of acute ischemic stroke patients within 48 hours. The subject has a clinical diagnosis of acute ischemic stroke, within 48 hours from stroke onset to start of study treatment, with a National Institutes of Health Stroke Scale (NIHSS) between 6 and 20, had a total score of upper and lower limbs on motor deficits ≥ 2. The primary outcome is the proportion of subjects with mRS score ≤ 1 at 90 days after treatment.

- EligibilityCriteria: Inclusion Criteria: Only those who meet all of the following items will be enrolled: age ≥18 years and <81 years, male or female; National Institutes of Health Stroke Scale (NIHSS) score: 6 ≤ NIHSS ≤ 20, and the sum of item 5 Upper Extremity and item 6 Lower Extremity scores ≥ 2 after the onset of this event; The onset of the disease is within 48 hours (including 48 hours); Patients who are diagnosed with ischemic stroke according to the requirements of the latest guidelines such as "Diagnostic Points of Various Major Cerebrovascular Diseases in China 2019" or "Clinical Management Guidelines of Cerebrovascular Diseases in China (2nd edition)", and who have a good healing after the first onset or the last onset (mRS score ≤1 before this onset); Obtaining informed consent approved by the Ethics Committee voluntarily signed by the patients or their legal representatives. Exclusion Criteria: Those who met one of the following items at screening will not be eligible for enrollment: intracranial hemorrhagic disease as seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.; if blood seepage only, the suitability for enrollment may be based on the investigator's judgment; severe impairment of consciousness: item score >1 on the 1a level of consciousness of the NIHSS; thrombolysis, thrombolysis or intervention has been applied or is planned to be applied after this episode; transient ischemic attack (TIA); the patient's blood pressure remains ≥ 220 mmHg systolic or ≥ 120 mmHg diastolic after control; patients with a previous diagnosis of severe mental disorders as well as patients with dementia; patients who have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT or AST > 2.0 x ULN; patients who have been diagnosed with severe active renal disease, renal insufficiency; or serum creatinine > 1.5 × ULN; after the onset of the disease, the drug with neuroprotective effect has been used in the marketing, such as commercially available edaravone, edaravone dextran camphenol injection concentrated solution, nimodipine, gangliosides, cytidine diphosphate, piracetam, oracetam, butylphenyl peptide, human urokininogenin (eurycomelic acid), cinpirexit, murine nerve growth factor, cerebral vivax (hydrolysate of cerebral proteins), calf's blood deprivation of protein injection, calf's blood deprivation of protein extract injection and so on. Calf serum deprotein injection, calf blood deprotein extract injection, etc; previously diagnosed with concurrent malignant tumors and undergoing anti-tumor therapy; for subjects diagnosed with malignant tumors after enrollment, continued participation in the study may be based on the investigator's judgment and the subject's wishes; previously diagnosed with a serious systemic disease with an expected survival of <90 days; the patient is pregnant, breastfeeding and the patient/patient's partner has the potential for pregnancy and plans to become pregnant during the trial period patients with a previously known hypersensitivity to GD-11 for Injection and its excipients; history of major surgery within 4 weeks prior to enrollment that in the investigator's assessment affects neurologic function scores or affects 90-day survival; participation in another clinical study within 30 days prior to randomization or ongoing participation in another clinical study; Not considered by the investigator to be suitable for participation in this clinical study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 81 Years - StdAgeList: Adult, Older Adult

NCT06299553

Recruiting

Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND)

The PRO-MIND study is an Italian, multicenter, prospective observational cohort study to evaluate the effectiveness and the safety of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in patient with DLBCL.

- EligibilityCriteria: Inclusion Criteria: Patients are aged 18 years or older. Patients with DLBCL R/R disease non-transplant eligible. Patients who will initiate the treatment with commercially available tafasitamab and lenalidomide after the ICF signature. The decision to prescribe tafasitamab must have been made prior and regardless of the enrollment of the patient in the study. Patients are able of giving the signed informed consent. Exclusion Criteria: Concomitant participation in an interventional clinical study Any patient in the physician's opinion from whom initial diagnosis or follow-up data is unlikely to be obtained reliably data for the purposes of this observational study. Patients who started tafasitamab treatment before signing the ICF. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The enrollment will be done consecutively and starting from the list of patients identified in the Screening/Enrollment Log. Participating sites will be encouraged to enroll patients in a consecutive manner when patients come for their regular visit, in order to minimize bias in patient selection. At each participating site, the physician will assess patients to determine their eligibility for data collection within the study based on the selection criteria listed below. All patients will give their informed consent to participate in this study and will sign privacy disclosure before data collection is performed. All subjects documented are being treated according to local labeling specifications.The inclusion/exclusion criteria reflect the current approved Summary of Product Characteristics (SmPC) and AIFA monitoring registry. - SamplingMethod: Probability Sample

NCT06299540

Not yet recruiting

Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia

The purpose of this study is to assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G).

- EligibilityCriteria: Inclusion Criteria: Participants newly treated with ibrutinib for first line or relapsed CLL (treatment is being initiated or has been initiated within the last 8 days as a maximum) Participants agreed to follow the individual physical activity intervention (IPAI) Participants using or having access to a compatible and appropriate electronic device such as smartphone, laptop or tablet Participants with Internet access at home and email address Participants agreed to wear a connected watch 24 hours a day for all the duration of the study Exclusion Criteria: Pregnant participants or planning to become pregnant while enrolled in this study Participants with inability or deemed unsafe to practice physical activity Participants who have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the inclusion visit Participants who are currently involved in an interventional study Participants with probable difficulties in using the digital tool autonomously - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will include participants aged at least 18 years of age with chronic lymphocytic leukemia (CLL). - SamplingMethod: Probability Sample

NCT06299527

Recruiting

Clinical Outcomes of Asynchronous Telerehabilitation Are Equivalent to Synchronous Telerehabilitation in Patients With Fibromyalgia: a Randomized Control Study

Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).

- EligibilityCriteria: Inclusion Criteria: Diagnosed with FMS by the physician in accordance with ACR 2016 criteria, Having independent mobility, Not having advanced vision and hearing loss, Minimum literacy, participating voluntarily, making video calls, Internet and smartphone access Exclusion Criteria: Have a rheumatic disease with more prominent symptoms than FMS, Have an active infection, Have a surgical operation in the last three months, Have an uncontrollable chronic disease, Have another musculoskeletal disorder - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06299514

Not yet recruiting

RAFT-P&A Randomized Control Trial

Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some elderly patients find it difficult to tolerate medications and suffer the side effects of such treatments. In those instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker. A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). However, this has not been directly compared to BiVP in a robust randomized control trial. There is also not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of BiVP to CSP in patients who undergo AV node ablation for treating AF, in addition to comparing both pace and ablate methods to pharmacological therapy.

- EligibilityCriteria: Inclusion Criteria: . Patients with permanent AF/persistent AF (in AF) . Patients with NYHA Class II -IVa HF symptoms . NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year despite of guideline-driven medical therapy for HF of at least 3 months . any QRS duration for patients with LVEF >35%, QRS duration <150 ms for patients with LVEF ≤35% Exclusion Criteria: In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1year acute coronary syndrome <4 weeks or coronary revascularization <3months unable or unwilling to provide informed consent uncorrected primary valvular disease or prosthetic tricuspid valve restrictive, hypertrophic, or reversible form of cardiomyopathy severe pulmonary diseases such as cor pulmonale or pulmonary hypertension (≥35mmHg) patients enrolled in competitive clinical trials that will affect the objectives of this study; existing CRT/BiVP or pacemaker resting heart rate ≥110 bpm on Holter monitoring patients who are pregnant or intend to become pregnant - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299475

Not yet recruiting

Structured Online Contraceptive Counseling (LOWE Trial) at Emergency Contraception (EC) Pharmacy Provision LOWE+EC=LOWEC

To increase sexual and reproductive health and rights through the improvement of contraceptive counseling and easy access to service and, thus, women's use of effective contraceptives after purchase of an emergency contraceptive pill (ECP).

- EligibilityCriteria: Inclusion Criteria: Women >/=15 years visiting a pharmacy to buy ECP for her own use Has a smartphone with an electronic identification and ability to scan a QR code Ability to read Swedish or English Willing and able to provide informed consent Willing to participate in the follow-up Exclusion Criteria: * Ongoing pregnancy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 15 Years - StdAgeList: Child, Adult, Older Adult

NCT06299462

Not yet recruiting

PTCy and ATG for MSD and MUD Transplants

Hematopoietic stem cell transplantation is a curative treatment for a number of benign and malignant hematologic diseases. One of the key parts of hematopoietic stem cell transplantation is the prophylaxis of graft-versus-host disease. Since the end of the 1970s, with the introduction of cyclosporine, calcineurin inhibitors (cyclosporine and tacrolimus) have become part of almost all prophylactic regimens, even though they are a group of drugs with a poor toxicity profile that requires monitoring. constant serum level. Since 2008, post-transplant cyclophosphamide has been introduced with great success, associated with a calcineurin inhibitor and mycophenolate, in the prophylaxis of graft-versus-host disease in haploidentical transplantation (50% matched). Since then, in view of this enormous success, efforts have been made to incorporate post-transplant cyclophosphamide in matched related and unrelated transplants, or with a mismatch. This is a prospective, 2-arm, non-randomized study. Arm 1, with related donors, and arm 2, with unrelated donors. Patients will be allocated in these arms according to donor availability (patients with a matched-sibling donor will receive a matched-sibling transplant; patients with no related donors but with unrelated donors, an unrelated transplant). Patients who are ready for transplantation with matched-sibling or unrelated donors will be recruited to participate in the study. The stem cell collection target will be 5E6 CD34/kg recipient weight for peripheral source. If a quantity greater than this is collected, the remainder will be cryopreserved according to the institutional protocol. Graft-versus-host disease prophylaxis will be performed on D+3 and D+4 with cyclophosphamide and with ATG on D-1 or on D-2 and D-1, depending on ATG de-escalation, for matched-sibling transplants, according to prespecified criteria based on the 3+3 approach; and on D+3 and D+4 with cyclophosphamide and with ATG on D-2 and D-1, for unrelated donors.

- EligibilityCriteria: Inclusion Criteria: Patient with (1) acute leukemia in first or second remission; (2) myelodysplasia with less than 20% blasts; (3) Hodgkin's or non-Hodgkin's lymphoma, in partial remission after salvage therapy Who will receive a related or unrelated, HLA-compatible transplant; Who is a transplant candidate with FluMel, FluTBI, CyTBI, BuCy or BuFlu conditioning; Peripheral blood source; Age between 18 and 60 years. Exclusion Criteria: Renal dysfunction (Cr > 1.5 mg/dL) Hepatic dysfunction (transaminases x2 the normal value) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06299449

Recruiting

Artificial Intelligence Assisted Socket Shield With Computer Guided Implant Placement

Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach.

- EligibilityCriteria: Inclusion Criteria: above the age of 18years presence of non-restorable maxillary anterior tooth had intact socket walls following tooth extraction the gingival biotype was thick. Exclusion Criteria: history of systemic condition history of using bisphosphonates or other drugs that might impact bone turnover a history of smoking during the previous five years, a history of any acute infections at the surgical site, teeth having root resorptions - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 19 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06299436

Not yet recruiting

Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure

Right ventricular (RV) failure is recognized to worsen patient outcomes in the setting of heart failure with reduced ejection fraction (HFrEF)-related pulmonary hypertension (PH), yet the investigators fall short in trying to identify and treat it. The current proposal will (1) determine the best clinical indicators of intrinsic RV myocyte contractile failure in humans with HFrEF-PH, (2) clarify underlying mechanisms, and (3) test novel treatments on RV myocytes. The long-term goal of this proposal will be to better identify and treat RV failure in humans suffering from HFrEF-PH.

- EligibilityCriteria: Inclusion Criteria: Adult patients aged between 18 and 90 years of age Diagnosed with heart failure with reduced ejection fraction (LV ejection fraction ≤ 40%) Can safely hold direct oral anticoagulant (DOAC) vitamin K antagonist (VKA) for 48 hours prior to the procedure Exclusion Criteria: Unable to interrupt VKA anticoagulation Point of care International Normalized Ratio (INR) > 1.5 Pregnant patients Acute hospitalization or decompensation within 2 weeks prior to study date Participation in a study involving an investigational drug within 4 weeks prior to study date Inability to lie flat in the supine position Symptomatic hemodynamic instability at rest or during the procedure - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will include patients who have heart failure with reduced ejection fraction, defined by a left ventricular ejection fraction less than or equal to 40%. - SamplingMethod: Non-Probability Sample

NCT06299423

Recruiting

Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients

Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart Rate Variability (HRV) with the Howdy Senior ® device (Comftech Srl). Additionally, the study will also investigate the feasibility and effectiveness of the Howdy Senior® device in improving the postoperative patient's monitoring.

- EligibilityCriteria: Inclusion Criteria: Patients aged more than 18 years old. Established Crohn's disease (CD) or Ulcerative Colitis (UC) at the time of surgery indication with a proven histological diagnosis. Patients scheduled for elective intestinal resection. Exclusion Criteria: Diagnosis of Undetermined Colitis. Recurrent disease. Concomitant diagnosis of malignancy. Established diagnosis of major depressive disorder or anxiety disorder. Diagnosis of ventricular or supraventricular arrythmia. Active pharmacological treatment with β-blockers or other drugs affecting the heart rate. Known hypersensitivity to cotton or silver. Emergent surgery. Planned open surgery. Any concomitant surgery unrelated to the main surgical indication. Patients undergoing perianal surgery for related perianal disease can be included in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult