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NCT06297824

Recruiting

Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm

Deliberate self-harm (DSH) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. Emotion regulation group therapy (ERGT) is a brief treatment for DSH with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present. A quantitative feasibility open trial (N=20) followed up by a qualitative interview study will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents.

- EligibilityCriteria: Inclusion Criteria: 13-17 years of age; having engaged in deliberate self-harm (DSH)-behaviours ≥ 5 times the last year; having engaged in ≥1 DSH episode during the past month; having ongoing psychiatric treatment in the community; having at least one caregiver or other significant adult, committed to participate in the parent program; and stability of psychotropic medications Exclusion Criteria: a diagnosis of psychotic, bipolar I disorder or severe social anxiety disorder (SAD); ongoing substance dependence; the presence of co-occurring psychiatric disorders that require immediate treatment; having an autism spectrum disorder together with borderline intellectual disability or having an intellectual disability; insufficient understanding of the Swedish language - HealthyVolunteers: No - Gender: All - MinimumAge: 13 Years - MaximumAge: 17 Years - StdAgeList: Child

NCT06297811

Not yet recruiting

Myeloprotection With Trilaciclib in Pan-cancer Population

The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are: effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor type Participants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic/PD-X/anti-HER2 therapy.

- EligibilityCriteria: Inclusion Criteria: Age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance score 0-1; Histologically or cytologically confirmed advanced or recurrent solid malignant tumors, including: Unresectable stage III/IV non-small cell lung cancer (NSCLC); Recurrent or metastatic breast cancer (BC); Newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage IC-IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer without further surgical planning before disease progression; or recurrent platinum-sensitive ovarian cancer (OC); FIGO stage III-IV or recurrent endometrial cancer (EC), including endometrioid carcinoma and serous or clear cell carcinoma; FIGO stage IVB (including persistent) or recurrent cervical cancer (CC) (≤ 1 prior platinum-based therapy) not amenable to radical surgery or radiotherapy; Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (including primary lesions located in the larynx, oropharynx, hypopharynx, oral cavity, undifferentiated or poorly differentiated nasopharyngeal carcinoma, and salivary gland carcinoma), which is not suitable for further surgery or radiotherapy. At least one measurable lesion according to RECIST version 1.1; Received up to one prior systemic chemotherapy and no prior paclitaxel plus carboplatin chemotherapy; Adequate organ function meeting the following criteria: (1) adequate bone marrow function: Hb ≥ 100 g/L (no ESA or blood transfusion within 14 days before the first dose); ANC ≥ 2 × 10^9/L (no G-CSF within 14 days before the first dose); platelet count ≥ 100 × 10^9/L (no rhTPO, rhIL-11 or platelet transfusion within 14 days before the first dose); (2) adequate liver and kidney function: alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula); (3) adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 55%; Life expectancy ≥ 3 months; Females of childbearing potential agree to practice reliable contraception during the clinical trial and have a negative serum or urine pregnancy test within 7 days prior to dosing; Voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up. Exclusion Criteria: History of myeloid leukemia, myelodysplastic syndrome, or concomitant sickle cell disease; Symptomatic CNS metastases and/or leptomeningeal disease requiring immediate radiation or steroid therapy; Received surgery or radiotherapy within 4 weeks prior to the first dose of study drug; Receipt of any investigational drug ≤ 30 days or ≤ 5 half-lives (whichever is longer) prior to the first dose of study drug; Platinum-resistant OC (refractory to 1 line of platinum-based chemotherapy or recurrent platinum-based chemotherapy within 6 months prior to the first dose of study drug); Requires concurrent radiotherapy; Known history of hypersensitivity to the drug components of this protocol; Pregnant or lactating women; Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297798

Not yet recruiting

Effects of Telerehabilitation-Based Interventions on the Musculoskeletal System in Drivers

This study is designed to examine the effect of telerehabilitation application on the musculoskeletal system of drivers.The study will include 40 voluntary participants who work as drivers on inter-district routes in Sakarya. The participants' sociodemographic information, musculoskeletal problems, and postures will be assessed. Participants will be divided into two groups: one group will receive tele-rehabilitation with posture and stabilization exercises, while the other group will serve as the control group. The exercises will be implemented for 10 weeks, followed by an 8-week tapering period, after which the groups will be crossed over. A re-evaluation will be conducted after 10 weeks, with follow-up assessments scheduled for 3 months later.

- EligibilityCriteria: Inclusion Criteria: Individuals working as drivers in intercity minibuses in Sakarya. Those who have been working as drivers for at least one year. Age between 30 and 65. Male gender. Those who can use a smartphone. Those who can use at least one of the following applications: WhatsApp, Zoom, or Teams. Exclusion Criteria: Orthopedic surgeries undergone within the past year. Inability to obtain consent to participate in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - GenderDescription: The study will be conducted only on male drivers. - MinimumAge: 30 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06297785

Recruiting

Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS)

Adult IBS patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups. The primary outcome measure was change in gastro-intestinal symptom severity.

- EligibilityCriteria: Inclusion Criteria: IBS diagnosis Exclusion Criteria: Organic GI disease - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06297772

Not yet recruiting

Compare the Efficacy and Safety of Dec-FB4 and FB4 as Conditioning Regimen for AML-MR

A multicenter, randomized, controlled clinical study comparing the efficacy and safety of allogeneic hematopoietic stem cell transplantation with decitabine-Fludarabine- busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as pretreatment regimens for the treatment of acute myeloid leukemia in adults with MR gene abnormalities

- EligibilityCriteria: Inclusion Criteria: Age 16-65 years and with an ECOG physical fitness score of 0-2 and an HCT-CI of less than 3; Diagnosis: All enrolled cases were diagnosed with acute myeloid leukemia (AML-MR) after bone marrow cytomorphology, cytochemistry, immunophenotyping, chromosomal examination, and gene mutation, and achieved hematological remission (bone marrow smear primitive cells <5%) and negative MRD before transplantation. Have a medically qualified and suitable hematopoietic stem cell donor, including HLA-allogamous sibling donors, unrelated donors (HLA high-resolution 9-10/10 compatible) or related haploidentical donors; No dysfunction of the heart, liver, lungs, kidneys, or other important organs, as defined as follows: ALT and AST ≤3 times the upper limit of normal; total bilirubin ≤2 times the upper limit of normal); BUN and Cr ≤1.25 times the upper limit of normal; electrocardiograms not suggestive of acute myocardial infarction or serious arrhythmias; cardiac echocardiography left ventricular ejection fraction ≥50%, no significant cardiac enlargement, valvular disease, or congenital heart disease; pulmonary function examination FEV1, FVC, DLCO ≥ 60% of the predicted value. The patient and his/her legal representative have the desire and requirement to undergo hematopoietic stem cell transplantation and sign an informed consent, willingness and compliance with the treatment plan, follow-up schedule, laboratory tests, etc. Exclusion Criteria: AML in unremitting stage; or BM in remission but with concurrent CNS leukemia or presence of extramedullary lesions; Active hepatitis B (HBV-DNA ≥1×10^3 copies/ml); HIV-infected patients; Active infections requiring intravenous antibiotic therapy; There is severe impairment of vital organ function: respiratory failure, heart failure, decompensated hepatic insufficiency, renal insufficiency, etc; Patients who use drugs or chronic alcohol abuse to the extent that it interferes with the evaluation of test results; Mentally challenged/unable to obtain informed consent; Those judged by the investigator to be unsuitable for participation in this trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - MaximumAge: 65 Years - StdAgeList: Child, Adult, Older Adult

NCT06297759

Not yet recruiting

The Validity and Reliability Study of Turkish Version of the Sense of Competence in Dementia Care Staff (SCIDS) Scale

The purpose of the study is to adapt the SCIDS into the Turkish version and validate it in the social and cultural context of Turkey to assess staff competency in dementia care in the long-term care setting.

- EligibilityCriteria: Inclusion Criteria: Working as a dementia care staff for at least 1 year Exclusion Criteria: Not volunteering - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Working as a dementia care staff in Acıbadem Health Group - SamplingMethod: Non-Probability Sample

NCT06297733

Not yet recruiting

Turkish Adaptation, Validity and Reliability of the Approaches and Study Skills Inventory in Physiotherapy Students

The quality and quantity of learning are determined by the learning approach adopted by the student. When learning and studying approaches are mentioned, individual differences between learners' learning intentions during a learning situation or while studying and what types of strategies are used to achieve these intentions come to mind. These learning approaches are thought to determine the quality of learning outcomes. Many measurement tools have been developed to quantitatively measure learning and studying approaches. These developed tools are mostly applied at the higher education level. Among the purposes of using measurement tools; These include identifying low-performing students through screening, evaluating and identifying areas of difficulty that require prediction or improvement plans, evaluating before and after academic improvement programs, and raising awareness and advising students on their academic strengths and weaknesses. When multidimensional measurement tools that evaluate students' study approaches and skills are examined, it is seen that the use of the Approaches and Study Skills Inventory for Students (ASSIST) tool has become widespread in recent years. This vehicle; It has been reported that it measures learning strategies and skills for different students and is sensitive enough to distinguish between learning types. The Portuguese, Norwegian and Danish versions of the survey, which was developed in English and intended to be translated into Turkish as the Study Skills and Approaches Scale, have also been translated, its psychometric properties have been demonstrated and it has been observed that it is becoming widespread in the literature.

- EligibilityCriteria: Inclusion Criteria: Being between the ages of 18-30 Being a student at the Department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences Exclusion Criteria: People with vision problems that would prevent participation in the study Participants who have not filled out the forms completely will be excluded from the research. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult - StudyPopulation: The population of the research consists of undergraduate students of the physiotherapy and rehabilitation department. - SamplingMethod: Non-Probability Sample

NCT06297720

Not yet recruiting

Early Oral Hydration After Thoracoscopic Surgery

The goal of this clinical trial is to learn about the safety and feasibility of early oral hydration in patients receiving video-assisted thoracoscopic surgery after general anesthesia. The main questions aims to answer: the safety and feasibility of oral hydration supplementation in the recovery room following general anesthesia. the degree of improvement in sore throat and dry mouth after oral hydration. the side effects and risks of oral hydration supplementation, such as the incidence of postoperative nausea and vomiting. the impact of oral hydration supplementation in the recovery room following general anesthesia on hemodynamics. patient satisfaction with oral hydration supplementation in the recovery room following general anesthesia. Participants will receive a series of oral hydration from swab moistening, and ice cube hydration to water hydration in the recovery room. Researchers will compare with the standard, no-hydration group to see if it is safe and feasible to hydrate patients in the recovery room.

- EligibilityCriteria: Inclusion Criteria: Males and females aged 18 to 70. Anesthesia physical status classification III or below Body Mass Index 30 or below Elective video-assisted thoracoscopic surgery Exclusion Criteria: Pre-operative throat pain Impaired mental status Tendency to choke (inc. dysphagia, stroke hx.) Nil Per Os (NPO) less than 8 hours Pregnancy Nausea and vomiting in Operating room or Post-anesthesia care unit - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06297707

Recruiting

Effect of Aquatic High Intensity Resistive Training on Patients With Chronic Heart Failure

PURPOSE: to evaluate effect of aquatic high intensity resistive training on cardiac function and exercise capacity in patients with chronic heart failure. BACKGROUND: Heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of >37.7 million individuals globally. HF is a shared chronic phase of cardiac functional impairment secondary to many etiologies, and patients with HF experience numerous symptoms that affect their quality of life, including dyspnea, fatigue, poor exercise tolerance, and fluid retention.

- EligibilityCriteria: Inclusion Criteria: Age ranges from 45 to 60 years old. Have chronic heart failure (NYHA class I to III). Left ventricular ejection fraction (LVEF) > 50% clinically stable with optimal pharmacological therapy in greater than three months All patients didn't participate in any rehabilitation programs prior to the study. Exclusion Criteria: Signs of acute heart failure, unstable angina, or severe arrhythmia three months prior to enrolment in the study. Pacemakers. recently diagnosed acute coronary syndrome or a recent coronary intervention or both renal insufficiency (estimated glomerular filtration rate < 30 mL/min) liver abnormalities uncontrolled hypertension moderate-to-severe valvular disease uncompensated heart failure patients Chronic lung disease. Other disorders counteracting exercise conditions that limit lower limb mobility (for example, burns, fractures) - HealthyVolunteers: No - Gender: All - MinimumAge: 45 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06297694

Not yet recruiting

Clinical Interpretation and Cutoff Scores for ABILHAND Questionnaire in Rheumatoid Arthritis

In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. The ABILHAND-RA questionnaire possesses all these features, being a short and easily fillable survey. The aim is to determine of clinically significant cutoff scores for perceived manual ability evaluated by ABILHAND corresponding to observed and perceived upper extremity assessments in individuals with rheumatoid arthritis.

- EligibilityCriteria: Inclusion Criteria: People between the ages of 20-65, who were diagnosed with RA according to ACR criteria by the PAU Rheumatology clinic and who volunteered to participate in the study, will be included. Exclusion Criteria: Patients with RA who have a neurological disease that may affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident), a psychiatric disease that affects cooperation, heart failure and lung pathology that affect daily living activities, and those with other concurrent autoimmune and rheumatic diseases. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: PAU Romatology clinic - SamplingMethod: Probability Sample

NCT06297681

Not yet recruiting

Combination of Daratumumab and BD Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease

It is expected to include 40 patients with M-protein related cardiac disease. The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min).

- EligibilityCriteria: Inclusion Criteria: M-protein related cardiac disease aged 18 and above (at least one of the following criteria is met): (1) Systemic amyloidosis of the affected heart; (2) Presence of M component and presence of arrhythmia, cardiac enzyme abnormalities, cardiac function abnormalities, and exclusion of other diagnosable cardiac diseases; ECOG score 0-2; Sign a written informed consent form. Exclusion Criteria: Acute myocardial infarction; Severe functional abnormalities in important organs such as lungs, liver, and kidneys (the carbon monoxide diffusion ability caused by chronic respiratory diseases is 50% lower than expected); Major surgery, radiation therapy, infections requiring systemic antibiotic treatment, or other serious infections within 14 days after enrollment; Individuals with mental illness, comprehension disorders, or other reasons that make it difficult to control themselves; Pregnant or lactating women, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial. If the patient is male, refuse to use adequate contraceptive methods or donate semen during the study period and within 3 months after receiving the last cycle of drug study; Diagnosed or treated another malignant tumor within 2 years prior to enrollment; Individuals with allergies to daratumumab, bortezomib, or dexamethasone components or more severe allergic constitutions; HIV infected individuals (HIV antibody positive); Active infection of hepatitis B and hepatitis C (hepatitis B B virus surface antigen positive and/or hepatitis B core antibody positive, hepatitis B virus DNA more than 1x103 copies/mL; hepatitis C virus RNA more than 1x103 copies/mL); Participate in another clinical trial 30 days after the start of the trial and throughout the entire trial period; The researcher determined that patients who are not suitable to participate in this study; - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Observe patient data from Beijing Chaoyang Hospital affiliated with Capital Medical University, Beijing Chuiyangliu Hospital, and Beijing Boren Hospital. - SamplingMethod: Non-Probability Sample

NCT06297668

Not yet recruiting

A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) Hydrofluoroolefin (HFO) With a Spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) With a Spacer (Treatment A), as Well as BGF MDI HFO Without a Spacer (Treatment C).

This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer.

- EligibilityCriteria: Inclusion Criteria: Females must have a negative pregnancy test at screening and on admission to the Clinical Unit, must not be lactating, confirmed at screening. Women of childbearing potential who are sexually active with a non-sterilized male partner, must use 1 highly effective form of birth control from enrolment throughout the study and until at least 14 days after last dose of IMP. Women should be stable on their chosen method of birth control for at least 1 month from enrolment. Have a body mass index between 18 and 30 kg/m2 inclusive and weigh at least 50 kg. Have a Forced expiratory volume in the first second (FEV1) ≥ 80% of the predicted normal value and an FEV1/forced vital capacity> 70% regarding age, height, and ethnicity at screening. Demonstrate basic understanding of how to use an MDI device with and without a spacer after receiving training. Participants should be fully/sufficiently vaccinated as per local definitions against SARS-CoV-2 (in combination with confirmed past infections with SARS-CoV-2). Exclusion Criteria: History or current evidence of any clinically significant disease or disorder, including endocrinological diseases, such as thyrotoxicosis, which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results through participation in the study. Participants who have previously received BGF MDI HFO. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to BGF or to its excipients, such as norflurane. History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP). History of narrow angle glaucoma or change in vision that may be relevant. History of symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, which in the opinion of the investigator, is clinically significant. Unresectable cancer that has not been in complete remission for at least 5 years. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at screening as judged by the investigator. Any clinically significant abnormal findings in physical examination or vital signs at screening, as judged by the investigator. Any clinically significant abnormalities on 12-lead ECG at screening, as judged by the investigator. Any positive result on screening for serum hepatitis B surface antigen or anti-hepatitis B core antibody, indicative of hepatitis B, hepatitis C antibody, or human immunodeficiency virus. Positive reverse transcription polymerase chain reaction test for SARS-CoV-2 prior to randomization. Participant has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea, sore throat, fatigue, new smell or taste disorder or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission. Participant who had severe course of COVID-19 (ie, hospitalization, extracorporeal membrane oxygenation, or mechanically ventilated). Recent (within 14 days prior to admission to the Clinical Unit) exposure to someone who has COVID-19 symptoms or tested positive for SARS-CoV-2. History of any respiratory disorders such as asthma, COPD, or idiopathic pulmonary fibrosis. Known or suspected history of drug abuse. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening. Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP. Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life. Known or suspected history of alcohol or drug abuse or excessive intake of alcohol. Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06297655

Not yet recruiting

A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A

This study is a single arm, open, multicenter clinical trial in which the previous treated severe hemophilia A patients receive recombinant human coagulation factor VIII for injection to evaluate the efficacy and safety of on-demand treatment in the event of new bleeding events. If evaluable surgical cases occur, the overall efficacy and safety of recombinant human coagulation factor VIII for injection as a replacement therapy for severe hemophilia A PTPs during the perioperative period will be evaluated.

- EligibilityCriteria: Inclusion Criteria: The subjects voluntarily joined this study, signed an informed consent form, and had good compliance; Age: ≥ 12 years old and ≤ 65 years old (when signing the informed consent form, if it is a minor, parents should sign on behalf of it); Severe hemophilia A (coagulation factor VIII activity<1%), with exposure days (ED) of no less than 150 days prior to factor VIII (recombinant coagulation factor VIII or plasma derived coagulation factor VIII) treatment; Surgical patients need to have undergone at least 2 surgeries (including major surgeries) and plan to undergo elective surgery at the same time; The subjects must be HIV negative or have a viral load of < 200 particles/μ, HIV positive patients with l or < 400000 copies/ml. At baseline, no inhibitors were detected, and there was no history of Factor VIII inhibitor antibody formation (Bethesda method detection < 0.6 BU/ml, test result record required); Subjects of childbearing age who agree to take effective contraceptive measures throughout the entire trial period and continue until 28 days after the last medication. Exclusion Criteria: Known congenital or acquired hemorrhagic diseases other than hemophilia A; The subjects have used or planned to receive immunosuppressive treatments such as prednisone, cyclophosphamide, and cyclosporine in the week prior to enrollment, and are allowed to use inhaled or topical corticosteroids; Those who are known or suspected to have hypersensitivity reactions to the investigational drug, including human embryonic kidney cell protein; Significant liver and kidney dysfunction, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 5 upper limit of normal (ULN), and serum creatinine >1.5 ULN; Hemoglobin < 60 g/L; Expected to receive other drugs for the treatment of hemophilia A within 72 hours before the first administration (such as recombinant factor VIII, blood derived factor VIII, desmopressin, cryoprecipitate, plasma, etc.), or those who have used long-acting hemophilia A drugs for less than 5 half-lives before the first administration; Used within 14 days before the first administration or planned to use anticoagulants or antiplatelet drugs for treatment during clinical trials; Within 6 months prior to the first administration, use of Emicizumab; Serious cardiovascular and cerebrovascular diseases occurring within 6 months prior to the first administration, including but not limited to cerebral hemorrhage, cerebral infarction, unstable angina, malignant arrhythmia, acute myocardial infarction, congestive heart failure (New York Heart Association cardiac function classification ≥ III), and hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure 100 mmHg) that is poorly controlled despite treatment with one or more antihypertensive drugs; Participated in clinical trials of other drugs within 30 days prior to screening, or last used investigational drug with less than 5 half-lives; Alcohol abuse, drug abuse, mental disorders, and intellectual disabilities. - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 65 Years - StdAgeList: Child, Adult, Older Adult

NCT06297642

Not yet recruiting

TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors.

This study will evaluate the safety and efficiency of TQB2928 injection combined with Penpulimab in the treatment of patients with advanced malignant tumors.

- EligibilityCriteria: Inclusion Criteria: Subjects voluntarily participate in this study and sign informed consent; Age: ≥18 years old (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) score: 0 or 2 point; The expected survival period exceeds 3 months; Subject population: Histologically and/or cytologically confirmed advanced malignancies, including lymphomas and solid tumors. Relapse or treatment failure after previous standard treatment, or intolerance to standard treatment and no other better treatment options： Adequate treatment with PD-1/PD-L1 (including monotherapy or combination) without remission or disease progression after treatment. Adequate main organs function Female subjects of childbearing age should agree to use contraceptives (such as Intrauterine device, contraceptives or condoms) during the study period and within 6 months after the end of the study; The serum or urine Pregnancy test was negative within 7 days before the study was included, and must be non-lactating subjects; Male participants should agree to use contraception during the study period and within 6 months after the end of the study period. Exclusion Criteria: Tumor disease and history: Nodular lymphocyte dominant Hodgkin's lymphoma or gray area lymphoma. The tumor involves the central nervous system. People with a history of hemophagocytic syndrome or who have been assessed by the investigator as being at suspected risk. Has experienced or currently suffers from other malignant tumors within 3 years. Previous anti-tumor therapy: Previous use of other similar drugs. received systemic antitumor drugs (including drugs under investigation) within 4 weeks prior to initial administration, or received Chimeric Antigen Receptor T-cell (CAR-T) Therapy or Autologous hematopoietic stem cell transplantation( auto-HSCT) within 3 months prior to initial administration. Previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT). any major surgical procedure, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to initial dosing. Less than 5 drug half-lives between the first administration and the previous oral targeted therapy (calculated from the end time of the last therapy). Received within 2 weeks before the first administration of Chinese patent drugs (including compound cantharides capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea oil injection/capsule, Xiaoaiping tablet/injection, cinobufagin capsule, etc.) approved by the National Drug Administration (NMPA) with anti-tumor indications. Concomitant diseases and medical history: Liver abnormalities: Abnormal kidney: Cardiovascular and cerebrovascular abnormalities: History of immune deficiency: Lung diseases: Active bacterial, fungal, or viral infections requiring systemic treatment. Subjects with a history of hemolytic anemia from any cause (including Evans syndrome) or a positive Coombs test within 3 months prior to initial dosing. A prior history of unexplained severe allergies, known to be allergic to monoclonal drugs or exogenous human immunoglobulins. with a serious or poorly controlled disease that, in the judgment of the investigator and sponsor, poses a serious risk to the safety of the subjects or affects the completion of the study. History of drug abuse or drug use. Live attenuated vaccines were administered within 4 weeks before the first dose or during the planned study period. Inactivated Corona Virus Disease 2019 (COVID-19) and influenza vaccines are allowed. Subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are not suitable for enrollment for other reasons. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06297629

Not yet recruiting

A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation

To learn if ASTX727 given alone or in combination with donor lymphocyte infusion (DLI) can help to control certain types of hematological neoplasms (blood-based cancers) after a stem cell transplant.

- EligibilityCriteria: Inclusion Criteria: Diagnosis of AML and MDS according to World Health Organization (WHO) classification that underwent first or second allogeneic HSCT with either peripheral blood or bone marrow as the source of the hematopoietic stem cells. Age 18 to 75 years old. High risk patients defined per cohorts as below: Cohort #1: AML and MDS patients in morphological remission with persistence or reappearance of MRD by flow cytometry or molecular after allogeneic stem cell transplantation who are beyond day 100 after allogeneic stem cell transplantation. When MRD is detected by flow cytometry, disease level at or above the sensitivity level of the test will be required. MRD level at or above 0.1%. When MRD is detected by molecular testing, disease level at or above the sensitivity level of the test will be required. The limit of detection is 0.01% Cohort #2: High risk AML and MDS patients who are in complete remission morphologically with no evidence of minimal residual disease by flow cytometry or cytogenetic or molecular testing within 100 days after allogeneic stem cell transplantation. MDS patients: Moderate-high, high or very high-risk groups by International Prognostic Scoring System-Molecular (IPSS-M) classification if classification is available (58). TP53 with biallelic mutations(49). Therapy-related MDS(50). Presence of mutation ASXL1, SRSF2, DNMT3A, RUNX1, U2AF1, TP53, EZH2, STAG2, CBL, NRAS, BCOR ((49, 51-54)) Bone marrow blast count 10% or higher prior to allogeneic stem cell transplantation. AML patients Cytogenetics and molecular features consistent with adverse risk group by 2017 European LeukemiaNet classification for AML(55) Presence of MRD by multi-color flow cytometry or cytogenetics or molecular studies by the last bone marrow evaluation prior to HSCT. Primary induction failure defined as absence of complete remission after two different lines of anti-leukemia therapy following diagnosis. Presence of active disease defined as bone marrow blast count >5% but <= 20% at the time of HSCT. Patients transplanted beyond first CR. Therapy-related AML. Overexpression of EVI1 (52) All patients in cohort #2: Post-transplant bone marrow consistent with complete remission with no evidence of minimal residual disease by flow-cytometry or cytogenetics or molecular testing. Adequate engraftment within 7 days prior to starting study drug: Absolute neutrophil count (ANC) >/= 1.0 x 109/L without daily use of myeloid growth factor (G-CSF) for at least 7 days; and,platelet >/= 30 x 109/L without platelet transfusion within 1 week. ECOG performance status of 0, 1, or 2. Creatinine clearance greater or equal than 40 cc/min as defined by the Cockcroft-Gault Equation*. Males (mL/min) :(140-age) *IBW (kg) / 72*(serum creatinine(mg/dl)) Females (mL/min):0.85*(140-age) *IBW (kg) / 72*(serum creatinine(mg/dl)). Serum bilirubin </= 1.5 x upper limit of normal (ULN). Aspartate transaminase (AST) or alanine transaminase (ALT) </= 2.5 x ULN. Alkaline phosphatase </= 2.5 x UL. No active bleeding. No clinical evidence of life-threatening infection. Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent. Negative serum or urine pregnancy test for women with reproductive potential. The only subjects who will be exempt from this criterion are postmenopausal women (defined as women who have been amenorrheic for > 12 months) or subjects who have been surgically sterilized or otherwise proven sterile. Females of childbearing potential must refrain from becoming pregnant and commit to either apply highly effective method of birth control (two reliable methods of birth control) or continue abstinence from heterosexual intercourse during study period and for at least 6 months after last dose of ASTX727. Male subjects who are sexually active with a women of childbearing potential (WOCBP) and who have not had vasectomies must be willing to use a barrier method of contraception and refrain from sperm donation from initial study drug until 3 months after last dose of study drug. Exclusion Criteria: Use of any anti-leukemic agents after MRD is documented (note that the use of these anti-leukemic agents given as post-transplant maintenance therapy is allowed in this study, e.g., subcutaneous or oral 5-Azacytidine or FLT3 inhibitors for maintenance, for cohort #1 patients. However, all those agents will be discontinued once the patient enrolls into the current trial for cohort #1. Use of any of the following after transplantation and prior to starting study therapy for cohort #2. Anti-leukemic agents given as post-transplant maintenance therapy (e.g., subcutaneous or oral 5-Azacytidine or FLT3 inhibitors for maintenance). Overall grade II-IV acute GVHD. However, upon complete resolution of acute GVHD-related symptoms, patients are eligible for enrollment if they are on prednisone 0.5 mg/kg daily dose or lower, tacrolimus, sirolimus and ruxolitinib. Chronic GvHD, moderate or severe by NIH criteria. Active uncontrolled systemic fungal, bacterial or viral infection. However, patients receiving anti-microbial agents including antibiotics, antiviral and antifungal therapies are allowed if hemodynamically stable. Symptomatic or uncontrolled arrhythmias. Significant active cardiac disease within the previous 6 months, including: New York Hear Association (NYHA) class III or IV congestive heart failure; Unstable angina or angina requiring surgical or medical intervention, and/or; Myocardial infarction. Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV). Patients with known active hepatitis B virus (HBV) infection will be excluded because of potential effects on immune function and/or drug interactions. However, if a patient has HBV history with an undetectable HBV load by polymerase chain reaction (PCR), no liver-related. complications, and is on definitive HBV therapy that is not contraindicated on this study, then he/she would be eligible for study. Patients with known active hepatitis C virus (HCV) infection will be excluded because of potential effects on immune function and/or drug interactions. However, if a patient with a history of HCV infection has received definitive therapy (and is now HCV viral load negative), or if a patient has a reactive HCV antibody test but has an undetectable viral load by PCR, then he/she would be eligible. Patients with known active HIV infection will be excluded out of concern for the drug-drug interaction with venetoclax and highly active antiretroviral therapy (HAART). - Prior history of solid tumors other than AML and MDS, unless the subject has been free of the disease for >/= 1 year. However, subjects with the following history/concurrent conditions are allowed: Basal or squamous cell carcinoma of the skin; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging system). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06297616

Not yet recruiting

A Study of LY3841136 in Japanese Participants With Obesity or Overweight

The main purpose of this study is to learn about the side effects of LY3841136 when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last about 28 weeks and may include up to 17 visits.

- EligibilityCriteria: Inclusion Criteria: Male or female participants who agree to contraception requirements Have a body mass index (BMI) within the range of 27 to 40 kg/m², inclusive Have had a stable weight for the 3 months Exclusion Criteria: Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder within the last 3 years Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus Have a history of chronic medical conditions involving the heart, liver, or kidneys Have a history of any malignancy within the past 5 years Have a history or presence of a GI disorder Have had within the last 6 months, or plan to have during the study, a device-based or surgical treatment use for obesity Have been treated, or plan to be treated, with prescription medications or other non-approved drugs intended to promote weight loss, within 3 months prior to screening - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06297603

Not yet recruiting

Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.

- EligibilityCriteria: Inclusion Criteria: Have Type 2 Diabetes (T2D) Have HbA1c ≥7.0% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol) Have moderate or severe renal impairment Have been on the following stable diabetes treatment during 90 days prior to screening basal insulin (≥20 International Units (IU)/day) with or without metformin and/or SGLT2 inhibitor Are of stable weight for at least 90 days prior to screening Have a Body Mass Index (BMI) ≥23.0 kilograms per meter squared (kg/m2) Exclusion Criteria: Have Type 1 Diabetes (T1D) Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema Have a history of unstable or rapidly progressing renal disease Have a prior or planned surgical treatment for obesity Have New York Heart Association Functional Classification III or IV congestive heart failure Have had acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening Have a known clinically significant gastric emptying abnormality Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2. Have any lifetime history of a suicide attempt Had chronic or acute pancreatitis Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297590

Not yet recruiting

A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease

The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD. The study will be comprised of two parts, A and B. Part B is optional, and participants from Part A may also have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or placebo administered into the spinal fluid. The study will last up to approximately 69 weeks for Part A, and, if conducted, 73 weeks for Part B. If conducted, the optional bridging period for Part A participants would last up to approximately 1 year after their completion of Part A. If the optional bridging period is conducted, participants in Part A could be enrolled in the separate potential study for up to approximately 120 weeks.

- EligibilityCriteria: Inclusion Criteria: Have a body mass index (BMI) within the range 18 (17 for Japan participants) to 40 kilograms per square meter (kg/m²), inclusive, at screening. Have gradual and progressive change in memory function for greater than or equal to (≥) 6 months as reported by the participant or informant. Have a mini mental state examination (MMSE) score of 18 to 30 at screening. Have a clinical dementia rating (CDR) global score of 0.5 to 1.0, with a memory box score ≥ 0.5 at screening. Meet flortaucipir positron emission tomography (PET) criteria demonstrating evidence of tau pathology. Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP). Participants must have up to 2 study partners who are with contact with the participant at least 10 hours per week and one of whom can attend study appointments. Exclusion Criteria: Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic (other than Alzheimer's Disease), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of less than (<)24 months. Have a sensitivity to flortaucipir 18F. Have contraindication to magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker. Have a current exposure to an amyloid targeted therapy (ATT). Prior exposure to ATTs greater than 1 year from the last dose may be permitted at the discretion of the sponsor and in consultation with the sponsor. Have previous exposure to any Investigational Medicinal Product administered IT or previous exposure to any anti-tau therapy. Have a history of clinically significant back pain, back pathology and/or back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with lumbar puncture. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06297577

Not yet recruiting

Clinical Evaluation of Injectable Alb-PRF in the Management of Intrabony Defect in Stage-III Periodontitis Patients

Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are: will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST.

- EligibilityCriteria: Inclusion Criteria: Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intrabony defect ≥3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥5mm and probing pocket depth (PPD) ≥6 mm with no defect extending to a root furcation area. Vital teeth. No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months. No periodontal therapy carried out in the past 6 months. Ability to sign an informed consent form. Patients age ≥18 years old. Patients who are cooperative, motivated, and hygiene conscious. Systemically free according to Cornell Medical Index. Exclusion Criteria: Patient undergoing orthodontic treatment. Pregnant females or breast feeding. Smokers. Teeth mobility greater than grade I. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06297551

Recruiting

Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA)

Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow and the most common form of acute leukemia in adults. Patient with AML have the shortest survival compared to other forms of leukemia. In the past 6 years, several new therapies have been approved. Biomarkers are in urgent need to guide therapeutic regimen selection in order to maximize the benefit of available therapies and minimize treatment toxicity. Current standard practice is to perform bone marrow biopsy at end of treatment cycle (each cycle around 28 days), and based on bone marrow finding, to decide further treatment plan. It is invasive and time consuming. The research we are proposing here is to investigate whether tracking leukemia stem cells (LSC) in peripheral blood during early treatment cycle may provide a non-invasive method to predict therapeutic outcome at end of treatment cycle. Our retrospective study have found that LSC fractional change, defined by two LSC markers, named CLL1 and CD45RA, is highly correlated with therapeutic outcome. Further more, CLL1 and CD45RA positive LSC fraction demonstrates a high concordance between bone marrow and peripheral blood, offering the opportunity to track CLL1 and CD45RA positive LSC fraction non-invasively in peripheral blood during treatment. This pilot study will allow us to decide whether testing CLL1 and CD45RA positive LSC in peripheral blood during leukemia treatment is feasible in clinical practice. This result will lay the foundation for designing future trials using CLL1 and CD45RA positive LSC fractional change to optimize therapeutic strategy for patients with AML.

- EligibilityCriteria: Inclusion Criteria: diagnosis of acute myeloid leukemia ability to receive treatment for acute myeloid leukemia at the research center elevated values of CLL1A and CD45RA positive cells at the time of diagnosis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adults diagnosed with acute myeloid leukemia, undergoing systemic chemotherapy (high or low intensity) - SamplingMethod: Non-Probability Sample

NCT06297538

Recruiting

Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation

Cortical-basal ganglia gamma oscillations are pathologically reduced in Parkinson's disease (PD) and the plasticity of the primary motor cortex (M1) is impaired. Enhancing gamma oscillations through transcranial alternating current stimulation (tACS), a non-invasive neurophysiological tool that modulates cortical rhythms, can restore this alteration. However, whether tACS-related normalization of M1 plasticity results in positive clinical effects is unknown. Motor learning is also impaired in PD and gamma oscillations play a relevant role in different forms of learning in humans. Nevertheless, whether motor learning abnormalities relate to reduced gamma oscillations in PD is another unclear issue. It can be hypothesized that gamma oscillations impairment in M1 contributes to altered motor control, plasticity and learning in PD. Accordingly, in this project, the authors intend to test whether gamma-tACS on M1 in PD patients ameliorates motor performance and learning, as objectively assessed with kinematic techniques.

- EligibilityCriteria: Inclusion Criteria: PD diagnosis Exclusion Criteria: severe cognitive and psychiatric comorbidities H&Y>3 levodopa-induced dyskinesia and tremor-dominant phenotype history of additional neuropsychiatric disorders intake of medications acting on brain excitability or plasticity contraindications to non-invasive brain stimulation - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297525

Not yet recruiting

Study of STP938 in Advanced Solid Tumours

The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy. The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.

- EligibilityCriteria: Main Inclusion Criteria: Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization. Male or female aged ≥ 18 years. Advanced disease not curable by available therapies and requires systemic therapy. Histologically confirmed diagnosis of eligible cancer type. Must have tumor tissue available for biomarker testing. Measurable disease (Part 1) and measurable disease per RECIST (Part2) Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Life expectancy > 3 months as assessed by the Investigator. Adequate organ function (bone marrow, hepatic, renal function and coagulation). All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment. Main Exclusion Criteria: Pregnant or breastfeeding females and women of childbearing potential or males unwilling to comply with contraception requirements. Known active or symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease or a history of spinal cord compression Active malignancy within 2 years of study enrollment Prior radiation within 2 weeks of start of therapy. Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or <5 half-lives since completion of previous investigational therapy, whichever is shorter. Uncontrolled intercurrent illness. Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months. Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection. Subjects with corrected QT interval >470 msec based on averaged triplicate electrocardiogram (ECG) readings at the Screening Visit using the QT interval corrected for heart rate using Fridericia's method (QTcF). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297512

Recruiting

Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).

Glioblastoma (GBM) and diffuse intrinsic bridge gliomas (DIPG) only the most aggressive forms of cancer, and their prognosis remains bleak. Currently, the standard of treatment is TMZ concomitant with radiotherapy, and, at the end of combined treatment, as adjuvant therapy. In vitro and in vivo experimental studies have suggested that anthracyclines are effective antineoplastics for the treatment of gliomas. In patients with solid tumors treated with anthracyclines, continuous infusion administration compared with bolus administration has been shown to provide a better safety profile especially with regard to cardiotoxicity. Based on this evidence, this study aims to evaluate the safety and antitumor activity of combined treatment with Dox, WBRT (whole body radiotherapy), and TMZ in pediatric and young adult patients affected by GMB

- EligibilityCriteria: Inclusion Criteria: Patients with histological-molecular diagnosis according to WHO 2016 classification: IDH-wildtype glioblastoma (9440/3), giant cell glioblastoma (9441/3), gliosarcoma (9442/3), epithelioid glioblastoma (9440/3), IDH-mutated glioblastoma (9445/3), glioblastoma NOS (9440/3), diffuse astrocytoma (9400/3), diffuse midline glioma H3 K27M mutated, including multifocal, metastatic or gliomatosis cerebri pictures of first diagnosis Not previously treated (with chemo and radiotherapy) or treated only surgically (total, near partial, partial, biopsy). Males and females between the ages of 3 and 30 years old Life expectancy ≥ 12 months karnofsky/Lansky ≥ 80 % Adequate hematologic function: Absolute leukocyte count ≥ 2.0 x 109/l, Hemoglobin ≥ 10 g/dl, Platelet count ≥ 50 x 109/l Adequate liver function: Total bilirubin ≤ 2.5 x ULN, ALT/AST ≤ 5.0 x ULN Adequate renal function:Serum creatinine ≤ 1.5 x ULN Written informed consent from the patient, parents or legal guardians Patient's willingness during treatment and ability to comply with the protocol Exclusion Criteria: Evidence of any other serious disease or condition that is a contraindication to study therapy (e.g. severe mental retardation, severe cerebral palsy, severe syndromes congenital syndromes, heart disease) Performance of a course of 1st-line chemotherapy at the same time as study initiation Concurrent participation in other research projects Pregnancy or lactation status Use of inappropriate contraceptive methods - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 30 Years - StdAgeList: Child, Adult

NCT06297499

Not yet recruiting

Ondansetron Use for Preventing Pruritus In Patients Undergoing Cesarean Section

Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration.

- EligibilityCriteria: Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status 1-3 Adult parturient (18 -50 years of age) scheduled to undergo elective cesarean delivery under spinal anesthesia Patients must be willing and cognitively able to give written informed study consent Exclusion Criteria: Patients with an ASA physiological assessment greater than grade 3 Allergies to local anesthetics, opioids, or ondansetron Coagulopathies precluding provision of spinal anesthesia Pre-eclampsia with severe features Eclampsia Pre-intrathecal pruritus Psychiatric or language deficiencies affecting assessment of pain Insufficient understanding of the pain scoring system Patients who receive any other regional anesthesia techniques Patients on higher than a 100mg of daily morphine equivalent Cardiac issues that would preclude spinal anesthesia (Congestive heart failure, Mitral or Aortic valve pathology. Confounding neural issues that would preclude spinal anesthesia. Coadministration of drugs that would potentially interact with ondansetron. Including Apomorphine, Phenytoin, Carbamazepine, Rifampicin, Tramadol and Chemotherapy drugs. Coadministration of drugs that would potentially prolong QTc interval. Including Antiarrhythmic, Antidepressants, Antipsychotics, and the following list of medications. a. Levofloxacin, Ciprofloxacin, Gatifloxacin, Moxifloxacin, Clarithromycin, Erythromycin, Ketoconazole, Itraconazole, Cisapride, Sumatriptan, Zolmitriptan, Arsenic, Dolasetron, Methadone Coadministration of drugs that would potentially lead to the development of serotonin syndrome. Including the following: a. Selective serotonin reuptake inhibitors, Serotonin and norepinephrine reuptake inhibitors, antidepressants, carbamazepine , valproic acid, triptans, Chronic pain medications prior to procedure (Fentanyl, Hydrocodone, Meperidine, Oxycodone, tramadol),Lithium, dextromethorphan, Linezolid and Ritonavir Patients having the following Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation Concomitant use of apomorphine History of QTc interval prolongation (QTc >440) and Torsade de Pointes Serotonin syndrome Phenylketonuric patients Concurrent use of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06297486

Not yet recruiting

Study of a Gene Therapy Treatment for Hemophilia A

The purpose of this study is to evaluate the efficacy of SPK-8011 in preventing bleed episodes compared with FVIII prophylaxis in participants with hemophilia A without FVIII inhibitors on routine FVIII prophylaxis.

- EligibilityCriteria: Inclusion Criteria: Are adult males with severe or moderately severe hemophilia A, defined as endogenous FVIII activity ≤3%, as documented by a certified laboratory (historically or during the Screening Period) and where the FVIII:C level is measured more than 96 hours after the prior dose of an extended-half-life FVIII Have ≥150 documented exposure days to an FVIII protein product such as recombinant, plasma-derived, or extended half-life FVIII product Have no prior history of hypersensitivity or anaphylaxis associated with the administration of any FVIII product. Have screening hepatic ultrasound without evidence of cirrhosis and no laboratory or clinical evidence per the Investigator's judgment of advanced liver disease or cirrhosis. Have a negative test for inhibitor against FVIII (ie, <0.6 Bethesda units [BU]) during screening. Have no documented FVIII inhibitor (ie, <0.6 BU), FVIII half-life <6 hours, or FVIII recovery <66% in the 5 years prior to screening. Candidates who completed successful immune tolerance induction (ITI) at least 5 years before screening are eligible, provided they have had no evidence of inhibitor recurrence (permanent or temporary) within 5 years prior to screening as may be indicated by detection of an inhibitor, FVIII half-life <6 hours, or FVIII recovery <66% since completing ITI. If human immunodeficiency virus (HIV)-positive at screening, have an adequate cluster of differentiation 4 (CD4) count (>200/mm3) and undetectable viral load (<50 genome copies [gc]/mL), are on an antiretroviral drug regimen, and have completed at least 12 weeks of this treatment regimen prior to screening. Meet the following inclusion criteria by cohort: Cohort A: have documented history of prior treatment with FVIII prophylaxis (defined as receiving a prescribed dose and frequency of FVIII infusions with the intent to treat continuously for 52 weeks per year) for a minimum of 6 months prior to screening; and are willing to continue their FVIII prophylaxis during the Lead-In Period of this study (minimum of 24 weeks). Cohort B: have documented history of prior treatment with FVIII on demand for a minimum of 6 months that shows ≥5 treated bleeds in the last 6 months prior to screening. Cohort C: have documented history of prior treatment with emicizumab prophylaxis for a minimum of 6 months prior to screening. Exclusion Criteria: Have a positive anti-AAV-Spark200 neutralizing antibody (NAb) test result. Have an inherited or acquired bleeding disorder other than hemophilia A Have inherited or acquired thrombophilia, have signs of thromboembolic disease in the Investigator's judgment, or are on current treatment for thromboembolic disease. A history of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing is not considered an exclusion criterion. Have concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study or that would, in the opinion of the Investigator or Sponsor, preclude the candidate's safe participation in and completion of the study, or the interpretation of the study results. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297473

Not yet recruiting

Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors.

The primary purpose of this study is to compare the safety of routine telephone assessment versus in-person assessment during a two-year period for patients with non-functioning pituitary adenomas. Secondly, to compare the quality of pituitary care in persons having biochemical assessment once versus twice a year. Thirdly, to assess the rationale of repeated assessment of pituitary function and imaging in patients with small pituitary tumors (microadenomas).

- EligibilityCriteria: Inclusion Criteria: Non-functioning pituitary tumor Diagnosed > 6 months from enrollment, i.e. found on MRI. Exclusion Criteria: Planned pituitary surgery Planned radiotherapy Poor Danish skills Patient is considered by the treating physician unsuitable for follow-up by telephone or video - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297447

Recruiting

Keeping it Simple Study (KISS)

Problem: The number of patients living with chronic musculoskeletal (MSK) pain has steadily increased over the past decade with costs rising equally. Long-standing pain is associated with significant maladaptive beliefs about pain, psychological characteristics and associated behaviors which involve structural and functional neurobiological characteristics which share common pathophysiological mechanisms as chronic pain. The investigators recent priority setting partnership investigated the research priorities from 1000 patients with chronic MSK pain, relatives, and clinicians. Better pain education was rated as one of the three most important research areas. Solution: Pain science education has the potential to target maladaptive psychological and behavioral components that may contribute to the maintenance of chronic pain. The KISS project will evaluate the effect of a pain neuroscience education program (PNE4Adults) on rehabilitation outcomes in patients with chronic MSK pain. This intervention has the potential to change beliefs and behaviors surrounding pain in patients with chronic MSK pain. If this is successful in disrupting maladaptive cycles contributing to chronicity, this may improve outcomes for many thousand citizens.

- EligibilityCriteria: Inclusion Criteria: Patients referred for rehabilitation in the municipalities Køge, Holbæk, and Solrød With chronic (>3 months) musculoskeletal pain. Adult patients (≥18 years) - no upper limit Able to understand, speak, and write Danish. Exclusion Criteria: Known cognitive deficits (e.g., dementia). Diagnosed with cancer or other serious pathologies, e.g., cauda equina. Pregnancy Drug addiction defined as the use of cannabis, opioids, or other drugs. Neurologic or psychiatric diagnoses that hinder participation, e.g., stroke and borderline. Lack of ability to cooperate. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297434

Recruiting

Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH

The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH.

- EligibilityCriteria: Inclusion Criteria: A subject aged ≥19 years to ≤75 years Meeting all of the following criteria: Screening MRI-PDFF with ≥8% steatosis Screening MRE with liver stiffness ≥2.5 kPa ALT or AST ≤250 IU/L at screening Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study Voluntarily provide written consent to participate in the study Exclusion Criteria: A subject who has past or current history of liver diseases A subject who has the following medical or surgical history Severe cardiac diseases, Malignant tumors, Clinically significant hypersensitivity reaction to any drugs containing components of the 11β-HSD1 inhibitor or same class A subject who has the following concomitant diseases liver disease, uncontrolled hypertension, uncontrolled DM, etc. A subject who has taken the following medications Systemic glucocorticoids, NSAIDs, any medication that may induce fatty liver disease, etc. A subject who has taken IP of another study A subject who does not agree with appropriate methods of contraception - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06297421

Not yet recruiting

A Study to Evaluate the Efficacy and Safety of Homogenized Prescription Enterobacteria Capsule in Patients With IBS-D

The purpose of this study is to evaluate the efficacy and safety of Homogenized Prescription Enterobacteria Capsule compared with placebo in the treatment of participants with irritable bowel syndrome with diarrhea.

- EligibilityCriteria: Inclusion Criteria: Voluntarily sign informed consent, be able to comply with the protocol and be able to carry out related procedures, including the completion of diary during the induction period and throughout the study period. Age between 18 and 70 years old (including two-end values, based on the date of signing the Master Informed consent), regardless of gender. IBS-D patients with clinical symptoms meeting the Rome IV definition, that is, the course of disease for at least 6 months, repeated abdominal pain in the past 3 months, an average of at least 1 day per week, combined with two or more of the following conditions: (a) Abdominal pain is related to defecation; （b） Abdominal pain accompanied by changes in the frequency of defecation; （c） Abdominal pain accompanied by changes in fecal trait. When abnormal stool occurred in the last 3 months, the proportion of abnormal stool was >25% for Bristol fecal trait type 6 or 7, and <25% for Bristol fecal trait type 1 or 2 . Colonoscopy has been completed within 12 months before the run-in period. The ileocecal part should be observed during endoscopy, and the ileocecal flap image recording should be included in the report. They may be included if one of the following conditions is met: (i) The colonoscopy report is normal; (ii) Abnormalities reported by colonoscopy, such as hemorrhoids and intestinal polyps (diameter ≤5mm and number ≤3), were determined by the investigator to be eligible for inclusion; (iii) Colonoscopy reported that the diameter of intestinal polyps was >5mm or the number of intestinal polyps was >3; after endoscopic treatment, the diameter of residual intestinal polyps was ≤5mm and the number of intestinal polyps was ≤3, and the investigators determined that they could be included in the group. The patient had not used any relief drugs or analgesics in the 14 days prior to randomization. During the period from the signing of the master informed consent to the end of the final study visit, patients agreed to maintain their usual diet and lifestyle, such as no changes in dietary structure or exercise patterns. Exclusion Criteria: Patients with constipated, mixed and amorphous IBS. Patients with organic gastrointestinal diseases were excluded from the following conditions: superficial gastritis, grade I erosive gastritis, chronic atrophic gastritis found by endoscopy but judged by the investigator to be eligible for admission (for example, no mucosal erosion or bleeding under endoscopy, and no abdominal distension, epigastric pain, acid reflux and other symptoms). Parenteral diseases of the digestive system such as tuberculous peritonitis, pancreatitis, cirrhosis, and biliary tract diseases are present, except for fatty liver disease that has not progressed to hepatitis, and gallstones that lack related symptoms. Known to have lactose intolerance and celiac disease. There are other systemic diseases, including serious diseases of the heart, lungs and kidneys, malignant tumors, autoimmune diseases, metabolic diseases (such as diabetes, diseases affecting thyroid function), reproductive system diseases (such as ovarian cysts, endometriosis, severe dysmenorrhea requiring medical treatment), etc. Previous history of abdominal and pelvic surgery, except appendectomy, caesarean section but no intestinal complications, hernia repair. Patients with a previously diagnosed psychiatric disorder or moderate to severe depression or generalized anxiety disorder requiring medication (PHQ-9≥10 or GAD-7≥10 during screening). Fecal examination results showed occult blood (+) and above (except for cases caused by hemorrhoids or female menstrual periods) or white blood cells (+) and above, and were judged by the investigator to be clinically significant. People who are positive for antibodies against hepatitis C virus (HCV), or human immunodeficiency virus (HIV), or syphilis, or hepatitis B surface antigen (HBsAg) and need antiviral therapy at the screening stage. Laboratory tests showed significant abnormalities, and the investigator determined that the patient's participation in the study may compromise his or her safety, including but not limited to: (i) Creatinine ≥1.5 times the upper limit of normal (ULN); (ii) AST≥2 times upper limit of normal (ULN) and/or ALT≥2 times upper limit of normal (ULN) and/or total bilirubin ≥1.5 times upper limit of normal (ULN). A history of drug or alcohol abuse. Even with the help of liquids, patients are unable to take oral solid dosage forms. Allergic to experimental drugs, rescue drugs and their ingredients. During the trial, drugs that affect gastrointestinal movement and function cannot be discontinued, It includes antibiotics (such as erythromycin), drugs that regulate intestinal microecology (such as bifidobacterium), parasympathetic inhibitors (such as scopolamine, atropine, belladona, etc.), muscle relaxants (such as succinylcholine), antidiarrheal agents (such as loperamide, montmorillonite powder, etc.), opioids, drugs that inhibit gastric acid secretion, etc. A woman who is pregnant or breastfeeding. At the time of the trial, both the patient and his partner were unable or unwilling to use reliable contraception to prevent pregnancy, or the female or male patient's partner had a recent pregnancy plan. Have participated in any clinical trial and used the experimental drug or device within 3 months prior to signing the informed consent. The patient had previously participated in a clinical study of FMT and received FMT therapy. According to the judgment of the investigator, the participants are not suitable to participate in this clinical trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06297408

Not yet recruiting

Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus

To assess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.

- EligibilityCriteria: Inclusion Criteria: Voluntarily signed an informed consent form (ICF). Applicants must be between 18 and 70 years old (inclusive) at the time of signing the ICF, male or female. Diagnosed with SLE according to the 2012 SLICC or 2019 EULAR/ACR version of the revised criteria. Disease remaining active after receiving corticosteroids combined immunosuppressive therapy and/or biological agents, with a stable treatment plan for at least 2 months and a stable dose for at least 2 weeks before screening. Oral corticosteroids must meet the following requirements: Prednisone (or equivalent) ≥7.5 mg/day and ≤60 mg/day. When used in combination with immunosuppressants, there is no minimum daily dose requirement for corticosteroids. 5. Positive antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody at screening. 6. SELENA-2k score ≥7 points during the screening period. 7. Active organ involvement during screening period. 8. No active infection (e.g., pneumonia, tuberculosis) within 2 weeks prior to screening period. 9. Vascular access is sufficient for leukapheresis. 10. Adequate organ function: Renal function: defined as creatinine clearance (Cockcroft-Gault) ≥40 mL/min calculated without hydration assistance. Bone marrow function: defined as absolute neutrophil count (ANC) ≥1000 /μL, absolute lymphocyte count (ALC) ≥100 /μL, hemoglobin (Hb) ≥60 g/L, platelet count (PLT) ≥20,000 /μL. Blood transfusions and CSF must not be used to meet these requirements during the 7 days prior to eligibility screening. Liver function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, total bilirubin < 2.0 mg/dL (total bilirubin < 3.0 mg/dL in subjects with Gilbert syndrome, except for caused by SLE). Coagulation function: defined as international ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN. Lung function: defined as ≤CTCAE grade 1 dyspnea and blood oxygen saturation (SpO2) ≥92% in indoor air (measured by pulse oximeter). Cardiac function: defined as left ventricular ejection fraction (LVEF) ≥40% as assessed by echocardiography (ECHO) or cardiac radionuclide angiography (MUGA) within 8 weeks prior to screening. 11. Fertile women (defined as all women biologically capable of becoming pregnant) must consent to the use of a highly effective contraceptive method for contraception from at least 28 days before the start of lymphodepleting and 2 years after infusion of Relma-cel (including the duration of the dose-interrupted study treatment). Men whose partners are fertile must agree to use an effective barrier method of contraception from the start of lymphodepleting until 2 year after Relma-cel infusion and should not donate semen or sperm throughout the study period. 12. Fertile women must test negative for serum beta human chorionic gonadotropin (β-hCG) at the time of screening and within 48 hours before the first day of lymphodepleting treatment. Exclusion Criteria: Subjects who meet any of the following exclusion criteria should not be included in this study Severe lupus nephritis within 2 months before screening requires hemodialysis, or treatment with prednisone(or equivalent hormone) ≥100 mg/d for more than 14 days. Suffering from lupus crisis within 1 months before screening, assessed by the researcher as unsuitable for participation in this study. Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Central nervous system manifestations caused by lupus before screening, including but not limited to lupus headache, epileptic seizures, cognitive impairment, impaired intellectual function, visual impairment, etc. Combined with other autoimmune diseases, systemic treatment is required. History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation. When screening: 1) Active hepatitis B. However, hepatitis B surface antigen (HBsAg) positive and/or anti-hepatitis B core antibody (HBcAb) positive, and HBV DNA below the lower limit of the central reference value are eligible for inclusion in this study, and investigators need to provide preventive antiviral therapy to participants as appropriate. 2) Hepatitis C or human immunodeficiency virus (HIV) or syphilis infection. 7. A history of any of the following cardiovascular diseases in the 6 months prior to screening: Class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant heart disease. 8. Use any other clinical study drugs within 1 month before screening. However, if the research treatment is ineffective or the disease relapses, and at least 3 half-life period have been passed before screening, enrollment is allowed. 9. Previously received CAR-T cell or other genetically modified T cell therapies. 10. There was a history of ≥grade 2 bleeding within 30 days prior to screening, or long-term treatment with anticoagulants (such as warfarin, low molecular weight heparin, or factor Xa inhibitors). 11. Plasma exchange, plasma separation or hemodialysis were performed within 14 days before leukapheresis. 12. Use any live vaccine against infectious diseases within 1 month prior to screening. 13. Known life-threatening allergic reactions, hypersensitivities, or intolerances to Relma-cel or their excipients, including DMSO. 14. A history or evidence of suicidal thoughts in the 6 months before signing the ICF, or any suicidal behavior in the 12 months prior, or is considered by the investigator there is a significant risk of suicide. 15. Malignant tumor within 2 years before signing the ICF. Exceptions include non-melanoma skin cancer after radical treatment, localized prostate cancer, biopsy-confirmed cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely resected breast carcinoma in situ. 16. Pregnant or lactating women. 17. Other situations in which the investigator determines that the subject has poor compliance or is unwilling or unable to comply with the study protocol. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06297395

Not yet recruiting

Subaxial Cervical Traumatic Injuries

The aim of this study is to assess the mid-term outcomes of treating subaxial cervical traumatic injury cases admitted to the Trauma Unit of Assiut University Hospital.

- EligibilityCriteria: Inclusion Criteria: All patients presenting with subaxial cervical spine traumatic injuries with and without cervical cord injury who complete a minimum of one year follow up Exclusion Criteria: Patients who refuse to participate in the study Patients with pathological fractures - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: All patients fulfilling the inclusion criteria presenting to our hospital will be included in the study (Total coverage). Based on hospital records, we usually receive around 100 cases each year. We will also include all patients prospectively recorded in our data base starting from 11-01-2022. This data base includes 96 to date. - SamplingMethod: Non-Probability Sample

NCT06297382

Not yet recruiting

Impact of ChatGPT-based Nursing Process Training

The goal of this randomized controlled study is to determine the impact of ChatGPT based nursing process training on nursing students' clinical decision-making competencies and artificial intelligence anxiety. Population and Sample: The population of the research consists of senior students studying at Gülhane Faculty of Nursing, University of Health Sciences. Power analysis was performed to determine the number of people to be included in the study. The power of the test was calculated with the G*Power 3.1 program. In a similar study in the relevant literature, the effect size regarding the change in clinical decision-making level was calculated as 0.898. In order to exceed the 99% value in determining the power of the study; At the 5% significance level and 0.898 effect size, 44 people, 22 people in the groups, need to be reached (df=21; t=1.721). In the research, it was aimed to reach a total of 60 people, 30 people in the groups, considering the high power of the test and the losses.

- EligibilityCriteria: Inclusion Criteria: Being a senior student at the faculty of nursing in the 2023-2024 academic year Agreeing to participate in the research Exclusion Criteria: Having previously received ChatGPT training Withdrawing from the research voluntarily Incompletely filled forms - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06297369

Recruiting

Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients

Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients

- EligibilityCriteria: Inclusion Criteria: Patients are eligible for inclusion if they meet the following criteria: Cancer patients aged >18 years receiving cisplatin-containing chemotherapy. A cisplatin dose starting from 75 mg/m2. Various cancer types. Both males and females. No history of organ transplantation or kidney dialysis. Eastern cooperative oncology group performance (ECOG):0-2 Exclusion Criteria: Patients with peripheral neuropathy. Preexisting unilateral or bilateral moderate to severe sensorineural hearing loss Patients with speech discrimination affection or those who are unable to participate in audiologic evaluation Co-administration of ifosfamide with cisplatin, because of the known risk of nephrotoxicity. Pregnancy or lactation. Infection with the human immunodeficiency virus (HIV). Prior administration of cisplatin. Intraperitoneal chemotherapy. Inadequate liver function (bilirubin > 1.5 times upper normal limit [ULN] and alanine transaminase [ALT] or aspartate transaminase [AST] > 3 times the upper normal limit [ULN] or up to 5.0 upper normal limit [ULN] in the presence of hepatic metastases). Inadequate renal function (creatinine > 1.25 times upper normal limit [ULN], creatinine clearance < 50mL/min). Serious comorbid systemic disorder incompatible with the study (uncontrolled diabetes mellitus or hypertension, myocardial infarction within the last 6 months). Patients diagnosed with kidney cancer. Exposure to any nephrotoxic drugs or agents. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297356

Recruiting

The Effect of Stress Ball Utilisation on Treatment Duration, Dyspnea Severity and Anxiety Level in Nebuliser Therapy

Nebul Therapy is very effective in quickly improving the symptoms of respiratory system diseases. While applying this treatment, patients are expected to complete a sufficient period of time. However, this waiting and the symptoms of the disease may cause anxiety in the patient. The aim of the study was to enable patients to spend their nebul period actively by using a stress ball. Thus, it was thought that it would make a positive contribution to dyspnea severity and anxiety levels. The main questions it aims to answer are: Does using a stress ball contribute positively to nebulizer usage time? Is the use of a stress ball effective in reducing the severity of dyspnea? Is using a stress ball effective in reducing anxiety levels? For this purpose, participants will be asked to tighten and loosen the stress ball with one hand during the nebuliser therapy. They will be expected to continue this with at least two nebuliser therapy per day. A control group will be used to determine the effectiveness of the stress ball. This group will not use a stress ball while receiving nebulizer treatment.

- EligibilityCriteria: Inclusion Criteria: Hospitalized for at least three days Having nebulizer treatment at least twice a day Medicines that have the same effect as prescribed (bronchodilators) Patients who are required to have at least 4 ml of medication in the reservoir Patients who have previous experience of using a nebulizer at home Exclusion Criteria: Those who have severe exacerbation attacks People with speech problems People who experience severe dyspnea due to heart disease Those with high anxiety levels for any reason (death of a relative, etc.) Those with muscle or nerve problems in their hands Those who did not consent to participate in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297343

Not yet recruiting

Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula

The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation.

- EligibilityCriteria: Inclusion Criteria: Age ≥ 18 years; Stage 5 chronic kidney disease, on dialysis or not on dialysis; Requiring the creation of an arteriovenous fistula; Membership of a social insurance scheme; Patient having been informed and having formulated his/her oral non-opposition to participate in the research. Exclusion Criteria: Contraindication to the proposed surgery ; Reduced life expectancy in the opinion of the investigator; Medical or biological conditions which, in the opinion of the investigator, could influence the interpretation of the results of the study or the safety of the patient; Patient uncooperative with protocol requirements or unable to attend scheduled visits to the centre; Other surgical or medical intervention planned during the study; Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding; Participating in another clinical trial, or in a period of exclusion from another clinical trial; Patient under guardianship or deprived of liberty. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will be adult patients suffering from chronic renal failure for whom the creation of an arteriovenous fistula is planned. - SamplingMethod: Non-Probability Sample

NCT06297330

Recruiting

Sleep for Optimal MEdical StudentS (PROMESS)

Medical students have been shown to have a greater prevalence of poor sleep leading to poorer quality of life than other groups of students. Among medical students, poor sleep quality and insomnia have been associated with higher level of stress, as well as poorer academic performance. Our field surveys carried out in 2022 and 2023 at the Lyon Est medical school make the same alarming observation. They revealed that 53% of students had significant sleep problems.They also showed that students presented high levels of physical and mental fatigue. It is expected that these disorders will significantly degrade their quality of life as well as their health. Indeed, lack of sleep is associated with serious health problems such as illnesses cardiovascular or immune system deficiencies. The PROMESS - SLEEP project aims to offer solutions to students to improve their sleep during their medical studies. It responds to a demand expressed by students: our field study showed that 40% of 4th year students declared being "very interested and/or interested" in following an intervention that aimed at improving sleep. An early knowledge of sleep optimization tools would allow students to quickly acquire the tools necessary to cope with the difficult conditions encountered during their training and lives of future doctors.The objective of this study is to determine the influence of an intervention program based on sleep improvement and fatigue reduction among medical students.

- EligibilityCriteria: Inclusion Criteria: Being a 4th-year or a 5th-year medical student at the Faculty of Medicine Lyon East during the academic year 2023-2024. Having read the information note. Having signed the written consent. Exclusion Criteria: No exclusion criteria will be applied. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06297304

Recruiting

Sedentary Behaviors Reduction and Physical Activity Promotion for Optimal Medical StudentS

Medical students are under great competitive pressure throughout their studies. Our field surveys conducted in 2022 and 2023 at the Lyon Est Faculty of Medicine revealed that 78% of 482 students showed an excessive sedentary lifestyle compared to the threshold set by WHO. It is expected that a low level of physical activity and/or too high a sedentary lifestyle deteriorates significantly their quality of life and their health. In 2014, a British survey of 356 students in Medicine showed that lack of physical activity was an major predictor of burnout symptoms. Numerous studies show that regular physical activity improves the mental health of students and their cognitive performance. The PROMESS - PHYSICAL ACTIVITY project aims to offer solutions to students to decrease their sedentary behavior and to improve their physical activity level during their medical studies through an intervention program. From a long term perspective, this intervention may also prevent disorders related to inadequate levels of physical activity and/or sedentary behavior. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested and/or interested" in following an intervention that aimed at improving physical activity. The objective of this study is to determine the influence of an intervention based on sedentary behavior reduction and physical activity promotion among medical students.

- EligibilityCriteria: Inclusion Criteria: Being a 4th-year or a 5th-year medical student at the Faculty of Medicine Lyon East during the academic year 2023-2024. Having read the information note. Having signed the written consent. Exclusion Criteria: -No exclusion criteria will be applied. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06297291

Not yet recruiting

Global Paradise System US Post Approval Study

The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.

- EligibilityCriteria: Inclusion Criteria: Signed and dated study informed consent Documented history of hypertension Documented history of prior or current antihypertensive medication(s) Mean seated office systolic BP at screening ≥ 140 mmHg Mean pre-procedure home systolic BP of ≥ 135 mmHg Estimated glomerular filtration rate (eGFR) of ≥30 mL/min/m2 RADIANCE CAP patients must provide signed and dated informed consent for inclusion in long-term follow-up. No other criteria are required for inclusion. Exclusion Criteria: Patients who meet the following will be excluded from participation: Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter Patient under the age of 18 years old at the time of consent Patient is pregnant Patients with transplanted kidney Presence of abnormal kidney (or secreting adrenal) tumors To confirm eligibility for treatment with the Paradise System, the following contraindications listed in the IFU may be determined at the time of procedure prior to treatment: Renal arteries with diameter < 3mm and > 8mm Renal artery with fibromuscular dysplasia (FMD) Stented renal artery Renal artery aneurysm Renal artery diameter stenosis >30% Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control BP will be identified from the general population by the enrolling center. Subjects enrolled in the RADIANCE CAP study will be transferred to the US GPS study after completion of their 12-month follow-up visit in the RADIANCE CAP study, to complete the remainder of the long-term annual follow-up visits under the post approval study protocol. - SamplingMethod: Non-Probability Sample

NCT06297278

Recruiting

Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids

Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth.

- EligibilityCriteria: Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and available for the duration of the study 14-17 years of age upon enrollment Right-handed In good general health as evidenced by medical history Adolescent and parent/guardian are English-speaking, as study assessments are in English Availability of a parent or legal guardian who is willing to provide consent and attend all study visits Exclusion Criteria: Traumatic brain injury with ongoing symptoms Sensory (e.g., hearing) or physical (e.g., motor, balance) impairment or significant developmental delay MRI participants: MRI contraindication (e.g., braces, implants, claustrophobia) Any condition that would contraindicate blood draws (e.g., hemophilia, sickle cell) Past or current diagnosis or presence of likely neurological disorder (e.g., epilepsy), psychotic disorder (e.g., schizophrenia, schizoaffective disorder), or bipolar disorder Severe/unstable medical condition (e.g., diabetes, rheumatoid arthritis) Current (past 1-month) use of cannabis or cannabinoid products including CBD unless willing to stop for at least 4 weeks prior to entering the study Currently pregnant, lactating, or positive pregnancy test at screening visit Current homicidal thoughts or suicide attempt in the past year Current suicidal thoughts requiring immediate intervention Concurrent use (past 6 weeks) of oral contraceptives Diagnosed or probable substance use disorder (past 1-month) Positive drug test at baseline visit (e.g., THC, cocaine) Moderate/severe drug or alcohol use in the past 8 weeks Current or recent (past 1-month) COVID-19 diagnosis or febrile illness Treatment with investigational drug or intervention (past 1-month) Current smoker, vaper, or tobacco or nicotine use (past 1-month) Ongoing exposure to abuse - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - GenderBased: Yes - GenderDescription: Females must not be pregnant, breastfeeding, or postpartum less than 6 months - MinimumAge: 14 Years - MaximumAge: 17 Years - StdAgeList: Child

NCT06297265

Not yet recruiting

Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery

This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. Manual lymphatic drainage is a gentle massage technique used to reduce swelling. It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer.

- EligibilityCriteria: Inclusion Criteria: Cis female with native breasts and localized breast cancer who are status post-lumpectomy surgery, will receive whole breast radiation therapy with/without nodal irradiation, with standard fractionation or moderate hypofractionation Age >= 18 years Ability to understand and the willingness to sign a written informed consent in English or Spanish Exclusion Criteria: Underlying diagnosis of chronic inflammatory illness or collagen vascular disorder, e.g. scleroderma, lupus, rheumatoid arthritis, fibromyalgia as these conditions may significantly affect the likelihood and magnitude of radiation related toxicity Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants Inability to provide written informed consent in English or Spanish Patients receiving ultra-hypofractionation, and/or partial breast or chest wall radiation therapy are excluded Individuals who are cis male, transgender female and cis female without intact native breasts will be excluded - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Participants must be cis female with native breasts. Cis males, transgender females, and cis females without intact native breasts are excluded. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297252

Not yet recruiting

Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population

Young women represent a population at risk of psychiatric disorders, the first signs of which often appear between the ages of 15 and 25. Psychiatric disorders are a major source of disability and healthcare costs. The perinatal period is an additional period of psychological vulnerability, during which women are at increased risk of developing or worsening psychiatric disorders. Unfortunately, psychiatric disorders seem to be largely under-diagnosed during this period, and therefore under-treated. The goal of this Prospective multicenter study is to determine the prevalence of the presence of at least one characterized psychiatric disorder, as defined by the use of the Mini International Neuropsychiatric Interview (MINI), in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment. Participants will complete self-questionnaires and have a standardized psychiatric evaluation at T2 ultrasound and at 2 months postpartum.

- EligibilityCriteria: Inclusion Criteria: Women 18 years and over Pregnant and consulting for scheduled second trimester ultrasound Able to read and write with a good knowledge of French Exclusion Criteria: Unable to understand French Illiterate Underage patient at time of second trimester ultrasound Patient under guardianship or curatorship Patient deprived of liberty Patient not affiliated to or not benefiting from a social security scheme Refusal of consent after information Participant in another research project with an ongoing exclusion period - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Pregnant women only - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297239

Recruiting

Argentine Registry of Lp(a)

The Argentine Registry on Lipoprotein(a) (LP(a)), orchestrated by the Argentine Group for LP(a) Study, stands as a pioneering and extensive prospective initiative. This registry systematically collects geolocation data, including patient postal codes, demographic information, and a multifaceted array of health parameters to unravel the intricate associations surrounding LP(a) levels. The dataset encompasses diverse patient characteristics, ranging from standard metrics like blood pressure, weight, and race to broader factors such as diabetes, smoking habits, menopausal status, and hypothyroidism. This holistic approach enables a nuanced exploration of the interplay between LP(a) levels and various risk factors, providing invaluable insights for both clinical and public health considerations. One distinctive feature of this registry lies in its focus on medication history, shedding light on the impact of routine pharmaceutical interventions on LP(a) profiles. Additionally, it delves into the intricate web of inflammatory diseases, recognizing their potential role in LP(a) modulation. Genetic predispositions are meticulously examined, with a specific emphasis on identifying homozygous and heterozygous variants associated with hypercholesterolemia. This genetic dimension adds a layer of complexity to the understanding of LP(a) dynamics, contributing significantly to the ongoing discourse on cardiovascular risk. The prospective nature of this registry allows for dynamic analyses, fostering a continuous exploration of emerging patterns and trends. By amalgamating geographical, clinical, and genetic data, the Argentine LP(a) Registry emerges as a comprehensive platform poised to unlock novel facets of LP(a) biology and its implications for cardiovascular health. As the dataset matures, it holds the promise of guiding personalized interventions and refining risk stratification strategies, thereby advancing the landscape of preventive cardiovascular care.

- EligibilityCriteria: Inclusion Criteria: Adult patients with validated Lp(a) values - Exclusion Criteria: Associated pathologies that can increase the Lp(a) value in a non-specific manner - - HealthyVolunteers: No - Gender: All - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients residing in Argentina - SamplingMethod: Probability Sample

NCT06297226

Not yet recruiting

Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma.

- EligibilityCriteria: Inclusion Criteria Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria. Received at least 4 classes of MM treatment [including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, and anti-B cell maturation antigen (BCMA) therapy], and at least 3 prior lines of therapy (LOT). Documented disease progression during or after their last anti-myeloma regimen as per IMWG. Participants must have measurable disease during screening. Have measurable disease during screening. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria Active or history of central nervous system involvement with MM. Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis. Other protocol-defined Inclusion/Exclusion criteria apply. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297213

Not yet recruiting

R-2487 in Patients With Sjogren's Syndrome (SS)

The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome. Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.

- EligibilityCriteria: Inclusion Criteria: Diagnosis of SS according to American-European Consensus Group Criteria Able to provide informed consent Subjects receiving prednisone (10 mg or less/day) must be on a stable dose for more than 2 weeks All male and female subjects who are biologically capable of having children must agree to use medically acceptable method of birth control for the duration of the study. All female subjects who are biologically capable of having children must have a negative pregnancy test result before administration of investigational product. The use of probiotics prior to study enrollment is accepted; however, during the course of the study, the use of probiotics is forbidden. Exclusion Criteria: No known active overlapping or associated other autoimmune disease Prior allogenic or autologous bone marrow or organ transplantation Subjects with prior irradiation to the head and neck, including radioactive iodine treatment for hyperthyroidism Subjects who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Subjects who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations. Subjects with positive results for human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV) Subjects with active viral, bacterial, or fungal infection, or history of severe opportunistic infection within the preceding 3 months, or COVID-19 infection in the past 3 months Subjects with evidence of active or latent tuberculosis Active infection of the salivary or lacrimal glands Prior immunotherapy, biologics, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to the first dose of R-2487 DP Pregnant or breastfeeding women Current clinical findings of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, endocrine, neurological, or cerebral disease with laboratory values as following: Hemoglobin level < 9.0 g/dL Absolute white blood cell (WBC) count of <3.0×109/L (<3000/mm3), or absolute neutrophil count of <1.2×109/L (<1200/mm3), or absolute lymphocyte count of <0.8×109/L (<800/mm3). Thrombocytopenia, defined by platelet count <100×109/L (<100,000/mm3) Chronic kidney disease defined as Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, based on the age appropriate calculation. Proteinuria ≥3+. Total bilirubin (T-bili), aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 1.5 times upper limit of normal (ULN). Previously diagnosed hepatic cirrhosis (Child Pugh A or higher) or previously diagnosed significant liver fibrosis (> F3) Any form of vaccination in the last 30 days, to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio. Subjects should not receive any of the following medications: Rituximab or belimumab within 6 months prior to Day 1 Abatacept within 3 months prior to Day 1 Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months prior to Day 1 Etanercept, Anakinra, Immunoglobulin, or blood products within 28 days prior to Day 1 Prior immunotherapy, including systemic corticosteroids, such prednisone, biologics, Janus kinase (JAK) inhibitors (such as tofacitinib, or upadacitinib), ozanimod, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to Day 0, unless otherwise specified. In the case of cell-depleting therapies, such as B or T cell depletion, cell counts must have recovered to acceptable or baseline levels (use of licensed agents for indications not listed in the package insert is permitted). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06297200

Not yet recruiting

Low-Intensity Focused Ultrasound and the Complex Patient

Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.

- EligibilityCriteria: Inclusion Criteria: Males and females aged 18-65 years Current diagnosis of Chronic Back Pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months. Have evidence of central sensitization (CS) as measured by the Widespread Pain/Symptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥ 9. Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-5. Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone. Meet the DSM-5 criteria for a current anxiety disorder: generalized anxiety disorder, post-traumatic stress disorder or social anxiety disorder as diagnosed by the Structured Clinical Interview for DSM-5. Exclusion Criteria: Evidence of neuropathic pain Previous spine surgery Current substance use disorder other than OUD or tobacco use disorder Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder Chronic Pain Conditions other than chronic back pain Daily opiate use other than buprenorphine/methadone for OUD/pain control Pregnant or breastfeeding History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases History of metastasizing cancers, inflammatory disorder (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus or polymyositis), unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI) Evidence of arteriovenous malformation, aneurysm, infarct, meningioma, parenchymal brain tumor or evidence of neurodegenerative processes and/or white matter lesions greater than that expected for age as determined by the study neuroradiologist Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06297174

Not yet recruiting

Bioequivalence Study of Generic Racecadotril 100 mg Capsules Under Fasting Conditions

Objectives: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions Study Design: An open label, randomized, two-treatment, four-period, two-sequence, replicate crossover bioequivalence study in healthy Thai volunteers under fasting conditions with at least 7 days washout period between the administrations of investigational products of each period

- EligibilityCriteria: Inclusion Criteria: Healthy Thai male or female subjects between the ages of 18 to 55 years. Body mass index between 18.5 to 30.0 kg/m2. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study. Non-pregnant woman (negative pregnancy test) and not currently breast feeding. Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 4. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1: Postmenopausal for at least 1 year or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 4. Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study Exclusion Criteria: History of allergic reaction or hypersensitivity to the active substance or to any of the excipients. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes mellitus), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19. History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period. History or evidence of angioedema. History of febrile illness within 7 days prior to check-in in each period. History or evidence of antibiotic-associated colitis such as pseudomembranous colitis. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. History of problems with swallowing tablet or capsule. History of sensitivity to heparin or heparin-induced thrombocytopenia. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy. History of diarrhea, dehydration or vomiting within 24 hours prior to check-in in each period. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine). Investigation with blood sample shows positive test for HBsAg. Abnormal liver function, ≥1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test. History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study. History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy, etc.). History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study or alcohol breath test shows positive result. In case of alcohol breath test result represents the alcohol concentration range of 1 - 10 mg% BAC and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not more than 10 minutes. The result of the last time should be used for subject's eligibility which must be 0 mg%BAC. History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study. Consume or drink juice of grapefruit or orange or pomelo or its supplement/containing products and cannot abstain for at least 7 days prior to check-in in Period 1 and continued for entire duration of the study. Use of prescription or nonprescription drugs (e.g. paracetamol, ACE inhibitors, other drug that can induced angioedema such as angiotensin II receptor blockers, direct renin inhibitors, betalactam antibiotics and other non-steroidal anti-inflammatory drugs (NSAIDs), etc.), herbal medications or supplements (e.g. St. John's wort), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to check-in in Period 1 and continued for entire duration of the study. Participated in other clinical trials within 90 days prior to check-in in Period 1 (except for the subjects who drop out or withdrawn from the previous study prior to Period 1 dosing) or still participates in the clinical trial or participates in other clinical trials during enrollment in this study. Blood donation or blood loss ≥ 1 unit (1 unit is equal to 350-450 mL of blood) within 90 days prior to check-in in Period 1 or during enrollment. Subjects with poor venous access or intolerant to venipuncture. Unwilling or unable to comply with schedule visit, treatment plan and other study procedures until end of study. Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide written informed consent or cooperate with clinical team. Subjects who are employees of International Bio Service Co., Ltd., Pharma Nueva Co., Ltd. or Siam Pharmaceutical Co., Ltd. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06297161

Not yet recruiting

A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML).

The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice. This study is seeking for participants who are: Adult Patients who are just confirmed to have Chronic Myeloid Leukemia (CML) defined in Local Product Document (LPD). CML is a type of cancer that starts in the blood-forming cells of the bone marrow and invades the blood. LPD explains what a medicine's benefits and problems are. LPD also explains how to use the medicine correctly in Korea. willing to take part in the study after being informed about the study. All participants in this study will receive bosulif. All participants who have entered this study should meet the usual prescribing criteria for bosulif as per the LPD. The participants will be treated with bosulif under routine clinical practice in Korea. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective. In this study all treatment and checking of the patients will be done as per the study doctor. The study can be performed in Korean health care centers where bosulif is prescribed to treat CML after the patients have agreed to take part in the study.

- EligibilityCriteria: Inclusion Criteria: Adult Patients newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) or CP, AP, BP Ph+ CML with resistance or intolerance to prior therapy Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: - Patients to whom bosulif is contraindicated as per the local labeling- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with Newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) or Chronic phase, accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy who are administrated Bosulif according to the approval label in Korea. - SamplingMethod: Non-Probability Sample

NCT06297148

Not yet recruiting

The HIP Self-management Study

The HIPS-study will be an observer blinded, single-centre, parallel-group randomized controlled trial (RCT). The main purpose of the study is: To investigate the clinical effectiveness of a self- management program versus usual care for patients with greater trochanteric pain syndrome (GTPS). H0: There is no difference between a self-management program and usual care on pain and function in patients with GTPS. H1: There is a difference between a self-management program and usual care on pain and function in patients with GTPS. To investigate if self-management is more cost-effective than usual care in the treatment of patients with GTPS. Participants will be randomly allocated into one of two groups: 1) self-management program or 2) usual care. Follow-up will be at 3-, 6- and 12-months.

- EligibilityCriteria: Inclusion Criteria: Participants between 18 and 70 years of age History of lateral hip pain > 3 months Pain ≥ 3 on a numeric rating scale the last 3 months Pain at palpation of the greater trochanter region In addition, lateral hip pain on at least one of the following tests: Single leg stance test: standing 30 seconds on the affected leg FADER: passive stretch/compression of gluteus medius/minimus FADER-R: static muscle test with resistance to internal hip rotation ADD: passive stretch to hip adduction in sidelying ADD-R: resisted hip abduction in sidelying FABER (Patrick's) test A positive test is defined as a spontaneous reproduction of the participant's lateral hip pain. In participants with bilateral lateral hip pain, the worst hip will be included, and presence of bilateral pain will be documented. Exclusion Criteria: Significant pain from the lumbar spine, causing referred pain to the hip or clinical signs of lumbar radiculopathy Moderate or severe hip osteoarthritis (OA)/total hip replacement (Kellgren-Lawrence grade ≥2, if relevant, confirmed by hip x-rays. If the participants have taken a previous appropriate x-ray within the last 6 months, they will not require a second x-ray) History of trauma or surgery on the affected side Not able to fill in questionnaires in Norwegian language Pregnancy Post-partum pelvic pain (<12 months) Active cancer - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06297135

Recruiting

A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits

This study evaluates the feasibility and preliminary impacts of a new parent support program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content is focused on teaching parents strategies to better manage one of the commonly reported challenges children face, a transition to a non-preferred activity. Parents with children demonstrating inattentive, hyperactive and impulsive behavior and experiencing difficulties with daily transition routines are invited to participate in the study.

- EligibilityCriteria: Inclusion Criteria: Parents with children aged 4-10, who experience difficulties with transitions. The program will be advertised that it was developed targeting children demonstrating behaviors consistent with ADHD, and the ADHD symptoms will be measured pre-post. However, children are not required to have a diagnosis of ADHD or show elevated levels of ADHD symptoms for the parents to sign up. Exclusion Criteria: Parents who do not understand Japanese (the language the program is offered in). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06297122

Not yet recruiting

Severe Group A Streptococcus Infections in Paris, France, 2018-2023

Streptococcus pyogenes, commonly referred to as Group A Streptococcus (GAS), has the ability to induce a diverse range of illnesses. In several European countries and the United States, a notable surge in invasive GAS (iGAS) infections has been documented since mid-2022. This sharp increase contrasts with the gradual rise in iGAS incidence observed among children over the past three decades. As demonstrated for several viral infections, the recent upturn in iGAS infections is potentially linked to the relaxation of mitigation measures implemented during the COVID-19 pandemic, such as face mask usage and school closures. Since November 2022, concerns have been raised by French public health authorities regarding the rise in levels of iGAS infections, and an unexpected increase in pediatric severe GAS infections was reported in a French single-center study. However, this study ended in December 2022 and could only explore short-term trends. The Necker - Enfants malades Hospital in Paris, France, represents an excellent opportunity to examine the impact of the COVID-19 pandemic and the associated non-pharmaceutical interventions on the incidence of severe GAS infections, during, and after the pandemic. This study aims to investigate trends of severe GAS infection incidence in children in the Paris area over the course of the COVID-19 pandemic.

- EligibilityCriteria: Inclusion Criteria: Children under the age of 18 years. Admitted to Necker-Enfants Malades hospital for community-acquired or healthcare-associated severe Group A Streptococcus (GAS) infections between January 1, 2018, and December 31, 2023. Severe GAS infections comprises "invasive" and "probable invasive" GAS illnesses. "Invasive" GAS infection will be defined as: isolation by culture or polymerase chain reaction (PCR) of GAS from a normally sterile site (e.g., blood, pleural fluid, cerebrospinal fluid, joint fluid, bone, bronchoalveolar lavage fluid); or isolation of GAS from a sterile or non-sterile site accompanied by necrotizing fasciitis or streptococcal toxic shock syndrome. "Probable invasive" GAS will be defined as acute infections with GAS isolated from a non-sterile site, which includes sputum, otorhinolaryngology surgical specimens (mastoiditis, ethmoiditis, pharyngeal abscess) accompanied with one or more of the following severity criteria: intravenous (IV) antibiotics; surgery; and/or admission to the PICU. Exclusion Criteria: Non-severe GAS infection, such as acute otitis media with otorrhea, pharyngitis, scarlet fever, GAS skin carriage. GAS identified on minor/superficial skin lesions. Otolaryngology infections (e.g., parapharyngeal abscess) that do not require IV antibiotics, surgery, or PICU admission. Opposition to the use of routine data. - HealthyVolunteers: No - Gender: All - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: All consecutive children under the age of 18 years with community-acquired or healthcare-associated severe Group A Streptococcus (GAS) infections admitted to Necker-Enfants Malades hospital between January 1, 2018, and December 31, 2023. - SamplingMethod: Non-Probability Sample

NCT06297109

Recruiting

Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery

Orthognathic surgery is a type of jaw surgery where a surgeon cuts the bones of the upper and lower jaw and places them better. There are two ways they can put the bones in the correct place and keep them in place after the surgery. One way, called the "conventional method", is to use a 3D-printed guide called a splint to set the bones in the right place and then screw the bones together using metal plates that the surgeon bends into shape to fit during the surgery. Another way is to use a patient-specific implants (PSI) that has been 3D-printed in titanium beforehand that because of its unique shape both places and keeps all the bones in the correct place after they are screwed in. Both ways of doing it are golden standards, meaning they are already approved. Measuring the accuracy of the surgery is done by comparing the positions of the bones after the surgery with the intended positions of those bones, according to the surgical plan. The closer the achieved position of each bone is to the intended position, the more accurate the result. Measuring the stability of the surgery is done by comparing the positions of the bones after the surgery with the positions of the bones two years later. The less the position is changed, the more stable the result. The goal of this clinical trial is to see how accurate and stable PSIs are in orthognathic surgery when the maxilla is split in 3 pieces, and to compare them with the conventional method in patients with overjet or overbite. The main questions it aims to answer are: Does using PSIs provide accurate movements of the maxilla pieces? Does using PSIs provide more accurate movements of the maxilla pieces than the conventional method? Does using PSIs provide stable movements of the maxilla pieces after 2 years? Does using PSIs provide more stable movements of the maxilla pieces than the conventional method? Participants will get orthognathic surgery as part of their normal orthodontic treatment. Investigators will compare the PSI and conventional groups to see if the PSIs are more accurate than the conventional method.

- EligibilityCriteria: Inclusion Criteria: Mandibular retrognathia Occlusion class II Three-piece Le Fort I osteotomy, as part of bimaxillary orthognathic surgery with or without genioplasty Exclusion Criteria: Cleft lip Craniofacial syndromes Former trauma Obstructive sleep apnea - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297096

Not yet recruiting

Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease

The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks.

- EligibilityCriteria: Inclusion Criteria: Men or women aged 18-74 at the date of signing the informed consent. Written informed consent in accordance with the International Harmonization Guidelines Harmonized Tripartite: Guidelines for Good Clinical Practice (ICH-GCP) and local regulations signed prior to any study procedure. Documented diagnosis of systemic sclerosis according to the criteria of the American College of Rheumatology (ACR) and The European Alliance of Associations for Rheumatology (former name - European League Against Rheumatism) - EULAR, meeting the criteria of active disease [patients with limited and diffused SSc)] and with an overall disease duration of less than or equal to (≤ 72 months). Patients with interstitial lung disease (ILD) confirmed by HRCT (min. 10% lung involvement). Evaluation of skin induration with the modified Rodnan skin score (mRSS) from 10 to 45 units inclusive. Patients treated with conventional drugs such as mycophenolate mofetil, methotrexate; should be on stable doses for ≥ 8 weeks prior to and including the screening visit (W0). Patients may be treated with standard therapy, but no new therapy or withdrawal of therapy within 8 weeks prior to the first screening visit (W0). Patients taking oral glucocorticosteroids (GCS) should be on a stable dose of ≤ 10 mg/day prednisone or equivalent for at least 8 weeks prior to the baseline visit. Patients of childbearing potential should agree to abstain from sexual activity or use a highly effective method of contraception throughout the study and for at least 3 months after the last dose of medicinal products. Exclusion Criteria: Patients not fully capable of giving informed consent. Pregnant or breastfeeding women. Major surgery within 8 weeks prior to screening (W0A). Rheumatic disease other than systemic sclerosis (systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease), diagnosis of secondary Sjögren's syndrome is acceptable. Active diverticulitis and severe enteritis. Untreated lipid disorders (initiation of treatment and modification of the lipid profile enables re-screening for examination, rescreaning, after 8 weeks from the start of hypolipidemic treatment). Immunization with a live or attenuated vaccine within 4 weeks prior to scheduled treatment. Known hypersensitivity to human, humanized or murine monoclonal antibodies and hypersensitivity to peanut, soya. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) >1.5 x ULN, if normalized, patient may be considered for re-screening. Bilirubin >1.5 x ULN. Creatinine clearance <30 ml/min. Significant pulmonary hypertension (PH). Airway obstruction (forced expiratory volume before bronchodilation in 1 second (FEV1)/FVC <0.7) and other clinically significant pulmonary abnormalities. Cardiovascular diseases with heart failure NYHA III/IV. More than 4 digital ulcers or a history of severe digital necrosis requiring hospitalization or severe other digital ulcers. Bleeding risk (such as bleeding tendency, fibrinolysis, full dose of anticoagulants, high dose of antiplatelet therapy, history of central nervous system (CNS) bleeding events in the last year. (INR) >2, prothrombin time (PT) and partial thromboplastin (PTT) > 1.5 x ULN) and history of a thrombotic event within the last year, history of thrombosis still requiring full therapeutic anticoagulant therapy, fibrinolysis or high-dose antiplatelet therapy > 150 mg ASA per day. History of stroke, myocardial infarction within 6 months prior to screening. Prior treatment with pirfenidone or nintedanib if a minimum of 6 months had not been completed prior to enrolling the patient in the NINTOC-TU study. Plasmapheresis and/or plasma exchange within the last 12 weeks prior to screening and use of immunoglobulins within the last 12 weeks and treatment with tocilizumab, treatments targeting B cell depletion, biologics (e.g. tumor necrosis factor antagonists), tyrosine kinase inhibitors, current treatment with alkylating agents (chlorambucil), autologous bone marrow transplantation, thalidomide, antithymocyte globulin, extracorporeal photopheresis. Treatment with prednisone >10 mg/day, azathioprine, hydroxychloroquine, colchicine, D-penicillamine, sulfasalazine if within 8 weeks prior to W0. Cyclophosphamide within < 8 weeks of randomization visit (W 1). Rituximab within 6 months of visit (randomization W1). Unstable (fluctuating) background therapy with mycophenolate mofetil or methotrexate in the last 8 weeks. Patients with chronic liver disease (Child Pugh A, B, C hepatic impairment). Active or significant history of infection, including treatment with intravenous antibiotics within the last 4 weeks or oral antibiotics within 2 weeks prior to screening. Including active confirmed tuberculosis or latent tuberculosis without chemoprophylaxis in accordance with applicable local recommendations. Active infection with HBV, HCV, Herpes-Zoster virus in the last 12 months. Human Immunodeficiency Virus (HIV) infection. A positive result of the SARS-CoV-2 PCR test during the "0" visit is an exclusion criterion, while a history of infection more than 4 weeks before the screening tests and confirmed by a negative SARS-CoV-2 PCR test is not an exclusion criterion. Active or history of malignancy, except for excised/cured local basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ. Active or past drug or alcohol abuse. The inability to understand and comply with the requirements of the protocol (lack of compliance) excludes from participation in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 74 Years - StdAgeList: Adult, Older Adult

NCT06297083

Not yet recruiting

Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy

This study will compare the effectiveness of three different treatments to treat peanut allergy

- EligibilityCriteria: Inclusion Criteria: Aged 1-10 years. >7kg (the weight considered safe for the administration of an adrenaline injector); Confirmed diagnosis of peanut allergy as defined by a failed DBPCFC with peanut and a positive SPT or sIgE to peanut at screening; Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf Exclusion Criteria: History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction) Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction) Ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines) Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis Use of beta-blockers, and angiotensin converting enzyme (ACE) inhibitors Reacting to the placebo component during the study entry DBPCFC Have received other food immunotherapy treatment in the preceding 12 months Currently taking immunomodulatory therapy (including allergen immunotherapy) Past or current major illness that in the opinion of the Site Investigator may affect the subject's ability to participate in the study e.g. increased risk to the participant History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE) Subjects who in the opinion of the Site Investigator are unable to follow the protocol Another family member already enrolled in the trial (to maintain blinding, safety and equity of access) or in any other clinical trial from the same study group. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 1 Year - MaximumAge: 10 Years - StdAgeList: Child

NCT06297070

Recruiting

Lifestyle Care for Fertility Outcome Evaluation

An observational outcome evaluation of the Lifestyle Care for Fertility program.

- EligibilityCriteria: Inclusion Criteria: Adult with a uterus aged from 18 to 50 years Participating in the Lifestyle Care for Fertility program Able to speak and understand English. Has email address and access to mobile device with a functioning data plan. Infertility-related diagnosis Exclusion Criteria: Age < 18 or > 50 years Having a significant and uncorrected visual, hearing, or cognitive impairment Inability to provide consent Current pregnancy - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: Study participants will be patients of University Hospitals Connor Whole Health who have a fertility-related diagnosis and who are participating in the Lifestyle Care for Fertility program - SamplingMethod: Non-Probability Sample

NCT06297057

Not yet recruiting

Acquisition and Analysis Protocol Optimization of Neurophysiological Data Neurorehabilitation Settings

The study aims to optimize and validate protocols for acquiring neurophysiological data, specifically resting state functional connectivity, using advanced research techniques (hdEEG and MEG) and a user-friendly device (MUSE). Previous studies have extensively explored functional connectivity repeatability in resting conditions using functional MRI, yet few have focused on hdEEG and MEG data. Additionally, the impact of subjects' eye conditions (open or closed) during resting state recordings on network identification remains debated. The investigation involves assessing the effect of eye conditions on brain network identification and determining the most stable and repeatable measures of functional connectivity over time. This analysis is crucial for discerning whether observed changes in patients' functional connections are intrinsic to the methodology or indicative of genuine physiological alterations. The study aims to optimize protocols for rehabilitation by evaluating changes in functional connectivity metrics during and between experimental sessions. Furthermore, it seeks to identify the conditions (eyes closed or open) that yield more reliable and repeatable functional measurements. Following the optimization of advanced techniques, the study explores the feasibility of utilizing the MUSE EEG system in clinical settings. MUSE, known for its portability and user-friendliness, has demonstrated quality in experimental psychology and clinical research. The objective is to establish relevant functional correspondences between measurements obtained through research techniques (hdEEG and MEG) and those acquired with MUSE. The primary goal is to establish a protocol highlighting subjects' responses to acoustic stimuli or a reproducible pattern of resting state activity. The secondary objectives include investigating temporal and spatial characteristics of neurophysiological signals in healthy subjects over time and defining prognostic biomarkers for monitoring patients undergoing rehabilitation. This comprehensive approach aims to enhance the understanding of resting state functional connectivity and its applications in clinical settings. Therefore, to meet these goals, the present study will consist of multiple recordings of brain activity: by high-density electroencephalography (hdEEG), magnetoencephalography (MEG), and low-density EEG with a MUSE handheld device, during five experimental blocks on healthy subjects.

- EligibilityCriteria: Inclusion Criteria: age between 18 and 65 ability to sign an informed consent form Exclusion Criteria: has suffered/is suffering from epileptic seizures. has had severe neurological or psychiatric disorders has eyesight problems that prevent him/her from reading, which she cannot correct with contact lenses (she will not be able to wear glasses during registration) habitually abused drugs or abused alcoholic substances has abused substances such as alcohol or drugs in the last three days is a wearer of hearing aids has metal and/or skull clips or other metal in any part of the head except the mouth has non-removable tattoos has piercings, earrings or other metal accessories that cannot be removed. is or could be pregnant (pregnancy in the first trimester) is a carrier of sickle cell anaemia is a cardiac pacemaker wearer or has an artificial heart valve has mechanical devices that he/she uses to administer medication has a surgical clip (vascular clips and metallic arterial prostheses made of ferromagnetic material) has a cochlear implant, a neurostimulator or a programmable hydrocephalic electrical conductor (shunt) has had brain surgery has implants or metal fragments in the body - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06297005

Recruiting

The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study

Tobacco smoking in pregnancy is now widely accepted as having adverse health outcomes for both the mother and fetus. Tobacco smoking in pregnancy is associated with increased incidence of miscarriage, stillbirth and preterm birth as well as low birthweight, respiratory infections, wheeze and asthma in childhood. E-cigarettes are a popular method for trying to quit smoking in Ireland and there has been an explosion in the use of e-cigarettes over the past ten years. However, there is currently insufficient evidence on their long-term safety and effectiveness as a smoking cessation tool. E-cigarettes contain varying combinations of compounds and flavours which are used differently in different e-cigarette types, with unknown long-term effects. Research has shown that pregnant women perceive e-cigarettes to be a healthier option when compared with tobacco smoking. But, there is very little known about the long-term health impact of exposure of unborn babies to e-cigarettes during pregnancy. The ECHO study will determine what the long-term health outcomes are in children born to mothers who use e-cigarettes during pregnancy. Specifically, we will focus on birth, nutritional, brain development and respiratory outcomes in children. To answer this research question, the ECHO study will recruit infants born to women who use e-cigarettes during pregnancy across three maternity hospitals and follow them up over 2 years. We will invite women at their booking visit to take part in this research study. We plan to also recruit a similar number of both non-smoking and tobacco smoking pregnant women for comparison. We will record a detailed record of e-cigarette and tobacco use by women during pregnancy as well as checking smoking using special monitoring tools. After the baby is born, we will perform growth measurements, neurocognitive assessments and a respiratory questionnaire at 6 months, one year and two years of age.

- EligibilityCriteria: Inclusion Criteria: Women aged 18 or greater and less than 46 years of age at booking Pregnant with a singleton fetus Smokers (exhaled CO reading of greater than or equal to 4) or Self-reported vaper or Dual user (smoker/vaper) Non-smokers Able to understand and read English. Willing to agree to follow-up for the two-year duration of the study in the postnatal period (ie. unlikely to move out of the catchment area). Exclusion Criteria: Women pregnant with twins or higher order multiples Late bookers - defined as booking after 24+0 weeks' gestational age Fetus or infant diagnosed with a major congenital abnormality (major structural abnormality, ie congenital diaphragmatic hernia (CDH), omphalocele, major cardiac defects ie. which require immediate admission to NICU +/- transfer to cardiology for surgery, chromosomal abnormalities, syndromes - Turner's/Noonan's) or a lethal fetal anomaly Any inherited disorder of metabolism or Cystic Fibrosis on Guthrie Card/ neonatal blood spot screening History of significant medical disorder in pregnancy e.g. cardiac, haematological, or endocrine disease (including gestational diabetes requiring insulin) Significant maternal psychiatric disorder, e.g. delusional or psychotic disorders, severe depression requiring hospitalisation, use of >1 psychotropic drugs for treatment Serious co-morbid addiction issues e.g. opiate abuse, methadone maintenance program Severe intellectual disability or lack of capacity - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Pregnant woment - MinimumAge: 18 Years - MaximumAge: 46 Years - StdAgeList: Adult - StudyPopulation: The population under scrutiny in this prospective observational cohort are adult (18 to 46 years of age) women pregnant with a singleton, non-anomalous fetus, who can understand English and can give consent to partake in the study for its duration. Participants who smoke cigarettes, use vapes and controls will be invited to partake when they attend for the booking appointment at any of the Dublin maternity hospitals. They will be given written information about the study in their first visit booking back either in electronic or hardcopy format. - SamplingMethod: Non-Probability Sample

NCT06296992

Not yet recruiting

Type 1 Diabetes, Exercise and Mentoring Trial

The proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D). The study will generate knowledge and support knowledge mobilization about the effectiveness of a novel model of care for psychosocial health and self-management for adolescents living with type 1 diabetes (T1D). The novel model of care is the recruitment and training if young adult mentors to deliver a behavioural intervention that empowers adolescents with T1D to increase daily physical activity. The study will also advance the development and implementation of this peer mentoring model to improve the psychosocial health of adolescents with T1D.

- EligibilityCriteria: Inclusion Criteria: want to increase their daily PA currently use a continuous glucose monitor (CGM) Exclusion Criteria: were diagnosed with T1D within 12 months of randomization have diabetes secondary to medications or surgery have cancer evidence of drug/alcohol abuse have an eating disorder an orthopedic injury or illness that would limit their ability to engage in daily PA a suicide attempt in the previous 12 months - HealthyVolunteers: No - Gender: All - MinimumAge: 13 Years - MaximumAge: 17 Years - StdAgeList: Child

NCT06296979

Not yet recruiting

Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity.

Pain, particularly shoulder pain, is a social and economic problem worldwide. Although visceral pathology is not yet taken into account in the diagnosis of these pains, it is likely that on numerous occasions the hepatobiliary visceral condition causes referred pain in the metameric area belonging to the shoulder due to the involvement of the phrenic nerve. Therefore, the aim of this project is to study the response of treatment by neuromodulation of the phrenic nerve for shoulder pain in patients with associated hepatobiliary pathologies, assessing the possible visceral involvement in the symptomatology.

- EligibilityCriteria: Inclusion Criteria: Over 18 years of age and under 64 years of age. Subjects presenting right shoulder pain at the time of enrollment in the study. Presentation of a hepatobiliary visceral disorder that may justify the visceral etiology of the pain. That they agree to participate in the project by signing the informed consent form. Exclusion Criteria: Patients with chronic pain due to other diseases such as malignant disease. Patients with rheumatic diseases. Cutaneous infection in the area of pain. Disease of neurological, traumatic, oncologic, or infectious origin that rules out the visceral origin of the pain. Uncooperative subject. Severe psychiatric disease. Loss of cognitive capacity. Contraindication to electrotherapy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 64 Years - StdAgeList: Adult

NCT06296966

Recruiting

A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye

The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.

- EligibilityCriteria: Inclusion Criteria: Be at least 18 years of age of either gender and any race. Provide written informed consent and sign the HIPAA form. Be willing and able to follow all instructions and attend all study visits. Exclusion Criteria: Use of any of the disallowed medications during the washout and study period. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296953

Not yet recruiting

Safety & Feasibility of PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis

This will be an explorative, proof-of-principle, open, multi-center investigation. The investigation aims to investigate the safety of the PERIsign system and the ability of physicians to differentiate between healthy individuals and subjects with involuntary muscle defense as a sign of peritonitis by utilizing PERIsign data. The investigation will include a total of 20 subjects admitted to hospital for suspected appendicitis and planned for emergency surgery and 20 healthy volunteers. Both male and female subjects aged 18-70 years will be enrolled. All subjects will undergo PERIsign examinations. Subjects with suspected appendicitis will undergo 1-2 PERIsign examinations before their planned appendectomy surgery. For the healthy volunteers, there is only 1 PERIsign examination. During each examination, 4 PERIsign curves will be obtained, one from each quadrant of the abdomen. The attending physician will interpret the appearance of the PERIsign curves of all subjects, including those from the healthy volunteers. The duration of the PERIsign examination will be documented, and usability data will be gathered, including the need for sensor adjustments, subject perception of the examination, and any discomfort experienced. In addition, blinded physicians will evaluate all subjects' PERIsign curves and determine whether each subject has involuntary muscle defense as a sign of peritonitis. These blinded physicians will have access to all 4 PERIsign curves obtained during each examination, while other data will not be disclosed to them. Safety will be evaluated through analysis of reported adverse events and device deficiencies

- EligibilityCriteria: Inclusion Criteria: Inclusion criteria for healthy volunteers For enrolment in the investigation, healthy volunteers must fulfil all the following criteria: Subject is 18-70 years of age The subject reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all assessments The subject should have a sufficient height and physical build to enable the attachment of the PERIsign sensors to their abdomen, as judged by the Investigator Inclusion criteria for the patient group For enrolment in the investigation, patients must fulfil all the following criteria: Patient is 18-70 years of age The patient reports having understood and has signed the ICF and is willing to comply with all assessments The patient is admitted to the hospital with suspected appendicitis and scheduled for emergency surgery within 24 hours. Patient is deemed clinically stable, as judged by the Investigator The patient should have a sufficient height and physical build to enable the attachment of the PERIsign sensors to their abdomen, as judged by the Investigator Exclusion Criteria: Exclusion criteria for healthy volunteers Healthy volunteers meeting any of the following criteria will not be permitted to enter the investigation: BMI >30 Presence of any known pathological diseases in the abdomen Subject who previously underwent abdominal surgery Subject with spinal cord injury Subject with pacemaker Pregnancy at the time of enrollment, as confirmed by either knowledge or a urine test The subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation The subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason Subject already enrolled (within 30 days prior to enrolment) in another investigational drug/s or device/s clinical study Exclusion criteria for the patient group Patients meeting any of the following criteria will not be permitted to enter the investigation: BMI >30 Patient who previously underwent abdominal surgery The patient is currently undergoing immunosuppressive therapy, including systemic corticosteroid treatment for two weeks prior to enrollment Patient with spinal cord injury Patient with pacemaker Known abdominal ventral hernia Known abdominal rectus muscle diastasis Retrocecal appendix according to radiology Other known pathological conditions of the abdomen that may interfere with the performance, evaluation and outcome of the clinical evaluation, as determined by the Investigator The patient must not be pregnant at the time of enrollment, as confirmed by either prior knowledge or a urine test The patient has a cognitive incapacity or language barrier precluding adequate understanding or cooperation The patient is considered by the Investigator to be unsuitable to participate in the investigation for any other reason The PERIsign examination is deemed to interfere with the standard of care Subject already enrolled (within 30 days prior to enrolment) in another investigational drug/s or device/s clinical study - - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06296940

Recruiting

Written Exposure in Substance Treatment

The purpose of this pilot randomized clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) within the context of residential substance use disorder (SUD) treatment. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. The main questions the study aims to answer are: 1) Is the delivery of WET feasible in short term residential SUD treatment for individuals with severe SUD; 2) Do participants in the TAU+WET condition have greater reductions in PTSD symptoms pre/post treatment compared to participants in TAU alone?

- EligibilityCriteria: Inclusion Criteria: At least 18 years old Fluent in English Cognitively able to provide consent to the research Enrolled in inpatient treatment at the clinical site where the research takes place Meet criteria for probable PTSD based on PCL-5 score Be early enough in their residential stay to allow time to complete the WET protocol Have a clear memory of the traumatic event so they are able to write about itin detail Exclusion Criteria: Reports significant suicidal or homicidal ideation with intent, untreated psychosis, or have other health limitations that may interfere with their ability to participate in the research - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296927

Not yet recruiting

The Effect of the Emotional Freedom Technique on Perceived Pain, Situational Anxiety, Cortisol and Satisfaction Levels in Mammography Screening.

This study was planned to determine the effect of Emotional Freedom Technique on perceived pain level, situational anxiety, salivary cortisol and satisfaction level during mammography screening.

- EligibilityCriteria: Inclusion Criteria: Having a first mammography screening Knowing how to read and write, Having entered menopause (at least 1 year has passed since the last menstruation) Exclusion Criteria: Having any cognitive or hearing-related problems, Having used analgesic medication before the procedure, Not having chronic diseases (insulin resistance, hypertension, obesity) (as saliva may affect cortisol level), Having a psychiatrically diagnosed disease (Schizophrenia, bipolar disorder) Having epilepsy (since it is contraindicated for EFT applications), Presence of oral diseases, inflammation or lesions (as saliva may affect cortisol level), Having eaten, drank, chewed gum or brushed teeth 30 minutes before. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 40 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06296914

Recruiting

A mHealth System for Patients With POTS

Postural Orthostatic Tachycardia Syndrome (POTS) affects approximately 500,000 - 3 million Americans. This number will only increase due to the large number of patients experiencing POTS due to "long COVID." POTS patients experience several symptoms, including tachycardia, palpitations, dizziness, and pre-syncope or syncope, among others. POTS can be very debilitating and not only affect patients physically but also emotionally and financially. It takes an average of four years and seven doctors for POTS patients to achieve a diagnosis and it is often a frustrating and negative experience fraught with misdiagnoses, stigma, and depression and anxiety. Recent research demonstrates that mHealth technology may be one way that POTS patients can improve their experience in the healthcare system by providing objective data to their healthcare providers. Patients may also better take care of themselves through symptom monitoring and instant patient education via mHealth technology. The two study aims are: 1) Developing a mHealth app to improve the delay to diagnosis and the quality of life of POTS patients; and 2) Evaluate the usability and feasibility of the mHealth app and study design. To achieve these aims, researchers in this study will work with a programmer and leaders from the mHealth Application Modernization and Mobilization Alliance (MAMMA) and stakeholders (patients, caregivers, and providers) to co-design a mHealth app for POTS patients, including key educational components guided by the IDEA model, an instructional risk communication approach. A group of diagnosis-seeking POTS (n=20) patients will pilot test the app and provide feedback for improvement as well as evaluate its usability. Results from this study will allow researchers to acquire necessary data to apply for external funding to conduct a larger clinical trial to evaluate its influence on health outcomes, such as patient experience during visits with physicians, perceived stigma, and time to diagnosis.

- EligibilityCriteria: Inclusion Criteria: patients who have not received a POTS diagnosis from a physician must have experienced at least two symptoms of POTS within the past three months (one symptom must include dizziness or pre-syncope upon standing) must have a clinic visit scheduled within 2-4 months post-recruitment Exclusion Criteria: have been diagnosed with POTS already is not at least 18 years of age is not experiencing at least two symptoms of POTS within the past three months, including dizziness or pre-syncope upon standing. does not have a clinic visit scheduled within 4 months post-enrollment is taking a beta blocker. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296901

Not yet recruiting

To Wipe or Not To Wipe?: That Is The Question

The primary aim of this randomized control trial is to characterize whether a mid-stream clean catch sample using a cleansing wipe in the setting of symptomatic UTI in a female patient is associated with a lower rate of contamination. We hypothesize that using a perineal cleansing wipe at the time of a midstream urine sample will decrease rates of contamination for female patients with a symptomatic UTI.

- EligibilityCriteria: Inclusion Criteria: adult female patients >18 who present to the urology clinic at IRL or 3RC with a symptomatic UTI: symptoms include urgency, frequency, urgency urinary incontinence increased from baseline symptoms, dysuria, fevers, flank pain, suprapubic pain/pressure, low back pain, cloudy urine, malodorous urine Exclusion Criteria: patients who are asymptomatic, have an indwelling catheter, SPT, stent, nephrostomy tube, perform CIC, are on daily antibiotic prophylaxis, or already on existing antibiotics - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult

NCT06296875

Not yet recruiting

The Krill Ageing Muscle Mechanisms (KAMM) Study

This study aims to determine the mechanisms via which krill oil supplementation increases muscle strength and whether this translates to improvements in gait and functional characteristics in older adults. The studies we will carry out will establish, in healthy older adults, the effects of 6 months of supplementation with krill oil Objective 1) Muscle structure and function Hypothesis: Krill oil supplementation will increase muscle size and strength alongside positive changes in muscle architecture (pennation angle and fascicle length). Objective 2) Neuromuscular control and central nervous system (CNS) function Hypothesis: Krill oil supplementation will improve Neuromuscular Junction (NMJ) transmission stability and increase central drive and intramuscular coherence, as a measure of muscle synergy. Objective 3) Gait and functional characteristics Hypothesis: Krill oil supplementation will improve gait and functional characteristics.

- EligibilityCriteria: Inclusion Criteria: body mass index (BMI) </= 30 kg/m2 Age >/= 65 years Capacity to consent Living within the Glasgow area Exclusion Criteria: Diabetes mellitus Severe cardiovascular disease Seizure disorders Uncontrolled hypertension (>150/90mmHg) Active cancer or cancer that has been in remission <5 years Participation in any resistance exercise training within the last 6 months Impairments which may limit ability to perform assessments of muscle function Dementia Fish/shellfish allergy Taking medication known to affect muscle (e.g. steroids, Selective serotonin reuptake inhibitors) or anticoagulants (e.g. warfarin) Taking omega-3 supplements in the last 3 months Regularly consuming 1 or more portions of oily fish per week Not able to understand English - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 65 Years - MaximumAge: 90 Years - StdAgeList: Older Adult

NCT06296862

Not yet recruiting

Effect of DASH on HF Outcomes Heart Failure Status in Older Adults (DASH HF)

The purpose of this study is to examine the effect of the Dietary Approaches to Stop Hypertension (DASH) diet has on heart failure status in older adults. This study is important because it may provide a low-cost strategy to help reduce hospitalizations and deaths for heart failure patients. Participants will be adults age 65 and older with heart failure. They will have 4 study visits, each lasting about 2 hours, and will be in the study for 12 weeks. They will also be asked about their dietary consumption 6 times, each time lasting about 45 minutes. All in-person study visits will take place in the Emory GCRC. Participants will have physical exams, body measurements, blood tests, urinalysis, chart review, and answer surveys. They will be randomized to eat only the DASH diet provided to them for 4 weeks either at the beginning or end of their participation in the study. Participants will be recruited from heart failure patients at Emory University Hospital, Emory University Hospital Midtown, and Emory Outpatient Advanced Heart Failure Therapy Center. The total enrollment planned under Emory's oversight, accounting for screen failures and withdrawals, will be n=38 participants. The study team will obtain informed consent prior to the first study visit either in person, or, alternatively, over the phone, if requested by participants. Specimens and data obtained in this study will not be banked for future use.

- EligibilityCriteria: Inclusion Criteria: 65+ years of age Heart failure diagnosis and symptoms, as outlined by the 2021 European Society of Cardiology diagnostic guidelines Residence within 50 miles of Emory University Have undergone hemodynamic monitoring device implantation (CardioMEMS, Abbott) Have received optimized HF therapy for 3+ months post CardioMEMS implantation Exclusion Criteria: Heart failure-related hospitalization or heart failure medication changes within 1 month Renal disease stages IV-V Expected survival < 12 months Dementia or Alzheimer's disease Limited English literacy and communication skills - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - MaximumAge: 110 Years - StdAgeList: Older Adult

NCT06296849

Recruiting

Dyadic Financial Incentive Treatments for Dual Smoker Couples

Smokers partnered with other smokers (i.e., dual-smoker couples) represent ~2/3 of all smokers. Dual-smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Despite their high prevalence and risk for persistent smoking, however, there are limited data on smoking cessation interventions among DSCs. Building on previous research that suggests a) financial incentive treatments (FITs) are effective at increasing quit rates and b) dyadic adaptations of FITs are feasible for implementation in DSCs, the proposed study will systematically two versions of FITs to enhance smoking cessation among DSCs. In addition to determining the efficacy of these dyadic FITs for smoking abstinence in DSCs, the investigators will consider the cost and cost effectiveness of each adaptation as well as mechanisms of change to inform future implementation research. The investigators will additionally consider secondary outcomes including abstinence during treatment and long-term abstinence maintenance after end of treatment. The investigators will address these questions in a three-group randomized controlled trial (RCT). In all conditions, individuals who have smoking partners (i.e., targets) will receive usual care (combination fast and slow acting Nicotine Replacement Therapy + quitting resources). In two conditions, participants will receive incentives for abstinence at three time points (1, 3, and 6 months post-baseline). In the SFIT condition, only the target in a couple will be offered incentives; in the DFIT condition, both target and partner will be offered incentives. Primary efficacy outcome is % point-prevalence abstinence at 6 months post-baseline among targets. Secondary outcomes are point-prevalence abstinence at 1 and 3 months during the treatment and 6 months post-treatment (12-months post-baseline), as well as partner outcomes. The investigators will evaluate possible mechanisms of change including partner support and individual and partner motivation to quit as well as evaluate the cost and relative cost of each abstainer within and across condition. These data on the efficacy, mechanisms, and costs of FITs for DSCs will inform population level implementation and promote successful quitting in this treatment refractory population.

- EligibilityCriteria: Inclusion Criteria: 1) age of 18+; 2) smoking of 5+ cigarettes/day; 3) relationship status of married to or living with a daily smoker of 5+ cigarettes who is also above the age of 18; and 4) romantic relationship duration of at least six months. Exclusion Criteria: 1) less than 8th grade capacity to read and write in English; 2) recent hospitalization (past 6 months) 3) psychosis risk; 4) regular (4+ days weekly) use of e-cigarettes; 5) Contra-indication for NRT (e.g., pregnancy, heart disease); 6) Marijuana use. Inclusion and exclusion criteria apply to both members of each couple; both members of each couple must be eligible for the target to enroll. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296836

Not yet recruiting

Effect of Continuing Versus Holding Metformin During Hospitalizations.

A randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality.

- EligibilityCriteria: Inclusion Criteria: Adult (18+ years of age) Admitted to an internal medicine service. On Metformin prior to admission. Exclusion Criteria: Inability to take oral medications eGFR < 30 ml/min/1.73 m2 Dialysis Current Acidosis (pH < 7.35) including diabetic ketoacidosis Child-Turcotte-Pugh class C hepatic cirrhosis Acute Decompensated Heart Failure Cognitively impaired and/or unable to consent Lack of or unwillingness to share contact information Pregnant women - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 110 Years - StdAgeList: Adult, Older Adult

NCT06296823

Recruiting

Biomarkers for Peripheral Circadian Clocks in Humans

The purpose of this project is to improve our understanding of peripheral circadian rhythms in humans. Circadian clocks are present in most tissues of the body with importance for optimal physiological function, health, and behavior. This project will utilize simulated jetlag protocols to systematically test novel hypotheses about the regulation of peripheral circadian rhythms in humans. Specifically, we will examine how changes in the time of when we are exposed to light and the timing of when we eat impacts proteins in the blood and saliva that represent rhythms from clocks in the brain (e.g., rhythms of the hormones melatonin and cortisol coordinated by the brain) and rhythms from clocks in body tissues (e.g., proteins made by immune and bone cells, and cells in the stomach and liver). We also aim to discover new blood-based biomarkers of peripheral rhythms in humans. We anticipate our findings will be the first step in developing novel circadian based treatments for aligning peripheral clocks under conditions such as jetlag, and for developing novel circadian biomarkers that will advance our scientific understanding of circadian rhythms.

- EligibilityCriteria: Inclusion Criteria: 1) 17-35 years old 2) English speaking 3) Healthy 5) Altitude history: Currently residing at Denver altitude or higher Exclusion Criteria: 1. Any medical, psychiatric, or sleep disorder. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 17 Years - MaximumAge: 35 Years - StdAgeList: Child, Adult

NCT06296810

Not yet recruiting

Adaptive DBS to Offset STN Dysregulation During Exercise in PD

The investigators conduct a prospective study to evaluate the effects of exercise on Parkinson's Disease brain biomarkers detected with the PerceptTM PC neurostimulator.

- EligibilityCriteria: Inclusion Criteria: Persons with PD, who have a Medtronic DBS implant with a Percept IPG. - Exclusion Criteria: Persons not meeting the above listed age and implant criteria, who are not able to complete the study exercise, or not able to comprehend and consent to study participation. - - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Persons with PD, who have a Medtronic DBS implant with a Percept IPG. - SamplingMethod: Probability Sample

NCT06296797

Not yet recruiting

Patient-centered Information on Permanent Contraception

The goal of this study is to understand whether providing information to women with a strong desire to avoid future pregnancy about how tubal sterilization compares to long-acting reversible contraceptives improves perceived access to available contraceptives. Participants will: Complete a baseline survey Receive access to web-based educational resources Complete a brief follow up survey immediately after exploring these web-based resources Complete a follow-up survey 3 months after enrolling The investigators will compare outcomes among participants provided with access to a new website (intervention) summarizing recent patient-centered outcomes research (PCOR) comparing interval laparoscopic tubal sterilization and long-acting reversible contraception (LARC) to control participants provided with access to the existing Planned Parenthood website on tubal sterilization.

- EligibilityCriteria: Inclusion Criteria: Self-reported fertility Have a strong desire to avoid future pregnancy Speak English or Spanish Exclusion Criteria: Current pregnancy The inability to speak English or Spanish Prior tubal sterilization or Essure procedure Menopause Infertility Hysterectomy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 21 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06296771

Not yet recruiting

The Effect of a Combined Aerobic and Resistance Exercise (CARE) Training Programme on Cardiometabolic Outcomes in Individuals With Chronic Spinal Cord Injury: A Randomised Controlled Trial

The goal of this study is to investigate the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on the cardiometabolic health outcomes of individuals with chronic spinal cord injury. This study is a randomised controlled trial conducted at a single centre, consisting of two parallel arms. The main questions it aims to answer are: the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on cardiometabolic disease biomarker outcomes in individuals with chronic SCI the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on fitness and health outcomes. Twenty-one participants will be randomly assigned in a 2:1 allocation ratio. The participants will be assigned to either the dietary energy restriction and exercise group (D+E) group, which combines dietary energy restriction and exercise intervention, or the dietary energy restriction group (D) group, which just undergoes dietary energy restriction using sealed envelopes.

- EligibilityCriteria: Inclusion Criteria: The inclusion criteria for participation in this study are that patients have a chronic SCI that occurred at least one year before, an age range between 18 and 65 years, and sufficient upper limb function to engage in the exercise intervention. Participants must self-report that they use a wheelchair for the majority of their waking hours, namely 75% of their day, and have continually maintained a stable weight within a range of ± 3 kg over the duration of the previous three months. Exclusion Criteria: The study will exclude participants who have provided information about their medical conditions, such as unresolved pressure sores, urinary tract infections, active medical conditions that may be a contraindication to exercise testing (ACSM Exercise Testing Guidelines), or current musculoskeletal symptoms of the upper extremities. Individuals who have self-reported the use of medication for type 2 diabetes or pharmaceuticals that influence glucose metabolism will be excluded from involvement in the research. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06296758

Not yet recruiting

SiFi vs FNB Local Anesthesia for Hip Fracture Surgeries

The goal of this clinical trial is to compare two commonly used local/regional anesthesia techniques in adults patients undergoing hip fracture surgery. The main question[s] it aims to answer are: • the impact of both interventions on patient level of pain. • impact on postoperative analgesics administered Participants will be randomly assigned to one of two local/regional anesthesia techniques, either femoral nerve block (FNB) or suprainguinal fascia iliaca block (SiFi). Both techniques are the usual practice at the hospital, and we are NOT aiming to experiment on new anesthesia technique in this study.

- EligibilityCriteria: Inclusion Criteria: Age 18 or greater Having hip fracture surgery at the University of Alberta Hospital Suitable for multimodal analgesia including a peripheral nerve block Exclusion Criteria: Contraindication to a nerve block technique Refuses consent for a nerve block technique - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296745

Not yet recruiting

Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib.

Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in treating non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. An international multi-center clinical study published in 2019 confirmed that double dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, the choice of treatment after resistance to targeted therapy is a hot topic in clinical practice, with 78% of patients in the study above who responded to double-dose osimertinib still showing progression at the time of follow-up. The purpose of this study was to observe the safety and efficacy of intrathecal pemetrexed for leptomeningeal metastasis from lung adenocarcinoma that progressed after a double dose of a third-generation TKI such as osimertinib.

- EligibilityCriteria: Inclusion Criteria: Male or female aged between 18 and 75 years. Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations (L858R or Exon19Del). Confirmed diagnosis of leptomeningeal metastasis according to ESMO/ EANO guidelines. Progression after previous double doses of third-generation TKIs such as Osimertinib. Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3. No history of severe nervous system disease. No severe dyscrasia. Exclusion Criteria: Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11. Any evidence of extensive and lethal progressive systemic diseases without effective treatment. Patients with poor compliance or other reasons that were unsuitable for this study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06296732

Recruiting

Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification

Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. The presence of IDRF (image-defined risk factors) and tumor size (>4-7 cm) are considered as common contraindications for minimally invasive surgery in neuroblastoma. However, the recent studies have shown that presence of IDRF is not an absolute contraindication for laparoscopic surgery. This open-label, nonrandomized, observational, phase III evaluates role and weight of different surgical risk factors (including IDRF, tumor size, tumor localization, tumor volume/patient height ratio, previous open surgical procedures, previous chemotherapy etc.) in the laparoscopic neuroblastoma resections. The aim of this study is to create novel risk factors scoring system for laparoscopic surgery in abdominal neuroblastoma.

- EligibilityCriteria: Inclusion Criteria: Patients with neurogenic tumors meeting the criteria of groups I-III: Group I low or moderate risk group according to pilot difficulty scoring system (less than 5 points, see supplementary material); no IDRF; Group II: low or moderate risk group according to pilot difficulty scoring system (less than 5 points); patients with any number of IDRFs and without central tumor location and/or tumor extension across the midline and/or tumor volume (cm3)/patient height (m) ratio = 28 or more. Group III: 2 and more IDRF + central tumor location and/or tumor extension across the midline; 2 and more IDRF + tumor volume (cm3)/patient height (m) ratio = 28 or more; 2 and more IDRF + 2 and more other risk factors according to pilot difficulty scoring system; 1 IDRF + tumor extension across the midline + tumor volume (cm3)/patient height (m) ratio = 28 or more. Age from 0 to 18 years. Preoperative imaging (abdominal contrast-enhanced computed tomography (CT), performed no later than 14 days before the planned surgery). Indications for surgery based on the decision of multidisciplinary experts board in centers- participants. Written voluntary informed consent of the patient and / or his legal representative. Exclusion Criteria: 3 and more IDRF + central tumor location and/or tumor extension across the midline and/or tumor volume (cm3)/patient height (m) ratio = 28 or more. Severe concomitant pathology, increasing anesthesiologic and surgical risks, via the desicion of the research physician or conclusion by multidisciplinary team in centers- participants. Tumor volume does not technically allow to provide minimally-invasive surgery, based on the conclusion of multidisciplinary experts board team in centers- participants. Therapy strategy: observation - - Gender: All - MinimumAge: 1 Day - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: Patients with abdominal neurogenic tumors in 0-18 years of age - SamplingMethod: Non-Probability Sample

NCT06296719

Not yet recruiting

The Chit-Chat Educational Intervention to Promote Advance Care Planning in the Community

The purpose of this study is to estimate the effect size of the Chit-Chat intervention on ACP engagement among family members of older adults with multi-morbidity.

- EligibilityCriteria: Inclusion Criteria: age 18 or above; a family member of a relative who aged 60 or above and lives with at least two severe chronic diseases such as cancer, dementia, lung, heart, liver, and renal disease. they perceived themselves will take part in taking care of their relatives in the near future; able to read and communicate in Cantonese. Exclusion Criteria: they are cognitively incompetence (Mini-Mental State Examination (MMSE) < 23); their relatives have been referred to palliative care service before the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296706

Not yet recruiting

A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer

This trial is a multicenter, randomized, controlled phase Ш clinical study of comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with previous first-line treatment failure.

- EligibilityCriteria: Inclusion Criteria: Age: 18-75 years (inclusive) (Whichever is on the day of signing the informed consent form). Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology. Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction that has progressed after receiving first-line systematic treatment (defined as platinum/fluorouracil containing dual drug chemotherapy, with or without immunotherapy). Evidence of disease progression on imaging during or after the last systemic treatment as confirmed by investigator. At least one assessable lesion according to RECIST V1.1; the area should not have received previous radiotherapy, or there should be evidence of definite progress of the lesion after completion of radiotherapy. Previous history with positive Her-2 expression requires anti-Her-2 medication; unknown Her-2 expression should define Her-2 status before enrollment. Adequate main organ function. Eastern Cooperative Oncology Group (ECOG) score 0-1. Expected lifetime≥ 3 months. Female patients of childbearing age must have a negative serum pregnancy test within 7 days prior to randomization; patients must agree to take adequate contraception from signing of ICF through 6 months after last dose, during which time women are not breastfeeding; male patients must agree to contraception and refuse sperm donation. Fully understand this clinical trial and willing to sign a written informed consent form. Exclusion Criteria: Diagnosed as Krukenberg tumor, unless radical resection has been performed and there is no visible tumor residue. Medical history of other malignant tumors or other active malignant tumors within 5 years prior to randomization (cured local tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included). Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 14 days before randomization (Additional intervention is required within 2 weeks after intervention, such as pleural effusion, abdominal effusion, pericardial effusion, etc., excluding exfoliative cytology testing of exudate). Patients with central nervous system metastasis. Patients who have used paclitaxel/docetaxel in the past (except patients with disease progression more than one year after neoadjuvant/adjuvant treatment with paclitaxel/docetaxel). Patients whose previous medical history shows dMMR/MSI-H (deficient Mismatch Repair or High Microsatellite Instability) and who have not received immunotherapy in the past are not suitable for enrollment, and those whose dMMR/MSI status is unknown need to clarify the status before enrollment. History of serious cardiovascular or cerebrovascular disease, including but not limited to: 1) Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc; 2) Acute coronary syndrome, congestive heart failure, stroke, or other level 3 or higher cardiovascular events occurring within 6 months before randomization; 3) The New York Heart Association (NYHA) heart function rating of ≥ Grade Ⅱ or left ventricular ejection fraction (LVEF) of<50%; 4) Long QTc syndrome or QTc interval>480 milliseconds, as well as the use of any known concomitant medication that can prolong the QT interval; 5) Poor control of hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg during the screening period). 8. History of gastrointestinal perforation and/or fistula within 6 months before randomization. 9. Patients with active hepatitis B(Hepatitis B surface antigen (HBsAg) or HBcAb positive, and in the active phase of hepatitis B (HBV-DNA ≥ 10^4 cps/mL or ≥ 2000 IU/mL)), hepatitis C(Hepatitis C antibody (Anti HCV) positive and tested positive for HCV RNA by PCR) or HIV. 10. Patients with severe chronic or active infections that require systemic antimicrobial, antifungal, or antiviral therapy within 14 days before randomization. Note: Patients with viral hepatitis are allowed to receive antiviral treatment. 11. Tuberculosis treatment history within 2 years before randomization. 12. Patients with gastrointestinal obstruction and active inflammatory bowel disease within 28 days before randomization. 13. Toxic reaction caused by any previous treatment has not recovered to level 1 or below (CTCAE5.0) (excluding anemia, alopecia, fatigue, poor appetite, or other toxicities that the investigator deems to have no safety risk to patients). 14. Received major organ surgery or invasive intervention treatment within 28 days before randomization. Or planned to undergo systematic or local tumor resection surgery during the study period. 15. Received intravenous chemotherapy or biopolymer therapy within 28 days before randomization. Or received oral chemotherapy, immunotherapy (such as interleukin, interferon, thymosin, etc.), hormone therapy, small molecule targeted therapy, or any experimental intervention within 14 days or 5 half-lives (whichever is shorter) before the first treatment. Received traditional Chinese medicine or traditional Chinese patent medicines with anti-tumor indications within 14 days before randomization. 16. Have received powerful CYP3A4 inhibitor or inducer within 14 days before randomization. 17. Allergic to and/or contraindication to albumin or docetaxel. 18. Known allergy and/or contraindication to glucocorticoids (including but not limited to active gastrointestinal ulcers, severe hypertension, severe hypokalemia, glaucoma, etc). 19. Patients with psychiatric neurological disorders that may affect trial adherence, or patients with a history of drug dependence/alcohol dependence. 20. Patients participated in another clinical study at the same time, unless it is an observational (non-intervention) clinical study or is in the follow-up period of an intervention study. 21. Other situations that the investigator thinks are not suitable for patients in this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06296693

Not yet recruiting

Diagnostic Accuracy of Pocket-size Lung Ultrasound in Pneumonia Etiology and Complications in Hospitalized Children

Background and study aims Pneumonia is the leading infectious cause of death in children worldwide. Although the diagnosis is clinical, a chest radiograph (CXR) is often necessary to clarify it, exposing the patient to radiation. Ultrasound has been increasingly used in the evaluation of the lung parenchyma without exposing patients to radiation. The pocket-size Point-of-Care Ultrasound (POCUS) can be used at the patient's bedside proving comfort and saving time. Evidence suggests that ultrasound can detect CAP (community-acquired pneumonia) in children with similar accuracy and reliability as CXR. However, few studies evaluated the ability to distinguish the aetiology of pneumonia and none used a pocket-size POCUS device. This study aims to assess, for the first time, the diagnostic accuracy of a pocket-size POCUS device for the etiological diagnosis of CAP vs. CXR, in paediatric ages. Secondarily, the investigators intend to evaluate the correlation between CXR image vs. ultrasound, the correlation between clinical progression and ultrasound images, and the diagnostic accuracy to detect complications. Who can participate: The investigators will include, consecutively, all children aged >12 months and <18 years hospitalized to the Paediatric Department with the diagnosis of CAP on admission. The investigators will exclude children hospitalized with nosocomial pneumonia, with cystic fibrosis diagnosis or on long-term domiciliary ventilation. What does the study involve: The diagnostic accuracy between POCUS and CXR in differentiating the type of pneumonia will be assessed. All participants will perform a POCUS at admission, daily during hospitalization, 15 days and 1 month after discharge. All children will also undergo a CXR upon admission and whenever necessary. What are the possible benefits and risks of participating: Children will have a more frequent and serial assessment of CAP, which does not involve risks. Where is the study run from: The study if from Centro Materno Infantil do Norte - Centro Hospitalar Universitário de Santo António, a tertiary paediatric referral centre. When is the study starting and how long is it expected to run for: The recruitment period is expected to start in January/2024 and end in January 2025.

- EligibilityCriteria: Inclusion Criteria: Age >12 months and <18 years Hospitalization in the Paediatric Department CAP diagnosis on admission (based on the physician's clinical judgment, namely through clinical, analytical and/or CXR criteria) Exclusion Criteria: Nosocomial pneumonia Cystic fibrosis diagnosis Long-term use of domiciliary ventilation. - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Months - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06296641

Recruiting

Needs Navigation for Caregivers of AYAs

The overall aim of the study is to address unmet health-related social needs and reduce outcome disparities among AYA cancer survivors. Aim 1 aimed to refine a needs navigation model in partnership with expert consultants. Aim 2 and 3 will involve the deployment and pilot testing of the adapted needs navigation intervention among caregivers of younger AYAs with cancer.

- EligibilityCriteria: Inclusion Criteria: We are enrolling dyads (AYA and caregivers) for this study. AYA patient participants: Age 15 - 26 years old English or Spanish-speaking In between 3-months of diagnosis of cancer date and up to 1-year post-treatment completion without progression or recurrence of cancer Caregiver/financial partner participants: Parent or financially-responsible adult of non-adult AYA (<18 years) OR Identified by the AYA as caregiver, parent, or partner who is financially-responsible or a financial partner for AYA Exclusion Criteria: Dyad with caregiver or younger AYA that previously participated in study AAAU2405 Unable to complete financial survey questions or contraindicated (as outlined in Protection of Human Subjects) Dyad with younger AYAs who are enrolled on hospice or receiving other end-of-life care - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 15 Years - MaximumAge: 26 Years - StdAgeList: Child, Adult

NCT06296628

Not yet recruiting

Rehabilitation Device for Hand Mirror Therapy

This study is a randomized and open comparative study that uses two parallel groups: a control group training with conventional therapy and another group that trains with the device "Miraπ". The participants are patients with stroke with motor weakness in one hand. Two measurement visits are required. During those visits, different hand function assessments will be carried out to analyze the motor function of the subjects hand. The measurements will be done during their inpatient rehabilitation stay, one at time of admission and the second at discharge, each taking 20 minutes. In the time between the measurement visits, the hand therapy takes place fivemtimes a week.

- EligibilityCriteria: Inclusion Criteria: Participants currently accepted and cleared for rehabilitation in the inpatient rehabilitation unit by the rehabilitation medical director. Participants with paralysis or motor function problems of only one hand. Participants spasticity of the affected hand ( as assessed by by the occupational therapist) Participants need mirror therapy because of their health condition. Participants are able to memorize easy tasks, and able to follow instructions e.g., moving the healthy fingers. Exclusion Criteria: Participants who are not cleared physically or medically to participate in standard acute inpatient rehabilitation therapies by the rehabilitation medical director Participants who are not able to memorize easy tasks, e.g., moving the healthy fingers. Participants with spasticity of the affected hand ( as assed by the occupational therapist) Vulnerable populations - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296602

Recruiting

Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV (ANAPreP'HPV)

This is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation.

- EligibilityCriteria: Inclusion Criteria: Men sex Men Using Pre-exposure Prophylaxis for HIV Follow up au CHU de Besançon. Exclusion Criteria: Women No MSM Under 18 History of HPV related cancer - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296589

Not yet recruiting

Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure

The goal of this clinical trial is to learn if receiving Trauma-Informed Guilt Reduction (TrIGR) Therapy is as effective as receiving Prolonged Exposure Therapy among veterans with PTSD and trauma related guilt. The main questions it aims to answer are: Will TrIGR be comparable to PE in terms of PTSD symptom reduction? Will it TrIGR be comparable to PE in improving functioning and reducing depression symptoms? Will it be superior in improving trauma-related guilt and shame?

- EligibilityCriteria: Inclusion Criteria: U.S. Veterans age 18 or older who served in the military since the start of Operation Enduring Freedom/Operation Iraqi Freedom; OEF/OIF) meets diagnostic criteria for PTSD; a score of 2 or higher ("true" to "extremely true") on feeling trauma-related guilt much or all of the time or scoring 3 or higher ("very true" or "extremely true") on at least one guilt cognition factor (hindsight bias/responsibility, wrongdoing, or lack of justification) on the Trauma Related Guilt Inventory not currently receiving trauma-focused treatment such as PE or CPT willingness to attend psychotherapy and assessment sessions Exclusion Criteria: current risk of suicidal/homicidal behavior that requires immediate intervention current severe substance use disorder (in the past two months) based on DSM-5 criteria current unmanaged psychosis or mania life threatening or unstable medical illness inability to read - HealthyVolunteers: No - Gender: All - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296576

Not yet recruiting

Acceleration Time Assessment for Prediction of Critical Limb Ischemia

Critical Limb Ischaemia (CLI), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it. The growing prevalence of this condition and the associated healthcare costs make it an important public health objective. Diagnostic criteria for Critical Limb Ischaemia differ between learned societies and countries. Its diagnosis is most frequently based on the combination of a clinical criterion (ischaemic decubitus pain and/or necrotic wounds, with a time to onset > 2 weeks) and a haemodynamic criterion (ankle systolic pressure (ASP) < 50mmHg or toe systolic pressure (TSP) < 30 mmHg or transcutaneous oxygen pressure (TCPO2) < 30 mmHg). Recent studies have highlighted the importance of pulsed Doppler flow analysis in quantifying arteriopathy of the lower limbs, both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries (dorsal artery of the foot and lateral plantar artery). The main aim of our study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from CLI so that they can be referred to a reference centre as early as possible.

- EligibilityCriteria: Inclusion Criteria: Age ≥ 18 years; Patient referred to the vascular medicine department of one of the investigating centres for arterial Doppler ultrasound of at least one lower limb and for whom a measurement of the systolic pressure index at the toe will be performed. Presence of proven arterial disease, asymptomatic or not, defined by the presence of one of the following criteria: Rest ankle systolic pressure index ≤ 0.90 Rest toe systolic pressure index ≤ 0.70 Exclusion Criteria: Patient with haemodynamic instability, unable to tolerate a delay in therapeutic management caused by the ultrasound examination and measurement of systolic pressure at the toe; Patients with surgical management of the lower limb (in relation to lower limb arteriopathy), already scheduled at the time of inclusion. Patients with a life expectancy of less than 24 hours; History of transmetatarsal amputation or amputation at a more proximal level compromising the measurement of systolic pressure and occlusion at the toe and/or TCPO2; Refusal to participate - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patient referred to the vascular medicine department of one of the investigating centres for arterial Doppler ultrasound of at least one lower limb - SamplingMethod: Non-Probability Sample

NCT06296563

Not yet recruiting

Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC

The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are: How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery. Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year.

- EligibilityCriteria: Inclusion Criteria: 1. Pathological diagnosis as malignant tumor of Intrahepatic Cholangiocarcinoma; 2. According to the UICC/AJCC TNM staging system (8th edition, 2017), resectable subjects were classified as Ib-IIIb stages; 3. aged ≥ 18 years at the time of signing the Informed consent form (ICF); 4. Expected survival time>3 months; 5. Both men and women are eligible; 6. The patient's Eastern Oncology Collaborative Group (ECOG) physical condition score is 0 or 1; 7. No serious complications, such as hypertension, coronary heart disease, or history of mental illness, and no history of severe allergies; Non pregnancy and non lactation period; 8. The organ and blood system functions of the subjects meet the following requirements: Absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9/L; Platelet count ≥ 75 × 10 ^ 9/L; Hemoglobin ≥ 90 g/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN; Albumin ≥ 3g/dL Creatinine ≤ 1.5 x ULN 9. The subjects can understand and sign the informed consent form to participate in the experimental study; Good compliance. 10. Participants who have not undergone any local or systemic treatment for tumors in the past, and have undergone radical resection surgery for biliary tract cancer before recurrence for at least 2 years, can be included; 11. Subjects with potential fertility need to use a medically approved contraceptive measure (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and within one month after the end of the study treatment period; And within 72 hours before enrollment, the serum or urine HCG test must be negative and must be non lactating; Exclusion Criteria: 1. Patients who received PD-1, PD-L1, PD-L2, or CTLA-4 inhibitors before enrollment, or patients who directly received another stimulating or co inhibitory T cell receptor (such as CTLA-4, CD137); 2. Use any other investigational drugs within 4 weeks prior to enrollment; 3. Any history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy); Children with asthma who have completely improved in adulthood and do not require any intervention can be included, but patients who require intervention with bronchodilators cannot be included; 4. Congenital or acquired immunodeficiency, such as infection with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA 500IU/ml), hepatitis C (hepatitis C antibody positive, HCV-RNA above the detection limit of the analysis method), or co infection with hepatitis B and hepatitis C; 5. Serious infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or unexplained fever>38.5 ° C occurred during screening/before the first administration; 6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Suffering from uncontrollable mental illness; 8. The simultaneous occurrence of serious and/or uncontrollable diseases may affect the participation of the study, such as unstable angina pectoris, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, poorly controlled diabetes, serious activities, uncontrollable infection after insufficient biliary drainage (such as tumor blocking the bile duct); 9. Pregnancy (positive pregnancy test) or lactation period; 10. Other cancers that have occurred in the past (within the past 5 years) or simultaneously, excluding non melanoma skin cancer and in situ cancer; 11. History of allergy or hypersensitivity to any investigational drug; 12. Currently abusing alcohol or illegal drugs; 13. Unable or unwilling to sign informed consent form. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296550

Not yet recruiting

Enhancing Digitally Delivered Diabetes Education With Real-Time CGM

The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.

- EligibilityCriteria: Inclusion Criteria: Diagnosed with type 2 diabetes Are on non-inuslin therapies HbA1c 7.5% to greater than or equal to 12.0% Access to a mobile phone that accepts texts and counts steps Exclusion Criteria: Are using insulin therapies Are pregnant Are currently participating in another CGM-related study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296537

Recruiting

Effectiveness of Balance Training And Dynamic Neuromuscular Stabilization Training in Amateur Athletes With Chronic Ankle Instability

The goal of this clinical trial is to determine and compare the effects of balance and dynamic neuromuscular stabilization training on ankle function ability, functional instability severity, physical activity level, muscle strength, proprioception, stabilization, balance, reaction time and performance of amateur athletes with chronic ankle instability. The main questions it aims to answer are: Do balance and dynamic neuromuscular stabilization training positively affect functionality, balance, stabilization, proprioception and performance in amateur athletes with chronic ankle sprains? Does balance training or dynamic neuromuscular stabilization training have a more positive effect on functionality, balance, stabilization, proprioception and performance in amateur athletes with chronic ankle sprains? Participants will apply: a dynamic neuromuscular stabilization training program consisting of a series of special exercises based on the developmental kinesiology steps of a healthy baby. balance training which consist of an effective postural stability program. conventional training program which consist of stretching, joint range of motion, strengthening and postural control exercises. Researchers will compare balance and dynamic neuromuscular stabilization training to see if effectiveness of ankle function ability, functional instability severity, physical activity level, muscle strength, proprioception, stabilization, balance, reaction time and performance.

- EligibilityCriteria: Inclusion Criteria: Being between the ages of 18-25 Being a non-smoker Being an athlete at amateur level Score 25 or less on the Cumberland Ankle Instability Questionnaire At least 1 acute ankle inversion sprain resulting in swelling, pain, and dysfunction that occurred at least 12 months before the study Feeling of giving way in the ankle at least 2 times in the last 6 months Exclusion Criteria: If the patient has any mental problems Neurological diseases Cerebellar, vestibular, cochlear and inner ear dysfunction Surgeries on musculoskeletal structures, chronic musculoskeletal disorders, severe acute lower extremity injuries or head trauma in the last 6 months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 25 Years - StdAgeList: Adult

NCT06296524

Recruiting

Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot

Pes Planus is a medical condition in which arch of the foot is flattened, causing the entire sole of the foot to contact the floor. For those with flat feet, footcore exercises might be an effective non-invasive therapy. Footcore exercises aim to strengthen the intrinsic foot muscles that maintain the foot arch, enhance foot function and reduce the risk of injury in persons with flatfoot.

- EligibilityCriteria: Inclusion Criteria: Individuals having flat feet. those with a height difference of ≥ 10 mm during the navicular drop test. No history of foot or ankle surgery. Exclusion Criteria: Any lower limb injury Healing fracture of lower limb33 Any neuromuscular disorder 25 Recent surgery Any open wound. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult

NCT06296498

Recruiting

Application of L-PRF in Periodontal Surgery

The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception.

- EligibilityCriteria: Inclusion Criteria: Patients between age 18 and 89 Patients needing open flap debridement procedures for periodontal disease in one or more teeth in the same arch bilaterally (split mouth) Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report Female patients to include non- pregnant women of child-bearing potential. Exclusion Criteria: Patients who disclose that they will not be able to cooperate with the follow-up schedule. Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report) Pregnant women or women intending to become pregnant during the study period Smokers who smoke > 10 cigarettes per day - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 89 Years - StdAgeList: Adult, Older Adult

NCT06296485

Not yet recruiting

Safer Aging With Diabetes Monitoring

Older adults with type 2 diabetes are at higher risk for severe hypoglycemia and its related complications (including hospitalization and death) when taking insulin. This study proposes to evaluate, in a randomized clinical trial, a strategy of safe insulin prescribing based on an educational program that leverages continuous glucose monitoring to support older adults at high risk for hypoglycemia. If the aims of this project are achieved, this novel care strategy could be widely applied to reduce severe hypoglycemia episodes in older, high-risk adults with type 2 diabetes.

- EligibilityCriteria: Inclusion Criteria: Age 75 years and older Diagnosis of Type 2 Diabetes Current treatment with insulin Increased hypoglycemia risk (prior year hypoglycemia by self-report or utilization) Able to communicate in English Able to access email and the Internet Exclusion Criteria: On renal dialysis Dementia Pacemaker or Automatic Implantable Cardioverter Defibrillator Using insulin pump Severe Mental Illness Severe Visual Impairment In Hospice Current or recent CGM use - HealthyVolunteers: No - Gender: All - MinimumAge: 75 Years - StdAgeList: Older Adult

NCT06296472

Recruiting

De Quervain's Disease in the Acute Phase:a Study Aimed at Evaluating the Effectiveness of Standard Physiotherapy Treatment (HANDGUIDE), Compared to Experimental Treatment After Performing Ultrasound-guided Infiltrative Therapy.

The objective of the study is to compare pain reduction and disability reduction in two groups of patients diagnosed with de Quervain syndrome who will undergo ultrasound-guided infiltrative treatment with corticosteroid as per normal clinical practice: the control group will subsequently be subjected to a standard treatment based on the European guidelines of the HANDGUIDE group, the experimental group will subsequently carry out a program of eccentric exercises.

- EligibilityCriteria: Inclusion Criteria: Patients of both sexes with a minimum age of 18 years; Medical diagnosis of de Quervain syndrome assessed through orthopedic clinical examination e confirmation by ultrasound; Signing of the informed consent and participation in the study. Exclusion Criteria: Patients who are not self-sufficient or not able to understand and want; Presence of other pathologies in the hand affected by de Quervain pathology, such as intersection syndrome, neuropathies, fractures, rhizoarthrosis, arthrosis of the radio-carpal or intercarpal joint, intercarpal instability, cervical radiculopathy, rheumatic or metabolic pathologies; Pregnant or breastfeeding women. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296459

Recruiting

Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

A closed sinus augmentation is performed for dental implant placement.

- EligibilityCriteria: Inclusion Criteria: Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement. At least 5mm of native bone below the maxillary sinus. Nonsmokers. If diabetic, current HbA1C <7.0 (less than or equal to 7.0) Exclusion Criteria: Maxillary sinus disease. Pregnancy or attempting to become pregnant. Diseases that affect bone metabolism. Use of medications known to affect bone metabolism. Tobacco use. Alcoholism or recreational drug use. Diabetic with HbA1C >7.0 (above 7.0) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06296446

Not yet recruiting

Disability of People With Fibromyalgia in Poland

Fibromyalgia is a syndrome characterized by chronic, generalized pain in muscles and joints with the presence of characteristic, symmetrically occurring so-called "tender points" - areas of the body that are excessively sensitive to pressure. The condition is associated with a feeling of chronic fatigue, mood and sleep disturbances and a sensation of body stiffness. These complaints are bothersome and significantly impair patients' functioning in every aspect of their lives. There are few studies evaluating the functioning and disability of people with fibromyalgia. No such study has been conducted in Poland to date. Therefore, the purpose of this study is to evaluate the functioning and disability of fibromyalgia patients and the relationship of the level of disability with selected factors, such as pain intensity, emotional state, sleep quality, etc.

- EligibilityCriteria: Inclusion Criteria: People aged 18 and over People suffering from fibromyalgia People who give informed consent to participate in the study Exclusion Criteria: Tłumaczenie Underage persons People without fibromyalgia People who do not give informed consent to participate in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adults with fibromyalgia in Poland. - SamplingMethod: Probability Sample

NCT06296433

Not yet recruiting

Extended Reality-Assisted Therapy for Chronic Pain Management

The goal of this clinical trial is to test a home-based virtual reality rehabilitation application in patients with chronic low back pain. The main question it aims to answer are: Is a prototype of a novel VR software application effective at reducing pain, improving daily function, improving range of motion, and reducing fear of movement in adult patients with chronic low back pain compared with a passive VR intervention? Participants in the treatment group will use the application daily for 20 minutes for a period of 3 weeks at home and unsupervised. Researchers will compare use of the VR application with a control group that watches 2D video to see if the treatment group have improved pain, disability, range of motion, and fear of movement.

- EligibilityCriteria: Inclusion Criteria: Adults aged 18-65 of either sex Diagnosis of chronic low back pain of >12 weeks, with or without associated somatic referred leg pain Average pain intensity over the previous month ≤7/10 and ≥ 2/10) Exclusion Criteria: Spondylolysis, fracture, cauda equina syndrome, active spinal infection Acute radiculopathy or compromised nerve root Recent spinal surgery (<12 months) or lower limb surgery (<3 months) Major depressive symptoms as indicated by the Patient Health Questionnaire-2 depression screen score of 4 or more. Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, balance disorder, or other neurological diseases that may prevent the use of virtual reality or adverse effects. Cardiopulmonary or pulmonary disorder with contraindication to physical exercise Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06296420

Recruiting

Dysphagia After Thyroidectomy

The goal of this observational study is to develop a questionnaire for measuring swallowing and throat discomfort symptoms in patients with goiter or thyroidectomy, which complies with the model of Rasch and which satisfies the fundamental measurement axioms (e.g., unidimensionality, linearity, generalizability). Developing a scale with such characteristics would provide clinicians and researchers with a reliable tool for assessing the impact of goiter and for measuring the outcomes after surgery. Also, the study will assess the psychological impact of goiter and thyroidectomy, as well as the characteristics of the surgical scar after thyroidectomy. The questionnaire will be developed in the first phase of the study. Items and response categories will be identified through interviews performed with patients affected by goiter or after thyroidectomy. In the following phases of the study, the questionnaire will be administered to patients before and after thyroidectomy.

- EligibilityCriteria: Inclusion Criteria: Diagnosis of goiter or thyroidectomy. Exclusion Criteria: Diagnosis of other neurological disorders or disorders involving the aerodigestive tract that could cause swallowing disorders. Previous surgery of the neck or involving the aerodigestive tract. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: In the first phase, the study will recruit patients with diagnosis of goiter who are candidates to thyroidectomy and patients who have undergone thyroidectomy. Patients will be interviewed by the researchers. The interviews will face the symptoms of goiter or thyroidectomy, dealing (not exclusively) with throat and swallowing symptoms. The interviews will be recorded and analysed. The content of the interviews will be used to develop the items and the response categories of the questionnaire. In the second phase, the study will recruit patients who are candidates for thyroidectomy. The questionnaire (and the other outcome measures of the study) will be administered to the patients before and after surgery. All patients who are candidates for thyroidectomy at the Istituto Auxologico Italiano in Milan, Italy, will be recruited (if they comply with inclusion and exclusion criteria and if they provide consent). General, clinical and surgical data will be collected. - SamplingMethod: Non-Probability Sample

NCT06296407

Recruiting

Psychophysical Analysis of Adolescent Patients With Obesity and Efficacy of the Respiratory Approach (PSICOFISADOLOB).

Specifically, the project aims to pursue the following objectives: To evaluate in male and female adolescents with obesity the interaction between different psycho-body aspects such as respiration - posture - self-perception and affectivity and tolerance to physical exercise; To evaluate in a subgroup of male and female adolescents the effectiveness of exercises aimed at respiratory muscles and of respiratory consciousness on the parameters above indicated and on their interaction. The final objective of this project is to define and propose "take home" specific respiratory exercises to promote greater body awareness and a condition of psychophysical well-being stable over time, creating a condition that can favor further interventions on obesity. Finally, the project aims to build solid scientific bases to insert respiratory exercise among the intervention guidelines to prevent and reduce obesity, particularly youth obesity.

- EligibilityCriteria: Inclusion Criteria: BMI standard deviation score (SDS) > 2; absence of structured programs of physical activity (regular activity for more than 120min/week) for the 6 months before the study; absence of signs/symptoms related to cardiovascular, respiratory, gastrointestinal, skeletal-muscle pathologies contraindicated for the test execution Exclusion Criteria: BMI standard deviation score (SDS) < 2; presence of structured programs of physical activity (regular activity for more than 120min/week) for the 6 months before the study; presence of signs/symptoms related to cardiovascular, respiratory, gastrointestinal, skeletal-muscle pathologies contraindicated for the test execution - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06296394

Not yet recruiting

Health Outcomes of Parents With Cystic Fibrosis-Aim 2

The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are: H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression. H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stress H3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulators Participants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link.

- EligibilityCriteria: Inclusion Criteria: Diagnosed with cystic fibrosis via sweat test or genotype analysis Became a first-time parent (including foster parent, step parent, adoptive parent, or legal guardian) to a child under 5 years of age within the last 90 days Exclusion Criteria: Undergone a lung transplant Does not speak/read English or Spanish - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Individuals with cystic fibrosis who have become first-time parents to a child under 5 years of age. - SamplingMethod: Non-Probability Sample

NCT06296381

Not yet recruiting

Normative Values for Peripheral Muscle Strenght in Critical Patients and Healthy Individuals

Muscle strength is an important indicator of overall health and is a factor that has been associated with increased mortality in critical patients. Its measurement must be reliable and reproducible to ensure a quality outcome for clinical applicability. Recently, the use of digital handheld dynamometers in intensive care has gained support; however, analysis becomes challenging due to the absence of standardized reference equations for the Brazilian population. Our aim is to develop reference equations for the Brazilian population and define specific cutoff points for men, women, healthy individuals, and critical patients.

- EligibilityCriteria: Inclusion Criteria: Healthy individuals of both sexes Patients and volunteers aged between 18 and 90 years old (youth/adults/elderly). Patients admitted to the ICU. No recent muscle injuries of both limbs for a past 6-months. Exclusion Criteria: Patients and volunteers < 20 years and > 90 years Healthy individuals Unable to follow command completely Severe osteoporosis or neuromuscular disease leading to decreased muscle strength Presence of opened or infectious wound Presence of pain in evaluating muscle groups Patients in ICU Unable to follow command completely Acute stroke Hip fracture, unstable cervical spine or pathological fracture Recent surgery involving the upper airways, chest, abdomen, or limbs Presence of opened or infectious wound Presence of pain in evaluating muscle groups - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The population comprised adult and elderly individuals of both sexes able to do volitional tests. For the healthy sample, volunteers without barriers to the assessment of peripheral muscle strength will meet the inclusion criteria while, for the critical patient population, the sample will include individuals hospitalized in the Intensive Care Unit (ICU) who also do not have barriers to the assessment. - SamplingMethod: Non-Probability Sample

NCT06296368

Not yet recruiting

DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics

The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care.

- EligibilityCriteria: Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Written or verbal informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator. Age ≥ 60 years at the time of consent. New patient to either the hematologic malignancies clinic or the bone marrow transplant/cellular therapy clinic. Exclusion Criteria All subjects meeting any of the exclusion criteria listed below at baseline will be excluded from study participation: 1. Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent or participation in the intervention. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult

NCT06296355

Not yet recruiting

Impacts of Warning Labels on Ultra-Processed Foods

Purpose: The overall purpose of this study is to identify the impacts of an ultra-processed (UPF) health warning label and UPF identify warning label compared to a control label (i.e., a barcode). Participants: ~4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency, recruited from a Latino-focused panel company. Procedures: Participants will be randomly assigned to view food products with one of three label types: health warning labels, identity labels, or barcode control labels. Participants will be asked a series of questions about the products and the label they were assigned.

- EligibilityCriteria: Inclusion Criteria: Identifying as Latino or Hispanic Ages 18-55 years old Currently resides in the United States Exclusion Criteria: Not identifying as Latino or Hispanic Less than 18 or greater than 55 years old Not residing in the United States - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06296342

Not yet recruiting

Message Framing and Policy Support for Front-of-package Labeling

This study aims to assess whether different message framing about front-of-package labeling policies elicits more policy support than the control (no framing) among Latino and limited English proficiency populations. The study also seeks to identify which message framing elicits the most policy support.

- EligibilityCriteria: Inclusion Criteria: Identifying as Latino or Hispanic Ages 18-55 years old Residing in the United States Exclusion Criteria: Not identifying as Latino or Hispanic Less than 18 or greater than 55 years old Not residing in the United States - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult