pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study to Learn How Different Amounts of the Study Medicine Danuglipron Are Taken up Into the Blood in Otherwise Healthy Adults With Overweight or Obesity
NCT Number: NCT06568731
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Obesity
Interventions: DRUG: Danuglipron
Sponsor: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-23
Completion Date: 2025-03-31
Locations: Pfizer Clinical Research Unit - New Haven, New Haven, Connecticut, 06511, United States

Summary:
The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese:

* how the study medicine, danuglipron, is taken up into the blood
* about the safety and tolerability of danuglipron

The total number of weeks of the study is about 15 (about 4 months).

Primary Outcome Measures: Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron, Predose to 24 hours post danuglipron administration|Steady-state maximum observed concentration (Cmax) for danuglipron, Predose to 24 hours post danuglipron administration|Steady-state time to reach maximum observed concentration (Tmax) for danuglipron, Predose to 24 hours post danuglipron administration
Secondary Outcome Measures: Number of participants reporting Treatment Emergent Adverse Events (TEAEs), From baseline up to 28-35 days post last dose taken|Number of participants reporting clinically significant clinical laboratory abnormalities, From baseline up to 28-35 days post last dose taken|Number of participants reporting clinically significant vital sign abnormalities, From baseline up to 28-35 days post last dose taken|Change from baseline in body weight, From baseline up to 28-35 days post last dose taken|Number of participants reporting clinically significant changes ECG abnormalities, From baseline up to 28-35 days post last dose taken
Hypofractionated Online Adaptive Radiotherapy of Breast Cancer
NCT Number: NCT06568705
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer
Interventions: RADIATION: Moderate hypofractionated Radiation Treatment|RADIATION: Ultrafractionated Radiation Treatment
Sponsor: Peking Union Medical College Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12
Locations: Peking Union Medical College Hospital, Beijing, China

Summary:
The goal of this clinical trial is to explore the application of online adaptive radiotherapy in patients who receive moderate hypofractionated or ultrafractionated radiotherapy after breast cancer surgery. The main questions it aims to answer are:

* Can online adaptive radiotherapy improve the accuracy of dose delivery?
* In patients undergoing online adaptive radiotherapy, how are the treatment-related toxicities and tumor control outcomes?

Participants will Receive moderate hypofractionated radiotherapy using online adaptive radiotherapy, a dose of 43.5Gy in 15 fractions or receive ultrafractionated radiotherapy using online adaptive radiotherapy, a dose of 26Gy in 5 fractions.

Primary Outcome Measures: The dose coverage of target volume as assessed by planning tumor volume V100%, Planning tumor volume V100%, defined as the planning tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume., 3 months after radiotherapy
Secondary Outcome Measures: Treatment-related toxicity, Toxicity is evaluated by Common Terminology Criteria for Adverse Events v5.0., Baseline; Every week during radiotherapy; 1 week, 2 weeks, 3/6/12/24 months after radiotherapy.|Local recurrence rate (LRR), LRR will be deducted from the local recurrence survival defined as the interval between date of surgery and the occurrence of local relapse., 3, 6, 12, 24 months after radiotherapy
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
NCT Number: NCT06568692
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer|TNBC - Triple-Negative Breast Cancer|HER2-negative Breast Cancer
Interventions: DRUG: PCS6422 and capecitabine|DRUG: Capecitabine
Sponsor: Processa Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-10
Locations: Clinical Research Alliance, Westbury, New York, 11590, United States|Gabrail Cancer Center Research, Canton, Ohio, 44718, United States

Summary:
This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors.

Primary Outcome Measures: Evaluation of Objective Response Rate (ORR), The proportion of patients who achieved a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), Up to 24 weeks post End of Treatment (EoT)|Number of patients with adverse events (AEs), Frequency, duration, and severity of AEs across treatment groups, During treatment, an average of 8 months
Secondary Outcome Measures: Evaluation of Disease Control Rate (DCR), The proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST 1.1, Up to 24 weeks post End of Treatment (EoT)|Evaluation of Duration of Response (DOR), Up to 24 weeks post End of Treatment (EoT)|Evaluation of Time to Response (TTR), Every 12 weeks during treatment|Evaluation of Progression Free Survival (PFS), Up to 24 weeks post End of Treatment (EoT)
The Effect of Lumbar and Sacroiliac Manipulation on Football Players
NCT Number: NCT06568666
Acronym: ELSMFP
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sports Physical Therapy|Neuromuscular Subluxation of Joint
Interventions: OTHER: Lumbar spinal manipulation|OTHER: Sacroiliac joint manipulation
Sponsor: SEFA HAKTAN HATIK
Sex: MALE
Age: ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-01
Completion Date: 2024-08-01
Locations: Sefa Haktan Haktik, Sinop, Turkey

Summary:
The purpose of this study was to assess the immediate effects of chiropractic spinal manipulation methods on the lumbar and sacroiliac regions on professional soccer players' flexibility and leaping abilities.

Primary Outcome Measures: V-Sit Reach Test, The participant is advised to sit on the floor with his legs straight front. The toes are pointed up, the heels are in touch with the ground, and there is about a 30-centimeter distance between them. A line is drawn connecting the spots where the heels strike the ground, and this line is used as the zero line for measurements. The patient is urged to reach forward with his hands as far as he can while keeping his knees extended. The distance between the attained point and the zero point is measured in centimeters. The numerical value is preceded by (+) and (-), which denote the location relative to the zero point. The knees should be kept in extension during the test. To obtain a measurement result, the tested person repeats the movement twice and the practitioner records the best result (+) or (-) in cm., This test was performed 5 minutes before and immediately after the manipulation.|Vertical Jump, The athlete stands facing the platform allocated for the test. With one arm, he/she reaches the highest point possible, and the test administrator marks the platform. The athlete jumps and touches the highest place he or she is able to reach, and is then noted. The test administrator measures the distance between these two spots and notes it in centimeters. The test must be taken twice. The best results are considered., This test was performed 5 minutes before and immediately after the manipulation.|Horizontal Jump, It is a test that assesses athletes' balance, jumping strength, and lower extremity strength in both vertical and horizontal planes. The test starting location is marked on the floor with a marker. In this stance, the individual being tested waits for the required acceleration. They leap as far as possible utilizing their single and double legs, as directed by the test administrator. The distance from the starting position to the leap point is measured. The test is repeated twice, and the best result is recorded in centimeters., This test was performed 5 minutes before and immediately after the manipulation.
Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula
NCT Number: NCT06568653
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Fistula Perianal
Interventions: PROCEDURE: exosome|PROCEDURE: routine conventional fistulotomy
Sponsor: Tehran University of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2025-02-15

Summary:
The goal of this clinical trial is to learn if human placenta mesenchymal stem cells (MSC)-derived exosomes work to treat complex perianal fistula in adults without Crohn's disease. The safety of this treatment will also be learned. The main questions it aims to answer are:

* Does treatment with MSC-derived exosomes lower the number of fistula recurrences in participants?
* Is treatment with MSC-derived exosomes safe? We will compare treatment with MSC-derived exosomes to the routine treatment which is fistulotomy (surgery to close the fistula) alone to see if MSC-derived exosomes work better to treat complex fistula.

Participants will:

* Undergo fistulotomy plus MSC-derived exosome injections or fistulotomy alone.
* Visit the clinic the week after surgery and then every 4 weeks for checkups and tests

Primary Outcome Measures: The number of fistula openings (orifices) will be assessed before and after our intervention., clinical improvement, 3 months
Secondary Outcome Measures: QoL questionnaire, quality of life improvement (before and after intervention) assessed by Persian (Farsi) version of the QoLAF (quality of life in patients with anal fistula) questionnaire, 3 months
Superselective Adrenal Arterial Embolization for Refractory Hypertension: A Proof-of-Concept Study
NCT Number: NCT06568640
Acronym: SAAE-RH
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Essential Hypertension
Interventions: PROCEDURE: Superselective adrenal arterial embolization
Sponsor: Second Affiliated Hospital of Nanchang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-12
Locations: The Second Affiliated Hospital of Nanchang University, Nanchang, China

Summary:
The subjects of this study were patients with essential refractory hypertension. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary refractory hypertension.After the subject completes the SAAE, an 8-week follow-up will be conducted to assess the safety and effectiveness of the SAAE.

Primary Outcome Measures: 24-hour mean systolic blood pressure, ambulatory blood pressure monitoring, 8 weeks after SAAE
Secondary Outcome Measures: Proportion of patients with non-refractory hypertension, Describe how many patients are converted from refractory hypertension to non-refractory hypertension, 8 weeks after SAAE|24-hour mean diastolic blood pressure, ambulatory blood pressure monitoring, 8 weeks after SAAE|Safety monitoring:Procedure-related complications, Procedure-related complications include but are not limited to the following: transient arrhythmia during the SAAE procedure, incidence of hypertensive encephalopathy; post-procedure complications such as pleural effusion, brachial artery pseudoaneurysm, brachial artery thrombosis, pancreatitis, and contrast-induced nephropathy., up to 8 weeks|Safety monitoring:Adrenal-related hormones, Plasma aldosterone concentration, plasma renin activity, plasma cortisol concentration, corticotropin-releasing hormone level, blood catecholamine levels, sex hormone levels., 8 weeks after SAAE|Safety monitoring:Kidney function, Estimated Glomerular Filtration Rate, 8 weeks after SAAE|Safety monitoring:Plasma electrolyte levels, Plasma potassium, 8 weeks after SAAE
Other Outcome Measures: Daytime average systolic blood pressure, Daytime average systolic blood pressure, 8 weeks after SAAE|Daytime average diastolic blood pressure, Daytime average diastolic blood pressure, 8 weeks after SAAE|Nighttime average systolic blood pressure, Nighttime average systolic blood pressure, 8 weeks after SAAE|Nighttime average diastolic blood pressure, Nighttime average diastolic blood pressure, 8 weeks after SAAE
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
NCT Number: NCT06568627
Acronym: VALUE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Venous Leg Ulcer (VLU)
Interventions: DRUG: EscharEx (EX-03)|DRUG: Placebo (Gel vehicle)
Sponsor: MediWound Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 216
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2026-10

Summary:
The main objective of this study is:

To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU).

Primary Outcome Measures: Incidence of complete debridement, clinically (visually) assessed after each application, counting events of complete debridement, up to 2 weeks|Incidence of complete wound closure, counting events of complete wound closure, up to 12 weeks
Secondary Outcome Measures: Incidence of complete healthy viable granulation tissue, as assessed clinically, counting events of complete granulation, up to 2 weeks|Time to the first declaration of complete debridement, clinically assessed, count in days, up to 12 weeks|Time to complete wound closure, clinically assessed, count in days, up to 12 weeks|Percent change in wound area, as assessed by eKare inSightTM, count in percentage, up to 12 weeks
Other Outcome Measures: Incidence and severity of systemic and local adverse events, up to 27 weeks|Incidence of target wound infections, counting events, up to 27 weeks|Incidence of discontinuation due to adverse events, counting events of discontinuation, up to 27 weeks|Change in pain, as assessed by Numeric Pain Rating Scale (NPRS), up to 12 weeks|Immunogenicity evaluation, measurement of Anti-Drug-Antibodies levels, baseline, post last daily visit, 4 and 10 weeks following last daily visit, and on last monthly visit
Study of SYH2039 in Participants With Advanced Solid Tumors
NCT Number: NCT06568614
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced or Metastatic MTAP-deleted Solid Tumors
Interventions: DRUG: SYH2039
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 186
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-21
Completion Date: 2026-12-30

Summary:
This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD and preliminary anti-tumor activity of SYH2039 in adult patients with selected advanced or metastatic advanced solid tumors who are unresponsive to standard of care therapy. SYH2039 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).

Primary Outcome Measures: Dose-limiting Toxicities (DLTs) of SYH2039, Incidence of DLTs of SYH2039 will be determined, 24 days following the first dose of SYH2039|Recommended Phase 2 Dose (RP2D) of SYH2039, RP2D of SYH2039 will be determined, Approximately 2 years
Secondary Outcome Measures: Maximum Concentration (Cmax) of SYH2039, Approximately 2 years|Time to Maximum Concentration (Tmax) of SYH2039, Approximately 2 years|Objective response rate (ORR), ORR will be assessed by Investigator using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), Approximately 2 years|Duration of response (DOR), DOR will be assessed by Investigator using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), Approximately 2 years|S-adenosylmethionine (SAM), Change from Baseline in Circulating Concentration of SAM, Approximately 2 years
Pharmacogenomic Informed Statin Prescribing
NCT Number: NCT06568601
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypercholesterolemia
Interventions: GENETIC: Pharmacogenetic and polygenic risk testing|OTHER: Active control
Sponsor: VA Office of Research and Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 410
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-12-02
Completion Date: 2028-07-28
Locations: Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis, Indiana, 46202-2884, United States|Durham VA Medical Center, Durham, NC, Durham, North Carolina, 27705-3875, United States

Summary:
Statins are the most cost-effective medications to lower cholesterol and cardiovascular disease (CVD) risk. However, many patients at high-risk for CVD do not accept or adhere to statins. This gap in patient's use of statins limits the full impact of these effective medications resulting in higher cholesterol levels and CVD risk. The main barriers to using statins are patients' perceived lack of benefit, excess risk of statin toxicity as well as their misperceptions of their CVD risk. Statin pharmacogenomic testing - an application of precision medicine - is a readily available, feasible, and inexpensive intervention that addresses this barrier by using genetic testing to identify the nearly 1 out of 2 patients with enhanced benefit and/or reduced risk of statin toxicity or increased risk for CVD. By communicating statin pharmacogenomic test results to Veterans at high-risk for CVD not taking statin therapy, the investigators aim to improve patients' perceptions of their risk of CVD and statins and, in turn, their acceptance of and adherence to statins to reduce their cholesterol levels and CVD risk.

Primary Outcome Measures: Change in low density lipoprotein cholesterol, The primary effectiveness outcome will be the change in LDL-cholesterol level from baseline to 15-months., 15-months
Coiling of Echogenic Sciatic Nerve Perineurial Catheters With Integral Stylet
NCT Number: NCT06568510
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pain|Trauma
Interventions: PROCEDURE: Continuous peripheral nerve block
Sponsor: Attikon Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-10
Completion Date: 2024-07-15
Locations: Department of anesthesia ,ATTIKON UNIVERSITY HOSPITAL OF ATHENS, Athens, Attica, 15562, Greece

Summary:
Coiling of perineurial catheters under the sciatic nerve and examination of catheters position through ultrasound imaging 36 hours postoperatively.

Primary Outcome Measures: Rate of correct placement of coiled perineural catheters under the sciatic nerve, A Tuohy needle is placed underneath the sciatic nerve. Then, a catheter is headed out through the curved tip of the Tuohy needle and coils underneath the sciatic nerve. Catheter's position was assessed after 36 hour postoperatively. Catheters tip internal displacement was assessed after contact with the nerve of 3 cc of local anesthetic injecting via the catheter (maximum three tines)., 10 minutes
Dairy and Vegan Cheese: Effect on Satiety and Blood Glucose
NCT Number: NCT06568497
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Glucose|Satiety Response
Interventions: OTHER: Food
Sponsor: Mount Saint Vincent University
Collaborators: Dairy Farmers of Canada
Sex: ALL
Age: ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-04
Completion Date: 2025-12-31
Locations: Mount Saint Vincent University, Halifax, Nova Scotia, B3M 2J6, Canada

Summary:
The project will consist of two studies. One study will explore the satiating properties of dairy cheese and its dairy-free substitute when consumed ad libidum, and another study will investigate their effects on postprandial glycemia. Both studies will involve healthy young adults. The secondary outcomes of these studies will be food sensory characteristics, diet-induced thermogenesis, subjective feeling of fatigue and energy, gastrointestinal comfort level, and food intake. The proposed project results will help to better understand the health properties of the cheese and its dairy-free substitute.

Primary Outcome Measures: Blood glucose, The concentrations of blood glucose, 0-120 minutes|Insulin, The concentrations of insulin, 0-120 minutes|Satiety, The components of average subjective appetite including desire to eat, hunger, fullness, and a prospective food consumption measured with 100mm visual analogue scales., 0-120 minutes|Food intake, Energy intake with an ad libitum meal at 120 minutes, 0 minutes, 120 minutes
Secondary Outcome Measures: Energy and Fatigue, Subjective perception of feeling energetic and fatigue, 0-120 minutes|Gastrointestinal comfort, The subjective feeling of wellness and gastrointestinal discomfort parameters including the feeling of nausea, stomach cramps, flatulency, diarrhea and a subjective feeling of wellness, each measured with 100mm visual analogue scales., 0-120 minutes|Diet-induced thermogenesis, Indirect calorimetry, 0-120 minutes|Sensory characteristics, The perception of pleasantness of the treatments (0 minutes) and a test meal (at 120 minutes) will be measured with 9-point hedonic and 100mm visual analogue scales., 0 minutes, 120 minutes
A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Ninetedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants
NCT Number: NCT06568458
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: Nintedanib|DRUG: BMS 986278
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 73
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-17
Completion Date: 2024-11-22

Summary:
The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants

Primary Outcome Measures: Maximum Observed Serum Concentration (Cmax), Days 4, 17, 21 (Part-1); Days 1, 7, 13 (Part-2); Days 1, 7 (Part-3)|Area under the plasma concentration-time curve within a dosing interval AUC(TAU), Day 4, 17 and 21 of Part 1|Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T), Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)|Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF), Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Secondary Outcome Measures: Number of participants with non-serious AEs (Adverse events), Up to 28 Days post discontinuation of dosing|Number of participants with Serious AEs, Up to 28 Days post discontinuation of dosing|Number of participants with AEs leading to discontinuation, Up to 28 Days post discontinuation of dosing|Number of participants with Physical examination abnormalities, Up to 28 Days post discontinuation of dosing|Number of participants with vital sign abnormalities, Up to 28 Days post discontinuation of dosing|Number of participants with 12-lead electrocardiogram (ECG) abnormalities, Up to 28 Days post discontinuation of dosing|Number of participants with clinical laboratory abnormalities, Up to 28 Days post discontinuation of dosing|Time of maximum observed plasma concentration (Tmax), Day 4, 17, 21 (Part-1), Day 1 (part-2 and Part-3), Day 7 (Part2 and 3), Day 13) (Part-2)|Apparent terminal phase half-life (T-HALF), Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)|Apparent total body clearance (CLT/F), Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)|Apparent volume of distribution of terminal phase (Vz/F), Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Effectiveness of Calisthenic Exercises in Post-Covid Syndrome
NCT Number: NCT06568393
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Quality of Life
Interventions: OTHER: Calisthenic exercise
Sponsor: Bahçeşehir University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 176
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2024-04-15
Locations: Igdır University, Igdır, Center, 76000, Turkey

Summary:
Post-Covid syndrome is known as the appearance of some symptoms for 12 weeks or more after Covid-19 infection, affecting the patient's quality of life. The wide range of symptoms that occur after post-Covid syndrome has led to the development of different interventions. In this study, we tried to measure changes in quality of life in people with post-covid syndrome as a result of using calisthenics with therapists and home exercise. Quality of life scale scores were compared before and after an 8-weeks exercise intervention.

Primary Outcome Measures: EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version), Depending on the answers given in this questionnaire, 1 - 3 points are assigned, while a low score indicates a healthy state, a high score indicates a problem that reduces the quality of life. In the second part of the questionnaire, there is a part where a score between 0-100 is asked to explain the state of being healthy today, in this part, low scores indicate that there are health problems and high scores define the state of being healthy., Baseline of the study
Validation of a Boindicator as Monitoring Tool for Oyster Norovirus Outbreak
NCT Number: NCT06568380
Acronym: VIROYSTER
Status: WITHDRAWN
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastroenteritis Norovirus
Interventions: OTHER: Oyster consumption
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT
Enrollment: 0
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2020-01
Completion Date: 2020-02
Locations: CHRU Nancy, Nancy, Lorraine, 54000, France

Summary:
Noroviruses are responsible for 700M of annual cases of gastroenteritis, of which 15M are directly related to the consumption of contaminated food, including oysters. Current regulations do not require control of human noroviruses in shellfish. However, an ISO standard recommended to detect their genome in high-risk foodstuffs. However, presence of viral genome doesn't testify to the presence of infectious particles. Routine application of this standard would therefore wrongly lead to the withdrawal of shellfish from market, since norovirus genomes are widely found in the environment and in food without indicating a viral risk. Given the difficulty of cultivating human noroviruses in vitro and thus of discriminating infectious particles from non-infectious particles only based on genome detection, it is necessary to identify an indicator of the infectious nature of these pathogenic viruses. To be suitable, the indicator must first be associated with the presence of norovirus genome in the environment. This is the case of fecal bacteriophage F-specific RNA. Since bacteriophages are cultivable in the laboratory, it is easy to estimate the proportion of genomes of these bacteriophages corresponding to infectious particles. To confirm this indicator, it is necessary to demonstrate a relationship between the presence of infectious bacteriophages with that of infectious norovirus. This is only estimable by the occurrence of a gastroenteritis after consumption of a contaminated food by humans. We propose this randomized controlled clinical trial to evaluate the incidence of norovirus infection after consumption of oysters free from or containing infectious F-specific RNA bacteriophages.

The purpose of this study is to evaluate if norovirus infections incidence is significantly weak after the consumption of oysters free of F-specific infectious RNA bacteriophages, compared to the consumption of oysters containing these same infectious bacteriophages.

Primary Outcome Measures: Norovirus concentration in feces (genome copy number/grammes of feces), A norovirus genome augmentation may indicate virus replication, Baseline (J0) and during symptoms if any or within 36-60 hours after consumption in another case|Gastroenteritis symptoms, within 3 days after consumption|Immunoglobulin A (IgA) detection in feces, In case of asymptomatic infection, IgA are secreted, within 3-5 days after consumption
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
NCT Number: NCT06568367
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Excessive Sleepiness|Shift-work Disorder
Interventions: DRUG: Solriamfetol 150 mg|DRUG: Solriamfetol 300 mg|DRUG: Placebo
Sponsor: Axsome Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 520
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-12
Locations: Clinical Research Site, Chula Vista, California, 91910, United States|Clinical Research Site, Long Beach, California, 90805, United States|Clinical Research Site, Atlanta, Georgia, 30238, United States|Clinical Research Site, Stockbridge, Georgia, 30281, United States|Clinical Research Site, Huntersville, North Carolina, 28078, United States|Clinical Research Site, Cincinnati, Ohio, 45212, United States|Clinical Research Site, Cincinnati, Ohio, 45245, United States|Clinical Research Site, Wyomissing, Pennsylvania, 19610, United States|Clinical Research Site, Columbia, South Carolina, 29201, United States|Clinical Research Site, San Antonio, Texas, 78229, United States

Summary:
SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder (SWD).

Primary Outcome Measures: Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT)., 12 weeks|Change from Baseline to Week 12 in the Clinical Global Impressions of Severity of Illness (CGI-S) for sleepiness during the night shift., 12 weeks
Turkish Validity-Reliability of the Outcome Expectations For Yoga Scale
NCT Number: NCT06568341
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Adults
Interventions: OTHER: validity and reability study
Sponsor: Hacettepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-02-28

Summary:
Evaluation of the Turkish validity and reliability of the outcome Expectations for Yoga (OEY) Scale, which was developed to evaluate attitudes and beliefs related to yoga practice

Primary Outcome Measures: The Outcome Expectations for Yoga (OEY) Scale, Reliability and Validity of OEY scale by Correlation Analysis., 6 months
Secondary Outcome Measures: Five Facet Mindfulness Questionnaire Short Form, Individuals' mindfulness levels will be evaluated. The scale evaluates individuals' mindfulness levels under 5 factors ("Observing", "Describing", "Acting with Awareness", "Non-Judgement", and "Non-Reactivity"). A 5-point Likert-type assessment (1=Never, 2=Rarely, 3=Sometimes, 4=Frequently, 5=Almost Always) is used in the evaluation of scale items. Higher scores are indicative of someone who is more mindful in their everyday life., 6 months|Exercise Self Efficacy Scale, Individuals' exercise self-efficacy will be assessed. The Exercise Self-Efficacy Scale consists of 6 questions scored between 0-100 (0=not confident at all, 100=completely confident) on a visual analog scale and measures the self-efficacy of individuals to exercise despite various barriers. The total score is obtained by summing the scores of the 6 questions. As the score increases, the level of self-efficacy also increases., 6 months|International Physical Activity Questionnaire-Short Form, Physical activity levels of individuals will be evaluated., 6 months|Short Form-12 Health Survey, Individuals' quality of life will be assessed. Short Form-36 is a 36-item self-reported test developed to measure eight different health concepts (physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/fatigue, bodily pain, and general health perception) in any general or clinical population. Short Form-12 is a shorter version of Short Form-36 and includes the same sub-dimensions. The scale can be scored between 0-100. Higher scores indicate higher quality of life., 6 months
Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD
NCT Number: NCT06568328
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Graft vs Host Disease
Interventions: BIOLOGICAL: Chimeric Natural Killer Receptor Universal T-cells (CNK-UT)
Sponsor: Fujian Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 17
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-08-31
Locations: First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China

Summary:
This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with steroid-refractory/resistant or steroid-dependent GVHD.

Primary Outcome Measures: Incidence of Treatment Related adverse events (AEs), Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs) assessed by NCI-CTCAE v5.0 criteria, up to 1 year|Identification of Maximum Tolerated Dose (MTD) & incidence of Dose-limiting Toxicities (DLTs), Incidence of dose-limiting toxicities (DLTs), up to 21 days since first infusion of CNK-UT cells
Secondary Outcome Measures: Objective Response Rate (ORR), Overall response is defined as either a complete or partial response (CR+PR), the response should be confirmed no less than 4 weeks after the first evaluation., 6 months|Best Overall Response (BOR), The best efficacy recorded from the beginning of treatment to the progression or recurrence of the disease., 6 months|Duration of Response (DOR), The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause., 6 months|Progression-free Survival (PFS), The period from the day when the participant receives the cell therapy to the first recorded disease progression (whether treated or not) or death of any cause, which occurs first., 6 months|Overall survival (OS), The period from the first infusion to any cause of death., 6 months|Pharmacokinetics (PK) (Cmax), The Peak Plasma concentration (Cmax) of amplified CNK-UT DNA in peripheral blood after infusion., up to 48 weeks|Pharmacokinetics (PK) (Tmax), The time to reach the maximum concentration (Tmax), up to 48 weeks|Pharmacokinetics (PK), The Area under the plasma concentration versus time curve (AUC) of amplified CNK-UT DNA in peripheral blood after infusion., up to 48 weeks|Levels of peripheral blood lymphocyte subsets, Percentage of CD45+CD3+TCR+T cell、CD3+CD8+ CD25+ CD69+T cell、CD3+CD4+CD25+ CD69+ T cell and Treg（CD4+CD25+FoxP3+）cell in peripheral blood detected by FCM after infusion., up to 48 weeks
Other Outcome Measures: Biomarkers, ST2、REG3α and Elafin will be analyzed, Enrollment and evaluated as complete remission (CR), or if necessary，up to 48 weeks|HLA typing, Evaluate the impact of HLA typing matching between donors and participants on the survival time and efficacy of CNK-UT in vivo., Enrollment.
The Long-term Safety and Efficacy of SerpinPC in Subjects With Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
NCT Number: NCT06568302
Acronym: PRESent-6
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Hemophilia A|Hemophilia B|Hemophilia A With Inhibitor|Hemophilia B With Inhibitor
Interventions: DRUG: SerpinPC
Sponsor: ApcinteX Ltd
Collaborators: Centessa Pharmaceuticals plc
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-11
Completion Date: 2028-11
Locations: Arensia Clinical Research Unit, Tbilisi, 0112, Georgia|Arensia Clinical Research Unit, Chisinau, Moldova, Republic of

Summary:
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia

Primary Outcome Measures: Treated bleeds, expressed as annualized bleeding rate (ABR), Month 0 to Month 25 or Early termination
Secondary Outcome Measures: Treated spontaneous bleeds (expressed as ABR), Month 0 to Month 25 or Early termination|Treated spontaneous joint bleeds (expressed as ABR), Month 0 to Month 25 or Early termination|All bleeds requiring treatment (expressed as ABR, ie, all treated bleeds and all bleeds that would ordinarily be treated with factor concentrate/bypass agent if therapy were available), Month 0 to Month 25 or Early termination|Total coagulation factor and/or bypass product consumption, Month 0 to Month 25 or Early termination
Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae
NCT Number: NCT06568289
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lignocaine|Bupivacaine|Postpartum Perineal Pain|Vaginal Delivery|Episiotomy|Primigravidae
Interventions: DRUG: Lignocaine|DRUG: Bupivacaine
Sponsor: Ain Shams University
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2024-09-01
Locations: Ain Shams University, Cairo, Egypt

Summary:
In this study, we will compare the effect and safety of lignocaine versus bupivacaine infiltration for postpartum perineal pain after vaginal delivery with episiotomy in primigravidae.

Primary Outcome Measures: Degree of pain, Degree of pain will be assessed using the visual analogue scale (VAS) is the scale that will be used to assess postoperative pain and its intensity. A respondent will select a whole number (0- 10 integers) that best reflects the intensity of her pain, 1-10 will be recorded.

Postoperative analgesic effect will be assessed using numeric version of the visual analogue scale (VAS) after delivery and local anesthetic infiltration (immediately after delivery, after 2 hours, after 4 hours, and after 6 hours)., 6 hours postoperatively
Secondary Outcome Measures: The time till first analgesic requirement, The time till first analgesic (non-steroidal anti-inflammatory drugs (NSAIDs) requirement which is defined as the time (immediately after delivery, after 2 hours, after 4 hours and after 6 hours) after delivery and local anesthetic infiltration. Rescue analgesia of morphine will be given as 3 mg bolus if the visual analogue scale \> 3 to be repeated after 30 min if pain persists until the visual analogue scale \< 4. VAS will be assessed after delivery, after 2 hours, after 4 hours, and after 6 hours., 6 hours postoperatively|Total analgesics consumption, Total analgesics consumption over 12-hour period post-operative with mentioning the number and time of drugs given and the total dose of each drug post-operative (presented by hours post-operative).Rescue analgesia of morphine will be given as 3 mg bolus if the visual analogue scale \> 3 to be repeated after 30 min if pain persists until the visual analogue scale \< 4. VAS will be assessed after delivery, after 2 hours, after 4 hours, and after 6 hours., 12 hours postoperatively|Incidence of compilation, Incidence of compilation will be recorded such as as allergy, nausea, vomiting, fever, angioedema or respiratory distress., 6 hours postoperatively|Time of post-operative ambulation, Post-operative ambulation enhancement in the form of time of start of ambulation (in hours) starting from end of surgery- walking- climbing stairs will be recorded., 12 hours postoperatively
Celiac Disease and Quality of Life in Children and Adolescents (CeliaQLife)
NCT Number: NCT06568263
Acronym: CeliaQLife
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Celiac Disease in Children|Nutritional Deficiency|Quality of Life
Sponsor: Oslo University Hospital
Collaborators: University of Oslo
Sex: ALL
Age: CHILD, ADULT
Enrollment: 160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2025-12-20
Locations: Oslo University Hospital, Oslo, 0372, Norway|University of Oslo, Oslo, 0372, Norway

Summary:
Celiac disease is a disorder commonly diagnosed during childhood. The treatment is a lifelong gluten-free diet. Both the condition and the diet can influence the children's physical and emotional well-being.

The main goal of this observational study is to learn about nutritional status in a group of children with celiac disease compared to a group of healthy children.

The nutritional assessment includes information on diet, biochemical measurement, and body composition. Quality of life will also be assessed.

The study can contribute to ensure good health and well-being in children on a gluten-free diet.

Primary Outcome Measures: Iron deficiency will be assessed from hemoglobin and ferritin in children with celiac disease and in healthy children. Differences in the prevalences of iron deficiency between children with celiac disease and healthy children will be described., Blood samples will be analyzed for blood hemoglobin and serum ferritin., All participants will be assessed once. The study time frame is from August 2024 until December 2025.
Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention - UG3 Pilot
NCT Number: NCT06568250
Acronym: RAMP UG3
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pain
Interventions: BEHAVIORAL: RAMP program
Sponsor: Minneapolis Veterans Affairs Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-07
Completion Date: 2025-02
Locations: Minneapolis VAMC, Minneapolis, Minnesota, 55417, United States

Summary:
This project addresses the significant challenge of providing evidence-based non-pharmacologic pain management to rural-dwelling Veterans in the VA healthcare system who have chronic pain. For this preparatory phase (UG3) the investigators will conduct a pilot study of 40 rural VA patients with chronic pain to assess the feasibility of delivering RAMP (experimental intervention for the UH3 trial) in terms of recruitment and engagement, intervention fidelity and adherence, data collection, and other key metrics.

Primary Outcome Measures: Number of Participants Recruited, 40 rural-dwelling VA patients recruited, 3 months|Percentage of Female and Racial/Ethnic Minoritized Participants Recruited, At least 35% female and 35% racial/ethnic minority patients recruited, 3 months|Percentage of Participants Who Report Being "Somewhat Satisfied" or "Very Satisfied" with the Program on a 7-point Scale, 75% satisfied with RAMP program, 3 months|Percentage of Participants Who Attend/Engage with Recommended Number of Sessions, 75% attend/engage with recommended # of sessions (≥ 7/12), 3 months|Intervention Fidelity Based on Observation By Trained Raters, Facilitators deliver 90% of session activities 90% of the time, 3 months|Percentage of Participants Who Complete Post-Treatment Data Collection, \>80% complete post-treatment data collection (at 3 months), 3 month
Therapeutic Effect of Methalazine on 27 Cases of Suppurative Hidradenitis
NCT Number: NCT06568224
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hidradenitis Suppurativa
Interventions: DRUG: Mesalazine
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-05-01
Completion Date: 2023-09-01
Locations: Jiangsu Provincial People's Hospital, Nanjing, Nanjing, 210029, China

Summary:
Background: Hidradenitis suppurativa (HS) is a chronic inflammatory relapsing disease involving the axillae, breast ,groin and anogenital regions. The therapies of the disease are diverse, including medication and surgery. However, responses to treatments are variable and relapse is common, with no single agent being consistently effective.

Objective: To evaluate the efficacy and safety of oral mesalazine treatment for hidradenitis suppurativa .

Methods: Investigators reported a series of cases of patients who received oral mesalazine(1g qid) for hidradenitis suppurativa in our institution between May 2020 and September 2023. A total of 27 patients, 22 in the mild to moderate group and 5 in the severe group, were included in this study.

Primary Outcome Measures: Therapeutic Effect of Methalazine on 27 Cases of Suppurative Hidradenitis, We registered the number of patients who achieved HiSCR（%）., Three and a half years
Modulation Effect of tACS on Chronic Low Back Pain
NCT Number: NCT06568198
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Low-back Pain
Interventions: DEVICE: Real tACS|DEVICE: Sham tACS
Sponsor: Massachusetts General Hospital
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2025-03
Completion Date: 2028-03

Summary:
Investigating the modulation effect of tACS

Primary Outcome Measures: thalamo-sensory-cortex connectivity, Functional connectivity between the thalamus and sensory-motor cortex as measured by Functional magnetic resonance imaging (fMRI) and Magnetoencephalography (MEG) using MRI scanner and MEG device, about one month, data will be collected at baseline and after one month treatment
Secondary Outcome Measures: Low back pain intensity, As measured by pain visual analog scale (0-10), about one month, data will be collected at baseline and after one month treatment