pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Intern Health Study 2024
NCT Number: NCT06465680
Acronym: IHS
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Mood|Sleep|Physical Activity
Interventions: BEHAVIORAL: Intern Health Study behavioral change mobile notification
Sponsor: University of Michigan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-06-30
Locations: University of Michigan, Ann Arbor, Michigan, 48109, United States

Summary:
The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.

Primary Outcome Measures: Average daily mood, Through the mobile app, participants enter a mood score (scale 1 - 10) every day of the study. 1 corresponds to lowest mood and 10 corresponds to highest mood., Daily, through study completion at the end of intern year (1 year)|Average daily step count, Participant's daily step counts are recorded through a fitness tracker. High step counts are considered a positive outcome as it indicates more physical activity., Daily, through study completion at the end of intern year (1 year)|Average nightly sleep duration, Participant's nightly sleep duration (in minutes) is recorded through a fitness tracker. High sleep duration is considered a positive outcome., Daily, through study completion at the end of intern year (1 year)|Patient Health Questionnaire-9 (PHQ-9), Prior to the start of the intervention and at quarterly intervals throughout internship year, all participants complete the Patient Health Questionnaire 9. High scores on the PHQ-9 correspond to a larger number of depressive symptoms., Quarterly (every 3 months for 1 year)
Improving Engagement With a Process Measure Dashboard Through Precision Feedback
NCT Number: NCT06465667
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Behavior
Interventions: BEHAVIORAL: Dashboard|BEHAVIORAL: Precision Feedback Push
Sponsor: University of Michigan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-17
Completion Date: 2025-10
Locations: University of Michigan, Ann Arbor, Michigan, 48109, United States

Summary:
The study seeks to assess the impact of e-mailing specific, targeted, practice-pattern based information ("precision feedback") on provider engagement with a dashboard for a quality process measure (showing stent omission after pre-stented ureteroscopy), compared with generic information ("one size fits most" feedback).

Primary Outcome Measures: Clickthrough rate to the online dashboard, Clickthrough is defined as a link ever being clicked in the three months following e-mail send date, at which point in time a new e-mail will be sent. Clickthrough rate will be calculated as the number of clickthroughs divided by number of links sent (i.e., opportunities for clickthrough)., Every 3 months up to 15 months
Secondary Outcome Measures: Total number of dashboard visits, Dashboard visits captured by Google Analytics., 15 months|Cumulative time (minutes) spent on the dashboard, Time spent will be captured by Google Analytics., 15 months|Urologist opt-out rate, 15 months|Helpful/not helpful rate, There will be one question if the intervention was helpful or not., 15 months|Stent rate for pre-stented ureteroscopy, 15 months|E-mail open rate, E-mail open rate will be measured as number of e-mail opens divided by number of e-mails sent., Every 3 months up to 15 months
Methylphenidate in KBG Syndrome: N-of-1 Series
NCT Number: NCT06465641
Acronym: KBGS_N_of_1
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Kbg Syndrome|ADHD - Combined Type
Interventions: DRUG: Methylphenidate Hydrochloride|DRUG: Placebo
Sponsor: Radboud University Medical Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-10-01

Summary:
The goal of this clinical trial\] is to learn about the effect of methylphenidate in children and adolescents with KBG syndrome. The main question it aims to answer is:

• What is the effectiveness of methylphenidate on attention deficit and ADHD-related symptoms in children and adolescents with KBG syndrome?

Participants will receive multiple blocks of treatment with methylphenidate and placebo and fill out various questionnaires.

Primary Outcome Measures: Strenghts and difficulties questionnaire, ADHD subscale, Minimum score 1, maximum score 10 (higher score is worse outcome)., Baseline, and daily in week 1,3,5,7,9,11
Secondary Outcome Measures: Strenghts and difficulties questionnaire, emotional problems subscale, Minimum score 1, maximum score 10 (higher score is worse outcome)., Baseline, and daily in week 1,3,5,7,9,11|Dutch shortened version of the Emotion Dysregulation Inventory (EDI) reactivity index, Minimum score 0, maximum score 28 (higher score is worse outcome), Baseline, and daily in week 1,3,5,7,9,11|Goal Attainment Scoring (GAS), Personal goals, no minimum or maximum score, Baseline, and at the end of week 1,3,5,7,9,11|Personal Questionnaire (PQ), Personal goals, no minimum or maximum score, Baseline, and at the end of week 1,3,5,7,9,11|Adverse Effects checklist for methylphenidate, Checklist of adverse effects, Baseline, and daily in week 1,3,5,7,9,11|McMaster Family assessment device (FAD), subscale General Functioning, 10 items, 4 point scale, maximum score 40, Baseline, and at the end of week 1,3,5,7,9,11|Autism diagnostic observation scale (ADOS-2), Minimum score 15, maximum score 60 (cut-off score for autism is 30), Baseline
Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)
NCT Number: NCT06465576
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Urinary Incontinence in Children
Interventions: DRUG: Solifenacin|DRUG: Mirabegron|DRUG: Solifenacin + Mirabegron
Sponsor: University of Aarhus
Sex: ALL
Age: CHILD
Enrollment: 216
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-27
Completion Date: 2027-12-01
Locations: Department of Pediatric and Adolescent Medicine, Aarhus University Hospital, Aarhus, Aarhus N, 8200, Denmark|Department of Pediatric and Adolescent Medicine, Aalborg University Hospital, Aalborg, 9000, Denmark|Department of Pediatric and Adolescent medicine, Esbjerg Hospital, Esbjerg, 6700, Denmark|Department of Pediatric and Adolescent Medicine, Gødstrup Hospital, Herning, 7400, Denmark|Department of Pediatric and Adolescent Medicine, Kolding Hospital, Kolding, 6000, Denmark

Summary:
The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy (solifenacin and/or mirabegron) influences the risk of recurrence of incontinence.

Children aged 5-14 years diagnosed with urinary incontinence, treated with pharmacotherapy of solifenacin and/or mirabegron and ready for withdrawal will be randomized 1:1 to either abrupt or gradual withdrawal, according to the medical treatment that the child is receiving.

Primary Outcome Measures: Recurrence of incontinence after withdrawal, Assessed by a 14-day calendar of incontinence episodes, Baseline and up to 12 months follow-up
Secondary Outcome Measures: Development of any symptoms related to abrupt or gradual withdrawal symptoms, Assessed by a questionnaire on withdrawal symptoms, Baseline up to 44 days after initiation of withdrawal
Adebrelimab With or Without SHR-8068 in Combination With Cisplatin Plus Gemcitabine as First-line Treatment in Patients With Advanced Biliary Tract Cancer
NCT Number: NCT06465563
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Biliary Tract Cancer
Interventions: DRUG: SHR-8068|DRUG: Adebrelimab|DRUG: Cisplatin|DRUG: Gemcitabine
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-02
Completion Date: 2026-12-30
Locations: The First Affiliated Hospital，Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China

Summary:
This study aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab in Combination With Cisplatin Plus Gemcitabine(CisGem), compared with Adebrelimab in Combination With CisGem, as first-line treatment in patients with Advanced Biliary Tract cancer.

Primary Outcome Measures: Objective Response Rate, ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the investigator according to RECIST v1.1., From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)
Secondary Outcome Measures: Disease Control Rate, DCR is defined as the proportion of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD), as determined by the investigator according to RECIST v1.1., From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)] (up to approximately 14 months)|Progression-Free-Survival (PFS), PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)., From randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 14 months)|Duration of Response (DoR), DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)., From the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 14 months)
CRISPR/Cas9 Instantaneous Gene Editing Therapy to Intraocular Hypertensive POAG With MYOC Mutation
NCT Number: NCT06465537
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Primary Open Angle Glaucoma
Interventions: GENETIC: BD113vVLP
Sponsor: Shanghai BDgene Co., Ltd.
Collaborators: Beijing Tongren Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2025-12
Locations: Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing, 100730, China

Summary:
This study is intented to evaluate the safety, tolerability and preliminary efficacy of CRISPR/Cas9 Instantaneous Gene Editing Therapy (BD113 virus-like particle, also BD113vLVP) in patients with primary open-angle glaucoma (POAG) with elevated intraocular pressure and MYOC gene mutation. The main objectives to evaluate the safety and tolerability BD113vLVP) in POAG patients with intraocular hypertension and MYOC mutation, and secondary objectives is to explore the preliminary efficacy and the metabolism characteristics of BD113vLVP in participants.

Primary Outcome Measures: Ocular adverse events (AEs), The charactaristics of ocular adverse events include endophthalmitis, hypopyon, hyphaema and corneal injection site reaction etc. will be evaluated at Week 1, Week 2, Week 3, Week 4, Month 6 and Month 12 after BD113vVLP administration., 12 months|Number and percentage of participants whose IOP decrease ≤21 mmHg, at Month 1, Month 2, Month 3, Month 6 and Month 12 after BD113vVLP administration, 12 months
Secondary Outcome Measures: Systemic adverse events (AEs): The type, number and incidence of AEs and serious adverse events (SAEs), Systemic adverse events (AEs): The type, number and incidence of AEs and serious adverse events (SAEs) will be analysized within 12 months after BD113vVLP administration., 12 months|Number and percentage of participants whose IOP decrease by ≥ 20% from baseline, at Month 1, Month 2, Month 3, Month 6 and Month 12 after BD113vVLP administration, 12 months|Any ocular maligancies related to BD113vVLP, after BD113vVLP administration, 12 months|Changes in BCVA from baseline, at Month 3, Month 6 and Month 12 after BD113 vVLP administration, not applicable to group 1., 12 months|Changes in visual fields from baseline, at Month 3, Month 6 and Month 12 after BD113 vVLP administration, not applicable to group 1., 12 months|Changes in RNFL from baseline, at Month 3, Month 6 and Month 12 after BD113 vVLP administration, not applicable to group 1., 12 months|P24 and Cas9 proteins concentration in aqueous humor, at hour 0 and Month 1 after BD113vVLP administration, 1 months|P24 and Cas9 proteins concentration in blood, at hour 0 and Day 7 after BD113vVLP administration, 7 days|Blood antibodies of anti-p24 protein and anti-Cas9 proteins, at Month 6 and Month 12 after BD113vVLP administration, 12 months
A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma
NCT Number: NCT06465446
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Classic Hodgkin Lymphoma
Interventions: BIOLOGICAL: Tislelizumab|BIOLOGICAL: IMM01|DRUG: Bendamustine|DRUG: Gemcitabine
Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 202
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2029-07

Summary:
The purpose of this study is to compare efficacy of IMM01 plus Tiselizumab with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of IMM01 plus Tiselizumab. The primary study hypotheses are that IMM01 plus Tiselizuma is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).

Primary Outcome Measures: Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC), PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first., approximately 24 months
Secondary Outcome Measures: Overall Survival (OS), OS is defined as the time from randomization to death due to any cause., approximately 36 months|Duration of Response (DOR), DOR is defined as the time from the first documented evidence of complete response or partial response until disease progression or death due to any cause, whichever occurs first., approximately 24 months|Number of Participants Who Experienced At Least One Adverse Event (AE), An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention., approximately 18 months
Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
NCT Number: NCT06465433
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hematologic Malignancies
Interventions: DRUG: Tafasitamab
Sponsor: Incyte Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-11-08
Completion Date: 2027-08-29
Locations: Petz Aladar County Teaching Hospital, Gyor, 09023, Hungary|Hospital S.M. Terni University of Perugia, Terni, 05100, Italy|Samsung Medical Center, Seoul, 06351, Korea, Republic of|Clinica Universitad de Navarra, Pamplona, 31008, Spain|Gazi University Hospital Gazi University Faculty of Medicine, Ankara, 06500, Turkey

Summary:
This extension study is designed to enroll participants with hematologic malignancies who are receiving clinical benefit from tafasitamab treatment in a parent study with tafasitamab..

Primary Outcome Measures: Number of participants with Treatment-emergent Adverse Events (TEAEs), Defined as any Adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug., up to approximately 2 years
Collagen Protein Versus Placebo on Muscle Recovery
NCT Number: NCT06465407
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anthropometrics: Height and Weight|Isometric Standing and Seated Plantarflexion|Calf Muscle Thickness|Achilles Tendon Length and Thickness|Myotonography of the Calf Musculature and Achilles Tendon|Pain Pressure Threshold of the Calf|Pain Scale|Endurance Calf Test|Dietary Analysis
Interventions: DIETARY_SUPPLEMENT: Collagen|DIETARY_SUPPLEMENT: Maltodextrin
Sponsor: University of Central Florida
Sex: MALE
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-01
Completion Date: 2024-12-01
Locations: University of Central Florida, Orlando, Florida, 32816, United States

Summary:
This study is focused on exploring the gap in the literature by comparing the effects of collagen protein versus placebo supplementation on the musculotendinous unit following muscle damaging protocol. Thus, the purpose of this study is to identify and compare the effect of collagen protein versus placebo supplementation on indirect markers of musculotendinous unit recovery following eccentric calf exercises.

Primary Outcome Measures: Calf muscle thickness, Portable B-mode Ultrasound (GE Logiq e BT12, GE Healthcare, Milwaukee, WI, USA) and a multi-frequency linear- array probe (12 L-RS, 5-13 MHz, 38.4-mm field of view, GE Healthcare, Milwaukee, WI, USA) will be used to determine changes in muscle thickness of the randomized leg. The distance between the medial point of the knee joint space and the central point of the medial malleolus will be measured at 70% and ultrasound gel will be placed on this location prior to measurement. The highest and mean values of 3-5 measurements will be recorded for each assessment. All measurements will be done on one randomized leg., 5 days
Secondary Outcome Measures: Achilles tendon thickness., Achilles tendon will be scanned using a B-mode US imaging device (GE Logiq e, GE Healthcare,Wauwatosa, WI, USA) and a multi-frequency linear-array probe (12 L-RS, 5-13 MHz, 38.4-mm field of view; GE Healthcare). The same researcher will perform the assessments. All ultrasound imaging analyses will be performed using Image-J software 1.8.0 (National Institute of Health, Bethesda, MD, USA). Achilles tendon length will be determined using the segmented line function between calcaneal notch and muscle-tendon junction along the midline of the Achilles tendon. Additionally, sagittal images of the Achilles tendon will be collected with the ankle passively dorsiflexed to approximately 90 degrees. Tendon thickness will be measured at reference point of 2 cm proximal to the superior aspect of the calcaneus., 5 days
Exercise-induced Hypoalgesia and Proprioceptive Changes, Comparing Isometric to Isotonic Neck Exercises
NCT Number: NCT06465394
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Exercise
Interventions: PROCEDURE: Exercise
Sponsor: University of South Dakota
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-12
Completion Date: 2025-05-05

Summary:
Exercised induced hypoalgesia (EIH) (reduction in pain) after exercise has been studied in the literature, but no comparisons have been made specifically looking at different types of exercise (isometric/dynamic moving through a range of motion with resistance versus isotonic/applying static resistance to a joint not moving) with neck muscle strengthening. This study will explore to see if one form of exercise is superior to the other in providing EIH.

Another benefit of exercise is improving proprioception (knowing where our body is in space). Again no specific investigation has been done comparing isometric versus isotonic exercises for neck muscles.

Both of these exercises are often prescribed in physical therapy so further understanding the benefits of them can help improve the prescription of exercises for patients.

Primary Outcome Measures: PPT, Pain Pressure Threshold with use of algometer, Pre post measure before and after exercise session taking approximately 10 minutes
Secondary Outcome Measures: JPE, Joint position error utilizing measurement in cm from baseline, Pre post measure before and after exercise session taking approximately 10 minutes
Safety Planning and Cognitive Behavioral Therapy for Adolescent Suicide Prevention in Mozambique
NCT Number: NCT06465381
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Suicide Prevention
Interventions: BEHAVIORAL: Safety Planning Intervention|BEHAVIORAL: Enhanced Usual Care|BEHAVIORAL: Transdiagnostic Cognitive Behavioral Therapy for Suicide Prevention
Sponsor: University of Washington
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 21000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-03-01
Completion Date: 2029-03-31

Summary:
This implementation research project aims to test the effectiveness and implementation outcomes of suicide safety planning along and a transdiagnostic cognitive behavioral intervention for suicide prevention on decreasing suicidal behaviors in secondary school students in Mozambique. This study will also result in hypothesized mechanisms of intervention effects, costs and cost-effectiveness.

Primary Outcome Measures: Suicidal Behavior, As reported on the Columbia Suicide Severity Rating Scale,, baseline, 3-, 6-, 12-, and 24-months post intervention
Secondary Outcome Measures: Suicidal Ideation, As reported on the Columbia Suicide Severity Rating Scale, baseline, 3-, 6-, 12-, and 24-months post intervention|Depressive Symptoms, Depressive symptoms as measured on the Patient Health Questionnaire 9 - MZ, the scoring range is 0-27 with higher scores indicative of more severe symptoms, baseline, 3-, 6-, 12-, and 24-months post intervention
Effects of an Air Bolus on Primary Peristalsis
NCT Number: NCT06465355
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Deglutition Disorders
Interventions: PROCEDURE: pharyngo-esophageal high-resolution manometry
Sponsor: Medical College of Wisconsin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2019-10-10
Completion Date: 2025-03-19
Locations: Medical College of Wisconsin, Milwaukee, Wisconsin, 53086, United States

Summary:
Understanding the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.

Primary Outcome Measures: striated esophageal muscle contractile integral, Motility pressure metric to measure contractile vigor of the proximal esophagus in mmHg-cm-seconds, through study completion, an average of 1 year|smooth esophageal muscle contractile integral, Motility pressure metric to measure contractile vigor of the distal esophagus in mmHg-cm-seconds, through study completion, an average of 1 year|peristaltic wave velocity, average speed at which the primary peristaltic pressure wave traverses the esophagus in cm/second, through study completion, an average of 1 year|esophageal clearance time, time for the entire swallowed bolus to travers the esophagus in seconds, through study completion, an average of 1 year
LUTEIN BY SCLERAL IONTOPHORESIS IN PATIENTS WITH STAGE 3 AGE-RELATED MACULAR DEGENERATION (AMD)
NCT Number: NCT06465342
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: DML Stage 3
Sponsor: OFFHEALTH S.p.A.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-12
Completion Date: 2025-12-12

Summary:
The objective of the clinical investigation is to evaluate the performance, safety and degree of tolerability resulting from the use of the iontophoresis medical device in adult subjects diagnosed with AMD stage 3 (AREDS classification) in one or both eyes.

Primary Outcome Measures: BCVA changes, Changes in best distance-corrected visual acuity (BCVA) at the End of Study Visit compared to baseline., 12 months
Secondary Outcome Measures: BCVA changes, Changes in best distance-corrected visual acuity (BCVA) at scheduled controls (Visit 3, Visit 4, Visit 5, and Visit 6) compared to baseline, 3, 4, 5 and 6 monhs
A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)
NCT Number: NCT06465329
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-Small Cell Lung Cancer
Interventions: DRUG: Cemiplimab|DRUG: Platinum-based chemotherapy|DRUG: REGN7075
Sponsor: Regeneron Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2030-05-21

Summary:
This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned.

The aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.

The study is also looking at several other research questions, including:

* What are the side effects associated with the investigational treatments in comparison to the control treatment?
* Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed?
* How much of the study drug(s) are in the blood at a given time?
* Does the body make antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)?

Primary Outcome Measures: Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR), Up to 12 weeks
Secondary Outcome Measures: Pathologic complete response (pCR) rate as determined by central BIPR, Up to 12 weeks|Residual viable tumor (RVT) as determined by central BIPR, Up to 12 weeks|Median event-free survival (EFS), Up to 3 years|EFS rate, Up to 3 years|Objective response rate (ORR), Up to 9 weeks|Overall survival (OS), Up to 3 years|Incidence of treatment-emergent adverse events (TEAEs), Up to 76 weeks|Severity of TEAEs, Up to 76 weeks|Incidence of TEAEs leading to death, Up to 76 weeks|Incidence of TEAEs leading to treatment discontinuation, Up to 76 weeks|Incidence of serious adverse events (SAEs), Up to 76 weeks|Incidence of adverse events of special interest (AESIs), Up to 76 weeks|Incidence of immune-mediated adverse events (imAEs), Up to 76 weeks|Incidence of infusion-related reactions (IRRs), Up to 76 weeks|Incidence of grade ≥3 laboratory abnormalities, As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades), Up to 76 weeks|Proportion of delayed surgeries due to TEAEs, Up to 76 weeks|Proportion of cancelled surgeries due to TEAEs, Up to 76 weeks|Incidence of anti-drug antibodies (ADAs) to cemiplimab over time, Up to 67 weeks|Titer of ADAs to cemiplimab over time, Up to 67 weeks|Incidence of ADAs to novel anti-cancer agents over time, Up to 67 weeks|Titer of ADAs to novel anti-cancer agents over time, Up to 67 weeks
A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)
NCT Number: NCT06465303
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: ST Elevation Myocardial Infarction
Interventions: DRUG: RTP-026|DRUG: Placebo
Sponsor: ResoTher Pharma
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2025-12-21
Locations: Hjertecenteret, Rigshospitalet, Copenhagen, 2100, Denmark

Summary:
This is an exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026.

The study population will consist of men and women with documented evidence of ST-elevation myocardial infarction (STEMI) referred to primary Percutaneous Coronary Intervention (PCI).

Primary Outcome Measures: Change in Cardiac Troponin T (cTNT), Change in cTnT determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI., 24 hours|Change in Creatinine kinase-MB (CK-MB), Change in CK-MB determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI., 24 hours
CMR Right Ventricular Contractile Reserve Following Lung Resection
NCT Number: NCT06465277
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer|Surgery|Anesthesia
Interventions: DIAGNOSTIC_TEST: Dobutamine stress CMR|DIAGNOSTIC_TEST: Cardiac biomarker sample
Sponsor: Belfast Health and Social Care Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-21
Completion Date: 2024-11
Locations: Belfast Health and Social Care Trust, Belfast, Northern Ireland, BT12 6BA, United Kingdom

Summary:
Feasibility study investigating CMR dobutamine stress testing before and after lung resection

Primary Outcome Measures: 1) Feasibility of dobutamine stress CMR to measure RVCreserve following lung resection., Reliability and variability will be assessed through dual reporting of the CMR images, testing intra-/inter-observer intraclass correlation coefficient (ICC) and coefficient of variation (CV). Study design will allow comparison to our previous resting studies published exercise literature and between pre- and post-operative imaging., Pre-operative and 2 months post-operative
Secondary Outcome Measures: 1) Acceptability of the dobutamine stress CMR protocol to patients, by questionnaire, Assessed by patient satisfaction questionnaires rate compared to our previous CMR studies that were performed without dobutamine stress testing., Pre-operative and 2 months post-operative|1) Acceptability of the dobutamine stress CMR protocol to patients, by completion, Assessed by patient recruitment/withdrawal rate compared to our previous CMR studies that were performed without dobutamine stress testing., Pre-operative and 2 months post-operative|2) Incidence of complications related to dobutamine stress CMR, We will assess for the onset of any of the following during the scan

1. New onset atrial fibrillation
2. Ventricular tachycardia
3. Angina, chest pain, shortness of breath and/or ischaemic ECG changes, Pre-operative and 2 months post-operative|3) Change in RVCreserve change following lung resection, Comparison of the change in RVEF on stress pre- and post-operatively, Pre-operative and 2 months post-operative|4) Change in PVreserve change following lung resection, Comparison of change in wave reflection on stress pre- and post-operatively, Pre-operative and 2 months post-operative|5) Association between the changes in RVCreserve and markers of cardiac inflammation, BNP, Comparison of change in RVCreserve and the change in BNP, Pre-operative and 2 months post-operative|5) Association between the changes in RVCreserve and markers of cardiac inflammation, hsTnT, Comparison of change in RVCreserve and the change in hsTnT., Pre-operative and 2 months post-operative|1) Post-operative change in BNP, Post-operative change in BNP in oesophagectomy compared to lung resection and gastrectomy., Peri-operative blood samples, pre-op, immediately post-op, post-op days 1 and 2, 4-8 weeks post-op
To Assess Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine or Allisartan Isoproxil
NCT Number: NCT06465264
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Essential Hypertension
Interventions: DRUG: Allisartan Isoproxil/Amlodipine group 1|DRUG: Amlodipine group 1|DRUG: Allisartan Isoproxil/Amlodipine group 2|DRUG: Allisartan Isoproxil group 2
Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 499
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-04-29
Completion Date: 2023-02-24
Locations: Beijing Chaoyang Hospital, Capital Medical University, Beijing, Beijing, 100020, China

Summary:
The main objective of the study will be to assess the efficacy and safety of Allisartan Isoproxil/Amlodipine (240 mg/5 mg) in patients with mild to moderate essential hypertension uncontrolled after 4-week treatment with Amlodipine besylate（5 mg) or Allisartan Isoproxil (240 mg).

Primary Outcome Measures: Change from baseline in mean sitting systolic blood pressure after 12 weeks of randomized, double-blind treatment, Twenty-four hour mean msSBP will be performed at baseline and week 12 of double-blind treatment, Baseline, week 12
Secondary Outcome Measures: Change from baseline in mean sitting diastolic blood pressure after 12 weeks of randomized, double-blind treatment, Twenty-four hour mean msDBP will be performed at baseline and week 12 of double-blind treatment, Baseline, week 12|Change from baseline in mean sitting systolic blood pressure and mean sitting diastolic blood pressure after 4 and 8 weeks of randomized, double-blind treatment, Twenty-four hour mean msSBP will be performed at baseline and week 4, week 8 of double-blind treatment, Baseline, week 4, week 8|The proportion of responders to antihypertensive treatment after 12 weeks of randomized, double-blind treatment, Responders is the ratio of the number of participants achieving SBP/DBP\<140/90 mmHg or a reduction from baseline of \>20 mmHg in mean systolic blood pressure and or \>10 mmHg in mean diastolic blood pressure to the total number of participants in each group, Week 12|The proportion of patients meeting the mean sitting blood pressure target after 4, 8, and 12 weeks of randomized, double-blind treatment, Sitting blood pressure target is SBP/DBP\<140/90 mmHg, Week 4, week 8, week 12
Other Outcome Measures: The proportion of patients meeting the mean sitting blood pressure target after 20 weeks of extended treatment, Sitting blood pressure target is SBP/DBP\<140/90 mmHg, Week 36|The proportion of patients meeting the mean sitting blood pressure target at the end of treatment, Sitting blood pressure target is SBP/DBP\<140/90 mmHg, Week 56
Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLC
NCT Number: NCT06465238
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: NSCLC
Interventions: DRUG: SHR-A2009|DRUG: SHR-A1921
Sponsor: Henan Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2027-06
Locations: Henan cancer hospital, Zhengzhou, Henan, China

Summary:
This study is an open-label Phase II clinical trial to evaluate the safety and efficacy of SHR-A1921 or SHR-A2009 in patients with advanced NSCLC who progressed after standard therapy.

Primary Outcome Measures: Overall response rate (ORR), Assessed by Investigator According to RECIST v1.1, up to 12 months
Secondary Outcome Measures: Progression-free survival (PFS), Assessed by Investigator According to RECIST v1.1, up to 12 months|overall survival (OS), OS is the time from the date of first dose until the date of death by any cause., up to 24 months|Duration of response(DoR ), Assessed by Investigator According to RECIST v1.1, up to 12 months|Disease control rate (DCR), Assessed by Investigator According to RECIST v1.1, up to 12 months|Time to Response (TTR), Assessed by Investigator According to RECIST v1.1, up to 12 months|The incidence and severity of adverse events (AEs), Rated based on CTCAE V5.0, from Day1 to 90 days after last dose
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress
NCT Number: NCT06465225
Acronym: PRESERVE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pressure Ulcer
Interventions: DEVICE: Use of a powered alternating pressure air mattress
Sponsor: Nausicaa Medical
Collaborators: Clin-Experts
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-06-30
Locations: Multiples Facilities, Multiple Locations, France

Summary:
The aim of the study is to determine the clinical value of using a powered alternating pressure air overlay mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk.

This study is noncomparative, observational study.

Patients older than 18 years of age, with a medium to high risk of PI, without PI, up during the day, and lying between 15 and 20 hours per day on a specific P-APAM will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department.

Patients will be followed up for 35 days. The use of the P-APAM is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who will develop at least one PI of at least stage 2 on the sacrum, spine, or heel between day 0 and day 35 . Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.

Primary Outcome Measures: Percentage of patients who developed at least one stage 2 pressure injury, Percentage of patients who developed at least one stage 2 PI of the sacrum, backbone, or heel (areas of support when lying down), 35 days after installation on the mattress (at day 35)
Secondary Outcome Measures: Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between, 35 days after installation on the mattress (at day 35)|Assessment by the patient (or family or staff in the case of incapacity) of the comfort of the mattress (general comfort, stability), On a scale from 0 (not satisfied at all) to 4 (very satisfied), 35 days after installation on the mattress (at day 35)|Assessment by the nursing staff with the use of the mattress (implementation, cleaning maintenance turning, changing to a sitting position), On a scale from 0 (not satisfied at all) to 4 (very satisfied), 35 days after installation on the mattress (at day 35)|Assessment of the degree of maceration, On a scale from 1 (constantly moist) to 4 (rarely moist), 35 days after installation on the mattress (at day 35)|Assessment of mattress safety, By collecting any adverse event or mattress malfunction during the follow up, At day 35
Personalized Shared Eye-care Identification of Age-related Macular Degeneration Using Artificial Intelligence and Telemedicine by Matching Optometrist Office-based Sites With Clinical Supervision
NCT Number: NCT06465212
Acronym: PYRENEES
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Age-Related Macular Degeneration
Interventions: DEVICE: TopCon Maestro 2 OCT
Sponsor: Medical University of Vienna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2026-07

Summary:
Office-based optometrist centres equipped with low-cost OCT devices can be used for screening of age-related macular degeneration. Matching next-door optometrist centres with clinical sites introduces a shared care service in an unprecedented and broad manner and offers timely and inclusive access to eye care for all citizens affected by the most frequent blinding disease in western countries.

The aim of the study is to detect AMD in a next-door office-based setting on an individual level using low-cost OCT, through a telemedicine feedback loop.

The specific aims of this study are:

* Setting up a network of optometrist centres matched to clinical sites to perform shared care to protect eyesight in the elderly population.
* Identify imaging biomarkers of age-related macular degeneration from OCT imaging.
* Give a risk estimation of progression using a one-time low-cost OCT scan

Primary Outcome Measures: Identification of different AMD stages on OCT images from a community-based setting to calculate the real-world prevalence of AMD, AMD staging will be carried out by a certified ophthalmologist at the Medical University of Vienna according to the following parameters:

1. Healthy aging retina, including drupelets \< 63 µm \[3\]
2. Early AMD as defined in the protocol \[3\] (see 7.3 disease definitions): Medium drusen \>63 µm and \>125 µm. No AMD pigmentary abnormalities.
3. Intermediate AMD as defined in the protocol \[3\] (see 7.3 disease definitions): Large druse \> 125 µm and/or and pigmentary abnormalities
4. Late AMD: Geographic Atrophy as defined in the protocol \[3,6\] (see 7.3 disease definitions)
5. Other diseases: including neovascular AMD, RVO, DME, CCS, Stargardt disease, Pattern dystrophy, etc., 2 years
Secondary Outcome Measures: Further biomarkers of AMD that are expected to be present in the cohort will be analyzed in order to assess whether they can be identified and quantified in this real-world cohort., Biomarkers include:

* Drusen presence/Refractile drusen/Hyporeflective Core Drusen (yes/no)
* Hyperreflective foci presence (yes/no)
* Presence of subretinal drusenoid deposits (SDD) (yes/no)
* Loss of outer retinal layers (retinal pigment epithelium, ellipsoid zone) (scale, mm2)
* Fluid (intraretinal fluid, subretinal fluid, pigment epithelium detachment) (yes/no), 2 years|As a post-hoc analysis, the diagnostic accuracy of AI algorithms to recognize changes associated with age-related macular degeneration in OCT volumes, will be evaluated in this real-world cohort., 2 years
A Study to Evaluate the MNV-201 in Patients With Low Risk MDS
NCT Number: NCT06465160
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Myelodysplastic Syndromes
Interventions: BIOLOGICAL: MNV-201 (Autologous CD34+ Cells Enriched with allogenic Placenta Derived Mitochondria)
Sponsor: Minovia Therapeutics Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-27
Completion Date: 2029-12-31
Locations: Shaare Zedek Medical Center, Jerusalem, 9103102, Israel

Summary:
Myelodysplastic syndromes (MDS) are a group of bone marrow failures that occur when the blood-forming cells in the bone marrow become abnormal leading to an abnormal differentiation and production of one or more blood cell types. According to the American Cancer Society, in the United States, MDS occurs at a rate of 4.8 cases for every 100,000 people; MDS affects an estimated 60,000 persons in the United States, with 10,000-15,000 new cases recorded each year. MDS is defined by ineffective haematopoiesis resulting in blood cytopenias (a reduction in the number of mature blood cells), and clonal instability with a risk of evolution to acute myeloid leukaemia (AML). Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenias and AML. MDS is generally a disease that develops with ageing; the median age at diagnosis of MDS is \~70 years, and patients frequently have comorbid conditions. The goals of therapy for patients with MDS are to reduce disease-associated symptoms and the risk of disease progression and death, thereby improving both quality and quantity of life.

Minovia Therapeutics Ltd. ("Minovia") is a biotech company developing novel therapeutics based on its mitochondrial augmentation technology (MAT). MNV-201 is a cell therapy produced by MAT that consists of the participant's autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) enriched with allogeneic placental-derived mitochondria, manufactured in Minovia's GMP facility.

Primary Outcome Measures: Occurrence of treatment-related adverse events, Occurrence of treatment-related adverse events as assessed by CTCAE v5.0 following MNV-201 infusion, during a follow up period of 12 months post treatment., 1 year
Secondary Outcome Measures: Anemia assessment, change in the anemia will be counted by the change in the average Hgb level in G/dL as measured monthly in balks of three months -3-1(prior to infusion), 1-3, 4-6, 7-9, 10-12 months., 1 year|Blood transfusion assessment, Changes in frequency of blood transfusions during a follow up period of 12 months post treatment compared to the 6 months period before treatment., 1 year|Assessment of Quality of Life by the Functional Assessment of Cancer Therapy - Anemia, Change in health-related quality-of-life (HRQoL) assessed by the Functional Assessment of Cancer Therapy - Anemia (FACT-An) from baseline during a follow up period of 12 months post treatment. The higher the score, the better the Quality of Life. The minimum Score is 0 the maximum score is 4., 1 year
REACT-01: Reversing Autoimmunity Through Cell Therapy
NCT Number: NCT06465147
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Systemic Lupus Erythematosus
Interventions: BIOLOGICAL: SCRI-CAR19v3
Sponsor: Seattle Children's Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2041-07
Locations: Seattle Children's Hospital, Seattle, Washington, 98105, United States

Summary:
This is a phase 1, open-label, non-randomized study enrolling pediatric and young adult research participants with treatment-refractory Systemic Lupus Erythematosus (SLE), to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to express CD19 specific chimeric antigen receptor (CAR)

A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have their T cells collected. The T cells will then be bioengineered into a CAR T cell that targets circulating and tissue residing B cells.

Primary Outcome Measures: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], The investigators will assess and described the type, frequency, severity, and duration of adverse events associated with the CAR T cell product., 28 days post-infusion|Rate of SCRI-CAR19v3 Manufacturing Success, We will measure the number of successfully manufactured SCRI-CAR19v3 products., 28 days