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Personalized Therapy of Long-term Low FODMAP in IBS Treatment: Role of Mobile Application and "Microbiota-gut-brain" Axis

IBS - Irritable Bowel Syndrome

The purpose of this study is to evaluate the effectiveness of a mobile application (app) in helping clinicians and dietitians provide personalized low-FODMAP diet (LFD) therapy for patients with Irritable Bowel Syndrome (IBS). The study also aims to explore the potential biological mechanisms behind the clinical outcomes of this dietary intervention. Participants diagnosed with IBS will be recruited and screened through clinical questionnaires. Eligible participants will receive dietary education from a dietitian and be randomly assigned to one of two groups: the AI-assisted LFDapp group or the LFD booklet group. The study consists of three main phases: Initial Intervention (4-6 weeks): Participants will follow their assigned diet intervention and complete assessments regarding gastrointestinal symptoms, psychological traits (such as anxiety and depression), and quality of life. Reintroduction Phase (12 weeks): Participants who respond well to the diet will enter a phase where specific foods are gradually reintroduced. Personalization \& Follow-up (4 weeks): A personalized diet will be established, followed by a final evaluation of bowel function and mental well-being. Researchers will use various standardized questionnaire to track changes in symptoms and overall well-being throughout the study period.

Начало: 01.04.2026 Край: 01.06.2029 Възраст: 20–65 г.

Taiwan Taipei Veterans General Hospital, Taiwan NCT07543354

Предстои набиране Фаза 2

A Proof-of-Concept Study of LAD328 in Adults With Hidradenitis Suppurativa

Hidradenitis Suppurativa

The main purpose of this study is to evaluate the effect of LAD328 compared to placebo in participants with moderate-to-severe Hidradenitis Suppurativa (HS), and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.

Начало: 01.04.2026 Край: 01.04.2027 Възраст: 18–65 г.

Almirall, S.A. NCT07547813

Предстои набиране Фаза 1

A Study of Eltrekibart (LY3041658) in Healthy Participants

Healthy

The main purpose of this study is to evaluate how eltrekibart is absorbed by the body when it is given under the skin to healthy participants. The study will last about 17 weeks.

Начало: 01.04.2026 Край: 01.08.2026 Възраст: 21–65 г.

Singapore Eli Lilly and Company NCT07545590

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Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis

HEPATITIS B CHRONIC Cirrhosis, Liver Hepatocellular Carcinoma (HCC)

This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Shi-re-du-yun syndrome and have an aMAP score \>60 points. The objective is to evaluate whether combining Babao Dan Capsule with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.

Начало: 01.04.2026 Край: 30.11.2028 Възраст: 18–65 г.

Nanfang Hospital, Southern Medical University NCT07544121

Предстои набиране Фаза 2

EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.

Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis

Psoriasis affecting sensitive anatomical regions, such as the skin folds (flexural or inverse psoriasis) and genitalia, presents unique therapeutic challenges. These manifestations often result in a disproportionately high burden of disease, causing significant physical discomfort and a profound negative impact on a patient's quality of life and sexual health. While topical creams are the standard first-line treatment, many patients have "topically resistant" disease that requires a systemic (oral) approach. This 16-week randomized controlled trial is the first to directly compare two oral medications for these specific sites: roflumilast (a daily 500 mcg pill) and methotrexate (a standard weekly dose). The study's primary objective is to evaluate which treatment is more effective at clearing psoriatic lesions in the skin folds and genital area, and how each drug improves the patient's overall quality of life and symptoms like pruritus (itching). Participants are randomly assigned to one of the two treatment groups and are monitored monthly to assess skin clearance, symptom relief, and safety/tolerability. The goal of this research is to provide patients and healthcare providers with evidence-based data on a convenient, oral treatment option that does not require intensive laboratory monitoring.

Начало: 01.04.2026 Край: 01.08.2026 Възраст: от 18 г.

Eman Raafat Said NCT07543640

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Bachmann Bundle Pacing for Prevention of New-Onset Atrial Fibrillation in Patients With Heart Failure

Heart Failure Atrial Fibrillation (AF) Cardiac Insufficiency

This is a multi-center, prospective, single-blind, randomized controlled clinical trial to evaluate the efficacy and safety of Bachmann bundle pacing (BBP) in preventing new-onset atrial fibrillation (AF) in patients with chronic cardiac insufficiency who have indications for cardiac resynchronization therapy with left bundle branch pacing (CRT/LBBP) or implantable cardioverter defibrillator (ICD) implantation. A total of 110 eligible patients will be randomly assigned 1:1 to the BBP group or the traditional right atrial appendage (RAA) pacing group. All patients will receive guideline-directed medical therapy (GDMT) for at least 3 months and standardized follow-up for 12 months after device implantation. The primary endpoint is the incidence of new-onset AF within 12 months after implantation. Secondary endpoints include time to first new-onset AF, procedural success rate, changes in cardiac function parameters, and incidence of adverse events. This study aims to provide high-level evidence-based medical evidence for BBP as a new atrial pacing strategy to prevent AF in heart failure patients.

Начало: 01.04.2026 Край: 01.04.2028 Възраст: 18–70 г.

China Fu Wai Hospital, Beijing, China NCT07547449

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Performance and Impact of the Sepsis ImmunoScore

Sepsis

The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore.

Начало: 01.04.2026 Край: 01.12.2027 Възраст: от 18 г.

Prenosis, Inc. NCT07543497

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Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada

Asthma Chronic Obstructive Pulmonary Disease (COPD) Lung Cancer

Wildfire smoke (WFS) is the leading climate-related risk in Canada and the main source of harmful air pollution. While short-term breathing problems caused by smoke are well known, there is limited knowledge on how repeated exposure contributes to long-term lung disease. This study is a controlled human exposure to varying concentrations of WFS in a safe setting. By comparing the effects of different concentrations, this research will improve understanding of health impacts, identify who may be most vulnerable to exposures, and explore biological changes that could lead to chronic illness.

Начало: 01.04.2026 Край: 31.08.2030 Възраст: 19–80 г.

University of British Columbia NCT07536178

Предстои набиране Фаза 1

A Clinical Study to Evaluate the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects With Impaired Liver Function Versus Normal Liver Function

Lung Cancer

Evaluation of the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects with Impaired Liver Function versus Normal Liver Function

Начало: 01.04.2026 Край: 01.09.2027 Възраст: 18–65 г.

China Chia Tai Tianqing Pharmaceutical Group Co., Ltd. NCT07538973

Предстои набиране Фаза 2

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)

Irritable Bowel Syndrome Diarrhea

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 35 weeks.

Начало: 01.04.2026 Край: 01.11.2027 Възраст: 18–75 г.

Belgium, Canada, China +7 Eli Lilly and Company NCT07545759

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A Lay Navigation Intervention for Patients With Lung Cancer

Lung Cancer Non-Small Cell Cancer (NSCLC) Lung Cancer Small Cell Lung Cancer (SCLC) Patient Navigation

Background: In Canada, lung cancer accounts for approximately 25% of cancer deaths each year. There are also known sociodemographic and racial inequities in the diagnosis and treatment of lung cancer. Studies have consistently found that patients with cancer have a high number of unmet needs, including psychological, physical, and informational. Navigation programs represent a potentially promising, equitable, and cost-effective approach to address the unmet needs of patients with lung cancer, but there is limited evidence about their effectiveness in patients with lung cancer. The investigators developed and have implemented a volunteer lay navigator program, Care and Connect (C\&C), which aims to proactively reduce distress in patients, provide information and support, and increase access to treatment and supportive care resources. The proposed pilot randomized controlled trial (RCT) project plans to 1) assess the feasibility and acceptability of referral to C\&C and, 2) examine the preliminary effectiveness of C\&C. Methods: The current study is a 2-arm, parallel group, mixed methods, pilot RCT with a 1:1 allocation ratio and 3 timepoints: baseline (T0), 3 months (T1), 6 months (T2). It is designed to test the trial feasibility and acceptability of the C\&C intervention in patients with lung cancer. In total, 50 participants will be randomized to receive the C\&C intervention or usual care only (25 per arm). At each timepoint, data will be collected on participants' access to psychosocial (PSO) services, psychological wellbeing, and satisfaction with care through participant medical record and a survey. To gain additional insights regarding the acceptability, feasibility, and impact of C\&C, a subset of 15 participants from the intervention group will be contacted for qualitative exit interviews. Expected outcomes: There is limited evidence about the effects of lay navigation programs on access to PSO services among patients with lung cancer. This work addresses this knowledge gap by evaluating the feasibility, acceptability, and preliminary impact of C\&C on patients with lung cancer. The findings of the proposed work will expand the body of evidence supporting lay navigation to the lung cancer population, contributing to the evidence base for patient-centred care.

Начало: 01.04.2026 Край: 01.12.2027 Възраст: от 18 г.

Canada University Health Network, Toronto NCT07548788

Предстои набиране Фаза 2

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old

Congenital Adrenal Hyperplasia

The main objective of this study is to assess the safety and tolerability of crinecerfont in pediatric participants 3 months to \

Начало: 01.04.2026 Край: 01.03.2028 Възраст: 3–47 г.

Neurocrine Biosciences NCT07536269

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First Responder Safety Training (FiRST)

Resilience and Mental Health of First Responders

As a result of chronic exposures to traumatic and stressful events, first responders are at elevated risk for experiencing post-traumatic stress disorder (PTSD) and other mental health problems. Resilience training can reduce the risk for developing mental health symptoms in first responders. The National Institute for Environmental Health Sciences and the Substance Abuse Mental Health Services Administration developed the Worker Resilience Training (WRT) program - a 4-hour interactive workshop to educate responders on the effects of traumatic exposures, PTSD and ways to increase adaptive coping resources and promote resilience. The investigators completed a randomized clinical trial (RCT) of the WRT for active responders (n = 167). Results indicated that the WRT, as compared to a waitlist control group, helped prevent the development of PTSD and depression symptoms, and improved important resilience indicators (i.e., healthy lifestyle behaviors, stress management, physical activity) over the course of three months. The proposed multi-site RCT seeks to build on our initial study by conducting a Stage III efficacy trial of the WRT workshop in N=800 first responders in New York (NY) and Texas (TX). Our specific aims are: Aim 1. To evaluate the efficacy of the WRT program for improving resilience indicators, defined as health promoting lifestyle behaviors, stress management and physical activity, and improving perceived resilience over the course of one year. Aim 2. To evaluate whether the WRT program serves to prevent the development or worsening of psychological symptoms and impairments in functioning over the course of one year among those first responders who are exposed to traumatic events after participation in the study workshop. Aim 3. To identify the target treatment mechanisms of the WRT for preserving mental and occupational health outcomes and functioning over the course of one year in first responders who are exposed to traumatic events post-workshop. Aim 4. To gather qualitative data to further inform a future effectiveness trial including perceptions about the use and potential impact of peer leaders delivering the program content, and perceptions about mode of program delivery via open-ended questions at follow-up. The investigators will use a cluster RCT design and multi-modal assessments including self-report measures, a web-based stress reactivity performance task, and real-time accelerometry. Participants in both conditions will also receive a booster session at 3 months post workshop to reinforce skills and intervention knowledge. This study will contribute to our understanding of how resilience training may serve to protect the mental health and functioning of first responders. This study has important clinical and public health implications, including preserving/strengthening mental health and reducing overall personal and financial costs. This study also takes a research to practice approach by working collaboratively with fire departments and EMS organizations in NY and TX. If successful, the investigators will work with these leaders to develop a method for annual WRT trainings to foster resilience and promote well-being long-term for first responders.

Начало: 01.04.2026 Край: 30.06.2030 Възраст: от 18 г.

United States Stony Brook University NCT07478250

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MEDITERRANEAN DIET AND OXIDATIVE STRESS IN TYPE 1 DIABETES

Type 1 Diabetes (Juvenile Onset) Continuous Glucose Monitoring System Oxidative Stress

Achieving optimal glycemic control in type 1 diabetes requires a holistic approach that includes individualized medical nutrition therapy in addition to appropriate insulin therapy. When diabetes is poorly managed, metabolic control is impaired. Hyperglycemic events increase oxidative stress in the body and can lead to complications. The aim of this study is to examine the effect of a 12-week Mediterranean diet on oxidative stress markers in children with type 1 diabetes who do not meet the metabolic target (HbA1c \> 7%) and whose adherence to the Mediterranean diet is "poor" and "needs improvement". The study, planned between March 2026 and March 2027, will be conducted with girls aged 10-18 years with type 1 diabetes who are followed up at the Department of Pediatric Endocrinology, Istanbul Faculty of Medicine, Istanbul University. In the first phase, participants were divided into groups based on their HbA1c levels: those with HbA1c ≤ 7 met the metabolic target (Group A); Those with HbA1c \> 7 will be divided into two groups: those not meeting the metabolic target (Group B). In the second stage, the intervention group will be determined according to the results of the KIDMED, the pediatric Mediterranean diet adherence scale. Those in Group B who did not meet the metabolic targets and those with "poor" and "need improvement" KIDMED results will form the intervention group (Group C). Adolescents in Group C will receive a 12-week Mediterranean diet intervention. Information will be collected from participants using questionnaires, scales, and experimental methods. This includes completing the 'Personal Information Form', 'Biochemical Parameters Form', '3-Day Nutrition Questionnaire', 'KIDMED scale', and 'Sensor Data Form'. The obtained data will be analyzed both individually and before-and-after using SPSS 26. The findings are expected to show improvement in OS markers in the intervention group. Improvement in glycemic control markers is also predicted. A decrease in HbA1c levels, a reduction in blood sugar fluctuations, and an increase in the duration of staying within the target range are expected. This study is expected to contribute to the literature by revealing the effects of the Mediterranean diet on oxidative stress and metabolic control parameters in type 1 diabetes. It is anticipated that the findings will support the potential role of dietary approaches with antioxidant properties not only in glycemic control but also in oxidative stress levels and long-term complication risks.

Начало: 01.04.2026 Край: 01.03.2027 Възраст: 10–18 г.

Istanbul University NCT07544368

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U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures

Bone Tumor Osteoporosis Traumatic Fracture

The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults. The main question is the determination of the rate of feasible procedures assisted by the Epione device Participants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be: * The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate * Additional CT or CBCT scans during the procedure.

Начало: 01.04.2026 Край: 01.10.2026 Възраст: от 22 г.

United States Precision IO Group NCT07325578

Предстои набиране Фаза 2

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)

Irritable Bowel Syndrome Constipation

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 35 weeks.

Начало: 01.04.2026 Край: 01.09.2027 Възраст: 18–75 г.

United States Eli Lilly and Company NCT07545772

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Enhancing Letter-Speech Sound Learning and Reading Network Activation With Transcranial Electrical Stimulation

Dyslexia, Developmental Reading Dyslexia Learning +1

This study investigates the effects of transcranial electrical stimulation (tES) on the brain and its potential to enhance reading-related learning. Adult participants with a range of reading abilities will receive transcranial random noise stimulation (tRNS) while they perform an artificial orthography learning task. This task simulates letter-speech sound learning, an important first step during reading acquisition known to be impaired in individuals with developmental dyslexia. The effects of the intervention will be assessed using both behavioral measures and functional magnetic resonance imaging (fMRI).

Начало: 01.04.2026 Край: 01.06.2027 Възраст: 18–35 г.

Switzerland Silvia Brem NCT07546292

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Preoperative Oncogeriatric Assessment in Patients Undergoing Hepatectomy

Hepatic Malignancies Comprehensive Geriatric Assessment Hepatectomy

This study aims to bridge the gap between geriatric medicine and surgical oncology. The findings will provide valuable insights into optimizing perioperative care for older adults, enhancing surgical safety, and improving long-term recovery trajectories, thereby supporting a more patient-centered, multidisciplinary approach in the management of elderly patients undergoing hepatectomy

Начало: 01.04.2026 Край: 01.09.2029 Възраст: от 70 г.

Italy Fondazione Policlinico Universitario Agostino Gemelli I NCT07537569

Предстои набиране

Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials

Cancer

Wearable sensors offer opportunities to improve the people's experiences with cancer treatment and to improve care delivery. This is a single-arm, prospective, unblinded pilot study designed to evaluate the feasibility and acceptability of wearable sensor-based monitoring and incorporating electronic patient-reported outcomes (ePROs) in Phase I oncology clinical trials. The study will enroll participants enrolled in early phase clinical trials at the Cleveland Clinic Novel Therapeutics Clinic and aims to establish the foundation for future, larger-scale prospective studies integrating digital health technologies into early-phase cancer clinical trials. Participants will be offered a smartwatch device compatible to their phone's operating system and be guided through the installation and use of the researchers' free study mobile application. Participants already owning compatible smartwatch devices may elect to use their own smartwatch for the study.

Начало: 01.04.2026 Край: 01.01.2027 Възраст: от 18 г.

United States Case Comprehensive Cancer Center NCT07541365

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The Hugo RAS Colorectal Collaborative

Colorectal Surgery Robotic Surgery ColoRectal Cancer and Inflammatory Bowel Disease

The Hugo RAS Colorectal Collaborative (HRCC) is an international, multicenter dataset of patients undergoing colorectal surgery using the Hugo RAS system. The registry aims to analyze short and long-term outcomes to provide real-world evidence on the safety and effectiveness of the system.

Начало: 01.04.2026 Край: 01.06.2029 Възраст: от 18 г.

IRCCS Azienda Ospedaliero-Universitaria di Bologna NCT07541352

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