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Набира участници

Feasibility Study of a Combined Intervention for Suicidal Inpatients in Psychiatric Crisis Units.

Suicide Prevention

Since 2014, suicide prevention has been a national priority and is one of the 3 priority areas of the mental health plan's roadmap . Hospitalization offers a crucial opportunity for life-preserving intervention . Brief health interventions and contacts are reputed to be easy to implement, effective and inexpensive . The Hope Box is a practical emotional management tool that aims to encourage the expression of reasons for living by materializing them in a customizable box, filled with objects, photos, writings and memories in order to find comfort and hope . Peer support use their experiential knowledge of disorders and recovery to accompany people and help humanize care . They can play a decisive role in suicide prevention . In contrast to an approach focusing only on risk factors, peer support and the Hope Box are both focus on protective factors, the strengths of the people concerned and hope. The primary objective of this study is to evaluate the feasibility of the HOPAIR intervention (peer-support and Hope Box, completed by a reminder postcard) with suicidal people hospitalized in psychiatric crisis units. Its secondary objective is to assess the potential effectiveness on intensity of hopelessness, sense of self-efficacy, reasons for living, perceived social support and suicidal recurrence at 3 months. This is a mixed-methods study involving 40 patients and 2 peer support in two crisis hospitalization units.

Начало: 24.09.2025 Край: 15.10.2029 Възраст: от 18 г.

France Hôpital le Vinatier NCT07119671

Набира участници

Comparison of Effectiveness of Low Dose Laser and Transcutaneous Electrical Stimulation in Hemiplegic Shoulder

Hemiplegic Shoulder Pain

The primary aim of this study is to compare the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Low Level Laser Therapy (LLLT), which are analgesic modalities that play an important role in the treatment of this frequently encountered complication. The secondary aim of the study is to evaluate its effectiveness on upper extremity function, quality of life, sleep, and fatigue.

Начало: 24.09.2025 Край: 31.07.2026 Възраст: 18–75 г.

Turkey (Türkiye) Ankara Etlik City Hospital NCT07203222

Набира участници Фаза 1/2

First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies

Participants With Advanced Solid Tumor Malignancies

This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts an accelerated titration for the first dose level, followed by BOIN design to identify the MTD and/or RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC101.

Начало: 23.09.2025 Край: 01.07.2028 Възраст: от 18 г.

United States VelaVigo Bio Inc NCT07136779

Набира участници Фаза 1

A Study of PHN-012 in Patients With Advanced Solid Tumors

Colon Cancer Pancreatic Cancer Lung Cancer (NSCLC) Advanced Cancer +1

This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-012, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.

Начало: 23.09.2025 Край: 01.05.2028 Възраст: от 18 г.

Spain, United States Pheon Therapeutics NCT07127874

Набира участници

Suitability of the 26 °C Indoor Temperature Upper Limit for Older Adults: Impacts of Clothing and Daily Activity

Heat Stress Physiological Stress

While an upper limit of 26°C has been shown to be protective for heat-vulnerable older occupants (DOI: 10.1289/EHP11651), this recommendation did not consider the added heat burden associated with increases in internal heat production accompanying activities of daily living or the restriction to heat loss caused by clothing insulation. To safeguard the health of older adults, health agencies worldwide recommend the remain in cool space indoors, avoid strenuous activity, wear lightweight clothing, and drink cool water regularly throughout the day. However, older adults do not sense heat as well as their younger counterparts. Consequently, they may not take appropriate countermeasures to mitigate physiological strain from indoor overheating. This may include overdressing despite high indoor temperatures. In other cases, individuals may wear insulated clothing in hot weather to observe cultural or religious modesty requirements, which serve as expressions of faith and identity rather than a tool for thermoregulation. Further, individuals may be unaware of the consequences of increases in physical activity on heat gain and may therefore not adjust their normal day-to-day activity levels to prevent potentially dangerous rises in body temperature. Consequently, this may necessitate a lowering of recommended upper indoor temperature limit during hot weather. To address these important considerations, on separate occasions the investigators will assess the change in body temperature and cardiovascular strain in older adults (65-85 years) exposed for 8 hours to the recommended indoor temperature upper limit of 26°C and 45% relative humidity equivalent humidex of 29 (considered comfortable) while they A) perform seated rest dressed in light clothing (t-shirt, shorts and socks), B) perform light exercise (stepping exercise to simulate activities of daily living, 4-4.5 METS) every hour (except during lunch hour period) dressed in light clothing, C) perform light exercise (4-4.5 METS) every hour (except during lunch hour period) dressed in light clothing (t-shirt, shorts and socks) and an added clothing layer (sweatshirt and sweatpants) and D) perform seated rest dressed in light clothing (t-shirt, shorts and socks) and an added clothing layer (sweatshirt and sweatpants). With this experimental design, investigators will assess the effects of added clothing insulation and light activity, representative in activities of daily living on physiological strain and identify whether refinements in the recommended 26°C indoor temperature limit may be required.

Начало: 23.09.2025 Край: 31.03.2027 Възраст: 65–85 г.

Canada University of Ottawa NCT07189507

Набира участници Фаза 1

A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer (NSCLC) Anaplastic Lymphoma Kinase (ALK) Positive

Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with non small cell lung cancer (NSCLC) have a faulty ALK gene. ALK stands for anaplastic lymphoma kinase. People with NSCLC who have the faulty ALK gene are called ALK-positive. ALK inhibitors are an approved treatment for people with ALK positive NSCLC. Some people stop responding to treatment with ALK inhibitors over time due to more changes happening in their faulty ALK gene, so there is an unmet medical need. Gilteritinib is an approved treatment for people with acute myeloid leukemia (AML) with the faulty FLT3 gene who haven't responded to previous treatment, or their cancer came back after previous treatment. Gilteritinib also blocks changes in the ALK gene which could help people with ALK-positive NSCLC. A study needs to be done with gilteritinib in people with ALK-positive NSCLC. The main aim of the study is to check the safety of gilteritinib in people with ALK-positive NSCLC and if they tolerate gilteritinib. People in this study will be adults with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC). Locally advanced means the cancer has spread to nearby tissue. Metastatic means the cancer has spread to other parts of the body. They have stopped responding to treatment with ALK inhibitors, including alectinib or lorlatinib, over time. The key reasons people cannot take part are if they have symptomatic cancers in the brain or nervous system, their cancer has spread to the thin tissue that covers the brain and spinal cord (leptomengingeal metastasis), have recently had or planning to have major surgery, have certain heart conditions, or have recently had an infection, a stroke or mini-stroke. People in the study will take tablets of gilteritinib once a day in a 28-day cycle. They may be given up to 2 different doses of gilteritinib. People in the study will start on the lower dose but can eventually switch to the higher dose if they tolerate the lower dose and meet the safety checks. Whilst taking gilteritinib, people will have regular scans of their tumors. People will continue taking gilteritinib until their cancer gets worse, they have medical problems from gilteritinib that they can't tolerate, they ask to stop taking gilteritinib, they start other cancer treatment or, sadly pass away. People will visit the clinic about 7 days and then 30 days after they stop taking gilteritinib. They will be asked about any medical problems and will have a safety check. After this, people who stopped taking gilteritinib, but their cancer hadn't become worse, will continue to have regular scans of their tumors. If their cancer does get worse, they will no longer have scans of their tumors. After finishing gilteritinib, people will be phoned every 12 weeks to check on their health. People will be in the study for up to 4 years, depending on how they respond to gilteritinib.

Начало: 22.09.2025 Край: 31.12.2029 Възраст: от 18 г.

France, Spain, United States Astellas Pharma Global Development, Inc. NCT07140016

Набира участници Фаза 4

A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

Chronic Obstructive Pulmonary Disease

LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive). Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.

Начало: 22.09.2025 Край: 04.04.2029 Възраст: 40–85 г.

Argentina, Brazil, Canada +14 Sanofi NCT07053423

Набира участници Фаза 1

DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer

Ovarian Cancer Ovarian Carcinoma Recurrent Ovary Cancer Recurrent Platinum-Resistant Ovarian Carcinoma

The purpose of this research study is determining the highest dose of the study drug DT2216 in combination with paclitaxel that can be safely and tolerably administered in recurrent ovarian cancer. The names of the study drugs involved in this study are: * DT2216 (a type of proteolysis-targeting chimera degrader of BCL-XL protein) * Paclitaxel (a type of antimicrotubule agent)

Начало: 22.09.2025 Край: 30.12.2027 Възраст: от 18 г.

United States Elizabeth Stover, MD, PhD NCT06964009

Набира участници Фаза 3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

Plaque Psoriasis

A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis

Начало: 22.09.2025 Край: 16.01.2031 Възраст: от 40 г. Лечение

Argentina, Australia, Belgium +22 Bristol-Myers Squibb NCT07116967

Набира участници Фаза 2/3

A Self-Controlled Study on the Treatment of Restless Legs Syndrome in Uremia With Dipyridamole

Restless Leg Syndrome Due to Uraemia

The purpose of this clinical trial is to determine whether dipyridamole can treat restless legs syndrome in patients with uremia. In addition, the safety of dipyridamole will also be evaluated. The main questions this study aims to answer include: Can dipyridamole improve the symptoms of restless legs syndrome in participants? Can dipyridamole improve participants' anxiety, depression, sleep quality, and quality of life? What adverse reactions might participants experience while taking dipyridamole? This study is a self-controlled trial in which all participants receive active drug treatment. Participants will take dipyridamole daily (50 mg per dose, three times a day) for 12 weeks. The efficacy of dipyridamole will be evaluated by comparing relevant scale scores and laboratory indicators before and after treatment. In addition, adverse reactions during the treatment follow-up will be monitored to assess the safety of dipyridamole in this patient population.

Начало: 20.09.2025 Край: 31.12.2026 Възраст: 18–75 г.

China Yunfeng Xia NCT07199504

Набира участници Фаза 2

Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap

Neuroma Neuropathic Pain

In 2016, one in five individuals in the United States (US) experienced chronic pain, and approximately 40% of them suffered from neuropathic pain. The physical and emotional burden on patients results in costs of billions of dollars annually. Digital amputations affect over 23,000 people each year in the US and may lead to neuropathic pain and neuroma formation in the transected nerves. Previous studies have reported a 6.6% incidence of symptomatic neuroma, and more than 60% of these patients require surgery to reduce the negative impact on their daily living activities. To minimize neuroma formation after digital amputation, various techniques have been described, such as traction neurectomies (TN) and dorsal transpositions (DT), with and without nerve coaptation. However, it remains unclear whether these techniques improve patient-reported outcome measures in individuals undergoing this type of procedure. Previously published studies are descriptive in nature, focus on a single surgical technique, or include patients with established symptomatic neuromas. The only prospective trial on this topic was published in 2000 and compared two conventional techniques that have since been modified to better minimize neuroma formation or to reduce mechanical pressure by transposing the nerve ends to the dorsal aspect of the hand. However, that study used different scales to measure outcomes and did not incorporate aspects of pain that affect patients' emotional and social well-being. Currently, two randomized controlled trials are enrolling patients. One compares surgical techniques for the treatment of neuroma rather than its prevention. The other excludes digits with injuries located distal to the interphalangeal joints. Both studies focus on more complex surgical techniques. Given the extent of this problem, there has been recent innovation aimed at preventing neuroma formation. One promising product is the Tulavi Allay™ Nerve Cap, which has demonstrated encouraging results in basic science studies and anecdotally in early clinical use cases. In this study, the investigators have designed a prospective trial to assess the efficacy of the Tulavi Allay™ Nerve Cap when used to prevent symptomatic digital nerve neuroma following traumatic digital amputation.

Начало: 20.09.2025 Край: 01.04.2027 Възраст: от 22 г.

United States Massachusetts General Hospital NCT06915662

Набира участници Фаза 2

Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)

Primary Membranous Nephropathy

The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein creatinine ratio (UPCR).

Начало: 19.09.2025 Край: 09.07.2027 Възраст: 18–75 г. Лечение

Argentina, Australia, Brazil +7 Alexion Pharmaceuticals, Inc. NCT07157787

Набира участници Фаза 2/3

The Investigators Will Evaluate the Diagnostic Performance of [18F]-AlF-FAPI-74 PET/CT in Inflammatory Disorders and Compare it With the Current Gold Standard for Inflammation, FDG PET/CT, in Three Patient Cohort: Patients Presenting With Fever of Unknown Origin, IgG4-RD and AxSpA.

Fever of Unknown Origin IgG4 Related Disease Axial Spondylarthritis (axSpA) Inflammation of Unknown Origin

The aim of the study to evaluate the performance of new \[18F\]-AlF-FAPI-74 PET/CT in three inflammatory disorders (fever of unknown origin, IgG4-related disease and axial spondyloarthritis) and compare with the current stand-of-care \[18F\]-FDG PET/CT

Начало: 17.09.2025 Край: 31.03.2030 Възраст: от 18 г.

Belgium Universitaire Ziekenhuizen KU Leuven NCT07535554

Набира участници

Night Owl Sleep Study: The Effect of Sleep on Fecal Microbiota

Sleep

The goal of this clinical trial is to assess differences in the fecal microbiota and metabolome associated with insufficient and sufficient sleep, and to evaluate the response and recovery of the microbiota to changes in participant sleep profiles. Researchers will compare the effect of sleep intervention on both insufficient and sufficient sleepers to identify differences in fecal microbiota structure and function between cohorts during habitual sleep and during the sleep alteration intervention period.. Participants will be assigned to one of two cohorts based on their current sleep habits. Cohort 1 are participants who have insufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours more in bed per night. Cohort 2 are participants who have sufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours less in bed per night. The sleep intervention lasts for 14 days.

Начало: 17.09.2025 Край: 01.07.2026 Възраст: 20–40 г.

United States Danisco NCT07243574

Набира участници Фаза 3

Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype

Chronic Obstructive Pulmonary Disease

This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.

Начало: 17.09.2025 Край: 22.01.2030 Възраст: 40–80 г. Лечение

Argentina, Australia, Brazil +10 Sanofi NCT07190222

Набира участници Ранна Фаза 1

Positron Emission Tomography (PET) Contrast Agent Kinetics and Safety: [18F]-Fluoromannitol

Healthy

This is a Phase 0 interventional, non-therapeutic study investigating the biodistribution and safety of \[18F\]-fluoromannitol as a radiotracer (a substance used to help detect disease or infection) in Positron Emission Tomography (PET) scans. The primary objective of this study is to generate safety data in healthy adult human volunteers. In the future, this tracer may help to determine if a medical problem is infectious in people who have Sickle Cell Disease, cancer or other conditions that impact the immune system, or with people who have joint implants. Primary Objective \- Generate safety data, biodistribution and perform human organ dosimetry for \[18F\]- fluoromannitol as a novel PET tracer. Participants will be recruited primarily from St. Jude Children's Research Hospital employees and SJLIFE participants, and from the broader Memphis community if needed.

Начало: 17.09.2025 Край: 01.05.2027 Възраст: 18–75 г.

United States St. Jude Children's Research Hospital NCT07110519

Набира участници

Sisters of Heart (Hermanas de Corazón): A Community Health Worker Initiative for Improving Heart Health in Migrant Farmworker Women

Occupational Stress Gender Related Stress Social Isolation Hypertension +3

The goal of this hybrid Type 1 effectiveness-implementation trial is to test the extent to which a peer support and community resource navigation intervention improves psychological well-being, addresses social determinants of health and thus reduces cardiometabolic risk among rural, migrant, low-income farmworker women aged 18-45 years. The main questions it aims to answer are: * If and to what extent does the intervention reduce stress, social isolation, and psychological distress by improving social support and access to needed resources? * If and to what extent does the intervention improve cardiometabolic health, measured by the American Heart Association's Life's Essential 8 (LE8) score? Researchers will compare the CHW-led Sisters of Heart (Hermanas de Corazón) intervention to a Basic intervention (LE8 assessment and resource information) to assess the effect of peer support and community resource navigation on heart health outcomes.

Начало: 16.09.2025 Край: 01.12.2028 Възраст: 18–50 г.

United States Emory University NCT07111026

Набира участници Фаза 3

Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

Chronic Obstructive Pulmonary Disease

Начало: 16.09.2025 Край: 22.01.2030 Възраст: 40–80 г.

Argentina, Brazil, Canada +6 Sanofi NCT07190209

Набира участници Фаза 1

First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics

Influenza

A randomized, double-blind, placebo-controlled Phase 1 study conducted at a single center with approximately 78 healthy adults aged 18-59 years. Part 1 Single Ascending Dose (SAD) will enroll 48 participants into six cohorts (S1-S6) to receive single oral doses of VNT-101 (100-1500 mg) or placebo under fasting or fed (S5 only) conditions. Part 2 Multiple Ascending Dose (MAD) will enroll 30 participants into three cohorts (M1-M3) to receive multiple oral doses of VNT-101 (250-750 mg BID Days 1-5, QD Day 6) or placebo under fasting conditions. Dose escalation in both parts will proceed after Protocol Safety Review Team (PSRT) review. The primary objective for Part 1 is to evaluate the safety and tolerability of single ascending oral (SAD) doses of VNT-101 in healthy adult participants under either fasting or fed conditions. The primary objective for part 2 is to evaluate the safety and tolerability of multiple ascending oral (MAD) doses of VNT-101 in healthy adult participants.

Начало: 16.09.2025 Край: 01.11.2026 Възраст: 18–59 г.

United States National Institute of Allergy and Infectious Diseases ( NCT07169318

Набира участници

Long Term Effect of Brain Stimulation in PPA

Primary Progressive Aphasia(PPA)

The goal of this clinical trial is to investigate the effect of non-invasive brain stimulation techniques in the progression of primary progressive aphasia for 6 months. We will compare three modalities of brain stimulation (TMS, tDCS, TMS+tDCS) against sham stimulation. All patients will receive also language therapy.

Начало: 15.09.2025 Край: 01.12.2028 Възраст: от 18 г.

Spain Hospital San Carlos, Madrid NCT07158216

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