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Набира участници Фаза 2

A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis

AL Amyloidosis

This is a multicenter open-label, phase 2 study in participant with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the benefit of teclistamab

Начало: 02.07.2025 Край: 01.09.2028 Възраст: от 18 г. Лечение

Australia, France, Germany +3 European Myeloma Network B.V. NCT06649695

Набира участници Фаза 2

Ketamine, SGB and Combination Treatment for TBI

Posttraumatic Headache Posttraumatic Stress Disorder

Post-Traumatic Stress Disorder (PTSD) and traumatic brain injury (TBI) with associated headache are amongst the most common injuries sustained by our deployed forces in Iraq and Afghanistan, as well as in more recent conflicts in Eastern Europe and the Middle East. This study aims to determine whether a procedural intervention (stellate ganglion block (SGB)) or medication (ketamine), alone or in combination, can alleviate PTSD and TBI-associated headache. Determining efficacious treatments in a randomized, double-blind, placebo-controlled, multicenter study trial may improve quality of life in those with TBI and PTSD, and identifying factors associated with treatment outcome (personalized medicine) may enhance selection, thereby improving the risk: benefit and cost-effectiveness ratios. Primary Objectives: 1. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for TBI-related headache; 2. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for PTSD; 3. To determine the comparative effectiveness of SGB and ketamine infusion, and the effect of combination treatment on TBI-related headache and PTSD; 4. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance; 5. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups. Secondary Objectives: 1. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance (Biomedical levels and MRI not included at Northwestern University Site). 2. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.

Начало: 02.07.2025 Край: 30.04.2028 Възраст: от 18 г.

United States Northwestern University NCT06608277

Набира участници Фаза 3

TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Transthyretin Amyloidosis With Cardiomyopathy

The purpose of this study is to: * Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events * Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death * Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life

Начало: 02.07.2025 Край: 30.11.2032 Възраст: 18–85 г. Лечение

Argentina, Australia, Belgium +26 Alnylam Pharmaceuticals NCT07052903

Набира участници Фаза 1

A Study of AK146D1 for Injection in the Treatment of Advanced Solid Tumors

Advanced Solid Tumors

This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK146D1 for injection in advanced solid tumors.

Начало: 02.07.2025 Край: 05.05.2027 Възраст: 18–75 г. Лечение

Australia Akeso NCT06929663

Набира участници Фаза 3

Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies

Alzheimers Disease

This study is a pre-screening process used to assess participants' potential eligibility for Roche interventional Alzheimer's disease studies.

Начало: 02.07.2025 Край: 31.07.2035 Възраст: 50–90 г. Скрининг

Argentina, Australia, Brazil +11 Hoffmann-La Roche NCT07177352

Набира участници

Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

Systemic Lupus Erythematosus

PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.

Начало: 01.07.2025 Край: 15.04.2031

United States AstraZeneca NCT06659029

Набира участници

Inspiratory Muscle Training After Vertebroplasty in Osteoporotic Fracture Patients

Osteoporotic Vertebral Compression Fractures Restrictive Pulmonary Disorders Inspiratory Muscle Weakness Postoperative Pulmonary Function

This study investigates the long-term effects of inspiratory muscle training (IMT) on pulmonary function, functional capacity, and quality of life in individuals with osteoporotic vertebral compression fractures who have undergone percutaneous vertebroplasty. Participants aged 50 and older, diagnosed with osteoporosis and having undergone thoracic vertebroplasty within the past 3 months, will be randomly assigned to either an intervention group (IMT + standard rehabilitation) or a control group (standard rehabilitation only). The primary outcome measure is spirometry-based pulmonary function. Secondary outcome measures include inspiratory muscle strength, functional walking capacity (6-minute walk test), diaphragmatic structure and elasticity, and quality of life (SGRQ, NHP). This randomized controlled trial will be conducted at the Cardiopulmonary Rehabilitation Unit of Nuh Naci Yazgan University and aims to provide scientific evidence for integrating IMT into routine post-vertebroplasty rehabilitation protocols.

Начало: 01.07.2025 Край: 30.04.2026 Възраст: от 50 г.

Turkey (Türkiye) Istinye University NCT07024095

Набира участници

Video-Based Patient Navigation to Support Cervical Cancer Screening Among Black Women

Uterine Cervical Neoplasms

The goal of this clinical trial is to test whether an interactive, video-based patient navigation program can improve cervical cancer screening among African American women who are currently overdue for screening. The main questions it aims to answer are: Can an interactive video navigation tool (mNav), when paired with in-person navigation, improve screening adherence compared to a standard educational video alone? Does the intervention improve knowledge, reduce barriers, and increase intentions to get screened? Researchers will compare participants who receive both the interactive video (guided by an on-screen navigator) and in-person navigation to those who receive only a standard educational video to see if the tailored support increases screening rates. Participants will: Complete two phone surveys (one at the beginning and one six months later) Be randomly assigned to one of two groups: One group will receive an interactive video experience tailored to their concerns plus support from an in-person navigator The other group will receive a standard educational video designed for African American women Have their clinic records reviewed six months later to check for cervical cancer screening completion

Начало: 01.07.2025 Край: 31.03.2027 Възраст: 21–65 г.

United States ISA Associates, Inc. NCT07011836

Набира участници Фаза 2

Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy

The goal of this clinical trial is to assess the efficacy of Levagen+ supplementation for the symptoms of diabetic peripheral neuropathy (DPN) in patients with DPN. Participants will have remote visits and attend a local pathology centre for blood draws. They will take the study product for 12 weeks, from baseline to week 12 they will have remote visits every 3 weeks.

Начало: 01.07.2025 Край: 01.05.2026 Възраст: 18–75 г. Лечение

Australia RDC Clinical Pty Ltd NCT07028528

Набира участници

Lentiviral Gene Therapy for CGD

Chronic Granulomatous Disease

This is a Phase I/II clinical trial of gene therapy for treating Chronic Granulomatous Disease using a high-safety, high-efficiency, self-inactivating lentiviral vector TYF to functionally correct the defective gene. The objectives are to evaluate the safety and efficacy of the TYF-CGD gene transfer clinical protocol.

Начало: 01.07.2025 Край: 31.12.2029

China Shenzhen Geno-Immune Medical Institute NCT03645486

Набира участници Фаза 1/2

Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells

Cancer

The primary objectives are to evaluate the safety and efficacy of infusion of autologous tumor associated antigen-specific engineered immune effector cells (EIE).

Начало: 01.07.2025 Край: 31.12.2029 Възраст: 1–80 г.

China Shenzhen Geno-Immune Medical Institute NCT03535246

Набира участници Фаза 1/2

Immunotherapy Treating GI Cancer

Cancer

The primary objectives are to evaluate the safety and efficacy of infusion of autologous gastro-intestinal (GI) cancer antigen-specific engineered immune effector cells (EIE).

Начало: 01.07.2025 Край: 31.12.2028 Възраст: 1–80 г.

China Shenzhen Geno-Immune Medical Institute NCT03614650

Набира участници

Study of the Photoprotection and Prevention of Actinic Damage With Anthelios Fluide 100 KA+ UVMune 400 in Patients With Multiple Actinic Keratoses

Actinic Keratosis (AK)

Participants will be invited to take part in a research study as they have been diagnosed with multiple actinic keratosis lesions (AK). AK usually present as small, rough, dry, scaly and/or crusty patches or papules of the skin that can be skin-coloured pink, red, tan or a combinationof colours and are often easier to feel than see at their earlier stages. AK are commonly diagnosed in adults, particularly in patients aged 45 years and older and are considered to be pre-cancerous lesions. The research is aiming to investigate the protective effect of an investigational sunscreen known as Anthelios Fluide 100 KA+ UVMune 400, when used together with good sun protection habits (which include staying in the shade during the hours of 11 am and 3 pm, wearing sun-protective clothing, wearing a wide-brimmed hat) in participants with multiple Actinic keratoses's. Eligible participants will be randomly assigned into 1 of 2 groups - an intervention or control group The study main objective is to evaluate tested sunscreen prevention on actinic keratosis lesions.

Начало: 01.07.2025 Край: 01.03.2029 Възраст: от 60 г. Превенция

Australia Cosmetique Active International NCT07335003

Набира участници Ранна Фаза 1

A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study

Insomnia

The goal of this clinical trial is to explore the potential benefits of an inhaled version of melatonin compared to oral melatonin tablets on adults with insomnia. The main question the trial aims to answer is: does inhaled melatonin affect the sleep profiles of adults with insomnia differently than oral melatonin tablets? 10 Participants will: * Visit the research institute for a screening visit, for an overnight visit at the beginning of each study drug treatment and for a blood collection visit at the end of the conclusion of each study drug treatment period (5 visits in total) * Take 100 µg of inhaled melatonin (2 inhaler puffs) nightly for two weeks * Take a 4 mg of oral melatonin (2 tablets) nightly for two weeks

Начало: 01.07.2025 Край: 01.05.2026 Възраст: от 55 г. Лечение

Australia Woolcock Institute of Medical Research NCT06802913

Набира участници Ранна Фаза 1

A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Pharmacokinetic Study

Insomnia

The goal of this clinical trial is to explore the potential benefits of an inhaled version of melatonin compared to oral melatonin tablets on adults with insomnia. The main question the trial aims to answer: is the time required for inhaled melatonin to reach peak concentration in the blood and then be eliminated from body different to that of oral melatonin tablets, in adults with insomnia? 5 participants will: * Visit the research institute for a screening visit and for a daytime visit to take a melatonin treatment then provide blood samples over the course of 8 hours for each study drug treatment (3 visits in total) * Take 100 μg of inhaled melatonin (2 inhaler puffs) once * Take a 4 mg of oral melatonin (2 tablets) once

Начало: 01.07.2025 Край: 01.05.2026 Възраст: от 55 г. Лечение

Australia Woolcock Institute of Medical Research NCT06801379

Набира участници Фаза 3

Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC

Prostate Cancer

The purpose of this study is to determine whether \[225Ac\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \[177Lu\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.

Начало: 01.07.2025 Край: 04.11.2032 Възраст: 18–100 г. Диагностика

Australia, Brazil, China +8 Novartis Pharmaceuticals NCT06855277

Набира участници

DLPFC and Sympathetic Reactivity in RPL With Anxiety

Recurrent Pregnancy Loss Without Current Pregnancy Anxiety Disorder

We propose an exploratory clinical study (NEURO-CARD-2) that employs simultaneous functional near-infrared spectroscopy (fNIRS) and electrocardiography (ECG) to investigate interhemispheric dysfunction in the dorsolateral prefrontal cortex (DLPFC) and its relationship with autonomic sympathetic activation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. Using a standardized multisensory aversive emotional stimulation paradigm, the study will assess cortical and cardiac responses within the framework of the Brain-Heart-Emotion interaction model. The objective is to identify neurobiological signatures underlying emotion-autonomic dysregulation in this population, thereby informing future development of precision-targeted interventions.

Начало: 01.07.2025 Край: 30.04.2026 Възраст: 18–45 г.

China Shenyang Medical College NCT07045818

Набира участници

Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up

Genital Diseases, Female Ectopic Pregnancy Uncertain Viability of Pregnancy Abortion, Missed +1

The GYNAB study aims to compare patient satisfaction and clinical outcomes between dematerialized post-emergency gynecological follow-up using a connected health app and traditional in-person follow-up. Conducted by Drs. Laëtitia CAMPIN and Louis MARCELLIN at Hôpital Cochin, it is sponsored by Assistance Publique - Hôpitaux de Paris. The main objective is to assess patient satisfaction at day 7 on a scale from 0 to 10, considering symptom management, follow-up quality, and task performance. Secondary objectives include comparing satisfaction at day 28, PROM-ED scores for symptom relief, understanding, reassurance, and care planning at days 7 and 28, hospitalization rates, unscheduled consultations, surgical interventions, total hospital time by day 28, and physician satisfaction at 28 days. This randomized trial involves women aged 18-60 needing follow-up for conditions like genital infections, non-complicated ectopic pregnancies, unlocated pregnancy, first trimester metrorrhagia, miscarriages , and severe vomiting before 12 weeks. Inclusion criteria are women aged 18-60 needing specified follow-up. Exclusion criteria are severe clinical intolerance, severe criteria ultrasound findings, non-French speakers, and inability to use digital applications. The intervention group uses a connected health app for data collection and communication, logging symptoms and test results, with medical team notifications for urgent updates. The control group receives traditional in-person follow-up with scheduled consultations and emergency contact information. The study hypothesizes that digital follow-up will improve patient experience, reduce hospital visits, and provide comparable or superior satisfaction and clinical outcomes. The results could promote broader digital health adoption in various medical fields.

Начало: 30.06.2025 Край: 30.07.2027 Възраст: 18–60 г.

France Assistance Publique - Hôpitaux de Paris NCT06615843

Набира участници Фаза 3

A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of GM1 Gangliosidosis or GM2 Gangliosidosis

Gangliosidoses, GM2 Gangliosidosis, GM1

An 18-month double-blind, randomized, placebo-controlled, multicenter, Phase 3 study to evaluate the safety and efficacy of oral nizubaglustat (AZ-3102) in late-infantile and juvenile forms of GM1 gangliosidosis or GM2 gangliosidosis

Начало: 30.06.2025 Край: 04.11.2027 Възраст: от 4 г. Лечение

Argentina, Australia, Brazil +13 Azafaros A.G. NCT07082543

Набира участници Фаза 3

A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of Niemann-Pick Type C Disease (NPC)

Niemann-Pick Type C Disease

Начало: 30.06.2025 Край: 04.11.2027 Възраст: от 4 г. Лечение

Argentina, Australia, Brazil +11 Azafaros A.G. NCT07082725

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