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Recruiting Phase 1

Universal 4SCAR7U Targeting CD7-positive Malignancies

T-cell Acute Lymphoblastic Leukemia T-cell Acute Lymphoblastic Lymphoma Acute Myeloid Leukemia NK Cell Lymphoma

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T cells based on 4SCAR7U design against CD7-positive hematological malignancies using CD7 specific universal CAR T cells. The study also aims to learn more about the function of CD7 targeting CAR T cells and their persistence in patients of hematological malignancies.

Начало: 31.10.2023 Край: 31.12.2026 Възраст: 6–75 г.

China Shenzhen Geno-Immune Medical Institute NCT05995028

Recruiting Phase 4

Positioning of Esketamine Treatment in the Real-world Management of Depression

Major Depressive Disorder

The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are: * to investigate whether Esketamine is effective when added to ongoing antidepressant treatment * to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice Participants will: * attend the clinic for supervised self-administration of intranasal Esketamine treatment * be observed for 2 hours following Esketamine administration including blood pressure monitoring * be asked to complete a battery of questionnaires * be reimbursed for travel expenses

Начало: 31.10.2023 Край: 15.01.2026 Възраст: 18–65 г. Treatment

Australia Royal North Shore Hospital NCT06103760

Recruiting Phase 3

Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)

Progressive Pulmonary Fibrosis Interstitial Lung Disease

Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.

Начало: 30.10.2023 Край: 01.11.2027 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +12 United Therapeutics NCT05943535

Recruiting Phase 1/2

PK and PD Study of NPI-001 and Cysteamine Bitartrate

Cystinosis

Safety, pharmacokinetics, and pharmacodynamics of NPI-001 oral solution in cystinosis patients compared with cysteamine.

Начало: 29.10.2023 Край: 01.08.2026 Възраст: от 10 г. Treatment

Australia Nacuity Pharmaceuticals, Inc. NCT05994534

Recruiting

Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Multiple Sclerosis

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries). The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

Начало: 27.10.2023 Край: 06.07.2032

Australia, Germany, Ireland +3 Biogen NCT05658497

Recruiting Phase 2/3

Nectero EAST System Clinical Study

Abdominal Aortic Aneurysm

The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.

Начало: 25.10.2023 Край: 31.12.2029 Възраст: 21–85 г. Treatment

Australia, New Zealand, United States Nectero Medical, Inc. NCT06001918

Recruiting

Dynamic Deconstructive Psychotherapy Versus Brief Intervention and Contact for Suicidal Adolescents and Young Adults

Suicidal Ideation

The purpose of this clinical trial is to assess whether 6 months of treatment with Dynamic Deconstructive Psychotherapy (DDP) is more effective for reducing thoughts of suicide in suicidal adolescents and young adults than usual care in the community supplemented with Brief Intervention and Contact (BIC). DDP and BIC are two evidence-based practices shown to be more effective than usual care at reducing suicidality. Participants will be randomly assigned to receive DDP treatment with safety planning and optional medication management or BIC treatment with safety planning and optional medication management. Participants in both groups will receive the assigned treatment at SUNY Upstate Medical University's Psychiatry High Risk Program (PHRP). Each participant is anticipated to take part in this trial for up to one year.

Начало: 25.10.2023 Край: 01.09.2027 Възраст: 14–40 г.

United States State University of New York - Upstate Medical Universi NCT05988489

Recruiting Phase 3

ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions

Myelodysplastic Syndromes

The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).

Начало: 24.10.2023 Край: 11.03.2030 Възраст: от 18 г. Treatment

Argentina, Australia, Brazil +18 Bristol-Myers Squibb NCT05949684

Recruiting

VOLT CE Mark Study

Atrial Arrhythmia Atrial Fibrillation Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation

This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

Начало: 24.10.2023 Край: 01.12.2026 Възраст: от 18 г. Treatment

Australia, Belgium, Czechia +6 Abbott Medical Devices NCT06106594

Recruiting Phase 1/2

A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer

Colorectal Cancer Metastatic

This study aims to determine the safety and best response of treatment with CNA3103 (Leucine-rich repeat-containing G protein-coupled receptor 5 \[LGR5\]-targeted, Autologous Chimeric Antigen Receptor (CAR) -T Cells), for participants with Metastatic Colorectal Cancer. Participants may undergo a pre-screening biopsy procedure to determine expression of LGR5. Participants will undergo screening procedures, including leukapheresis (collection of T cells) and lymphodepletion (chemotherapy), up to 47 days prior to CNA3103 dosing. Participants will receive a single Intravenous dose of CNA3103. Expansion cohorts will open after determination of the maximum tolerated dose and recommended phase 2 dose in the dose escalation stage. Participants will be followed up, monitored and will attend study visits for safety and research related tests and procedures for 2 years until disease progression, unacceptable toxicity or intolerable adverse event/s, death or withdrawal of consent.

Начало: 24.10.2023 Край: 01.12.2027 Възраст: от 18 г. Treatment

Australia Carina Biotech Limited NCT05759728

Recruiting Phase 2

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

Multiple Myeloma

This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients

Начало: 23.10.2023 Край: 01.10.2027 Възраст: от 18 г.

United States SCRI Development Innovations, LLC NCT05972135

Recruiting Phase 3

A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

Lymphoma

The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Начало: 22.10.2023 Край: 31.03.2028 Възраст: от 18 г. Treatment

Australia, Brazil, Canada +10 Hoffmann-La Roche NCT06084936

Recruiting

Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

Gastroschisis

The goal of this clinical trial is to evaluate the safety and feasibility of fetal repair of complex gastroschisis (GS) via a fetoscopic surgical approach by assessing maternal, fetal, neonatal, and infant outcomes in a cohort of 10 patients. The hypothesis is that in utero repair of GS will reduce postnatal mortality and morbidity in complex GS infants with minimal maternal and fetal risk.

Начало: 20.10.2023 Край: 01.12.2029 Възраст: от 18 г.

United States Baylor College of Medicine NCT05704257

Recruiting Phase 1

A Phase I Study of Single and Multiple Doses of VG290131 in Healthy Subjects

Healthy Volunteers

This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability and PK profiles of orally administered VG290131 in healthy subjects. The main questions it aims to answer are: 1. The safety and tolerability of VG290131 when administered orally as a single dose and multiple doses in healthy subjects. 2. The pharmacokinetic (PK) profiles of VG290131 and the food effect on the PK profiles of VG290131 in healthy subjects. Approximately 86 subjects will be enrolled in the study.

Начало: 20.10.2023 Край: 01.12.2024 Възраст: 18–45 г. Other

Australia Zhejiang Vimgreen Pharmaceuticals, Ltd. NCT06081465

Recruiting Phase 1

A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)

Relapsed Advanced Lymphomas

An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.

Начало: 19.10.2023 Край: 30.08.2027 Възраст: 18–99 г.

India Aurigene Discovery Technologies Limited NCT05984147

Recruiting

An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant

Chronic Kidney Disease (CKD)

The main purpose of this study is to continue to see how vonsetamig works in the body and to monitor the outcomes after kidney transplant for participants previously treated in the R5459-RT-1944 study (NCT05092347). No study drug will be given during this study.

Начало: 19.10.2023 Край: 23.02.2028 Възраст: 18–70 г.

United States Regeneron Pharmaceuticals NCT05106387

Recruiting Phase 2

Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor

Prostatic Neoplasms Prostate Cancer Prostate Adenocarcinoma

Background: The current standard treatment of prostate cancer is either surgery or radiation. Typically, this includes either the removal or radiation of the whole prostate gland. Many people now seek out focal therapy options to decrease the side effects of treatment. Until now, several forms of physical destruction with heat (thermal ablation), cold (cryotherapy), sound waves (HIFU), laser (FLA), and electrical energy (IRE). A new type of radiation (SBRT) may be an effective way to cure men of early-stage prostate cancer with fewer side effects than standard treatments. Objective: To see how people with untreated localized prostate cancer will respond to focal therapy with SBRT. Eligibility: People aged 18 years and older with untreated localized prostate cancer (prostate cancer which has not spread outside of the prostate gland). Design: * Participants will undergo screening including blood tests, an MRI, a PSMA PET/CT (18F-DCFPyL), and a biopsy. * Small, non-radioactive, gold seeds about the size of a grain of rice will be placed in and/or around the tumor to help target the radiation treatment. * Radiation (SBRT) will occur in 2 separate sessions about 1 week apart. No sedation is used, these sessions are painless. Each session will take about 1-2 hours. Participants can go home afterwards. * Follow-up will continue for 2 years with repeat scans (MRI and PSMA PET/CT) and blood (PSA) tests. * After two years, a biopsy will be done to understand the impact of this new treatment on prostate cancer.

Начало: 19.10.2023 Край: 01.12.2028 Възраст: 18–120 г.

United States National Cancer Institute (NCI) NCT05616650

Recruiting Phase 3

Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25

Breast Cancer

This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

Начало: 18.10.2023 Край: 01.07.2034 Възраст: 18–60 г.

Canada, Colombia, Japan +5 NRG Oncology NCT05879926

Recruiting

Risk-guided Disease managEment Plan to prevEnt CAD in Patients Treated With Previous Cancer

Coronary Artery Disease

REDEEM-CAD is a prospective multi-centre study of CAD risk evaluation and management in cancer survivors 40-70 years with chemotherapy or radiotherapy \>5 years ago.

Начало: 18.10.2023 Край: 01.05.2026 Възраст: 40–70 г.

Australia Baker Heart and Diabetes Institute NCT05366153

Recruiting Phase 2

Semaglutide Therapy for Alcohol Reduction (STAR)

Addiction Alcohol Use Disorder

Background: Alcohol use disorder (AUD) is a problematic pattern of alcohol use accompanied by clinically significant medical consequences. Medications can help most people reduce their drinking, but the number is limited, and additional treatment options are needed. Objective: To test if a medication named Semaglutide is safe and may reduce alcohol drinking in people with AUD. Who can participate? All Adults aged 18 or older with AUD might be eligible to participate in the study. What will happen during the study? Participants will visit the National Institute on Drug Abuse (NIDA) in Baltimore once a week for about 20 weeks (5 months). Each visit will last between 2 and 6 hours depending on the tasks scheduled for that visit. Participants will be assigned by chance (like flipping a coin) to receive either Semaglutide or placebo. A placebo looks just like a real drug but contains no medicine. The study medication is given as a shot under the skin each week. Participants will undergo different tests throughout the study: They will give blood, urine, and saliva samples. They will engage in self-paced behavioral therapy on a computer. They will answer questions about their mood, diet, alcohol drinking and craving, tobacco use, etc. They will taste several sweet liquids and tell their preferences. They will sit in a bar-like room and be exposed to cues that might make them feel the urge to eat food or drink alcohol. They will wear a virtual reality headset that creates a cafeteria setting. They will walk the virtual cafeteria and choose food and drinks from a buffet. They will have a functional magnetic resonance imaging (fMRI) scan to take pictures of their brain. During the scans, participants will be shown pictures of alcohol-containing drinks, food, and other items.They will perform tasks on a computer screen. Participants will have a follow-up visit about 7 weeks after their last shot.

Начало: 17.10.2023 Край: 31.12.2030 Възраст: 18–110 г.

United States National Institute on Drug Abuse (NIDA) NCT06015893

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