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Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression

Post Stroke Depression

The study evaluates the effect of HBOT on depression in patients suffering from persistent symptoms of post stroke depression (PSD) in an double blind sham control study.

Начало: 08.11.2023 Край: 01.12.2030 Възраст: 50–85 г.

Israel Assaf-Harofeh Medical Center NCT07423273

Набира участници Фаза 1

Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers

Metastatic Colorectal Carcinoma Metastatic Malignant Solid Neoplasm Stage IV Colorectal Cancer AJCC v8 Unresectable Colorectal Carcinoma +1

This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with the usual treatment with capecitabine in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and that it has progressed on previous standard treatment. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. Capecitabine is in a class of medications called antimetabolites. It is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Giving ZEN003694 in combination with capecitabine may be safe in treating patients with metastatic or unresectable solid tumors.

Начало: 08.11.2023 Край: 30.06.2026 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT05803382

Набира участници Фаза 1/2

TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II

Lymphoblastic Leukemia

The purpose of this study is to improve upon the TINI study treatment. The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.

Начало: 03.11.2023 Край: 01.12.2033 Възраст: до 1 г.

Canada, United States Tanja Andrea Gruber NCT05848687

Набира участници

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Carcinoma, Hepatocellular Cirrhosis

The study is a randomized trial of two different screening methods for early detection of liver cancer in patients with cirrhosis of the liver. The goal of PREMIUM is to compare an abbreviated version of the diagnostic gold standard for HCC (aMRI) +AFP to the standard-of-care screening (US+AFP) in patients at high risk of developing HCC. The investigators hypothesize that HCC will be detected at earlier stages, allowing for more curative treatments and resulting in a reduction in HCC-related mortality.

Начало: 03.11.2023 Край: 01.09.2031 Възраст: 18–75 г.

United States VA Office of Research and Development NCT05486572

Набира участници

ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

Breast Cancer

This prospective, blinded, single-arm study aims to test the performance of nanomechanical phenotype in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response compared to the gold standard of histopathological assessment. The study involves patients with suspicious breast lesions who will undergo a breast biopsy procedure indicated by standard of care. The nanomechanical phenotype will be measured on the freshly obtained breast biopsies or tissue from breast surgeries.

Начало: 02.11.2023 Край: 01.11.2035 Възраст: от 18 г.

Spain, Switzerland, United States ARTIDIS AG NCT06085833

Набира участници

Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria

Urothelial Carcinoma

It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that cannot be seen with the naked eye). This is because the risk of disease (bladder cancer - urothelial carcinoma) is relatively low in this population group, approximately 3%. Invasive procedures such as cystoscopy can cause anxiety and pain, in addition to other potential side effects. This has resulted in low admittance for cystoscopy among patients with hematuria (blood in urine) in urology clinics. Therefore, there is a need for a simpler, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. Cxbladder, a non-invasive, urine-based test, has the potential to fill this role.

Начало: 02.11.2023 Край: 30.06.2026 Възраст: 18–89 г.

United States Pacific Edge Limited NCT05889195

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IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion

Depression

The goal of this Hybrid Type 2 Implementation-Effectiveness Cluster Randomised Controlled Trial is to reduce the treatment gap for depression through the integrated implementation of interventions in facility and community platforms, in Goa, India. The primary question is to examine whether a community intervention ("Community Model") enhances the demand for, and improves the outcomes of, an evidence-based, brief psychological treatment for depression delivered by non-specialist health workers in primary health care facilities ("Facility Model"). Participants in the Facility Model arm will receive only a psychosocial intervention for depression (the Healthy Activity Program - HAP) while participants in the Community Model will receive both the HAP and the community intervention. We will compare the Facility Model and the Community Model to assess if the latter is superior in increasing the demand for depression treatment in primary care, increasing uptake of treatment by people with depression, increasing treatment completion rates, and reducing the severity of depression.

Начало: 01.11.2023 Край: 30.04.2026 Възраст: от 18 г.

India Sangath NCT05890222

Набира участници Фаза 3

Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Metastatic Breast Cancer

The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

Начало: 31.10.2023 Край: 01.04.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +14 LeonaBio NCT05696626

Набира участници Фаза 1

Universal CAR-T Cells Targeting Multiple Myeloma

Multiple Myeloma in Remission

The aim of this study is to assess the feasibility, safety and efficacy of universal CAR T cells targeting multiple myeloma. Another goal of the study is to learn more about the persistence and function of the universal CAR T cells in the body.

Начало: 31.10.2023 Край: 31.12.2026 Възраст: 18–80 г.

China Shenzhen Geno-Immune Medical Institute NCT06006741

Набира участници Фаза 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

Набира участници Фаза 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. Лечение

Argentina, Australia, Belgium +12 United Therapeutics NCT05943535

Набира участници

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

Набира участници Фаза 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

Набира участници

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

Набира участници Фаза 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

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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

Набира участници Фаза 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

Набира участници Фаза 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

Набира участници Фаза 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

Набира участници

Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison

Knee Arthropathy

MADISON Total Knee Prosthesis is intended to be used for total knee arthroplasty to reduce pain and restore joint mobility of the knee. Clinical data for MADISON Total Knee Prosthesis available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product. Thus, in order to maintain compliance with the EU regulation (2017/745) related to medical devices and following ISO 14/155:2020, SERF has set up post-market clinical follow-up study (PMCF) to confirm safety and performance of Total Knee Arthroplasty system MADISON. This study is designed to cover the expected 15-years follow-up, to retrieve data according to implant feature (Posterior Stabilized or Ultra Congruent) or fixation method and to gather data related to the revision of partial knee prosthesis. The primary objective of this study is to assess the clinical safety of MADISON total knee prostheses. The secondary objective is to evaluate the survival rates, the clinical performances and clinical benefits of MADISON total knee prosthesis.

Начало: 17.10.2023 Край: 31.12.2040 Възраст: от 18 г.

France Societe dEtude, de Recherche et de Fabrication NCT06120023

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