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Набира участници Фаза 1

A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

Advanced Urothelial Carcinoma Oral Drug Administration Open Label

The goal of this clinical trial is to study the safety and tolerability in all advanced solid tumors, including advanced urothelial carcinoma. The main question\[s\] it aims to answer are: * Is FX-909 safe and tolerable, as a monotherapy and in combination with Pembrolizumab * What is the right dose level for patients Participants will be asked to take FX-909 daily in tablet form, or FX-909 daily and Pembrolizumab every 3 weeks, and record any outcomes from taking the drug. Participants will also be asked to return for multiple site visits for various blood tests and to collect blood and tumor samples as well as have regular CT/MRI scans.

Начало: 24.08.2023 Край: 30.01.2028 Възраст: от 18 г.

United States Flare Therapeutics Inc. NCT05929235

Набира участници Фаза 2

At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer

Advanced Anal Carcinoma Advanced Biliary Tract Carcinoma Advanced Bladder Carcinoma Advanced Breast Carcinoma +40

This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.

Начало: 23.08.2023 Край: 01.01.2027 Възраст: от 18 г.

United States Mayo Clinic NCT05969860

Набира участници

Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation

Atrial Fibrillation Functional Mitral Regurgitation Functional Tricuspid Regurgitation

A prospective, observational cohort study designed to identify clinical phenotypes and evaluate predictors \& outcomes of functional mitral and tricuspid valve regurgitation in patients with atrial fibrillation. Participant will under go: * Baseline echocardiography * Cpex Echocardiography * Blood test: BNP * 1 year follow up Echocardiography Participants will be stratified into three subgroups: * Atrial Functional MR * Atrial Functional TR * Mixed MR \& TR

Начало: 23.08.2023 Край: 01.08.2027 Възраст: от 18 г.

United Kingdom Barts & The London NHS Trust NCT05920824

Набира участници Фаза 4

The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial

Coronary Artery Disease

Heart disease remains the leading cause of death in Veterans. Inflammation in the arteries of the heart may increase the risk of cardiac death. Patients with heart disease undergoing major surgery are at increased risk of complications after surgery, including heart attack, stroke, and death. The proposed research seeks to better understand the role of inflammation in the damage to the heart and blood vessels after major surgery. This research also seeks to identify the potential beneficial role of a safe medication, colchicine, which has direct effects on inflammatory cells and has been used in the treatment of inflammatory diseases for more than 2000 years, on reducing the rate of complications after surgery. With its quick onset of action and excellent safety profile, colchicine may have the potential to reduce risk of heart injury, stroke, or death after major surgery.

Начало: 21.08.2023 Край: 30.04.2029 Възраст: от 18 г.

United States VA Office of Research and Development NCT05618353

Набира участници

OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis

ATTR Amyloidosis

The overall aim of this observational study is to generate real-world evidence on the pre- and post-diagnosis disease journeys, including baseline characteristics, treatment patterns and selected clinical, economic, and humanistic outcomes (for example Health Related Quality of Life (HRQoL), Neuropathy impairment score, activities of daily living (ADL) assessments) in patients with ATTR amyloidosis, and to better understand how the disease is presented.

Начало: 21.08.2023 Край: 30.09.2026

Canada, China, Denmark +7 AstraZeneca NCT06355934

Набира участници

5-Cog 2.0: A Pragmatic Clinical Trial

Dementia Cognitive Impairment

Cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. This problem is more prevalent in health disparities populations. The investigators developed the 5-Cog brief cognitive assessment that is simple to use, standardized, takes \

Начало: 18.08.2023 Край: 01.11.2027 Възраст: от 65 г.

United States Albert Einstein College of Medicine NCT05515224

Набира участници Фаза 1/2

First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

Advanced Solid Tumor Metastatic Solid Tumor

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Начало: 18.08.2023 Край: 15.02.2027 Възраст: от 18 г.

Belgium, Canada, China +5 Daiichi Sankyo NCT05875168

Набира участници Фаза 2

Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

Radiation Induced Fibrosis

This study will evaluate the efficacy of losartan (LOS), an FDA-approved transforming growth factor beta-1 (TGF-β1) blocker, to decrease radiation induced fibrosis (RIF) in the breast and the lung of breast cancer patients, testing the hypothesis that Losartan will decrease RIF, TGF- β1 and cellular senescence/inflammation in the breast and the lung of irradiated breast cancer patients relative to placebo treatment and consequently improve clinical outcomes in breast cancer patients.

Начало: 17.08.2023 Край: 17.08.2027 Възраст: от 18 г.

United States Shaw Cancer Center NCT05637216

Набира участници Фаза 4

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits

Epilepsy

Methylphenidate (MPH) is a stimulant, FDA-approved for the treatment of attention deficit hyperactivity disorder (ADHD). It is unknown, however, if stimulants would be of benefit for memory and thinking problems due to epilepsy. In this study, participants will be assigned randomly (i.e., by flip of a coin), to a group that takes MPH and a group that takes a placebo (sugar pill). Participants will not know the group to which they have been assigned. Tests of attention and memory will be completed before taking the study pills and at Week 8. All participants will then have the option of taking MPH for the next two months, and attention and memory will be tested again at Week 16. The study will determine whether methylphenidate is helpful for the treatment of attention and memory problems in adults with epilepsy, and whether the medication is safe and beneficial when taken over an extended time period.

Начало: 14.08.2023 Край: 31.05.2028 Възраст: от 18 г.

United States VA Office of Research and Development NCT04419272

Набира участници Фаза 1

Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer

Hormone-refractory Prostate Cancer

The study will be conducted in 4 parts and will commence with dose escalation of VIR-5500 as a monotherapy (Part 1), followed by combination escalation (Part 3a), monotherapy dose expansion (Part 2) and combination dose expansion (Part 4a). * Part 1 (Monotherapy Dose Escalation): Single-agent VIR-5500 dose escalation * Part 2 (Monotherapy Dose Expansion): Single-agent VIR-5500 dose expansion * Part 3 (Combination Dose Escalation): VIR-5500 plus another therapeutic agent dose escalation o Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI) (enzalutamide or darolutamide) * Part 4 (Combination Dose Expansion): VIR-5500 plus another therapeutic agent dose expansion o Part 4a (Combination Dose Expansion): VIR-5500 in combination with an ARSI (enzalutamide or darolutamide)

Начало: 10.08.2023 Край: 29.09.2027 Възраст: от 18 г. Лечение

Australia, Spain, United Kingdom +1 Vir Biotechnology, Inc. NCT05997615

Набира участници Фаза 1/2

Safety, Tolerability, PK and PD of ADX-038 in Healthy Participants and Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

Paroxysmal Nocturnal Hemoglobinuria (PNH)

The first-in-human Phase 1/Phase 2a study described herein will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in both healthy participants (HP) and in patients with paroxysmal nocturnal hemoglobinuria (PNH).

Начало: 07.08.2023 Край: 31.07.2028 Възраст: от 18 г. Лечение

Australia, United Kingdom ADARx Pharmaceuticals, Inc. NCT05876312

Набира участници Фаза 1/2

Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma

Carcinoma, Renal Cell

A phase I/II, open-label, study to determine the safety and preliminary efficacy of orellanine in patients with metastatic clear-cell or papillary renal carcinoma who have failed standard-of-care therapy. All participants must have end-stage kidney disease and be receiving stable chronic hemodialysis.

Начало: 04.08.2023 Край: 31.12.2027 Възраст: от 18 г.

Portugal, Sweden, United States Oncorena AB NCT05287945

Набира участници Фаза 2

Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer

Merkel Cell Carcinoma

The purpose of this study is to find out what effects an immunotherapy drug, called pembrolizumab, combined with a radioactive drug, called lutetium Lu 177 dotatate (Lutathera®) have on patients with Merkel cell carcinoma. Pembrolizumab works by helping patient's immune system to fight cancer. Lutathera works by killing cancer cells. Pembrolizumab is approved by the FDA to treat Merkel cell cancer and has caused some Merkel cell cancers to shrink and/or resolve. Lutathera is FDA-approved to treat some neuroendocrine tumors and has caused some patient's neuroendocrine tumors to shrink and allowed them to live longer, but it is not approved by the FDA to treat Merkel cell cancer. The combination of Lutathera and pembrolizumab to treat Merkel cell cancer is investigational, which means this combination is not approved by the FDA to treat Merkel cell cancer.

Начало: 03.08.2023 Край: 01.12.2028 Възраст: от 18 г.

United States Weill Medical College of Cornell University NCT05583708

Набира участници

Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer

Bladder Cancer

BCDx is a urine-based multi-omic assay for early cancer recurrence detection in patients with a history of bladder cancer. This prospective, blinded study evaluates its efficacy in detecting recurrent NMIBC, offering a noninvasive monitoring solution.

Начало: 26.07.2023 Край: 31.08.2026 Възраст: от 18 г.

United States Early is Good Inc. NCT05982561

Набира участници

CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee

Revision Total Hip Arthroplasty (RTHA) Revision Total Knee Arthroplasty

The goal of this clinical trial is to compare two types of skin preparation solutions (chlorhexidine gluconate-alcohol solution and povidone-iodine solution) that help eliminate harmful bacteria on the skin at the time of surgery for patients having revision arthroplasty surgery of the hip or knee. The main outcome of interest for the definitive study is the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery. For the pilot trial, our main interest is to determine feasibility of a definitive trial. Feasibility outcomes will include: ability to recruit patients, ability to randomize patients, ability to collect complete data, estimate the event rate of our primary outcome, ability to carry out data linkages and determine the accuracy of collected data. Participants will be contacted at two time points after surgery to complete a 5-minute survey: after 30 days, and after 1 year.

Начало: 25.07.2023 Край: 01.11.2026 Възраст: от 18 г.

Canada Sunnybrook Health Sciences Centre NCT05828810

Набира участници

The Enteric Nervous System in Spinal Cord Injury: Study of the Enteric Nervous System and the Intestinal Epithelial Barrier Via Colonic Biopsies in Spinal Cord Injury Patients

Spinal Cord Injuries

The goal of this clinical trial is to learn more about the enteric nervous system (ENS) and the intestinal epithelial barrier (IEB) in patients with spinal cord injury (SCI). The main questions it aims to answer are : * to characterize the functional (permeability, serotonin production, enteric neuronal phenotype, etc.), proteomic (junction molecules) and transcriptomic (inflammation genes, neuromediator expression, etc.) remodeling of the colonic mucosa and ENS in SCI patients, in comparison with control data. * to correlate intestinal permeability (and all remodeling parameters) with the type of neurological impairment i.e. the neurological level of the lesion, quantification of neurological impairment (motor and sensory scores) and the completeness and incompleteness of a lesion. * to identify a link with disease severity markers * to identify therapeutic targets that could subsequently be tested in the animal model before being proposed in clinical trials. Participants will have colonic biopsies taken following a colonoscopy/rectosigmoidoscopy previously indicated for spinal cord injured patients. Biopsies will be obtained from the right and left colon.

Начало: 24.07.2023 Край: 01.10.2027 Възраст: 18–80 г.

France Nantes University Hospital NCT05954845

Набира участници

Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda

HIV Infections

This study aims to test a new approach to support people living with Human Immunodeficiency Virus (HIV) in Uganda. Traditional healers (TH) will be trained to provide counselling and testing for HIV, help patients start antiretroviral therapy quickly, and offer guidance on taking medications and staying in HIV care. This support will be given in addition to the regular care provided at clinics. The main goal of the study is to see if this new approach can help more people in rural areas achieve viral suppression.

Начало: 20.07.2023 Край: 01.01.2029 Възраст: от 18 г.

Uganda Weill Medical College of Cornell University NCT05943548

Набира участници

Asciminib RMP Study

Chronic Myeloid Leukemia

This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Asciminib in the real-world clinical setting in Korean Chronic myeloid leukemia (CML) patients.

Начало: 19.07.2023 Край: 07.06.2030 Възраст: 18–100 г.

South Korea Novartis Pharmaceuticals NCT05943522

Набира участници

Optimizing INtrinsic Capacity for Functional INdependence and to Impede FrailTY in Older Adults: Adaptation of the WHO-ICOPE for Healthy Ageing in Singapore

Frailty in Older Adults Intrinsic Capacity Age-related Functional Decline Healthy Ageing

The goal of this intervention study is to screen and identify frailty and decline in intrinsic capacity (physical and mental capacities) in community-dwelling older adults in Singapore, and to evaluate whether early identification and targeted interventions can improve health outcomes and support healthy ageing. The main questions it aims to answer are: * Can combined frailty and intrinsic capacity screening with targeted interventions prevent or reduce functional decline in older adults, as measured by changes in life space mobility? * Will at least 80% of screened older adults adhere to recommended care pathways and interventions? * Can this screening and intervention programme demonstrate sustainability through continued community participation and recruitment of new partner organizations beyond the initial implementation phase? The investigators will compare an intervention group (receiving immediate assessment and clinical referrals based on identified needs) to a wait-list control group (receiving the same interventions 12 months later) to see if early intervention leads to better health outcomes and quality of life. Participants will: * Attend 4 study visits over 2 years (at 6-monthly intervals in the first year, with final assessment at end of year 2), each lasting up to 2 hours. * Undergo comprehensive screening assessments including mobility, cognition, mental health, hearing, vision, and nutritional status. * Receive 2 follow-up phone calls at 3-month and 9-month intervals to monitor progress. * If in the intervention group: receive personalized referrals for further care (which may include comprehensive geriatric assessment, primary care reviews, rehabilitation, or dietitian consultations) and guidance on using a mobile health monitoring application. * If in the wait-list control group: receive the same interventions after their 3rd study visit (12 months later).

Начало: 17.07.2023 Край: 15.01.2028 Възраст: от 60 г.

Singapore Sengkang General Hospital NCT07477561

Набира участници Фаза 2

Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia

Leukemia

To learn if cyclophosphamide, vincristine, and dexamethasone (called mini hyper-CVD) in combination with intrathecal (delivered into the spine) chemotherapy (methotrexate, hydrocortisone, cytarabine) and compressed rituximab, blinatumomab, and inotuzumab ozogamicin (called cRIB) can help to control the disease.

Начало: 14.07.2023 Край: 31.12.2029 Възраст: 1–25 г.

United States M.D. Anderson Cancer Center NCT05645718

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