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Набира участници Фаза 1

Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Diffuse Large B-Cell Lymphoma, Not Otherwise Specified High Grade B-Cell Lymphoma Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

This phase I trial studies the side effects and best dose of mosunetuzumab when given together with polatuzumab vedotin and lenalidomide in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab and polatuzumab vedotin are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab, linked to a toxic agent called vedotin, attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Giving mosunetuzumab with polatuzumab vedotin and lenalidomide may work better in treating patients with relapsed/refractory DLBCL.

Начало: 20.05.2024 Край: 30.06.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT06015880

Набира участници

Manipulating E-Cigarette Nicotine to Promote Public Health

Tobacco-Related Carcinoma

This clinical trial explores the manipulation of e-cigarette (EC) nicotine to promote public health. Researchers are trying to understand and gather information about how the strength, form, and structure of nicotine in products play a significant role in their potential for addiction and how they might affect health risks. The information gained from this study may allow researchers to understand how these aspects of nicotine influence the potential for addiction, how people puff on ECs, how the body processes nicotine, and any potential harmful effects it might have on health. Exploring these specific characteristics of nicotine may also determine if an EC product standard could help identify optimal nicotine levels for users.

Начало: 20.05.2024 Край: 20.05.2027 Възраст: 21–65 г.

United States Ohio State University Comprehensive Cancer Center NCT06448351

Набира участници Фаза 3

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Clostridium Difficile Clostridium Difficile Infections Clostridium Difficile Infection Recurrence Clostridioides Difficile Infection +6

The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).

Начало: 20.05.2024 Край: 01.10.2027 Възраст: от 12 г. Превенция

Australia, Belgium, Brazil +21 Vedanta Biosciences, Inc. NCT06237452

Набира участници Фаза 2

Antibiotic Tumescent For Chronic Wounds

Non-healing Wound

Chronic non-healing wounds are becoming an increasingly more common problem. Eligible, consenting patients with chronic wounds in the lower extremities, upper extremities or trunk, will either continue to the standard of care or will be randomized to the treatment cohort where antibiotic solution will be injected in the area around the wound. All patients will continue standard wound care as dictated by the wound care clinic. Subjects of both the control and treatment will have approximately 6 study specific visits that may or may not coincide with previously schedule wound care clinic visits. As these specified visits wound size and healing will be documented and patients will complete surveys. The study will conclude for the subject after approximately 6 months. Again, these patients may continue standard wound care but will no longer have study obligations.

Начало: 17.05.2024 Край: 25.05.2028 Възраст: от 18 г.

United States University of California, Los Angeles NCT06327113

Набира участници Фаза 2

A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy

Cerebral Amyloid Angiopathy

The purpose of the study is to evaluate the effect of ALN-APP on measures of CAA disease progression and to characterize the safety, tolerability, and pharmacodynamics (PD) of ALN-APP in adult patients with sporadic CAA (sCAA) and Dutch-type CAA (D-CAA). The study will be conducted over 2 periods: a 24-month double-blind treatment period and an optional 18-month open-label extension (OLE) period. The estimated duration of study participation, inclusive of screening, treatment, and additional safety follow-up, is up to 50 months.

Начало: 17.05.2024 Край: 14.12.2029 Възраст: от 30 г. Лечение

Australia, Canada, Netherlands +3 Alnylam Pharmaceuticals NCT06393712

Набира участници

Natural History Study of Kaposi Sarcoma

Kaposi Sarcoma HIV

Background: Kaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract. KS is most common in people with compromised immunity, but it also appears in otherwise healthy people. Researchers want to understand more about how KS develops, why it may recur, and how it affects the immune system and organs. Objective: To learn more about the natural history of KS. Eligibility: People aged 18 years and older with KS. Design: Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan. They may need a new biopsy: Tissue samples may be cut from their tumor. Their ability to perform normal activities will be assessed. Participants will visit the clinic to have their KS evaluated. In addition to the imaging scans and other tests performed during screening, procedures may include: Eye exam. Ultrasound exam of the heart (electrocardiogram). Collection of saliva and urine samples. Biopsies of the skin or lymph nodes. Swabs of the anus and cervix. Photographs of skin lesions. Removal of fluid samples from the space around the lungs, intestine, or heart. The evaluation visit will be repeated 5 more times over 18 months and then yearly for up to 10 years. Participants will follow their standard treatment for KS during the study.

Начало: 15.05.2024 Край: 31.12.2036 Възраст: 18–120 г.

United States National Cancer Institute (NCI) NCT06375122

Набира участници Фаза 1/2

Autoimmune Disease Treatment With Mesenchymal Stem Cells (MSCs) and CAR-T Cells

Autoimmune Diseases

The purpose of this study is to assess the feasibility, safety and efficacy of mesenchymal stem cells (MSCs) in combination with CAR-T cells in treating autoimmune disease. Another goal of the study is to learn more about the safety and function of the MSCs combined with CAR-T cells and their long term effects in autoimmune disease patients.

Начало: 15.05.2024 Край: 31.12.2027 Възраст: 18–75 г.

China Shenzhen Geno-Immune Medical Institute NCT06435897

Набира участници Фаза 2

Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma

Indolent B-Cell Non-Hodgkin Lymphoma Recurrent Indolent B-Cell Non-Hodgkin Lymphoma Refractory Indolent B-Cell Non-Hodgkin Lymphoma Recurrent Indolent Non-Hodgkin Lymphoma +1

This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard of care radiation treatment for indolent non-Hodgkin lymphoma is usually delivered in 12 treatments. Studies have shown indolent lymphoma to be sensitive to radiation treatment, however, larger doses have higher rates of toxicities. A reduced radiation dose may be safe, tolerable and/or effective compared to standard of care radiation dose in treating patients with indolent non-Hodgkin lymphoma.

Начало: 15.05.2024 Край: 30.05.2027 Възраст: от 18 г.

United States Mayo Clinic NCT06386315

Набира участници

Clinical Study of GT201 in Combination With PD-1 Inhibitor for Advanced Head and Neck Tumors

HNSCC

This study is a single-arm early exploratory clinical study. designed to evaluate the safety and tolerability of GT201 in combination with a PD-1 inhibitor for the treatment of advanced head and neck tumor subjects with safety and tolerability, as well as pharmacokinetic characterization and efficacy The study consists of two phases. The study consists of two phases, a dose-escalation phase and a dose-expansion phase.

Начало: 12.05.2024 Край: 30.04.2027 Възраст: 18–70 г.

China Grit Biotechnology NCT06190275

Набира участници Фаза 1

Engineered Dendritic Cell Vaccines for Multiple Myeloma

Multiple Myeloma or Plasmacytoma

The purpose of this study is to determine the feasibility, safety, and efficacy of dendritic cell (DC) vaccines in the treatment of multiple myeloma (MM) or plasmacytoma based on immune-modified DC vaccines (DCvac). This approach is aimed to achieve prolonged maintenance of remission in multiple myeloma or plasmacytoma patients.

Начало: 11.05.2024 Край: 31.12.2027 Възраст: 18–80 г.

China, Russia Shenzhen Geno-Immune Medical Institute NCT06435910

Набира участници Фаза 1/2

Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma

Multiple Myeloma Plasmacytoma

The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.

Начало: 11.05.2024 Край: 31.12.2027 Възраст: 18–80 г.

China, Russia Shenzhen Geno-Immune Medical Institute NCT06429150

Набира участници

Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)

Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Indeterminate Colitis +8

This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation.

Начало: 10.05.2024 Край: 01.01.2030 Възраст: 6–21 г.

United States Seattle Children's Hospital NCT06315179

Набира участници Фаза 1

Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

Graft Vs Host Disease Graft-versus-host-disease Graft Versus Host Disease

Allogeneic hematopoietic cell transplantation (HCT) is one of the only curative intent therapies available for hematologic malignancies. HLA-matched sibling donors have historically offered the best clinical results but are unavailable for the majority of patients, while most patients do have readily available haploidentical donors. One of the risks of a haploidentical HCT is graft vs. host disease (GVHD), but it is difficult to reduce the incidence of GVHD without compromising the graft vs. leukemia (GVL) effect. The hypothesis of this study is that JAK inhibition with and without CTLA-4 Ig with haploidentical HCT may mitigate GVHD and cytokine release syndrome while retaining the GVL effect and improving engraftment.

Начало: 07.05.2024 Край: 27.11.2027 Възраст: от 18 г.

United States Washington University School of Medicine NCT06008808

Набира участници

The Natural History of Mitochondrial Diseases

Mitochondrial Diseases Neurological Diseases or Conditions Genetic Disease

The Natural History of Mitochondrial (MITO) Diseases (a longitudinal study observing the natural history of mitochondrial diseases) The goal of this observational study (non-randomised retrospective and prospective) is to fully characterise primary MITO disease; that includes both sexes/genders, over 18 years of age and healthy volunteers\]. The main question\[s\] it aims to answer is to: • better characterise MITO phenotypes (organ involvement, severity, progression) and collect biospecimens to create a biobank that can be used for future biomarker discovery to improve early diagnosis, prognostication and management of mitochondrial disease. The study will be a longitudinal, retrospective, prospective, observational study of participants (400) with confirmed MITO and relevant controls followed for up to 10 years. Data will be collected at regularly scheduled standard-of-care (SOC), 6 to 12 monthly appointments. The 100 control participants will therefore be comprised of (i) unaffected asymptomatic family members of MITO participants with no genetic risk; (ii) participants with non-MITO movement disorders that are not classified as MITO by their clinical presentation and genetic tests (for example Parkinson's disease) and/or (iii) age-matched healthy controls recruited from the NeuRA database of volunteers. Demographic data, medical history, biochemical, histological, genetic, social and other clinical SOC data will be collected. Additionally, seizure and migraine frequency in participants who experience these, will be collected and a quality-of-life questionnaire (SF-12v2), as part of the validated neurological assessment using the Newcastle Mitochondrial Disease Adult Scale (NMDAS).

Начало: 07.05.2024 Край: 07.05.2034 Възраст: от 18 г.

Australia Neuroscience Research Australia NCT06504433

Набира участници

Peanut-based School Meals in Rural Ghana to Improve Attendance and Retention

School Attendance School Dropouts School Enrollment School Feeding Programs +1

The goal of this clinical trial is to test daily provision of peanut paste-based milk-containing ready-to-use school food (PM-RUF) in children 5-17 years of age in Ghana . The main question it aims to answer is: \- Will provision of PM-RUF as a daily school meal improve attendance, improve matriculation, and/or reduce dropouts among Ghanaian schoolchildren 5-17 years of age in Mion District as compared with provision of a common local flour made of rice/millet?

Начало: 07.05.2024 Край: 01.11.2026 Възраст: 5–17 г.

Ghana Washington University School of Medicine NCT06397989

Набира участници Фаза 2

Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

Malignant Female Reproductive System Neoplasm Malignant Solid Neoplasm Recurrent Malignant Female Reproductive System Neoplasm Recurrent Malignant Solid Neoplasm

This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.

Начало: 07.05.2024 Край: 20.02.2027 Възраст: от 18 г.

Puerto Rico, United States National Cancer Institute (NCI) NCT06126276

Набира участници

Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors

Hodgkin Lymphoma, Adult

SURVIVORS Study participants are being asked to take part in this research study called HODNIRS because the participant is a survivor of Hodgkin Lymphoma (HL) treated with chest radiation and bleomycin at St. Jude Children's Research Hospital. The study is being done to help investigators understand the link between long term effects of chest radiation and bleomycin for HL and brain function in survivors. Primary Objective To evaluate dynamic changes in CBF and oxygenation during exercise with Near Infrared Spectroscopy (NIRS) in HL survivors and non-cancer controls matched for age, sex, race, and ethnicity. . Secondary Objectives To examine the degree of CO2 clearance (DLCO/ETCO2) during rest and exercise in Hodgkin Lymphoma (HL) survivors compared to non-cancer controls matched for age, sex, race, and ethnicity. CONTROLS Volunteers are being asked to take part in this research study because they are non-first degree relative or friend of someone who received treatment for a childhood cancer or similar illness at St. Jude Children's Research Hospital or are an employee/affiliate of St. Jude Children's Research Hospital and have agreed to be a St. Jude Life Cohort Study (SJLIFE) community control.

Начало: 06.05.2024 Край: 01.12.2027 Възраст: от 18 г.

United States St. Jude Children's Research Hospital NCT06421987

Набира участници Фаза 4

Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery

Ophthalmology

Regular use of Systane COMPLETE in dry eye subjects before cataract surgery may optimize the ocular surface.

Начало: 02.05.2024 Край: 31.12.2027 Възраст: 20–85 г.

Taiwan National Taiwan University Hospital NCT06763731

Набира участници

rTMS Over the Dorsolateral Prefrontal Cortex for the Treatment of Impulse Control Disorders in Parkinson's Disease

Impulse Control Disorder Parkinson Disease

This study's objective is to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC) of patients with Parkinson's Disease (PD) who experience impulse control disorders (ICDs) on impulse control symptoms and cognitive behaviors linked to ICDs: reinforcement learning and delay-discounting. This is a randomized sham-controlled cross-over trial. All patients will undergo a session of active rTMS and a session of sham rTMS, with the order of sessions randomized across participants. Following recruitment and eligibility screening, the eligible participants will undergo two sessions of rTMS (active and sham), immediately followed by neurocognitive tasks and questionnaires, no more than 1-2 weeks apart. Each session will have a duration of approximately 1-1.5 hours.

Начало: 01.05.2024 Край: 01.05.2027 Възраст: от 18 г.

United States West Virginia University NCT06237868

Набира участници Фаза 2

BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers

Diabetic Foot Ulcer

This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer.

Начало: 01.05.2024 Край: 31.12.2028 Възраст: от 20 г.

Taiwan Blue Blood Biotech Corp. NCT06383013

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