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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

A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

Breast Neoplasms Gastroesophageal Junction Adenocarcinoma HER2 Low Breast Neoplasms HER2 Positive Breast Neoplasms +6

This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer. Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®. This study will test how safe and how well DV with tucatinib works for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

Начало: 20.05.2024 Край: 28.07.2029 Възраст: от 18 г. Лечение

Australia, Canada, Germany +7 Seagen, a wholly owned subsidiary of Pfizer NCT06157892

Набира участници Фаза 1

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Ovarian Neoplasms Endometrial Neoplasms Uterine Cervical Neoplasms Carcinoma, Non-Small-Cell Lung +3

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Начало: 20.05.2024 Край: 01.04.2027 Възраст: от 18 г. Лечение

Australia, France, Italy +4 Eli Lilly and Company NCT06400472

Набира участници

CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care

Critical Illness

Critically ill patients admitted to the Intensive Care Unit (ICU) often need to be connected to a breathing machine (ventilator) and are unable to eat. During this time, liquid nutrition is delivered via a feeding tube to the stomach or bowel (termed enteral nutrition (EN)) to ensure nutrition needs are provided until such time that the patient can eat normally. The delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow. One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube (termed extubation). The practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU. There is currently no scientific consensus on whether pausing of EN is necessary, or for how long. Because of this, some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN. This study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN. The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation.

Начало: 20.05.2024 Край: 01.04.2025 Възраст: от 18 г. Здравни услуги

Australia Emma Ridley NCT06382727

Набира участници

Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery

Delirium, Postoperative Anesthesia Surgery-Complications Cognition Disorder +2

The goal of this clinical trial (Balanced-2 study) is to compare light to deep general anesthesia using widely available brain monitors, to see if 'light' anesthesia could reduce rates of delirium, cognitive decline, and disability in older adults undergoing major surgery. Delirium is the most common serious surgical complication, occurring in an estimated one in four older adults undergoing major surgery. Delirium causes significant distress to patients and family, and is associated with prolonged hospital stay, physical disability, progression to dementia-like illnesses, and discharge to long-term care. Between 10 - 30% of adults aged 70 years and above have surgery every year, and preserving brain health and wellbeing is an important priority during this time. Older adults (aged ≥65 years, or Indigenous, Pacific patients aged ≥55 years) undergoing major surgery with general anesthesia (excluding heart and brain surgery) and able to provide consent will be able to participate. Participants will be randomized to two groups - a lighter general anesthesia group and a deeper general anesthesia group using processed electroencephalography (a brain monitor that provides information on depth of anesthesia using brain waves). The anesthesiologist will titrate anesthetic drugs according to the brain monitor. Participants will be followed up to determine if they experience delirium after surgery, and longer term impact of delirium such as cognitive and physical decline will also be measured. If found to be effect, this simple, cheap, and widely available treatment could reduce disability, preserve brain health and wellbeing of many older adults undergoing surgery worldwide, and save millions in healthcare dollars.

Начало: 20.05.2024 Край: 31.12.2028 Възраст: от 55 г. Превенция

New Zealand Auckland City Hospital NCT06268080

Набира участници Фаза 3

Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Начало: 19.05.2024 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +19 AbbVie NCT06158841

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 Фаза 3

Evaluation of the efficacy and safety of stiripentol in patients 6 years and older with primary hyperoxaluria type 1, 2 or 3

Primary Hyperoxaluria (PH) of all subtypes (PH1 PH2 and PH3)

Trial status: Authorised Percent change in 24-hour urinary oxalate excretion corrected for body surface area (BSA) from baseline to Month 3, Absolute change in 24-hour urinary oxalate excretion corrected for body surface area (BSA) from baseline to Month 3 and Month 6, Change in 24-hour urine oxalate/creatinine ratio from baseline to Month 3 and Month 6, Proportion of patients with near normalisation of 24-hour urinary oxalate level corrected for BSA (defined as urinary oxalate lower than 1.5 x upper limit of normal (ULN)) at Month 3 and Month 6, Proportion of patients with normalisation of 24-hour urinary oxalate level corrected for BSA at Month 3 and Month 6, Change in estimated glomerular filtration rate (eGFR) from baseline to Month 6, Occurrence and frequency of kidney stone events during the follow-up, Change in urine oxalate/creatinine ratios as assessed in spot urine collections between baseline and Month 6, Change in biological parameters related to kidney stone formation between baseline and Month 6, Absolute change in the Pediatric Quality of Life Inventory (PedsQL [the generic and kidney failure (KF) modules]) for patients < 18 years of age (at screening) or in the Kidney Disease Quality of Life Questionnaire (KDQOL) for patients ≥ 18 years of age (at screening), Change in Euro Quality of Life Health State Profile Questionnaire (EQ-5D) and EQ-5D Visual Analog Scale (VAS) Percent change in 24-hour urinary oxalate excretion corrected for body surface area (BSA) from baseline to Month 6

Начало: 16.05.2024 Възраст: от 18 г.

Belgium, France, Italy Biocodex 2023-508062-15-00

Набира участници Фаза 3

Evaluating Efficacy and Safety of CBD TPM Capsules for Use in Insomnia

Insomnia

Insomnia is a common sleep disorder in which a person has difficulty falling asleep or staying asleep or getting good quality sleep. Consequences of insomnia include daytime sleepiness, poor memory function, decline in concentration with negative impacts on social and work activities. Although medical cannabis and cannabis products are widely used worldwide for the management of symptoms associated with insomnia, there is little clinical data available to support the efficacy or utility of CBD in the management of sleep disorders. The proposed study will assess whether nightly doses of 75mg or 150mg of an 8 week period are able to improve patient reported sleep quality when compared to a placebo.

Начало: 16.05.2024 Край: 01.02.2026 Възраст: от 18 г. Лечение

Australia Avecho Biotechnology NCT05840822

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 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 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

Respiratory Adaptive Computed Tomography: Feasibility Study on Real-Time Gated 4DCT for Lung Cancer Radiotherapy

Lung Cancer

This study does not involve a therapeutic intervention as standard radiation therapy treatment will be prescribed. This study involves one additional 4DCT scan (i.e. the Real-Time Gated 4DCT scan) acquired immediately before or following the conventional 4DCT scan. This will take place on the day of the patient's treatment simulation, as per the current standard of care. The scanning sequence (i.e. conventional first versus gated first) will be randomised. The Real-Time Gated 4DCT is anticipated to take longer than the conventional 4DCT scan, due to its gated (beam-pause) nature. However, upper limits for timing will be implemented in the software, and the scan aborted for highly erratic breathing traces that would not benefit from a Real-Time Gated 4DCT scan.

Начало: 15.05.2024 Край: 01.12.2025 Възраст: от 18 г. Друго

Australia University of Sydney NCT05030207

Набира участници Фаза 1/2

A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome

Dravet Syndrome

ENDEAVOR is a Phase 1/2, 2-part, multicenter study to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet syndrome aged ≥6 to \

Начало: 14.05.2024 Край: 01.01.2033 Възраст: 6–17 г. Лечение

Australia, United Kingdom, United States Encoded Therapeutics NCT05419492

Набира участници Фаза 2

MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma

Relapsed/Refractory Large B-cell Lymphoma

This is a Phase II open-label, two-arm randomised non-comparative, multi-centre study to evaluate the efficacy of Epcor-only (Epcoritamab alone) or Epcor-R2 (Epcoritamab, lenalidomide and rituximab) as consolidation post anti-CD19 CAR T-cell therapy for patients that have responded by conventional criteria but who are at high risk of progression by virtue of being Minimal Residual Disease (MRD) positive as determined by a Circulating Tumour DNA (ctDNA) assay.

Начало: 14.05.2024 Край: 01.05.2028 Възраст: от 16 г. Лечение

Australia Peter MacCallum Cancer Centre, Australia NCT06414148

Набира участници Фаза 2/3

Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

Focal Epilepsy

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Начало: 13.05.2024 Край: 01.05.2026 Възраст: 18–75 г. Лечение

Australia, Denmark, Finland +11 Biohaven Therapeutics Ltd. NCT06309966

Набира участници Фаза 4

The PHENOSAR trial: Antibiotic treatment of biopsy confirmed phenotypes in sarcoidosis: a proof of concept clinical trial.

sarcoidosis

Trial status: Authorised Reduction of sarcoidosis related inflammation.

Начало: 13.05.2024 Възраст: от 18 г.

Netherlands Sint Antonius Ziekenhuis Stichting 2024-513534-38-00

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

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