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Набира участници Фаза 1

Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors

Solid Tumor, Adult Advanced Solid Tumor Advanced Renal Cell Carcinoma

This is an open label, single-arm, multicentre dose escalation (Part 1) and dose expansion (Part 2) study to evaluate different combinations of 3 radioactive dose levels of 177Lu-TLX250 administered intravenously with 3 different doses of peposertib in patients with CAIX-expressing solid tumors.

Начало: 23.05.2023 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia Telix Pharmaceuticals (Innovations) Pty Limited NCT05868174

Набира участници Фаза 2

EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma

Ovarian Carcinosarcoma Uterine Carcinosarcoma

The EPOCH study population is patients with tubo-ovarian carcinosarcoma or uterine carcinosarcoma with evidence of recurrence or progression. The study aims to determine the activity of eribulin as a single agent and the combination of eribulin and pembrolizumab as measured by clinical benefit rate (CBR) at 12 weeks. Additionally, the study aims to establish whether high mobility group A2 (HMGA2) protein expression is a good functional biomarker to predict response to eribulin and pembrolizumab.

Начало: 22.05.2023 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, Canada, United Kingdom Australia New Zealand Gynaecological Oncology Group NCT05619913

Набира участници Фаза 1/2

EMITT-1 (ERAP Mediated Immunopeptidome Targeting Trial - 1)

Advanced Solid Malignancy

This is a Phase I/II, open-label, first-in human study of GRWD5769 alone, and in combination with another anti-cancer agent in advanced solid cancers.

Начало: 21.05.2023 Край: 30.04.2028 Възраст: от 18 г. Лечение

Australia, France, Spain +1 Grey Wolf Therapeutics NCT06923761

Набира участници

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction

Erectile Dysfunction Following Radical Prostatectomy

The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy. The main questions it aims to answer are: * Is the device safe? * Does the device works well? Are the participants satisfied with the device? Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up: * Come to the hospital for follow-up visits, * Complete questionnaires, * Activate the device every day, * Measure erection hardness. Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.

Начало: 19.05.2023 Край: 31.08.2026 Възраст: 30–70 г. Лечение

Australia Comphya Australia NCT05650866

Набира участници Фаза 3

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Ulcerative Colitis Crohn's Disease

The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.

Начало: 16.05.2023 Край: 15.08.2031 Възраст: от 2 г. Лечение

Australia, Belgium, Canada +12 Takeda NCT05442567

Набира участници Фаза 1

DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Lymphoma, Non-Hodgkin

This study will treat patients with B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy.

Начало: 15.05.2023 Край: 30.10.2027 Възраст: от 18 г. Лечение

Australia, United States Dizal Pharmaceuticals NCT05824585

Набира участници

Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants

Inherited Retinal Degeneration Retinitis Pigmentosa

This is an international, multicenter study with two components: Registry * A standardized genetic screening and a prospective, standardized, cross-sectional clinical data collection * Enrollment is open to all genes on the RD Rare Gene List Natural History Study * A prospective, standardized, longitudinal Natural History Study * Enrollment opens gene-by-gene, based on funding and within-gene Registry enrollment The study objectives are as follows. Registry Objectives 1. Genotype Characterization 2. Cross-Sectional Phenotype Characterization (within gene) 3. Establish a Link to My Retina Tracker Registry (MRTR) 4. Ancillary Exploratory Studies - Pooling of Genes Natural History Study Objectives 1. Natural History (within gene) 2. Structure-Function Relationship (within gene) 3. Risk Factors for Progression (within gene) 4. Ancillary Exploratory Studies - Pooling of Genes

Начало: 11.05.2023 Край: 15.12.2030 Възраст: от 4 г.

Australia, Belgium, Brazil +11 Jaeb Center for Health Research NCT05589714

Набира участници Фаза 1/2

Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma

Relapsed Non-Hodgkin Lymphoma Refractory Non-Hodgkin Lymphoma Non-Hodgkin Lymphoma Large B-cell Lymphoma

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of rondecabtagene autoleucel (ronde-cel) also known as LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.

Начало: 09.05.2023 Край: 30.06.2031 Възраст: от 18 г. Лечение

Australia, United States Lyell Immunopharma, Inc. NCT05826535

Набира участници Фаза 3

A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

Focal Onset Seizures

The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Начало: 09.05.2023 Край: 01.12.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +15 Xenon Pharmaceuticals Inc. NCT05716100

Набира участници Фаза 3

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

Heart Failure

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

Начало: 08.05.2023 Край: 02.07.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +38 Novo Nordisk A/S NCT05636176

Набира участници

Study Using the ShiraTronics Migraine Therapy System

Chronic Migraine, Headache

The purpose of this pilot study is to assess the preliminary safety and efficacy of the ShiraTronics Migraine Therapy System in prophylactic treatment of patients with refractory chronic migraine.

Начало: 05.05.2023 Край: 01.03.2025 Възраст: от 22 г. Лечение

Australia ShiraTronics NCT05700318

Набира участници Фаза 3

An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

Cholangiocarcinoma

A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.

Начало: 03.05.2023 Край: 01.12.2027 Възраст: от 18 г. Лечение

Armenia, Australia, Belgium +12 Servier Affaires Médicales NCT05876754

Набира участници

Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)

Hearing Impairment

The goal of this clinical trial is to find out whether hearing test results using functional near-infrared spectroscopy (fNIRS) will help to fast-track early intervention for infants born with a hearing loss. fNIRS is a method of imaging brain activity using light. The main questions are: 1. Can audiologists make more confident decisions about the optimal interventions at different critical points in the hearing care pathway when they are given additional fNIRS information compared to when they have standard audiology test results alone? 2. Is the experience of their infant having an fNIRS test acceptable and comfortable for the parents or care givers?

Начало: 02.05.2023 Край: 28.04.2028 Възраст: от 24 г. Здравни услуги

Australia The Bionics Institute of Australia NCT05847426

Набира участници

Automated Fetal Cardiac Function in Babies Affected by Heart Diseases

Congenital Heart Defect Cardiac Function

The goal of this international multicentre prospective observational cohort study with a nested case-control study is to test some automated fetal heart functional parameters in healthy babies compared to those affected by a congenital heart condition. The main questions it aims to answer are: * If there is a significant difference between the two populations of infants * Whether these parameters could significantly improve the predictive value of actual cardiovascular profile score to predict hydrops Participants will be offered two automated cardiac function assessments between 27+6 and 29+6 gestational weeks and between 34+6 and 36+6 weeks of gestation. Functional parameters will be compared between the two study groups and evaluated over time.

Начало: 01.05.2023 Край: 01.02.2028 Възраст: от 18 г.

Australia, Israel, Italy +2 Anna Erenbourg NCT05698277

Набира участници

A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms

Gastrointestinal Diseases Irritable Bowel Syndrome

This research project aims to test whether early interventions delivered remotely and prior to integrated care clinic appointments are effective. Patients with chronic unexplained gastrointestinal symptoms will initially undergo structured assessment of symptoms and wheat intolerance delivered remotely. Patients who continue to experience symptoms will then be randomised to a pre-consultation intervention ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing) followed by randomisation to the consultation intervention ((a) consultant-led outpatient clinic or b) a integrated care clinic depending on their response to the initial intervention.

Начало: 01.05.2023 Край: 31.12.2025 Възраст: 18–90 г. Лечение

Australia The University of Queensland NCT05274854

Набира участници

Platform of Randomized Adaptive Clinical Trials in Critical Illness

Respiratory Insufficiency Extracorporeal Membrane Oxygenation Complication Mechanical Ventilation Pressure High

PRACTICAL is a randomized multifactorial adaptive platform trial for acute hypoxemic respiratory failure (AHRF). This platform trial will evaluate novel interventions for patients with AHRF across a range of severity states (i.e., not intubated, intubated with lower or higher respiratory system elastance, requiring extracorporeal life support) and across a range of investigational phases (i.e., preliminary mechanistic trials, full-scale clinical trials). AHRF is a common and life-threatening clinical syndrome affecting millions globally every year. Patients with AHRF are at high risk of death and long-term morbidity. Patients who require invasive mechanical ventilation are at risk of ventilator-induced lung injury and ventilator-induced diaphragm dysfunction. New treatments and treatment strategies are needed to improve outcomes for these very ill patients. Utilizing advances in Bayesian adaptive trial design, the platform will facilitate efficient yet rigorous testing of new treatments for AHRF, with a particular focus on mechanical ventilation strategies and extracorporeal life support techniques as well as pharmacological agents and new medical devices. The platform is designed to enable evaluation of novel interventions at a variety of stages of investigation, including pilot and feasibility trials, trials focused on mechanistic surrogate endpoints for preliminary clinical evaluation, and full-scale clinical trials assessing the impact of interventions on patient-centered outcomes. Interventions will be evaluated within therapeutic domains. A domain is defined as a set of interventions that are intended to act on specific mechanisms of injury using different variations of a common therapeutic strategy. Domains are intended to function independently of each other, allowing independent evaluation of multiple therapies within the same patient. Once feasibility is established, Bayesian adaptive statistical modelling will be used to evaluate treatment efficacy at regular interim adaptive analyses of the pre-specified outcomes for each intervention in each domain. These adaptive analyses will compute the posterior probabilities of superiority, futility, inferiority, or equivalence for pre-specified comparisons within domains. Each of these potential conclusions will be pre-defined prior to commencing the intervention trial. Decisions about trial results (e.g., concluding superiority or equivalence) will be based on pre-specified threshold values for posterior probability. The primary outcome of interest, the definitions for superiority, futility, etc. (i.e., the magnitude of treatment effect) and the threshold values of posterior probability required to reach conclusions for superiority, futility etc., will vary from intervention to intervention depending on the phase of investigation and the nature of the intervention being evaluated. All of these parameters will be pre-specified as part of the statistical design for each intervention trial. In general, domains will be designed to evaluate treatment effect within four discrete clinical states: non-intubated patients, intubated patients with low respiratory system elastance (\

Начало: 30.04.2023 Край: 31.03.2027 Възраст: от 18 г. Лечение

Australia, Canada, Colombia +6 University Health Network, Toronto NCT05440851

Набира участници Фаза 1

A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

Metastatic Castration-resistant Prostate Neoplasms Metastatic Hormone-sensitive Prostate Cancer

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).

Начало: 26.04.2023 Край: 23.05.2028 Възраст: от 18 г. Лечение

Australia, Spain, United States Janssen Research & Development, LLC NCT05818683

Набира участници Фаза 1

A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)

Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia Follicular Lymphoma

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), or R/R CLL. Adverse events will be assessed. ABBV-319 is an investigational drug being developed for the treatment of R/R DLBCL, R/R FL, or R/R CLL. This study will include a dose escalation phase to determine the doses of ABBV-319 that will be used in the next phase and a dose expansion phase to determine the change in disease activity in participants with R/R DLBCL, R/R FL, and R/R CLL. Approximately 154 adult participants with R/R B cell lymphomas including R/R DLBCL, R/R FL, and R/R CLL will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the Phase 2 dose is determined. In the dose expansion phase of the study participants receive intravenously infused ABBV-319 in 21-day cycles. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Начало: 26.04.2023 Край: 01.02.2027 Възраст: от 18 г. Лечение

Australia, Canada, Israel +3 AbbVie NCT05512390

Набира участници Фаза 3

A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma

Asthma

The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.

Начало: 25.04.2023 Край: 15.01.2027 Възраст: 12–17 г. Лечение

Argentina, Australia, Chile +3 GlaxoSmithKline NCT05757102

Набира участници Фаза 1

Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes

Healthy Subjects Obesity Type 2 Diabetes

The phase 1 portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-6740 after single- and multiple-ascending doses in healthy subjects. The phase 1b portion of the study is designed to assess the safety, tolerability, and PK of TLC-6740 in subjects with obesity, with or without type 2 diabetes mellitus.

Начало: 22.04.2023 Край: 01.06.2026 Възраст: 18–70 г. Лечение

New Zealand OrsoBio, Inc NCT05822544

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