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Намерени 4,436 изпитвания Стр. 168 от 222
Recruiting
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. Health services research
Australia The Bionics Institute of Australia NCT05847426
Recruiting
Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
Posttraumatic Stress Disorder Insomnia Disorder

This study will investigate treatments for insomnia in Veterans who have posttraumatic stress disorder (PTSD). The purpose of this study is to compare a brief behavioral treatment for insomnia (BBTI) to a treatment that helps promote relaxation (progressive muscle relaxation training or PMRT). The investigators will examine improvements in psychosocial functioning and insomnia severity. The investigators will also examine whether treatment gains last over time and whether suicidal ideation decreases following insomnia treatment.

Начало: 01.05.2023 Край: 30.04.2027 Възраст: 18–75 г.
United States VA Office of Research and Development NCT05780177
Recruiting
Immersive Virtual Reality Techniques on the Effects on Cognition in People With Cancer
Cancer Cognitive Impairment

OncoBRAIN aims to assess the effect of an innovative immersive virtual reality-based (IVR) intervention that includes cognitive, physical activity and mindfulness exercises in people diagnosed with cancer and Chemotherapy-Related Cognitive Deficits (CRCD). The main objective of OncoBRAIN is to determine the benefits of RVI intervention on the cognitive, and emotional state and quality of life of people with cancer and CRQD. We hypothesize that in OncoBRAIN we will find improvements in people with cancer and CRCD who have received IVR stimulation compared to the control group with cancer and CRCD who have not received IVR stimulation. People in the experimental group will perform better than patients in the control group in cognition (episodic memory, executive function, attention, and information processing speed), show better emotional well-being and perceive a better quality of life at the end of the intervention.

Начало: 01.05.2023 Край: 30.06.2027 Възраст: 18–65 г.
Spain Consorci Sanitari de Terrassa NCT05907265
Recruiting
Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect
Cesarean Section; Dehiscence

GnRH-a will be used to postpone period after vaginal repair for Cesarean Section Scar Defect(CSD) patients with adenomyosis which will be compared with CSD patients with adenomyosis who receive transvaginal surgery without GnRH-a, whether delayed period improving the CSD prognosis will be assessed.

Начало: 01.05.2023 Край: 30.12.2027 Възраст: 18–50 г.
China Xinhua Hospital, Shanghai Jiao Tong University School o NCT05206682
Recruiting
Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing
Genetic Predisposition to Disease Genetic Predisposition

This research is being done to develop the electronic platform Nest for young adults (ages 18-39) who have had prior cancer genetic testing. The platform will give patients and their clinicians access to continuously updated information about both pathogenic variants and variants of uncertain significance (VUS). The name of the intervention used in this research study is: Nest portal (electronic platform for patients and clinicians)

Начало: 01.05.2023 Край: 30.07.2026 Възраст: 18–39 г.
United States Dana-Farber Cancer Institute NCT05759143
Recruiting
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
Recruiting
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. Treatment
Australia The University of Queensland NCT05274854
Recruiting
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. Treatment
Australia, Canada, Colombia +6 University Health Network, Toronto NCT05440851
Recruiting
Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by ECMO-VA for Refractory Cardiogenic Shock
Cardiac Rhythm Disorder

Brief Summary : Rhythm disorders are a frequent and potentially serious complication of critical patients in the ICU and postoperative cardiac surgery. In particular, atrial fibrillation (AF) is the most common rhythm disorder in patients admitted to the ICU and is associated with excess mortality during acute circulatory failure. In postoperative cardiac surgery, AF affects 15 to 45% of patients. In addition to hemodynamic effects, AF increases the risk of stroke, bleeding, respiratory or renal failure, and doubles mortality at 30 days and 6 months. In the longer term, the recurrence rate of AF within 1 year after hospital discharge is about 50%. Similarly, other rhythm disorders, supraventricular or ventricular, can be life-threatening in ICU patients. While the incidence and complications of rhythm disorders are well documented during sepsis, cardiogenic shock or after cardiac surgery, there are to our knowledge no data on the frequency and complications of rhythm disorders in patients assisted by VA ECMO. The primary objective is to describe the incidence of supraventricular rhythm disorders in patients assisted by VA ECMO.

Начало: 28.04.2023 Край: 28.04.2028 Възраст: от 18 г.
France Assistance Publique - Hôpitaux de Paris NCT05788120
Recruiting Phase 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. Treatment
Australia, Spain, United States Janssen Research & Development, LLC NCT05818683
Recruiting Phase 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. Treatment
Australia, Canada, Israel +3 AbbVie NCT05512390
Recruiting Phase 2
Atezolizumab and Cabozantinib for the Treatment of Adolescents and Young Adults With Recurrent or Metastatic Osteosarcoma, TACOS Study
Locally Advanced Osteosarcoma Metastatic Osteosarcoma Recurrent Osteosarcoma Refractory Osteosarcoma +1

This phase II trial studies the effect of atezolizumab and cabozantinib in treating adolescents and young adults with osteosarcoma that has come back (recurrent) or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab and cabozantinib may help to control the osteosarcoma.

Начало: 25.04.2023 Край: 31.12.2027 Възраст: от 12 г.
United States M.D. Anderson Cancer Center NCT05019703
Recruiting Phase 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. Treatment
Argentina, Australia, Chile +3 GlaxoSmithKline NCT05757102
Recruiting Phase 2
Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial
Recurrent Endometrial Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma

This phase II ComboMATCH treatment trial compares selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian (fallopian tube and primary peritoneal) cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. The addition of olaparib to selumetinib could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to selumetinib alone.

Начало: 25.04.2023 Край: 01.10.2028 Възраст: от 18 г.
Puerto Rico, United States National Cancer Institute (NCI) NCT05554328
Recruiting Phase 2
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
Hepatocellular Carcinoma Biliary Tract Cancer

GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.

Начало: 24.04.2023 Край: 28.10.2027 Възраст: от 18 г.
China, Hong Kong, Italy +6 AstraZeneca NCT05775159
Recruiting Phase 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. Treatment
New Zealand OrsoBio, Inc NCT05822544
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular

RADIATE-VT is a pivotal, multicenter, randomized trial comparing safety and efficacy between cardiac radioablation (CRA) using the Varian CRA System and repeat catheter ablation (CA), for patients with high-risk refractory ventricular tachycardia (VT) who have experienced VT recurrence after CA and are candidates for additional CA.

Начало: 21.04.2023 Край: 01.05.2030 Възраст: от 18 г.
United States Varian, a Siemens Healthineers Company NCT05765175
Recruiting
The Prognostic Impact of Symptoms and Lesion Depth in Partial Removal of Carious Tissue
Deep Caries Pulpitis Reversible Pulp Hyperemia

The goal of this prospective, observational clinical cohort study is to study the effect of the preoperative condition of the tooth on the outcome of partial removal of carious tissue in mature teeth in adults. The main questions the study aims to answer are: * Do preoperative symptoms affect the outcome? * Does the depth of the carious lesion affect the outcome? One hundred participants will be recruited. Patients who meet the eligibility criteria will be asked to give their informed consent to participate in the study. Partial carious tissue removal will be performed regardless of participation in the study because selective carious tissue removal is the standard treatment of choice for a vital tooth with a deep carious lesion according to the Finnish national treatment guidelines. Participants will be asked to fill in a questionnaire regarding symptoms 7 days post-treatment. The teeth will then be followed up for 12-24 months. The null hypothesis is that there is no difference in the success between i) deep and extremely deep carious lesions and ii) initial and mild pulpitis.

Начало: 21.04.2023 Край: 31.12.2027 Възраст: 18–50 г.
Finland University of Helsinki NCT05816525
Recruiting Phase 1/2
Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
Non-small Cell Lung Cancer Histiocytic Neoplasm Histiocytosis BRAF Gene Mutation +28

BDTX-4933-101 is a first-in-human, open-label, Phase 1/2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced/metastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and/or CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced/metastatic NSCLC with KRAS and/or BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.

Начало: 18.04.2023 Край: 01.06.2028 Възраст: от 18 г.
Japan, United States Institut de Recherches Internationales Servier NCT05786924
Recruiting Phase 3
Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Endometrial Cancer

The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v 1.1\]) after completing at least 12 weeks of platinum-based therapy. A total of 276 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

Начало: 18.04.2023 Край: 01.01.2028 Възраст: от 18 г. Treatment
Australia, Belgium, Canada +14 Karyopharm Therapeutics Inc NCT05611931
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