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Набира участници

Ablative Radiotherapy to Restrain Every Metastasis Safely Treatable (ARREST-2): A Randomized Phase II/III Trial

Metastatic Cancer

This is a phase II/III international multicentre randomized trial. Patients will be randomized in a 1:2 ratio between the standard of care (Arm 1) and SABR (Arm 2) to all sites of disease. The study will start as a phase II trial with an opportunity to convert to a phase III trial. The objective of this trial is to determine the impact of SABR on overall survival, progression-free survival, quality of life, and toxicity in patients with polymetastatic disease.

Начало: 16.10.2023 Край: 01.01.2034 Възраст: от 18 г.

Canada, Switzerland London Health Sciences Centre Research Institute OR Law NCT05508464

Набира участници

Identification of Therapeutic Targets in Metastatic Gastric Cancer

Stomach Neoplasms, Benign

This is a pilot study aiming at identifying novel therapeutic molecular targets in patients with gastric cancer with lymph nodes or distant metastasis. All patients who are diagnosed with gastric cancer with metastases in the Prince of Wales Hospital will be screened for eligibility.

Начало: 15.10.2023 Край: 01.10.2033 Възраст: 18–80 г.

Hong Kong Chinese University of Hong Kong NCT07551440

Набира участници

Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Feeding Disorders

The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.

Начало: 12.10.2023 Край: 01.04.2028 Възраст: от 1 г.

United States Boston Children's Hospital NCT05417958

Набира участници

PRostate Olaparib Real World Evidence Study

Metastatic Castration-resistant Prostate Cancer

This French non-interventional longitudinal multicenter cohort study is conducted to study the added value of olaparib in the treatment of patients with mCRPC in the real world setting in terms of treatment sequencing, effectiveness, safety and BRCA testing patterns and thus inform future clinical practice.

Начало: 11.10.2023 Край: 13.10.2028 Възраст: от 18 г.

France AstraZeneca NCT06031805

Набира участници Фаза 3

AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Community-acquired Pneumonia

This is an international, open-label, stratified randomized controlled trial with Bayesian adaptive stopping rules to compare the effects of therapeutic-dose heparin vs. usual care pharmacological thromboprophylaxis on outcomes in patients admitted to hospital with community acquired pneumonia (CAP).

Начало: 10.10.2023 Край: 31.03.2029 Възраст: от 18 г.

Brazil, Canada, United States University of Manitoba NCT05848713

Набира участници Фаза 1

HNC: Human Neural Circuits Electrophysiology During Cognition

Psychiatric Disorder

The purpose of this study is to understand how ketamine brings about dissociative symptoms.

Начало: 05.10.2023 Край: 01.09.2030 Възраст: от 18 г.

United States Stanford University NCT05962424

Набира участници

Impact of Bright Light Therapy on Prader-Willi Syndrome

Prader-Willi Syndrome Excessive Daytime Sleepiness Hyperphagia Body Weight +2

This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome

Начало: 01.10.2023 Край: 01.12.2026 Възраст: 6–88 г.

United States Maimonides Medical Center NCT05939453

Набира участници Фаза 1/2

Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Neuroendocrine Tumors

Neuroendocrine Tumors Unresectable Neuroendocrine Tumor Metastatic Gastroenteropancreatic Neuroendocrine Tumor Bronchial Neuroendocrine Tumor +2

This study is Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

Начало: 27.09.2023 Край: 26.12.2029 Възраст: 18–90 г.

United States Perspective Therapeutics NCT05636618

Набира участници Фаза 1/2

First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations

Non-Small Cell Lung Cancer NSCLC EGFR/HER2 Exon 20 Insertion Mutation

Study STX-721-101/PFL-721CI101 is an open label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721/PFL-721 in participants with non-small cell lung cancer (NSCLC) carrying EGFR or HER2 exon 20 insertion (ex20ins) mutations.

Начало: 26.09.2023 Край: 01.12.2029 Възраст: от 18 г.

France, Germany, Netherlands +4 Pierre Fabre Medicament NCT06043817

Набира участници Фаза 3

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)

Leiomyosarcoma

The primary objective of this phase III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.

Начало: 21.09.2023 Край: 30.08.2029 Възраст: от 18 г.

Austria, Belgium, France +9 PharmaMar NCT06088290

Набира участници

PET/MRI/EEG Imaging Study in Epilepsy

Epilepsy

This study aims to better understand how epilepsy alters brain function through neuroimaging of healthy people and people with epilepsy. The study investigates how changes in brain metabolism (sugar consumption, measured by positron emission tomography \[FDG-PET\], and blood flow, measured by functional magnetic resonance imaging \[fMRI\]) relate to abnormal interictal electrical activity associated with epilepsy (measured by electroencephalography \[EEG\]). The study will also compare how the three imaging modalities localize regions of abnormal function in the brain.

Начало: 21.09.2023 Край: 31.12.2026 Възраст: от 18 г.

United States Massachusetts General Hospital NCT06974305

Набира участници Фаза 1

A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors

Advanced Solid Tumor Solid Tumor

This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808.

Начало: 21.09.2023 Край: 30.09.2027 Възраст: от 18 г. Лечение

Australia, China, New Zealand +1 BeOne Medicines NCT05981703

Набира участници

An Evidence-based Family Support Program for Parents and Children in Palestine: A Theory-based Intervention

Adolescent Psychopathology Parent-Child Relations Violence

Few evidence-based programs exist to support children and families affected by sociopolitical conflict, despite documented evidence of their heightened risk for emotional and behavioral adjustment problems associated with exposure to conflict and violence at multiple levels of the social ecology (e.g., political, community, and family). Thus, a critical need exists for an evidence-based program to ameliorate the impact of political violence on the overall well-being of children and families. The current study will conduct a rigorous evaluation of a theoretically-driven, family-based intervention program in Palestine, including both the West Bank and Gaza. Firmly grounded in the cultural context of Palestine but with broad implications for individuals exposed to sociopolitical violence, the long-term goal of this project is to provide a family-focused intervention program (Promoting Positive Family Futures; PPFF) that may facilitate individuals' sense of safety and support in the context of chronic adversity. The objective is to evaluate this intervention program in the context of a randomized clinical trial (RCT) in the West Bank and Gaza (N=300). The central hypothesis is that the program will have direct positive effects on family conflict, parent psychopathology and parental security in the family as well as on adolescent emotional security in the family, with cascading effects on adolescent adjustment. Consistent with family systems theory, we further hypothesize that treatment effects on parents will mediate on the effects of the treatment on adolescent adjustment. The rationale is that bolstering resilience in family systems is a key approach to promoting positive functioning in families exposed to chronic violence. The hypothesis will be evaluated with three specific aims: 1) evaluate the efficacy of an evidence-based family support program; 2) examine process models of treatment change, and 3) examine interrelations between parent and child functioning. To achieve these aims, the study will be an RCT employing a longitudinal design (N=300) with multi-method assessments at baseline (T1), post-test (T2), 6-month follow-up (T3) and 12-month follow-up (T4). Families included in the study will be evenly divided between the West Bank (n=150) and Gaza Strip (n=150). Families will be randomized into the intervention condition (PPFF) or treatment as usual (TAU). Each territory will have an implementing partner, and implementing partners and investigators will work together to ensure the study procedures are implemented in parallel across sites. Data collection will be conducted by trained research staff from a third-party survey and policy research organization. The proposal seeks to shift current research and clinical paradigms in these contexts by employing novel theoretical concepts, approaches, and methodologies. The contribution will be significant by 1) further developing new directions for empirically-based interventions in these high-risk contexts, and 2) advancing a relatively brief, cost-effective program that can be readily implemented to help children and families exposed to continuing conflict in Palestine, with the potential to be brought to scale in other contexts.

Начало: 19.09.2023 Край: 31.07.2027 Възраст: 12–75 г.

United States University of Notre Dame NCT05706376

Набира участници Фаза 4

Optimized Treatment of Pulmonary Edema or Congestion

Pulmonary Edema Congestive Heart Failure Acute Heart Failure

Background: Intravenous (IV) loop-diuretics have been a key component in treating pulmonary edema since the nineteen sixties and has a Class 1 recommendation in the 2021 European Society of Cardiology guidelines for heart failure. Conversely, vasodilation was downgraded in the treatment of acute heart failure due to a lack of trials that compare vasodilation with loop-diuretics in a hyperacute clinical setting. This clinical equipoise will be tested in a trial including patients with pulmonary congestion immediately at hospital admission. Primary objective: To determine the superior strategy of loop-diuretics (furosemide), vasodilation (nitrates) or the combination during emergency treatment. Design: Investigator-initiated, randomized, double-blinded, placebo-controlled trial with 1:1:1 allocation. Intervention: Intervention-phase will last 6 hours from study-inclusion, and patients will be allocated to one of three groups: * Boluses of 40 mg IV furosemide + nitrate-placebo as soon as possible and repeated up to 10 times. * Boluses of 3 mg IV isosorbide dinitrate + furosemide-placebo as soon as possible. * Boluses of both 3 mg IV isosorbide dinitrate + of 40 mg as soon as possible.

Начало: 14.09.2023 Край: 31.05.2027 Възраст: от 18 г.

Denmark Rigshospitalet, Denmark NCT05276219

Набира участници Фаза 3

Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome

Polycystic Ovary Syndrome Reproductive Medicine

The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double blinded. It will include patients with PCOS (polycystic ovary syndrome, defined by the Rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation induction by CC. Half of them will receive MYO + levomefolic acid (5-MTHF) in addition to the CC, while the other half will receive a placebo containing only 5-MTHF in addition to the CC. The MYO supplementation will be initiated at least one month before taking CC and will be continued throughout this treatment until pregnancy or before switching to another type of treatment for ovulation induction if no pregnancy is obtained after 6 ovulatory cycles.

Начало: 12.09.2023 Край: 01.12.2027 Възраст: 18–35 г.

France University Hospital, Lille NCT03059173

Набира участници

Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA

Dental Implant

This study aims to characterise the stability of crestal bone levels one year after loading, the associated aesthetic outcomes, immunological response, prosthodontic outcomes as well as overall patient reported outcome measures for modSLA (SLActive, Institut Straumann AG, Switzerland) and NGA (TiUltraNP, Nobel Biocare AG, Switzerland) dental implants.

Начало: 05.09.2023 Край: 31.03.2027 Възраст: от 18 г.

United Kingdom Barts & The London NHS Trust NCT06086873

Набира участници Фаза 1

A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)

Relapsed Malignant Solid Neoplasm

An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.

Начало: 05.09.2023 Край: 01.06.2027 Възраст: от 18 г.

India Aurigene Discovery Technologies Limited NCT05865002

Набира участници

The Effect of Water Carbonation on Orthostatic Tolerance

Orthostatic Hypotension Syncope Vasovagal Syncope

The primary purpose of this investigation is to determine whether water carbonation can improve orthostatic tolerance in healthy control volunteers. Orthostatic tolerance refers to the ability to maintain an adequate blood pressure when standing. In some individuals blood pressure can fall when standing, predisposing to dizzy spells or fainting episodes. Drinking water can boost blood pressure and making fainting episodes less likely. However, it is not clear whether the carbonation of the water has any further impact on the blood pressure response. This is important because it may be that carbonated water expands the stomach (gastric distension), provoking an increase in sympathetic activity. The increase in sympathetic nervous system activity boosts blood pressure. Resolving this question would have important implications for patients with syncope. This study will test whether carbonated water will have any further impact on blood pressure than the already known effect of non-carbonated water.

Начало: 01.09.2023 Край: 01.04.2027 Възраст: 19–50 г.

Canada Simon Fraser University NCT05621460

Набира участници Фаза 2

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

Schwannomatosis Schwannomas Pain, Chronic

This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN). This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies: * Investigational Drug Sub-Study A: Siltuximab * Investigation Drug Sub-Study B: Erenumab-Aooe

Начало: 31.08.2023 Край: 30.11.2027 Възраст: от 18 г.

United States Massachusetts General Hospital NCT05684692

Набира участници Фаза 1

A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors

Advanced or Metastatic Solid Tumor

This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \[primary resistance\]) or relapsed \[secondary resistance\]) after at least 3 months from the start of treatment with pembrolizumab. The study will consist of 2 main parts: * Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design with accelerated titration * Part 2: Dose-expansion cohorts using Simon's 2-stage design

Начало: 30.08.2023 Край: 01.06.2030 Възраст: от 18 г.

United States Pliant Therapeutics, Inc. NCT06270706

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