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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 2

MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach

Anal Squamous Cell Carcinoma

The proposed study is a phase II, single arm, open-label trial of MR-guided radiation therapy (RT) with risk stratified RT dose selection in patients with anal cancer. Based on previous data, a risk adaptive treatment approached is proposed in 4 groups: Low risk, standard risk, intermediate risk, and high risk. Human papillomavirus (HPV) DNA will be analyzed to identify novel biomarkers that predict chemoradiotherapy (CRT) response and toxicity.

Начало: 29.09.2023 Край: 01.09.2028 Възраст: от 18 г. Лечение

Australia, Canada, United States University Health Network, Toronto NCT06050707

Набира участници

Post-Market Clinical Follow Up Study With Navitor Valve

Aortic Stenosis

Evaluation of the safety and performance of the Navitor TAVI System in a Global Study

Начало: 29.09.2023 Край: 01.12.2031 Възраст: 18–100 г.

Australia, France, Germany +6 Abbott Medical Devices NCT06008080

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 2

Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke

Acute Ischemic Stroke

STARS is a prospective, multicentre, open-label, dose escalation, Phase IIa study to assess the safety and tolerability of TBO-309, an adjuvant antiplatelet therapy, in patients with AIS. Acute ischaemic stroke (AIS) is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain. Standard therapies target the blocked artery by either dissolving the blockage or removing the blockage. However, even after successful treatment, re-blockage of arteries can occur. The use of an antiplatelet therapy, TBO-309, in addition to standard therapies offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage.

Начало: 27.09.2023 Край: 01.05.2026 Възраст: от 18 г. Лечение

Australia The Florey Institute of Neuroscience and Mental Health NCT05363397

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 1

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Myeloproliferative Neoplasms

This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.

Начало: 25.09.2023 Край: 29.02.2028 Възраст: от 18 г. Лечение

Australia, Canada, Denmark +5 Incyte Corporation NCT05936359

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 to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

Prostate Cancer

A Study to Investigate the Biological Effects of Saruparib (AZD5305) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men with Newly Diagnosed Prostate Cancer (ASCERTAIN).

Начало: 21.09.2023 Край: 17.08.2026 Възраст: от 18 г. Фундаментална наука

Australia, Canada, Netherlands +4 AstraZeneca NCT05938270

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 Фаза 1/2

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A

Hemophilia A

WP44714 is a Phase I/II, open-label, non-randomized, global, multicenter trial consisting of two parts: * Part 1 is a multiple-ascending dose (MAD) study in adult and adolescent male participants with severe or moderate hemophilia A with or without factor VIII (FVIII) inhibitors. * Part 2 is a multiple-dose study in pediatric male participants with severe or moderate hemophilia A with or without FVIII inhibitors. The overall aim of the study is to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of NXT007.

Начало: 21.09.2023 Край: 16.06.2030 Възраст: 2–59 г. Лечение

Canada, Italy, New Zealand +3 Hoffmann-La Roche NCT05987449

Набира участници

Red Blood Cell Transfusion in ECMO - A Feasibility Trial

Blood Loss Anemia Extracorporeal Membrane Oxygenation Complication Disability Physical Cognitive Ability, General +1

Extracorporeal Membrane Oxygenation (ECMO) is an invasive and resource intense treatment used to support critically ill patients who have suffered severe cardiac arrest, cardiac failure or respiratory failure (including severe cases of COVID-19). ECMO acts as a mechanical circulatory support temporarily replacing the function of the heart or lungs by oxygenating blood and removing carbon dioxide, allowing time for these organs to recover. Many critically ill patients, including those on ECMO, have an increased risk of bleeding and reduced production/increased destruction of red blood cells (RBCs). This can lead to anaemia (haemoglobin levels \

Начало: 20.09.2023 Край: 30.12.2025 Възраст: от 18 г. Здравни услуги

Australia Australian and New Zealand Intensive Care Research Cent NCT05814094

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 1

A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors

HER-2 Positive Advanced Solid Tumors

This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid tumors.

Начало: 19.09.2023 Край: 19.12.2028 Възраст: от 18 г. Лечение

Australia, China, United States D3 Bio (Wuxi) Co., Ltd NCT05957536

Набира участници

Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)

Colorectal Polyp Colon Adenoma Colon Cancer

Randomised controlled trial comparing cold snare endoscopic mucosal resection (EMR) with cold snare EMR and adjuvant margin STSC in the complete resection of 15-40mm lateral-spreading adenomas

Начало: 19.09.2023 Край: 01.10.2028 Възраст: от 18 г. Лечение

Australia Western Sydney Local Health District NCT05041478

Набира участници Фаза 2

MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder

PTSD Alcohol Use Disorder Alcohol Dependence Post-traumatic Stress Disorder +1

To explore the effectiveness of of MDMA-assisted prolonged exposure therapy in improving treatment outcomes for individuals with comorbid PTSD and alcohol use disorder in a double-blind randomised placebo-controlled trial.

Начало: 19.09.2023 Край: 01.05.2026 Възраст: от 18 г. Лечение

Australia University of Sydney NCT05709353

Набира участници Фаза 3

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

Relapsed Refractory Multiple Myeloma (RRMM)

This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies). This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. This study is looking at several other research questions, including: * How long participants benefit from receiving linvoseltamab compared with EPd * How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much * What side effects happen from taking linvoseltamab compared to EPd * How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd * If there is any improvement in pain after treatment with linvoseltamab compared to EPd

Начало: 18.09.2023 Край: 19.04.2033 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +15 Regeneron Pharmaceuticals NCT05730036

Набира участници Фаза 1

Phase 1 Study of AWT020 in Advanced Cancer

Advanced Cancer

The aims of this clinical trial are (1) to assess the safety of AWT020 at different dose levels; (2) to determine the pharmacokinetics and pharmacodynamics of AWT020 in subjects with locally advanced or metastatic cancer who have failed standard therapy.

Начало: 15.09.2023 Край: 30.09.2026 Възраст: от 18 г. Лечение

Australia Anwita Biosciences NCT06092580

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

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