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Duration of Anti-PD-1 Therapy in Metastatic Melanoma

Unresectable/Metastatic Melanoma

The purpose of this study is to compare the effects on patients with metastatic melanoma of taking a government approved and paid-for PD-1 inhibitor intermittently, with taking the same type of agent continuously. Researchers want to see if the two ways of giving this type of treatment work equally well in extending the life of patients with melanoma, or not.

Начало: 31.10.2016 Край: 31.12.2029 Възраст: от 18 г. Лечение

Australia, Canada Canadian Cancer Trials Group NCT02821013

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ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome

Mycosis Fungoides Non-Hodgkin's Lymphoma

The purpose of the study is to develop a prognostic index model for the rare disease of mycosis fungoides and sezary syndrome. This will be done by collecting standardized clinical data at various institutions. The investigators hope this will enable the identification of low- and high-risk groups for survival in order to improve patient care and outcome.

Начало: 01.10.2016 Край: 01.03.2027

Argentina, Australia, Brazil +4 Stanford University NCT02848274

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Primary Tumor Research and Outcomes Network

Spinal Column Tumor

This project aims to establish a network of spine oncology centers dedicated to prospective multicenter research of patients diagnosed with a primary tumor of the spine and will include a comprehensive prospective clinical database which will serve as a shared research platform. Demographic, clinical, diagnostic, and therapeutic variables will be used to answer questions about survival and local recurrence, as well as questions about adverse events (AEs), morbidity data, and health-related quality of life (HRQOL) outcomes.

Начало: 01.10.2016 Край: 01.12.2028

Australia, Canada, China +6 AO Innovation Translation Center NCT02790983

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The Global Angelman Syndrome Registry

Angelman Syndrome

The Global Angelman Syndrome Registry is an online patient organisation driven registry to collect information about the natural history of children and adults with Angelman Syndrome. The registry will facilitate 1) recruitment for clinical trials into therapies and interventions to benefit participants with Angelman Syndrome and their families, and 2) advancement of research and best standards of care for Angelman Syndrome. The registry is currently available in English, Spanish, Traditional Chinese, Italian, Polish, Hindi, and Brazilian Portuguese.

Начало: 28.09.2016 Край: 31.12.2099

Australia Foundation for Angelman Syndrome Therapeutics, Australi NCT05293184

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REtroperitoneal SArcoma Registry: an International Prospective Initiative

Retroperitoneal Sarcoma

Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority. Primary Objectives of this study are: * to prospectively collect standardized clinical data and radiological and pathological material from primary RPS patients treated with surgery at reference centers. * patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM). Secondary Objectives: * to estimate the efficacy and safety of surgical treatment, including extended surgical approach to primary RPS; * to prospectively evaluate the impact of multimodality therapy, including radiation therapy and chemotherapy; * to identify clinical, radiological and pathological characteristics that may influence the oncological outcome or may be used as predictors of LR/DM/OS. These may be important biomarkers of disease; * to utilize collected pathological material for research collaborations.

Начало: 01.09.2016 Край: 31.12.2030 Възраст: от 18 г.

Australia, Canada, France +8 Fondazione IRCCS Istituto Nazionale dei Tumori, Milano NCT03838718

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Montalcino Aortic Consortium: Precision Medicine for Heritable Thoracic Aortic Disease

Aortic Aneurysm Aortic Dissection Aortic Diseases

The Montalcino Aortic Consortium (MAC) will provide the infrastructure to assemble large cohorts of patients with mutations in known heritable thoracic aortic disease (H-TAD) genes, define the phenotype associated with these genes, and determine genetic and environmental modifiers of H-TAD.

Начало: 15.06.2016 Край: 01.01.2037

Australia, Belgium, Canada +3 The University of Texas Health Science Center, Houston NCT04005976

Набира участници Фаза 4

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

End-Stage Kidney Disease

This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.

Начало: 01.06.2016 Край: 01.12.2026 Възраст: от 18 г. Здравни услуги

Australia, Canada, Germany +3 University of Sydney NCT02823821

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Quality of Pediatric Resuscitation in a Multicenter Collaborative

Cardiac Arrest Cardiopulmonary Arrest

This is a prospective, observational, multi-center cohort study of pediatric cardiac arrests. The purpose of the study is to determine the association between chest compression mechanics (rate, depth, flow fraction, compression release) and patient outcomes. In addition, the investigators will determine the association of post cardiac arrest care with patient outcomes.

Начало: 02.05.2016 Край: 01.01.2030 Възраст: до 18 г.

Australia, Brazil, Canada +12 Children's Hospital of Philadelphia NCT02708134

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Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation

Lung Transplant Rejection

Objective: To evaluate the potential impact of molecular phenotyping of transbronchial biopsies in lung transplant recipients with allograft dysfunction, and the potential for developing a safer endobronchial mucosal biopsy format.

Начало: 01.05.2016 Край: 01.12.2026 Възраст: от 18 г.

Australia, Canada, Czechia +2 University of Alberta NCT02812290

Набира участници Фаза 3

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Community-acquired Pneumonia, Influenza, COVID-19

REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.

Начало: 11.04.2016 Край: 01.02.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +25 UMC Utrecht NCT02735707

Набира участници Фаза 3

International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia

Acute Myeloid Leukaemia

The main purpose of this study is : 1. To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses) is tolerated and can be safety delivered in combination with cytarabine plus mitoxantrone or liposomal daunorubicin in induction 2. To compare mitoxantrone (anthracenedione) \& cytarabine with liposomal daunorubicin (anthracycline) \& cytarabine as induction therapy. (Randomisation 1 (R1) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.) 3. To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined with induction chemotherapy. 4. To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine \& cytarabine (FLA) in standard risk patients. 5. To compare the toxicity and effectiveness of two haemopoietic stem cell transplant (HSCT) conditioning regimens of different intensity: conventional myeloablative conditioning (MAC) with busulfan/cyclophosphamide and reduced intensity conditioning (RIC) with fludarabine/busulfan.

Начало: 01.04.2016 Край: 01.12.2032 Възраст: до 17 г. Лечение

Australia, France, Ireland +3 University of Birmingham NCT02724163

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The Oxford Risk Factors And Non-Invasive Imaging Study

Cardiovascular Diseases Cardiovascular Risk Factors

ORFAN is a prospective, multi-centre, multi-ethnic cohort observational study collecting CT scans, biological material and outcomes data, to develop and validate novel biomarkers of cardiometabolic and other disease risk.

Начало: 23.02.2016 Край: 01.02.2030 Възраст: 18–99 г.

Australia, Belgium, China +12 University of Oxford NCT05169333

Набира участници Фаза 4

NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients

Heart Diseases Diabetes Mellitus, Type 2

Purpose and rationale The purpose of this study is to evaluate the effect of high dose Renin-Angiotensin System (RAS)-antagonists and beta-blocker treatment for the primary prevention of cardiac events in a population of patients with Type 2 diabetes mellitus (T2DM) with no evidence of a preexisting cardiac disease. An additional aim is to demonstrate an interaction between concentrations of amino-terminal pro-B type natriuretic peptide (NT-proBNP as a surrogate of imminent cardiac risk) and treatment effects and the economic impact of the intervention overall and in the biomarker stratified subgroups. Primary objective Superiority of high dose treatment with RAS-antagonists and beta-blockers compared to conventional therapy regarding the reduction of unplanned hospitalization or death due to a cardiac event in T2DM patients with a NT-proBNP \> 125pg/ml. There is an additional eye-substudy for Viennese sites only. The purpose of this sub-study is to evaluate the effect of high dose RAS-antagonists and beta blocker treatment on early subclinical signs of diabetic micro-angiopathy and neuropathy. An additional aim will be the evaluation of the possible impact of the cardiovascular risk factor NT-proBNP on the onset and progression of diabetic retinopathy.

Начало: 01.02.2016 Край: 01.12.2026 Възраст: от 18 г. Лечение

Austria, Netherlands, New Zealand +2 Martin Huelsmann NCT02817360

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Short Period Incidence Study of Severe Acute Respiratory Illness

Severe Acute Respiratory Infection

This is a multi-centre, prospective, short period incidence observational study of patients in participating hospitals and intensive care units (ICUs) with SARI. The study period will occur, in both Northern and Southern hemispheric winters. The study period will comprise a 5 to 7-day cohort study in which patients meeting a SARI case-definition, who are newly admitted to the hospitals / ICUs at participating sites, will be included in the study. The study will be conducted in 20 to 40-hospital/ ICU-based research networks globally. All clinical information and sample data will only be recorded if taken as part of the routine clinical practice at each site and only fully anonymised and de-identified data will be submitted centrally. The primary aim of this study is to establishing a research response capability for a future epidemic / pandemic through a global SARI observational study. The secondary aim of this study is to investigate the descriptive epidemiology and microbiology profiles of patients with SARI. The tertiary aim of this study is to assess the Ethics, Administrative, Regulatory and Logistic (EARL) barriers to conducting pandemic research on a global level.

Начало: 01.01.2016 Край: 01.12.2026

Australia Australian and New Zealand Intensive Care Research Cent NCT02498587

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Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation

Cardiac Transplant Disorder

Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care for heart transplant patients.

Начало: 01.01.2016 Край: 01.07.2027 Възраст: от 18 г.

Australia, Canada, Czechia +4 University of Alberta NCT02670408

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Project: Every Child for Younger Patients With Cancer

Adrenal Gland Pheochromocytoma Carcinoma In Situ Central Nervous System Neoplasm Childhood Immature Teratoma +14

This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Начало: 03.11.2015 Край: 31.12.2030 Възраст: до 25 г.

Australia, Canada, New Zealand +3 Children's Oncology Group NCT02402244

Набира участници Фаза 3

CAR-T Long Term Follow Up (LTFU) Study

Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

Начало: 02.11.2015 Край: 22.02.2036 Възраст: до 100 г. Друго

Australia, Belgium, Canada +18 Novartis Pharmaceuticals NCT02445222

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A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients

Prostate Cancer Cardiovascular Disease

RADICAL PC1 is a prospective cohort study of men with a new diagnosis of prostate cancer. RADICAL PC2 is a randomized, controlled trial of a systematic approach to modifying cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer.

Начало: 21.10.2015 Край: 01.12.2026 Възраст: от 45 г. Лечение

Australia, Brazil, Canada +4 McMaster University NCT03127631

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White Light vs Narrow Band Imagingin the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy

Adenoma Colon

A randomized controlled crossover study to determine if narrow band imaging or white light endoscopy is superior in detecting right colonic polyps in average risk subjects undergoing screening colonoscopy

Начало: 01.08.2015 Край: 01.11.2025 Възраст: от 18 г. Диагностика

Australia Western Sydney Local Health District NCT05935124

Набира участници Фаза 3

JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer

Non-Small Cell Lung Cancer

To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC

Начало: 01.07.2015 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia, Canada, United Kingdom +1 University of Texas Southwestern Medical Center NCT02468024

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