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Набира участници Фаза 2

A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity Intraventricular Hemorrhage Retinopathy of Prematurity (ROP)

The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.

Начало: 09.05.2019 Край: 21.01.2028 Възраст: до 24 г. Превенция

Australia, Canada, Finland +11 OHB Neonatology Ltd. NCT03253263

Набира участници Фаза 3

A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis

The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.

Начало: 05.04.2019 Край: 01.07.2031 Възраст: 1–18 г. Лечение

Argentina, Australia, Belgium +15 Eli Lilly and Company NCT03773965

Набира участници

Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator

Chronic Pain

The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems.

Начало: 13.03.2019 Край: 01.12.2029 Възраст: от 18 г.

Australia, Belgium, Germany +6 Abbott Medical Devices NCT03876054

Набира участници Фаза 1/2

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Leukemia, Myeloid, Acute Refractory AML Relapsed Adult AML Myelodysplastic Syndrome With Excess Blasts-2 +1

The main purpose of this study is to identify a safe and potentially effective dose of tuspetinib to be used in future studies in study participants diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2 (MDS-IB2), or chronic myelomonocytic leukemia (CMML) that is relapsed or refractory after at least one line of prior therapy, or in study participants with newly diagnosed AML. Tuspetinib will be administered as a single agent or in combination with other drugs (venetoclax or venetoclax plus azacitidine), as specified for each part of the study.

Начало: 11.03.2019 Край: 01.04.2027 Възраст: от 18 г. Лечение

Australia, Germany, New Zealand +3 Aptose Biosciences Inc. NCT03850574

Набира участници Фаза 1

Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

Non-Hodgkin Lymphoma B-cell Acute Lymphoblastic Leukemia Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

This is a Phase 1/1b, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of azer-cel, an allogeneic anti-CD19 CAR T, in adults with r/r B ALL, r/r B-cell NHL and CLL/SLL.

Начало: 11.03.2019 Край: 01.06.2027 Възраст: от 18 г. Лечение

Australia, United States Imugene Limited NCT03666000

Набира участници

International Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry

Spontaneous Coronary Artery Dissection

The aim of "iSCAD," the International Spontaneous Coronary Artery Dissection (SCAD) Registry, is to serve as an internationally collaborative, multicenter registry coordinated by an experienced and centralized coordinating center in an effort to increase the pace of participant recruitment, and thereby increase statistical power of studies related to SCAD. The ultimate goal of iSCAD Registry is to facilitate the development of best practices and clinical guidelines for preventing SCAD or its recurrence. This observational study will be prospective and retrospective in its recruitment and will collect clinical information to better understand the natural history and prognosis for SCAD.

Начало: 08.03.2019 Край: 31.12.2025 Възраст: от 18 г.

Australia, United States SCAD Alliance NCT04496687

Набира участници

The EXCEL Registry of Patients Requiring ECMO

Critically Ill Acute Respiratory Failure Acute Heart Failure Cardiac Arrest

ECMO is associated with significant costs, risks and requires specialist training and expertise. EXCEL is a novel, high-quality, detailed prospective registry of patients requiring ECMO in Australia and New Zealand. The registry provides information on patient selection, complications, costs and patient reported outcome measures. EXCEL uses the Theoretical Domains Framework to identify evidence-practice gaps and explore barriers and enablers to tailor implementation of evidence

Начало: 01.02.2019 Край: 31.12.2027 Възраст: от 18 г.

Australia, New Zealand Australian and New Zealand Intensive Care Research Cent NCT03793257

Набира участници

The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

Oncology Breast Cancer Prostate Cancer Gynecologic Cancer +34

The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.

Начало: 01.02.2019 Край: 01.08.2030 Възраст: от 18 г.

Australia, Belgium, Canada +5 UMC Utrecht NCT04075305

Набира участници

Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset

Infant, Extremely Premature Obstetric Labor, Premature Premature Birth Intensive Care, Neonatal +1

The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.

Начало: 01.01.2019 Край: 01.01.2028 Възраст: до 1 г.

Australia, Canada, Germany +4 The University of Texas Health Science Center, Houston NCT05685745

Набира участници

Estab Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1)

Myotonic Dystrophy 1 DM1

Building on previous work of the Myotonic Dystrophy Clinical Research Network (DMCRN), the present study seeks to overcome insufficient data on natural history; lack of reliable biomarkers; and incomplete characterization and limited biological understanding of the phenotypic heterogeneity of Myotonic Dystrophy 1 by examining strategies to improve the reliability by making further refinements in our sample collection and analysis procedures by developing strategies for managing patient heterogeneity going forward. Funding Source- FDA OOPD

Начало: 01.01.2019 Край: 01.12.2026 Възраст: 18–70 г.

Canada, Germany, Italy +4 Virginia Commonwealth University NCT03981575

Набира участници

Study of Individuals Affected With Hypoplasminogenemia

Plasminogen Deficiency

This is an Investigator initiated retrospective and prospective single cohort study. The study will utilize an international registry and develop a specimen biobank to provide an improved understanding of the natural history of hyposplasminogenemia, to elucidate the heterogeneity of phenotypic expression, identify markers to predict disease course, and inform improved therapeutic modalities

Начало: 18.12.2018 Край: 19.04.2027

Argentina, Australia, Canada +7 Indiana Hemophilia &Thrombosis Center, Inc. NCT03797495

Набира участници

Pulmonary Hemodynamics During Exercise - Research Network

Pulmonary Circulation Diseases

The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data.

Начало: 01.12.2018 Край: 31.12.2029 Възраст: от 18 г.

Australia, Belgium, Brazil +9 Medical University of Graz NCT03954574

Набира участници Фаза 3

Extension Study for the Port Delivery System With Ranibizumab (Portal)

Neovascular Age-Related Macular Degeneration

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.

Начало: 20.09.2018 Край: 31.10.2029 Възраст: от 50 г. Лечение

Argentina, Australia, Belgium +11 Hoffmann-La Roche NCT03683251

Набира участници Ранна Фаза 1

APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies

Hematologic Malignancies

This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study consists of the dose escalation stage and the dose expansion stage.

Начало: 07.08.2018 Край: 15.02.2025 Възраст: от 18 г. Лечение

Australia, United States Ascentage Pharma Group Inc. NCT03537482

Набира участници Фаза 2/3

Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

Neoplasms

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Начало: 19.07.2018 Край: 30.11.2036 Друго

Australia, Belgium, Canada +15 Celgene NCT03435796

Набира участници Фаза 3

Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017

Acute Lymphoblastic Leukemia, Pediatric

The understanding of acute lymphoblastic leukemia (ALL) in childhood and adolescence has largely changed due to extensive genetic research in recent years: ALL is now considered to be a very heterogeneous disease group. The leukemia cells present themselves with quite differently activated regulatory mechanisms of the malignant phenotype. The introduction of more accurate methods of assessing therapy response ("minimal residual disease \[MRD\] tests") has provided new insights into very different mechanisms of action, including factors influenced by host factors; this has had practical clinical consequences for the use of more individualized therapy. Multimodal therapies have enabled a cure level of over 80% for ALL in this age group. However, the own and international study data show that the therapy toxicity of the contemporary chemotherapy concepts has become unacceptably high, in particular with respect to those intensified therapies used for the treatment of patients at high risk of ALL relapse. The AIEOP-BFM ALL 2017 study therefore aims for an innovative integrated approach that will not only adapt the risk stratification to new prognostic markers using more comprehensive diagnostics, but above all, qualitatively reorient the therapy. The most important consequence will be that this study is testing immunotherapy with the bispecific antibody blinatumomab as an alternative to particularly intensive and toxic chemotherapy elements in precursor B-cell ALL (pB-ALL) patients with detectable chemotherapy resistance and at high risk of relapse. With the aim to complement the effects of the conventional chemotherapy, Blinatumomab is in addition tested in the large group of pB-ALL patients at intermediate relapse risk with seemingly unremarkable leukemia, but who account for a large proportion of all relapses. Targeted therapy is also used in the form of the proteasome inhibitor bortezomib for patients with pB-ALL and slow response to the drugs of the induction chemotherapy with the aim to overcome intrinsic chemotherapy resistance of the ALL cells. In patients with T-lineage ALL, who have particularly poor chances for cure after relapse, the established consolidation chemotherapy has proved to be particularly effective. This chemotherapy phase is therefore tested in a longer and more intensive form in such T-ALL patients with intermediate or slow early treatment response with the aim to reduce the relapses rate in this subgroup.

Начало: 15.07.2018 Край: 14.07.2028 Възраст: до 17 г. Лечение

Australia, Czechia, Germany +4 Martin Schrappe NCT03643276

Набира участници Фаза 1/2

Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

Recurrent Ovarian Cancer Recurrent Fallopian Tube Cancer Recurrent Primary Peritoneal Cancer Recurrent Endometrial Cancer +2

The main purpose of this study is to: * Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus * The study will also look at the levels of ubamatamab and/or cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics * The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus * To find out how safe and tolerable pretreatment is in combination with ubamatamab and to see how well it works to prevent or minimize Cytokine Release Syndrome (CRS)

Начало: 21.05.2018 Край: 31.01.2027 Възраст: от 18 г. Лечение

Australia, Belgium, France +7 Regeneron Pharmaceuticals NCT03564340

Набира участници Фаза 1

Adoptive Cell Therapy Long-term Follow-up (LTFU) Study

Neoplasms

This trial will evaluate long term safety of participants who have received AdaptImmune (ADP) adoptive cell therapy for up to 15 years following last adoptive cell therapy infusion.

Начало: 09.04.2018 Край: 01.04.2032 Друго

Australia, Canada, Germany +5 USWM CT, LLC NCT03391778

Набира участници Фаза 1/2

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

Metastatic Breast Cancer

This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, six cohorts will be enrolled in parallel in this study: Cohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \[1L\] PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \[2L\] CIT-naïve cohort). Cohort 3, 5, and 6 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations. Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.

Начало: 30.03.2018 Край: 30.09.2030 Възраст: от 18 г. Лечение

Australia, France, Germany +6 Hoffmann-La Roche NCT03424005

Набира участници Фаза 3

A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy

Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD) Solid Organ Transplant Complications Lymphoproliferative Disorders Allogeneic Hematopoietic Cell Transplant +1

The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

Начало: 29.12.2017 Край: 01.08.2030 Лечение

Australia, Belgium, Canada +5 Pierre Fabre Medicament NCT03394365

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