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Набира участници Фаза 1/2

Study to Evaluate the Safety and Tolerability of EP0042

Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes

A research study looking at a new treatment for patients with advanced cancer, to investigate different doses of the experimental study drug, EP0042, in order to determine a dose, which is safe, well-tolerated and likely to be effective in treating AML (acute myeloid leukaemia).

Начало: 02.11.2020 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, Netherlands, United Kingdom Ellipses Pharma NCT04581512

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Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis

Lumbar Disc Disease

To implant a complete lumbar disc prosthesis removal of the anterior portion of the annulus fibrosus is required. As the anterior portion of the annulus limits the movement in extension and axial rotation, we would like to know how much increase these two disc movements and also the effect on the postoperative prevertebral scar on the reduction of these abnormal movement ranges. We also aim to see if repairing intraoperatively the anterior portion of the annulus has any advantage in the final result achieved.

Начало: 01.11.2020 Край: 28.12.2029 Възраст: 18–50 г.

Spain University of Valencia NCT04641039

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CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

Mitral Regurgitation

This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.

Начало: 01.11.2020 Край: 31.12.2030 Възраст: от 18 г.

Australia, Canada, Denmark +6 Universitätsklinikum Hamburg-Eppendorf NCT04688190

Набира участници Фаза 1/2

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)

Advanced Liver Cancers

This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.

Начало: 01.11.2020 Край: 30.09.2027 Възраст: от 18 г. Лечение

China, France, Israel +4 Hoffmann-La Roche NCT04524871

Набира участници Фаза 1/2

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Advanced Solid Tumor Advanced Malignant Neoplasm Metastatic Cancer Metastatic Solid Tumor +26

The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.

Начало: 29.10.2020 Край: 31.12.2027 Възраст: от 12 г. Лечение

Australia, France, Germany +6 PMV Pharmaceuticals, Inc NCT04585750

Набира участници Фаза 1

Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors

Advanced Solid Tumors Metastatic Pancreatic Cancer Pediatric Solid Tumor Advanced Breast Cancer +2

Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs. Objective: To find a safe dose of metarrestin and to see if this dose shrinks tumors. Eligibility: Adults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options. Design: Participants will be screened with: * blood tests * physical exam * documentation of disease confirmation or tumor biopsy * electrocardiogram to evaluate the heart * review of their medicines and their ability to do their normal activities Participants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary. Participants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body. Adult participants may have tumor biopsies. Participants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.

Начало: 27.10.2020 Край: 31.12.2028 Възраст: 12–120 г.

United States National Cancer Institute (NCI) NCT04222413

Набира участници Фаза 1

A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer

Solid Tumor Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.

Начало: 26.10.2020 Край: 30.06.2028 Възраст: от 18 г. Лечение

Australia, Bosnia and Herzegovina, Bulgaria +4 K-Group, Beta, Inc., a wholly owned subsidiary of Zenta NCT04516447

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Abbott Vascular Medical Device Registry

Acute Myocardial Infarction Restenoses, Coronary Coronary Artery Lesions Venous Embolism +1

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

Начало: 25.10.2020 Край: 01.11.2031 Възраст: от 18 г.

Australia, Belgium, China +10 Abbott Medical Devices NCT04573660

Набира участници Фаза 2

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis

Myelofibrosis Indolent Systemic Mastocytosis

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.

Начало: 22.10.2020 Край: 31.12.2025 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +10 Telios Pharma, Inc. NCT04655118

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NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

Aortic Dissection Aortic Aneurysm Intramural Hematoma Penetrating Aortic Ulcer

Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.

Начало: 20.10.2020 Край: 01.10.2029 Възраст: от 18 г. Лечение

New Zealand, United States Endospan Ltd. NCT04471909

Набира участници Фаза 2

A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT

Anaplastic Kidney Wilms Tumor Recurrent Kidney Wilms Tumor Stage II Kidney Wilms Tumor Stage III Kidney Wilms Tumor +1

This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).

Начало: 19.10.2020 Край: 01.07.2027 Възраст: до 30 г. Лечение

Australia, Canada, New Zealand +3 Children's Oncology Group NCT04322318

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Thoracoabdominal Asynchrony and Respiratory Distress

Respiratory Insufficiency

The investigators hypothesize that a simple 3-point tracking device that uses motion sensors attached to the abdomen and chest of a child will provide information regarding thoracoabdominal asynchrony (TAA), a major component of respiratory distress, and ultimately help guide a clinician to initiate, escalate, de-escalate, or stop respiratory support interventions. AIMS To determine if the TAA-monitoring device can be used to detect differences in respiratory synchrony in a manner that is clinically applicable. The investigators hope that the device will detect 1) major asynchrony events in a timely manner so as to prompt clinician intervention during future use; and 2) asynchrony events that may be less visible to the naked eye that may be precursors to more severe events.

Начало: 16.10.2020 Край: 01.06.2026 Възраст: 28–17 г.

United States Massachusetts General Hospital NCT04626154

Набира участници Фаза 1/2

Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy

Metastatic Castration-Resistant Prostate Carcinoma Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Neoplasm in the Lymph Nodes Stage IVB Prostate Cancer AJCC v8

This phase I/II trial studies the best dose of M3814 when given together with radium-223 dichloride or with radium-223 dichloride and avelumab and to see how well they work in treating patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as radium-223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to find out the better treatment between radium-223 dichloride alone, radium-223 dichloride in combination with M3814, or radium-223 dichloride in combination with both M3814 and avelumab, to lower the chance of prostate cancer growing or spreading in the bone, and if this approach is better or worse than the usual approach for advanced prostate cancer not responsive to hormonal therapy.

Начало: 14.10.2020 Край: 30.04.2026 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT04071236

Набира участници Фаза 1/2

Clinical Trials of Multivalent Opioid Vaccine Components

Opioid-use Disorder

Currently, abuse of prescription opioid analgesics and heroin is a serious problem in the U.S. Although several medications, including methadone, buprenorphine, and naltrexone, are available and effective in treating opioid use disorder (OUD), long-term relapse rates remain high. The current study is designed to examine a new approach to treating OUD, namely use of a vaccine targeted against oxycodone \[Oxy(Gly)4-sKLH\], one of the most commonly abused prescription opioids. The vaccination approach to treating substance use disorders relies on the ability of the vaccine to produce antibodies that bind the target drug in blood and reduce its ability to enter the brain. The long-term goal of this research will be to develop a combined vaccine against oxycodone and heroin. However, in this trial the Oxy(Gly)4-sKLH vaccine will be studied separately. This is a multi-site study, being conducted at the New York State Psychiatric Institute and the Clinilabs clinical research unit (CRU) in Eatontown, New Jersey. The current study proposes to evaluate safety (Aim 1), degree of antibody production (Aim 2), and efficacy (i.e., ability to reduced drug liking following opioid administration) (Aim 3). The oxycodone vaccine (Oxy(Gly)4-sKLH) will be tested in participants with OUD (target # completers = 45 across two study sites). This study will provide a great deal of information about the safety and potential effectiveness of the Oxy(Gly)4-sKLH vaccine in reducing the abuse of opioids. The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.

Начало: 08.10.2020 Край: 30.03.2027 Възраст: 18–59 г.

United States New York State Psychiatric Institute NCT04458545

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Effect of the MobiusHD® in Patients With Heart Failure

Heart Failure With Reduced Ejection Fraction

This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and effectiveness of the MobiusHD® in patients with heart failure and reduced ejection fraction.

Начало: 02.10.2020 Край: 01.06.2026 Възраст: от 18 г. Лечение

Australia, Canada, Georgia +2 Vascular Dynamics, Inc. NCT04590001

Набира участници Фаза 1

Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults

Glioblastoma Malignant Glioma Recurrent Glioblastoma Recurrent Malignant Glioma +2

This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Начало: 02.10.2020 Край: 01.03.2029 Възраст: 6–25 г. Лечение

Australia, United States Sabine Mueller, MD, PhD NCT04323046

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Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant: A Prospective, Multi-Center Global Registry

Rotator Cuff Injuries

This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System. The Registry will include up to 50 centers in the United Kingdom (UK), Europe, Australia, and up to 400 patients for the initial evaluation. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 2 years post-surgery.

Начало: 01.10.2020 Край: 31.12.2027 Възраст: от 18 г.

Australia, France, Germany +2 Smith & Nephew, Inc. NCT06857084

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The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery

Peripheral Arterial Disease Vascular Diseases Stenosis Femoropopliteal Stenosis

To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery

Начало: 22.09.2020 Край: 01.03.2030 Лечение

Australia, New Zealand Efemoral Medical, Inc. NCT04584632

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Pancreatic Cancer Early Detection Consortium

Pancreas Cancer Pancreas Cyst Pancreatic Ductal Adenocarcinoma Genetic Predisposition

The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.

Начало: 18.09.2020 Край: 31.12.2030 Възраст: 18–90 г.

Australia, Canada, Hungary +8 Arbor Research Collaborative for Health NCT04970056

Набира участници Фаза 1/2

FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

Rhabdomyosarcoma

FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS)

Начало: 17.09.2020 Край: 01.06.2030 Лечение

Australia, Belgium, Czechia +14 University of Birmingham NCT04625907

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