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Намерени 4,436 изпитвания Стр. 195 от 222

Набира участници Фаза 2

Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer

Anatomic Stage IV Breast Cancer AJCC v8 Invasive Breast Carcinoma Metastatic Triple-Negative Breast Carcinoma

This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, 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. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.

Начало: 13.04.2021 Край: 30.12.2026 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT03606967

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Intermittent Fasting to Improve Insulin Secretion

PreDiabetes Diabetes type2 Intermittent Fasting Insulin Secretion

Type 2 diabetes (T2D) mellitus is a challenge for health care systems as the numbers increases constantly. In 2014, 422 million people had been living with diabetes worldwide. The absolute numbers of people with prediabetes have also grown substantially over 25 years worldwide. In Germany, about 10% of the population has T2D and another 21 % of the population has prediabetes.Overall, 16% of all deaths in Germany are attributable to type 2 diabetes. Macro- and microvascular complications of diabetes imply a significant threat for the patients and are already present in the prediabetic state. Short term and long term complications, the burden of treatment, and reduced quality of life are major burdens of the disease. Accumulating data indicate that currently recommended therapeutic diet regimens in patients with obesity and diabetes are not sustainable on the long term. Novel concepts are therefore urgently needed. T2D occurs when insulin secretion from pancreatic beta-cells cannot sufficiently be increased to compensate for insulin resistance. Causes of beta-cell dysfunction are heterogeneous. In addition, the most important determinants of diabetes remission are the extend of weight loss and restoration of beta-cell function. In the course of diabetes progression, the inability to recover insulin secretion might identify the state of no return to normal glucose tolerance. It is therefore crucial to improve insulin secretion in treatment and prevention of diabetes. Up to now lifestyle intervention trials in prediabetes or pharmacological intervention trials in diabetes did not show improvement of insulin secretion after intervention. However, one recent small human trial shows that intermittent fasting (early time restricted fasting) is able to improve insulin secretion.Currently, there are no trials that examine the effect of intermittent fasting in individuals with a broad range of impaired glucose metabolism (from prediabetes to diabetes). Recently novel subtypes of diabetes and prediabetes with high risk for the early manifestation of diabetes complications have been identified. Currently, prevention strategies for this high risk individuals have not been examined yet. We will study for the first time the effectiveness of 4 weeks intermittent fasting on changes in insulin secretion capacity in subphenotypes of diabetes and in prediabetes.

Начало: 08.04.2021 Край: 01.03.2027 Възраст: 18–70 г.

Germany University Hospital Tuebingen NCT04607096

Набира участници Ранна Фаза 1

A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion

High Grade Glioma Diffuse Intrinsic Pontine Glioma

This is a pilot study that will evaluate disease status in children that have been newly diagnosed high-grade glioma with TRK fusion. The evaluation will occur after 2 cycles of the medication (Larotrectinib) have been given. The study will also evaluate the safety of larotrectinib when given with chemotherapy in your children; as well as the safety larotrectinib when given post-focal radiation therapy.

Начало: 08.04.2021 Край: 01.12.2036 Възраст: до 21 г. Лечение

Australia, Canada, Germany +2 Nationwide Children's Hospital NCT04655404

Набира участници Фаза 2

Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

Hematologic Malignancies Waldenstroms Macroglobulinaemia Non-Hodgkins Lymphoma Chronic Lymphocytic Leukaemia

The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).

Начало: 05.04.2021 Край: 04.01.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +18 Merck Sharp & Dohme LLC NCT04728893

Набира участници Фаза 1

Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer

Prostatic Neoplasms, Castration-Resistant

This is a Phase 1, open-label, international, dose escalation study to evaluate the safety of \[225Ac\]Ac-PSMA-617 (225Ac-PSMA-617) in men with PSMA-positive prostate cancer who have and have not had prior exposure to \[177Lu\]Lu-PSMA-617 (177Lu-PSMA-617) or \[177Lu\]Lu-PSMA I\&T (177Lu-PSMA I\&T).

Начало: 01.04.2021 Край: 01.01.2027 Възраст: от 18 г. Лечение

Australia, South Africa Endocyte NCT04597411

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Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study

Chronic Pancreatitis Exocrine Pancreas Carcinoma Recurrent Acute Pancreatitis

This clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer.

Начало: 01.04.2021 Край: 02.02.2027 Възраст: до 17 г.

Australia, Canada, Israel +1 M.D. Anderson Cancer Center NCT06651580

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Management of Type 1 Supracondylar Humeral Fractures

Elbow Fracture Trauma

This study compares the clinical outcomes of treating pediatric Type 1 supracondylar fracture with a long arm soft cast and no clinical or radiographic follow-up versus the standard treatment in a long arm cast with clinical follow-up. This is the first multicenter randomized control trial looking at the clinical effectiveness, safety and parental satisfaction of managing inherently stable Type I supracondylar fractures without clinical or radiological follow-up. If found to be safe; children can be managed effectively without in-person follow-up, freeing clinic appointments to children on the waiting list and in these COVID times avoiding unnecessary contacts.

Начало: 01.04.2021 Край: 01.06.2025 Възраст: 3–8 г. Лечение

Australia, Canada University of British Columbia NCT04642807

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Neural Correlates of Psychiatric Disorders

Psychiatric Disorder Memory Disorders

This ClincialTrials.gov record originally corresponded to the protocol approved under IRB # 202370. The study was expanded to include stimulation and recordings approved under new IRB #211037, as well as IRB #251231. The participant data originally acquired from IRB# 202370 will be included in this new record: This study seeks to better understand the neural activity underlying neuro cognitive disorders. Resting state local field potential recordings will be collected from medically refractory epilepsy patients implanted with depth electrodes for seizure localization, and metrics of neural activity will be correlated with psychiatric symptoms as measured from questionnaires. Subjects will also participate in neuro cognitive tasks while neural recordings are performed, and/or receive neural stimulation through implanted depth electrodes. A better understanding of disordered neural activity underlying neuropsychiatric disorders may additionally contribute to novel methods for diagnosing, treating, and preventing these diseases.

Начало: 31.03.2021 Край: 01.12.2026 Възраст: от 18 г.

United States Vanderbilt University Medical Center NCT04725409

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Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients With BAP1 Tumor Predisposition Syndrome

Familial Cancer BRCA1-Associated Protein-1 (BAP1) Mutations Tumor Predisposition Syndrome (TPDS) Mesothelioma

Background: A germline mutation is a change to a person s genes that is carried through their DNA. These mutations can be passed on from parents to their offspring. Germline mutations in a gene called BAP1 are linked to the development of mesothelioma and other cancers. Researchers want to follow people with these mutations to learn more. Objective: To see if researchers can improve how people who have or are suspected to have a BAP1 mutation are monitored over time. Eligibility: People age 30 and older who are suspected to have a BAP1 germline mutation. Design: Participants will be screened with a personal and family medical history. Their medical records may be reviewed. They will give a blood or saliva sample to test for a BAP1 mutation. They will get genetic counseling. To take part in this study, participants will enroll on 2 to 3 other protocols. Participants will have a physical exam. They may have a tumor biopsy. They will give blood and urine samples. They will have skin and eye exams. Some participants will have video-assisted thoracoscopy to examine the chest and lungs and diagnose suspicious areas. For this, a small camera is inserted into the chest through a small incision. Some participants will have laparoscopy to examine the organs inside the abdomen. For this, a small camera is inserted into the abdomen through a small incision. Participants will have imaging scans of the chest, abdomen, and pelvis. They may have brain scans. Participants will visit the NIH once a year for follow-up exams. Participation lasts indefinitely.

Начало: 30.03.2021 Край: 30.06.2038 Възраст: 30–120 г.

United States National Cancer Institute (NCI) NCT04431024

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Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature

Peripheral Vascular Diseases

The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.

Начало: 29.03.2021 Край: 01.01.2028 Възраст: от 18 г.

Australia, Austria, Canada +8 Boston Scientific Corporation NCT04674969

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Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

Kidney Disease, End-Stage End-stage Renal Disease Arteriovenous Fistula

A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.

Начало: 26.03.2021 Край: 01.09.2027 Възраст: от 18 г. Лечение

Australia, United States C. R. Bard NCT04634916

Набира участници Фаза 1/2

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

Solid Tumor, Adult Mesothelioma NSCLC

This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, and biological activity of VT3989 administered, alone or in combination, once daily in patients with mesothelioma and/or metastatic solid tumors that are resistant to standard therapy or for which no effective standard therapy is available.

Начало: 24.03.2021 Край: 02.03.2030 Възраст: от 18 г. Лечение

Australia, United States Vivace Therapeutics, Inc NCT04665206

Набира участници Фаза 3

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis

Plaque Psoriasis

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric participants aged 4 to \

Начало: 23.03.2021 Край: 08.09.2033 Възраст: 4–18 г. Лечение

Argentina, Australia, Brazil +10 Bristol-Myers Squibb NCT04772079

Набира участници Фаза 1/2

UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL

B-cell Acute Lymphoblastic Leukemia B-cell Non Hodgkin Lymphoma

This phase I/II trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric patients with B-cell NHL and patients in primary relapse.

Начало: 10.03.2021 Край: 01.07.2026 Възраст: 31–30 г.

United States University of Colorado, Denver NCT04544592

Набира участници Фаза 1

Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.

Начало: 09.03.2021 Край: 30.06.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +16 AstraZeneca NCT04686305

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Cancer Predisposition Testing by Family-based Whole-genome Sequencing (WGS) in Every Child With Newly Diagnosed Cancer

Neoplastic Syndromes, Hereditary Cancer Genetic Predisposition to Disease

Assessment of the utility of family-based (trio) whole-genome sequencing for cancer predisposition testing in sequential newly diagnosed paediatric and adolescent cancer patients

Начало: 08.03.2021 Край: 15.06.2028 Възраст: до 21 г.

Australia Sydney Children's Hospitals Network NCT04903782

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Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy

Prostate Cancer

Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

Начало: 08.03.2021 Край: 30.04.2030 Възраст: от 18 г.

France Elsan NCT04638088

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TAS Test: Online Motor-cognitive Tests for Early Detection of Alzheimer's Disease

Alzheimer Disease Dementia Age-related Cognitive Decline

Global dementia prevalence is rising. Alzheimer's disease (AD), the most common cause, has devastating effects on people's quality of life. AD has a preclinical (pre-AD) period of 10-20 years when brain pathology silently progresses before any cognitive symptoms appear. Current tests for pre-AD are invasive, costly and unsuitable for screening at population level. Similar to screening for pre-diabetes and carcinoma in situ, it is important to detect AD at the preclinical stage in order to offer early interventions before the pathology progresses to the irrerversible degenerative stage. In the study, research will develop a new scalable test (TAS Test) by combining two innovative ideas: hand-movement tests to detect pre-AD \>10 years before cognitive symptoms begin; and computer vision so people can "self-test" online using home computers. This unique approach builds on recent discoveries that hand-movement patterns change in pre-AD. The research team will use exquisitely precise computer vision methods to automatically analyse movement data from thousands of participants, and combine this with machine learning of overall motor-cognitive performance. The project team has access to 3 well-phenotyped cohorts, \>10,000 existing participants and a cutting-edge assay for a blood AD biomarker, ptau181. The research team will develop a TAS Test algorithm to classify hand-movement and cognitive test data for pre-AD risk (p-taua181 levels) and determine TAS Test's precision to prospectively predict 5-year risks of cognitive decline and AD.

Начало: 05.03.2021 Край: 01.12.2030 Възраст: от 50 г.

Australia University of Tasmania NCT05194787

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Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

Multiple Sclerosis

The goal of this interventional non-pharmacological study is to evaluate the involvement of the autonomic nervous system in patients with relapsing-remitting and primary progressive multiple sclerosis. The main questions it aims to answer are: * Is it possible to define the characteristics of dysautonomia to improve treatment on patients with multiple sclerosis through the management of conditions such as orthostatic hypotension or thermoregulation disorders that inevitably condition the patient's life and the response to rehabilitation ? * Does the severity of the functional alterations correlate with impairment of small somatic and autonomic cutaneous nerve fibers in patients with multiple sclerosis ? * How much the involvement of the autonomic nervous system affects the clinical history and progression of the disease ? * Do different clinical variants of multiple sclerosis manifest with different patterns of involvement of the sensory-autonomic nervous system ? Participants will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment. Patients will perform a sensory and autonomic functional study and a morphological analysis of cutaneous nerves through skin biopsy. Researchers will compare results between the two groups (relapsing-remitting and primary progressive) and between patients and data from control subjects.

Начало: 04.03.2021 Край: 30.05.2027 Възраст: от 18 г.

Italy Istituti Clinici Scientifici Maugeri SpA NCT05748015

Набира участници Фаза 1

A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma

B-cell Non Hodgkin Lymphoma Diffuse Large B Cell Lymphoma High-grade B-cell Lymphoma Follicular Lymphoma

This phase 1 study will investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AZD0486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with B-cell non-Hodgkin lymphoma (B-NHL).

Начало: 02.03.2021 Край: 19.04.2028 Възраст: 18–130 г. Лечение

Australia, Japan, South Korea +2 AstraZeneca NCT04594642

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