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Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions

Multiple Chronic Conditions Adverse Event

This study aims to predict and minimize post-discharge adverse events (AEs) during care transitions through early identification and escalation of patient-reported symptoms to inpatient and ambulatory clinicians by way of predictive algorithms and clinically integrated digital health apps. We will (1) develop and prospectively validate a predictive model of post-discharge AEs for patients with multiple chronic conditions (MCC); (2) combine, adapt, extend, and iteratively refine our EHR-integrated digital health infrastructure in a series of design sessions with patient and clinician participants; (3) conduct a RCT to evaluate the impact of ePRO monitoring on post-discharge AEs for MCC patients discharged from the general medicine service across Brigham Health; and (4) use mixed methods to evaluate barriers and facilitators of implementation and use as we develop a plan for sustainability, scale, and dissemination.

Начало: 01.02.2022 Край: 15.10.2026 Възраст: от 18 г.

United States Brigham and Women's Hospital NCT05282654

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Visual Remapping to Aid Reading With Field Loss

Age-related Macular Degeneration

Reading performance in patients with Central Vision Loss and age matched controls with artificial scotomas will be measured with and without different kinds of remapping of missing text to different parts of the visual field.

Начало: 01.02.2022 Край: 01.07.2026 Възраст: от 16 г.

United States University of Minnesota NCT03848663

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Correlation Between Intestinal Microecology Imbalance and Stroke in Young Adults

Ischemic Stroke Hemorrhagic Stroke

The relationship between the intestinal microecology and stroke has become a research hotspot in neurology field today. Maintaining the balance of the intestinal microbiota are expected to bring new breakthroughs for prevention and treatment of stroke. In recent years, stroke in young adults has an increasing incidence and a considerable socioeconomic impact because of high disability rate and health-care costs. So there is an urgent need to explore the role and mechanism of intestinal microecology imbalance in stroke, especially in the development and prognosis of stroke in young people. This study aims to use multi-omics technologies, including microbial diversity, metagenomics and metabonomics, to reveal the characteristics of intestinal flora in young stroke patients, identify biomarkers for predicting outcome after stroke and early detection of young people at high risk of stroke, and to further explore the role of gut-brain axis in the pathogenesis of stroke.

Начало: 01.02.2022 Край: 31.12.2027 Възраст: 18–45 г.

China Shanghai 6th People's Hospital NCT05113043

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Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation

Transtibial Amputation Transfemoral Amputation

The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.

Начало: 31.01.2022 Край: 31.03.2027 Възраст: 18–65 г.

United States VA Office of Research and Development NCT05989243

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Predictors of Poor Prognosis in HFpEF

HFpEF

Patients with HFpEF who have undergone meticulous clinical and instrumental evaluation (including diastolic exercise testing) between 2013 and 2020, will be followed up for at least 3 years.

Начало: 31.01.2022 Край: 31.12.2026 Възраст: от 40 г.

Russia National Medical Research Center for Cardiology, Minist NCT06844032

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WithHolding Enteral Feeds Around Blood Transfusion (International)

Necrotizing Enterocolitis

The WHEAT International trial is a comparative effectiveness trial exploring whether withholding enteral feeds around the time of blood transfusion in very premature infants (\

Начало: 28.01.2022 Край: 31.03.2027 Възраст: до 30 г.

Canada, United Kingdom IWK Health Centre NCT05213806

Набира участници Фаза 2/3

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

DLBCL Diffuse Large B-Cell Lymphoma

The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR. With protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab \[BR\] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.

Начало: 14.01.2022 Край: 24.09.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +22 Merck Sharp & Dohme LLC NCT05139017

Набира участници Фаза 2

A Prospective, Randomized, Multicenter, Comparative Study of the Efficacy of Imatinib Resumption Combined With Atezolizumab Versus Imatinib Resumption Alone in Patients With Unresectable Advanced Gastrointestinal Stromal Tumors (GIST) After Failure of Standard Treatments

Unresectable Gastrointestinal Stromal Tumor (GIST) Locally Advanced Gastrointestinal Stromal Tumor (GIST) Metastatic Gastrointestinal Stromal Tumor

This trial is a prospective, randomized (1:1 ratio), multicenter, comparative and phase II study, conducted in patients with unresectable advanced gastrointestinal stromal tumors (GIST) after failure of imatinib (disease progression),sunitinib and regorafenib (either disease progression or intolerance) In the first arm, patients will be treated with imatinib + atezolizumab (experimental arm), whereas in the second arm, patients will be treated with imatinib alone (control arm). The comparison between this two arms will allow to compare whether or not atezolizumab and imatinib is efficient for disease control, in terms of Progression-Free Survival improvement.

Начало: 14.01.2022 Край: 01.10.2027 Възраст: от 18 г.

France Centre Leon Berard NCT05152472

Набира участници Фаза 3

Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

AMD nAMD Wet Age-related Macular Degeneration wAMD +2

ABBV-RGX-314 (also known as RGX-314 and surabgene lomparvovec (sura-vec)) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.

Начало: 13.01.2022 Край: 01.11.2027 Възраст: 50–89 г.

Canada, France, Germany +7 AbbVie NCT05407636

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Pancreatic Cancer Screening in a Population at High Risk

Pancreatic Ductal Adenocarcinoma Hereditary Diseases Pancreatitis, Chronic

Pancreatic cancer is one of the diseases with the worst prognosis, which is mainly due to the initial asymptomatic prognosis. Unfortunately, the incidence of this disease in the Czech Republic is still increasing. In a certain proportion of patients, it is possible to predict the disease, e.g. due to family burdens. Regular follow-up of such individuals is the subject of the SCREPAN study: "Pancreatic Cancer Screening in High-Risk Persons".

Начало: 07.01.2022 Край: 06.01.2028 Възраст: от 18 г.

Czechia Masaryk Memorial Cancer Institute NCT06330441

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Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II

Refractory Angina

To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.

Начало: 04.01.2022 Край: 01.01.2032 Възраст: от 18 г.

Canada, United Kingdom, United States Shockwave Medical, Inc. NCT05102019

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Long Lasting Effect of Hyperbaric Oxygen Therapy on Cognitive Function in Traumatic Brain Injury Patients

TBI (Traumatic Brain Injury)

To evaluate the cognitive functions of patients who suffered brain injury due to traumatic head injury and were previously treated in a hyperbaric chamber between one and four years after the end of treatment.

Начало: 28.12.2021 Край: 01.01.2030 Възраст: от 18 г.

Israel Assaf-Harofeh Medical Center NCT07430150

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Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma (RADIO-RYTHMIC-01)

Thymoma Malignant Recurrent

The primary objective of the study : to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.

Начало: 28.12.2021 Край: 28.12.2032 Възраст: 18–75 г.

France Institut Curie NCT04731610

Набира участници Фаза 1

A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)

Adult Glioblastoma High Grade Glioma WHO Grade III or IV Malignant Glioma

The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG). Funding Source - FDA OOPD

Начало: 13.12.2021 Край: 01.07.2029 Възраст: от 4 г.

United States University of Florida NCT04573140

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The Severe Von Willebrand Disease (sVWD) Patient Registry

VWD - Von Willebrand's Disease

A web-based registry will be created by the sponsor, VWD Connect Foundation (VCF), to collect data on patients with severe Von Willebrand Disease (sVWD). Data will be self-reported by patients and/or collected by registry personnel, as appropriate. The purpose of the sVWD Patient Registry is to create a database of well-characterized (with respect to demographics, medical history, symptoms, laboratory and genetic data, etc.) patients with sVWD for participation in retrospective and prospective research.

Начало: 10.12.2021 Край: 01.12.2031

United States VWD Connect Foundation NCT05437536

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Stress Phenotypes and Preterm Birth

Preterm Birth Inflammation Stress Mental Health Issue

Pregnancy ends in preterm birth (PTB) for approximately 1 in 10 women, though more often for Non-Hispanic Black women, 14.12% PTB rate, compared to 9.09% for Non-Hispanic White women. Psychosocial stress and childhood trauma each are associated with risk for PTB and PTB has an intergenerational impact: mothers born preterm are more likely to give birth preterm, especially amongst Black women. In this project, we will study mitochondria, which contain their own genome, the mitochondria DNA, and are inherited from the mother, as they represent a potential intersection point between psychosocial experiences and their biological embedding in underlying disease outcomes such as PTB

Начало: 09.12.2021 Край: 01.12.2027 Възраст: от 18 г.

United States Columbia University NCT05229666

Набира участници Фаза 2

Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen

Peripheral Blood Stem Cell Transplantation

The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Chidamide intensified conditioning regimen in patients with Acute B cell Lymphoblast leukemia Underwenting Haploidenticl Peripheral blood Stem Cell Transplantation.

Начало: 01.12.2021 Край: 01.06.2031 Възраст: 12–65 г.

China Chinese PLA General Hospital NCT05088226

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Exercise Therapy for PAD Using Mobile Health

Peripheral Artery Disease

Peripheral artery disease (PAD) is a highly prevalent condition affecting up to 10% of Veterans that leads to loss of walking ability and increased risk of amputation. Veterans have limited access to supervised exercise therapy, a facility-based program proven to improve walking ability in PAD, which is poorly attended due to the inconvenience and cost of attending a 12-week program with multiple weekly sessions. This CDA-2 application will investigate the feasibility of home-based exercise therapy (HBET) delivered using mobile health (mHealth) technologies in Veterans with symptomatic PAD. We will partner with the MOVE! program to deliver HBET through group behavioral coaching and a novel wearable activity monitor in a newly proposed program called Smart MOVE!. There is a clear need to provide effective and convenient alternatives to supervised exercise for Veterans with PAD. This study will provide evidence to proceed with Smart MOVE!, a much-needed patient-centered rehabilitation program for Veterans with PAD.

Начало: 01.12.2021 Край: 30.09.2026 Възраст: от 40 г.

United States VA Office of Research and Development NCT04889105

Набира участници Фаза 2/3

(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis

Indolent Systemic Mastocytosis Smoldering Systemic Mastocytosis

This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of elenestinib (BLU-263) + symptom directed therapy (SDT) with placebo + SDT in participants with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by SDT. Parts 1 and 2 will enroll participants with ISM. Participants enrolled in Part 2 will roll over onto Part 3 to receive treatment with elenestinib in an open-label fashion following completion of the earlier Part. Part K will enroll participants with ISM who have previously received an approved selective KIT inhibitor. The study also includes pharmacokinetic (PK) groups that will enroll participants with ISM.

Начало: 30.11.2021 Край: 30.09.2032 Възраст: от 18 г. Лечение

Argentina, Australia, Austria +15 Blueprint Medicines Corporation NCT04910685

Набира участници Фаза 1/2

Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas

Neurofibromatosis 1

Background: NF1 is a genetic disease that causes tumors called atypical neurofibromas. These tumors, which arise from nerves, can cause serious medical problems. The only treatment is surgery. Researchers want to see if a drug called abemaciclib can help. Objective: To find a safe, tolerable dose of abemaciclib for treating atypical neurofibromas. Eligibility: People ages 12 and older who have NF1 and have one or more atypical neurofibromas that cannot or will not be removed with surgery Design: Participants will be screened with: Medical history and physical exam Blood, urine, and heart tests MRI: Participants will lie in a machine that takes pictures of the body. A padding or coil will be placed around their head. They may have a contrast agent injected into a vein. Biopsy sample: A small piece of tumor will be removed using a large needle. Participants will have frequent visits during the study. These will include repeats of the screening tests as well as the following: PET scan: Participants will lie in a machine that takes pictures of the body. They will have a contrast agent injected into their arm. Questionnaires about the effects of abemaciclib on pain and quality of life Possible photographs of tumors Participants will take abemaciclib capsules orally twice daily in 28-day cycles. They will take the drug for up to 2 years. Some may be able to take it for longer. Participants will have a follow-up visit about 30 days after their last dose of the study drug. Then they will have visits every 3 months for 1 year.

Начало: 29.11.2021 Край: 31.12.2029 Възраст: от 12 г.

United States National Cancer Institute (NCI) NCT04750928

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