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Investigational Use of Neuromuscular Ultrasound

Muscular Dystrophy Peripheral Neuropathy Motor Neuron Disorder Normal Physiology

Background: Current techniques used to measure the health and function of a person s nerves and muscles are generally effective, but they do have limits. Researchers are looking for ways to improve the ability to observe nerves and muscles and how they function in this natural history protocol. Objective: To study the use of ultrasound (sound waves) to learn more about nerves and muscles. Eligibility: Healthy adults, aged 18 and older, with no history of stroke, nerve or muscular disorders, or spine surgery are also needed. A smaller population of adults aged 18 and older who have a neuromuscular disorder or show symptoms of nerve or muscle disorder will also be evaluated. Design: Participants will be screened with a medical record review. Participants will have up to 5 outpatient clinic visits. Most participants will have 1 or 2 visits. Visits will last for less than 3-4 hours each. During each visit, participants will give a brief medical history and have a physical exam. Participants will have ultrasounds to get pictures and measurements of their nerves and muscles. Gel will be applied to their skin. A probe will be placed on the skin surface. Sound waves sent through the probe will be used to create pictures. Participants may have nerve conduction studies. Wires will be taped to the skin surface near a muscle or nerve in the arm or leg. The nerve will be stimulated with a small electric current that feels like a rubber band flick. The response will be recorded through the wires.

Начало: 18.04.2022 Край: 03.08.2026 Възраст: 18–110 г.

United States National Institute of Neurological Disorders and Stroke NCT05237973

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Early Tracking of Childhood Health Determinants (ETCHED) Study

Diabetes Mellitus Obesity Fatty Liver

Background: Children s weight has increased sharply in recent years. This may put them at higher risk for health problems. High blood glucose in a pregnant mother and too much weight gain during pregnancy also may have long-term effects on the child s health. Children who become overweight or obese during childhood tend to remain so as adults. Researchers want to study many risk factors during and after pregnancy, and how these affect a child s development. They will also follow the mother s health and well-being after pregnancy. Objectives: To learn how a pregnant mother s environment, lifestyle, and health conditions may affect her child s growth and development from birth until adulthood. Eligibility: American Indian/Alaska Native (AI/AN) or Hispanic adult pregnant women and their offspring. Design: Mothers will have 3 visits during pregnancy. In the child s first year, mothers will have 2 visits and their child will have 4. Children will have 2 visits in their second year and 1 each year until they turn 18. Mothers will have a visit 2 years after birth and 4-5 years later. Both the mother and child s medical records will be reviewed. They will have physical exams and give blood and stool samples. Mothers may give cord blood and placenta samples. They will give breastmilk and urine samples. They will fill out questionnaires. They will have an ultrasound. They may get an activity monitor. Mother and child will be followed until the child s 18th birthday. ...

Начало: 14.04.2022 Край: 31.12.2041 Възраст: 1–99 г.

United States National Institute of Diabetes and Digestive and Kidney NCT03481829

Набира участници Фаза 4

Stanford Pragmatic Effectiveness Comparison

Chronic Pain

Chronic pain is a major healthcare problem with an annual cost of above $600 billion. The quality of data available for treatments of chronic pain is not optimal. Generalizability of explanatory randomized controlled trial data is problematic as these trials exclude up to 90% of patients: leaving out real-world patients with serious medical and psychological comorbidities. Pragmatic trials embedded in patient care compare effectiveness of currently used treatments in real-world application leading to findings that generalize to broader range of patients. The changes in clinical practice and workflow necessary to integrate this type of research within patient care present pragmatic challenges. In this research, the overall objective is to overcome these challenges using an open-source learning health care system - CHOIR. CHOIR is currently used to track patients' clinical trajectory and treatment response across multiple academic sites resulting in over 25 publications characterizing chronic pain. Through the pilot studies, the investigators have already developed a point-of-care randomization for CHOIR that facilitates integration of research and patient care by allowing the physicians to randomize patients during clinic visits. The investigators have already demonstrated feasibility of the randomization and data collection platform in two ongoing pilot pragmatic clinical trials. The investigators are proposing to better integrate pragmatic research within clinical practice through conducting a randomized comparative effectiveness trial in 450 patients with chronic pain comparing effectiveness of anti-convulsants and anti-depressants (two most commonly used classes of medications for treatment of chronic pain). The investigators will also perform a qualitative interview with all physicians in our clinic to study the impact of integrating pragmatic research into clinical care. The investigators will use the data available in CHOIR as well as the real-world data generated from this clinical trial to build, validate and test a model to predict what clinical characteristics can predict response to either of these classes of medications. The proposed study is the first step to use flexible point-of-care randomization to compare effectiveness of different treatments in different subgroups of patients whenever equipoise exists. The prediction model will guide decision making process of clinicians choosing between these medications based on clinical characteristics of individual patients.

Начало: 12.04.2022 Край: 30.04.2027 Възраст: от 18 г.

United States Stanford University NCT04441034

Набира участници Фаза 3

Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor

HPV-unrelated Head and Neck Squamous Cell Carcinoma

This multicenter, open-label, randomized phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab monotherapy (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on a PD-1/L1 inhibitor (given as monotherapy or in combination with other therapy).

Начало: 06.04.2022 Край: 28.02.2028 Възраст: от 18 г.

United States Washington University School of Medicine NCT04966481

Набира участници Фаза 1

Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery

Brain Metastases, Adult Brain Metastases Brain Cancer

The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.

Начало: 04.04.2022 Край: 01.12.2027 Възраст: от 18 г.

United States Baptist Health South Florida NCT04689048

Набира участници Фаза 3

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)

Colorectal Neoplasms

In this study, Chinese participants with MSI-H or dMMR advanced colorectal cancer will be assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for treatment. There is no hypothesis testing for this study.

Начало: 02.04.2022 Край: 19.09.2028 Възраст: от 18 г.

China Merck Sharp & Dohme LLC NCT05239741

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Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits

Chronic Stroke

This study will evaluate the effects of combining motor learning-based therapy with use of the MyoPro , a wearable exoskeletal myoelectrically controlled orthotic device. MyoPro uses electromyographic (EMG) signals from the weak muscles to assist movement of the user's affected arm. The primary objective of this randomized controlled trial is to study the efficacy of using MyoPro in motor learning-based therapy for individuals with chronic stroke (\>6 months post) with severe upper limb motor deficits (Fugl-Meyer for Upper Limb score less than 30) compared with a similar dose of motor learning-based therapy alone. The secondary objectives are to evaluate neuroplasticity mechanisms, identify biomarkers of greater response to the intervention, and explore cost-effectiveness.

Начало: 01.04.2022 Край: 01.04.2027 Възраст: 18–89 г.

United States VA Office of Research and Development NCT05296408

Набира участници

The Effect of Interval Exercise on Functional Outcomes in Veterans With COPD and OSA

COPD OSA

The term "Overlap Syndrome" (OS) is used to describe the presence of both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in a single patient. Due to premature aging, patients with OS are prone to developing functional decline up to 20 years earlier than the general population. The International Classification of Functioning, Disability and Health (ICF) evaluates functional status in chronic pulmonary disease globally in 5 domains. The investigators propose to study validated outcomes in 3 of these domains: 1) participation in life situations; 2) physical activity; and 3) cardiovascular health. The investigators long-term goal is to develop an exercise strategy tailored to Veterans with OS which will reduce the risk of functional decline through increased PA.

Начало: 01.04.2022 Край: 01.04.2027

United States VA Office of Research and Development NCT05254431

Набира участници Фаза 2/3

Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease

Proteinuric Kidney Disease

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.

Начало: 30.03.2022 Край: 07.05.2030 Възраст: 10–65 г.

Belgium, Brazil, Canada +10 Vertex Pharmaceuticals Incorporated NCT05312879

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Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam

Sedation and Analgesia

In this parallel, multicenter, single-blind randomized controlled trial, mechanical ventilated patients will be randomly assigned to two groups. One receives remimazolam to achieve sedation goals, while the other receives Midazolam. The primary outcome is the effect of remimazolam on duration of mechanical ventilated of critical patients compared to midazolam.

Начало: 29.03.2022 Край: 31.12.2027 Възраст: 18–80 г.

China Zhujiang Hospital NCT05160987

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Observational Study to Deeply Phenotype Major Organs in Sickle Cell Disease After Curative Therapies

Mortality in Sickle Cell Sickle Cell Cardiopulmonary Complications Sickle Cell Organ Damage Sickle Cell Life Expectancy and Risk Factors for Early Death +1

Background: People with sickle cell disease (SCD) have problems with their heart, brain, kidneys, liver, and lungs as they age. These problems may improve after transplant. Researchers want to learn how and why this happens. Objective: To study the benefits of treatments that are intended to cure SCD. Eligibility: People aged 18 and older with SCD who are either receiving curative therapy in the next 3 months or don t have any plans to receive a curative therapy in the next 2 years. Design: At their first visit, participants will be screened with their medical history and a physical exam. Participants will then have a baseline visit. This will take about a week to complete and will include: Blood and heart tests MRI of the brain, heart, and lungs. Participants will lie on a bed that will move into the MRI scanner. Special padding may be placed around their head to keep it still. Interactive games. Participants will complete computer games that test memory, attention, problem solving, language, spatial orientation, processing speed, and emotion. Questionnaire rating quality of life Iothalamate test. An IV catheter will be placed into a vein. A contrast agent will be injected through the IV. Blood will then be collected at different time points. Lung function tests and a 6-minute walk test Vibration controlled transient elastography. A probe placed on the abdomen will measure liver scarring. DOS test. A light attached to the finger or toe will measure blood oxygen. Participants will have an end-of-study visit about 2 years after their baseline visit. This will include repeats of the baseline visit tests.

Начало: 24.03.2022 Край: 01.06.2035 Възраст: 18–100 г.

United States National Heart, Lung, and Blood Institute (NHLBI) NCT05213572

Набира участници Фаза 4

Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring

Intraoperative Neurophysiological Monitoring Magnesium Sulfate

Magnesium Sulfate(MgSo4) is increasingly being used as part of the multimodal pain regimen in the perioperative period. The intraoperative neurophysiological monitoring (IONM) is utilized in complex spine and cranial surgeries to assess the functional integrity of the neural pathways. The effect of Magnesium sulfate on IONM has not been studied. This is a prospective, double blind, randomized placebo controlled trial to study the effect of Magnesium sulfate bolus on the amplitude and latency of somatosensory(SSEPs) and motor evoked potentials(MEPs) in patients undergoing surgery requiring IONM.

Начало: 18.03.2022 Край: 01.03.2027 Възраст: 18–80 г.

United States Loma Linda University NCT04938765

Набира участници Фаза 3

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

Active Juvenile Psoriatic Arthritis

The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.

Начало: 17.03.2022 Край: 29.12.2028 Възраст: 5–17 г.

Austria, Belgium, France +12 Amgen NCT04804553

Набира участници Фаза 3

A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

Relapsed/Refractory Follicular Lymphoma Marginal Zone Lymphoma

The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R\^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R\^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.

Начало: 10.03.2022 Край: 01.06.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Austria +25 BeiGene NCT05100862

Набира участници Фаза 1/2

Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers

Cholangiocarcinoma Bile Duct Neoplasm Biliary Tract Malignancy

Background: Cholangiocarcinoma (CCA) is an aggressive cancer of the bile ducts. People with CCA have few treatment options and poor survival. Researchers want to see if a new drug can stop or slow CCA growth. Objective: To find the safest and most effective dose of tivozanib to treat CCA and learn its overall response rate. Eligibility: Adults ages 18 and older with CCA not removable with surgery and have been treated with at least one type of chemotherapy. Design: Participants will be screened with the following: * Medical history * Physical exam * Assessment of their ability to do daily activities * Medicine review * Blood tests, including thyroid function tests * Urine tests * Electrocardiogram, to check heart function * Pregnancy test, if needed * Tumor biopsy, if needed * Computed tomography scans * Magnetic resonance imaging, if needed Some screening tests may be repeated during the study. Participants will be asked to enroll in protocol #13C0176. This will allow any remaining tumor or blood samples to be used in future research. Participants will take tivozanib by mouth, once a day for 21 days per cycle or every other day per cycle. Each cycle is 28 days. They can take the drug until they have bad side effects, their CCA gets worse, or if they become pregnant. They will record their blood pressure twice daily at home. They will also keep a medication diary of each dose of tivozanib they take and any side effects. Participants will have study visits before starting each new cycle and every 8 weeks. They will also have a follow-up visit 30 days after treatment ends at NIH, or if they are unable to come to NIH by phone, videocall, or other NIH-approved platform. Then they will be contacted 6 and 12 months later, and then once a year.

Начало: 04.03.2022 Край: 31.12.2029 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT04645160

Набира участници

Nutritional Intervention for Endometriosis

Endometriosis

In a 12-week parallel study, women with a verified diagnosis of endometriosis will be randomly assigned to follow a low-fat plant-based diet or to stay on their usual diets for 12 weeks. Participants in both groups will be asked to make no changes to their exercise patterns for the study period. Changes in pain, quality of life, and inflammatory biomarkers from baseline to final will be the primary outcomes. Secondary outcomes will include changes in body weight, blood lipids, gut microbiome composition, and hormonal changes.

Начало: 02.03.2022 Край: 01.12.2029 Възраст: 18–45 г.

United States Physicians Committee for Responsible Medicine NCT05175248

Набира участници Фаза 3

MetfOrmin BenefIts Lower Extremities With Intermittent Claudication

Intermittent Claudication

Peripheral arterial disease (PAD) affects over 20% of aged adults and is very common among Veterans due significant tobacco use. PAD is due to the progressive blockage of peripheral arteries, predominantly to the legs, and results in intermittent claudication (IC) or recurrent muscle pain with activity secondary to insufficient blood supply. Those with PAD and IC experience a progressive decline in walking and poor quality of life. There is no effective medical treatment for PAD and IC. Metformin is a safe and effective treatment for Type 2 diabetes but it can also reduce inflammation, oxidative stress, and improve energy requirements as well as improve blood flow to the legs. Therefore, the investigators will test the ability of Metformin to improve overall functional status, reduce PAD progression, and reduce systemic inflammation in Veterans suffering from PAD and IC in a randomized, placebo controlled trial: Metformin BenefIts Lower Extremities with Intermittent Claudication (MOBILE IC) Trial. The success of this trial may identify a safe and effective treatment for PAD and IC.

Начало: 01.03.2022 Край: 28.02.2032 Възраст: 35–89 г.

United States VA Office of Research and Development NCT05132439

Набира участници Фаза 2

MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers

Venous Stasis Ulcer Venous Leg Ulcer

DL-VSU-201 is a randomized, double-blind, placebo-controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of MTX-001.

Начало: 26.02.2022 Край: 31.05.2027 Възраст: от 18 г.

United States Merakris Therapeutics NCT04647240

Набира участници Фаза 3

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

Non-Small Cell Lung Cancer

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

Начало: 18.02.2022 Край: 01.10.2030 Възраст: от 18 г.

Belgium, Brazil, Canada +25 AstraZeneca NCT05211895

Набира участници Фаза 1/2

Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms

Acute Biphenotypic Leukemia Acute Myeloid Leukemia Mixed Phenotype Acute Leukemia Myeloid Neoplasm +9

This phase I/II trial finds the best dose, side effects and how well giving venetoclax in combination with cladribine, cytarabine, granulocyte colony-stimulating factor, and mitoxantrone (CLAG-M) in treating patients with acute myeloid leukemia and high-grade myeloid neoplasms. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with CLAG-M may kill more cancer cells.

Начало: 04.02.2022 Край: 31.12.2028 Възраст: от 18 г.

United States University of Washington NCT04797767

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