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Набира участници Фаза 2

Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies

Primary T-cell Immunodeficiency Disorders Common Variable Immunodeficiency Immune System Diseases Autoimmune Lymphoproliferative +1

Background: Allogeneic blood or marrow transplant is when stem cells are taken from one person s blood or bone marrow and given to another person. Researchers think this may help people with immune system problems. Objective: To see if allogeneic blood or bone marrow transplant is safe and effective in treating people with primary immunodeficiencies. Eligibility: Donors: Healthy people ages 4 or older Recipients: People ages 4-75 with a primary immunodeficiency that may be treated with allogeneic blood or marrow transplant Design: Participants will be screened with medical history, physical exam, and blood tests. Participants will have urine tests, EKG, and chest x-ray. Donors will have: Bone marrow harvest: With anesthesia, marrow is taken by a needle in the hipbone. OR Blood collection: They will have several drug injections over 5-7 days. Blood is taken by IV in one arm, circulates through a machine to remove stem cells, and returned by IV in the other arm. Possible vein assessment or pre-anesthesia evaluation Recipients will have: Lung test, heart tests, radiology scans, CT scans, and dental exam Possible tissue biopsies or lumbar puncture Bone marrow and a small piece of bone removed by needle in the hipbone. Chemotherapy 1-2 weeks before transplant day Donor stem cell donation through a catheter put into a vein in the chest or neck Several-week hospital stay. They will take medications and may need blood transfusions and additional procedures. After discharge, recipients will: Remain near the clinic for about 3 months. They will have weekly visits and may require hospital readmission. Have multiple follow-up visits to the clinic in the first 6 months, and less frequently for at least 5 years....

Начало: 19.11.2015 Край: 31.12.2036 Възраст: 4–75 г.

United States National Cancer Institute (NCI) NCT02579967

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Psychological Treatments for Youth With Severe Irritability.

Irritability

Background: When children have severe irritability and temper outbursts, they can be so cranky or angry that it leads to problems at home, in school, and with friends. This is called Disruptive Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed specifically for children with this problem. Researchers think two forms of therapy, Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help children with DMDD. Objective: To test two whether IBT and CBT can decrease severe irritability in children and youth. Eligibility: Children 8-17 years old with DMDD. Their symptoms must have started before age 10. Design: Participants will be screened with a review of their symptoms. Parents and participants will answer questions. Participants can do only one or both of these treatments if they wish. Those who wish to do both will start with IBT. Participants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent will participate in part of the sessions. Participants will talk about what makes them irritable and how it affects them. They may be put in situations that might make them annoyed or irritable. Participants will rate how intense their irritability is. Parents and participants will complete rating scales, questionnaires, and interviews. Participants will do practice activities at home. Participants doing IBT will have up to 14 sessions over 10 weeks. Participants will view 15 faces, one at a time, on a computer. They will choose if the face looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will complete some sessions at the NIH and some at home. Participants and parents answer questions about their progress. ...

Начало: 17.11.2015 Край: 08.05.2028 Възраст: 8–17 г.

United States National Institute of Mental Health (NIMH) NCT02531893

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Development and Validation of Patient Reported Outcome (PRO) Measures for Individuals With Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (pNFs)

Neurofibromatosis 1 Plexiform Neurofibromas

Background: People with neurofibromatosis 1 (NF1) who have plexiform neurofibromas (pNFs) can have pain that affects their daily lives. This study aims to improve questionnaires that measure their pain, daily living, and physical functioning. Objectives: To examine and improve questionnaires about daily living for people with NF1 and pNFs. Eligibility: People ages 5 and older with NF1 and a pNF Design: Participants will be screened with medical history. This study will have 2 phases. Phase 1 participants will talk about existing pain assessment questionnaires and how pNFs affect their life. They will have group discussions of up to 8 people of a similar age with NF1 and pNFs, or the parents of children with it. These will last about 90 minutes. Children ages 5 to 7 and their parents will have one-on-one meetings instead. These will last about 45 minutes. Discussions will be audiotaped. After the questionnaires have been changed, individual interviews will discuss the new wording, instructions, questions, and electronic format of the new forms. Phase 2 is now complete. Phase 1 participants may be invited to Phase 2. Phase 2 participants will complete the new questionnaires. These may be pen-and-paper or electronic. The questionnaires will take about 30 minutes for adults and teens. Children will work one-on-one with a staff member and may need up to 45 minutes. A small group of participants will be complete the forms twice-in clinic and 1 month later at home. Also, a small group who start a new pain treatment or have a dose increase in their treatment will complete the forms twice-before the treatment change and 1 month later.

Начало: 13.11.2015 Край: 31.12.2026 Възраст: от 5 г.

United States National Cancer Institute (NCI) NCT02544022

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Project: Every Child for Younger Patients With Cancer

Adrenal Gland Pheochromocytoma Carcinoma In Situ Central Nervous System Neoplasm Childhood Immature Teratoma +14

This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Начало: 03.11.2015 Край: 31.12.2030 Възраст: до 25 г.

Australia, Canada, New Zealand +3 Children's Oncology Group NCT02402244

Набира участници Фаза 3

CAR-T Long Term Follow Up (LTFU) Study

Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

Начало: 02.11.2015 Край: 22.02.2036 Възраст: до 100 г. Друго

Australia, Belgium, Canada +18 Novartis Pharmaceuticals NCT02445222

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A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients

Prostate Cancer Cardiovascular Disease

RADICAL PC1 is a prospective cohort study of men with a new diagnosis of prostate cancer. RADICAL PC2 is a randomized, controlled trial of a systematic approach to modifying cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer.

Начало: 21.10.2015 Край: 01.12.2026 Възраст: от 45 г. Лечение

Australia, Brazil, Canada +4 McMaster University NCT03127631

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Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion and Non-Contrast MRI

Prostate Neoplasm

This study evaluates if technical improvements in MRI can be used to provide improved performance contrast-enhanced MRI as used for angiography and perfusion as well as in non-contrast MRI.

Начало: 30.09.2015 Край: 30.09.2030 Възраст: от 18 г.

United States Mayo Clinic NCT06315595

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Human Biospecimen Procurement Protocol: Biorepository to Support Translational Research to Identify Disease Mechanism(s)

Undiagnosed Diseases Cardiovascular Disease

Background: Studies show that rare genetic variants might lead to diseases. Researchers want to collect blood and tissue samples so they can study them and better understand diseases. Objective: To collect blood and tissue samples for studies to identify underlying causes of disease. Eligibility: People of all ages Design: Participants will have blood and/or tissue samples collected. Samples can be collected at the NIH Clinical Center. Participants doctors can collect the samples and send them to NIH. NIH staff can collect samples off site. For blood samples, blood is taken from an arm vein using a needle. Tissue collection may involve: Buccal smear: Cells are collected by scraping the inside of the cheek with a cotton swab. Saliva collection: Participants spit into a cup. Skin biopsy: A special needle takes a very small skin sample. Surgical waste tissue: If participants have surgery, NIH may receive samples of tissue that would routinely be removed. Umbilical cord or cord blood collection: If a participant has a baby, NIH may receive a small piece of the umbilical cord or blood from the cord once the baby is delivered.

Начало: 17.09.2015 Край: 22.05.2050 Възраст: 1–100 г.

United States National Heart, Lung, and Blood Institute (NHLBI) NCT02543996

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Natural History, Pathogenesis and Outcome of Melorheostosis A Rare Osteosclerotic Disease

Rheumatic Disease

Background: \- The rare disease melorheostosis causes bones to thicken. This may lead to pain, and can affect bones, joints, and muscles. Researchers want to learn more about the disease and how it progresses. Objective: -To see what happens to people with melorheostosis over time and understand the causes of the disease. Eligibility: * People 18 and over with melorheostosis. * Their unaffected relatives. Design: * All participants will have a medical history and physical exam. * Participants who are relatives will give samples of blood or cheek cells. * Other participants will be in the study for about 1 week. * They will have blood and urine collected. * Strength, walking, and range of motion will be measured. * Participants may also have * X-rays and scans. * A pain and neurological evaluation. * Their skin evaluated by a dermatologist. * A small sample of bone taken. * Nerve conduction studies. Small electrodes with to wires will be put on the skin. A metal probe will give a small electrical shock. * Electromyography. A thin needle will be placed into the muscles. * An ultrasound, which uses sound waves to examine the muscles and nerves. An ultrasound probe will be placed over the skin. * A bone scan. They will get a small amount of radioactive fluid through a needle in an arm vein. This fluid travels to the bones. The bones will be photographed in a machine. * Bone Densitometry, a low-level x-ray. * Photographs taken. * A small circle of skin removed with a surgical instrument. * Questionnaires about their quality of life. * Participants will be asked to return about every 2 years. At these visits, participants may have blood and urine tests and x-rays.

Начало: 16.08.2015 Край: 01.07.2030 Възраст: 18–90 г.

United States National Institute of Arthritis and Musculoskeletal and NCT02504879

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White Light vs Narrow Band Imagingin the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy

Adenoma Colon

A randomized controlled crossover study to determine if narrow band imaging or white light endoscopy is superior in detecting right colonic polyps in average risk subjects undergoing screening colonoscopy

Начало: 01.08.2015 Край: 01.11.2025 Възраст: от 18 г. Диагностика

Australia Western Sydney Local Health District NCT05935124

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Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates

Malaria

Background: \- Malaria is a disease that affects many people in African countries. It is caused by germs that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away. Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want to create a vaccine that will prevent malaria infection during pregnancy. Objectives: \- To create a vaccine that will prevent malaria infection during pregnancy. To assess possible vaccines using in-vitro tests with parasites taken from pregnant women. Eligibility: \- Pregnant women ages 15-25 Design: * The study site is an area in Mali, West Africa. * Participants: * Will have blood drawn. * Will give consent for the blood sample to be used for future research. * May have a physical exam. * Participants who have malaria or anemia will get treatment.

Начало: 28.07.2015 Край: 30.06.2028 Възраст: 15–25 г.

Mali National Institute of Allergy and Infectious Diseases ( NCT02471378

Набира участници Фаза 3

JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer

Non-Small Cell Lung Cancer

To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC

Начало: 01.07.2015 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia, Canada, United Kingdom +1 University of Texas Southwestern Medical Center NCT02468024

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Prospective Athlete's Heart Study

Athlete Heart

The Pro@Heart (Prospective Athlete's Heart) study is an international multicentre long-term prospective trial. The primary objective of the Pro@Heart study is to investigate the impact of training load (i.e. accurately evaluated in term of type, frequency, duration and intensity) and genotype on the variability of structural, functional and electrical exercise induced cardiac remodeling (EICR) in young competitive endurance athletes. The second objective is to determine how EICR, training load and genotype are associated with physical performance, health benefits and cardiac pathology (e.g. exercise-related cardiomyopathies and arrhythmias) during follow-up over several decades.

Начало: 23.06.2015 Край: 23.06.2040 Възраст: 14–23 г.

Australia, Belgium Universitaire Ziekenhuizen KU Leuven NCT05164328

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Clinical Outcomes Study of the Nexel Total Elbow

Elbow Joint Destruction Post-traumatic Lesions Ankylosed Joints Advanced Rheumatoid Arthritis +6

The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.

Начало: 01.06.2015 Край: 01.12.2036 Възраст: от 18 г. Лечение

Australia, Finland, France +5 Zimmer Biomet NCT02469662

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Inflammatory and Infectious Diseases of the Nervous System

Brain Disease

Background: \- Inflammation is how the body reacts to infection or injury. Infections or inflammation in the brain and nerves can be serious. There aren t always good tests to detect this. Researchers want to learn more about how diseases affect the brain and nerves to develop better tests and treatments. Objective: \- To learn more about how inflammation and infections hurt the brain and nervous system. Eligibility: \- People at least 2 years old with a diagnosis or suspected diagnosis of nervous system infection or inflammation. Design: * For some participants, a clinician outside of NIH will collect blood, tissue, and other samples. These will be sent to NIH and analyzed. * Other participants will have several visits to NIH. Children may not have all these tests. * Participants will have: * Medical history. * Physical and neurological exam. * Blood and urine samples collected. * Saliva collected. They will chew on a piece of sterile cotton for one minute. * Magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. Participants will get a contrast agent through an intravenous (IV) catheter during the MRI. A needle will be used to guide a thin plastic tube (catheter) into an arm vein. * Lumbar puncture. Skin will be numbed and a needle will be inserted into the space between the bones in the back. Fluid will be removed. * Some participants may have optional study procedures. These may include eye tests, memory and thinking testing, tests with electrodes on the head, or skin biopsy.

Начало: 06.05.2015 Край: 29.11.2026 Възраст: 2–110 г.

United States National Institute of Neurological Disorders and Stroke NCT02435810

Набира участници Фаза 1

Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...

Neurofibroma, Plexiform Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Promyelocytic, Acute Sarcoma

Background: \- Some people with cancer have solid tumors. Others have refractory leukemia. This may not go away after treatment. Researchers want to see if a drug called TURALIO(R) can shrink tumors or stop them from growing. Objectives: \- To find the highest safe dose and side effects of TURALIO(R). To see if it helps treat certain types of cancer. Eligibility: \- People ages 3-35 with a solid tumor or leukemia that has returned or not responded to cancer therapies. Design: * Individuals will be screened with: * Medical history * Physical exam * Blood and urine tests * Heart tests * Scans or other tests of the tumor * Individuals will take TURALIO(R) as a capsule once daily for a 28-day cycle. They can do this for up to 2 years. * During the study, participants will have many tests and procedures. They include repeats of the screening tests. Individuals will keep a diary of symptoms. * Individuals with solid tumors will have scans or x-rays. * Individuals with leukemia will have blood tests. They may have a bone marrow sample taken. * Some individuals may have a biopsy. * When finished taking TURALIO(R), individuals will have follow-up visits. They will repeat the screening tests and note side effects.

Начало: 29.04.2015 Край: 31.12.2028 Възраст: 3–35 г.

United States National Cancer Institute (NCI) NCT02390752

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Children s Growth and Behavior Study

Obesity Eating Behaviors Healthy Volunteers

Background: \- Studies show that many factors affect children's eating behavior and health. These include sleep, mood, thinking skills, and genetics. Studying children over time may identify children at higher risk for eating-related health concerns. Objective: \- To understand how genes and environment influence eating behavior and health over time. Eligibility: \- Children ages 8-17 in good general health. Design: * Screening visit 1: Medical history, physical exam, body measurements, and questions. * 14 days: Participants will wear a wrist monitor and answer smartphone prompts about eating and mood. They may give a stool sample. * Screening visit 2: * Body measurements. * Saliva, urine, and blood samples. * Heart tests. * Meals provided (after fasting overnight). * Questionnaires and interview. * Behavior, thinking, and exercise tests. * X-ray of left wrist and full body.\ * Some parents may have medical history, physical exam, and questions at screening visits. They may answer questions at the yearly visits. * Participants will have up to 6 yearly visits. They will give a urine sample and body measurements, and repeat the X-rays. They will have questions and behavior and thinking tasks. They may give stool samples. Visits will range from 3 to 8 hours. * Participants may choose to participate in other studies: * Stress and Hormones, 1 visit: While resting, participants will give saliva samples and have their heart monitored. Then they will do math. They will repeat the resting part, then do a computer task. * Brain Imaging, 2 visits: Twice, participants will perform tasks with a magnetic cone on their head then answer questions. Once, they will have an MRI, lying still in a scanner with a coil on their head. Before the first visit, participants will collect at-home saliva samples once a day for three days. During both visits, participants will perform tasks and answer questions that gauge their thinking skills and mood. * Experiment 3 (sleep/fatigue): Participants will complete 2 additional visits. During these visits, participants will complete a task on the computer for 2 hours, or watch a movie for two hours. After completion of the task/movie, they will answer questions and be provided with food. Participants will be compensated for the time and inconvenience involved with completing study procedures. ...

Начало: 21.04.2015 Край: 31.12.2030 Възраст: 8–100 г.

United States Eunice Kennedy Shriver National Institute of Child Heal NCT02390765

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Characterization of Diseases With Salivary Gland Involvement

Healthy Volunteer Sjogren's Syndrome Salivary Gland Disease

Background: \- Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders can affect a person s quality of life. Studying people who have a disease that affects their salivary gland(s) may teach researchers about the disorders and their genetics. Objectives: \- To study salivary gland diseases and disorders. To collect data and samples from people with salivary gland problems and their relatives. Eligibility: * People more than 4 years old who have or are suspected to have a disease involving salivary glands. * Their relatives more than 4 years old. * Healthy volunteers 18 years or older. Design: * Participants may be screened with: * Medical history * Physical exam * Blood and urine tests * General oral and dental history and exam * Saliva collection * Eye exam and test for dry eyes * Health questionnaires (adults) * Biopsy of some minor salivary glands. A small incision will be made on the inside of the lower lip and several tiny salivary glands will be removed. * Participants will have 2-3 visits. These may include: * Repeats of some screening tests * Ultrasounds of some glands. Researchers will put some gel on the face, then press on it with a smooth wand. * Adults may have other biopsies * A small catheter inserted into the opening of the parotid gland duct on the inside of the cheek. A saline solution (in a syringe) will fill the duct. * Swishing a saltwater solution in the mouth for 10 seconds and then spitting into a cup * Scrapings collected from teeth, tongue, and cheeks

Начало: 03.04.2015 Край: 01.04.2032 Възраст: 4–100 г.

United States National Institute of Dental and Craniofacial Research NCT02327884

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C-Brace Prospective Registry

Pareses Lower Extremity

To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.

Начало: 01.04.2015 Край: 01.04.2026

Australia, Germany, Japan +1 Otto Bock Healthcare Products GmbH NCT04640584

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Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)

Healthy Volunteers Non-Healthy/Non-Frail Frail

Background: \- Biomarkers are substances in people s blood and tissues. They help researchers understand diseases and signs of aging. Scientists want to do more research on biomarkers to find ways to improve quality of life in old age. Objective: \- To learn more about biomarkers and their relationship to aging. Eligibility: \- Adults at least 20 years old who weigh at least 110 pounds and have a body mass index below 30. They must agree that their genetic samples can be collected, studied, and stored. Design: * Participants will be screened with medical history, physical exam, EKG and blood and urine tests. * Participants will have 3-day visits. They will return every 2 years. * All visits include: * Blood and urine collection * Physical performance tests * Health questionnaires * Memory and problem-solving tests * Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT) scans. * Muscle metabolism/ exercise tests * Taste strips * Muscle and/or skin biopsies/ red light therapy * Retinal imaging/ eye tracking * Sleep study * ODD visits also include: * Cytapheresis * Bone marrow aspirate * EVEN visits also include: * Hyperglycemic CLAMP * Lumbar Puncture (LP) * Continuous Glucose Monitor (CGM)

Начало: 15.03.2015 Край: 31.12.2099 Възраст: 20–120 г.

United States National Institute on Aging (NIA) NCT02339012

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