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Deep Brain Stimulation Therapy in Movement Disorders

Parkinson's Disease

Background: \- In deep brain stimulation (DBS), a device called a neurostimulator is placed in the chest. It is attached to wires in parts of the brain that affect movement. DBS might help people with movement disorders like Parkinson s disease (PD), dystonia, and essential tremor (ET). Objective: \- To provide DBS treatment to people with some movement disorders. Eligibility: \- Adults 18 years and older with PD, ET, or certain forms of dystonia. Design: * Participants will be screened with medical history and physical exam. They will have blood and urine tests and: * MRI brain scan. The participant will lie on a table that slides in and out of a metal cylinder with a magnetic field. They will be in the scanner about 60 minutes. They will get earplugs for the loud noises. During part of the MRI, a needle will guide a thin plastic tube into an arm vein and a dye will be injected. * Electrocardiogram. Metal disks or sticky pads will be placed on the chest, arms, and legs. They record heart activity. * Chest X-ray. * Tests of memory, attention, concentration, thinking, and movement. * Eligible participants will have DBS surgery. The surgery and hospital care afterward are NOT part of this protocol. * Study doctors will see participants 3 4 weeks after surgery to turn on the neurostimulator. * Participants will return every month for 3 months, then every 3 months during the first year, and every 6 months during the second year. Each time, participants will be examined and answer questions. DBS placement will be evaluated with MRI. The neurostimulator will be programmed. At two visits, participants will have tests of movements, thinking, and memory.

Начало: 02.04.2014 Край: 01.12.2030 Възраст: 18–100 г.

United States National Institute of Neurological Disorders and Stroke NCT02119611

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Celiac Disease Genomic Environmental Microbiome and Metabolomic Study

Celiac Disease

Celiac disease (CD) is a complex disease caused by eating gluten, a protein contained in wheat, rye, and barley. It is well known that many factors contribute to the development of CD, including the genes that you have and the foods that you eat. In the CDGEMM study, we will consider as many of these factors as possible and study how they each contribute to disease development. If the investigators find that any one factor, or combination of factors, increases the risk of developing CD, we will be able to apply this information and help prevent or detect disease in high-risk children in the future.

Начало: 01.03.2014 Край: 01.12.2027 Възраст: до 6 г.

Italy, United States Massachusetts General Hospital NCT02061306

Набира участници Фаза 2

Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome

ACTH Cushing's Syndrome

Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In approximately 50% of these patients, the tumoral source of ACTH cannot be found initially despite very detailed and extensive imaging, including studies such as computed tomography, magnetic resonance imaging, and octreotide scan (Octreoscan) using the standard dose of indium- 111 pentetreotide (\[111In-DTPA-D-Phe\]-pentetreotide). The sensitivity and specificity of structurally based imaging studies depends on anatomic alterations and the size of the tumor. In contrast, positron emission tomography (PET) and somatostatin ligand imaging detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This protocol tests the ability of \[18F\]-L-3,4-dihydroxyphenylalanine (18F-DOPA) PET, and the somatostatin imaging analogue, 68Ga-DOTATATE-PET, to localize the source of ectopic ACTH production.

Начало: 12.02.2014 Край: 31.12.2030 Възраст: 18–80 г.

United States National Institute of Diabetes and Digestive and Kidney NCT02019706

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Heart Health Study in Washington D.C. to Develop a Community-Based Behavioral Weight Loss Intervention

Cardiovascular Disease Obesity

Background: \- Past studies suggest that the best way to improve heart health in the Black community is through community-based programs. Researchers will partner with DC community leaders. They will collect information about the health and health needs of people in mostly Black churches in DC. They will study things that affect heart health, like diabetes, blood pressure, cholesterol, and weight. They will also study how technology can keep track of activities and health. The information will show the health needs of church-based communities or faith-based organizations. Objectives: \- The primary objective of this study is to estimate the percentage of the population that meet ideal, intermediate, and poor criteria for each of the cardiovascular health factors (BMI, physical activity, dietary intake, blood pressure, total cholesterol, fasting plasma glucose, and cigarette smoking) in churches or faith-based organizations in the DMV area. This data will inform the design and implementation of a behavioral weight-loss intervention within the faith-based community immediately following this study. The secondary objectives are to: 1) evaluate usage of handheld devices for objectively measuring physical activity and dietary intake; 2) evaluate usage of web-based technology for monitoring cardiovascular health markers, including dietary intake; 3) examine referral methods for untreated hypertension, diabetes, and hypercholesterolemia; 4) compare lifestyle behaviors across levels of psychosocial factors, cultural norms, and neighborhood environment factors; and 5) formalize a community advisory board involved in the implementation of the health screening and needs assessment program and a future behavioral weight-loss intervention. Eligibility: \- Adults ages 19 to 85 who attend one of the study churches. Design: * Participants will visit their church for a 4-hour health exam. They will have their blood pressure and body measurements taken. They will have a drop of blood taken from their finger with a small needle. This blood will be tested for blood sugar and cholesterol. Participants will be given the results of these tests. * Participants will answer questions about their health. * All participants will be given an activity monitor to wear for 1 month. The activity monitor is worn around the wrist. Some participants will also receive an activity monitor that is worn around the waist. Participants will be given instructions on how to wear the activity monitors and follow the results on a website. * At the end of 1 month, participants will return one device (they can keep the other). They may receive a gift card for completing the study.

Начало: 08.02.2014 Възраст: 19–85 г.

United States National Heart, Lung, and Blood Institute (NHLBI) NCT01927783

Набира участници Фаза 2

Spironolactone for Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

Background: \- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. In spite of recent advances in treatment, the death rate remains unacceptably high. Lung blood vessel function can be harmed by progressive injuries, such as inflammation, leading to worsening of the disease. A drug called spironolactone has been known to improve blood vessel function and reduce inflammation. Some people with PAH take spironolactone to help treat fluid retention. However, its effect on inflammation and blood vessel function in patients with PAH is not known. Researchers want to see if spironolactone can help these conditions in people with PAH. Objectives: \- To test the effectiveness of spironolactone in treating pulmonary arterial hypertension. Eligibility: \- Individuals at least 18 years of age with pulmonary arterial hypertension. Design: * This study will last for 24 weeks. Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants will take either spironolactone or a placebo. They will take their study drug or placebo for 7 weeks. Treatment will be monitored with regular blood tests. * In Week 8, participants who have had no reaction to the treatment will receive a higher dose of the drug or placebo. * In Week 12, participants will have a study visit with heart and lung function tests. They will also have a 6-minute walk test, and provide blood and urine samples. * After additional study visits for blood samples, participants will have a final visit in Week 24. The tests from Week 12 will be repeated at this visit.

Начало: 10.01.2014 Край: 31.12.2026 Възраст: 18–100 г.

United States National Institutes of Health Clinical Center (CC) NCT01712620

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Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis

Sepsis, Severe

To evaluate the discriminative power of BIS monitoring to classify the degree of mental state associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the improvement or deterioration of sepsis.

Начало: 01.01.2014 Край: 01.12.2030

China Suez Canal University NCT03244293

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Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy

Prostatic Neoplasms Prostate Cancer

Background: \- Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes them to die. Radiation can be effective, but some tumors may be harder to treat with radiation or even with surgery. This happens to a small number of men who have either radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do not know if the tumor has recurred only in the prostate or has spread to another area. Also, men whose prostate cancer has recurred only after radiation may have different treatment options. This study will use improved imaging studies to better understand why some men do not respond as well to initial radiation treatments. Objectives: \- To use detailed imaging studies to look at the results of local radiation therapy for prostate cancer. Eligibility: * Men at least 18 years of age who are scheduled to have radiation for prostate cancer. * Men at least 18 years of age whose prostate cancer has returned after earlier treatments. Design: * All participants will have a medical history and physical exam. Blood and urine samples will be collected. Imaging studies will be used to evaluate the cancer at the start of the study. * All participants will have an initial full magnetic resonance imaging (MRI) scan of the prostate. Tumor and healthy tissue samples will be collected. * Those whose cancer has recurred after treatment will discuss possible treatment options with the study doctors. * Participants who are scheduled to have radiation will have radiation therapy. This will be given according to the current standard of treatment. * After radiation, participants will have regular follow-up tests and imaging studies. They will have another full MRI scan 6 months after the end of radiation treatment.

Начало: 13.11.2013 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT01834001

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Natural History Study of GATA2 Deficiency and Related Disorders

GATA2 Deficiency

Background: \- GATA2 deficiency is a genetic disorder that can cause problems with a person s immune system and other body systems. Some people who have this disorder develop few problems from it. Others can have a wide range of health problems, from skin problems, to hearing loss, to cancer. These problems can happen at any age. Researchers want to study GATA2 deficiency to better understand what types of health problems it can cause, and why it causes problems in some people but not others, and at different ages. Objectives: \- To improve understanding of GATA2 deficiency so there can be better diagnostic tests and treatments in the future. Eligibility: \- People 2 years of age or older who have a GATA2 gene mutation or certain health conditions that are commonly seen in people with this mutation and their blood relatives. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected to see whether participants have the GATA2 genetic mutation. Several other tests may be recommended, but participants can decline to take them. * Participants will be eligible to receive standard care for GATA2 deficiency through this protocol. They may be eligible for other clinical trials at the National Institutes of Health as well. * Participants will have regular study visits once a year to evaluate their GATA2 deficiency. Participants will take part in the study for at least 3 years and up to 15 years. At these follow-up visits, participants will fill out a questionnaire and take a physical exam and blood tests. Other tests may be performed as needed.

Начало: 26.08.2013 Възраст: 2–100 г.

United States National Institute of Allergy and Infectious Diseases ( NCT01905826

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Cerebral Palsy and the Study of Brain Activity During Motor Tasks

Cerebral Palsy Children

Background: \- Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS) and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it is active. EEG records electrical activity in the brain. Both have been used safely for many years, even in very young children. NIRS or EEG can be used while a person is moving to show which parts of the brain are the most active. Researchers want to use NIRS and EEG to study brain activity during movement in people with cerebral palsy and healthy volunteers. Learning more about how people with and without cerebral palsy use their brain to control their muscles may lead to new ways of training people with cerebral palsy to move better. Objectives: \- To study how the brain controls body movement in people with and without cerebral palsy. Eligibility: * Individuals at least 5 years of age who have cerebral palsy. * Healthy volunteers at least 5 years of age. Design: * This study has three parts. People with cerebral palsy will be selected for all three. Healthy volunteers will be asked to do only two of them. Everyone who participates will have NIRS and/or EEG exams during movement. People with cerebral palsy may also have biofeedback sessions to train coordination of movement and brain activity. * Participants will be screened with a physical exam and medical history. Urine samples may be collected. * All participants will have at least one session of NIRS and/or EEG imaging studies. Sessions may also include the following tests: * Magnetic resonance imaging to look at the brain * Electromyography to measure electrical activity of the muscles * Motion analysis of specific body parts * Ultrasound to measure activity of the muscles * Motorized, robotic, and electrical stimulation of the muscles * Other clinical tests of muscle movement as needed. * Participants with cerebral palsy will have biofeedback sessions. These sessions will help them learn to coordinate muscle movement and brain activity.

Начало: 22.08.2013 Възраст: 5–100 г.

United States National Institutes of Health Clinical Center (CC) NCT01829724

Набира участници Фаза 2

Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations

GATA2 Immunodeficiency MDS

Background: \- GATA2 deficiency is a disease caused by mutations in the GATA2 gene. It can cause different types of leukemia and other diseases. Researchers want to see if a stem cell transplant can be used to treat this condition. A stem cell transplant will give stem cells from a matching donor (related or unrelated) to a recipient. It will allow the donor stem cells to produce healthy bone marrow and blood cells that will attack the recipient s cancer cells. Objectives: \- To see if stem cell transplants are successful at treating GATA2 mutations and related conditions. Eligibility: \- Recipients who are between 6 and 70 years of age and have GATA2 deficiency. Design: * All participants will be screened with a physical exam and medical history. Blood samples will be collected. Recipients will have imaging studies and other tests. * Recipients will have chemotherapy or radiation to prepare for the transplant. On the day of the transplant, they will receive the donated stem cells. * Recipients will stay in the hospital until their condition is stable after transplant. * Frequent blood tests and scans will be required for the first 6 months after the transplant, followed by less frequent visits over time.

Начало: 24.07.2013 Край: 31.12.2028 Възраст: 6–70 г.

United States National Cancer Institute (NCI) NCT01861106

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Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer

Colorectal Neoplasms Gastric Neoplasms Cholangiocarcinoma Bile Duct Cancer +1

Background: \- Recent advances in cancer research have led to new therapies to treat the disease. It is important to continue these advances and discover new ones. To do that, researchers need tissue samples from solid tumors. This study will collect such samples from people already scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC). Objectives: \- To collect tissue samples for use in studying new ways to treat tumors. Eligibility: * Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled to have surgery or a biopsy at the NIHCC. * Children under the age of 18 but who are older than 2 years of age are eligible to be enrolled on the research sample collection portion of this study if they will have a biopsy or surgery as part of their medical care. Design: * Before their procedure, participants will have a small blood sample taken. * Some participants will undergo leukapheresis. In this procedure, blood is removed through a tube in one arm and circulated through a machine that removes white blood cells. The blood, minus the white blood cells, is returned through a tube in the other arm. The procedure takes 3-4 hours. * For all participants, during the surgery or biopsy, pieces of the tumor and pieces of normal tissue near it will be removed for this study. The rest of the tumor or precancerous growth will be sent to a lab for analysis. * Participants will return to the clinic about 6 weeks after the operation for a routine checkup. Some may have to return for additional follow-up.

Начало: 21.07.2013 Възраст: от 2 г.

United States National Cancer Institute (NCI) NCT01915225

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Thinking and Memory Problems in People With HIV

HIV Positive

Background: \- People with human immunodeficiency virus (HIV) can sometimes develop thinking and memory problems. These problems can vary widely, from few symptoms to severe problems with memory and concentration. It initially was thought that good HIV treatment could prevent almost all HIV-related memory problems. However, even people with low HIV viral loads can have these problems. It may be caused by HIV affecting the brain and spinal fluid. It is not yet clear why HIV causes these problems and why they may be worse in some people than others. Researchers want to study people with HIV and healthy volunteers to see how HIV may affect people with only small amounts of the virus in their blood. Objectives: \- To study thinking and memory problems in individuals with HIV that is otherwise controlled with medications. Eligibility: * Individuals between 18 of age or older whose HIV has been controlled with medications for at least 1 year. * Healthy volunteers between 18 of age or older. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. A neurological test will also be given. Participants will have a baseline imaging study of the brain. * Within 12 weeks of the first visit, participants will have a second visit. Additional blood samples will be drawn. Another brain imaging study will be performed. * Within 8 weeks of the second visit, participants will have a third visit to collect more blood samples. They will also provide spinal fluid samples, either as a single visit or a longer procedure. * After this visit, participants will return every 12 months for up to 10 years. Blood samples will be collected as needed at these visits. Thinking and memory tests and imaging studies may also be given as needed. Spinal fluid may be collected at one visit a year....

Начало: 08.07.2013 Възраст: 18–110 г.

United States National Institute of Neurological Disorders and Stroke NCT01875588

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Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers

Neuromuscular Disease Motor Neuron Disease Inherited Neuromuscular Conditions Inherited Neuropathies

Background: \- Electrical impedance myography (EIM) is a new technique being studied to see if it is helpful in evaluating muscle disorders and nerve disorders. EIM looks at how a mild, painless electrical current travels through muscles. Researchers want to gain experience in using the EIM device. They will collect information on the results of using it on people with and without nerve and muscle diseases, and compare that with information from other standard tests. First, they will test the device on healthy people. Then they will test people with a variety of neuromuscular diseases. Because the test is noninvasive and not painful, researchers will test both children and adults. Objectives: \- To gain experience using the EIM muscle testing device. Eligibility: * Healthy volunteers at least 2 years old. * Individuals at least 2 years old who have neuromuscular disease. Design: * Participants will be screened with a medical history and physical exam. * Participants will have one 2-3 hour clinic visit. Researchers may request follow-up visits. * Participants will be tested with the EIM device. The device and small electrodes will be placed on their skin. An electric current will pass through the device, but the participants will not feel this. * Participants may have an ultrasound test. A gel will be put on their skin, and a device will be moved over the skin. * Participants may have a nerve test. Electrodes will be placed on their skin, and they will feel a small shock. * Participants may have a test where a thin needle is inserted in their muscle.

Начало: 20.06.2013 Край: 01.06.2026 Възраст: 2–110 г.

United States National Institute of Neurological Disorders and Stroke NCT01900132

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Evaluation of Post-PACU Pain Management in Pediatric Surgery

Pain

This study aims to assess the differences in overall pain severity, pain management, and satisfaction during recovery period between two groups of children who either receive or do not receive additional education related to expectation and management of postoperative pain.

Начало: 01.06.2013 Край: 01.12.2027 Възраст: 1–6 г.

United States Columbia University NCT02352116

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Lymphatic Anomalies Registry for the Assessment of Outcome Data

Lymphatic Malformation Generalized Lymphatic Anomaly (GLA) Central Conducting Lymphatic Anomaly CLOVES Syndrome +6

Lymphatic anomalies are a rare subset of vascular anomalies that are poorly understood. the understanding of the natural history, long-term outcomes, risk factors for morbidity and mortality, and the relative benefit of medical therapies and procedures is limited.The goal of this project is to better understand these diseases and improve the care of theses rare patients. To do this, the investigators are conducting an observational study of patients with lymphatic anomalies, including an annual follow-up questionnaire to gather prospective data on mortality, morbidity, treatments, and functionality as well as quality of life.

Начало: 01.06.2013 Край: 01.06.2035

United States Boston Children's Hospital NCT02399527

Набира участници Фаза 2/3

Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer

Oropharyngeal p16INK4a-Negative Squamous Cell Carcinoma Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7 Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7 Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 +5

This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

Начало: 22.03.2013 Край: 01.01.2027 Възраст: от 18 г.

Canada, Hong Kong, United States National Cancer Institute (NCI) NCT01810913

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Predictors of Prognosis in IBD Patients

Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease

A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease

Начало: 11.03.2013 Край: 31.12.2026 Възраст: от 18 г.

South Korea Seoul National University Bundang Hospital NCT05653011

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Cancer Experience Registry (CER) for Cancer Patients and Caregivers

Neoplasms Cancer Caregiver

The Cancer Experience Registry®: An Online Survey Research Study to Understand the Experiences of Those Impacted By a Cancer Diagnosis. The Registry is a web-based platform to distribute cross-sectional and longitudinal surveys. Study surveys are designed based on input from advisor experts, including patients and caregivers, and focus on the social, emotional, physical, financial and decision-making experiences of those who have been diagnosed with cancer and their caregivers. Findings contribute toward enhancing care for patients, survivors and caregivers via programming and policy initiatives.

Начало: 01.03.2013 Край: 01.12.2035 Възраст: от 18 г.

United States Cancer Support Community, Research and Training Institu NCT02333604

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Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer

Malignant Neoplasm

This research trial studies the use of targeted genomic analysis of blood and tissue samples from patients with cancer. Genomic sequencing is a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing can be used to find changes in areas of the genome that may be important in the development of cancer. It may also help doctors improve ways to diagnose and treat patients with rare cancers with poor prognosis or lack of effective therapy.

Начало: 01.02.2013 Край: 01.05.2030 Възраст: от 1 г.

United States Rutgers, The State University of New Jersey NCT02688517

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Gastroparesis Outcome Longitudinal Database Enrolled Numerically

Gastroparesis

GOLDEN is a longitudinal database of patients with the symptoms (Sx) of gastroparesis (Gp) who were seen and recorded at the University of Louisville from 2012 and is ongoing. Patients are enrolled and followed by sequential numbers and may include legacy patients seen at other centers by some of the same team and who are reported as part of the series. Outcome relate to patients Sx, survival, quality of life and other measures as detailed below, over time. The study tracks patients regardless of treatment but specifically focuses on GI Neuromodulation (gastric electrical stimulation - GES), Immunotherapy (IVIG), and Pyloric therapies (pyloroplasty, endoscopic). If treatments were administered GOLDEN allows for examination and stratification of outcome by groups both at baseline and at follow up.

Начало: 01.01.2013 Край: 01.01.2028

United States University of Louisville NCT03876288

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