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NCT ID: NCT03733067 Withdrawn - Clinical trials for CTLA4 Haploinsufficency

Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Haploinsufficiency

Start date: November 30, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Background: CTLA4 stands for cytotoxic T-lymphocyte antigen-4. It is a protein the body makes naturally to check its immune system from attacking itself. Some people don t produce enough CTLA4 protein, causing problems due to overactive immune system such as big spleens, repeated lung infections, breathing problems, stomach and intestine symptoms as well as inflamed brain and nerve problems. Many have problems with their bone marrow causing low numbers of blood cells like platelets, red blood cells or white blood cells, which is called cytopenia. Researchers want to see if the drug abatacept can treat cytopenias by replacing the missing protein CTLA4. Objective: To see if abatacept is safe and helps treat cytopenias caused by CTLA4 deficiency. Eligibility: People ages 8-65 years who have CTLA4 deficiency with cytopenia Design: Participants will be screened with medical history, medication review, physical exam and blood and urine tests. They will continue their current medications and may start taking antibiotics daily. Participants will receive either abatacept or placebo through a vein for 6 months. The study team will not know if you are receiving the study drug or the placebo Women who can become pregnant must agree to use birth control measures. Men who get someone pregnant during the study will be asked to collect information and have the partner contact the study team. Participants will undergo the following procedures before starting the study and at the completion: - radiology scans of body and brain - heart and lung function tests - Bone marrow examination by a needle inserted into the hip bone to remove a small amount of tissue to study. - Participants may have a small camera on a long, thin tool passed down the throat into the stomach and small intestine for evaluation of their gut. - Questionnaires about their disease, symptoms and quality of life Over 6 months, participants will have regular study visits and get 8 doses of the study drug or a placebo by intravenous injection. They will repeat some of the same tests done earlier at the end of the study at assess response. About 1 month after the last study drug visit, participants will have a final study visit. Some participants may join a treatment extension for the study drug abatacept with no placebo. They will sign a separate consent form for this.

NCT ID: NCT03731702 Withdrawn - Clinical trials for Microbial Composition

Optimization of Collection Methods for Studies of the Human Microbiota

Start date: November 1, 2018
Phase:
Study type: Observational

Background: The human microbiota is the bacteria and other microbes found in and on the human body. Scientists study the microbiota because it is related to many health conditions. The way samples are collected and handled can greatly affect microbiota study findings. Researchers want to learn more about how collection methods affect these studies. Objectives: To compare different oral and fecal collection methods. To test the effect of new methods to get DNA out of these samples. Eligibility: Adults ages 18 and older who are National Cancer Institute employees and have not taken antibiotics in the past 3 months Design: Participants will discuss the study with researchers. Participants will give an oral or fecal sample or both. For the oral sample, participants will be told what not to do beforehand. This includes chewing gum and smoking. Participants will spit saliva into a tube. Then they will get mouthwash in a vial. They will swish and gargle the mouthwash for 30 seconds then spit it back in the vial. Participants giving a fecal sample will get a collection kit. They can collect the sample at home or elsewhere. Participants will have a bowel movement into the collection container. They will smear some of it on a card with a stick and put the rest in 2 tubes. They will mix the feces with the solution in the tubes. Participants will write the date and time of collection on the instructions and return the sample within 24 hours. Participants providing both samples could have 3 study visits: 1 to give an oral sample, 1 to get the fecal sample collection kit, and 1 to return that sample.

NCT ID: NCT03731598 Withdrawn - Insulin Resistance Clinical Trials

Ceramides in Muscle During Insulin Resistance

Start date: May 1, 2018
Phase:
Study type: Observational

Overnutrition and physical inactivity promote the accumulation of sphingolipids such as ceramides which block insulin signaling and anabolic metabolism. Implementation of pharmacological or genetic interventions to reduce sphingolipid levels in rodents prevents or reverses an impressive array of metabolic pathologies (e.g. insulin resistance, diabetes, steatohepatitis, hypertension, cardiomyopathy, and atherosclerosis). To elucidate the tissue-specific mechanisms through which ceramides contribute to these diseases, mice have been produced to allow for the conditional, cell-type restricted ablation of enzymes required for ceramide biosynthesis or degradation (i.e. serine palmitoyltransferase and dihydroceramide desaturases-1) or degradation (i.e. acid ceramidase). Aims of the project include the following: To use these novel mouse models to evaluate the effect of muscle-specific ceramide depletion or induction on insulin sensitivity, muscle growth, and genomic/proteomic signatures under conditions of overnutrition and inactivity. To apply a ceramide flux assay in isolated human myotubes to identify the regulatory mechanisms that influence rates of ceramide biosynthesis; and, To determine the efficacy of a new class of inhibitors of dihydroceramide desaturases-1, our preferred target in the ceramide synthesis pathway, as therapeutics that improve muscle insulin sensitivity and prevent muscle loss in rodents. Findings obtained from these studies could uncover new nutrient-sensing machinery that modulates insulin sensitivity and muscle growth. Moreover, the translational component could lead to new pharmacological approaches for improving muscle health.

NCT ID: NCT03731533 Withdrawn - Clinical trials for Type 2 Diabetes Mellitus

WellStart Reboot Study

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

This is a randomized, controlled comparison study that will evaluate the effectiveness of WellStart, a virtual intensive therapeutic lifestyle change program to control type 2 diabetes.

NCT ID: NCT03730779 Withdrawn - Retinal Ischemia Clinical Trials

Oxygen Therapy for Retinal Ischemia

Start date: November 30, 2018
Phase: Phase 4
Study type: Interventional

The investigators will be using nocturnal normobaric hyperoxia therapy in patients with diagnoses of conditions related to retinal ischemia.

NCT ID: NCT03729310 Withdrawn - Chronic Sinusitis Clinical Trials

Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis

Start date: March 2020
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to learn whether there is a difference in postoperative (after surgery) endoscopic appearance of the sinus cavities (the way that the sinuses look through a camera) between sinuses that receive one of two types of resorbable steroid eluting sinus packing (a sponge-like material which dissolves within several days while releasing a steroid): 1) Propel Implant or 2) Nasopore soaked with triamcinolone at the time of endoscopic sinus surgery (ESS) for chronic rhinosinusitis.

NCT ID: NCT03729141 Withdrawn - Cholesterol Clinical Trials

Dietary Cholesterol and Adipose Tissue Inflammation

Start date: October 2019
Phase: N/A
Study type: Interventional

Hypothesis: increasing dietary cholesterol in humans will increase visceral, but not subcutaneous adipocyte size, free cholesterol content, and inflammatory gene expression. Visceral and abdominal subcutaneous adipose tissue biopsies will be obtained from non-obese subjects undergoing elective abdominal surgery at Wake Forest Baptist Medical Center after 3 weeks of zero (control) or 1g dietary cholesterol supplementation. Blood samples will also be taken before and after 3 weeks of dietary supplementation (0 vs. 1g dietary cholesterol) to measure plasma lipids levels, and ex vivo monocyte chemotaxis. Blood will also be used to isolate CD14+ monocytes for RNA extraction and storage for future transcriptome studies. Measurements of adipocyte size, free cholesterol content, and inflammatory gene and protein expression in the adipose tissue biopsies to test the hypothesis. Adipocytes and the stromal vascular fraction will be isolated and evaluated for CD14+ macrophages for RNA extraction and storage for future transcriptome analysis.

NCT ID: NCT03728205 Withdrawn - Solid Tumor, Adult Clinical Trials

Yoga for Solid Tumor

Start date: December 15, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to ascertain the effect of yoga interventions on radiation-related fatigue, and stress in cancer patients with stage I and II solid tumors.

NCT ID: NCT03727815 Withdrawn - Nose Deformity Clinical Trials

Effects of Mindfulness Meditation on Rhinoplasty Outcomes

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

A key factor in determining success of facial plastic plastic surgery is overall patient satisfaction. While a number of patient-reported outcomes tools has been developed, there is still limited research in how physicians can improve patient satisfaction and post-operative outcomes. The goal of this study is to investigate the effect of a mindfulness meditation phone application on rhinoplasty outcomes. This study will also explore whether mindfulness meditation is a feasible adjunct to current pharmacological modalities of postoperative pain control as well as its potential impact on patient satisfaction. These questions will be answered using a randomized controlled trial.

NCT ID: NCT03724955 Withdrawn - Clinical trials for Cystic Fibrosis Related Bone Disease

Pilot E2 for Hypogonadal Women With CFBD

Start date: April 2019
Phase: Phase 4
Study type: Interventional

The study is a prospective, double blinded, placebo controlled, randomized study to evaluate the effects of daily oral estrogen supplements on bone health, sexual and reproductive health, quality of life and markers of inflammation and lung function when given to hypogonadal women with Cystic Fibrosis related Bone Disease (CFBD).