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NCT03097861
The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).
NCT03225118
Background: The immune system helps the body fight off disease. Most people infected with HIV cannot control the infection and need daily medicine. Combination antiretroviral therapy (cART) are drugs taken to prevent HIV infection from damaging the immune system. Researchers want to study why some people develop resistance to the drugs or have permanent side effects. Objective: To study the impact of a short-term treatment stop on HIV that persists even while taking cART. Eligibility: Adults 18-65 years old with HIV who are being treated with cART Design: * Participants will first be screened with a physical exam and medical history. They may have a chest x-ray. They will have heart, blood, and urine tests. * At the baseline visit, participants will repeat the screening tests except the x-ray. They will get counseling about HIV and risk behavior. * Participants will have leukapheresis. Blood will be removed through a needle in one arm. A machine will separate white blood cells from the rest of the blood. The remainder of the blood will be returned to the body by a different needle. * Participants will stop their current treatment on day 0. They will visit the clinic each week until they meet the criteria to restart cART. These visits will have the same procedures as the baseline visit. * Before restarting cART, most participants will have leukapheresis. * After restart, participants will be seen weekly for 4 weeks and then monthly for about 11 months. Participants will have blood drawn, physical exam, and medical history. They will have leukapheresis 2 more times over 1 year.
NCT00001803
The Von Hippel-Lindau (VHL) Disease Genetic Epidemiology Study is a family-based case-control study to be conducted by the National Cancer Institute. The study subjects are 603 individuals who were determined to belong to families with VHL disease confirmed through screening under NIH protocol #89-C-0086 between 1988 and 1998. There are 293 patient volunteers with VHL disease and 310 volunteer patients free of VHL disease, most of whom have already had genetic testing for mutations in the VHL gene. Adults as well as children aged 13 - 17 will be included. All subjects will give informed consent prior to participation; for minor subjects, assent will be obtained from the minor and consent from the parent/guardian. This protocol provides the potential to benefit people with VHL disease (although not necessarily the study subjects themselves) and possibly people with sporadic (non-hereditary) forms of the tumors which occur in VHL disease. The risks and discomfort associated with this study are minor. The present protocol is a new epidemiologic component to VHL research at NIH which will relate the expression of VHL tumors to lifestyle factors (tobacco and alcohol use; physical activity), occupational exposures, reproductive and hormonal factors, demographic factors, medication use, diet, and putative susceptibility genes. Information will be collected by telephone interview and a written, self-administered diet questionnaire. A cheek cell sample will be obtained for analyses of genetic polymorphisms. Medical records will be obtained to document events reported by the subject at interview. Primary comparisons will be between VHL patients with a particular manifestation and VHL patients who are free of that condition. Additional comparisons may be made with unaffected family members who lack a mutation in the VHL gene, as appropriate.
NCT03233841
The primary objective of this study is to establish the natural history of Farber disease (acid ceramidase deficiency) through the collection and analysis of retrospective and prospective data on patients diagnosed with Farber disease. All patients diagnosed with Farber disease are eligible, including both those who have and have not undergone hematopoietic stem cell transplantation (HSCT). Additionally, data and records from deceased patients will provide valuable retrospective data for this study. The secondary objective of the study is to establish a set of clinical data, laboratory data (biomarkers), and functional data potentially useful for: * Assessing the efficacy of HSCT and the efficacy of potential future therapies (for example with RVT-801, recombinant human acid ceramidase) in Farber disease * Characterizing changes in symptoms of patients over time * Characterizing distinct groups (phenotypes) within the patient population * Documenting the disease histories of individual patients to serve as intra-subject control data for those who may enroll in any future clinical studies with therapies for Farber disease The exploratory objectives of the study are: * To explore the relationship between patient disease activity or phenotype and specific ceramide levels or specific immunologic markers (cytokines/chemokines) in blood * To evaluate a standardized tool, the Farber Disease Natural History Instrument (FDNI), to be used for the collection of patient history information, data from clinical, laboratory, genetic, and functional studies, and data from review of medical records
NCT02109939
Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 8 of the study.
NCT01110733
Prospective, longitudinal, multinational, observational study that will collect data on how patients with peripheral T-cell lymphoma (PTCL) are treated in academic and community practices.
NCT00819403
To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.
NCT04136808
The primary purpose of this expanded access program is to evaluate safety and tolerability of enfortumab vedotin (EV) in participants in the United States with locally advanced or metastatic urothelial carcinoma (UC) who have exhausted standard of care therapies and are not eligible to participate in an ongoing EV clinical study. This program will also evaluate the efficacy of EV.
NCT01511653
The investigators are undertaking a multi-center, 13000 subject validation study of several biomarkers for early detection of colon cancer. There are stool based biomarkers and blood based biomarkers being validated in this study. The biomarkers will be compared with colonoscopy and with FIT (fecal immunohistochemistry) tests which are the current standards for colon cancer screening. This is an NCI-early Detection Research Network funded project. The population targeted for this study are those persons undergoing colonoscopy for screening. Prior to colonoscopy or even prepping for colonoscopy, subjects will provide blood and stool samples as well as specific data regarding their GI and general medical history and concomitant medications. If subjects are interested in participating, arrangements will be made to see them. The informed consent process will take place, blood will be obtained, data will be obtained, and the stool kit described and given to the subject to take home. Stool samples will be sent back to the University of Michigan using prepaid mailing labels.
NCT02081391
The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product (IMP) in children and adolescents who had undergone surgery that would produce moderate to severe pain during opioid treatment.
NCT02471781
The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.
NCT03710707
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL201 in subjects with Parkinson's disease.
NCT02464943
The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.
NCT03168828
The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with neurogenic detrusor overactivity (NDO) resulting from spinal cord injury (SCI).
NCT03036878
To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for osteochondral lesions
NCT02904096
The primary objective of this study is to evaluate the safety of Radiesse implantation for very severe volume loss in the dorsum of the hand at 6 months after treatment.
NCT01183689
The Study of Novel Approaches for Prevention (SNAP) is randomized trial designed to test whether behavioral interventions based on self-regulation can prevent weight gain in young adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Two different self-regulation interventions for weight gain prevention will be compared in this trial; one intervention will focus on making small, consistent, changes in eating and exercise behavior to prevent weight gain or reverse weight gain if it occurs, whereas the other will emphasize larger changes in eating and exercise that occur periodically, with a goal of producing weight loss and thereby providing a buffer against anticipated weight gains. The primary aim of the trial is to test whether the magnitude of weight gain from baseline across an average three-year follow-up differs across the three groups, with the hypotheses that weight gain will be greater in the Control group than in either intervention and greater in the Small Changes than Large Changes group. SNAP-E (Extension) will determine whether the effects of the intervention can be maintained over an additional 3 years (i.e. through a total of 6 years).
NCT03200912
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the superiority of the two active products over the vehicle gel in the treatment of AK on the face and scalp.
NCT02605642
To assess persistence of CT-P13 in patients with Rheumatoid Diseases (Rheumatoid arthritis \[RA\], ankylosing spondylitis \[AS\], and psoriatic arthritis \[PsA\]) who are naïve to biologics or are switching from stable Remicade to CT-P13. The main objectives of the study are: * To evaluate real-life drug persistence in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade * To characterise the patient populations and drug usage patterns of RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade * To assess the safety of CT-P13 in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade for up to 2 years
NCT03505125
The 165-901 study is designed to identify the appropriate tools for use in future interventional studies on the neurocognitive effects of pegvaliase on adults with PKU.