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Discover 15,496 clinical trials near North Carolina. Find research studies in your area.
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NCT02240121
The primary objective is to determine the efficacy of rifaximin DR also referred to as Extended Intestinal Release (EIR) tablets vs. placebo for the induction of clinical remission and endoscopic response following 16 weeks of treatment in participants presenting with active moderate Crohn's disease. A key secondary objective is to evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.
NCT02407080
This research looks at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes too many platelets and red blood cells to be made. Platelets are particles which circulate in the blood stream and normally prevent bleeding and bruising. Having too many platelets in the blood increases the risk of developing blood clots, which can result in life threatening events like heart attacks and strokes. When the number of red blood cells is increased in PV this will slow the speed of blood flow in the body and increase the risk of developing blood clots. The purpose of Part A of this study is to test the safety and tolerability of drug RG7388 patients and identify the recommended phase II dose in a single agent dose escalation study. The investigators want to find out what effects, good and/or bad it has on the disease. The purpose of Part B of this study is to test the safety and tolerability of the combination of RG7388 and Pegylated Interferon Alfa-2a or Pegasys in PV/ET patients from Part A who did not achieve at least a partial response by the end of three cycles of single agent RG7388. Essential Thrombocythemia (ET) and Polycythemia Vera (PV) have been difficult diseases to treat. RG7388 is a selective inhibitor of the p53-MDM2 binding that frees p53 from negative control and activates the p53 pathway in cancer cells, leading to cell cycle arrest and apoptosis in vitro and in vivo. It has been used to treat solid tumors and Acute Myelogenous Leukemia (AML) in clinical trials. Pegasys is a drug that is the standard of care for patients who have Chronic Hepatitis B (CHB). RG7388 is a drug that is not yet approved by the Federal Drug Administration (FDA) for the treatment of patients with essential thrombocythemia or polycythemia vera. Pegasys is a drug that is approved by the FDA for the treatment of CHB. The use of RG7388 alone and in combination with Pegasys is experimental.
NCT02601820
The PROP UP research study is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate all-oral treatment regimens for chronic hepatitis C viral (HCV) infection regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups. Participants will be recruited from 9 U.S. liver centers. Approximately 1920 patients with HCV infection who are prescribed a regimen containing Sofosbuvir/Ledipasvir(SOF/LED), SOF/Velpatasvir(SOF/VEL), Grazoprevir/Elbasvir(GRZ/ELB), OBV/PTV/r + DSV (PRoD), or daclatasvir/SOF (DAC/SOF) will be recruited and approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. PRO surveys will be evaluated before, during and after HCV treatment. PROP UP is a collaborative effort between behavioral and biomedical researchers, a patient engagement group and a patient advocacy organization.
NCT01842581
The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.
NCT01890746
The purpose of this randomized, blinded, placebo-controlled study was to provide clinical safety and exploratory efficacy data on the use of Eltrombopag in adult subjects with Acute Myeloid Leukemia (AML) receiving standard induction chemotherapy with daunorubicin plus cytarabine. A minimum of 120 evaluable subjects newly diagnosed with AML was stratified by antecedent malignant hematologic disorder and age.
NCT02688764
This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3 clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and adolescent patients with CKD, and to provide safety and dosing information for this patient population. The Phoslyra (comparator) group provides information for a descriptive comparison of PA21 against a commonly used calcium-based phosphate binder (calcium acetate).
NCT03270670
The purpose of this study is to test whether the 19-gauge needle can collect more tissue and get better sampling during a bronchoscopy procedure.
NCT01602120
This is a multicenter, open-label extension study of safety and tolerability of lampalizumab administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week treatment in Study GX29455 (NCT02288559).
NCT02891070
The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.
NCT03415178
Primary Objective: To collect real-use (usability) data assessing the robustness and user interaction of the new alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised settings. Secondary Objective: Device-related: * To collect real-use (usability) data assessing the robustness and user interaction of SYDNEY and the current alirocumab auto-injector device (which is referred to as AI) in supervised settings. Pharmacokinetics: * To compare alirocumab pharmacokinetics (PK) administered using SYDNEY and AI. * To evaluate alirocumab PK administered using SYDNEY. Anti-drug antibodies: * To evaluate the development of anti-drug (alirocumab) antibodies (ADA). Efficacy/pharmacodynamics: * To compare the percent and absolute change in low-density lipoprotein cholesterol (LDL-C) using SYDNEY and AI. * To evaluate the percent and absolute change in LDL-C using SYDNEY. Safety: * To evaluate the safety and tolerability of alirocumab using both SYDNEY and AI.
NCT01949779
The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures
NCT00355849
A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder \[also known as AIR® Inhaled Insulin\]\[AIR® is a registered trademark of Alkermes,Inc.\] in patients with Type 2 diabetes who are currently being treated with once daily insulin glargine injections. The present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily insulin glargine injections.
NCT02092909
Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 90% of the patients with Waldenström's macroglobulinemia. MYD88 is a key linker protein in the signaling pathway of Toll Like Receptors (TLRs) 7, 8, and 9, and IMO-8400 is an oligonucleotide specifically designed to inhibit TLRs 7,8, and 9. The scientific hypothesis for use of IMO-8400 to treat patients with Waldenström's macroglobulinemia depends on the inhibition of mutant MYD88 signaling in the TLR pathway, thereby interrupting the proliferation of cell populations responsible for the propagation of the disease.
NCT02556645
The purpose of this randomized controlled trial is to compare the efficacy and potential biological mechanisms of action of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8-weeks to 10 sessions of Present Centered Treatment (PCT) delivered over 8-weeks by a therapist in 120 active duty military personnel with PTSD. Up to 170 individuals will be consented to obtain data from 120 for analysis. Participants will be assessed at pre-treatment, mid-treatment, and 1-, 3- and 6-months after treatment completion.
NCT01287585
This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with hepatocellular carcinoma who have failed prior systemic treatment (chemotherapy). Hepatocellular carcinomas have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the hepatocellular carcinoma cells will starve and die.
NCT01663857
A study for women with ovarian cancer that has returned at least 6 months after platinum-based chemotherapy.
NCT02556177
This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical neuropsychological assessments and GE Research Pack II advanced MR imaging in mTBI patients. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.
NCT02518113
The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma (T-ALL/T-LBL).
NCT01226485
The purpose of this study is to find a recommended dose level and schedule of dosing LY2940680 that can safely be taken by participants with advanced cancer. The study will also explore the changes in a cancer marker level in skin, hair follicles, buccal cells, and tumor cells. Finally, the study will help document any antitumor activity this drug may have.
NCT00005799
This clinical trial studies fludarabine phosphate, low-dose total body irradiation, and donor stem cell transplant in treating patients with hematologic malignancies or kidney cancer. Giving chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine before the transplant and cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
