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Discover 20,428 clinical trials near North Carolina. Find research studies in your area.
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NCT00106691
The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).
NCT00632853
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.
NCT05736861
The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. They will self-report any new or worsening symptoms or medical events they may experience while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to see them in person. Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. This protocol was originally registered under NCT04885530. Per recent guidance on reporting master protocol research programs (MPRPs), a separate record for Arm A was created.
NCT03305562
Pediatric hypertension is increasingly common and is a precursor for adult cardiovascular and renal disease. But even during childhood, hypertension is associated with significant morbidity, including cognitive impairment and organ damage. However, the cause of pediatric hypertension, the response to treatment, and the mechanisms behind organ damage are incompletely understood. Due to these limitations, there are no first-line medications, and treatment is often inadequate. An improved comprehension of the course of pediatric hypertension could enhance clinical care. The goal of this proposal is to create a registry of patients with hypertension to better enable research into this important disease. This patient registry will enhance the investigators ability to quickly collect and analyze data for research studies.
NCT03740048
The optimal frequency of hemodialysis treatments in patients with incident end-stage kidney disease in not known. This pilot trial will randomize patients with incident end-stage kidney disease due to chronic kidney disease progression to two different regimens of hemodialysis: i) twice-weekly hemodialysis for six weeks with adjuvant pharmacologic medications followed by thrice-weekly hemodialysis, or ii) thrice-weekly hemodialysis. The study will test feasibility of stepwise hemodialysis, and the effects of the two regimens of hemodialysis on residual kidney function.
NCT04281108
This is a 2-part randomized, double-blind, placebo-controlled study followed by an open-label extension (OLE) of APT-1011 in adults with EoE. Part A will evaluate the efficacy and safety of APT-1011 3 mg administered hora somni (HS; at bedtime) for the induction of response to treatment (histologic and symptomatic) over 12 weeks. Part B will evaluate histological relapse-free status in patients re-randomized to continue APT-1011 or placebo (active treatment withdrawal) until Week 52. Part C, the OLE, will continue until regulatory approval of APT-1011 or Sponsor termination of the study.
NCT01094691
To prospectively test whether the detection of three-dimensional, cast-like polyomavirus aggregates, termed Haufen, in voided urine samples can serve as an accurate biomarker of intra-renal disease, i.e. polyoma-BK-virus nephropathy (PVN). We want to correlate the detection of 'Haufen' with histologic findings made in renal biopsies as well as signs of polyomavirus activation, i.e. viremia and viruria. The prospective study is designed to further validate our retrospective findings (manuscript in press, J Am Soc Nephrology) and more specifically to correlate 'Haufen' shedding with the histologically confirmed course of PVN.
NCT05596500
This study is the human clinical trial component of an SBIR grant with Sinnovatek (funded). Cyclists (n=20) will consume a blueberry-protein, blueberry, or placebo supplement for 2 weeks prior to cycling for 2.5 h at high intensity. Washout periods (2 weeks) will separate the 3 trials, and the cyclists will crossover (randomized) to one of the two others supplements for 2 weeks, and then engage in additional 2.5 h cycling bouts. Blood and urine samples will be collected pre- and post-supplementation for each of the 3 trials. Blood samples will also be collected immediately after and 1.5h- and 24h-post-exercise. Blood samples will be analyzed for inflammation and oxidative stress outcomes. Urine samples will be analyzed for blueberry gut-derived phenolics.
NCT05409092
Vigorous exercise can stress the body. Consuming special types of diet supplements may help the body recover better from exercise. This includes a bright red supplement called astaxanthin that is found in certain algae and causes the pink-red color in salmon. Astaxanthin is an antioxidant and may protect cells from damage and improve the way the immune system functions. The main purpose of this study is to determine if 4 weeks of consuming astaxanthin improves recovery from 2.25 hours of intensive running on a treadmill. This study will also measure whether or not astaxanthin supplementation improves skin health
NCT01866930
To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1
NCT02416622
This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector expressing retinoschisin (rAAV2tYF-CB-hRS1) in patients with X-linked retinoschisis. Up to 27 participants will be enrolled and 3 dose levels will be evaluated in a dose escalation format.
NCT03397394
The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
NCT02580305
This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized, parallel group, placebo-controlled study to compare the efficacy and safety of treatment with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving stable doses of donepezil HCl and memantine HCl.
NCT03324880
Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve symptoms in adults with hypoparathyroidism. In this study, participants will receive 1 of 2 treatments: rhPTH(1-84) or a placebo. A placebo looks like the medicine being studied but does not have medicine in it. In this study, the placebo will be a standard treatment which is either active Vitamin D, or active Vitamin D with calcium. Active Vitamin D is a form of vitamin D that has a faster effect on the body. These treatments will be given as a daily injection just under the skin. Participants will not know which treatment they received, nor will their study doctors. This is to help make sure the results are more reliable. All participants will also take active vitamin D and calcium supplements during treatment. Participants will record their symptoms in a tool called the hypoparathyroidism symptom diary. This tool is used to assess symptoms and their impact and will give an overall score for each participant. The study doctors will also check for side effects from the study treatments. After treatment, researchers will check if there is any difference in the diary scores between the 2 treatment groups. A difference in score means there is a difference in symptoms and their impact. From this, researchers will learn if symptoms have improved for participants treated with rhPTH(1-84) compared with those treated with placebo.
NCT05020470
The proposed randomized control trial will evaluate auricular point acupressure (APA) treatment administered by the participant themselves with the use of a phone app on chronic musculoskeletal pain (CMP) outcomes. This study will randomly assign participants into three groups: (1) Self-guided mAPA (S-mAPA), (2) In-Person Training + mAPA (IP-mAPA), and (3) Usual Care Control (UC). EMA will be used to assess momentary pain outcomes and APA adherence. Data will be collected at pre- (T1), post-completion of intervention (T2), follow-ups at post 1M- (primary endpoint) (T3), 2M (T4), and 3M (secondary endpoint, long-term sustained effect) (T5) for a total of four assessments.
NCT04537832
This is a multicenter, prospective, 2-year observational study in infants and children with developmental and epileptic encephalopathies (DEEs). The DEE currently being investigated is SCN1A-positive Dravet Syndrome.
NCT04122625
Part A (dose-optimization)- to determine the recommended phase 2 dose (RP2D) taking into account dose-limiting toxicity (DLT/s) in Cycle 1, overall safety/tolerability and pharmacokinetic (PK), by optimizing doses of Debio 1143 when combined with the standard dose of nivolumab, as well as treatment compliance in participants with advanced solid malignancies who failed prior systemic standard treatments. Part B (basket trial)- to evaluate the preliminary anti-tumor activity of Debio 1143 at the RP2D in combination with nivolumab at the standard dose, overall and in each participant cohort (Cohort 1: small cell lung cancer \[SCLC\]; Cohort 2: squamous cell carcinoma of the head and neck \[SCCHN\]; Cohort 3: gastrointestinal (GI) cancers with known microsatellite instability-high/mismatch repair deficiency (MSI-H/MMRd) or other deoxyribonucleic acid (DNA) damage repair (DDR) abnormalities, including homologous recombination deficiency (HRD); Cohort 4: platinum-resistant epithelial ovarian cancer \[EOC\], endometrial cancer, primary peritoneal cancer (PPC) or cervical cancer, with known MSIH/MMRd, hereditary/somatic mutations of the breast cancer 1 (BRCA1) and BRCA2 genes or other DNA DDR abnormalities (incl. HRD).
NCT05242146
The STAR CNS trial is a 3-part study, comprising a phase 1b dose escalation, dose expansion, and a phase 2, to assess the safety, tolerability, dose-limiting toxicity(ies), maximum tolerated dose, and/or optimal biological dose, determine the recommended phase 2 dose, preliminary anti-tumor activity and efficacy of the recommended phase 2 dose of GB5121.
NCT03074474
The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other types of available meshes. 100 subjects will be included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair surgery, a baseline visit will be performed during which the patient's eligibility for the study will be evaluated. The surgical technique used for the repair will be determined by the investigator/surgeon. Additional study data will be collected during the hospital stay, 30 and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits, the surgical site will be evaluated by the surgeon, both the surgeon and patient will be asked to rate their satisfaction with the repair and the subject will be asked to complete two Quality of Life questionnaires.
NCT00481091
The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. The Extension Study portion will allow active subjects to continue to receive ABT-263 for up to 11 years after the last subject transitions with less frequent study evaluations.
