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NCT00304031
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known which schedule of temozolomide when given together with radiation therapy is more effective in treating glioblastoma or gliosarcoma. PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma or gliosarcoma.
NCT03219320
To evaluate the efficacy of multiple dose levels of NYX-2925 versus placebo in treating the neuropathic pain associated with Diabetic Peripheral Neuropathy.
NCT02277769
This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).
NCT02475200
The Phoenix Post-Approval Registry is a prospective, multi-center, single arm registry sponsored by Volcano Corporation to evaluate the short and long term performance and clinical outcomes of the Phoenix Atherectomy System.
NCT03403712
Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion \[test\] versus oral netupitant/palonosetron (300 mg/0.5 mg) combination \[control\]; each administered with oral dexamethasone prior to initial and repeated cycles of AC chemotherapy in female breast cancer patients.
NCT03425396
The purpose of this study is to evaluate the safety and efficacy of oral omadacycline as compared to oral nitrofurantoin in the treatment of female adults with cystitis.
NCT02120924
The purpose of the study is to compare the safety and efficacy profiles of a generic Azelaic Acid Gel, 15% to the reference listed Finacea® (azelaic acid) Gel, 15% in the treatment of moderate facial rosacea.
NCT03811288
The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes patients across ten countries across the world. Participants will be asked to give information about their health. Participants will continue their normal way of life and will not get any medication other than prescribed to them by their doctor. Participants' participation will be one day/one visit at their doctor. The study will last for about 6 months in total.
NCT03204539
The primary goal of the INITIATE trial is to compare the clinical outcome of individualized lot selection to random lot selection utilizing one plasma-derived von Willebrand factor (VWF)/coagulation factor (FVIII) complex concentrate for immune tolerance induction (ITI) in subjects with congenital Hemophilia A, FVIII activity ≤2%, and a historical high-titer inhibitor \[≥5 Bethesda Unit (BU)\].
NCT03354637
Primary: • To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical Solution, compared to vehicle in subjects with alopecia areata (AA) Secondary: • To evaluate key clinical outcome assessments
NCT02898753
This Phase I/II open-label, randomized, dose-escalation study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of VAL-1221 versus Myozyme®/Lumizyme® in participants with late-onset glycogen storage disease-II (GSD-II) (Pompe disease)
NCT02358369
The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension. This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).
NCT03955939
The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.
NCT03313050
This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage. In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group). In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).
NCT00855712
The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.
NCT02737514
Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon
NCT02993861
The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to characterize the pharmacokinetics and safety of four oral anti-epileptics drugs (levetiracetam, valproic acid \[divalproex sodium ER or immediate release formulation if inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese children and adolescents. The study's duration will be up to eleven days (up to seven days of screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18 years will be identified through outpatient clinic schedules and inpatient admissions at each clinic site. Participants receiving at least one of the study drugs per local standard of care will have pharmacokinetic concentrations in plasma drawn according to the specific dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip ratio, medical history, concomitant medication history, documentation of study drug oral intake, adverse effects, and physical examination. The sample size will include 24 participants for each anti-epileptic drug (total 96).
NCT01790243
The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.
NCT00579280
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
NCT03579758
This phase III trial studies how well chemotherapy before and after surgery works in treating participants with gallbladder cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin, gemcitabine, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery may kill more tumor cells.