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NCT01055496
This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.
NCT02594254
The purpose of this study is to evaluate if C16G2 Gel administered over a certain period of time either with a toothbrush or a custom dental tray can effectively kill bacteria in the mouth that cause dental cavities.
NCT01601535
The goal of the first part of this clinical trial (Phase I portion) is to study the side effects, drug breakdown (pharmacokinetics), and dosing of the drug MLN8237 when added to standard chemotherapy drugs, irinotecan and temozolomide. The goal of the second part of this clinical trial (Phase II portion) is to learn how many children and young adults show improvements in their neuroblastoma when treated with the combination of MLN8237, irinotecan, and temozolomide.
NCT00116558
The purposes of the study are to determine the energy balance and evaluate the nutritional status of patients with ALS, and to investigate the use of NIPPV as respiratory support to treat patients with ALS.
NCT02269397
The primary goal of this observational study is to establish the accuracy of CNS-specific Assay for Recurrent Paroxysmal Events (CARPE) as a diagnostic blood test for epilepsy. The target population is patients who have been newly referred to the Penn Epilepsy Center or patients who are admitted to HUP for continuous video EEG monitoring. (Subjects without an epilepsy diagnosis will be included.) Subjects will be asked to provide consent, agree to allow the study team to collect information from their medical record, and to provide at least one blood sample.
NCT01821300
The purpose of this research study is to determine which measures best capture cardiovascular disease (CVD) risk and type 2 diabetes (T2DM) risk in children and adolescents with Down syndrome (DS). We hypothesize that DS is associated with worse cardiometabolic risk factors for a given body mass index compared to controls. This difference arises at least in part, from increased fat tissue.
NCT01756885
Upwards of 33-50% of cancer patients who smoked prior to diagnosis continue to smoke following diagnosis and treatment. With medical advances in cancer care yielding a growing constituency of cancer survivors, addressing nicotine dependence in this population is a priority. While PHS guidelines recommend acute treatment durations with approved medications for tobacco use, extending the duration of treatment beyond the standard treatment duration significantly increases quit rates, reduces the risk for a relapse, and promotes recovery to abstinence following a lapse. Varenicline may be particularly effective for cancer patients given the drug's beneficial effects on affect and cognition. In this trial, 374 cancer patients will be randomized to standard varenicline treatment (12 weeks active + 12 weeks placebo) or extended varenicline treatment (24 weeks active). The investigators hypothesize that 1) Extended varenicline therapy will increase 24- and 52-week biochemically-confirmed abstinence versus standard varenicline treatment, 2) Quality of life will be rated higher in the extended therapy group versus the standard therapy group, and there will be no significant differences between groups in terms of severe side effects, and 3) Improved affect and reduced cognitive impairment will mediate the effect of extended therapy on quit rates.
NCT02461589
This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes
NCT02097277
The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults with type-2 diabetes.
NCT01561053
The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales.
NCT01372878
This study was design to establish the effectiveness of PillCam® Platform with the PillCam® COLON 2 capsule as demonstrated by the identification of subjects with polyps as compared to optical colonoscopy.
NCT03008447
E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less after lemborexant than after zolpidem tartrate extended release following a single-dose administration at bedtime.
NCT00440791
This multi-center, prospective, cohort study of 394 subjects that are indicated for standard colonoscopy due to suspected or known colonic disease examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy. This study aims a. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy. This study will evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE)
NCT01236352
The purpose of this first in human study is to determine if BMS-911543 is safe and tolerable in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to permit clinical testing at the Maximum Tolerated Dose or at a Clinically Active Dose, and to determine if BMS-911543 will demonstrate efficacy in symptomatic myelofibrosis.
NCT01001442
This Phase I/IIa clinical study is to test safety and anti-tumor activity of BT062 to define the best dose in treating patients with relapsed or refractory multiple myeloma with multiple doses of BT062.
NCT02601703
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).
NCT02156076
The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation (AF) through its effect on AF burden (AFB), or the percent of time in AF, in subjects with paroxysmal AF (pAF) when administered orally at a range of doses (2 mg once daily (QD), 5 mg QD, 12 mg QD following a 1-week period of loading doses of 3 mg QD, 8 mg QD and 20 mg QD, respectively) for a total of 4 weeks. It is hypothesized that treatment with BMS-919373 will reduce AF burden as compared to baseline relative to placebo.
NCT02302807
This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.
NCT02940626
The purpose of this study is the prevention of Staphylococcus aureus pneumonia in mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis. Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is an investigational monoclonal antibody product that targets the toxins produced by S. aureus to protect subjects from developing S. aureus pneumonia.
NCT00623623
This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B. The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated. All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.