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NCT02277990
Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.
NCT01241253
The study uses a randomized, placebo-controlled experimental design consisting of 4 different test treatments matched on carbohydrate (CHO) content. The three beans are similar in their CHO content amount for ½ cup at \~20 grams CHO. Each of the bean varieties will be served in a \~½ cup serving size with \~ ½ cup of plain steamed white rice (30 grams CHO) for a total of 50 grams of CHO per meal for each of the three test treatments. The 4th placebo or control treatment consists of \~ 7/8 cup of rice alone, an amount consistent with the CHO content of the test meals. Most diabetic meal plans recommend no more than 45-60 grams of CHO per meal. Fifty grams of CHO is a standard amount for glycemic response testing in general. The investigators hypotheses were: * The test meals containing the three bean types in combination with white rice will decrease the participants' glycemic response when eaten as part of a meal. * The reduction in post-prandial glycemia will not differ between bean types in the elicited responses among individuals with type 2 diabetes.
NCT04144920
This study aims to determine the most effective strategy of reducing sedentary behavior to improve health. Specifically, we aim to answer the following questions: (a) To determine if there is a significant difference in acute post-prandial glucose response between continuous sitting and two intermittent standing regimes (high frequency, low duration breaks (HFLD) and low frequency, high duration breaks (LFHD)). We hypothesize that intermittent standing (combined HFLD breaks and LFHD breaks regimes) will result in lower overall acute post-prandial glucose compared to continuous sitting. (b) To determine if there is a significant difference in acute post-prandial glucose response between two strategies to reduce sitting with standing (HFLD standing breaks vs. LFHD standing breaks). We hypothesize that the HFLD breaks condition will elicit lower acute post-prandial glucose level compared to the LFHD breaks condition. All eligible participants will be consented and subjected to all three study conditions: (i) Uninterrupted sitting, (ii) HFLD breaks, and (iii) LFHD breaks. The order at which participants were subjected to these conditions will be randomly determined and each condition were performed a week apart. Standardized meals (breakfast and lunch) will be provided during each lab visit and participants will be then be asked to perform their usual work activity using a sit-stand workstation in the lab. Depending on their assigned condition, the participants will be prompted to stand or sit for a given period of time. A continuous glucose monitor will be used to measure glucose response to the intervention while an activPAL device will be used to make sure that participants are compliant with the study protocol.
NCT02271503
This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences. Objectives: * Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease. * Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.
NCT03178071
This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib
NCT00547651
This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.
NCT03859986
This is a Phase 2, randomized, double-blind, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of ALX-101 Gel 5% and a matching ALX-101 Gel Vehicle when applied topically twice daily for 56 days in adult and adolescent subjects with moderate atopic dermatitis
NCT03172481
This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric subjects between 6 to 12 years of age.
NCT01130493
This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.
NCT01836029
The purpose of this study is to compare the progression-free survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with VTX-2337 + cisplatin or carboplatin + 5-FU + cetuximab versus patients treated with cisplatin or carboplatin + 5-FU + cetuximab alone (standard-of-care; SOC). Safety and overall survival will also be evaluated.
NCT00771953
The primary objective is to determine the anti-tumor activity of the combination of apricoxib + either docetaxel (AP/DC) or pemetrexed (AP/PE) compared with placebo + either docetaxel (P/DC) or pemetrexed (P/PE) as measured by progression free survival in patients with Stage IIIb (pleural effusion)or Stage IV non-small cell lung cancer (NSCLC).
NCT00915083
The purpose of the study is to determine whether amrubicin is safe and effective in the treatment of patients with advanced solid tumors. The study will assess the pharmacokinetics of the amrubicin and if it has an effect on the heart.
NCT00326209
To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets \[MP\]) in participants with ulcerative colitis currently in remission.
NCT00106431
GPI-04-0001 was a Phase II, non-randomized, open label, single arm study that was conducted at approximately 30 sites, primarily in the United States, Europe and Russia. It assessed the efficacy, safety, and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma (CTCL). Study patients (pts) received romidepsin in a dose of 14 mg/m\^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although pts who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.
NCT02829489
The purpose of this study is to evaluate the current state of nutrition care and patient related outcomes in patients with head, neck and esophageal cancers in North America, Europe and Australia.
NCT00038129
The purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.
NCT01560780
This is a randomized-controlled clinical trial that will randomize 120 patients undergoing clinically-indicated coronary artery bypass graft surgery to prasugrel at a dose of 10 mg daily or matching placebo for 12 months, starting at the time of hospital dismissal from surgery. The primary goal of the study is to determine whether prasugrel administration will prevent thrombus (clot) formation within a saphenous vein graft at 12 months, as examined by optical coherence tomography.
NCT01190176
This study is intended to provide up to a maximum of four years of annual oncogenic human papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their concluding NCT00294047 study visit. Women who were pregnant at their concluding NCT00294047 study visit may also be included in this study, as no cervical sample could be collected at that visit. The objectives and outcome measures of the primary phase (NCT00294047) are presented in a separate protocol posting.
NCT02423434
Through the multinational pooled dataset approach, this trial will aim to derive and validate specific in vivo Corneal Confocal Microscopy (CCM) parameter thresholds for the identification of diabetic polyneuropathy, and - more importantly - the identification of individuals at future risk. Results of the study will permit application in clinical practice and intervention trials for diabetic polyneuropathy (DPN) risk stratification. The primary goal of the study is to re-examine individuals with type 1 and type 2 diabetes with and without neuropathy, who had CCM performed in the past as a part of their neurological examination, to assess concurrent and predictive validity of different CCM parameters in individuals . These subjects will be invited to the study to be re-examined by CCM along with other neurological tests (physical exam, nerve conduction studies, quantitative sensory testing, blood test and in some centres also skin biopsy) during the single study visit. Additionally CCM data will be analyzed both manually and by recently developed automated analytical software to evaluate accuracy of the automated method. Evaluation of automated image analysis will influence likelihood of successful knowledge translation of this surrogate biomarker for DPN into clinical practice - in which the procedure could be harmonized with annual retinal examinations - and into intervention trials. Secondary aim of the study is to determine the factors associated with CCM parameters and their longitudinal change and collect bio-samples for future research in this field.
NCT00270712
The causes of deterioration of transplanted kidney function are poorly understood. The purpose of this study is to determine the disease processes that cause transplanted kidney dysfunction and loss in patients who received a kidney either recently or over a year prior to entering this study. This study will also identify specific characteristics in kidney transplant recipients that predict whether a kidney transplant will be successful.