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NCT02159573
The primary objective of the study is to evaluate relapse activity, as measured by the proportion of participants relapsed at 12 months, in participants with relapsing-remitting multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in the real-world setting. The secondary objective is to further evaluate relapse activity, defined as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid use, during the first year of Tecfidera treatment following transition from Tysabri treatment.
NCT00486668
The primary purpose of this study is to determine whether breast cancer tumors respond (as measured by pathologic complete response: the absence of microscopic evidence of invasive tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide) followed by paclitaxel plus trastuzumab or lapatinib or both given before surgery to patients with HER2-positive breast cancer. Trastuzumab will also be given to all patients after surgery. The study will also evaluate the toxic effects of the chemotherapy combination, including effects on the heart, and will determine survival and progression-free survival 5 years after treatment. Also, the study will look at whether there are gene expression profiles in the tumor tissue that can predict pathologic complete response.
NCT01492426
The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients
NCT01455870
Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.
NCT01974986
Athletes participating in multiple training sessions a day can be at increased risk of suboptimal hydration and heat illness during their second training session, especially when the environment is hot and humid. With the exception of the absolute volume of water delivered by a rehydration beverage, characteristics of the beverage consumed play a role in the recovery and completeness of rehydration. The amount of sodium in the beverage has been shown to be a primary factor in rehydration. Recently, an effect of the carbohydrate concentration of the beverage was been reported, with its effects mediated by the renal system in response to elevated serum insulin. The purpose of this study is to compare sodium and carbohydrate effects on rehydration and recovery.
NCT02467634
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.
NCT00144014
A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke
NCT02060331
In our experience, women with severe pelvic organ prolapse (POP) frequently have bothersome nocturia. The International Continence Society (ICS) defines nocturia as "having to wake at night one or more times to void." Though some of this nocturia may be secondary to obstructed bladder emptying, the investigators hypothesize that in some women compression of the bilateral ureters due to prolapsed pelvic organs during the day and subsequent relief of that prolapse while the patient lays supine overnight results in nighttime post-obstructive diuresis (inability to concentrate urine) and resultant large nighttime urine volumes and nocturia. Previous case reports have proposed that vaginal and uterine vault prolapse causes obstruction due to descent of the bladder floor which leads to compression of the bilateral ureters between the uterus and the borders of the genital opening. No large prospective studies, however, have evaluated the possible impact of this phenomenon on patients or the possible post-operative changes following surgical correction of POP. Using the Nocturnal Enuresis, and Sleep interruption Questionnaire (NNES-Q), voiding diaries, and urine studies, the investigators aim to evaluate the pre-operative and post-operative voiding habits and urinary parameters of women with severe pelvic organ prolapse and bothersome nocturia who undergo colpocleisis. Colpocleisis is a procedure which surgically obliterates the vaginal lumen to treat severe POP in properly counseled patients with \>90% satisfaction rates. Other treatments offered to women, such as the laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, and sacrospinous ligament suspension, also offer high rates of success. The investigators aim to determine whether surgical correction of severe pelvic organ prolapse, to be defined as either with colpocleisis, laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension, results in improvement and/or resolution of nocturia and post-obstructive diuresis.
NCT00216086
Preoperative induction chemotherapy has been successfully used in a variety of malignancies and provides several advantages over postoperative therapy. Combination of 5-FU/Leucovorin/CPT-11 has demonstrated significantly better response rate than 5-FU/Leucovorin alone. Replacing 5-FU with oral capecitabine in combination with CPT-11 has emerged as a potentially more effective, safe and convenient treatment option for metastatic colorectal cancer. Capecitabine is also well tolerated in concurrent treatment with radiation. Recent data has shown that preoperative radiation appears to be significantly more effective in increasing resectability rates. This trial will investigate the activity of capecitabine and CPT-11 combination in the preoperative setting followed by chemoradiation with capecitabine in locally advanced rectal cancer to improve response and decrease local recurrence. We will also study whether TS, TP, DPD and carboxyesterase expressions correlate with the objective response rate with this chemotherapy and chemoradiation regimen.
NCT01278173
The purpose of the study is to evaluate the change in visual fields by means of automated static perimetry and to evaluate the change in retinal structure by means of spectral domain optical coherence tomography (SD-OCT) in adult patients with refractory complex partial seizures (CPS) being treated with vigabatrin (Sabril®)
NCT01290887
The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.
NCT01710644
The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis
NCT00993018
The purpose of this study is to evaluate the analgesic efficacy, safety and tolerability of multiple doses of JNJ-42160443 when administered as a single, subcutaneous injection every 28 days to patients with diabetic painful neuropathy (a disease condition in diabetic patients that affects all peripheral nerves including pain fibers, motor neurons and the autonomic nervous system).
NCT01610765
This study is to identify if a Novel Antiviral Drug could be used to treat babies with Herpes Simplex Virus (HSV) with central nervous system (CNS) disease. In this study the investigators will identify the best dose for young children as well as identify additional safety information about the Novel Antiviral Drug.
NCT02466061
This randomized, controlled study evaluates the efficacy of weigh loss interventions in endometrial cancer survivors, using novel technology-based weight loss platforms. This is a multi-site, pilot feasibility study which will provide preliminary data to support a larger NIH funded, mult-center trial.
NCT01013324
There has not been any systemic therapy approved in the United States or in Europe for treating advanced or recurrent endometrial cancer (EC). This study will evaluate the safety and preliminary efficacy of XL147 in advanced or recurrent EC. Constitutively active phosphatidylinositol-3 kinase (PI3K)/phosphatase and tensin homolog on chromosome 10 (PTEN) pathway signaling is common in EC and involved in the development and/or progression of the disease. PTEN deficiency and/or activating mutations/amplification in the PIK3CA gene that encodes the p110α catalytic subunit of PI3K have been frequently detected in EC patients. XL147 is a potent and highly selective inhibitor of the Class I PI3K family of lipid kinases. In addition, in vivo preclinical data have demonstrated that XL147 targets both proximal and distal signaling in the PI3K/PTEN pathway. Therefore, XL147 may have utility in the treatment of subjects with advanced or recurrent EC.
NCT01912222
This is a phase 1, 2-part, pharmacokinetic study in patients with advanced solid tumors or hematologic malignancies and varying degrees of liver dysfunction (normal function, moderate hepatic impairement or severe hepatic impairment) as defined by the National Cancer Institute (NCI) Organ Dysfunction Working Group.
NCT00574275
The main objective of the study was to evaluate the effectiveness of aflibercept treatment by comparison to placebo in increasing the overall survival (OS) in participants with metastatic pancreatic cancer, treated with gemcitabine. The secondary objectives were to evaluate progression free survival, clinical benefit, overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1: Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine). The study included an interim analysis of OS. In accordance with the study protocol, an interim analysis was performed for the purpose of futility and overwhelming efficacy. On the basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this study be terminated for futility based on predefined boundary rules.
NCT00417209
The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.
NCT01527617
The objective of this randomized, double-blind, placebo-controlled, parallel-design clinical trial is to investigate the potential antioxidant benefits of a cranberry beverage. The investigators hypothesize the chronic consumption of this beverage will improve indices of oxidative stress, inflammation, endothelial function, and glucoregulation. The investigators also hypothesize that these benefits will be particularly evident following an oral glucose tolerance test.