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NCT00343291
The primary objective of this study will be to determine the progression free survival of patients with stage IIIb/IV non-small cell lung cancer (NSCLC) treated with dual agent monoclonal antibody therapy consisting of cetuximab and bevacizumab in combination with two different regimens of paclitaxel and carboplatin chemotherapy.
NCT01134159
Multicenter, retrospective registry to collect 9-12 month follow-up data to evaluate major adverse cardiac events in patients whom have undergone percutaneous coronary intervention and received either Taxus Liberte or Xience V.
NCT00100386
Primary Outcome Measures:Incidence density of colonization with MRSA or VRE (number of new colonization events per 1000 patient days at risk) during the intervention phase. Secondary Outcome Measures:The effect of the 2 strategies on the incidence density of colonization with MRSA and VRE individually will be determined and compared descriptively. The effect of the strategies on the cumulative incidence of bacteremia caused by MRSA and VRE will be determined to assess the clinical relevance of the strategy in preventing infection. The trial will evaluate the frequency of hand hygiene and the use of gloves and gowns by healthcare workers to substantiate whether the effect of the intensive control strategy is mediated, as expected, by an increase in the use of gloves and gowns due to an increase in the number of patients cared for using Contact Precautions.
NCT00033839
This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in the treatment of an episodic cluster headache period compared to placebo (medically inactive substance which does not contain any active ingredients).
NCT00853463
Brigham and Women's Hospital will coordinate a Quality Improvement Initiative at other hospitals that focuses on whether physician notification prior to discharge of high risk VTE patients will reduce the incidence of VTE after hospital discharge.
NCT00235391
This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators.
NCT00395629
Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y.
NCT01098734
Welichem Biotech has developed a small molecule drug candidate, WBI-1001, that selectively targets the pathogenic features of inflammatory skin diseases, including atopic dermatitis (a form of eczema).The purpose of this clinical trial is to further test the safety and efficacy of WBI-1001 as a topically applied cream over an extended period of 12 weeks on patients with mild to moderate atopic dermatitis.
NCT00419705
The purpose of this pivotal study is to demonstrate safety and effectiveness of the NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset.
NCT00492284
The objective of this study is to determine if combination therapy (reduced-fluence Visudyne followed by Lucentis \[within 2 hours\] or either of two regimens of reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy \[within 2 hours\]) reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile.
NCT00465088
To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are currently off lipid-modifying therapy. This was a prospective, randomized, open-label, blinded endpoint (PROBE) study.
NCT00550004
This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).
NCT00798707
The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.
NCT00171210
A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years. The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.
NCT00249782
The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea. ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12 years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An investigational use is one that is not approved by the FDA. Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline and Week, 2, 4 and 12.
NCT00975455
The purpose of the study is to evaluate subjects with gross or microscopic hematuria undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.
NCT00942994
The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients.
NCT00164463
This substudy of TBTC Studies 27 and 28 compares 1) the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the pharmacokinetics of moxifloxacin among patients with tuberculosis being treated with multidrug therapy (isoniazid or ethambutol, rifampin, and pyrazinamide) to those of healthy volunteers receiving moxifloxacin plus rifampin. It also evaluates the association between polymorphisms of MDR1 genotype (P-glycoprotein) and rifampin pharmacokinetic parameters, the effect of polymorphisms of MDR1 genotype and/or rifampin pharmacokinetics on isoniazid pharmacokinetic parameters adjusted for N-acetyltransferase genotype (NAT2), and determines by multivariate regression analyses the associations between moxifloxacin or rifampin pharmacokinetic parameters and markers of tuberculosis disease severity including the covariates of two-month culture positivity, cavitary lung disease, Body Mass Index, weight, duration of study treatment prior to PK, co-morbidities and C-reactive protein. Healthy volunteers and TB patients receive frequent scheduled blood draws during a 24 hour period after ingesting a dose of TB drugs.
NCT00644293
To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.
NCT00705575
This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.