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NCT ID: NCT01767467 Completed - Herpes Zoster Clinical Trials

Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers

Start date: March 1, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.

NCT ID: NCT01767155 Completed - Endometrial Cancer Clinical Trials

Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer

ZoptEC
Start date: April 2013
Phase: Phase 3
Study type: Interventional

Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin.

NCT ID: NCT01765387 Completed - Health Behavior Clinical Trials

Spa Effects After Exercise

Start date: February 2012
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the recovery effect of Spa therapy after aerobic exercise in cardiovascular, performance and perceived fatigue. A pragmatic controlled repeated measures, single-blind, trial is conducted. Thirty-four recreational sportspeople are required to visit a Sport-Centre and are assigned to a Spa-therapy or rest in a bed (control group) after complete a spinning session.

NCT ID: NCT01765244 Completed - Clinical trials for Severe Trophic Corneal Ulcers Refractory to Conventional Treatment

Allogeneic Tissue Engineering (Nanostructured Artificial Human Cornea) in Patients With Corneal Trophic Ulcers in Advanced Stages, Refractory to Conventional (Ophthalmic) Treatment

Start date: January 17, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective, phase I-II, randomised, open-label clinical trial that will evaluate the safety and feasibility, as well as clinical efficacy evidence, of a bioengineered anterior corneal substitute in adults with severe trophic corneal ulcers. This model of human anterior allogeneic cornea will provide an alternative approach in cases where human donor keratoplasty is not an option.

NCT ID: NCT01764841 Completed - Bronchiectasis Clinical Trials

Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)

RESPIRE 1
Start date: May 2, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

NCT ID: NCT01764633 Completed - Dyslipidemia Clinical Trials

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

FOURIER
Start date: February 8, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

NCT ID: NCT01764594 Completed - Autoimmune Diseases Clinical Trials

Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

Start date: January 2013
Phase: Phase 1
Study type: Interventional

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

NCT ID: NCT01764490 Completed - Clinical trials for Clinically Significant Bacteremia

Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to Extended-spectrum Beta-lactamase (ESBL) or Carbapenemase-producing Enterobacteriaceae: an Observational Multinational Study

INCREMENT
Start date: January 2013
Phase: N/A
Study type: Observational

Main objective: to observationally assess the efficacy of different antimicrobials in Bloodstream Infection (BSI) due to Enterobacteriaceae producing ESBLs or carbapenemases. Specific objectives: Bacteraemic infections due to ESBL-producing Enterobacteriaceae: - To demonstrate that β-lactam/β-lactam inhibitors are not associated with worse cure rate and mortality than carbapenems after controlling for confounders, both as empirical and definitive therapy. - To demonstrate that fluoroquinolones as definitive therapy are not associated with worse cure rate and mortality than carbapenems after controlling for confounders. - To demonstrate that empirical cephalosporins in monotherapy are associated with worse cure rate and mortality than carbapenems after controlling for confounders in infections others than urinary tract infections. - To demonstrate that the association of active aminoglycosides with cephalosporins or fluoroquinolines is not associated with worse cure rate and mortality than carbapenems after controlling for confounders. - To demonstrate that combination empirical and definitive therapy is not associated with better cure rate than monotherapy after controlling for confounders. - For tigecycline, colistin, and fosfomycin, no hypothesis. The objective is to provide adjusted estimations of their association with outcome variables in comparison with carbapenem monotherapy according to clinical situation and infection. Bacteraemic infections due to carbapenemase-producing Enterobacteriaceae: - To demonstrate that combination therapy is associated with worse cure rate and mortality than monotherapy after controlling for confounders. - To show that carbapenems are associated with worse cure rate and mortality when used in infections other than urinary tract caused by isolates showing MIC <2 µg/mL for imipenem or meropenem in comparison to those caused by isolates with higher MIC, after controlling for confounders. - To show that colistin used at a dose >6 million IU per day is associated with improved outcomes in comparison with lower dose, after controlling for confounders.

NCT ID: NCT01763918 Completed - Hyperlipidemia Clinical Trials

Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

RUTHERFORD-2
Start date: February 7, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).

NCT ID: NCT01763905 Completed - Hyperlipidemia Clinical Trials

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

GAUSS-2
Start date: January 24, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).