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NCT ID: NCT01597973 Completed - Pneumonia Clinical Trials

Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)

Start date: October 6, 2012
Phase: Phase 3
Study type: Interventional

Approximately 444 subjects who are greater than or equal to 18 to 95 years of age, are non-pregnant, and are in the inpatient setting of one of the study sites will be evaluated to treatment efficacy. Analysis will include subjects with bloodstream infection (BSI) or pneumonia due to at least one of the following gram-negative bacilli organisms: Acinetobacter baumannii, Klebsiella spp, Escherichia coli, Enterobacter spp. and/or Pseudomonas aeruginosa that demonstrates in vitro non-susceptibility defined as extensively drug-resistant Gram-negative bacilli (XDR-GNB) which includes XDR-AB, XDR-PA and CRE. If a subject has both BSI and pneumonia at the time of study enrollment, they will be included as a subject with pneumonia. Objectives: Primary: •Determine whether the treatment regimen of Colistimethate sodium (colistin) combined with a carbapenem (imipenem or meropenem) is associated with a decreased risk for mortality compared to colistin alone for subjects with bloodstream infection (BSI) and/or pneumonia due to XDR-GNB. Secondary: •Determine what treatment regimen (colistin monotherapy or colistin combined with a carbapenem (imipenem or meropenem) is more likely to reduce the emergence of colistin resistance among XDR-GNB isolates during therapy.

NCT ID: NCT01597024 Completed - Obesity Clinical Trials

Full4Health: Understanding Food-gut-brain Axis Across the Lifecourse

F4H
Start date: May 2012
Phase: N/A
Study type: Interventional

The primary aim of this work is, to 'relate psychological and behavioural parameters of hunger/satiety and food preference to gut hormones, neural activation and energy metabolism by dietary manipulation, across the human lifespan'.

NCT ID: NCT01596114 Completed - Clinical trials for Chronic Myeloid Leukemia

European Stop Tyrosine Kinase Inhibitor Study

EURO-SKI
Start date: May 30, 2012
Phase: Phase 3
Study type: Interventional

The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy. Secondary goals include: - Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of Complete molecular remission (CMR), risk score, duration of TKI treatment, type of TKI pretreatment) - Evaluation of quality of life (QoL) in patients stopping TKI - Evaluation of medico-economic impact of stopping TKI - Estimating the number of patients in CMR who are eligible for stopping TKI therapy by setting up a screening log - Time to recovery of CMR There will be no randomised comparison. Based on the experience of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. An interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. Formally, it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival probability P ≤ 40% against the alternative hypothesis H1: Six-month molecular-relapse-free survival probability P > 40%. Eligible are adult CML patients in chronic phase on TKI treatment in CMR for at least one year (> 4 log reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be performed during 3 years: Associated scientific projects are performed. Recruitment period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500

NCT ID: NCT01595438 Completed - Clinical trials for Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

Start date: October 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

NCT ID: NCT01592500 Completed - Clinical trials for Pediatric Growth Hormone Deficiency

Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

Start date: February 2012
Phase: Phase 2
Study type: Interventional

This is a phase II, open label, active-controlled, randomized safety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone deficient children.

NCT ID: NCT01590173 Completed - Infertility Clinical Trials

Addition of Prednisolone and Heparin in Patients Undergoing IVF With Failed IVF Cycles

Start date: January 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The addition of heparin and prednisolone increases pregnancy outcome parameters in women undergoing In Vitro Fertilisation (IVF) with failed IVF cycles.

NCT ID: NCT01585948 Completed - Clinical trials for Patients Undergoing Coronary Angiography

Study of the Effect of Diabetes on the Incidence and the Extent of Coronary Artery Disease

Start date: November 2009
Phase:
Study type: Observational

In the present study the investigators will measure the extent of coronary artery disease via coronary angiography and the correlating risk factors.

NCT ID: NCT01584674 Completed - Acne Vulgaris Clinical Trials

A Clinical Trial Evaluating the Safety and Efficacy of the KLOX Biophotonic System in Moderate to Severe Acne

Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the KLOX Biophotonic System in patients with moderate to severe facial acne vulgaris using a split-face design (treated hemiface vs untreated hemiface).

NCT ID: NCT01584648 Completed - Melanoma Clinical Trials

A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

Start date: May 4, 2012
Phase: Phase 3
Study type: Interventional

This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.

NCT ID: NCT01582451 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus

IMAGINE 5
Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks: - Change in participants' overall blood sugar control - The rate of night time low blood sugar episodes - The number of participants that reach blood sugar targets without low blood sugar episodes at night - The rate of low blood sugar episodes reported over a 24-hour period