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NCT ID: NCT01616095 Completed - Clinical trials for Growth Hormone Deficiency

Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype

GHAT
Start date: April 2011
Phase:
Study type: Observational

This study is designed as a follow up study to that performed in 2005. In the Baseline study (2005) extensive clinical whole body metabolic phenotyping was combined with in depth molecular and cellular biology analyses aimed at investigating the adipose tissue morphology as well as metabolic and inflammatory phenotypes in the adult GHD patients. Results published in (Ukropec et al., 2008) In this study identical endpoints will be investigated with the same methodology and within the same population; in order to seek relevant answers to questions on how the 6-yrs of rhGH therapy affects the - whole body insulin sensitivity - energy expenditure - body fat distribution - hepatic and skeletal muscle lipid content; as well as how it influences the adipose tissue - endocrine, - metabolic & - inflammatory phenotypes. The strength of the planned study lies in the extensive whole body and adipose tissue phenotyping before and after the 6-year rhGH replacement therapy, that allows to determine the long-term effects of rhGH replacement therapy in GHD adults. Envisaged weakness is the limited size of the population; GHD adults (n=20); controls [age BMI and gender matched] (n=20). This, however, reflects [is limited by] the complexity of the study protocol as well as the stringency of the inclusion criteria. The clinical data obtained by methods of - integrated physiology would provide an excellent interpretation background for molecular-genetic studies at the tissue (adipose tissue) and cellular (adipocytes) level. Integration of the two could bring a new quality in the investigators understanding of metabolic derangements present in GHD, and will allow extending the investigators knowledge on the mechanisms of the long-term rhGH-therapy-induced improvement on body composition, metabolic health and the cardiovascular risk.

NCT ID: NCT01610284 Completed - Breast Cancer Clinical Trials

Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

BELLE-2
Start date: August 7, 2012
Phase: Phase 3
Study type: Interventional

This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.

NCT ID: NCT01609478 Completed - Asthma Clinical Trials

Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

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

To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.

NCT ID: NCT01609296 Completed - Clinical trials for Peripheral Arterial Disease

IN.PACT Global Clinical Study

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

The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiralâ„¢ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

NCT ID: NCT01609140 Completed - Clinical trials for Coronary Heart Disease

A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease

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

The purpose of this study is to evaluate the safety and cholesterol lowering effects of MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a high risk of cardiovascular events and LDL-c levels well above goal.

NCT ID: NCT01606995 Completed - Atrial Fibrillation Clinical Trials

Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation

XANTUS
Start date: June 12, 2012
Phase:
Study type: Observational

This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.

NCT ID: NCT01604278 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

GLOW6
Start date: May 2012
Phase: Phase 3
Study type: Interventional

This study assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.

NCT ID: NCT01599650 Completed - Clinical trials for Branch Retinal Vein Occlusion

Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion

BRIGHTER
Start date: May 2012
Phase: Phase 3
Study type: Interventional

This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.

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.