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NCT ID: NCT01121835 Completed - Clinical trials for Diabetes Mellitus, Type 2

Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study

GALAPAGOS
Start date: February 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate the superiority of a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1 mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents. Secondary Objectives: To assess the effect of insulin glargine in comparison with premixed insulin on : - Evolution of HbA1c level during the treatment period Percentage of patients who reach the target of HbA1c < 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L) - Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L) >Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L) >Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles - Evolution of weight - Hypoglycemia occurrence - Dose of insulins - Evolution of liver function - Overall safety

NCT ID: NCT01097759 Completed - Clinical trials for Prolapsed Hemorrhoids

LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy

Start date: January 2006
Phase: N/A
Study type: Observational

This study was designed to compare the outcome of LigaSure hemorrhoidectomy and stapled hemorrhoidopexy for prolapsed hemorrhoids.

NCT ID: NCT01089023 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Start date: January 2010
Phase: Phase 4
Study type: Interventional

This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.

NCT ID: NCT01081626 Completed - Ovulation Induction Clinical Trials

Recombinant Follicle Stimulating Hormone (FSH) (Gonal-f®): Use in Ovulation Induction

Start date: March 2009
Phase: Phase 4
Study type: Interventional

This is an open-label, prospective, randomized, controlled, multicentric, multinational, phase IV study to evaluate the use of Gonal-f in inducing ovulation in female subjects with chronic anovulation. It has been observed that conventional high dose set up regimen of gonadotropin and human chorionic gonadotropin (hCG) is effective in anovulatory subjects in terms of overall pregnancy rates. However, development of multiple follicles leading to multiple pregnancy and/or ovarian hyperstimulation syndrome (OHSS) is the major complications associated with this high dose set up. Chronic low-dose (CLD) protocols of follicle stimulating hormone (FSH), aimed at finding the threshold amount of FSH necessary to promote monofolliculogenesis, have been found to be successful in reducing the rate of OHSS almost to nil and the rate of multiple pregnancies to a minimum. This post-marketing study will investigate tailoring of recombinant follicle stimulating hormone (r-FSH) in a large population (N=310) of subjects from a region (North Africa/Middle East) that has not been included in previous studies of ovulation induction in subjects with chronic anovulation. The study aims to increase current knowledge of the efficacy and safety of Gonal-f, and provide fertility physicians with experience in Gonal-f treatment in anovulatory infertility, thereby contributing to the development of FSH dosing guidelines for ovulation induction by defining the optimal CLD and Low dose (LD) regimens.

NCT ID: NCT01042223 Completed - Complications Clinical Trials

Laryngomalacia Exposed

Start date: January 2006
Phase:
Study type: Observational

Laryngomalacia is the most common congenital laryngeal anomaly and the most frequent cause of stridor in infants and children. Symptoms usually appear within the first 2 weeks of life. Its severity increases up to 6 months. 15-60% of infants with laryngomalacia have synchronous airway anomalies.

NCT ID: NCT00972764 Completed - Laryngomalacia Clinical Trials

Laryngomalacia No Longer An Ambiguity

Start date: January 2006
Phase:
Study type: Observational

The purpose of this study is to expose some of the factors that may be associated or predisposing to development of laryngomalacia.

NCT ID: NCT00968708 Completed - Clinical trials for Diabetes Mellitus, Type 2

Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome

EXAMINE
Start date: September 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

NCT ID: NCT00949442 Completed - Clinical trials for Diabetes Mellitus, Type 2

Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment

LANCELOT
Start date: July 2009
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period. Secondary Objective: To compare between treatment groups: - Plasma glucose (fasting, nocturnal) over time, - Changes from baseline in HbA1c over time, - Percentage of patients who reach the target of HbA1c <7 and <6.5, - Use of prandial insulin as rescue medication at month 6, - Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe), - Daily dose of insulin, - Change in body weight from baseline, - Evolution of 8-point plasma-glucose (PG) profiles, - Overall safety, - Patient reported outcomes (treatment satisfaction).

NCT ID: NCT00944424 Recruiting - Breast Cancer Clinical Trials

Phase III Trial of High Dose vs. Standard Dose Vit D2 With Docetaxel in Met Breast ca

GORG-002
Start date: July 2009
Phase: Phase 3
Study type: Interventional

Randomized phase III trial to determine the effectiveness of High dose versus Standard dose of Vitamin D2 (Ergocalciferol) given with Docetaxel in patients with metastatic breast cancer

NCT ID: NCT00930488 Completed - Clinical trials for Acute Bacterial Sinusitis

Treatment of Patients With Acute Sinusitis

Start date: March 2007
Phase: N/A
Study type: Observational

For each patient, an initial visit and at least one follow-up visit at the end of treatment should be documented by the treating physician in the case report form.