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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: NCT01121666 Completed - Infertility Clinical Trials

Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment

Start date: June 2010
Phase: Phase 3
Study type: Interventional

Ther purpose of this study is to show equivalence with regard to the number of oocytes retrieved between AFOLIA and Gonal-f® in women for assisted reproductive treatment

NCT ID: NCT01120977 Completed - Clinical trials for Growth Hormone Deficiency

Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study

Start date: May 2010
Phase: N/A
Study type: Observational

The treatment of Growth Hormone deficiency (GHD) patients with GH, often induce fluid retention; this effect is dose dependent and temporary. The symptoms are swelling of soft tissue and joint stiffness. The objective of this study is to create bioelectric impedance/arm muscle area (BIA/AMA) reference data, as a measurement of hydration status, of healthy persons of both genders in the age 20-70 years.

NCT ID: NCT01120691 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations

SPARK
Start date: April 2010
Phase: Phase 3
Study type: Interventional

This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.

NCT ID: NCT01120184 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)

Start date: July 31, 2010
Phase: Phase 3
Study type: Interventional

This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.

NCT ID: NCT01119209 Completed - Clinical trials for Hip Fracture of Intertrochanteric Type

Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type

Start date: February 2008
Phase: Phase 4
Study type: Interventional

Reducing pain is an essential factor for early mobilization after osteosynthesis of intertrochanteric fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.

NCT ID: NCT01118936 Completed - COPD Clinical Trials

Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease

Start date: October 2010
Phase: N/A
Study type: Interventional

The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease. The aim of this part of the project is to study the effect of a daily magnesium supplement for COPD-patients

NCT ID: NCT01118923 Completed - Asthma Clinical Trials

Bronchial Challenge Test of Magnesium-treated Asthmatics

Start date: October 2010
Phase: N/A
Study type: Interventional

The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease. The aim of this part of the project is to study the effect of a daily magnesium supplement on the grade of bronchial hyperreactivity in asthmatics.

NCT ID: NCT01116609 Completed - Healthy Clinical Trials

Local Effects of Epinephrine on Lactate, Glucose, Lipid and Protein Metabolism in Bilaterally Perfused Human Legs

Start date: October 2004
Phase: N/A
Study type: Interventional

The purpose of this study is to define the local metabolic effects of epinephrine in the bilaterally perfused human leg.

NCT ID: NCT01116583 Completed - Pain, Postoperative Clinical Trials

The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy

GABATEA
Start date: May 2011
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to investigate the effect of gabapentin on thoracic epidural analgesia following thoracotomy, including assessment of both analgesia, pain intensity, pain quality and whether or not gabapentin prevents the development of chronic pain conditions following thoracotomy. The main hypothesis is that gabapentin reduces the proportion of patients who develop a persistent pain condition following thoracotomy from 50% to 20%. Furthermore gabapentin is expected to reduce both pain intensity measured on a 11-point numerical rating scale, usage of epidural infusions of local and/or opioid analgesics, morbidity, hospital length of stay, consumption of opioid analgesics and analgesia-related side-effects. In addition gabapentin is expected to improve postoperative recovery by means of postoperative lung function, walking ability, health related quality of life and patient satisfaction