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NCT ID: NCT01110382 Terminated - Infection Clinical Trials

A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections

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

The purpose of the study is to evaluate the safety and tolerability of doripenem compared with meropenem in children hospitalized with complicated intra-abdominal infections.

NCT ID: NCT01107886 Completed - Clinical trials for Type 2 Diabetes Mellitus

Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications

SAVOR- TIMI 53
Start date: May 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications

NCT ID: NCT01107093 Completed - Contraception Clinical Trials

Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge

Start date: May 2008
Phase: Phase 2
Study type: Interventional

Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered after the onset of the LH surge on the outcome of the leading ovary follicle: - echographic follicle rupture - inhibition of follicle rupture - luteal phase progesterone levels - anovulatory progesterone levels

NCT ID: NCT01106014 Completed - Clinical trials for Pulmonary Arterial Hypertension

Selexipag (ACT-293987) in Pulmonary Arterial Hypertension

GRIPHON
Start date: December 1, 2009
Phase: Phase 3
Study type: Interventional

The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.

NCT ID: NCT01099579 Completed - HIV Infections Clinical Trials

PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)

PRINCE1
Start date: October 13, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether atazanavir powder combined with ritonavir is safe and well tolerated and produces appropriate drug exposure in children ≥3 months to <6 years of age.

NCT ID: NCT01093482 Completed - Clinical trials for Acute Respiratory Failure

Third International Study on Mechanical Ventilation

ISMV
Start date: April 2010
Phase: N/A
Study type: Observational

The objective of this study is to obtain a better understanding of the spectrum of use of mechanical ventilation in intensive care units: 1. Main analysis: To know the all-cause mortality rate in mechanically ventilated patients 2. Secondary analyses: - To know the current status of mechanical ventilation in the intensive care unit and determine the number and percentage of patients who are admitted to an intensive care unit and require mechanical ventilation. - To compare the results with prior data collected in previous observational studies (1998 and 2004) - Non-invasive positive pressure ventilation - Weaning - Use of adjuvant therapies as steroids or selective digestive decontamination - Sedation including prevalence of delirium in mechanically ventilated patients - Prediction of the duration of mechanical ventilation - Other

NCT ID: NCT01090362 Completed - Atrial Fibrillation Clinical Trials

Global Anticoagulant Registry in the Field

GARFIELD-AF
Start date: December 21, 2009
Phase:
Study type: Observational

The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) is a non-interventional, observational study that characterized a global population of non-valvular atrial fibrillation patients. The registry was used to document global baseline characteristics, current treatment strategies and outcome measures. Characterisation of a number of AF sub-populations was also completed. GARFIELD-AF is an independent academic research initiative sponsored by the Thrombosis Research Institute (London, UK) and supported by an unrestricted research grant from Bayer AG (Berlin, Germany).

NCT ID: NCT01084252 Completed - Clinical trials for Hematological Malignancy

Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies

Start date: June 10, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab). Phase 2 (stage 1): To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone. Phase 2 (stage 2): To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm). Secondary Objectives: Phase 1: - To characterize the global safety profile including cumulative toxicities. - To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing schedule(s). - To assess the pharmacodynamics (PD), immune response, and preliminary disease response. Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent: - Safety - Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex): - Safety - Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. - Participant-reported changes in health-related quality of life, symptoms of multiple myeloma and generic health status. - Pharmacokinetic profile of Isatuximab. - Immunogenicity of Isatuximab. - Investigate the relationship between CD38 receptor density and CD38 receptor occupancy (Stage 1 only) on multiple myeloma cells and parameters of clinical response.

NCT ID: NCT01082874 Completed - Clinical trials for Cardiovascular Disease

PeriOperative ISchemic Evaluation-2 Trial

POISE-2
Start date: July 2010
Phase: Phase 3
Study type: Interventional

Major surgeries not involving the heart are common, and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested. There is encouraging data suggesting that small doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems. The POISE-2 Trial is a large international study to test if ASA and Clonidine can prevent heart attacks and deaths from heart problems around the time of surgery.

NCT ID: NCT01082185 Completed - Clinical trials for Abdominal Aortic Aneurysm

South American Abdominal Stent Graft Trial

Start date: November 2009
Phase: Phase 1
Study type: Interventional

A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System