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NCT ID: NCT01105208 Completed - Clinical trials for Anti-Infective Agents

Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension

Start date: March 2010
Phase: Phase 1
Study type: Interventional

A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences

NCT ID: NCT01101945 Terminated - Clinical trials for Type 2 Diabetes Mellitus

Long-term Extension Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus

Start date: July 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.

NCT ID: NCT01101425 Active, not recruiting - Breast Cancer Clinical Trials

Male Breast Cancer: Understanding the Biology for Improved Patient Care

Start date: December 2010
Phase:
Study type: Observational [Patient Registry]

Rationale: Gathering medical information and tumor samples from patients with male breast cancer may help doctors learn more about the disease. Purpose retrospective part: to perform a large international retrospective analysis of clinical and biological data of male BC patients treated in the participating centers from 1990 to 2010. Purpose prospective part: to create a registry of men with breast cancer for a period of 30 months (starting early 2014).

NCT ID: NCT01101035 Completed - Clinical trials for Cardiovascular Disease

Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)

CARES
Start date: April 23, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events).

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: NCT01099293 Completed - Clinical trials for Hepatic Encephalopathy

Cerebrovascular Reactivity in Hepatic Encephalopathy

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

It has been observed that patients with cirrhosis present a generalized state of vasoconstriction as an homeostatic response to splanchnic arteriolar vasodilatation. On progression of the disease, vascular regulation is mismatched, causing altered systemic blood flow and lose in the cerebrovascular reactivity. The investigators hypothesize that the altered cerebrovascular reactivity induces neurological disturbances related to hepatic encephalopathy and, therefore, the existence of a correlation between cerebrovascular reactivity and the stage of hepatic encephalopathy.

NCT ID: NCT01096498 Completed - Contraception Clinical Trials

Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

LEVEQ-2
Start date: February 2009
Phase: Phase 1
Study type: Interventional

A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods. Treatment groups were balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.

NCT ID: NCT01096485 Completed - Contraception Clinical Trials

Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

LEVEQ-1
Start date: February 2009
Phase: Phase 1
Study type: Interventional

A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods. Treatment groups were balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.

NCT ID: NCT01095003 Completed - Breast Cancer Clinical Trials

Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer

Start date: May 2009
Phase: Phase 3
Study type: Interventional

The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line metastatic settings, led to a raise of patients presenting with metastatic breast cancer after treatment with these agents. Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. The high level of in-vitro synergy of vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the encouraging response rate observed while combining IV vinflunine to oral capecitabine make it a promising combination to investigate further in a phase III trial. This phase III trial will evaluate the effectiveness and the safety profile of such combination for the treatment of patient with advanced breast cancer previously treated with or resistant to anthracycline and taxane resistant.

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