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NCT ID: NCT00925002 Completed - ATTR-PN Clinical Trials

Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis

Start date: August 5, 2009
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label study designed to obtain additional long-term safety and efficacy data for oral tafamidis (20 mg soft gelatin capsule) administered once daily (QD). In addition, this study continued to provide tafamidis to Val30Met subjects who had completed Protocol Fx-006 (a 1-year, open-label extension study to Protocol Fx-005 which was a randomized, double-blind, placebo-controlled, 18-month study to evaluate the safety and efficacy of tafamidis) or non-Val30Met subjects who had completed Protocol Fx1A-201 (a Phase 2, open-label study to evaluate TTR stabilization, safety, and tolerability of tafamidis) for up to 10 years or until subjects had access to tafamidis for ATTR-PN via prescription. Upon regulatory approval for the treatment of ATTR-PN in their respective country and access to prescription tafamidis, subjects may have been withdrawn from the study. Such subjects were considered study completers.

NCT ID: NCT00924846 Completed - Clinical trials for Acute Hypoxemic Respiratory Failure

High-Frequency Oscillatory Ventilation Associated With Inhaled Nitric Oxide in Children

Start date: April 2005
Phase: Phase 3
Study type: Interventional

Background/Objectives: Acute hypoxemic respiratory failure (AHRF) is a frequent cause of pediatric ICU admission. Early treatment with inhaled nitric oxide (iNO) plus conventional mechanical ventilation (CMV) improves oxygenation, responsiveness being significantly influenced by alveolar recruitment level. High-frequency oscillatory ventilation (HFV) is conceptually very attractive as constant mean airway pressure optimizes lung recruitment; this could maximize iNO effects. Aims: To analyze the effects of HFV on oxygenation indexes in AHRF children under CMV and iNO. Methods: Children with AHRF (oxygenation index ≥10) aged between one month and 14 years under CMV with PEEP≥10cmH2O and 5ppm iNO for 1h were randomly assigned to CMV (CMVG, n=12) or HFV (HFVG, n=12) in a crossover design. Children with chronic cardiac or pulmonary diseases were excluded. Patients were kept under one of the two ventilation modes for 8h, crossing to the other for 8h, and then back again to complete 24h observation. Blood gas analysis, oxygenation indexes, and hemodynamic variables were recorded at enrollment (Tind), 1h after iNO start and then every 4h (T4h etc). The Mann-Whitney U test compared group ages and PRISM scores, and the Fisher test genders. Moments and groups were compared by repeated measure analysis for independent groups. Significance was considered at p<0.05.

NCT ID: NCT00922493 Completed - Weaning Clinical Trials

Inspiratory Muscle Training in Weaning

IMT
Start date: December 2007
Phase: Phase 4
Study type: Interventional

Background: the objective of the present inquiry was to evaluate the weaning process in intubated older people subjected to inspiratory muscle training and to correlate the predictors of ventilatory interruption with its success. Methods: the patients were divided randomly into an experimental group (EG, n=14; age=82±4 years) that received conventional physiotherapy plus inspiratory muscle training (IMT) with threshold IMT® and a control group (CG, n=14; age=81±6 years) that received only conventional physiotherapy. The predictors evaluates were the maximum inspiratory pressure (MIP) and the index of Tobin (IT). The protocol for muscle training consisted of an initial load of 30% MIP, which was increased by 10% daily; training was administered for five minutes, twice a day, seven times a week with supplemental oxygen for the entire period from the decision to wean up to extubation.

NCT ID: NCT00922350 Completed - Acute Asthma Clinical Trials

Heliox and Posture in Patients With Asthma

Start date: June 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to verify that nebulization with bronchodilators associated with heliox gas (helium + oxygen) and the posture of a leaning forward truck is effective in patients with an asthma attack.

NCT ID: NCT00922233 Completed - Healthy Clinical Trials

Pericoital Oral Contraception With Levonorgestrel

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

A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel

NCT ID: NCT00921791 Completed - Hypertension Clinical Trials

Efficacy of Home Blood Pressure Monitoring (MONITOR Study)

MONITOR
Start date: April 2006
Phase: N/A
Study type: Interventional

High blood pressure is the main risk factor for cardiovascular disease worldwide,but its control rate is unsatisfactory. Home Blood Pressure Monitoring (HBPM) with automatic oscillometric devices and pharmaceutical care have been proposed as interventions to increase therapeutic compliance and to guide treatment decisions. The purpose of this study is to evaluate the effect of HBPM and of pharmaceutical care in blood pressure control measured through 24h ambulatory blood pressure monitoring (ABPM).

NCT ID: NCT00921557 Completed - HIV Infection Clinical Trials

Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents

Start date: November 2009
Phase: Phase 2
Study type: Interventional

HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for HIV-uninfected people of similar age, weight and race. As the majority of perinatally HIV-infected U.S. children are entering or in adolescence, the potential for HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular concern. The primary purpose of this study was to compare changes from pre-treatment levels of BMD of the lumbar spine after 24 and 48 weeks of alendronate treatment with placebo in HIV-infected children and adolescents.

NCT ID: NCT00920543 Completed - Asthma Clinical Trials

GSK BHR Study (Sont)

Start date: February 2003
Phase: Phase 4
Study type: Interventional

The purpose of this study was to determine whether asthma control and reduced bronchial hyperresponsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent subjects with persistent asthma

NCT ID: NCT00919854 Completed - Clinical trials for Human Immunodeficiency Virus 1

A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.

NCT ID: NCT00917384 Completed - Gastric Cancer Clinical Trials

Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma

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

The purpose of this study is to gather information about the use of an investigational drug called Ramucirumab in adenocarcinomas of the stomach or gastroesophageal junction.