Clinical Trials Logo

Filter by:
NCT ID: NCT02178800 Completed - HIV Infections Clinical Trials

Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults

Start date: February 2015
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, and pharmacokinetics (which is how the body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in healthy, HIV-uninfected adults.

NCT ID: NCT02178592 Completed - HIV Infections Clinical Trials

Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infection

Start date: January 23, 2015
Phase: Phase 3
Study type: Interventional

HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is the most common cause of death in patients with HIV worldwide. Rifamycins (such as rifampicin [RIF]) are an important component of TB therapy because of their unique activity. The problem is that most protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors (NNRTI) used to treat HIV have significant drug-drug interactions with RIF that can lead to reduced concentrations of these agents with risk of treatment failure or resistance. The non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV) does not present the same significant drug interactions with RIF. EFV-based HIV treatment was tested in patients concomitantly treated with RIF-containing TB therapy, demonstrating that their co-administration can be used safely and effectively. However, the side effect profile of EFV overlaps with the RIF-containing TB regimens and makes the management of treatment toxicities very complex. Integrase inhibitors (INI), such as dolutegravir (DTG), may offer an important alternative to EFV-based therapy in TB coinfected patients. A Phase I drug-drug interaction study was conducted in healthy, HIV-seronegative subjects, and showed that DTG at 50 mg twice daily given together with RIF was well-tolerated and resulted in DTG concentrations similar to those of DTG 50 mg given once daily alone, which is the recommended dose for INI-naive patients. Therefore, ART regimens using DTG 50 mg twice daily may represent a new treatment option for TB-infected patients who require concurrent treatment for HIV infection. This is a Phase III b, randomized, open-label study describing the efficacy and safety of DTG and EFV-containing ART regimens in HIV/TB co-infected patients. This study is designed to assess the antiviral activity of DTG or efavirenz (EFV) ART-containing regimens through 48 weeks. A total of approximately 115 +/-5% subjects will be randomly assigned in a 3:2 ratio to DTG (approximately 69 subjects) and EFV (approximately 46 subjects), respectively. This study will include a Screening Period, a Randomized Phase (Day 1 to 48 weeks plus a 4-week extension), and a DTG Open-label extension (OLE). During the DTG OLE, subjects will be supplied with DTG until it is locally approved and commercially available, the subject no longer derives clinical benefit, or the subject meets a protocol-defined reason for discontinuation, which ever comes first.

NCT ID: NCT02178111 Completed - Need of Episiotomy Clinical Trials

Comparison of Never Performing Episiotomy to Performing it in a Selective Manor

EPISIO
Start date: July 2014
Phase: Phase 4
Study type: Interventional

The study hypothesis is that not performing never episiotomies is safe and results are equivalent to performing episiotomies ina selective manor.

NCT ID: NCT02177968 Completed - Aging Clinical Trials

Public Health Concerns of Elderly Fallers and Non-fallers in a Community

Start date: August 2012
Phase: N/A
Study type: Observational

The purpose of this study is to identify the prevalence and the characterization of health of elderly fallers and non-fallers in the southeastern community of Brazil in the state of São Paulo.

NCT ID: NCT02177955 Completed - Anxiety Clinical Trials

Comparative Study of Hemodynamic Changes Caused by Diazepam and Midazolam During Third Molar Surgery

Start date: January 2011
Phase: Phase 4
Study type: Interventional

Objective: The aim of the present study was to compare hemodynamic changes using 7.5 mg of midazolam and 10.0 mg of diazepam during the surgical removal of symmetrically positioned third molars. Study design: A prospective, randomized, double-blind, clinical trial was carried out involving 120 patients divided in three groups: Group 1 (diazepam and placebo), Group 2 (midazolam and placebo) and Group 3 (diazepam and midazolam). Each subject underwent two surgeries on separate occasions under local anesthesia.

NCT ID: NCT02177929 Recruiting - Clinical trials for Adaptive Sport in Spinal Cord Injury

Study About Acting of Adaptive Sport in Musculoskeletal, Cardiovascular System and the Quality of Life of Individuals With Spinal Cord Injury Through Biomedical Instrumentation

Adaptive sport
Start date: April 2013
Phase: N/A
Study type: Interventional

The hypothesis is to the fulfillment of canoeing, handbike and conventional physiotherapy activities the groups could show improvement in muscle strength of the arms, decreased resistance of the lower limbs (spasticity), improved trunk balance and movements of the upper limbs, improves cardiovascular function, bone health, and consequently improve the quality of life.

NCT ID: NCT02177643 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effect of Diacerein in the Metabolic Control of Patients With DM Type 2 and Secondary Failure to Metformin

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Considering that, Diacerein is on the market for almost 20 years, being used continuously in elderly patients with osteoarthritis without present significant side effects, and considering the anti-hyperglycemic effect and the improvement in the insulin resistance observed in animal models of type 2 diabetes and in a previously study from Mexico. The aim of our study is to investigate the effect of Diacerein, a medication with anti-osteoarthritic properties and moderately analgesic activity, anti-inflammatory and antipyretic, which demonstrates inhibit properties for the synthesis of pro-inflammatory cytokines such as interleukin 1 (IL-1). Administered for 12 weeks and the effect in the glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to metformin treatment.

NCT ID: NCT02175004 Completed - Amyloidosis Clinical Trials

Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)

Start date: June 26, 2014
Phase: Phase 3
Study type: Interventional

This study evaluates the safety and tolerability of extended dosing with IONIS-TTR Rx in patients with Familial Amyloid Polyneuropathy.

NCT ID: NCT02174627 Completed - Anemia Clinical Trials

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

Start date: June 26, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis

NCT ID: NCT02173067 Completed - Clinical trials for Type 2 Diabetes Mellitus

Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective

Start date: September 2009
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to investigate the variation in blood glucose levels, hemodynamic effects and patient anxiety score during tooth extraction in type 2 diabetes mellitus with coronary disease patient under local anesthesia with lidocaine 2% with and without epinephrine.