68 results

Randomized Dose-Ranging Controlled Trial of AQ-13, a Candidate Antimalarial, and Chloroquine in Healthy Volunteers

Fawaz Mzayek; Haiyan Deng; Frances J Mather et al.

PLoS Clinical Trials, Vol. 2 No. 1 · 2007 · English · PLOS

Objectives: To determine: (1) the pharmacokinetics and safety of an investigational aminoquinoline active against multidrug–resistant malaria parasites (AQ-13), including its effects on the QT interval, and (2) whether it has pharmacokinetic and safety profiles similar to chloroquine (CQ) in…

The Effect of Acclydine in Chronic Fatigue Syndrome: A Randomized Controlled Trial

Gerard K. H The; Gijs Bleijenberg; Jos W. M van der Meer

PLoS Clinical Trials, Vol. 2 No. 5 · 2007 · English · PLOS

Objectives: It is unclear whether insulin-like growth factor (IGF) function is involved in the pathophysiology of chronic fatigue syndrome (CFS). Unpublished data and reports in patient organization newsletters suggest that Acclydine, a food supplement, could be effective in the treatment of CFS by…

Artemether-Lumefantrine versus Dihydroartemisinin-Piperaquine for Treatment of Malaria: A Randomized Trial

Moses R Kamya; Adoke Yeka; Hasifa Bukirwa et al.

PLoS Clinical Trials, Vol. 2 No. 5 · 2007 · English · PLOS

Objectives: To compare the efficacy and safety of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) for treating uncomplicated falciparum malaria in Uganda. Design: Randomized single-blinded clinical trial. Setting: Apac, Uganda, an area of very high malaria transmission…

A Cluster Randomized Clinical Trial to Improve Prescribing Patterns in Ambulatory Pediatrics

Robert L Davis; Jeffrey Wright; Francie Chalmers et al.

PLoS Clinical Trials, Vol. 2 No. 5 · 2007 · English · PLOS

Objectives: Having shown previously that an electronic prescription writer and decision support system improved pediatric prescribing behavior for otitis media in an academic clinic setting, we assessed whether point-of-care delivery of evidence could demonstrate similar effects for a wide range of…

Tenofovir Disoproxil Fumarate for Prevention of HIV Infection in Women: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Trial

Leigh Peterson; Doug Taylor; Ronald Roddy et al.

PLoS Clinical Trials, Vol. 2 No. 5 · 2007 · English · PLOS

Objectives: The objective of this trial was to investigate the safety and preliminary effectiveness of a daily dose of 300 mg of tenofovir disoproxil fumarate (TDF) versus placebo in preventing HIV infection in women. Design: This was a phase 2, randomized, double-blind, placebo-controlled trial…

A Cluster-Randomised Trial Evaluating an Intervention for Patients with Stress-Related Mental Disorders and Sick Leave in Primary Care

Ingrid M Bakker; Berend Terluin; Harm W. J van Marwijk et al.

PLoS Clinical Trials, Vol. 2 No. 6 · 2007 · English · PLOS

Objective: Mental health problems often affect functioning to such an extent that they result in sick leave. The worldwide reported prevalence of mental health problems in the working population is 10%–18%. In developed countries, mental health problems are one of the main grounds for receiving…

When and How Can Endpoints Be Changed after Initiation of a Randomized Clinical Trial

Scott Evans

PLoS Clinical Trials, Vol. 2 No. 4 · 2007 · English · PLOS

A Randomized, Double-Blind, Placebo-Controlled Trial of Lessertia frutescens in Healthy Adults

Quinton Johnson; James Syce; Haylene Nell et al.

PLoS Clinical Trials, Vol. 2 No. 4 · 2007 · English · PLOS

Objectives: Indigenous medicines are widely used throughout Africa, despite a lack of scientific evidence for their safety or efficacy. The aims of this study were: (a) to conduct a pilot study of the safety of a common indigenous South African phytotherapy, Lessertia frutescens (Sutherlandia), in…

Haematological Safety of Perinatal Zidovudine in Pregnant HIV-1–Infected Women in Thailand: Secondary Analysis of a Randomized Trial

Nelly Briand; Marc Lallemant; Gonzague Jourdain et al.

PLoS Clinical Trials, Vol. 2 No. 4 · 2007 · English · PLOS

Objectives: To respond to the primary safety objective of the Perinatal HIV Prevention Trial 1 (PHPT-1) by studying the evolution of haematological parameters according to zidovudine exposure duration in HIV-1−infected pregnant women. Design: Multicenter, randomized, double-blind, controlled trial…

Efficacy of Antioxidant Treatment in Reducing Resistin Serum Levels: A Randomized Study

Simona Bo; Giovannino Ciccone; Marilena Durazzo et al.

PLoS Clinical Trials, Vol. 2 No. 5 · 2007 · English · PLOS

Objectives: Few in vitro studies have examined the participation of resistin, a recently discovered adipokine, in oxidative processes. We investigated whether in vivo treatment with the antioxidant vitamin C might affect resistin serum levels. Design: Randomized prospective open trial. Setting: San…

Effects of Growth Hormone and Pioglitazone in Viscerally Obese Adults with Impaired Glucose Tolerance: A Factorial Clinical Trial

Hamdee Attallah; Anne L Friedlander; Matilde Nino-Murcia et al.

PLoS Clinical Trials, Vol. 2 No. 5 · 2007 · English · PLOS

Objective: Recombinant human growth hormone (GH) and pioglitazone (PIO) in abdominally obese adults with impaired glucose tolerance were evaluated under the hypothesis that the combination attenuates GH-induced increases in glucose concentrations, reduces visceral adipose tissue (VAT), and improves…

Development and Evaluation of a Pedagogical Tool to Improve Understanding of a Quality Checklist: A Randomised Controlled Trial

Lola Fourcade; Isabelle Boutron; David Moher et al.

PLoS Clinical Trials, Vol. 2 No. 5 · 2007 · English · PLOS

Objective: The aim of this study was to develop and evaluate a pedagogical tool to enhance the understanding of a checklist that evaluates reports of nonpharmacological trials (CLEAR NPT). Design: Paired randomised controlled trial. Participants: Clinicians and systematic reviewers. Interventions…

Correction: A Randomised Trial of Subcutaneous Intermittent Interleukin-2 without Antiretroviral Therapy in HIV-Infected Patients: The UK-Vanguard Study

PLoS Clinical Trials, Vol. 2 No. 5 · 2007 · English · PLOS

Correction: Short-Term Efficacy of Rofecoxib and Diclofenac in Acute Shoulder Pain: A Placebo-Controlled Randomized Trial

PLoS Clinical Trials, Vol. 2 No. 5 · 2007 · English · PLOS

Recovery after Minor Traffic Injuries: A Randomized Controlled Trial

Carin Ottosson; Hans Pettersson; Sven-Erik Johansson et al.

PLoS Clinical Trials, Vol. 2 No. 3 · 2007 · English · PLOS

Objectives: To assess the efficacy of an acute multidisciplinary group intervention on self-perceived recovery following minor traffic-related musculoskeletal injuries. Design: Open, randomized controlled trial. Setting: A large inner-city hospital. Participants: 127 patients (≥15 y) with…

Evidence-Based Treatment for HIV-Associated Dementia and Cognitive Impairment: Why So Little

Ronald J Ellis

PLoS Clinical Trials, Vol. 2 No. 3 · 2007 · English · PLOS

Factors in AIDS Dementia Complex Trial Design: Results and Lessons from the Abacavir Trial

Bruce J Brew; Mark Halman; Jose Catalan et al.

PLoS Clinical Trials, Vol. 2 No. 3 · 2007 · English · PLOS

Objectives: To determine the efficacy of adding abacavir (Ziagen, ABC) to optimal stable background antiretroviral therapy (SBG) to AIDS dementia complex (ADC) patients and address trial design. Design: Phase III randomized, double-blind placebo-controlled trial. Setting: Tertiary outpatient…

Phase 1 Study of Two Merozoite Surface Protein 1 (MSP1 42 ) Vaccines for Plasmodium falciparum Malaria

Elissa Malkin; Carole A Long; Anthony W Stowers et al.

PLoS Clinical Trials, Vol. 2 No. 4 · 2007 · English · PLOS

Objectives: To assess the safety and immunogenicity of two vaccines, MSP142-FVO/Alhydrogel and MSP142-3D7/Alhydrogel, targeting blood-stage Plasmodium falciparum parasites. Design: A Phase 1 open-label, dose-escalating study. Setting: Quintiles Phase 1 Services, Lenexa, Kansas between July 2004 and…

Can Biomarkers Identify Women at Increased Stroke Risk? The Women's Health Initiative Hormone Trials

Charles Kooperberg; Mary Cushman; Judith Hsia et al.

PLoS Clinical Trials, Vol. 2 No. 6 · 2007 · English · PLOS

Objective: The Women's Health Initiative hormone trials identified a 44% increase in ischemic stroke risk with combination estrogen plus progestin and a 39% increase with estrogen alone. We undertook a case-control biomarker study to elucidate underlying mechanisms, and to potentially identify…

Intermittent Intravaginal Antibiotic Treatment of Bacterial Vaginosis in HIV-Uninfected and -Infected Women: A Randomized Clinical Trial

Taha E Taha; Newton I Kumwenda; George Kafulafula et al.

PLoS Clinical Trials, Vol. 2 No. 2 · 2007 · English · PLOS

Objective: Assess efficacy of intermittent intravaginal metronidazole gel treatment in reducing frequency of bacterial vaginosis (BV). Design: Randomized, double-masked, placebo-controlled phase 3 trial. Setting: Postnatal and family planning clinics of the Queen Elizabeth Central Hospital and two…