Clinical Trials Logo

Filter by:
NCT ID: NCT00345098 Completed - Depressive Disorder Clinical Trials

A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder

CALYPSO
Start date: May 2006
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.

NCT ID: NCT00343252 Completed - Back Pain Clinical Trials

Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

Start date: June 2006
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.

NCT ID: NCT00343031 Completed - DDT Clinical Trials

Effect of the Antiandrogen DDE on Anthropometric Measures at Birth

Start date: May 14, 2001
Phase:
Study type: Observational

Experimental studies have documented the p'p-DDT, p'p-DDE (a metabolite of DDT) and other organochlorine (OC) compounds have estrogenic and/or antiandrogenic activities capable of altering normal endocrine functions. It has been postulated that exposure to these toxins during embriogenesis may cause urogenital malformations. However, this hypothesis has not yet been evaluated in humans populations with relatively high levels of exposure. The primary goal of this project is to study in utero exposure to DDE in relation to anogenital distance in humans. Anogenital distance is measured from a gender and species specific landmark on the genitalia, such as the junction of the penis and the scrotum in male humans, to the center of the anus. Altered anogenital distance is a sensitive manifestation of prenatal endocrine disruption in animal models; whether it is a sensitive endpoint in humans has not been studied. We will test the hypothesis that DDE, an androgen-receptor blocker, decreases anogenital distance in male humans who have been chronically but not occupationally exposed to DDT in Mexico. Study participants will be newborns and their mothers who live in the state of Chiapas, Mexico and who have been exposed to DDT through house spraying programs to control malaria in this area. Anogenital distance will be measured at birth and in utero exposure to DDE will be determined by measuring DDE in maternal blood. Demonstration that p'p-DDT or p'p-DDE may interfere with normal endocrine functions during embriogenesis will provide a model to increase our understanding of how other- more prevalent-environmental estrogens may act and will open new possibilities for research and potential control of etiologic factors related with this important public health problem....

NCT ID: NCT00342758 Completed - Respiratory Ilness Clinical Trials

Early Life Factors and Respiratory Health in Mexico City Children

Start date: October 1, 2001
Phase: N/A
Study type: Observational

Early life exposures now appear to be important in modulation of the immune response and tendency to develop asthma. We plan to enroll a cohort of children at birth to study early life factors in the development of wheezing and respiratory illness during the first six years of life in Mexico City. In particular, we will consider the role of early diet (particularly antioxidant intake, lactation and obesity), infections, dust mite and cockroach antigens, traffic related air pollution, and environmental tobacco smoke. We will also consider the potential modifying effect of genetic predisposition with respect to the exposures of interest. Approximately 6,800 children will be enrolled at birth. The goal is to follow the cohort though age 6. To increase the number of expected cases of asthma, we will partially enrich the cohort for increased risk of asthma by virtue of having a parent with doctor diagnosis of asthma or allergies; the remaining cohort will not be enriched to preserve generalizability. Pregnant women enrolled in a prepaid health plan in Mexico City (the Insituto Mexicano de Seguridad Social, henceforth referred to as IMSS) will be screened for the study and invited to enrolled their newborns when they come for delivery at one of two IMSS hospitals. An initial home visit during the first three months of life will include assessment of environmental exposures and infant diet. Children will be followed through age six with yearly home visits, monitoring of acute lower respiratory illness during the first year of life and periodic review of the IMSS medical records. We have chosen Mexico City because of the relatively low rates of asthma in the face of prevalent exposures to factors that are thought to increase asthma risk in urban areas in the United States. These include dust mites, cockroach, airborne pollutants and social factors such as low income and young maternal age. This pattern suggests that protective factors may be operating in Mexico City that could shed light on the etiology of worldwide childhood asthma epidemic. Potential candidates include exposure to certain early infections that shift the developing immune system away from the pattern of allergic asthmatic response. We are also especially interested in potential protective effects of early nutrition. Exposure to ozone in this population is the highest in North American and thus antioxidant intake may be especially important. In order to evaluate these protective hypotheses, we will also collect information on risk factors believed to be related to increased risk of asthma in US cities such as allergens, traffic related air pollutants, and lower respiratory infection with respiratory syncytial virus.

NCT ID: NCT00340704 Completed - Bladder, Neurogenic Clinical Trials

PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder

Start date: April 2006
Phase: Phase 2
Study type: Interventional

Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment.

NCT ID: NCT00339612 Completed - HIV Clinical Trials

NISDI Pediatric Latin American Countries Epidemiologic Study (PLACES): A Prospective Observational Study of HIV-Infected Children at Clinical Sites in Latin American Countries

Start date: July 30, 2002
Phase:
Study type: Observational

This is an observational, prospective cohort study to describe the demographic, clinical, immunologic, and virologic characteristics of HIV-infected children at participating clinical sites in Latin American countries. Enrollment in this study will consist of approximately 500 HIV-infected children in two cohorts who acquired HIV infection through mother-to-child transmission (MTCT). The first group will be a static cohort consisting of HIV-infected children who were five years of age or younger when previously enrolled into the NISDI Pediatric Protocol. The second cohort will be a dynamic cohort of prospectively enrolled, HIV-infected children who are five years of age or younger. We will characterize complications from both the disease and its treatments. Subjects will be evaluated every six months for approximately five years and assessments of growth, morbidity, disease progression and mortality will be made.

NCT ID: NCT00339521 Completed - Asthma Clinical Trials

Genetic Susceptibility to Childhood Respiratory IIlness in Mexico City

Start date: May 15, 1999
Phase:
Study type: Observational

We propose to add a collection of genetic material to a clinical trial of anti-oxidant supplementation for the amelioration of asthma in 7-12 year olds being conducted at a public pediatric hospital in Mexico City. The anti-oxidant study has been approved by the Institutional Review Board of the National Institute of Public Health in Mexico City and is scheduled to begin in September 1998. The purpose of this add-on study is to examine genetic polymorphisms that may be related to asthma. Asthma cases will be compared with their parents as controls. In partaicular, we will save the buffy coat from the blood collection being done on the asthmatic child for measurements of plasma micronutrients in the anti-oxidant trial for extraction of DNA. This part of the sample would otherwise be discarded. In addition, we will enroll the parents of the asthmatic child as controls for the child. From the parents, either a 10 ml blood sample or if they prefer, a sample of buccal cells will be collected. Although our current plan is to compare the asthmatic child to the parents using statistical methods based on the "transmission disequilibrium test" because research into various family designs for candidate gene studies is rapidly evolving and various sibling control sample strategies have been discussed, we would also like to collect a genetic sample on as many of the child's siblings as possible with priority given to those closest in age. This will enhance the future usefulness of the samples. We anticipate enrolling approximately 200 families....

NCT ID: NCT00338897 Completed - Clinical trials for Venous Thromboembolism

Dose Ranging Study in Elective Total Hip Replacement Surgery

DRIVE
Start date: May 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective is to: - demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism (VTE) by the demonstration of a dose-response in patients undergoing total hip replacement surgery. The secondary objectives are to: - evaluate the safety of SR123781A in the prevention of VTE after elective total hip replacement surgery; and - to assess the SR123781A pharmacokinetic profile in patients undergoing elective total hip replacement surgery.

NCT ID: NCT00338884 Completed - Clinical trials for Carcinoma, Renal Cell

Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer

Start date: September 2006
Phase: Phase 2
Study type: Interventional

A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.

NCT ID: NCT00338845 Completed - HIV Infections Clinical Trials

Share Safer Sex Counseling Program for Changing Sexual Risk Behaviors in Mexican Female Sex Workers

Start date: December 2003
Phase: Phase 2
Study type: Interventional

This study will evaluate the effectiveness of the Share Safer Sex Program in reducing sexual risk behaviors among female sex workers in four Mexican cities close to the U.S. border.