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NCT ID: NCT00600756 Completed - Clinical trials for Schizophrenic Disorders

Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone

RECOVER
Start date: January 2008
Phase: Phase 3
Study type: Interventional

The trial is designed to assess the long term subjective well-being in schizophrenic outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible dose in a naturalistic setting over a period of one year. Secondary outcome measures have been selected for helping in the differentiation of the compared atypical antipsychotics. The primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K

NCT ID: NCT00600548 Completed - Clinical trials for Treatment of Cutaneous Leishmaniasis in Brazil.

Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

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

The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - Glucantime®).

NCT ID: NCT00596713 Completed - Healthy Clinical Trials

Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City

Start date: June 2007
Phase: N/A
Study type: Observational

Sleep disturbances are of great relevance within the context of public health as they affect a sizable portion of the population with far reaching consequences. Many automobile and labor accidents as well as poor school and work performance can be traced to sleep disturbances, which are also linked to cardiovascular disease, metabolic syndrome, and psycho-cognitive alterations. OBJECTIVES: 1. Establish the epidemiologic profile of sleep disturbances among the adult population of the city of Sao Paulo in 2007; 2. Investigate associations between sleep patterns and disturbances in that population, taking into account the following variables: social-demographic status, anthropometrics, clinical, activity/rest cycle, eating and physical activity habits, mood disturbances, sexual dysfunction in males, alcoholism, drug addiction, genetic markers, biochemical, hematological, endocrine, immunologic and inflammatory indicators; 3. assess the compatibility of the results collected in the current study with those of epidemiologic sleep investigations of said city carried out in 1987 and 1995 with the aim of determining the secular sleep disturbance trend. METHODS: The two-stage cluster randomized sample included 1100 individuals of the city of Sao Paulo, representing the population proportionally to gender, age groups and social classes. Data were amassed as follows: 1. the application of home and institution questionnaires; 2. description of the sleep patterns and disturbances through polysomnography and actigraphy, performed at the Sleep Institute; 3. collection of peripheral blood for biochemical, hematologic, endocrine and genetic assays. STATISTICS: Subsequent to double typing (inputting) and analysis of data consistency, descriptive and analytical statistical assessments will be performed with the aim of describing patterns of sleep disturbances associated to the explanatory variables under investigation. In the light of bi-varied analysis, predictive/explanatory multivaried models were adjusted.

NCT ID: NCT00596661 Completed - Clinical trials for Coronary Artery Disease

The TRIMAXX Coronary Stent Trial

Start date: May 2004
Phase: Phase 1
Study type: Interventional

The primary objective of the trial is to demonstrate the safety and feasibility of treating coronary artery lesions which have not been previously treated with the TRIMAXX Coronary stent system as compared to the reported results for commercially available non-drug eluting coronary stent systems which are indicated for the same treatments.

NCT ID: NCT00596297 Completed - Clinical trials for Diabetic Retinopathy

Preoperative Bevacizumab for Vitreous Hemorrhage

IBEVI
Start date: November 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether preoperative intravitreal bevacizumab is effective in reducing intra-operative and postoperative bleeding in diabetic patients submitted to pars plana vitrectomy for vitreous hemorrhage.

NCT ID: NCT00594204 Completed - Smoking Cessation Clinical Trials

Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

Start date: April 2008
Phase: Phase 4
Study type: Interventional

The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.

NCT ID: NCT00593788 Completed - Auditory Perception Clinical Trials

The Gaps-in-Noise Test: Gap Detection Thresholds in Normal-Hearing Young Adults

Start date: March 2003
Phase: N/A
Study type: Observational

The aim of this study was to establish parameters for the Gaps-in-Noise test in normal-hearing young adults. One hundred subjects (50 males and 50 females) received an audiological evaluation to rule out hearing loss and auditory processing disorder. The Gaps-in-Noise test was then conducted on all subjects. The mean gap detection threshold was 4.19 msec. A psychometric function by gap duration was constructed, revealing that the percentage of correct responses was less than or equal to 5% for a gap duration of 2 msec, 10-30% for a gap duration of 3 msec, 60-70% for a gap duration of 4 msec, and over 96% for gap durations of 5 msec or longer. The results suggest that the data obtained can be applied as reference values for future testing. In the subjects evaluated, the Gaps-in-Noise test proved to be consistent with low variability.

NCT ID: NCT00592969 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes

Start date: December 3, 2003
Phase: Phase 4
Study type: Interventional

This trial is conducted in South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with type 2 diabetes.

NCT ID: NCT00591994 Completed - Tinnitus Clinical Trials

Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

piribedil
Start date: November 2006
Phase: N/A
Study type: Interventional

Tinnitus is defined as the perception of sound in the absence of a external source. About 15 % of the population is believed to experience tinnitus and for about 20 % of them it may become a very serious problem. Total comprehension of tinnitus pathophysiology has not yet been achieved, but modern theories focus in brain hyperactivity following inner ear damage, with involvement of various neurotransmitters. Piribedil,a dopamin agonist, has been used to treat tinnitus, focusing in dopamine release, which is inhibitory. Electrophysiological methods,like acoustic otoemissions and electrocochleography may reveal the changes in peripherical and central auditory pathways and help to choose the specific patients who could benefit from piribedil treatment.

NCT ID: NCT00585481 Completed - Clinical trials for Respiratory Tract Infection

Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children

Start date: January 2008
Phase: N/A
Study type: Observational

The primary objective of this study is to determine the incidence of severe RSV LRTI requiring hospitalization among infants born < 35 weeks gestational age for one year of follow-up.