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NCT ID: NCT01572038 Completed - Breast Neoplasms Clinical Trials

A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer

PERUSE
Start date: June 1, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

NCT ID: NCT01571284 Completed - Clinical trials for Colorectal Cancer Metastatic

Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen

Start date: May 30, 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: To provide metastatic colorectal cancer participants with access to aflibercept and to document the overall safety in these participants Secondary Objective: To document the Health-Related Quality of Life of aflibercept in this participants population

NCT ID: NCT01571115 Completed - Insomnia Clinical Trials

Effects of Resistance Physical Exercise in Patients With Chronic Primary Insomnia

IER
Start date: January 2012
Phase: N/A
Study type: Interventional

INTRODUCTION: The primary insomnia, according to the concepts of the DSM IV, is a disorder characterized by difficulty initiating or maintaining sleep, waking early or by non-restorative sleep, resulting in losses in the daily functioning of patients, such as lack of attention, concentration and memory, fatigue, moodiness and irritability that are potentially associated with changes in sleep architecture, especially the reduction in slow-wave sleep. The most widely used therapy for the treatment of insomnia is the drug, but currently the resistive exercise is an important non-pharmacological intervention known to provide enough increase in slow wave sleep, and improve other parameters of sleep, as well as reducing symptoms of anxiety that are directly associated with the framework of insomnia. OBJECTIVE: To evaluate the effect of chronic resistive exercise in sleep patterns, the profile of mood and quality of life of patients with chronic primary insomnia. METHODOLOGY: 30 patients will be selected (male and female) with chronic primary insomnia. (Clinical diagnosis based on DSM-IV) referred for ambulatory sleep disorders Sleep Institute - AFIP. The protocol will be conducted at the Center for Psychobiology and Exercise (CEPE) of the AFIP and the Sleep Institute. Volunteers will be randomized into 2 groups of 15 participants, which will hold a resistive exercise and the other stretching exercise. This study will consist of three assessments: Pre-intervention (baseline), intermediate Rating (2 months) and post-intervention (at the end of 4 months). In the program of resistive exercise will be held 48 sessions that involve upper and lower limbs, abdominal and paraspinal region. It will be initially used a relative intensity 50% 1-RM. After 2 months of training intensity will be increased to 60% of 1-RM. Each exercise will be conducted in three sets of 12 repetitions, at intervals of 30 seconds between sets and one minute between each exercise. The total duration of the training session will be approximately 50 minutes. Before starting the training, participants will hold for 5 minutes stretching and warming on a bicycle ergometer (Life Cycle 9100) or treadmill (Life Fitness 9100) for the same period. After the session, the volunteers performed repeated stretches at the start of training. The group submitted to follow the practice of stretching protocol performed by Tworoger et al. that consist of 48 sessions of stretching for 60 minutes of low intensity, three times a week. The session will begin with 5 minutes of walking around the room, followed by 45 minutes of stretching exercises that involve the upper and lower limbs, 8 to 10 types for each region and end with 10 minutes of relaxation. STATISTICAL ANALYSIS: The variables of sleep, body composition and maximal repetition test will be analyzed using the software Statistica 7.0 (StaSoft, INC). The appropriate statistical test, parametric or nonparametric, will be chosen according to the data of the sample groups.

NCT ID: NCT01571050 Completed - Dental Fluorosis Clinical Trials

Systemic Fluoride Bioavailability From Toothpastes Containing Calcium Carbonate or Silica as Abrasives

Start date: January 2011
Phase: Phase 1
Study type: Interventional

The risk of dental fluorosis development is related to the systemic exposure to fluoride during enamel formation. Currently, diet and fluoride toothpastes are the main sources of fluoride to children at the age-risk for fluorosis development. However, when estimating the risk of fluorosis from toothpaste inadvertently ingested, it has not been considered the systemic fluoride bioavailability. Since some toothpaste formulations may contain part of fluoride as insoluble salts, the hypothesis behind this study is that only soluble fluoride in toothpastes would be absorbed when they are inadvertently ingested. To test that, adult volunteers will ingest a standardized dose of total fluoride from commercially available toothpastes, which present different concentrations of soluble fluoride. Fluoride systemic bioavailability will be assessed by the release of fluoride in saliva up to 3 hours after ingestion (as an indicator of blood fluoride) and by urinary fluoride excretion.

NCT ID: NCT01570218 Completed - Breast Cancer Clinical Trials

Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy

Start date: February 2010
Phase: N/A
Study type: Interventional

OBJETIVE: To study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast's or gynecology's cancer, during the radiotherapy treatment.

NCT ID: NCT01569308 Completed - Clinical trials for Hemodynamic Instability

Pulse Pressure Variation Helps to Predict Fluid Responsiveness in Patients Ventilated With Low Tidal Volumes

Start date: May 2006
Phase: N/A
Study type: Observational

Objective: To determine the value of pulse pressure variation (ΔRESPPP) to predict fluid responsiveness in patients ventilated with low tidal volumes (VT), and to investigate whether a lower ΔRESPPP cut-off point should be used when patients are ventilated with low tidal volumes. Methods: This cross-sectional, observational study included 37 critically ill patients with acute circulatory failure requiring fluid challenge. They were sedated and mechanically ventilated with Tidal Volume (VT) 6-7 ml/kg IBW (ideal body weight), monitored by pulmonary artery catheter and arterial line. Mechanical ventilation and hemodynamic parameters, including ΔRESPPP, were measured before and after fluid challenge with 1,000 ml crystalloids or 500 ml colloids. Fluid responsiveness was defined as an increase of at least 15% in cardiac index. The present study was designed to (1) determine the value of ΔRESPPP to predict fluid responsiveness in patients ventilated with low tidal volumes, and (2) to investigate whether a lower ΔRESPPP cut-off point should be used when patients are ventilated with low tidal volumes. The study hypothesis is not a good predictor of fluid responsiveness in patients ventilated with low tidal volumes.

NCT ID: NCT01568866 Completed - Multiple Myeloma Clinical Trials

Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients

ENDEAVOR
Start date: June 20, 2012
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.

NCT ID: NCT01568840 Completed - Scapular Dyskinesis Clinical Trials

Global Postural Reeducation and Segmental Exercises in Patients With Scapular Dyskinesis and Cervicalgia

Start date: July 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the effectiveness of global postural reeducation relative to segmental exercises in the treatment of scapular dyskinesis with cervicalgia.

NCT ID: NCT01568541 Completed - Healthy Individuals Clinical Trials

Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes

F
Start date: October 2007
Phase: N/A
Study type: Interventional

There are controversial data about fluoride intake by children when tooth brushing with children's or regular toothpastes. However, a study have showed that children were exposed to a dose of 0.051 mg F/Kg/day and 0.046 mg F/kg/day by tooth brushing with children's and and regular toothpaste, respectively. Fluorides doses were too close and is questioned if there is a real clinical relevance in terms of risk of dental fluorosis. It is important to evaluate if children's toothpastes does really represent a risk of fluoride intake when compared to the regular toothpastes in terms of risk of dental fluorosis. The hypothesis is that both children's and regular toothpastes can represente risks of development of dental fluorosis and can represent similar fluoride exposure by children.

NCT ID: NCT01567878 Completed - Clinical trials for Spondylitis, Ankylosing

Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects

Start date: May 2009
Phase: N/A
Study type: Observational

- Evaluate the correlation of ultrasound MASEI index with clinical, functional, radiographic and laboratorial variables in patients with ankylosing spondylitis. - Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound (synovitis, erosions, power doppler) with same variables. - Evaluate correlation between articular and enthesis ultrasound exam in this study. - Compare patients and healthy individuals data, to calculate the ROC curve to estimate predictor value of disease.