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NCT ID: NCT03060161 Completed - Human Clinical Trials

Health in the Right Measure: Promoting Healthy Food and Regular Physical Activity Practice for UFRJ Servers

HRM
Start date: May 10, 2018
Phase: N/A
Study type: Interventional

Introduction: The epidemiological transition is one of the factors related to the increase in the prevalence of chronic noncommunicable diseases (CNCD), such as cardiovascular diseases, diabetes and cancer. Among the risks of risk to the development of CNCD are obesity, smoking, alcoholism, sedentary lifestyle and inadequate eating habits, with the last two levels having a high impact on gender and disease progression. Objectives: To promote healthy eating habits and to combat physical inactivity through nutritional monitoring and regular physical exercise, using a competition to stimulate adherence of the institution's employees. Methods: The present project is in agreement with the longitudinal study with the work of evaluation (anthropometric, body composition, laboratory and food consumption), in the eats of the times (at the beginning and end of the four-month intervention period). According to nutritional monitoring and individual guidance on regular physical exercise practice over a period of 12 weeks. Weight reduction, body fat reduction, changes in working methods and eating habits, and the relationship to routine physical activity after the intervention period, and are retested after six months. Expected results: Reduction of sedentary lifestyle, weight loss and body fat, improvement of eating habits, quality of life without working environment and health condition of the participants.

NCT ID: NCT03058042 Completed - Clinical trials for Urinary Incontinence, Stress

Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. The hypothesis of this study is that home pelvic floor muscle training is as effective as outpatient pelvic floor muscle training for the treatment of stress urinary incontinence.

NCT ID: NCT03057977 Completed - Heart Failure Clinical Trials

EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)

Start date: March 6, 2017
Phase: Phase 3
Study type: Interventional

The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.

NCT ID: NCT03057951 Completed - Heart Failure Clinical Trials

EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)

Start date: March 2, 2017
Phase: Phase 3
Study type: Interventional

This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin lowers the chances of patients having to go to hospital for heart failure and whether it improves their survival. The study is open to patients with a type of chronic heart failure called chronic heart failure with preserved ejection fraction. Participants stay in the study until researchers have enough information about how effective empagliflozin is. It is expected that participants who enter at the very beginning of the enrolment period may be in the study for over 3 years, while participants who enter near the end of the enrolment period may be in the study for less than 2 years. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo tablets look like empagliflozin tablets but contain no medicine. Participants visit the doctors regularly. During these visits, the doctors collect information about the participant's health. The doctors want to know how many patients had to go to hospital because of heart failure or who died from cardiovascular disease.

NCT ID: NCT03057483 Completed - Influenza Vaccines Clinical Trials

Active Surveillance for Adverse Events Following Immunization With the Influenza Vaccine Produced at Butantan Institute

FLU-05-IB
Start date: April 6, 2017
Phase: N/A
Study type: Observational

Rationale and background: Since 2013, IB has been performing passive pharmacovigilance activities related to TIV. Objetive: To implement an active surveillance study as part of our pharmacovigilance plan while passive surveillance activities will continue. Pharmacovigilance data on TIV, via active surveillance, is being implemented in response to WHO requirements for pre-qualification of TIV. Study Design: This is a prospective cohort study. Population: Target groups for vaccination defined by The National Immunization Program of Brazil: children between six months and five years old; pregnant women; postpartum women (mothers until 45 days after birth); healthcare workers; and elderly (people over 60 years old). Study Size: A total of 900 individuals (300 health care workers, 300 elderly, 100 pregnant women, 100 post-partum women and 100 children between six months and five years old), presenting for immunization with IB TIV, and who agree to participate after providing Informed Consent. Data Analyses: Descriptive approaches will be used to meet the defined objectives described in the protocol, as well as formal statistical tests when appropriate.

NCT ID: NCT03057210 Completed - Healthy Volunteers Clinical Trials

Effects of Massage on the Short-term Post-exercise Recovery

Start date: April 3, 2017
Phase: N/A
Study type: Interventional

Objectives: To analyze the behavior of the effects of massage on clinical, metabolic and functional variables in different scenarios: i) under no stress or massage application; ii) after massage; iii) after exhaustion protocol; iv) after the immediate application of post-exercise massage; v) after application of the massage 1hour post-exercise. Method: This was a randomized cross-over clinical trial in which 24 participants had their clinical, functional and metabolic outcome data analyzed under different scenarios: i) control scenario (CO): basal condition (under no stress or massage application); ii) Massage (MA): after receiving the massage; iii) Exhaustion protocol (PE): after protocol of exhaustion; iv) PE + immediate massage (EMI): after the protocol of exhaustion followed immediately by massage; iv) PE + delayed massage (EMT): after the protocol of exhaustion and massage received 1h after its end. The exhaustion protocol used consisted of 10 series of 10 jumps and one Wingate test and the manual massage protocol was composed of 12 minutes of massage, 3 minutes for the anterior region of the thigh of each lower limb and 6 minutes to the dorsal trunk. The variables studied were: muscle soreness, perceived recovery, maximal voluntary isometric contraction (MVIC), strength and power in the guided bar, vertical jump and blood lactate concentration [Lac]. Measurements. The primary outcome measures will be measured 2h after the start of each stage, and the secondary outcome measures will be measured at specific times during each stage. The primary outcome includes measures of functional performance, and the measures of secondary outcome includes clinical and metabolic variables.

NCT ID: NCT03055754 Completed - Obesity Clinical Trials

Endoscopic Argon Plasma Coagulation Vs. Control For Weight Regain After Gastric Surgery

Start date: May 2016
Phase: N/A
Study type: Interventional

Bariatric surgery procedures have consistently been demonstrated to reduce long-term co-morbidities and mortality. Despite its benefits, weight regain is common, usually initiating around two years after the initial procedure, the underlying mechanism often being an enlargement of the anastomosis diameter for the Roux-en-Y gastric bypass. Although a reduction in the anastomosis diameter has been reported in association with endoscopic argon plasma coagulation, to our knowledge this therapy has not been formally tested in a randomized controlled trial. the objective of this study is to conduct a randomized, parallel controlled trial comparing endoscopic argon plasma coagulation to reduce the enlargement of the anastomosis diameter for the Roux-en-Y gastric bypass versus control with an initial diagnostic endoscopic followed by observation. The investigators hypothesize that the argon coagulation arm will achieve greater weight reduction, with a low incidence of adverse events.

NCT ID: NCT03053089 Completed - Clinical trials for Mucopolysaccharidosis I

Safety and Dose Ranging Study of Human Insulin Receptor MAb-IDUA Fusion Protein in Adults and Children With MPS I

Start date: October 2015
Phase: Phase 1/Phase 2
Study type: Interventional

AGT-181 is a fusion protein containing alpha-L-iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This is a safety and tolerability study to obtain safety and exposure data as well as information on the biological activity of the investigational drug. This is a two-stage, sequential, single and multi-dose study of AGT-181 in patients with MPS I. The first stage will be an open-label, single-dose, dose-escalation cohort study and the second stage will be an open-label, multi dose, adaptive dose escalation cohort study.

NCT ID: NCT03049735 Completed - Uterine Fibroid Clinical Trials

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Start date: April 26, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.

NCT ID: NCT03048422 Completed - HIV Infections Clinical Trials

Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants

VESTED
Start date: January 19, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil fumarate, and efavirenz/emtricitabine/tenofovir disoproxil fumarate in pregnant women living with HIV-1 and to compare the safety of these regimens for their infants.