There are about 10004 clinical studies being (or have been) conducted in Brazil. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product) Amgen.
This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. As of June 4, 2024, this study is no longer accepting any newly screened participants.
Obstructive sleep apnea (OSA) is a highly prevalent and morbid sleep disorder. Among the factors associated with its pathophysiology, the role of intermittent hypoxia stands out, contributing to the development of oxidative stress and inflammation. It is known that cumulative levels of these factors negatively influence the final portion of the DNA, known as telomere. In this sense, the investigators hypothesize that OSA is capable of accelerating aging process through telomere shortening mediated by inflammatory and oxidative markers. Thus, the aim of this study is to investigate the effect of OSA and its treatment with CPAP on the variation of telomere length and their associated mechanisms. For this, a randomized, double-blind, sham-controlled clinical study with 6 months duration will be conducted. We will recruit male participants with OSA diagnosis (apnea-hypopnea indexe15/hour), aged between 35-65 years and body mass index<35 kg/m2, which will be randomized to use CPAP or sham-CPAP for 6 months. Participants will visit the laboratory 7 times (baseline and after 1, 2, 3, 4, 5 and 6 months) and will be submitted to clinical and otorhinolaryngological evaluation, sleep questionnaires, polysomnography and blood collection for DNA and extraction and measurement of telomere length, as well as the expression of telomerase and oxidative and inflammatory markers (ADMA, homocysteine, cysteine, TBARS, 8-oxodG, TNF-a, IL-6 and IL-10). This project aims to contribute to the elucidation of the effect of OSA on telomere length maintenance, as well as the adjacent mechanisms to this relationship.
This study is to evaluate antiviral activity, efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3810109A in HIV-1 infected treatment naive adults. Participants will receive a single dose of GSK3810109A administered either intravenously (IV) or subcutaneously (SC). The study includes a screening phase, a randomized monotherapy phase and a standard of care follow-up phase.
Introduction: Heart failure (HF) is considered an epidemic with high morbidity and mortality that imposes limitations on affected individuals, decreases the quality of life, restricts social life and makes it difficult to carry out daily activities including work. Almost 50% of diagnosed patients are readmitted in less than 90 days after discharge. Therefore, rehospitalization is considered as a predictive cause of the increased risk of intrahospital death in patients hospitalized with HF due to underlying disease. Related to chronic diseases, self-care is essential in maintaining physical and psychological well-being because it corroborates the success of the treatment. The patient's observational and resolving capacity is necessary in view of the appearance of signs and symptoms that would be postponed or alienated and would end up in hospital. Objective: To verify whether an intervention focused on self-care reduces the number of readmissions, improves quality of life and provides greater post-traumatic growth in patients with HF. Method: Randomized clinical trial, parallel by intention to treat, with blinding for evaluation of outcomes. Adult patients who were admitted to a Hospital in the Serra Gaúcha and who were identified as having HF by the attending physician will be included. Upon discharge, patients will leave the hospital with a date and time to return to the HF Ambulatory. In the first consultation, patients will be invited to participate in the study and will answer a nursing screening instrument and the following instruments: WHOQOL-BREF and ICPT (respectively, quality of life and post-traumatic growth). In order of date and time when signing the informed consent form, patients will be randomized in 1: 1. From the second consultation, the intervention group will be followed up for guidance on the disease and treatment, totaling 12 sessions in 6 months. The control group will go through medical consultations as instructed by the doctor and will not receive intervention for health education by the nurse. After the end of the treatment, the patients will be followed in order to verify the occurrence of new hospitalizations in 6 months and in 1 year. At the end of 1 year the instruments will be replicated. Results: It is expected to enable the patient to remain free of the symptoms of the disease, following the prescribed treatment and being able to recognize any changes that signal an aggravation of the disease. It is hoped that the intervention in health education can decrease the rate of rehospitalization of patients, improve the quality of life and provide greater post-traumatic growth in patients with HF.
Context: CEMENT PBS CIMMO DTA® has physical and biological properties that classify it as a biocompatible material and inducer of biomineralization, attributes that qualify it as material as an indirect pulp capper in permanent tooth restorations. Objective: The present clinical study proposes the use of PBS CIMMO DTA® cement as an indirect pulp capper, in resin restorations composed of permanent molars and premolars. The objective was to minimize postoperative sensitivity arising from restorative procedures. Method: Randomized clinical trial with two arms, double blind, interventional, prospective. The sample consisted of 20 male patients, with an average age of 20 years. Totaling 70 teeth to be treated. The teeth were divided into two groups: Group R (Control Group, n = 35), treated with a standard restorative procedure. Group D (Study group n = 35), treated using CEMENT PBS CIMMO DTA®, as an indirect capper of the pulp wall. The evaluation was carried out by a masked examiner for both groups. Sensitivity tests were performed before the restorative procedure, at 48 hours, 7, 15 and 30 days after the procedure. The analysis included pain caused by thermal stimuli: Cold Test (TM); horizontal (TPH) and vertical (TPV) percussion; Bite Test (TM) and Pain Decline Time (DD) was measured. Measured using Visual Analog Scale (EVA).
To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs. Effects of the DX technology on related events, such as delivery of therapies and medical management, including eventual complications. Extended benefits offered by DX devices when associated with daily remote monitoring, by means of BIOTRONIK's Home Monitoring Service Center (HMSC).
The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) in male outpatients with mild to moderate COVID-19 disease
The present study refers to a three-arm randomized controlled trial that investigated the effects of two types of RT on frailty status, physical performance, cognitive function, and blood pressure of prefrail and frail older adults.
Insomnia is a frequent complaint and is associated with impairments in physical and psychological health. Although Cognitive-Behavioral Therapy (CBT) demonstrates effective results for insomnia, there are those who do not respond to this type of intervention or present difficulties in adherence. Acceptance and Commitment Therapy (ACT) presents itself as a potentially useful intervention for the treatment of insomnia, for which, instead of focusing on controlling the symptoms, the respective approach focuses on accepting the feelings and thoughts associated, through value-based actions. The aim of this study is to evaluate the effectiveness of ACT for chronic insomnia in adults. Participants will be 150 adults aged between 18 and 59 years, diagnosed with chronic insomnia who will be randomly assigned to the ACT, CBT and wait list (WL) groups. For both groups (ACT and CBT), the intervention will be performed in six group and weekly sessions. Assessments of sleep patterns, insomnia, depression, anxiety, psychological flexibility, acceptance of sleep, beliefs about sleep, personality traits will be performed in the pre-treatment, post-treatment and six-month follow-up. After the intervention is completed, participants will respond to an inventory of compliance and satisfaction. Treatment effects will assessed using the fixed effects of group variables (ACT vs. CBT-I and ACT vs. waitlist) and their interaction with time (pre-test vs. post-test and pretest vs. six-month follow-up). Estimated pairwise contrasts to examine changes across time within groups will be used. Variables will analyzed using generalized mixed models (GMM).