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NCT ID: NCT03220230 Completed - Lung Neoplasms Clinical Trials

Validation of Molecular Diagnostic Thecnologies for Lung Cancer Patients.

NIRVANA
Start date: July 6, 2015
Phase:
Study type: Observational

This is a non-interventional multi-center with investigational sites in Chile and Brasil diagnostic study to validate novel diagnostic technologies, such as Next Generation Sequencing (NGS) from both tissue and blood compared to the current gold standard. As a non-interventional study, patients will receive the treatment indicated by their doctor independently of their participation on this study. Many cancer cells look the same under the microscope. But as these cells are studied at the molecular level, some genetic alterations or defects that are more common to certain types of cancer are identified. In some cases, these defects are what make the cells grow and multiply abnormally. Biomarkers are the molecular fingerprints of these genetic defects. By testing a sample of your tumor for biomarkers, doctors can learn if your cancer has one of these defects, and that may point to a specific treatment choice. One of the genetic biomarkers that are believed to cause some cancers to grow is the ALK fusion gene. About 3% to 5% of people with NSCLC may test positive for ALK. ROS1 is a receptor found in 1 to 2% of people with this type of cancer. The present study is designed to advance the molecular testing methodologies to identify ALK+ and ROS1+ NSCLC patients. A positive correlation with these new technologies will mean an efficient, more accurate diagnostic test, which could impact a greater number of cancer patients around world.

NCT ID: NCT03220152 Recruiting - HIV, Prevention Clinical Trials

Implementation of PrEP to HIV in Brazilian Transgender Women

PrEParadas
Start date: July 10, 2017
Phase: Phase 4
Study type: Interventional

Subjects preliminarily eligible who choose to receive PrEP will be included after obtaining the informed consent and confirmation of eligibility within 45 days after the screening visit. Once included, participants will be examined in a follow-up visit performed four weeks later and evaluated for evidence of seroconversion to HIV, medication compliance and clinical toxicity. The second follow-up visit will occur at 12th week and every 12 weeks successively (quarterly). Quarterly visits include HIV testing, serum creatinine and counseling on medication compliance and risk reduction. The study has a total of 6 visits plus 2 extra visits for those participants enrolled in the PK study. In all visits will be assessed the risks, HIV testing will be performed, monitoring of renal function and dispensing of the drug Truvada [emtricitabine 1 tablet (FTC) / tenofovir (TDF) (200/300 mg) once a day orally for 12 months]. Participants who have completed 48 weeks of follow-up or prematurely discontinue a PrEP will be encouraged to return for a follow-up visit after discontinuation of medication for monitoring of the status and evaluation of HIV as the resolution of side effects.

NCT ID: NCT03219437 Completed - Psoriasis Clinical Trials

A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

Start date: July 30, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis.

NCT ID: NCT03219216 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection

Start date: June 6, 2018
Phase: Phase 3
Study type: Interventional

This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 to GT6 infection, without cirrhosis or with compensated cirrhosis, who were HCV treatment-naïve.

NCT ID: NCT03218891 Completed - Refractory Angina Clinical Trials

Cardiac Rehabilitation in Patients With Refractory Angina

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and feasibility of cardiovascular rehabilitation in Patients with refractory angina, evaluate the effect of cardiovascular rehabilitation in patients with angina Refractory, by maximal oxygen consumption (VO2max) and global myocardial ischemic load by Stress Echocardiography; To evaluate the presence of myocardial injury, caused by physical stress, through ultra-sensitive troponin after sessions of aerobic physical activity, evaluating the behavior during the training period; To evaluate the effect of rehabilitation on the modulation of sympathetic activity and inflammation, muscular blood flow and lipid metabolism; To evaluate of the effect of rehabilitation on ventricular function through Stress echocardiography; Detection of ischemic episodes and arrhythmias identified during the Rehabilitation sessions through external cardiac monitoring (telemetry); Evaluate the quality of life assessment through the SF-36 questionnaire, Canadian Cardiovascular Society, the number of symptomatic episodes of ischemia, daily sublingual nitrate intake.

NCT ID: NCT03218800 Terminated - Clinical trials for Urinary Tract Infections

Ertapenem Administered Subcutaneously Versus Intravenously

Start date: June 1, 2017
Phase: Phase 3
Study type: Interventional

Infections requiring intravenous antimicrobial therapy are very common events in patients with advanced cancer. Nevertheless, these patients frequently present vascular damages becoming extremely difficult to access and maintain intravenous route for hydration and nutritional support. In this context, the subcutaneous route could be implemented as an alternative route for replacement of fluids, electrolytes and drugs. Few studies have evaluated the possibility of using the subcutaneous route for treatment of infections though. Patients in palliative care often have infections caused by multidrug resistant bacterial such as beta-lactamase producing bacteria. In this context, we hypothesize Ertapenem subcutaneously is not inferior to the same drug intravenously for the treatment of urinary infections in patients on oncologic palliative care. A non-inferiority clinical trial would be adequate and could provide stronger evidence on the possibility of this alternative route for antibiotic therapy in urinary tract infections, with important advantages such as greater convenience of use.

NCT ID: NCT03217981 Recruiting - Sepsis Clinical Trials

Sepse: Critical Analysis of New Sepse Definitions and Retrospective Evaluation of Sepse Protocol at a Tertiary Hospital in Brazil

HUVR
Start date: August 2, 2017
Phase: N/A
Study type: Observational

Research in the databases Lilacs, BIREME, SciELO by the terms: systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis and septic shock and their equivalents in the English language. Selection of the main articles of the last five years to study and contextualize the reality presented since the implantation of the HUVR sepsis protocol. Statistical analysis of data since the implementation of the sepsis protocol in the HUVR, in July 2014 until June 2016.

NCT ID: NCT03217929 Not yet recruiting - Obesity Clinical Trials

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Food Craving in Obese Individuals.

taVNS
Start date: October 2017
Phase: N/A
Study type: Interventional

Background: Obesity is one of the most important diseases around the globe; with a continuous increase and public health concern. Current treatments present some limitations. Craving is a symptom usually noticeable and has been described as a "strong desire or urge to use", especially with foods. The vagus nerve and its relations to the neurocircuitry of the reward system play essential roles in food intake regulation and this can be done transcutaneously trough the auricular branch of the vagus nerve (taVNS). Based on the neurobiology of food craving and on the initial data on taVNS demonstrating safety and efficacy in open-label and randomized sham controlled trials, the investigators propose the first randomized, sham controlled, triple-blind trial on taVNS for food craving in obesity. Methods: This will be a two-arm, triple-blinded, randomized controlled trial with 54 subjects with food craving assigned to either: 1) a 10-session treatment protocol of real taVNS, or 2) a 10-session treatment protocol of sham taVNS, besides qualitative electroencephalogram (qEEG) and heart rate variability (HRV). Participants will be evaluated for primary outcome measures (Food Craving Questionnaire - State [FCQ-S] and Food Craving Questionnaire - Trait [FCQ-T]) before and after intervention, with a follow-up visit of 30 days after the end of treatment. A comparison between sham and active groups will be performed in three occasions [baseline (T1), at the end of the stimulation protocol (T2) and 30 days after the last day of stimulation (T3)]. Discussion: Given the epidemiological situation and economic and social burdens, the possibility of modulating the reward system neurocircuitry trough the vagus nerve with an easy-to-use, low-cost, safe and potential at-home use could represent a breakthrough in treating obesity. The investigators hypothesized that food craving in obese individuals would decrease at least 50%, as well as their intake of high fat, high sugar and processed food, commonly described as palatable foods. Beyond that, the investigators expect that these individuals would improve anxiety symptoms.

NCT ID: NCT03217136 Completed - Clinical trials for Complicated Intra-Abdominal Infection

MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)

Start date: April 3, 2018
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) plus metronidazole, compared with that of meropenem in pediatric participants with cIAI.

NCT ID: NCT03217006 Active, not recruiting - Clinical trials for Coronary Artery Disease

Randomization of Single vs Multiple Arterial Grafts

ROMA
Start date: January 7, 2018
Phase: N/A
Study type: Interventional

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival. Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.