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NCT ID: NCT03977363 Terminated - Atrial Fibrillation Clinical Trials

The Portuguese Survey on Anticoagulated Patients Register (START-Portugal-Register)

START-Portugal
Start date: January 27, 2020
Phase:
Study type: Observational [Patient Registry]

Anticoagulants are used to prevent thrombotic events in patients with predisposing factors. However, the use of such therapies is associated with bleeding complications, which can be a serious safety issue. Thus, it is important to evaluate the safety and effectiveness of such therapies based on data collected in clinical practice in order to generate relevant scientific data that could be used to support clinical and regulatory decisions. This is an open, prospective, multicenter, observational cohort study that aims to prospectively record the clinical history of adult patients receiving anticoagulant treatment, irrespectively of the prescribed drug and the indication for its use.

NCT ID: NCT03976375 Active, not recruiting - Clinical trials for Metastatic Non-Small Cell Lung Cancer

Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)

Start date: June 26, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).

NCT ID: NCT03974477 Active, not recruiting - Hypertension Clinical Trials

Study With an Innovative Equipment to Monitor and Control SALT During Cooking

iMC_SALT
Start date: June 1, 2019
Phase: N/A
Study type: Interventional

In this study, the researchers will evaluate the efficacy of an intervention using the SALT CONTROL H instrument (an innovative equipment to monitor and control salt) in workers at the University of Porto to reduce dietary salt intake. This is a randomized clinical trial with intervention conducted according to good clinical practice guidelines. The researchers will randomize 260 workers who meet the eligibility criteria and are enrolled in occupational health appointments. Prior to the intervention, the informed consent of the participants will be obtained and those who agree to participate will be allocated randomly in one of the two arms of the study (control or intervention), with balance of baseline characteristics (sex and hypertension). The intervention will last for 8 weeks, an individual session of presentation of SALT CONTROL H will be carried out, with explanation of how the equipment works in the culinary preparation with an adequate salt content, will be used an illustrative video and recipes with an adequate salt content; use of SALT CONTROL H at home by the participant to control the use of salt during the cooking process; supervision and enhancement of the use of equipment; daily occurrence log; and the application of a satisfaction questionnaire on the use of SALT CONTROL H. A leaflet will also be delivered about "The new Food Wheel, a guide to the daily food choice!". Control Group: No intervention will be carried out except the provision of a leaflet on "The new Food Wheel, a guide to the daily food choice!" to the participants. Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention analysis will cover the following domains: urinary sodium excretion corresponding to a 24 hour urine collection as a proxy for salt intake; 24-hour urinary potassium excretion, sodium:potassium ratio, systolic and diastolic blood pressure, and anthropometric measurements. Urine samples will be collected according to standardized procedures and analyzed by a certified laboratory. Secondary data such as satisfaction questionnaire, daily use of equipment, iodine analysis of salt used and excreted in urine 24h, hydration status, analysis of quality of life and quality of diet will also be analyzed, as well as intestinal microbiota.

NCT ID: NCT03971682 Completed - Conduct Disorder Clinical Trials

The Efficacy of a Compassion Focused Therapy-based Intervention in Detained Youth

PSYCOMP
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

This non-randomized controlled trial with a control group aimed to assess the efficacy of a 20-session individualized Compassion Focused Therapy-based intervention, the PSYCHOPATHY.COMP, in reducing psychopathic traits (primary outcomes), aggression, shame, emotion regulation problems, and fears of compassion, as well as in increasing social safeness, self-compassion, and compassion towards others (secondary outcomes). The PSYCHOPATHY.COMP's impact on psychophysiological (i.e., Heart Rate/Heart Rate Variability) and behavioral indicators (i.e., number disciplinary infractions and number of days in punishment) were also tested, in order to ascertain if changes observed in self-report questionnaires were reflected in more adjusted psychophysiological and behavioral patterns. Mental Health disorders, as well as the number of Conduct Disorder criteria, were also tested as moderators of treatment effects.

NCT ID: NCT03971071 Completed - Migraine Headache Clinical Trials

A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache

Start date: October 7, 2019
Phase: Phase 4
Study type: Interventional

Study 20170703 is a phase 4, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of erenumab against placebo in participants with chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are diagnosed with medication overuse headache (MOH).

NCT ID: NCT03969329 Recruiting - Clinical trials for Secondary Hyperparathyroidism

A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

Start date: December 20, 2019
Phase: Phase 3
Study type: Interventional

Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric subjects between ≥ 2 to < 18 years of age, with chronic kidney disease (CKD) on hemodialysis

NCT ID: NCT03967613 Completed - Stroke Clinical Trials

Functional Eletrical Stimulation in Post Stroke Patients

FES-ABLE
Start date: June 15, 2019
Phase: N/A
Study type: Interventional

The FES-ABLE project results from an Iberian partnership and aims to evaluate the impact of an intervention based on a functional electrical stimulation (FES) prototype on the upper limb movement quality during functional tasks. The results of this project will contribute to the definition of the therapeutic window of FES to improve upper limb function in stroke rehabilitation.

NCT ID: NCT03965416 Completed - Communication Clinical Trials

Influence of White Coat During Family Medicine Consultation: Interventional Study

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Introduction: The white coat is a physician attire worn since the antiquity time. Several studies in other countries have shown that it influences doctor-patient's relationship and that there is some kind of preference over what a doctor should wear. In Portugal there are few data on this subject. Objectives: Investigate the influence of the white coat on satisfaction, confidence and empathy in relation to patients. Secondly, its impact on what patients perceive about medical knowledge, patients' opinions about medical clothing, and the level of satisfaction and comfort of physicians in consultation with or without the use of a white coat. Methods: An interventional study with a quasi-randomized representative sample of the population attending the health centers belonging to ARS Centro, consisting of 286 participants. The investigators collaborated with 16 doctors, male and female and of different ages which usually wore white coat in their medical appointments. The investigators included the first and last patients in consultation every day for 10 consecutive days, and every other day the doctor consulted with the use of a white coat or without the use of a white coat. At the end of the consultation, a questionnaire was distributed to the patient. This questionnaire had simple questions with a Lickert scale response, the portuguese version of the scale "Trust in physician" to assess the trust in the physician, both globally and in the medical-patient's relationship and their medical competences, and the JSPPPE-VP scale to evaluate empathy. A questionnaire was also distributed to the physician in which the doctor indicated what type of attire that used on that appointment and how satisfied and comfortable was with the consultation.

NCT ID: NCT03962608 Withdrawn - Clinical trials for Non-Alcoholic Steatohepatitis

Safety and Tolerability of Yaq-001 in Patients With Non-Alcoholic Steatohepatitis

Start date: January 31, 2021
Phase: N/A
Study type: Interventional

Gut-derived endotoxaemia, microbial imbalance and bacterial translocation play an increasingly recognized role in the progression from non-alcoholic fatty liver disease (NAFLD) to its more advanced state, NASH (non-alcoholic steatohepatitis). Animal model studies confirmed that Yaq-001 reduces liver injury and prevents steatosis in these models which leads to the theoretical potential of Yaq-001 altering the microbiome and gut permeability in patients with NASH. The purpose of this clinical trial is to study the safety and tolerability of Yaq-001 in patients with NASH. Results from this study will lead to the design of future pivotal performance and safety trials for registration purposes. Candidate patients must be between 18-70 years old and have a clinical diagnosis of NASH, determined histologically or phenotypically, as well as meeting other clinical inclusion/exclusion criteria. Eligible patients will be randomly assigned to receive standard of care treatment plus Yaq-001, or standard of care treatment plus placebo). The treatment lasts for 48 weeks. During treatment, the patient will have 6 study visits. At all the visits, the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital. On two occasions the patient will have a liver Multiscan and on three occasions the patient will have a liver Fibroscan. 70 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.

NCT ID: NCT03961958 Completed - Surgery Clinical Trials

Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning

Start date: July 2009
Phase: N/A
Study type: Interventional

Induction of anesthesia and the knee-chest position are associated with hemodynamic changes that may impact patient outcomes. Changes from baseline in cardiac output and other hemodynamic variables following induction of anesthesia and knee-chest positioning were compared. Propofol plasma concentrations were also measured after induction of anesthesia and after the knee-chest position. The aim of this study was to assess whether planned reductions in target-controlled infusion propofol concentrations attenuate the hemodynamic changes associated with anesthesia induction and knee-chest position. The secondary aim was to quantify the variation in propofol measured plasma concentrations (Cm), both after induction and after KC positioning, and correlate them with predicted concentrations (Cp) by the Schnider Pk model.