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NCT ID: NCT03784547 Not yet recruiting - Multiple Sclerosis Clinical Trials

Real-world Data of Ocrelizumab in Multiple Sclerosis in LATAM

RWD_ocre
Start date: February 1, 2019
Phase:
Study type: Observational

It has been almost 25 years since the publication of the pivotal trial results for the first disease-modifying therapy (DMT) for RRMS. Currently disease modifying therapies (DMTs) for MS approved by the European Medicine Agency (EMA) and Food and Drug Administration (FDA) include interferon beta (IFNβ) 1-a and 1-b, glatiramer acetate (GA), mitoxantrone, natalizumab, fingolimod, teriflunomide, dimethyl fumarate, alemtuzumab, daclizumab and ocrelizumab. Despite evidence about ocrelizumab exist in many patients from Eurpe and North America, scarce real world evidence exists about epidemiolofcal aspects of patients that used ocrelizumab in Latin America. The aim of this study is therefore to evaluate patient profiles and persistence to treatment during follow up in a retrospective study of patients who had been prescribed ocrelizumab for the treatment of MS in Latin America (LATAM). The investigators will include MS patients that received ocrelizumab in Latin America and describe epidemiological aspects and persistance to treatment during the last 12 months.

NCT ID: NCT03784391 Not yet recruiting - Chagas' Disease Clinical Trials

Study on Benefits of Therapy With Nifurtimox in Chagas Disease, a Parasitic Illness Mostly Transmitted to Humans by a Bug, Using Information From Patient Medical Records in Argentina

Start date: December 31, 2018
Phase:
Study type: Observational

The researchers in this trial want to analyze prerecorded patient data which provide information on benefits of the drug nifurtimox in patients with a sudden (acute) and long lasting (chronic) Chagas´ disease an illness caused by parasites mostly transmitted to humans by a bug. They also want to learn how often organs, especially the heart, are affected by the illness in treated and untreated chronic Chaga's patients. In order to find this out medical records of adult and pediatric patients in Argentina will be analyzed.

NCT ID: NCT03775863 Completed - Liver Carcinoma Clinical Trials

AFP Model and Liver Transplantation.

Start date: November 11, 2017
Phase:
Study type: Observational

Background & Aim: Presence of microvascular invasion (mvi) in the explanted liver defines a higher risk of recurrence of hepatocellular carcinoma (HCC) after liver transplantation (LT). The aim of this study is to evaluate pre LT selection models of HCC recurrence specifically in patients without mvi in the explanted liver. Methods: Three multicenter cohorts are going to be included: a Latin American, a French and an Italian cohort of consecutive adult patients with HCC a first LT performed during two different periods: 2005-2011 and 2012-2016. AFP model is going to be compared against Milan and San Francisco criteria according to each models accuracy and prediction of HCC recurrence among patients without microvascular invasion in the explanted liver considering these candidates as "Low-risk patients". Multivariate Cox regression analysis, with hazard ratios (HR) and 95% confidence intervals (CI) for 5-year recurrence is going to be done with Competing Risk Regression analysis and corresponding Subhazard Ratios (SHR).

NCT ID: NCT03775798 Recruiting - Hepatitis C Clinical Trials

Incidence of de Novo Hepatocellular Carcinoma After Antiviral Agents for HCV.

Start date: May 1, 2016
Phase:
Study type: Observational [Patient Registry]

The main risk factor for development of hepatocellular carcinoma (HCC) is cirrhosis of any etiology, with an annual incidence risk between 1-6%; currently the leading cause of death in patients with cirrhosis and the 2nd cause of death by cancer worldwide. Chronic hepatitis C (HCV) is the first single cause associated to cirrhosis and HCC in the Western world. With the advent of new direct antiviral agents (DAA) of chronic HCV infection, virological cure generally exceeds 90% of the cases. Previous studies have shown that the incidence of HCC is lower in patients with virologic cure after treatment with pegINF schemes. However, recently published data, open up more controversy regarding the incidence of HCC after virologic cure with DAA. An increasing incidence of HCC after virologic cure in patients treated with DAA has been observed, opening a paradox yet unexplained. This project proposes to answer the following clinical research question: in patients with HCV cirrhosis treated with DAA, is there a change in the incidence of hepatocellular carcinoma? To answer this question a prospective longitudinal cohort study of patients with Child Pugh A-B cirrhosis will be held at 3 years minimum follow-up. A minimum of 210 patients will be included with clinical or histological or non-invasive diagnosis of cirrhosis Child Pugh A or B, with HCV treated with DAA and without hepatocellular carcinoma at the time of enrollment. From this cohort, patients who develop HCC during follow-up will be identified. Routine screening will be done through ultrasound every 6 months in all subjects enrolled and the diagnosis of HCC will be according to recommendations of European and American guidelines.

NCT ID: NCT03775551 Recruiting - Clinical trials for Cardiovascular Diseases

Counter-referral System Improvement Collaborative

BIDCR-R
Start date: June 8, 2018
Phase: N/A
Study type: Interventional

Coordination between different levels of care has been identified as one of the main components of care among people with chronic diseases. In this sense, an adequate referral and counter-reference system facilitates the management of the care process with timely access to the required referral. The objective of this project is to evaluate the effectiveness of a multicomponent strategy that improves the counter- referral process in patients with cardiovascular diseases in the public health system. Population: The study will be carried out in selected hospitals of the provinces of Mendoza, Tucumán and Salta in Argentina. Patients who have been hospitalized with a diagnosis of heart failure, hypertension (requires hospitalization) and / or coronary disease (unstable angina) will be included. Design and methods: a Randomized clinical study by clusters. 10 hospital will be included: 5 will be randomly assigned to receive an intervention to increase the improve counter referral rates (improvement cycles) and 5 to the control branch (usual care). 51 participants will be included in each hospital, in total, 510 participants. Intervention: An innovative vision is proposed, which combines a participatory and dynamic methodology based on improvement cycles. This approach includes the implementation of participatory learning sessions for health providers, involving the effectors of the design of the intervention. In the intervention branch at least 6 workshops (sessions) will be held with the members of the care system, in order to identify opportunities for improvement oriented to the design and application of an innovative intervention based on best practices. Each one of the sessions will constitute an analysis of the improvement cycle, following the following steps: 1) Selection of participants of the initial workshop; 2) Development of work model based on bibliographic review and initial qualitative phase; 3) Initial workshop with effectors for training in continuous improvement, objectives, interventions and data collection; 4) Learning workshops to discuss results, applicability of interventions and modifications to the work plan; 5) Closing session to evaluate preliminary results and discuss continuity of interventions beyond the project. Outcomes: 1) consultation in the PHC after hospital discharge; 2) readmission's; 3) consultations in the hospital; 4) follow-up in the PHC; 5) patient perspective (satisfaction).

NCT ID: NCT03773978 Recruiting - Clinical trials for Juvenile Idiopathic Arthritis

A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

JUVE-BASIS
Start date: December 17, 2018
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.

NCT ID: NCT03773965 Not yet recruiting - Clinical trials for Juvenile Idiopathic Arthritis

A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

JUVE-X
Start date: March 15, 2019
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV or I4V-MC-JAHU.

NCT ID: NCT03767244 Not yet recruiting - Prostatic Neoplasms Clinical Trials

A Study of Apalutamide in Participants With High‑Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Start date: February 15, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with androgen deprivation therapy (ADT) plus apalutamide (with or without abiraterone acetate with prednisone [AAP]) before and after radical prostatectomy in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS), as compared to ADT plus placebo.

NCT ID: NCT03766789 Active, not recruiting - Clinical trials for Adherence, Medication

Use of a Smartphone Application to Increase Adherence to Medical Treatment in Patients With an Acute Coronary Syndrome.

ADHERENCE
Start date: June 12, 2018
Phase: N/A
Study type: Interventional

ADHERENCE is a randomized unicentric study that will be carried out from a monovalent center of cardiology of the Autonomous City of Buenos Aires. Patients will be randomized hospitalization for acute coronary syndromes (ACS) with and without ST segment elevation at the time of hospital discharge to receive access to a digital application for smartphones or receive written instructions regarding the taking of medication as prescribed by doctors . They will have a total follow-up period of 90 days, in which the adherence to medical treatment will be evaluated through a questionnaire validated for that purpose. The objective of the study is to demonstrate that the use of a digital platform for smartphones increases the adherence to medical treatment by 30% in relation to the group without intervention

NCT ID: NCT03765918 Recruiting - Clinical trials for Head and Neck Neoplasms

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

Start date: December 17, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves major pathological response and event-free survival compared to radiotherapy (with or without cisplatin) alone.