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NCT ID: NCT04293315 Active, not recruiting - Clinical trials for Colorectal Neoplasms

Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina

Start date: June 9, 2018
Phase: N/A
Study type: Interventional

Introduction: Early detection of certain types of cancer significantly increases the likelihood of successful treatment and reduces mortality from these causes. However, the use of screening and the early detection of selected tumors such as colorectal cancer (CRC) are lower than those expected in our country. The objective of this project is to evaluate the effectiveness of a multicomponent strategy that improves the screening and early detection of CRC in the population at risk of Primary Health Care Clinics (PCCs) of the public health system. Population: people leaving in the catchment area of 10 selected primary care clinics from the public health system in the province of Mendoza, Argentina. Design and methods: a Randomized clinical study by clusters. 10 PCCs will be included: 5 will be randomly assigned to receive an intervention to increase the CRC screening rates (improvement cycles) and 5 to the control arm (usual care). 150 participants will be included in each PCCs, in total, 1500 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 3 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) Percentage of the population at risk that completes the screening; 2) Percentage of the population classified as at habitual risk or increased by risk factors.

NCT ID: NCT04278417 Active, not recruiting - Clinical trials for Proliferative Diabetic Retinopathy

Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

CONDOR
Start date: November 19, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

NCT ID: NCT04277325 Active, not recruiting - Clinical trials for Partner Relational Problems

Efficacy of Emotionally Focused Therapy Among Spanish Speaking Couples

E(f)FECTS
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

70 couples (married or cohabiting) will be recruited across 5 countries (12-18 in each country: Argentina, Costa Rica, Guatemala, México, and Spain). After their entry into the study is confirmed, couples will be randomly allocated into one of two groups: intervention or control (no intervention). In each country, both groups will have equal number of couples. Couples in the intervention group will receive 20 sessions of Emotionally Focused couple Therapy (EFT). Couples in the control group will receive no intervention during the study period (they will receive a shorter intervention after the trial is over). Participants of both groups will fill questionnaires before allocation, during the intervention period and after the intervention period. The main outcomes will be couple attachment, couple satisfaction and dyadic adjustment. The original timeline for the study was to start in Argentina and Guatemala in February 2020, and the remaining countries in September 2020. The study started in February 2020 for Argentina and Guatemala, but in April 2020 the process was postponed due to mobility constrains during covid-19 crisis. During these two months, the process remained in the recruitment phase. Therefore, couples were not randomly assigned. Due to an improvement in the pandemic situation, the study started in Spain in September 2021.We expect the remaining countries will start during 2022. The study period for each couple will be around 6 months.

NCT ID: NCT04274101 Active, not recruiting - Chagas Disease Clinical Trials

Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment

Start date: June 1, 2018
Phase:
Study type: Observational

Chagas disease is caused by parasite Trypanosoma Cruzi. In Argentina, there is an estimated of 1.600.000 infected people. Due to migration phenomenon, most cases live in urban areas without vectorial transmission. Pharmacological treatment is given to prevent development of cardiac and gastrointestinal sequelae. There are two available drugs for this disease; Nifurtimox and Benznidazole. They both has proven efficacy for acute face treatment, with different security profiles. There are not enough adequate studies comparing both drugs made in a large number of subjects. Investigators will study 900 patients treated with both drugs and compare security and efficacy in a retrospective cohort.

NCT ID: NCT04273945 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension

UNISUS
Start date: June 30, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.

NCT ID: NCT04271475 Terminated - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

MACiTEPH
Start date: July 7, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).

NCT ID: NCT04271085 Completed - Terminal Care Clinical Trials

Living Well, Dying Well. A Research Programme to Support Living Until the End

iLIVE
Start date: September 1, 2020
Phase:
Study type: Observational

The iLIVE project involves a cohort study in which patients with an estimated life expectancy of six months or less are followed until they die. In total, the investigators will include 2200 patients in 11 countries, i.e. 200 per country. The primary outcome for the cohort study is a descriptive assessment of the concerns, expectations and preferences around dying and end-of-life care of patients and their relatives, in different settings and cultures..

NCT ID: NCT04267393 Terminated - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)

Start date: March 17, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).

NCT ID: NCT04266301 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

STIMULUS-MDS2
Start date: April 14, 2013
Phase: Phase 3
Study type: Interventional

This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high-risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator. The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with IPSS-R intermediate, high, very high risk MDS and CMML-2.

NCT ID: NCT04258891 Completed - Clinical trials for Kidney Transplant Failure

Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation

DYNAKT
Start date: January 1, 2004
Phase:
Study type: Observational

The incidence of end stage renal disease (ESRD) is rapidly increasing, now affecting an estimated 7.4 million people worldwide. Numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, ultimately leading to ESRD. Although some ESRD prediction models have been derived in the past years, none of these models are dynamic: they do not integrate the repeated measurements recorded throughout individuals' follow-up. As highlighted in several studies, kidney function repeated measurements (i.e., trajectories) are highly associated with graft survival after kidney transplantation. The investigators made the hypothesis that these trajectories may bring relevant information in the context of graft survival risk prediction model. Hence, combining these trajectories with standard graft survival risk factors may enhance prediction performance. This could permit to derive a robust tool that could be updated over time by continuously capturing patient' personal evolution.