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NCT ID: NCT04287543 Withdrawn - Parkinson Disease Clinical Trials

Melatonin on Clock Genes in Parkinson's Disease

Start date: May 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Parkinson's disease (PD) is the second most important neurodegenerative disease that affects about 2% of the population over 60 years of age. About 40% of the Mexican population with PD suffer from sleep disorders, which has been linked to a deregulation of the circadian cycle and therefore of the clock genes. Melatonin is a hormone produced by the pineal gland that regulates the sleep-wake cycle, at pharmacological doses, it is used to decrease sleep disorders; it is suggested that is used could also normalize the levels of the clock genes expression. In rats with PD, a decrease in clock genes levels has been observed, which are restored by administering melatonin. The aim of the study is to evaluate the effect of melatonin on the expression of the PER1 and BMAL1 clock genes in patients with PD during 12 months. A controlled, double-blind, randomized clinical trial will be carried out in patients with a diagnosis of PD. A survey will be applied in order to know the course of the disease and two more tests to rule out some sleep disorder, at the beginning of the study, at the 6th month and at the 12th month. A blood sample (approximately 15 ml) will be taken every 3 months for a year. By random assignment, the participant will be given Melatonin or placebo, which should be taken every day in the morning and evening after meals for one year.

NCT ID: NCT04286854 Recruiting - Reference Values Clinical Trials

Echocardiographic Assessment of the Right Ventricle in Healthy Subjects During Stress Test in the Mexican Population

ECORVStressMx
Start date: April 1, 2020
Phase:
Study type: Observational [Patient Registry]

The echocardiographic indices of the right ventricle function vary significantly with demographic and anthropometric of each population factors and are associated with poor prognosis in several cardiovascular diseases. This study aims to investigate exercise-induced changes in echocardiographic indices of the right ventricle function in healthy volunteers and establish the reference values to the Mexican population.

NCT ID: NCT04280705 Completed - COVID-19 Clinical Trials

Adaptive COVID-19 Treatment Trial (ACTT)

Start date: February 21, 2020
Phase: Phase 3
Study type: Interventional

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

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: NCT04274114 Terminated - Clinical trials for Generalized Anxiety Disorder

Treatment of Adults With Generalized Anxiety Disorder Using Glutamine

Start date: January 18, 2019
Phase: Phase 2
Study type: Interventional

The objective of this randomized clinical trial is to examine the efficacy of L-glutamine for the treatment of generalized anxiety disorder compared versus placebo.

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: NCT04271215 Active, not recruiting - Clinical trials for Leukemia, Lymphoblastic

Overweight and Obesity as Prognostic Factors for Survival in Children With Acute Lymphoblastic Leukemia

Start date: January 1, 2010
Phase:
Study type: Observational

Background: Mexico City has one of the highest incidences and mortality rates of acute lymphoblastic leukemia (ALL) in the world and a high frequency of early relapses (17%) and early mortality (15%). Otherwise, childhood overweight and obesity are reaching epidemic proportions. They have been associated with poor outcomes in children with ALL. The aim of present study is to identify if overweight and obesity are prognostic factors associated with survival rates in Mexican children with ALL. Methods: Multicenter cohort study. ALL children younger than 15 years old are included and followed-up. Overweight and obesity are classified according World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) criteria. Deaths and relapses are the main outcomes.

NCT ID: NCT04270747 Completed - Clinical trials for Neovascular (Wet) Age-related Macular Degeneration (AMD)

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD]

Start date: June 22, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular degeneration. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by intravitreal (IVT) injection.