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NCT ID: NCT06111144 Enrolling by invitation - Healthy Volunteers Clinical Trials

Effects of Polarized and Pyramidal Training Combined With or Without Mindfulness in Amateur Runners

Start date: August 16, 2023
Phase: N/A
Study type: Interventional

Road running in athletics has grown worldwide in recent years, which has led to an increase in the number of recreational runners. Despite this growth, research addressing this population is scarce, with major limitations and methodological weaknesses. Two of the topics of recent interest in runners are the effects of training intensity distribution (TID) and mental training using mindfulness on running time, body composition and physiological parameters related to performance in endurance sports; the maximal oxygen consumption (VO2max), maximal aerobic speed (MAS) and ventilatory thresholds (VT). The scarce evidence found identifies the TID polarized model as the most effective in sports performance and TID pyramidal model as the most used by elite runners. For mindfulness, it is identified as an emerging program that could contribute to performance in endurance sports.

NCT ID: NCT05966623 Enrolling by invitation - Deafness Clinical Trials

Assessing the Impact of Vidéo Remote Sign Language Interpreting in Healthcare

Impact of VRI
Start date: August 24, 2023
Phase: N/A
Study type: Interventional

This is a randomise study that looks at what is the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors versus the 'available standard of care of the usual communication tools, including informal interpretation, lip or note reading, using their mobile phones to contact a formal or informal interpreter, for Deaf patients aged 18 and older in Bogota Colombia

NCT ID: NCT05492799 Enrolling by invitation - MPS III B Clinical Trials

Safety, Tolerability and Efficacy of ICV AX 250 Treatment in MPS IIIB -OLE

Start date: December 2, 2022
Phase: Phase 4
Study type: Interventional

This is a Phase 3B/4, multicenter, multinational, open label study to further evaluate intracerebroventricular (ICV) delivered AX 250 treatment in MPS IIIB subjects that complete Study 250-202 for up to an additional 3 years (144 weeks) of treatment with AX 250 administered by ICV infusion every other week. Subjects will be evaluated for neurocognitive function, communication, adaptive behavior, quality of life, imaging characteristics and biochemical markers of disease burden. Safety will be assessed by adverse events, clinical labs, and physical exams.

NCT ID: NCT05352919 Enrolling by invitation - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus

EMERALD
Start date: June 10, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE). The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.

NCT ID: NCT05339048 Enrolling by invitation - Clinical trials for Cardiovascular Diseases

The Cartagena Cohort Study

CaReS
Start date: October 3, 2020
Phase:
Study type: Observational [Patient Registry]

Cardiovascular and respiratory diseases are the first and third cause of death, respectively. Cardiovascular risk is known to increase in groups with impaired lung function; however, the mechanisms behind this association are not fully understood. The aim of CaReS is to elucidate the shared pathophysiology of impaired lung function and cardiovascular risk, and to investigate the risk factors associated with them. The CaReS Cohort Study includes adults (18-80 years old) from Cartagena de Indias, a tropical city on Colombian Caribbean Coast, where recent population admixture settled a three-hybrid genetic structure (European, African and Ameridian ancestry). At baseline, the cohort will generate extensive data on -omics (e.g., genomics, transcriptomics, metabolomics, and epigenomics), socio-economic wellbeing, lifestyle, medical history, cardiometabolic, inflammatory and liver function markers, as well as objective measures of ventilatory and cardiovascular performance. The cohort will collect data every three years, for a total period of ten years. Prospective risk of cardiovascular disease and chronic obstructive pulmonary disease (COPD) will be investigated, and their risk factors. Throughout the study period, changes in prevalence, and interactions of various risk factors with these changes will also be ascertained. A predictive risk score for cardiovascular and chronic respiratory disability will be built, using cross-sectional and longitudinal data.

NCT ID: NCT04987229 Enrolling by invitation - Schizophrenia Clinical Trials

Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

Start date: October 22, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder

NCT ID: NCT04976322 Enrolling by invitation - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

Start date: July 27, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.

NCT ID: NCT04887246 Enrolling by invitation - Covid19 Clinical Trials

Monitoring the Effectiveness and Safety of COVID-19 Vaccines at National University of Colombia

Start date: March 15, 2021
Phase:
Study type: Observational

There are relevant questions that need to be answered about the effectiveness and safety of COVID-19 vaccines. The objective of this observational study is to follow up the clinical outcomes after vaccination in all the headquarters of the National University of Colombia. It is a project that is considered institutional importance and is part of the actions that the National University of Colombia has proposed to the national government to accompany the national vaccination program. The proposed follow-up includes the sociodemographic, cultural, clinical and pharmacological characterization of the vaccinated population, including the report of adverse events occurring after the vaccination process, the behavior of the population after the administration of the vaccine, monitoring serological outcomes, identification of medication errors and therapeutic failure. Three stages are proposed in which the population affiliated to UNISALUD is gradually included, then the beneficiaries and later the student community and their families. The scope of the attached protocol includes Stage I, which corresponds to teachers and administrative staff (active and retired) linked to UNISALUD.

NCT ID: NCT04829981 Enrolling by invitation - Clinical trials for Water-Related Diseases

SAFEWATER Health & Behaviour Impact Field Trials; Colombia

SAFEWATER
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

At least 1.8 billion people globally use a source of drinking water that is faecally contaminated and thus likely to lead to diarrheal illness: nearly 1,000 children die each day due to water and sanitation-related diarrhoeal diseases. Diseases related to the consumption of contaminated drinking-water place a major burden on human health. In 2017, 785 million people still lacked access to an improved drinking water source, and these are mostly the poor and marginalised. Almost a quarter of those people rely on surface water that is untreated and over 90% live in rural areas. Many people are forced to rely on sources that are microbiologically unsafe, leading to a higher risk of contracting waterborne diseases, including typhoid, hepatitis A and E, polio and cholera. The objectives of the SAFEWATER project is to develop technologies to provide clean water to economically deprived communities in rural Colombia and Mexico. These water technologies will be tested under real conditions with the cooperation of the rural communities. The SAFEWATER field trials aims to evaluate the health and behaviour impacts of implementing SAFEWATER water treatment technologies for drinking water disinfection, with a behavioral change intervention, within rural communities in Colombia and Mexico The project has three specific objectives: 1. Assess water quality improvement at household level 2. Assess behaviors and test behavioral interventions' 3. Assess child growth and related health outcomes Three communities in Colombia and one community in Mexico were recruited to take part in the study. Communities were selected based on factors such as current availability of clean water, accessibility, safety, community size and current activities within the communities. Pilot and feasibility studies were carried out prior to commencing field trials, thus the design of the trials vary across countries. Mexico field trial: The trial in Mexico will use a stepped-wedge design, randomized at household level over a 12-month period (6-12 steps dependent on adherence and feasibility). All households (max n200) willing to be involved will be recruited (separate clinicaltrials.gov registration). Colombia field trial: the trial in Colombia will use a non-randomized parallel design (2:1; intervention:control). A maximum of 84 households (54:30; intervention:control) will be recruited to take part, with families with young children (<12 years) prioritized. Outcomes for both countries will include 1) water quality, 2) water-related behaviour (e.g. frequency of system use, uses of treated / raw water), and 3) health, e.g. diarrhoea prevalence, growth (height/weight), school attendance, water insecurity status, gut integrity. Impact: The development and deployment of the SAFEWATER technology has the potential to impact on clean drinking water access for participating communities in Mexico and Colombia, and subsequently on the health and wellbeing of those individuals involved. Additionally if successful, the work will also provide an evidence based model for the provision of improved access to clean drinking water for rural communities in developing regions more widely.

NCT ID: NCT04736615 Enrolling by invitation - Clinical trials for Water-Related Diseases

SAFEWATER Health & Behaviour Impact Field Trials; Mexico

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

At least 1.8 billion people globally use a source of drinking water that is faecally contaminated and thus likely to lead to diarrheal illness: nearly 1,000 children die each day due to water and sanitation-related diarrhoeal diseases. Diseases related to the consumption of contaminated drinking-water place a major burden on human health. In 2017, 785 million people still lacked access to an improved drinking water source, and these are mostly the poor and marginalised. Almost a quarter of those people rely on surface water that is untreated and over 90% live in rural areas. Many people are forced to rely on sources that are microbiologically unsafe, leading to a higher risk of contracting waterborne diseases, including typhoid, hepatitis A and E, polio and cholera. The objectives of the SAFEWATER project is to develop technologies to provide clean water to economically deprived communities in rural Colombia and Mexico. These water technologies will be tested under real conditions with the cooperation of the rural communities. The SAFEWATER field trials aims to evaluate the health and behaviour impacts of implementing SAFEWATER water treatment technologies for drinking water disinfection, with a behavioral change intervention, within rural communities in Colombia and Mexico The project has three specific objectives: 1. Assess water quality improvement at household level 2. Assess behaviors and test behavioral interventions 3. Assess child growth and related health outcomes Three communities in Colombia and one community in Mexico were recruited to take part in the study. Communities were selected based on factors such as current availability of clean water, accessibility, safety, community size and current activities within the communities. Pilot and feasibility studies were carried out prior to commencing field trials, thus the design of the trials vary across countries. Mexico field trial: The trial in Mexico will use a stepped-wedge design, randomized at household level over a 12-month period (6-12 steps dependent on adherence and feasibility). All households (max n200) willing to be involved will be recruited (separate clinicaltrials.gov registration). Colombia field trial: the trial in Colombia will use a non-randomized parallel design (2:1; intervention:control). A maximum of 84 households (54:30; intervention:control) will be recruited to take part, with families with young children (<12 years) prioritized. Outcomes for both countries will include 1) water quality, 2) water-related behaviour (e.g. frequency of system use, uses of treated / raw water), and 3) health, e.g. diarrhoea prevalence, growth (height/weight), school attendance, water insecurity status, gut integrity. Impact: The development and deployment of the SAFEWATER technology has the potential to impact on clean drinking water access for participating communities in Mexico and Colombia and subsequently on the health and wellbeing of those individuals involved. Additionally if successful, the work will also provide an evidence based model for the provision of improved access to clean drinking water for rural communities in developing regions more widely.