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NCT ID: NCT06362655 Enrolling by invitation - Physical Inactivity Clinical Trials

ACTIBESE Project - Active Behaviour in School Education

ACTIBESE
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The ACtive BEhaviour in School Education (ACTIBESE) project aims to assess and intervene in Chilean schoolchildren's active behaviours by examining the influence of personal, interpersonal, and school factors. This study includes a cross-sectional and intervention study involving 152 schools in the Valparaíso and Araucanía Regions, representing urban and rural areas. Participants, divided into children (8-11 years old) and adolescents (12-17 years old), will undergo a comprehensive evaluation, including sociodemographic characteristics, physical activity (PA) levels, parental and peer support, teaching styles of the teachers, and school environment characteristics. For the cross-sectional study, questionnaires, interviews, accelerometry, and pedometry will be used to collect data on various factors influencing PA in schoolchildren. In the intervention study, a 5-month continuous training program for teachers will be implemented, focusing on improving teaching styles and enhancing teaching competencies related to physical education and health classes. The program aims to positively affect schoolchildren's PA indirectly through improved teaching practices. The research will use mixed models, ANCOVA (Analysis of Covariance) , and logistic regressions for data analysis, incorporating multilevel logistic regressions to account for school-level dependencies. The study's outcomes will contribute valuable insights into the complex interactions between school, interpersonal, and personal factors influencing schoolchildren's PA, aiding the development of targeted interventions. This comprehensive approach aligns with the project's goal of fostering a physically active lifestyle among Chilean schoolchildren.

NCT ID: NCT06162065 Enrolling by invitation - Clinical trials for Urinary Bladder, Overactive

Effectiveness of Oral Boldo in Women With Overactive Bladder

Start date: November 1, 2023
Phase: Phase 1
Study type: Interventional

The objective of this clinical trial is to know if boldo oral powder capsules works well in the management of urinary symptoms in women with overactive bladder. The main questions it aims to answer are: - Is boldo supplementation safe? - Does boldo improve urinary parameters and body stability? 5 participants will be treated with an oral antimuscarinic (oxybutynin) and supplemented with oral spray bolus. The urinary chart will be applied to measure urinary frequency and voiding intervals. In addition, urinary symptoms and the level of discomfort they generate will be measured. Finally, the MiniBest test will be applied using a portable device which acts as an inertial sensor to record the movements made. For comparative purposes, 5 women who will only be treated with the oral antimuscarinic (oxybutynin) will be measured to see if there are significant differences between the medication alone versus the supplemented medication.

NCT ID: NCT05454904 Enrolling by invitation - Metabolic Syndrome Clinical Trials

Mediterranean Diet- and Psychological Well-being Theory-based Intervention to Reverse Metabolic Syndrome in Chile

CHILEMED
Start date: March 15, 2021
Phase: N/A
Study type: Interventional

Promotion of MedDiet adherence and psychological well-being in Chile offers a great potential to confront our ongoing epidemiological transition to increased risk factors and non-communicable chronic diseases. The main aims of this clinical trial are to design, implement, and evaluate the impact of a MedDiet- and psychological well-being-based intervention on reversal rate of MetS -compared to a control low fat diet- in Chilean adult population.

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: NCT05288478 Enrolling by invitation - Clinical trials for Epidermolysis Bullosa

Dose-ranging Study of Dentoxol® Mouthrinse for Managing Oral Symptoms in People With Epidermolysis Bullosa.

Start date: April 6, 2022
Phase: Phase 2
Study type: Interventional

Inherited Epidermolysis Bullosa (EB) is a disorder that causes skin fragility and blistering in skin and mucous membranes, including the mouth. Recurrent oral blisters and ulcer result in oral pain and discomfort. Dentoxol® is a mouthrinse that has anti-inflammatory, antimicrobial and analgesic effects. It has significant potential to reduce EB related oral symptoms. This study includes people living with Inherited Epidermolysis Bullosa aged 6 and above; and is aimed at determining the efficacy of two different dose regimens of Dentoxol mouthrinse in reducing oral symptoms.

NCT ID: NCT05221242 Enrolling by invitation - Healthy Clinical Trials

Clinical Trial on Ceramic Partial Laminate Veneers With Different Luting Agents

Start date: January 4, 2021
Phase: N/A
Study type: Interventional

Partial laminate veneers is a type of dental restoration made of a glass-matrix ceramic used to restore small teeth fractures, or to correct morphology defects of teeth (i.e.: diastema, conoid teeth or small misalignment). As tooth surface reduction, or tooth preparation is not needed for this type of restoration, it can be considered as a non-tooth preparation minimally invasive procedure. As non-preparation is required for the restoration with ceramic partial laminate veneers, bonding relies on adhesion between the intaglio surface of the ceramic restoration and the tooth surface, which in most of the cases is enamel. For this purpose, many light-curing resin cement materials are available for bonding procedures. Nowadays, pre-heated resin composites are available as a resin luting material which has been indicated for laminate veneers and partial indirect posterior restorations. As pre-heated resin composite has not been yet studied for partial laminate veneers, the objective of this randomized split mouth clinical trial, is to evaluate the survival of ceramic partial laminate veneers when bonded with two different resin composite luting agents.

NCT ID: NCT05020041 Enrolling by invitation - Physical Activity Clinical Trials

Change Physical Activity and School Play Space. Randomized Study Protocol.

Play&Cognition
Start date: July 22, 2021
Phase: N/A
Study type: Interventional

Physical activity is a factor that contributes to a motor and cognitive development in early childhood. Currently, childhood obesity has grown steadily in Chile. This study aims to evaluate the impact of a school environmental intervention on the physical activity and cognitive functions in 1st-grade schoolchildren during the COVID-19 pandemic. The study will use a randomized experimental design with a sample of 300 schoolchildren divided into a control and an intervention group (n=150 each group). Sociodemographic characteristics and lifestyle of the schoolchildren will be obtained through a questionnaire answered by parents/guardians. Cognitive function will be evaluated using the TENI test by tablet and physical activity will be measured during 7 consecutive days using accelerometers (Actigraph GT3X and wGT3X-BT). Both groups will receive a lecture aimed at schoolchildren. Teachers of the intervention group will also receive a talk regarding the intervention that will take place in their school environment, which includes a circuit of psychomotor games painted on the recess playground floor. ANCOVA analysis will be performed, adjusted for age and sex; then, a multivariate linear regression model will be applied considering the significant variables and adjustment. The significance level will be p<.05. SPSSv25 and R version 3.14 will be used for the analyses. The intervention is expected to contribute to the increase of physical activity favoring the school environment within a context of vulnerability and with a low-cost initiative

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: NCT04905693 Enrolling by invitation - Clinical trials for Idiopathic Pulmonary Fibrosis

Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

TETON-OLE
Start date: September 6, 2022
Phase: Phase 3
Study type: Interventional

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.

NCT ID: NCT04729907 Enrolling by invitation - Clinical trials for Muscular Atrophy, Spinal

Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With Nusinersen

ONWARD
Start date: April 19, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA) who previously participated in study 232SM203 (NCT04089566). The secondary objective of this study is to evaluate the long-term efficacy of nusinersen administered intrathecally at higher doses to participants with SMA who previously participated in study 232SM203 (NCT04089566).