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NCT ID: NCT06166901 Recruiting - Presbyopia Clinical Trials

Evaluation of Long-term Safety and Performance of PanOptix Intraocular Lens (IOLs)

Start date: April 27, 2024
Phase: N/A
Study type: Interventional

The purpose of this Post-Market Clinical Follow-up (PMCF) study is to describe the long-term safety and performance of the AcrySof PanOptix Trifocal toric and non-toric IOL models in subjects bilaterally implanted with these IOLs for 3 to 5 years. This study will be conducted in Spain.

NCT ID: NCT06166355 Recruiting - Anorexia Nervosa Clinical Trials

Improving the Treatment of Anorexia Nervosa in Children Through Virtual Reality Body Exposure

EOAN-VR-ABM
Start date: May 13, 2024
Phase: N/A
Study type: Interventional

The age of onset of anorexia nervosa has been progressively decreasing in recent years. Also, the prevalence rates of childhood anorexia in many countries have grown significantly. This increase was already observed before the COVID-19 pandemic, but the confinements and the stress derived from them have caused this increase to accelerate. As in adolescent and adult patients, in childhood anorexia some of the core signs and symptoms are an extreme fear of gaining weight and avoidance of food. The consequences of the early-onset of anorexia can be very important since the maturation of the organism is more incomplete in children than in adolescents. Weight loss can have very severe consequences, since in children the percentage of body fat is lower. On the other hand, hormonal disorders derived from food deprivation also have very severe consequences for the development of different organs. General physical development and growth can be affected, with consequences such as not being able to reach normal height. The research carried out to date on the efficacy of treatments for childhood anorexia is very scarce. There are no specific treatment strategies or settings for children with anorexia, and little research has been done to tailor treatment for younger patients. Given the need to explore new treatments for anorexia nervosa specifically aimed at children, the objective of this project is to develop a program to carry out exposure to one's own body through virtual reality, gradually, with progressive increases in size until achieving a healthy weight. In the virtual exposure, patients will observe the image of an avatar in a mirror for the time necessary in each session to produce the reduction of the anxiety response. The avatars that will be developed for this purpose will have a physical constitution corresponding to children under 14 years of age, and physical proportions equivalent to those of each patient. The positive results obtained with a previous version of this treatment originally developed for adolescents and adults suggest that its adaptation to children can open new ways for exploring effective treatments for childhood anorexia.

NCT ID: NCT06165978 Not yet recruiting - Clinical trials for Post-COVID-19 Syndrome

Physical Activity Coaching in Patients With Post-COVID-19

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

This randomized clinical trial aims to compare the effects of a 12-week behavioral physical activity intervention (i.e., physical activity coaching) with usual care (i.e., World Health Organization recommendations for being physically active) in patients with post-COVID-19 (i.e., patients who suffered from COVID-19 at any degree of severity in acute phase and experience symptoms for at least three months after discharge). This study aims to answer the following question: 1) Which are the effects of a physical activity coaching intervention compared with usual care in patients post-COVID-19 in the short-, middle- and long-term?

NCT ID: NCT06165666 Active, not recruiting - Stroke Clinical Trials

Effectiveness of Physiotherapy After Stroke

EPTAS
Start date: February 12, 2024
Phase: N/A
Study type: Interventional

The World Health Organization (WHO) defines Stroke or Cerebrovascular Accident as clinical sign of focal disorder in brain functioning of rapid onset, with a presumed vascular origin and duration of more than 24 hours. It represents the first cause of physical disability in adults, and approximately half of people who survive stroke present motor and sensitivity disorders, which cause alterations in functionality, especially in activities of daily living, with the consequent impact negative in participation in the environment and the quality of life of people and their families. The objective of the study is to know the effectiveness of a Physiotherapy intervention, based on the achievement of objectives, in improving functionality, participation and quality of life after a Stroke compared to treatment protocol. Methodology: single-blind randomized controlled clinical trial. The sample of 62 subjects (31 in each group) will be recruited at the Ramon y Cajal University Hospital. The Physiotherapy intervention will consist of 30 sessions, 3 times/week, for 10 consecutive weeks, in which the treatment for the Experimental Group will be based on training of specific tasks aimed at functional objectives previously agreed upon with the person/user vs. the Control Group who will receive a conventional Physiotherapy treatment protocol. The outcome variables are: perception of quality of life (Spanish version of The Newcastle Stroke-specific Quality of Life Measure); degree of functional disability (Barthel Index); level of gait functionality (Spanish version of Functional Ambulation Categories); dynamic balance and trunk control (Spanish version of Trunk Impairment Scale); postural control (Spanish version of the Postural Assessment Scale for Stroke Patients); and participation in the environment (Spanish version of the Oxford Participation and Activities Questionnaire). They will be collected at three times: before starting the study, initial assessment (V0), at the end of the intervention for each group, intermediate assessment (V1) and 6 months after V0 (V2).

NCT ID: NCT06165406 Recruiting - Clinical trials for Coronary Artery Disease

Distal Radial Access for Coronary Procedures

DISTAL
Start date: August 1, 2020
Phase:
Study type: Observational

Distal radial access (DRA) in the anatomical snuffbox (AS) is a relatively novel approach that can be considered an alternative to trans radial access (TRA) for coronary procedures. Several observational and randomized studies have established its feasibility and safety, with evidence of certain advantages over TRA, such as a reduction in hemostasis time, a lower incidence of complications at the puncture site, and a lower incidence of radial artery occlusion (RAO). Notwithstanding that a recent randomized study reported a similar RAO rate between DRA and TRA, several meta-analyzes confirm the advantages of DRA, despite a consistently higher crossover rate. The objective of this observational study is to assess the performance of the procedure and to compare clinical characteristics in an all-comer population undergoing diagnostic or interventional coronary procedures. The main questions it aims to answer are: - Determine the success rate of DRA and measure the incidence of RAO in an all-comer population undergoing coronary procedures. - Compare the clinical and anatomical characteristics of patients with DRA for coronary procedures and determine predictors of failure of access.

NCT ID: NCT06164951 Enrolling by invitation - Achondroplasia Clinical Trials

A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia

PROPEL3
Start date: November 10, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of infigratinib in children and adolescents with achondroplasia (ACH) who have completed at least 26 weeks of participation in the QED-sponsored study PROPEL (QBGJ398-001).

NCT ID: NCT06164041 Completed - Physical Activity Clinical Trials

Training and Detraining Effects of a Physical Activity Program Implemented Through Mobile Applications in Adolescents.

Start date: January 9, 2023
Phase: N/A
Study type: Interventional

The use of mobile applications to promote the practice of physical activity has begun to be used in the adolescent population in recent years. This has made it possible to carry out interventions inside and outside the educational setting, the latter being the ones that have brought the greatest benefits. Thus, it has been observed that the promotion of the use of mobile applications in out-of-school hours from the subject of physical education has reported significant benefits on body composition and fitness in the adolescent population. However, there is no known research that has analyzed whether the effect achieved with mobile applications when their use is mandatory disappears when they are no longer promoted from the physical education subject. Therefore, this project goes further and tries to find out whether after the ten-week period of mandatory use of the applications, adolescents continue to use the applications autonomously and the beneficial effects achieved are maintained or disappear due to the lack of use. For this purpose, a 10-week intervention was planned in which the adolescents used the mobile applications. Prior to the start of the intervention, the adolescents' body composition and fitness (pre) were measured. At the end of the intervention of mandatory use of the mobile applications, the adolescents were measured again (post). And after the post measurement, the adolescents were left for 10 weeks during which they could use the applications autonomously. A third measurement of the adolescents was performed after this 10-week period (post 2). The aim of this project was to find out the effects of stopping the use of the mobile fitness apps on body composition and fitness of the adolescents.

NCT ID: NCT06163716 Completed - Cognitive Decline Clinical Trials

GOIZ ZAINDU Feasibility Multi Domain Trial to Prevent Dementia.

GOIZ_ZAINDU
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

GOIZ ZAINDU ("caring early" in Basque) is a pilot study to adapt the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) methodology to the Basque population and evaluate feasibility and adherence to a FINGER-like multidomain intervention program. Additional aims included the assessment of efficacy on cognition and collecting data to design a large efficacy trial.

NCT ID: NCT06163391 Recruiting - Clinical trials for Advanced Solid Tumor

A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer

Start date: May 9, 2024
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SOT201 as monotherapy for participants aged 18 years or above with advanced unresectable or metastatic solid tumors During dose escalation, the recommended dose(s) of SOT201 given every 3 weeks (Q3W) will be determined

NCT ID: NCT06161883 Completed - Dietary Exposure Clinical Trials

Effect of Tomato Soffritto Intake on Biomarkers of Cardiovascular Disease in an Overweight and Obesity

FRITOCARD
Start date: March 15, 2013
Phase: N/A
Study type: Interventional

The study is a prospective, controlled, randomized two-arm longitudinal crossover trial, performed in a single-centre. Hence, the investigators designed a clinical study aimed to investigate the effects of a daily intake of soffritto in overweight or obese class-1 individuals without other cardiovascular risk. After a run-in period of two-week, participants were randomly separated in two different intervention sequences (two-arms) of six-weeks in which volunteers were administered with a soffritto (100 g/day) or a control group (without soffritto). After the first six-week period, participants had a wash-out phase of two-week followed by a second six-week period in which groups exchanged their interventions. During the duration of the study, the volunteers were asked to maintain their usual diet, excluding raw or cooked tomatoes, as well as tomato-based products (sauces, ketchup, juices, etc.) other than those administered during the study in the corresponding periods.