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NCT ID: NCT06448832 Not yet recruiting - Clinical trials for Abnormality, Congenital

Relationship of Muscular Agenesis: Thin Plantar and Palmar Long as a Biomarker of Injury and Performance Marker in the Lower Limb and Upper Limb Respectively

MA-TP-PL
Start date: September 1, 2024
Phase:
Study type: Observational

This study investigates muscle agenesis, specifically the absence of the palmaris longus and plantaris muscles, and its effects on injury risk, strength, and performance. Muscle injuries are common in sports, and the presence or absence of certain muscles can impact biomechanics and injury susceptibility. The study involves 132 subjects, divided into those with and without muscle agenesis, assessing injuries with the Nordic and CMDQ questionnaires and measuring strength with dynamometers. Results aim to clarify the controversial impact of muscle agenesis on functional disability and performance adaptation in the scientific literature.

NCT ID: NCT06448182 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effect of a Postbiotic Intake on Glucose Control and Microbiota Composition of Type 2 Diabetic Subjects: a Randomized Controlled Trial.

Diabet2Predict
Start date: June 3, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to evaluate the effect of the administration of a postbiotic on glycemic control, insulin resistance and microbiota composition in subjects with type 2 diabetes. The main questions it aims to answer are: - Study the evolution of biochemical variables related to glycemic metabolism: basal glucose, basal insulin, glycemic variability through sensors, glycosylated hemoglobin (HbA1c), HOMA-IR index, C peptide. - Perform a metagenomic analysis of intestinal microbiota in stool samples. - Perform a metabolomics analysis on blood samples. - Analyze the genetic profile in blood. - Evaluate the evolution of biochemical variables related to lipid metabolism: total serum cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides. - Assess the evolution of variables related to liver function: transaminases (ALT/AST). - Analyze the evolution of the blood count. - Evaluate the evolution of anthropometric variables (weight, height, waist and hip) and body composition. - Analyze the evolution of blood pressure. - Analyze eating and physical activity habits. - Evaluate adherence to treatment and adverse events. - Personalization on the use of postbiotics and other nutritional recommendations based on the genetic profile and the identification of patient clusters. For this purpose, a randomized, double blind parallel study has been designed. Target sample size is 158 subjects. Participants will be allocated in two groups for 12 weeks: - Experimental group (n=79): daily consumption of one postbiotic capsule. - Placebo group (n=79): daily consumption of one placebo capsule. Researchers will compare the consumption of a postbiotic supplement to a placebo. Participants will visit nutritional intervention unit at week 0, week 2, week 10 and week 12 of the study.

NCT ID: NCT06447506 Not yet recruiting - Dermatitis, Atopic Clinical Trials

Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.

AtDvance
Start date: June 4, 2024
Phase: Phase 2
Study type: Interventional

The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).

NCT ID: NCT06446934 Not yet recruiting - Hypertension Clinical Trials

AKTIIA OBPM to Assess CPAP Effect on Blood Pressure in Obstructive Sleep Apnea

AVLA1
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if positive airway pressure (CPAP) therapy works for blood pressure (BP) control in obstructive sleep apnea (OSA) adult patients plus undiagnosed hypertension (HBP), using a cuffless bracelet for continual optical BP monitoring (AKTIIA OBPM). It will also learn if CPAP improves cardiac function in these patients using speckle tracking echocardiography (STE) and to learn about ease of use and patient experience with AKTIIA device and AKTIIA OBPM. The main questions it aims to answer are: - Does CPAP reduce systolic BP (and other BP metrics) in this population? - Does CPAP improve cardiac function in the same population? Researchers will compare BP metrics derived from AKTIIA OBPM and STE metrics in a before and after CPAP therapy to evaluate its therapeutic effect. Participants will: - Take a CPAP titration and telemonitoring program for 12 weeks (from the titration date) - Take an AKTIIA OBPM one week before CPAP and 12 weeks since CPAP titration date - Take a STE test twice, before starting CPAP and 12 weeks after CPAP titration date - Take an online survey about easy of use and patient experience with AKTIIA OBPM device

NCT ID: NCT06444789 Not yet recruiting - Parkinson Disease Clinical Trials

AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)

dBM-DEV
Start date: July 15, 2024
Phase:
Study type: Observational

dBM-dev study is a multicentre low-intervention research study which concerns REM sleep behaviour disorder (RBD) who is the best predictor for neurodegenerative diseases including Parkinson's disease (PD). RBD can only be confirmed by polysomnography, which is a cumbersome procedure. The main objective of this study is to identify a novel, robust dBM for the detection of RBD using smartwatch-based recordings of passive data.The study is conducted step-wise on two subsequent cohorts referred to as the development cohort and the confirmation cohort.

NCT ID: NCT06443502 Not yet recruiting - Pouchitis Clinical Trials

A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

Start date: June 25, 2024
Phase: Phase 3
Study type: Interventional

When some people have their large bowel removed, a surgeon can make a "pouch" from part of the small bowel to connect it to the back passage (anus). Pouchitis is when the pouch becomes inflamed (swollen) or infected. The main aim of this study is to find out if vedolizumab improves pouchitis symptoms and pouch inflammation. Other aims include to find out if vedolizumab is well tolerated and if it causes any medical problems (adverse events or side effects) and to look for any changes in the well-being of participants during their treatment with vedolizumab. Participants will receive up to 6 infusions of vedolizumab. First 3 infusions are in first 6 weeks (Day 1, Week 2 and Week 6). Participants who are getting benefit may continue with the treatment for up to 7.5 months (30 weeks) in total. After completing treatment with vedolizumab, participants will visit their clinic for a health check at Week 34. One final health check will be scheduled 4.5 months (18 weeks) after the last vedolizumab infusion. Participants who continue to benefit from their treatment at the end of this study will be invited to continue treatment with vedolizumab in another clinical study (Vedolizumab-3042).

NCT ID: NCT06442774 Not yet recruiting - Pregnancy Related Clinical Trials

MamaConecta: Digital Tool for Maternal Mental Health

DDT
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period. The primary purpose is to improve maternal well-being, early detection of mental health issues, and aid in the diagnosis and monitoring by healthcare professionals in women transitioning into motherhood. The main questions it aims to answer are: - Does the app improve overall maternal well-being during the perinatal period? - Can the app increase the early detection rates of perinatal mental health disorders? - Can the app be an effective tool to support healthcare professionals to diagnose perinatal mental health problems? - How effective is the app in improving obstetric outcomes and the psychological and cognitive development of infants? Researchers will compare the group using the app with a control group not using the digital tool to see if Dana provides significant improvements in maternal and infant health outcomes. Participants will: - Use the mobile application from 12-14 weeks of gestation until 24 months postpartum. - Undergo regular assessments to monitor their emotional state, lifestyle, clinical, and obstetric data. - Participate in evaluations for their infants' psychological and cognitive development at various stages from birth to two years old. This trial is conducted at multiple centers, including Hospital Vall d'Hebron, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona and ASSIR Litoral (Barcelona), Hospital del Mar, following CONSORT standards. The study aligns with the Health and Culture priorities of the Spanish Government's Scientific, Technical, and Innovation Research Plan 2021-2023.

NCT ID: NCT06440668 Not yet recruiting - Quality of Life Clinical Trials

Management of Chronic Non-Cancer Pain With Non-Pharmacological Therapies

Start date: June 10, 2024
Phase: N/A
Study type: Interventional

A randomized controlled clinical trial will be conducted, involving a psychoeducational activity as the intervention. There will be a control group of patients with non-cancer chronic pain who will continue their usual treatment. The trial will end after 3 months. Pain, well-being, medication management, mood, self-esteem, and quality of life will be compared just before starting the workshop with the status at the end of the workshop (one month later) to assess the immediate effect, and three months later to evaluate the medium-term effect. These measurements will be taken in both the control and intervention groups. Additionally, for the intervention group, a follow-up will be conducted six months after the workshop ends to assess the long-term effect duration. This study does not allow blinding of patients or professionals conducting the intervention, but the person analyzing the data to compare the effect produced in the control and intervention groups will be blinded. Therefore, it is an observer-blind evaluation.

NCT ID: NCT06439277 Not yet recruiting - Obesity Clinical Trials

A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Start date: June 2024
Phase: Phase 3
Study type: Interventional

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.

NCT ID: NCT06438666 Not yet recruiting - Clinical trials for Hemiparetic Cerebral Palsy

Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation (tCDS) in Children With Spastic Hemiparetic Cerebral Palsy

PeditCDS
Start date: March 20, 2025
Phase: N/A
Study type: Interventional

Spastic Hemiparetic Cerebral Palsy (SHCP) uses to limit the manual function. Using anodic transcranial direct current stimulation, it is possible to activate certain cerebral areas depending on where the electrodes are. This study will use this kind of stimulation on the contralateral primary motor cortex of the affected upper limb and analyze the effects.