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NCT ID: NCT06469632 Recruiting - Clinical trials for To be Approved by the Ethics Committee

Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain

RASDOP
Start date: June 27, 2023
Phase: N/A
Study type: Interventional

About 30% of women experience pain in the perineum and pelvic region one year after the vaginal labor, rising up to 50% when it is triggered during vaginal penetration, called this pain as dyspareunia. An early physiotherapy treatment could be the solution to the pain relief of these women. Thus, the objectives of the present randomised clinical trail are (i) to determine the effectiveness of a physiotherapy treatment based on education therapeutic, the treatment of myofascial pain syndrome (MPS) of the pelvic floor muscles (PFM), and PFM specific training with or without radiofrequency in reducing pain and improving sexual function; and, (ii) to know the facilitating factors and barriers in adherence and perceived self-efficacy towards physiotherapy treatment of women with pelviperineal pain in the postpartum. Methodology: randomized clinical trial with examinator blinding and two parallel groups, followed by a qualitative study. Thirty eight women per group will be needed with postpartum pelviperineal pain between 8 weeks after labour, with intensity ≥ 4 cm on the visual analogue scale. The assignment will be random to an Experimental 1 group based on therapeutic education, plus conservative and invasive treatment of MPS and specific PFM exercise versus an Experimental 2 group consisted in the same treatment plus non-ablative radiofrequency treatment. In both cases, 12 individual supervised sessions will be held by a physiotherapist specialized in women's health, with evaluations pre- and post-intervention, at 3 and 6 months. The outcome variables will be the intensity of the pain, the presence of MPS at PFM, the PFM contraction quality, sexual function and specific quality of life. The qualitative study will be carried out in the assessment 6 months post-intervention, through interviews semi-structured and focus groups. The interviews will be guided with previous questions established, recorded, transcribed and thematically analyzed by a panel of experts.

NCT ID: NCT06469554 Recruiting - Frailty Clinical Trials

Effect of a Multicomponent Exercise Program With Virtual Reality (MEP-VR) vs Standard Approaches on Functional and Cognitive Domains in Hospitalized Geriatric Patients: Study Protocol for a Randomized Controlled Trial.

MEP-VR
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the effectiveness of a Multicomponent Exercise Program with Virtual Reality (MEP-VR) compared to a Multicomponent Exercise Program (MEP-only) or usual care, in terms of functional and cognitive outcomes in hospitalized older adults. The main questions it aims to answer are: - Does the MEP-VR program improve the functionality of hospitalized older adults compared to the other groups? - Does the MEP-VR program improve the cognitive, mood, and quality of life outcomes of hospitalized older adults compared to the other groups? Participants will be randomly assigned to one of three groups: a control group or one of the two intervention groups. The intervention groups will receive either the MEP-VR or MEP-only program, which consists of supervised aerobic exercise, resistance training, and balance training, with or without a virtual reality component designed specifically for this study. The intervention will take place over four consecutive days, with each session lasting 30-40 minutes. The primary outcome will be the functional changes at the time of discharge. Cognition, mood, quality of life, and VR usability will also be assessed. Technological advances are rapidly increasing with population aging, creating potential benefits for integrating technology into the care of older adults. This study comprehensively evaluates the implementation of VR combined with the multicomponent exercise program. If the hypothesis is confirmed, it would pave the way for modifying the hospitalization system and reducing the critical healthcare burden resulting from the commonly acquired disability in the older population.

NCT ID: NCT06468527 Recruiting - Cystic Fibrosis Clinical Trials

Clinical Trial to Evaluate the Efficacy and Safety of Dirocaftor/Posenacaftor/Nesolicaftor in Adults With CF

CHOICES
Start date: June 3, 2024
Phase: Phase 2
Study type: Interventional

CF is caused by mutations in the gene that encodes the 'Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)' channel. To re-establish the function of this complex chloride channel, typically two to three drug modes of action are needed. To date, clinical studies of CFTR modulators have focused on patients carrying the F508del CFTR mutation, which is present in approximately 80% of CF patients, or gating mutations which are present in 5% of CF patients (gating mutations result in a reduced opening of the CFTR-channel at the cell surface which limits the flow of chloride ions through the CFTR channel). Although CF is a monogenetic disease, the 15% remaining patients represent more than 2000 different rare and mostly uncharacterized CFTR mutations. Multiple pharma companies have one or more CF drugs in their developmental pipeline. However, it is not known which patients may respond to the drugs in the pipeline. It is hypothesized that by using individual patient's intestinal organoids to screen for drug response, a subset of patients with rare CFTR mutations can be identified who will clinically respond to drugs in the developmental pipeline. The Human Individualized Therapy of CF (HIT-CF) project has been designed to further evaluate this hypothesis. The project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 755021. The core of the project consists of a two-step approach to identify patients outside the existing drug label who may also benefit from CFTR-modulator treatment. In the first step of the project (HIT-CF Organoid Study, NTR7520), novel CFTR modulators and their combinations were tested on organoids from over 500 European and Israeli CF patients with rare CFTR mutations to identify patients who are predicted to clinically benefit from these treatments. The second step will evaluate the predicted clinical effect of the CFTR modulators in subjects identified by their organoid response to investigational products. CFTR modulators from the HIT-CF participating pharmaceutical company, FAIR Therapeutics, will be evaluated in the CHOICES clinical study described in this protocol. Data from this clinical study will be compared with the HIT-CF Organoid Study results to validate the organoid model.

NCT ID: NCT06468111 Recruiting - Emotional Stress Clinical Trials

Dog-Assisted Therapy in Children During Blood or Dental Extraction.

Extra-can
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

The purpose of the present study is to evaluate the efficacy of Animal Assisted Therapy (AAT) during blood extraction or dental procedures in a Primary Care Pediatric Service. Determine the improvement in facilitating the task of venipuncture or dental extraction for nursing or dental professionals. Estimate the reduction in the child's emotional stress during these procedures with the support of a therapy dog. Evaluate the emotional stress in the accompanying family member. These objectives will be accomplished through a randomized open label two-arm controlled study of AAT for children who need a blood or dental extraction.

NCT ID: NCT06467396 Recruiting - Clinical trials for Acute Ischemic Stroke

Blood Biomarkers to Predict the Prognosis of a Stroke Patient Undergoing Mechanical Thrombectomy

TROMBOPOCT
Start date: April 9, 2024
Phase:
Study type: Observational

The goal of this observational study is to evaluate the accuracy of a panel of blood biomarkers and clinical variables in predicting the prognosis of stroke patients treated by mechanical thrombectomy, specifically to predict futile recanalization and mortality.

NCT ID: NCT06467019 Recruiting - Clinical trials for Benzodiazepine-Related Disorders

Informative Exhibition for Deprescribing Benzodiazepines

ESUB
Start date: June 13, 2024
Phase:
Study type: Observational

The goal of this trial is to determine if an interactive and informative exhibition in the waiting room of a Primary Care Clinic can reduce the use of benzodiazepines in adults. The main question it aims to answer is: • Does an interactive and informative exhibition reduce the number of participants using benzodiazepines? Researchers will compare benzodiazepine consumption before and after the interactive and informative exhibition implementation at study center. Participants will receive an informative and interactive exhibition on the risks of chronic benzodiazepine use. A single informative session on the same topic will be conducted for health professionals.

NCT ID: NCT06466291 Recruiting - Wilson Disease Clinical Trials

Spanish Wilson Disease Registry

Start date: December 2, 2021
Phase:
Study type: Observational [Patient Registry]

The main objective and purpose of the Registry is to know the current status of Wilson Disease in Spain. As secondary objectives, the prevalence and incidence of the disease will be analysed. Likewise, the analysis aims to define future areas of interest in its pathogenesis, diagnosis, natural history, follow-up, prognosis and treatment. Improving knowledge at a national level can help to design screening strategies and improve diagnostic circuits.

NCT ID: NCT06464042 Recruiting - Clinical trials for Myocardial Infarction

Influence of Air Quality on the Development and Progression of Premature Coronary Artery Disease

AIRHEART
Start date: May 23, 2024
Phase:
Study type: Observational

The new global guidelines from the World Health Organization on air quality provide evidence of the damage that air pollution inflicts on human health at even lower concentrations than previously thought. Different studies have shown an increase in the incidence of coronary artery disease (CAD) in young people in recent decades. The main objective of this project is to study the impact of environmental pollutants on the premature manifestation of CAD from different epidemiological approaches and their impact on the evolution of these patients with a gender perspective. It is a retrospective analytical case-control study nested in a cohort of patients ≤40 years old with a clinical history of CAD including: ST-segment elevation myocardial infarction, non-ST-segment elevation acute coronary syndrome, unstable angina, stable angina or silent angina according to the international classification of diseases.

NCT ID: NCT06462352 Recruiting - Clinical trials for Small Intestine Disease

Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology

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

Since its introduction in 2001, small bowel capsule endoscopy has been pivotal in diagnosing small bowel pathology due to its minimally invasive nature and high diagnostic accuracy. However, the technology has limitations, including prolonged reading times and the need for specialized endoscopists. The Navicam endoscopic capsule, leveraging artificial intelligence (AI) with ProScan™ for automated reading, promises to address these limitations by reducing reading times and enhancing diagnostic efficiency. This study aims to assess the diagnostic concordance and to compare the efficiency of the AI-based Navicam capsule with the conventional Pillcam SB3 in the exploration of the small bowel.

NCT ID: NCT06460922 Recruiting - Kienbock Disease Clinical Trials

3D Printing Models in Surgical Planning of Osteotomies in Kienbock´s Disease Stages II-III

Start date: May 10, 2024
Phase:
Study type: Observational

Ischemic necrosis of lunate bone, osteonecrosis or Kienböck´s disease was described by Kienböck in 1910. Numerous surgical procedures for this disease had been proposed. These surgical options, that depends of the radiological stage and anatomical risk factors, can be classified into lunate unloading procedures, lunate revascularization, replacement procedures and salvage procedures. These procedures, except the salvage procedures, has been successful in reconstructing and maintaining the height of the carpus, avoiding progression of the disease and with reduction of the pain. The lunate unloading procedures are surgical treatments that make a radial osteotomy for modify differents anatomical risk factors associated with the osteonecrosis.