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NCT ID: NCT06286553 Not yet recruiting - Clinical trials for Diastasis Recti And Weakness Of The Linea Alba

Rehabilitation of Abdominal Diastasis After Childbirth: Trunk and Inspiratory Muscle Training

DR-TIME
Start date: February 19, 2024
Phase: N/A
Study type: Interventional

Diastasis Recti Abdominis (DRA) is the separation of the rectus muscles caused by stretching and thinning of the linea alba during pregnancy and childbirth. It's a common condition, affecting 66-100% of women post-birth and can persist for many years, leading to abdominal protrusion, discomfort, and aesthetic concerns. It might also contribute to back pain, urinary issues, and reduced abdominal strength, impacting quality of life. Recent guidelines propose that conservative management, such as rehabilitation interventions, should be prioritized for DRA. However, there is a lack of consensus among researchers regarding the most effective exercise regimen, resulting in diverse rehabilitation programs. Recent evidence advocates not only for closing the gap but also for achieving optimal function. Current studies often neglect to address functional rehabilitation, underscoring the necessity for robust clinical trials, which is the primary focus of this study. Additionally, although breathing exercises are commonly prescribed for DRA, the precise role of the diaphragm, the primary respiratory muscle, in rehabilitation hasn't been fully examined. The diaphragm forms the upper boundary of the abdominal cavity and plays a key role in the stability of the trunk, working together with the abdominal and pelvic floor muscles. A recent study found reduced diaphragm excursion in postpartum women with lumbopelvic pain during a low postural demanding task, while previous studies suggest that diaphragm training could alleviate such symptoms influencing factors such as diaphragm thickness and excursion, which may be linked to improved trunk stability. Hence, training the diaphragm and accessory inspiratory muscles through Inspiratory Muscle Training (IMT) could potentially play a crucial role in managing DRA. In summary, the goal of this study is to develop and assess a comprehensive rehabilitation program aimed at effectively reducing DRA and addressing associated dysfunctions. The program will integrate evidence-based rehabilitation interventions, such as trunk stabilization exercises and IMT, targeting all related dysfunctions caused by DRA, and introducing a novel therapeutic protocol not previously implemented. The study will take the form of a prospective, randomized controlled trial (RCT).

NCT ID: NCT06284850 Recruiting - Tissue Oxygenation Clinical Trials

Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

Start date: November 30, 2023
Phase:
Study type: Observational

The aim of this study is to investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors.

NCT ID: NCT06283966 Not yet recruiting - Clinical trials for COPD (Chronic Obstructive Pulmonary Disease)

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

THARROS
Start date: February 22, 2024
Phase: Phase 3
Study type: Interventional

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

NCT ID: NCT06273748 Recruiting - Uveitis Clinical Trials

Retrospective and Prospective Observational Study on Non-infectious Chronic Uveitis in Pediatric Age

Start date: February 10, 2022
Phase:
Study type: Observational

Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the DPCM of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The AOU Meyer IRCCS is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases

NCT ID: NCT06269796 Completed - Child Development Clinical Trials

Identification of Neuromotor Signs in Preschool Children Suspected of Developmental Coordination Disorder

Start date: March 1, 2021
Phase:
Study type: Observational

This prospective study aimed to detect neuromotor signs early in preschool children suspected of Developmental Coordination Disorder (DCD). Preschool children aged 3-5 years old from municipal kindergartens in Thessaloniki participated in this study. The Little DCDQ questionnaire and the BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency) were used for assessment.

NCT ID: NCT06269770 Recruiting - Chronic Pain Clinical Trials

Tapentadol vs Tramadol in Total Knee Arthroplasty

Start date: May 1, 2023
Phase: Phase 4
Study type: Interventional

Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR).

NCT ID: NCT06269107 Recruiting - Type 2 Diabetes Clinical Trials

A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4)

COMBINE 4
Start date: February 15, 2024
Phase: Phase 3
Study type: Interventional

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks).

NCT ID: NCT06268873 Not yet recruiting - Clinical trials for Chronic Kidney Disease and Hypertension

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

Start date: March 29, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone. Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.

NCT ID: NCT06265259 Recruiting - Circulatory Shock Clinical Trials

Efficacy of the Use of Vasopressin as a Primary Vasoconstrictor in Critically Ill Patients

Start date: December 15, 2023
Phase: Phase 4
Study type: Interventional

Current guidelines recommend the inititaion of noradrenaline and if shock is refractory, then vasopressin should be administered. Data indicate that the earlier use of vasopressin may improve survival. Two large randomized controlled trial failed to prove a survival benefit from the early use of vasopressin. The present study will investigate the effect of an early initiation protocol of vasopressin (as the first vasoconstrictor drug) on the degree of multiorgan failure improvement and also on the course of sepsis (if in septic patients) versus early initiation of noradrenaline as first vasoconstrictor drug in hemodynamically unstable patients.

NCT ID: NCT06261957 Not yet recruiting - Asthma Clinical Trials

A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants 12 Years of Age and Older With Asthma

Start date: April 19, 2024
Phase: Phase 3
Study type: Interventional

The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged 12 years and above with asthma.