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Congenital Abnormalities clinical trials

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NCT ID: NCT06172790 Not yet recruiting - Clinical trials for Pulmonary Arterial Hypertension

The Effects of the Otago Exercise Program

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

The objective of this experimental study is to conduct a comparative evaluation of the effects of a supervised Otago Exercise Program (OEP) functional exercise capacity, blood lactate levels, dyspnea, fatigue, peripheral muscle strength, functional mobility, balance performance, quality of life, sleep status, and comorbidities in adults with pulmonary arterial hypertension (PAH) associated with congenital heart disease (CHD), as compared to a control group. The primary questions driving our study are: - Does the Otago Exercise Program contribute to an increase in functional capacity? - Does the Otago Exercise Program have positive effects on blood lactate levels, dyspnea, fatigue, peripheral muscle strength, functional mobility, balance performance, quality of life, sleep status, and comorbidities? The study participants will be randomly allocated into two groups (n = 50) using a randomized controlled design. The training group (n = 25) will undergo the Otago exercise program, supervised by a physiotherapist, conducted three days a week within a hospital setting for an 8-week intervention period. Following the initial assessment, a patient education session will be administered for the control group (n = 25) and all participants, providing information on disease pathophysiology and the benefits of physical activity. Evaluations will be conducted at baseline and post the 8-week intervention period. Our research project is designed to investigate the effectiveness of the supervised OEP in adults with CHD associated with PAH. Researchers will compare the training and control groups to determine the effects on functional capacity, blood lactate levels, dyspnea, fatigue, peripheral muscle strength, functional mobility, balance performance, quality of life, sleep status, and comorbidities.

NCT ID: NCT06114043 Not yet recruiting - Clinical trials for Hallux Valgus Deformity

Operative Versus Non-operative Treatment for Mild to Moderate Hallux Valgus Deformity

Start date: March 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to investigate operative treatment versus conservative treatment in participants suffering from mild to moderate hallux valgus deformity. The main question it aims to answer are; Is surgery superior to conservative treatment? The participants will be randomized in to two groups, operative and conservative group. Investigators will compare the groups measuring the clinical results using the patient-reported outcome measure (PROM) Manchester-Oxford Foot Questionnaire (MOxFQ), Visual analog scale (VAS), likert scale 0-5. Participants will be observed for a period og two years.

NCT ID: NCT06091332 Not yet recruiting - Clinical trials for Brain Stem Hemorrhage

Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: a Single Centre, Randomised, Placebo-controlled Trial

CALM
Start date: December 1, 2023
Phase: Phase 2
Study type: Interventional

This study employs a single-center, prospective, randomized controlled, double-blind exploratory research design. To investigate whether Sirolimus can reduce the rebleeding rate of brainstem cavernous malformations within 24 months after the first symptomatic bleeding event.

NCT ID: NCT06089629 Not yet recruiting - Ankyloglossia Clinical Trials

Frenuloplasty for Speech and Myofunctional Outcomes

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

Children with ankyloglossia (tongue tie) can have abnormal tongue function, putting them at a disadvantage when it comes to speech and articulation. Furthermore, abnormal tongue posture within the oral cavity increases the likelihood of myofunctional disorders.

NCT ID: NCT06077890 Not yet recruiting - Clinical trials for Arthritis, Rheumatoid

Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in Hand Arthritis

Start date: July 2024
Phase: N/A
Study type: Interventional

This study investigates the effectiveness of SIMPLI.REHAB, a digital tool employed as an interface for administering occupational rehabilitation programs to patients diagnosed with Rheumatoid and Psoriatic Arthritis. Both of these conditions are inflammatory joint disorders capable of causing significant morphofunctional alterations in the hands, especially in their advanced stages. The introduction of digital technology emerges as a complementary tool when implementing rehabilitation programs. Utilizing a prospective, longitudinal, single-blinded experimental study, 35 patients will be allocated into two groups: one receiving a complementary digital intervention through SIMPLI.REHAB and the other through a conventional rehabilitation program. Each group consists of six patients and the program spans seven weeks, focusing on therapeutic exercises, training in manual dexterity, and motor coordination, among other interventions, led by a Physiatrist. The study intends to measure outcomes based on functionality scores, pain, disease activity, joint range, grip, pinch strength, and manual dexterity, both before and after each intervention, in order to ascertain the efficacy of integrating dynamic content through the digital tool SIMPLI.REHAB, as a supplementary resource in occupational rehabilitation programs. The potential limitations of the study include potential losses of follow-up and difficulties in assessing adherence to the digital tool precisely. Nonetheless, the digital tool aims to augment functional gains in rehabilitation programs by providing patients with accessible dynamic content of home-based strategies.

NCT ID: NCT06053489 Not yet recruiting - Pediatric Disorder Clinical Trials

Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients

Start date: June 30, 2024
Phase:
Study type: Observational

The most commonly used anesthetic for general anesthesia in pediatric patients is sevoflurane, an inhalation anesthetic. However, the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients is high, with reports of up to 67%. Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) has a short context-sensitive half-life of 7.5 minutes, and the time it takes from the end of anesthesia until the patient wakes up is predictable. According to a study by Yang X et al., administering a small amount of remimazolam (0.2 mg/kg) intravenously at the end of general anesthesia using sevoflurane reduced the incidence of emergence agitation. However, very few studies have evaluated the use of remimazolam in general anesthesia in pediatric patients.

NCT ID: NCT06020417 Not yet recruiting - Spinal Fusion Clinical Trials

Pedicle Screw Malposition in Spine Arthrodesis Surgeries With O-ARM-guided Navigation

NoHARM
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Background: Throughout the history of spinal deformity there have been continuous advances in the surgical treatment. Although many techniques have been successfully developed despite the anatomy complex, screw placement still remains difficult with a significant risk of misplaced implants. The O-ARM guided Navigation is a scanner that allows imaging of screws intraoperatively and could be a tool to facilitate screw revision and reduce the occurrence of misplaced implants. Methods: This is a prospective and randomized clinical study that will be carried out at the University Hospital of the Federal University of Piaui, which provides exclusive assistance to patients of the Unified Health System (UHS), in northeastern Brazil.

NCT ID: NCT06011226 Not yet recruiting - Syringomyelia Clinical Trials

Development of a Patient-reported Outcome Measure for Chiari Malformation and Syringomyelia

BCS-score
Start date: September 2023
Phase:
Study type: Observational

Chiari malformation corresponds to the herniation of cerebellar tonsils into the foramen magnum resulting in obstruction of cerebrospinal fluid circulation, which may eventually lead to the formation of an intramedullary cavity called syringomyelia. Chiari and syringomyelia can be responsible of variable symptoms, based on which neurosurgeons might propose surgical treatment. Yet, there is no properly developped and validated patient reported outcome measure (PROM) to assess the clinical severity of Chiari malformation and/or syringomyelia. The lack of such evaluation tool is a major issue to determine the optimal therapeutic strategy and to achieve a standardized and reproducible follow-up.

NCT ID: NCT05983159 Not yet recruiting - Clinical trials for Arteriovenous Malformations

A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations

TARGET-VM
Start date: August 2024
Phase: Phase 2
Study type: Interventional

Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways. Targeted drugs specific to these pathways have been developed and shown to be effective in treating cancer. This study will describe the effectiveness of (i) 48 weeks of alpelisib therapy for participants with slow-flow vascular malformations and a gene mutation in one of these signalling pathways (module 1) and (ii) 48 weeks of mirdametinib therapy for participants with fast-flow vascular malformations and a gene mutations in the other signalling pathway (module 2).

NCT ID: NCT05982808 Not yet recruiting - Spinal Deformity Clinical Trials

CLIF Correction VS. Conventional Correction Strategy for ASD

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

The present study intends to: 1)establish a multi-center large-sample randomized controlled trial to explore the technical advantages and surgical indications of the novel surgical technique of CLIF correction for ASD compared with the conventional correction strategy; 2)analyze the postoperative clinical and imaging results, and to explore the related complications and preventive measures; 3) establish 2-year follow-up to further quantify the clinical and radiographical outcomes of CLIF correction.