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NCT ID: NCT06230627 Completed - Spinal Cord Injury Clinical Trials

Feasibility of Home-Based Rehabilitation on Body Composition, Some Anthropometric Measures and Muscular Strength After Interruption 4-5 Years of Spinal Cord Injury: Serial Cases Study on ISIS War Survivors in Iraq

HBRP-SCI
Start date: December 21, 2021
Phase: N/A
Study type: Interventional

Feasibility of Home-Based Rehabilitation on Body Composition, some Anthropometric Measures and Muscular Strength after interruption 4-5 years of Spinal Cord Injury: Serial Cases Study on ISIS War Survivors in Iraq Summary Background: The war in Mosul wrecked hospitals and rehab centers, leaving a gap in rehabilitation services. This resulted in a need for alternative solutions for rehabilitation. Objectives: This study aims to create a home-based rehabilitation program (HBRP) that fits the participants' surroundings, and also detect and evaluate how effective it is in improving body composition, some anthropometric measurements, and muscle strength after a (4-5) year break in rehabilitation. Methods: This voluntary controlled trial included 18 volunteers split into three groups: 13 people with Spinal Cord Injury (SCI) their injuries time since (53.4-55) months. They joined voluntarily into Two groups, Eight in the experimental group (Exp.) and Five in the first control (1st Con.); while Five were healthy individuals in the second control (2nd Con.); all around (21.2) years old on average. The HBRP focused on muscles and whole-body joints by using the basic equipment and exercises right at the patient's homes. The program consisted of five weekly sessions with a gradually increasing achievement time of (45-120) minutes per session, participants were given rest time between exercises based on their level and severity of injury. The assessment was every three months. Results: The study found that HBRP were not significant differences in weight, BMI, some anthropometric measures and some muscle strength tests However, the HBRP had significant effects on waist/abdomen, pelvis, and left thigh anthropometric variables, with a large effect sizes and ranged between (η2= 0.84 - 0.95); and improvement percentages ranging from (IP= 2.4-16.2%), also had a large effect size on all lower extremity tests, head, and trunk, also improvement percentages were ranging (29.6-242.8%), exclude the pelvis elevating test. Also, there was a significant difference between the Exp. and 1st Con group in the Eight muscles test (P= <0.05) for the favour Exp. group. Innovatively, this study stands out by introducing an HBRP tailored for individuals with SCI after interruption sustained (4 - 5) years ago. This unique approach not only addresses the challenges posed by the interruption of previous rehabilitation efforts but also seeks to uncover the efficacy of rehabilitation in these specific circumstances. Conclusions: The study concluded that HBRP affected positively the muscles morphologically and functionally despite a stop in rehabilitation for a long period of (4-5) years for individuals with SCI.

NCT ID: NCT06103747 Completed - Fed Conditions Clinical Trials

Bioequivalence Study to Compare Metformin / Vildagliptin (850 mg/50 mg) Versus Galvumet®

Start date: February 21, 2023
Phase: Phase 1
Study type: Interventional

The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (850 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by SAIPH versus the reference product Galvumet® tablets (850 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis. This study also aims to monitor the safety of the subjects. This study is an open-label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing. Eighteen (18) Tunisian subjects will be enrolled in this study. Subjects will be healthy volunteers, adults, aged between eighteen to fifty (18-50) years, (both inclusive), within the accepted limits for body height & weight and meeting the selection criteria for this study

NCT ID: NCT06073600 Completed - Fed Conditions Clinical Trials

Bioequivalence Study to Compare Metformin / Vildagliptin Versus Galvumet®

Start date: May 20, 2022
Phase: Phase 1
Study type: Interventional

The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia versus the reference product Galvumet® tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis. This study also aims to monitor the safety of the subjects. This study is an open label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing. Eighteen (18) Tunisian subjects will be enrolled for this study. Subjects will be healthy volunteers, adults, aged between eighteen to fifty (18-50) years, (both inclusive), within the accepted limits for body height & weight and meeting the selection criteria for this study.

NCT ID: NCT06061198 Completed - Anxiety Clinical Trials

Impact of Virtual Reality on Patient's Anxiety Who Underwent Surgery Uner Regional Anesthesia

VRanxiety
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

this study was conducted in TAHER SFAR Hospital . it included 68 patients and it aims to evaluate the impact of virtual reality on patients undergoing upper limb surgery under regional anesthesia and evaluate the consumption of hypnotics during surgery , anxiety levels and patients satisfaction. this study contain 2 arms , each arm contain 34 patients . first arm received regional anesthesia and surgery under virtual reality using a VR gear . second arm received standard care

NCT ID: NCT05968014 Completed - Clinical trials for Enhanced Recovery After Surgery

Quality of Recovery After Hip Fracture Surgery: US-guided PENG Block Versus FICB

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Patients were randomly divided into two groups to receive either ultrasound-guided pericapsular nerve group block (PENG group) or fascia iliaca compartment block (FICB group), using 20 ml of 0.2% ropivacaine

NCT ID: NCT05886283 Completed - Clinical trials for Effect of Cataract Surgery on Corneal Endothelium; About 2 Techniques

Qualitative and Quantitative Endothelium Changes After Cataract Surgery: Ultrasound Phacoemulsification vs Nanolaser Technique

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Purpose: The aim of this study was to evaluate corneal endothelial cell density and morphology, central corneal thickness, and best visual acuity using US phacoemulsification or Nanosecond laser technique. Setting: Department of ophthalmology, Nabeul, Tunisia. Design: Prospective cohort study. Methods: The study included eyes with nuclear cataract density grade 1, 2, 3, or 4 according to LOCS III, divided into two groups; Group 1 had conventional US, and group 2 had nanosecond laser. The Endothelial Cell Density (ECD), coefficient of variation (CoV) in cell size, percentage of hexagonal cells, central corneal thickness and best visual acuity were evaluated over 24 months.

NCT ID: NCT05874583 Completed - Clinical trials for Arthroplasty, Replacement, Knee

Prevention of Bleeding in Total Joint Replacement: Combined Route Administration of Tranexamic Acid

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

The investigators aimed to compare two doses of intravenous (IV) tranexamic acid (TXA) with a combined single dose of topical and IV TXA on haemoglobin decline 24 hours after total joint arthroplasties. The investigators conducted randomized, double-blind trial. The participants were randomized to either intrvenous group receiving 2 doses of 1 gram TXA in intravenous route 3 hours apart, or a combined application group receiving the first 1 gram IV and the topical dose was 1.5 gram after reduction of the fascia.

NCT ID: NCT05874531 Completed - Ultrasonography Clinical Trials

End-expiratory Occlusion Test and Prediction of Preload Dependence

Start date: May 15, 2023
Phase:
Study type: Observational

Three sets of measurements of hemodynamic parameters and sub-aortic VTI were performed: before and at the end of 15 seconds end-expiratory occlusion and after 250 mL saline administration over 10 minutes. Patients were considered responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion. SPSS was used for statistic study. A p < 0.05 was considered significant. The investigators performed univariate and then multivariate analysis.

NCT ID: NCT05871073 Completed - Clinical trials for Lumbar Spinal Stenosis

Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery

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

Introduction: Improving postoperative pain management after spinal surgery is a significant challenge for surgeons and anesthesiologists. Pain following spinal surgery, can lead to significant morbidity, limit early mobility, and increase the risk of chronic pain. This trial examines the analgesic effects of dexamethasone as an adjuvant to ropivacaine in wound infiltration after lumbar surgery. Methods: In this study, we randomly assigned sixty patients undergoing lumbar laminectomy and/or osteosynthesis into two groups of 30 patients each. The control group (R-group) received only Ropivacaine (150 mg of Ropivacaine 7.5% (20 ml) added to 2 ml of normal saline in the wound infiltration), while the intervention group (RD-group) received Ropivacaine with the addition of dexamethasone (150 mg of Ropivacaine 7.5% (20 ml) added to 8 mg of dexamethasone in the wound infiltration). Both groups were administered patient-controlled analgesia (PCA) with morphine for self-medication. Postoperatively, a blinded evaluator assessed pain at H0, recorded the assessment of surgical scar pain using the Visual Analog Scale (VAS) at 4, 6, 12, 24, and 48 hours, as well as the time to the first opioid request, cumulative morphine consumption, opioid-related side effects, and length of stay. All patients were scheduled for a 3-month follow-up call to monitor chronic pain progression.

NCT ID: NCT05859542 Completed - Airway Management Clinical Trials

Place of the Video-laryngoscope in Learning Intubation by Simulation

Start date: June 1, 2023
Phase:
Study type: Observational

The aim of the study was to determine the impact of the videolaryngoscope on reducing the time needed to intubate on a low-fidelity manikin for beginners. The investigators conducted a randomised crossover study, which took place in the simulation department of the medical school of Tunis. They used a low-fidelity manikin designed for learning airway management. The first part of our session consisted in a theoretical training. The second part was the practical training with procedural simulation.