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NCT ID: NCT06410365 Not yet recruiting - Clinical trials for Nausea and Vomiting, Postoperative

Impact of Intrathecal vs Intravenous Dexmedetomidine

Start date: June 1, 2024
Phase: Phase 4
Study type: Interventional

The purpose of this research is to evaluate the impact of intrathecal dexmedetomidine in comparison with intravenous route in patients undergoing cesarean section. Alternate hypothesis :Dexmedetomidine is more effective when given intrathecally as adjuvant to bupivacaine in elective cesarean section Null Hypothesis: Dexmedetomidine is more effective when given intravenously as adjuvant to bupivacaine in elective cesarean section Study Design: Randomized controlled trial Study setting: Watim General Hospital Study Duration: 18 months after synopsis approval Sampling technique: Simple random sampling Sample Size: Using the Open Epi program, a sample size of 60 patients (30 in each group) was determined with a 95% confidence interval and 80% power. Inclusion Criteria: - Pregnant women between ages 18-35 years - Belongs to ASA class I or II - Subjected to elective C-section Exclusion Criteria: - Any history of gastrointestinal disease diabetes, thyroid disease, hypertension, obesity, or anemia - History of alcohol or drug abuse; - Major complications of pregnancy - Patients have contraindication to spinal block or allergic to any of drug

NCT ID: NCT06410313 Not yet recruiting - Clinical trials for Superficial Femoral Artery Stenosis

First In Human Study to Assess Safety and Efficacy of the ChampioNIRâ„¢ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease

CHAMPIONSHIP
Start date: July 15, 2024
Phase: N/A
Study type: Interventional

This is a prospective, open label, multicenter, single arm, first in human clinical study. Patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled. The patients will be treated with the ChampioNIR Stent System. All implanted patients will be followed up at 30 days and 6, 12, 24 and 36 months. The follow-up visits will include patency evaluation by duplex ultrasound

NCT ID: NCT06409741 Not yet recruiting - Acute Pancreatitis Clinical Trials

PrEveNtion of Biliary Events After Acute Pancreatitis In NonSUrgicaL pAtients: PENINSULA Trial

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

Acute pancreatitis (AP) is a common condition and its main etiology is biliary. Cholecystectomy is the standard preventive treatment for recurrence of AP after admission. However, due to an increasingly older population and increased patient comorbidity, it is not always a possible option these days. If cholecystectomy is not performed, there is a significant risk for a recurrence of a biliopancreatic event (pancreatitis, biliary colic, choledocholithiasis, cholecystitis or cholangitis) of around 50% in the first year. This can lead to further episodes of pain, patient readmissions, and a reduced quality of life. Additionally, frequent readmissions can create a high cost burden on the health system. Currently, certain clinical guidelines propose biliary sphincterotomy as an alternative for patients in whom surgery is not feasible. However, this recommendation is based on retrospective studies with small sample size and the adherence to this recommendation is very low (12-23%). The goal of this clinical trial is to evaluate the recurrence of biliopancreatic events in the first year after admission for an acute biliary pancreatitis episode in patients that are not suitable for surgery. The main question it aims to answer is: Does biliary sphincterotomy prevent biliopancreatic event recurrence in non surgical patients after an episode of biliary acute pancreatitis? Researchers will compare biliary sphincterotomy vs conservative treatment to see if there is a reduction in biliopancreatic events during the first year after admission for acute pancreatitis in non surgical patients. Participants will be randomized to conservative treatment or biliary sphincterotomy and will be followed up for one year at 1 month, 6 months and 12 months to evaluate recurrence of BPE, readmissions, quality of life and mortality. Security of the technique will also be assessed in this specific population.

NCT ID: NCT06409611 Not yet recruiting - Clinical trials for Intensive Care Unit Acquired Weakness

MUSCLE EFFECTS OF NEUROMUSCULAR ELECTROSTIMULATION IN MECHANICALLY VENTILATED PATIENTS IN AN ICU

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

To prevent the development of ICUAW, both early mobilization and neuromuscular electrical stimulation (NMES) have been shown to prevent muscle atrophy in critically ill patients by preserving muscle mass. Furthermore, it is of great value that muscle assessment using kinesiological ultrasound becomes routine to monitor this patient's profile with regard to strength, muscle quality and muscle mass. Our objective is to evaluate the muscular changes promoted by NMES in patients under mechanical ventilation. This is a randomized clinical trial study, which will perform NMES sessions for at least 10 days in mechanically ventilated patients. They will also undergo ultrasound assessments of the quadriceps. Patients will be divided into a control group and an NMES group. In addition, general information recorded in the medical record will be collected, such as basic characteristics, laboratory tests and general assessments.

NCT ID: NCT06409364 Not yet recruiting - Clinical trials for Aneurysmal Subarachnoid Hemorrhage

FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage

FLASH
Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

A multi-centre, prospective, blinded, randomised clinical trial of fludrocortisone compared with placebo in patients presenting with aneurysmal subarachnoid haemorrhage. The study aim is to determine if early administration of enteral fludrocortisone in aneurysmal subarachnoid haemorrhage reduce death and dependency at six months.

NCT ID: NCT06408987 Not yet recruiting - Clinical trials for Developmental Dysplasia of the Hip

Arthroscopically Assisted Versus Open Surgical Reduction of the Hip in Patients With Irreducible DDH Before the Walking Age

Start date: May 15, 2024
Phase: N/A
Study type: Interventional

To determine the role of arthroscopy in treatment of the DDH.

NCT ID: NCT06408259 Not yet recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Start date: July 9, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).

NCT ID: NCT06407401 Not yet recruiting - Clinical trials for Musculoskeletal Pain

Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Women With Early Breast Cancer

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

This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+/HER2- early breast cancer with joint, muscle and/or bone pain caused by the endocrine therapy. The purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and/or bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).

NCT ID: NCT06407258 Not yet recruiting - Insomnia Clinical Trials

Promoting Sleep and Physical Activity Among Adolescent Psychiatric Patients

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

Mental health disorders pose a significant burden on adolescent populations globally, often accompanied by sleep disturbances. Emerging evidence suggests that addressing sleep issues can improve mental health outcomes, while physical activity is increasingly recognized as beneficial for both sleep and mental well-being. This study aims to assess the effectiveness of a novel intervention (SLEEPAC), combining cognitive-behavioral therapy for insomnia (CBT-I), circadian treatment, and PA counseling, compared to treatment as usual (TAU), in improving psychopathology among adolescent psychiatric outpatients with sleep disturbances. Secondary outcomes include improvements in sleep health, physical activity levels, cognitive performance and self-esteem. Additionally, the study seeks to explore the predictive value of sleep neurophysiological biomarkers using high-density sleep electroencephalography (EEG), contributing to advancements in precision psychiatry for this population.

NCT ID: NCT06406309 Not yet recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD

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

The goal of this study is test the hypothesis that sleep problems for children with ADHD are linked to sensory over-responsivity, a type of sensory processing difference that causes a person to interpret daily sensory input as stressful. This study examines the impact of sensory over-responsivity on bedtime arousal levels in 30 children with ADHD (ages 6-10). We will also test a bedtime intervention targeting sensory over-responsivity at bedtime and examine how it impacts bedtime arousal levels and sleep difficulties.