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NCT ID: NCT05910788 Recruiting - Thoracic Surgery Clinical Trials

High-Flow Nasal Catheter (HFNC) Compared With Conventional Oxygenation

Start date: July 28, 2023
Phase: N/A
Study type: Interventional

The purpose of this study, is to clarify whether there is benefit from the perioperative use of HFNC in thoracic surgeries, from intubation to the postoperative period, evaluating hipoxemia during orotracheal intubation, immediate complications after intubation, mortality and in-hospital complications.

NCT ID: NCT05910632 Completed - Depression Clinical Trials

Eccentrically Reinforced Resistance Training vs. Traditional Resistance Training in Sedentary Older Women

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

There are easily accessible and safe strategies, such as physical exercise, that can contribute to reducing depressive symptoms and to the preservation of physical and executive function in elderly women. Resistance exercise is defined as performing in water or on land. It involves exercise using a constant load or a uniform weight regardless of the training program. There are many types of resistance exercise equipment, including free weights, pneumatic resistance machines, and elastic bands. Specifically, eccentric muscle contraction occurs when the force applied to the muscle exceeds the momentary force produced by the muscle itself, resulting in forced lengthening of the muscle-tendon system while contracting. To date, a body of evidence has been found derived from randomized controlled trials, which have compared the effectiveness of aerobic, resistance exercise and Pilates in decreasing depressive symptoms and improving physical and executive function in elderly women. Although there are experimental studies demonstrating the effectiveness of physical exercise, the effect of short-term eccentrically reinforced strength training on depressive symptoms, physical and executive function in sedentary older women is unclear. Therefore, this study aims to evaluate the safety and effect of eccentrically reinforced resistance exercise vs. traditional resistance training on depressive symptoms, physical and executive function, quality of life, different manifestations of muscle strength, body composition, vital signs and abdominal circumference, risk of falls, quality of sleep sedentary older women for 8 weeks.

NCT ID: NCT05910515 Recruiting - Injuries Clinical Trials

Improving Performance in Pediatric Trauma by Teaching Nontechnical Skills

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

The goal of this trial is to test a debriefing protocol to improve non-technical skills (NTS) in medical students. The study aims to answer the following questions: - Does a debriefing intervention improve medical students' NTS? - Does the intervention have an impact on the students' performance in simulated scenarios? Participants in the study will be randomly assigned to one of the teams, each consisting of a trauma team leader and three assistants. The teams will rotate across four different scenarios, allowing participants to switch roles and act as team leaders. The intervention teams will be debriefed using the study protocol, while the control groups will receive standard technical feedback without focusing on NTS. The primary outcome measure will be the Non-Technical Skills for Surgeons (NOTSS) score, which is a validated assessment tool for NTS. Secondary outcome measures include the number of correct interventions performed in each scenario. The study will involve 40 medical students, and the sample size was determined based on previous studies and statistical considerations. A panel of health educators will define the debriefing protocol, and the trial has been approved by the McGill Research Ethics Board office. The study findings are expected to contribute significantly to the training of providers of trauma care for children worldwide. By exploring the impact of debriefing on NTS in pediatric trauma education, this project aims to fill a critical gap in current training models.

NCT ID: NCT05910216 Enrolling by invitation - Parkinson Disease Clinical Trials

Online Dance Versus Therapeutic Exercise for Parkinson Disease.

Start date: October 16, 2023
Phase: N/A
Study type: Interventional

This is a randomized clinical trial in an online format, which will only include people with PD randomly divided into two groups: Group 1 - Social Telerehabilitation with Dance and Music Group 2 - Social Telerehabilitation with Multimodal Therapeutic Exercise and Music

NCT ID: NCT05909397 Active, not recruiting - Breast Cancer Clinical Trials

A Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer

VERITAC-3
Start date: August 9, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to understand the safety and effects of the study medicine ARV-471 (PF-07850327) given together with palbociclib in advanced breast cancer. In particular, the study will compare the combination of ARV-471 plus palbociclib to standard of care therapy (letrozole plus palbociclib). Both letrozole and palbociclib are medicines already used for treatment of breast cancer. ARV-471 is a new medicine under study. This study is seeking participants who have breast cancer that: - Have a locally advanced or metastatic disease and cannot be fully cured by surgery or radiation therapy. A metastatic disease is when disease has spread to other parts of the body. - Is sensitive to hormonal therapy such as tamoxifen. This is called estrogen receptor positive disease. - Have not received any prior medicine for advanced disease. Example medications include tamoxifen or letrozole or exemestane. The study will have an open-label SLI (study lead-in) before initiation of Phase 3 trial. During SLI, two dose levels of palbociclib in combination with ARV-471 will be explored in parallel. Assignment to the palbociclib dose is by chance. Half of the participant will receive one dose and the other half another palbociclib dose. The purpose of SLI is to determine the recommended Phase 3 dose of palbociclib to be administered in combination with ARV-471. In the Phase 3, half of the participants will take ARV-471 plus palbociclib while the other half will take letrozole plus palbociclib. In both SLI and Phase 3, participants will take the study medicines by mouth, with food, once a day. Participants will take the study medicines until breast cancer increase in size or side effects become too severe. Side effects refer to unwanted reactions to medications. Participants will visit the study clinic about once every 4 weeks.

NCT ID: NCT05909150 Recruiting - Acute Kidney Injury Clinical Trials

Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation

HSS-HT
Start date: November 8, 2023
Phase: Phase 2
Study type: Interventional

The goal of this study is to evaluate if hypertonic saline solution can prevent or attenuate acute kidney injury after heart transplantation in the early postoperative phase.

NCT ID: NCT05908357 Recruiting - Clinical trials for Autism Spectrum Disorder

Study of Two Exercises Protocols for Autism Spectrum Disorder

STEP-TEA
Start date: August 25, 2023
Phase: N/A
Study type: Interventional

Introduction: Autism Spectrum Disorder (ASD) is characterized as a neurodevelopmental disorder, with motor symptoms that may predispose to falls and gait changes. Exercises through virtual reality (exergaming) showed good results in children with ASD, but no studies were found that evaluated the effects of exergaming on gait and the risk of falls. Objective: To evaluate the effects of exergaming on motor performance during gait and the risk of falls in children with ASD. Method: Pilot study of a clinical trial. There will be 22 participants, diagnosed with ASD, level I or II; age: 5 to 9 years old; that they do not use medications that interfere with postural balance and falls; without physiotherapy care for at least 2 months. They will be divided into Exergaming Group (EG, n=11) and Control Group (GC, n=11). The GC will receive guidance through booklets. The EG will be submitted to a treatment with exergaming for 3 months, with 2 weekly sessions of 45 min each (initial 10 min, 25-30 of exergaming with the Xbox360 console with Kinect sensor and game "Kinect Adventures!", 5 min of cool down ). They will be assessed using CARS-BR (Childhood Autism Rating Scale - Brazilian version), DCDQ (Developmental Coordination Disorder Questionnaire), EEP (Pediatric Equilibrium Scale), a semi-structured questionnaire to assess the history of falls and prevalence of falls, an adapted motivational scale for ASD, a satisfaction survey, and three-dimensional assessment of gait through the Gait Laboratory. Descriptive analysis will be performed and continuous variables will be summarized in mean and standard deviation, and categorical variables in absolute and relative frequencies. To compare the independent and paired variables, parametric tests will be used and a significance level of 5% will be considered (p <0.05). Pearson's correlation will be used to assess correlations between continuous variables and the Chi square test to assess the relationship between categorical variables. Expected results: It is expected that children from the EG will obtain better results than the CG on gait variables and the risk of falling, with clinical and statistical significance.

NCT ID: NCT05907408 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Omics Techniques in Fatty Liver Disease

Start date: July 1, 2023
Phase:
Study type: Observational [Patient Registry]

Nonalcoholic steatohepatitis (NASH) is the most common cause of chronic liver disease in Western countries and one of the leading causes of liver transplantation in the world. Its spectrum ranges from simple steatosis to decompensated cirrhosis, resulting from progressive fibrosis due to inflammation and cellular injury. The reasons why patients with the same degree of steatosis have different evolutions are not sufficiently known. The objective of this project is to identify biomarkers that predict disease progression, using omics techniques, which can serve to develop new therapeutic strategies.

NCT ID: NCT05907291 Recruiting - Clinical trials for Congenital Adrenal Hyperplasia

Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)

Start date: July 3, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of CRN04894 in participants with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency.

NCT ID: NCT05907239 Recruiting - Clinical trials for Temporomandibular Joint Disorders

Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin

Start date: April 20, 2023
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in improving pain in patients with TMD pain after 5 weeks of treatment, 1 month and 3 months after the end of treatment. As secondary objectives, we plan to evaluate the effectiveness of focal shockwave therapy in relation to: 1. Range of motion (ROM) of the temporomandibular joint using goniometry after 5 weeks of treatment; 2. Degree of inflammation, using ultrasound evaluation in the temporomandibular joint relating to the degree of pain after focal shockwave therapy for 5 weeks; 3. Jaw movement (MM), joint noise (RA), joint pressure (PA) and disability index (DI) will be measured at each treatment session and after 5 weeks of treatment, 1 month and 3 months after the end of treatment in the affected joints; 4. Quality of life will be assessed using the "Short Form Health 36" questionnaire (SF-36) during the 5 weeks of treatment, 1 month and 3 months after the end of treatment; 5. Pain control medication will also be considered and compared before and after the proposed treatment for 5 weeks. Safety will be assessed throughout the study by monitoring the incidence of study-related adverse events. All patients will be contacted periodically and encouraged to report any side effects.