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NCT ID: NCT05721443 Recruiting - Clinical trials for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Cetuximab Plus Dalpicilib in Patients With HPV Negative, PD-1 Resistant R/M HNSCC

Start date: April 1, 2023
Phase: Phase 2
Study type: Interventional

This study is the first clinical study in PD-1 resistant patients with head and neck squamous cell carcinoma with drugs targeting EGFR signaling pathway combined with CDK4/6 inhibitors, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.

NCT ID: NCT05723263 Recruiting - Gonorrhea Clinical Trials

Pay-it-forward Gonorrhea and Chlamydia Testing Among Men in China

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

PIONEER is a three-arm, programmatic cluster randomized controlled trial (RCT) to compare effectiveness of three implementation strategies, followed by a mixed-methods implementation evaluation study

NCT ID: NCT05723536 Recruiting - Atrial Fibrillation Clinical Trials

PLAI-AF Trial: Hybrid Endo-epicardial Partial Left Atrial Isolation vs. Endocardial Ablation in Patients With Persistent Atrial Fibrillation

PLAI-AF
Start date: April 1, 2023
Phase: Phase 3
Study type: Interventional

In patients with symptomatic atrial fibrillation (AF), current clinical guidelines recommend ablation for rhythm control. While percutaneous ablation has good results in patients with paroxysmal AF, it is not clear which is the best technique in patients with persistent or long-standing persistent AF. Our group performed the first randomized study of thoracoscopic epicardial ablation vs. endocardial catheter ablation (FAST Trial), which showed better results for epicardial ablation but with a higher rate of complications. Hybrid epicardial and endocardial ablation strategies have recently been described sequentially, showing better results in patients with persistent AF, but 40% of patients are still refractory to ablation. Our study aims to compare the conventional strategy (catheter ablation) with partial electrical isolation of the left atrium endo-epicardially (pulmonary veins, posterior wall and left atrial appendage) in a single procedure in the group of patients most refractory to ablation. Likewise, using magnetic resonance imaging and echocardiography to analyze the atrial remodeling factors that can predict the success and failure of both therapies. Methodology: A 1:1 randomized clinical trial in patients with persistent and long-standing persistent AF in two groups: conventional ablation vs. partial endo-epicardial isolation. Prior to ablation, cardioversion will be performed and functionality and atrial size will be verified by echocardiography and delayed-enhancement magnetic resonance imaging (MRI) will detect the degree of fibrosis and atrial remodeling. During the ablation procedure, a continuous rhythm recording device will be implanted. Likewise, at three months the MRI will be repeated to detect post-ablation fibrosis. At six months the echocardiography will be performed to assess atrial function and size. Main Expected Results: The expected results include: 1. an improvement in the rate of patients with no atrial arrhythmias recurrence in patients undergoing endo-epicardial ablation; 2. a lower AF burden in patients undergoing endo-epicardial ablation who have had recurrence; 3. To know the degree of atrial fibrosis associated with the success/failure of each technique; 4. To know the degree of fibrosis that both techniques produce; 5. To know the degree of ventricular function associated with the success/failure of each technique; 6. To know the degree of potentially lost atrial function; 7. To Compare the safety of both techniques

NCT ID: NCT05726357 Recruiting - Clinical trials for Pulpitis - Irreversible

Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis

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

high-quality evidence is needed to add to current knowledge and also assess the long-term outcomes for full/complete pulpotomy after carious pulpal exposure in patients with signs and symptoms indicative of irreversible pulpitis

NCT ID: NCT05731349 Recruiting - Sepsis Clinical Trials

Impact of Early Sepsis Care Guided by the National Early Warning Score 2 in the Emergency Department

NEWS-1-TRIPS
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot clinical trial is to determine the feasibility of conducting a fully powered type 1 hybrid effectiveness-implementation trial on early sepsis care that is guided by early warning score in adult emergency department (ED) patients who have infection. The main questions it aims to answer are: - Is it feasible to execute the trial procedure and fulfill the progression criteria to a full-scale trial? - Does the Surviving Sepsis Campaign (SSC) Hour-1 Bundle care reduce the mortality of adult ED patients with a clinical diagnosis of infection and a National Early Warning Score 2 (NEWS2) equal to or greater than 5? - What are the barriers to and facilitators of the implementation of the SSC Hour-1 Bundle in the ED settings? Participants will receive the following SSC Hour-1 Bundle care during the intervention period: - Blood lactate level measurement - Blood cultures collection before administering antibiotics - Broad-spectrum antibiotics - Intravenous fluid - Vasopressors if the blood pressure remains low during or after fluid replacement to maintain the mean arterial blood pressure equal to or greater than 65 mmHg Researchers will compare patients who receive SSC Hour-1 Bundle triggered by a NEWS2 equal to or greater than 5 and patients who receive standard treatment based on clinical judgement to see if the SSC Hour-1 that is triggered by a high NEWS2 score could reduce mortality of adult ED patients with infection.

NCT ID: NCT05739747 Recruiting - Chronic Pain Clinical Trials

Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section

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

Chronic post-surgical pain is a problem that has historically been underestimated. Over the last few years there has been a search for strategies to both predict and prevent its occurrence in patients undergoing surgery. The Gendolcat index is the only predictive model that uses only objective pre-surgical variables to assess the risk of suffering chronic post-surgical pain. However, it is only validated for the following surgeries: thoracotomy, hysterectomy and open inguinal hernia. Our aim is to test whether the Gendolcat model is also valid for cesarean section.

NCT ID: NCT05741892 Recruiting - Fracture Tibia Clinical Trials

3D Planned Surgery of Acute Fractures Performed With 3D Guides Printed at the Point of Care

3DFRG
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The aim of the study is to assess the accuracy of fracture reduction performed with surgical guides designed and 3D printed at the point of care in comminuted fractures of femur- and tibia-shaft.

NCT ID: NCT05742152 Recruiting - Pain Clinical Trials

Reliability and Validity of Outcome Measures for Pain in Multiple Sclerosis

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

This project aims to provide values of test-retest reliability and insights from concurrent validity of outcome measures for pain in multiple sclerosis.

NCT ID: NCT05744271 Recruiting - Stroke Clinical Trials

Evaluation of FES+VFBT With Individuals With Lived Experience

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

Falls are an "emerging public health crisis" that cost the Canadian health care system billions of dollars each year. Moreover falls have a significant, detrimental impact on the lives of those who fall. In addition to physical injury and hospital admission, individuals may experience a post-fall syndrome characterized by dependence, depression, and reduced mobility and participation. Individuals living with the effects of neurological disease or injury are at a particularly high risk of falling. For example, 69-78% of individuals with spinal cord injury or disease (SCI/D) and 73% of individuals post-stroke fall at least once per year. Despite this high fall risk, evidence-based initiatives to prevent falls among those with SCI/D or stroke are lacking in neurorehabilitation. Furthermore, little time is dedicated to improving balance during inpatient neurorehabilitation. For example, ambulatory inpatients with SCI/D spend, on average, a mere 2.0±2.0 hours on balance training over the course of their entire inpatient stay. Our team is developing effective solutions to the "high-volume, high-risk and high-cost challenge" of falls. Our long-term objective is to develop an intervention that improves balance in a clinically meaningful and feasible way, facilitating the recovery of safe upright mobility and addressing the current health crisis of falls in individuals living with neurological disease or injury. The intervention will be developed with a focus on neurological populations, as these patient groups have a critical need for balance training; however, the intervention will be transferrable to other populations at risk of falls, such as older able-bodied adults. A probable solution to the gap in balance interventions is functional electrical stimulation (FES), whereby an electrical current is applied to peripheral nerves to facilitate muscle contractions. By applying the appropriate amount of electrical stimulation at the appropriate time during movement execution, the central nervous system can be re-educated, facilitating motor and functional improvements. The investigators developed a closed-loop FES system whose controller mimics the physiological control system. By combining this system with visual feedback balance training (VFBT), the investigators developed a prototype system of FES and VFBT (FES+VFBT). This intervention involves standing on a force plate with one's centre of pressure (COP) presented on a monitor. As the user moves his/her COP in response to a game, FES is delivered to the plantarflexor and dorsiflexor muscles through the device, MyndSearch.

NCT ID: NCT05745558 Recruiting - Cancer Head Neck Clinical Trials

PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)

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

The objective of this study is to determine the feasibility (main aim) and effectiveness (secondary aim) of a prehabilitation program in patients with head and neck cancer or liver cancer. Participating patients will participate in a 3-to-6 week rehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.