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NCT ID: NCT04254679 Completed - Abdominal Surgery Clinical Trials

Pilot Trial: Postoperative Opioid-free Analgesia

Start date: January 29, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

North America is facing an opioid epidemic fueled by surgeons, who are the second largest subgroup of physicians involved in opioid prescribing. Surgery often serves as the initial event for opioid-naïve patients to obtain a prescription for opioids and spiral into misuse and addiction. From the perspective of perioperative care clinicians, the answer to the opioid crisis may be using opioid-free analgesia. However, the number of comparative studies in this field is limited and existing small trials do not reflect current standards of care in North America. Lack of evidence means that the decision to prescribe opioids after outpatient surgery largely depends on surgeon preference and healthcare culture. Hence, there is an urgent need for a robust randomized controlled trial (RCT) to guide clinical decision-making. The feasibility and optimal design of this RCT should be informed by a pilot trial. The overarching goal of this pilot RCT is to investigate the feasibility of conducting a full-scale RCT to assess the comparative-effectiveness of opioid versus opioid-free analgesia after outpatient general surgery.

NCT ID: NCT04254523 Completed - Pain, Postoperative Clinical Trials

Programmed Intermittent Bolus Versus Continuous Infusion for Epidural Analgesia in Abdominal Surgery

Start date: November 14, 2019
Phase: N/A
Study type: Interventional

Epidural analgesia is an efficient way to relieve pain after major abdominal surgery. Two different protocols are used to provide analgesia: continuous epidural infusion (CEI) and programmed intermittent boluses (PIEB). CEI consists in the delivery of a continuous administration of the intended hourly dose. PIEB consists in the administration of sequential high pressure boluses of the intended dose. Although some studies in the postoperative setting have observed that PIEB reduces the total dose needed to ensure adequate pain control, the clinical value of this finding is still uncertain. Moreover, nursing and medical interventions to the epidural infusion rates are frequently needed in the first 48 postoperative hours to optimize the provision of analgesia. These interventions add to the already important nursing workload associated with major abdominal surgery, and are correlated with suboptimal analgesia for the patient. This randomized controlled trial aims to compare the effect of epidural PIEB on the workload as a reflection of adequate analgesia compared to the standard CEI protocol in use. The investigators hypothesize that the use of PIEB decreases the number of interventions needed to obtain adequate analgesia.

NCT ID: NCT04254302 Completed - Motor Disorders Clinical Trials

Using Telerehabilitation to Support Families of Children With Motor Difficulties Aged 3-8 Years Old

WeCare
Start date: February 20, 2020
Phase: N/A
Study type: Interventional

Background: Many children (about 1 child out of 20) have motor delays that are sometimes seen as "minor" and are not immediately explained by a specific diagnosis. These children are often underserved by existing health and rehabilitation services even though they are at risk of developing important negative outcomes in the long run. The most recent scientific evidence indicates that motor delays can be effectively addressed via early interventions supporting families and stimulating the child's development. Some researchers have proposed that such interventions could be efficiently and conveniently delivered online but no patient-centred, interactive online intervention has been formally trialed in Canada for children with motor delay and their families. Objectives: The goal of this study is to determine whether an online intervention can support families of children with motor delay. This study will determine whether the online intervention can improve the child's motor skills and parental self-efficacy, decrease parental stress, as well as increase the quality of life of both the parent and child. Description: The investigators will recruit 118 families of children with motor delay, 3 to 8 years of age, who are not yet receiving public rehabilitation services. These children will have been identified as at-risk of motor difficulties by their parents who will have completed a self-reported screening test for motor difficulties. Families will be randomly assigned to one of two groups: 1) control group (usual care) or 2) intervention group (access to the WECARE web platform, including one-on-one virtual meetings with health professionals, group and private discussions, verified resources). This study, conducted in Quebec, will be led by researchers, telerehabilitation experts, decision makers and patient advocates. Relevance: This study will evaluate an innovative, convenient and accessible intervention providing assistance for an important yet underserved population of children and their families.

NCT ID: NCT04253730 Completed - Clinical trials for Hypothermia Due to Cold Environment

Characterization of Corticospinal Excitability During Progressive Skin Cooling

Start date: August 22, 2019
Phase: N/A
Study type: Interventional

This study characterizes the changes in corticospinal excitability that accompany basic cold stress via skin cooling that result in reduced skin or core temperature and shivering.

NCT ID: NCT04253717 Completed - Lumbopelvic Pain Clinical Trials

Motor Control Exercise Program for Pregnant Women With a History of Lumbopelvic Pain

Start date: April 2, 2021
Phase: N/A
Study type: Interventional

This study protocol was designed to establish the feasibility of conducting a motor control exercise program with pregnant women presenting a history of lumbopelvic pain (LBPP) in order to reduce LBPP occurrence or limit its intensity. This randomized controlled trial also aims to preliminary assess the effectiveness of the program. To do so, 40 pregnant women with a history of LBPP will be recruited and randomly allocated to one of 2 groups: control (20 participants) or intervention (20 participants). The control group will receive standard care, including basic information on what to do when suffering from LBPP. The intervention group will participate in a weekly 40-minute group session and two more 40-minute weekly home exercise sessions. The motor control exercise program will be designed to target strengthening of the lumbo-pelvic-hip core muscles in order to improve stabilization and protection of the spine and pelvis. Participants of this group will also receive standard care. Adequate prevention and treatment of LBPP, experienced by women during pregnancy, should help reduce LBPP occurrence or limit its intensity during pregnancy.

NCT ID: NCT04253548 Completed - Clinical trials for Solid Organ Transplant

iPeer2Peer Pediatric Thoracic Transplantation

Start date: May 20, 2021
Phase: N/A
Study type: Interventional

With the on-going presence of a chronic illness, daily immunosuppressive medications, and the need for continuous medical supervision, pediatric transplant recipients face considerable psychosocial stresses. Treatment nonadherence is a major issue in pediatric transplantation and can lead to increased rates of hospitalization, rejection episodes, graft loss and death. An online peer support mentorship program (iPeer2Peer) is proposed as one intervention that could enhance patient care management, increase treatment adherence, reduce social isolation and improve health outcomes for this highly vulnerable population. The proposed trial will determine 1) implementation outcomes of the iPeer2Peer intervention in terms of: (a) feasibility and adoption, (b) acceptability and appropriateness and (c) level of engagement with the program, and 2) effectiveness of the iPeer2Peer intervention on improving health outcomes including disease self-management skills, treatment adherence, quality of life, perceived social support, stress and coping.

NCT ID: NCT04251390 Completed - Cerebral Palsy Clinical Trials

Initial Outcomes of Robotic Lower Extremity Exoskeleton Use by a Non-ambulatory Child With CP

Start date: December 6, 2019
Phase:
Study type: Observational

There are very few evidence-based interventions for children with cerebral palsy who cannot walk. The Trexo-Home is a device that is newly available for rent by families, but its impact is unknown. By tracking and recording various outcome measures throughout this project, the investigators hope to inform future larger scale controlled studies.

NCT ID: NCT04251195 Completed - Schizophrenia Clinical Trials

Verbal Memory Training Using Virtual Reality in Schizophrenia

Start date: February 12, 2019
Phase: N/A
Study type: Interventional

Verbal episodic memory is an independent declarative memory system associated with language and is responsible for storage and conscious recall of previous personal experiences. Verbal episodic memory is impaired in schizophrenia and is related to patients' functional outcomes. Because no medication has shown clear positive effects on verbal memory impairment in schizophrenia, there is a great need to find effective cognitive remediation treatments (CRT) that could improve this domain in this psychiatric population. Although CRT programs have shown small to moderate positive effects on verbal memory in individuals with schizophrenia, traditional lab-based computerised cognitive interventions have notable attrition rates. In recent years, along with the advancement of technology, the development of Virtual Reality (VR) has allowed the possibility for new training techniques. Previous studies have established the initial feasibility and safety of using VR in schizophrenia population. However, no studies have examined the feasibility, safety and efficacy of combining VR technology with verbal memory training among individuals with schizophrenia. Thus, in this study, we will adapt an exercise from the Strategy for Semantic Association Memory (SESAME; (Guimond et al., 2018; Guimond & Lepage, 2016) training to a VR environment. We aim to determine the feasibility of using virtual reality in the context of a cognitive remediation intervention and to assess the initial efficacy of our verbal memory training on the use of semantic encoding strategies in people with schizophrenia. We also aim to assess participants' experience and tolerability of the VR training.

NCT ID: NCT04250350 Completed - Atopic Dermatitis Clinical Trials

Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis

ADore
Start date: February 11, 2020
Phase: Phase 3
Study type: Interventional

This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to <18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.

NCT ID: NCT04250337 Completed - Atopic Dermatitis Clinical Trials

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

ADhere
Start date: February 3, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.