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NCT ID: NCT05454592 Completed - Quality of Life Clinical Trials

Peer-Presented Versus Mental Health Service Provider-Presented Mental Health Outreach Programs for University Students

Start date: January 3, 2020
Phase: N/A
Study type: Interventional

The overarching goal of the present study was to evaluate a MHSP-presented versus peer-presented mental health resilience skills-building online video outreach program against a wait-list comparison group.

NCT ID: NCT05454072 Recruiting - Sinusitis, Chronic Clinical Trials

Microbiota Transfer for Chronic Rhinosinusitis

SNMT
Start date: June 15, 2022
Phase: N/A
Study type: Interventional

Chronic sinusitis (CRS) is a common inflammatory condition of the sinuses that affects up to 2.5% of the Canadian population, and is thought to be caused by bacterial infection, resistant biofilms, chronic inflammation and possibly an unhealthy population of sinus microbes (or microbiota). Symptoms include nasal obstruction and discharge, facial pain, loss of smell and sleep disturbance, which all strongly impact quality of life. CRS treatment involves nasal or oral steroids, repeated rounds of antibiotic, and sinus surgery. Despite maximal treatment, some recalcitrant patients suffer with CRS for years. The lack of new, effective therapies to treat CRS leads the investigators to test whether a SinoNasal Microbiota Transfer (SNMT) could trigger CRS recovery. SNMT is defined as the endoscopic transfer of a healthy sinus microbiota from a fully screened donor's sinus to a CRS patient's sinus(es). Similar to a fecal transplant used to treat Clostridioides difficile diarrhea, the sinonasal microbiota transfer may eliminate sinus pathogens and restore the sinus microbiota to a healthy state. SNMT will be combined with a one-time, high volume, high pressure "sinus power wash" pre-treatment to temporarily clear the way for the donor microbiota to establish itself. The investigators will conduct a proof-of-principle, randomized, double-blind, placebo-controlled trial of 80 subjects to test whether a sinus power wash plus SNMT improves clinical outcomes in CRS patients.

NCT ID: NCT05453968 Active, not recruiting - Pediatric Clinical Trials

Berotralstat Treatment in Children With Hereditary Angioedema

APeX-P
Start date: October 25, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of berotralstat to determine the appropriate weight-based dose for pediatric participants 2 to < 12 years old for prophylactic treatment to prevent attacks of hereditary angioedema (HAE).

NCT ID: NCT05453695 Recruiting - Sepsis Clinical Trials

Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

IDEALSepsisI
Start date: January 17, 2023
Phase: Phase 1
Study type: Interventional

Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.

NCT ID: NCT05453032 Completed - Clinical trials for Borderline Personality Disorder

The Effect of Non Invasive Brain Stimulation on Impulsivity in Borderline Personality Disorder

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

A pilot study to examine the effects of Non-Invasive Brain stimulation on impulsive behaviour in patients diagnosed with Borderline Personality Disorder. patients who received the neurostimulation sessions will be enrolled in short term psychotherapy (3-month)

NCT ID: NCT05452876 Recruiting - Low Back Pain Clinical Trials

Alberta Back Care Pathway (ABCp) - Edmonton West Primary Care Network (EWPCN) & Alberta Health Services' Calgary Chronic Pain Centre (CPC)

Start date: March 31, 2021
Phase: Phase 2
Study type: Interventional

Every year, the pain, disability, addiction, and expense associated with LBP increase in Alberta. This escalation is largely because most people with LBP seek care from family physicians who are unable to provide effective, guideline-based interventions due to three recognized barriers: 1) a lack of training, 2) a lack of no (or low) cost access to these interventions and 3) a lack of physician time and reimbursement to deliver these interventions. As a result, most LBP care provided in Alberta is "low-value". With input from Alberta patients, healthcare providers, administrators and international scientists, the Alberta Back Carepathway (ABCp) was designed to overcome these barriers by giving family physicians a common, guideline-based approach to coordinate, assess and manage LBP patients in day-to-day practice. The ABCp trains family physicians to quickly and easily place patients into 5 categories each having evidence-based interventions that can be provided by physicians at no or low cost to patients and no net cost to the healthcare system. By designing the ABCp to resolve barriers related to training, access and delivery, the ABCp will "pull" rather than "prod" patients and clinicians toward sustained, long-term implementation of this cost-effective solution. This study is based on a multi-clinic, controlled, non-randomized stepped-wedge study designed for urban and rural primary care networks (PCNs). The primary outcome will be decreased healthcare resource utilization with secondary improvements in quality of life and opioid consumption. Overall, the savings realized through ABCp will create a self-sustaining, scalable solution for LBP care in Alberta.

NCT ID: NCT05452824 Active, not recruiting - Prostate Cancer Clinical Trials

Participating in Tai Chi to Reduce Anxiety and Keep up Physical Function

PEAK-RP
Start date: June 21, 2021
Phase: N/A
Study type: Interventional

The goal of the proposed project is to test the implementation strategy, in terms of feasibility and utility, of an online Tai Chi intervention as a prehabilitation model to prepare prostate cancer patients and their caregivers for radical prostatectomy (RP). The investigators' hypothesis is that, by using an online teaching module, the proposed prehabilitation model is feasible on the prostate cancer care pathway in a simple, efficient, and minimally disruptive manner. In addition, participating in the Tai Chi intervention will improve patient anxiety leading up to the RP and improve physical function as well as post-operative side-effects associated with RP. Our primary objective is to test the feasibility of the implementation strategy from multi-stakeholder perspectives. The investigators will use mixed-methods to assess the barriers and facilitators related to implementing the online Tai Chi intervention from multi-stakeholder perspectives guided by the Consolidated Framework for Implementation Research. Our secondary objective is to examine the effect of the Tai Chi intervention on patient outcomes at peri-RP and post-RP. The investigators will quantitatively test the effect of the intervention to reduce peri- and post-RP anxiety and improve peri- and post-RP physical function and general disease specific patient-reported outcomes. An exploratory objective is to explore the effect of the Tai Chi intervention on surgical outcomes. The study team will quantitatively describe the difference in post-RP surgical outcomes between the intervention and control groups.

NCT ID: NCT05452785 Completed - Pharmacokinetics Clinical Trials

A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects

Start date: May 7, 2022
Phase: Phase 1
Study type: Interventional

Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence, single-dose, crossover study.

NCT ID: NCT05452070 Active, not recruiting - Clinical trials for Mid Face Volume Deficit

A Study to Assess Adverse Events and Change in Disease Activity of HArmonyCa Lidocaine Injectable Gel for Mid Face Soft Tissue Augmentation in Adult Participants

Start date: September 2, 2022
Phase: Phase 3
Study type: Interventional

The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The rapid restoration of soft tissue augmentation is commonly achieved by the use of dermal fillers. HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation. The purpose of this study is to assess adverse events and effectiveness of HArmonyCa Lidocaine injectable gel in adults seeking mid face soft tissue augmentation. HArmonyCa Lidocaine Injectable Gel is an investigational device being developed for soft tissue augmentation in the mid face. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 160 adult participants seeking soft tissue augmentation will be enrolled in the study at approximately 15 sites worldwide. Participants in the treatment group will receive HArmonyCa Lidocaine injectable gel at Day 1 and followed for up to 25 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of HArmonyCa Lidocaine injectable gel during the follow-up duration period. Participants in the control group are followed for 3 months and then can opt to receive HArmonyCa Lidocaine Injectable Gel at the end of month 3. The control group will participate in the study for up to 25 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

NCT ID: NCT05452057 Recruiting - Spinal Deformity Clinical Trials

Prehab for Adult Spinal Deformity Surgery

Start date: March 24, 2022
Phase: N/A
Study type: Interventional

Prehabilitation is defined as the process of enhancing patients' functional capacity and overall fitness to enable them to withstand a forthcoming stressor (e.g. surgery). Although there are different models of prehabilitation, multimodal prehabilitation is recommended to address the physical and psychological health outcomes prior to surgery. Multimodal prehabilitation commonly consists of exercise-training, nutritional, and psychological support. Evidence suggests that prehabilitation improves preoperative physical fitness and reduces postoperative complications and length of stay in patients undergoing major abdominal surgery. However, the evidence for the feasibility and effects in spinal deformity surgery are less understood. This study is a two arm, pilot randomized controlled trial to assess the feasibility of a multimodal prehabilitation program prior to surgery for spinal deformity in adults. Participant outcomes will be measured using standardized fitness testing, self-report questionnaires, and medical record reviews at baseline, one week preoperatively, and at 30 days postoperatively.