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Filter by:Internet-based health promotion programs have the potential to reach more individuals than in person interventions, without overtaxing healthcare resources. Having a high quality, user-centered web-based program can help maximize user engagement and adherence. Thus, the primary objective of this pilot study is to examine the feasibility, time, cost, and acceptability of a web-based physical activity behavior change program with Canadian Adults who have had to start practising/following the social distancing guidelines due to the COVID-19 situation. We will also be examining changes other behavioral indicators related to PA as a secondary outcome measure.
The clinical picture of the novel corona virus 2 (SARS-CoV-2) disease (COVID-19) is rapidly evolving. Although infections may be mild, up to 25% of all patients admitted to hospital require admission to the intensive care unit, and as many as 40% will progress to develop severe problems breathing due to the acute respiratory distress syndrome (ARDS). ARDS often requires mechanical ventilation, with a 50% risk of mortality. Researchers at the Ottawa Hospital Research Institute (OHRI) have been studying the potential therapeutic role of mesenchymal stromal/stem cells, or MSCs, for the treatment of ARDS for over a decade. This has led to the world's first clinical trial using MSC therapy for patients with severe infections (sepsis) which is often associated with ARDS (NCT02421484). This trial demonstrated tolerability, and potential signs of efficacy. In addition, the investigators have established expertise in producing clinical-grade MSCs and have received approval from Health Canada for the use of MSCs in three different clinical studies. This protocol consists of 2 sequential trials using the same trial infrastructure, noted as the Phase 1 trial 'CIRCA-1901' and the Phase 2a trial 'CIRCA-1902'. CIRCA-1901 is an open-label, dose-escalating and safety trial using a 3+3+3 design to determine the safety, and maximum feasible tolerated dose of repeated delivery of Umbilical Cord Mesenchymal Stromal Cells (UC-MSC) intravenously. The investigators will enroll up to 9 patients; each receiving repeated unit doses of UC-MSCs delivered by IV infusion on each of 3 consecutive days (24±4 hours apart) according to the following dose-escalation schedule (3 patients per dose panel): (i) Panel 1: 25 million cells/unit dose (cumulative dose: 75 million MSCs), (ii) Panel 2: 50 million cells/unit dose (cumulative dose: 150 million MSCs), (iii) Panel 3: up to 90 million cells/unit dose (cumulative dose: up to 270 million MSCs). If no safety issues are identified, we will continue to the Phase 2a trial. CIRCA-1902 is a single-arm, open-label extension of the CIRCA-1901 trial to assess early signs of efficacy (major morbidity and mortality). The Phase 2a trial (CIRCA-1902) will enroll 12 patients to assess early signals of benefit on mortality and major morbidity in a high risk, high mortality population.
For 28 days, 30 participants aged 3 to 18 years of age (inclusive) with a condition requiring a ketogenic diet will incorporate Ketoflo into their usual dietary regime. Ketoflo is a nutritionally complete Food For Special Medical Purposes and is suitable for administration by both tube feeding and use as a sip feed. Data on gastrointestinal tolerance, participants adherence to recommended intakes and their thoughts on the product's palatability will be self-reported in Daily Study Diaries.
The aim of this study was to evaluate the survival rate and healing time of compromised teeth and seriously compromised teeth that were endodontically treated in patients which received bisphosphonate therapy . Clinical complications, success and survival rate was reported. Mean clinical parameters, clinical symptoms and presence of periapical radilucency were recorded.
The purpose of the study is to evaluate the influence of different durations of the end-expiratory occlusion test to predict fluid responsiveness in mechanically ventilated patients in the operating room.
Sleep deprivation (SD) has a powerful degrading effect on cognitive performance, particularly psychomotor vigilance (PV) and reaction time. Caffeine is well known to be an effective countermeasure to the effects of SD. However, individuals differ in both their response to SD and to the administration of caffeine. This has made it difficult to provide individualized recommendations regarding the use of caffeine to sustain alertness when needed. For the past two decades, the Army's Biotechnology HPC Institute (BHSAI), in collaboration with the Walter Reed Army Institute of Research, have been developing statistical models to predict individual performance during prolonged SD. Recently, this resulted in the publication of the 2B-Alert app, a computer algorithm based on large datasets that can learn an individual's response to SD by combining actigraphic sleep data with simultaneously acquired PV performance data. The 2B-Alert algorithm can predict an individual's sleep need and performance after ~2 weeks of training the model. Recently, the model has been extended to incorporate individualized responses to caffeine. This was recently validated in a retrospective study published by BHSAI in 2019. The present study is designed to test the predictive capacity of the 2B-Alert app in real time. During Phase 1 a total of 21 healthy participants will wear an actigraph & complete multiple daily PV tests on a personal cell phone. After 2 weeks, these individuals will attend Phase 2 involving an in-laboratory stay & SD. Participants will have an 8-hour period of sleep in the laboratory, followed by 62 hours of continuous wakefulness. During these 62 hours, participants will complete PV and mood testing every 3 hours. The 2B-Alert app will be used to predict individual caffeine need to sustain performance at near-baseline levels based on the statistical model. At 44 hours SD, participants will undergo a 6-hour "alertness window" where they may receive individualized doses of caffeine based on the recommendations of the model. After 62 hours of SD, Phase 3 begins, involving a night of monitored recovery sleep and additional sessions of PV and mood testing until release from the study at 6 pm on the final day. It is hypothesized that the 2B-Alert app will be effective at providing caffeine dosing recommendations that return PV and mood performance to normal levels during the alertness window.
The aim of our study was to evaluate the difference of effectiveness between daily and after-each-case room disinfection in the endoscopy unit during the COVID-19 pandemic.
Primary objectives: - To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and infants (after each and any injection). - To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) - To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in infants (Groups 5-8) - To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in infants (Groups 5-8) Secondary objectives: - To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) - To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in a subset of infants (Groups 5-8) - To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in a subset of infants (Groups 5-8) - In toddlers: to describe the Ab responses against Pentacel antigens before and 1 month following injection of Pentacel - In infants: to describe the Ab responses against antigens of the routine pediatric vaccines (Pentacel, RotaTeq, ENGERIX-B, M-M-RII, and VARIVAX) when administered concomitantly with either SP0202 or Prevnar 13 (at pre-Dose 1 (as applicable) for RotaTeq, Diphteria, Tetanus and Pertussis antigens; at PD3 for ENGERIX-B, RotaTeq, and Pentacel; at PD4 for M-M-RII and VARIVAX])
Introduction: Traumatic oral lesions are common in the beginning of the orthodontic treatment, and pathogenic oral bacteria might be involved. We tested whether the probiotic Lactobacillus brevis CD2 (L brevis) is benefic in this condition. Methods: In a double-blind clinical trial, 20 patients were randomized to 21 days course of lozenges containing L brevis CD2 (4 billion colony-forming units after breakfast, lunch and dinner) or placebo, starting on the day of installation of the fixed orthodontic appliance. Main outcomes were days without oral lesions and oral pain score [ranging between 0 (no pain) and 10 (maximum)]. Oral health related quality of life was measured by OHIP-14 before and after treatments.
This trial will evaluate the pharmacokinetics, safety, and tolerability of centanafadine in pediatric subjects with ADHD.