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NCT ID: NCT05590403 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above

Start date: October 28, 2022
Phase: Phase 3
Study type: Interventional

The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults >=60 YOA

NCT ID: NCT05590377 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma

iinnovate-3
Start date: January 26, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.

NCT ID: NCT05590130 Recruiting - Respiratory Failure Clinical Trials

Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation

Oxygap pong
Start date: November 16, 2022
Phase: N/A
Study type: Interventional

The investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared SpO2 with SaO2 obtained on arterial gas. Correlations between SaO2 and SpO2 were poor for all oximeters, as previously known, and SpO2-SaO2 bias were different between oximeters. Some oximeters (Masimo, Nellcor) had lower biases but they detected less well hypoxemia. Some oximeters underestimated SaO2 (Nonin) but detected very well hypoxemia, and some overestimated SaO2 (Philips). The investigators concluded that oximeters provide different informations to clinicians, and oxygenation targets should take into account for these differences. The assumption is that the SpO2 target AND oximeter used will both have an impact on oxygen flows and that these effects will add up. With a high SpO2 target, oxygen flows will be significantly greater and with the Nonin oximeter, the required flows will be greater than with the Philips oximeter. NB: the results obtained were in a population with light skin pigmentation (96% of the patients were Fitzpatrick 1-2, reflecting the local hospitalized population).

NCT ID: NCT05589831 Recruiting - Sleep Clinical Trials

Respiratory Support and Brain Health in Preterm Infants

Start date: July 4, 2023
Phase:
Study type: Observational

Premature babies often require breathing support during their neonatal intensive care unit stay. This is because their lungs are not fully developed to perform the work of breathing on their own. Although breathing support can be provided via a breathing tube, it is preferable to provide breathing support non-invasively from a breathing machine which is then connected to a mask or prongs placed on the baby's nose. In premature babies born under 32 weeks gestation, a commonly used mode of non-invasive breathing support is called Non-Invasive Positive Pressure Ventilation (NIPPV). In this mode, the breathing machine provides 2 levels of support: one is the constant distending pressure to keep the lungs open and the other provides additional 'breaths' on top of that distending pressure. This is to mimic regular breathing. These breaths are set at a fixed rate and pressure. Although NIPPV protects the lungs from injury caused by a breathing tube, the breaths are not in sync with the baby's own breathing effort. Another mode of non-invasive breathing support recently being used in premature infants called Neurally Adjusted Ventilatory Assist (NAVA). When NAVA is provided non-invasively using a mask or prongs similar to NIPPV, it is called Non-invasive NAVA (NIV-NAVA). During NIV-NAVA a special feeding tube is used that detects the baby's own breathing movement from the electrical signal of the baby's diaphragm and feeds back to the machine which then provides a 'top-up' to the baby's own breath. This top-up breath also provides only as much pressure as the baby needs on top on their own breathing effort. Therefore, this is thought to be in sync with the baby's own breathing effort. However, it is not known if this mode of ventilation leads to improved sleep, improved brain oxygen levels, reduced discomfort and improved functioning of the diaphragm. The investigators aim to examine these indices in this research project.

NCT ID: NCT05589714 Recruiting - Clinical trials for Retinitis Pigmentosa

Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants

Uni-Rare
Start date: May 11, 2023
Phase:
Study type: Observational

This is an international, multicenter study with two components: Registry - A standardized genetic screening and a prospective, standardized, cross-sectional clinical data collection - Enrollment is open to all genes on the RD Rare Gene List Natural History Study - A prospective, standardized, longitudinal Natural History Study - Enrollment opens gene-by-gene, based on funding and within-gene Registry enrollment The study objectives are as follows. Registry Objectives 1. Genotype Characterization 2. Cross-Sectional Phenotype Characterization (within gene) 3. Establish a Link to My Retina Tracker Registry (MRTR) 4. Ancillary Exploratory Studies - Pooling of Genes Natural History Study Objectives 1. Natural History (within gene) 2. Structure-Function Relationship (within gene) 3. Risk Factors for Progression (within gene) 4. Ancillary Exploratory Studies - Pooling of Genes

NCT ID: NCT05589701 Recruiting - Spinal Metastases Clinical Trials

Comparing SBRT to CRT in Patients With Spinal Metastases

COMBAT
Start date: December 12, 2022
Phase:
Study type: Observational [Patient Registry]

This is a single institutional registry-based, prospective, observational study to describe radiation oncologists' decision making during evaluation of patients and to compare real-world outcomes of SBRT vs CRT. A registry-based trial involves observing the effect of something without manipulating it.

NCT ID: NCT05589259 Not yet recruiting - Clinical trials for Complex Regional Pain Syndromes

Feasibility Study of Combined Peripheral Nerve Block and Physiotherapy for CRPS

Start date: February 1, 2025
Phase: N/A
Study type: Interventional

Chronic pain is a debilitating condition affecting 1 in 5 Canadians with a yearly economic cost of over $40 billion in healthcare spending and loss of productivity. Since the prevalence of chronic pain is increasing, especially as the population ages, effective low-cost treatment is key to reduce the impact of chronic pain on patient quality of life and on healthcare costs. Due to the complexity of chronic pain and differences between the multitudes of pain conditions, developing effective treatments is challenging. This is especially true for Complex Regional Pain Syndrome (CRPS). CRPS is characterized by severe pain out of proportion to tissue trauma, with local autonomic and inflammatory changes. The severity of pain from CRPS may result in an inability to work, depression, sleep disorders, or suicidal ideation. Although its prevalence is low in Canada, CRPS is considered one the most debilitating and least understood pain conditions. As most current treatment options have low evidence of effectiveness, there is no definitive treatment available and most often, patients are struggling to maintain an acceptable quality of life. Thus, there is a pressing need to identify new and improved treatments for adults with CRPS. An early hypothesis of CRPS pathophysiology posited that sympathetic nervous system over-activity led to many of the signs and symptoms of CRPS. As such, sympathetic nerve blocks, including stellate ganglion and lumbar sympathetic blocks, have been repeatedly investigated as a potential treatment of CRPS. However, a recent meta-analysis suggests that these blocks provided no benefits for those suffering with CRPS. Newer evidence suggests that a peripheral microvascular dysfunction may underlie CRPS pathophysiology. However, no clinical trials have investigated the efficacy of a treatment targeting this peripheral pathway. The goal of this project is to assess the efficacy of a single-shot axillary approach to the brachial plexus block plus physiotherapy as a novel treatment protocol for CRPS. Our primary hypothesis is that providing a brachial plexus block in conjunction with a physiotherapy program would be superior to physiotherapy alone in treating pain and function in CRPS. Since this is a novel treatment protocol for CRPS, the purpose of our proposed study is to determine the feasibility of conducting a fully powered clinical trial.

NCT ID: NCT05589142 Not yet recruiting - Clinical trials for eTRE (Early Time Restricted Eating)

Effect of Early Eating and BCAA Supplementation on Body Composition

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

To our knowledge, as of this day there are only four studies which examined the effects of eTRE with a duration of 12 weeks. There are no studies that examined this phenomenon beyond 12 weeks, one study that lasted five weeks and four studies that lasted 4 weeks or less, some even days. The four studies that lasted 12 weeks in duration all have opportunities to improve upon, which will be discussed here. The first study performed by Gabel et al., focused primarily on measuring body weight, not body composition in older adults. The eating window also began later in the morning at 1000h and finished at 1800h. There also was no restriction on participants consuming caffeine during the fasting window. The second study conducted by Gasmi et al., was focused on strictly older male participants that were active and healthy, again, without measuring body composition. The third study conducted by Wilkinson et al., did not measure body composition and the eating window lasted 10 hours instead of 8. The fourth study performed by Chow et al., examined eTRE with adults aged 45+/-12 years old and did not mention any exclusion criteria based upon physical activity levels or restrictions on caffeine/artificial sweetener intake during the fasting window. Furthermore, none of the studies mentioned above examined eTRE against eTRE with BCAA supplementation directly. We believe that the proposed study will address the concerns mentioned previously and further knowledge associated with eTRE.

NCT ID: NCT05589064 Not yet recruiting - Clinical trials for Brain Injury Traumatic Mild

Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms

Start date: October 2022
Phase: N/A
Study type: Interventional

Concussions affect thousands of Canadians every year. Although the effects are usually temporary, 10-15% of adults experience persistent symptoms likely to last several weeks or even months. It is suggested that nutritional interventions should be considered in concussion management because nutrition can act on several mechanisms of brain injury. However, to date, no study has assessed the impact of dietary interventions on the recovery of people with persistent post-concussive symptoms. This randomized controlled trial aims to determine the impact of a dietary and nutritional intervention on the physical, cognitive, behavioural and emotional symptoms of patients with persistent post-concussive symptoms in New Brunswick, Canada. Patients will be randomized to one of three groups: 1) dietary treatments and nutritional supplements (experimental group A), 2) nutritional supplements (experimental group B), and 3) physiotherapy treatments (control group). Patients in group A will receive four consultations with a dietitian over eight weeks, in addition to conventional physiotherapy treatments. These patients will receive nutritional counselling and omega-3, vitamin D and creatine supplements. Patients in group B will be prescribed the same supplements as those in group A by their doctor and receive physiotherapy treatments. Finally, patients in the control group will only receive physiotherapy treatments. Patient symptoms will be measured using a questionnaire constructed from tools commonly used in practice. This questionnaire will be completed at the first physiotherapy session and 2, 4 and 8 weeks after the start of the intervention.

NCT ID: NCT05588947 Not yet recruiting - Stroke/Brain Attack Clinical Trials

The Tele-Taking Charge After Stroke Randomized Controlled Feasibility Trial

TeleTaCAS
Start date: October 10, 2022
Phase: N/A
Study type: Interventional

Take Charge is a novel, community-based treatment for stroke developed to harness a person's self-determination. Two prior clinical trials with 572 stroke survivors showed that Take Charge improves quality of life, independence, and social participation up to a year after stroke. Take Charge has also been shown to be overall cost-saving to the health system and is a useful adjunct to standard care after stroke. Because of the COVID-19 pandemic, a lot of healthcare has moved into a telehealth approach. The simplicity of Take Charge may lend itself to being effective if delivered by telehealth, allowing greater access for people with stroke in rural communities. Improving the care we provide in underserved regions of the country is important to help the health of Canadians. We are proposing a new study, working closely with the researchers who ran the previous Take Charge studies. The goal of this feasibility clinical trial is to learn about Tele-Take Charge in adults with stroke who live in Southern Alberta. The main questions it aims to answer are: - is delivering Take Charge by telehealth feasible? - is Take Charge by telehealth acceptable to this population? Participants will meet with facilitators online via Zoom at 4 to 16 weeks after stroke, and be randomized to receive either: - two Tele-Take Charge sessions six weeks apart - one control tele-education session. Researchers will compare the Tele-Take Charge and control groups to see if there are any differences in outcome measures. these differences will help researchers to estimate the number of participants that will be needed for a larger, multi-centred effectiveness trial.