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NCT ID: NCT03953768 Recruiting - Epilepsy Clinical Trials

VNS Prospective Neuromodulation of Autonomic, Immune and Gastrointestinal Systems

VNSAIG
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Vagal nerve stimulation is a neurosurgical procedure consisting of implantation of an impulse generator battery with leads placed into the vagus nerve in the neck. This procedure was FDA approved for epilepsy in the 1990s and is commonly performed as an outpatient surgery. The mechanism of efficacy is not well understood; however it is increasingly recognized that electrical stimulation of the vagus nerve may impact other organ systems in the body including the immune, gastrointestinal and autonomic systems. The primary objective of this study is to characterize the pre- and post-operative bowel habits and gut microbiome of patients implanted with vagal nerve stimulator (VNS) for epilepsy. Secondary objectives of this study include: (1) to characterize the pre- and post-operative autonomic profile, (2) characterize the pre- and post-operative immune profile, and (3) to elucidate whether gut microbiota changes are related to VNS efficacy for epilepsy.

NCT ID: NCT04008563 Recruiting - Endometrial Cancer Clinical Trials

Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium

B-FiERCE
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

A growing population of young women with obesity are developing atypical hyperplasia (pre-cancer) and endometrial cancer. Progestin is the standard treatment for women who wish to preserve fertility, but this approach does not address the underlying cause of endometrial cancer/atypical hyperplasia (obesity); thus response rates are low and recurrence rates are high. Significant weight loss by bariatric surgery, in combination with progestin therapy may result in greater and more durable response rates.

NCT ID: NCT04058457 Recruiting - Parkinson Disease Clinical Trials

DBS and Respiration

Start date: April 1, 2021
Phase:
Study type: Observational

Patients referred to neurosurgery routinely and safely undergo deep brain stimulation (DBS) for treatment of neurological conditions, most commonly Parkinson's disease. The investigators have observed that respiratory problems (breathlessness) sometimes occur subsequent to DBS of the subthalamic nucleus (STN). This study aims to determine whether this is indeed a consequence of STN stimulation. Secondary objectives include identification of the respiratory physiological mediators of any interoceptive neuromodulation observed, changes in daily physical activity and MRI structural connectivity analysis.

NCT ID: NCT04099966 Recruiting - Sickle Cell Disease Clinical Trials

AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion

Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

Children, adolescents, and young adults with malignant and non-malignant conditionsundergoing an allogeneic stem cell transplantation (AlloSCT) will have the stem cells selected utilizing α/β CD3+/CD19+ cell depletion. All other treatment is standard of care.

NCT ID: NCT04100564 Recruiting - Trauma Injury Clinical Trials

LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

PACT
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The Prehospital Airway Control Trial (PACT) is a proposed 5 year, open label, multi-center, stepped-wedge randomized trial comparing airway management strategies of prehospital trauma patients. The initial airway attempt will be randomized to either usual care (control) or a supraglottic airway management approach (intervention). The primary outcome will be 24 hour survival, with secondary outcomes to include survival to hospital discharge, expected clinical adverse events, airway management performance, ICU length of stay, ventilator days, incidence of ARDS, and incidence of ventilator associated pneumonia. Subjects will be enrolled across approximately 17 prehospital agencies at select LITES Network sites and will enroll a total of 2,009 subjects.

NCT ID: NCT04101838 Recruiting - Influenza Clinical Trials

B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults

Start date: April 1, 2021
Phase: Phase 4
Study type: Interventional

This study will examine how various FDA-approved seasonal influenza vaccine types, used in a manner consistent with their approved use, impact the characteristics of influenza specific antibodies in humans, and how these responses differ based on age and prior immunization history.

NCT ID: NCT04207281 Recruiting - Poor Quality Sleep Clinical Trials

Honey to Improve Sleep Quality

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Inadequate sleep quality and duration affects quality of life, and can cause adverse health outcomes, for many Canadians. Existing sleep therapies have limitations, such as inability to adhere to a cognitive behaviour modification or the risk of dependence on pharmaceutical therapies. Raw honey has a long history of anecdotal reports supporting its use to improve sleep quality. In an effort to develop an evidence base for honey as a sleep aid, we completed a preliminary proof-of-principle study to assess feasibility and potential effectiveness of honey to improve sleep quality. Results of our preliminary study demonstrate that honey is safe and effective for improving quality of sleep with no associated adverse effects, as compared to melatonin. The current study design builds off the experiences of the preliminary trial and will add more scientific rigor to the evidence base we have started to build.

NCT ID: NCT04231006 Recruiting - Prostate Cancer Clinical Trials

Salvage HDR for Locally Recurrent Prostate Cancer

PROSALBRA
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy

NCT ID: NCT04253951 Recruiting - Cerebral Palsy Clinical Trials

Lung Ultrasound for Infants' Swallowing Disorders

LUNCH
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The aim is to test the effectiveness of lung ultrasound (LUS) in the dynamic assessment of aspiration related to abnormal swallowing in infants and young children with neurological impairment (cerebral palsy/developmental disabilities). Neither standardized measure is available, nor protocols for invasive fibre-optic endoscopic examination of swallowing (FEES) and x-Ray videofluoroscopic swallowing study (VFSS) to be used in such population. LUS offers several advantages: time saving for aspiration diagnosis; safeness (neither invasiveness nor radiation); repeatability with different meal consistencies or to monitor interventions efficacy; cost-effectiveness; savings of x-Ray exposition (compared to VFSS). All these advantages may lead infants to improve clinical behavioural and neurological outcomes and reduce stressful interactions with caregivers, and to reduce morbidities and hospitalization costs for respiratory and non-respiratory complications related to swallowing disorders.

NCT ID: NCT04283175 Recruiting - Hemiparesis Clinical Trials

Validation Study of Posturology Platforms for Evaluating Postural Control of Hemiparetic and Neuro-muscular Patients

KPLATES
Start date: April 1, 2021
Phase:
Study type: Observational

The instrumental evaluation of standing postural control by posturographic analysis supplements the clinical evaluation and, as such, is recommended by the French National Authority for Health (HAS 2007). The quantitative data obtained after a standardized postural examination appear relevant for the longitudinal follow-up of neuromuscular patients and hemiparetic patients. Neuro muscular (NM) diseases are progressive, these instrumental evaluations can highlight a deterioration or stabilization of postural control possibly not observable with the scores on clinical scales. The K-Force Plates, recently developed appear to be an interesting alternative to the stabilometry platforms currently used. Static and dynamic conditions in upright position are tested. Moreover, posturologic, kinematics data and clinical scores are correlated to increase understanding of strategies during postural control tasks in patients with stroke and in patients with NM disorders.