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NCT ID: NCT05107713 Completed - Clinical trials for Evaluation of Preterm NAVA Catheter Placement

Positioning of EDI Catheter In Premature Infants

PIPI
Start date: November 1, 2021
Phase:
Study type: Observational

Nasogastric (NG) and orogastric (OG) feeding tubes have a high incidence of malpositioning, occurring in up to 59% of preterm infants (Lopes 2019). Ideally, the tip of the feeding tube (including the orifices) should be located within the body of the stomach. Malpositioning of the feeding tube can be classified as (i) being "too far out" where the tip of the catheter is located in the esophagus above the gastro-esophageal junction, potentially resulting in reflux, aspiration, apnea or (ii) being inserted "too far in" where the tip is located in the pylorus or the duodenum, leading to malabsorption of nutrients, diarrhea, and poor weight gain. Feeding tubes can also be found "curled up" inside the stomach (Quandt 2009) as much as 35% of the time. As well, one cannot ignore the risk of perforation, where the incidence has been reported to be 1.1% in extremely low birth weight (ELBW) infants (<1000g) (n = 7/646) (Thanhaeuser M, 2019); of note: perforations occurred on the third day of life (range days 2-14) not during initial feeding tube placement. In 2008, a modified feeding tube was introduced to the market (Maquet Critical Care AB), which contains sensors placed in its wall, 13 mm above the feeding orifices, used for measuring the electrical activity of the diaphragm (Edi) during spontaneous breathing. The Edi signal is then used to neurally control mechanical ventilation, or for neural monitoring of the breathing pattern (Sinderby 1999; Beck 2016). The so-called "Edi catheter" comes with the manufacturer's recommended insertion measurements and verification window. In the Servo-I, the insertion distance is provided by a formula on the catheter packaging. In the Servo-U and Servo-n, the calculation for predicted insertion is provided by a tool in the ventilator. There is no available, published data upon which the manufacturer's recommendations were based. It is possible that obtaining appropriate positioning of the Edi catheter - based on a pattern of electrical signals from the sensors - could reduce the incidence of malposition. This proposed study is observational, and non-interventional. The purpose is to verify the position of a neurally guided, clinically-placed, Edi catheter using radiography (Ellett 2011). We will also record physical measurements and weights of the babies in order to validate previously described methods of predicting insertion length. The x-rays will be taken with "near-simultaneous" screenshots of the Edi catheter positioning window.

NCT ID: NCT05107440 Completed - COVID-19 Clinical Trials

BREATHE: Virtual Self-management for Long COVID-19

Start date: January 3, 2022
Phase: N/A
Study type: Interventional

A mixed-methods evaluation of a virtual self-management program for people living with long COVID in Alberta.

NCT ID: NCT05107115 Completed - Clinical trials for Chronic Spontaneous Urticaria

Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine

RILECSU
Start date: November 24, 2021
Phase: Phase 2
Study type: Interventional

The first phase of this study will be a parallel, 12-week treatment, Phase 2, double-blind, 4 arm study to assess the safety and effectiveness of 3 oral doses of SAR444671 (rilzabrutinib), i.e. dose A, B and C, compared with placebo for decreasing the frequency and severity of itch and urticaria in male and female participants aged 18 years inclusive or older with CSU. After completion of the double-blind phase of the study, participants will be given the option of enrolling in the 40-week open label extension (OLE) phase of the study. Participants will receive open-label rilzabrutinib at dose C (the dose may be modified based on the 12-week safety and efficacy data). Due to the fact that some participants may be receiving rilzabrutinib for the first time, all participants will be monitored at Week 14, Week 16, Week 20, and Week 24. Afterwards, participants will be monitored at Week 36 and Week 52.

NCT ID: NCT05106010 Completed - Balance; Distorted Clinical Trials

The Effect of Yoga on Decreasing Risk of Fall-Related Injury in Peri and Post-Menopausal

Start date: November 1, 2018
Phase:
Study type: Observational

The primary objective of this study is to evaluate the effect of yoga on both fall risk factors AND capacity to successfully control landing and descent during a simulated fall among peri-and post- menopausal women. Older women are particularly vulnerable to sustaining fall-related injuries and although targeted exercises focusing on balance and strength may decrease the risk of falls, the ideal type of intervention to prevent injury when a fall is unavoidable is not known. Yoga is an increasingly popular health practice with potential benefits linked to improving balance, muscle strength and quality of life, but there is no evidence that yoga can improve the capacity to reduce the risk of fall-related injury. Such evidence will help to inform health promotion and fall/injury risk management for older adults.

NCT ID: NCT05105776 Completed - Parkinson Disease Clinical Trials

Multimodal Neuromodulation in Individuals With Parkinson's Disease

Start date: February 9, 2022
Phase: N/A
Study type: Interventional

Multimodal non-invasive neuromodulation paired with physical therapy is a promising treatment modality for Parkinson's Disease ("PD"), however the optimal stimulation method, dose, and associated therapeutic protocol for long-lasting clinical benefits have not yet been identified for this population. Here the investigators aim to develop and execute a preliminary clinical study exploring the potential benefits of multimodal non-invasive neuromodulation. The therapeutic intervention will involve translingual neurostimulation +/- galvanic neurostimulation, paired with an intensive physical and cognitive therapy program.

NCT ID: NCT05105074 Completed - Arthropathy of Knee Clinical Trials

Does the Use of Intrathecal Morphine Increase the Length of Hospital Stay in Fast Track Orthopedic Procedures?

Start date: January 19, 2019
Phase: N/A
Study type: Interventional

This is a clinical trial of intrathecal morphine for patients Patient with primary as well as revision knee and hip arthroplasty under regional anesthesia. This study would include a total of 134 patients. It is the intention to randomize these patients postoperatively into 2 groups of patients: Group 1 - Patients will receive intrathecal morphine 100 mcg in addition to the standard dose of bupivacaine and 15 mcg of fentanyl for spinal anesthesia. Group 2 - Patients will not receive intrathecal morphine. Patients will receive only bupivacaine and 15 mcg of fentanyl for spinal anesthesia. It is postulated that the use of intrathecal morphine may be associated with an increase length of stay in the hospital.

NCT ID: NCT05104892 Completed - Asthma Clinical Trials

Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe Asthma

Start date: December 12, 2021
Phase: Phase 2
Study type: Interventional

This is a parallel, treatment, Phase 2, double-blind, 2 arm, 12-week Proof of Concept (PoC) study with 2 staggered cohorts (2 arms in each cohort) that is designed to assess the efficacy, safety, and tolerability of rilzabrutinib in adult participants (aged 18-70 years) with moderate-to-severe asthma who are not well controlled on ICS/LABA therapy. Study treatment includes investigational medicinal product (IMP) (rilzabrutinib or placebo) added-on to a background therapy of ICS/LABA (fluticasone/salmeterol [non-investigational medicinal product], standardized at screening). Background therapy of ICS/LABA will be withdrawn during the 12week randomized treatment period and resumed at the end of the IMP treatment period, as outlined below: - Screening period (4 weeks) - Randomized IMP treatment period (12 weeks ± 3 days) - Background therapy stabilization phase (4 weeks) - Background therapy withdrawal phase (4-5 weeks) - No background therapy phase (3-4 weeks) - Post IMP treatment safety follow-up period (4 weeks ± 3 days)

NCT ID: NCT05102890 Completed - Aging Clinical Trials

Implementation of a Telemedicine Tool in Primary Care for Older Adults

ESOGER-PC
Start date: November 22, 2021
Phase: N/A
Study type: Interventional

The pandemic has served a major catalyst propelling telehealth to the frontline of health care. For older adults who often live many chronic health problems, telehealth, which means to give medical check-ups by phone, email or by video conferencing, has become a lifeline to accessing a doctor when they need one. Even without the pandemic, telehealth can help ease access to care, especially for those living in rural areas who often need to travel long distances to see a doctor. However, there is a lack of telehealth tools that have been adapted for older patients. For example, only a few studies have looked at how well they work in improving outcomes for older patients like their quality of life, autonomy and use of health services. Telehealth could also lead to unfair differences between urban and rural patients who don't have the same access to technology. All these factors can make it difficult for family doctors to feel confident about using telehealth for their older patients. With telehealth likely to become mainstream for family doctors and older patients even after the pandemic, it is important to support the growing use of telehealth through tools that are adapted for older patients, fair and based on reliable evidence. This project aims to support the shift to telehealth in caring for older people living in the community by implementing and evaluating ESOGER, a telehealth support tool, in family medicine clinics. The ESOGER tool provides s a quick and reliable evaluation of the health and social needs of older patients. It can be done by phone making it accessible for everyone. This tool is expected to give family doctors a standardized and feasible way to determine the health and social needs of their older patients using telehealth which will help improve patients' autonomy, quality of life and health service use. The tool will be tested in four clinics in both urban and rural regions of Quebec to find out if it helped doctors better address their patients' needs and helped patients to live well at home. The study investigators will also study any differences in improvement between urban and rural older patients. They will discuss the results with the clinics and patient-partners to learn from their experiences and make the telehealth tool and the way to use it be as optimal as possible for family doctors to help maintain the health, quality of life and autonomy of older patients living at home.

NCT ID: NCT05102409 Completed - Dry Eye Clinical Trials

An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease

Start date: September 9, 2021
Phase: Phase 2
Study type: Interventional

An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry Eye Disease in a Dry Eye Chamber

NCT ID: NCT05099640 Completed - Phenylketonuria Clinical Trials

A Study of PTC923 in Participants With Phenylketonuria

Start date: September 30, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this trial is to evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in participants with phenylketonuria as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (that is, the average of each respective treatment dose 2-week period of double-blind treatment).