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NCT ID: NCT03633617 Completed - Clinical trials for Eosinophilic Esophagitis

Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

Start date: September 24, 2018
Phase: Phase 3
Study type: Interventional

The primary objectives of the study by study part are: Part A: To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures and to inform/confirm the final sample size determination for Part B. Part B: To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures. Part C: To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures. The secondary objectives of the study are: - To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE - To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses - To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation - To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks and 52 weeks of treatment in adult and adolescent patients with EoE who have previously received swallowed topical corticosteroids

NCT ID: NCT03633396 Completed - Clinical trials for Palmoplantar Pustulosis

A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis

POPLAR
Start date: May 20, 2019
Phase: Phase 2
Study type: Interventional

A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP)

NCT ID: NCT03633305 Recruiting - Insomnia Disorder Clinical Trials

Optimization of Insomnia Treatment in Primary Care

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The primary objective of this pragmatic clinical trial is to evaluate the efficacy, feasibility, and adaptability of pharmacological and non-pharmacological treatments for insomnia disorder, delivered in primary care clinics. The second objective is to evaluate the efficacy of a sequential (stepped care) approach for persistent insomnia.

NCT ID: NCT03633253 Active, not recruiting - Dementia Clinical Trials

The "Motoric Cognitive Risk" Syndrome in the Quebec Population

Start date: December 7, 2016
Phase:
Study type: Observational

The overall objective of the proposal is to examine the epidemiology of the newly reported "motoric cognitive risk" (MCR) syndrome, which is a pre-dementia syndrome combining subjective cognitive complaint (i.e.; memory complaint) with objective slow gait speed, in the Quebec elderly population. Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with physiological and pathological aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion. Both declines in cognition and locomotion are associated, furthermore the temporal nature of their association has been unclear for a long time. Recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that MCR syndrome is a pre-dementia syndrome, suggesting that low gait performance is the first symptom of dementia. The uniqueness of MCR syndrome is that it does not rely on a complex evaluation or laboratory investigations. Indeed, this syndrome combined subjective cognitive complaint and objective slow gait speed, and is easy to apply in population-based settings. Prevalence and incidence of MCR syndrome, as well as its association with incidence of cognitive decline and impairment, have never been reported in Canada. Nutrition as a determinant of successful aging: The Quebec longitudinal Study (the NuAge study) is a Quebec population-based observational cohort study performed in healthy older community-dwellers adults which provides a unique opportunity to: 1) obtain reliable estimates of MCR syndrome prevalence and incidence, 2) determine the distribution of clinical characteristics associated with MCR syndrome, 3) examine the association of MCR syndrome with cognitive decline and incidence of cognitive impairment in the Quebec elderly population.

NCT ID: NCT03633240 Recruiting - Emergencies Clinical Trials

Emergency Room Visits and Older Patients (ER2)

ER2
Start date: September 1, 2017
Phase:
Study type: Observational

Today's population is living longer than prior generations. Senior patients, defined as 65 years or older, are therefore increasing in number, and representing a larger number of hospitalized patients. Thus, assessing and addressing the needs of the growing number of older ER users is essential. The overall objective of the study is to examine the feasibility and the epidemiology of two screening tools ("Programme de Recherche sur l'Intégration des Services pour le Maintien de l'Autonomie" (PRISMA-7) and Emergency Room Evaluation and recommendations (ER2)) used in the Emergency Room of Jewish General Hospital to screen older patients (i.e.; ≥65 years) at risk of adverse health events. A prospective observational cohort design will be used for the study's two phases; phase 1- assessment and phase 2- assessment as well as recommendations.

NCT ID: NCT03633227 Terminated - Clinical trials for Liver Cirrhosis, Biliary

Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

Start date: June 22, 2018
Phase: Phase 4
Study type: Interventional

This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment period. Participants who have completed their 48-week double blind treatment period will continue double-blind treatment until all randomized participants have completed their 48-week treatment period and the database for that period is locked. An open-label extension study in which all participants receive OCA will be considered following review of blinded safety and PK data.

NCT ID: NCT03633136 Completed - Quality of Life Clinical Trials

A Randomized Controlled Trial of a Pre-Transplant Education Intervention

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

A multi-center, randomized, controlled clinical trial will be conducted to test the effectiveness of a home-based video intervention on improving kidney transplant candidate's knowledge, self-efficacy, quality of life, beliefs in medications, and education satisfaction as compared to usual care.

NCT ID: NCT03632863 Active, not recruiting - Depression Clinical Trials

PDA for Antidepressant Use in Pregnancy

Start date: October 18, 2018
Phase: N/A
Study type: Interventional

Depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. Unfortunately, antidepressant medication, a first-line treatment for depression in pregnancy, also comes with risks, making this a complex decision. Clinical care appears to be insufficient for ensuring that women make decisions that are consistent with their own values and with which they feel satisfied. Patient decision support tools can address such barriers. We have created and piloted with positive results an online patient decision aid (PDA) that has the potential to improve the decision-making process for women regarding antidepressant use in pregnancy in conjunction with clinical care. The overall objective of this study is to conduct a Randomized Controlled Trial (RCT) to assess the efficacy of our PDA for antidepressant use in pregnancy.

NCT ID: NCT03632343 Recruiting - Clinical trials for Therapy-Associated Cancer

The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Pain negatively affects the quality of life of adolescents with cancer (AWC). It can also represent a high cost to the healthcare system and families. In response, our team has built a smartphone-based app, called Pain Squad+, which can give AWC real-time advice to manage their pain. The app uses pain diaries and personalized pain advice plus support from a registered nurse to give real-time pain management in all settings. This study will look at the impact of Pain Squad+, with or without the nurse support, on AWC health quality and healthcare costs over time.

NCT ID: NCT03632304 Completed - Anesthesia, Local Clinical Trials

Local Anesthesia With Minimal Sedation and Brachial Plexus Block in Hand Surgery

Start date: August 17, 2018
Phase: N/A
Study type: Interventional

A major innovation in hand surgery in the last decade is the popularization of Wide Awake Hand Surgery (WAHS). This technique consists of numbing the surgical area with local anesthesia with epinephrine and allowing the patient to actively move their hand intra-operatively to assess the strength and quality of repairs or fixations. Despite its theoretical advantages, the application in clinical practice has seldom spread further than simple hand operations, such as carpal tunnel and trigger finger releases. In many institutions, the current standard of care for hand surgery is the brachial plexus block. The primary objective of the study to directly compare the effects of local anesthesia with minimal sedation, performed by the surgeon, and the brachial plexus block, performed by the anesthesiologist, on patient-reported quality of recovery. Currently, there are no studies in the surgical literature directly comparing patient-reported quality of recovery, post-operative pain control, or time efficiency between local anesthesia and the brachial plexus block in hand surgery. This lack of information is a major impediment to the acceptance and adoption of a simple yet effective anesthesia technique that may increase patient satisfaction and time efficiency in the operating room. This proposed prospective randomized controlled study will quantitatively compare local anesthesia and brachial plexus block on three fronts: 1) patient-reported recovery at 24-hours post-surgery using the validated Quality of Recovery 15 score (QoR-15), 2) post-operative pain and opioid use at 24-hours post-surgery, and 3) nonsurgical time (defined as the time elapsed from one surgery's end time to the next surgery's start time) as a metric for turnover efficiency. The investigators hypothesize that patients randomized to the local anesthesia group will have a more positive recovery experience, a similar pain profile compared to the brachial plexus block despite common beliefs, and a shorter anesthesia-related and nonsurgical time. The importance of patient-centered care cannot be understated in a successful and high-quality health care system. The results of this study will provide valuable information regarding the patient experience during their post- operative recovery.