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NCT ID: NCT05732454 Terminated - Atopic Dermatitis Clinical Trials

A Study to Learn About the Study Medicine Etrasimod in Adults With Moderate to Severe Atopic Dermatitis (AD) Who Have Already Tried Treatments Taken by Mouth or by Injection

Start date: January 18, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to learn about the safety and effects of the study medicine called etrasimod for the possible treatment of atopic dermatitis (AD), also called eczema, in adults who have already tried AD treatments taken by mouth or by injection that work all over the body. These adults can have moderate to severe AD. This study is seeking participants who: - have AD for at least 1 year - have moderate-to-severe AD - have tried treatments that work all over the body and saw no effects - are willing to apply a moisturizer at least once daily during the study This is a 2-part study that is only selecting about 60 participants for Part 1 as of now. In Part 1, half of the participants will receive etrasimod, a pill to be taken by mouth once daily. The other half will receive a placebo, a pill that looks like etrasimod but has no medicine also taken by mouth once daily. No one will know what treatment the participant is taking. The Sponsor will compare participant experiences of those taking etrasimod to those taking placebo for 16 weeks. This will help determine if the study medicine is safe and effective. After the first 16 weeks, some participants may continue the study knowing they are taking etrasimod for an additional 52 weeks. Those participating for just the first 16-weeks, will need to visit the study clinic at least 6 times during the study (about every 4 weeks), and will have to come for 2 safety follow up visits at 2nd and 4th week after the last dose of study medicine. People who want to and can continue for an additional 52 weeks will need to visit the study clinic for at least 6 more visits making 12 total visits over 68 weeks followed by 2 safety follow up visits at the 2nd and 4th week after the last dose of study medicine. In Part 2 of the study, around 340 more participants will be participating. Everyone will receive etrasimod pills once daily for 52 weeks. Participants will need to go to the study clinic at least 9 times after which they will have to go for 2 more safety follow up visits at the 2nd and 4th weeks after the last dose of study medicine. At every study visit in Part 1 and Part 2, the focus will be on signs and symptoms of AD (like lesions, itch, and pain) as well as general health and overall side effects. Blood samples and vital signs will be taken at every visit. Due to the way the study medicine works, the in-study clinic visit will last at least 4 hours on Day 1 (Part 1 and Part 2) and Week 16 (Part 1).

NCT ID: NCT05732233 Terminated - Colon Adenoma Clinical Trials

RITUAL Ultivision AI CADe Randomized Controlled Trial

RITUAL
Start date: July 21, 2023
Phase: N/A
Study type: Interventional

Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas). Ultivision AI CADe is indicated for white light colonoscopy only.

NCT ID: NCT05731960 Recruiting - Spinal Anesthesia Clinical Trials

Evaluating the Effect of Intravenous Dexamethasone on the Duration of Spinal Anesthesia After Cesarean Delivery

Start date: March 6, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to determine the effects of intravenous (IV) dexamethasone on spinal anesthesia in healthy women having an elective Cesarean delivery (CD) at the IWK Health Centre. The main questions it aims to answer are: 1. What effect does IV dexamethasone have on the resolution of motor blockade in patients having spinal anesthesia for elective CDs? 2. What effect does IV dexamethasone have on the sensory recovery of spinal blockade, the total hydromorphone requirement in the first 24 h postoperatively, the incidence of pruritis perioperatively, and the incidence of nausea and vomiting? The spinal anesthesia technique will be standardized and will be administered as per routine care at IWK Health. Computer generation will randomize patients to either Group SD, who will receive IV dexamethasone, or group SM who will receive IV metoclopramide, an alternative anti-emetic, immediately after spinal anesthesia by the attending anesthesia provider. Each patient will receive ondansetron, a second anti- emetic as recommended for Enhanced Recovery After Surgery (ERAS) protocol. Participant sensation, pain, nausea, pruritus, and motor blockade will be assessed in recovery. The patient's sensation and Bromage score will be assessed every 15 minutes until sensation is reached at L3 and a Bromage score of 4 is achieved. The investigators will determine if there is a difference between groups regarding motor blockade, the length of time of spinal anesthesia, and side effects after CD.

NCT ID: NCT05731843 Completed - Clinical trials for Healthy Volunteer Study

Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir

AT-527
Start date: January 30, 2023
Phase: Phase 1
Study type: Interventional

Drug-drug interaction study of Ruzasvir and Bemnifosbuvir

NCT ID: NCT05731778 Completed - Gingivitis Clinical Trials

Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

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

Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.

NCT ID: NCT05731609 Recruiting - Cerebral Palsy Clinical Trials

Resistance Intensive Personal Training for Youth With Cerebral Palsy

RIPT
Start date: March 13, 2023
Phase: N/A
Study type: Interventional

Changes related to Cerebral Palsy (CP) include differences in muscle architecture and cortical activity. These result in weakness, decreased functional ability and limited participation in physical activity. Strength training programs, particularly those including power training components, show great potential in improving the gross motor function of youth with CP. However, this intervention is not currently offered in the Calgary area. Delivered via an innovative partnership with community stakeholders, this project will investigate the preliminary effectiveness of the program to enable youth with CP to achieve child and family centered goals. It will also investigate the feasibility of offering this type of program via a community-hospital partnership. Research Question & Objectives: 1. Can youth with cerebral palsy achieve their goals and improve their motor function through RIPT (Resistance Intensive Personal Training), a power training program offered jointly by specialized physiotherapists and fitness professionals in community settings? 2. What are the barriers and facilitators to delivery of RIPT in a community setting for youth, caregivers, clinicians, and program staff?

NCT ID: NCT05731544 Suspended - Clinical trials for Type 2 Diabetes Mellitus

Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D)

Start date: August 17, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/ 2 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMF-219, an Oral Covalent Menin Inhibitor, in Healthy Adult Subjects and in Adult Subjects with Type 2 Diabetes Mellitus.

NCT ID: NCT05731388 Active, not recruiting - Clinical trials for Gastrointestinal Diseases

Assessing Depth of Small Bowel Insertion at Push Enteroscopy by Using Capsule Endoscopy

Start date: July 1, 2019
Phase:
Study type: Observational

Bleeding from the gastrointestinal tract can originate from the small bowel. Typically, upper and lower endoscopies are unable to identify the site of bleeding and patients need to undergo special endoscopies with longer cameras to examine the small bowel and find the bleeding site. One of the most commonly used scopes to investigate the first part of the small intestinal is called "push enteroscopy". This is an upper endoscopy that uses a pediatric colonoscope, which is longer. To date, it is unknown what percentage of small bowel can be observed with this technique. Hence, this study aimed to determine the extent of small bowel examined by push enteroscopy. Consecutive patients with suspected bleeding from the small intestine will undergo a push enteroscopy and the depth of the examination will be marked with metallic clips. Subsequently, patients will have a capsule endoscopy, which is a little camera that will take multiple pictures of the whole small intestine. The percentage of small bowel that the push enteroscopy examined will be determined by the percentage of small bowel corresponding to the location of the clips visualized on capsule endoscopy.

NCT ID: NCT05731323 Completed - Clinical trials for Major Depressive Disorder

D-Cycloserine+iTBS PK Study

Start date: October 12, 2022
Phase: Phase 1
Study type: Interventional

Background & Rationale: Major Depressive Disorder (MDD) is a common and debilitating illness that that commonly does not respond to conventional treatments. Transcranial magnetic stimulation (TMS) and intermittent theta-burst stimulation (iTBS) are non-invasive neurostimulation treatments for depression that are Health Canada approved. These work by generating magnetic fields outside of the body to change the activity of brain cells to change how the brain works. They have a very favorable profile, with many patients experiencing improvement with minimal side effects. The investigators recently completed a study pairing iTBS with an FDA approved medication that was chosen because it might enhance iTBS improvements. This medication is called D-cycloserine, an old antibiotic that is rarely used in modern times. Years after it stopped being useful as an antibiotic, scientists recognized other properties that the molecule has, and it is some of these that make it interesting to pair with iTBS. When the investigators did so, they found that compared to iTBS with a placebo, participants who received iTBS+D-cycloserine were more likely to benefit from treatment. In this original study, all participants received a fixed dose of 100mg daily. This means that people of very different sizes could have had different drug levels, and the investigators do not know how that impacted outcomes. With this study, there will be no placebo condition because the purpose is to understand whether dosing according to weight matters. Research Question and Objectives: To describe the pharmacokinetic profile of 100mg oral D-cycloserine and weight-based oral D-cycloserine dosed 25mg/17.5kg among individuals with depression undergoing non-invasive intermittent theta-burst stimulation to the left dorsolateral prefrontal cortex (DLPFC) in Major Depressive Disorder.

NCT ID: NCT05731128 Recruiting - Colitis Ulcerative Clinical Trials

A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))

Start date: January 12, 2023
Phase: Phase 2
Study type: Interventional

The protocol of this Phase 2 clinical trial consists of a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of dupilumab in participants with moderately to severely active Ulcerative Colitis (UC) with an eosinophilic phenotype. Screening period: 2 to up to 4 weeks Treatment period: 52-week investigational medicinal product (IMP) intervention (dupilumab or matching placebo) from Week 0 to Week 52 Open-label arm (optional): administration of open-label dupilumab therapy for study participants who qualify. Follow-up period: 12 weeks The maximum duration of study per participant is up to 68 weeks.