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NCT ID: NCT04018664 Completed - Opioid Abuse Clinical Trials

Oral Abuse Potential Study of Nalbuphine

Start date: May 29, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients). The amount of nalbuphine levels in the blood will also be measured and the safety of the study drugs will be evaluated. This study has 2 parts: Part A and Part B.

NCT ID: NCT04018027 Completed - Atopic Dermatitis Clinical Trials

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

KARE
Start date: June 29, 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, 4-arm, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with atopic dermatitis (AD) and moderate to severe pruritus.

NCT ID: NCT04017221 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients With Type 2 Diabetes

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

The purpose of this study is to compare the risk of serious adverse events associated with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in comparison with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes. More specifically, the investigators will assess the risk of severe urinary tract infection (urosepsis), diabetic ketoacidosis and lower extremity amputation. The investigators hypothesize that the use of SGLT2 inhibitors will be associated with an increased risk of serious adverse events in comparison with the use of DPP-4 inhibitors. The investigators will carry out separate population-based cohort studies using health care databases in seven Canadian provinces and the United Kingdom. Separate study cohorts will be created for each of the three safety outcomes. The study cohorts will be defined by the initiation of a SGLT2 inhibitor or a DPP-4 inhibitor after SGLT2 inhibitors entered the market. Patients will be followed up until the occurrence of an adverse event. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the risk of serious adverse events in users of SGLT2 inhibitors in comparison to users of DPP-4 inhibitors.

NCT ID: NCT04016324 Completed - Overactive Bladder Clinical Trials

InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study

BASIC
Start date: November 28, 2019
Phase: N/A
Study type: Interventional

Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation.

NCT ID: NCT04016103 Completed - Clinical trials for Acute Compartment Syndrome

MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time

Start date: July 17, 2020
Phase: N/A
Study type: Interventional

Compartment syndrome can result from extremity trauma. It can also be caused by procedural cases that involve lower or upper extremity surgery. This condition results in muscle death, chronic pain, infection, and possible amputation. Early diagnosis is essential to institute interventions that can avoid complications. Subjective pain of the patient remains the mainstay for diagnosis. A method or device is needed that would improve our accuracy in diagnosing compartment syndrome. Ideally, this would be suited for single and/or continuous pressure read-outs. The aim is to reduce the incidence of missed compartment syndrome and diminish delays that would lead to significant disability. Despite awareness, delayed diagnosis and treatment occurs in modern orthopaedic practice. As noted in many studies, once a diagnosis has been made, immediate fasciotomy is necessary to provide the best chance for a favourable clinical result. Therefore, there is a need for improved devices in order to obtain an early and reliable diagnosis.

NCT ID: NCT04015518 Completed - Clinical trials for Palmoplantar Pustulosis (PPP)

A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis

Start date: July 31, 2019
Phase: Phase 2
Study type: Interventional

The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety. Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.

NCT ID: NCT04014335 Completed - Clinical trials for Primary IgA Nephropathy

A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA Nephropathy

Start date: December 4, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of IONIS-FB-LRx, an antisense inhibitor of complement factor B messenger ribonucleic acid (CFB mRNA), and to evaluate the effect of IONIS-FB-LRx on plasma factor B (FB) levels and serum AH50, CH50 activity in participants with primary immunoglobulin A (IgA) nephropathy.

NCT ID: NCT04013711 Completed - Clinical trials for Radiotherapy Side Effect

Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy

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

A significant proportion of patients treated with whole-breast or head and neck radiotherapy will experience skin toxicity, i.e. skin dermatitis, which may lead to erythema, dry desquamation and wet desquamation. It is hypothesized that quantitative thermal imaging can be used to measure radiation-induced skin toxicity.

NCT ID: NCT04013451 Completed - Anxiety Clinical Trials

The Kiss of Kindness Study II

Start date: September 27, 2019
Phase: N/A
Study type: Interventional

The objective of this study is to assess the impact of engaging in deliberate acts of kindness on resilience (primary outcome); social interaction anxiety and affect (secondary outcomes); and mood (exploratory outcome) of undergraduate and graduate students at Western University (UWO). Recruitment of 200 participants consisting of 150 full-time undergraduate and 50 graduate students, randomized to either the intervention (n=100) or control group (n=100) will be achieved via a mass email to all full-time students at UWO. Both intervention and control groups will receive an email with access to a relaxation and stress management booklet from UWO's Wellness Education Centre (http://studentexperience.uwo.ca/docs/RelaxationAndStressManagement.pdf). In addition, the intervention group will be asked to (1) complete and log/submit a minimum of three deliberate acts of kindness per day for one month, and (2) join the study-dedicated online site to connect with, support, and share experiences and ideas with each other around acts of kindness. Individuals in the intervention group will also receive a list of deliberate acts of kindness ideas, for reference. Baseline, immediate post intervention, and three-months post intervention data will be collected using previously validated questionnaires associated with each outcome of interest, and posted to Qualtrics, an online survey tool. Additionally, immediately following the intervention and 3 months post intervention all participants will complete an open-ended question asking them to describe their overall experience being involved in the study. Quantitative and qualitative data analysis will occur upon the completion of the study.

NCT ID: NCT04012723 Completed - Clinical trials for Compartment Syndrome Traumatic Lower Extremity

Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome

Start date: November 17, 2020
Phase: N/A
Study type: Interventional

Compartment syndrome remains a very serious complication of lower extremity trauma and/or procedural cases that involved lower or upper extremity surgery. This condition results in muscle death, chronic pain, infection, and possible amputation. Early diagnosis is essential to institute interventions to avoid complications. Unfortunately, the subjective pain of the patient remains the mainstay for diagnosis. A method or device is needed that would improve the investigator's ability to diagnose this potentially devastating condition. The purpose of this trial is to evaluate the safety and functionality of MY01, an investigational device that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. This is a single centre, non-randomized, non-controlled, unblinded, prospective trial of the MY01 device. A cohort of 25 participants will be prospectively enrolled to document the performance of the device.