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NCT ID: NCT03822832 Completed - Dermatitis, Atopic Clinical Trials

A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated

Start date: February 12, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to investigate the safety, tolerability and efficacy of BI 655130 in patients with Atopic Dermatitis (AD) following repeated intravenous administrations compared to placebo.

NCT ID: NCT03822351 Completed - Clinical trials for Stage III Non-small Cell Lung Cancer

Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC

COAST
Start date: December 19, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

NCT ID: NCT03821649 Completed - Overdose Clinical Trials

SOONER Feasibility Study Protocol

SOONER
Start date: January 23, 2019
Phase: N/A
Study type: Interventional

Opioid Overdose Education and Naloxone Distribution programs (OEND) involve training and equipping people who are likely to be bystanders to opioid overdose to recognize and respond to opioid-related emergencies by activating emergency services, delivering basic life support and administering naloxone. The goal of the Surviving Opioid Overdose with Naloxone Education and Resuscitation (SOONER) trial is to identify if point-of-care OEND increases rates of satisfactory bystander resuscitative performance to simulated opioid overdose in comparison with the existing standard of care. Recruitment and retention of participants at risk of overdose, and the acceptability of the simulated overdose outcome may challenge the feasibility of the SOONER trial. The primary objective is to identify if an integrated participant recruitment and retention strategy can recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition in the context of a randomized trial on point-of-care OEND and simulated overdose resuscitation performance in family practice, emergency department, and addictions settings in Toronto, Ontario. After the initial 28 participants, we are continuing to recruit up to 50 more participants in a bridging phase that leads into the full trial.

NCT ID: NCT03820726 Completed - Clinical trials for Lung Diseases, Interstitial

A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Start date: April 16, 2019
Phase: Phase 3
Study type: Interventional

The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).

NCT ID: NCT03820219 Completed - Clinical trials for Surgical Site Infection

Incisional Negative Pressure Wound Therapy in Patients Undergoing Spine Surgery

Start date: July 15, 2019
Phase: N/A
Study type: Interventional

Introduction: Posterior post-operative spine wounds involving surgery at multiple levels are known to have higher rates of wound complications relative to other areas of the body. Instrumentation, repeat surgery and prior radiation all contribute to more hostile environments for wound healing. The purpose of this study is to determine whether incisional vacuum dressings can help improve the healing/complication rates associated with these wounds. Methods: Patients will be recruited over a two year span as part of the initial pilot study to determine the capabilities/practicality of recruitment locally. Patients will be followed in and out of hospital for 3 months or until the wound has healed clinically. The primary outcome, surgical site infection (SSI), will be evaluated using prior Centre for Disease Control (CDC) definitions. STATA will be used for statistical analysis. Anticipated results: Although the incisional vacuum system (PrevenaTM) has been used previously for spine wounds, there are no randomized control trials compared with standard dressings. Since the infection rate in these wounds has been founds previously to be quite high (10-25%) a reduction could have profound significant benefits on patient morbidity and overall costs to the healthcare system. The pilot study will help inform the direction of a larger, potentially multi-centered trial. Conclusion: If a large treatment effect is demonstrated with the PrevenaTM System then this could potentially change the standard of care for complex spine wounds.

NCT ID: NCT03819790 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians

VARIATION 2 SA
Start date: October 2, 2018
Phase: Phase 4
Study type: Interventional

The overall objective of this study is to compare the effects of Soliqua, a titratable combination of insulin and GLP-1 receptor agonist in a single pen versus Glargine U100 insulin (Basaglar or Lantus) and gliclazide MR, both added to metformin, on measures of glucose variability using masked CGM data among people of South Asian origin living in Canada with type 2 diabetes (T2DM).

NCT ID: NCT03817918 Completed - Clinical trials for Mechanical Ventilation Complication

A New Ultrasonographic Tool to Assess Pulmonary Strain in Patients Under One-lung Ventilation.

STRAIN-VUP
Start date: March 21, 2019
Phase: N/A
Study type: Interventional

Mechanical ventilation is frequently used in the operating room and the intensive care settings. Although essential in many cases, mechanical ventilation can be responsible for ventilator-induced lung injury (VILI). The relationship between mechanical ventilation and VILI has been clearly demonstrated in animals and is highly suspected in humans. The putative mechanism responsible for VILI is excessive pulmonary strain or overdistension. Frequently observed in mechanically ventilated patients, the presence of a severe pre-existing pulmonary disease can increase the risk of overdistension. The development of a tool allowing early detection of pulmonary overdistension would represent a great asset in the prevention of VILI by allowing safer adjustments of mechanical ventilation parameters. Ultrasonographic imaging is a non-radiant, non-invasive technique already available in the intensive care setting. Already used for cardiac strain measurements, ultrasonography is a promising avenue to assess pulmonary strain. This pilot study will aim to create a small dataset of local pleural strain values assessed at predetermined pulmonary areas using ultrasound imaging in patients undergoing thoracic surgery requiring one-lung ventilation. This dataset will be used to help plan larger scale studies.

NCT ID: NCT03817749 Completed - Clinical trials for Overweight and Obesity

Ketone Supplementation, Glucose Control, and Cardiovascular Function

Start date: February 6, 2019
Phase: N/A
Study type: Interventional

Post-prandial hyperglycemic excursions induce a cascade of deleterious effects on the body, including increased inflammation, production of reactive oxygen species, and impaired cardiovascular function. Ingestion of an exogenous oral ketone supplement blunts hyperglycemia in response to an oral glucose tolerance test. Accordingly, it is hypothesized that exogenous ketone supplement ingestion prior to a meal could be an effective strategy for blunting postprandial hyperglycemia. Therefore, the purpose of this study is to investigate the effect of short-term (14-days) pre-meal exogenous ketone supplementation on glucose control, cardiovascular function, inflammation, and oxidative stress in individuals at an elevated risk of type 2 diabetes.

NCT ID: NCT03817333 Completed - Asthma Clinical Trials

The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome

Start date: March 2014
Phase:
Study type: Observational

RATIONALE: In asthmatic subjects, smoking can lead to several changes in disease characterictics. in smokers of more than 20 pack-years, chronic obstructive pulmonary disease (COPD) can be associated with asthma, also called asthma-COPD overlap syndrome (ACOS). Increasing data support the concept that ACOS is a clinical entity. However, this should be further studied in order to better target therapy. AIM: The objective of this study is to evaluate the comparative features of ACOS METHODS: This will be a descriptive study comparing the features of the ACOS with the features of asthmatic subjects with an incomplete reversibility of airway obstruction (IRAO).The study will be done over 1 or 2 visits (within a week interval), according to subjects' availability. The visit will include completion of different questionnaires (asthma control asthma quality of life, medical history, exacerbations, etc.), a thoracic examination, allergy skin-prick tests, spirometry and bronchodilator response, lung volumes and compliance measurements, exhaled nitric oxide measurement, blood sampling and a sputum induction.

NCT ID: NCT03816891 Completed - Prurigo Nodularis Clinical Trials

Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis

Start date: March 11, 2019
Phase: Phase 2
Study type: Interventional

Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of Vixarelimab (KPL-716) in subjects with prurigo nodularis.