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NCT ID: NCT03009929 Completed - Clinical trials for Postoperative Complications

Validation Study of ClassIntra®

ClassIntra®
Start date: February 15, 2017
Phase:
Study type: Observational

Whereas there are several validated systems for reporting postoperative complications, there are only a few and not prospectively validated systems for reporting intraoperative complications. The investigators developed a definition and CLASSification for Intraoperative Complications CLASSIC within a Delphi study involving international interdisciplinary experts. As both surgery and anaesthesia may be involved in complications in the perioperative period, all patient-related intraoperative complications occurring between skin incision and closure are considered in this reporting system. CLASSIC was updated to ClassIntra® v1·0, by encompassing five severity grades to align with the validated Clavien-Dindo Classification for grading postoperative complications. The aim of this international multicentre observational cohort study is to assess the validity and practicability of this newly derived and updated classification system ClassIntra® in patient undergoing an in-hospital surgical procedure. Providing an easy applicable and internationally validated classification system is a contribution to improve quality of health care and patient safety.

NCT ID: NCT03005782 Completed - Malignancies Clinical Trials

Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

Start date: November 7, 2016
Phase: Phase 1
Study type: Interventional

The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma. The primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as measured by objective response rate (ORR).

NCT ID: NCT02998177 Completed - Pain, Postoperative Clinical Trials

Characterization of Rebound Pain Following Peripheral Nerve Block and Its Association With Gut Microbiome Diversity

Start date: November 2016
Phase: N/A
Study type: Observational

The objective of this study is to determine the association between gut microbiome diversity and the characteristics of rebound pain at offset of peripheral nerve block in patients who have undergone upper limb surgery. Other purposes of this study are to determine associations between gut microbiome constitution and persistent post-surgical pain; and describing rebound pain by quantifying its clinical, psychological and neurophysiological characteristics in this patient cohort.

NCT ID: NCT02994927 Completed - Clinical trials for ANCA-Associated Vasculitis

A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis

ADVOCATE
Start date: March 15, 2017
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab.

NCT ID: NCT02993107 Completed - Peanut Allergy Clinical Trials

PALISADE Follow-on Study (ARC004)

Start date: December 29, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.

NCT ID: NCT02986425 Completed - Clinical trials for 5 or More Regular Drugs

OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People

OPERAM
Start date: December 2016
Phase: N/A
Study type: Interventional

The objective of this Randomised Controlled Trial (RCT) is to evaluate whether the Systematic Tool to Reduce Inappropriate Prescribing (STRIP) including STRIP assistant (STRIPA) implemented by an appropriately qualified team will lead to an improvement in clinical and economic outcomes among patients aged 70 years and more with multimorbidity and polypharmacy.

NCT ID: NCT02980276 Completed - Clinical trials for Gestational Diabetes

A Randomized Placebo Controlled Trial of the Effectiveness of Metformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects

EMERGE
Start date: June 6, 2017
Phase: Phase 3
Study type: Interventional

The overall objective of the EMERGE trial is to determine whether metformin + usual care, compared to placebo + usual care (introduced at the time of initial diagnosis of GDM), reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive maternal weight gain; c) maternal and neonatal morbidities and, d) cost of treatment for women with Gestational Diabetes Mellitus.

NCT ID: NCT02976623 Completed - Simulation Training Clinical Trials

Metric-based Feedback Training for the Acquisition of Sonographic Skills

Start date: June 2016
Phase: N/A
Study type: Interventional

The investigators hypothesized that feedback based on previously developed and validated metrics will improve novices' learning of procedural skills. The objective of this study was to determine the effect of a structured, objective and terminal feedback on novices' performance skills of ultrasonography part of ultrasound-guided axillary brachial plexus block.

NCT ID: NCT02967224 Completed - Clinical trials for Diabetes Mellitus, Type 2

A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Naïve Patients Initiating Insulin

Reach-Control
Start date: November 5, 2015
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change Secondary Objectives: - To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority is met, measured as HbA1c change. - To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification. - Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on Hypoglycemia). - Change in fasting plasma glucose (FPG). - Change in body weight. - Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs and DTSQc). - Change in hypoglycemic control subscale (HCS) - Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

NCT ID: NCT02967211 Completed - Clinical trials for Diabetes Mellitus, Type 2

A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin

REGAIN CONTROL
Start date: December 21, 2015
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change Secondary Objectives: - To demonstrate superiority of Toujeo versus "standard of care" basal insulin if non-inferiority criterion is met, measured by HbA1c change. - To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification. - Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or severe (according to ADA Working Group). - Change in fasting plasma glucose (FPG). - Change in body weight. - Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc). - Change in hypoglycemic control subscale (HCS). - Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.