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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: NCT03006068 Active, not recruiting - Clinical trials for Ulcerative Colitis (UC)

A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

U-ACHIEVE
Start date: January 31, 2017
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.

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: NCT02998710 Recruiting - Clinical trials for Homocystinuria Due to CBS Deficiency

Natural History Study of Homocystinuria Caused by Cystathionine Beta-Synthase Deficiency (ACAPPELLA)

Start date: January 2017
Phase:
Study type: Observational

The purpose of the study is to characterize the clinical course of homocystinuria in pediatric and adult patients aged 1 to 65 years under current clinical management practices

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: NCT02991469 Recruiting - Clinical trials for Juvenile Idiopathic Arthritis

A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)

Start date: August 9, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for adequate treatment of this population. Secondary Objective: To describe the pharmacodynamics (PD) profile, the efficacy, and the long term safety of sarilumab in patients with sJIA.

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.