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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: NCT03006094 Completed - Chronic Hip Pain Clinical Trials

The Greek Version of the Chronic Pain Grade Questionnaire (CPGQ)

Start date: May 2014
Phase: N/A
Study type: Observational

The aim of the present study is to investigate and report on the psychometric properties of a Greek version of the Chronic Pain Grade Questionnaire (CPGQ).

NCT ID: NCT03002116 Completed - Clinical trials for Peripheral Arterial Disease

Microwave Radiometry Thermometry for the Diagnosis of Critical Limb Ischemia in Diabetic Patients

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

Diagnosis of vascular involvement in diabetic foot disease remains challenging. Differential diagnosis between pure neuropathic or neuro-ischemic diabetic foot requires a combination of clinical examination, medical history and ankle-brachial index (ABI) measurement, which is considered the "gold standard" non-invasive modality for limb ischemia diagnosis. However, in diabetic patients with suspected arterial ischemia resulting in tissue loss (critical limb ischemia; CLI), false negative ABI results are frequent due to Monckeberg medial sclerosis producing incompressible vessels, while clinical signs are subjective and not accurate in posing definite diagnosis of CLI. The investigators conducted a proof of concept study of the feasibility of microwave radiometry thermometry for non-invasive diagnosis of CLI in diabetic patients with tissue loss.

NCT ID: NCT03001622 Completed - Clinical trials for Hidradenitis Suppurativa

Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa

Start date: December 2016
Phase: Phase 2
Study type: Interventional

The trial enrolls patients with moderate to severe Hidradenitis Suppurativa (HS). The primary goal of the trial is to evaluate the safety and tolerability of IFX-1 administered over 8 weeks in these patients. In addition the trial aims to characterize the pharmacokinetics and pharmacodynamics of IFX-1 as well as to generate preliminary data on the efficacy of IFX-1 on clinical endpoints (e.g., Hidradenitis Suppurativa Clinical Response (HiSCR), Dermatology Life Quality Index (DLQI), Visual Analog Scale (VAS) for disease, VAS for pain, Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA), Modified Sartorius Score (mSS)).

NCT ID: NCT03000452 Completed - Multiple Myeloma Clinical Trials

A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

FUSION-MM-005
Start date: March 14, 2017
Phase: Phase 2
Study type: Interventional

This is a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the combination regimen of daratumumab plus durvalumab (D2). The study will consist of 2 parts; Part 1 has a 2-stage design while Part 2 consists of an expansion phase. Subjects will receive intravenous (IV) DARA at 16 mg/kg on the same dosing schedule (weekly [QW], every 2 weeks [Q2W] or every 4 weeks [Q4W] of each 28-day cycle) received on their last prior therapy containing DARA. The dosing schedule for DARA may be adjusted during the course of the study as outlined in the protocol. Subjects will also receive IV DURVA at 1500 mg on Day 2 (Cycle 1) and on Day 1 (Cycles ≥ 2) of each 28-day treatment cycle.

NCT ID: NCT02997202 Completed - Clinical trials for Acute Myeloid Leukemia

A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)

Start date: June 7, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.

NCT ID: NCT02992288 Completed - Heart Failure Clinical Trials

A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction

PANTHEON
Start date: February 22, 2017
Phase: Phase 2
Study type: Interventional

The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).

NCT ID: NCT02991781 Completed - Asthma Clinical Trials

Combined Bio- and Neuro- Feedback vs. Varenicline Use for Smoking Cessation

Start date: January 2017
Phase: N/A
Study type: Interventional

This study will develop and experimentally test the efficiency of a neurofeedback training protocol vs. varenicline use for smoking cessation.

NCT ID: NCT02990338 Completed - Plasma Cell Myeloma Clinical Trials

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients

ICARIA-MM
Start date: December 22, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM). Secondary Objectives: - To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm. - To compare the Overall Survival (OS) between the two arms. - To evaluate the Time To Progression (TTP) in each arm. - To evaluate the PFS in high risk cytogenetic population in each arm. - To evaluate the Duration of Response (DOR) in each arm. - To evaluate the safety in both treatment arms. - To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide. - To evaluate the immunogenicity of isatuximab. - To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.

NCT ID: NCT02989558 Completed - Clinical trials for Aortic Valve Stenosis

A Trial to Assess the Safety and Efficacy of Prophylactic TicagrelOr With Acetylsalicylic Acid Versus CLopidogrel With Acetylsalicylic Acid in the Development of Cerebrovascular EMbolic Events During TAVI

PTOLEMAIOS
Start date: December 2016
Phase: Phase 3
Study type: Interventional

Ticagrelor administered with Acetylsalicylic Acid (ASA) will provide better cerebral protection from microembolization in the cerebral circulation during Transcatheter Aortic Valve Implantation (TAVI) and 30 days afterwards, than Clopidogrel plus ASA. This hypothesis will be investigated by measuring the number of High Intensity Transient Signals (HITS) as assessed with transcranial Doppler (TCD) on middle cerebral arteries.