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NCT ID: NCT03138200 Recruiting - Anemia Clinical Trials

The Role of Central Venous Oxygen Saturation (ScvO2) as an Indicator of Blood Transfusion in the Critically Ill

Start date: March 8, 2017
Phase: N/A
Study type: Interventional

Transfusion of red blood cells is an everyday practice in critical care with the primary aim of restoring adequate tissue oxygenation. However, blood transfusion may also be harmful and costly, therefore a so called restrictive transfusion regime has been suggested by recent guidelines. These transfusion guidelines consider certain levels of hemoglobin as transfusion trigger, which on its own gives little information if any about the balance between oxygen delivery (DO2) and consumption (VO2). Hence, there is a clear need for additional physiologic transfusion trigger values. One of the potentially useful and easily obtainable physiological parameters is the central venous oxygen saturation (ScvO2), which has been shown to be a potential transfusion trigger value in hemodynamically stable but anemic patients. However, the role of ScvO2 as a transfusion trigger value was examined only in a retrospective observational study and in animal experiment. The normal value of ScvO2 in a resting adult at rest is around 70-75%, which is the product of the VO2 and DO2 relationship. Low ScvO2 usually indicates inadequate DO2. It was found in an observational study that if ScvO2>70% before transfusion due to transfusion only the value of hemoglobin increased but the value of ScvO2 did not change. This finding indicates that the DO2 may have been adequate in spite of the low hemoglobin value and the transfusion may have been unnecessary. In one of their recent animal experiments, the investigators reported that in an isovolemic-anemia model the value of ScvO2<70% was only reached when the value of hemoglobin was far less, 59 g/L, than the recommended lowest value of 70g/L as transfusion trigger by guidelines. Despite the pathophysiological rationale and the encouraging results of retrospective studies and animal experiments, prospective randomized trials in order to test the effects of an ScvO2-assisted transfusion protocol are yet to be performed. The aim of this study is to investigate the effects of an ScvO2-assisted transfusion protocol as compared to the guideline-based, hemoglobin levels guided transfusion practice.

NCT ID: NCT03136614 Recruiting - Anaesthesia Clinical Trials

Prognostic Value of the Arteriograph in the Surgical Theatre and at the Intensive Care Unit

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

To investigate how pulse wave velocity, aortic augmentation index and the arterial pulse wave given by the Arteriograph contributes to preoperative assesment, intraoperative and intensive care monitoring.

NCT ID: NCT03093116 Recruiting - Clinical trials for Metastatic Solid Tumors

A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

TRIDENT-1
Start date: March 7, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

NCT ID: NCT03053505 Recruiting - Clinical trials for Clostridium Difficile Infection

A Novel Faecal Microbiota Transplantation System for Treatment of Primary and Recurrent Clostridium Difficile Infection

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

This study is a two-arm, interventional, prospective, open-label, multi-center clinical trial with randomized and non-randomized study groups to evaluate the safety and effectiveness of faecal microbiota transplantation (FMT) for the treatment of adult patients suffering from primary or recurrent Clostridium difficile infection (CDI), using a novel, standardized microbiota transplantation system.

NCT ID: NCT03025737 Recruiting - Athletes Heart Clinical Trials

Semmelweis Sport Study

Start date: January 2017
Phase: N/A
Study type: Observational [Patient Registry]

The aim of the present proposal is to investigate the development of distinct morphological, functional, biochemical and molecular aspects of short- and long-term sport-induced changes in the heart, to get a better understanding on the (patho)physiology of athlete's heart. The main goal of our research is to deepen our knowledge on the proper differentiation between beneficial (physiological) and harmful (pathological) consequences of professional sport, thereby effectively preventing potential cardiovascular complications of athletes.

NCT ID: NCT02988128 Recruiting - Stroke, Ischemic Clinical Trials

Neurovascular Product Surveillance Registry

INSPIRE
Start date: December 2016
Phase:
Study type: Observational [Patient Registry]

Post market surveillance registry

NCT ID: NCT02986516 Recruiting - Chordoma Clinical Trials

Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease

SACRO
Start date: March 16, 2017
Phase: N/A
Study type: Interventional

Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma

NCT ID: NCT02947555 Recruiting - Clinical trials for Diabetic Patients With/Without Atherosclerotic Diseases

Cardiovascular Risk Assesment in Diabetic Patients Via Lens Autofluorecscence Detection

CRADILA
Start date: May 1, 2016
Phase:
Study type: Observational

The rate of lens autofluorescence will be compared in diabetic and non diabetic patients with/without atherosclerotic vascular diseases to evaluate if it is associated with the risk of cardiovascular diseases.

NCT ID: NCT02935803 Recruiting - Clinical trials for Urinary Stress Incontinence

A Study on the Anti-incontinent Effectiveness of the mTVM Method in POPQ Stage II-III Patients

TVMvsmTVM
Start date: July 2016
Phase: N/A
Study type: Interventional

An increasing number of specific procedures have been described for the surgical repair of pelvic organ prolapse (POP) and concomitant stress urinary incontinence (SUI). The investigators introduced an alternative operative method for POP-Q II-III repair and anti-incontinence with the trans vaginal mesh (TVM) anterior edge fixed to the periurethral tissues at the level of mid-urethra. The efficacy and short- and long-term complication profile, of this new surgical technique as compared with those of non-modified TVM.

NCT ID: NCT02932410 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)

TOMORROW
Start date: October 24, 2017
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with pulmonary arterial hypertension (PAH).