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NCT ID: NCT02774031 Completed - Clinical trials for Female Urogenital Diseases

Comparison of Gas Consumption From Two Different Anesthesia Machines

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

Low flow anesthesia (LFA) is used less than desirable, partly because one has considered that there might be danger of underdosing of anesthesia gas and thus risk of awareness under anesthesia.LFA has several advantages such as reducing loss of moisture and heat in the inhaled air under anesthesia and to reduce the consumption of anesthetic gas. A few anesthesia machines include an automatic gas control system: the Aisys machine, by GE Healthcare (Madison, WI, USA), and the Flow-i machine, by Maquet (Sweden). Since these machines were introduced, only a few studies have reported their functionality and effect on gas consumption. 20 to 55% reduction of gas consumption was found. The potential reduction may have been underestimated because in the majority of cases a FGF higher than 1 l/min was still used. In this study the consumption of anesthetic gas (desflurane) delivered by two different anesthesia machines (Aisys and Flow-i) will be compared, with and without gas control delivery systems. Gas consumption and the time needed to reach the target level of anesthetic gas concentration will be assessed. Data needed will be collected directly from the anesthesia machine, PICIS ( Electronic anesthesia record) and EPJ (Electronic patient journal). The results of this study are of interest for intraoperative ventilation and of economic and ecological interest

NCT ID: NCT02772471 Completed - Brain Injuries Clinical Trials

Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device

Start date: March 2014
Phase: N/A
Study type: Interventional

Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical information. HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP waveform safely and accurately with minimal discomfort to patients, compared to standard invasive ICP monitoring procedures used at the participating institutions.

NCT ID: NCT02770807 Completed - Genetic Syndrome Clinical Trials

Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Telangiectasia Patients

ATTeST
Start date: March 2, 2017
Phase: Phase 3
Study type: Interventional

Objectives: The objective of study was to evaluate the safety and the efficacy of EryDex (Dexamethasone sodium phosphate encapsulated in autologous erythrocytes, using the EryDex System - EDS) at two dose levels (low dose and high dose DSP/infusion), compared to placebo, on Neurological Symptoms in Patients With Ataxia Telangiectasia. Initial Double-Blind Treatment Period (0 to 6 Months) Primary Efficacy Objective: • Evaluate the effect of EryDex at two dose levels (low dose and high dose DSP/infusion), compared to placebo, on central nervous system (CNS) symptoms measured by the change in the Modified International Cooperative Ataxia Rating Scale (mICARS) from baseline to Month 6 (Visit 9) in patients with ataxia telangiectasia (A-T). Secondary Efficacy Objectives: - Evaluate the effect of EryDex, compared to placebo, on the Clinical Global Impression of Change (CGI-C) in patients with A-T from baseline to Month 6 (Visit 9). - Evaluate the effect of EryDex, compared to placebo, on measures of Clinical Global Impression of Severity (CGI-S; structured) in patients with A-T from baseline to Month 6 (Visit 9) - Evaluate the effect of EryDex, compared to placebo, on measures of Adaptive behavior measures in patients with A-T by the Vineland Adaptive Behavior Scales (VABS) from baseline to Month 6 (Visit 9). Safety Objectives: • Evaluate the safety and tolerability of two non-overlapping doses of EryDex, compared to placebo, in patients with A-T over the 12-month double-blind study duration. Extension Treatment Period (6-12 Months): Primary Objective: • Evaluate the efficacy of EryDex at two dose levels (low dose and high dose DSP/infusion) compared to placebo, in treating CNS symptoms in A-T patients during longer-term treatment (up to 12 months), as measured by the mICARS. Secondary Objectives: - Evaluate the longer-term (up to 12 months) safety and tolerability of EryDex in A-T patients. - Compare the effects of EryDex on the CGI-C and CGI-S (structured), VABS, and QoL using the EQ-5D-5L scale.

NCT ID: NCT02770599 Active, not recruiting - Crohn Disease Clinical Trials

Improving the Health Care in Inflammatory Bowel Disease.

Start date: May 15, 2016
Phase:
Study type: Observational

Inflammatory Bowel Disease (IBD) refers to two chronic diseases (Crohn's disease and Ulcerative colitis) both complex disorders requiring a long-term management, with significant healthcare resource consumption. Traditionally IBD patients has been treated by a variety of health care professional including doctors with specialist qualifications, assistant doctors, general practitioner or scarcity of follow-up-service. Lately there has been a shift in the health care service from conventional follow - up (CF) to a rising numbers of health care models in term of Multidisciplinary team (MDT) also including care for IBD patients. MDT- models have been identified as important for continuity in patient centred care where nurses have a key role within the team by enhancing patient care. Patients have directly access to the IBD nurse who performing independently consultations at the IBD - Policlinic. This study will test the hypothesis that MDT including an IBD - nurse is preferable concerning; patient reported Health Related Quality of Life (HRQoL) Quality of Care (QoC), and clinical outcomes including adherence. This will be a retrospective clinical quality survey with a single time point measurement, with consecutive recruitments of patients in the course of a 12-month period. Data will be collected from medical records and patient questionnaires. Investigators plan involving 300 participants aged >18 and < 80 recruited from Medical departments in North Norway and from Diakonhjemmet in Oslo. Half will be from CF-models and half from the IBD - MDT. The study have approval from the local Ethics committee and application to the Data protection Officer has been submitted. All participants are asked for provide written consent. The results can potentially contribute; to a better utilization of health care resources, improve quality of health and quality of care. In a nurse-perspective, this organising model can be valuable in recruiting nurses by presenting a new challenging task concept, and identify the gaps in their own knowledge and skills. A well-established MDT can also be reasonable in a cost effective way by decreasing hospitalisation and fee up clinical spaces for the gastroenterologist.

NCT ID: NCT02769507 Completed - Psychotic Disorders Clinical Trials

Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations

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

The present study aims to investigate whether transcranial direct current stimulation (tDCS) reduces auditory hallucinations in patients with psychosis. In addition, the neuronal changes of tDCS will be examined.

NCT ID: NCT02768922 Completed - Stroke Clinical Trials

Aphasia Telerehabilitation

AT
Start date: May 3, 2016
Phase: N/A
Study type: Interventional

This study aims at contributing with scientific evidence to the field of aphasia telerehabilitation. In Norway today, there is an unmet need for language training in post stroke aphasia and not all patients are offered language training. Early start of aphasia rehabilitation and satisfying intensity do not seem to be standard clinical practice. Language training by telemedicine could improve this situation, and this study seeks to answer the question whether aphasia rehabilitation delivered by videoconference can improve language function in aphasia post stroke.

NCT ID: NCT02767557 Completed - Clinical trials for Unresectable Pancreatic Carcinoma

Study of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab in Pancreatic Cancer Patients

PACTO
Start date: January 26, 2017
Phase: Phase 2
Study type: Interventional

This is a multicenter center, 2-arms prospective randomized phase II trial which evaluates whether tocilizumab with gemcitabine/nab-paclitaxel is more effective than gemcitabine/nab-paclitaxel.

NCT ID: NCT02767505 Active, not recruiting - Severe Obesity Clinical Trials

Bypass Equipoise Sleeve Trial (BEST)

BEST
Start date: September 2015
Phase: N/A
Study type: Interventional

This is nationwide registry-based randomised clinical multicenter trial in which patients will be randomised to gastric bypass (RYGB) or sleeve gastrectomy (SG). The co-primary endpoint are weight control over 5 years and the amount of severe adverse events. Additionally the investigators have predefined a number of secondary endpoints, and the trial has a sufficient number of patients to allow comparisons across subgroups.

NCT ID: NCT02765607 Completed - Coronary Disease Clinical Trials

Circulatory Oscillations in Post Cardiac Surgery Patients

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

In this observational study investigators examine the presence of circulatory oscillations in blood pressure, heart rate, and doppler laser flow before and after planned cardiac surgery.

NCT ID: NCT02762396 Completed - Clinical trials for Ischemic Stroke at a Young Age

The Norwegian Stroke in the Young Study II

NOR-SYSII
Start date: March 1, 2016
Phase:
Study type: Observational [Patient Registry]

NOR-SYS II is designed for finding the cause of acute ischemic stroke lesions in Young adults, age 15 to 49 years. Risk factors, arterial wall changes by intima-media thickness and plaques and consequences of stroke are examined by standardized diagnostics.