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NCT ID: NCT03497754 Recruiting - Hypovolemia Clinical Trials

The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients

Soundprobe
Start date: February 15, 2018
Phase: N/A
Study type: Interventional

Study to assess the feasibility of an external ultrasound fixator (ProbeFix)

NCT ID: NCT03497741 Recruiting - Sepsis Clinical Trials

Predictive Value of Procalcitonin for Bacteremia in the ICU

Start date: October 1, 2017
Phase:
Study type: Observational

Association between plasma procalcitonin levels and positive blood cultures in critical illness patients in the ICU.

NCT ID: NCT03496012 Recruiting - Choroideremia Clinical Trials

Efficacy and Safety of AAV2-REP1 for the Treatment of Choroideremia

STAR
Start date: December 11, 2017
Phase: Phase 3
Study type: Interventional

The objective of the study is to evaluate the efficacy and safety of a single sub-retinal injection of AAV2-REP1 in subjects with Choroideremia.

NCT ID: NCT03495830 Recruiting - Clinical trials for Carotid Artery Stenosis

Stratification of Patient With Carotid Disease

TAXINOMISIS
Start date: March 29, 2018
Phase:
Study type: Observational

Introduction: Taxinomisis trial is part of the Taxinomisis project. The concept of the Taxinomisis project is to stratify carotid artery disease relying on new modern data corresponding to contemporary patients based on information from longitudinal studies. Taxinomisis trial will validate this tool and adjust such stratification. Initial step of the project is characterization of symptomatic and asymptomatic carotid atherosclerotic plaque lesions, identification of risk and susceptibility factors through the exploitation of longitudinal cohort data and multiomics and disintegration of carotid artery disease phenotypes into endotypes through joint modeling of multipleomics data sets and systems medicine approaches. Finally such stratification model will be validated and adjusted in the Taxinomisis clinical trial.

NCT ID: NCT03495297 Not yet recruiting - Clinical trials for Ventricular Arrythmia

A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing

PRAETORIAN-DFT
Start date: May 2018
Phase: N/A
Study type: Interventional

This study will test the hypothesis that implantation of a subcutaneous implantable cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first shock in a spontaneous arrhythmia episode when implant position is confirmed with PRAETORIAN score.

NCT ID: NCT03493698 Not yet recruiting - Clinical trials for Drug Interaction Potentiation

A Fixed-Sequence, Drug-Drug Interaction Study Between Multiple Oral Doses of Inarigivir Soproxil and a Single Oral Dose of Midazolam in Healthy Subjects

Start date: May 2018
Phase: Phase 1
Study type: Interventional

This is a single center, open-label, fixed sequence study to investigate the effect of multiple oral dosing of Inarigivir Soproxil and a single oral dose of Midazolam in Healthy Subjects

NCT ID: NCT03493672 Recruiting - Neoplasms Clinical Trials

Counting Steps! Integration of Objectively Assessed Physical Activity and Fitness With Smartphones in Clinical Oncology Practice.

Start date: October 18, 2017
Phase:
Study type: Observational

Rationale: Optimal selection of patients with cancer eligible for a clinical trial, is of utmost importance, but can be very difficult. Patients must be sufficiently fit and have a reasonable life expectancy, to be eligible for participation in clinical trials. In current clinical practice, the ECOG/WHO performance status, is used to select patients for clinical trials, and it has proven to be an independent predictor of survival in patients with cancer. This score is based on a subjective assessment of the treating physician, which can, together with the strong motivation of some patients to participate, lead to overestimation of a patient's actual physical condition and may thereby contribute to early trial discontinuation. Participation of these patients may not only harm them, but will also hamper trial conduct and outcomes. Both, physical activity and fitness are positively associated with survival in patients with cancer. This gives rise to the investigators hypothesis that objective measurements can be of added value in the selection process. Additionally, preliminary results in 50 patients with cancer that participated in part 1 of the "Counting Steps!" project revealed that the smartphone can produce valid and reliable assessments of physical activity and fitness, and the user friendliness was rated "good" by patients. The investigators hypothesize that measurements of physical activity and fitness with smartphones will provide more objective and accurate information about the actual physical condition of a patient with cancer. With a better prediction of trial feasibility (without early trial discontinuation) and overall survival in patients participating in phase I-II clinical trials, the selection of eligible trial participants could be improved. In this way, it is possible to more adequately identify patients who are most likely to successfully participate in a clinical trial and thereby have the highest chance to benefit from trial participation. Successful trial participation will provide optimal palliative care to patients and improve their quality of life. In addition, it may prohibit participation of patients who are currently incorrectly included in clinical trials and suffer from toxic therapies without having a chance to benefit from treatment. A better selection of patients will be beneficial for the trial outcomes and subsequently for the development of new anticancer drugs or treatment regimens. Objective: The investigators aim to: 1. Identify whether objective smartphone measurements of physical activity and fitness is predictive for trial feasibility (without early trial discontinuation) in patients with cancer participating in phase I-II clinical trials. 2. Evaluate the feasibility and acceptability of the use of the smartphone's objective assessments of physical activity and fitness in clinical practice. Study design: Observational study Study population: • 135 patients with hematologic or solid cancer referred to the VU medical center for participation in phase I-II clinical trials. Intervention: In this observational study, patients will not receive an additional intervention. Main study parameters/endpoints: Prior to the start of medical treatment, physicians will rate the performance status, and participants will wear a smartphone for one week to measure the daily number of steps, to complete the 6 minute walk test using the smartphone application, and to fill out the 5-item physical function subscale of the EORTC QLQ-C30. These assessments will be repeated after 4 and 8 weeks. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No extra visits to the hospital will be necessary. Participation in this study will not cause any additional risks or expected benefits for participants. It will only deliver knowledge, which may be used in the future to better select patients eligible for participation in phase I-II clinical trials or even for regular treatment. Participation in the study will only cost time for patients. The patients will be asked to wear a smartphone for a week, have to perform a six-minute walk test (6MWT) once in this week and have to complete a questionnaire about their own physical function once. Subsequently, patients will repeat those measurements 4 and 8 weeks after inclusion in the phase I-II clinical trial.

NCT ID: NCT03493659 Enrolling by invitation - Clinical trials for Problem-Based Learning

The Effects of Standing Tutorials on Problem-Based Learning (PBL) Among Undergraduate Students

Start date: April 10, 2018
Phase: N/A
Study type: Interventional

Problem-based learning (PBL) is an education model utilized by Maastricht University and many other universities worldwide. PBL occurs in small, collaborative tutorials, under the facilitation of a tutor. This study explores the effects of standing tutorials, compared against sitting tutorials, on PBL among undergraduate students. A quantitative approach will be taken to objectively measure students' learning, and a qualitative approach will be taken to obtain a deeper understanding of the processes of learning. It is hypothesized that students in the standing tutorials will be able to recall more academic concepts and link the concepts better than students in the sitting tutorials (H1). Audio-recording of the tutorials will be used to measure the discussions within the tutorials. The transcriptions obtained from the recording will be studied through text analysis. It is hypothesized that students in the standing tutorials will produce more discussions, and therefore a higher word count (H2). It is also hypothesized that the students in the standing tutorials will use more word categories that are conducive to the discussion and learning process (H3). Through the qualitative approach, the content of the transcriptions will be analysed through a thematic analysis. It is hypothesized that the students in the standing tutorials will produce more learning-oriented interactions (H4). Two additional factors that would be measured are subsequent physical activity and academic achievement. ActivPAL accelerometers will be used to measure the students' daily activity, to find out if the students' daily activities are affected by the standing tutorials, for example, students may sit more as a result of fatigue from the standing tutorials, or conversely transfer the active behaviour from the standing tutorials to other activities outside the tutorial group.It is hypothesized that standing tutorials do not affect the students' subsequent physical activity, and therefore there will be no significant differences of daily activity between students in the sitting and standing tutorials (H5). With regards to academic achievement, it is hypothesized that the students in the standing tutorials will have higher academic achievements after the course compared to the students in the sitting tutorials (H6).

NCT ID: NCT03493503 Recruiting - Clinical trials for Childhood Asthma With Status Asthmaticus

Status Asthmaticus on the PICU; Intravenous Salbutamol

STATIC IV
Start date: April 5, 2017
Phase: Phase 4
Study type: Interventional

Although IV salbutamol is frequently used in children in a wide range, pharmacodynamic data are scarce. To date, there is an insufficient evidence base to guide initial and subsequent dosing recommendation for its IV use in children. Especially the need for a loading dose needs to be addressed. Therefore, pharmacodynamic and kinetic data are needed to guide initial dosing strategies of IV salbutamol in children. To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the loading dose, compared to placebo.

NCT ID: NCT03490773 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

Type 1 Diabetes, Immunology, Genetics & Endogenous Insulin Production

TIGI
Start date: November 1, 2014
Phase:
Study type: Observational

Type I diabetes(T1D)T occurs when an individual loses the ability to make enough insulin to control their blood sugar levels. They need insulin injections to replace the insulin production that has been lost. Traditionally people with T1D are thought to make none of their own insulin after diagnosis, but we have recently identified that there are some people who have T1D but go one making insulin for many years. We would like to explore this in more depth and understand why some people with T1D go on making insulin and some do not. This will help us understand the causes of T1D and may help work out ways to protect this remaining insulin production, with improved blood sugar control, and reduced long-term complications of diabetes We aim to explore genetic and immunological factors which impact on the ability of an individual diagnosed with Type I diabetes (T1D) to produce their own insulin. We aim to study individuals who have been diagnosed with T1D with variable duration and assess the genetic and immunological profile of those whose are thought to be producing significant amounts of insulin despite a long duration and those who despite a very short duration, lose insulin production very quickly.