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NCT ID: NCT03886610 Completed - Clinical trials for Spinal Cord Injuries

Association of Quantitative and Functional Imaging With Clinical Outcome After Spinal Cord Injury

Start date: March 27, 2019
Phase:
Study type: Observational

The overall study aim is to provide additional magnetic resonance imaging parameters of the cervical spinal cord, brainstem and brain and a better understanding of changes after spinal cord injury (SCI) and to define new magnetic resonance (MR) biomarkers to correlate with sensomotoric functioning and clinical outcome.

NCT ID: NCT03885856 Completed - Rotator Cuff Injury Clinical Trials

Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair

RCR
Start date: April 3, 2019
Phase:
Study type: Observational

This study is to analyse whether there is a difference in clinical and radiological outcomes between single row and double row repair techniques for the treatment of shoulder's rotator cuff tears.

NCT ID: NCT03884257 Active, not recruiting - Clinical trials for Peripheral Arterial Disease

A Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon.

BIOPACT-RCT
Start date: February 18, 2020
Phase: N/A
Study type: Interventional

The BIOPACT RCT tiral investigates the efficacy and safety of stenosis, restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 2,3 or 4 with a Passeo-18 Lux drug-coated balloon of Biotronik. The Paclitaxel eluting balloons are designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation and deliver the paclitaxel locally. An expected total of 151 patients will be treated with the Passeo-18 Lux and compared to a control group of another 151 patients that will be treated with the IN.PACT Admiral drug-coated balloon of Medtronic. Assignment to the treatment groups will be at random. The study will be conducted in two phases. A first pilot study phase of 120 patients distributed evenly over both treatment groups and a second phase to formally test the non-inferiority hypothesis. The balloon is coated with Paclitaxel intended to avoid cellular proliferation. The drug is released by means of rapid inflation as to release a high dose in a short amount of time. Patients will be invited for a follow-up visit at 1, 6 and 12 months post-procedure. The primary efficacy endpoints are defined as follows. Freedom from clinically-driven target lesion revascularization at 12 months. Freedom from device- and procedure-related death through 30 days post-index procedure, major target limb amputation through 12 months post-procedure and clinically-driven target vessel revascularization through 12 months post-index procedure. The secondary endpoints are defined as acute device success, acute procedural success , freedom from all cause of death, major target limb amputation and clinically driven target vessel revascularisation through 30 days post-procedure, sustained clinical improvement, no major adverse events through 6 and 12 months post-procedure, primary patency, target lesion revascularisation, target vessel revascularisation, binary restenosis, major target limb amputation, thrombosis at target lesion, change of walking impairment questionnaire score from baseline, change in target limb rutherford classification or ABI.

NCT ID: NCT03883516 Recruiting - Status Epilepticus Clinical Trials

Improving Emergency Management of Status Epilepticus

SESIM
Start date: September 30, 2019
Phase: N/A
Study type: Interventional

In the trial the effectiveness of pre-briefing physicians with the current guideline on Status epilepticus (SE) treatment or a consolidated "one page" guideline regarding quality enhancement of the physician's clinical performances is investigated.

NCT ID: NCT03883503 Completed - Alcohol Drinking Clinical Trials

The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption

Start date: February 25, 2019
Phase: N/A
Study type: Interventional

The main interest of this study is to investigate the influence of moderate alcohol consumption (beer) on salt-water homeostasis. Therefore, 10 healthy volunteers will participate in 4 Intervention: - Beer alone - Beer and water - Beer and salt (stock/bouillon) - Water alone During the study day, copeptin, sodium, osmolality and urinary sodium/osmolality will be measured at 6 timepoints.

NCT ID: NCT03883425 Completed - Clinical trials for Frail Elderly Syndrome

Frailty and Complexity Among Home Service Recipients

fraXity
Start date: September 1, 2018
Phase:
Study type: Observational

The purpose of the study is to develop frailty and complexity computation algorithms based on the French version of the interRAI-HC and, in doing so, to provide homecare nurses with valid and reliable screening tools for their routine practice. By relying on a prospective observational case-control longitudinal study, the study intends to assess the predictive validity of the proposed indices with respect to undesirable health outcomes. Repeated measurement occasions, separated by 6-month intervals, will also allow for estimation of intra-individual change in frailty and complexity. In the study, elders living in the community and aged 65 or older are the target population, and three samples will be considered based on the a priori risks of adverse outcomes (case 1: formal home service recipients; case 2: formal home care recipients; control: free of formal home care or service). These groups will be compared on the observed rates of frailty and complexity and on their evolution over time. Results will allow for identification of subgroups of the aged population for whom early screening of frailty and complexity appears most relevant. Based on the findings, practice guideline will be proposed. They will entail the interpretation of the scores and recommendations for mounting adapted preventive strategies. Finally, the study will contribute to enhancing knowledge on the relation between frailty, a well-known concept in gerontology, and complexity, a concept increasingly referred to in the care literature but that still deserves operational and consensual definitions.

NCT ID: NCT03883009 Completed - Clinical trials for Surgical Site Infection

Understanding the Drivers of Surgical Site Infection: Investigating and Modeling the Swissnoso Surveillance Data

WATUSSI
Start date: August 1, 2018
Phase:
Study type: Observational

Surgical site infection (SSI) is the most common healthcare-associated infection, multifactorial in nature, and a typical preventable harm. Many healthcare systems require hospitals to determine the corresponding infection rates as a quality indicator and often stipulate public reporting of these data. Several agencies, among them the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC), have issued evidence-based prevention guidelines. Despite efforts in implementing best practice, SSI continue to be a relevant complication of modern surgical procedures and generate enormous costs for the healthcare system. Moreover, prevention guidelines acknowledge that the evidence backing their recommendations is low to moderate in most cases, which is partly due to the complexity of SSI pathogenesis. Swissnoso, the Swiss expert group for infection prevention and hospital epidemiology, oversees the nationwide collection of data on select procedures and the associated SSI. Since the inception of this dedicated surveillance in 2009, more than 300'000 procedures have been included and the corresponding patients were followed to ascertain SSIs. Although primarily conceived as a national surveillance system and then used for public reporting starting in 2014, Swissnoso is a prime data source for better understanding the epidemiology of SSI. Here, the investigators seek to raise the quality of evidence behind future prevention guidelines. For this purpose, the investigators will move from a risk factor analysis for SSI (of which a substantial part occurs after patient discharge from the hospital, rendering surveillance difficult) to the collection of additional data (in order to better characterize certain determinants of SSI and their recognition) and, finally, to a mathematical model (which will simulate the probability of developing SSI so the investigators can test what may modulate this risk).

NCT ID: NCT03881462 Completed - Nerve Injury Clinical Trials

Deltoid Muscle Contribution to Shoulder Function

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

There is only one study in the literature about the quantitative effect of M. deltoideus on the movement of the shoulder. Here, the author described a 35-80% loss of abduction power after selective blockade of the N. axillaris. Gerber, on the other hand, found a loss of abduction force of 73-86% after blockade of the suprascapular nerve. These results are partly contradictory, which is why the investigators think that further investigation is needed. For many questions in the field of shoulder orthopedics, this knowledge would provide an important additional basis for therapeutical decision-making. For example, in the treatment of rotator cuff ruptures but also in the implantation of both inverse and anatomical shoulder prostheses. Also, statements about different outcome prognoses could be made more precisely. Therefore, the investigators would like to perform muscle strength measurements of the deltoid muscle on 12 healthy volunteers on the dominant arm. Abduction, flexion, external rotation and internal rotation Mm. Infraspinatus, Supraspinatus and Subscapularis are tested respectively. The investigators plan to carry out the measurements three times before and after an-anaesthesiological nerve block of the axillary nerve thus inactivating the deltoid muscle (performed exclusively by an anesthesiologist specialized in regional anesthesia). The success of the nerve block is confirmed by needle electromyographies (EMG) by a neurologist specialized in electrophysiology. Using EMG neurogenic pathologies within the tested muscles are also ruled out. In order to exclude relevant rotator cuff pathologies the investigators will perform shoulder radiography in three planes and sonography of the rotator cuff before conducting the experiment described above.

NCT ID: NCT03880500 Recruiting - Pain, Back Clinical Trials

Spinal Segment MRI Perfusion and Diffusion Response to Spinal Manipulation in Low Back Pain Patients

Start date: March 6, 2019
Phase: N/A
Study type: Interventional

The main objective is to quantify changes in diffusion and perfusion in the intervertebral disc and adjacent spinal muscle tissue of a spinal segment receiving a spinal manipulative or control intervention using diffusion-weighted magnetic resonance Imaging (MRI) (DWI, used for quantifying diffusion) and intravoxel incoherent motion MRI (IVIM, used for quantifying perfusion). Additional objectives are to test if clinical parameters such as pain and disability, radiological parameters, or pain-related inflammatory parameters in venous blood have predictive value in relation to these perfusion and diffusion effects, and if these effects correlate to clinical outcome. An additional objective is to test the repeatability of IVIM-MRI in assessing perfusion changes in musculoskeletal tissue, and, as a positive control, assessing diurnal changes in perfusion and diffusion parameters in spinal tissue of healthy controls.

NCT ID: NCT03880162 Active, not recruiting - PreDiabetes Clinical Trials

Metabolic Effects of a Low Carbohydrate Versus a Standard Diet in Morbidly Obese With Prediabetes

CaPrO
Start date: May 13, 2019
Phase: N/A
Study type: Interventional

To investigate the metabolic effects of a low carbohydrate versus energy-matched standard diet in morbidly obese individuals with prediabetes awaiting bariatric surgery.