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NCT ID: NCT03392831 Not yet recruiting - Infection Clinical Trials

PIcc Cost EffectiveneSS and Safety of Infusional Therapy

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

Infusion therapy comprises the parenteral administration of solutions, through peripheral or central vascular access. Some solutions and drugs are highly irritating to the vascular endothelium and therefore cannot be administered in peripheral vessels, because increase the risk of phlebitis and/or tissue necrosis. Thus, the alternative is the central venous catheter (CVC) where the access can be by direct puncture of a central vessel or peripheral vessel puncture with progression of the catheter until central positioning, through a peripherally inserted central catheter (PICC). We must take into account that indication, insertion, handling and maintenance must be balanced with risks, benefits and costs. The insertion and maintenance of both catheters are not free of complications. Among the most frequent are: Infection, thrombosis, lumen occlusion and accidental early removal of the catheter. This often implies in the need for new vascular access, impacting on morbidity and increased treatment costs. The PICC has some advantages over CVC, for example: avoids repetitive punctures and consequently decreased handling/pain; a lower risk of infection; avoids the use of venous dissections; reduces the risks of pneumothorax/hemothorax; reduces the risk of infiltration, extravasation, necrosis tissue and chemical phlebitis. Further, the PICC can be used as a long-term catheter with easy handling in extra-hospital condition. All these advantages suggest that this technology offers lower cost to the health system and more benefits for patients. However, PICC is not available for use in infusion therapy in patients of the Brazilian public health system, except for neonates. The available literature does not address cost-effectiveness studies of this technology in the international scope comparing the PICC versus CVC. And, similarly, we do not have studies conducted in Brazil to incorporate this technology into our public health system, based on its benefits and potential cost reduction. In order to fill this gap, this study aims to test if the use of PICC in patients with infusional therapy equal or superior to 10 days (Intervention Group), will show a lower incidence in the outcomes (infection, thrombosis or mechanical complications), besides being more cost-effective when compared to the use of CVC of short stay (Control Group).

NCT ID: NCT03397303 Not yet recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy

Quantification of Nerve Stiffness in Neuropathies

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

This project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls.

NCT ID: NCT03414697 Not yet recruiting - Cerebral Palsy Clinical Trials

Transplantation of Umbilical Cord-derived Mesenchymal Stem Cells Via Different Routes

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

To preliminarily evaluate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSCs), and compare the efficacy of UC-MSCs administered through the intravenous, intrathecal, and intranasal routes, in the treatment of cerebral palsy in children.

NCT ID: NCT03420170 Not yet recruiting - Clinical trials for Spinal Cord Injuries

Physical Fitness, Exercise Self-efficacy, Physical Activity Level in People With Spinal Cord Injury (SCI)

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

This is a single blind randomized controlled trial study which will conducted on people with paraplegia wheelchair users. The objectives of this study is to investigates the effects of 16 weeks of 'Graded Exercise Integrated Education' over conventional physical therapy on physical fitness, exercise self-efficacy and the level of physical activity. There will be a significant difference between the experimental and control group.

NCT ID: NCT03420287 Not yet recruiting - Clinical trials for Cleft; Alveolar Process

Evaluation of MPM Prepared From Allogenic Bone Graft in Alveolar Cleft Closure: A Prospective Randomized Clinical Trial

Start date: April 2018
Phase: Early Phase 1
Study type: Interventional

The aim of this trial is to figure out the efficiency of Mineralized Plasmatic Matrix prepared from allogenic bone graft on cleft alveolus and oro-nasal fistula closure, adequate bone volume and acceptable density at the site of grafting.MPM might improve the physiological properties of allogenic bone graft and facilitate its handling and application during surgical grafting.This might decrease the need of the second surgical site for harvesting autogenous bone to be grafted with its all complications and hurdles.This trial will help the practitioners in taking the decision of using the MPM prepared from allogenic bone in alveolar cleft closure or not.

NCT ID: NCT03428308 Not yet recruiting - Hypertension Clinical Trials

Detection and Treatment of Somatic Disease in Patients With Severe Mental Disease

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

In Denmark, around 2 % of the population live with severe mental disease. People with severe mental disease live 15-20 years less than the general population. The majority of the years of life lost are a consequence of the excess mortality due to somatic disease. The high prevalence of somatic disease among people with severe mental disease can be largely attributed to physical inactivity, unhealthy diet and side effects from psychopharmacological drugs. Apart from the impacts of unhealthy lifestyle and medication side effects, research suggests that individuals with severe mental disease do not receive the same treatment for their somatic diseases as do the rest of the population. The inequality in diagnostics and treatment can be attributed to stigmatization from healthcare providers and patients' lacking awareness of symptoms and reluctance to seek medical care. Further, the increasing specialization within both somatic and psychiatric care has led to a division between these two treatment systems (8,9). Patients with severe mental disease who simultaneously have one or more somatic diseases need their treatment to be coordinated; such treatment should span general practice, the municipality and the psychiatric and somatic hospital. Accordingly, the following elements are necessary to create effective and coordinated treatment trajectories: detailed preparation, qualitative process evaluation as an integrated part of the courses of treatment, and involvement of all stakeholders from the start. The overall aim of the project is to optimize the detection of selected chronic somatic diseases, including cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol, in individuals with schizophrenia, schizoaffective disorder or bipolar disorder; to initiate medical treatment; and to ensure treatment compliance among patients. Accordingly, the project has the following objectives: - To develop an intervention targeting individuals with schizophrenia, schizoaffective disorder or bipolar disorder that can optimize the detection of selected chronic somatic diseases, including cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol - To test whether the developed intervention can optimize the detection of cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol in individuals with schizophrenia, schizoaffective disorder or bipolar disorder The project's hypotheses are that an interdisciplinary and intersectoral intervention targeting individuals with schizophrenia, schizoaffective disorder or bipolar disorder can - optimize detection of cardiovascular diseases (ischaemia and cardiac insufficiency), diabetes, hypertension and high cholesterol by systematic screening in general practice - lead to initiation and maintenance of relevant medical treatment. Moreover, we hypothesize that the complete intervention in a long-term perspective will lead to decreased mortality within the target group.

NCT ID: NCT03452657 Not yet recruiting - Clinical trials for Diabetic Retinopathy

Multicenter Clinical Study of Anti-VEGF Treatment on High Risk Diabetic Retinopathy (DR)

Start date: April 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of intravitreous ranibizumab treatment versus sham injections for prevention of high-risk DR.

NCT ID: NCT03454659 Not yet recruiting - Clinical trials for Supratentorial Brain Tumor

Comparison of the Effect of Low and High Fraction of Inspired Oxygen on Postoperative Surgical Field Infection

Start date: April 2018
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to compare the effect of high 0.8 and low 0.4 *FiO2 ventilation primarily on surgical field infection and secondarily on postoperative pulmonary complications in patients are undergoing supratentorial craniotomy surgeons. *fraction of inspired oxygen

NCT ID: NCT03458286 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

A Study Measuring the Effectiveness of Combined Modulated Ultrasound and Electric Current Stimulation as an Adjunctive Treatment in Treating Diabetic Foot Ulcers

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

The study aims to investigate if combined modulated ultrasound and electric current stimulation (CUSECS) is an effective adjunctive treatment to use to treat diabetic foot ulcers when compared against usual care. Consenting patients with diabetic foot ulcers (DFUS) and meet the inclusion criteria will be randomly allocated in to either an experimental group or a control group. The experimental group will receive the adjunctive CUSECS treatment along their usual treatment for their diabetic ulcer. They will be required to attend the Diabetic Foot clinic in St. James's hospital twice a week for a maximum of eight weeks. The CUSECS is provided by attaching small electrodes around the ulcers to provide electric current stimulation. A probe is used on the ulcers to provide the ultrasound waves. Both aiming to increase the blood flow to an area to increase wound healing. The control group will be required to attend the diabetic foot clinic for their usual care for their diabetic foot ulcer once a week for a maximum for eight weeks. Once a week both groups ulcers will be assessed and measured and a photograph solely of the wound will be taken for documentation of wound healing. Wound pain as determined using the 0-10 Numeric pain rating scale will also be measured once a week. The movement in participant's ankle will be measured (flexion, extension, inversion) at the start and at the end of the study to see if treatment has improved its movement. As part of this study participants' will also be requested to fill out a SF-36 questionnaire at the start and at the end of the 8 week trial. This questionnaire evaluates a person's health related quality of life in which the research wants to see if it is affected by a diabetic foot ulcer. The self-efficacy of participants will also be assessed using PROMIS® Item Bank v.1.0 - General Self-Efficacy at the start and at the end of the 8 week trial. The cost of treatment for each arm will be calculated taking into account both direct (cost of treatments, consumables etc.) and indirect costs (loss of earnings, travel, parking etc.). Therefore, as part of this study, participants will be asked about mode of transport and transport time to and from the clinic and if their diabetic foot ulcer has affected their ability to work. Diabetic foot ulcer reoccurrence rates will be monitored in both groups by a follow up appointment 4 weeks after each group completes treatment or monitoring. Data from both groups will be examined and compared to see if CUSECS is effective in healing DFUs. The primary outcome of interest is wound healing and is determined by the number of wounds healed and the time to complete wound healing within eight weeks. All data will be stored confidentially. The study hypothesis is that there is be increased healing rates in subjects treated with CUSECS in combination with standard care compared to those treated with standard care alone. This study aims to provide evidence for continuing improvement in treatment for those suffering with diabetic foot ulcers.

NCT ID: NCT03460340 Not yet recruiting - Clinical trials for Studying Efficacy of dTMS in FM

dTMS as a Treatment for Patients With Fibromyalgia

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

Purpose: The purpose of the study is to explore the efficacy of H1 deep TMS for the treatment of FMS. Design: Prospective randomized sham controlled trial Study Population & sample size:forty (40) FMS subjects between 18-80 years of age. No. of Centers: Four centers- 1. Shalvata Mental Health Center, Tel -Aviv University, Israel. 2. Soraski medical center, Tel-Aviv University, Israel. 3. Sheba Medical Center, Tel-Aviv University, Israel 4. Beer-Yakov Mental Health Center, Tel-Aviv University, Israel. Duration and intensity of Treatment: All subjects will receive prefrontal deep rTMS of H1 Coil (75 trains of 2 seconds, 20 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold, a total of 3000 pulses per session), for 4 weeks, 5 days a week, overall 20 sessions. Name of device: The Brainsway Ltd. H1-Coil Study Endpoints: Clinical outcome: primary outcome Change in self-reported average pain intensity over the last 24 hours will be measured at the end point with the numerical scale (0 = no pain, 10 = maximal pain imaginable) of the VAS-FIQ. secondary outcome 1. Change of sensory and affective pain dimensions will be measured at the end point using the McGill Pain Questionnaire. 2. Change of the impact of pain and FMS on quality of life, will be measured at the end point using the BPI items for pain interference. 3. change of sensitivity to painful stimuli will be evaluated by physical measurements: - WPI - SSS 4. Changes in cognitive functions in domains of attention, working memory, spatial memory, executive functions and social cognition will be measured at the beginning and end point of the study using the Penn Web-Based Computerized Neurocognitive Battery (WebCNP).