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Filter by:Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited arrhythmia disorder with high risk of ventricular tachycardia or fibrillation, and implantable cardioverter defibrillator remains as therapy of choice. Antiarrhythmic therapy with different agents including beta-blockers, sotalol and amiodarone are usually not effective in reducing risk of arrhythmic events. Recent data indicated that flecainide effectively prevented the arrhythmias observed in the experimental ARVC animals and in small series of ARVC patients. These observations provide a strong rationale for conducting a pilot randomized clinical trial to determine whether flecainide will reduce ventricular arrhythmias in high-risk ARVC patients. This pilot study is designed as randomized double-blinded placebo-controlled crossover trial with administration of 100 mg of Flecainide or matching placebo twice a day for 4 weeks each with a washout period. Primary specific aim of this pilot trial is to determine whether Flecainide administration is associated with a significant reduction of number of ventricular ectopic beats (VEBs) in ARVC patients with implantable cardioverter-defibrillator (ICD).
Postoperative nausea and vomiting (PONV) is a common problem and may lead to catastrophic complications, especially in neurosurgical cases. The aim of this study was to evaluate the effects of dexamethasone and ondansetron for preventing PONV in patients who underwent microvascular decompression surgery (MVD).
This is a prospective, double-blinded, randomized, multi-centre, cross-over study. All subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each.
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas. The study is divided into two parts: single agent FT-2102 followed by combination therapy. Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or altered dose schedules may be explored. Part 2: An open-label study of FT-2102 in combination with other anti-cancer agents. Patients will be enrolled across 4 different disease cohorts, examining the effect of FT-2102 + azacitidine (glioma and chondrosarcoma), FT-2102 + nivolumab (hepatobiliary tumors), and FT-2102 + gemcitabine/cisplatin (intrahepatic cholangiocarcinoma). There will be a safety lead-in followed by a Phase 2 evaluation in up to four cohorts of patients.
Countries across sub-Saharan Africa are scaling up Community Health Worker (CHW) programmes, yet there remains little high-quality research assessing strategies for CHW supervision and performance improvement. This randomised controlled trial aims to determine the effect of a personalised performance dashboard used as a supervision tool on the quantity, speed, and quality of CHW care. This study is a randomised controlled trial in a large health catchment area in peri-urban Mali. One hundred forty-eight CHWs conducting proactive case-finding home visits were randomly allocated to receive individual monthly supervision with or without the CHW Performance Dashboard from January to June 2016. Randomisation was stratified by CHW supervisor, level of CHW experience, and CHW baseline performance for monthly quantity of care (number of household visits). With regression analysis, we used a difference-in-difference model to estimate the effect of the intervention on monthly quantity, timeliness (percentage of children under five treated within 24 hours of symptom onset), and quality (percentage of children under five treated without protocol error) of care over a six-month post-intervention period relative to a three-month pre-intervention period.
There is still limited number of studies in the literature provides insufficient evidence to support the use of ESWT in the treatment of insertional Achilles tendinopathy and the contribution of a placebo effect to the shock waves was not assessed by previous study. So the investigators conducted a double-blinded randomized-controlled trial at the orthopedic out-patient clinic, Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital between December 2016 and June 2018. Hypothesized that ESWT might be effective on insertional Achilles tendinopathy
TX-SMILE is an investigator-initiated, multi-center, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety, and tolerability of intra-lymphatic administration of an approved allergenic extract for the immunotherapy treatment of allergic rhinitis and conjunctivitis due to pollen from the conifer Mountain Cedar.
The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor at term pregnancy.
Comparison of capillary whole blood INR determined by LumiraDx Instrument to venous plasma INR determined by laboratory reference method (IL ACL ELITE PRO) for method comparison and assessment of accuracy and bias by regression analysis and other analytical methods.
Introduction / background Orthognathic surgery is an operation in which one or both jaws are fixed in a more favorable position performed by an osteotomy. In this way, large skeletal differences between the upper and lower jaw can be corrected surgically. The aim is to obtain a good and stable occlusion as well as to improve the facial aesthetics off the patient, where this would not be possible without surgery. These surgical procedures are accompanied by swelling of the face that can last for several days. The swelling is often considered unpleasant by the patients. The post-operative application of ice on the face can reduce the swelling. Also, performing manual lymphatic drainage (MLD) at the head and neck region would have a positive effect on the swelling after the operation. Manual lymphatic drainage is a kind of gentle massage performed by physiotherapists to reduce swelling in a faster way after surgery. This therapy is performed during the first days after the surgery and lasts about 30 minutes per session. There is still insufficient evidence to be whether or not this technique offers added value for patients undergoing jaw surgery. Goal The aim of this study is to investigate whether or not manual lymphatic drainage provides added value for patients undergoing jaw surgery. The facial swelling will be studied as the primary outcome variable. Other postoperative discomforts associated with orthognathic surgery are the secondary outcome variables. This study may or may not justify performing MLD and ensure that it is included in a postoperative protocol. Methodological approach The investigators would like to measure and compare the swelling in the face in an objective way between patients who received manual lymphatic drainage (intervention group) and patients who did not undergo manual lymphatic drainage (control group) The control group receives the standard postoperative care that is applied at the University Hospital Ghent. The intervention group also receives the same postoperative cares, as well as 5 MLD sessions during the first postoperative week (1st, 2nd, 3rd, 4th, 7th postoperative day).The objective measurement of the swelling can be done on the basis of a laser scan that can create 3D images of the face. For this, the patient should take a natural head position at rest and have a relaxed facial expression. This technique of imaging is non-invasive and there is no x-ray radiation involved! The 3D images are taken at the following times: 3 days, 1 week, 2 weeks, 1 month, 3 months and 6 months after the operation. Together with the scans, the patients were asked to fill in a questionnaire to frame the subjective postoperative discomfort associated with orthognathic surgery. The change in swelling can be analyzed on the basis of specific measurements on the 3D images as well as by recording surface changes. The last 3D image is used as a reference to superimpose the other 3D images as there is no longer any swelling on this 3D image. After analyzing these data, it can be assessed to what extent manual lymphatic drainage offers an advantage to reduce swelling after orthognathic surgery.