È anticorpo monoclonale per la seconda linea, rimborsato da Aifa
Risultati per: Standard di qualità sulla Fibrillazione Atriale
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Study of Rivaroxaban for Cerebral Venous Thrombosis: A Randomized Controlled Feasibility Trial Comparing Anticoagulation With Rivaroxaban to Standard-of-Care in Symptomatic Cerebral Venous Thrombosis
Stroke, Ahead of Print. Background:Emerging data suggest that direct oral anticoagulants may be a suitable choice for anticoagulation for cerebral venous thrombosis (CVT). However, conducting high-quality trials in CVT is challenging as it is a rare disease with low rates of adverse outcomes such as major bleeding and functional dependence. To facilitate the design of future CVT trials, SECRET (Study of Rivaroxaban for Cerebral Venous Thrombosis) assessed (1) the feasibility of recruitment, (2) the safety of rivaroxaban compared with standard-of-care anticoagulation, and (3) patient-centered functional outcomes.Methods:This was a phase II, prospective, open-label blinded-end point 1:1 randomized trial conducted at 12 Canadian centers. Participants were aged ≥18 years, within 14 days of a new diagnosis of symptomatic CVT, and suitable for oral anticoagulation; they were randomized to receive rivaroxaban 20 mg daily, or standard-of-care anticoagulation (warfarin, target international normalized ratio, 2.0–3.0, or low-molecular-weight heparin) for 180 days, with optional extension up to 365 days. Primary outcomes were annual rate of recruitment (feasibility); and a composite of symptomatic intracranial hemorrhage, major extracranial hemorrhage, or mortality at 180 days (safety). Secondary outcomes included recurrent venous thromboembolism, recanalization, clinically relevant nonmajor bleeding, and functional and patient-reported outcomes (modified Rankin Scale, quality of life, headache, mood, fatigue, and cognition) at days 180 and 365.Results:Fifty-five participants were randomized. The rate of recruitment was 21.3 participants/year; 57% of eligible candidates consented. Median age was 48.0 years (interquartile range, 38.5–73.2); 66% were female. There was 1 primary event (symptomatic intracranial hemorrhage), 2 clinically relevant nonmajor bleeding events, and 1 recurrent CVT by day 180, all in the rivaroxaban group. All participants in both arms had at least partial recanalization by day 180. At enrollment, both groups on average reported reduced quality of life, low mood, fatigue, and headache with impaired cognitive performance. All metrics improved markedly by day 180.Conclusions:Recruitment targets were reached, but many eligible participants declined randomization. There were numerically more bleeding events in patients taking rivaroxaban compared with control, but rates of bleeding and recurrent venous thromboembolism were low overall and in keeping with previous studies. Participants had symptoms affecting their well-being at enrollment but improved over time.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT03178864.
Systematic Identification of Copositivity Groups in Standard Series Patch Testing Through Hierarchical Clustering
This retrospective analysis uses patient data to systematically determine allergen copositivity groups in the Mayo Clinic Standard Series to provide guidance on contact avoidance protocols.
Fibrillazione atriale dopo crioablazione rispetto all’ablazione con radiofrequenza
CME Exam 2: Hemostatic Powder vs Standard Endoscopic Treatment for Gastrointestinal Tumor Bleeding: A Multicenter Randomized Trial
Standard Diet or Low-Protein, Low-Calorie Diet in the Intensive Care Unit?
Patients left the ICU sooner when lower nutritional goals were targeted.
Weekly Adaptive Radiotherapy vs Standard Intensity-Modulated Radiotherapy for Head and Neck Cancer
This phase 3 randomized clinical trial conducted in France investigates whether systemic weekly radiotherapy replanning compared with standard intensity-modulated radiotherapy decreases xerostomia in adult patients with squamous cell oropharyngeal cancer.
La qualità e motilità degli spermatozoi è migliore in estate
Giorlandino (Sidip), per il picco endocrino che avviene in Primavera
Effect of Initial Treatment With a Single Pill Containing Quadruple Combination of Quarter Doses of Blood Pressure Medicines Versus Standard Dose Monotherapy in Patients With Hypertension on Ambulatory Blood Pressure Indices: Results From the QUARTET Study
Circulation, Volume 148, Issue 4, Page 375-377, July 25, 2023.
Determining efficacy of dynamic multimedia bowel preparation instructions versus standard instructions on adenoma detection and patient reported measures (DIGICLEAN trial): a study protocol for a multicentre, colonoscopist-blinded, randomised controlled trial
Introduction
Colonoscopy plays important roles in bowel cancer screening and treatment. Poor bowel preparation occurs in 20–25% of colonoscopies. This negatively impacts adenoma and sessile serrated lesion detection rates, procedural time, requirement for repeat colonoscopies, healthcare costs and likelihood of patient withdrawal from screening programmes. It is unclear whether a combination of multimedia modalities can improve bowel preparation quality, adenoma detection rates and patient-reported measures in those undergoing colonoscopy assessment.
Methods
The DIGICLEAN trial is a prospective, parallel, multicentre, colonoscopist-blinded, randomised controlled trial. The trial will enrol 1294 participants aged 45 years and older who are indicated for a colonoscopy as an outpatient with a positive faecal occult blood test, iron deficiency anaemia or rectal bleeding. Participants will be randomised into the interventional arm, where bowel preparation instructions are delivered via a web-based application which uses scheduled short messaging service, regular patient survey assessment, email and videos; or the control arm, where routine standard written, verbal or emailed instructions are administered. The web-based application will assess patient-reported bloating, constipation and dietary adherence leading up to the colonoscopy. Depending on patient responses, additional aperients may be encouraged digitally in the interventional arm with same instructions made available in written format for the control arm. Patient-reported measures will be collected in both arms the day after the procedure using the validated Newcastle ENDOPREM questionnaire. In some sites, participants will undergo digital pre-anaesthetic screening as well. The co-primary endpoints are the adenoma detection rates and patient-reported measures taken after the colonoscopy.
Ethics and dissemination
Ethics approval for this study was obtained from the Western Sydney Local Health District Human Research Ethics Committee (2022/ETH00059). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals.
Trial registration number
ACTRN12622000747729.
Fibrillazione atriale curata senza raggi X, primo caso a Torino
Intervento su paziente di 28 anni con sistema elettroanatomico
Individualised versus standard duration of antibiotic therapy in children with acute uncomplicated febrile urinary tract infection: a study protocol and statistical analysis plan for a multicentre randomised clinical trial
Introduction
Febrile urinary tract infection is one of the most common bacterial infections in children. Currently, recommended antibiotic duration is 10 days. However, recent evidence suggests that 90%–95% of children with febrile urinary tract infections are afebrile and clinically improved 48–72 hours after treatment initiation. Accordingly, individualised duration of antibiotic therapy, according to the recovery time, might be more beneficial than current recommendations, but no evidence exists.
Methods and analysis
An open-label randomised clinical trial equally randomising children aged 3 months to 12 years from eight Danish paediatric departments with uncomplicated febrile (≥38°C) urinary tract infection to either individualised or standard duration of antibiotic therapy. Children allocated to individualised duration of antibiotic therapy will terminate antibiotic therapy 3 days after clinical improvement with no fever, flank pain or dysuria. Children allocated to standard duration will receive 10 days of antibiotic therapy. Co-primary outcomes are non-inferiority for recurrent urinary tract infection or death within 28 days after the end of treatment (non-inferiority margin 7.5 percentage points) and superiority for the number of days with antibiotic therapy within 28 days after treatment initiation. Seven other outcomes will also be assessed. A total of 408 participants are needed to detect non-inferiority (one-sided alpha 2.5%; beta 80%).
Ethics and dissemination
This trial has been approved by the Ethics Committee (H-21057310) and the Data Protection Agency (P-2022-68) in Denmark. Regardless of the trial’s findings (whether positive, negative or inconclusive), the results will be compiled into one or more manuscripts for publication in international peer-reviewed scientific journals and presented at conferences.
Trial registration number
NCT05301023.
Long Covid, fatica è il sintomo che più incide su qualità vita
Studio, può influire più di alcune gravi malattie
P2Y12 inhibitor monotherapy 1 to 3 mo after PCI did not differ from standard DAPT for fatal or ischemic events
Annals of Internal Medicine, Ahead of Print.
In TB, an 8-wk, 5-drug regimen was noninferior to a standard 24-wk, 4-drug regimen for clinical outcomes at 96 wk
Annals of Internal Medicine, Ahead of Print.
Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma
New England Journal of Medicine, Ahead of Print.