Edoxaban for 12 Months Versus 3 Months in Cancer Patients With Isolated Distal Deep Vein Thrombosis (ONCO DVT study): An Open-label, Multicenter, Randomized Clinical Trial

Circulation, Ahead of Print. Background:The optimal duration of anticoagulation therapy for isolated distal deep vein thrombosis (DVT) in patients with cancer is clinically relevant, but the evidence is lacking. The prolonged anticoagulation therapy could have a potential benefit for prevention of thrombotic events, however, it could also increase the risk of bleeding.Methods:In a multicenter, open-label, adjudicator-blinded, randomized clinical trial at 60 institutions in Japan, we randomly assigned cancer patients with isolated distal DVT, in a 1-to-1 ratio, to receive either a 12-month or 3-month edoxaban treatment. The primary endpoint was a composite of a symptomatic recurrent venous thromboembolism (VTE) or VTE-related death at 12 months. The major secondary endpoint was major bleeding at 12 months, according to the criteria of the International Society on Thrombosis and Hemostasis. The primary hypothesis was that a 12-month edoxaban treatment was superior to a 3-month edoxaban treatment with respect to the primary endpoint.Results:From April 2019 through June 2022, 604 patients were randomized, and after excluding 3 patients who withdrew consent, 601 patients were included in the intention-to-treat population: 296 patients in the 12-month edoxaban group and 305 patients in the 3-month edoxaban group. The mean age was 70.8 years, 28% of the patients were men, and 20% of the patients had symptoms of DVT at baseline. The primary endpoint of a symptomatic recurrent VTE event or VTE-related death occurred in 3 of the 296 patients (1.0%) in the 12-month edoxaban group and in 22 of the 305 (7.2%) in the 3-month edoxaban group (odds ratio, 0.13; 95% CI, 0.03 to 0.44). The major secondary endpoint of major bleeding occurred in 28 of the 296 patients (9.5%) in the 12-month edoxaban group and in 22 of the 305 (7.2%) in the 3-month edoxaban group (odds ratio, 1.34; 95% CI, 0.75 to 2.41). The prespecified subgroups did not affect the estimates on the primary endpoint.Conclusions:In cancer patients with isolated distal DVT, 12 months was superior to 3 months for an edoxaban treatment with respect to the composite outcome of a symptomatic recurrent VTE or VTE-related death.

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Agosto 2023

Factors associated with first antenatal care (ANC) attendance within 12 weeks of pregnancy among women in Lira City, Northern Uganda: a facility-based cross-sectional study

Objective
This study aimed at assessing factors associated with first antenatal care (ANC) attendance within 12 weeks of pregnancy among women in Lira City.

Design
A cross-sectional study.

Settings
The study was conducted in health facilities offering ANC services in Lira City, Northern Uganda.

Participants
The study was among 368 pregnant mothers attending their first ANC in the three selected facilities (Lira Regional Referral Hospital, Ober Health Center IV and Pentecostal Assembly of God Mission Health Center IV) in Lira City.

Primary and secondary outcome measures
Level of first ANC attendance within 12 weeks of pregnancy and associated factors.

Results
Early ANC attendance was 36.1%. Women who were: unmarried (adjusted OR (aOR): 0.40, 95% CI: 0.16 to 0.99), took >2 hours to reach a health facility (aOR: 0.21, 95% CI: 0.07 to 0.62), or not visited by village health teams or healthcare workers at home (aOR: 0.33, 95% CI: 0.12 to 0.92) were less likely to attend their first ANC early. On the other hand, women who were: not knowing first that ANC guides parents on infant care (aOR: 2.22, 95% CI: 1.06 to 4.67); pregnant without consent of spouse (aOR: 4.29, 95% CI: 1.75 to 10.55); attending ANC from a private facility (aOR: 2.89, 95% CI: 1.27 to 6.15); and having two to three healthcare workers present at the ANC clinic (aOR: 1.79, 95% CI: 1.03 to 3.13) were more likely to attend ANC early.

Conclusions
Despite the fact that the WHO recommends that all women begin ANC within 12 weeks after conception, Lira City in Northern Uganda had a low overall incidence of timely ANC initiation. Being unmarried, distance to reach a health facility, and being visited by village health teams or healthcare workers at home were all linked to timely ANC commencement. As a result, intervention efforts should concentrate on the highlighted determinants in order to promote ANC initiation in Lira City, Northern Uganda. This can be accomplished by providing information and education to the community on the timing and necessity of ANC in Northern Uganda.

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Luglio 2023

Impact of a 12-week olfactory training programme in women with migraine with aura: protocol for a double-blind, randomised, placebo-controlled trial

Introduction
Migraine is a leading cause of disability and suffering worldwide. However, conventional pharmacological migraine preventive therapies are often challenging and accompanied by adverse effects. Recently, structured odour exposure has shown to successfully increase pain thresholds in patients with chronic back pain. Despite the importance of the olfactory system in migraine, there are no studies investigating the impact of structured odour exposure in patients with migraine.

Methods and analysis
This double-blind randomised placebo-controlled trial will be conducted at the Headache Clinic of the University Pain Center at TU Dresden, Germany and aims at investigating the impact of a 12-week structured exposure to odours in women with migraine. Fifty-four women between 18 and 55 years with migraine with aura will be recruited and randomised to training with odours and odourless training. The primary outcomes are mechanical and electrical pain thresholds. Secondary outcomes comprise olfactory threshold and the number of headache days. Other exploratory measurements are headache associated pain intensity, acute analgesic intake, symptoms of anxiety and depression, and quality of life. Additionally, this protocol assesses neuroanatomical and neurofunctional changes associated with the 12-week olfactory training. Data analysis will be executed on the basis of the general linear model considering repeated measurements.

Ethics and dissemination
Ethical approvals were obtained from the Ethics Board of the TU Dresden (Protocol No. BO-EK-353082020). Participation will only be possible after written informed consent is provided. Findings will be disseminated through peer-reviewed journals and scientific conferences.

Trial registration number
DRKS00027399.

Leggi
Luglio 2023