Conectar
Phasix mesh is a fully resorbable synthetic mesh for use in clean and contaminated ventral incisional hernia repairs. Long-term absorbable Phasix mesh appears to be a safe and promising device in incisional hernia repair, with low recurrence rates; however, data on long-term complications after surgery, particularly after the resorption period of the mesh, are scarce.
This protocol describes a study of several European registries on the use of a Phasix mesh in incisional hernia repair. The primary endpoint of the study is long-term complications at 2–5 year follow-up after mesh implantation, with secondary endpoints including hernia recurrence and complications during short-term follow-up.
Ethical approval was not required for this protocol as the study is based on anonymised registry data collected with prior patient consent in each registry. Each participating registry has its own ethical approval process, and this study will adhere to those regulations. The results will be disseminated through peer-reviewed publications and conference presentations.
To investigate whether treatment with oral corticosteroids and intravenous immunoglobulin (IVIg) improves pregnancy outcomes in women with unexplained recurrent pregnancy loss (RPL) following assisted reproduction technology (ART) treatment.
A randomised, double-blinded, parallel-group, placebo-controlled trial conducted from January 2021 to February 2024.
A single-centre trial at a Danish tertiary clinic for RPL management.
80 women with at least two consecutive early pregnancy losses following ART, age 18–41 years, body mass index below 35, and no identified cause of RPL. Forty participants were allocated to each group, with 37 fulfilling the protocol criteria in each group.
Participants were randomised to receive either a combination of low-dose oral prednisolone starting on the first day of menstruation and IVIg given the first time around the time of embryo transfer; or matching placebo tablets and albumin infusions. Treatment continued until gestational week 8+4 in those who conceived with a total of four infusions.
The primary outcomes were the ongoing pregnancy rate (OPR) defined as a living fetus in gestational week 13 among all randomised participants and in those who conceived after embryo transfer, respectively, based on intention-to-treat (ITT) and per-protocol (PP) analyses. Secondary outcomes included safety outcomes related to pregnancy complications and neonatal health.
OPR was equal to live birth rate. Among all randomised participants (ITT), the OPR was 25.0% in the treatment group and 15.0% in the placebo group (relative risk 1.67; 95% CI 0.67 to 4.15; p=0.26). Among participants without major protocol deviations (PP), OPRs were 21.6% and 16.2%, respectively (relative risk 1.33; 95% CI 0.51 to 3.47; p=0.55). Among participants who became pregnant following embryo transfer, ongoing pregnancy occurred in 83.3% of the treatment group and 42.9% of the placebo group (relative risk 1.94; 95% CI 1.01 to 3.75; p=0.05). No differences in adverse events or neonatal outcomes were observed between the two groups.
The combination of oral corticosteroids and IVIg did not improve overall pregnancy rates in women with RPL after ART. However, among those who achieved pregnancy after embryo transfer, the risk of pregnancy loss appeared reduced. Larger randomised trials are needed to confirm these findings.
ClinicalTrials.Gov: NCT04701034. Registration date: 5 January 2021
EudraCT number: 2020-000256-35; Registration date: 11 November 2020
The North Denmark Region Committee on Health Research Ethics: N-20200066, Registration date: 16 December 2020
The Data Protection Agency: 2020-156; Registration date: 4 November 2020
WHO universal trial number: U1111-1273-8585
Date of first patient’s enrolment: 28 January 2021.
The aetiology of eating disorders (EDs) is complex, involving an interplay of genetic and environmental factors. Children at familial high risk (FHR) for EDs demonstrate increased risk of developing EDs themselves compared with children born to parents without EDs, though the majority remain unaffected. The BLOOM study is an FHR study that aims to identify biological, neurocognitive and psychosocial risk and protective pathways to EDs. Results of this study will help identify trait markers of EDs, inform targeted preventive intervention strategies and clarify how to mitigate genetic risk of EDs.
This prospective cohort study will enrol 510 children aged 8–10 years, including 360 at FHR for developing EDs (comprising 120 children each from mothers with anorexia nervosa, bulimia nervosa and binge ED) and 150 children not at FHR. Participants will be recruited over 2 years and followed up every 2 years. Data collection will include dual X-ray absorptiometry scans to evaluate body composition, saliva samples for genotyping, neurocognitive testing, self and parent-reported questionnaires and semistructured diagnostic interviews of psychopathology and well-being. Optional data collection will include fasting blood samples, stool samples and brain MRI scans. Mothers and secondary caregivers will complete questionnaires regarding family functioning and their mental health.
The study has been approved by the Danish Data Protection Agency (p-2023-14826) and the Regional Ethics Committee of Health Research of the Capital Region of Denmark (H-23043100). Written consent will be obtained from all participants. Results will be disseminated at scientific conferences, in peer-reviewed publications, PhD dissertations and to relevant stakeholders.
Early-life exposures, such as nutritional deficiencies, stress, smoking, toxins, medications, diseases, infections and inflammation may affect multiple physiological and metabolic systems in the offspring, including hormonal regulation, bone metabolism and mineralisation, and body composition. Moreover, the effect of these early-life exposures on later health may potentially be mediated through adverse neonatal epigenetic reprogramming of bone-related genes affecting health later in life, especially skeletal development and bone density. Thus, to advance this research further, the overall aim of the project is to investigate if (a) neonatal epigenetic and genetic signature; (b) maternal risk factors during preconception and pregnancy, such as medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle; (c) risk factors at birth, such as instrumental delivery, mode of delivery, medicine use, injuries, diseases, weight, size for gestational age, ponderal index, gestational age; and (d) childhood risk factors, such as diseases, medicine use, major life events, weight, growth and lifestyle are associated with hormonal status, lipids, bone turnover markers, bone mineral density, fat mass and lean body mass at age 18–19 years.
Population-based, nationwide, cross-sectional clinical study with potential for longitudinal reassessment. Danish women and men aged 18–19 years old will be selected at random from the Danish National Population Registry and invited if they have available neonatal dried blood spot cards. A total of 2000 individuals will be enrolled. The study combines register data, and neonatal epigenetic and genetic analyses from stored blood with clinical and survey data. Body composition will be measured using dual-energy X-ray absorptiometry. Adult blood and hair samples will be obtained to assess hormonal status, lipids and bone turnover markers. Height, weight, waist and hip circumference, and blood pressure will be measured. Questionnaires on well-being, sleep patterns, dietary and exercise habits, onset of puberty, use of cannabis, nicotine, alcohol and pain medication will be included. Information on medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle will be obtained from the national administrative and health registers at the time of conception and during pregnancy for the parents, as well as from the participants throughout their lifetime. Health registries include the Danish Medical Birth Register, the National Patient Register, the Danish National Prescription Register, the National Child Health Register and Statistics Denmark. Multivariate regression analyses will be performed.
This nationwide study has been approved by the Regional Committees on Health Research Ethics for Southern Denmark (S-20230105). The study participants will be enrolled in the study following their informed written consent. Results will be submitted for publication. The Strengthening the Reporting of Observational Studies in Epidemiology Statement guidelines will be used for reporting.
A substantial number of patients with major depressive disorder experience non-remission despite treatment with psychotherapy and several antidepressant drugs. This has increased the interest in new treatment strategies, including non-invasive brain stimulation methods. This randomised controlled trial examines a new treatment method using transcranial-pulsed electromagnetic fields (T-PEMF) delivered via a MoodHeadBand (MHB). The main study objective is to examine the antidepressant effect of T-PEMF on moderate to severe depression.
A double-blinded, randomised (1:1), sham-controlled trial with 96 participants diagnosed with moderate to severe depression without psychotic symptoms, recruited from Psychiatric Center Copenhagen. Participants receive daily 30 min at-home T-PEMF or sham treatment for 8 weeks with the MHB. Depressive symptomatology is examined using the Inventory of Depressive Symptomatology (Self-Report) (primary outcome) and Hamilton-D-17 Items Rating Scale at baseline and treatment completion. Cognitive functions are examined using a battery of emotion-laden and non-emotion-laden tests at baseline, after 1 week and at treatment completion. The participants fill out the Quick Inventory of Depressive Symptomatology (Self-Report) and sleep logs weekly. Summary statistics, generalised linear models, proc mixed models, mixed model repeated measures and Kaplan-Meier analysis will be applied as appropriate to analyse data on depressive symptoms, cognition and sleep.
The Danish Medicines Agency (CIV-23-01-041987) and the Medical Research Ethics Committee (2215332) have approved the trial. The project concurs with the EU directive for medical devices 2017/745 of 5 April 2017 and the ISO 14155 standard. Participants give written informed consent before any trial-related activities. Results will be published in peer-reviewed journals and presented at relevant conferences.
Distal radius fractures account for one-fifth of all fractures in the active elderly population and may cause chronic pain, loss of hand function and reduced work productivity, imposing a significant socioeconomic burden. Most are initially treated with closed reduction and casting, but 30% subsequently require surgery due to insufficient realignment. The current approaches for analgesia for closed reduction are suboptimal. A brachial plexus nerve block provides complete pain relief and muscle relaxation distal to the elbow, potentially creating better conditions for realignment of the fractured bone ends. This may ultimately translate into reduced need for surgery and result in better functional outcomes and fewer complications compared to a haematoma block, which is the current standard care in Denmark.
The BLOCK Trial is an investigator-initiated, parallel-group, allocation-concealed, outcome assessor and analyst-blinded, superiority, randomised, controlled, clinical multicentre trial performed at 11 Danish emergency departments. Eligible adult patients with a distal radius fracture who need closed reduction will be included and allocated 1:1 to either an ultrasound-guided brachial plexus nerve block or a haematoma block. The primary outcome is the proportion of patients with distal radius fracture surgery 90 days after closed reduction. We will include 1716 participants to detect or discard a relative risk reduction of surgery of 20%. Secondary outcomes include treatment-related complications, patient-reported wrist function, pain during closed reduction and proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.
The trial is approved by the Danish Medicines Agency and the Danish Research Ethics Committees (EU CT number: 2024-512191-35-00). All results will be summarised on www.theblocktrial.com, clinicaltrials.gov and euclinicaltrials.eu after publication. Primary and secondary outcome results from 0 to 90 days will be presented in the main article and submitted to a peer-reviewed journal. Results from outcomes on the 12-month follow-up will be presented separately.
FreshRSS 