Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): statistical and qualitative analysis plan for a randomised controlled feasibility trial
ConclusionThe publication of this analysis plan is designed to aid transparency and to reduce the potential for reporting bias.Trial registrationNIH registry (www.clinicaltrials.gov), registration number NCT03975894 (registered 05/06/19); ISRCTN (www.isrctn.com), registration number ISRCTN52684446 (retrospectively registered 02/08/19). (Source: Trials)
Source: Trials - March 24, 2023 Category: Research Source Type: clinical trials
Promoting mental health and well-being in schools: examining mindfulness, relaxation and strategies for safety and well-being in English primary and secondary schools —study protocol for a multi-school, cluster randomised controlled trial (INSPIRE)
AbstractThere are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based universal prevention programmes are thought to be one way of helping tackle such difficulties. This paper describes an update to a four-arm cluster randomised controlled trial (http://www.isrctn.com/ISRCTN16386254), investigating the effectiveness of three different interventions when compared to usual provision, in English primary and secondary pupils. Due to the COVID-19 pandemic, the trial was put on hold and subsequently prolonged. Data collection wi...
Source: Trials - March 23, 2023 Category: Research Source Type: clinical trials
BEAT CF pulmonary exacerbations core protocol for evaluating the management of pulmonary exacerbations in people with cystic fibrosis
DiscussionThe BEAT CF PEx cohort will report clinical, treatment, and outcome data for PEx among people with CF and is intended to serve as a core (master) protocol for future nested, interventional trials evaluating treatment(s) for these episodes. The protocols for nested sub-studies are beyond the scope of this document and will be reported separately.Trial registrationANZCTR BEAT CF Platform – ACTRN12621000638831. Registration date: Sept. 26, 2022. (Source: Trials)
Source: Trials - March 22, 2023 Category: Research Source Type: clinical trials
Contribution of Psychological Autopsy to the Understanding of Suicidal Behaviors in French Overseas Territories
Condition: Suicide, Mental Disorders and Socio-health Profile of Suicided Persons Intervention: Other: other Sponsors: University Hospital Center of Martinique; Department for Research, Studies, Evaluation and Statistics, French Health and Social Affairs Ministry, France; French National Institute for Health and Medical Research, MOODS Unit; Clinical research and Innovation Office, Martinique; SO S KRIZ, Martinique; Amiens University Hospital, France; Suicide Prevention Resource Center, French Guiana; Cayenne Hospital Center, French Guiana; University Hospital, La Réu...
Source: ClinicalTrials.gov - March 17, 2023 Category: Research Source Type: clinical trials
