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496 results for “randomised controlled trials”
Data from: Ibobbly mobile health intervention for suicide prevention in Australian Indigenous youth: a pilot randomised controlled trial
Objectives: Rates of youth suicide in Australian Indigenous communities are four times the national youth average and demand innovative interventions. Historical and persistent disadvantage is coupled with multiple barriers to help-seeking. Mobile phone applications offer the opportunity to deliver therapeutic interventions directly to individuals in remote communities.The pilot study aimed to evaluate the effectiveness of a self-help mobile app (ibobbly) targeting suicidal ideation, depression, psychological distress, and impulsivity among Indigenous youth in remote Australia. Setting: Remote and very remote communities in the Kimberley region of north Western Australia Participants: Indigenous Australians aged 18-35 years. Interventions: 61 participants were recruited and randomised to receive either an app (ibobbly) which delivered acceptance-based therapy over 6 weeks or were waitlisted for 6 weeks and then received the app for the following 6 weeks. Primary and secondary outcome measures: The primary outcome was the Depressive Symptom Inventory – Suicidality Subscale (DSI-SS) to identify the frequency and intensity of suicidal ideation in the previous weeks. Secondary outcomes were the Patient Health Questionnaire 9 (PHQ-9), the Kessler Psychological Distress Scale (K10), and the Barratt Impulsivity Scale (BIS-11). Results: Although pre- post-intervention change on the (DSI-SS) was significant in the ibobbly arm (t=2•40; df=58•1; p=0•0195), this difference was not significant compared to the waitlist arm (t=1•05; df=57•8; p=0•2962). However, participants in the ibobbly group showed substantial and statistically significant reductions in PHQ-9 and K10 scores compared to waitlist. No differences were observed in impulsivity. Waitlist participants improved after 6 weeks of app use. Conclusions: Apps for suicide prevention reduce distress and depression but do not show significant reductions on suicide ideation or impulsivity. A feasible and acceptable means of lowering symptoms for mental health disorders in remote communities is via appropriately designed self-help apps. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000104752.
Data from: Umbilical vein oxytocin for the treatment of retained placenta (Release Study): a double-blind, randomised controlled trial.
BACKGROUND: Retained placenta is associated with post-partum haemorrhage. Meta-analysis has suggested that umbilical injection of oxytocin could increase placental expulsion without the need for a surgeon or anaesthetic. We assessed the effect of high-dose umbilical vein oxytocin as a treatment for retained placenta. METHODS: In this double-blind, placebo-controlled trial, haemodynamically stable women with a retained placenta for more than 30 min were recruited from 13 sites in the UK, Uganda, and Pakistan. 577 women were randomly assigned by a computer-generated randomisation list stratified by centre to 30 mL saline containing either 50 IU oxytocin (n=292) or 5 mL water (n=285), which was injected into the placenta through an umbilical vein catheter. All trial participants, study workers, and data handlers were masked to individual allocations. The primary outcome was the need for manual removal of the placenta. Analysis was by intention to treat. This study is registered, number ISRCTN 13204258. FINDINGS: The primary outcome was recorded for all participants. We detected no difference between the groups in the need for manual removal of placenta (oxytocin 179/292 [61.3%] vs placebo 177/285 [62.1%]; relative risk 0.98, 95% CI 0.87-1.12; p=0.84). The need for manual removal was higher in the UK (overall 250/361 [69%]) than in Uganda (90/190 [47%]) or Pakistan (16/26 [62%]). Adverse events did not differ between the two groups. INTERPRETATION: Umbilical oxytocin has no clinically significant effect on the need for manual removal for women with retained placenta. FUNDING: WHO, WellBeing of Women, Pakistan Higher Education Commission.
A Comparison of Kneipp Hydrotherapy With Conventional Physiotherapy in the Treatment of Osteoarthritis of the Hip or Knee: Protocol of a Prospective Randomised Controlled Clinical Trial
ClinicalTrials.gov study NCT00950326. IPD Sharing: Not stated. Countries: 1. Publications: 2.
A Randomised Controlled Trial on LESS Versus Conventional Laparoscopic Appendicectomy.
ClinicalTrials.gov study NCT01203566. IPD Sharing: Not stated. Countries: 1. Publications: 4.
A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis
ClinicalTrials.gov study NCT02398994. IPD Sharing: Not stated. Countries: 1. Publications: 2.
Short-time Intervention in Post-Covid Syndrome Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial
ClinicalTrials.gov study NCT05196451. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Preference-based Tools for Smoking Cessation Among Disadvantaged Smokers, a Pragmatic Randomised Controlled Trial
ClinicalTrials.gov study NCT04654585. IPD Sharing: NO. Countries: 1. Publications: 1.
Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial.
ClinicalTrials.gov study NCT03531333. IPD Sharing: UNDECIDED. Countries: 1. Publications: 1.
Epstein-Barr Virus Suppression in Chronic Obstructive Pulmonary Disease (EViSCO): a Phase 2 Randomised Control Trial
ClinicalTrials.gov study NCT03699904. IPD Sharing: UNDECIDED. Countries: 1. Publications: 1.
A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial
ClinicalTrials.gov study NCT04278742. IPD Sharing: NO. Countries: 1. Publications: 2.
Duplex UltraSound afTer Endo Revascularisation - Feasibility Randomised Control Trial (DUSTER)
ClinicalTrials.gov study NCT06702306. IPD Sharing: YES. Countries: 1. Publications: 1.
Promoting Wellbeing for Women With Depression: A Pragmatic Randomised Controlled Trial (RCT) of an Exercise Programme
ClinicalTrials.gov study NCT00546221. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)
ClinicalTrials.gov study NCT06084052. IPD Sharing: NO. Countries: 1. Publications: 4.
Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women
ClinicalTrials.gov study NCT04689178. IPD Sharing: NO. Countries: 1. Publications: 1.
Hull Early Walking Aids for Transtibial Amputees - Randomised Control Trial (HEART)
ClinicalTrials.gov study NCT01024023. IPD Sharing: Not stated. Countries: 1. Publications: 1.
A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.
ClinicalTrials.gov study NCT03191201. IPD Sharing: NO. Countries: 1. Publications: 1.
Comparison of Intubation Rate of Macintosh Size 2 and 3 Blades in Asian Female: a Randomised Controlled Trial
ClinicalTrials.gov study NCT04566224. IPD Sharing: NO. Countries: 1. Publications: 4.
Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)
ClinicalTrials.gov study NCT00685217. IPD Sharing: UNDECIDED. Countries: 1. Publications: 1.
A Novel Nano-iron Supplement to Safely Combat Iron Deficiency and Anaemia in Young Children: a Doubleblind Randomised Controlled Trial
ClinicalTrials.gov study NCT02941081. IPD Sharing: Not stated. Countries: 1. Publications: 3.
Ranibizumab in Diabetic Vitrectomy. A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study
ClinicalTrials.gov study NCT01306981. IPD Sharing: Not stated. Countries: 1. Publications: 1.
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International Brain Laboratory public data
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OpenNeuro
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