Development, acceptability, appropriateness and appeal of a cancer clinical trials implementation intervention for rural- and minority-serving urology practices
ConclusionsLEARN|INFORM|RECRUIT is a promising implementation intervention to address low accrual to clinical trials, poised for implementation and effectiveness testing. The implementation intervention is appealing to its target audience and may have equal uptake among trial-na ïve and trial-experienced practices. (Source: Trials)
Source: Trials - October 7, 2019 Category: Research Source Type: clinical trials

The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial
DiscussionBoth trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for common adolescent mental health problems.Trial registrationBoth trials are registered prospectively with the National Institute of Health registry (www.clinicaltrials.gov), registration numbersNCT03633916 andNCT03630471, registered on 16th August, 2018 and 14th August, 2018 respectively). (Source: Trials)
Source: Trials - September 18, 2019 Category: Research Source Type: clinical trials

A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hanson's Yeast) in Chinese Women Aged 9-45 Years
Conditions:   HPV Infection;   HPV-Related Cervical Carcinoma Interventions:   Biological: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha);   Biological: Placebo Sponsors:   National Vaccine and Serum Institute, China;   Chengdu Institute of Biological Products Co.,Ltd.;   Simoon Record Pharma Information Consulting Co., Ltd;   Guangxi Center for Disease Control and Prevention;   Beijing Kantorico Statistical Technology Co., Ltd. Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 10, 2019 Category: Research Source Type: clinical trials

N-acetylcysteine for cessation of tobacco smoking: rationale and study protocol for a randomised controlled trial
DiscussionThe planned trial addresses an issue of major importance to human health and, if an effect is shown, may result in substantial changes to the management of smoking and nicotine addiction with overt public health implications.Trial registrationAustralian New Zealand Clinical Trials registry (ANZCTR),ACTRN12617001478303. Registered on 19 October 2017. (Source: Trials)
Source: Trials - September 10, 2019 Category: Research Source Type: clinical trials

Anifrolumab Phase III Trial Meets Primary Endpoint in Systemic Lupus Erythematosus
29 August 2019 -- AstraZeneca today announced that the Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of systemic lupus erythematosus (SLE), met its primary endpoint, achieving a statistically-significant and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 29, 2019 Category: Pharmaceuticals Source Type: clinical trials

Comparing the effect of STan (cardiotocographic electronic fetal monitoring (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with CTG alone on emergency caesarean section rates: study protocol for the STan Australian Randomised controlled Trial (START)
This study will be a single-centre, parallel-group, randomised controlled trial, conducted over 3  years. The primary hypothesis will be that the proportion of women with an emergency caesarean section on ST analysis will not equal that for women on cardiotocography monitoring alone. Participants will be recruited at the Women’s and Children’s Hospital, a high-risk specialty facility with approximately 5000 deliveries per annum. A total of 1818 women will be randomised to the treatment or conventional arm with an allocation ratio of 1:1, stratified by parity. The primary outcome is emergency caesarean se...
Source: Trials - August 29, 2019 Category: Research Source Type: clinical trials

Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial
ConclusionsOur analysis highlights the scope of relevant activities, rigorous training and monitoring, number and types of required personnel, and time required to conduct a multicentre ICU rehabilitation intervention trial. Our lessons learned can help others interested in implementing complex intervention trials, such as rehabilitation.Trial registrationClinicalTrials.gov,NCT02377830. Registered prospectively on 4 March 2015. (Source: Trials)
Source: Trials - August 28, 2019 Category: Research Source Type: clinical trials

Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival
ConclusionsWe found that our re-estimation procedure performed reasonably well in estimating the control group failure probabilities at the time of re-estimation. Particularly for time-to-event outcomes, pre-planned blinded SSRE procedures may be the best option to aid in maintaining power.Trial registrationClinicalTrials.gov,NCT00201851. Registered on 9 September 2005. Retrospectively registered. (Source: Trials)
Source: Trials - August 23, 2019 Category: Research Source Type: clinical trials

VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho
DiscussionThe VIBRA trial is among the first to evaluate the delivery of ART by VHWs immediately after ART initiation. It assesses the entire HIV care cascade from testing to viral suppression. As most countries in sub-Saharan Africa have cadres like the VHW program in Lesotho, this model —if shown to be effective—has the potential to be scaled up. The system impact evaluation will provide valuable cost estimations, and the qualitative research will suggest how the model could be further modified to optimize its impact.Trial registrationClinicaltrials.gov,NCT03630549. Registered on 15 August 2018. (Source: Trials)
Source: Trials - August 22, 2019 Category: Research Source Type: clinical trials

Efficacy of acetaminophen with and without oxycodone for analgesia in non-operative treatment of extremity fractures in adults: protocol for a double-blind randomized clinical trial
In this study, we aim to determine whether acetaminophen is non-inferior to the acetaminophen/oxycodone combination for pain relief after non-operative fixation of an extremity limb fracture. We hypothesize that acetaminophen is non-inferior to the acetaminophen/oxycodone combination.MethodsA double-blind randomized controlled trial will be conducted. Power analysis determined that 1226 participants will be needed (P 
Source: Trials - August 17, 2019 Category: Research Source Type: clinical trials

Managing uncertain recovery for patients nearing the end of life in hospital: a mixed-methods feasibility cluster randomised controlled trial of the AMBER care bundle
ConclusionsA full trial of the AMBER care bundle is technically feasible but impractical due to fundamental issues in operationalising the intervention ’s eligibility criteria, which prevents optimal recruitment. Since this complex intervention continues to be used in clinical care and advocated in policy, alternative research approaches must be considered and tested.Trial registrationInternational Standard Randomised Controlled Trial Number (ISRCTN) Register,ISRCTN36040085. (Source: Trials)
Source: Trials - August 16, 2019 Category: Research Source Type: clinical trials

Regional cerebral oxygen saturation and postoperative delirium in endovascular surgery: a prospective cohort study
ConclusionsElevated rSO2 desaturation score was predictive of the occurrence of postoperative delirium following endovascular surgery. Monitoring rSO2 is invaluable for managing controlled hypotension during endovascular surgery and reducing postoperative delirium.Trial registrationClinicalTrials.gov,NCT02356133. Registered 1 February 2015. All statistical analysis results submitted August 4, 2018. (Source: Trials)
Source: Trials - August 14, 2019 Category: Research Source Type: clinical trials

The HOSENG trial – Effect of the provision of oral self-testing for absent and refusing individuals during a door-to-door HIV-testing campaign on testing coverage: protocol of a cluster-randomized clinical trial in rural Lesotho
DiscussionThe HOSENG trial tests whether oral HIVST may be an add-on during door-to-door testing campaigns towards achieving optimal testing coverage. The provision of oral self-test kits, followed up by VHWs, requires little additional human resources, finances and logistics. If cost-effective, this approach should inform home-based HIV-testing policies not only in Lesotho, but in similar high-prevalence settings.Trial registrationClinicalTrials.gov, (ID:NCT03598686). Registered on 25 July 2018. More information is available atwww.getonproject.wordpress.com. (Source: Trials)
Source: Trials - August 13, 2019 Category: Research Source Type: clinical trials

Manual therapy versus therapeutic exercise in non-specific chronic neck pain: study protocol for a randomized controlled trial
DiscussionOur study aims to provide knowledge about postural stability and its relationship with pain in subjects with non-specific chronic neck pain. Analyzing the results produced by different types of therapy will allow us to draw conclusions about the mechanisms, structural or central, that may elicit these alterations.Trial registrationBrazilian Clinical Trials Registry,RBR-2vj7sw. Registered on 28 November 2018. (Source: Trials)
Source: Trials - August 9, 2019 Category: Research Source Type: clinical trials

Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan
ConclusionWe have developed a SAP for the WBRTMel trial which will be followed to ensure high-quality standards of internal validity to minimise analysis bias.Trial registrationANZ Clinical Trials Registry,ACTRN12607000512426. Registered on 9 October 2007. ClinicalTrials.gov,NCT01503827. Registered on 4 January 2012. Trial group reference numbers ANZMTG 01.07, TROG 08.05. (Source: Trials)
Source: Trials - August 5, 2019 Category: Research Source Type: clinical trials

Update to the study protocol, including statistical analysis plan, for the multicentre, randomised controlled OuTSMART trial: a combined screening/treatment programme to prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies
DiscussionChanges to the primary outcome permit recruitment of fewer participants to achieve the same statistical power. Pre-stating the statistical analysis plan guards against changes to the analysis methods at the point of analysis that might otherwise introduce bias through knowledge of the data. Any deviations from the analysis plan will be justified in the final report.Trial registrationISRCTN registry, ID:ISRCTN46157828. Registered on 26 March 2013;EudraCT 2012 –004308-36. Registered on 10 December 2012. (Source: Trials)
Source: Trials - August 5, 2019 Category: Research Source Type: clinical trials

A randomized clinical trial on the effects of bupropion and buprenorphine on the reduction of methamphetamine craving
ConclusionsThe results support the safety and effectiveness of buprenorphine and bupropion in the treatment of methamphetamine withdrawal craving. Administration of 8  mg of buprenorphine per day can be recommended for the treatment of methamphetamine withdrawal cravings. We should note that it is to be expected that craving decreases over time without any medication. So the conclusion may not be that bupropion and buprenorphine both lower the craving. As the b uprenorphine is superior to bupropion, only buprenorphine does so for sure.Trial registrationIranian Registry of Clinical Trials (IRCT) registration number:I...
Source: Trials - July 30, 2019 Category: Research Source Type: clinical trials

Tranexamic acid for acute gastrointestinal bleeding (the HALT-IT trial): statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial
We present the statistical analysis of the HALT-IT trial. This plan was published before the treatment allocation was unblinded.Trial registrationCurrent Controlled Trials, ID:ISRCTN11225767. Registered on 3 July 2012;Clinicaltrials.gov, ID:NCT01658124. Registered on 26 July 2012. (Source: Trials)
Source: Trials - July 30, 2019 Category: Research Source Type: clinical trials

Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial
ConclusionsThis pRCT provides the first hints  on the way information on AEs is reported in PILs can affect the nocebo effect. This pRCT shows that a definitive RCT is feasible. If the results are confirmed in a definitive large RCT, a revision of the current practice for designing PILs should be considered.Trial registrationClinicalTrials.gov identifier:NCT03428035. Registered 2 February 2018. (Source: Trials)
Source: Trials - July 26, 2019 Category: Research Source Type: clinical trials

Clinical efficacy of different marginal forms of endocrowns: study protocol for a randomized controlled trial
DiscussionThe results of this trial will provide a clinical basis for clinicians to restore teeth by endocrowns and to improve long-term restoration for patients.Trial registrationClinicalTrials.gov identifier:NCT03398395. Registered on 12 January 2018. (Source: Trials)
Source: Trials - July 24, 2019 Category: Research Source Type: clinical trials

Pathways to Cardiovascular Disease Prevention (DCRI Central and Statistical Coordinating Center)
Conditions:   HIV/AIDS;   Cardiovascular Diseases Intervention:   Sponsors:   Duke University;   National Institute on Minority Health and Health Disparities (NIMHD) Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 18, 2019 Category: Research Source Type: clinical trials

Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial
This study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA.Methods/designThis is a multi-center three-arm randomized controlled trial. It will enroll 480 participants with KOA in China. Participants will be randomly assigned 1:1:1 to receive 24 sessions of electro-acupuncture, manual acupuncture, or sham acupuncture over 8  weeks. The primary outcome is the response rate, which is the proportion of patients who achieve the minimal clinically important improvement in pain and function at 8 weeks. The primary outcome will be analyzed using theZ...
Source: Trials - July 4, 2019 Category: Research Source Type: clinical trials

Trial to Investigate the Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF in Comparison With a Multifocal and a Monofocal IOL
Conditions:   Aphakia, Postcataract;   Cataract; Eye Disease Interventions:   Device: POD L GF IOL;   Device: Symfony® IOL;   Device: AcrySof® IOL Sponsors:   Physiol;   ORA, Inc.;   Statistics & Data Corporation Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 2, 2019 Category: Research Source Type: clinical trials