A Randomised Controlled Trial of the Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy) Compared with 0.25% Desoximetasone Cream (Topicorte) for the Treatment of Scalp Psoriasis

IntroductionElectroacupuncture at ‘four sacral points’, also known as electrical pudendal nerve stimulation therapy, combines the advantages of pudendal nerve neuromodulation and the technique of deep insertion of long acupuncture needles. It has been used to treat stress urinary incontinence, female urgency-frequency syndrome, idiopathic urgency urinary incontinence and neurological bladders in previous studies. Here, we describe the protocol for a randomised controlled trial for evaluation of the efficacy and safety of electroacupuncture at ‘four sacral points’ for the management of urinary incontinence after stroke.Methods and analysisThis is an open-label randomised controlled trial with blinded assessments and analyses. A total of 140 eligible patients will be randomly allocated to two groups. The treatment group (n=70) will receive electroacupuncture at ‘four sacral points’ along with routine medical care, while the control group will receive conventional electroacupuncture along with routine medical care. Twenty treatment sessions will occur over a period of 4 weeks. The primary outcome measures will be the self-recorded findings in an incontinent episode diary at baseline and at 4 weeks after baseline. The secondary outcome measures will be the International Consultation on Incontinence Questionnaire Urinary Incontinence—Short Form (ICIQ-UI SF) score and the Barthel Activities of Daily Living Index (Barthel ADL Index) score at baseline and at 4 and 28 weeks after baseline.Ethics and disseminationThis protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059–01). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.Trial registration numberChiCTR-IOR-17012847; Pre-result.

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Faculty Opinions recommendation of Efficacy and safety of co-administered ivermectin and albendazole in school-aged children and adults infected with Trichuris trichiura in Côte d'Ivoire, Laos, and Pemba Island, Tanzania: a double-blind, parallel-group, phase 3, randomised controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.741267002.793590492 ◽

2021 ◽

Author(s):

Pedro Legua Leiva

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Trichuris Trichiura ◽

Efficacy And Safety ◽

Phase 3 ◽

Double Blind ◽

School Aged Children ◽

Pemba Island ◽

Parallel Group ◽

Randomised Controlled

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Efficacy and safety of aerosolized intra-tracheal dornase alfa administration in patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS): a structured summary of a study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-020-04488-8 ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 4

Author(s):

J. P. Desilles ◽

C. Gregoire ◽

C. Le Cossec ◽

J. Lambert ◽

O. Mophawe ◽

...

Keyword(s):

Acute Respiratory Distress Syndrome ◽

Randomised Controlled Trial ◽

Respiratory Distress Syndrome ◽

Respiratory Distress ◽

Study Protocol ◽

Distress Syndrome ◽

Controlled Trial ◽

Efficacy And Safety ◽

Dornase Alfa ◽

Randomised Controlled

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Prospective, single-centre, randomised controlled trial to evaluate the efficacy and safety of ischaemia-free liver transplantation (IFLT) in the treatment of end-stage liver disease

BMJ Open ◽

10.1136/bmjopen-2019-035374 ◽

2020 ◽

Vol 10 (5) ◽

pp. e035374

Author(s):

Changjun Huang ◽

Shanzhou Huang ◽

Yunhua Tang ◽

Qiang Zhao ◽

Dongping Wang ◽

...

Keyword(s):

Liver Transplantation ◽

Liver Disease ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Efficacy And Safety ◽

Single Centre ◽

Donor Liver ◽

End Stage Liver Disease ◽

Randomised Controlled ◽

End Stage

IntroductionDuring conventional liver transplantation (CLT), ischaemia-reperfusion injury (IRI) is inevitable and is associated with complications such as early allograft dysfunction (EAD), primary non-function and ischaemic-type biliary lesions. We have established a novel procedure called ischaemia-free liver transplantation (IFLT). The results from a pilot study suggest that IFLT might prevent IRI and yield better transplant outcomes than CLT. The purpose of this study was to further assess the efficacy and safety of IFLT versus CLT in patients with end-stage liver disease.Methods and analysisThis is an investigator-initiated, open-label, phase III, prospective, single-centre randomised controlled trial on the effects of IFLT in patients with end-stage liver disease. Adult patients (aged 18–75 years) eligible for liver transplantation will be screened for participation in this trial and will be randomised between the IFLT group (n=34) and the CLT group (n=34). In the IFLT group, the donor liver will be procured, preserved and implanted with continuous normothermic machine perfusion (NMP). In the CLT group, the donor liver will be procured after a fast cold flush, preserved in 0°C–4°C solution and implanted under hypothermic and hypoxic conditions. Patients in both groups will be managed according to the standard protocol of our centre. The primary end point is the incidence of EAD after liver transplantation. Intraoperative and postoperative parameters of donor livers and recipients will be observed and recorded, and postoperative liver graft function, complications and recipient and graft survival will be evaluated. After a 12-month follow-up of the last enrolled recipient, the outcomes will be analysed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.Ethics and disseminationThe protocol was reviewed and approved by the Ethics Committee of The First Affiliated Hospital of Sun Yat-sen University. The findings will be disseminated to the public through conference presentations and peer-reviewed scientific journals.Trial registration numberChiCTR1900021158.

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