Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial

IntroductionWhile most children recover from a concussion shortly after injury, approximately 30% experience persistent postconcussive symptoms (pPCS) beyond 1-month postinjury. Existing research into the treatment of pPCS have evaluated unimodal approaches, despite evidence suggesting that pPCS likely represent an interaction across various symptom clusters. The primary aim of this study is to evaluate the effectiveness of a multimodal, symptom-tailored intervention to accelerate symptom recovery and increase the proportion of children with resolved symptoms at 3 months postconcussion.Methods and analysisIn this open-label, assessor-blinded, randomised clinical trial, children with concussion aged 8–18 years will be recruited from The Royal Children’s Hospital (The RCH) emergency department, or referred by a clinician, within 17 days of initial injury. Based on parent ratings of their child’s PCS at ~10 days postinjury, symptomatic children (≥2 symptoms at least 1-point above those endorsed preinjury) will undergo a baseline assessment at 3 weeks postinjury and randomised into either Concussion Essentials (CE, n=108), a multimodal, interdisciplinary delivered, symptom-tailored treatment involving physiotherapy, psychology and education, or usual care (UC, n=108) study arms. CE participants will receive 1 hour of intervention each week, for up to 8 weeks or until pPCS resolve. A postprogramme assessment will be conducted at 3 months postinjury for all participants. Effectiveness of the CE intervention will be determined by the proportion of participants for whom pPCS have resolved at the postprogramme assessment (primary outcome) relative to the UC group. Secondary outcome analyses will examine whether children receiving CE are more likely to demonstrate resolution of pPCS, earlier return to normal activity, higher quality of life and a lower rate of utilisation of health services, compared with the UC group.Ethics and disseminationEthics were approved by The RCH Human Research Ethics Committee (HREC: 37100). Parent, and for mature minors, participant consent, will be obtained prior to commencement of the trial. Study results will be disseminated at international conferences and international peer-reviewed journals.Trial registration numberACTRN12617000418370; pre-results.

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An open-label randomised clinical trial to compare the efficacy of dietary caloric restriction and physical activity for weight loss in overweight pet dogs

The Veterinary Journal ◽

10.1016/j.tvjl.2018.11.013 ◽

2019 ◽

Vol 243 ◽

pp. 65-73 ◽

Cited By ~ 3

Author(s):

M. Chapman ◽

G.R.T. Woods ◽

C. Ladha ◽

C. Westgarth ◽

A.J. German

Keyword(s):

Physical Activity ◽

Clinical Trial ◽

Weight Loss ◽

Caloric Restriction ◽

Randomised Clinical Trial ◽

Open Label ◽

Pet Dogs

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Effectiveness and cost-effectiveness of a nurse-delivered intervention to improve adherence to treatment for HIV: a pragmatic, multicentre, open-label, randomised clinical trial

The Lancet Infectious Diseases ◽

10.1016/s1473-3099(16)30534-5 ◽

2017 ◽

Vol 17 (6) ◽

pp. 595-604 ◽

Cited By ~ 27

Author(s):

Marijn de Bruin ◽

Edwin J M Oberjé ◽

Wolfgang Viechtbauer ◽

Hans-Erik Nobel ◽

Mickaël Hiligsmann ◽

...

Keyword(s):

Clinical Trial ◽

Cost Effectiveness ◽

Randomised Clinical Trial ◽

Adherence To Treatment ◽

Open Label

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Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial

European Respiratory Journal ◽

10.1183/13993003.01471-2021 ◽

2021 ◽

pp. 2101471

Author(s):

Leo Sekine ◽

Beatriz Arns ◽

Bruna R. Fabro ◽

Murillo M. Cipolatt ◽

Rafael R. G. Machado ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Improvement ◽

Critically Ill ◽

Primary Outcome ◽

Ventilatory Support ◽

Standard Of Care ◽

Randomised Clinical Trial ◽

Open Label ◽

Hospitalised Patients ◽

Significant Difference

BackgroundThe effects of convalescent plasma (CP) therapy hospitalised patients with coronavirus disease 2019 (COVID-19) remain uncertain. This study investigates the effect CP on clinical improvement in these patients.MethodsThis is an investigator-initiated, randomised, parallel arm, open-label, superiority clinical trial. Patients were randomly (1:1) assigned to two infusions of CP plus standard of care (SOC) or SOC alone. The primary outcome was the proportion of patients with clinical improvement 28 days after enrolment.ResultsA total of 160 (80 in each arm) patients (66.3% were critically ill and 33.7%, severe) completed the trial. The median age was 60.5 years (interquartile range [IQR], 48–68), 58.1% were men and the median time from symptom onset to randomisation was 10 days (IQR, 8–12). Neutralising antibodies titres >1:80 were present in 133 (83.1%) patients at baseline. The proportion of patients with clinical improvement on day 28 was 61.3% in the CP+SOC and 65.0% in the SOC group (difference, −3.7%; 95% Confidence Interval [CI], −18.8%-11.3%). The results were similar in the subgroups of severe and critically ill. There was no significant difference between CP+SOC and SOC groups in prespecified secondary outcomes, including 28-day mortality, days alive and free of respiratory support and duration of invasive ventilatory support. Inflammatory and other laboratorial markers values on days 3, 7 and 14 were similar between groups.ConclusionsCP+SOC did not result in a higher proportion of clinical improvement on at day 28 in hospitalised patients with COVID-19 compared to SOC alone.

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P3BEP (ANZUP 1302): An international randomised phase 3 trial of accelerated versus standard BEP chemotherapy for adult and paediatric male and female patients with intermediate and poor-risk metastatic germ cell tumours (GCTs).

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.tps4592 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. TPS4592-TPS4592

Author(s):

Peter S. Grimison ◽

Nicola Jane Lawrence ◽

Martin R. Stockler ◽

Andrew James Martin ◽

Sonia Yip ◽

...

Keyword(s):

Clinical Trial ◽

Age Groups ◽

Progression Free Survival ◽

Complete Response ◽

Randomised Clinical Trial ◽

Open Label ◽

Phase 3 ◽

Poor Risk ◽

Males And Females ◽

Line Chemotherapy

TPS4592 Background: Bleomycin, etoposide, cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for metastatic GCTs. Accelerating regimens by giving them 2-weekly rather than 3-weekly has improved cure rates in other cancers. This is the first international randomised clinical trial for intermediate and poor-risk metastatic extra-cranial GCTs involving both adult and paediatric age groups open to both males and females. We aim to determine if accelerated BEP is superior to standard BEP. Methods: DESIGN: Open-label, randomised, stratified multicentre, 2 stage, phase 3 trial. Primary endpoint for stage I (n = 150) is complete response rate (RR), and for entire trial (n = 500) is progression free survival (PFS). SAMPLE SIZE: 150 and 500 patients gives > 80% power to detect a 20% improvement in RRs and 7% absolute improvement in 2yr PFS, respectively. POPULATION: Males and females aged 11-45 yrs with intermediate or poor-risk metastatic GCTs of the testis, ovary, retroperitoneum or mediastinum for 1st line chemotherapy. TREATMENT:Randomisation 1:1 to 4 cycles of “standard BEP” or “accelerated BEP”: cisplatin 20mg/m2 IV days 1-5; etoposide 100mg/m2 IV days 1-5; bleomycin 30000 IU IV weekly; and pegylated G-CSF 6mg SC on Day 6; given every 3 weeks or every 2 weeks respectively. Accelerated BEP arm receives 4 additional weekly doses of bleomycin. ASSESSMENTS: Response assessments at 30-day safety assessment, and 6 months from randomisation or after all post-chemotherapy intervention is completed. Regular follow-up to 5 years, then annually. Archival tumour tissue and baseline blood collected for translational substudies. STATUS: 27 sites open in ANZ, 34 patients recruited by February 2017. International collaborations with UK (led by Cambridge Clinical Trials Unit) and US (led by Childrens Oncology Group) confirmed with sites expected to open by early 2017, and more sites sought for stage 2. Funded by Cancer Council Australia and Cancer Australia. ANZUP supported by Cancer Australia and previously CINSW. ANZCTR: ACTRN12613000496718. Clinical trial information: NCT02582697.

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