scholarly journals Total wrist arthrodesis with and without arthrodesis of the carpoMetacarpal joint (WAWWAM): study protocol

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
David H. Owen ◽  
Diana M. Perriman ◽  
Igor Policinski ◽  
Maurizio Damiani ◽  
Paul N. Smith ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Primary Outcome ◽  
Randomised Clinical Trial ◽  
Late Complications ◽  
Dash Score ◽  
Carpometacarpal Joint ◽  
Single Centre ◽  
Wrist Arthrodesis ◽  
End Stage ◽  
Clinical Trials Registry

Abstract Background It is controversial whether or not the carpometacarpal joint (CMCJ) should be included in total wrist arthrodesis (TWA). Complications commonly occur at this site and studies examining its inclusion and exclusion are conflicting. A randomised clinical trial comparing wrist arthrodesis with CMCJ arthrodesis and spanning plate to wrist arthrodesis with CMCJ preservation and non-CMCJ spanning plate has not been performed. Method A single centre randomised clinical trial including 120 adults with end-stage isolated wrist arthritis will be performed to compare TWA with and without the CMCJ included in the arthrodesis. The primary outcome is complications in the first post-operative year. Secondary outcomes are Disabilities of the Arm, Shoulder and Hand (DASH) score, Patient Rated Wrist Evaluation (PRWE) and grip strength measured at 1, 2 and 5 years. Late complications, return to work and satisfaction will also be recorded. Discussion It is unknown whether the CMCJ should be included in TWA. This trial will contribute to an improved understanding of optimal management of the CMCJ in total wrist arthrodesis. Trial registration This trial was prospectively registered with the Australia New Zealand Clinical Trials Registry with identifying number ACTRN12621000169842 on the 16th February 2021. WHO: U1111–12626523. ANZCTR: ACTRN12621000169842

Multicolour versus monocolour inking specimens after pancreaticoduodenectomy for periampullary cancer: A single centre prospective randomised clinical trial

2018 ◽  
Vol 51 ◽  
pp. 63-70 ◽  
Author(s):  
Riccardo Casadei ◽  
Claudio Ricci ◽  
Giovanni Taffurelli ◽  
Carlo Alberto Pacilio ◽  
Donatella Santini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Clinical Trial ◽  
Periampullary Cancer ◽  
Single Centre

Binocular game versus part-time patching for treatment of anisometropic amblyopia in Chinese children: a randomised clinical trial

2019 ◽  
Vol 104 (3) ◽  
pp. 369-375
Author(s):  
Jing Yao ◽  
Hye-Won Moon ◽  
Xiaomei Qu
Keyword(s):  
Clinical Trial ◽  
Primary Outcome ◽  
Randomised Clinical Trial ◽  
Chinese Children ◽  
Interocular Suppression ◽  
Anisometropic Amblyopia ◽  
Minimum Angle ◽  
Part Time ◽  
Secondary Outcomes ◽  
The Difference

AimsTo compare amblyopic-eye visual acuity (VA) and binocularity improvement of a binocular game with part-time patching in the treatment of Chinese children with anisometropic amblyopia.Methods103 Chinese children aged 3–13 years with anisometropic amblyopia were recruited in a randomised clinical trial. Eligible participants were randomly assigned to the binocular, patching and combined groups. Primary outcome was amblyopic-eye VA improvement at 3 months. Secondary outcomes included reduction of suppression and change of stereoacuity.ResultsOf 85 completed participants, 44 (52%) were women and mean (SD) age was 5.99 (2.33) years. At 3 months, mean (95% CI) amblyopic-eye VA improved 0.18 (0.10–0.26), 0.28 (0.19–0.36) and 0.30 (0.21–0.39) logarithm of the minimum angle of resolution in the binocular, patching and combined groups, respectively. After adjusting for baseline VA, the difference was statistically significant (F=6.29, p=0.003), favouring as follows: the combined group, the patching group and the binocular group. After treatment, Titmus (x2binocular=9.75, p=0.007; x2combined=9.35, p=0.009) and dynamic stereoacuity (x2binocular=12.56, p=0.01; x2combined=12.66, p=0.01) improved only in the binocular and combined groups. Among groups, only Titmus improvement differed significantly (F=49.55, p<0.001). Changes of other types of stereoacuity and interocular suppression were similar.ConclusionsThe binocular game used in this study could improve amblyopic-eye VA and binocularity in Chinese children with anisometropic amblyopia, but it was less effective than patching in amblyopic-eye VA improvement and showed no superiority in binocularity over patching. It remains unclear whether the low treatment response of this binocular game was due to limitations of the study or its low treatment effect.

scholarly journals Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial

2017 ◽  
Vol 31 (9) ◽  
pp. 814-824 ◽  
Author(s):  
Mogens Groenvold ◽  
Morten Aagaard Petersen ◽  
Anette Damkier ◽  
Mette Asbjoern Neergaard ◽  
Jan Bjoern Nielsen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Palliative Care ◽  
Advanced Cancer ◽  
Standard Care ◽  
Primary Outcome ◽  
Randomised Clinical Trial ◽  
Sensitivity Analyses ◽  
Specialist Palliative Care ◽  
Beneficial Effects ◽  
Secondary Outcomes

Background: Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal. Aim: To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments. Setting/participants: The Danish Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients with advanced cancer were screened for palliative needs. Patients with scores exceeding a predefined threshold for problems with physical, emotional or role function, or nausea/vomiting, pain, dyspnoea or lack of appetite according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were eligible. The primary outcome was the change in each patient’s primary need (the most severe of the seven QLQ-C30 scales) at 3- and 8-week follow-up (0–100 scale). Five sensitivity analyses were conducted. Secondary outcomes were change in the seven QLQ-C30 scales and survival. Results: Totally 145 patients were randomised to early specialist palliative care versus 152 to standard care. Early specialist palliative care showed no effect on the primary outcome of change in primary need (−4.9 points (95% confidence interval −11.3 to +1.5 points); p = 0.14). The sensitivity analyses showed similar results. Analyses of the secondary outcomes, including survival, also showed no differences, maybe with the exception of nausea/vomiting where early specialist palliative care might have had a beneficial effect. Conclusion: We did not observe beneficial or harmful effects of early specialist palliative care, but important beneficial effects cannot be excluded.

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

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.

O-198 Progesterone supplementation in women with threatened miscarriage: A randomised placebo-controlled clinical trial

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
L McLindon ◽  
G James ◽  
M M Beckmann ◽  
J Bertolone ◽  
K Mahomed ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Live Birth ◽  
Perinatal Outcomes ◽  
Randomised Clinical Trial ◽  
Single Centre ◽  
Birth Rates ◽  
Live Birth Rates ◽  
Threatened Miscarriage ◽  
Progesterone Supplementation ◽  
Micronized Progesterone

Abstract Study question In women with threatened miscarriage, does progesterone supplementation increase the probability of live birth? Summary answer In women with threatened miscarriage, 400 mg progesterone nightly, from onset of bleeding until 12 weeks, did not increase live birth rates. What is known already Women with a history of miscarriage who present with bleeding in early pregnancy may benefit from the use of vaginal micronized progesterone 400 mg. A recently published large randomised clinical trial indicated no overall benefit for progesterone until 16 weeks, although subgroup analysis in women with bleeding and at least one previous miscarriage, progesterone might be of benefit (Coomarasamy et al; N Engl J Med 2019;380:1815-1824). Study design, size, duration We performed a single centre placebo-­controlled randomised clinical trial. After informed consent, women with threatened miscarriage as apparent from vaginal bleeding under 10 weeks, were randomised to 400 mg vaginal micronized progesterone or placebo. The primary endpoint was livebirth. Secondary endpoints were perinatal outcomes, including preterm birth and birthweight. The planned sample size was 386 women. At a planned interim analysis randomisation was halted at 278 women due to lack of effectiveness and slow recruitment. Participants/materials, setting, methods Between February 2012 and April 2019 we randomised 139 women to 400 mg vaginal micronized progesterone and 139 women to placebo. Primary outcome data are available for 134 women in the progesterone arm and 130 women in the placebo arm. Mean age was 30.7 and 30.4 years. The number of women without a previous miscarriage was 68 (51%) and 55 (42%), while 66 (49%) and 75 (58%) women had at least one previous miscarriage. Main results and the role of chance The live birth rates were 113/134 (84.3%) and 112/130 (86.2%), respectively (RR 0.98, 95% CI 0.89-1.08). Among women with at least 1 miscarriage live birth rates were 55/66 (83.3%) and 65/75 (86.7%) (RR 0.96, 95% CI 0.84-1.11). The number of women with more than 1 miscarriage was limited (26 vs 33 in total), but no effect was seen from progesterone in these women. Preterm birth rates were 12.9% and 9.3% (RR 1.38; 95% CI 0.69 to 2.78). There were five pregnancy losses between 20 and 23 weeks, all in the progesterone arm. Mean birth weight was 3310 vs 3300 gram (p=.99). There were also no other differences in obstetric and perinatal outcomes. Anxiety, stress and depression scores did not differ between the groups. Limitations, reasons for caution Our study was single centre and did not reach the planned sample size. We stopped study medication at 12 weeks which might explain the difference between our study and studies that continued progesterone till 16 weeks. Wider implications of the findings In women with threatened miscarriage, 400 mg vaginal progesterone did not improve live birth rates. Trial registration number ACTRN12611000405910

scholarly journals Comparison of chewing gum and ibuprofen in alleviating orthodontic pain: a single centre, randomised clinical trial

2021 ◽  
Vol 36 (1) ◽  
pp. 38-44
Author(s):  
Mohadeseh Delavarian ◽  
Mohammad Moslem Imani ◽  
Fatemeh Delavarian ◽  
Shahin Bayani
Keyword(s):  
Clinical Trial ◽  
Randomised Clinical Trial ◽  
Chewing Gum ◽  
Single Centre ◽  
Orthodontic Pain
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