Allergic diseases and the effect of inhaled epinephrine in children with acute bronchiolitis: follow-up from the randomised, controlled, double-blind, Bronchiolitis ALL trial

2015 ◽  
Vol 3 (9) ◽  
pp. 702-708 ◽  
Author(s):  
Håvard Ove Skjerven ◽  
Leif Bjarte Rolfsjord ◽  
Teresa Løvold Berents ◽  
Hanne Engen ◽  
Edin Dizdarevic ◽  
...  
Keyword(s):  
Allergic Diseases ◽  
Acute Bronchiolitis ◽  
Double Blind ◽  
Randomised Controlled

Efficacy of memantine in the treatment of fibromyalgia: A double-blind, randomised, controlled trial with 6-month follow-up

Pain ◽  
2014 ◽  
Vol 155 (12) ◽  
pp. 2517-2525 ◽  
Author(s):  
Bárbara Olivan-Blázquez ◽  
Paola Herrera-Mercadal ◽  
Marta Puebla-Guedea ◽  
Mari-Cruz Pérez-Yus ◽  
Eva Andrés ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Double Blind ◽  
Randomised Controlled

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

Reflexology for the treatment of pain in people with multiple sclerosis: a double-blind randomised sham-controlled clinical trial

2009 ◽  
Vol 15 (11) ◽  
pp. 1329-1338 ◽  
Author(s):  
CM Hughes ◽  
S. Smyth ◽  
AS Lowe-Strong
Keyword(s):  
Multiple Sclerosis ◽  
Primary Outcome Measure ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Positive Effects ◽  
Vas Scores ◽  
Clinically Significant ◽  
Randomised Controlled

Multiple sclerosis (MS) results in pain and other symptoms which may be modified by conventional treatment, however, MS is still not curable. Several studies have reported positive effects of reflexology in the treatment of pain, however, no randomised controlled clinical trials for the treatment of pain have been conducted within this population. The objective of this study was to investigate the effectiveness of reflexology on pain in and MS population. We randomly allocated 73 participants to receive either precision or sham reflexology weekly for 10 weeks. Outcome measures were taken pre-and post-treatment with follow-up at 6 and 12 weeks by a researcher blinded to group allocation. The primary outcome measure recorded pain using a Visual Analogue Scale (VAS). A significant (p < 0.0001) and clinically important decrease in pain intensity was observed in both groups compared with baseline. Median VAS scores were reduced by 50% following treatment, and maintained for up to 12 weeks. Significant decreases were also observed for fatigue, depression, disability, spasm and quality of life. In conclusion, precision reflexology was not superior to sham, however, both treatments offer clinically significant improvements for MS symptoms via a possible placebo effect or stimulation of reflex points in the feet using non-specific massage.

scholarly journals The Stanley Foundation Bipolar Network

2001 ◽  
Vol 178 (S41) ◽  
pp. s169-s176 ◽  
Author(s):  
Robert M. Post ◽  
Kirk D. Denicoff ◽  
Gabriele S. Leverich ◽  
Willem A. Nolen ◽  
Ralph W. Kupka ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Clinical Case ◽  
Case Series ◽  
Controlled Trials ◽  
Omega 3 Fatty Acids ◽  
Omega 3 ◽  
Double Blind ◽  
Bipolar Illness ◽  
Randomised Controlled

BackgroundThe Stanley Foundation Bipolar Network (SFBN) was created to address the paucity of help studies in bipolar illness.AimsTo describe the rationale and methods of the SFBN.MethodThe SFBN includes five core sites and a number of affiliated sites that have adopted consistent methodology for continuous longitudinal monitoring of patients. Open and controlled studies are performed as patients' symptomatology dictates.ResultsThe reliability of SFBN raters and the validity of the rating instruments have been established. More than 500 patients are in continuous daily longitudinal follow-up. More than 125 have been randomised to one of three of the newer antidepressants (bupropion, sertraline and venlafaxine) as adjuncts in a study of mood stabilisers and 93 to omega-3 fatty acids. A number of open clinical case series have been published.ConclusionsWell-characterised patients are followed in a detailed continuous longitudinal fashion in both opportunistic case series and double-blind, randomised controlled trials with reliable and validated measures.

scholarly journals Colchicine for children with pericarditis: systematic review of clinical studies

2016 ◽  
Vol 101 (10) ◽  
pp. 953-956 ◽  
Author(s):  
Samer Alabed ◽  
Giordano Pérez-Gaxiola ◽  
Amanda Burls
Keyword(s):  
Systematic Review ◽  
Case Reports ◽  
Data Extraction ◽  
Experimental Studies ◽  
Case Series ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Randomised Controlled

ObjectiveTo review the evidence for the efficacy and safety of colchicine in children with pericarditis.DesignSystematic review.Search strategyThe following databases were searched for studies about colchicine in children with pericarditis (June 2015): Cochrane Central, Medline, EMBASE and LILACS.Eligibility criteriaAll observational and experimental studies on humans with any length of follow-up and no limitations on language or publication status were included. The outcomes studied were recurrences of pericarditis and adverse events.Data extractionTwo authors extracted data and assessed quality of included studies using the Cochrane risk of bias tool for non-randomised trials.ResultsTwo case series and nine case reports reported the use of colchicine in a total of 86 children with pericarditis. Five articles including 74 paediatric patients were in favour of colchicine in preventing further pericarditis recurrences. Six studies including 12 patients showed that colchicine did not prevent recurrences of pericarditis.LimitationsNo randomised controlled trials (RCTs) were found.ConclusionsAlthough colchicine is an established treatment for pericarditis in adults, it is not routinely used in children. There is not enough evidence to support or discourage the use of colchicine in children with pericarditis. Further research in the form of large double-blind RCTs is needed to establish the efficacy of colchicine in children with pericarditis.

scholarly journals 308 Transcriptomic analysis of melanoma patients in adjuvant setting treated with anti PD1 therapy: real life study

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A332-A333
Author(s):  
Domenico Mallardo ◽  
Claudia Trojaniello ◽  
Maria Grazia Vitale ◽  
grazia d’angelo ◽  
Andrew White ◽  
...  
Keyword(s):  
Stage Iii ◽  
Adjuvant Setting ◽  
Relapse Free Survival ◽  
Phase 3 ◽  
Double Blind ◽  
Free Survival ◽  
Melanoma Patients ◽  
Resected Stage ◽  
Randomised Controlled

BackgroundAdjuvant treatment of melanoma patients with immune-checkpoint inhibition (ICI) significantly improved relapse-free survival (RFS).1 In the phase 3 keynote-054 trial showed that pembrolizumab (anti-PD1) administration in adjuvant setting provided a longer RFS (59,8%) than the placebo group (41,4%) at a 3.5-year median follow-up.2 Moreover, 4 years RFS results from the phase 3 checkmate 238 trial, showed a superior efficacy of nivolumab versus ipilimumab in patients with resected AJCC-7 stage III or IV melanoma. RFS rate was of 58% in the nivolumab arm and 45% in the ipilimumab arm.3 Although treatment with ICIs has improved the RFS of melanoma patients in adjuvant setting, there is still a large proportion of patients who do not respond to the treatment and then relapse. The aim of this study was to investigate the molecular mechanisms underlying resistance to anti-PD1 treatment in the adjuvant setting.MethodsFrom December 2018 to July 2020, n. 121 melanoma patients in stage III or IV NED were treated with anti-PD1s as adjuvant (minimum follow up of 12 months, range 12–30 months). These patients received nivolumab (n=95) or pembrolizumab (n=26). Distant and local metastases was observed in 33 (27%) and 7 (6%) patients, respectively (patients baseline characteristics are listed in table1). Gene expression profiles, using NanoString IO 360 panel, were performed from peripheral blood mononuclear cell (PBMCs), collected retrospectively, from n.73 patients (of which n.26 had relapse). All patients have appropriately signed informed consent. Statistical analysis was performed via Bonferroni correction, P< 0.05 was considered statistically significant for median stratification.ResultsAt a minimum follow-up of 12 months, the 12-month rate of Relapse-free survival was 72%, confirming the data reported by checkmate 238 trial. In the transcriptomic analysis we observed that in patients with local-regional metastases there was a higher expression of ITGA2 (p<0.05), a gene that promotes malignant tumor aggression by up-regulating PD-L1 expression through STAT3 pathway and the downregulation of DUSP1 (p<0.05) that is linked in promotion of angiogenesis, invasion and metastasis. Moreover, in male group we found a higher expression of HLA-DQB1 and HLA-DQA1 which belonged to HLA class II beta chains.Abstract 308 Table 1ConclusionsIn this preliminary report we found that RFS 1-yr rate is similar to checkmate 238 study, and that patients with local metastasis have a higher expression of genes related to promote PDL1 levels. Further investigations are needed to get additional information.AcknowledgementsThe study was supported by the Institutional Project ”Ricerca Corrente” of Istituto Nazionale Tumori IRCCS Fondazione ”G. Pascale” of Napoli, Italy.ReferencesWeber J, Mandala M, Del Vecchio M, et al, CheckMate 238 Collaborators. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med 2017 November 9;377(19):1824–1835.Eggermont AMM, Blank CU, Mandalà M, et al. EORTC melanoma group. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial. Lancet Oncol 2021 May;22(5):643–654.Ascierto PA, Del Vecchio M, Mandalá M, et al. Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Oncol 2020 November;21(11):1465–1477.Ethics ApprovalThe study was approved by internal ethics board of the Istituto Nazionale Tumori IRCCS Fondazione ”G. Pascale” of Napoli Italy, approval number of registry 33/17 OSS.ConsentWritten informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal.

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