scholarly journals Randomized controlled trial of ragweed sublingual immunotherapy tablet in the subpopulation of Canadian children and adolescents with allergic rhinoconjunctivitis

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Anne K. Ellis ◽  
Remi Gagnon ◽  
David I. Bernstein ◽  
Hendrik Nolte
Keyword(s):  
Children And Adolescents ◽  
Sublingual Immunotherapy ◽  
Controlled Trial ◽  
Mean Difference ◽  
Ragweed Pollen ◽  
Total Study Population ◽  
Amb A 1 ◽  
Secondary Endpoints ◽  
Study Population ◽  
Post Hoc

Abstract Background Post hoc analyses of randomized placebo-controlled trials have demonstrated efficacy and tolerability of the ragweed sublingual immunotherapy (SLIT)-tablet in Canadian adults with ragweed pollen-induced allergic rhinitis/conjunctivitis (AR/C). This post hoc analysis evaluated the efficacy and tolerability of the ragweed SLIT-tablet in the subpopulation of Canadian children and adolescents with AR/C in a previously described randomized, double-blind, placebo-controlled trial. Methods The trial (NCT02478398) was conducted in North American and European children/adolescents ages 5–17 years with ragweed pollen-induced AR/C with or without asthma (FEV1 ≥ 80% predicted). Participants were randomized to daily ragweed SLIT-tablet (12 Amb a 1-U) or placebo for up to 28 weeks. The primary endpoint was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary endpoints were TCS during the entire RPS, and DSS and DMS during peak RPS. Post hoc analyses of the primary and key secondary endpoints were conducted in the subpopulation of Canadian participants. Results Of the 1025 randomized participants, 246 (SLIT-tablet, n = 116; placebo, n = 130) were in the Canadian subpopulation. In the total study population, relative TCS (95% CI) improvement with ragweed SLIT-tablet versus placebo was − 38.3% (− 46.0%, − 29.7%; least square [LS] mean difference, − 2.73; P < 0.001) during peak RPS. In the Canadian subpopulation, relative TCS improvements with ragweed SLIT-tablet versus placebo were − 40.8% (− 54.5%, − 20.2%; LS mean difference, − 1.59; P = 0.001) during peak RPS and − 36.6% (− 50.2%, − 16.5%; LS mean difference, − 1.36; P = 0.002) during the entire RPS. DSS and DMS during peak RPS in the Canadian subpopulation improved with SLIT-tablet versus placebo by − 30.6% (− 45.2%, − 7.7%; LS mean difference, − 0.94; P = 0.010) and − 77.2% (− 97.5%, − 44.2%; LS mean difference, − 0.66; P = 0.003), respectively. No events of anaphylaxis, airway compromise, intramuscular epinephrine administration, eosinophilic esophagitis, or severe treatment-related systemic allergic reactions were reported in the overall population or Canadian subpopulation. Conclusion Efficacy and safety of the ragweed SLIT-tablet in Canadian children/adolescents with ragweed pollen-induced AR/C was consistent with the total study population. The ragweed SLIT-tablet resulted in clinically meaningful improvement in symptoms, decreased symptom-relieving medication use, and was well tolerated in Canadian children/adolescents. Trial registration: clinicaltrials.gov, NCT02478398. Registered June 23, 2015, https://clinicaltrials.gov/ct2/show/NCT02478398?term=NCT02478398&draw=2&rank=1

scholarly journals Elucidating the impact of obesity on hormonal and metabolic perturbations in polycystic ovary syndrome phenotypes in Indian women

PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0246862
Author(s):  
Roshan Dadachanji ◽  
Anushree Patil ◽  
Beena Joshi ◽  
Srabani Mukherjee
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Obese Women ◽  
Contributing Factors ◽  
Ovary Syndrome ◽  
Total Study Population ◽  
Study Population ◽  
Post Hoc ◽  
The Impact ◽  
Rotterdam Criteria

Polycystic ovary syndrome is a complex endocrinopathy with heterogeneous presentation and multifactorial etiology. We have undertaken this case-control study to compare metabolic and endocrine characteristics in different phenotypic subgroups of women with PCOS and the impact of obesity on them. Women with PCOS (n = 489) were classified into 4 phenotypes according to Rotterdam criteria. Comparisons of clinical, biochemical and hormonal parameters were performed across all phenotypic groups of PCOS and with controls (n = 270) by Welch’s ANOVA with subsequent Games-Howell post-hoc test. We found maximum prevalence of normoandrogenic phenotype D, which is milder form of PCOS in terms of insulin resistance, gonadotropin levels and dyslipidemia, followed by phenotype A, in our total study population. After classification of the study group into lean and obese groups, only few insulin and lipid-related traits showed marked differences between phenotypes. Further, we noted that obese women showed adverse metabolic but not androgenic traits compared to lean counterparts in the same phenotype. Metabolic syndrome frequency is increased in hyperandrogenic phenotypes with HDL-C and waist circumference being most predominant contributing factors in total, lean and obese groups. We demonstrate that in our study population there is greater occurrence of phenotype D of PCOS. Our study highlights the importance of clinicians concurrently employing Rotterdam criteria along with obesity status for ascertaining accurate PCOS status and formulating suitable therapeutic intervention.

scholarly journals Endurance-oriented training program with children and adolescents on maintenance hemodialysis to enhance dialysis efficacy—DiaSport

2021 ◽  
Author(s):  
Markus Feldkötter ◽  
Sarah Thys ◽  
Anne Adams ◽  
Ingrid Becker ◽  
Rainer Büscher ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Controlled Trial ◽  
Bicycle Ergometer ◽  
Maintenance Hemodialysis ◽  
Control Group ◽  
Intention To Treat ◽  
Link Type ◽  
Secondary Endpoints ◽  
Set Up ◽  
Bicycle Ergometer Training

Abstract Objective Pediatric patients spend significant time on maintenance hemodialysis (HD) and traveling. They are often not capable of participating in sports activities. To assess the effects of exercise training during HD on dialysis efficacy in children and adolescents, we set up a multi-center randomized controlled trial (RCT). Methods Patients on HD, age 6 to 18 years, were randomized either to 3× weekly bicycle ergometer training or to no training during HD for 12 weeks. Change in single-pool Kt/V (spKt/V) was the primary outcome parameter. Results We randomized 54 patients of whom 45 qualified (23 in the intervention and 22 in the waiting control group, 14.5 ± 3.01 years, 32 male and 13 female) for the intention-to-treat (ITT) population. Only 26 patients finished study per-protocol (PP). Training was performed for an average of 11.96 weeks (0.14–13.14) at 2.08 ± 0.76 times per week and for a weekly mean of 55.52 ± 27.26 min. Single-pool Kt/V was similar in the intervention compared to the control group (1.70 [0.33] vs. 1.79 [0.55]) at V0 and (1.70 [0.36] vs. 1.71 [0.51]) at V1; secondary endpoints also showed no difference in both ITT and PP analysis. No significant adverse events were reported. No bleeding or needle dislocation occurred in 1670 training sessions. Conclusions Intradialytic bicycle training is safe, but does not improve dialysis efficacy and physical fitness. However, the study can be considered underpowered, particularly because of high dropout rates. Future studies need better strategies to increase motivation and compliance and other more effective/intensive exercise measures should be evaluated. Trial registration The trial was registered in ClinicalTrials.Gov (Clinicaltrials.gov identifier: NCT01561118) on March 22, 2012.

Does oral anticoagulation improve femoropedal graft patency in diabetic patients? Lessons from the Dutch BOA Study

VASA ◽  
2001 ◽  
Vol 30 (Supplement 58) ◽  
pp. 47-49 ◽  
Author(s):  
Chantelau
Keyword(s):  
Oral Anticoagulation ◽  
Controlled Trial ◽  
Oral Anticoagulants ◽  
Graft Patency ◽  
Diabetic Patients ◽  
Graft Occlusion ◽  
Total Study Population ◽  
Diabetic Status ◽  
Significant Difference ◽  
Study Population

Graft patency rates after arterial reconstruction benefit from aspirin treatment. The Dutch Bypass Oral anticoagulant or Aspirin (BOA) Study, a randomized controlled trial, compared the use of oral anticoagulants (e.g. phenprocoumon) versus aspirin in a large sample of patients after infrainguinal arterial bypass surgery. Graft occlusion was the primary endpoint. A total of 2650 bypasses were performed, 531 of which were femorocrural or femoropedal grafts. Of the latter, 194 (37%) were carried out in the subgroup of 700 diabetic patients (i.e. 26% of the total study population). There was no significant difference in patency rates of these particular grafts with either drug. Hence, aspirin 100 mg/day is as effective as oral anticoagulation to benefit patency rates in femorocrural and femoropedal bypass grafts, irrespective of the diabetic status of the patients. Aspirin is sufficient, and oral anticoagulation is not required for this particular type of reconstruction.

Muscle-targeted nutritional support for rehabilitation in patients with parkinsonian syndrome

Neurology ◽  
2019 ◽  
Vol 93 (5) ◽  
pp. e485-e496 ◽  
Author(s):  
Michela Barichella ◽  
Emanuele Cereda ◽  
Giovanna Pinelli ◽  
Laura Iorio ◽  
Diana Caroli ◽  
...  
Keyword(s):  
Vitamin D ◽  
Whey Protein ◽  
Muscle Mass ◽  
Nutritional Support ◽  
Walking Speed ◽  
Handgrip Strength ◽  
Controlled Trial ◽  
Mean Difference ◽  
Secondary Endpoints ◽  
Intensive Rehabilitation

ObjectiveWe evaluated the efficacy of muscle-targeted nutritional support on the functional outcomes of multidisciplinary intensive rehabilitation treatment (MIRT) in patients with Parkinson disease (PD) or parkinsonism.MethodsWe conducted a pragmatic, bicentric, randomized (1:1), assessor-blind controlled trial (Protein, Leucine and Vitamin D Enhancing Rehabilitation [PRO-LEADER]; April 2017 to January 2018) in cognitively intact patients with PD or parkinsonism and undergoing a 30-day MIRT. Patients (n = 150) received a standard hospital diet with or without a whey protein–based nutritional supplement enriched with leucine and vitamin D twice daily. The primary efficacy endpoint was the increase in the distance walked during a 6-minute walking test (6MWT). Secondary endpoints were changes in 4-meter walking speed, Timed Up and Go test (TUG), Berg balance scale, handgrip strength, Self-assessment Parkinson's Disease Disability Scale, body weight, and skeletal muscle mass (SMM).ResultsNutritional support resulted in greater increase in the distance walked during 6MWT (mean 69.6 meters [95% confidence interval (CI) 60.7–78.6]) than no support (51.8 meters [95% CI 37.0–66.7]): center-adjusted mean difference, 18.1 meters (95% CI 0.9–35.3) (p = 0.039). Further adjustment for changes in dopaminergic therapy and SMM yielded consistent results: mean difference, 18.0 meters (95% CI 0.7–35.2) (p = 0.043). A meaningful effect was also found for the following secondary endpoints: 4-meter walking speed (p = 0.032), TUG (p = 0.046), SMM, and SMM index (p = 0.029). Six patients discontinued the nutritional therapy due to mild side effects.ConclusionThe consumption of a whey protein–based nutritional formula enriched with leucine and vitamin D with MIRT improved lower extremity function and preserved muscle mass in patients with PD or parkinsonism.Clinicaltrials.gov identifierNCT03124277.Classification of evidenceThis study provides Class I evidence that for patients with parkinsonism undergoing intensive rehabilitation, a whey protein–based nutritional formula enriched with leucine and vitamin D increased distance walked on the 6MWT.

scholarly journals Pathogen- and antibiotic-specific effects of prednisone in community-acquired pneumonia

2016 ◽  
Vol 48 (4) ◽  
pp. 1150-1159 ◽  
Author(s):  
Sebastian A. Wirz ◽  
Claudine A. Blum ◽  
Philipp Schuetz ◽  
Werner C. Albrich ◽  
Christoph Noppen ◽  
...  
Keyword(s):  
Multiple Testing ◽  
Pneumococcal Pneumonia ◽  
Controlled Trial ◽  
Community Acquired Pneumonia ◽  
Double Blind ◽  
Interaction Terms ◽  
Specific Effects ◽  
Hospitalised Patients ◽  
Secondary Endpoints ◽  
Study Population

In a double-blind, randomised, placebo-controlled trial of hospitalised patients with community-acquired pneumonia (CAP), we demonstrated shorter time to clinical stability (TTCS) with adjunct corticosteroid therapy compared with placebo.We did a pre-planned, exploratory analysis of any association between microbiological diagnosis, antibiotic treatment and procalcitonin level and effect of prednisone on TTCS, mortality, and CAP complications (n=726 participants, enrolled between December 2009 and May 2014). Multiplex viral real time PCR was systematically performed in nasopharyngeal swabs beginning November 2011 (n=489). Other investigations and treatments were at the discretion of the physician. Effect modification was tested with inclusion of interaction terms in the statistical models.Reduced TTCS with prednisone was seen in all microbiological, antibiotic, procalcitonin and afebrile patient subgroups. We found evidence for a different prednisone response in patients with pneumococcal pneumonia in whom intravenous antibiotic duration was not shorter (interaction p=0.01) with prednisone, as was observed in the remaining study population. In patients without macrolide treatment, rehospitalisations were not lower with prednisone (interaction p=0.04). After adjustment for multiple testing, these subgroup effects were no longer significant.Prednisone was associated with shorter TTCS independent of CAP aetiology. In pneumococcal pneumonia, prednisone effects on secondary endpoints may be less favourable.

The Link Between Verbal Short-Term Memory and Anomia Treatment Gains

2019 ◽  
Vol 28 (3) ◽  
pp. 1039-1052
Author(s):  
Reva M. Zimmerman ◽  
JoAnn P. Silkes ◽  
Diane L. Kendall ◽  
Irene Minkina
Keyword(s):  
Short Term Memory ◽  
Controlled Trial ◽  
Treatment Success ◽  
Linear Regression Models ◽  
Language Performance ◽  
Short Term ◽  
Term Memory ◽  
Treatment Gains ◽  
Post Hoc

Purpose A significant relationship between verbal short-term memory (STM) and language performance in people with aphasia has been found across studies. However, very few studies have examined the predictive value of verbal STM in treatment outcomes. This study aims to determine if verbal STM can be used as a predictor of treatment success. Method Retrospective data from 25 people with aphasia in a larger randomized controlled trial of phonomotor treatment were analyzed. Digit and word spans from immediately pretreatment were run in multiple linear regression models to determine whether they predict magnitude of change from pre- to posttreatment and follow-up naming accuracy. Pretreatment, immediately posttreatment, and 3 months posttreatment digit and word span scores were compared to determine if they changed following a novel treatment approach. Results Verbal STM, as measured by digit and word spans, did not predict magnitude of change in naming accuracy from pre- to posttreatment nor from pretreatment to 3 months posttreatment. Furthermore, digit and word spans did not change from pre- to posttreatment or from pretreatment to 3 months posttreatment in the overall analysis. A post hoc analysis revealed that only the less impaired group showed significant changes in word span scores from pretreatment to 3 months posttreatment. Discussion The results suggest that digit and word spans do not predict treatment gains. In a less severe subsample of participants, digit and word span scores can change following phonomotor treatment; however, the overall results suggest that span scores may not change significantly. The implications of these findings are discussed within the broader purview of theoretical and empirical associations between aphasic language and verbal STM processing.

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