Search

Retrospective chart reviews have reported hypophosphatemia associated with elemental formula use in infants and children with systemic disease involving multiple diagnoses. The present study aims to evaluate the bioavailability of phosphorus from 2 commercial elemental formulas and to test our hypothesis of bioequivalence of the 2 products in healthy volunteers receiving gastric acid-suppressive medication. A single-center, double-blind, randomized, cross-over study was conducted in healthy volunteers with esomeprazole-induced hypochlorhydria. After a standardized low phosphorus meal followed by overnight fasting, subjects consumed 1 gram of phosphorus in a single oral dose of 1217 kcal of Product A (Neocate) or Product B (Elecare). The alternate product was given following a 1-week washout period. Blood and urine were collected at baseline and different time-points for up to 6 hours after product consumption. Area-under-the-curve (AUC) and peak values (C-peak) for serum phosphate and calcium and urinary creatinine-corrected phosphate and calcium were assessed for bioequivalence of Products A and B. Results show that the geometric mean ra tio (GMR) and 90% CI for serum phosphate were 1.041 (0.998-1.086) and 1.020 (0.963-1.080) for AUC(0-360) and C-peak, respectively, meeting the predetermined criteria for bioequivalence. Urinary creatinine-corrected phosphate followed a similar pattern after intake of Product A and B, but did not reach bioequivalence criteria (GMR: AUC(70-370) = 1.105 (0.918-1.330); C-peak = 1.182 (1.040-1.343)). Serum calcium concentrations (GMR: AUC(0-360) = 1.002 (0.9961.009); C-peak = 0.991 (0.983-0.999)) and urinary creatinine-corrected calcium excretion (GMR: AUC(70-370) = 1.117 (1.023-1.219); C-peak = 1.157 (1.073-1.247)) demonstrated bioequivalence of the products. In conclusion, both elemental infant formulas showed equivalent serum phosphorus and calcium bioavailability in healthy volunteers even if combined with treatment with acid-suppressive medication. (c) 2020 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/ )

Background The possible effect of transcranial direct current stimulation (tDCS) in improving cognitive function is clear from studies involving pre-dementia stage mild cognitive impairment (MCI). However, the application of tDCS in actual clinical practice entails repeated hospital visits almost every day for treatment. The objective of this study is to confirm the possibility of self-application of tDCS at home by elderly patients with declined cognitive function and the significant clinical effect of tDCS administered at home. Methods/design This study will be conducted in 20 elderly people aged 60 to 80 years with complaints of subjective memory impairment while maintaining general functions with limited activities of daily living. This study involves a cross-over design that will include 2-week active or sham stimulation of both dorsolateral prefrontal cortexes (left, anode; right, cathode) randomly with a 2-week wash-out phase. Changes in cognitive function will be evaluated using visual recognition tasks and neuropsychological tests. In this study, tDCS will be carried out by each patient at his/her home and its safety and suitability will be evaluated. Discussion In this study, patients will apply a portable tDCS, developed for home use, for more than 2 weeks. Such studies can contribute to the use of tDCS as a realistic therapy. In addition, the utility of home-based tDCS will be confirmed by application of tDCS at home by the elderly with declined cognitive function. Furthermore, confirmation of tDCS as a significant therapeutic method can facilitate treatment of Alzheimer’s dementia at an early stage, including MCI. Trial registration Clinical Research Information Service (CRIS), KCT0002721. Registered on 9 March 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3360-1) contains supplementary material, which is available to authorized users.

Background: Cleansing the teeth with a toothbrush and paste is an indubitable mechanical plaque control method practiced by almost everyone. Eliminating dental plaque is an essential, fundamental and mandatory step to prevent the occurrence of periodontal diseases that are rife globally. The aim of the present study is to compare the antiplaque effectiveness of a prepared herbal and commercially available dentifrice. Materials and Methods: Thirty healthy individuals within the age group of 18–25 years were recruited to participate in the study. After achieving induced gingivitis and measuring plaque levels using Turesky modification of the Quigley Hein Plaque index in all the subjects, they were randomly divided into test arms A and B. Commercial dentifrice was distributed to one group, whereas the other group received prepared herbal dentifrice. Supervised brushing was carried out for 5 min, and plaque amounts after brushing were noted. After a washout period of 1 week, the same steps were repeated as per the cross-over study protocol. Unpaired t-test and paired t-tests were employed with P < 0.05. Results: Both the toothpastes show the difference in plaque scores immediately after brushing when compared to baseline and was statistically significant (P = 0.001). The mean plaque scores of commercial dentifrice (1.93 ± 1.52) were less than that of the prepared herbal dentifrice (2.35 ± 1.39) after brushing. Conclusion: The prepared herbal dentifrice had good antiplaque action. However, the plaque inhibitory action of self-prepared herbal toothpaste was marginally less when compared to commercial dentifrice.

Objectives: The tolerability and efficacy of lanthanum carbonate has not been studied in the Indian population. This study was, therefore, undertaken to compare the efficacy and tolerability of lanthanum carbonate with calcium acetate in patients with stage 4 chronic kidney disease. Design: A randomized open label two group cross-over study. Materials and Methods: Following Institutional Ethics Committee approval and valid consent, patients with stage 4 chronic kidney disease were randomized to receive either lanthanum carbonate 500mg thrice daily or calcium acetate 667 mg thrice daily for 4 weeks. After a 4-week washout period, the patients were crossed over for another 4 weeks. Serum phosphorous, serum calcium, serum alkaline phosphatase, and serum creatinine were estimated at fixed intervals. Results: Twenty-six patients were enrolled in the study. The mean serum phosphorous concentrations showed a declining trend with lanthanum carbonate (from pre-drug levels of 7.88 ± 1.52 mg/dL-7.14 ± 1.51 mg/dL) and calcium acetate (from pre-drug levels of 7.54 ± 1.39 mg/dL-6.51 ± 1.38 mg/dL). A statistically significant difference was seen when comparing the change in serum calcium produced by these drugs (P < 0.05). Serum calcium levels increased with calcium acetate (from pre-drug levels of 7.01 ± 1.07-7.46 ± 0.74 mg dL), while it decreased with lanthanum carbonate (from pre-drug levels 7.43 ± 0.77-7.14 ± 0.72 mg/dL). The incidence of adverse effects was greater with lanthanum carbonate. Conclusion: Lanthanum carbonate and calcium acetate are equally effective phosphate binders with trends obvious in the first 4 weeks of therapy. The decrease in serum calcium levels with lanthanum carbonate when compared to the increase in serum calcium levels due to calcium acetate is statistically significant. The drawback of lanthanum carbonate is its high cost and relatively higher incidence of adverse events during treatment.

Made available in DSpace on 2015-08-06T16:14:45Z (GMT). No. of bitstreams: 0 Previous issue date: 2014-10-01. Added 1 bitstream(s) on 2015-08-06T16:44:25Z : No. of bitstreams: 1 S0103-64402014000500391.pdf: 292711 bytes, checksum: 0056d15f065f1ed9a650f6f72e7427b2 (MD5) Made available in DSpace on 2015-08-06T16:14:45Z (GMT). No. of bitstreams: 0 Previous issue date: 2014-10-01. Added 1 bitstream(s) on 2015-08-06T16:44:25Z : No. of bitstreams: 1 S0103-64402014000500391.pdf: 292711 bytes, checksum: 0056d15f065f1ed9a650f6f72e7427b2 (MD5) Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) O objetivo deste estudo foi avaliar o efeito da utilização de um adesivo para prótese na satisfação e nos parâmetros cinesiográficos em usuários de próteses totais por meio de um estudo cross-over. Cinquenta pacientes desdentados receberam novas próteses totais bimaxilares. Após um período de adaptação, os participantes incluídos no estudo receberam uma sequência de tratamento: Protocolo 1- utilização do adesivo para prótese durante os primeiros 15 dias, seguida por não utilização do adesivo os próximos 15 dias; Protocolo 2- não utilização do adesivo durante os primeiros 15 dias; seguida por utilização do adesivo nos próximos 15 dias. Os resultados foram avaliados após 15 dias de cada sequência de tratamento. Um questionário para avaliar a satisfação dos pacientes e um cinesiógrafo para registrar os movimentos mandibulares e o padrão de movimento da prótese total maxilar durante mastigação foram utilizados. O teste de Wilcoxon (α=0,05) e o t-test de Student para amostras pareadas (α=0,05) foram utilizados para comparar o grau de satisfação dos pacientes e os dados cinesiográficos, respectivamente. O adesivo para prótese melhorou significativamente a satisfação geral dos participantes (p

To investigate the effects of a hand-training programme on grip, pinch and wrist force, manual dexterity and activities of daily living, in adults with myotonic dystrophy type 1 (DM1).In this randomised controlled trial with a crossover design, 35 adults with DM1 were, after stratification for grip force, assigned by lot to two groups. Group A started with 12 weeks of hand training, while group B had no intervention. After a wash-out period of 12 weeks, where none received training, the order was reversed. The Grippit® was used as primary outcome measure and the hand-held Microfet2™ myometer, the Purdue Pegboard, the Canadian Occupational Performance Measure (COPM) and the Assessment of Motor and Process Skills (AMPS) were secondary outcome measures. Assessments were performed before and after training and control periods, i.e. four times altogether.Ten persons dropped out and 13 had acceptable adherence. Intention-to-treat analyses revealed significant intervention effects for isometric wrist flexor force (p = 0.048), and for COPM performance (p = 0.047) and satisfaction (p = 0.027). On an individual level, improvements were in general showed after a training period.The hand-training programme had positive effects on wrist flexor force and self-perception of occupational performance, and of satisfaction with performance. No evident detrimental effects were shown.Myotonic dystrophy type 1 (DM1) is a slowly progressive neuromuscular disease characterised by myotonia and muscle weakness and wasting. People with DM1 are often concerned about their ability to carry out ADL and to participate in, e.g. work, sports and hobbies when they gradually become weaker. This pilot study showed that a hand-training programme improved wrist flexor force and self-perception and satisfaction of occupational performance. Resistance training of hand muscles with a silicon-based putty can be a therapy option for people with DM1 in clinical practise.