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The pharmacokinetic properties of three formulations of vitacoxib were investigated in horses. To describe plasma concentrations and characterize the pharmacokinetics, 6 healthy adult Chinese Mongolian horses were administered a single dose of 0.1 mg/kg bodyweight intravenous (i.v.), oral paste, or oral tablet vitacoxib in a 3-way, randomized, parallel design. Blood samples were collected prior to and at various times up to 72 hr postadministration. Plasma vitacoxib concentrations were quantified using UPLC-MS/MS, and pharmacokinetic parameters were calculated using noncompartmental analysis. No complications resulting from the vitacoxib administration were noted on subsequent administrations, and all procedures were tolerated well by the horses throughout the study. The elimination half-life (T1/2λz ) was 4.24 ± 1.98 hr (i.v.), 8.77 ± 0.91 hr (oral paste), and 8.12 ± 4.24 hr (oral tablet), respectively. Maximum plasma concentration (Cmax ) was 28.61 ± 9.29 ng/ml (oral paste) and 19.64 ± 9.26 ng/ml (oral tablet), respectively. Area under the concentration-versus-time curve (AUClast ) was 336 ± 229 ng hr/ml (i.v.), 221 ± 94 ng hr/ml (oral paste), and 203 ± 139 ng hr/ml, respectively. The results showed statistically significant differences between the 2 oral vitacoxib groups in Tmax value. T1/2λz (hr), AUClast (ng hr/ml), and MRT (hr) were significantly different between i.v. and oral groups. The longer half-life observed following oral administration was consistent with the flip-flop phenomenon.

Experiences of racism contribute to the mental health burden of Black individuals in the United States, and during emerging adulthood, these impacts may be especially intensified. The majority of research on racism captures individual-level experiences and utilizes frequency-based measures. This mixed methods investigation examines convergence and divergence between a measure of recent experiences of racism and a measure of worst experiences of racism at multiple levels (individual, cultural, institutional). A sample of 186 Black college-attending emerging adults (Mage = 19.36; 62.7% female) reported their recent experiences using a quantitative measure and their worst experiences via a qualitative open-ended response, which were analyzed via convergent parallel design. The results indicated that a majority of reported worst experiences had an institutional-level component. Although the quantitative measure of recent experiences corresponded with reports of individual-level worst experiences, the institutional- and cultural-level worst experiences were rarely fully captured by the recent experiences measure. Implications for the mental health of Black college-attending emerging adults are discussed. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Background Tranexamic acid (TXA), an antifibrinolytic drug, is usually administered intravenously; however, intra-articular administration has recently been proven to be as effective as intravenous administration. Limited information regarding the pharmacokinetics (PK) of TXA after intra-articular administration has been reported. Aims The aim of this study was to develop a population PK model of TXA administered as a single intra-articular dose and as two intravenous doses, and to study the sources of interindividual variability (IIV) in the PK processes of TXA. The developed model was used to simulate PK profiles of TXA at different dosage regimens and in patients with renal impairment. Methods Patients who underwent primary unilateral total knee replacement (TKR) received 1 g/10 mL (concentration of 100 mg/mL) of TXA applied directly to the surgical field before wound closure, or 2 g (two doses of 1 g) of intravenous TXA. A population PK model was developed using a nonlinear mixed-effects approach and sources of IIV, such as sex, age, body weight, height, body mass index (BMI), preoperative haemoglobin, preoperative haematocrit, and creatinine clearance. Results Twenty-four patients were included, 12 in each group. Twenty patients were female, mean age (standard deviation) was 73.7 years (5.6). The disposition of TXA was best described as a two-compartment model with clearance dependent on creatinine clearance. Bootstrap results indicated that the model was stable and robust. The estimated bioavailability for intra-articular administration was 81%. Simulations indicated that 100% of patients would have plasma concentrations associated with partial fibrinolysis at 8 h post-administration with the dosages and routes of administration used in the present study. Intra-articular administration would produce complete inhibition of fibrinolysis in only 12% of patients compared with 72.5% with intravenous administration. No adverse events were reported. Conclusions This population PK model demonstrated that a single dose of high-concentration, low-volume intra-articular TXA can achieve antifibrinolytic plasma concentrations of the drug for 8 h, providing both local and systemic effects in patients undergoing TKR. TXA administration to the surgical field could be an alternative to the intravenous; route for patients undergoing TKR; however, clinical studies are needed to assess the toxic local effects of TXA.

Objectives: Our study was planned to investigate the effect of Clinical Pilates exercises in children and adolescents with Juvenile Idiopathic Arthritis (JIA). Methods: Fifteen participants diagnosed with JIA (mean age = 12.00 ±3.40 years) were included. The participants were randomly divided into two groups as Clinical Pilates exercise group (n = 6), and home exercise group (n = 9). Clinical Juvenile Arthritis Disease Activity Score (cJADAS), Wong Baker Face Scale, Brunininks-Oseretsky Test of Motor Proficiency Second Edition Short Form (BOT-2 SF), Juvenile Arthritis Biopsychosocial Scale (JAB-Q scale), and Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module was used for evaluation before and after treatment. Exercises were performed by both groups 3 times a week for 6 weeks. Results: In the analysis of the before and after treatment results, a significant difference was observed in cJADAS (p = .027), manual dexterity (p = .020), running speed and agility (p = .027) subtests of BOT-2 SF, total score of BOT-2 SF (p = .042) and daily activity (p = .043) subtests of PedsQL child form in the Clinical Pilates exercise group. While there was statistically significant differences in manual dexterity (p = .024), running speed and agility (p = .041) and upper limb coordination (p = .034) subtests of BOT-2, and parent form of JAB-Q (p = .041) in home exercise group. When the delta values were compared, the difference was significant in the upper limb coordination subtest of BOT-2 SF (p = .008), and daily activities subtest of PedsQL child form (p = .003) in favour of the Clinical Pilates exercise group. Conclusions: Clinical Pilates exercises are a safe and useful method for children/adolescent with JIA. RESUMEN Objetivos: Nuestro estudio fue planeado para investigar el efecto de los ejercicios de pilates clínico en niños y adolescentes con artritis idiopática juvenil (AIJ). Métodos: Se incluyeron 15 participantes diagnosticados con AIJ (edad media = 12,00 ±3,40 años). Los participantes fueron divididos al azar en 2 grupos como grupo de ejercicio de pilates clínico (n = 6) y grupo de ejercicio en el hogar (n = 9). Para la evaluación antes y después del tratamiento se utilizó la puntuación de actividad de la artritis juvenil clínica (cJADAS), la escala Wong-Baker FACES®, la prueba Brunininks-Oseretsky de proficiencia motora en su segunda edición (BOT-2 SF), la escala biopsicosocial de artritis juvenil (escala JAB-Q) y el inventario de calidad de vida pediátrica (módulo PedsQL® 3.0) de artritis. Se realizaron ejercicios a ambos grupos, 3 veces por semana, durante 6 semanas. Resultados: Cuando se analizaron los resultados, antes y después del tratamiento, se observó una diferencia significativa en las subpruebas de cJADAS (p = 0,027), destreza manual (p = 0,020), velocidad y agilidad en la carrera (p = 0,027) de BOT-2 SF, puntuación total de BOT-2 SF (p = 0,042) y actividad diaria (p = 0, 043) subpruebas de PedsQL® forma infantil en el grupo de ejercicio de pilates clínico, mientras que hubo una diferencia estadísticamente significativa en la destreza manual (p = 0,024), la velocidad y la agilidad en la carrera (p = 0,041) y la coordinación de las extremidades superiores (p = 0,034) subpruebas de BOT-2 SF y forma parental de JAB-Q (p = 0,041) en el grupo de ejercicio en casa. Cuando se compararon los valores delta, la diferencia fue significativa en la subprueba de coordinación de los miembros superiores de BOT-2 SF (p = 0,008) y en la subprueba de actividades diarias de la forma infantil de PedsQL® (p = 0,003) a favor del grupo de ejercicio de pilates clínico. Conclusiones: Los ejercicios de pilates clínico son un método seguro y útil para niños/adolescentes con AIJ.

Trauma is prevalent among HIV-infected populations and associated with negative HIV care outcomes. While several agencies have called for integrating trauma-informed care into HIV services, uptake has been limited and effective methods have not been delineated. To develop comprehensive trauma screening strategies tailored to a large, urban HIV care center, we aimed to first understand provider and staff perceptions of the center's current level of trauma screening and barriers and facilitators to universal screening uptake. We used a mixed-methods convergent parallel design: quantitative assessments with 31 providers and staff and in-depth interviews with 19 providers and staff. Quantitative assessments highlighted center strengths (i.e. assessing effects of trauma, explaining care plans to patients, providing opportunities for questions) and gaps (i.e. asking about head injuries, emotional safety). Qualitative interviews suggested center screening practices were highly-variable and limited, identified gaps in interdepartmental communication regarding results of trauma screening that led to repeated screenings and potential patient re-traumatization, screening barriers (i.e. limited time, competing clinical priorities) and facilitators (i.e. provider-driven, standardized, non-disruptive screening with clear cut-points and follow-up steps). This study provides tangible strategies for the center to begin integrating universal trauma screening, many of which could be adapted by other U.S. HIV clinics.

Introduction Cold snare polypectomy (CSP) is safe and effective for the removal of small adenomas (≤10 mm); however, reported incomplete resection rates (IRRs) vary. The optimal CSP technique, where a wide margin of normal tissue is resected around the target lesion, and snare design have both been hypothesized to reduce the IRR after CSP. We sought to investigate the efficacy of a thin-wire versus thick-wire diameter snare on IRR, using the standardized CSP technique. Methods This was an international multicenter parallel design randomized trial with 17 endoscopists of varying experience (NCT02581254). Patients were randomized in a 1:1 ratio to the use of a thin-wire (0.30 mm) or thick-wire (0.47 mm) snare for CSP of small (≤10 mm) colorectal polyps. The primary end point was the IRR as determined by the histologic assessment of the defect margin after polypectomy. Results Over 52 months to January 2020, 1,393 patients were eligible. A total of 660 patients with polyps (57.4% male) were randomized to a thin-wire (n = 339) or thick-wire (n = 321) snare. The overall IRR of the cohort was 1.5%. There was no significant difference in the IRR between the thin- and thick-wire arms; relative risk-0.41, 95% CI (0.11-1.56), P = 0.21. No significant differences were observed in the rate of adverse events. Discussion In this multicenter randomized trial, CSP is safe and effective with very low rates of incomplete resection independent of the diameter of the snare wire used. This suggests that the optimal operator technique is more important than the snare design alone in minimizing residual adenoma after CSP.

Objective To evaluate the feasibility and impact of telelactation via personal electronic devices on breastfeeding duration and exclusivity among rural women. Methods The Tele-MILC trial, a pragmatic, parallel design trial, recruited 203 women during their postpartum hospitalization in a critical access hospital in Pennsylvania and randomized them to receive telelactation (n=102) or usual care (n=101). We used intent-to-treat (ITT) and instrumental variable (IV) approaches to analyze study data for the 187 participants who completed follow-up. The primary outcomes were any breastfeeding and exclusive breastfeeding at 12 weeks postpartum. Results Among participants in the telelactation arm, 50% (47/94) reported participating in video calls. At 12 weeks, 71% of participants in the telelactation arm vs. 68% of control participants were breastfeeding in the ITT model (3% difference, p=0.73), whereas 73% of participants in the telelactation arm vs. 68% of control participants were breastfeeding in the IV model (5% difference, p=0.74). Among participants who were still breastfeeding at 12 weeks, 51% participants in the telelactation arm were breastfeeding exclusively vs. 46% of control participants in the ITT model (5% difference, p=0.47), whereas 56% of participants in the telelactation arm were breastfeeding exclusively vs. 45% of control participants in the IV model (11% difference, p=0.48). In all models, participants in the telelactation arm were breastfeeding at higher rates; however, differences were not statistically significant. Conclusions This trial demonstrated that telelactation can be implemented with a rural underserved population. Though this trial was not powered to detect differences in breastfeeding duration and exclusivity, and none were observed, telelactation remains a promising approach for further investigation. ClinicalTrials.gov Identifier: NCT02870413

Introduction: The ageing population represents significant nutritional challenges; where vulnerabilities to obesity, malnutrition and age-related diseases are exacerbated by impaired dental and oral health status. As natural teeth are lost, many older adults choose softer, more manageable foods lacking in essential micronutrients and fibre, yet replacing missing natural teeth alone does not positively influence diet. This systematic review synthesised literature relating to oral rehabilitation coupled with dietary intervention in adults. The primary outcome was diet/nutritional status; secondary outcomes pertained to health status (e.g. body mass index (BMI)), oral health and dietary intervention characteristics including: theoretical basis, intervention delivery and behaviour change techniques (BCTs). Methods: MEDLINE, Web of Science, PubMed and CENTRAL were searched systemically, alongside hand-searching reference lists and contacting authors. Studies were eligible if they replaced missing teeth in edentate/partially dentate adults and included a dietary intervention, reporting diet/nutritional outcomes. Results: Nine studies were included. Study designs were heterogeneous (three RCTs; five single-arm; one parallel-groups) involving 526 participants. Narrative synthesis identified improvements in all studies for least one aspect of patients' oral health (i.e. chewing) alongside at least one positive diet/nutrition outcome post-intervention (including some plasma biomarkers). Dietary outcomes included increased fruit/vegetable (F/V), protein and fibre intake. F/V results were pooled for three studies using meta-analysis techniques resulting in a standardised mean difference (SMD) of 0.29 [CI -0.54, 1.12], p = 0.49, but with marked heterogeneity (p = 0.0007). Five of nine studies reported BMI at baseline (three reported average BMI values of 22.5-22.9 kg/m2; two reported average BMI values of 26.8-27.4 kg/m2). Despite positive dietary changes in four of these studies, BMI did not change significantly post-intervention (reported in two studies with overweight participants only). Few interventions were theory- based with intervention components and delivery poorly described. Identifiable BCTs ranged from one to nine; five interventions tailored dietary information, and the most common BCT was giving information on the health consequences of diet. Conclusion: Narrative synthesis indicated support for dietary intervention coupled with oral rehabilitation on improving intake. Impact on BMI from dietary intervention was unclear from the limited results reported. Meta-analysis of F/V intake was only possible with three studies, highlighting limitations. Further research with large-scale, appropriately designed and described trial methodologies is needed.

Background and purpose Customized mouth-opening-tongue-depressing-stents (MOTDs) may reduce toxicity in patients with head and neck cancers (HNC) receiving radiotherapy (RT). However, making MOTDs requires substantial resources, which limits their utilization. Previously, we described a workflow for fabricating customized 3D-printed MOTDs. This study reports the results of a prospective trial testing the non-inferiority of 3D-printed to standard and commercially-available (TruGuard) MOTDs as measured by patient reported outcomes (PROs). Materials and methods PROs were collected at 3 time points: (t1) simulation, (t2) prior to RT, (t3) between fractions 15–25 of RT. Study participants received a 3D-printed MOTDs (t1, t2, t3), a wax-pattern (t1), an acrylic-MOTDs (t2, t3) and an optional TruGuard (t1, t2, t3). Patients inserted the stents for 5–10 min and completed a PRO-questionnaire covering ease-of-insertion and removal, gagging, jaw-pain, roughness and stability. Inter-incisal opening and tongue-displacement were recorded. With 39 patients, we estimated 90% power to detect a non-inferiority margin of 2 at a significance level of 0.025. Matched pairs and t-test were used for statistics. Results 41 patients were evaluable. The 3D-printed MOTDs achieved a significantly better overall PRO score compared to the wax-stent (p = 0.0007) and standard-stent (p = 0.0002), but was not significantly different from the TruGuard (p = 0.41). There was no difference between 3D-printed and standard MOTDs in terms of inter-incisal opening (p = 0.4) and position reproducibility (p = 0.98). The average 3D-printed MOTDs turn-around time was 8 vs 48 h for the standard-stent. Conclusions 3D-printed stents demonstrated non-inferior PROs compared to TruGuard and standard-stents. Our 3D-printing process may expand utilization of MOTDs.

(1) Aim: the aim of this secondary analysis was to report the variability in response to n-3 long chain polyunsaturated fatty acids (LCPUFA) supplementation in erythrocytes, plasma and whole blood of a previously published dose response study. (2) Methods: a randomized, double-blind, placebo-controlled trial of parallel design was conducted, whereby pre-menopausal women were randomly assigned to consume 0, 0.35, 0.7 or 1 g/day of supplemental eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA). Fasted blood samples were taken at baseline and after eight weeks intervention. Erythrocyte, plasma and whole blood fatty acids were extracted using the method of Lepage and Roy and analysed using gas chromatography. (3) Results: There were significant increases in EPA plus DHA levels in the 0.7 g and 1 g dose groups, with the highest increase with the 1 g dose notably: in erythrocytes (from 5.69% to 7.59%), plasma (from 2.94% to 5.48%) and in whole blood (from 3.81% to 6.03%). There was high variability in response to the supplement in erythrocytes, plasma and whole blood across the different doses. (4) Conclusion: there is high individual variability in n-3 LCPUFA levels in response to n-3 LCPUFA supplementation, which should be taken into account in clinical trials using n-3 LCPUFA supplements.

Purpose: Cleft is one of the most common anomalies affecting 1 in every 500-750 newborns. Depending on the type of cleft and its size, these children may experience feeding problems immediately after birth. Cleft has consequences for the child, as well as for the parents. The aim of this study was to gain a better understanding on the factors influencing the psychological well-being of the parents. Also, the experiences of parents of children with feeding problems and the received medical guidance were studied. Design and methods: A mixed method convergent parallel design was used. In the quantitative study, a cross-sectional design was applied, in which parents completed 3 validated questionnaires about their psychological well-being. For the qualitative research a phenomenological design was used to conduct semi-structured interviews. Ninety parents agreed to join the quantitative study, of which 15 participated in the qualitative study as well. Results: The timing of the diagnosis revealed a significant difference in the depression and stress scores, while the number of children was significant for depression, anxiety, and stress. Other parental- and child-related factors did not cause a significant difference in psychological well-being. Different opinions about medical guidance and feeding problems came up during the interviews. Conclusion: With these results, a recommendation toward future medical guidance can be given. The number of children and the timing of diagnosis were found to be significant variables determining the psychological wellbeing of the parents. All parents agreed on the need for a point of contact and an umbrella framework for a clearer guidance. Moreover, caregivers should have more knowledge about cleft and associated feeding problems. (c) 2019 Elsevier Inc. All rights reserved.

Pain management is one of the essentials of emergency care. Renal colic secondary to urinary stone disease forms one of the most intense pain types. The present study aimed to compare the effect of intravenous ibuprofen to paracetamol in ceasing renal colic. This randomised double-blind study was composed of two intervention arms, intravenous paracetamol and intravenous ibuprofen. Study subjects were randomised to receive a single dose of either paracetamol, 1 g in 100 ml normal saline, or ibuprofen (800 mg in 100 ml normal saline) in a blinded fashion. Subjects reported pain intensity on a visual analogue scale with lines intersection multiples of ten just before the drug administration, 15 and 30 min after the study drug administration. Two hundred patients were randomised to either of two study arms: however, 97 patients in ibuprofen group and 99 patients in paracetamol groups were included into 30 minute analysis. Differences of pain improvements between two groups was 9.5 (5.4–13.7) at 15 min (p = 0.000) and 17.1 (11.9–22.5) at 30 min, those both favouring ibuprofen over paracetamol (p = 0.000). Although ten (10.1%) patients in paracetamol group needed rescue drug, there were only two (2%) patients in ibuprofen group (difference: 8%; 95% CI 0.7–16%, p = 0.02). Intravenous 800 mg ibuprofen is more effective than IV paracetamol in ceasing renal colic at 30 min. © 2017, Springer-Verlag GmbH Germany.

The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension.Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ≥ 90 mm Hg in part 1 were enrolled to the up-titration extension study with lercanidipine 20 mg/valsartan 160 mg (L20/V160) (part 2).Of 772 patients screened, 497 were randomized to 3 groups (166 in the L10 group, 168 in the L10/V80 group, and 163 in the L10/V160 group). Mean (SD) age was 55 (9.9) years, and male patients comprised 69%. The mean (SD) baseline systolic blood pressure (SBP)/DBP were 148.4 (15.1)/94.3 (9.5) mm Hg. No significant differences were found between groups in baseline characteristics except the percentages of previous history of antihypertensive medication. The primary end points, the changes of mean (SD) DBP at week 8 from the baseline were -2.0 (8.8) mm Hg in the L10 group, -6.7 (8.5) mm Hg in L10/V80 group, and -8.1 (8.4) mm Hg in L10/V160 group. The adjusted mean difference between the combination groups and the L10 monotherapy group was -4.6 mm Hg (95% CI, -6.5 to -2.6; P0.001) in the L10/V80 group and -5.9 mm Hg (95% CI, -7.9 to -4.0, P0.001) in the L10/V160 group, which had significantly greater efficacy in BP lowering. A total of 74 patients were enrolled in the part 2 extension study. Changes of mean (SD) DBP and SBP from week 8 to week 12 and week 16 were -5.6 (7.9)/-8.0 (12.0) mm Hg and -5.5 (7.0)/-8.5 (11.3) mm Hg, respectively. For evaluation of the safety profile, the frequencies of adverse events between groups were also not significantly different. The most frequently reported adverse events were headache (6 cases, 20.7%) in the L10 group, dizziness (8 cases, 16.3%) in L10/V80 group, and nasopharyngitis (3 cases, 9.4%) in L10/V160 group, and the incidences of adverse events were not different between groups.Treatment of L10/V80 or L10/V160 combination therapy resulted in significantly greater BP lowering compared with L10 monotherapy. Moreover, the L20/V160 high dose combination had additional BP lowering effect compared with nonresponders with the L10/V160 combination. ClinicalTrials.gov: NCT01928628.

Background/aim Feedback on clinical reasoning skills during fieldwork education is regarded as vital in occupational therapy students' professional development. The nature of supervisors' feedback however, could be confirmative and/or corrective and corrective feedback could be with or without suggestions on how to improve. The aim of the study was to evaluate the impact of supervisors' feedback on final-year occupational therapy students' clinical reasoning skills through comparing the nature of feedback with the students' subsequent clinical reasoning ability. Method A mixed-method approach with a convergent parallel design was used combining the collection and analysis of qualitative and quantitative data. From focus groups and interviews with students, data were collected and analysed qualitatively to determine how the students experienced the feedback they received from their supervisors. By quantitatively comparing the final practical exam grades with the nature of the feedback, their fieldwork End-of-Term grades and average academic performance it became possible to merge the results for comparison and interpretation. Results Students' clinical reasoning skills seem to be improved through corrective feedback if accompanied by suggestions on how to improve, irrespective of their average academic performance. Supervisors were inclined to underrate high performing students and overrate lower performing students. Conclusions Students who obtained higher grades in the final practical examinations received more corrective feedback with suggestions on how to improve from their supervisors. Confirmative feedback alone may not be sufficient for improving the clinical reasoning skills of students.

Background Problem gambling-specific cognitive therapy (CT) and behavioural (exposure-based) therapy (ET) are two core cognitive-behavioural techniques to treating the disorder, but no studies have directly compared them using a randomised trial. Aims To evaluate differential efficacy of CT and ET for adult problem gamblers at a South Australian gambling therapy service. Methods Two-group randomised, parallel design. Primary outcome was rated by participants using the Victorian Gambling Screen (VGS) at baseline, treatment-end, 1, 3, and 6 month follow-up. Findings Of eighty-seven participants who were randomised and started intervention (CT = 44; ET = 43), 51 (59%) completed intervention (CT = 30; ET = 21). Both groups experienced comparable reductions (improvement) in VGS scores at 12 weeks (mean difference −0.18, 95% CI: −4.48–4.11) and 6 month follow-up (mean difference 1.47, 95% CI: −4.46–7.39). Conclusions Cognitive and exposure therapies are both viable and effective treatments for problem gambling. Large-scale trials are needed to compare them individually and combined to enhance retention rates and reduce drop-out.

A key mechanism of risk transmission between maternal risk and child outcomes are the mother’s representations. The current study examined the effects of an attachment-based, trauma-informed parenting intervention, the Mom Power (MP) program, in optimizing maternal representations of high-risk mothers utilizing a randomized, controlled trial design (NCT01554215). High-risk mothers were recruited from low-income community locations and randomized to either the MP Intervention (n = 42) or a control condition (n = 33) in a parallel design. Maternal representations were assessed before and after the intervention using the Working Model of the Child Interview. The proportion of women with balanced (secure) representations increased in the MP group but not in the control group. Parenting Reflectivity for mothers in the treatment group significantly increased, with no change in the control condition. Participation in the MP program was associated with improvements in a key indicator of the security of the parent–child relationship: mothers’ representations of their children.

Background: A 12-week, double-blind, parallel, multi-center randomized controlled trial in 316 adult patients with major depressive disorder (MDD) was conducted to evaluate the effectiveness of pharmacogenetic (PGx) testing for drug therapy guidance. Methods: Patients with a CGI-S = 4 and requiring antidepressant medication de novo or changes in their medication regime were recruited at 18 Spanish public hospitals, genotyped with a commercial PGx panel (Neuropharmagen®), and randomized to PGx-guided treatment (n = 155) or treatment as usual (TAU, control group, n = 161), using a computer-generated random list that locked or unlocked psychiatrist access to the results of the PGx panel depending on group allocation. The primary endpoint was the proportion of patients achieving a sustained response (Patient Global Impression of Improvement, PGI-I = 2) within the 12-week follow-up. Patients and interviewers collecting the PGI-I ratings were blinded to group allocation. Between-group differences were evaluated using ?2-test or t-test, as per data type. Results: Two hundred eighty patients were available for analysis at the end of the 12-week follow-up (PGx n = 136, TAU n = 144). A difference in sustained response within the study period (primary outcome) was not observed (38.5% vs 34.4%, p = 0.4735; OR = 1.19 [95%CI 0.74-1.92]), but the PGx-guided treatment group had a higher responder rate compared to TAU at 12 weeks (47.8% vs 36.1%, p = 0.0476; OR = 1.62 [95%CI 1.00-2.61]), and this difference increased after removing subjects in the PGx-guided group when clinicians explicitly reported not to follow the test recommendations (51.3% vs 36.1%, p = 0.0135; OR = 1.86 [95%CI 1.13-3.05]). Effects were more consistent in patients with 1-3 failed drug trials. In subjects reporting side effects burden at baseline, odds of achieving a better tolerability (Frequency, Intensity and Burden of Side Effects Rating Burden subscore =2) were higher in the PGx-guided group than in controls at 6 weeks and maintained at 12 weeks (68.5% vs 51.4%, p = 0.0260; OR = 2.06 [95%CI 1.09-3.89]). Conclusions: PGx-guided treatment resulted in significant improvement of MDD patient's response at 12 weeks, dependent on the number of previously failed medication trials, but not on sustained response during the study period. Burden of side effects was also significantly reduced. © 2017 The Author(s).

The aerosol generated by an ultrasonic scaler contains microorganisms that can penetrate into the body through the respiratory system of dental surgeons and patients. The aim of this pilot study is to evaluate and compare the efficacy of commercially available preprocedural mouthrinses containing 0.2% chlorhexidine gluconate, an herbal mouthwash, and water in reducing the levels of viable bacteria in aerosols.This single-center, double-masked, placebo-controlled, randomized, three-group parallel design was conducted over a period of 45 days. Twenty-four patients with chronic periodontitis were divided randomly into three groups (A, B, and C) of eight patients each to receive 0.2% chlorhexidine gluconate, herbal mouthwash, and water, respectively, as a preprocedural rinse. The aerosol produced by the ultrasonic unit was collected at patient's chest area, doctor's chest area, and assistant's chest area on blood agar plates in all three groups. The blood agar plates were incubated at 37°C for 48 hours, and the total number of colony-forming units (CFUs) was counted and statistically analyzed.The results showed that CFUs in groups A and B were significantly reduced compared with group C, P0.001 (analysis of variance). Also, CFUs in group A were significantly reduced compared with group B, P0.05 (independent t-test). The numbers of CFUs were highest at the patient's chest area and lowest at the assistant's chest area.This study suggests that a routine preprocedural mouthrinse could eliminate the majority of bacterial aerosols generated by the use of an ultrasonic unit, and that 0.2% chlorhexidine gluconate is more effective than herbal mouthwash.

Introduction : Minimal access surgery is common in all fields of medicine. We compared a new minimally invasive strabismus surgery (MISS) approach with a standard paralimbal strabismus surgery (SPSS) approach in terms of post-operative course. Materials and Methods: This parallel design study was done on 28 eyes of 14 patients, in which one eye was randomized to MISS and the other to SPSS. MISS was performed by giving two conjunctival incisions parallel to the horizontal rectus muscles; performing recession or resection below the conjunctival strip so obtained. We compared post-operative redness, congestion, chemosis, foreign body sensation (FBS), and drop intolerance (DI) on a graded scale of 0 to 3 on post-operative day 1, at 2-3 weeks, and 6 weeks. In addition, all scores were added to obtain a total inflammatory score (TIS). Statistical Analysis: Inflammatory scores were analyzed using Wilcoxon′s signed rank test. Results: On the first post-operative day, only FBS (P = 0.01) and TIS (P = 0.04) showed significant difference favoring MISS. At 2-3 weeks, redness (P = 0.04), congestion (P = 0.04), FBS (P = 0.02), and TIS (P = 0.04) were significantly less in MISS eye. At 6 weeks, only redness (P = 0.04) and TIS (P = 0.05) were significantly less. Conclusion: MISS is more comfortable in the immediate post-operative period and provides better cosmesis in the intermediate period.

Made available in DSpace on 2018-11-26T17:12:14Z (GMT). No. of bitstreams: 0 Previous issue date: 2016-12-01 Department of Prosthodontics and Periodontics, Division of Periodontics, Piracicaba Dental School, State University of Campinas-UNICAMP The objective of this study is to clinically evaluate the outcomes following treatment of single gingival recessions with either coronally advanced flap technique (CAF) alone or combined with a porcine collagen matrix graft (CM). This is a randomized parallel design clinical trial, including forty patients with single Miller Class I or II gingival recession, with a depth ae 2 mm and located at upper canines or premolars. The patients were randomly assigned to receive either CAF or CAF + CM. The primary outcome variable was gingival recession reduction (Rec Red). Baseline recession depth was 3.14 +/- A 0.51 mm for CAF group and 3.16 +/- A 0.65 mm for CAF + CM group (p > 0.05). Both groups showed significant Rec Red (p < 0.05), up to 6 months. Rec Red for CAF + CM was 2.41 +/- A 0.73 mm and was 2.25 +/- A 0.50 mm for CAF alone (p > 0.05). Root coverage was 77.2 % in the CAF + CM group and 72.1 % in the CAF group (p > 0.05). Complete root coverage (CRC) was found in 40 % of the cases in the CAF + CM group and in 35 % of the sites treated with CAF. Keratinized tissue thickness (KTT) was 0.26 mm higher in CAF + CM group (p < 0.05). It can be concluded that CAF + CM does not provide a superior recession reduction when compared to CAF; however, it may offer a small gain in KTT after 6 months. CAF + CM can be suggested as a valid therapeutic option to achieve root coverage and some increase in soft tissue thickness after 6 months. State Univ Campinas UNICAMP, Dept Prosthodont & Periodont, Div Periodont, Piracicaba Dent Sch, Ave Limeira 901, Sao Paulo, Brazil State Univ Sao Paulo, Dept Periodontol, Sao Jose Campos Dent Sch, Sao Paulo, Brazil Univ Bern, Dept Periodontol, Bern, Switzerland State Univ Sao Paulo, Dept Periodontol, Sao Jose Campos Dent Sch, Sao Paulo, Brazil

Background: This study is designed to investigate the effect of three different analgesics, used to treat pain in AP, on oxidative stress, DNA damage in mononuclear leukocytes, and on oxidative status. Methods: This parallel design randomized controlled trial is composed of three treatment arms, intravenous paracetamol, intravenous dexketoprofen, and intravenous tramadol. Results: A total of 107 patients were diagnosed with acute pancreatitis within the study period in the ED. Seventy-seven of them were included in the study; 26 patients for the paracetamol group, 24 patients for the dexketoprofen group, and 27 patients for the tramadol group. The mean age of study subjects was 52.73 ± 15.38 and 66% (n = 51) of them were men. At the beginning of the study (before treatment), mean levels of DNA damage, TOS, and OSI levels were significantly higher and TAS was significantly lower in the acute pancreatitis groups than in the control group. DNA damage and OSI in HAPS-positive patients were found to be significantly greater than HAPS-negative patients (p = 0.046). DNA damage and oxidative stress were compared between the three groups. There were no differences between the groups in terms of DNA damage (p = 0.42) and also for the oxidatif stress parameters (OSI,TAS,TOS had p-values of p = 0.26, p = 0.78, p = 0.35, respectively). Conclusions: There is no difference between the effects of paracetamol, dexketoprofen, and tramadol, which are commonly used to manage acute pain in AP, on DNA damage in human T-lymphocytes and on serine parameters of oxidative status. © 2016, Verlag Klinisches Labor GmbH. All rights reserved.

Objectives A short-term and long-term cost-effectiveness analysis (CEA) of two pedometer-based walking interventions compared with usual care. Design (A) Short-term CEA: parallel three-arm cluster randomised trial randomised by household. (B) Long-term CEA: Markov decision model. Setting Seven primary care practices in South London, UK. Participants (A) Short-term CEA: 1023 people (922 households) aged 45–75 years without physical activity (PA) contraindications. (b) Long-term CEA: a cohort of 100 000 people aged 59–88 years. Interventions Pedometers, 12-week walking programmes and PA diaries delivered by post or through three PA consultations with practice nurses. Primary and secondary outcome measures Accelerometer-measured change (baseline to 12 months) in average daily step count and time in 10 min bouts of moderate to vigorous PA (MVPA), and EQ-5D-5L quality-adjusted life-years (QALY). Methods Resource use costs (£2013/2014) from a National Health Service perspective, presented as incremental cost-effectiveness ratios for each outcome over a 1-year and lifetime horizon, with cost-effectiveness acceptability curves and willingness to pay per QALY. Deterministic and probabilistic sensitivity analyses evaluate uncertainty. Results (A) Short-term CEA: At 12 months, incremental cost was £3.61 (£109)/min in ≥10 min MVPA bouts for nurse support compared with control (postal group). At £20 000/QALY, the postal group had a 50% chance of being cost saving compared with control. (B) Long-term CEA: The postal group had more QALYs (+759 QALYs, 95% CI 400 to 1247) and lower costs (−£11 million, 95% CI −12 to −10) than control and nurse groups, resulting in an incremental net monetary benefit of £26 million per 100 000 population. Results were sensitive to reporting serious adverse events, excluding health service use, and including all participant costs. Conclusions Postal delivery of a pedometer intervention in primary care is cost-effective long term and has a 50% chance of being cost-effective, through resource savings, within 1 year. Further research should ascertain maintenance of the higher levels of PA, and its impact on quality of life and health service use., This research was supported by the Health Technology Assessment (HTA) Programme, National Institute for Health Research (project number HTA 10/32/02 ISRCTN42122561).

Introduction Lifestyle Triple P is a general parenting intervention which focuses on preventing further excessive weight gain in overweight and obese children. The objective of the current study was to assess the effectiveness of the Lifestyle Triple P intervention in the Netherlands. Method We used a parallel randomized controlled design to test the effectiveness of the intervention. In total, 86 child-parent triads (children 4-8 years old, overweight or obese) were recruited and randomly assigned (allocation ratio 1:1) to the Lifestyle Triple P intervention or the control condition. Parents in the intervention condition received a 14-week intervention consisting of ten 90-minute group sessions and four individual telephone sessions. Primary outcome measure was the children' s body composition (BMI z-scores, waist circumference and skinfolds). The research assistant who performed the measurements was blinded for group assignment. Secondary outcome measures were the children's dietary behavior and physical activity level, parenting practices, parental feeding style, parenting style, and parental self-efficacy. Outcome measures were assessed at baseline and 4 months (shortterm) and 12 months (long-term) after baseline. Multilevel multiple regression analyses were conducted to determine the effect of the intervention on primary and secondary outcome measures. Results No intervention effects were found on children's body composition. Analyses of secondary outcomes showed positive short-term intervention effects on children's soft-drink consumption and parental responsibility regarding physical activity, encouragement to eat, psychological control, and efficacy and satisfaction with parenting. Longer-term intervention effects were found on parent 's report of children's time spent on sedentary behavior and playing outside, parental monitoring food intake, and responsibility regarding nutrition. Conclusion Although the Lifestyle Triple P intervention showed positive effects on some parent reported child behaviors and parenting measures, no effects were visible on children's body composition or objectively measured physical activity. Several adjustments of the intervention content are recommended, for example including a booster session. © 2015 Gerards et al.

Introduction Lifestyle Triple P is a general parenting intervention which focuses on preventing further excessive weight gain in overweight and obese children. The objective of the current study was to assess the effectiveness of the Lifestyle Triple P intervention in the Netherlands. Method We used a parallel randomized controlled design to test the effectiveness of the intervention. In total, 86 child-parent triads (children 4–8 years old, overweight or obese) were recruited and randomly assigned (allocation ratio 1:1) to the Lifestyle Triple P intervention or the control condition. Parents in the intervention condition received a 14-week intervention consisting of ten 90-minute group sessions and four individual telephone sessions. Primary outcome measure was the children’s body composition (BMI z-scores, waist circumference and skinfolds). The research assistant who performed the measurements was blinded for group assignment. Secondary outcome measures were the children’s dietary behavior and physical activity level, parenting practices, parental feeding style, parenting style, and parental self-efficacy. Outcome measures were assessed at baseline and 4 months (short-term) and 12 months (long-term) after baseline. Multilevel multiple regression analyses were conducted to determine the effect of the intervention on primary and secondary outcome measures. Results No intervention effects were found on children’s body composition. Analyses of secondary outcomes showed positive short-term intervention effects on children’s soft-drink consumption and parental responsibility regarding physical activity, encouragement to eat, psychological control, and efficacy and satisfaction with parenting. Longer-term intervention effects were found on parent’s report of children’s time spent on sedentary behavior and playing outside, parental monitoring food intake, and responsibility regarding nutrition. Conclusion Although the Lifestyle Triple P intervention showed positive effects on some parent reported child behaviors and parenting measures, no effects were visible on children’s body composition or objectively measured physical activity. Several adjustments of the intervention content are recommended, for example including a booster session. Trial Registration Nederlands Trial Register NTR 2555

Objectives: To assess the efficacy of an exercise program on a whole-body vibration platform (WBV) in improving body balance and muscle performance and preventing falls in institutionalized elderly people. Design/Setting/Participants: A multicentre randomized parallel assessor-blinded clinical trial was conducted in elderly persons living in nursing homes. Interventions: Participants were randomized to an exercise program performed either on a whole body vibratory platform (WBV plus exercise group) or on a stationary surface (exercise group). The exercise program for both groups consisted of static and dynamic exercises (balance and strength training over a 6-week training period of 3 sessions per week). The frequency applied on the vibratory platform was 30 to 35Hz and amplitude was 2 to 4mm. Measurements: The primary outcome measurement was static/dynamic body balance. Secondary outcomes were muscle strength and number of falls. Efficacy was analyzed on an intention-to-treat basis and per protocol. The effects of the intervention were evaluated using the t test, Mann-Whitney test, or chi-square test, depending on the type of outcome. Follow-up measurements were collected 6weeks and 6months after randomization. Results: A total of 159 participants from 10 centers were included: 81 in the WBV plus exercise group and 78 in the control group. Mean age was 82years, and 67.29% were women. The Tinetti test score showed a significant overall improvement in both groups (P

Simulation models of parallel, rotary, and side-opening milking parlors were built that could predict milking parlor performance according to herd size, number of milking stalls, labor quality, and cow characteristics. The models were validated by statistically comparing the duration of the simulated milking process with actual data collected at 3 dairy farms during 12 mo. Various scenarios were generated to study parlor performance, and the results indicated that for a parlor with up to 14 milking stalls, a side-opening design provided greater capacity than parallel or rotary parlors. Performance of a side-opening parlor was reduced by enlargement up to 20 milking stalls. For 10 to 40 milking stalls, a rotary design gave better performance than a double parallel design in terms of milking process duration and stall utilization. The presented models can serve as a practical tool in designing new parlors or changing operations of existing ones.

An increased consumption of fruits and vegetables (F&V) has been suggested as a way to limit, or even lower, energy and fat intakes. The present study examined the effects of incorporating F&V supplements into the diets of adults who reported consuming 2) were each provided with supplements of 0, 300 or 600g F&V per d. Food, nutrient and energy intakes were measured before, during and at the end of the supplementation period using 7 d weighed records. Mean daily energy intakes were not different among the three groups before (P=0·151) or during the supplementation periods (P=0·407), although changes in energy intakes over the study period tended to be more positive with increasing amounts of F&V supplements (P=0·078). There was no difference in changes of body weights during the study (P=0·242). Carbohydrate (PPPP=0·022) increased in the treatment groups. There were no significant differences, or changes, in fat intakes among the three groups. Consumption of mandatory F&V supplements for 8 weeks produced beneficial changes in diet composition, but did not result in lower reported energy or fat intakes, and did not result in loss of body weight.

ObjectiveTo assess the effectiveness of a behaviour change approach, with or without financial support, in improving vitamin A (VA) intake and serum retinol concentration through mango and liver consumption by children.DesignA parallel design (no control area) was used to assess changes in VA intake and serum retinol over a 15-week period.Setting and subjectsA pilot study was implemented in the Department of Kokologho, a rural area in central west Burkina Faso. One hundred and fifty children aged 2–3 years were randomly selected and assigned to two treatment groups: PA$$ (promotional activities and financial support) and PA (promotional activities).ResultsThe intervention significantly increased (PPP=0.004) in PA$$ compared with PA. Mean serum retinol concentration increased significantly by 26% (PP−1 in PA$$ vs. 0.17 μmol l−1 and in PA) did not differ significantly (P=0.455) between groups over the intervention.ConclusionPromotional activities on mango and liver intake effectively increased VA intake and serum retinol concentrations. Although an additional beneficial effect of financial support on liver intake was observed, this did not translate into a further increase in serum retinol concentration.

Objectives: To evaluate the efficacy of two power toothbrushes (Cybersonic and Braun 3D Excel) and one manual brush (Elmex super 29). Material and Methods: After professional toothcleaning 120 subjects were randomly assigned to three groups. Four weeks later, at baseline, the Quigley–Hein plaque index (QHI), the modified approximal plaque index (API), and the papillary bleeding index (PBI) were recorded. Thereafter the subjects used the assigned toothbrushes for 8 weeks. Improvements of the indices after 4 and 8 weeks were calculated as medians. Kruskal–Wallis- and Mann–Whitney U-test served for statistical analysis. Results: All indices showed statistically significant reductions for both power toothbrushes which were superior to the manual brush (4 weeks: Cybersonic: API, 0.21; PBI, 0.25; QHI, 0.23; Braun: API, 0.20; PBI, 0.39; QHI, 0.22; Elmex: API, 0.04; PBI, 0.02; QHI, 0.07; 8 weeks: Cybersonic: API, 0.28; PBI, 0.36; QHI, 0.41; Braun: API, 0.36; PBI, 0.61; QHI, 0.35; Elmex: API, 0.03; PBI, 0.10; QHI, 0.08; p

A recent study suggests that the addition of enamel matrix derivative to demineralized freeze-dried bone allograft may enhance osseoinduction. The purpose of this study was to evaluate the use of demineralized freeze-dried bone allograft (DFDBA) in combination with enamel matrix derivative (EMD + DFDBA) compared to enamel matrix derivative (EMD) alone in the treatment of human intrabony periodontal defects.Forty patients with a total of 67 sites (intrabony defector = 3 mm deep) were selected to participate in this single-masked, parallel design, randomized, controlled clinical trial. Each subject received either EMD alone (34 sites) or in combination with DFDBA (33 sites). Soft tissue measurements included probing depth (PD), clinical attachment level (CAL), and recession. Hard tissue measurements included defect depth, alveolar crestal resorption, and defect morphology. Following 6 months of healing, all soft tissue measurements were repeated. Forty-nine sites (EMD + DFDBA = 26 sites, EMD alone = 23 sites) were surgically reentered. Statistical analyses were performed using unpaired and paired Student t tests.Analyses showed a significant improvement in soft tissue parameters for both treatment groups (P0.001) as compared to preoperative measurements. There were no statistical differences between treatment groups. The probing depth reduction (PDR) for the EMD + DFDBA was 3.6 +/- 0.2 mm, while the EMD alone had a PDR of 4.0 +/- 0.3 mm. The CAL gain for the EMD + DFDBA group was 3.0 +/- 0.3 mm and 3.2 +/- 0.3 mm for the EMD alone group. The mean value for bone fill in the EMD + DFDBA group was 3.7 +/- 0.2 mm (74.9%), while the EMD alone group demonstrated a mean bone fill of 2.6 +/- 0.4 mm (55.3%). While there were no significant differences between the two treatments with regards to soft tissue measurements, the combination of EMD + DFDBA therapy yielded statistically significant improvements in bone fill, crestal resorption, and percentage of sites gaining greater than 50% and 90% bone fill when compared to EMD alone (P0.001).The results of this study indicate that there may be an enhancement of hard tissue parameters when enamel matrix derivative is added to demineralized freeze-dried bone allograft.

To determine the effect of three-dimensional (3D) audiovisual (AV) distraction in reducing dental anxiety of children. A randomised clinical trial with a parallel design carried out on 90 children (49 boys and 41 girls) aged between 7 and 10 years (mean age of 8.4 years) to ascertain the comparative efficacy of audio (music) and AV (3D video glasses) distraction in reducing the dental anxiety of children during local analgesia (LA) administration. Ninety children were randomly divided into three groups; control (basic behaviour guidance techniques without distraction), audio (basic techniques plus music) and AV (basic techniques plus 3D AV) distraction groups. All the children experienced LA administration with/without distraction and the anxiety was assessed using a combination of measures: MCDAS(f) (self-report), pulse rate (physiological), behaviour (using Wright’s modification of Frankl behaviour rating scale and Houpt scale) and preferences of children. All 90 children completed the study. A highly significant reduction in the anxiety of audiovisual group as reported by the MCDAS(f) values (p

In the present double-blind, randomised, parallel intervention study, the effects of the intake of galacto-oligosaccharides (GOS) on the gut microbiota of twelve healthy adult subjects (aged 18-45 years with a normal BMI (18-25 kg/m2)) receiving amoxicillin (AMX) treatment were determined. All the subjects were treated with AMX (375 mg; three times per d) for 5 d and given either GOS (n 6) or placebo (maltodextrin, n 6) (2·5 g; three times per d) during and 7 d after AMX treatment. Faecal samples were collected twice before starting the treatment and on days 2, 5, 8, 12, 19 and 26. Due to AMX treatment, a decrease in the abundance of Bifidobacterium spp., an overgrowth of Enterobacteriaceae, and a disruption of the metabolic activity of the microbiota (increase in succinate, monosaccharide and oligosaccharide levels in the faecal samples) were observed in both groups (P< 0·05). Positive effects of GOS intake were observed on the levels of bifidobacteria, although not found to be significant. Data revealed that the levels of bifidobacteria were higher upon GOS intake than upon placebo intake, especially after AMX treatment. The activity of bifidobacteria and subsequent cross-feeding activity of the microbiota upon GOS intake compared with those upon placebo intake were reflected by the significant increase in butyrate levels (P< 0·05) in the faecal samples after AMX treatment. Despite the small number of subjects, our findings confirm previous results obtained in vitro, namely that GOS intake supports the recovery of the beneficial bifidobacteria and, indirectly, the production of butyrate after AMX treatment. © 2014 The Authors. Chemicals/CAS: amoxicillin, 26787-78-0, 34642-77-8, 61336-70-7; maltodextrin, 9050-36-6; succinic acid, 110-15-6

In the present double-blind, randomised, parallel intervention study, the effects of the intake of galacto-oligosaccharides (GOS) on the gut microbiota of twelve healthy adult subjects (aged 18–45 years with a normal BMI (18–25 kg/m2)) receiving amoxicillin (AMX) treatment were determined. All the subjects were treated with AMX (375 mg; three times per d) for 5 d and given either GOS (n 6) or placebo (maltodextrin, n 6) (2·5 g; three times per d) during and 7 d after AMX treatment. Faecal samples were collected twice before starting the treatment and on days 2, 5, 8, 12, 19 and 26. Due to AMX treatment, a decrease in the abundance of Bifidobacterium spp., an overgrowth of Enterobacteriaceae, and a disruption of the metabolic activity of the microbiota (increase in succinate, monosaccharide and oligosaccharide levels in the faecal samples) were observed in both groups (PPin vitro, namely that GOS intake supports the recovery of the beneficial bifidobacteria and, indirectly, the production of butyrate after AMX treatment.

Objective To assess the barriers and facilitators to using African American churches as sites for implementation of evidence‐based HIV interventions among young African American women. Design Mixed methods cross‐sectional design. Setting African American churches in Philadelphia, PA. Participants 142 African American pastors, church leaders, and young adult women ages 18 to 25. Methods Mixed methods convergent parallel design. Results The majority of young adult women reported engaging in high‐risk HIV‐related behaviors. Although church leaders reported willingness to implement HIV risk‐reduction interventions, they were unsure of how to initiate this process. Key facilitators to the implementation of evidence‐based interventions included the perception of the leadership and church members that HIV interventions were needed and that the church was a promising venue for them. A primary barrier to implementation in this setting is the perception that discussions of sexuality should be private. Conclusion Implementation of evidence‐based HIV interventions for young adult African American women in church settings is feasible and needed. Building a level of comfort in discussing matters of sexuality and adapting existing evidence‐based interventions to meet the needs of young women in church settings is a viable approach for successful implementation.

Objectives: In 60 healthy humans, a blend of commonly used edible vegetable fats was compared with the same fat blend after random chemical interesterification, for their effects in terms of nutritional safety on blood lipids, blood enzymes and hemostasis parameters. Design: Both fat blends were supplied double-blind at two energy levels (4 and 8% of energy) in margarine according to a parallel design. At either energy level, the two fat blends were consumed according to a cross-over design for two periods of three weeks, without an intermediate wash-out period. Results: The 30 parameters studied revealed no statistically significant differences between the two fat blends, except for slightly (∼10%) lower D-dimers concentrations after consumption of the interesterified fat blend. Conclusions: Increased levels of the fibrin-degradation products D-dimers are positively associated with risk for coronary heart disease. Thus, it was concluded that the inclusion of a chemically interesterified vegetable fat blend in the diet of healthy people does not influence fasting blood lipids, blood enzymes and/or hemostasis parameters in an adverse way, when compared with a non-interesterified fat blend with the same fatty acid composition.

The relationship between quality of life (QoL) and antiretroviral treatment (ART) has mainly been studied using quantitative scales often not appropriate for use in other contexts and without taking peoples' lived experiences into consideration. Sub-Saharan Africa has the highest incidence of HIV and AIDS yet there is paucity in research done on QoL. This research report is intended to give an account of the use of a mixed method convergent parallel design as a novice approach to evaluate an instrument's context specificity, appropriateness and usefulness in another context for which it was designed. Data were collected through a qualitative exploration of the experiences of QoL of people living with HIV or AIDS (PLHA) in Africa since being on ART, as well as the quantitative measurements obtained from the HIV/AIDS-targeted quality of life (HAT-QoL) instrument. This study was conducted in three African countries. Permission and ethical approval to conduct the study were obtained. Purposive voluntary sampling was used to recruit PLHA through mediators working in community-based HIV/AIDS organisations and health clinics. Interviews were analysed through open coding and the quantitative data through descriptive statistics and the Cronbach's alpha coefficient. A much wider range and richness of experiences were expressed than measured by the HAT-QoL instrument. Although an effective instrument for use in the USA, it was found not to be sensitive, appropriate and useful in an African context in its present form. The recommendations focus on adapting the instrument using the data from the in-depth interviews or to develop a context-sensitive instrument that could measure QoL of PLHA in Africa http://www.tandfonline.com/doi/full/10.1080/09540121.2013.859651 http://dx.doi.org/10.1080/09540121.2013.859651

ObjectiveTo determine the postprandial lipaemia response before and after intervention with healthy diets in the Medi-RIVAGE cohort of subjects with moderate risk factors of CVD.DesignOne hundred and thirty-five adults (fifty-two men and eighty-three women) followed either a Mediterranean-type (MED) diet or a low-fat American Heart Association-type diet in a parallel design for 3 months. At entry and after 3 months, lipids, glucose and insulin were measured in the fasting samples; TAG and apolipoprotein B48 (ApoB48; a marker of intestinally derived chylomicrons) levels were measured in the fasting and postprandial samples after a standard test meal.ResultsThe MED diet only lowered (P< 0·028) fasting TAG and both diets reduced TAG and ApoB48 levels 5 h after the test meal. The overall 5 h postprandial ApoB48 response (area under curve (AUC)/incremental AUC) was lowered after both diets but this effect was more marked after the MED-diet intervention. Whatever the TAG level at entry, normo- and hyper TAG subjects showed a reduction in the postprandial ApoB48 levels after 3-month diets. BMI at entry did not impact the effect of diets given subjects with BMI < or >25 kg/m2showed reduced postprandial ApoB48. Men and women displayed comparable postprandial changes after dietary challenges.ConclusionsA MED diet appears efficient to improve postprandial lipaemia, a recently acknowledged CVD risk, in men and women at moderate cardiovascular risk.

The purpose of this pilot study was to evaluate the remineralisation of eroded enamel by NaF rinses in an intra-oral model.Serving as their own control, subjects (N=80) participated in a randomised, four-leg (20 subjects/leg), 28-day, parallel design study. In each leg, each participant wore a customised orthodontic bracket attached to a mandibular molar that contained one tooth block having an initial erosive lesion (0.3% citric acid, pH 3.75, 2 h). Within the 28-day period, participants engaged in twice-daily brushing for 1 min with a fluoride-free dentifrice followed by 1-min rinsing with one of the following aqueous rinses: fluoride-free (0 ppm F), 225 ppm F, 225 ppm F plus functionalised β-tricalcium phosphate (fTCP), and 450 ppm F. Following intra-oral exposure, appliances were removed and specimens were analysed using surface microhardness (SMH) and transverse microradiography (TMR).Statistically significant (p0.05) remineralisation, as determined by SMH and TMR, of the eroded enamel relative to baseline occurred for each fluoride system. No significant differences in SMH were observed amongst the fluoride groups (p0.05), however, 225 ppm plus fTCP produced 27% and 7% SMH indent length reduction relative to 225 ppm F and 450 ppm F, respectively. No significant differences in TMR were observed amongst the fluoride groups (p0.05), however, 225 ppm F plus fTCP and 450 ppm F produced significant (p0.05) mineral gains relative to the fluoride-free control, whilst 225 ppm F did not (p0.05). Relative to the 225 ppm F group, the 450 ppm F and 225 ppm F plus fTCP groups produced 65% and 61% greater mineral change, respectively.These pilot results demonstrate this model is sensitive to fluoride and that addition of fTCP to an aqueous rinse containing 225 ppm F may provide significant remineralisation benefits. Therefore, the combination of relatively low levels of fluoride and fTCP might be an effective alternative to a high fluoride treatment for anti-erosion benefits.

Fifty-five patients with winter seasonal affective disorder (SAD) were treated with a light visor, a newly developed portable light-delivery system, in a controlled parallel design. A dim (400 lux) visor was compared with a bright (6000 lux) visor for either 30 or 60 minutes in the morning for 1 week. Response rates for these two treatments were 36% and 56%, respectively; the duration of treatment sessions did not affect outcome. There was no evidence that the brighter visor was superior in efficacy to the dimmer one. Significantly greater relapse occurred following withdrawal of the dimmer visor. Alternative explanations for these findings are that the light visor is acting as a placebo or that it is equally effective over a wide range of intensities.

Objective This study sought to determine whether dawn simulation was superior to a shorter dimmer "placebo" dawn signal in treating winter depression. Method In a randomized, parallel design, 22 patients with winter depression were treated with either 1 week of a 2-hour dawn simulation peaking at 250 lux or 1 week of a 30-minute dawn simulation peaking at 0.2 lux. The subjects were told that they would receive either a "gradual" dawn or a "rapid" dawn reaching an intensity that would be dimmer than standard bright light treatment. At the end of both the baseline week and the treatment week, subjects were assessed in a blind manner with the Hamilton Rating Scale for Depression. Analysis of covariance was used to compare the two dawn treatments. Results The 2-hour, 250-lux dawn simulation resulted in Hamilton depression scale scores that were significantly lower than scores after the 30-minute, 0.2-lux dawn simulation. Conclusions This study indicates that dawn simulation is an effective treatment for winter depression.

Maropitant is a neurokinin-1 inhibitor that acts to prevent and treat vomiting by blocking stimuli to the final common pathway in the emetic centre of the brain. The field efficacy and safety of a single oral dose of maropitant were investigated for the prevention of vomiting in dogs with a history of motion sickness resulting from transportation by car in two blinded, placebo-controlled studies. In an exploratory study designed as a two-way crossover trial with 17 dogs, 10 of the dogs given the placebo vomited during a car journey but only three of the dogs vomited under maropitant treatment. In a larger multicentred parallel design study, 69 of 105 dogs treated with the placebo vomited during the journey compared with 15 of 106 dogs treated with maropitant (P < 0.0001).

Objective: To determine the effect of folic acid, vitamin B6 and B12 fortified spreads on the blood concentrations of these vitamins and homocysteine. Design and setting: A 6-week randomized, double-blinded, placebo-controlled, parallel trial carried out in a clinical research center. Subjects: One hundred and fifty healthy volunteers (50% males). Interventions: For 6 weeks, the subjects consumed the test spreads (20 g/day): containing per 20 g (1) 200μ g folic acid, 2μ g vitamin B12 and 1 mg vitamin B6, or (2) 400μ g folic acid, 2μ g vitamin B12 and 1 mg vitamin B6 or (3) no B-vitamins (control spread). Results: The B-vitamin status increased on using the test spreads, with the largest effect on the serum folate concentration: 48% in men and 58% in women on spread 1 and 92 and 146%, respectively, on spread 2 (P-values all

Objective: To determine the effect of folic acid, vitamin B6 and B12 fortified spreads on the blood concentrations of these vitamins and homocysteine. Design and setting: A 6-week randomized, double-blinded, placebo-controlled, parallel trial carried out in a clinical research center. Subjects: One hundred and fifty healthy volunteers (50% males). Interventions: For 6 weeks, the subjects consumed the test spreads (20 g/day): containing per 20 g (1) 200μ g folic acid, 2μ g vitamin B12 and 1 mg vitamin B6, or (2) 400μ g folic acid, 2μ g vitamin B12 and 1 mg vitamin B6 or (3) no B-vitamins (control spread). Results: The B-vitamin status increased on using the test spreads, with the largest effect on the serum folate concentration: 48% in men and 58% in women on spread 1 and 92 and 146%, respectively, on spread 2 (P-values all

Purpose To investigate the efficacy of reducing the drop-skin contact to prevent dermatologic side effects of bimatoprost 0.03% topical therapy. Design Prospective, randomized, single-blinded, internally controlled study. Methods Enrolled subjects started bimatoprost 0.03% therapy once at night in both eyes and were instructed to wipe selectively only one eye (eye 1) with an adsorbent pad during and after drops administration for four months. The fellow eye acted as the internal control. Eyelash growth, regional skin hypertrichosis, and pigmentation on the periocular skin were assessed at baseline and during the four months of follow-up. Results A lower incidence of eyelash growth and skin pigmentation in the inferonasal pericanthal region were observed in eye 1. The incidence of pigmentation in the inferotemporal skin region and skin hypertrichosis were similar in the two eyes. Conclusion The reduction of the drop-skin contact affects the regional incidence and the extent of dermatologic skin changes that are related to bimatoprost 0.03% topical therapy.

BACKGROUND: For some years, there has been a debate as to the place of the crossover trial in assisted reproduction technology (ART). We aimed to investigate whether crossover and parallel designs result in different estimates of treatment effects. METHODS: We carried out computer simulation of cohorts of patients undergoing either intra-uterine insemination (IUI) or IVF under both parallel and crossover designs, under scenarios involving censoring and carryover effects. Results of the simulation were analysed using a maximum likelihood approach. RESULTS: No relevant difference was found between the designs. The crossover design resulted in slightly more pregnancies than the parallel design. Carryover effects may slightly distort the estimates of treatment effects. Crossover and parallel designs will produce essentially the same statistical estimates of treatment effect and percentage of pregnancies. The crossover design is an acceptable design in infertility research provided the data are analysed correctly.

It has been reported that bovine colostrum (BC) supplementation improves buffer capacity (beta) during exercise, but whether the improvement results from changes in tissue and/or blood buffer systems has not been determined. The purpose of the present study was to examine the effect of supplementation with BC on blood buffer systems. Thirteen elite females rowers were supplemented with 60 g.day(-1) of either BC ( n=6) or whey protein (WP, n=7) during 9 weeks of pre-competition training in a randomised, double-blind, placebo-controlled, parallel design. All subjects undertook the study as a group and completed the same training program. Resting haemoglobin (Hb) concentration and plasma buffer capacity (pbeta) (determined by titration with HCl) were measured pre- and post-supplementation. There were no differences in macronutrient intakes ( P>0.56) or training volumes ( P>0.99) between BC and WP during the study period. There were no differences in Hb [BC 13.28 (0.28) mg.dl(-1), WP 13.70 (0.26) mg.dl(-1); P=0.45] or pbeta [BC 14.8 (1.1) nmol HCl.ml(-1).pH(-1), WP 14.8 (0.5) nmol HCl.ml(-1).pH(-1); P=0.68] between groups at week 0. pbeta increased in both groups during the study period ( P

Soy has received attention as an alternative to conventional hormone replacement therapy (HRT) largely because it is a unique dietary source of isoflavones. Isoflavones are diphenolic compounds that have both hormonal and nonhormonal properties and are considered to be selective estrogen receptor modulators. The estrogen-like effects of isoflavones in combination with the low reported frequency of hot flushes in Japan has prompted investigation of the effect of soy on menopausal symptoms. The purpose of this review is to evaluate the efficacy of soyfoods and isoflavone supplements for the alleviation of hot flushes. Nineteen trials (13 using a parallel design) involving more than 1,700 women were identified. Six trials were excluded from analysis: two that involved breast cancer patients, two that reported data on severity but not hot flush frequency, one that was not blinded, and one that did not include a control group. Based on a simple regression analysis of the remaining data set (13 trials), there was a statistically significant relationship (P =.01) between initial hot flush frequency and treatment efficacy. Initial hot flush frequency explained about 46% of the treatment effects, and hot flush frequency decreased by about 5% (above placebo or control effects) for every additional initial hot flush per day in women whose initial hot flush frequency was five or more per day. Although conclusions based on this analysis should be considered tentative, the available data justify the recommendation that patients with frequent hot flushes consider trying soyfoods or isoflavone supplements for the alleviation of their symptoms.

Aim: To compare the potential efficacy of two prototype chewing gums in extrinsic stain removal on natural teeth. Setting: Dental school clinics. Design: Double-blind, two groups, parallel design. Participants: 76 adult volunteers (32m, 44f, mean age: 20.6 years old). Methods: Oral hard and soft tissue health was examined. The subjects were randomly assigned to use either Product A (without active ingredients) or Product B (with active ingredients). Each subject was asked to brush their teeth for one minute twice daily (mornings and nights) and chew the gums supplied for 15 min (2 dragees each time), three times daily, once after each meal (breakfast, lunch and dinner) for the entire four-week duration. Dental stain assessment was made on the 12 incisors using the Lobene Stain Index (LSI). Results: The overall difference between the stain scores after 4-weeks' use of the chewing gums was statistically significant (p

Objective: To evaluate both efficacy and safety in humans of long-term consumption of spreads containing plant sterol esters. Design: Randomized double-blind placebo-controlled parallel trial. Subjects: Hundred and eighty-five healthy volunteers (35-64y). Intervention: Volunteers daily consumed 20g spread enriched with 1.6g plant sterols as fatty acid esters or a control spread for 1 y. They continued their habitual diet and lifestyle. Outcome measures included efficacy markers such as total and LDL-cholesterol, a large range of safety parameters, and reporting of adverse events. Results: Consumption of the plant sterol ester-enriched spread consistently lowered total and LDL cholesterol during the 1 y period on average by 4 and 6%, respectively (0.01 < P < 0.05). Plant sterols intake did on average not result in a lower carotenoid concentration (when expressed per LDL-cholesterol) after 52 weeks (P > 0.05). However, carotenoid concentrations changed over time. Plant sterols intake reduced lipid adjusted α- and β-carotene-concentrations by only 15-25% after 1 y, relative to control. Lipid-adjusted fat-soluble vitamin concentrations remained unchanged. Plant sterol concentrations in serum were increased from 2.76 to 5.31 (μmol/mmol total cholesterol) for campesterol (P < 0.0001) and from 1.86 to 2.47 (μmol/mmol total cholesterol) for β-sitosterol (P < 0.0001). The increase in total plant sterol concentration in red blood cells (5.29-9.62 μg/g) did not affect red blood cell deformability. Hormone levels in males (free and total testosterone) and females (luteinizing hormone, follicle stimulating hormone, β-estradiol and progesterone) as well as all clinical chemical and hematological parameters measured were unaffected. Adverse events reported were not different between subjects consuming control spread and subjects consuming plant sterol esters-enriched spread. Conclusion: Consumption of a plant sterol esters-enriched spread is an effective way to consistently lower blood cholesterol concentrations and is safe to use over a long period of time.

Objective: To evaluate both efficacy and safety in humans of long-term consumption of spreads containing plant sterol esters. Design: Randomized double-blind placebo-controlled parallel trial. Subjects: Hundred and eighty-five healthy volunteers (35-64y). Intervention: Volunteers daily consumed 20g spread enriched with 1.6g plant sterols as fatty acid esters or a control spread for 1 y. They continued their habitual diet and lifestyle. Outcome measures included efficacy markers such as total and LDL-cholesterol, a large range of safety parameters, and reporting of adverse events. Results: Consumption of the plant sterol ester-enriched spread consistently lowered total and LDL cholesterol during the 1 y period on average by 4 and 6%, respectively (0.01 < P < 0.05). Plant sterols intake did on average not result in a lower carotenoid concentration (when expressed per LDL-cholesterol) after 52 weeks (P > 0.05). However, carotenoid concentrations changed over time. Plant sterols intake reduced lipid adjusted α- and β-carotene-concentrations by only 15-25% after 1 y, relative to control. Lipid-adjusted fat-soluble vitamin concentrations remained unchanged. Plant sterol concentrations in serum were increased from 2.76 to 5.31 (μmol/mmol total cholesterol) for campesterol (P < 0.0001) and from 1.86 to 2.47 (μmol/mmol total cholesterol) for β-sitosterol (P < 0.0001). The increase in total plant sterol concentration in red blood cells (5.29-9.62 μg/g) did not affect red blood cell deformability. Hormone levels in males (free and total testosterone) and females (luteinizing hormone, follicle stimulating hormone, β-estradiol and progesterone) as well as all clinical chemical and hematological parameters measured were unaffected. Adverse events reported were not different between subjects consuming control spread and subjects consuming plant sterol esters-enriched spread. Conclusion: Consumption of a plant sterol esters-enriched spread is an effective way to consistently lower blood cholesterol concentrations and is safe to use over a long period of time.