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This 24-mo randomized controlled trial was based on a double-blind parallel design, and it compared the effectiveness of 2 fluoride application protocols in arresting dentine caries in primary teeth. Three-year-old children with active dentine caries were recruited and randomly allocated to 2 treatment groups. Children in group A received a semiannual application of a 25% silver nitrate (AgNO3) solution followed by a commercially available varnish with 5% sodium fluoride (NaF) on the carious tooth surfaces. Children in group B received a semiannual application of a 25% AgNO3 solution followed by another commercially available varnish with 5% NaF containing functionalized tricalcium phosphate (fTCP). Carious tooth surfaces that were hard when probing were classified as arrested. Intention-to-treat analysis and a hierarchical generalized linear model were undertaken. A total of 408 children with 1,831 tooth surfaces with active dentine caries were recruited at baseline, and 356 children (87%) with 1,607 tooth surfaces (88%) were assessed after 24 mo. At the 24-mo evaluation, the mean (SD) number of arrested carious tooth surfaces per child were 1.8 (2.2) and 2.6 (3.3) for group A (without fTCP) and group B (with fTCP), respectively ( P = 0.003). The arrest rates at the tooth surface level were 42% for group A and 57% for group B ( P < 0.001). Results of the hierarchical generalized linear model indicated that protocol B (with fTCP) had a higher predicted probability (PP = 0.656) in arresting dentine caries than protocol A (without fTCP; PP = 0.500) when the carious lesions were on buccal/lingual surfaces, were on anterior teeth, had dental plaque coverage, and were in children from low-income families ( P = 0.046). In conclusion, protocol B, which applied a 25% AgNO3 solution followed by a commercially available 5% NaF varnish with fTCP semiannually, is more effective in arresting dentine caries in primary teeth as compared with protocol A, which applied a 25% AgNO3 solution followed by another commercially available 5% NaF varnish without fTCP semiannually (ClinicalTrials.gov NCT03423797).

We performed a study to compare the efficacy of Vitamin D3 oral solution with a conventional tablets and capsules in hypovitaminosis D patients. One hundred eighty subjects were divided into three different groups and received vitamin D3 60000 IU per week for eight weeks either in the form of an oral solution or a tablet or a capsule. A significant increase in serum 25(OH)D was observed in vitamin D3 oral solution from baseline (P=0.0001) as compared to a tablet(P=0.0001) and capsule (P=0.0001). A significant decrease in iPTH levels was seen in the vitamin D3 oral solution group from baseline (P=0.0001) and also as compared to a tablet(P=0.0001) and capsule (P=0.0001). Oral solution of vitamin D3 is a nanotechnology-based formulation which was found to be effective and safe. Thus, treatment with vitamin D3 oral solution in hypovitaminosis D patients may result in faster and higher improvement in the normalization of vitamin D levels.

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.

Objectives: This study compared the longevity of high strength posterior glass ionomer and metal-reinforced glass ionomer using ART in rural settings within an 18-month observation period. Study Design: A nonblinded parallel design randomized controlled trial was conducted among children who attended dental outreach programs in a rural area of Southern India. Atraumatic Restorative Treatment (ART) was performed in 92 permanent posterior teeth with either high strength posterior glass ionomer or metal-reinforced glass ionomer restorations. The allocation ratio was 1:1. Restorations were evaluated at 1, 6, 12 and 18 months after placement. Results: The success rate of metal-reinforced glass ionomer restorations was 100%, 95.4%, 90.4% and 87.2% as compared to high strength posterior glass ionomer whose success rates were 100%, 93%, 85% and 61.8% at the four follow ups respectively. There was a statistically significant difference between the success rate of the two materials at the end of 18 months with the metal-reinforced glass ionomer restorations having a higher success rate (p=0.015). Conclusions : Although the clinical performance of both materials were largely similar, the metal-reinforced glass ionomer restorations had a higher success rate than the conventional GIC at the end of 18 months of follow-up.

BackgroundAfrican American (AA) adults are 60% more likely to be diagnosed with diabetes mellitus (DM) and experience more complications than non-Hispanic White adults. Cognitive behavioral therapy (CBT) is a technique that combines traditional care with cognitive and psychosocial techniques. We aimed to assess the effects of CBT integrated with motivational interviewing (MI) on glycemic control in AA participants and understand their perspectives, attitudes, and experiences toward CBT. MethodsUsing a randomized, parallel design pilot study (web-based group vs in-person group), 20 participants aged >18 years, identifying as AA, and having a glycosylated hemoglobin (HbA1c) > 8%, were recruited. CBT was administered in six sessions over three months. Participants completed baseline and follow-up assessments on measures for diabetes control (HbA1c), self-efficacy, generalized anxiety, depression, perceived stress, health-related quality of life and cognitive ability. Post-CBT focus groups were conducted to determine patient perspectives regarding the intervention. ResultsFourteen participants completed the study, their mean HbA1c improved from 8.5% to 7.7%. The Diabetes Distress Scale demonstrated decreased distress overall (t(26)=2.6; p- value=0.02). The Generalized Anxiety Disorder Scale demonstrated decreased generalized anxiety for all participants (t(26)=2.2; p =0.04). Themes identified in focus groups included: (1) intervention group social support through information sharing; (2) mental health and personal identities in diabetes understanding and management; (3) receptivity to CBT/MI Intervention positively impacts self-efficacy through improved health literacy. ConclusionGroup-based CBT intervention for type 2 DM care was positively received by AA participants and helped improve diabetes control, as demonstrated by the change in HbA1c. There were additional benefits of social support through group interactions and a stronger sense of self-efficacy due to health education. A comprehensive treatment plan like CBT, may be useful in promoting healthy diabetes self-management.Trial registrationThis trial is registered at ClinicalTrials.gov with the identifier NCT03562767. 70 Registered 19 June 2018, https://clinicaltrials.gov/ct2/show/NCT03562767?term=NCT03562767&draw=2&rank=1

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.

Background: Treatment of pressure injury (PI) stage III and IV in patients with spinal cord injury (SCI) requires complex interdisciplinary and inter-professional management described in comprehensive concepts. Although the implementation of these concepts in the clinical management is still difficult due to practical aspects as information and coordination challenges for example. The aim of this study was to develop, implement and test a computerized decision support system (CDSS) to increase concept adherence, improve inter-professional collaboration and optimize clinical outcome compared to usual care. Method: We implemented a CDSS picturing the Basel Decubitus Concept in an acute and rehabilitation clinic specialized for SCI as part of a quality improvement project in a real life two-group parallel design. We randomly allocated patients with SCI and PI stage III/IV for inpatient treatment to usual or CDSS supported care. We used an inclusive participatory development process, a qualitative focus group-based (30 participants) approach to capture the user perspective and prospective chart analyses to compare complication rates, length of stay and costs. Results: In both groups 15 patients were included showing no differences in SCI characteristics, comorbidities, and PI characteristics (localisation: ischium (19 PI, 63%), sacrum (10 PI, 33%), recurrent PI in 21 patients (70%)). Twenty-seven patients received surgical treatment (rotation flap in 12 patients (40%), posterior thigh flap in 15 patients (50%)). No statistically significant group differences were observed in the frequency of major (20% vs 13% between CDSS and control group) and minor (33% vs 27%) complications and length of stay (98 (±28) vs 81 (±23) days). The costs were similar. Although, health care professionals experienced the CDSS as helpful, high workload and difficulties in the information technology processes hindered its implementation.Conclusion: The introduction of a CDSS in the treatment of PI stage III/IV in patients with SCI was feasible, but technical and application problems limited its effectiveness. During the implementation and testing we learned that a clear definition of the whole treatment concept includes milestones, interventions and outcome definition. Technical requirements should include efficient reminder systems and clear visibility for all disciplines of the whole process. Trial registration: As a quality assurance study, this project holds a declaration of no objection by the Ethics Committee northwest/central Switzerland (EKNZ UBE-16/003) and received an ethical approval (EKNZ Req-2017-00860).

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.

Aim The objectives of this study were to compare (a) esthetic, (b) clinical, (c) radiographic, and (d) patient-centered outcomes following immediate (Type 1) and early implant placement (Type 2). Material and methods Forty-six subjects needing a single extraction (premolar to premolar) were randomly allocated to Type 1 or Type 2 implant placement. One year following permanent restoration, evaluation of (a) Esthetics using soft tissue positions, and the pink and white esthetic scores (PES/WES), (b) Clinical performance using probing depth, modified plaque index, and sulcus bleeding index (c) Radiographic bone level, and (d) Patient satisfaction by means of visual analogue scales (VAS) was recorded. Results Thirty-five patients completed the one-year examination (Type 1, n = 20; Type 2, n = 15). Type 1 implants lost 1.03 ± 0.24 mm (mean ± SE) of mid-facial soft tissue height while Type 2 implants lost 1.37 ± 0.28 mm (p = 0.17). The papillae height on the mesial and distal was reduced about 1 mm following both procedures. Frequency of clinical acceptability as defined by PES ≥ 6 (Type 1: 55% vs. Type 2 40%), WES ≥ 6 (Type 1: 45% vs. Type 2 27%) was not significantly different between groups (p > 0.05). Clinical and radiographic were indicative of peri-implant health. Patient-centered outcomes failed to demonstrate significant differences between the two cohorts. Conclusion One year after final restoration, there were no significant differences in esthetic, clinical, radiographic, and patient-centered outcomes following Type 1 and Type 2 implant placement. At one year, patient satisfaction may be achieved irrespective of the two placement protocols.

Background: Influenza is a highly variable infection that can cause fatal complications. Universal approaches, such as general stimulation of the immune system to activate its natural antiviral capacities, seem to be a rational measure. Methods: A total of 410 patients with influenza-like infections (ILI) were randomly assigned to one of three treatment groups and one control group. Interferon gamma (IFN-γ) was administered by intranasal introduction of 1 to 3 drops into each nostril 5 times per day daily for 5 days. The first dose of investigational medicine was given within 48h of the onset of the influenza-like symptoms. One drop of the solution contains 1,000 IU of active substance. All patients received basic complex therapy without any antiviral or immunomodulating agents. The patients were followed up for 7 days. Treatment efficacy was evaluated by the mean duration of symptoms (MDS), the period of viral antigen detection (VAD) measured after 1-2 and 4-5 days of treatment, and the incidence of complications. We used conventional indicators to evaluate the safety of IFN-γ in the treatment of ILI. Results: The administration of 2 or 3 drops of IFN-γ in each nasal passage led to better outcomes manifested in the considerable (P

BACKGROUND Child-to-child approach is an innovative strategy for preventing and reducing the morbidity and mortality burden of unintentional childhood injuries. OBJECTIVES To test effectiveness of Child-to-child Approach in preventing unintentional childhood injuries and their consequences. STUDY DESIGN Community-based non-randomized cluster-controlled trial of parallel design. PARTICIPANTS 397 children and adolescents. INTERVENTION Eldest literate adolescent of selected families of intervention area were trained on prevention of injuries. They were to implement the knowledge gained to prevent injuries in themselves and their younger siblings and also disseminate this knowledge to other members of their families. OUTCOME Data was collected from both intervention and control areas during pre- and post-intervention phases on the magnitude of injuries, time for recovery from injuries, place for seeking treatment, cost of treatment, knowledge and practice of participants and their families regarding injuries. RESULTS During post-intervention phase, the intervention group experienced a significant reduction in incidence of injuries, increased preference for institutional treatment of injuries and increased knowledge and practice regarding injuries, in com-parison to its pre-intervention data and data of the control group in post-intervention phase. Total time for recovery and cost of treatment for injuries also decreased in intervention group in post-intervention phase, though differences were not statistically significant. CONCLUSIONS Child-to-child approach is effective in reducing childhood injuries, improving choice of place for seeking treatment, increasing knowledge of participants, improving family practices regarding prevention of injuries and reducing expenditure on treatment of childhood injuries.

This systematic review aims to investigate the effects of green tea supplementation on exercise-induced oxidative stress. Four electronic databases were searched from inception to December 2020: SPORTDiscuss, PubMed, Scopus, and Web of Science. The search strat- egy was established in the following manner: (green tea) (Title/Abstract) AND (exercise OR training) (Title/Abstract) AND (oxidative stress OR antioxidant OR oxidation) (Title). After the application of inclusion and exclusion criteria 11, randomized or non-randomized control trials were included, 6 with a parallel design and 5 with a crossover design. Study methodological quality was assessed with the PEDro scale, and all studies were considered of moderate quality. Overall, acute green tea ingestion does not appear to influence antioxidant status or reduce exercise-induced oxidative stress. In contrast, green tea supplementation before exercise, for periods of more than 1 week, in a dose range of 400 to 800 mg of catechins per day, appears to be efficacious to increase total antioxidant status and protect cells against exercise-induced oxidative stress. Future investigations should focus on beginning green tea supplementation more than 7 days before exercise and completing it 2 or 3 days after while monitoring the change of markers of oxidative stress up to 48-72 h after exercise., Universidad Pablo de Olavide. Departamento: Deporte e Informática.

Background/Objective Brief transdiagnostic psychotherapies are a possible treatment for emotional disorders. We aimed to determine their efficacy on mild/moderate emotional disorders compared with treatment as usual (TAU) based on pharmacological interventions. Method: This study was a single-blinded randomized controlled trial with parallel design of three groups. Patients (N = 102) were assigned to brief individual psychotherapy (n = 34), brief group psychotherapy (n = 34) or TAU (n = 34). Participants were assessed before and after the interventions with the following measures: PHQ-15, PHQ-9, PHQ-PD, GAD-7, STAI, BDI-II, BSI-18, and SCID. We conducted per protocol and intention-to-treat analyses. Results: Brief psychotherapies were more effective than TAU for the reduction of emotional disorders symptoms and diagnoses with moderate/high effect sizes. TAU was only effectivein reducing depressive symptoms. Conclusions: Brief transdiagnostic psychotherapies might be the treatment of choice for mild/moderate emotional disorders and they seem suitable to be implemented within health care systems. Yes Antecedentes/Objetivo: Las psicoterapias breves son un posible tratamiento para los trastornos emocionales. Nuestro propósito fue determinar su eficacia en los trastornos emocionales leves/moderados en comparación con el tratamiento habitual basado en intervenciones farmacológicas. Método: Este estudio fue un ensayo clínico aleatorizado simple ciego con diseño paralelo de tres grupos. Los pacientes (N = 102) fueron asignados a psicoterapia breve individual (n = 34), psicoterapia breve grupal (n = 34) o tratamiento habitual (n = 34). Los participantes fueron evaluados antes y después del tratamiento con los siguientes instrumentos: PHQ-15, PHQ9, PHQ-PD, GAD-7, STAI, BDI-II, BSI-18 y SCID. Se realizaron análisis por protocolo y por intención de tratar. Resultados: Las psicoterapias breves fueron más efectivas que el tratamiento habitual para la reducción de síntomas y diagnósticos de los trastornos emocionales. El tratamiento habitual solo fue efectivo en reducir los síntomas depresivos. Conclusiones: Las psicoterapias breves pueden ser el tratamiento de elección para los trastornos emocionales leves/moderados y podrían implementarse en los sistemas de salud.

Background: Scabies, an infectious disease caused by Sarcoptes scabiei mites, is still one of the most common skin diseases found in developing countries, including Indonesia. The 5% permethrin cream for scabies treatment has been investigated as having 2–3 time to cure scabies. Tea Tree Oil (TTO) is one of the agents that has been proven to have acaricidal potential as an anti-inflammatory, antibacterial, and antipruritic agent. It has minimal side effects in topical use. Purpose: To evaluate the effectiveness of 5% TTO cream and 10% TTO cream in scabies treatment of pediatric patients. Methods: This was an experimental, analytical study with controlled clinical trial methods, and a double-blind, parallel design comparing 5% TTO cream (treatment 1), 10% TTO cream (treatment 2), with 5% permethrin cream (control) to children with scabies. Result: The 5% TTO cream gave a cure rate of 61.5% and was significantly different from the 5% permethrin cream groups with a p-value = 0.044 in the first week of the study. The 5% permethrin cream gave a cure rate of 15.4%, and the cure rate of 10% TTO cream was 53.8% in the first week of the study. Conclusion: There was a significant difference between the 5% TTO cream and 5% permethrin cream in the first week of the study. The highest and fastest cure rates were found in the 5% TTO cream treatment group.

Objective: To compare the effects of manual and interactive powered toothbrushes on periodontal status of patients during fixed orthodontic treatment. Materials and methods: Thirty-six patients aged 12 to 18 years were included in this parallel design randomized clinical trial. Patients were randomly divided into two groups: manual toothbrushes (MT group) and interactive powered toothbrushes (PT group). The plaque index (PI), gingival index (GI), and bleeding on probing (BOP) scores were obtained before brushing (T0), 4 weeks (T1), 2 months (T2), and 4 months (T3) after brushing initiation. Periodontal measurements were performed by the same researcher that blinded to the groups’ randomization. Data were analyzed with Mann-Whitney U and Friedman tests for the comparison of parameters between groups and times. Results: Significant differences were found in PI values at all time intervals (P < 0.001), with one exception (T2-T3 in the MT group). The GI changes between timepoints were parallel to the BOP findings of the PT group. Both groups had significantly lower bleeding scores in both T0-T2 and T0-T3 time intervals (P < 0.001). There was a significant reduction in the bleeding score of PT group between T1-T3 time interval (P < 0.05); however, there were no significant differences between the groups at any timepoint. PI and GI scores were statistically decreased in the PT group compared with the MT group from baseline to 4 months (P < 0.05). Conclusion: All periodontal parameters decreased during the 4-month study period. The interactive powered toothbrushes may be an alternative to manual toothbrushes in terms of maintenance of periodontal health during fixed orthodontic treatment. © 2020 World Federation of Orthodontists

IntroductionThe Mediterranean diet (MD) is a traditional regional dietary pattern and a healthy diet recommended for the primary and secondary prevention of various diseases and health conditions. Results from the higher level of primary evidence, namely randomised controlled trials (RCTs), are often used to produce dietary recommendations; however, the robustness of RCTs with MD interventions is unknown.MethodsA systematic search was conducted and all MD RCTs with dichotomous primary outcomes were extracted from PubMed. The fragility (FI) and the reverse fragility index (RFI) were calculated for the trials with significant and non-significant comparisons, respectively.ResultsOut of 27 RCTs of parallel design, the majority failed to present a significant primary outcome, exhibiting an FI equal to 0. The median FI of the significant comparisons was 5, ranging between 1 and 39. More than half of the comparisons had an FI ConclusionsIn essence, the present study shows that even in the top tiers of evidence hierarchy, research on the MD may lack robustness, setting concerns for the formulation of nutrition recommendations.

Background: Kaempfera (K.) parviflora (i.e., Thai ginseng) is believed to have medicinal properties associated with good health (e.g., increased vitality, metabolism booster) because it expands blood vessels, which allows for increased blood flow. These effects might extend into the realm of improving physical performance, specifically that of the cardiovascular system. Objectives: A randomized, placebo-controlled, parallel design study was conducted to determine the effects of 12 weeks of K. parviflora supplementation on the cardiovascular endurance of healthy male adults. Methods: Participants included 57 Thai air force cadets who were undergoing physical training for sports competition. Participants were randomly divided into either the treatment group (n = 30) (Age = 20.30 + 0.65 yrs.) or control group (n = 27) (Age = 20.37 + 0.68 yrs.). Treatment group participants received 360 mg of K. parviflora extract in capsule form, and those in the control group received a placebo capsule. Measurements included lactate threshold and heart rate recovery, assessed at baseline and weeks 6 and 12. Group differences were assessed using a 2 (group) × 3 (time) repeated-measures ANOVA. Results: No main or interaction effects were observed for the lactate threshold (all P > 0.05). No group differences were observed for heart rate recovery (P > 0.05); however, a significant time effect was observed for heart rate recovery at weeks 6 and 12 (P < 0.05), which also marked the beginning of an interaction effect showing that those in the experimental group improved more than those in the control group (P > 0.05). Conclusions: In this set of observations, 12-weeks of K. parviflora supplementation had no effect on the lactate threshold; however, it does appear that it might have improved heart rate recovery.

Introduction: It has been established that phototherapy with LED technology is more effective than conventional phototherapy to treat neonatal hyperbilirubinemia by reducing the number of hours of treatment required in term and preterm newborns. The objective of this study was to carry out a randomized clinical study with three types of lamps, including a prototype. Methods: This was a clinical study with a parallel design of three groups, including newborns in need of treatment for hyperbilirubinemia, admitted to the Neonatology Unit of the “Homero Castanier Crespo” Hospital in Azogues-Ecuador. The newborns were divided into three groups: Phototherapy with a fluorescent lamp (Group 1, G1); commercialized LED phototherapy (Medix®, Mediled®) (Group 2, G2); and with prototype LED phototherapy (Group 3, G3). The bilirubin concentration and the mean difference of its reduction in each group were measured to demonstrate non-inferiority. Results: The weight in G1 (n = 30) was 3050 ± 134 g, in G2 (n = 30) was 3200 ± 186 g, and in G3 (n = 30) was 3034 ± 234 g (P = 0.70). The gestational ages were 39 ± 1 weeks in G1, 39.1 ± 1.1 weeks in G2, and 39 ± 1.1 weeks in G3 (P = 0.80). Bilirubin levels were 15.8 ± 6.2 in G1, 14. 93 ± 5.9 in G2, and 15.62 ± 5.9 mg/dl in G3 (P = 0.60). The differences in bilirubin (Delta 1) pre-treatment and at 24 h of treatment were -2.4 mg/dl in G1, -2.4 mg/dl in G2, and -2.25 mg/dl in G3 (P = 0.60). Delta 2 at 48 h was -4.5 mg/dl in G1, -4.26 mg/dl in G2, and -4.42 mg/dl in G3 (P = 0.62). Conclusion: The three treatments demonstrated non-inferiority in the treatment of neonatal hyperbilirubinemia.

Background The aim of this study is to assess the feasibility of acupuncture treatment for the management of subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures. Methods A total of 30 participants who have undergone thoracotomy after traumatic multiple rib fractures will be recruited. Participants will be invited and equally randomised into acupuncture plus usual care and usual care alone groups. A computer-generated random number sequence will be used and concealed using opaque, sealed, sequentially numbered envelopes. Twelve sessions of manual and electrical acupuncture performed by Korean medicine doctors will be provided over a span of 3 months to participants allocated to the acupuncture group. Participants in the usual care group will continue pain medication, exercise and physical therapy as required. Study feasibility will be measured based on the proportion of patients who complete the measurement of pain at 12 or 24 weeks after baseline. The clinical outcomes will include; the average pain intensity over the recent week at rest, movement and cough, quality of life, patient’s global assessment of recovery, respiratory function measured by the pulmonary function test and use of pain medication at 4, 8, 12 and 24 weeks after enrolment. Adverse events will be recorded for all participants. Written informed consent will be obtained from all participants. The local ethics committee has approved the study. This pilot trial will inform further studies investigating the potential role of acupuncture for subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures.

Purpose To investigate the effects of eating wholegrain rye bread with high or low amounts of phytate on iron status in women under free-living conditions. Methods In this 12-week, randomized, parallel-design intervention study, 102 females were allocated into two groups, a high-phytate-bread group or a low-phytate-bread group. These two groups were administered: 200 g of blanched wholegrain rye bread/day, or 200 g dephytinized wholegrain rye bread/day. The bread was administered in addition to their habitual daily diet. Iron status biomarkers and plasma alkylresorcinols were analyzed at baseline and post-intervention. Results Fifty-five females completed the study. In the high-phytate-bread group (n = 31) there was no change in any of the iron status biomarkers after 12 weeks of intervention (p > 0.05). In the low-phytate bread group (n = 24) there were significant decreases in both ferritin (mean = 12%; from 32 ± 7 to 27 ± 6 µg/L, geometric mean ± SEM, p p Conclusions In Swedish females of reproductive age, 12 weeks of high-phytate wholegrain bread consumption had no effect on iron status. However, consumption of low-phytate wholegrain bread for 12 weeks resulted in a reduction of markers of iron status. Although single-meal studies clearly show an increase in iron bioavailability from dephytinization of cereals, medium-term consumption of reduced phytate bread under free-living conditions suggests that this strategy does not work to improve iron status in healthy women of reproductive age.

Article Title and Bibliographic Information A randomized controlled trial of caries prevention in dental practice. Tickle M, O'Neill C, Donaldson M, Birch S, Noble S, Killough S, Murphy L, Greer M, Brodison J, Verghis R, Worthington HV. J Dent Res 2017; 96:741-46. Source of Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme in UK. Type of Study/Design Randomized clinical trial with a parallel design.

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.

Nanozymes are an excellent class of optical reporters for the development of sensitive biosensors for widespread applications. In this study, mesoporous core-shell palladium@platinum (Pd@Pt) nanoparticles were synthesized and then applied as signal amplifier in a dual lateral flow immunoassay (LFIA) and integrated with a smartphone-based device for use in simultaneous detection of Salmonella Enteritidis and Escherichia coli O157:H7. After optimization, the limit of detections were calculated to be ∼20 cfu/mL for S. Enteritidis and ∼34 cfu/mL for E. coli O157:H7, respectively. The greatly improved sensitivity was contributed by the peroxidase-like catalytic activity of the Pd@Pt nanoparticles for signal enhancement and the parallel design of dual detection for eliminating the cross-interference. The estimated recoveries of the dual LFIA range from 91.44 to 117.00%, which indicated that the developed method is capable of detecting live bacteria in food samples. This approach provides an attractive platform for S. Enteritidis and E. coli O157:H7 detection using a smartphone-based device as the sole piece of equipment, indicating great promise for foodborne pathogen analysis or in-field food safety tracking.

Enhanced knowledge of the biological and genetic basis of cancer is re-defining the target population for new treatments. In oncology, potential targets for a new therapeutic agent often include various solid and hematologic malignancies that share common signaling pathways. New agents are often tested in multiple tumor types across which information can be borrowed. We propose a hierarchical Bayesian design (HBD) to simultaneously test a novel agent in multiple groups for randomized Phase II clinical trials with binary endpoints. Compared to parallel design for individual tumor groups, the HBD has greatly reduced sample size. Therefore, this improves efficiency and decreases the financial cost of conducting randomized Phase II clinical trials. An R package hbdct has been developed to implement the HBD and streamline the sample size calibration.

Article Title and Bibliographic Information Single post-extractive ultra-wide 7-mm-diameter implants versus implants placed in molar healed sites after socket preservation. Tallarico M, Xhanari E, Pisano M, De Riu G, Tullio A, Meloni SM. Eur J Oral Implantol 2016;9(3):263-75. Source of Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Type of Study/Design Randomized clinical trial with parallel design.

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

espanolObjetivo: Determinar la efectividad antinflamatoria de la dexametasona mas complejo B en la cirugia de terceros molares inferiores. Metodos: El presente es un ensayo clinico controlado aleatorizado a doble ciego y de diseno en paralelo. Se llevo a cabo en la Clinica Estomatologica de la Universidad Privada Antenor Orrego (UPAO) de Trujillo durante el ano 2010. La muestra estuvo conformada por 36 pacientes divididos de forma aleatoria en dos grupos. Cada paciente firmo un consentimiento informado. Una hora antes de la cirugia se administro al grupo control (A) una dosis intramuscular de dexametasona y al grupo experimental (B) una dosis intramuscular de dexametasona mas complejo B. El efecto antinflamatorio se determino por la medicion horizontal de la interseccion de los puntos anatomicos: trago-pogonion de tejidos blancos y gonion-angulo externo del ojo. Las medidas se realizaron a las 24, 48 y 96 horas despues de la cirugia. Resultados: Al comparar los grupos se observo que, al administrar dexametasona mas complejo B, existia una menor inflamacion postoperatoria que al administrar dexametasona sola a las 24, 48 y 96 horas (p = 0,03; p = 0,002; p = 0,001). Los mismos resultados se observaron para el genero masculino (p = 0,01), femenino (p = 0,00001), los menores de 25 anos (p = 0,011) y los mayores o iguales a 25 anos (p = 0,029). Conclusion: La administracion intramuscular de dexametasona mas complejo B antes de la cirugia de terceros molares produce una menor inflamacion postoperatoria y es independiente del genero y la edad. EnglishObjective: To determine the antiinflammatory effectiveness of dexamethasone plus complex B in lower third molar surgery. Methods: The present study is a double-blind randomized controlled trial of parallel design. It was carried out in the Stomatologic Clinic of the Universidad Privada Antenor Orrego (UPAO) of Trujillo during 2010. The sample consisted of 36 patients randomly divided into two groups. Each patient signed an informed consent. One hour prior to surgery, an intramuscular dose of dexamethasone and an intramuscular dose of dexamethasone plus complex B were administered to the control group (A). The anti-inflammatory effect was determined by the horizontal measurement of the intersection of the dots anatomical: tragus-white tissue pogonion and gonion-external angle of the eye. Measurements were performed at 24, 48 and 96 hours after surgery. Results: When comparing the groups, it was observed that the administration of dexamethasone plus B complex showed a lower postoperative inflammation than that of dexamethasone alone at 24, 48 and 96 hours (p = 0.03; p = 0.002; p = 0.001). The pivotal results were observed for males (p = 0.01), females (p = 0.00001), those under 25 years (p = 0.011) and greater than or equal to 25 years (p = 0.029). Conclusion: Intramuscular administration of dexamethasone plus B complex prior to third molar surgery produces less post-operative inflammation and is independent of gender and age.

Objective: This study aimed to examine the effect of overdenture over vital and nonvital abutment teeth on teeth stability (teeth mobility and attachment loss). Materials and Methods: An experimental, parallel design was used and the study was conducted over a 12-month period (December 2013 to November 2014). Thirty patients who voluntarily opted to participate in this study were recruited; the first group received overdenture over vital abutment teeth while the second group received overdenture over nonvital abutment teeth. Attachment loss and teeth mobility were periodically evaluated after 3 months, 6 months, and 12 months. The data were then analyzed by a computerized method [Statistical Package for Social Sciences (SPSS) version 20]. Results: Overdenture over vital abutment teeth showed lower attachment loss and teeth mobility, compared to the overdenture over nonvital abutment teeth. These differences were statistically significant. Conclusion: It was concluded that the overdenture over vital abutment teeth was more stable, with a lower incidence of tooth mobility and less attachment loss than overdentures placed on nonvital teeth.

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.

Introduction Patients with cystic fibrosis (CF) exhibit changes in their intestinal microbial profile which may result in poorer clinical outcomes. Symbiotic supplements which have both prebiotic and probiotic properties may have role in ameliorating pulmonary exacerbations. However, there have been a limited number of studies conducted to support this claim. The aim of this study was to evalute the effect of synbiotic supplementation on pulmonary exacerbation and body mass index (BMI) in CF patients. Methods A double-blind, parallel design randomized clinical trial was conducted in children with CF. Forty children were assigned to receive either two synbiotic supplements or placebo each day for 6 months. Main outcomes were the number of pulmonary exacerbations, the frequency of hospitalization and BMI z-score changes over 6 months. Results There were no significant differences in the number of pulmonary exacerbation (P = 0.92), duration and number of hospitalization (P = 0.91 and P = 0.98, respectively) between groups during the intervention. The synbiotic also did not have a significant effect on forced expiratory volume in one second (FEV1, P = 0.22) and BMI z-score (P = 0.77). Conclusions The synbiotic had no significant effect on pulmonary and anthropometric outcomes in children with CF. Further studies are necessary to confirm these findings.

Introduction: Imbalance and fear of falling are common symptoms in multiple sclerosis (MS) patients. Drug therapy and complementary and alternative medicine and the use of medicinal plants are considered treatment options in this regard. Accordingly, the present study was conducted to investigate the effect of cinnamon edible drop on balance and fear of falling in MS patients. Materials and Methods: This experimental study was a controlled clinical trial with a parallel design. It was conducted using convenience sampling method. Accordingly, 62 MS patients were randomly divided into control and intervention groups, so that 31 patients were placed in the control group and 31 patients were placed in the intervention group. Data collection tools included the Berg balance scale and Falls Efficiency Scale (international form). The data were analyzed at 5% error level through SPSS version 22 software. Results: The balance scores of the patients in the control and intervention groups at the end of the first and second months were not significantly different than those before the intervention (p >0.05), but the patients' fear of falling score was significantly higher at the end of the third month compared to that before the intervention (p 0.05). Conclusion: Based on the results of the present study, it can be concluded that daily consumption of cinnamon in MS patients can improve their balance status after 3 months, while its effect on fear of falling in these patients was not proven.

Background: Probiotics and tulsi extract mouthrinses are a breakthrough approach to preventing plaque and gingivitis through their different defence mechanism. Objective: Comparison of the effectiveness of chlorhexidine (CHX), tulsi extract and probiotic mouthrinses among 12–15-year-old school children of Mysore, India. Materials and Methods: Triple-blinded randomized controlled clinical trial-concurrent parallel design. The study was done in school which was selected by the lottery method. A total of 60 children who fulfilled the eligibility criteria were randomly selected for the study. After baseline examination using computer generated table divided into three groups – Group A: 0.2%CHX mouthrinse, Group B: tulsi extract mouthrinse, and Group C: probiotic mouthrinse. Results: There was a significant reduction in plaque and gingivitis among all three study products (P

BackgroundTrustworthy (i.e. low risk of bias) randomized clinical trials (RCTs) play an important role in evidence-based decision making. We aimed to systematically assess the risk of bias of trials published in high-impact endocrinology journals.MethodsWe searched the MEDLINE/PubMed database between 2014 and 2016 for phase 2-4 RCTs evaluating endocrine-related therapies. Reviewers working independently and in duplicate used the Cochrane Risk of Bias Tool (CCRBT) to determine the extent to which the methods reported protected the results of each RCT from bias.ResultsWe assessed 292 eligible RCTs, of which 40% (116) were judged to be at low risk, 43% (126) at moderate, and 17% (50) at high risk of bias. Blinding of outcome assessment was the least common domain reported 43% (125), while selective reporting of outcomes was the most common 97% (282). In multivariable analysis, RCTs with a parallel design (OR 2.4; 95% CI; 1.2-4.6) and funded by for-profit sources (OR 2.2; 95% CI; 1.3-3.6) were more likely to be at low risk of bias.ConclusionsTrustworthy evidence should ultimately shape care to improve the likelihood of desirable patient outcomes. Six out-of 10 RCTs published in top endocrine journals are at moderate/high-risk of bias. Improving this should be a priority in endocrine research.

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.

There is currently a consensus about the positive effects of physical exercise on cognition. However, the exercise intensity-dependent effect on executive function remains unclear. Thus, the aim of this study was to compare the acute effects of high-intensity aerobic interval training (HIIT), progressive resistance training (PRT), or combined training (PRT + HIIT) on executive function indicators in overweight inactive adult men (aged 18–30 years old). The participants were screened and excluded for medical conditions known to impact cognitive functioning, which was measured with the Montreal Cognitive Assessment (MoCA) screening cognitive test. A randomised, parallel-group clinical trial was conducted among 36 adults who were randomly assigned to a HIIT (n = 12), PRT (n = 7), PRT + HIIT (n = 7), or control group (n = 10) until the energy expenditure of 400–500 kcal. Cognitive inhibition and attention capacity were examined using the Stroop test and d2 test of attention, respectively, and were obtained pre-exercise for baseline measurement and 1 min post-exercise for each exercise training modality. Cognitive inhibition measured by the Stroop test was improved after the HIIT protocol for the domains of reading by +5.89 (?2 = 0.33), colour naming +9.0 (?2 = 0.60), interference +10.1 (?2 = 0.39), and index interference +6.0 (?2 = 0.20). Additionally, the PRT + HIIT group had an increase for the reading condition of +7.1 (?2 = 0.40), colour naming +7.5 (?2 = 0.80), and interference +5.8 (?2 = 0.39). In regard to attentional capacity, the HIIT group elicited small to medium improvements in the concentration level domain of +21.7 (?2 = 0.44), total performance domain +56.6 (?2 = 0.50), and consistency domain ?3.0 (?2 = 0.27). These results were similar in the PRT and PRT + HIIT groups in the concentration level and items-processed domains (P and lt; 0.05). In conclusion, acute HIIT and PRT + HIIT sessions reported important effect sizes than PRT alone for cognitive inhibition and attention capacity. Taken together, the results suggest that even short-term exercise interventions can enhance overweight adults' executive functions. © 2018 Elsevier Inc.

WOS: 000439385200007, PubMed ID: 30123882, Objective: As patients with increased human epidermal growth factor receptor (HER2) overexpression are more likely to benefit from trastuzumab treatment, the accuracy of HER2 receptor status in breast cancer patients is significant for appropriate disease management. However, this assessment is not harmonized and results may be highly variable between centers. The aim of this study was to investigate the degree of interlaboratory variability in the results of HER2 expression reported by 5 participating centers and to assess the concordance between these centers and a reference laboratory. Materials and Methods: A total of 30 breast cancer samples were tested and scored for HER2 expression using immunohistochemical method in 5 centers from Turkey and in a reference laboratory from Netherlands (Academic Medical Center, Amsterdam). All the participating centers had an experience of more than 10 years regarding the HER2 testing. The results were compared both among the centers and with the reference laboratory. Results: When the concordance of participating centers and the reference laboratory was evaluated regarding negative (0-1+), equivocal 2(+) and positive 3(+) classification of HER2 immunostaining, the highest concordance was found in Center-A, and the lowest in Center-C (Kendall's tau-b concordance coefficient 0.911 and 0.724, respectively). The concordance of the centers with reference laboratory was 80.0% both in equivocal and positive samples, while it increased up to 91.8% in negative samples. Conclusions: This study showed that in general there is sufficiently good agreement between the reference laboratory and the participating centers for immunohistochemical HER2 assessment.

Background: A considerable proportion of contemporary youth have a high risk of obesity-related disorders such as cardiovascular disease, metabolic syndrome, or non-alcoholic fatty liver disease (NAFLD). Although there is consistent evidence for the positive effects of physical activity on several health aspects, most adolescents in Colombia are sedentary. It is, therefore, important to implement strategies that generate changes in lifestyle. The HEPAFIT study aims to examine whether a 6-month exercise program has benefits for hepatic fat content and cardiovascular health outcomes among overweight/obese adolescents from Bogotá, Colombia. Methods/design: Altogether, 100 hundred overweight/obese, sedentary adolescents (aged 11–17 years) attending two public schools in Bogotá, Colombia, will be included in a parallel-group randomized controlled trial. Adolescents will be randomly assigned to an intervention group following one of four curricula: (1) the standard physical education curriculum (60 min per week of physical activity, n = 25) at low-to-moderate intensity; (2) a high-intensity physical education curriculum (HIPE, n = 25), consisting of endurance and resistance games and non-competitive activities, such as running, gymkhanas, lifting, pushing, wrestling, or hauling, for 60-min sessions, three times per week, with an energy expenditure goal of 300 to 500 kcal/session at 75–85% maximum heart rate (HRmax); (3) a low-to-moderate intensity physical education curriculum (LIPE, n = 25) consisting of endurance and resistance games and non-competitive activities (e.g., chasing, sprinting, dribbling, or hopping) for 60-min sessions, three times per week with an energy expenditure goal of 300 kcal/session at 55–75% HRmax; and (4) a combined HIPE and LIPE curriculum (n = 25). The HIPE, LIPE, and combined interventions were performed in addition to the standard physical education curriculum. The primary outcome for effectiveness is liver fat content, as measured by the controlled attenuation parameter 1 week after the end of the intervention program. Discussion: The translational focus may be suitable for collecting new information in a school setting on the possible effects of physical activity interventions to reduce liver fat content and to improve metabolic profiles and the cardiometabolic health of overweight/obese adolescents. This may lead to the more efficient use of school physical education resources., The HEPAFIT study was carried out with the financial support of Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología “Francisco José de Caldas” COLCIENCIAS (code 59700 and no 122277757900). Katherine González-Ruíz receive a scholarship from Universidad del Rosario, Colombia, Escuela de Medicina y Ciencias de la Salud, to do a Doctorate. This article presents independent research commissioned by COLCIENCIAS under its Program Grants for Applied Research funding scheme (Convocatoria 777–2017).

Metabolomics can be of great value in the study of exercise metabolism. However, because of the high intraindividual and interindividual biological variability of the human metabolome, special considerations should be taken into account when designing an acute-exercise metabolomic study. To study different exercise parameters, e.g., different exercise modes, intensities, etc., a crossover study design, where each participant acts as their own control, is preferable to a parallel design, one involving different groups of participants. Moreover, the study should include a no exercise, control trial. Before each trial, participants should follow carefully designed preparatory steps to control for possible confounding factors, i.e., maintain repeatable and constant conditions for all individual trials of the study to minimize variation due to factors other than the one(s) being studied. This chapter focuses on the design of human metabolomic studies, where the intervention is an acute metabolic challenge, such as an exercise bout or a test meal, and presents some basic steps for screening potential participants, performing preliminary tests, preparing for the trial day, and performing the trial.

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.

The objective of the study was to identify all parallel design randomised controlled trials (RCTs) comparing treatments for eczema in recent dermatology literature that have failed to report a between-group analysis. The GREAT database (www.greatdatabase.org.uk) was searched to identify parallel group RCTs comparing two or more interventions published in the English language in the last decade, 2004 to 2013. The primary outcome was the number of studies that had not reported a between-group analysis for any of the outcomes. Where possible we re-analysed the data to determine whether a between-group analysis would have given a different conclusion to that reported. Out of a total of 304 RCTs in the study period, 173 (56.9%) met the inclusion criteria. Of the 173 eligible studies, 12 (6.9%) had not conducted a between-group analysis for any of the reported outcomes. There was no clear improvement over time. Five of the eight studies that were re-analysed yielded non-significant between-group differences yet reported significant within-group comparisons. All but one of the 12 studies implied that the experimental intervention was successful despite not undertaking any between-group comparisons. Although the proportion of all RCTs that fail to report an appropriate between-group analysis is small, the fact that any scientist who purports to compare one treatment against another then chooses to omit the key comparison statistic is worrying.

Vicks VapoRub® (VVR) is a pharmaceutical preparation containing a combination of levomenthol, eucalyptus oil, turpentine oil and camphor as active ingredients, and thymol, cedarwood oil, and white soft paraffin as excipients. VVR is a petrolatum-based ointment to be either applied topically to the chest, throat, and back or added to hot water and the aromatic vapours inhaled. When used topically, the actives are evaporated by body temperature and inspired. The main therapeutic effects are the feeling of relief from nasal congestion and relief from cough. These were primarily experienced by patients as the trigeminal and olfactory impact of the aromatics and were hypothesized to be experienced within minutes. This was a randomized, single-(Investigator) blind, controlled, 2-arm (VVR vs. petrolatum), parallel design pilot study in 50 otherwise healthy adult patients suffering from common cold and experiencing nasal congestion. Speed to detection of a sensation of nasal cooling and nasal decongestion was assessed following application of the recommended amount of product. The time to first experience of a sensation of nasal cooling was significantly (p < 0.001) faster for patients who received VVR compared to control (median times of 23 and 99 seconds respectively). VVR delivered a statistically significant sensation of nasal cooling at all times from 12 seconds to 15 minutes after product application. The time to first experience of a sensation of nasal decongestion was significantly (p = 0.0102) faster for patients who received VVR compared to control (median times of 62 and 126 seconds respectively). VVR delivered a statistically significant sensation of nasal decongestion at all times from 62 seconds to 15 minutes after product application. No adverse events were reported during the study. Conclusion: Patients using Vicks VapoRub® as directed experienced significant differences from control for sensation of nasal cooling in 12 seconds and the sensation of nasal decongestion in 62 seconds.