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Prevention of Orbitopathy by Oral or Intravenous Steroid Prophylaxis in Short Duration Graves' Disease Patients Undergoing Radioiodine Ablation: A Prospective Randomized Control Trial Study.
Vannucchi, G, Covelli, D, Campi, I, Currò, N, Dazzi, D, Rodari, M, Pepe, G, Chiti, A, Guastella, C, Lazzaroni, E, et al
Thyroid : official journal of the American Thyroid Association. 2019;(12):1828-1833
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Abstract
Background: Radioiodine (RAI) is a known risk factor for activation or de novo occurrence of Graves' orbitopathy (GO). Several studies demonstrated that GO can be prevented by glucocorticoids (GCs) in patients with pre-existing GO. We have previously shown that Graves' disease duration (GDd) <5 years is a risk factor for RAI-induced GO. We studied the effect of prophylaxis with either oral GCs (OGCs) or intravenous GCs (IVGCs) on GO activation in patients with GDd. Methods: In total, 99 hyperthyroid patients without GO or with pre-existing inactive GO with GDd <5 years were randomized to receive IVGCs (N = 49) or OGCs (N = 50) before RAI; 22 patients with GDd >5 did not receive steroids and were studied as controls. All patients underwent ophthalmological assessment before and 45, 90, 180 days and for a 5-year follow-up after RAI. Serum thyrotropin (TSH) receptor antibodies (TRAbs), thyroid hormones, and thyroid volume (TV) were also measured in response to RAI therapy and steroid prophylaxis. Results: No patient on prophylaxis developed GO after RAI. One woman of the control group, without steroid prophylaxis, and who had a marked elevation of her TSH, showed transient reactivation of GO, which spontaneously improved after restoring euthyroidism. On follow-up at 12 and 20 months after RAI, two patients developed overt optic neuropathy. A smaller TV was associated with a higher prevalence of RAI-induced hypothyroidism. Serum TRAbs increased significantly after RAI (p < 0.0001) but less in patients receiving steroids than in those without prophylaxis at 45 days (p < 0.01). Conclusions: The risk of RAI-induced GO can be prevented in all patients with GDd <5 years by steroids. Such treatment may not be necessary in patients with GDd >5 years. The blunting of TRAb elevation after RAI may be related to the prophylactic effect of steroids.
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Towards reducing behavioral risk factors of non-communicable diseases among adolescents: protocol for a school-based health education program in Bangladesh.
Salwa, M, Atiqul Haque, M, Khalequzzaman, M, Al Mamun, MA, Bhuiyan, MR, Choudhury, SR
BMC public health. 2019;(1):1002
Abstract
BACKGROUND Developing strategies aimed at reducing behavioral risk factors and hence the prevalence of non-communicable diseases (NCDs) is a major challenge to the policy makers today. Like the same age group worldwide, the prevalence of obesity, unhealthy dietary habit, physical inactivity, smoking and alcohol intake is high among the adolescents of Bangladesh. Studies showed promising results of an early intervention at adolescent age in reducing the likelihood of NCDs at adult age. So, this study is designed to implement a behavior change intervention and evaluate the effectiveness of the intervention in reducing the behavioral risk factors of NCDs among the adolescents of Bangladesh. METHODS A before-after designed intervention study will be conducted in two randomly selected secondary schools- one will be selected randomly as intervention school and the another as control school. A baseline survey will be conducted among the students of both schools by a pre-tested questionnaire to attain their current status of knowledge, attitude and practices related to NCDs. Afterward, students will be enrolled in the intervention group who will meet the eligibility criteria from the intervention school. The intervention will be given through a health promotion session to a group of students, not more than 25 at a time, by trained facilitators. A post-intervention end line survey will be conducted among all the participants from both schools using the same questionnaire 3 months after the baseline survey. DISCUSSION An intervention has been developed based on some principals of two psychosocial theory- Motivational Interview and Social Cognitive Theory. Emphasis will be given on motivating the adolescents towards a healthy lifestyle, supporting self-efficacy to be changed, guiding self-regulatory ways along with facilitating desired changing process by empowering them with choices about the preventive measures of NCDs. This intervention is expected to increase awareness by equipping the adolescents with specific knowledge and skills and thus, facilitate an eventual change in their practiced risk behaviors. Besides, this intervention will address multiple behaviors at a time, and will be delivered to a group of adolescents, to attain the cost-effectiveness and thereby making it more realistic in the resource-poor context of Bangladesh. TRIAL REGISTRATION ClinicalTrials.gov NCT03975335, registered on 01.06.2019. Retrospectively registered.
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Serum Brain-Derived Neurotrophic Factor is Related to Platelet Reactivity and Metformin Treatment in Adult Patients With Type 2 Diabetes Mellitus.
Eyileten, C, Mirowska-Guzel, D, Milanowski, L, Zaremba, M, Rosiak, M, Cudna, A, Kaplon-Cieslicka, A, Opolski, G, Filipiak, KJ, Malek, L, et al
Canadian journal of diabetes. 2019;(1):19-26
Abstract
OBJECTIVES The aim of this study was to investigate the association of serum brain-derived neurotrophic factor (BDNF) levels with platelet reactivity and antidiabetes treatment, as well as serum adipocytokine concentrations. METHODS This observational, open-label study enrolled 149 patients. Serum BDNF, hematologic, biochemical parameters and platelet reactivity were measured. Blood samples were taken after the last acetylsalicylic acid dose. RESULTS Patients with high BDNF levels were younger (65.60±8.956 vs. 68.59±8.516) and smoked cigarettes more frequently (14.6% vs. 4.1%); they were more commonly being treated by metformin (77.3% vs. 54%); had higher platelet counts (245.81±68.85 103/mm3 vs. 206.61±44.48 103/mm3); had shorter collagen-adenosine diphosphate closure time (CADP-CT) values (104.88±69.73 s vs. 140.93±86.63 s); had higher triglyceride concentrations (140.73±67.5 vs. 121.76±60.49) and had higher concentrations of serum thromboxane B2 (0.938±1.59 vs. 0.364±0.76). In univariate linear regression analyses, predictive factors for serum BDNF levels above the median were metformin treatment, current smoking, platelet count, triglyceride concentration, total cholesterol concentration and CADP-CT >74 s. In multivariate backward stepwise analysis CADP-CT >141 s; adiponectin concentration >4.22 µg/mL; total cholesterol and low-density lipoprotein levels were independently associated with serum BDNF levels above the median. CONCLUSIONS Our results suggest that BDNF may be associated with lipid metabolism and that increased production of BDNF may be related to metformin treatment. Moreover, we showed an association between BDNF levels and platelet reactivity; we found that serum BDNF levels in patients with type 2 diabetes who had high platelet reactivity were higher than in subjects with normal platelet reactivity despite antiplatelet therapy.
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Comparison of metformin plus myoinositol vs metformin alone in PCOS women undergoing ovulation induction cycles: randomized controlled trial.
Agrawal, A, Mahey, R, Kachhawa, G, Khadgawat, R, Vanamail, P, Kriplani, A
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2019;(6):511-514
Abstract
The present study was planned to evaluate the benefit of synergetic effect of Metformin plus Myo-inositol versus Metformin alone in infertile polycystic ovarian syndrome (PCOS) women undergoing ovulation induction. One hundred and twenty infertile PCOS women were randomized: Group I (n = 60) received Metformin (500 mg) plus Myoinositol(600 mg) three times a day; Group II received Metformin 500 mg three times a day. Subjects were advised to try for spontaneous conception. Those who did not conceive after 3 months, were given three cycles of ovulation induction + intrauterine insemination. Hormonal and biochemical profile parameters were done at baseline and after 3 months of therapy. Primary outcome measure was live birth rate. Secondary outcomes were improvement in menstrual cycle, hormonal and biochemical parameters, spontaneous conception, abortions, multiple pregnancy, and ovarian hyperstimulation syndrome. Baseline demographic, hormonal and biochemical parameters were comparable in two groups. There was a significant improvement in menstrual cycles (cycle length and bleeding days) in Group I as compared to Group II. The improvement in biochemical and hormonal parameters were comparable in the two groups after 3 months. Live birth rate was significantly higher in the Group I as compared to Group II [55% (33/60); 26.67% (16/60); p = .002]. The study concluded significantly higher live birth rate in women receiving the combination as compared to metformin alone.
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The FLEX study school-based physical activity programs - measurement and evaluation of implementation.
Wright, CM, Chomitz, VR, Duquesnay, PJ, Amin, SA, Economos, CD, Sacheck, JM
BMC public health. 2019;(1):73
Abstract
BACKGROUND Increasing children's physical activity (PA) at school is critical to obesity prevention and health promotion. Implementing novel, low-cost PA programs offers potential to contribute to children's in-school PA, particularly in resource-constrained schools. This evaluation describes implementation fidelity, reach, and dose of two PA programs in the Fueling Learning through Exercise (FLEX) Study. METHODS Thirteen diverse, low-income Massachusetts elementary schools were recruited and randomized to the 100 Mile Club walking/running program (n = 7) or CHALK/Just Move classroom activity break PA program (n = 6). Intervention programs were delivered across two school years. Surveys with program champions/teachers and children, in-session measurement of children's PA by accelerometry (Actigraph GT3X) in a subset of schools, and key informant interviews were used to collect information on implementation, including fidelity, dose, reach, and sustainability, and to calculate an implementation score. RESULTS Six CHALK/Just Move schools implemented the program in both years. Two schools randomized to 100 Mile Club did not implement at all, and only three schools implemented both years. Implementing schools had similar implementation scores (range = 0-3; 100 Mile Club = 2.0 vs. CHALK/Just Move = 1.9) but fidelity to core and enhanced elements differed between programs. In 100 Mile Club schools, dose of program delivered was greater than in CHALK/Just Move schools (34.9 vs. 19.7 min per week). Dose of PA received per session was also greater in 100 Mile Club schools (n = 55, 2 schools) compared with CHALK/Just Move schools (n = 160, 2 schools) (13.6 min vs. 2.7 min per session). A slightly higher proportion of eligible children participated in CHALK/Just Move compared to 100 Mile Club (54.0% vs. 31.2%). Both programs were well received by champions/teachers and students. CONCLUSIONS Program implementation varied across programs and schools, and erosion in delivery was seen over the two years. However, among implementing schools, additional PA was delivered and received, and the programs were generally well-received. Although school resource issues remain barriers to implemention, this evaluation demonstrates that low-cost programs may enhance PA opportunities. Future research should evaluate how multiple programs can be implemented to increase children's PA at school. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02810834 . Registered May 11, 2015.
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Could there be Haemodynamic Stress Effects on Pro-Inflammatory CD14+CD16+ Monocytes during Convective-Diffusive Treatments? A Prospective Randomized Controlled Trial.
Bolasco, P, Spiga, P, Arras, M, Murtas, S, La Nasa, G
Blood purification. 2019;(4):385-394
Abstract
BACKGROUND The main aim is to compare the pro-inflammatory CD14+CD16+ monocytes blood levels in patient in end-stage renal disease (ESRD) undergoing Mixed online Haemodiafiltration (Mixed OL-HDF) vs. post-dilution OL-HDF and online high-efficiency haemodialysis. METHODS The study is a prospective double-blind randomized controlled cross-over trial. Dialysis monitor, membrane, duration and dialytic adequacy, volume ultrapure dialysate/infusion were the same in all treatments. Monocyte CD14+CD16+, CD14-CD16+, IL-2R, TNFα, IL-1β, IL-8, IL-6, IL-10, β2-microglobulin outcome were measured. RESULTS Mixed OL-HDF showed a less expression on the activated monocytes CD14+CD16+, CD14-CD16+ (-15.5%). There was no difference between cytokines and high sensitivity C-reactive protein and in other haemato-chemical inflammatory parameters except a significative decrease of TNF-α during Mixed OL-HDF. CONCLUSION We found that Mixed OL-HDF could inhibit the CD14+CD16+ peripheral blood lymphocytes related to a less hemorheology stress inside capillary dialysis filter but in this study there is not still ascertainable its superiority compared to post OL-HDF and post OL-HEH.
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Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes.
Lim, K, Chi, C, Chan, SY, Lim, SL, Ang, SM, Yoong, JS, Tsai, C, Wong, SR, Yew, TW, Tai, ES, et al
BMC public health. 2019;(1):1287
Abstract
BACKGROUND Gestational diabetes (GDM) is a known risk factor for type 2 diabetes mellitus (T2DM), and women with a history of GDM have a 7-fold increased risk of developing the disease. Achieving a healthy weight post-delivery is key in reducing the risk of future diabetes in these women. The aim of this trial is to investigate the use of an interactive smartphone application (APP) to restore women to optimal weight following delivery. METHODS This will be an open-label randomized controlled trial. Two hundred women with gestational diabetes will be randomized to receive the intervention or standard care following delivery. Participants will be reviewed at 6 weeks and 4 months post-delivery. The intervention is an APP serving as a platform for weight, diet and physical activity tracking. The APP provides 3-5 min educational videos suggesting suitable lifestyle adjustments relevant to postnatal period such as breast feeding, diet and exercise. Lastly, the APP will allow real-time interaction between users and the team of dietitians, physiotherapists and occupational therapists to encourage restoration of optimal weight. Women in the control arm will be informed about the increased risk of developing T2DM and advised to maintain a healthy weight. Primary outcome measure is the restoration of participants' booking weight if booking BMI ≤ 23, or weight loss of at least 5% from booking weight if booking BMI > 23 over the 4 month period. Secondary outcome measures will assess serum metabolic and inflammatory markers, quality of life via questionnaires and cost-effectiveness of the intervention at each follow-up visit. DISCUSSION This will be the first randomised controlled trial investigating the use of a smartphone application for postpartum weight loss in women with gestational diabetes. The major ethnic groups in our study population represent the majority of ethnic groups in Asia, amongst which the prevalence of diabetes is high. If shown to be effective, this APP may be used in wider clinical settings to improve postpartum weight loss and reduce the risk of developing T2DM in these women. TRIAL REGISTRATION This study was registered on clintrials.gov on the 30th of October 2017, under the trial registration number: NCT03324737 .
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The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism.
Susantitaphong, P, Vadcharavivad, S, Susomboon, T, Singhan, W, Dumrongpisutikul, N, Jakchairoongruang, K, Eiam-Ong, S, Praditpornsilpa, K
Renal failure. 2019;(1):326-333
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BACKGROUND Secondary hyperparathyroidism (SHPT) is associated with high incidences of cardiovascular disease, bone fracture, and mortality. This study was conducted to demonstrate the effectiveness of cinacalcet treatment on chronic kidney disease-mineral bone disorder (CKD-MBD) markers in chronic hemodialysis patients with severe SHPT. METHODS In phase 1, 30 adult HD patients were randomized to cinacalcet or control groups for 12 weeks to explore the achievement of >30% reduction of iPTH. In phase 2, 45 patients were participated to further explore the effect of cinacalcet on CKD-MBD parameters for 24-week follow up and 12 additional weeks after cinacalcet discontinuation. RESULTS In phase 1, the baseline serum iPTH levels were not different [1374 (955, 1639) pg/mL in the control group vs. 1191 (1005, 1884) pg/mL in the cinacalcet group], the percentage of patients achieving iPTH target were significantly higher in the treatment group [80% vs. 13%, p = .001]. In phase 2, the significant reductions of iPTH, FGF-23, tartrate-resistant acid phosphatase 5b, and slightly decreased size of parathyroid gland and stabilized vascular calcification were observed at 24-week follow up and markedly rebounded after discontinuation of cinacalcet. CONCLUSIONS The effectiveness of cinacalcet were still obviously demonstrated even in chronic HD patients with severe SHPT. In addition, the improvements of bone markers and FGF-23, and stabilization of vascular calcification were observed. Therefore, cinacalcet can provide salutary effects on CKD-MBD in severe SHPT and might be an initially effective PTH-lowering therapy prior to surgical parathyroidectomy as well as an alternative treatment in the patients unsuitable for surgery. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov: NCT02056730. Date of registration: February 4, 2014.
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Effect of Donor Milk Supplementation on Breastfeeding Outcomes in Term Newborns: A Randomized Controlled Trial.
Kair, LR, Flaherman, VJ, Colaizy, TT
Clinical pediatrics. 2019;(5):534-540
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BACKGROUND Pasteurized donor human milk (DHM) use for healthy newborns is increasing; however, no studies have explored its effect on breastfeeding outcomes. PATIENTS AND METHODS We enrolled 60 healthy, term breastfeeding newborns with ≥4.5% weight loss in the first 36 hours in a randomized controlled trial. Thirty newborns were randomly assigned to early limited-volume DHM supplementation and 30 newborns to exclusive breastfeeding. Mothers were surveyed at 1 week and 1, 2, and 3 months regarding the mode of infant feeding. Comparing infants randomized to DHM supplementation with those exclusively breastfeeding, there was no significant difference in the proportion using formula at 1 week (21% vs 7%, P = .15), nor in the proportion of any breastfeeding (79% vs 90%, P = .30) or breastfeeding without formula at 3 months (62% vs 77%, P = .27). Conclusion For newborns with ≥4.5% weight loss in the first 36 hours, early limited-volume supplementation with DHM is unlikely to have a significant favorable impact on breastfeeding outcomes.
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Is dietary melatonin supplementation a viable adjunctive therapy for chronic periodontitis?-A randomized controlled clinical trial.
El-Sharkawy, H, Elmeadawy, S, Elshinnawi, U, Anees, M
Journal of periodontal research. 2019;(2):190-197
Abstract
BACKGROUND AND OBJECTIVE Melatonin is synthesized naturally by pineal gland and responsible for regulation of sleep/waking cycle. It showed appreciated anti-inflammatory and antioxidant properties. The aim of this randomized clinical trial (RCT) was to assess the additive effect of melatonin supplementation in insomniac individuals with generalized chronic periodontitis (gCP) after scaling and root planing (SRP). MATERIAL AND METHODS Seventy-four gCP patients with primary insomnia participated in this 6-month RCT and randomized into two groups. Melatonin group included 38 patients who were subjected to SRP with a 2-month regimen of 10 mg oral melatonin capsule once daily before bedtime. In the control group, SRP was performed for 36 participants provided with matching placebo capsules. The primary treatment outcome was the measurement of clinical attachment level gain (CAL gain) after 3 and 6 months of therapy, whereas the measurements of pocket depth reduction (PD reduction), bleeding on probing (BOP %), and the changes in salivary TNF-α levels and Athens insomnia scale (AIS) scores represented the secondary endpoints. RESULTS Melatonin group showed significantly greater CAL gain and PD reduction measurements compared to the control group at 3 and 6 months of therapy, P < 0.01. Likewise, salivary TNF-α levels and AIS scores were significantly lower in the melatonin group compared to placebo group. BOP% improved significantly in both groups without any difference. However, salivary TNF-α levels exhibited no correlation with other clinical variables in both melatonin and placebo groups. CONCLUSION Daily dietary 10 mg of melatonin supplementation might serve as a viable adjunct to SRP that yielded significantly greater CAL gain and PD reduction and lower salivary TNF-α levels and AIS scores in gCP patients with primary insomnia.