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Sample records for 12-month pramlintide treatment

  1. Review of pramlintide as adjunctive therapy in treatment of type 1 and type 2 diabetes

    PubMed Central

    Ryan, Gina; Briscoe, Tim A; Jobe, Lynette

    2008-01-01

    Pramlintide (Symlin®), a synthetic analog of a neurohormone amylin, was approved by the US Food and Drug Administration for use along with premeal insulin in patients with type 1. In patients with type 2 diabetes, pramlintide is approved for addition to premeal insulin in those patients who are either only on premeal insulin or those receiving the combination of insulin and metformin and/or a sulfonylurea. This article reviews the pharmacology, pharmacokinetics, dosing, clinical trials, safety, contraindications, and drug interactions of pramlintide therapy. A search for published clinical trials and therapeutic reviews in the English language was done in the following databases: Iowa Drug Information Service (1966 to July 2008), MEDLINE (1966 to July 2008), and International Pharmaceutical Abstracts (1970 to July 2008). Pramlintide and amylin were used as keywords and title words. References of key articles were also reviewed to identify additional publications. Amylin is a 37 amino acid peptide neurohormone cosecreted from the beta cells of the pancreas, along with insulin, in response to meals. Amylin lowers serum glucose by decreasing glucagon release, slowing gastric emptying and decreasing food intake. Pramlintide, a synthetic analog of amylin, reduces 2-hour postprandial blood glucose between 3.4 and 5 mmol/L, reduces A1C by 0.2% to 0.7% and has no effect on fasting glucose levels. The use of pramlintide was associated with up to a 1.6 kg weight loss. Nausea was the most commonly reported adverse event. Pramlintide is an amylin analog that was FDA approved for the treatment of type 1 and type 2 diabetes. Its use results in modest reduction of A1C and the most frequent side effects are hypoglycemia and nausea. PMID:19920907

  2. The role of prandial pramlintide in the treatment of adolescents with type 1 diabetes

    USDA-ARS?s Scientific Manuscript database

    Pramlintide, a synthetic analog of amylin, improves postprandial hyperglycemia. We compared subcutaneous (s.c.) pramlintide injection with square wave pramlintide infusion in adolescents with type 1 diabetes (T1DM). Eight subjects with T1DM underwent two randomized studies. Subcutaneous pramlintide ...

  3. Parents’ perceived treatment match and treatment retention over 12 months among youth in the LAMS study

    PubMed Central

    Young, Andrea S.; Horwitz, Sarah M.; Findling, Robert L.; Youngstrom, Eric A.; Arnold, L. Eugene; Fristad, Mary A.

    2015-01-01

    Objective The goal of these analyses was to describe the 12-month prevalence and identify predictors of mental health services retention for youth, ages 6–12 years, using data from the Longitudinal Assessment of Manic Symptoms (LAMS) study. Methods In a longitudinal cohort study, 416 children and their parents completed measures of mental health services use and parents’ perception of the services and semi-structured psychodiagnostic interviews at a baseline and 12-month assessment. Logistic regression analyses examined the effects of demographic and clinical variables and parents’ perception of how well their children’s treatment matched their needs on 12-month treatment retention. Results Sixty-nine percent of youth (n=289) continued to use services at 12 months. White race (p<.001) and greater functional impairment (p=.024) were associated with treatment retention; greater perceived treatment match at baseline significantly predicted retention above and beyond the effects of sociodemographic and clinical variables (p=.001). Conclusions White race and parents’ perceptions about appropriateness of treatment predict 12-month treatment retention. PMID:26522675

  4. Dose Accuracy and Injection Force of Disposable Pens Delivering Pramlintide for the Treatment of Diabetes

    PubMed Central

    Merritt, Douglas; Schreiner, Barb; Harris, Scott; DeYoung, Mary Beth; Strobel, Susan; Lauinger, Joseph

    2010-01-01

    Background The pen injection format, typically used for insulin administration, has been adapted for the injectable, noninsulin diabetes therapy pramlintide. Administered before major meals, pramlintide therapy requires two to four injections/day in addition to the patients’ usual insulin injections. The dose accuracy and injection force was determined for the 60 and 120 µg pramlintide pens. Methods Dose accuracy testing was conducted at two sites on multiple 60 µg (15, 30, and 60 µg doses) and 120 µg pens (60 and 120 µg doses) at prespecified temperatures (5–40 °C) and humidities (0–75%) using 29 G half-inch needles. All pens were stabilized under testing conditions for 4 h prior to testing. One site used a compression load cell (Zwick device) to test pens; one site performed tests manually. Injection-force testing was conducted at one site on multiple 60 and 120 µg pens at multiple temperatures (18–28 °C) and humidities (25–75%) using 29 and 31 G half-inch needles and an injection speed of 150 m/min. Injection-force testing was performed using a Zwick device. Results Dose accuracy for all pens tested, regardless of location, reproducibly met/exceeded acceptance criteria. Mean percentage of dose accuracy was 96.04 to 102.45% [standard deviations (SDs) 0.3 to 1.4 µg] for the 60 µg pen and 98.16 to 101.83% (SDs 0.4 to 2.5 µg) for the 120 µg pen. The average injection force across both pens did not exceed 7 N regardless of needle size. Conclusions High dose accuracy and low injection force were observed for the 60 and 120 µg pens under a variety of conditions. PMID:21129339

  5. Dose accuracy and injection force of disposable pens delivering pramlintide for the treatment of diabetes.

    PubMed

    Merritt, Douglas; Schreiner, Barb; Harris, Scott; DeYoung, Mary Beth; Strobel, Susan; Lauinger, Joseph

    2010-11-01

    The pen injection format, typically used for insulin administration, has been adapted for the injectable, noninsulin diabetes therapy pramlintide. Administered before major meals, pramlintide therapy requires two to four injections/day in addition to the patients' usual insulin injections. The dose accuracy and injection force was determined for the 60 and 120 µg pramlintide pens. Dose accuracy testing was conducted at two sites on multiple 60 µg (15, 30, and 60 µg doses) and 120 µg pens (60 and 120 µg doses) at prespecified temperatures (5-40 °C) and humidities (0-75%) using 29 G half-inch needles. All pens were stabilized under testing conditions for 4 h prior to testing. One site used a compression load cell (Zwick device) to test pens; one site performed tests manually. Injection-force testing was conducted at one site on multiple 60 and 120 µg pens at multiple temperatures (18-28 °C) and humidities (25-75%) using 29 and 31 G half-inch needles and an injection speed of 150 m/min. Injection-force testing was performed using a Zwick device. Dose accuracy for all pens tested, regardless of location, reproducibly met/exceeded acceptance criteria. Mean percentage of dose accuracy was 96.04 to 102.45% [standard deviations (SDs) 0.3 to 1.4 µg] for the 60 µg pen and 98.16 to 101.83% (SDs 0.4 to 2.5 µg) for the 120 µg pen. The average injection force across both pens did not exceed 7 N regardless of needle size. High dose accuracy and low injection force were observed for the 60 and 120 µg pens under a variety of conditions. © 2010 Diabetes Technology Society.

  6. Suicide Attempts within 12 Months of Treatment for Substance Use Disorders

    ERIC Educational Resources Information Center

    Britton, Peter C.; Conner, Kenneth R.

    2010-01-01

    There are limited prospective data on suicide attempts (SA) during the months following treatment for substance use disorders (SUD), a period of high risk. In an analysis of the Drug Abuse Treatment Outcomes Study, a longitudinal naturalistic multisite study of treated SUDs, variables associated with SA in the 12 months following SUD treatment…

  7. Suicide Attempts within 12 Months of Treatment for Substance Use Disorders

    ERIC Educational Resources Information Center

    Britton, Peter C.; Conner, Kenneth R.

    2010-01-01

    There are limited prospective data on suicide attempts (SA) during the months following treatment for substance use disorders (SUD), a period of high risk. In an analysis of the Drug Abuse Treatment Outcomes Study, a longitudinal naturalistic multisite study of treated SUDs, variables associated with SA in the 12 months following SUD treatment…

  8. Intravitreal bevacizumab treatment for choroidal neovascularization in pathologic myopia: 12-month results.

    PubMed

    Gharbiya, Magda; Allievi, Francesca; Mazzeo, Luigi; Gabrieli, Corrado Balacco

    2009-01-01

    To evaluate the short-term efficacy and safety of intravitreal bevacizumab for the treatment of myopic choroidal neovascularization (CNV). Prospective, nonrandomized, interventional case series. Twenty eyes from 20 patients with CNV secondary to pathologic myopia participated in this prospective nonrandomized interventional case series. All patients were scheduled for three monthly intravitreal bevacizumab 1.25 mg injections. Early Treatment Diabetic Retinopathy Study best-corrected visual acuity (BCVA), foveal center thickness (FCT) on optical coherence tomography (OCT), and fluorescein angiographic findings were examined before and after treatment. Patients were followed up for 12 months. The mean BCVA (+/- standard deviation [SD]) at baseline was 24.8 (+/- 11.86) letters (Snellen equivalent: 20/80). At 12 months after treatment, the mean BCVA (+/- SD) improved significantly (P = .000001) to 43 (+/- 12.38) letters (Snellen equivalent: 20/35). At 12 month follow-up, BCVA improved 10 letters or more in 18 (90%) out of 20 treated eyes and improved 15 letters or more in 14 (70%) out of 20 treated eyes. No treated eyes experienced a worsening of BCVA from baseline. The mean FCT (+/- SD) at baseline was 223 (+/- 47.43) microns. At 12 months after treatment, the mean FCT (+/- SD) reduced to 206 (+/- 50.87) microns. This reduction in FCT after treatment was not statistically significant (P = .11). At 12 months follow-up, absence of fluorescein leakage from the CNV was demonstrated in 19 (95%) out of 20 treated eyes and persistent leakage in one eye (5%). None of the 19 eyes that had CNV closure experienced recurrence at 12-month follow-up. No ocular or systemic adverse effects from treatment were encountered. These results of intravitreal bevacizumab in myopic CNV are very promising with no apparent short-term safety concerns. At 12 months, treated eyes had a significant improvement in visual acuity (VA). OCT findings, as well, showed a trend consistent with the

  9. Suicide attempts within 12 months of treatment for substance use disorders.

    PubMed

    Britton, Peter C; Conner, Kenneth R

    2010-02-01

    There are limited prospective data on suicide attempts (SA) during the months following treatment for substance use disorders (SUD), a period of high risk. In an analysis of the Drug Abuse Treatment Outcomes Study, a longitudinal naturalistic multisite study of treated SUDs, variables associated with SA in the 12 months following SUD treatment were examined. Participants included 2,966 patients with one or more SUDs. By 12 months, 77 (2.6%) subjects had attempted suicide. Multivariate logistic regression analyses were used to identify variables associated with SA. Variables collected at baseline that were associated with SA included lifetime histories of SA, suicidal ideation (SI), depression, cocaine as primary substance of use, outpatient methadone treatment, and short-term inpatient treatment. Male sex, older age, and minority race or ethnicity were associated with lower likelihood of SA. After controlling for baseline predictors, variables assessed at 12 months associated with SA included SI during follow-up and daily or more use of cocaine. The data contribute to a small but growing literature of prospective studies of SA among treated SUDs, and suggest that SUDs with cocaine use disorders in particular should be a focus of prevention efforts.

  10. Non-fatal overdose in the 12 months following treatment for substance use disorders

    PubMed Central

    Britton, Peter C.; Wines, James D.; Conner, Kenneth R.

    2009-01-01

    Background Overdose (OD) is a leading cause of mortality and morbidity for individuals with substance use disorders (SUDs), and there are limited prospective data on OD during the months following treatment for SUDs. Methods Variables associated with an OD in the 12 months after leaving an initial treatment episode were examined in an analysis of the Drug Abuse Treatment Outcomes Study (DATOS), a longitudinal naturalistic multisite study. Participants included 2,966 patients with one or more SUDs. Non-fatal OD was ascertained by a positive response to “In the past 12 months, have you overdosed on drugs?” Multivariate logistic regression analyses were used to identify variables associated with OD. Results By 12 months, 93 (3.1%) participants reported one or more ODs. Variables associated with OD were lifetime history of OD, injection drug use (IDU), male sex, greater pain, and history of sexual abuse. Conclusions OD-risk appears to be increased by IDU, lifetime OD, sexual abuse history, and pain. The latter finding is novel for a prospective report and requires further study. PMID:19828263

  11. South Texas Residency Screening, Brief Intervention, and Referral to Treatment (SBIRT) Training: 12-Month Outcomes.

    PubMed

    Malone, Glenn P; Vale Arismendez, Shruthi; Schneegans Warzinski, Suyen; Amodei, Nancy; Burge, Sandra K; Wathen, Patricia I; Conde, Michelle V; Palmer, Raymond; Williams, Janet F

    2015-01-01

    Screening, brief intervention, and referral to treatment (SBIRT) is an efficacious and cost-effective skill set when implemented in primary care settings regarding hazardous alcohol use. This study assesses the impact of medical resident SBIRT training across 3 specialties and identifies predictors of change in trainee behavior, attitudes, and knowledge over 12 months. This program's substance use SBIRT training was developed and tailored to fit diverse curricular objectives and settings across an array of medical residency programs in South Texas. The 329 residents training in pediatrics, family medicine, and internal medicine during 2009-2012 constituted the trainee group reported in this analysis. Surveys assessing SBIRT-related knowledge, current practice, confidence, role responsibility, attitudes, beliefs, and readiness to change were completed by 234 (71%) trainees at 3 time points: pre-training, then 30 days and 12 months post-initial training. SBIRT-related knowledge, confidence, and practice increased from pre-training to 12-month follow-up. Residents who reported the least amount of pre-training clinical and/or prior academic exposure to substance use reported the greatest SBIRT practice increases. When controlling for demographic and prior exposure variables, the largest contributor to variance in SBIRT practice was attributed to residents' confidence in their SBIRT skills. SBIRT training that employs diverse educational methodologies as part of customizing the training to residency specialties can similarly enhance SBIRT-related knowledge, confidence, and practice. Trainee report of limited prior clinical or academic exposure to substance use and/or low confidence regarding SBIRT skills and their professional role responsibilities related to substance use predicted trainee success and sustained SBIRT strategy application. When customizing SBIRT training, curriculum developers should consider leveraging and capacity building related to those factors

  12. Early childhood caries (ECC): a preventive-conservative treatment mode during a 12-month period.

    PubMed

    Peretz, Benjamin; Gluck, George

    2006-01-01

    To evaluate a preventive treatment mode for early childhood caries (ECC). The population to be studied included 30 children who, over a 12-month period, presented with ECC to a private dental clinic. Parents preferred non-invasive, preventive treatment over restorations. Parents were given hygiene and proper feeding instructions. Mesial slicing was performed where proximal caries was observed. Children were examined once every two months. They received supervised professional topical fluoride treatment. Plaque level, brushing, stopping the bottle, eating sweets, appearance of new lesions or exacerbation of existing condition were observed and recorded. In the vast majority of patients, the progression of ECC was arrested after the preventive regimen. Three children required restorations. They had failed to limit sugar consumption and to comply with brushing instruction. General improvement was observed in plaque control, brushing habits and sweets consumption. Preventive measures may successfully arrest ECC and thereby avoid invasive procedures as well as the need of anesthesia.

  13. Factors associated with recurrent tuberculosis more than 12 months after treatment completion

    PubMed Central

    Kim, Lindsay; Moonan, Patrick K.; Heilig, Charles M.; Yelk Woodruff, Rachel S.; Kammerer, J. Steve; Haddad, Maryam B.

    2016-01-01

    SUMMARY Setting Even in persons with complete treatment of their first tuberculosis (TB) episode, patients with a TB history are at higher risk for having TB. Objective Describe factors from the initial TB episode associated with recurrent TB among patients who completed treatment and remained free of TB for at least 12 months. Design US TB cases, stratified by birth origin, during 1993–2006 were examined. Cox proportional hazards regression was employed to assess the association of factors during the initial episode with recurrence at least 12 months after treatment completion. Results Among 632 US-born patients, TB recurrence was associated with age 25–44 (adjusted hazard ratio [aHR] 1.77, 99% confidence interval [CI] 1.02–3.09, attributable fraction [AF] 1%–34%), substance use (aHR 1.57, 99%CI 1.23–2.02, AF 8%–22%), and treatment supervised by health departments (aHR 1.42, 99%CI 1.03–1.97, AF 2%–28%). Among 211 foreign-born patients, recurrence was associated with HIV infection (aHR 2.24, 99%CI 1.27–3.98, AF 2%–9%) and smear-positive TB (aHR 1.56, 99%CI 1.06–2.30, AF 3%–33%). Conclusion Factors associated with recurrence differed by birth origin and might be useful for anticipating greater risk for recurrent TB among certain patients with a TB history. PMID:26688528

  14. Day Hospital Treatment for Anorexia Nervosa: A 12-Month Follow-up Study.

    PubMed

    Abbate-Daga, Giovanni; Marzola, Enrica; De-Bacco, Carlotta; Buzzichelli, Sara; Brustolin, Annalisa; Campisi, Stefania; Amianto, Federico; Migliaretti, Giuseppe; Fassino, Secondo

    2015-09-01

    Day hospitals (DHs) represent a treatment option for anorexia nervosa (AN), a mental disorder that is difficult to treat and has no evidence-based treatments available. We aimed to determine the effectiveness of a DH treatment that was specifically focused on the emotions of severe AN patients. Body mass index and eating psychopathology were the primary outcome measures. Fifty-six adult patients with AN were assessed upon admission, at the end of treatment (EOT) and at a 12-month follow-up evaluation (T18) using Eating Disorders Inventory-2, Beck Depression Inventory, Hamilton Rating Scale for Anxiety and Brief Social Phobia Scale. All participants received a multidisciplinary treatment programme that focused on psychodynamic psychotherapy. Seventy-eight per cent of participants reported positive outcomes at EOT and 68% at T18. Moreover, 82.1% and 65.4% of long-standing patients showed positive outcomes at EOT and T18, respectively. All measures of psychopathology were significantly improved at EOT and were maintained at follow-up. Our DH was effective at treating severe AN patients; however, further investigations of the processes of change are warranted.

  15. Enhanced weight loss following coadministration of pramlintide with sibutramine or phentermine in a multicenter trial.

    PubMed

    Aronne, Louis J; Halseth, Amy E; Burns, Colleen M; Miller, Stephan; Shen, Larry Z

    2010-09-01

    Preclinical evidence suggests that pharmacotherapy for obesity using combinations of agents targeted at distinct regulatory pathways may produce robust additive or synergistic effects on weight loss. This randomized placebo-controlled trial examined the safety and efficacy of the amylin analogue pramlintide alone or in combination with either phentermine or sibutramine. All patients also received lifestyle intervention. Following a 1-week placebo lead-in, 244 obese or overweight, nondiabetic subjects (88% female; 41 +/- 11 years; BMI 37.7 +/- 5.4 kg/m(2); weight 103 +/- 19 kg; mean +/- s.d.) received placebo subcutaneously (sc) t.i.d., pramlintide sc (120 microg t.i.d.), pramlintide sc (120 microg t.i.d.) + oral sibutramine (10 mg q.a.m.), or pramlintide sc (120 microg t.i.d.) + oral phentermine (37.5 mg q.a.m.) for 24 weeks. Treatment was single-blind for subjects receiving subcutaneous medication only and open-label for subjects in the combination arms. Weight loss achieved at week 24 with either combination treatment was greater than with pramlintide alone or placebo (P < 0.001; 11.1 +/- 1.1% with pramlintide + sibutramine, 11.3 +/- 0.9% with pramlintide + phentermine, -3.7 +/- 0.7% with pramlintide; -2.2 +/- 0.7% with placebo; mean +/- s.e.). Elevations from baseline in heart rate and diastolic blood pressure were demonstrated with both pramlintide + sibutramine (3.1 +/- 1.2 beats/min, P < 0.05; 2.7 +/- 0.9 mm Hg, P < 0.01) and pramlintide + phentermine (4.5 +/- 1.3 beats/min, P < 0.01; 3.5 +/- 1.2 mm Hg, P < 0.001) using 24-h ambulatory monitoring. However, the majority of subjects receiving these treatments remained within normal blood pressure ranges. These results support the potential of pramlintide-containing combination treatments for obesity.

  16. Metronomic chemotherapy for metastatic breast cancer to prolong time to treatment failure to 12 months or more

    PubMed Central

    KONTANI, KEIICHI; HASHIMOTO, SHIN-ICHIRO; MURAZAWA, CHISA; NORIMURA, SHOKO; TANAKA, HIROAKI; OHTANI, MASAHIRO; FUJIWARA-HONJO, NAOMI; DATE, MANABU; HOUCHI, HITOSHI; YOKOMISE, HIROYASU

    2013-01-01

    The objective of treatment for metastatic breast cancer (MBC) is to control the disease or disease-related symptoms. Prolonged survival has also often been achieved by chemotherapeutic regimens in this setting. Long-term administration of one therapeutic regimen is essential for prolonging survival as well as for maintaining quality of life in these patients. In this study, we focused on time to treatment failure (TTF) as a parameter that predicts patient survival and we retrospectively compared clinical outcomes of patients with MBC who showed TTF of ≥12 months (26 patients) and <12 months (29 patients). The proportion of hormone receptor-positive tumors and the number of prior chemotherapy regimens for MBC were significantly higher and tumor grade was lower in patients with TTF ≥12 months compared to those with TTF <12 months. With regard to clinical outcomes, the objective response rate (ORR) in patients with TTF ≥12 months was significantly higher and median time to progression (TTP) and overall survival (OS) were longer compared to those with TTF <12 months. Of note, the proportion of patients who received metronomic regimens was significantly higher in patients with TTF ≥12 months compared to those with TTF <12 months (80.8 vs. 24.1%, P=0.00003). To assess the clinical benefit of metronomic regimens, the efficacy in patients receiving metronomic and those receiving non-metronomic regimens was compared. Although there was no difference in ORR between the two groups, median TTP and OS were significantly longer in the metronomic compared to the non-metronomic group (TTP: 30 vs. 4 months, P=0.0017; OS: 68 vs. 28 months, P=0.0005). The results suggested that metronomic chemotherapy is useful for palliative care and also improved clinical outcomes as a regimen for which long-term administration may be expected. PMID:24649151

  17. Embolization for the treatment of intractable epistaxis: 12 month outcomes in a two centre case series.

    PubMed

    Robinson, Anthony E; McAuliffe, William; Phillips, Timothy J; Phatouros, Constantine C; Singh, Tejinder P

    2017-10-03

    Embolization is a treatment option for intractable epistaxis, however concerns regarding tissue necrosis, stroke and blindness persist in the literature. A retrospective review of patients from September 2010 - January 2016 treated with embolization for epistaxis was performed. No patient was excluded. Followup was 12 months and no patient was lost. 62 embolizations on 59 patients occurred. 21 cases were taking anticoagulants, P2Y12 inhibiting agents or had a systemic coagulopathy. Embolized territories typically involved bilateral distal internal maxillary arteries with unilateral or bilateral facial arteries with polyvinyl alcohol particles. 60 cases had procedural general anesthesia. There were no major complications. 6 died of unrelated causes. Of the surviving 53 patients, excluding the 3 patients with hereditary hemorrhagic telangiectasia, 5 had recurrent epistaxis post embolization. Four were taking P2Y12 inhibiting and/or anticoagulants, none of which required surgery, prolonged packing or repeat embolization. This group had a propensity to recur compared to cases taking aspirin only or no antiplatelet/anticoagulant (77.8% vs 97.1%, p=0.04). The fifth underwent repeat embolization after previously only having ipsilateral distal internal maxillary and facial arteries treated. Embolization for epistaxis is safe and effective. Of those who had recurrent epistaxis post embolization, most were taking P2Y12 inhibition and/or anticoagulation. We prefer bilateral distal internal maxillary artery and unilateral facial artery embolization under general anesthesia for optimal safety and efficacy. Advances in knowledge: Embolization with this technique seems to facilitate superior outcomes without complications despite the large proportion of patients taking anticoagulating or P2Y12 inhibiting agents.

  18. Analysis of correlation between initial alveolar bone density and apical root resorption after 12 months of orthodontic treatment without extraction

    PubMed Central

    Scheibel, Paula Cabrini; Ramos, Adilson Luiz; Iwaki, Lilian Cristina Vessoni; Micheletti, Kelly Regina

    2014-01-01

    OBJECTIVE: The aim of the present study was to investigate the correlation between initial alveolar bone density of upper central incisors (ABD-UI) and external apical root resorption (EARR) after 12 months of orthodontic movement in cases without extraction. METHODS: A total of 47 orthodontic patients 11 years old or older were submitted to periapical radiography of upper incisors prior to treatment (T1) and after 12 months of treatment (T2). ABD-UI and EARR were measured by means of densitometry. RESULTS: No statistically significant correlation was found between initial ABD-UI and EARR at T2 (r = 0.149; p = 0.157). CONCLUSION: Based on the present findings, alveolar density assessed through periapical radiography is not predictive of root resorption after 12 months of orthodontic treatment in cases without extraction. PMID:25715722

  19. Finasteride in the treatment of Taiwanese men with androgenetic alopecia: a 12-month open-label study.

    PubMed

    Lin, Jeng-Hsien; Chen, Wen-Chieh

    2002-08-01

    Finasteride 1 mg/day is effective in the treatment of androgenetic alopecia (AGA). Our open-label study assessed the efficacy and safety of finasteride for the treatment of Taiwanese men with AGA. We enrolled 34 Taiwanese men (aged 18-40 yr) with AGA of modified Norwood/Hamilton scale (MNHS) grade II-V. In investigator assessments at 12 months, five of 21 subjects (23.8%) had two-grade improvement in MNHS grade and 12 of 21 subjects (57.1%) had one-grade improvement; the others remained at the same grade. In global photographic evaluation, five of 31 subjects (15.1%) had observable hair growth at 6 months and 11 of 21 subjects (52.4%) had observable hair growth at 12 months. Patient self-assessment of hair growth was favorable across all questions in the treatment course, more significantly at 12 months than at 6 months; nine of 21 subjects (42.9%) were satisfied with their overall appearance at 12 months. Serum prostate specific antigen levels had decreased by 23.4% at 12 months. Adverse effects, including abnormal liver function (5/34), were minimal, and the causal relationship with finasteride could not be established. Thus, in Taiwanese men with AGA, finasteride 1 mg/day for 1 year slowed the progression of hair loss and increased hair growth.

  20. Vagus nerve stimulation for chronic major depressive disorder: 12-month outcomes in highly treatment-refractory patients.

    PubMed

    Christmas, David; Steele, J Douglas; Tolomeo, Serenella; Eljamel, M Sam; Matthews, Keith

    2013-09-25

    There are limited treatment options for patients with chronic, treatment-refractory major depression who do not respond to routinely-available treatments. Vagus Nerve Stimulation (VNS) may represent an alternative to ablative neurosurgery for a specific group of patients. 12-month response rates for 28 patients with chronic (≥2 years) major depression who had failed to respond to ≥4 adequate treatment trials in the D03 European open clinical trial of VNS were described along with response rates for 13 consecutive patients who underwent VNS within the neurosurgical treatment programme in Dundee. In the D03 cohort (N=28), the response rate at 12 months (defined as a 50% reduction in symptom score) was 35.7%. In the Dundee VNS case series (N=13), the equivalent response rate was 30.8%. These data are from unblinded and open studies, and there is no control group. Other factors may have contributed to some of the improvement seen, although this is unlikely in very chronic populations. Outcomes are not reported beyond 12 months. Response rates at 12 months for patients with chronic and highly-refractory major depression are broadly consistent with previously published results in more heterogeneous and less refractory clinical trial populations. In highly treatment-resistant patients, the rate of response with VNS at 12 m is at least twice that anticipated with 'treatment-as-usual'. © 2013 Elsevier B.V. All rights reserved.

  1. Buprenorphine-naloxone treatment in opioid dependence and risk of liver enzyme elevation: results from a 12-month observational study.

    PubMed

    Soyka, Michael; Backmund, Markus; Schmidt, Peggy; Apelt, Sabine

    2014-01-01

    Some case series mention possible liver toxicity in opioid-dependent patients under buprenorphine treatment. This 12-month prospective observational follow-up study in opioid-dependent patients under buprenorphine-naloxone treatment assessed outcome and safety issues. At baseline, 337 eligible datasets were available; 181 patients completed the 12-month study. Liver enzymes were tested at baseline and after 12, 24, and 52 weeks' treatment. One to two percent of patients showed mostly discrete elevations of liver enzymes, but no patient met the criteria for drug-induced liver injury. No serious liver-related adverse events occurred, but two non-serious cases of liver enzyme increase were recorded. No patient dropped out of treatment for liver-related disorders. This study is in line with some recent studies and provides further evidence that buprenorphine-naloxone is relatively safe with respect to liver injury. © American Academy of Addiction Psychiatry.

  2. Early transconjunctival needling revision with 5-fluorouracil versus medical treatment in encapsulated blebs: a 12-month prospective study.

    PubMed

    Suzuki, Ricardo; Susanna-Jr, Remo

    2013-10-01

    To compare the efficacy of transconjunctival needling revision with 5-fluorouracil versus medical treatment in glaucomatous eyes with uncontrolled intraocular pressure due to encapsulated bleb after trabeculectomy. Prospective, randomized, interventional study. A total of 40 eyes in 39 patients with elevated intraocular pressure and encapsulated blebs diagnosed at a maximum five months after primary trabeculectomy with mitomycin C were included. The eyes were randomized to either transconjunctival needling revision with 5- fluorouracil or medical treatment (hypotensive eyedrops). A maximum of two transconjunctival needling revisions per patient was allowed in the needling arm. All patients underwent follow-up for 12 months. Successful treatment was defined as an intraocular pressure ≤ 18 mmHg and a 20% reduction from baseline at the final follow-up. Clinicaltrial.gov: NCT01887223. Mean intraocular pressure at the final 12-month follow-up was lower in the transconjunctival needling revision group compared to the medical treatment group. Similar numbers of eyes reached the criteria for treatment success in both the transconjunctival needling revision group and the medical treatment group. Despite similar success rates in eyes randomized to transconjunctival needling revision with 5-fluorouracil compared to eyes receiving medical treatment, there was a significantly lower mean intraocular pressure at 12 months after transconjunctival needling revision.

  3. Early response to inhaled bronchodilators and corticosteroids as a predictor of 12-month treatment responder status and COPD exacerbations

    PubMed Central

    Calverley, Peter M; Postma, Dirkje S; Anzueto, Antonio R; Make, Barry J; Eriksson, Göran; Peterson, Stefan; Jenkins, Christine R

    2016-01-01

    Background Early treatment response markers, for example, improvement in forced expiratory volume in 1 second (FEV1) and St George’s Respiratory Questionnaire (SGRQ) total score, may help clinicians to better manage patients with chronic obstructive pulmonary disease (COPD). We investigated the prevalence of clinically important improvements in FEV1 and SGRQ scores after 2-month budesonide/formoterol or formoterol treatment and whether such improvements predict subsequent improvements and exacerbation rates. Methods This post hoc analysis is based on data from three double-blind, randomized studies in patients with moderate-to-very-severe COPD receiving twice-daily budesonide/formoterol or formoterol alone for 6 or 12 months. Prebronchodilator FEV1 and SGRQ total score were measured before treatment and at 2 and 12 months; COPD exacerbation rates were measured during months 2–12. Responders were defined by ≥100 mL improvement in prebronchodilator FEV1 and ≥4-point decrease in SGRQ total score. Results Overall, 2,331 and 1,799 patients were included in the 0–2- and 0–12-month responder analyses, respectively, and 2,360 patients in the 2–12-month exacerbation rate analysis. At 2 months, 35.1% of patients were FEV1 responders and 44.3% were SGRQ responders. The probability of response was significantly greater with budesonide/formoterol than with formoterol or placebo for both parameters. Two-month responders had a greater chance of 12-month response than 2-month nonresponders for both FEV1 (odds ratio, 5.57; 95% confidence interval, 4.14–7.50) and SGRQ (odds ratio, 3.87; 95% confidence interval, 2.83–5.31). Two-month response in FEV1 (P<0.001), but not SGRQ (P=0.11), was associated with greater reductions in exacerbation risk. Conclusion Early FEV1 and SGRQ treatment responses relate to their changes at 12 months. FEV1 response, but not SGRQ response, at 2 months predicts the risk of a future COPD exacerbation in some, but not all patients. This is

  4. Early response to inhaled bronchodilators and corticosteroids as a predictor of 12-month treatment responder status and COPD exacerbations.

    PubMed

    Calverley, Peter M; Postma, Dirkje S; Anzueto, Antonio R; Make, Barry J; Eriksson, Göran; Peterson, Stefan; Jenkins, Christine R

    2016-01-01

    Early treatment response markers, for example, improvement in forced expiratory volume in 1 second (FEV1) and St George's Respiratory Questionnaire (SGRQ) total score, may help clinicians to better manage patients with chronic obstructive pulmonary disease (COPD). We investigated the prevalence of clinically important improvements in FEV1 and SGRQ scores after 2-month budesonide/formoterol or formoterol treatment and whether such improvements predict subsequent improvements and exacerbation rates. This post hoc analysis is based on data from three double-blind, randomized studies in patients with moderate-to-very-severe COPD receiving twice-daily budesonide/formoterol or formoterol alone for 6 or 12 months. Prebronchodilator FEV1 and SGRQ total score were measured before treatment and at 2 and 12 months; COPD exacerbation rates were measured during months 2-12. Responders were defined by ≥100 mL improvement in prebronchodilator FEV1 and ≥4-point decrease in SGRQ total score. Overall, 2,331 and 1,799 patients were included in the 0-2- and 0-12-month responder analyses, respectively, and 2,360 patients in the 2-12-month exacerbation rate analysis. At 2 months, 35.1% of patients were FEV1 responders and 44.3% were SGRQ responders. The probability of response was significantly greater with budesonide/formoterol than with formoterol or placebo for both parameters. Two-month responders had a greater chance of 12-month response than 2-month nonresponders for both FEV1 (odds ratio, 5.57; 95% confidence interval, 4.14-7.50) and SGRQ (odds ratio, 3.87; 95% confidence interval, 2.83-5.31). Two-month response in FEV1 (P<0.001), but not SGRQ (P=0.11), was associated with greater reductions in exacerbation risk. Early FEV1 and SGRQ treatment responses relate to their changes at 12 months. FEV1 response, but not SGRQ response, at 2 months predicts the risk of a future COPD exacerbation in some, but not all patients. This is potentially useful in clinical practice, although

  5. Bisphosphonate therapy improves the outcome of conventional periodontal treatment: results of a 12-month, randomized, placebo-controlled study.

    PubMed

    Lane, Nancy; Armitage, Gary C; Loomer, Peter; Hsieh, Susan; Majumdar, Sharmila; Wang, H-Y; Jeffcoat, Marjorie; Munoz, Thelma

    2005-07-01

    Bone loss in periodontitis results from inflammatory reactions that stimulate osteoclastic bone resorption. Bisphosphonates inhibit bone resorption and increase bone mass. This study evaluated the effect of bisphosphonate therapy as an adjunct to non-surgical periodontal treatment in patients with moderate to severe chronic periodontitis. Patients were randomized (2:1) to one of two bisphosphonate therapies or placebo for 1 year. All patients received non-surgical periodontal treatment (scaling, root planing) and periodontal maintenance therapy every 3 months. Clinical assessments at baseline and 6 and 12 months included clinical attachment level (CAL), probing depth (PD), and bleeding on probing (BOP). Periodontal bone mass was assessed by dental radiographs at baseline and 12 months using fractal analysis and digital subtraction radiography (DSR). Seventy patients were randomized, 43 to the bisphosphonate group and 27 to the placebo group. Bisphosphonate therapy significantly improved CAL, PD, and BOP relative to the placebo group during the 6- to 12-month period (CAL, P = 0.0002; PD, P = 0.0156; BOP, P = 0.0079). There was no difference in the change in periodontal bone mass between the bisphosphonate and placebo groups as measured by fractal analysis and DSR. These data suggest that bisphosphonate treatment improves the clinical outcome of non-surgical periodontal therapy and may be an appropriate adjunctive treatment to preserve periodontal bone mass.

  6. Reinforcement-based therapy: 12-month evaluation of an outpatient drug-free treatment for heroin abusers.

    PubMed

    Jones, Hendree E; Wong, Conrad J; Tuten, Michelle; Stitzer, Maxine L

    2005-08-01

    This controlled study examined the efficacy of reinforcement-based therapy (RBT) for producing enhanced abstinence outcomes over 12 months in opioid-dependent patients exiting a brief residential detoxification. Patients were randomly assigned upon completing their medically managed taper (i.e., detoxification) to RBT (N=66) or usual care (N=64) referral to community treatment programs. The 6-month RBT program offered an array of abstinence-based incentives including rent payment for recovery housing, program-led recreational activities and skills training for procuring employment. RBT produced significantly higher self-report and urinalysis-confirmed rates of abstinence from opioids and cocaine relative to usual care at 1 (42% versus 15%) and 3 (38% versus 17%) months during treatment but not at 6 or 12 months after enrollment. The RBT but not the usual care group showed significant increases in the number of days worked and the amount of legal income earned at 3, 6 and 12 months. The results of this randomized study suggest that an intensive reinforcement-based therapy that includes abstinence-based recovery housing is a promising approach; however, further research is needed to determine the role of treatment intensity and the specific efficacy of RBT's component parts.

  7. Parental stress and child behavioral outcomes following substance abuse residential treatment. Follow-up at 6 and 12 months.

    PubMed

    Killeen, T; Brady, K T

    2000-07-01

    Residential treatment programs specifically designed for alcohol/drug-addicted women and their children have become a popular treatment modality across the United States. Outcome evaluation of these programs are beginning to show promising results. In this article, outcome data from a study of a residential substance abuse treatment program for women and young children in rural South Carolina will be presented. Data from 35 women and 23 children in the area of addiction severity, parenting and child emotional and behavioral development at 6 and 12 months following discharge from a substance abuse residential treatment program is examined. Results showed that women who completed treatment had better scores on addiction severity and parental stress, and their children had improved behavioral and emotional functioning at 6 and 12 months after discharge from the program. These results suggest that residential treatment has benefits for mothers and their children. This data adds to the growing body of evidence supporting intensive and inclusive care for certain groups of individuals with substance use disorders during critical periods.

  8. Early Therapeutic Alliance, Treatment Retention, and 12-Month Outcomes in a Healthy Lifestyles Intervention for People with Psychotic Disorders.

    PubMed

    Andrews, Michelle; Baker, Amanda L; Halpin, Sean A; Lewin, Terry J; Richmond, Robyn; Kay-Lambkin, Frances J; Filia, Sacha L; Castle, David; Williams, Jill M; Clark, Vanessa; Callister, Robin

    2016-12-01

    Engaging and retaining individuals with psychotic disorders in psychosocial treatments is difficult. Early therapeutic alliance, treatment retention, and 12-month outcomes were examined in a subsample of smokers with a psychotic disorder (N = 178) participating in a healthy lifestyles study comparing a telephone versus face-to-face delivered intervention. Therapeutic alliance was assessed using the Agnew Relationship Measure; primary outcomes were treatment retention and changes in symptoms and health behaviors. Contrary to expectations, early alliance did not predict treatment retention. However, elements of both client- and therapist-rated alliance predicted some clinical outcomes (e.g., higher confidence in the therapeutic alliance at session 1 predicted improvements in 12-month depression). Some modest interactions between early alliance and intervention condition were also identified (e.g., clients initially with lower self-perceived initiative, or higher therapist-perceived bonding benefited preferentially from the telephone-delivered intervention), highlighting the need to further examine the interplay between therapeutic alliance and treatment modality.

  9. Enhanced weight loss with pramlintide/metreleptin: an integrated neurohormonal approach to obesity pharmacotherapy.

    PubMed

    Ravussin, Eric; Smith, Steven R; Mitchell, Julie A; Shringarpure, Reshma; Shan, Kevin; Maier, Holly; Koda, Joy E; Weyer, Christian

    2009-09-01

    The neurohormonal control of body weight involves a complex interplay between long-term adiposity signals (e.g., leptin), and short-term satiation signals (e.g., amylin). In diet-induced obese (DIO) rodents, amylin/leptin combination treatment led to marked, synergistic, fat-specific weight loss. To evaluate the weight-lowering effect of combined amylin/leptin agonism (with pramlintide/metreleptin) in human obesity, a 24-week, randomized, double-blind, active-drug-controlled, proof-of-concept study was conducted in obese or overweight subjects (N = 177; 63% female; 39 +/- 8 years; BMI 32.0 +/- 2.1 kg/m(2); 93.3 +/- 13.2 kg; mean +/- s.d.). After a 4-week lead-in period with pramlintide (180 microg b.i.d. for 2 weeks, 360 microg b.i.d. thereafter) and diet (40% calorie deficit), subjects achieving 2-8% weight loss were randomized 1:2:2 to 20 weeks of treatment with metreleptin (5 mg b.i.d.), pramlintide (360 microg b.i.d.), or pramlintide/metreleptin (360 microg/5 mg b.i.d.). Combination treatment with pramlintide/metreleptin led to significantly greater weight loss from enrollment to week 20 (-12.7 +/- 0.9%; least squares mean +/- s.e.) than treatment with pramlintide (-8.4 +/- 0.9%; P < 0.001) or metreleptin (-8.2 +/- 1.3%; P < 0.01) alone (evaluable, N = 93). The greater reduction in body weight was significant as early as week 4, and weight loss continued throughout the study, without evidence of a plateau. The most common adverse events with pramlintide/metreleptin were injection site events and nausea, which were mostly mild to moderate and decreased over time. These results support further development of pramlintide/metreleptin as a novel, integrated neurohormonal approach to obesity pharmacotherapy.

  10. Convergent chemoenzymatic synthesis of a library of glycosylated analogues of pramlintide: structure-activity relationships for amylin receptor agonism.

    PubMed

    Kowalczyk, Renata; Brimble, Margaret A; Tomabechi, Yusuke; Fairbanks, Antony J; Fletcher, Madeleine; Hay, Debbie L

    2014-11-07

    Pramlintide (Symlin®), a synthetic analogue of the naturally occurring pancreatic hormone amylin, is currently used with insulin in adjunctive therapy for type 1 and type 2 diabetes mellitus. Herein we report a systematic study into the effect that N-glycosylation of pramlintide has on activation of amylin receptors. A highly efficient convergent synthetic route, involving a combination of solid phase peptide synthesis and enzymatic glycosylation, delivered a library of N-glycosylated variants of pramlintide bearing either GlcNAc, the core N-glycan pentasaccharide [Man3(GlcNAc)2] or a complex biantennary glycan [(NeuAcGalGlcNAcMan)2Man(GlcNAc)2] at each of its six asparagine residues. The majority of glycosylated versions of pramlintide were potent receptor agonists, suggesting that N-glycosylation may be used as a tool to optimise the pharmacokinetic properties of pramlintide and so deliver improved therapeutic agents for the treatment of diabetes and obesity.

  11. Rapid response predicts 12-month post-treatment outcomes in binge-eating disorder: theoretical and clinical implications

    PubMed Central

    Grilo, C. M.; White, M. A.; Wilson, G. T.; Gueorguieva, R.; Masheb, R. M.

    2011-01-01

    Background We examined rapid response in obese patients with binge-eating disorder (BED) in a clinical trial testing cognitive behavioral therapy (CBT) and behavioral weight loss (BWL). Method Altogether, 90 participants were randomly assigned to CBT or BWL. Assessments were performed at baseline, throughout and post-treatment and at 6- and 12-month follow-ups. Rapid response, defined as ≥70% reduction in binge eating by week four, was determined by receiver operating characteristic curves and used to predict outcomes. Results Rapid response characterized 57% of participants (67% of CBT, 47% of BWL) and was unrelated to most baseline variables. Rapid response predicted greater improvements across outcomes but had different prognostic significance and distinct time courses for CBT versus BWL. Patients receiving CBT did comparably well regardless of rapid response in terms of reduced binge eating and eating disorder psychopathology but did not achieve weight loss. Among patients receiving BWL, those without rapid response failed to improve further. However, those with rapid response were significantly more likely to achieve binge-eating remission (62% v. 13%) and greater reductions in binge-eating frequency, eating disorder psychopathology and weight loss. Conclusions Rapid response to treatment in BED has prognostic significance through 12-month follow-up, provides evidence for treatment specificity and has clinical implications for stepped-care treatment models for BED. Rapid responders who receive BWL benefit in terms of both binge eating and short-term weight loss. Collectively, these findings suggest that BWL might be a candidate for initial intervention in stepped-care models with an evaluation of progress after 1 month to identify non-rapid responders who could be advised to consider a switch to a specialized treatment. PMID:21923964

  12. Intensive lipid lowering may reduce progression of carotid atherosclerosis within 12 months of treatment: the METEOR study.

    PubMed

    Bots, M L; Palmer, M K; Dogan, S; Plantinga, Y; Raichlen, J S; Evans, G W; O'Leary, D H; Grobbee, D E; Crouse, J R

    2009-06-01

    In several statin trials, vascular event rates for treatment groups begin to separate 1 year after commencement of treatment. For atherosclerosis progression, the temporal sequence of the effect has not been defined. We used data from the Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin (METEOR) trial to determine the earliest time point at which significant differences in atherosclerosis progression rates could be detected after initiation of statin therapy. The METEOR trial was a double-blind, randomized placebo-controlled trial that studied the effect of LDL-C lowering with 40 mg rosuvastatin on the rate of change of carotid intima media thickness (CIMT) measured by B-mode ultrasound amongst 984 low risk subjects. Ultrasound assessments were made at baseline and every 6 months up to 2 years. Rosuvastatin treatment was associated with a 49% reduction in LDL-C-C, a 34% reduction in total cholesterol, an 8.0% increase in HDL-C and a 16% reduction in triglycerides (all P < 0.0001 compared with placebo). The difference in rate of mean maximum CIMT progression between the rosuvastatin and placebo groups (based on near and far wall measurements from both left and right common carotid and internal carotid segments and carotid bifurcation) was not statistically significant after 6 months (0.0023 mm year(-1) and 0.0106 mm year(-1), respectively P = 0.34). After 12 months, CIMT progression rates were significantly different between the groups: 0.0032 mm year(-1) and 0.0133 mm year(-1) in the rosuvastatin-treated and placebo-treated groups, respectively (P = 0.049). This divergence grew with further follow-up: -0.0009 mm year(-1) and 0.0131 mm year(-1) after 18 months (P < 0.001) and -0.0014 mm year(-1) and 0.0131 mm year(-1) after 24 months of treatment (P < 0.001). Results were stronger for the mean common CIMT progression (based on near and far wall measurements from both left and right common carotid segments). Aggressive LDL-C lowering seems

  13. Metabolic parameters and adipokine profile in growth hormone deficient (GHD) children before and after 12-month GH treatment.

    PubMed

    Meazza, C; Elsedfy, H H; Pagani, S; Bozzola, E; El Kholy, M; Bozzola, M

    2014-03-01

    It is a common knowledge that GH exhibits a large number of metabolic effects, involving lipid and glucose homeostasis. The aim of the study was to investigate the effect of one year GH therapy on metabolic parameters and adipokines in GH deficient (GHD) children. Sixteen prepubertal children (11 M and 5 F) with complete GHD (age range: 3.4-14.7 years) and 20 (13 M and 7 F) age and sex-matched healthy children (age range: 4.6-12.3 years) were studied. Blood was collected from patients before starting GH therapy (0.025 mg/kg/day) and one year later, and from healthy children to measure adiponectin, leptin, osteoprotegerin, resistin, interleukin (IL)-6, tumor necrosis factor (TNF)-α levels, and other glucose and lipid metabolism parameters. Adiponectin and resistin levels were significantly higher (49980 ng/ml vs. 14790 ng/ml and 11.0 pg/ml vs. 6.3, respectively) in GHD children before GH therapy than in controls. Serum IGF-I levels (p=0.0001) and height SDS (p<0.0001) significantly increased after 12 months' of GH therapy. There was a loss of body fat reflected by a significant decline in tricep (p=0.0003) and subscapular skinfold thickness SDS (p=0.0023). After 12 months, there was a significant rise in insulin (p=0.0052) and leptin levels (p=0.0048) and a significant decrease in resistin (p=0.0312) and TNF-α (p=0.0137). We observed that lipid and glucose metabolisms are only slightly affected in GHD children. Growth hormone replacement therapy affects some factors, such as leptin, resistin and fat mass, suggesting that also in children, GH treatment has a role in the regulation of factors secreted by adipose tissue. © Georg Thieme Verlag KG Stuttgart · New York.

  14. Treatment effect of ozone and fluoride varnish application on occlusal caries in primary molars: a 12-month study.

    PubMed

    Johansson, E; van Dijken, J W V; Karlsson, L; Andersson-Wenckert, I

    2014-09-01

    The aim of this study is to evaluate the effect of ozone and fluoride varnish on occlusal caries in primary molars in a split-mouth study. Caries risk was estimated by treating Public Dental Health Service dentists. Children with occlusal caries with Ekstrand index scores ≤3 (VI ≤3) were included. Selection of caries lesions was discontinued for ethical reasons due to non-acceptable clinical results during the follow-up. In the continued evaluation pairs of teeth with non-cavitated caries lesions, Ekstrand score ≤2a (VI ≤2) were selected. Fifty pairs of carious primary molars were included, 18 boys and 15 girls (mean 4.7 years, range 3-8). At baseline, the lesions were assessed by visual inspection (VI) and laser-induced fluorescence (LF), in each pair to treatment with 40 s ozone (HealOzone(TM), 2,100 ppm) or fluoride varnish Duraphat®. The treatments and evaluations were repeated at 3, 6 9 months and evaluations only at 12 months. Medium-high caries risk was observed in VI ≤3 children and low-medium risk in VI ≤2a children. In the 15 pairs VI ≤3 lesions, 8 treated with ozone and 9 with fluoride progressed to failure. In the 35 pairs VI ≤2a lesions, one lesion failed. Median baseline LF values in the VI ≤3 group were 76 and 69, for ozone and fluoride lesions, respectively, and 21 and 19 in the VI ≤2a group. At 12 months, LF values in the VI ≤2a group were 15 and 18. No improvement or difference in LF values was found over time between the caries lesions treated with ozone or fluoride. Neither ozone nor fluoride varnish treatments stopped the progression of caries in cavitated lesions. In low and medium caries risk children, non-cavitated lesions following both treatments showed slight or no progression. The use of ozone or fluoride varnish treatments in this regime as caries preventive method, added to the daily use of fluoridated toothpaste, to arrest caries progression in primary molars must therefore be questioned.

  15. Antiretroviral treatment and quality of life in Africans living with HIV: 12-month follow-up in Burkina Faso

    PubMed Central

    Jaquet, Antoine; Garanet, Franck; Balestre, Eric; Ekouevi, Didier K.; Azani, Jean Claude; Bognounou, René; Dah, Elias; Kondombo, Jean Charlemagne; Dabis, François; Drabo, Joseph

    2013-01-01

    Introduction The scale-up of highly active antiretroviral therapy (HAART) has led to a significant improvement in survival of the HIV-positive patient but its effects on health-related quality of life (HRQOL) are less known and context-dependent. Our aim was to assess the temporal changes and factors associated with HRQOL among HIV-positive adults initiating HAART in Burkina Faso. Methods HIV-positive people initiating HAART were prospectively included and followed over a one-year period in three HIV clinics of Ouagadougou. HRQOL was assessed at baseline and at each follow-up visit using physical (PHS) and mental (MHS) summary scores derived from the Medical Outcome Study 36-Item short-form health survey (MOS SF-36) questionnaire. Toxicity related to HAART modification and self-reported symptoms were recorded during follow-up visits. Determinants associated with baseline and changes in both scores over a one-year period were assessed using a mixed linear model. Results A total of 344 patients were included. Their median age at baseline was 37 years [interquartile range (IQR) 30–44] and their median CD4 count was 181 cells/mm3 (IQR 97–269). The mean [standard deviation (SD)] PHS score increased from 45.4 (11.1) at baseline to 60.0 (3.1) at 12 months (p<10−4) and the mean (SD) MHS score from 42.2 (8.7) to 43.9 (3.4) (p<10−2). After one year of treatment, patients that experienced on average two symptoms during follow-up presented with significantly lower PHS (63.9) and MHS (43.8) scores compared to patients that presented no symptoms with PHS and MHS of 68.2 (p<10−4) and 45.3 (p<10−3), respectively. Discussion The use of HAART was associated with a significant increase in both physical and mental aspects of the HRQOL over a 12-month period in this urban African population. Perceived symptoms experienced during follow-up visits were associated with a significant impairment in HRQOL. The appropriate and timely management of reported symptoms during the

  16. 12-months metabolic changes among gender dysphoric individuals under cross-sex hormone treatment: a targeted metabolomics study

    PubMed Central

    Auer, Matthias K.; Cecil, Alexander; Roepke, Yasmin; Bultynck, Charlotte; Pas, Charlotte; Fuss, Johannes; Prehn, Cornelia; Wang-Sattler, Rui; Adamski, Jerzy; Stalla, Günter K.; T’Sjoen, Guy

    2016-01-01

    Metabolomic analyses in epidemiological studies have demonstrated a strong sexual dimorphism for most metabolites. Cross-sex hormone treatment (CSH) in transgender individuals enables the study of metabolites in a cross-gender setting. Targeted metabolomic profiling of serum of fasting transmen and transwomen at baseline and following 12 months of CSH (N = 20/group) was performed. Changes in 186 serum metabolites and metabolite ratios were determined by targeted metabolomics analysis based on ESI-LC-MS/MS. RandomForest (RF) analysis was applied to detect metabolites of highest interest for grouping of transwomen and transmen before and after initiation of CSH. Principal component analysis (PCA) was performed to check whether group differentiation was achievable according to these variables and to see if changes in metabolite levels could be explained by a priori gender differences. PCA predicted grouping of individuals-determined by the citrulline/arginine-ratio and the amino acids lysine, alanine and asymmetric dimethylarginine - in addition to the expected grouping due to changes in sex steroids and body composition. The fact that most of the investigated metabolites did, however, not change, indicates that the majority of sex dependent differences in metabolites reported in the literature before may primarily not be attributable to sex hormones but to other gender-differences. PMID:27833161

  17. Parent-assessed quality of life among adolescents undergoing orthodontic treatment: a 12-month follow-up

    PubMed Central

    Abreu, Lucas Guimarães; Melgaço, Camilo Aquino; Abreu, Mauro Henrique Nogueira Guimaraes; Lages, Elizabeth Maria Bastos; Paiva, Saul Martins

    2015-01-01

    Objective: To assess parents' and caregivers' view of the first twelve months of adolescents' orthodontic treatment with fixed appliances and to assess the evaluative properties of the Brazilian version of the Parental-Caregiver Perceptions Questionnaire (P-CPQ) in the orthodontic setting. Methods: Data from a sample of 96 parents and caregivers of adolescents undergoing orthodontic treatment with fixed appliances were collected by means of P-CPQ. Assessments were performed before banding and bracket bonding (T1) and 12 months after placement of fixed appliances (T2). Statistical analysis included Wilcoxon signed-rank test for the overall P-CPQ score and Bonferroni correction for P-CPQ subscales. The evaluative properties of the P-CPQ were assessed through responsiveness calculation and the minimally clinical important difference (MCID). Results: Among the 96 participants, 76 were mothers of patients, 16 were fathers, and four were other family members. Adolescents' mean age was 11.49 ± 0.50 years. Most families earned equal to or less than three times the Brazilian monthly minimum wage. There was significant improvement in the emotional and social well-being subscales (p < 0.001), which contributed to improve patient's overall quality of life (p< 0.001). Reductions in scores were associated with clinically meaningful moderate changes in the overall score as well as in the emotional and social well-being subscales. The MCID was 6.16 for the P-CPQ overall score. Conclusion: Parents and caregivers reported significant improvement in the quality of life of adolescents undergoing orthodontic treatment with fixed appliances. PMID:26560827

  18. Does comorbid subthreshold anxiety affect clinical presentation and treatment response in depression? A preliminary 12-month naturalistic study.

    PubMed

    Altamura, A Carlo; Montresor, Claudio; Salvadori, Daniele; Mundo, Emanuela

    2004-12-01

    The aim of this study was to evaluate the effects of comorbid subthreshold anxiety on the course and the treatment of Depressive Disorders. The sample studied comprised four groups defined by the DSM-IV Axis I diagnosis: (1) Patients with a Major Depressive Disorder (MDD) and an Anxiety Disorder (DA); (2) patients with MDD and a subthreshold Anxiety Disorder (Da); (3) patients with subthreshold depression and an Anxiety Disorder (dA); (4) patients with subthreshold depression and subthreshold anxiety (da). HAMD, HAMA and CGI rating scales were administered monthly for 12 months while patients were treated with different antidepressants. Significant differences were found among the four groups with respect to the baseline depressive symptoms: Da presented more frequently suicidal ideation (chi2=9.568, d.f.=3, p=0.023), psychomotor retardation (chi2=12.568, d.f.=3, p=0.006), sexual dysfunctions (chi2=7.761, d.f.=3, p=0.05), hypochondriacal ideation (chi2=13.633, d.f.=3, p=0.003), weight loss (chi2=9.520, d.f.=3, p=0.023), and diurnal variation of symptoms (chi2=13.258, d.f.=3, p=0.004). With respect to the treatment response Da patients showed an overall worse response to antidepressants, having a longer latency and a lower reduction of symptoms. These results suggest that patients with Major Depression and subthreshold anxiety present with a more severe baseline clinical picture and seem to have a less efficient response to antidepressants.

  19. Malmö Treatment Referral and Intervention Study-High 12-Month Retention Rates in Patients Referred from Syringe Exchange to Methadone or Buprenorphine/Naloxone Treatment.

    PubMed

    Bråbäck, Martin; Ekström, Lars; Troberg, Katja; Nilsson, Suzan; Isendahl, Pernilla; Brådvik, Louise; Håkansson, Anders

    2017-01-01

    Heroin dependence is associated with high mortality. Opioid agonist treatment (OAT) with methadone or buprenorphine has strong evidence for treatment of this relapsing condition. In our setting, OAT has been associated with strict and demanding intake procedures, often with requirements of social stability, but also high, approximately 80 percent 12-month retention rates. In a recent randomized controlled trial, we demonstrated high rates of successful rapid referral from a syringe exchange programme (SEP) to treatment with methadone or buprenorphine, including actual treatment initiation. The objectives of this study were to assess 12-month retention rates, in order to assess whether a novel referral program of current drug users at a SEP would achieve retention rates comparable to more traditional intake procedures. The present report is a 12-month follow-up of 71 patients who successfully started treatment with methadone or buprenorphine/naloxone. Patient data from baseline and at 12 months were collected. Out of the 71 patients who started treatment, 58 (82%) were still in treatment after 12 months. This was a population, referred from a SEP, with a high drug use severity on admission and no pretreatment requirement for social stability, but there were still high retention rates at 12 months comparable to regular opioid agonist clinics in our setting.

  20. Treatment of femoropopliteal atherosclerotic lesions using the Ranger paclitaxel-coated balloon catheter - 12-month results from an all-comers registry.

    PubMed

    Lichtenberg, Michael; von Bilderling, Peter; Ranft, Jürgen; Niemöller, Kathrin; Grell, Holger; Briner, Lucas; Saucy, Françoise; Rassaf, Tienush; Breuckmann, Frank

    2017-10-03

    To evaluate 12-month effectiveness of the endovascular treatment of femoropopliteal (FP) atherosclerotic lesions with the Ranger drug-coated balloon (DCB) in a real-world setting. In this prospective, observational, multicenter trial (ClinicalTrials.gov Identifier: NCT02462005) 172 consecutive patients with 226 de novo, restenosed, or reoccluded native superficial femoral and/or popliteal artery lesions were treated with the Ranger paclitaxel- coated balloon angioplasty. Mean lesion length was 129 mm (5 - 400 mm). Fifty-nine (26%) of 226 lesions were moderately or heavily calcified. Provisional stenting was conducted in 55 (22%) of 226 lesions. Main effectiveness outcomes were procedural success, 6- and 12- month hemodynamic or clinical improvement, and primary patency based and clinically driven target lesion revascularization (TLR) at 6 and 12 months. Procedural success (<30% residual stenosis and no major adverse event within 30 days) was achieved in 126 (73%) of 172 patients with DCB alone and in all patients if bailout procedures were included. Primary patency was 91.0% at 6 months and 84.1% at 12 months. Freedom TLR was 92.4 % at 6 months and 89.2 % at 12 months. ABI, pain-free walking distance and Rutherford category improved significantly (p < 0.001) after 6 and 12 months. Results suggest that angioplasty with the Ranger paclitaxel-coated balloon with provisional stenting is efficacious for the treatment of a broad range of femoropopliteal atherosclerotic lesions. No safety concerns arose.

  1. Improving adherence and clinical outcomes in self-guided internet treatment for anxiety and depression: a 12-month follow-up of a randomised controlled trial.

    PubMed

    Titov, Nickolai; Dear, Blake F; Johnston, Luke; McEvoy, Peter M; Wootton, Bethany; Terides, Matthew D; Gandy, Milena; Fogliati, Vincent; Kayrouz, Rony; Rapee, Ronald M

    2014-01-01

    A recent paper reported the outcomes of a study examining a new self-guided internet-delivered treatment, the Wellbeing Course, for symptoms of anxiety or depression. This study found the intervention resulted in significant symptom reductions. It also found that automated emails increased treatment completion and clinical improvements in a subsample with elevated anxiety and depression. To examine the clinical outcomes and the effect of automated emails at 12 months post-treatment. Participants, who were randomly allocated to a Treatment Plus Automated Emails Group (TEG; n = 100), a standard Treatment Group (TG; n = 106) or delayed-treatment Waitlist Control Group (Control; n = 51), were followed up at 12 months post-treatment. Eighty-one percent, 78% and 87% of participants in the TEG, TG and treated Waitlist Control Group provided symptom data at 12-month follow-up, respectively. The primary outcome measures were the Patient Health Questionnaire-9 Item Scale (PHQ-9) and the Generalized Anxiety Disorder-7 Item Scale (GAD-7). Significant improvements in symptoms of anxiety and depression were observed over time in both the TEG and TG (Fs >69, ps <.001) these were sustained from post-treatment to 12-month follow-up (ps >.05), and were associated with large effect sizes. No statistically significant differences in symptoms were found between the TEG and TG at post-treatment, 3-month or 12-month follow-up. Previously reported symptom differences between TEG and TG participants with comorbid symptoms were no longer present at 12-month follow-up (ps >.70). The overall benefits of the Wellbeing Course were sustained at 12-month follow-up. Although automated emails facilitated Course completion and reductions in symptoms for participants with comorbid anxiety and depression from pre-post treatment, these differences were no longer observed at 12-month follow-up. The results indicate that automated emails promote more rapid treatment response for people with elevated and

  2. Improving Adherence and Clinical Outcomes in Self-Guided Internet Treatment for Anxiety and Depression: A 12-Month Follow-Up of a Randomised Controlled Trial

    PubMed Central

    Titov, Nickolai; Dear, Blake F.; Johnston, Luke; McEvoy, Peter M.; Wootton, Bethany; Terides, Matthew D.; Gandy, Milena; Fogliati, Vincent; Kayrouz, Rony; Rapee, Ronald M.

    2014-01-01

    Background A recent paper reported the outcomes of a study examining a new self-guided internet-delivered treatment, the Wellbeing Course, for symptoms of anxiety or depression. This study found the intervention resulted in significant symptom reductions. It also found that automated emails increased treatment completion and clinical improvements in a subsample with elevated anxiety and depression. Aims To examine the clinical outcomes and the effect of automated emails at 12 months post-treatment. Method Participants, who were randomly allocated to a Treatment Plus Automated Emails Group (TEG; n = 100), a standard Treatment Group (TG; n = 106) or delayed-treatment Waitlist Control Group (Control; n = 51), were followed up at 12 months post-treatment. Eighty-one percent, 78% and 87% of participants in the TEG, TG and treated Waitlist Control Group provided symptom data at 12-month follow-up, respectively. The primary outcome measures were the Patient Health Questionnaire-9 Item Scale (PHQ-9) and the Generalized Anxiety Disorder-7 Item Scale (GAD-7). Results Significant improvements in symptoms of anxiety and depression were observed over time in both the TEG and TG (Fs >69, ps <.001) these were sustained from post-treatment to 12-month follow-up (ps >.05), and were associated with large effect sizes. No statistically significant differences in symptoms were found between the TEG and TG at post-treatment, 3-month or 12-month follow-up. Previously reported symptom differences between TEG and TG participants with comorbid symptoms were no longer present at 12-month follow-up (ps >.70). Conclusions The overall benefits of the Wellbeing Course were sustained at 12-month follow-up. Although automated emails facilitated Course completion and reductions in symptoms for participants with comorbid anxiety and depression from pre-post treatment, these differences were no longer observed at 12-month follow-up. The results indicate that automated emails promote more

  3. A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated with ADHD in Central and Eastern Europe and Eastern Asia

    ERIC Educational Resources Information Center

    Goetz, Michal; Yeh, Chin-Bin; Ondrejka, Igor; Akay, Aynur; Herczeg, Ilona; Dobrescu, Iuliana; Kim, Boong Nyun; Jin, Xingming; Riley, Anne W.; Martenyi, Ferenc; Harrison, Gavan; Treuer, Tamas

    2012-01-01

    Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for…

  4. A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated with ADHD in Central and Eastern Europe and Eastern Asia

    ERIC Educational Resources Information Center

    Goetz, Michal; Yeh, Chin-Bin; Ondrejka, Igor; Akay, Aynur; Herczeg, Ilona; Dobrescu, Iuliana; Kim, Boong Nyun; Jin, Xingming; Riley, Anne W.; Martenyi, Ferenc; Harrison, Gavan; Treuer, Tamas

    2012-01-01

    Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for…

  5. Feasibility and indicative results from a 12-month low-energy liquid diet treatment and maintenance programme for severe obesity

    PubMed Central

    Lean, Michael; Brosnahan, Naomi; McLoone, Philip; McCombie, Louise; Higgs, Anna Bell; Ross, Hazel; Mackenzie, Mhairi; Grieve, Eleanor; Finer, Nick; Reckless, John; Haslam, David; Sloan, Billy; Morrison, David

    2013-01-01

    Background There is no established primary care solution for the rapidly increasing numbers of severely obese people with body mass index (BMI) > 40 kg/m2. Aim This programme aimed to generate weight losses of ≥15 kg at 12 months, within routine primary care. Design and setting Feasibility study in primary care. Method Patients with a BMI ≥40 kg/m2 commenced a micronutrient-replete 810–833 kcal/day low-energy liquid diet (LELD), delivered in primary care, for a planned 12 weeks or 20 kg weight loss (whichever was the sooner), with structured food reintroduction and then weight-loss maintenance, with optional orlistat to 12 months. Result Of 91 patients (74 females) entering the programme (baseline: weight 131 kg, BMI 48 kg/m2, age 46 years), 58/91(64%) completed the LELD stage, with a mean duration of 14.4 weeks (standard deviation [SD] = 6.0 weeks), and a mean weight loss of 16.9 kg (SD = 6.0 kg). Four patients commenced weight-loss maintenance omitting the food-reintroduction stage. Of the remaining 54, 37(68%) started and completed food reintroduction over a mean duration of 9.3 weeks (SD = 5.7 weeks), with a further mean weight loss of 2.1 kg (SD = 3.7 kg), before starting a long-term low-fat-diet weight-loss maintenance plan. A total of 44/91 (48%) received orlistat at some stage. At 12 months, weight was recorded for 68/91 (75%) patients, with a mean loss of 12.4 kg (SD = 11.4 kg). Of these, 30 (33% of all 91 patients starting the programme) had a documented maintained weight loss of ≥15 kg at 12 months, six (7%) had a 10–15 kg loss, and 11 (12%) had a 5–10 kg loss. The indicative cost of providing this entire programme for wider implementation would be £861 per patient entered, or £2611 per documented 15 kg loss achieved. Conclusion A care package within routine primary care for severe obesity, including LELD, food reintroduction, and weight-loss maintenance, was well accepted and achieved a 12-month-maintained weight loss of ≥15 kg for one

  6. Risk factors associated with high thyroglobulin level following radioactive iodine ablation, measured 12 months after treatment for papillary thyroid carcinoma

    PubMed Central

    Kim, Eun Young; Hyun, Kee Hoon; Park, Yong Lai; Park, Chan Heun

    2017-01-01

    Purpose The measurement of serum thyroglobulin (Tg) of papillary thyroid carcinoma patients, 12 months after total thyroidectomy and radioactive iodine (RAI) ablation following thyroxine hormone withdrawal (T4-off Tg) or recombinant human thyroid-stimulating hormone stimulation (rhTSH-Tg), is standard method for monitoring disease status. The aim of this study was to find predictive factors for detectable T4-off Tg during follow-up. Methods A retrospective review was conducted of 329 patients who underwent total thyroidectomy and RAI ablation between October 2008 and August 2012. Subjects were assigned to high (>1 ng/mL, n = 53) and low (≤1 ng/mL, n = 276) groups, based on T4-off Tg measured 12 months postoperatively. Demographic and clinicopathological characteristics at diagnosis and follow-up were compared between the 2 groups. Results The low and high T4-off Tg groups differed with respect to tumor size, preoperative Tg, ablative Tg, cervical lymph node metastasis, thyroglobulinemia out of proportion to results of diagnostic whole body scan, and American Thyroid Association 3-level stratification and restratification. Multivariate analysis confirmed that ablative Tg > 1.0 ng/mL (odds ratio [OR], 10.801; P = 0.001), more than 5 cervical lymph node metastasis (OR, 6.491; P = 0.003), and thyroglobulinemia out of proportion (OR, 9.221; P = 0.000) were risk factors. Conclusion Ablative Tg >1.0 ng/mL, more than 5 cervical lymph node metastasis, and thyroglobulinemia out of proportion were independent factors for T4-off Tg >1 ng/mL 12 months postoperative. In low-risk patients without these risk factors, the possible omission of Tg measurements could be considered during follow-up. PMID:28090499

  7. Effects of 12-month, 2000IU/day vitamin D supplementation on treatment naïve and vitamin D deficient Saudi type 2 diabetic patients

    PubMed Central

    Al-Shahwan, May A.; Al-Othman, Abdulaziz M.; Al-Daghri, Nasser M.; Sabico, Shaun B.

    2015-01-01

    Objectives: To determine whether 12-month, 2000IU/day vitamin D supplementation cardiometabolically improves treatment naïve type 2 diabetes mellitus (T2DM) Saudi patients with vitamin D deficiency. Methods: This 12-month interventional study was conducted at primary health centers in 5 different residential areas in Riyadh, Saudi Arabia between January 2013 and January 2014. Forty-five Saudi T2DM patients were enrolled. Baseline anthropometrics, glycemic, and lipid profiles were measured and repeated after 6 and 12 months. All subjects were provided with 2000IU vitamin D supplements for one year. Results: Vitamin D deficiency at baseline was 46.7%, 31.8% after 6 months, and 35.6% after 12 months, indicating an overall improvement in the vitamin D status in the entire cohort. Insulin and homeostatic model assessment-insulin resistance (HOMA-IR) after 12 months were significantly lower than a 6 months (p<0.05), but comparable to baseline values. Mean levels of triglycerides increased overtime from baseline (1.9±0.01 mmol/l) to 12 months (2.1±0.2 mmol). This modest increase in serum triglycerides was parallel to the insignificant decrease in circulating high-density lipoprotein -cholesterol levels. Conclusion: Twelve-month vitamin D supplementation of 2000IU per day in a cohort of treatment naïve Saudi patients with T2DM resulted in improvement of several cardiometabolic parameters including systolic blood pressure, insulin, and HOMA-IR. Further studies that include a placebo group are suggested to reinforce findings. PMID:26620985

  8. Maintained pain reduction in five patients with multiple myeloma 12 months after treatment of the involved cervical vertebrae with vertebroplasty.

    PubMed

    Pflugmacher, R; Schleicher, P; Schröder, R J; Melcher, I; Klostermann, C K

    2006-10-01

    To evaluate in a prospective study the clinical and radiographic outcome of vertebroplasty in patients with osteolytic lesions of the cervical spine caused by multiple myeloma. Pathological vertebral fractures associated with multiple myeloma were treated in five patients. Vertebroplasty was performed in 12 vertebral bodies. Symptomatic levels were identified by correlating the clinical presentation with magnetic resonance imaging (MRI), conventional radiographs, and computed tomography (CT). During the 12-month follow-up, pain symptoms were measured on a self-reported visual analog scale (VAS), neck pain disability index (NPDI, range 0-100%), and cervical spine functional score (CSFS, range 0-100). Medical imaging was performed pre- and postoperatively and after 3, 6, and 12 months. The vertebral height was measured to assess the restoration of the sagittal alignment. The median pain scores (VAS) as well as the NPDI and CSFS decreased significantly after vertebroplasty (P<0.05). Cement leakage occurred in two of 12 vertebral bodies (16.6%), without clinical relevance. The vertebral body height was stabilized during follow-up. Vertebroplasty in the cervical spine is an effective open surgical procedure for the stabilization of pathological vertebral fractures caused by multiple myeloma leading to a statistically significant reduction of pain status. Vertebral body height is stabilized and further deformities are avoided.

  9. High-intensity Statin Treatments in Clinically Stable Patients on Aspirin Monotherapy 12 Months After Drug-eluting Stent Implantation: A Randomized Study.

    PubMed

    Im, Eui; Cho, Yun-Hyeong; Suh, Yongsung; Cho, Deok-Kyu; Her, Ae-Young; Kim, Yong Hoon; Lee, Kyounghoon; Kang, Woong Chol; Yun, Kyeong Ho; Yoo, Sang-Yong; Cheong, Sang-Sig; Shin, Dong-Ho; Ahn, Chul-Min; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

    2017-07-14

    Current guidelines on the treatment of blood cholesterol recommend continuous maintenance of high-intensity statin treatment in drug-eluting stent (DES)-treated patients. However, high-intensity statin treatment is frequently underused in clinical practice after stabilization of DES-treated patients. Currently, the impact of continuous high-intensity statin treatment on the incidence of late adverse events in these patients is unknown. We investigated whether high-intensity statin treatment reduces late adverse events in clinically stable patients on aspirin monotherapy 12 months after DES implantation. Clinically stable patients who underwent DES implantation 12 months previously and received aspirin monotherapy were randomly assigned to receive either high-intensity (40mg atorvastatin, n = 1000) or low-intensity (20mg pravastatin, n = 1000) statin treatment. The primary endpoint was adverse clinical events at 12-month follow-up (a composite of all death, myocardial infarction, revascularization, stent thrombosis, stroke, renal deterioration, intervention for peripheral artery disease, and admission for cardiac events). The primary endpoint at 12-month follow-up occurred in 25 patients (2.5%) receiving high-intensity statin treatment and in 40 patients (4.1%) receiving low-intensity statin treatment (HR, 0.58; 95%CI, 0.36-0.92; P = .018). This difference was mainly driven by a lower rate of cardiac death (0 vs 0.4%, P = .025) and nontarget vessel myocardial infarction (0.1 vs 0.7%, P = .033) in the high-intensity statin treatment group. Among clinically stable DES-treated patients on aspirin monotherapy, high-intensity statin treatment significantly reduced late adverse events compared with low-intensity statin treatment. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01557075. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  10. Atorvastatin added to interferon beta for relapsing multiple sclerosis: 12-month treatment extension of the randomized multicenter SWABIMS trial.

    PubMed

    Kamm, Christian P; El-Koussy, Marwan; Humpert, Sebastian; Findling, Oliver; Burren, Yuliya; Schwegler, Guido; Donati, Filippo; Müller, Martin; Müller, Felix; Slotboom, Johannes; Kappos, Ludwig; Naegelin, Yvonne; Mattle, Heinrich P

    2014-01-01

    Statins have anti-inflammatory and immunomodulatory properties in addition to lipid-lowering effects. To report the 12-month extension of a phase II trial evaluating the efficacy, safety and tolerability of atorvastatin 40 mg/d added to interferon beta-1b (IFNB-1b) in relapsing-remitting multiple sclerosis (RRMS). In the randomized, multicenter, parallel-group, rater-blinded core study, 77 RRMS patients started IFNB-1b. At month three they were randomized 1∶1 to receive atorvastatin 40 mg/d or not in addition to IFNB-1b until month 15. In the subsequent extension study, patients continued with unchanged medication for another 12 months. Data at study end were compared to data at month three of the core study. 27 of 72 patients that finished the core study entered the extension study. 45 patients were lost mainly due to a safety analysis during the core study including a recruitment stop for the extension study. The primary end point, the proportion of patients with new lesions on T2-weighted images was equal in both groups (odds ratio 1.926; 95% CI 0.265-14.0007; p = 0.51). All secondary endpoints including number of new lesions and total lesion volume on T2-weighted images, total number of Gd-enhancing lesions on T1-weighted images, volume of grey and white matter, EDSS, MSFC, relapse rate, number of relapse-free patients and neutralizing antibodies did not show significant differences either. The combination therapy was well tolerated. Atorvastatin 40 mg/day in addition to IFNB-1b did not have any beneficial effects on RRMS compared to IFNB-1b monotherapy over a period of 24 months. ClinicalTrials.gov NCT01111656.

  11. Your Baby's Growth: 12 Months

    MedlinePlus

    ... Games, and the Internet Your Baby's Growth: 12 Months KidsHealth > For Parents > Your Baby's Growth: 12 Months Print A A A What's in this article? ... Child's Growth Your Child's Checkup: 1 Year (12 Months) Learning, Play, and Your 8- to 12-Month- ...

  12. Maintenance therapy for acne vulgaris: efficacy of a 12-month treatment with adapalene-benzoyl peroxide after oral isotretinoin and a review of the literature.

    PubMed

    Bettoli, Vincenzo; Borghi, Alessandro; Zauli, Stefania; Toni, Giulia; Ricci, Michela; Giari, Silvia; Virgili, Annarosa

    2013-01-01

    The correct therapeutic management of acne should include a maintenance therapy with topical retinoids to prevent recurrences after discontinuing a successful treatment. To investigate the efficacy of a 12-month maintenance treatment with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% fixed combination gel to control acne relapse after treatment with oral isotretinoin (OI). The study consisted of 2 phases, namely an active treatment phase (AP) and a maintenance phase (MP). In the AP, 70 consecutive patients with moderate to severe acne were treated with OI until acne remission. Then, patients entered the MP and were treated with adapalene-BPO fixed combination once daily for 12 months. The primary efficacy parameter was the relapse rate during MP. Sixty-eight patients completed the study. Relapse occurred in 2 patients (2.94%). Comparing our findings with published data, the association of a topical retinoid and BPO seems to provide favorable evidence for this combination as maintenance therapy.

  13. Lifetime and 12-month prevalence, severity and unmet need for treatment of common mental disorders in Japan: results from the final dataset of World Mental Health Japan Survey

    PubMed Central

    Ishikawa, H.; Kawakami, N.; Kessler, R. C.

    2016-01-01

    Background The aim of this study is to estimate the lifetime and 12-month prevalence, severity, and treatment of Diagnostic and Statistical Manual of Mental Disorders 4th ed. (DSM-IV) mental disorders in Japan based on the final data set of the World Mental Health Japan Survey conducted in 2002–2006. Methods Face-to-face household interviews of 4,130 respondents who were randomly selected from Japanese-speaking residents aged 20 years or older were conducted from 2002 to 2006 in 11 community populations in Japan (overall response rate, 56%). The World Mental Health version of the World Health Organization Composite International Diagnostic Interview (WMH-CIDI), a fully structured lay administered psychiatric diagnostic interview, was used for diagnostic assessment. Results Lifetime/12-month prevalence of any DSM-IV common mental disorders in Japan was estimated to be 20.3/7.6%. Rank-order of four classes of mental disorders was anxiety disorders (8.1/4.9%), substance disorders (7.4/1.0%), mood disorders (6.5/2.3%), and impulse control disorders (2.0/0.7%). The most common individual disorders were alcohol abuse/dependence (7.3/0.9%), major depressive disorder (6.1/2.2%), specific phobia (3.4/2.3%), and generalized anxiety disorder (2.6/1.3%). While the lifetime prevalence of any mental disorder was greater for males and the middle-aged, the persistence (proportion of 12-month cases among lifetime cases) of any mental disorder was greater for females and younger respondents. Among those with any 12-month disorder, 15.3% were classified as severe, 44.1% moderate, and 40.6% mild. Although a strong association between severity and service use was found, only 21.9% of respondents with any 12-month disorder sought treatment within the last 12 months; only 37.0% of severe cases received medical care. The mental health specialty sector was the most common resource used in Japan. Although the prevalence of mental disorders were quite low, mental disorders were the second

  14. Lifetime and 12-month prevalence, severity and unmet need for treatment of common mental disorders in Japan: results from the final dataset of World Mental Health Japan Survey.

    PubMed

    Ishikawa, H; Kawakami, N; Kessler, R C

    2016-06-01

    The aim of this study is to estimate the lifetime and 12-month prevalence, severity and treatment of Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM-IV) mental disorders in Japan based on the final data set of the World Mental Health Japan Survey conducted in 2002-2006. Face-to-face household interviews of 4130 respondents who were randomly selected from Japanese-speaking residents aged 20 years or older were conducted from 2002 to 2006 in 11 community populations in Japan (overall response rate, 56%). The World Mental Health version of the World Health Organization Composite International Diagnostic Interview (WMH-CIDI), a fully structured, lay administered psychiatric diagnostic interview, was used for diagnostic assessment. Lifetime/12-month prevalence of any DSM-IV common mental disorders in Japan was estimated to be 20.3/7.6%. Rank-order of four classes of mental disorders was anxiety disorders (8.1/4.9%), substance disorders (7.4/1.0%), mood disorders (6.5/2.3%) and impulse control disorders (2.0/0.7%). The most common individual disorders were alcohol abuse/dependence (7.3/0.9%), major depressive disorder (6.1/2.2%), specific phobia (3.4/2.3%) and generalized anxiety disorder (2.6/1.3%). While the lifetime prevalence of any mental disorder was greater for males and the middle-aged, the persistence (proportion of 12-month cases among lifetime cases) of any mental disorder was greater for females and younger respondents. Among those with any 12-month disorder, 15.3% were classified as severe, 44.1% moderate and 40.6% mild. Although a strong association between severity and service use was found, only 21.9% of respondents with any 12-month disorder sought treatment within the last 12 months; only 37.0% of severe cases received medical care. The mental health specialty sector was the most common resource used in Japan. Although the prevalence of mental disorders were quite low, mental disorders were the second most prevalent cause of

  15. Long-term effects of a single course of nicotine treatment in acute ulcerative colitis: remission maintenance in a 12-month follow-up study.

    PubMed

    Guslandi, M

    1999-11-01

    Patients with mild to moderate active colitis who are treated with mesalazine plus transdermal nicotine reportedly suffer fewer relapses than patients treated with mesalazine plus oral prednisone. A long-term follow-up period was carried out to confirm this. Thirty patients with remission of distal colitis after therapy with the above treatment schedules were monitored for 12 months (Rachmilewitz' activity index plus endoscopy). Relapsed patients were retreated in a cross-over fashion. After 12 months recurrences were observed in 14 of 15 patients initially treated with steroids and in 7 of 15 subjects who were had received transdermal nicotine (P = 0.007, Fisher's test). A higher proportion of relapsed patients from the prednisone group, after successful retreatment with nicotine patches, remained in remission after 6 months (20%) than relapsed patients who switched to steroid treatment (57%). Our present results confirm the concept that nicotine-induced remission of ulcerative colitis lasts longer than that obtained by oral corticosteroids.

  16. The Impact of Screening, Brief Intervention and Referral for Treatment in Emergency Department Patients’ Alcohol Use: A 3-, 6- and 12-month Follow-up

    PubMed Central

    2010-01-01

    Aims: This study aims to determine the impact of Screening, Brief Intervention and Referral for Treatment (SBIRT) in reducing alcohol consumption in emergency department (ED) patients at 3, 6, and 12 months following exposure to the intervention. Methods: Patients drinking above the low-risk limits (at-risk to dependence), as defined by National Institute of Alcohol Abuse and Alcoholism (NIAAA), were recruited from 14 sites nationwide from April to August 2004. A quasi-experimental comparison group design included sequential recruitment of intervention and control patients at each site. Control patients received a written handout. The Intervention group received the handout and participated in a brief negotiated interview with direct referral for treatment if indicated. Follow-up surveys were conducted at 3, 6, and 12 months by telephone using an Interactive Voice Response (IVR) system. Results: Of the 1132 eligible patients consented and enrolled (581 control, 551 intervention), 699 (63%), 575 (52%) and 433 (38%) completed follow-up surveys via IVR at 3, 6, and 12 months, respectively. Regression analysis adjusting for the clustered sampling design and using multiple imputation procedures to account for subject attrition revealed that those receiving SBIRT reported roughly three drinks less per week than controls (B = −3.00, SE = 1.06, P < 0.05) and the level of maximum drinks per occasion was approximately three-fourths of a drink less than controls (B = -0.76, SE = 0.29, P < 0.05) at 3 months. At 6 and 12 months post-intervention, these effects had weakened considerably and were no longer statistically or substantively significant. Conclusion: SBIRT delivered by ED providers appears to have short-term effectiveness in reducing at-risk drinking, but multi-contact interventions or booster programs may be necessary to maintain long-term reductions in risky drinking. PMID:20876217

  17. Developmental milestones record - 12 months

    MedlinePlus

    ... Sing songs. Have a play date with a child of a similar age. Avoid television and other screen time until age 2. Try using a transitional object to help with separation anxiety. Alternative ... milestones - 12 months; Growth milestones for children - 12 months; Childhood growth milestones - 12 months; Well ...

  18. Screening, brief intervention, and referral to treatment (SBIRT): 12-month outcomes of a randomized controlled clinical trial in a Polish emergency department.

    PubMed

    Cherpitel, Cheryl J; Korcha, Rachael A; Moskalewicz, Jacek; Swiatkiewicz, Grazyna; Ye, Yu; Bond, Jason

    2010-11-01

     A randomized controlled trial of screening, brief intervention, and referral to treatment (SBIRT) among at-risk (based on average number of drinks per week and drinks per drinking day) and dependent drinkers was conducted in an emergency department (ED) among 446 patients 18 and older in Sosnowiec, Poland. Patients were recruited over a 23-week period (4:00 pm to 12:00 midnight) and randomized to 1 of 3 conditions: screened-only (n = 147), assessed (n = 152), and intervention (n = 147). Patients in the assessed and intervention conditions were blindly reassessed via a telephone interview at 3 months, and all 3 groups were assessed at 12 months (screened-only = 92, assessed = 99, and intervention = 87). No difference was found across the 3 conditions in at-risk drinking at 12 months, as the primary outcome variable, or in decrease in the number of drinks per drinking day, with all 3 groups showing a significant reduction in both. Significant declines between baseline and 12 months in secondary outcomes of the RAPS4, number of drinking days per week, and the maximum number of drinks on an occasion were seen only for the intervention condition, and in negative consequences for both the assessment and intervention conditions. Data suggest that improvements in drinking outcomes found in the assessment condition were not because of assessment reactivity, with both the screened and intervention conditions demonstrating greater (although nonsignificant) improvement than the assessed condition. Only those in the intervention condition showed significant improvement in all outcome variables from baseline to 12-month follow-up. Although group by time interaction effects were not found to be significant, these findings suggest that declines in drinking measures for those receiving a brief intervention can be maintained at long-term follow-up. Copyright © 2010 by the Research Society on Alcoholism.

  19. Miglustat in late-onset Tay-Sachs disease: a 12-month, randomized, controlled clinical study with 24 months of extended treatment.

    PubMed

    Shapiro, Barbara E; Pastores, Gregory M; Gianutsos, John; Luzy, Cécile; Kolodny, Edwin H

    2009-06-01

    To evaluate the safety and efficacy of miglustat in patients with GM2 gangliosidosis. A randomized, multicenter, open-label, 12-month study involving patients aged 18 years or older, randomized 2:1 to miglustat (200 mg TID) or "no miglustat treatment." This study was followed by 24 months of extended treatment during which all patients received miglustat. Primary efficacy endpoints were change in eight measures of isometric muscle strength in the limbs and isometric grip strength, evaluated at baseline, and months 12 and 36. Secondary efficacy endpoints included gait, balance, disability, and other neurological assessments. Safety evaluations included adverse event reporting. Thirty patients (67% male, age range 18-56 years) with late-onset Tay-Sachs disease were enrolled; 20 were randomized to miglustat and 10 to "no miglustat treatment." Muscle and grip strength generally decreased over the study period. No differences were observed between the two groups in any efficacy measure, either during the 12-month randomized phase or the full 36 months. The most common treatment-related adverse events were decrease in weight and diarrhea. Miglustat treatment was not shown to lead to measurable benefits in this cohort of patients with late-onset Tay-Sachs disease. The observed safety profile was consistent with that of the approved dose (100 mg TID) in type 1 Gaucher disease.

  20. THE PREVALENCE OF CANNABIS WITHDRAWAL AND ITS INFLUENCE ON ADOLESCENTS’ TREATMENT RESPONSE AND OUTCOMES: A 12-MONTH PROSPECTIVE INVESTIGATION

    PubMed Central

    Greene, M. Claire; Kelly, John F.

    2014-01-01

    Background Withdrawal, a diagnostic indicator of cannabis use disorder, is often minimized or ignored as a consequence of cannabis use, particularly among adolescents. This study aims to characterize cannabis withdrawal among adolescents in outpatient treatment for substance use disorder and evaluate the clinical significance of withdrawal as a predictor of substance-related outcomes. Methods Adolescent outpatients (N=127) reporting cannabis as their drug of choice (n=90) were stratified by presence of withdrawal and compared on demographic and clinical variables at treatment intake. Hierarchical linear models compared the effect of withdrawal on percent days abstinent (PDA) and related outcomes over a 1-year follow-up period. Results Adolescents reporting withdrawal (40%) were more likely to meet criteria for cannabis dependence, have higher levels of substance use severity, report more substance-related consequences, and have a mood disorder. Withdrawal was not associated with PDA over the follow-up period; however, this relationship was moderated by problem recognition such that adolescents reporting withdrawal and a drug problem improved at a greater rate with respect to PDA than those that didn’t recognize a problem with drugs and didn’t report withdrawal. Discussion Withdrawal is common among adolescent outpatients and is associated with a more clinically severe profile. In this sample, all adolescents reporting withdrawal met criteria for cannabis dependence, suggesting that withdrawal is a highly specific indicator of cannabis use disorder. While withdrawal doesn’t appear to be independently associated with substance use outcomes post-treatment, moderating factors such as drug problem recognition should be taken into account when formulating treatment and continuing care plans. PMID:25100311

  1. 12-month effects of once-weekly sustained-release growth hormone treatment in adults with GH deficiency.

    PubMed

    Biller, Beverly M K; Ji, Hyi-Jeong; Ahn, Hyunji; Savoy, Conrad; Siepl, E Christine; Popovic, Vera; Coculescu, Mihail; Roemmler, Josefine; Gavrila, Catalin; Cook, David M; Strasburger, Christian J

    2013-09-01

    The weekly sustained-release recombinant human GH formulation LB03002, showed beneficial effects in GH-deficient (GHD) adults in a previous 26-week double-blind study. Prior studies of long-acting GH preparations in adults have only been conducted for 6 or 8 months, so the effects of longer-term use are unknown; this is important to address, as replacement is given for many years in GHD adults. This open-label, 26-week study extension evaluated longer-term safety and efficacy of LB03002 over 52 weeks in adults with GHD who had previously been randomized to GH, and provides additional safety and efficacy data over 26 weeks in the cohort who had previously been randomized to placebo. Of 147 adults with GHD who completed a preceding study, 136 patients continued in this open-label study to receive LB03002 over an additional 26 weeks. This represented a continuation of long-acting GH for 26 weeks in the cohort who took this medication in the prior study (LB03002 Throughout group), and describes the first use of long-acting GH in the cohort that was randomized to placebo in the prior study (Switched to LB03002 group). The LB03002 dose was adjusted according to serum insulin-like growth factor-I (IGF-I) levels. LB03002 treatment demonstrated mean significant decreases from baseline in fat mass (FM) for both 26 (Switched group, P = 0.001) and 52 weeks (Throughout group, P = 0.002) of 1.11 (1.95) kg and 1.06 (3.16) kg, respectively. Prolonged GH treatment was effective in sustaining the increase in lean body mass (LBM), serum IGF-I and IGFBP-3 levels achieved during the first 26 weeks. Long-term treatment with the sustained-release weekly GH preparation over both 26 and 52 weeks in adults with GHD demonstrated a sustained reduction of FM with a favorable safety profile. This study extends prior knowledge about long-acting GH because it reports the most prolonged treatment of adults with any long-acting GH preparation, thereby confirming the value and safety of such agents

  2. Patient and program predictors of 12-month outcomes for homeless veterans following discharge from time-limited residential treatment.

    PubMed

    McGuire, James; Rosenheck, Robert A; Kasprow, Wesley J

    2011-05-01

    The U.S. Department of Veterans Affairs provides transitional residential treatment to homeless veterans through three types of programs: VA-staffed Domiciliary care, and two types of community-based treatment (one funded through locally managed contracts and the other through national grants). This study compared treatment process and outcomes in these three programs and also sought to identify differences in outcome between dually diagnosed veterans, veterans with substance abuse problems or psychiatric problems alone, and those with no psychiatric diagnoses. Altogether, 1,338 veterans admitted to the 3 types of program were recruited to participate in a prospective naturalistic study which evaluated housing, clinical and community adjustment outcomes during the year following discharge. Data on 1,003 veterans for whom psychiatric diagnostic, social climate and length of stay data were available were used to compare participants in the three program types at baseline. Regression models were used to compare outcomes across program and diagnostic types net of baseline differences between study participants, and of differences in social climate and length of stay. The overall follow-up rate across all time points was 72%. Significant differences across programs were observed on only 2 baseline measures as well as on several baseline values of the outcome measures, length of stay and a measure of social climate. Adjusting for veteran baseline differences alone there were no differences in outcomes by program after correction for multiple comparisons. Dually diagnosed veterans had poorer mental health and overall quality of life outcomes. Longer length of stay and more positive social climate were associated with superior outcomes on several measures. The adjusted mean estimate of the proportion of veterans housed at 12 months follow-up was 78%, similar to published outcomes for supported housing. Length of stay, rather than program funding configuration or

  3. Sonidegib for the treatment of advanced basal cell carcinoma: a comprehensive review of sonidegib and the BOLT trial with 12-month update.

    PubMed

    Chen, Leon; Silapunt, Sirunya; Migden, Michael R

    2016-09-01

    The Hedgehog inhibitors are promising alternative for patients with advanced basal cell carcinoma that are not amenable to radiotherapy or surgery. Sonidegib, also known as LDE225, is an orally available SMO antagonist that was recently approved by the US FDA for the treatment of patients with locally advanced basal cell carcinoma. This article will provide an overview of the pharmacology and pharmacokinetics of sonidegib and in-depth analysis of the BOLT trial with additional data from the 12-month update. The present challenges associated with Hedgehog inhibitors will also be discussed.

  4. A 12-month, open-label, comparative study of quetiapine and risperidone in the acute and long-term treatment of schizophrenia.

    PubMed

    Perez, Victor; Cañas, Fernando; Tafalla, Monica

    2008-05-01

    This multicentre, observational, prospective, nonrandomized study compared the effectiveness and tolerability of quetiapine and risperidone in the acute and long-term treatment of schizophrenia in a clinical setting. Patients admitted to an acute unit with schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV), who were prescribed quetiapine or risperidone (3 : 1 ratio) within the first week of treatment, according to the physician's usual practice, were recruited. In total, 492 patients (quetiapine: 367; risperidone: 125) were followed up at weeks 1 and 2, discharge and 6 and 12 months thereafter. Mean doses at 12 months were: quetiapine 718.5 mg/day and risperidone 7.0 mg/day. Efficacy measures (Brief Psychiatric Rating Scale, Clinical Global Impression Severity of Illness and Improvement) indicated similar results for both agents. No difference was found in rehospitalization rate with either drug. In terms of tolerability, orthostatic hypotension was more frequent with quetiapine, but extrapyramidal symptoms and male sexual dysfunction were more frequent with risperidone. In conclusion, quetiapine and risperidone had comparable effectiveness, but there were differences between treatments in their side effect profile.

  5. Oral administration of a curcumin-phospholipid delivery system for the treatment of central serous chorioretinopathy: a 12-month follow-up study

    PubMed Central

    Mazzolani, Fabio; Togni, Stefano

    2013-01-01

    Background The therapeutic effects of Meriva®, a curcumin-phospholipid (lecithin) delivery system (formulated as Norflo® tablets), on visual acuity and retinal thickness in patients with acute and chronic central serous chorioretinopathy was previously investigated in a six-month open-label study. Methods In this follow-up study, visual acuity was again assessed by ophthalmologic evaluation and retinal thickness by optical coherence tomography (OCT). Norflo tablets were administered twice daily to patients with central serous chorioretinopathy. The study group consisted of 12 patients (total 18 eyes) who completed 12 months of follow-up. The primary endpoint was change in visual acuity before and after treatment with Norflo, and change in neuroretinal or retinal pigment epithelium detachment on OCT was the secondary endpoint. Results After 12 months of therapy, no eyes showed further reduction in visual acuity, 39% showed stabilization, and 61% showed statistically significant improvement (P = 0.0001 by Student’s t-test and P = 0.0005 by Wilcoxon signed rank test). Ninety-five percent of eyes showed a reduction in neuroretinal or retinal pigment epithelium detachment and 5% showed stabilization. The difference in retinal thickness after 12 months was statistically significant (P = 0.0001 by Student’s t-test and P = 0.0004 by Wilcoxon signed rank test). Conclusion These results, albeit preliminary, confirm our previous finding that this curcumin delivery system is effective in the management of central serous chorioretinopathy. When administered in a bioavailable formulation, curcumin is worth considering as a therapeutic agent for the management of inflammatory and degenerative eye conditions involving activation of retinal microglial cells. PMID:23723686

  6. A prospective, split-face, randomized, comparative study of safety and 12-month longevity of three formulations of hyaluronic acid dermal filler for treatment of nasolabial folds.

    PubMed

    Prager, Welf; Wissmueller, Esther; Havermann, Isabel; Bee, Eva K; Howell, David J; Zschocke, Ina; Simon, Jeannette

    2012-07-01

    Data regarding several hyaluronic acids (HAs) used identically for facial tissue augmentation have heretofore been unavailable. This prospective, split-face, randomized, two-armed study sought to determine the long-term safety and effectiveness of three HAs (HA-1 (Belotero Basic/Balance), HA-2 (Restylane), and HA-3 (Juvéderm Ultra 3/Juvéderm Ultra Plus XC) in the treatment of nasolabial folds (NLFs). Twenty participants in Arm A received HA-1 in one NLF and HA-2 in the other. In Arm B, 20 participants received HA-1 in one NLF and HA-3 in the other. Injection was at visit 2, with follow-up visits at 1, 6, 9, and 12 months. Mean volume of HA was slightly <1.5 mL/NLF. Adverse events were unremarkable across all HAs, with injection site erythema being the most frequent adverse event. Mean pretreatment NLF severity rating for both arms was 2.3; at 12 months, mean posttreatment severity rating was 1.5 for HA-1/HA-2 and 1.6 for HA-1/HA-3. Although not statistically significant, participants tended to show a preference for HA-1. All three HAs provided essentially equivalent results, except for 4-week evenness results, which favored HA-1. Injection volumes of the three HAs were also similar. © 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

  7. Levonorgestrel-releasing intrauterine device in the treatment of abnormal uterine bleeding: a 6- and 12-month morphological and clinical follow-up.

    PubMed

    Palmara, Vittorio; Sturlese, Emanuele; Villari, Daniela; Giacobbe, Valentina; Retto, Annalisa; Santoro, Giuseppe

    2013-08-01

    Abnormal uterine bleeding is defined as any alteration in the pattern or volume of menstrual blood flow, and it is preferably treated using hysterectomy, endometrial destruction or the levonorgestrel-releasing intrauterine system (Mirena(®) ). Recently, it has been demonstrated that studies of Mirena(®) were generally small and consequently imprecise. Our study was aimed at assessing the effects of a slow-release levonorgestrel (20 μg/day) intrauterine device in fertile and postmenopausal women experiencing abnormal uterine bleeding that did not respond to traditional medical management. A total of 40 women, of whom 24 were of reproductive capacity and 16 were postmenopausal, were enrolled in the trial. Removal of the intrauterine device was required for only 2 of the 24 fertile women and for only 3 of the 16 postmenopausal women. After 6 and 12 months of treatment, the remaining women were clinically evaluated and underwent ultrasound and hysteroscopy using biopsy specimens as a control. The EuroQol Group EQ-5D questionnaire was used for evaluation of quality of life. The device showed good tolerability and efficacy. It resulted in a reduction in the endometrial mucosal thickness with a regression of bleeding and collateral effects, which were more evident after 12 months of treatment. A positive effect of the device on the woman's quality of life was demonstrated. The slow-release levonorgestrel intrauterine device may be a valid therapeutic tool for treating basic symptomatology and increasing quality of life in women with abnormal uterine bleeding. © 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  8. Efficacy and tolerability of quetiapine in the treatment of bipolar disorder: preliminary evidence from a 12-month open-label study.

    PubMed

    Altamura, A C; Salvadori, Daniele; Madaro, Donato; Santini, Annalisa; Mundo, Emanuela

    2003-09-01

    The literature on the use of quetiapine for the treatment of bipolar disorder (BD) is limited to case reports, and there are no systematic studies on the efficacy of quetiapine in the prophylactic treatment of BD. The aim of the present study was to compare the efficacy of flexible doses of quetiapine and well established mood stabilizers in the maintenance treatment of BD. Twenty-eight DSM-IV BD outpatients were consecutively recruited into the study and were randomized to receive one of two open-label treatments, with quetiapine or classical mood stabilizers at flexible doses for 12 months. Clinical assessment was carried out using BPRS, CGI, YMRS and the 21-item HAM-D at baseline (T0) and every 2 months until the end of the study. ANOVAs with repeated measures were applied to the rating scale scores considering the time and the treatment group as main factors. All patients experienced a significant improvement on the BPRS, CGI and HAM-D scores, with no significant side-effects and a good compliance. This study should be considered preliminary given the small sample size investigated and the open-label design. If these results will be replicated on larger samples and in controlled studies, there could be relevant implications for the use of quetiapine as an alternative maintenance treatment for BD.

  9. Antithymocyte globulin treatment for patients with recent-onset type 1 diabetes: 12-month results of a randomised, placebo-controlled, phase 2 trial.

    PubMed

    Gitelman, Stephen E; Gottlieb, Peter A; Rigby, Mark R; Felner, Eric I; Willi, Steven M; Fisher, Lynda K; Moran, Antoinette; Gottschalk, Michael; Moore, Wayne V; Pinckney, Ashley; Keyes-Elstein, Lynette; Aggarwal, Sudeepta; Phippard, Deborah; Sayre, Peter H; Ding, Linna; Bluestone, Jeffrey A; Ehlers, Mario R

    2013-12-01

    .591). All except one participant in the ATG group had both cytokine release syndrome and serum sickness, which was associated with a transient rise in interleukin-6 and acute-phase proteins. Acute T cell depletion occurred in the ATG group, with slow reconstitution over 12 months. However, effector memory T cells were not depleted, and the ratio of regulatory to effector memory T cells declined in the first 6 months and stabilised thereafter. ATG-treated patients had 159 grade 3-4 adverse events, many associated with T-cell depletion, compared with 13 in the placebo group, but we detected no between-group difference in incidence of infectious diseases. Our findings suggest that a brief course of ATG does not result in preservation of β-cell function 12 months later in patients with new-onset type 1 diabetes. Generalised T-cell depletion in the absence of specific depletion of effector memory T cells and preservation of regulatory T cells seems to be an ineffective treatment for type 1 diabetes. Copyright © 2013 Elsevier Ltd. All rights reserved.

  10. Change in patients' body weight after 12 months of treatment with glimepiride or glibenclamide in Type 2 diabetes: a multicentre retrospective cohort study.

    PubMed

    Martin, S; Kolb, H; Beuth, J; van Leendert, R; Schneider, B; Scherbaum, W A

    2003-12-01

    Our study compared the effects of glimepiride or glibenclamide treatment on body weight over 12 months of treatment in patients with Type 2 diabetes in routine outpatient practice. This new retrospective study design used data from physicians in a restricted manner (retrolective). Data from case report forms from 520 patients from 91 randomly selected centres were assessed and covariance analysis performed. The influence of practice and patient characteristics on treatment assignment was low, reflecting the design of randomised controlled trials. Mean weight loss and reduction in body mass index from baseline to study endpoint were greater with glimepiride than with glibenclamide (-2.04+/-3.99 kg vs -0.58+/-3.65 kg, p<0.001; -0.71+/-1.38 kg/m(2) vs -0.20+/-1.28 kg/m(2), p<0.001). Duration of treatment at baseline influenced treatment outcome, but propensity score, sex, age and fasting blood glucose at baseline did not. Both glimepiride and glibenclamide led to decreases in fasting blood glucose (-2.43+/-0.24 mmol/l vs -3.03+/-0.24 mmol/l; p<0.001 vs baseline) and HbA(1c) (-1.23+/-0.09% vs -1.26+/-0.09%; p<0.001 vs baseline). Both treatments were associated with a decrease in serum total cholesterol and low density lipoprotein cholesterol. Triglycerides were lower in the glibenclamide group and high density lipoprotein cholesterol was higher in the glimepiride group only. Initial treatment of Type 2 diabetes with glimepiride was associated with a significantly greater decrease in body weight and body mass index than treatment with glibenclamide, while providing equivalent glycaemic control.

  11. Comparative effectiveness of switching antipsychotic drug treatment to aripiprazole or ziprasidone for improving metabolic profile and atherogenic dyslipidemia: a 12-month, prospective, open-label study.

    PubMed

    Chen, Yuejin; Bobo, William V; Watts, Kara; Jayathilake, Karuna; Tang, Tinlai; Meltzer, Herbert Y

    2012-09-01

    We studied the effects of switching antipsychotic drug-treated patients with schizophrenia or bipolar disorder who evidenced adverse metabolic side effects as indicated by a triglyceride/high-density lipoprotein ratio (TG/HDL) ≥ 3.5 to aripiprazole (ARIP; 5-30 mg/day, n = 24) or ziprasidone (ZIP; 40-160 mg/day, n = 28). Anthropometric and metabolic measures, psychopathology, quality of life and motor adverse effects were assessed over a 52-week period with evaluations at baseline, 6, 12, 26 and 52 weeks. There were statistically significant improvements in body weight, body mass index (BMI), TG, HDL and TG/HDL which did not differ between treatments. However, numerous secondary measures including weight and BMI, and the proportion of patients who lost ≥ 7% or who no longer met criteria for obesity, favored ZIP over ARIP. Decreases in total cholesterol and increases in HDL-cholesterol also favored ZIP. On the other hand, decreases in TG/HDL ratio and reduction in HgbA1c favored ARIP. There were no significant time or group × time interaction effects for most psychopathology measures; however, Global Assessment of Functioning Scores favored ARIP at 6 and 12 months. We conclude that switching patients with evidence of metabolic side effects to either ARIP or ZIP may be beneficial for some, but not all metabolic measures, with minimal risk of worsening of psychopathology and possibly some benefit in that regard as well.

  12. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial

    PubMed Central

    Deer, Timothy R.; Levy, Robert M.; Kramer, Jeffery; Poree, Lawrence; Amirdelfan, Kasra; Grigsby, Eric; Staats, Peter; Burton, Allen W.; Burgher, Abram H.; Obray, Jon; Scowcroft, James; Golovac, Stan; Kapural, Leonardo; Paicius, Richard; Kim, Christopher; Pope, Jason; Yearwood, Thomas; Samuel, Sam; McRoberts, W. Porter; Cassim, Hazmer; Netherton, Mark; Miller, Nathan; Schaufele, Michael; Tavel, Edward; Davis, Timothy; Davis, Kristina; Johnson, Linda; Mekhail, Nagy

    2016-01-01

    Abstract Animal and human studies indicate that electrical stimulation of dorsal root ganglion (DRG) neurons may modulate neuropathic pain signals. ACCURATE, a pivotal, prospective, multicenter, randomized comparative effectiveness trial, was conducted in 152 subjects diagnosed with complex regional pain syndrome or causalgia in the lower extremities. Subjects received neurostimulation of the DRG or dorsal column (spinal cord stimulation, SCS). The primary end point was a composite of safety and efficacy at 3 months, and subjects were assessed through 12 months for long-term outcomes and adverse events. The predefined primary composite end point of treatment success was met for subjects with a permanent implant who reported 50% or greater decrease in visual analog scale score from preimplant baseline and who did not report any stimulation-related neurological deficits. No subjects reported stimulation-related neurological deficits. The percentage of subjects receiving ≥50% pain relief and treatment success was greater in the DRG arm (81.2%) than in the SCS arm (55.7%, P < 0.001) at 3 months. Device-related and serious adverse events were not different between the 2 groups. Dorsal root ganglion stimulation also demonstrated greater improvements in quality of life and psychological disposition. Finally, subjects using DRG stimulation reported less postural variation in paresthesia (P < 0.001) and reduced extraneous stimulation in nonpainful areas (P = 0.014), indicating DRG stimulation provided more targeted therapy to painful parts of the lower extremities. As the largest prospective, randomized comparative effectiveness trial to date, the results show that DRG stimulation provided a higher rate of treatment success with less postural variation in paresthesia intensity compared to SCS. PMID:28030470

  13. Can Medication Free, Treatment-Resistant, Depressed Patients Who Initially Respond to TMS Be Maintained Off Medications? A Prospective, 12-Month Multisite Randomized Pilot Study.

    PubMed

    Philip, Noah S; Dunner, David L; Dowd, Sheila M; Aaronson, Scott T; Brock, David G; Carpenter, Linda L; Demitrack, Mark A; Hovav, Sarit; Janicak, Philip G; George, Mark S

    2016-01-01

    Repetitive transcranial magnetic stimulation (TMS) is efficacious for acute treatment of resistant major depressive disorder (MDD), but there is little information on maintenance TMS after acute response. This pilot feasibility study investigated 12-month outcomes comparing two maintenance TMS approaches--a scheduled, single TMS session delivered monthly (SCH) vs. observation only (OBS). Antidepressant-free patients with unipolar, non-psychotic, treatment-resistant MDD participated in a randomized, open-label, multisite trial. Patients meeting protocol-defined criteria for improvement after six weeks of acute TMS were randomized to SCH or OBS regimens. TMS reintroduction was available for symptomatic worsening; all patients remained antidepressant-free during the trial. Sixty-seven patients enrolled in the acute phase, and 49 (73%) met randomization criteria. Groups were matched, although more patients in the SCH group had failed ≥ 2 antidepressants (p = .035). There were no significant group differences on any outcome measure. SCH patients had nonsignificantly longer time to first TMS reintroduction, 91 ± 66 days, vs. OBS, 77 ± 52 days; OBS patients were nonsignificantly more likely to need reintroduction (odds ratio = 1.21, 95% CI .38-3.89). Reintroduction lasted 14.3 ± 17.8 days (SCH) and 16.9 ± 18.9 days (OBS); 14/18 (78%) SCH and 17/27 (63%) OBS responded to reintroduction. Sixteen patients (32.7%) completed all 53 weeks of the study. Maintaining treatment-resistant depressed patients off medications with periodic TMS appears feasible in some cases. There was no statistical advantage of SCH vs. OBS, although SCH was associated with a nonsignificantly longer time to relapse. Those who initially respond to TMS have a strong chance of re-responding if relapse occurs. Published by Elsevier Inc.

  14. Concurrent Heroin Use and Correlates among Methadone Maintenance Treatment Clients: A 12-Month Follow-up Study in Guangdong Province, China

    PubMed Central

    Luo, Xiaofeng; Zhao, Peizhen; Gong, Xiao; Zhang, Lei; Tang, Weiming; Zou, Xia; Chen, Wen; Ling, Li

    2016-01-01

    Objective: To assess concurrent heroin use and correlates among Methadone Maintenance Treatment (MMT) clients in Guangdong Province, China. Method: Demographic and drug use data were collected with a structured questionnaire, and MMT information was obtained from the MMT clinic registration system in Guangdong. Human immunodeficiency virus (HIV-) and hepatitis C virus (HCV) infected status and urine morphine results were obtained from laboratory tests. Logistic regressions were employed to investigate the factors associated with concurrent heroin use. Results: Among the 6848 participants, 75% continued using heroin more than once during the first 12 months after treatment initiation. Concurrent heroin use was associated with inharmonious family relationship (OR (odds ratio) = 1.49, 95% CI (confidence intervals): 1.24–1.78), HIV positivity (OR = 1.25, 95% CI: 1.01–1.55), having multiple sex partners (OR = 1.34, 95% CI: 1.07–1.69), having ever taken intravenous drugs (OR = 0.81, 95% CI: 0.69–0.95), higher maintenance dose (OR = 1.13, 95% CI: 1.01–1.28) and poorer MMT attendance (OR<20% = 1.32, 95% CI: 1.13–1.53; OR20%– = 1.33, 95% CI: 1.14–1.54; OR50%– = 1.69, 95% CI: 1.44–2.00). Among those who used heroin concurrently, the same factors, and additionally being older (OR35– = 1.26, 95% CI: 1.11–1.43; OR≥45 = 1.63, 95% CI: 1.30–2.05) and female (OR = 1.60, 95% CI: 1.28–2.00), contribute to a greater frequency of heroin use. Conclusions: Concurrent heroin use was prevalent among MMT participants in Guangdong, underscoring the urgent needs for tailored interventions and health education programs for this population. PMID:27005649

  15. Pharmacokinetics of an oral drug (acetaminophen) administered at various times relative to subcutaneous injection of pramlintide in subjects with type 2 diabetes.

    PubMed

    Kellmeyer, Terrie A; Kesty, Nicole C; Wang, Yan; Frias, Juan P; Fineman, Mark S

    2007-07-01

    Pramlintide, an adjunct treatment to mealtime insulin for patients with type 2 and type 1 diabetes, aids glycemic control by suppressing postprandial glucagon secretion, slowing gastric emptying, and enhancing satiety. Because gastric emptying affects oral medication absorption, this placebo-controlled, single-blind, crossover study examined the absorption of 1000 mg of acetaminophen elixir administered -2, -1, 0, +1, and +2 hours relative to pramlintide (120 microg) or 0 hours relative to placebo in 24 patients with type 2 diabetes. When acetaminophen administration occurred 0, +1, or +2 hours relative to pramlintide, the maximum observed plasma concentration of acetaminophen decreased 14% to 29%, and time to maximum observed plasma concentration increased by 0.8 to 1.2 hours compared with administration 0 hours relative to placebo. Pramlintide treatment slowed but did not alter the extent of acetaminophen absorption (area under the concentration-time curve). No serious adverse events or withdrawals were reported. Oral agents should be administered at least 1 hour before or 2 hours after pramlintide injection if rapid onset of action is required for efficacy.

  16. Assessment of risks of pulmonary infection during 12 months following immunosuppressive treatment for active connective tissue diseases: a large-scale prospective cohort study.

    PubMed

    Yamazaki, Hayato; Sakai, Ryoko; Koike, Ryuji; Miyazaki, Yasunari; Tanaka, Michi; Nanki, Toshihiro; Watanabe, Kaori; Yasuda, Shinsuke; Kurita, Takashi; Kaneko, Yuko; Tanaka, Yoshiya; Nishioka, Yasuhiko; Takasaki, Yoshinari; Nagasaka, Kenji; Nagasawa, Hayato; Tohma, Shigeto; Dohi, Makoto; Sugihara, Takahiko; Sugiyama, Haruhito; Kawaguchi, Yasushi; Inase, Naohiko; Ochi, Sae; Hagiyama, Hiroyuki; Kohsaka, Hitoshi; Miyasaka, Nobuyuki; Harigai, Masayoshi

    2015-04-01

    Pulmonary infections (PI) are leading causes of death in patients with connective tissue diseases (CTD). The PREVENT study (Pulmonary infections in patients REceiving immunosuppressiVE treatmeNT for CTD) assessed risk of PI in patients with active CTD in the contemporary era of advanced immunosuppressive therapy. In patients who started corticosteroids (n = 763), conventional immunosuppressants or biologics for active CTD were enrolled. Clinical and laboratory data, usage of drugs, and occurrence of PI were collected for 12 months. Baseline risk factors were investigated using Cox regression analysis. A nested case-control (NCC) study was performed with 1:2 matched case-control pairs to assess the risk for each drug category. During the observation period, 32 patients died (4.2%) and 66 patients were lost to followup (8.6%). Patients with PI (n = 61, 8%) had a significantly worse accumulated survival rate than patients without (p < 0.01). Cox hazard regression analysis using baseline data showed that these factors were significantly associated with PI: age ≥ 65 years (HR 3.87, 95% CI 2.22-6.74), ≥ 20 pack-years of smoking (2.63, 1.37-5.04), higher serum creatinine level (1.21, 1.05-1.41 per 1.0 mg/dl increase), and maximum prednisolone (PSL) dose during the first 2 weeks of treatment (2.81, 1.35-5.86 per 1.0 mg/kg/day increase). Logistic regression analysis by an NCC study revealed that maximum PSL dose within 14 days before PI (OR 4.82, 95% CI 1.36-17.01 per 1.0 mg/dl increase; 2.57, 1.28-5.16 if ≥ 0.5 mg/kg/day) was significantly associated with the events, while other immunosuppressants were not. Physicians should be aware of the higher risks for corticosteroids of PI than other immunosuppressants and assess these risk factors before immunosuppressive treatment, to prevent PI.

  17. Late-night salivary cortisol may be valuable for assessing treatment response in patients with Cushing's disease: 12-month, Phase III pasireotide study.

    PubMed

    Findling, James W; Fleseriu, Maria; Newell-Price, John; Petersenn, Stephan; Pivonello, Rosario; Kandra, Albert; Pedroncelli, Alberto M; Biller, Beverly M K

    2016-11-01

    Measuring salivary cortisol is a simple, convenient and accurate technique with potential value in monitoring patients with hypercortisolism. This analysis reports changes in late-night salivary cortisol (LNSC) during a 12-month, multicentre, Phase III study of patients with Cushing's disease who were randomized to pasireotide 600 or 900 μg sc bid. LNSC assessment was an exploratory objective based on a single, optional measurement at midnight ± 1 h on the same day as one of the 24-h urinary free cortisol (UFC) measurements. Of 162 enrolled patients, baseline LNSC was measured in 93. Sixty-seven patients had levels above the upper limit of normal (ULN); median baseline levels were 19.7 and 20.7 nmol/L in the groups subsequently randomized to 600 μg (n = 40) and 900 μg (n = 27), respectively. Median LNSC levels decreased from baseline to month 12; median changes in patients who had baseline LNSC > ULN in the 600 and 900 μg groups were -13.4 nmol/L (-52.6 %; n = 19) and -11.8 nmol/L (-56.1 %; n = 14), respectively. LNSC normalized at months 6 and 12 in 25/67 (37.3 %) and 13/67 (19.4 %) patients, respectively; 10/25 and 8/13 patients also had normalized UFC, and 7/25 and 4/13 had partial UFC control (UFC > ULN and ≥50 % decrease from baseline). There was a moderate correlation (r = 0.55) on the log scale between individual patient LNSC and UFC values when all time points were pooled. Pasireotide decreased LNSC levels during 12 months of treatment. Salivary cortisol may be a simple, convenient biomarker for assessing treatment response in patients with Cushing's disease.

  18. Supervised training and home-based rehabilitation in patients with stabilized ankylosing spondylitis on TNF inhibitor treatment: a controlled clinical trial with a 12-month follow-up.

    PubMed

    Masiero, Stefano; Poli, Patrizia; Bonaldo, Lara; Pigatto, Maurizia; Ramonda, Roberta; Lubrano, Ennio; Punzi, Leonardo; Maffulli, Nicola

    2014-06-01

    To assess the 12-month's follow-up effects on pain, mobility, and physical function outcomes of a supervised training and home-based rehabilitation for ankylosing spondylitis patients stabilized with TNF-inhibitor therapy. Controlled clinical trial (sequentially determined allocation) with 12-months' follow-up. Patients' homes. A total of 69 subjects were allocated to either a rehabilitation programme (rehabilitation group, n = 22), an educational-behavioural programme (educational group, n = 24), and to neither programme (control group, n = 23). Rehabilitation programme included supervised training and home exercises (stretching, strengthening, aerobic, chest, and spine/hip joint flexibility exercises); educational-behavioural programme included information on ankylosing spondylitis, pain and stress mechanisms, and control. Spinal pain intensity, Bath Ankylosing Spondylitis Metrology Index, Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Disease Activity Index, chest expansion, and cervical and lumbar spine active range of motion measured by a pocket goniometer. At baseline, the three groups exhibited comparable demographic characteristics and basal evaluations. Intra-group changes in the rehabilitation group from baseline to 12 months yielded statistically significant gains (p < 0.05) for all outcomes. At 12-months follow-up, compared with the control and educational-behavioural, the rehabilitation group exhibited significant differences in chest expansion (p = 0.001 and p < 0.001), Bath Ankylosing Spondylitis Disease Activity Index (p = 0.012 and p = 0.050), and in some goniometric measurements as cervical rotation (p = 0.007 and p = 0.014), toraco-lumbar rotation (p = 0.009 and p = 0.050), and total cervical movements (p = 0.009 and p = 0.001). In comparison with the educational-behavioural programme or no intervention, supervised training and home exercises improved long-term outcome in patients with ankylosing spondylitis. © The

  19. Your Child's Development: 1 Year (12 Months)

    MedlinePlus

    ... Year-Old Your Child’s Development: 1 Year (12 Months) KidsHealth > For Parents > Your Child’s Development: 1 Year (12 Months) A A A Your little one is now ... THIS TOPIC Your Child's Checkup: 1 Year (12 Months) Your Baby's Growth: 12 Months Your Baby's Hearing, ...

  20. Report of 12-months efficacy and safety of intravitreal fluocinolone acetonide implant for the treatment of chronic diabetic macular oedema: a real-world result in the United Kingdom.

    PubMed

    Alfaqawi, F; Lip, P L; Elsherbiny, S; Chavan, R; Mitra, A; Mushtaq, B

    2017-04-01

    PurposeTo report the 12-months visual and anatomical outcomes of chronic diabetic macular oedema (DMO) treated with ILUVIEN in a real-world clinical practice in a single tertiary referral centre.MethodRetrospective data collection and analysis of consecutive 28 eyes of 23 diabetic patients received ILUVIEN implant for refractory DMO. Standard assessment included visual acuity (VA), central retinal thickness (CRT), slit-lamp biomicroscopy, and Goldmann tonometry for intraocular pressure (IOP) at 1, 6, and 12 months.ResultsBaseline mean VA was 47 (SD 18) letters improved to 55 (SD 17) letters (P=0.004) at 12 months. VA was improved in 16 eyes (57%), stabilised in 9 eyes (32%), and decreased in 3 eyes (11%). Seven eyes (25%) gained ≥15 letters, and 10 eyes (36%) gained >10 letters from baseline. The percentage of eyes achieved driving vision (≥70 Early Treatment Diabetic Retinopathy Study letters) was doubled from baseline 18 to 36% at 6 months and 32% at 12 months. Mean CRT decreased by 198 μm from baseline 494 μm (SD 191) to 296 μm (SD 121) at 12 months (P<0.001). Two eyes received additional anti-vascular endothelial growth factor injections after 10 months.

  1. Vision-related quality of life: 12-month aflibercept treatment in patients with treatment-resistant neovascular age-related macular degeneration.

    PubMed

    Zhu, Meidong; Wijeyakumar, Wijeyanthy; Syed, Adil R; Joachim, Nichole; Hong, Thomas; Broadhead, Geoffrey K; Li, Haitao; Luo, Kehui; Chang, Andrew

    2017-03-01

    To assess changes in vision-related quality of life (VR-QoL) among patients with treatment-resistant neovascular age-related macular degeneration (nAMD) following intravitreal aflibercept treatment over 48 weeks. We conducted a prospective study in which 49 patients with nAMD resistant to anti-vascular endothelial growth factor therapy were switched to intravitreal aflibercept. Patients were treated with three loading doses every 4 weeks followed by injections every 8 weeks, for a total of 48 weeks. Ophthalmic examinations performed at each visit included best-corrected visual acuity (BCVA) and central macular thickness (CMT) measurement. The National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) was used to assess VR-QoL at baseline and weeks 24 and 48. Changes in NEI VFQ-25 composite and subscale scores were analyzed using paired t tests. The relationship between the change in VR-QoL and changes in BCVA and CMT, and the impact of the better-seeing eye (BSE, defined as the eye reading the greater number of letters at baseline) vs. the worse-seeing eye (WSE, the fellow eye to the BSE) were assessed. Mean NEI VFQ-25 composite scores improved significantly at weeks 24 and 48 compared to baseline (4.5 ± 9.2 and 4.4 ± 11.8, respectively, all p < 0.01). Among subscales, general vision and near and distance activities showed significant improvements at weeks 24 and 48 (all p < 0.05). Improvement in the NEI VFQ-25 composite score was significantly associated with increased BCVA at week 48 (β coefficient = 0.43, p = 0.029), but not with change in CMT (β coefficient = -0.007, p = 0.631). There was no association between VR-QoL changes and BSE or WSE. Despite previous anti-VEGF treatment in this cohort, overall VR-QoL improved following aflibercept therapy over 48 weeks. This improvement was related to improved vision in treatment eyes regardless of whether they were the BSE or WSE.

  2. Reconsultation, self-reported health status and costs following treatment at a musculoskeletal Clinical Assessment and Treatment Service (CATS): a 12-month prospective cohort study

    PubMed Central

    Roddy, Edward; Jordan, Kelvin P; Oppong, Raymond; Chen, Ying; Jowett, Sue; Dawes, Peter; Hider, Samantha L; Packham, Jon; Stevenson, Kay; Zwierska, Irena; Hay, Elaine M

    2016-01-01

    Objectives To determine (1) reconsultation frequency, (2) change in self-reported health status, (3) baseline factors associated with reconsultation and change in health status and (4) associated healthcare costs and quality-adjusted life-years (QALYs), following assessment at a musculoskeletal Clinical and Assessment Treatment Service (CATS). Design Prospective cohort study. Setting Single musculoskeletal CATS at the primary–secondary care interface. Participants 2166 CATS attenders followed-up by postal questionnaires at 6 and 12 months and review of medical records. Outcome measures Primary outcome was consultation in primary care with the same musculoskeletal problem within 12 months. Secondary outcome measures were consultation at the CATS with the same musculoskeletal problem within 12 months, physical function and pain (Short Form-36), anxiety and depression (Hospital Anxiety and Depression Scale), time off work, healthcare costs and QALYs. Results Over 12 months, 507 (38%) reconsulted for the same problem in primary care and 345 (26%) at the CATS. Primary care reconsultation in the first 3 months was associated with baseline pain interference (relative risk ratio 5.33; 95% CI 3.23 to 8.80) and spinal pain (1.75; 1.09 to 2.82), and after 3–6 months with baseline assessment by a hospital specialist (2.06; 1.13 to 3.75). Small mean improvements were seen in physical function (1.88; 95% CI 1.44 to 2.32) and body pain (3.86; 3.38 to 4.34) at 6 months. Poor physical function at 6 months was associated with obesity, chronic pain and poor baseline physical function. Mean (SD) 6-month cost and QALYs per patient were £422.40 (660.11) and 0.257 (0.144), respectively. Conclusions While most patients are appropriate for a ‘one-stop shop’ model, those with troublesome, disabling pain and spinal pain commonly reconsult and have ongoing problems. Services should be configured to identify and address such clinical complexity. PMID:27733409

  3. Comparison of the health-related quality of life, CD4 count and viral load of AIDS patients and people with HIV who have been on treatment for 12 months in rural South Africa

    PubMed Central

    Igumbor, Jude; Stewart, Aimee; Holzemer, William

    2013-01-01

    This study compared the level of CD4 count, viral load and health-related quality of life (HRQOL) between treatment-naïve AIDS patients and a cohort of people living with HIV who have been on treatment for 12 months. This study is based on a secondary data analysis of the records of 642 people with HIV consisting of 311 treatment-naïve AIDS patients and 331 people with HIV who have been on treatment for 12 months. The study findings are mostly presented in tables and analysed using the t-test to compare HRQOL scores, CD4 count and viral load in the two groups. The study generally noted poor financial capacity and low activity tolerance among the participants. Significant changes were noted in all the domains of HRQOL compared between the treatment-naïve patients and the 12 months treatment cohort. In the same manner, the median CD4 cell count and viral load differed significantly between both groups. The treatment-naïve and the 12 months treatment cohorts consistently reported much lower quality of life scores in the level of dependence domain which includes the measures of mobility, activity of daily living, dependence on medication and work capacity. There were little or no associations between the biomedical markers (CD4 count and viral load) and HRQOL indicators. However, the quality of life tended to increase with increase in the CD4 cell count. The poor to no association between the biomedical markers and HRQOL indicators show that these cannot be direct proxies of each other and that the CD4 cell count and viral load alone may be inadequate eligibility criteria for social support. PMID:23777555

  4. Treatment-completion rates with olanzapine long-acting injection versus risperidone long-acting injection in a 12-month, open-label treatment of schizophrenia: indirect, exploratory comparisons

    PubMed Central

    Ascher-Svanum, Haya; Montgomery, William S; McDonnell, David P; Coleman, Kristina A; Feldman, Peter D

    2012-01-01

    Background Little is known about the comparative effectiveness of atypical antipsychotics in long-acting injection formulation. Due to the absence of head-to-head studies comparing olanzapine long-acting injection and risperidone long-acting injection, this study was intended to make exploratory, indirect, cross-study comparisons between the long-acting formulations of these two atypical antipsychotics in their effectiveness in treating patients with schizophrenia. Methods Indirect, cross-study comparisons between olanzapine long-acting injection and risperidone long-acting injection used 12-month treatment-completion rates, because discontinuation of an antipsychotic for any cause is a recognized proxy measure of the medication’s effectiveness in treating schizophrenia. Following a systematic review of the literature, two indirect comparisons were conducted using open-label, single-cohort studies in which subjects were stabilized on an antipsychotic medication before depot initiation. The first analysis compared olanzapine long-acting injection (one study) with pooled data from nine identified risperidone long-acting injection studies. The second analysis was a “sensitivity analysis,” using only the most similar studies, one for olanzapine long-acting injection and one for risperidone long-acting injection, which shared near-identical study designs and involved study cohorts with near-identical patient characteristics. Pearson Chi-square tests assessed group differences on treatment-completion rates. Results Comparison of olanzapine long-acting injection data (931 patients) with the pooled data from the nine risperidone long-acting injection studies (3950 patients) provided almost identical 12-month treatment-completion rates (72.7% versus 72.4%; P = 0.87). When the two most similar studies were compared, the 12-month completion rate for olanzapine long-acting injection was significantly higher than for risperidone long-acting injection (81.3% versus 47

  5. Comparison of the population excess fraction of Chlamydia trachomatis infection on pelvic inflammatory disease at 12-months in the presence and absence of chlamydia testing and treatment: Systematic review and retrospective cohort analysis

    PubMed Central

    Turner, Katy M. E.; Leung, Stella; Yu, B. Nancy; Frølund, Maria; Benfield, Thomas; Blanchard, James; Westh, Henrik; Ward, Helen

    2017-01-01

    Background The impact of Chlamydia trachomatis (chlamydia) control on the incidence of pelvic inflammatory disease (PID) is theoretically limited by the proportion of PID caused by chlamydia. We estimate the population excess fraction (PEF) of treated chlamydia infection on PID at 12-months in settings with widespread chlamydia control (testing and treatment) and compare this to the estimated PEF of untreated chlamydia. Methods We used two large retrospective population-based cohorts of women of reproductive age from settings with widespread chlamydia control to calculate the PEF of treated chlamydia on PID at 12-months. We undertook a systematic review to identify further studies that reported the risk of PID in women who were tested for chlamydia (infected and uninfected). We used the same method to calculate the PEF in eligible studies then compared all estimates of PEF. Results The systematic review identified a single study, a randomised controlled trial of chlamydia screening (POPI-RCT). In the presence of testing and treatment <10% of PID at 12-months was attributable to treated (baseline) chlamydia infections (Manitoba: 8.86%(95%CI 7.15–10.75); Denmark: 3.84%(3.26–4.45); screened-arm POPI-RCT: 0.99%(0.00–29.06)). In the absence of active chlamydia treatment 26.44%(11.57–46.32) of PID at 12-months was attributable to untreated (baseline) chlamydia infections (deferred-arm POPI-RCT). The PEFs suggest that eradicating baseline chlamydia infections could prevent 484 cases of PID at 12-months per 100,000 women in the untreated setting and 13–184 cases of PID per 100,000 tested women in the presence of testing and treatment. Conclusion Testing and treating chlamydia reduced the PEF of chlamydia on PID by 65% compared to the untreated setting. But in the presence of testing and treatment over 90% of PID could not be attributed to a baseline chlamydia infection. More information is needed about the aetiology of PID to develop effective strategies for

  6. Comparison of the population excess fraction of Chlamydia trachomatis infection on pelvic inflammatory disease at 12-months in the presence and absence of chlamydia testing and treatment: Systematic review and retrospective cohort analysis.

    PubMed

    Davies, Bethan; Turner, Katy M E; Leung, Stella; Yu, B Nancy; Frølund, Maria; Benfield, Thomas; Blanchard, James; Westh, Henrik; Ward, Helen

    2017-01-01

    The impact of Chlamydia trachomatis (chlamydia) control on the incidence of pelvic inflammatory disease (PID) is theoretically limited by the proportion of PID caused by chlamydia. We estimate the population excess fraction (PEF) of treated chlamydia infection on PID at 12-months in settings with widespread chlamydia control (testing and treatment) and compare this to the estimated PEF of untreated chlamydia. We used two large retrospective population-based cohorts of women of reproductive age from settings with widespread chlamydia control to calculate the PEF of treated chlamydia on PID at 12-months. We undertook a systematic review to identify further studies that reported the risk of PID in women who were tested for chlamydia (infected and uninfected). We used the same method to calculate the PEF in eligible studies then compared all estimates of PEF. The systematic review identified a single study, a randomised controlled trial of chlamydia screening (POPI-RCT). In the presence of testing and treatment <10% of PID at 12-months was attributable to treated (baseline) chlamydia infections (Manitoba: 8.86%(95%CI 7.15-10.75); Denmark: 3.84%(3.26-4.45); screened-arm POPI-RCT: 0.99%(0.00-29.06)). In the absence of active chlamydia treatment 26.44%(11.57-46.32) of PID at 12-months was attributable to untreated (baseline) chlamydia infections (deferred-arm POPI-RCT). The PEFs suggest that eradicating baseline chlamydia infections could prevent 484 cases of PID at 12-months per 100,000 women in the untreated setting and 13-184 cases of PID per 100,000 tested women in the presence of testing and treatment. Testing and treating chlamydia reduced the PEF of chlamydia on PID by 65% compared to the untreated setting. But in the presence of testing and treatment over 90% of PID could not be attributed to a baseline chlamydia infection. More information is needed about the aetiology of PID to develop effective strategies for improving the reproductive health of women.

  7. Evaluation of insulin initiation on resource utilization and direct costs of treatment over 12 months in patients with type 2 diabetes in Europe: results from INSTIGATE and TREAT observational studies.

    PubMed

    Brismar, Kerstin; Benroubi, Marianna; Nicolay, Claudia; Schmitt, Henry; Giaconia, Joseph; Reaney, Matthew

    2013-08-01

    To describe the changes in resource utilization in seven European countries (Germany, Greece, Portugal, Romania, Sweden, Spain, and Turkey) and direct costs in four European countries (Germany, Spain, Sweden, and Greece) over the first 12 months of insulin treatment in patients with type 2 diabetes mellitus (T2DM). INSTIGATE and TREAT (2005-2010) were non-interventional, prospective, observational studies in patients with T2DM and initiating insulin for the first time. A 6-month retrospective data capture was conducted at baseline (insulin initiation) followed by prospective data collections at ∼3, 6, and 12 months. Statistical analyses were descriptive; estimated costs are presented as nominal values. This study presents data for 1450 patients. Overall, in the first 6 months after insulin initiation, the use and cost of blood glucose monitoring and insulin increased, while the cost of oral diabetic medication decreased. Contributors to total direct costs differed between countries. Ranges of total mean direct costs over the 6-month period before insulin initiation were €489.10-€658.50 (Greece-Spain); 0-6 months after insulin initiation, €573.40-€1084.70 (Greece-Spain); and 6-12 months after insulin initiation, €495.80-€859.30 (Greece-Germany). Thus, the mean cost of treatment increased in all countries in the first 6 months after insulin initiation and then returned to baseline except in Germany. Overall, 15% of patients were lost to follow-up over 12 months. Costs were not pro-rated to account for variation of visits. Participating centres may not have been fully representative of all levels of care. Contributors to total cost differed between countries, potentially reflecting local clinical practice patterns and insulin regimens. In each country, mean direct total costs of T2DM care increased during the first 6 months after insulin initiation and decreased thereafter.

  8. [Shortages in Swedish tuberculosis care. Good results only in 71 percent of cases after 12-month treatment as shown in a current study].

    PubMed

    Romanus, V; Julander, I; Blom-Bülow, B; Larsson, L O; Normann, B; Boman, G

    2000-11-29

    During the period August 1994-December 1995 783 cases of active tuberculos (TB) were notified to the health authorities in Sweden. By means of questionnaires sent to the consulting physicians (92 per cent response rate) the treatment outcome was studied twelve months after the diagnosis. Out of 676 patients only 71 per cent were reported to have completed the treatment and be cured of TB. This indicates that there is room for improvement as regards monitoring patients, if necessary by Directly Observed Therapy (DOT), in order to make sure that prescribed treatment is adhered to.

  9. Long-term (12-month) improvement in meibomian gland function and reduced dry eye symptoms with a single thermal pulsation treatment.

    PubMed

    Greiner, Jack V

    2013-08-01

    To determine the 1-year post-treatment dry eye status of subjects with meibomian gland dysfunction and dry eye symptoms after receiving a single LipiFlow Thermal Pulsation System treatment. Single-centre, prospective, observational, open-label, 1-month-registered clinical trial with a 1-year follow-up examination. Patients with evaporative dry eye disease with meibomian gland dysfunction and dry eye symptoms who had participated in the registered 1-month clinical trial. Eighteen of 30 subjects initially enrolled were able to return for a 1-year follow-up. Both eyes of all patients were treated with a single 12-min treatment using the LipiFlow Thermal Pulsation System. Meibomian gland function, tear break-up time and dry eye symptoms were measured. Data are presented for pretreatment (baseline), and 1-month and 1-year post-treatment. Meibomian gland secretion scores, and tear break-up time and dry eye symptoms. Significant improvement in meibomian gland secretion scores from baseline measurements (4.0 ± 3.4) to 1-month post-treatment (11.3 ± 4.7; P < 0.0005) was maintained at 1-year (7.3 ± 4.6; P < 0.05). Baseline tear break-up time (4.9 ± 3.0) was significantly increased at 1-month (9.5 ± 6.9; P < 0.05); however, this improvement was no longer evident at 1-year post-treatment (6.0 ± 4.4). The significant improvement in symptom scores on Ocular Surface Disease Index and Standard Patient Evaluation of Eye Dryness questionnaires observed at 1-month (P < 0.0005) was maintained at 1-year (Ocular Surface Disease Index [P < 0.05]; Standard Patient Evaluation of Eye Dryness [P < 0.0005]). A single 12-min treatment with the Lipi Flow Thermal Pulsation System offers an effective treatment for evaporative dry eye and meibomian gland dysfunction resulting in significant and sustained improvement in signs and symptoms for up to 1 year. © 2012 The Author. Clinical and Experimental Ophthalmology © 2012 Royal Australian and New Zealand College of Ophthalmologists.

  10. Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial.

    PubMed

    Weobong, Benedict; Weiss, Helen A; McDaid, David; Singla, Daisy R; Hollon, Steven D; Nadkarni, Abhijit; Park, A-La; Bhat, Bhargav; Katti, Basavraj; Anand, Arpita; Dimidjian, Sona; Araya, Ricardo; King, Michael; Vijayakumar, Lakshmi; Wilson, G Terence; Velleman, Richard; Kirkwood, Betty R; Fairburn, Christopher G; Patel, Vikram

    2017-09-01

    The Healthy Activity Programme (HAP), a brief behavioural intervention delivered by lay counsellors, enhanced remission over 3 months among primary care attendees with depression in peri-urban and rural settings in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of HAP over 12 months, and the effects of the hypothesized mediator of activation on clinical outcomes. Primary care attendees aged 18-65 years screened with moderately severe to severe depression on the Patient Health Questionnaire 9 (PHQ-9) were randomised to either HAP plus enhanced usual care (EUC) (n = 247) or EUC alone (n = 248), of whom 95% completed assessments at 3 months, and 91% at 12 months. Primary outcomes were severity on the Beck Depression Inventory-II (BDI-II) and remission on the PHQ-9. HAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up (difference in mean BDI-II score between 3 and 12 months = -0.34; 95% CI -2.37, 1.69; p = 0.74), with lower symptom severity scores than participants who received EUC alone (adjusted mean difference in BDI-II score = -4.45; 95% CI -7.26, -1.63; p = 0.002) and higher rates of remission (adjusted prevalence ratio [aPR] = 1.36; 95% CI 1.15, 1.61; p < 0.009). They also fared better on most secondary outcomes, including recovery (aPR = 1.98; 95% CI 1.29, 3.03; p = 0.002), any response over time (aPR = 1.45; 95% CI 1.27, 1.66; p < 0.001), higher likelihood of reporting a minimal clinically important difference (aPR = 1.42; 95% CI 1.17, 1.71; p < 0.001), and lower likelihood of reporting suicidal behaviour (aPR = 0.71; 95% CI 0.51, 1.01; p = 0.06). HAP plus EUC also had a marginal effect on WHO Disability Assessment Schedule score at 12 months (aPR = -1.58; 95% CI -3.33, 0.17; p = 0.08); other outcomes (days unable to work, intimate partner violence toward females) did not statistically significantly differ between the two arms. Economic analyses

  11. Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial

    PubMed Central

    Weobong, Benedict; Singla, Daisy R.; Hollon, Steven D.; Nadkarni, Abhijit; Park, A-La; Bhat, Bhargav; Anand, Arpita; Dimidjian, Sona; King, Michael; Vijayakumar, Lakshmi; Wilson, G. Terence; Velleman, Richard

    2017-01-01

    Background The Healthy Activity Programme (HAP), a brief behavioural intervention delivered by lay counsellors, enhanced remission over 3 months among primary care attendees with depression in peri-urban and rural settings in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of HAP over 12 months, and the effects of the hypothesized mediator of activation on clinical outcomes. Methods and findings Primary care attendees aged 18–65 years screened with moderately severe to severe depression on the Patient Health Questionnaire 9 (PHQ-9) were randomised to either HAP plus enhanced usual care (EUC) (n = 247) or EUC alone (n = 248), of whom 95% completed assessments at 3 months, and 91% at 12 months. Primary outcomes were severity on the Beck Depression Inventory–II (BDI-II) and remission on the PHQ-9. HAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up (difference in mean BDI-II score between 3 and 12 months = −0.34; 95% CI −2.37, 1.69; p = 0.74), with lower symptom severity scores than participants who received EUC alone (adjusted mean difference in BDI-II score = −4.45; 95% CI −7.26, −1.63; p = 0.002) and higher rates of remission (adjusted prevalence ratio [aPR] = 1.36; 95% CI 1.15, 1.61; p < 0.009). They also fared better on most secondary outcomes, including recovery (aPR = 1.98; 95% CI 1.29, 3.03; p = 0.002), any response over time (aPR = 1.45; 95% CI 1.27, 1.66; p < 0.001), higher likelihood of reporting a minimal clinically important difference (aPR = 1.42; 95% CI 1.17, 1.71; p < 0.001), and lower likelihood of reporting suicidal behaviour (aPR = 0.71; 95% CI 0.51, 1.01; p = 0.06). HAP plus EUC also had a marginal effect on WHO Disability Assessment Schedule score at 12 months (aPR = −1.58; 95% CI −3.33, 0.17; p = 0.08); other outcomes (days unable to work, intimate partner violence toward females) did not statistically significantly

  12. US-guided percutaneous treatment and physical therapy in rotator cuff calcific tendinopathy of the shoulder: outcome at 3 and 12 months.

    PubMed

    Pasquotti, Giulio; Faccinetto, Alex; Marchioro, Umberto; Todisco, Matteo; Baldo, Vincenzo; Cocchio, Silvia; De Conti, Giorgio

    2016-08-01

    To monitor the results of ultrasound (US)-guided percutaneous treatment of calcific tendinopathy of the shoulder at 12 months (T12) after treatment (T0). To verify the possible relations between some pre- and post-procedural variables with the clinical outcome at T12. Forty-seven patients (26 female and 21 male) were enrolled in the study. Patients' approval and written informed consent were obtained. Symptoms were assessed by Constant Shoulder Score (CSS) at T0 and T12. Thirty of these also underwent a CSS control at 3 months (T3). The treatment efficacy was statistically tested for relation with location and type of calcification, characteristics of the tendon and subdeltoid bursa, impingement, and rehabilitation treatments. There was a significant increase in the average CSS value between T0 and T12 (40.7 vs. 75.3). The variables analysed did not show a statistically significant effect on the outcome at T12. A link was noticed only between patients' increasing age and score improvement, particularly among female subjects. US-guided treatment of calcific tendonitis is a viable therapeutic option. No pre- or intra-procedural parameters emerged which might help in predicting the outcome, apart from patients' needs in everyday life. • US-guided tcreatment of shoulder calcific tendinopathy is an excellent therapeutic option • Long-term results seem greatly affected by patients' features and needs in everyday life • No proven pre- or intra-procedural parameters emerged that might predict the outcome.

  13. Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis

    PubMed Central

    Dirschka, T; Radny, P; Dominicus, R; Mensing, H; Brüning, H; Jenne, L; Karl, L; Sebastian, M; Oster-Schmidt, C; Klövekorn, W; Reinhold, U; Tanner, M; Gröne, D; Deichmann, M; Simon, M; Hübinger, F; Hofbauer, G; Krähn-Senftleben, G; Borrosch, F; Reich, K; Berking, C; Wolf, P; Lehmann, P; Moers-Carpi, M; Hönigsmann, H; Wernicke-Panten, K; Hahn, S; Pabst, G; Voss, D; Foguet, M; Schmitz, B; Lübbert, H; Szeimies, R-M

    2013-01-01

    Background Two phase III trials of photodynamic therapy (PDT) with BF-200 ALA, a recently approved nanoemulsion formulation of 5-aminolaevulinic acid (ALA) demonstrated high clearance rates in mild-to-moderate actinic keratosis (AK). The comparison to a registered methyl aminolaevulinate (MAL) cream demonstrated significantly superior total patient clearance rates. Objectives To evaluate long-term efficacy and safety of PDT for AK 6 and 12 months after the last PDT with BF-200 ALA, MAL or placebo. Methods The follow-up phase (FUP) was performed with patients of two phase III studies. Both studies compared BF-200 ALA with placebo, one of the studies additionally with MAL. Overall recurrence rates and various subgroups (light source, lesion severity, lesion location, complete responders after first PDT) were assessed 6 and 12 months after the last PDT. Results Recurrence rates were similar for BF-200 ALA and MAL, with a tendency to lower recurrence rates for BF-200 ALA. The proportion of patients who were fully cleared during PDT and remained completely clear for at least 12 months after PDT were 47% for BF-200 ALA (both studies) and 36% for MAL treatment. The subgroup that was illuminated with narrow wavelength LED lamps reached 69% and 53% for BF-200 ALA (both studies, respectively) and 41% for MAL. No safety concerns were reported. Conclusions The FUP data confirmed the high efficacy and safety of PDT with BF-200 ALA. The slightly lower recurrence rates after BF-200 ALA treatment compared with MAL treatment enhanced the better treatment outcome due to the significantly superior efficacy. PMID:23252768

  14. Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis.

    PubMed

    Dirschka, T; Radny, P; Dominicus, R; Mensing, H; Brüning, H; Jenne, L; Karl, L; Sebastian, M; Oster-Schmidt, C; Klövekorn, W; Reinhold, U; Tanner, M; Gröne, D; Deichmann, M; Simon, M; Hübinger, F; Hofbauer, G; Krähn-Senftleben, G; Borrosch, F; Reich, K; Berking, C; Wolf, P; Lehmann, P; Moers-Carpi, M; Hönigsmann, H; Wernicke-Panten, K; Hahn, S; Pabst, G; Voss, D; Foguet, M; Schmitz, B; Lübbert, H; Szeimies, R-M

    2013-04-01

    Two phase III trials of photodynamic therapy (PDT) with BF-200 ALA, a recently approved nanoemulsion formulation of 5-aminolaevulinic acid (ALA) demonstrated high clearance rates in mild-to-moderate actinic keratosis (AK). The comparison to a registered methyl aminolaevulinate (MAL) cream demonstrated significantly superior total patient clearance rates. To evaluate long-term efficacy and safety of PDT for AK 6 and 12 months after the last PDT with BF-200 ALA, MAL or placebo. The follow-up phase (FUP) was performed with patients of two phase III studies. Both studies compared BF-200 ALA with placebo, one of the studies additionally with MAL. Overall recurrence rates and various subgroups (light source, lesion severity, lesion location, complete responders after first PDT) were assessed 6 and 12 months after the last PDT. Recurrence rates were similar for BF-200 ALA and MAL, with a tendency to lower recurrence rates for BF-200 ALA. The proportion of patients who were fully cleared during PDT and remained completely clear for at least 12 months after PDT were 47% for BF-200 ALA (both studies) and 36% for MAL treatment. The subgroup that was illuminated with narrow wavelength LED lamps reached 69% and 53% for BF-200 ALA (both studies, respectively) and 41% for MAL. No safety concerns were reported. The FUP data confirmed the high efficacy and safety of PDT with BF-200 ALA. The slightly lower recurrence rates after BF-200 ALA treatment compared with MAL treatment enhanced the better treatment outcome due to the significantly superior efficacy. © 2012 Biofrontera Bioscience GmbH BJD © 2012 British Association of Dermatologists.

  15. Long-term treatment with ivabradine over 12months in patients with chronic heart failure in clinical practice: Effect on symptoms, quality of life and hospitalizations.

    PubMed

    Zugck, C; Störk, S; Stöckl, G

    2017-08-01

    Ivabradine is indicated to control heart rate in otherwise optimally treated patients with chronic heart failure (CHF) and reduced ejection fraction. However, data on its effectiveness outside clinical trials and longer-term effects are scarce. We performed a prospective cohort study involving 249 German resident cardiologists and analyzed the 1-year effectiveness and safety of ivabradine used in CHF outpatients. Data on symptoms, quality of life, and hospitalizations were collected. In total, 767 CHF patients were enrolled to receive ivabradine twice daily, of whom 684 (90%) were still on ivabradine at study end (mean treatment duration 11.2months). The cohort was representative of CHF patients seen in clinical practice in terms of age, risk factor profile, and comorbidities. Concomitant beta-blocker therapy was prescribed in 497 patients (65%). After one year, compared to baseline, heart rate in ivabradine-treated patients was 16bpm lower. This reduction was associated with a significant improvement in NYHA class, and less frequent signs of decompensation (36% to 8%). The proportion of hospitalized patients within 1year decreased from 23% before treatment, to 5% with ivabradine therapy. These improvements in clinical status were accompanied by a reduction in BNP and an increase in LVEF (+5.1% at 1year). Quality of life was significantly improved in all measured dimensions. Adverse drug reactions were noted in 26 patients (3%), and were in line with the known safety profile of ivabradine. Ivabradine was effective and well-tolerated in CHF patients seen in clinical practice throughout 1year of treatment. Copyright © 2017. Published by Elsevier B.V.

  16. Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream.

    PubMed

    Hanke, C William; Swanson, Neil; Bruce, Suzanne; Berman, Brian; Kulp, James; Levy, Sharon

    2011-02-01

    Assess long-term, sustained, complete clearance of actinic keratoses after treatment with imiquimod 3.75% or 2.5% cream using two two-week or three-week cycles of daily dosing. Adults with five to 20 baseline actinic keratoses who achieved complete clearance at the eight-week post-treatment visit in four phase 3 placebo-controlled treatment studies were followed for an additional 12 months. For imiquimod 3.75% and 2.5% cream, respectively, complete clearance was sustained for 12 months in 17/42 (40.5%) and 13/39 (33.3%) subjects from the two-week cycle studies, and in 23/48 (47.9%) and 16/37 (43.2%) subjects from the three-week cycle studies. There were no safety concerns during the follow-up. In subjects with a median of eight to nine baseline actinic keratoses who achieved complete clearance after treatment of the full face or balding scalp with topical imiquimod 3.75% cream, complete clearance of all lesions (baseline, recurrent or new) was sustained in ≥ 40 percent of subjects for at least 14 months after the last dose. Clinicaltrials.gov identifier NCT00668733.

  17. Enamel matrix protein derivative and/or synthetic bone substitute for the treatment of mandibular class II buccal furcation defects. A 12-month randomized clinical trial.

    PubMed

    Queiroz, Lucas Araujo; Santamaria, Mauro Pedrine; Casati, Marcio Z; Ruiz, Karina Silverio; Nociti, Francisco; Sallum, Antonio Wilson; Sallum, Enilson A

    2016-09-01

    This study aims to clinically evaluate the treatment of mandibular class II furcation defects with enamel matrix derivative (EMD) and/or a bone substitute graft made of β-tricalcium phosphate/hydroxyapatite (βTCP/HA). Forty-one patients, presenting a mandibular class II buccal furcation defect, probing pocket depth (PPD) ≥4 mm and bleeding on probing, were included. They were randomly assigned to the groups: 1-EMD (n = 13); 2-βTCP/HA (n = 14); 3-EMD + βTCP/HA (n = 14). Plaque index (PI), gingival index (GI), relative gingival margin position (RGMP), relative vertical and horizontal attachment level (RVCAL and RHCAL), and PPD were evaluated at baseline and 6 and 12 months. The mean horizontal clinical attachment level gain was considered the primary outcome variable. No significant intragroup differences were observed for RGMP, but significant changes were observed for RVCAL, RHCAL, and PPD for all groups (p < 0.05). After 12 months, the mean horizontal clinical attachment level gain was 2.77 ± 0.93 mm for EMD, 2.64 ± 0.93 mm for βTCP/HA, and 2.93 ± 0.83 mm for EMD + βTCP/HA, with no significant differences among the groups. At the end of the study, 85.3 % of the sites were partially closed; however, no complete closure was observed. EMD + βTCP/HA does not provide a significant advantage when compared to the isolated approaches. All three tested treatments promote significant improvements and partial closure of class II buccal furcation defects. Based on its potential to induce periodontal regeneration, EMD may be considered an attractive option for this type of defect, but complete closure remains an unrealistic goal. The partial closure of buccal furcation defects can be achieved after the three tested approaches. However, the combined treatment does not provide a significant benefit when compared to the isolated approaches.

  18. Efficacy of a new sealant to prevent white spot lesions during fixed orthodontic treatment : A 12-month, single-center, randomized controlled clinical trial.

    PubMed

    Hammad, Shaza M; Knösel, Michael

    2016-11-01

    White spot lesions (WSLs) are an undesirable side effect of fixed orthodontic appliance therapy and are reported to occur in 2-96 % of orthodontic patients. In this study, the efficacy of a new sealant to prevent WSLs during fixed orthodontic treatment was compared to a control group that did not receive sealant. For this 2-arm parallel-group randomized trial, 50 subjects aged 12-18 years (mean age 14.57 ± 2.04 years) were recruited from the orthodontics department at Mansoura University, Egypt. Eligibility criteria were no restorations, no active WSLs or caries, and adequate oral hygiene. Subjects were randomized in a 1:1 ratio to one of the two arms prior to undergoing fixed orthodontic treatment, namely a single application of SeLECT Defense™ sealant during the bracketing appointment or no sealant (control arm). Instructions and dentifrices for local home fluoridation regimen were identical in both groups. Oral hygiene was assessed using the Approximal Plaque Index (API) at specified time intervals. Dental photographs were taken for blinded WSLs assessment; inter- and intra-operator error were also calculated. Categorical data were tested using the χ (2) test, and a logistic regression model was adopted to detect associations between decalcification (WSLs), sealant application, and oral hygiene status. Only excellent or good oral hygiene were independent prognostic factors for preventing severe WSLs (p = 0.035). No significant effect on caries incidence was observed for the sealant. In combination with adequate oral hygiene SeLECT Defense™ helps to reduced the frequency of WSLs. However, the sealat showed no significant effect as sole preventive strategy.

  19. Single versus repeated doses of ivermectin and diethylcarbamazine for the treatment of Wuchereria bancrofti var. pacifica microfilaremia. Results at 12 months of a double-blind study.

    PubMed

    Cartel, J L; Spiegel, A; Nguyen Ngnoc, L; Cardines, R; Plichart, R; Martin, P M; Roux, J F

    1991-12-01

    In October 1989, 58 apparently healthy Polynesian Wuchereria bancrofti carriers in whom microfilarial (mf) density was greater than or equal to 100 mf/ml were randomly allocated to treatment groups receiving single doses of either ivermectin at 100 mcg/kg or diethylcarbamazine (DEC) at 3 and 6 mg/kg. Six months later, half of the carriers initially treated with ivermectin 100 mcg/kg or DEC 3 mg/kg were given a second similar dose while the rest were given a placebo. By day 360 (6 months after retreatment), comparison of adjusted geometric mean mf counts per group indicated that (i) among the 3 treatments given once a year the DEC 6 mg/kg dose resulted in the highest efficacy, (ii) nevertheless, regarding either ivermectin 100 mcg/kg or DEC 3 mg/kg, 2 successive doses resulted in higher efficacy than one annual dose and (iii) though no significant difference could be evidenced between efficacy of ivermectin 100 mcg/kg and DEC 3 mg/kg given twice a year, DEC seemed to sustain the mf reduction for a longer period of time. During the 3 days following retreatment, adverse reactions (mild to moderate) were observed in 46% of carriers treated with microfilaricidal drugs and in 20% of those treated with placebo. These results suggest that single dose therapy with either DEC or ivermectin is safe and effective for prevention of lymphatic filariasis due to Wuchereria bancrofti in French Polynesia. The real impact on transmission by the vector, Aedes polynesiensis, of the complete negativation of microfilaremia observed during the previous part of the trial in carriers treated with ivermectin should be evaluated in a community-based trial including entomological study.(ABSTRACT TRUNCATED AT 250 WORDS)

  20. Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial.

    PubMed

    de Ruiter, Maurits H T; Benoist, Linda B L; de Vries, Nico; de Lange, Jan

    2017-09-15

    The Sleep Position Trainer (SPT) is a new option for treating patients with positional obstructive sleep apnea (POSA). This study investigated long-term efficacy, adherence, and quality of life during use of the SPT device compared with oral appliance therapy (OAT) in patients with POSA. This prospective, multicenter trial randomized patients with mild to moderate POSA (apnea-hypopnea index [AHI] 5-30/h) to SPT or OAT. Polysomnography was performed at baseline and after 3 and 12 months' follow-up. The primary endpoint was OSA severity; adherence, quality of life, and adverse events were also assessed. Ninety-nine patients were randomized and 58 completed the study (29 in each group). Median AHI in the SPT group decreased from 13.2/h at baseline to 7.1/h after 12 months (P < 0.001); corresponding values in the OAT group were 13.4/h and 5.0/h (P < 0.001), with no significant between-group difference (P = 1.000). Improvements throughout the study were maintained at 12 months. Long-term median adherence was also similar in the two treatment groups; the proportion of patients who used their device for ≥ 4 h for 5 days in a week was 100% in the SPT group and 97.0% in the OAT group (P = 0.598). The efficacy of SPT therapy was maintained over 12 months and was comparable to that of OAT in patients with mild to moderate POSA. Adherence was relatively high, and similar in the two groups. www.clinicaltrials.gov (NCT02045576).

  1. Sustained effectiveness and cost-effectiveness of Counselling for Alcohol Problems, a brief psychological treatment for harmful drinking in men, delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial.

    PubMed

    Nadkarni, Abhijit; Weiss, Helen A; Weobong, Benedict; McDaid, David; Singla, Daisy R; Park, A-La; Bhat, Bhargav; Katti, Basavaraj; McCambridge, Jim; Murthy, Pratima; King, Michael; Wilson, G Terence; Kirkwood, Betty; Fairburn, Christopher G; Velleman, Richard; Patel, Vikram

    2017-09-01

    Counselling for Alcohol Problems (CAP), a brief intervention delivered by lay counsellors, enhanced remission and abstinence over 3 months among male primary care attendees with harmful drinking in a setting in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of CAP over 12 months, and the effects of the hypothesized mediator 'readiness to change' on clinical outcomes. Male primary care attendees aged 18-65 years screening with harmful drinking on the Alcohol Use Disorders Identification Test (AUDIT) were randomised to either CAP plus enhanced usual care (EUC) (n = 188) or EUC alone (n = 189), of whom 89% completed assessments at 3 months, and 84% at 12 months. Primary outcomes were remission and mean standard ethanol consumed in the past 14 days, and the proposed mediating variable was readiness to change at 3 months. CAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up, with the proportion with remission (AUDIT score < 8: 54.3% versus 31.9%; adjusted prevalence ratio [aPR] 1.71 [95% CI 1.32, 2.22]; p < 0.001) and abstinence in the past 14 days (45.1% versus 26.4%; adjusted odds ratio 1.92 [95% CI 1.19, 3.10]; p = 0.008) being significantly higher in the CAP plus EUC arm than in the EUC alone arm. CAP participants also fared better on secondary outcomes including recovery (AUDIT score < 8 at 3 and 12 months: 27.4% versus 15.1%; aPR 1.90 [95% CI 1.21, 3.00]; p = 0.006) and percent of days abstinent (mean percent [SD] 71.0% [38.2] versus 55.0% [39.8]; adjusted mean difference 16.1 [95% CI 7.1, 25.0]; p = 0.001). The intervention effect for remission was higher at 12 months than at 3 months (aPR 1.50 [95% CI 1.09, 2.07]). There was no evidence of an intervention effect on Patient Health Questionnaire 9 score, suicidal behaviour, percentage of days of heavy drinking, Short Inventory of Problems score, WHO Disability Assessment Schedule 2.0 score, days unable to

  2. Sustained effectiveness and cost-effectiveness of Counselling for Alcohol Problems, a brief psychological treatment for harmful drinking in men, delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial

    PubMed Central

    Nadkarni, Abhijit; Weobong, Benedict; Singla, Daisy R.; Park, A-La; Bhat, Bhargav; Katti, Basavaraj; Murthy, Pratima; King, Michael; Wilson, G. Terence; Fairburn, Christopher G.; Velleman, Richard

    2017-01-01

    Background Counselling for Alcohol Problems (CAP), a brief intervention delivered by lay counsellors, enhanced remission and abstinence over 3 months among male primary care attendees with harmful drinking in a setting in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of CAP over 12 months, and the effects of the hypothesized mediator ‘readiness to change’ on clinical outcomes. Methods and findings Male primary care attendees aged 18–65 years screening with harmful drinking on the Alcohol Use Disorders Identification Test (AUDIT) were randomised to either CAP plus enhanced usual care (EUC) (n = 188) or EUC alone (n = 189), of whom 89% completed assessments at 3 months, and 84% at 12 months. Primary outcomes were remission and mean standard ethanol consumed in the past 14 days, and the proposed mediating variable was readiness to change at 3 months. CAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up, with the proportion with remission (AUDIT score < 8: 54.3% versus 31.9%; adjusted prevalence ratio [aPR] 1.71 [95% CI 1.32, 2.22]; p < 0.001) and abstinence in the past 14 days (45.1% versus 26.4%; adjusted odds ratio 1.92 [95% CI 1.19, 3.10]; p = 0.008) being significantly higher in the CAP plus EUC arm than in the EUC alone arm. CAP participants also fared better on secondary outcomes including recovery (AUDIT score < 8 at 3 and 12 months: 27.4% versus 15.1%; aPR 1.90 [95% CI 1.21, 3.00]; p = 0.006) and percent of days abstinent (mean percent [SD] 71.0% [38.2] versus 55.0% [39.8]; adjusted mean difference 16.1 [95% CI 7.1, 25.0]; p = 0.001). The intervention effect for remission was higher at 12 months than at 3 months (aPR 1.50 [95% CI 1.09, 2.07]). There was no evidence of an intervention effect on Patient Health Questionnaire 9 score, suicidal behaviour, percentage of days of heavy drinking, Short Inventory of Problems score, WHO Disability

  3. Er:YAG ablative fractional laser-primed photodynamic therapy with methyl aminolevulinate as an alternative treatment option for patients with thin nodular basal cell carcinoma: 12-month follow-up results of a randomized, prospective, comparative trial.

    PubMed

    Choi, S H; Kim, K H; Song, K H

    2016-05-01

    Surgical excision is conventionally regarded as the treatment of choice for nodular basal cell carcinoma (nBCC), and methyl aminolevulinate photodynamic therapy (MAL-PDT) has relatively low efficacy for nBCC. However, Er:YAG ablative fractional laser (AFL)-primed MAL-PDT (Er:YAG AFL-PDT) may offer enhanced efficacy for nBCC, especially thin nBCC (thickness ≤2 mm). We compared Er:YAG AFL-PDT with conventional MAL-PDT for thin facial nBCC in Korean patients. Thirty-nine patients (42 lesions) with primary, histologically proven thin nBCCs were randomized to Er:YAG AFL-PDT (single session, n = 20) or conventional MAL-PDT (two sessions, 7 days apart, n = 19). Efficacy, recurrence rate, cosmetic outcomes and safety were assessed 1 week, 3 months and 12 months after the last treatment. Three months after the final treatment, overall complete response rates were 84.2% with Er:YAG AFL-PDT and 50% with MAL-PDT (P = 0.026). The recurrence rate was significantly lower with Er:YAG AFL-PDT (6.3%) than with MAL-PDT (55.6%) at 12 months (P = 0.006). Er:YAG AFL-PDT and MAL-PDT did not differ significantly with respect to cosmetic outcomes or safety. Er:YAG AFL-PDT can be used as an alternative treatment option for patients who have thin nBCC and are not suitable for surgical treatment. © 2015 European Academy of Dermatology and Venereology.

  4. Your Child's Development: 1 Year (12 Months)

    MedlinePlus

    ... Child Too Busy? Helping Your Child Adjust to Preschool School Lunches Kids and Food: 10 Tips for Parents Healthy Habits for TV, Video Games, and the Internet Your Child’s Development: 1 Year (12 Months) KidsHealth > For Parents > Your ...

  5. Breastfeeding beyond 12 months. An historical perspective.

    PubMed

    Piovanetti, Y

    2001-02-01

    A decade ago, child psychiatrist Coello-Novello, in her term as Surgeon General of the United States, said, "It's the lucky baby, I feel, who continues to nurse until he's two." The accumulated evidence supports her statement. The understanding of the benefits of breastfeeding beyond 12 months should support the cultural change in which eventually prolonged breastfeeding becomes normal.

  6. Effects of pramlintide, an amylin analogue, on gastric emptying in type 1 and 2 diabetes mellitus.

    PubMed

    Vella, A; Lee, J S; Camilleri, M; Szarka, L A; Burton, D D; Zinsmeister, A R; Rizza, R A; Klein, P D

    2002-04-01

    Pramlintide delays gastric emptying, possibly by a centrally mediated mechanism. Our aim was to determine whether the effects of pramlintide on gastric emptying differ in people with type 1 or type 2 diabetes who had no history of complications. Using a randomized, three-period, two-dose, crossover design, we studied the effects of 0, 30, or 60 microg t.i.d. pramlintide subcutaneously for 5 days each in six type 1 and six type 2 diabetic subjects. Gastric emptying of solids was measured by 13C-Spirulina breath test. Plasma pancreatic polypeptide (HPP) response to the test meal was also measured. Relative to placebo [t 50% 91 +/- 6 min (means +/- SEM)], pramlintide equally delayed gastric emptying following 30 or 60 microg t.i.d. (268 +/- 37 min, 329 +/- 49 min, respectively; P < 0.01]. Postprandial HPP levels were lower in response to 30 and 60 microg pramlintide compared to placebo. There were no significant differences in the effects on gastric emptying or HPP levels between type 1 and type 2 diabetic subjects. Pramlintide delays gastric emptying in diabetes unassociated with clinically detected complications. Further studies are needed in diabetic patients with impaired gastric motor function.

  7. Recovery 3 and 12 months after hysterectomy

    PubMed Central

    Theunissen, Maurice; Peters, Madelon L.; Schepers, Jan; Maas, Jacques W.M.; Tournois, Fleur; van Suijlekom, Hans A.; Gramke, Hans-Fritz; Marcus, Marco A.E.

    2016-01-01

    Abstract Chronic postsurgical pain (CPSP) is 1 important aspect of surgical recovery. To improve perioperative care and postoperative recovery knowledge on predictors of impaired recovery is essential. The aim of this study is to assess predictors and epidemiological data of CPSP, physical functioning (SF-36PF, 0–100), and global surgical recovery (global surgical recovery index, 0–100%) 3 and 12 months after hysterectomy for benign indication. A prospective multicenter cohort study was performed. Sociodemographic, somatic, and psychosocial data were assessed in the week before surgery, postoperatively up to day 4, and at 3- and 12-month follow-up. Generalized linear model (CPSP) and linear-mixed model analyses (SF-36PF and global surgical recovery index) were used. Baseline data of 468 patients were collected, 412 (88%) patients provided data for 3-month evaluation and 376 (80%) patients for 12-month evaluation. After 3 and 12 months, prevalence of CPSP (numeric rating scale ≥ 4, scale 0–10) was 10.2% and 9.0%, respectively, SF-36PF means (SD) were 83.5 (20.0) and 85.9 (20.2), global surgical recovery index 88.1% (15.6) and 93.3% (13.4). Neuropathic pain was reported by 20 (5.0%) patients at 3 months and 14 (3.9%) patients at 12 months. Preoperative pain, surgery-related worries, acute postsurgical pain on day 4, and surgery-related infection were significant predictors of CPSP. Baseline level, participating center, general psychological robustness, indication, acute postsurgical pain, and surgery-related infection were significant predictors of SF-36PF. Predictors of global surgical recovery were baseline expectations, surgery-related worries, American Society of Anesthesiologists classification, type of anesthesia, acute postsurgical pain, and surgery-related infection. Several predictors were identified for CPSP, physical functioning, and global surgical recovery. Some of the identified factors are modifiable and optimization of patients’ preoperative

  8. Office-based cryoablation of breast fibroadenomas: 12-month followup.

    PubMed

    Kaufman, Cary S; Littrup, Peter J; Freman-Gibb, Laurie A; Francescatti, Darius; Stocks, Lewis H; Smith, J Stanley; Henry, C Alan; Bailey, Lisa; Harness, Jay K; Simmons, Rache

    2004-06-01

    Fibroadenomas comprise between 30% and 50% of all breast biopsies. Despite their benign nature, many women have their fibroadenomas surgically removed. We previously reported on a minimally invasive therapy using cryoablation to treat fibroadenomas. We now report on 12-month followup using this technique. A prospective, nonrandomized trial was initiated in June 2000 with IRB approval. The Visica Treatment System was used to cryoablate 70 biopsy-proved fibroadenomas in 57 patients using a freeze-thaw-freeze cycle lasting 6 to 30 minutes. Each patient was serially evaluated for safety, efficacy, and satisfaction. Fifty-seven fibroadenomas (mean 2.1 cm, range 0.8 to 4.2 cm) in 47 patients were followed for 12 months. At 1 year, with 89% median tumor volume reduction measured by ultrasonography, 75% of fibroadenomas were nonpalpable. There were no adverse events and only minor complications. Two patients (4%) had their lesions excised after 12 months; pathology revealed no viable fibroadenoma. Serial mammograms showed resorption of the fibroadenoma leaving minimal residual density without calcifications. Cosmesis was excellent with no volume deficit, as no tissue is removed. Ninety-one percent of patients were satisfied at 12 months. Cryoablation is safe and effective in treating breast fibroadenomas. It offers a nonsurgical, office-based treatment that is well tolerated by patients and accurately monitored with ultrasonographic guidance. At 12 months we found progressive tumor volume reduction and reduced palpability, with no volume deficit, excellent cosmesis, and satisfied patients. Ultrasonography-guided cryoablation is a preferred option for treatment of breast fibroadenomas without open surgery.

  9. Polymer-Free Biolimus A9-Coated Stents in the Treatment of De Novo Coronary Lesions: 4- and 12-Month Angiographic Follow-Up and Final 5-Year Clinical Outcomes of the Prospective, Multicenter BioFreedom FIM Clinical Trial.

    PubMed

    Costa, Ricardo A; Abizaid, Alexandre; Mehran, Roxana; Schofer, Joachim; Schuler, Gerhard C; Hauptmann, Karl E; Magalhães, Marco A; Parise, Helen; Grube, Eberhard

    2016-01-11

    The purpose of this study was to evaluate the efficacy and long-term outcomes of a novel polymer/carrier-free drug-coated stent (DCS) in patients with de novo coronary lesions. The BioFreedom (BFD) DCS incorporates a low-profile, stainless-steel platform, with a surface that has been modified to create a selectively microstructured abluminal surface that allows adhesion and further release of Biolimus A9 (Biosensors Europe SA, Morges, Switzerland). A total of 182 patients (183 lesions) were randomized into a 1:1:1 ratio for treatment with BFD "standard dose" (BFD) or BFD "low dose" (BFD-LD) versus first-generation paclitaxel-eluting stents (PES) at 4 sites in Germany. Baseline and procedural characteristics were well matched. At 4-month angiographic follow-up (Cohort 1, n = 75), in-stent late lumen loss (LLL) was significantly lower with BFD and BFD-LD versus PES (0.08 and 0.12 mm vs. 0.37 mm, respectively; p < 0.0001 for BFD vs. PES, and p = 0.002 for BFD-LD vs. PES). At 12 months (Cohort 2, n = 107), in-stent LLL (primary endpoint) was 0.17 mm in BFD versus 0.35 mm in PES (p = 0.001 for noninferiority; p = 0.11 for superiority); however, the BFD-LD (0.22 mm) did not reach noninferiority (p = 0.21). At 5 years (175 of 182), there were no significant differences in major adverse cardiac events (23.8%, 26.4%, and 20.3%) and clinically indicated target lesion revascularization (10.8%, 13.4%, and 10.2%) for BFD, BFD-LD, and PES, respectively; also, there was no definite/probable stent thrombosis reported. The BFD, but not the BFD-LD, demonstrated noninferiority versus PES in terms of in-stent LLL, a surrogate of neointimal hyperplasia, at 12-month follow-up. At 5 years, clinical event rates were similar, without occurrence of stent thrombosis in all groups. (BioFreedom FIM Clinical Trial; NCT01172119). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  10. Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period.

    PubMed

    Emery, Paul; Burmester, Gerd R; Bykerk, Vivian P; Combe, Bernard G; Furst, Daniel E; Barré, Emilie; Karyekar, Chetan S; Wong, Dennis A; Huizinga, Tom W J

    2015-01-01

    To evaluate clinical remission with subcutaneous abatacept plus methotrexate (MTX) and abatacept monotherapy at 12 months in patients with early rheumatoid arthritis (RA), and maintenance of remission following the rapid withdrawal of all RA treatment. In the Assessing Very Early Rheumatoid arthritis Treatment phase 3b trial, patients with early active RA were randomised to double-blind, weekly, subcutaneous abatacept 125 mg plus MTX, abatacept 125 mg monotherapy, or MTX for 12 months. Patients with low disease activity (Disease Activity Score (DAS)28 (C reactive protein (CRP)) <3.2) at month 12 entered a 12-month period of withdrawal of all RA therapy. The coprimary endpoints were the proportion of patients with DAS28 (CRP) <2.6 at month 12 and both months 12 and 18, for abatacept plus MTX versus MTX. Patients had <2 years of RA symptoms, DAS28 (CRP) ≥3.2, anticitrullinated peptide-2 antibody positivity and 95.2% were rheumatoid factor positive. For abatacept plus MTX versus MTX, DAS28 (CRP) <2.6 was achieved in 60.9% versus 45.2% (p=0.010) at 12 months, and following treatment withdrawal, in 14.8% versus 7.8% (p=0.045) at both 12 and 18 months. DAS28 (CRP) <2.6 was achieved for abatacept monotherapy in 42.5% (month 12) and 12.4% (both months 12 and 18). Both abatacept arms had a safety profile comparable with MTX alone. Abatacept plus MTX demonstrated robust efficacy compared with MTX alone in early RA, with a good safety profile. The achievement of sustained remission following withdrawal of all RA therapy suggests an effect of abatacept's mechanism on autoimmune processes. NCT01142726. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  11. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial.

    PubMed

    Tepe, Gunnar; Laird, John; Schneider, Peter; Brodmann, Marianne; Krishnan, Prakash; Micari, Antonio; Metzger, Christopher; Scheinert, Dierk; Zeller, Thomas; Cohen, David J; Snead, David B; Alexander, Beaux; Landini, Mario; Jaff, Michael R

    2015-02-03

    Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease. The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94 ± 4.89 and 8.81 ± 5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedure-related deaths and no major amputations. In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease. http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and NCT01566461. © 2014 The Authors.

  12. Evaluation of Quality of Life, Functioning, Disability, and Work/School Productivity Following Treatment with an Extended-Release Hydrocodone Tablet Formulated with Abuse-Deterrence Technology: A 12-month Open-label Study in Patients with Chronic Pain.

    PubMed

    Hale, Martin E; Zimmerman, Thomas R; Ma, Yuju; Malamut, Richard

    2017-02-01

    This phase 3 study evaluated quality of life, functioning, and productivity after treatment with extended-release (ER) hydrocodone formulated with CIMA(®) Abuse-Deterrence Technology platform. Patients with chronic pain were rolled over from a 12-week placebo-controlled hydrocodone ER study or were newly enrolled. Hydrocodone ER doses were titrated (15 to 90 mg every 12 hours) to an analgesic dose, and patients received up to 52 weeks of open-label treatment. Assessments included Clinician Assessment of Patient Function (CAPF), Patient Assessment of Function (PAF), Brief Pain Inventory-Short Form (BPI-SF), 36-item Short-Form Health Survey (SF-36), Sheehan Disability Scale (SDS), and World Health Organization Health and Work Performance Questionnaire-Short Form (HPQ-SF). Of 330 enrolled patients, 291 composed the full analysis population. By week 4, ≥ 50% of patients showed improvement from baseline in all 5 CAPF domains (general activities, walking, work/daily living, relationships, and enjoyment of life) and 6 of 7 PAF domains (work attendance, work performance, walking, exercise, socializing, and enjoying life). Mean decreases from baseline of 2 to 3 points were noted for BPI-SF pain interference questions from week 4 through endpoint. Mean improvements from baseline to endpoint in SF-36 subscales ranged from 3.3 to 22.3, and SDS scores improved from moderate (4.8 to 5.1) to mild (2.5 to 2.8) disruptions in work/school, social life, and family life. At endpoint, mean HPQ-SF absolute absenteeism scores decreased from 13.6 to 10.0 hours lost/month and absolute presenteeism scores improved from 67.0 to 77.1. Patients receiving hydrocodone ER showed early numeric improvements in functioning that continued throughout this 12-month study. © 2016 World Institute of Pain.

  13. Senses and Your 8- to 12-Month-Old

    MedlinePlus

    ... TOPIC Feeding Your 8- to 12-Month-Old Sleep and Your 8- to 12-Month-Old Your Child's Vision Communication and Your 8- to 12-Month-Old Movement, Coordination, and Your 8- to 12-Month-Old Your Baby's Growth: 8 Months Your Child's Growth Learning, Play, and ...

  14. BRAVISSIMO: 12-month results from a large scale prospective trial.

    PubMed

    Bosiers, M; Deloose, K; Callaert, J; Maene, L; Beelen, R; Keirse, K; Verbist, J; Peeters, P; Schroë, H; Lauwers, G; Lansink, W; Vanslembroeck, K; D'archambeau, O; Hendriks, J; Lauwers, P; Vermassen, F; Randon, C; Van Herzeele, I; De Ryck, F; De Letter, J; Lanckneus, M; Van Betsbrugge, M; Thomas, B; Deleersnijder, R; Vandekerkhof, J; Baeyens, I; Berghmans, T; Buttiens, J; Van Den Brande, P; Debing, E; Rabbia, C; Ruffino, A; Tealdi, D; Nano, G; Stegher, S; Gasparini, D; Piccoli, G; Coppi, G; Silingardi, R; Cataldi, V; Paroni, G; Palazzo, V; Stella, A; Gargiulo, M; Muccini, N; Nessi, F; Ferrero, E; Pratesi, C; Fargion, A; Chiesa, R; Marone, E; Bertoglio, L; Cremonesi, A; Dozza, L; Galzerano, G; De Donato, G; Setacci, C

    2013-04-01

    The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

  15. [D-Leu-4]-OB3, a synthetic peptide amide with leptin-like activity, augments the effects of orally delivered exenatide and pramlintide acetate on energy balance and glycemic control in insulin-resistant male C57BLK/6-m db/db mice.

    PubMed

    Leinung, Matthew C; Grasso, Patricia

    2012-11-10

    The escalation predicted for the incidence of both type 2 diabetes mellitus and obesity has prompted investigators to search for additional pharmacotherapeutic approaches to their treatment. Two of these approaches, combination pharmacotherapy and utilization of leptin-related bioactive synthetic peptides as anti-diabetes/anti-obesity agents, were used in the present study. Exenatide or pramlintide acetate was reconstituted in dodecyl maltoside (DDM) in the absence or presence of [D-Leu-4]-OB3, and delivered orally by gavage to insulin-resistant male C57BLK/6-m db/db mice twice daily for 14 days. Body weight gain, food and water intake, blood glucose, and serum insulin levels were measured. Mice given DDM alone for 14 days were 19.7% heavier than they were at the beginning of the study, while oral delivery of exenatide or [D-Leu-4]-OB3 in DDM reduced body weight gain to only 13.9% and 11.5%, respectively, of initial body weight. Mice receiving exenatide and [D-Leu-4]-OB3 were 4.2% lighter than they were at the beginning of the study. In another study, Intravail® treated control mice gained 38.2% of their initial body weight, while mice receiving pramlintide acetate or [D-Leu-4]-OB3 were only 26.8% and 25.4% heavier, respectively, at the end of the study, Co-administration of pramlintide acetate and [D-Leu-4]-OB3 did not further enhance the effect of pramlintide acetate on body weight gain. Food intake was reduced by exenatide, pramlintide acetate, and [D-Leu-4]-OB3 alone, and co-delivery with [D-Leu-4]-OB3 did not induce a further decrease. Water intake was not affected by exenatide, pramlintide acetate, or [D-Leu-4]-OB3 alone, but co-delivery of exenatide or pramlintide acetate with [D-Leu-4]-OB3 resulted in a significant reduction in water intake. Oral delivery of exenatide or pramlintide acetate in DDM significantly lowered blood glucose levels by 20.4% and 30.2%, respectively. Co-delivery with [D-Leu-4]-OB3 further reduced blood glucose by 38.3% and 50

  16. Medical Care and Your 8- to 12-Month-Old

    MedlinePlus

    ... Old Medical Care and Your 8- to 12-Month-Old KidsHealth > For Parents > Medical Care and Your 8- to 12-Month-Old A A A What's in this article? ... baby visits during this period, once at 9 months and again at 12 months . If you have ...

  17. Feeding Your 8- to 12-Month-Old

    MedlinePlus

    ... 2-Year-Old Feeding Your 8- to 12-Month-Old KidsHealth > For Parents > Feeding Your 8- to 12-Month-Old Print A A A What's in this ... a 12 meses de edad By about 8 months old, most babies are pros at handling the ...

  18. Learning, Play, and Your 8- to 12-Month-Old

    MedlinePlus

    ... Old Learning, Play, and Your 8- to 12-Month-Old KidsHealth > For Parents > Learning, Play, and Your 8- to 12-Month-Old A A A What's in this article? ... baby becomes more mobile during these next few months. What Is My Child Learning? Your little one ...

  19. Feeding Your 8- to 12-Month-Old

    MedlinePlus

    ... 2-Year-Old Feeding Your 8- to 12-Month-Old KidsHealth > For Parents > Feeding Your 8- to 12-Month-Old A A A What's in this article? ... a 12 meses de edad By about 8 months old, most babies are pros at handling the ...

  20. Emotional and Social Development: 8 to 12 Months

    MedlinePlus

    ... Feeding & Nutrition Preemie Sleep Teething & Tooth Care Toddler Preschool ... and Social Development: 8 to 12 Months Page Content Article Body During these months, your child sometimes may seem like two separate babies. First ...

  1. Perceptual learning: 12-month-olds' discrimination of monkey faces.

    PubMed

    Fair, Joseph; Flom, Ross; Jones, Jacob; Martin, Justin

    2012-11-01

    Six-month-olds reliably discriminate different monkey and human faces whereas 9-month-olds only discriminate different human faces. It is often falsely assumed that perceptual narrowing reflects a permanent change in perceptual abilities. In 3 experiments, ninety-six 12-month-olds' discrimination of unfamiliar monkey faces was examined. Following 20 s of familiarization, and two 5-s visual-paired comparison test trials, 12-month-olds failed to show discrimination. However, following 40 s of familiarization and two 10-s test trials, 12-month-olds showed reliable discrimination of novel monkey faces. A final experiment was performed demonstrating 12-month-olds' discrimination of the monkey face was due to the increased familiarization rather than increased time of visual comparison. Results are discussed in the context of perceptual narrowing, in particular the flexible nature of perceptual narrowing.

  2. Family, Friends, and 12-month PTSD among African Americans

    PubMed Central

    Nguyen, Ann W.; Chatters, Linda M.; Taylor, Robert Joseph; Levine, Debra Siegel; Himle, Joseph A.

    2016-01-01

    Purpose Despite a growing literature on the influence of social support on mental health, little is known about the relationship between social support and specific psychiatric disorders for African Americans, such as PTSD. This study investigated the relationship between social support, negative interaction with family and 12-month PTSD among African Americans. Methods Analyses were based on a nationally representative sample of African Americans from the National Survey of American Life (n=3,315). Social support variables included emotional support from family, frequency of contact with family and friends, subjective closeness with family and friends, and negative interactions with family. Results Results indicated that emotional support from family is negatively associated with 12-month PTSD while negative interaction with family is predictive of 12-month PTSD. Additionally, a significant interaction indicated that high levels of subjective closeness to friends could offset the impact of negative family interactions on 12-month PTSD. Conclusions Overall, study results converged with previously established findings indicating that emotional support from family is associated with 12-month PTSD, while, negative interaction with family is associated with increased risk of 12-month PTSD. The findings are discussed in relation to prior research on the unique association between social support and mental health among African Americans. PMID:27189209

  3. Infants born to narcotic dependent mothers: physical growth patterns in the first 12 months of life.

    PubMed

    Vance, J C; Chant, D C; Tudehope, D I; Gray, P H; Hayes, A J

    1997-12-01

    To describe the physical growth patterns of infants born to narcotic dependent mothers (INDM) over a 12 months period and, if possible, to relate the growth to drug taking patterns during pregnancy. The growth of a cohort of 43 INDM was measured during the first 12 months of life. Weight and length measurements were compared with percentile charts and converted to Z scores. Questionnaire data about drug taking practices, demographic variables and the neonatal period (including withdrawal scores) were obtained. Twenty-four (55.8%) of INDM had evidence of neonatal drug withdrawal requiring treatment with phenobarbitone. At birth, Z scores for weight and length indicated relative intrauterine growth retardation. By 12 months, there had been some catch up growth, but Z scores for weight and length were still below zero. Persistent weight retardation at 12 months was correlated with methadone dosage during pregnancy, but not the need for phenobarbitone therapy. The growth patterns of INDM in the first 12 months of life indicated that at birth there was evidence of intrauterine growth retardation, but by 12 months the growth was little different from the rest of the community. There appears to be some influence of narcotic agents taken while pregnant on subsequent growth of INDM.

  4. Delayed Graft Function Phenotypes and 12-Month Kidney Transplant Outcomes.

    PubMed

    Hall, Isaac E; Reese, Peter P; Doshi, Mona D; Weng, Francis L; Schröppel, Bernd; Asch, William S; Ficek, Joseph; Thiessen-Philbrook, Heather; Parikh, Chirag R

    2017-08-01

    Ischemia-reperfusion injury (IRI) leading to delayed graft function (DGF), defined by the United Network for Organ Sharing as dialysis in the first week (UNOS-DGF), associates with poor kidney transplant outcomes. Controversies remain, however, about dialysis initiation thresholds and the utility for other criteria to denote less severe IRI, or slow graft function (SGF). Multicenter, prospective study of deceased-donor kidney recipients to compare UNOS-DGF to a definition that combines impaired creatinine reduction in the first 48 hours or greater than 1 dialysis session for predicting 12-month estimated glomerular filtration rate (eGFR). We also assessed 10 creatinine and urine output-based SGF definitions relative to 12-month eGFR. In 560 recipients, 215 (38%) had UNOS-DGF, 330 (59%) met the combined definition, 14 (3%) died, and 23 (4%) had death-censored graft failure by 12 months. Both DGF definitions were associated with lower adjusted 12-month eGFR (95% confidence interval)-by 7.3 (3.6-10.9) and 7.4 (3.8-11.0) mL/min per 1.73 m, respectively. Adjusted relative risks for 12-month eGFR less than 30 mL/min per 1.73 m were 1.9 (1.2-3.1) and 2.1 (1.1-3.7), with unadjusted areas under the curve of 0.618 and 0.627, respectively. For SGF definitions, postoperative day (POD) 7 creatinine had the strongest association with 12-month eGFR, and POD5 creatinine and creatinine reduction between POD1 and POD2 demonstrated modest separations in 12-month eGFR. Although UNOS-DGF does not adequately predict 12-month function on its own, our findings do not support changing the definition. Postoperative day 7 creatinine is correlated with 12-month eGFR, but large translational studies are needed to understand the biological link between IRI severity at transplant and longer-term outcomes.

  5. Cochlear implantation in children under 12 months of age.

    PubMed

    McKinney, Samantha

    2017-10-01

    Children with congenital hearing loss are being identified earlier, leading to earlier intervention. Current US Food and Drug Administration (FDA) criteria states a child must be 12 months or older for cochlear implantation. The purpose of this article is to review recent publications regarding the benefits of implanting infants under 12 months of age. Topics include: safety and efficacy of surgery, speech and language acquisition outcomes, audiologic components, and limitations. Since the early 1990s, the candidacy criteria evolved drastically. However, the FDA criteria for cochlear implantation in children has remained at 12 months of age or older since 2000. Recent research indicates implanting below 12 months of age a safe and effective procedure. Speech and language outcomes showed better speech and language advantages. In addition, infants implanted earlier showed normal auditory skills as early as 3 months post cochlear implant activation. This article will also address recent findings on the limitations of earlier implantation. Recent research demonstrates positive outcomes in children implanted under 12 months of age. Developing research on earlier implantation could lead to a change in the current FDA criteria allowing infants to reach their speech and hearing potential faster.

  6. The 12-month analysis from Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT): A phase II, randomized, double-blind study of sonidegib in patients with advanced basal cell carcinoma.

    PubMed

    Dummer, Reinhard; Guminski, Alexander; Gutzmer, Ralf; Dirix, Luc; Lewis, Karl D; Combemale, Patrick; Herd, Robert M; Kaatz, Martin; Loquai, Carmen; Stratigos, Alexander J; Schulze, Hans-Joachim; Plummer, Ruth; Gogov, Sven; Pallaud, Celine; Yi, Tingting; Mone, Manisha; Chang, Anne Lynn S; Cornélis, Frank; Kudchadkar, Ragini; Trefzer, Uwe; Lear, John T; Sellami, Dalila; Migden, Michael R

    2016-07-01

    The hedgehog pathway inhibitor sonidegib demonstrated meaningful tumor shrinkage in more than 90% of patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC in the BCC Outcomes with LDE225 Treatment study. This report provides long-term follow-up data collected up to 12 months after the last patient was randomized. In this multicenter, randomized, double-blind phase II study, patients were randomized 1:2 to sonidegib 200 or 800 mg. The primary end point was objective response rate assessed by central review. Objective response rates in the 200- and 800-mg arms were 57.6% and 43.8% in locally advanced BCC and 7.7% and 17.4% in metastatic BCC, respectively. Among the 94 patients with locally advanced BCC who responded, only 18 progressed or died and more than 50% had responses lasting longer than 6 months. In addition, 4 of 5 responders with metastatic BCC maintained an objective response. Grade 3/4 adverse events and those leading to discontinuation were less frequent with sonidegib 200 versus 800 mg (38.0% vs 59.3%; 27.8% vs 37.3%, respectively). No placebo or comparator arms were used because sonidegib demonstrated efficacy in advanced BCC in a phase I study, and the hedgehog pathway inhibitor vismodegib was not yet approved. With longer follow-up, sonidegib demonstrated sustained tumor responses in patients with advanced BCC. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  7. 12-Month Follow-Up of Fluoxetine and Cognitive Behavioral Therapy for Binge Eating Disorder

    ERIC Educational Resources Information Center

    Grilo, Carlos M.; Crosby, Ross D.; Wilson, G. Terence; Masheb, Robin M.

    2012-01-01

    Objective: The longer term efficacy of medication treatments for binge-eating disorder (BED) remains unknown. This study examined the longer term effects of fluoxetine and cognitive behavioral therapy (CBT) either with fluoxetine (CBT + fluoxetine) or with placebo (CBT + placebo) for BED through 12-month follow-up after completing treatments.…

  8. 12-Month Follow-Up of Fluoxetine and Cognitive Behavioral Therapy for Binge Eating Disorder

    ERIC Educational Resources Information Center

    Grilo, Carlos M.; Crosby, Ross D.; Wilson, G. Terence; Masheb, Robin M.

    2012-01-01

    Objective: The longer term efficacy of medication treatments for binge-eating disorder (BED) remains unknown. This study examined the longer term effects of fluoxetine and cognitive behavioral therapy (CBT) either with fluoxetine (CBT + fluoxetine) or with placebo (CBT + placebo) for BED through 12-month follow-up after completing treatments.…

  9. Associations with legal representation in a compensation setting 12 months after injury.

    PubMed

    Casey, Petrina P; Feyer, Anne Marie; Cameron, Ian D

    2015-05-01

    Many people with Whiplash Associated Disorder (WAD) seek treatment though a compensation system where factors such as legal involvement have been reported as having a negative impact on recovery outcomes. To compare those with and without legal involvement in their compensation claim, and identify associations with legal involvement at 12 months post injury; and longer term disability. Inception cohort study. 246 people with WAD compensation claim. Legal involvement and Functional Rating Index at 12 months post injury. Participants were recruited from an insurance database. Baseline health (Functional Rating Index, Pain Catastrophising Scale and SF-36), socio-economic, work capacity, and claims data were collected within three months of injury and 12 months. Logistic regression models were used to identify associations with legal involvement at 12 months; and disability (FRI) at 12 months. At baseline 246 participants were enrolled into the study in a median 72 days post injury. At 12 months post injury 52 (25%) had engaged a lawyer. The significant independent associations with legal involvement at 12 months were higher levels of initial disability, work disability, speaking a language other than English at home and lower levels of mental health. Specifically, the odds of lawyer involvement at 12 months post injury was 4.9 times greater for those with work disability; 2.3 times greater for those who spoke a language other than English at home. In terms of health, they had poorer mental health and for every 10 unit increase in the baseline FRI score the odds of having lawyer involvement increased by 38%. DISABILITY: at 12 months (FRI) was significantly independently associated with, PCS-helplessness (p<0.001), age (p<0.001) and prior claim (p=0.001). This study suggests the people with lawyer involvement in their claim 12 months after injury have socio-economic disadvantage, have had a prior claim and a worse baseline health profile compared to those without a

  10. Rational Imitation in 12-Month-Old Infants

    ERIC Educational Resources Information Center

    Schwier, Christiane; van Maanen, Catharine; Carpenter, Malinda; Tomasello, Michael

    2006-01-01

    Gergely, Bekkering, and Kiraly (2002) demonstrated that 14-month-old infants engage in "rational imitation." To investigate the development and flexibility of this skill, we tested 12-month-olds on a different but analogous task. Infants watched as an adult made a toy animal use a particular action to get to an endpoint. In 1 condition there was a…

  11. 12-Month-Olds Produce Others' Intended but Unfulfilled Acts

    ERIC Educational Resources Information Center

    Nielsen, Mark

    2009-01-01

    Following Meltzoff's (1995) behavioral reenactment paradigm, this study investigated the ability of 12-month-olds (N = 44) to reproduce a model's attempted-but-failed actions on objects. Testing was conducted using a novel set of objects designed to enable young infants to readily identify the potential outcome of the model's actions. Infants who…

  12. Walking and Eating Behavior of Toddlers at 12 Months Old

    ERIC Educational Resources Information Center

    Koda, Naoko; Akimoto, Yuko; Hirose, Toshiya; Hinobayashi, Toshihiko; Minami, Tetsuhiro

    2004-01-01

    Locomotive and eating behavior of 52 toddlers was observed at 12 months old in a nursery school and investigated in relation to the acquisition of independent walking. The toddlers who acquired walking ate more by themselves using the hands than the toddlers who did not start walking. This suggested that acquisition of walking was associated with…

  13. Perceptual Learning: 12-Month-Olds' Discrimination of Monkey Faces

    ERIC Educational Resources Information Center

    Fair, Joseph; Flom, Ross; Jones, Jacob; Martin, Justin

    2012-01-01

    Six-month-olds reliably discriminate different monkey and human faces whereas 9-month-olds only discriminate different human faces. It is often falsely assumed that perceptual narrowing reflects a permanent change in perceptual abilities. In 3 experiments, ninety-six 12-month-olds' discrimination of unfamiliar monkey faces was examined. Following…

  14. Perceptual Learning: 12-Month-Olds' Discrimination of Monkey Faces

    ERIC Educational Resources Information Center

    Fair, Joseph; Flom, Ross; Jones, Jacob; Martin, Justin

    2012-01-01

    Six-month-olds reliably discriminate different monkey and human faces whereas 9-month-olds only discriminate different human faces. It is often falsely assumed that perceptual narrowing reflects a permanent change in perceptual abilities. In 3 experiments, ninety-six 12-month-olds' discrimination of unfamiliar monkey faces was examined. Following…

  15. Fixed ratio dosing of pramlintide with regular insulin before a standard meal in patients with type 1 diabetes.

    PubMed

    Riddle, M C; Yuen, K C J; de Bruin, T W; Herrmann, K; Xu, J; Öhman, P; Kolterman, O G

    2015-09-01

    Amylin is co-secreted with insulin and is therefore lacking in patients with type 1 diabetes. Replacement with fixed ratio co-administration of insulin and the amylin analogue pramlintide may be superior to separate dosing. This concept was evaluated in a ratio-finding study. Patients with type 1 diabetes were enrolled in a randomized, single-masked, standard breakfast crossover study using regular human insulin injected simultaneously with pramlintide 6, 9 or 12 mcg/unit insulin or placebo. Insulin dosage was reduced by 30% from patients' usual estimates. Plasma glucose, glucagon and pramlintide and adverse events were assessed. All ratios reduced 0-3-h glucose and glucagon increments by >50%. No hypoglycaemia occurred. Adverse events were infrequent and generally mild. All pramlintide/insulin ratios markedly and safely reduced glycaemic excursions and suppressed glucagon secretion in the immediate postprandial state. Further study using one of these ratios to explore the efficacy and safety of longer-term meal-time and basal hormone replacement is warranted.

  16. Circadian feeding patterns of 12-month-old infants.

    PubMed

    Wee, Poh Hui; Loy, See Ling; Toh, Jia Ying; Tham, Elaine Kwang Hsia; Cheung, Yin Bun; Godfrey, Keith M; Gluckman, Peter D; Saw, Seang Mei; Chong, Yap-Seng; Lek, Ngee; Chan, Jerry Kok Yen; Goh, Daniel Yam Thiam; Chong, Mary Foong-Fong; Yap, Fabian

    2017-06-01

    Early life nutrition and feeding practices are important modifiable determinants of subsequent obesity, yet little is known about the circadian feeding pattern of 12-month-old infants. We aimed to describe the 24-h feeding patterns of 12-month-old infants and examine their associations with maternal and infant characteristics. Mothers from a prospective birth cohort study (n 431) reported dietary intakes of their 12-month-old infants and respective feeding times using 24-h dietary recall. Based on their feeding times, infants were classified into post-midnight (00.00-05.59 hours) and pre-midnight (06.00-23.59 hours) feeders. Mean daily energy intake was 3234 (sd 950) kJ (773 (sd 227) kcal), comprising 51·8 (sd 7·8) % carbohydrate, 33·9 (sd 7·2) % fat and 14·4 (sd 3·2) % protein. Mean hourly energy intake and proportion of infants fed were lower during post-midnight than pre-midnight hours. There were 251 (58·2 %) pre-midnight and 180 (41·8 %) post-midnight feeders. Post-midnight feeders consumed higher daily energy, carbohydrate, fat and protein intakes than pre-midnight feeders (all P<0·001). The difference in energy intake originated from energy content consumed during the post-midnight period. Majority (n 173) of post-midnight feeders consumed formula milk during the post-midnight period. Using multivariate logistic regression with confounder adjustment, exclusively breast-feeding during the first 6 months of life was negatively associated with post-midnight feeding at 12 months (adjusted OR 0·31; 95 % CI 0·11, 0·82). This study provides new insights into the circadian pattern of energy intake during infancy. Our findings indicated that the timing of feeding at 12 months was associated with daily energy and macronutrient intakes, and feeding mode during early infancy.

  17. Mindfulness Meditation and CBT for Insomnia: A Naturalistic 12-Month Follow-up

    PubMed Central

    Ong, Jason C.; Shapiro, Shauna L.; Manber, Rachel

    2016-01-01

    A unique intervention combining mindfulness meditation with cognitive behavioral therapy for insomnia (CBT-I) has been shown to have acute benefits at post-treatment in an open label study. The aim of the present study was to examine the long-term effects of this integrated intervention on measures of sleep and sleep-related distress in an attempt to characterize the natural course of insomnia following this treatment and to identify predictors of poor long-term outcome. Analyses were conducted on 21 participants who provided follow-up data at 6 and 12 months post treatment. At each time point, participants completed one week of sleep and meditation diaries and questionnaires related to mindfulness, sleep, and sleep-related distress, including the Pre-Sleep Arousal Scale (PSAS), Glasgow Sleep Effort Scale (GSES), Kentucky Inventory of Mindfulness Skills (KIMS), and the Insomnia Episode Questionnaire. Analyses examining the pattern of change across time (baseline, end-of-treatment, 6 month, and 12 month) revealed that several sleep-related benefits were maintained during the 12-month follow-up period. Participants who reported at least one insomnia episode (≥ 1 month) during the follow-up period had higher scores on the PSAS (p < .05) and GSES (p < .05) at end-of-treatment compared to those with no insomnia episodes. Correlations between mindfulness skills and insomnia symptoms revealed significant negative correlations (p < .05) between mindfulness skills and daytime sleepiness at each of the three time points but not with nocturnal symptoms of insomnia. These results suggest that most sleep-related benefits of an intervention combining CBT-I and mindfulness meditation were maintained during the 12-month follow-up period with indications that higher pre-sleep arousal and sleep effort at end-of-treatment constitute a risk for occurrence of insomnia during the 12 months following treatment. PMID:19114261

  18. Variability of bacterial vaginosis over 6- to 12-month intervals.

    PubMed

    Ness, Roberta B; Kip, Kevin E; Soper, David E; Stamm, Carol A; Rice, Peter; Richter, Holly E

    2006-06-01

    To examine variability in bacterial vaginosis (BV) over 6- to 12-month intervals. One thousand one hundred ninety-three women were followed for a median of 3 years with serial vaginal swab Gram stains for BV. Discrete time hazard models were fit to identify independent risk factors for BV. Women with BV at study entry were categorized as having normal flora at the next visit 20% of the time, and women with normal flora at study entry were categorized as having BV at the next visit 20% of the time. Among women with initially normal flora, factors associated with BV were black race, lower education, a history of BV, a history of chlamydial/gonococcal cervicitis, and lack of monogamy. About one fifth of women with normal flora develop BV over a given 6- to 12-month interval, and the modifiable risk factors of cervicitis and lack of monogamy contribute to the development of BV.

  19. Wideband acoustic immittance measures: developmental characteristics (0 to 12 months).

    PubMed

    Kei, Joseph; Sanford, Chris A; Prieve, Beth A; Hunter, Lisa L

    2013-07-01

    Rapid developmental changes of the peripheral auditory system in normal infants occur in the first year of life. Specifically, the postnatal development of the external and middle ear affects all measures of external and middle ear function including wideband acoustic immittance(WAI). This article provides an overview of WAI studies in newborns and infants from a developmental perspective. Normative WAI data in newborns are fairly consistent across studies. However, there are discrepancies in some WAI measures between studies, possibly due to differences in sampling, methodology, and instrumentation. Accuracy of WAI measurements is compromised when a good probe seal cannot be maintained during testing or an inaccurate estimate of the cross-sectional area of the ear canal of newborns occurs. Comparison of WAI data between age groups from 0 to 12 months reveals maturation effects. Additional age-specific longitudinal and cross-sectional normative WAI data for infants from birth to 12 months are required to validate and consolidate existing data.

  20. Public service stress and burnout over 12 months.

    PubMed

    Ravalier, J M; McVicar, A; Munn-Giddings, C

    2014-10-01

    Research indicates that workplace stress has the potential to harm employee health with stress and stress-related absence increasing significantly during economic recession and times of organizational change. To explore whether psychosocial hazards and burnout changed over a 12 month period in a public sector organization during a period of severely reduced organizational finances. The Management Standards Indicator Tool (MSIT) and the Maslach Burnout Inventory-General Scale (MBI-GS) were administered to employees of one local government department in July 2011 and July 2012. A total of 128 employees completed the questionnaires in July 2011 (response rate 67%) and 57 in July 2012 (response rate 54%). MSIT factor scores of demands, peer support and role worsened significantly over the period of study. Furthermore, all psychosocial hazards scored worse than the recommended level set by Health and Safety Executive. Two burnout dimensions, 'demands' and 'cynicism', significantly worsened over the 12 month period but professional efficacy increased. The MSIT and MBI-GS appeared to have utility in this comparison. Psychosocial hazards appeared to worsen over the 12 months of the study, as 'demands' and 'cynicism' increased. However, an increase in professional efficacy was also seen, which requires further investigation. © The Author 2014. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  1. Mindfulness meditation and cognitive behavioral therapy for insomnia: a naturalistic 12-month follow-up.

    PubMed

    Ong, Jason C; Shapiro, Shauna L; Manber, Rachel

    2009-01-01

    A unique intervention combining mindfulness meditation with cognitive behavioral therapy for insomnia (CBT-I) has been shown to have acute benefits at posttreatment in an open label study. The aim of the present study was to examine the long-term effects of this integrated intervention on measures of sleep and sleep-related distress in an attempt to characterize the natural course of insomnia following this treatment and to identify predictors of poor long-term outcome. Analyses were conducted on 21 participants, who provided follow-up data at six and 12 months posttreatment. At each time point, participants completed one week of sleep and meditation diaries and questionnaires related to mindfulness, sleep, and sleep-related distress, including the Pre-Sleep Arousal Scale, the Glasgow Sleep Effort Scale, the Kentucky Inventory of Mindfulness Skills, and the Insomnia Episode Questionnaire. Analyses examining the pattern of change across time (baseline, end of treatment, six months, and 12 months) revealed that several sleep-related benefits were maintained during the 12-month follow-up period. Participants who reported at least one insomnia episode (>or=1 month) during the follow-up period had higher scores on the Pre-Sleep Arousal Scale (P < .05) and the Glasgow Sleep Effort Scale (P < .05) at end of treatment compared with those with no insomnia episodes. Correlations between mindfulness skills and insomnia symptoms revealed significant negative correlations (P < .05) between mindfulness skills and daytime sleepiness at each of the three time points but not with nocturnal symptoms of insomnia. These results suggest that most sleep-related benefits of an intervention combining CBT-I and mindfulness meditation were maintained during the 12-month follow-up period, with indications that higher presleep arousal and sleep effort at end of treatment constitute a risk for occurrence of insomnia during the 12 months following treatment.

  2. Metacognitive functioning predicts positive and negative symptoms over 12 months in first episode psychosis.

    PubMed

    McLeod, Hamish J; Gumley, Andrew I; Macbeth, Angus; Schwannauer, Matthias; Lysaker, Paul H

    2014-07-01

    The negative symptoms of schizophrenia are a major source of impairment and distress but both pharmacological and psychological treatment options provide only modest benefit. Developing more effective psychological treatments for negative symptoms will require a more sophisticated understanding of the psychological processes that are implicated in their development and maintenance. We extended previous work by demonstrating that metacognitive functioning is related to negative symptom expression across the first 12 months of first episode psychosis (FEP). Previous studies in this area have either been cross-sectional or have used much older participants with long-standing symptoms. In this study, forty-five FEP participants were assessed three times over 12 months and provided data on PANSS rated symptoms, premorbid adjustment, metacognitive functioning, and DUP. Step-wise linear regression showed that adding metacognition scores to known predictors of negative symptoms (baseline symptom severity, gender, DUP, and premorbid academic and social adjustment) accounted for 62% of the variance in PANSS negative symptom scores at six months and 38% at 12 months. The same predictors also explained 47% of the variance in positive symptoms at both six and 12 months. However, exploration of the simple correlations between PANSS symptom scores and metacognition suggests a stronger univariate relationship between metacognition and negative symptoms. Overall, the results indicate that problems with mental state processing may be important determinants of negative symptom expression from the very early stages of psychosis. These results provide further evidence that metacognitive functioning is a potentially relevant target for psychological interventions.

  3. African American community members sustain favorable blood pressure outcomes through 12-month telephone motivational interviewing (MI) maintenance

    USDA-ARS?s Scientific Manuscript database

    Community approaches offer promise for addressing disparities experienced by African Americans in hypertension prevalence, treatment, and control. HUB City Steps, a community-based participatory research lifestyle intervention, tracked participants through a 12-month MI maintenance phase following a...

  4. Pramlintide Injection

    MedlinePlus

    ... of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk ...

  5. Maternal Antenatal Depression and Infant Disorganized Attachment at 12 months

    PubMed Central

    Hayes, Lisa J.; Goodman, Sherryl H.; Carlson, Elizabeth

    2012-01-01

    Although high rates of attachment disorganization have been observed in infants of depressed mothers, little is known about the role of antenatal depression as a precursor to infant attachment disorganization. The primary aim of this study was to examine associations between maternal antenatal depression and infant disorganization at 12 months in a sample of women (N = 79) at risk for perinatal depression. A secondary aim was to test the roles of maternal postpartum depression and maternal parenting quality as potential moderators of this predicted association. Among women with histories of major depressive episodes, maternal depressive symptoms were assessed at multiple times during pregnancy and the first year postpartum, maternal parenting quality was measured at 3 months postpartum, and attachment disorganization was assessed at 12 months postpartum. Results revealed that infants classified as disorganized had mothers with higher levels of depressive symptoms during pregnancy compared to infants classified as organized. Maternal parenting quality moderated this association, as exposure to higher levels of maternal depressive symptoms during pregnancy was only associated with higher rates of infant disorganized attachment when maternal parenting at 3 months was less optimal. These findings suggest that enhancing maternal parenting behaviors during this early period in development has the potential to alter pathways to disorganized attachment among infants exposed to antenatal maternal depressive symptoms, which could have enduring consequences for child wellbeing. PMID:23216358

  6. Stability of cocaine impurity profiles during 12 months of storage.

    PubMed

    Nielsen, Louise Stride; Villesen, Palle; Lindholst, Christian

    2016-07-01

    During the lifetime of a cocaine batch from production end to consumption, several alterations may occur, leading to possible changes in the original impurity profile. Such profile changes may eventually result in erroneous forensic evaluations. In the present study, the stability of both the alkaloid and the residual solvent impurity profiles of cocaine were evaluated over a period of 12 months under different storage conditions (temperature, purity and weight) using GC-MS and HS-GC-MS, respectively. The sample purity (p<0.001), time of storage (p<0.001) and storage temperature at 37°C (p<0.01) significantly influenced the alkaloid impurity profile. The most significant change was observed in low purity samples stored at 37°C. In contrast, no changes were observed in the residual solvent profile at all storage conditions for the entire 12-month study period. This finding indicates that the residual solvent profile may be more applicable than the corresponding alkaloid profile when cocaine seizures subjected to different storage conditions are compared. Our results clearly demonstrate that cocaine alkaloid profiles change over time and are most susceptible to sample purity and storage temperature. As a consequence, storage conditions and purity should be taken into account when cocaine comparison is conducted in criminal cases. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  7. Efficacy of transepithelial corneal collagen crosslinking for keratoconus: 12-month follow-up

    PubMed Central

    Heikal, Mohamed A; Soliman, Tarek Tawfik; Fayed, Ayser; Hamed, Abdelmonem M

    2017-01-01

    Purpose To evaluate the efficacy of transepithelial corneal collagen crosslinking (TE-CXL) in patients with progressive keratoconus. Patients and methods This is a prospective interventional consecutive study carried out on 30 eyes of 18 patients with progressive keratoconus who underwent TE-CLX using both ParaCel™ (riboflavin 0.25%, hydroxy propyl methyl cellulose, NaCl, ethylenediaminetetraacetic acid [EDTA], Tris, and benzalkonium chloride) and vibeX-Xtra (riboflavin 0.22%, phosphate-buffered saline solution). The procedure was carried out at Ebsar Eye Center in Egypt in the period from 2012 to 2014. The follow-up visits were scheduled on days 1, 3, 6, and 12 months after treatment. Results There were statistically significant improvements (P<0.001) in the mean best-corrected visual acuity (0.54±0.22 preoperatively vs 0.61±0.19 at 12 months postoperatively), the mean manifest refraction spherical equivalent (MRSE; −6.16±3.90 diopters [D] preoperatively and −5.91±3.72 D at 12 months postoperatively), and the mean preoperative corneal astigmatism (−3.39±2.11 D preoperatively and −2.46±2.60 D at 12 months postoperatively). Conclusion TE-CXL could halt the progression of keratoconus in adult patients. TE-CXL resulted in a statistically significant improvement in best-corrected visual acuity, manifest refraction, refractive and corneal astigmatism and K values in keratoconus patients at the 12-month follow-up. Larger sample sizes and longer follow-ups are required in order to make meaningful conclusions. PMID:28461739

  8. BRAVISSIMO study: 12-month results from the TASC A/B subgroup.

    PubMed

    Bosiers, M; Deloose, K; Callaert, J; Verbist, J; Keirse, K; Peeters, P

    2012-02-01

    The BRAVISSIMO study is a prospective, non-randomized, multicenter, multinational, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports on the BRAVISSIMO TASC A&B iliac lesion cohort, based on data collected up to the 13-month time point. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without Target Lesion Revascularization (TLR) within 12 months. Between July 2009 and February 2010, a total of 190 patients who presented with TASC A or TASC B aorto-iliac lesions were included, of which 140 patients were enrolled in Belgium and 50 in Italy. The demographic data were comparable for the TASC A and TASC B patients groups. The number of occlusions, the average degree of stenosis, the average lesion length was significantly higher in the group of TASC B lesions, which is congruent with the TASC lesions definitions. Similarly, there were significantly more unilateral lesions in the TASC A group, compared to the TASC B group. The 12-month primary patency rate was 94.0% for TASC A lesions and 96.5% for TASC B lesions, which is not statistically significant. The 12-month primary patency rate was 92.9% in lesions treated with the Omnilink Elite stent, 97.1% in lesions treated with the Absolute Pro stent groups, and 100% in lesions treated with both stents. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A/B aortoiliac lesions. Currently, we are collecting the 12-month data for the TASC C/D subgroup in the BRAVISSIMO study. Upon release of the results from this subgroup, we will be able to compare the results from both arms of this large-scale international study.

  9. Hypoglossal Nerve Stimulation Improves Obstructive Sleep Apnea: 12 Month Outcomes

    PubMed Central

    Kezirian, Eric J.; Goding, George S.; Malhotra, Atul; O'Donoghue, Fergal J.; Zammit, Gary; Wheatley, John R.; Catcheside, Peter G.; Smith, Philip L.; Schwartz, Alan R.; Walsh, Jennifer H.; Maddison, Kathleen J.; Claman, David M.; Huntley, Tod; Park, Steven Y.; Campbell, Matthew C.; Palme, Carsten E.; Iber, Conrad; Eastwood, Peter R.; Hillman, David R.; Barnes, Maree

    2013-01-01

    Reduced upper airway muscle activity during sleep is a key contributor to obstructive sleep apnoea (OSA) pathogenesis. Hypoglossal nerve stimulation (HGNS) activates upper airway dilator muscles, including the genioglossus, and has the potential to reduce OSA severity. The objective of this study was to examine the safety, feasibility, and efficacy of a novel HGNS system (HGNS®, Apnex Medical, Inc., St. Paul, MN) in treating OSA at 12 months following implantation. Thirty-one subjects (35% female, age 52·4±9·4 years) with moderate to severe OSA and unable to tolerate positive airway pressure underwent surgical implantation and activation of the HGNS system in a prospective single-arm interventional trial. Primary outcomes were changes in OSA severity (apnoea-hypopnoea index, AHI, from in-laboratory polysomnogram) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire, FOSQ). HGNS was used on 86±16% of nights for 5·4±1·4 hours per night. There was a significant improvement (p < 0·001) from baseline to 12 months in AHI (45.4±17·5 to 25·3±20·6 events/h) and FOSQ score (14·2±2·0 to 17·0±2·4) as well as other polysomnogram and symptom measures. Outcomes were stable compared to 6 months following implantation. Three serious device-related adverse events occurred: an infection requiring device removal and two stimulation lead cuff dislodgements requiring replacement. There were no significant adverse events with onset later than 6 months following implantation. HGNS demonstrated favourable safety, feasibility, and efficacy. PMID:24033656

  10. Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes.

    PubMed

    Kezirian, Eric J; Goding, George S; Malhotra, Atul; O'Donoghue, Fergal J; Zammit, Gary; Wheatley, John R; Catcheside, Peter G; Smith, Philip L; Schwartz, Alan R; Walsh, Jennifer H; Maddison, Kathleen J; Claman, David M; Huntley, Tod; Park, Steven Y; Campbell, Matthew C; Palme, Carsten E; Iber, Conrad; Eastwood, Peter R; Hillman, David R; Barnes, Maree

    2014-02-01

    Reduced upper airway muscle activity during sleep is a key contributor to obstructive sleep apnea pathogenesis. Hypoglossal nerve stimulation activates upper airway dilator muscles, including the genioglossus, and has the potential to reduce obstructive sleep apnea severity. The objective of this study was to examine the safety, feasibility and efficacy of a novel hypoglossal nerve stimulation system (HGNS; Apnex Medical, St Paul, MN, USA) in treating obstructive sleep apnea at 12 months following implantation. Thirty-one subjects (35% female, age 52.4 ± 9.4 years) with moderate to severe obstructive sleep apnea and unable to tolerate positive airway pressure underwent surgical implantation and activation of the hypoglossal nerve stimulation system in a prospective single-arm interventional trial. Primary outcomes were changes in obstructive sleep apnea severity (apnea-hypopnea index, from in-laboratory polysomnogram) and sleep-related quality of life [Functional Outcomes of Sleep Questionnaire (FOSQ)]. Hypoglossal nerve stimulation was used on 86 ± 16% of nights for 5.4 ± 1.4 h per night. There was a significant improvement (P < 0.001) from baseline to 12 months in apnea-hypopnea index (45.4 ± 17.5 to 25.3 ± 20.6 events h(-1) ) and Functional Outcomes of Sleep Questionnaire score (14.2 ± 2.0 to 17.0 ± 2.4), as well as other polysomnogram and symptom measures. Outcomes were stable compared with 6 months following implantation. Three serious device-related adverse events occurred: an infection requiring device removal; and two stimulation lead cuff dislodgements requiring replacement. There were no significant adverse events with onset later than 6 months following implantation. Hypoglossal nerve stimulation demonstrated favourable safety, feasibility and efficacy.

  11. Minimal reduction in insulin dosage with pramlintide therapy when pretreatment near-normal glycemia is established and square-wave meal bolus is used.

    PubMed

    King, Allen B

    2009-04-01

    To evaluate the effect of near-normal glucose control before initiation of pramlintide therapy and square-wave meal bolus on self-reported hypoglycemia and the percentage change in dosing parameters after attaining the maximum pramlintide dosage. In this prospective study, insulin pump-treated patients with type 1 diabetes had insulin dosages optimally titrated on the basis of daily continuous glucose monitoring (CGM). Pramlintide therapy was initiated, and the dosage was increased 15 mcg/meal per week. Insulin dosage was adjusted during 30-minute visits after review of self-monitored blood glucose records, adverse effects, and hypoglycemia diary. Within 2 weeks of achieving a pramlintide dosage of 60 mcg/meal, the second CGM-guided insulin dosage adjustment was done. The primary end point was the percentage change in total basal insulin dosage (TBD) from baseline. The secondary end points were the percentage change in the insulin to carbohydrate ratio (ICR) and the assessment of symptoms of nausea and hypoglycemia during the pramlintide dosing escalation. Nine patients were enrolled. The difference between before and during CGM-guided insulin dosing was a mean (+/- standard deviation) TBD change of -11.2 +/- 13.2% (P = 0.023) and mean ICR change of 7.8 +/- 13.4% (P = 0.053). Pramlintide was well tolerated and resulted in decrease in weight and hemoglobin A1c values. Hypoglycemia occurred in 6 patients during the study; the assistance of another person was not required in any of these cases. No hypoglycemia was reported in the first week of starting pramlintide. Mild to moderate nausea was reported in 6 patients during the titration phase. Patients with near-normal glucose control who use a square-wave bolus may not need initial bolus dosage reduction. With weight loss, small adjustments in both TBD and ICR may be required. Greater incidence of hypoglycemia seen in previous studies may in part be due to mismatched insulin dosing.

  12. Efficacy of healing process of bone defects after apicectomy: results after 6 and 12 months.

    PubMed

    Dominiak, M; Lysiak-Drwal, K; Gedrange, T; Zietek, M; Gerber, H

    2009-12-01

    The aim of this study was to assess the efficacy of selected surgical treatment techniques of bone defects after apectomy. A total of 106 postresection bone defects, located in maxilla and mandible were included in the study: the defects were treated with resorbable collagen membrane (BG I- 26 defects), xenogenic bovine material (BOC II- 30 defects) and xenogenic bovine material with platelet rich plasma (BOC/PRP III- 20 defects). In the control group the defects were left to heal spontaneously. Clinical and radiological assessment was performed at 6 and 12 months after the procedures. The analysis among groups revealed higher efficiency of the method of treatment that uses guide bone regeneration in comparison to the group in both post-operative control periods. After 6 months, the differences were statistically significant for each group using the regeneration methods, but after 12 months only for the BOC/PRP group. Treatment using selected guided bone regeneration techniques proved superior to the control group in both observation periods, but after 6 as well 12 months the best results in the BOC/PRP group were observed.

  13. Clinical features and outcomes of infants with Ewing sarcoma under 12 months of age.

    PubMed

    Wong, Thalia; Goldsby, Robert E; Wustrack, Rosanna; Cash, Thomas; Isakoff, Michael S; DuBois, Steven G

    2015-11-01

    Ewing sarcoma peaks in incidence in adolescence. Infants <12 months old have rarely been reported. We aimed to compare clinical features, treatment, and survival of infants <12 months to those of older pediatric patients with Ewing sarcoma. We utilized the SEER database to identify patients <12 months of age diagnosed with Ewing sarcoma between 1973 and 2011. We used Fisher exact tests to compare clinical features and treatment modalities between these patients and patients aged 1-19 years. We used Kaplan-Meier methods to describe overall survival in these two groups. Of 1,957 patients in the cohort, 39 (2.0%) were diagnosed at <12 months of age. Infants had a different distribution of primary tumor sites, with lower extremity tumors under represented. Compared to older patients, infants were more likely to have soft tissue tumors (81.6% vs. 27.1%; P < 0.001); have primitive neuroectodermal tumor/Askin tumor (61.5% vs. 19.9%; P < 0.001); and have tumors <8 cm (81.0% vs. 53.2%; P < 0.014). Infants were less likely to receive radiation therapy (13.2% vs. 53.3%; P < 0.001). Infants were at increased risk for early death (P < 0.013 by Wilcoxon), though long-term overall survival was not different between age groups (P < 0.25 by log rank). Ewing sarcoma is rare in infants, with different clinical presentations and treatment approaches. These patients appear to be at higher risk for early death, but long-term survival is similar to older pediatric patients. © 2015 Wiley Periodicals, Inc.

  14. 12-month efficacy of a single radiofrequency ablation on autonomously functioning thyroid nodules.

    PubMed

    Bernardi, Stella; Stacul, Fulvio; Michelli, Andrea; Giudici, Fabiola; Zuolo, Giulia; de Manzini, Nicolò; Dobrinja, Chiara; Zanconati, Fabrizio; Fabris, Bruno

    2016-11-15

    Radiofrequency ablation has been advocated as an alternative to radioiodine and/or surgery for the treatment of autonomously functioning benign thyroid nodules. However, only a few studies have measured radiofrequency ablation efficacy on autonomously functioning benign thyroid nodules. The aim of this work was to evaluate the 12-month efficacy of a single session of radiofrequency ablation (performed with the moving shot technique) on solitary autonomously functioning benign thyroid nodules. Thirty patients with a single, benign autonomously functioning benign thyroid nodules, who were either unwilling or ineligible to undergo surgery and radioiodine, were treated with radiofrequency ablation between April 2012 and May 2015. All the patients underwent a single radiofrequency ablation, performed with the 18-gauge needle and the moving shot technique. Clinical, laboratory, and ultrasound evaluations were scheduled at baseline, and after 1, 3, 6, and 12 months from the procedure. A single radiofrequency ablation reduced thyroid nodule volume by 51, 63, 69, and 75 % after 1, 3, 6, and 12 months, respectively. This was associated with a significant improvement of local cervical discomfort and cosmetic score. As for thyroid function, 33 % of the patients went into remission after 3 months, 43 % after 6 months, and 50 % after 12 months from the procedure. This study demonstrates that a single radiofrequency ablation allowed us to withdraw anti-thyroid medication in 50 % of the patients, who remained euthyroid afterwards. This study shows that a single radiofrequency ablation was effective in 50 % of patients with autonomously functioning benign thyroid nodules. Patients responded gradually to the treatment. It is possible that longer follow-up studies might show greater response rates.

  15. Recent and emerging therapeutic medications in type 2 diabetes mellitus: incretin-based, Pramlintide, Colesevelam, SGLT2 Inhibitors, Tagatose, Succinobucol.

    PubMed

    Lo, Margaret C; Lansang, M Cecilia

    2013-01-01

    Nearly 285 million people worldwide, with 10% being Americans, suffer from diabetes mellitus and its associated comorbidities. This is projected to increase by 6.5% per year, with 439 million inflicted by year 2030. Both morbidity and mortality from diabetes stem from the consequences of microvascular and macrovascular complications. Of the 285 million with diabetes, over a quarter of a million die per year from related complications, making diabetes the fifth leading cause of death in high-income countries. These startling statistics illustrate the therapeutic failure of current diabetes drugs to retard the progression of diabetes. These statistics further illustrate the continual need for further research and development of alternative drugs with novel mechanisms to slow disease progression and disease complications. The treatment algorithm updated in 2008 by American Diabetes Association and the European Association for the Study of Diabetes currently recommends the traditional medications of metformin, either as monotherapy or in combination with sulfonylurea or insulin, as the preferred choice in the tier 1 option. The algorithm only suggests addition of alternative medications such as pioglitazone and incretin-based drugs as second-line agents in the tier 2 "less well-validated" option. However, these traditional medications have not proven to delay the progressive course of diabetes as evidence of increasing need over time for multiple drug therapy to maintain sufficient glycemic control. Because current diabetes medications have limited efficacy and untoward side effects, the development of diabetes mellitus drugs with newer mechanisms of action continues. This article will review the clinical data on the newly available incretin-based drugs on the market, including glucagon-like peptide agonists and of dipeptidyl peptidase type-4 inhibitors. It will also discuss 2 unique medications: pramlintide, which is indicated for both type and type-2 diabetes, and

  16. Gist extraction and sleep in 12-month-old infants.

    PubMed

    Konrad, Carolin; Herbert, Jane S; Schneider, Silvia; Seehagen, Sabine

    2016-10-01

    Gist extraction is the process of excerpting shared features from a pool of new items. The present study examined sleep and the consolidation of gist in 12-month-old infants using a deferred imitation paradigm. Sixty infants were randomly assigned to a nap, a no-nap or a baseline control condition. In the nap and no-nap conditions, infants watched demonstrations of the same target actions on three different hand puppets that shared some features. During a 4-h delay, infants in the nap condition took a naturally scheduled nap while infants in the no-nap condition naturally stayed awake. Afterwards, infants were exposed to a novel forth hand puppet that combined some of the features from the previously encountered puppets. Only those infants who took a nap after learning produced a significantly higher number of target actions than infants in the baseline control condition who had not seen any demonstrations of target actions. Infants in the nap condition also produced significantly more target actions than infants in the no-nap condition. Sleep appears to support the storage of gist, which aids infants in applying recently acquired knowledge to novel circumstances.

  17. Meralgia paraesthetica: Ultrasound-guided injection at multiple levels with 12-month follow-up.

    PubMed

    Klauser, Andrea S; Abd Ellah, Mohamed M H; Halpern, Ethan J; Sporer, Isabella; Martinoli, Carlo; Tagliafico, Alberto; Sojer, Martin; Taljanovic, Mihra S; Jaschke, Werner R

    2016-03-01

    To evaluate the efficacy of ultrasound (US)-guided injections around the lateral femoral cutaneous nerve (LFCN) at different levels in meralgia paraesthetica (MP) patients. The study was approved by the university ethics committee and informed oral and written consent were obtained from all patients. Between June 2008 and August 2013, 20 patients with symptoms of MP, including nine men (mean age, 61.33 years) and 11 women (mean age 61.18 years), were treated with US-guided injection of steroids along the LFCN at three different levels in a mean of 2.25 sessions. A visual analogue scale (VAS) was used to measure symptoms before, immediately after and 12 months after treatment. Complete resolution of symptoms was documented in 15/20 patients (mean VAS decreased from 82 to 0), and partial resolution in the remaining five (mean VAS decreased from 92 to 42), which was confirmed at 12-month follow-up. By using the different levels of injection approach overall significantly better symptom relief was obtained (p < 0.05). The outcome of US-guided injection along the LFCN can be further improved by injections at different levels (p < 0.05), which was confirmed at 12-month long-term follow-up. Meralgia paraesthetica is an entrapment neuropathy of the lateral femoral cutaneous nerve. Ultrasound proved effective in diagnosis and in guiding injection therapy. Injection at the anterior superior iliac spine has been used previously. Multiple injections along the nerve course were used in this study. Long-term follow-up (12 months) confirmed the results.

  18. Hazardous Alcohol Drinking as Predictor of Smoking Relapse (3-, 6-, and 12-Months Follow-Up) by Gender.

    PubMed

    Rodríguez-Cano, Rubén; López-Durán, Ana; Martínez-Vispo, Carmela; Martínez, Úrsula; Fernández Del Río, Elena; Becoña, Elisardo

    2016-12-01

    Diverse studies have found a relation between alcohol consumption and smoking relapse. Few studies have analyzed the relation of smoking relapse with pretreatment alcohol consumption and gender differences. The main purpose of this study is to analyze the influence of alcohol consumption in smoking relapse over 12 months (3-, 6-, and 12-months follow-up) and to determine possible gender differences. The sample included 374 smokers who quit smoking by participating in a psychological smoking cessation treatment. We assessed hazardous pretreatment alcohol drinking (AUDIT), cigarette consumption (FTND; number of cigarettes) and sociodemographic variables. Higher scores on hazardous pretreatment alcohol drinking predict smoking relapse at 3-, 6-, and 12-months after smoking cessation. In males, higher scores on hazardous pretreatment alcohol drinking predict relapse at 6 and at 12 months. In females, higher scores on hazardous pretreatment alcohol drinking predict tobacco relapse at 3 months. Hazardous pretreatment alcohol drinking predicts relapse at all intervals after smoking cessation (3-, 6-, and 12-months follow-up). However, the influence of hazardous pretreatment alcohol drinking on smoking relapse differs as a function of gender, as it is a short-term predictor in women (3 months) and a long-term predictor in men (6 and 12 months). Copyright © 2016 Elsevier Inc. All rights reserved.

  19. Micropulse diode laser trabeculoplasty (MDLT): A phase II clinical study with 12 months follow-up

    PubMed Central

    Fea, Antonio Maria; Bosone, Alex; Rolle, Teresa; Brogliatti, Beatrice; Grignolo, Federico Maria

    2008-01-01

    Objective This pilot study evaluates the pressure lowering potential of subthreshold micropulse diode laser trabeculoplasty (MDLT) for a clinically meaningful duration in patients with medically uncontrolled open angle glaucoma (OAG). Design prospective interventional case series. Participants Thirty-two eyes of 20 consecutive patients with uncontrolled OAG (12 bilateral and 8 unilateral). Methods Confluent subthreshold laser applications over the inferior 180° of the anterior TM using an 810 nm diode laser in a micropulse operating mode. The intraocular pressure (IOP) was measured at baseline and at 1 hour, 1 day, 1 week, 3, 6, 9, and 12 months post-treatment. Flare was measured with a Kowa FM 500 flare-meter at baseline and at 3 hours, 1 day, 1 week, and 12 months post-treatment. After treatment, the patients were maintained on their pre-treatment drug regimen. Main outcome measures Criteria for treatment response were IOP reduction ≥3 mm Hg and IOP ≤21 mm Hg within the first week after MDLT. Eyes not complying to the above criteria during the follow-up were considered treatment failure. Mean IOP change and percentage of IOP reduction during the follow-up were calculated. Results One eye was analyzed for bilateral patients. A total of 20 eyes were thus included. Four eyes (20%) did not respond to treatment during the first week. One additional eye failed at the 6 month visit. The treatment was successful in 15 eyes (75%) at 12 months. The IOP was significantly lower throughout follow-up (p < 0.01). At 12 months, the mean percentage of IOP reduction in the 15 respondent eyes was 22.1% and 12 eyes (60%) had IOP reduction higher than 20%. During the first two postoperative days, one eye with pigmentary glaucoma experienced a significant increase of flare associated with an IOP spike (34 mm Hg) that was controlled with systemic drugs; afterwards it qualified as a respondent and completed the study. No increase of flare was found in any other patient. No

  20. A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant.

    PubMed

    Apter, Dan; Briggs, Paula; Tuppurainen, Marjo; Grunert, Julia; Lukkari-Lax, Eeva; Rybowski, Sarah; Gemzell-Danielsson, Kristina

    2016-07-01

    To compare the levonorgestrel intrauterine system (LNG-IUS 8), which has an average levonorgestrel release rate of ∼8 μg/24 hours during the first year (total levonorgestrel content 13.5 mg; Jaydess/Skyla), with the etonogestrel (ENG) subdermal implant (total content, 68 mg) with regard to the 12-month discontinuation rate (primary outcome). Randomized, open-label, phase III study. Thirty-eight centers in six European countries. Study population of 766 healthy nulliparous and parous women aged 18-35 years. The LNG-IUS 8 or the ENG implant. Discontinuation rate, by treatment group, at Month 12. The 12-month discontinuation rates were 19.6% and 26.8% in the LNG-IUS 8 and ENG implant groups, respectively. The -7.2% difference was statistically significant (95% confidence interval -13.2%, -1.2%). Fewer women in the LNG-IUS 8 group than in the ENG implant group discontinued because of increased bleeding (3.2% vs. 11.3%) or adverse events (14.3% vs. 21.8%). At 12 months, more women in the LNG-IUS 8 group than in the ENG implant group were "very/somewhat satisfied" with their bleeding pattern (60.9% vs. 33.6%) and reported a preference to use their study treatment after study completion (70.1% vs. 58.5%). The LNG-IUS 8 was associated with a significantly lower 12-month discontinuation rate compared with the ENG implant; mainly because ENG implant users frequently discontinued due to increased bleeding. More LNG-IUS 8 users than ENG implant users reported being "very/somewhat satisfied" with their bleeding pattern, and reported a preference to continue using their study treatment after the study. NCT01397097. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  1. Histamine-dependent behavioral response to methamphetamine in 12-month-old male mice

    PubMed Central

    Acevedo, Summer F.; Raber, Jacob

    2011-01-01

    Methamphetamine (MA) use is a growing problem across the United States. Effects of MA include hyperactivity and increased anxiety. Using a mouse model system, we examined behavioral performance in the open field and elevated zero maze and shock-startle response of 12-month-old wild-type mice injected with MA once (1mg/kg) 30 min prior to behavioral testing. MA treatment resulted in behavioral sensitization in the open field, consistent with studies in younger mice. There was an increased activity in the elevated zero maze and an increased shock-startle response 30 and 60 min post-injection. Since histamine mediates some effects of MA in the brain, we assessed whether 12-month-old mice lacking histidine decarboxylase (Hdc−/−), the enzyme required to synthesize histamine, respond differently to MA than wild-type (Hdc+/+) mice. Compared to saline treatment, acute and repeated MA administration increased activity in the open field and measures of anxiety, though more so in Hdc−/− than Hdc+/+ mice. In the elevated zero maze, opposite effects of MA on activity and measures of anxiety were seen in Hdc+/+ mice. In contrast, MA similarly increased the shock-startle response in Hdc−/− and Hdc+/+ mice, compared to saline-treated genotype-matched mice. These results are similar to those in younger mice suggesting that the effects are not age-dependent. Overall, single or repeated MA treatment causes histamine-dependent changes in 12-month-old mice in the open field and elevated zero-maze, but not in the shock-startle response. PMID:21466792

  2. Ethosuximide, Valproic Acid and Lamotrigine in Childhood Absence Epilepsy: Initial Monotherapy Outcomes at 12 months

    PubMed Central

    Glauser, Tracy A.; Cnaan, Avital; Shinnar, Shlomo; Hirtz, Deborah G.; Dlugos, Dennis; Masur, David; Clark, Peggy O.; Adamson, Peter C.

    2012-01-01

    Purpose Determine the optimal initial monotherapy for children with newly diagnosed childhood absence epilepsy based on 12 months of double blind therapy. Methods A double-blind, randomized controlled clinical trial compared the efficacy, tolerability and neuropsychological effects of ethosuximide, valproic acid and lamotrigine in children with newly diagnosed childhood absence epilepsy. Study medications were titrated to clinical response and subjects remained in the trial unless they reached a treatment failure criterion. Maximal target doses were ethosuximide 60 mg/kg/day or 2000 mg/day, valproic acid 60 mg/kg/day or 3000 mg/day and lamotrigine 12 mg/kg/day or 600 mg/day. Original primary outcome was at 16–20 weeks and included a video EEG assessment. For this report, the main effectiveness outcome was the freedom from failure rate 12 months after randomization and included a video EEG assessment; differential drug effects were determined by pairwise comparisons. The main cognitive outcome was the percentage of subjects experiencing attentional dysfunction at the Month 12 visit. Key Findings A total of 453 children were enrolled and randomized; seven were deemed ineligible and 446 subjects comprised the overall efficacy cohort. There were no demographic differences between the three cohorts. By 12 months after starting therapy, only 37% of all enrolled subjects were free from treatment failure on their first medication. At the Month 12 visit, the freedom-from-failure rates for ethosuximide and valproic acid were similar (45% and 44%, respectively; odds ratio with valproic acid vs. ethosuximide, 0.94; 95% confidence interval [CI], 0.60 to 1.48; P = 0.82) and were higher than the rate for lamotrigine (21%; odds ratio with ethosuximide vs. lamotrigine, 3.09; 95% CI, 1.86 to 5.13; odds ratio with valproic acid vs. lamotrigine, 2.90; 95% CI, 1.74 to 4.83; P<0.001 for both comparisons). The frequency of treatment failures due to lack of seizure control (p < 0

  3. Changes in Astigmatism, Densitometry, and Aberrations After SMILE for Low to High Myopic Astigmatism: A 12-Month Prospective Study.

    PubMed

    Pedersen, Iben Bach; Ivarsen, Anders; Hjortdal, Jesper

    2017-01-01

    To evaluate 12-month changes in refraction, visual outcome, corneal densitometry, and postoperative aberrations after small incision lenticule extraction (SMILE) for myopic astigmatism. This 12-month prospective clinical trial comprised 101 eyes (101 patients) treated with SMILE for myopic astigmatism with cylinder of 0.75 to 4.00 diopters (D). The preoperative, 1-week, and 1-, 3-, 6-, 9-, and 12-month examinations included measurement of manifest refraction, uncorrected distance visual acuity (UDVA), and corrected (CDVA) distance visual acuity. Astigmatic error vector analysis was performed using Al-pin's method. Densitometry and aberrations were evaluated with Pentacam HR (Oculus Optikgeräte, Wetzlar, Germany). Preoperative spherical equivalent averaged -6.78 ± 1.90 D with 1.81 ± 1.00 D in cylinder correction. After 12 months, 74% and 93% of the eyes were within ±0.50 and ±1.00 D of the attempted refraction, respectively. The logMAR UDVA and CDVA averaged 0.03 ± 0.16 and -0.08 ± 0.09, respectively. Vector analysis showed a with-the-rule undercorrection at 12 months with a mean difference vector of 0.31 D @ 91°. There was a minor counterclockwise rotation of the axis, with an arithmetic angle of error of 0.34° ± 14°. An undercorrection of approximately 11% per diopter of attempted correction was seen at 12 months. Spherical aberrations, coma, and higher order aberrations remained stable during the postoperative period (P < .09). After 12 months, no increase in densitometry could be identified. Treatment of astigmatism with SMILE seems to be predictable and effective, but with an astigmatic undercorrection of approximately 11% and a small counterclockwise rotation of the axis. [J Refract Surg. 2017;33(1):11-17.]. Copyright 2017, SLACK Incorporated.

  4. Safety testing of epimacular brachytherapy with microperimetry and indocyanine green angiography: 12-month results.

    PubMed

    Petrarca, Robert; Richardson, Matthew; Douiri, Abdel; Nau, Jeffrey; McHugh, Dominic; Stangos, Alexandros N; Jackson, Timothy L

    2013-06-01

    To determine if epimacular brachytherapy is associated with reduced retinal sensitivity or choroidal nonperfusion. A prospective intervention case series of 12 participants with neovascular age-related macular degeneration requiring frequent ranibizumab underwent vitrectomy and epimacular brachytherapy. The Strontium 90/Yttrium 90 source delivered a single 24-Gy dose at the center of the treatment zone. The dose attenuated with increasing distance from the source. Microperimetry and indocyanine green angiography were performed at baseline and 12 months. The main outcome measures were mean sensitivity and choroidal nonperfusion. A linear mixed model was used to assess the association between the dose of radiation and the change in mean sensitivity. Mean visual acuity remained within 1 letter of baseline at 12 months (-0.33 ± 13.2 letters). There was no statistically significant change in mean sensitivity within the neovascular age-related macular degeneration lesion area (gain of 0.94 ± 3.25 dB; P = 0.339) or in neighboring unaffected retina (0.66 ± 4.14 dB; P = 0.594), defined using fluorescein angiography. Within the lesion area, mean sensitivity improved by an average of 0.23 ± 0.16 dB (P = 0.006) for every additional gray of radiation received. Indocyanine green angiography failed to demonstrate any choroidal nonperfusion or radiation damage at 12 months after the treatment. Stable retinal sensitivity in areas not manifestly affected by neovascular age-related macular degeneration suggests that epimacular brachytherapy does not damage retinal function. The presence of a dose response suggests that the positive effect of epimacular brachytherapy relates more to beta irradiation than vitrectomy.

  5. Mediators of 12-Month Outcomes of Two Internet Interventions for Youth With Type 1 Diabetes

    PubMed Central

    Whittemore, Robin; Chao, Ariana; Jeon, Sangchoon; Faulkner, Melissa S.; Grey, Margaret

    2014-01-01

    Objective To determine mediators of 12-month outcomes of Internet interventions for youth with type 1 diabetes transitioning to adolescence. Methods In this multisite clinical trial, 320 youth were randomized to one of two Internet-based interventions: Coping skills (TEENCOPE™) or diabetes education (Managing Diabetes). Mediators of the interventions’ effects on glycosylated hemoglobin and quality of life were examined. Data were collected at baseline and at 3, 6, and 12 months. Results Self-efficacy mediated treatment effects on quality of life in both interventions. For TEENCOPE™, stress reactivity, primary control coping, and secondary control coping mediated treatment effects, whereas for Managing Diabetes, social acceptance mediated treatment effects. There were no significant effects of either intervention on glycosylated hemoglobin. Conclusions 2 Internet interventions for youth with type 1 diabetes resulted in improved quality of life by different mechanisms, suggesting components of both diabetes education and coping skills may help to achieve better outcomes in youth with type 1 diabetes. PMID:24163439

  6. National High Blood Pressure 12-Month Kit. May 1988.

    ERIC Educational Resources Information Center

    National Heart and Lung Inst. (DHHS/NIH), Bethesda, MD. National High Blood Pressure Education Program.

    Part I of this kit provides information for program planners and health professionals on ways to overcome barriers to health care among the medically underserved, promote high blood pressure control through the media and other community channels, and improve adherence to treatment among hypertensive patients. It lists additional resources for…

  7. Psychological adjustment in children after traumatic disfiguring injuries: a 12-month follow-up.

    PubMed

    Rusch, M D; Grunert, B K; Sanger, J R; Dzwierzynski, W W; Matloub, H S

    2000-12-01

    The psychological adjustment of 57 children (age range, 3 to 12 years) who sustained mutilating traumatic injuries to the face or upper or lower extremities was assessed over a 12-month interval. The injuries had occurred as a result of boating, lawn mower, or home accidents or dog bites. Within 5 days of the traumatic event, 98 percent of the children were symptomatic for posttraumatic stress disorder, depression, or anxiety. One month after the injury, 82 percent were symptomatic. Symptom frequency had declined by the time of the 3-month and 6-month evaluations, but 44 percent of the children continued to report symptoms at 12-month follow-up visits, and 21 percent met the diagnostic criteria for posttraumatic stress disorder. Typical symptoms included flashbacks, fear of re-injury, mood disorders, body-image changes secondary to disfigurement, sleep disturbances, and anxiety. These findings support the importance of psychological evaluation and treatment of children who suffer mutilating injuries that require the attention of plastic surgeons.

  8. Psychosocial and neurocognitive functioning in unipolar and bipolar depression: a 12-month prospective study.

    PubMed

    Godard, Julie; Baruch, Philippe; Grondin, Simon; Lafleur, Martin F

    2012-03-30

    Previous studies have revealed psychosocial and cognitive impairments in patients during unipolar and bipolar depression, which persist even in subsyndromal and euthymic states. Currently, little is known about the nature and the extent of psychosocial and cognitive deficits during depression. The aim of the present study was to characterize psychosocial and cognitive profiles among unipolar (MDD) and bipolar (BD) patients during a major depressive episode and to compare the profiles of the patient groups. Depressed patients with MDD (n=13) and BD (n=11) were followed over a period of 12 months. Clinical, psychosocial and neuropsychological assessments were conducted at baseline and at 6-week, 4-month, 8-month and 12-month follow-ups. In the case of severe mood disorders, psychosocial and neurocognitive functioning seem similar among MDD and BD patients during a depressive episode. All MDD and BD patients had global psychosocial dysfunction, characterized by occupational and relational impairments. Furthermore, the neurocognitive profile was heterogeneous with regard to the nature and extent of cognitive deficits but attentional processes were frequently compromised. After 1 year of treatment, occupational and relational impairments, as well as neurocognitive dysfunction, persisted sufficiently to alter daily functioning.

  9. Inhaled fluticasone in bronchiectasis: a 12 month study

    PubMed Central

    Tsang, K; Tan, K; Ho, P; Ooi, G; Ho, J; Mak, J; Tipoe, G; Ko, C; Yan, C; Lam, W; Chan-Yeung, M

    2005-01-01

    Background: The clinical efficacy of inhaled corticosteroid (ICS) treatment has not been evaluated in bronchiectasis, despite the presence of chronic airway inflammation. Methods: After three consecutive weekly visits, 86 patients were randomised to receive either fluticasone 500 µg twice daily (n = 43, 23F, mean (SD) age 57.7 (14.4) years) or matched placebo (n = 43, 34F, 59.2 (14.2) years) and reviewed regularly for 52 weeks in a double blind fashion. Results: 35 and 38 patients in the fluticasone and placebo groups completed the study. Significantly more patients on ICS than on placebo showed improvement in 24 hour sputum volume (OR 2.5, 95% CI 1.1 to 6.0, p = 0.03) but not in exacerbation frequency, forced expiratory volume in 1 second, forced vital capacity, or sputum purulence score. Significantly more patients with Pseudomonas aeruginosa infection receiving fluticasone showed improvement in 24 hour sputum volume (OR 13.5, 95% CI 1.8 to 100.2, p = 0.03) and exacerbation frequency (OR 13.3, 95% CI 1.8 to 100.2, p = 0.01) than those given placebo. Logistic regression models revealed a significantly better response in sputum volume with fluticasone treatment than with placebo among subgroups of patients with 24 hour sputum volume <30 ml (p = 0.04), exacerbation frequency ⩽2/year (p = 0.04), and sputum purulence score >5 (p = 0.03). Conclusions: ICS treatment is beneficial to patients with bronchiectasis, particularly those with P aerurginosa infection. PMID:15741443

  10. Smoking cessation after 12 months with multi-component therapy.

    PubMed

    Raich, Antònia; Martínez-Sánchez, Jose Maria; Marquilles, Emili; Rubio, Lídia; Fu, Marcela; Fernández, Esteve

    2015-03-01

    Smoking is one of the most important causes of morbidity and mortality in developed countries. One of the priorities of public health programmes is the reduction of its prevalence, which would involve millions of people quitting smoking, but cessation programs often have modest results, especially within certain population groups. The aim of this study was to analyze the variables determining the success of a multicomponent therapy programme for smoking cessation. We conducted the study in the Smoking Addiction Unit at the Hospital of Manresa, with 314 patients (91.4% of whom had medium or high-level dependency). We observed that higher educational level, not living with a smoker, following a multimodal programme or smoking cessation with psychological therapy, and pharmacological treatment are relevant factors for quitting smoking. Abstinence rates are not associated with other factors, such as sex, age, smoking behaviour characteristics or psychiatric history. The combination of pharmacological and psychological treatment increased success rates in multicomponent therapy. Psychological therapy only also obtained positive results, though somewhat more modest.

  11. Miniscalpel-Needle versus Steroid Injection for Plantar Fasciitis: A Randomized Controlled Trial with a 12-Month Follow-Up

    PubMed Central

    Li, Shuming; Shen, Tong; Liang, Yongshan; Zhang, Ying; Bai, Bo

    2014-01-01

    Plantar fasciitis is the most common cause of heel pain in adults. A novel alternative medical instrument, the miniscalpel-needle (MSN), which is based on an acupuncture needle, has been recently developed in China. The objective of this study was to evaluate the effectiveness of the MSN release treatment versus that of traditional steroid injection for plantar fasciitis. Patients with plantar fasciitis were randomly assigned to 2 groups and followed up for 12 months, with 29 receiving MSN treatment and 25 receiving steroid injection treatment. The results showed that visual analog scale scores for morning pain, active pain, and overall heel pain all were decreased significantly in the MSN group from 1 to 12 months after treatment. In contrast, treatment with steroid injection showed a significant effect only at the 1-month follow-up but not at 6 or 12 months after treatment. Moreover, the MSN group achieved more rapid and sustained improvements than the steroid group throughout the duration of this study. No severe side effects were observed with MSN treatment. Our data suggest that the MSN release treatment is safe and has a significant benefit for plantar fasciitis compared to steroid injection. PMID:25114704

  12. Neurocognitive outcome 12 months following cerebellar mutism syndrome in pediatric patients with medulloblastoma

    PubMed Central

    Palmer, Shawna L.; Hassall, Tim; Evankovich, Karen; Mabbott, Donald J.; Bonner, Melanie; Deluca, Cinzia; Cohn, Richard; Fisher, Michael J.; Morris, E. Brannon; Broniscer, Alberto; Gajjar, Amar

    2010-01-01

    The aim is to prospectively assess early neurocognitive outcome of children who developed cerebellar mutism syndrome (CMS) following surgical resection of a posterior fossa embryonal tumor, compared with carefully matched control patients. Children who were enrolled on an ongoing IRB-approved protocol for treatment of embryonal tumors, were diagnosed with postoperative CMS, and had completed prospectively planned neuropsychological evaluation at 12 months postdiagnosis were considered eligible. The cognitive outcomes of these patients were examined in comparison to patients without CMS from the same treatment protocol and matched with regard to primary diagnosis, age at diagnosis, and risk/corresponding treatment (n = 22 pairs). Seventeen were also matched according to gender, and 14 were also matched according to race. High-risk patients received 36–39.6 Gy CSI and 3D conformal boost to the primary site to 55.8–59.4 Gy. Average-risk patients received 23.4 Gy CSI and 3D conformal boost to the primary site to 55.8 Gy. Significant group differences were found on multiple cognitive outcomes. While the matched control patients exhibited performance in the average range, patients who developed CMS postsurgery were found to have significantly lower performance in processing speed, attention, working memory, executive processes, cognitive efficiency, reading, spelling, and math. Patients treated for medulloblastoma who experience postoperative CMS show an increased risk for neurocognitive impairment, evident as early as 12 months following diagnosis. This study highlights the need for careful follow-up with neuropsychological evaluation and for obtaining critical support for patients and their families. PMID:20713408

  13. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy

    PubMed Central

    2014-01-01

    Objective Assessment of 12-month safety of ospemifene 60 mg/day for treatment of postmenopausal women with vulvar and vaginal atrophy (VVA). Methods In this 52-week, randomized, double-blind, placebo-controlled, parallel-group study, women 40–80 years with VVA and an intact uterus were randomized 6 : 1 to ospemifene 60 mg/day or placebo. The primary objective was 12-month safety, particularly endometrial; 12-week efficacy was assessed. Safety assessments included endometrial histology and thickness, and breast and gynecological examinations. Efficacy evaluations included changes from baseline to week 12 in percentage of superficial and parabasal cells and vaginal pH. Results Of 426 randomized subjects, 81.9% (n = 349) completed the study with adverse events the most common reason for discontinuation (ospemifene 9.5%; placebo 3.9%). Most (88%) treatment-emergent adverse events with ospemifene were considered mild or moderate. Three cases (1.0%) of active proliferation were observed in the ospemifene group. For one, active proliferation was seen at end of study week 52, and diagnosed as simple hyperplasia without atypia on follow-up biopsy 3 months after the last dose. This subsequently resolved with progestogen treatment and dilatation and curettage. In six subjects (five ospemifene (1.4%), one placebo (1.6%)) endometrial polyps were found (histopathology); however, only one (ospemifene) was confirmed as a true polyp during additional expert review. Endometrial histology showed no evidence of carcinoma. Statistically significant improvements were seen for all primary and secondary efficacy measures and were sustained through week 52 with ospemifene vs. placebo. Conclusions The findings of this 52-week study confirm the tolerance and efficacy of oral ospemifene previously reported in short- and long-term studies. PMID:23984673

  14. West Indies Glaucoma Laser Study (WIGLS): 1. 12-Month Efficacy of Selective Laser Trabeculoplasty in Afro-Caribbeans with Glaucoma.

    PubMed

    Realini, Tony; Shillingford-Ricketts, Hazel; Burt, Darra; Balasubramani, Goundappa K

    2017-09-26

    To characterize the 12-month intraocular pressure (IOP)-lowering efficacy of selective laser trabeculoplasty (SLT) as sole therapy for primary open-angle glaucoma (POAG) in an Afro-Caribbean population. Stepped-wedge trial. Subjects in St. Lucia and Dominica with established POAG were randomized to prompt washout of IOP-lowering medications followed by SLT, 3-month delay followed by washout and SLT, or 6-month delay followed by washout and SLT. Baseline IOP was obtained on two different days after washout. Bilateral 360-degree SLT was performed in one session. Post-treatment assessments took place 1 hour, 1 week, and 3, 6, 9, and 12 months post-SLT. The main outcome measure was SLT success (defined as IOP < target IOP in both eyes) at 12 months. Target IOP was a 20% or greater reduction in IOP from post-washout baseline. Overall, 72 underwent SLT treatment. Mean IOP at enrollment was 15.4 ± 3.6 mmHg in right eyes and 15.4 ± 3.6 mmHg in left eyes, which rose to 21.0 ± 3.3 mmHg and 20.9 ± 3.0 mmHg, respectively, after washout. Mean IOP at 3, 6, 9 and 12 months ranged from 12.5 mmHg to 14.5 mmHg (29.7% to 39.5%; p<0.0001 in each eye at each time point). The 12-month success rate was 78%. Transient photophobia and discomfort were common. SLT monotherapy safely provides significant IOP reduction in Afro-Caribbean eyes with POAG. This treatment can play a significant role in preventing glaucoma vision loss and blindness in people of African descent living in resource-limited regions. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. The physical, functional, and developmental outcome of pediatric burn survivors from 1 to 12 months postinjury.

    PubMed

    Gorga, D; Johnson, J; Bentley, A; Silverberg, R; Glassman, M; Madden, M; Yurt, R; Nagler, W

    1999-01-01

    Fifty-one children with an average age of 27 months and who had sustained a burn injury were tested at 1, 6, and 12 months postinjury to determine their physical, functional, and developmental outcomes. Most parents were either African-American or Hispanic, lived on public assistance, and had a high school education or less. Most children had normal range of motion and were appropriate for their age in self-care skills. On the basis of the Home Screening Questionnaire, 48% of the children came from suspect home environments. Developmental delays were noted in language acquisition that persisted over the first year postburn. Although the outcomes of these burn injuries were good in physical and functional areas, the developmental findings raised concerns. The results alert clinicians to screen for potential developmental problems during the burned child's recovery phase and to include appropriate developmental activities and parental guidance in the treatment plan.

  16. Effects of Miniscalpel-Needle Release on Chronic Neck Pain: A Retrospective Analysis with 12-Month Follow-Up

    PubMed Central

    Li, Shuming; Shen, Tong; Liang, Yongshan; Zhang, Ying; Bai, Bo

    2015-01-01

    Objective Chronic neck pain is a highly prevalent condition, and is often treated with non-steroidal anti-inflammatory drugs. Limited clinical studies with short-term follow-up have shown promising efficacy of acupuncture as well as miniscalpel-needle (MSN) release. In this retrospective study, we examined whether MSN release could produce long-lasting relief in patients with chronic neck pain. Methods We retrieved the medical records of all patients receiving weekly MSN release treatment for chronic neck pain at this institution during a period from May 2012 to December 2013. Only cases with the following information at prior to, and 1, 6, and 12 months after the treatment, were included in the analysis: neck disability index (NDI), numerical pain rating scale (NPRS), and active cervical range of motion (CROM). The primary analysis of interest is comparison of the 12-month measures with the baseline. Patients who took analgesic drugs or massage within 2 weeks prior to assessment were excluded from the analysis. For MSN release, tender points were identified manually by an experienced physician, and did not necessarily follow the traditional acupuncture system. MSN was inserted vertically (parallel to the spine) until breaking through resistance and patient reporting of distention, soreness or heaviness. The depth of the needling ranged from 10 to 50 mm. The release was carried out by moving the MSN up and down 3–5 times without rotation. Results A total of 559 cases (patients receiving weekly MSN release treatment for chronic neck pain) were screened. The number of cases with complete information (NDI, NPRS, and CROM at baseline, 1, 6 and 12 months after last treatment) was 180. After excluding the cases with analgesic treatment or massage within 2 weeks of assessment (n = 53), a total of 127 cases were included in data analysis. The number of MSN release session was 7 (range: 4–11). At 12 months after the treatment, both NPRS and NDI were significantly lower

  17. Analysis of the ability of pramlintide to inhibit amyloid formation by human islet amyloid polypeptide reveals a balance between optimal recognition and reduced amyloidogenicity.

    PubMed

    Wang, Hui; Ridgway, Zachary; Cao, Ping; Ruzsicska, Bela; Raleigh, Daniel P

    2015-11-10

    The hormone human islet amyloid polypeptide (hIAPP or amylin) plays a role in glucose metabolism, but forms amyloid in the pancreas in type 2 diabetes (T2D) and is associated with β-cell death and dysfunction in the disease. Inhibitors of islet amyloid have therapeutic potential; however, there are no clinically approved inhibitors, and the mode of action of existing inhibitors is not well understood. Rat IAPP (rIAPP) differs from hIAPP at six positions, does not form amyloid, and is an inhibitor of amyloid formation by hIAPP. Five of the six differences are located within the segment of residues 20-29, and three of them are Pro residues, which are well-known disruptors of β-sheet structure. rIAPP is thus a natural example of a "β-breaker inhibitor", a molecule that combines a recognition element with an entity that inhibits β-sheet formation. Pramlintide (PM) is a peptide drug approved for use as an adjunct to insulin therapy for treatment of diabetes. PM was developed by introducing the three Pro substitutions found in rIAPP into hIAPP. Thus, it more closely resembles the human peptide than does rIAPP. Here we examine and compare the ability of rIAPP, PM, and a set of designed analogues of hIAPP to inhibit amyloid formation by hIAPP, to elucidate the factors that lead to effective peptide-based inhibitors. Our results reveal, for this class of molecules, a balance between the reduced amyloidogenicity of the inhibitory sequence on one hand and its ability to recognize hIAPP on the other.

  18. Analysis of the Ability of Pramlintide to Inhibit Amyloid Formation by Human Islet Amyloid Polypeptide Reveals a Balance between Optimum Recognition and Reduced Amyloidgenicity

    PubMed Central

    Wang, Hui; Ridgway, Zachary; Cao, Ping; Ruzsicska, Bela; Raleigh, Daniel P.

    2015-01-01

    The hormone human islet amyloid polypeptide (hIAPP or amylin) plays a role in glucose metabolism, but forms amyloid in the pancreas in type 2 diabetes (T2D) and is associated with β-cell death and dysfunction in the disease. Inhibitors of islet amyloid have therapeutic potential, however there are no clinically approved inhibitors and the mode of action of existing inhibitors is not well understood. Rat IAPP (rIAPP), differs from hIAPP at six positions, does not form amyloid and is an inhibitor of amyloid formation by hIAPP. Five of the six differences are located within residues 20-29, and three of them are Pro residues, which are well known disruptors of β-sheet structure. rIAPP is thus a natural example of a “β-breaker inhibitor”; a molecule which combines a recognition element with an entity that inhibits β-sheet formation. Pramlintide (PM) is a peptide drug approved for use as an adjunct to insulin therapy for treatment of diabetes. PM was developed by introducing the three Pro substitutions found in rIAPP into hIAPP. Thus, it more closely resembles the human peptide than does rIAPP. Here we examine and compare the ability of rIAPP, PM and a set of designed analogs of hIAPP to inhibit amyloid formation by hIAPP, in order to elucidate the factors which lead to effective peptide based inhibitors. Our results reveal, for this class of molecules, a balance between the reduced amyloidogenicity of the inhibitory sequence on the one hand and its ability to recognize hIAPP on the other. PMID:26407043

  19. Patterns of mother-infant interaction from 3 to 12 months among dyads with substance abuse and psychiatric problems.

    PubMed

    Siqveland, Torill S; Haabrekke, Kristin; Wentzel-Larsen, Tore; Moe, Vibeke

    2014-11-01

    The aim of this study was to investigate the development of mother-infant interaction patterns from 3 to 12 months among three groups of mother-baby pairs recruited during pregnancy: one group from residential substance abuse treatment (n=28), a second group from psychiatric outpatient treatment (n=22), and a third group from well-baby clinics (n=30). The mother-infant interaction at 3 and 12 months was assessed by the Parent-Child Early Relational Assessment (PCERA), which consists of maternal, child and dyadic subscales (Clark, 2006). Linear mixed effects models were used to analyze group differences and the changes in mother-infant interaction from 3 to 12 months. At 3 months, pairwise comparisons showed that the group with psychiatric problems had significantly more difficulties in the mother-infant interaction than the two other groups. The group with substance abuse problems was not significantly different from the two other groups. At 12 months, the mother-infant pairs in the substance abuse group showed significantly more relational disturbances than the non-clinical pairs, as well as a poorer affective quality of interaction than the dyads in the group with psychiatric problems. Analysis of change from 3 to 12 months showed that difficulties in the interaction increased among the mother-baby pairs in the substance abuse group, while improvements were displayed in the two other groups. These results underline that mother-infant pairs at double risk due to maternal substance abuse and other non-optimal factors, are in need for long-term follow up in order to prevent the development of negative interactional patterns.

  20. Effects of 12 Months Continuous Positive Airway Pressure on Sympathetic Activity Related Brainstem Function and Structure in Obstructive Sleep Apnea

    PubMed Central

    Henderson, Luke A.; Fatouleh, Rania H.; Lundblad, Linda C.; McKenzie, David K.; Macefield, Vaughan G.

    2016-01-01

    Muscle sympathetic nerve activity (MSNA) is greatly elevated in patients with obstructive sleep apnea (OSA) during normoxic daytime wakefulness. Increased MSNA is a precursor to hypertension and elevated cardiovascular morbidity and mortality. However, the mechanisms underlying the high MSNA in OSA are not well understood. In this study we used concurrent microneurography and magnetic resonance imaging to explore MSNA-related brainstem activity changes and anatomical changes in 15 control and 15 OSA subjects before and after 6 and 12 months of continuous positive airway pressure (CPAP) treatment. We found that following 6 and 12 months of CPAP treatment, resting MSNA levels were significantly reduced in individuals with OSA. Furthermore, this MSNA reduction was associated with restoration of MSNA-related brainstem activity and structural changes in the medullary raphe, rostral ventrolateral medulla, dorsolateral pons, and ventral midbrain. This restoration occurred after 6 months of CPAP treatment and was maintained following 12 months CPAP. These findings show that continual CPAP treatment is an effective long-term treatment for elevated MSNA likely due to its effects on restoring brainstem structure and function. PMID:27013952

  1. The Development of Rational Imitation in 9- and 12-Month-Old Infants

    ERIC Educational Resources Information Center

    Zmyj, Norbert; Daum, Moritz M.; Aschersleben, Gisa

    2009-01-01

    Studies on rational imitation have provided evidence for the fact that infants as young as 12 months of age engage in rational imitation. However, the developmental onset of this ability is unclear. In this study, we investigated whether 9- and 12-month-olds detect voluntary and implicit as well as nonvoluntary and explicit constraints in the head…

  2. The Development of Rational Imitation in 9- and 12-Month-Old Infants

    ERIC Educational Resources Information Center

    Zmyj, Norbert; Daum, Moritz M.; Aschersleben, Gisa

    2009-01-01

    Studies on rational imitation have provided evidence for the fact that infants as young as 12 months of age engage in rational imitation. However, the developmental onset of this ability is unclear. In this study, we investigated whether 9- and 12-month-olds detect voluntary and implicit as well as nonvoluntary and explicit constraints in the head…

  3. Patient powered prophylaxis: A 12-month study of individualized prophylaxis in adults with severe haemophilia A.

    PubMed

    Sun, Haowei Linda; McIntosh, Kam A; Squire, Sandra J; Yang, Ming; Bartholomew, Claude; Gue, Deb S; Camp, Pat G; Jackson, Shannon C

    2017-08-29

    Adults with severe haemophilia A (SHA) may experience breakthrough bleeds despite standard weight-based FVIII prophylaxis three times weekly. Individualized prophylaxis has evolved to optimize patient outcomes. This study aimed to evaluate the impact of a standardized approach to individualized prophylaxis on annualized bleeding rates (ABR), factor utilization, physical activity and quality of life in adults with SHA. In this prospective cohort study, patients with baseline FVIII:C <2% and ABR >3 on weight-based prophylaxis received a standardized approach to individualized prophylaxis. Changes in ABR, annualized FVIII consumption and adherence from the 12-month prestudy and 12-month intervention period were compared. Changes in Haemo-QoL-A total score, Physical Functioning (PF) subscale and physical activity level measured by accelerometry were also examined. Eighteen patients participated (median age 26 years). Individualized prophylaxis decreased total bleeds in the population by 69% and traumatic bleeds by 73%. The median ABR decreased from 7.5 to 2 (P<.001). Annualized factor consumption increased by 7.3%, as a result of 66% reduction in factor utilization for treatment of bleeds and 25% increase in factor utilization for prophylaxis. Adherence scores for frequency and dosing did not change. There was a significant increase in the Haemo-QoL-A total score (P=.02) and PF score (P=.01) from baseline to 4 months but no change in physical activity. Patients with SHA who switched from standard to individualized prophylaxis show reduced ABR and increased FVIII consumption, and also improved their health-related quality of life. The mechanism is independent of adherence to prescribed prophylactic regimen. © 2017 John Wiley & Sons Ltd.

  4. Work participation in Q-fever patients and patients with Legionnaires' disease: a 12-month cohort study.

    PubMed

    Van Loenhout, Joris A F; Hautvast, Jeannine L A; Akkermans, Reinier P; Donders, Nathalie C G M; Vercoulen, Jan H; Paget, W John; van der Velden, Koos

    2015-05-01

    The aim of the study was to assess long-term work participation of Q-fever patients and patients with Legionnaires' disease, and to identify which factors are associated with a reduced work participation in Q-fever patients. Q-fever patients participated at four time points until 12 months after onset of illness, patients with Legionnaires' disease only at 12 months. Data were self-reported using questionnaires on the amount of hours that patients worked, and on socio-demographic, medical, psychosocial and lifestyle aspects. Our study included 336 Q-fever patients and 190 patients with Legionnaires' disease. There was a decrease in the proportion of Q-fever patients with reduced work participation over time, from 45% at 3 months to 19% at 12 months (versus 15% of patients with Legionnaires' disease at 12 months). Factors associated with reduced work participation of Q-fever patients in a multivariate model were having symptoms, a higher level of sorrow, being a former smoker (compared to never smoking), not consuming any alcohol and following additional treatment for the long-term health effects of Q-fever. Despite an increase in work participation of Q-fever patients over time, almost one in five Q-fever patients and one in six patients with Legionnaires' disease still suffer from reduced work participation at 12 months. Occupational and insurance physicians need to be aware of the long-term impact of these diseases on work participation. © 2015 the Nordic Societies of Public Health.

  5. High Incidence of Vertebral Fractures in Children with Acute Lymphoblastic Leukemia 12 Months After the Initiation of Therapy

    PubMed Central

    Alos, Nathalie; Grant, Ronald; Ramsay, Timothy; Halton, Jacqueline; Cummings, Elizabeth A.; Miettunen, Paivi M.; Abish, Sharon; Atkinson, Stephanie; Barr, Ronald; Cabral, David A.; Cairney, Elizabeth; Couch, Robert; Dix, David B.; Fernandez, Conrad V.; Hay, John; Israels, Sara; Laverdière, Caroline; Lentle, Brian; Lewis, Victor; Matzinger, MaryAnn; Rodd, Celia; Shenouda, Nazih; Stein, Robert; Stephure, David; Taback, Shayne; Wilson, Beverly; Williams, Kathryn; Rauch, Frank; Siminoski, Kerry; Ward, Leanne M.

    2014-01-01

    Purpose Vertebral fractures due to osteoporosis are a potential complication of childhood acute lymphoblastic leukemia (ALL). To date, the incidence of vertebral fractures during ALL treatment has not been reported. Patient and Methods We prospectively evaluated 155 children with ALL during the first 12 months of leukemia therapy. Lateral thoracolumbar spine radiographs were obtained at baseline and 12 months. Vertebral bodies were assessed for incident vertebral fractures using the Genant semi-quantitative method, and relevant clinical indices such as spine bone mineral density (BMD), back pain and the presence of vertebral fractures at baseline were analyzed for association with incident vertebral fractures. Results Of the 155 children, 25 (16%, 95% Confidence Interval (CI) 11% to 23%) had a total of 61 incident vertebral fractures, of which 32 (52%) were moderate or severe. Thirteen of the 25 children with incident vertebral fractures (52%) also had fractures at baseline. Vertebral fractures at baseline increased the odds of an incident fracture at 12 months by an odds ratio of 7.3 (95% CI 2.3 to 23.1, p = 0.001). In addition, for every one standard deviation reduction in spine BMD Z-score at baseline, there was 1.8-fold increased odds of incident vertebral fracture at 12 months (95% CI 1.2 to 2.7, p = 0.006). Conclusion Children with ALL have a high incidence of vertebral fractures after 12 months of chemotherapy, and the presence of vertebral fractures and reductions in spine BMD Z-scores at baseline are highly associated clinical features. PMID:22734031

  6. 12-month Healing Rates after Endodontic Therapy Using the Novel GentleWave System: A Prospective Multicenter Clinical Study.

    PubMed

    Sigurdsson, Asgeir; Garland, Randy W; Le, Khang T; Woo, Stacey M

    2016-07-01

    This multicenter, prospective, nonsignificant risk clinical study evaluated healing rates for molars 12 months after endodontic therapy using the GentleWave System (Sonendo, Inc, Laguna Hills, CA). Eighty-nine patients needing endodontic therapy who met the inclusion criteria consented for this clinical study. All enrolled patients were treated with a standardized protocol consisting of conservative access, shaping of canals to #20/.07, GentleWave treatment, and warm vertical obturation. Six endodontists performed the clinical procedures and follow-up evaluations. Preoperative, intraoperative, and postoperative data were collected from the consented patients. Each patient was evaluated for clinical signs and symptoms. Two trained, blinded, and independent evaluators scored the subject's radiographs for signs of apical periodontitis using a periapical index. The teeth classified as healing or healed were considered as a success and accounted for the cumulative success rate of healing. Statistical analysis was performed by using the Fisher exact test, Pearson correlation, and multivariate logistic regression analyses of the preoperative prognostic factors at P = .05. Seventy-five teeth in 75 patients were evaluated at 12 months with a follow-up rate of 84.3%. The cumulative success of endodontic therapy was 97.3%. The success rates of necrotic and irreversible pulpitis were 92.9% and 98.4%, respectively; 3.8% of the patients experienced moderate postoperative pain within 2 days and no incidence of pain at 14 days, 6 months, and 12 months of initial therapy. Ten prognostic factors were identified using bivariate analyses. Using logistic analyses, the prognostic significant variable that was directly correlated to healing was the preoperative presence of lesions (P = .026). In this 12-month prospective multicenter clinical study, the GentleWave System showed a high level of success after a 12-month follow-up. Copyright © 2016 American Association of Endodontists

  7. Post-traumatic stress symptoms in mothers of children with leukaemia undergoing the first 12 months of therapy: predictive models.

    PubMed

    Tremolada, Marta; Bonichini, Sabrina; Schiavo, Simone; Pillon, Marta

    2012-01-01

    The aim of this study consists in the measurement of psychological health and adaptation in mothers of children during the first 12 months of treatment for leukaemia and in the identification of possible early predictors. Ninety-four mothers were followed longitudinally at one week (T1), one month (T2), six months (T3) and 12 months (T4) post-diagnosis. The instruments used were: PTSD symptom checklist, BSI-18, Problem Scale, Ladder of life and an in-depth interview (EFI-C). Couple connectedness, family routine reorganisation, parental communication around the child's illness and trust in the medical care significantly increased from T1 to T4. Two models are proposed concerning possible predictors of mothers' PTSS at T2 and at T3. Clinical suggestions are proposed on the basis of our empirical findings in order to plan informative, clinical and practical interventions for mothers of children under treatment for leukaemia.

  8. Clinical Outcome Following Radiofrequency Denervation for Refractory Sacroiliac Joint Dysfunction Using the Simplicity III Probe: A 12-Month Retrospective Evaluation.

    PubMed

    Hegarty, Dominic

    2016-01-01

    Sacroiliac joint syndrome (SIJ) is diagnosed in 10% to 25% of cases of lower back pain. The response to traditional radiofrequency (RF) denervation of the SIJ has being inconsistent. The Simplicity III RF probe (Neruotherm. Inc.) offers a novel treatment option. To evaluate the long-term clinical outcome (12 months) refractory SIJ syndrome in terms of pain intensity and functional improvement. A 50% reduction in intensity pain intensity (VAS) at 12 months was deemed clinically significant. A 12-month retrospective observational evaluation all of adults treated with RF for refractory SIJ. Chronic pain management center. The medical records of all adults treated with this technique was retrospectively reviewed. The primary outcome was pain intensity scores (VAS) over a 12 months period; Secondary outcomes included Roland-Morris Functional scores (RMF), Brief Pain Inventory (BPI), general health assessment (Sf12), and patient satisfaction scores (GPI), which were recorded pre and post denervation. Pain Intensity improved by 4.7 points compared to pre-treatment representing a 61% reduction in pain at 12 months (n=11, P < 0.001). Significant improvements in (a) RMF (P < 0.01, W2 = 0.63 (large effect size); (b) BPI (P < 0.001, W2 = 0.72 (strong effect size); and (c) Sf12 (P < 0.01) were noted. Overall patients were satisfied with the outcome (GPI = 77.7%). The retrospective in nature of the study and the small sample size are limitations. As it was our policy to monitor the progress of the individuals since the introduction of this technique a reliable method of recording the baseline and outcome variables at each point of contact was in place. Access to a complete set of variables in all individuals over a 12-month period was therefore possible, which we feel contributes to the quality of the dataset. By creating a consistent radiofrequency lesion between the sacral foramen and the SIJ will reliably capture the innervation to the SIJ with significant long-term clinical

  9. Comparison of the post-meal glucose response to different insulin bolus waveforms in insulin pump- and pre-meal pramlintide-treated type 1 diabetes patients.

    PubMed

    King, Allen B

    2010-02-01

    Both pramlintide and insulin pump waveforms separately provide improved post-meal glucose control. However, when used together there may be a mismatch in actions leading to hypoglycemia. We studied the three currently available waveforms and a "modified combination wave" (MC) in pramlintide-treated patients. The MC was a "square" (SQ) wave combined with a "standard" (ST) bolus that was delayed 1 h into the mealtime. Using the CGMS Gold (Medtronics, Northridge, CA) we measured the glucose response 0-4 h after the beginning of a meal and 15 min after the initiation of the insulin bolus wave and pramlintide (60 microg), bolus. Pump-treated type 1 diabetes subjects were randomized to one bolus waveform for one full day of three meals and then crossed over to the other bolus waveforms. In the first study nine subjects were randomized to the ST, SQ, or "combination" (C) wave consisting of a ST wave at the beginning of a SQ wave. In the second study nine subjects were randomized to SQ or MC. With ST and C waves glucose fell approximately 40 mg/dL 0-2 h post-meal and then returned to baseline by the fourth hour. Initially isoglycemic, the SQ wave increased approximately 20 mg/dL in the late meal period. The MC demonstrated minimal (approximately 10 mg/dL) change during the entire post-meal period. For currently available insulin pump bolus waves, SQ and MC may be least likely to cause hypoglycemia in pramlintide-treated patients.

  10. Patient-reported outcomes 3 months after spine surgery: is it an accurate predictor of 12-month outcome in real-world registry platforms?

    PubMed

    Parker, Scott L; Asher, Anthony L; Godil, Saniya S; Devin, Clinton J; McGirt, Matthew J

    2015-12-01

    .5% of patients who did not meet the MCID threshold at 3 months continued to improve and ultimately surpassed the MCID threshold at 12 months. For ODI, achieving MCID at 3 months accurately predicted 12-month MCID with only 62.6% specificity and 86.8% sensitivity. For postoperative health utility (EQ-5D), 8.5% of patients lost an MCID threshold improvement from 3 months to 12 months, while 4.0% gained the MCID threshold between 3 and 12 months postoperatively. For EQ-5D (quality-adjusted life years), achieving MCID at 3 months accurately predicted 12-month MCID with only 87.7% specificity and 87.2% sensitivity. CONCLUSIONS In a prospective registry, patient-reported measures of treatment effectiveness obtained at 3 months correlated with 12-month measures overall in aggregate, but did not reliably predict 12-month outcome at the patient level. Many patients who do not benefit from surgery by 3 months do so by 12 months, and, conversely, many patients reporting meaningful improvement by 3 months report loss of benefit at 12 months. Prospective longitudinal spine outcomes registries need to span at least 12 months to identify effective versus noneffective patient care.

  11. Chemo-mechanical caries removal with Papacarie™: case series with 84 reports and 12 months of follow-up.

    PubMed

    Bussadori, Sandra Kalil; Godoy, Camila Haddad Leal de; Alfaya, Thays Almeida; Fernandes, Kristianne Porta Santos; Mesquita-Ferrari, Raquel Agnelli; Motta, Lara Jansiski

    2014-03-01

    The aim of the present study was to determine the success rate after 12 months of follow-up in a series of cases in which chemo-mechanical caries removal (CMCR) was performed with Papacarie(TM), followed by restoration with glass ionomer cement. The development of conservative techniques for carious tissue removal and improvements in dental restoration materials have allowed better preservation of dental structures in the treatment of decayed teeth. Chemo-mechanical caries removal (CMCR) is a conservative atraumatic treatment option. Papacarie(TM) is a papain-based material developed to act only on the carious dentin, allowing its easy removal with a blunt curette. The study involved a total of 84 deciduous posterior teeth with occlusal dentinal caries. Only teeth without risk of pulp exposure were studied. After a period of 12 months, the restorations were evaluated based on criteria employed in previous studies. The radiographic evaluation revealed resorption and calcification of the affected teeth. The data were submitted to descriptive statistical analysis with the aid of the XLSTAT program. The success rate was 88.1% and 98.8% based on the clinical and radiographic evaluations, respectively. The difference between the success and failure rates was statistically significant (p < 0.0001). Papacarie(TM) is an effective product for CMCR on occlusal dentinal tissue in deciduous teeth, demonstrating a high clinical and radiographic success rate after 12 months of follow-up.

  12. Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC.

    PubMed

    Sekulic, Aleksandar; Migden, Michael R; Lewis, Karl; Hainsworth, John D; Solomon, James A; Yoo, Simon; Arron, Sarah T; Friedlander, Philip A; Marmur, Ellen; Rudin, Charles M; Chang, Anne Lynn S; Dirix, Luc; Hou, Jeannie; Yue, Huibin; Hauschild, Axel

    2015-06-01

    Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. An efficacy and safety analysis was conducted 12 months after primary analysis. This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  13. Extracorporeal shock wave lithotripsy in infants less than 12-month old.

    PubMed

    Turna, Burak; Tekin, Ali; Yağmur, İsmail; Nazlı, Oktay

    2016-10-01

    There is a lack of literature on children compared to adults regarding the long-term effects of extracorporeal shock wave lithotripsy (SWL), specifically in infants. The aim of the present study was to analyze the efficacy and safety of SWL in infants and also evaluate its potential adverse effects in the mid-term. Between May 1999 and December 2013, 36 infants with 39 renal units underwent SWL treatment for kidney stones with an electrohydraulic lithotripter (Dornier MPL 9000/ELMED Multimed Classic). All children were less than 12-month old. The mid-term effects of SWL were examined at the last follow-up by measuring arterial blood pressure, random blood glucose level and ipsilateral kidney size. Evaluation of treatment and its consequences was based on clinical examination, blood tests and conventional imaging (plain abdominal radiography and ultrasound). Overall stone-free rate was 84.6 % after 3-month follow-up without any major complications. Mid-term follow-up was available in 20 of 36 children with a mean follow-up of 3.2 ± 2.8 years (range 0.5-15.3). None of the infants were found to develop new onset of hypertension or diabetes. All treated infant kidneys' sizes were in the normal percentile range. SWL for management of infant kidney stones is effective and safe in the mid-term.

  14. The Acupuncture on Hot Flashes Among Menopausal Women study: observational follow-up results at 6 and 12 months.

    PubMed

    Borud, Einar Kristian; Alraek, Terje; White, Adrian; Grimsgaard, Sameline

    2010-03-01

    The previously published Acupuncture on Hot Flashes Among Menopausal Women study compared the effectiveness of individualized acupuncture treatment plus self-care versus self-care alone on hot flashes and health-related quality of life in postmenopausal women. This article reports on the observational follow-up results at 6 and 12 months. The Acupuncture on Hot Flashes Among Menopausal Women study was a pragmatic, multicenter randomized controlled trial with two parallel arms, conducted in 2006 to 2007. The 267 participants were postmenopausal women experiencing, on average, 12.6 hot flashes per 24 h. The acupuncture group received 10 individualized acupuncture treatments during 12 weeks and advice on self-care, whereas the control group received only advice on self-care. Hot flash frequency and intensity (0-10 scale) and hours of sleep per night were registered in a diary. Health-related quality of life was assessed by the Women's Health Questionnaire. From baseline to 6 months, the mean reduction in hot flash frequency per 24 hours was 5.3 in the acupuncture group and 5.0 in the control group, a nonsignificant difference of 0.3. At 12 months, the mean reduction in hot flash frequency was 6.0 in the acupuncture group and 5.8 in the control group, a nonsignificant difference of 0.2. Differences in quality-of-life scores were not statistically significant at 6 and 12 months. The statistically significant differences between the study groups found at 12 weeks were no longer present at 6 and 12 months. Acupuncture can contribute to a more rapid reduction in vasomotor symptoms and increase in health-related quality of life in postmenopausal women but probably has no long-term effects.

  15. Impact of thrombolysis on stroke outcome at 12 months in a population: the Bern stroke project.

    PubMed

    Fischer, Urs; Mono, Marie-Luise; Zwahlen, Marcel; Nedeltchev, Krassen; Arnold, Marcel; Galimanis, Aekatarini; Bucher, Sabine; Findling, Oliver; Meier, Niklaus; Brekenfeld, Caspar; Gralla, Jan; Heller, Regula; Tschannen, Beatrice; Schaad, Heinz; Waldegg, Gabriel; Zehnder, Thomas; Ronsdorf, Anke; Oswald, Phillip; Brunner, Georg; Schroth, Gerhard; Mattle, Heinrich P

    2012-04-01

    Thrombolysis improves outcome of patients with acute ischemic stroke, but it is unknown whether thrombolysis has a measurable effect on long-term outcome in a defined population. We prospectively assessed demographic data, management, and outcome of acute ischemic stroke patients admitted within 48 hours to 18 primary care hospitals of the canton of Bern (969 299 inhabitants) during 12 months. Blinded follow-up was obtained at 3 and 12 months. Predictors of mortality and favorable outcome (modified Rankin Scale score ≤2) at 3 and 12 months using logistic regression were analyzed. From December 2007 to December 2008, 807 patients (mean age, 72 years) were included. Median National Institutes of Health Stroke Scale score on admission was 5; 107 patients (13%) received intravenous, intra-arterial, or mechanical thrombolysis. Estimated cumulative mortality at 3 months was 20.6% and at 12 months 27.4%. Age 75 years or older, higher National Institutes of Health Stroke Scale scores, and higher Charlson comorbidity index were independent predictors of mortality at 3 and 12 months. Estimated favorable outcome at 3 months was 48.2% and at 12 months was 44.6%. Thrombolysis was the only modifiable independent predictor of favorable outcome at 3 (relative risk, 1.49; 95% CI, 1.18-1.89) and 12 months (relative risk, 1.59; 95% CI, 1.24-2.04), whereas age younger than 75 years, male gender, National Institutes of Health Stroke Scale score <4, and lower Charlson comorbidity index were nonmodifiable predictors. Thirteen percent of acute ischemic stroke patients admitted within 48 hours to Bernese hospitals underwent thrombolysis, which exerted a measurable effect on 3-month outcome in this population. This effect was sustained at 12 months. Age, stroke severity, Charlson comorbidity index, and male gender were independent nonmodifiable predictors of outcome.

  16. A 12-month exercise intervention decreased stress symptoms and increased mental resources among working adults - Results perceived after a 12-month follow-up.

    PubMed

    Kettunen, Oili; Vuorimaa, Timo; Vasankari, Tommi

    2015-01-01

    This study evaluated the effect of a 12-month physical exercise intervention accompanied by a 12-month followup evaluating stress symptoms (SS), mental resources (MR) and cardiorespiratory fitness (CRF) in healthy, working adults. We hypothesized that the stress symptoms would decrease and mental resources would increase during the intervention and that these results are associated with changes in CRF. The study group included healthy adults (N = 371). Three hundred thirty eight participants (212 women, 126 men) were allocated in the exercise group and 33 in the control group (17 women and 16 men). For the analysis, the exercise group was divided into subgroups according to the baseline SS and MR. Stress symptoms and MR were measured using the Occupational Stress Questionnaire. During the 12-month exercise intervention, SS decreased by 16% (p < 0.0001), MR increased by 8% (p < 0.0001) and CRF increased by 7% (p < 0.0001) in the exercise group, while no changes occurred in the control group (ANCOVA, p < 0.01). In the exercise group, the results (SS, MR, and CRF) remained improved during the follow-up. There was a positive correlation between the change in SS and the change in CRF (r = 0.19, p < 0.01). In the subgroup having the highest SS at baseline, SS during the intervention decreased most (26%) (ANCOVA, p < 0.0001). One year physical exercise intervention improved mental well-being among working adults and this was associated with an improvement in cardiorespiratory fitness. The positive changes remained after the 12-month follow-up. This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.

  17. Continuous positive airway pressure in older people with obstructive sleep apnoea syndrome (PREDICT): a 12-month, multicentre, randomised trial.

    PubMed

    McMillan, Alison; Bratton, Daniel J; Faria, Rita; Laskawiec-Szkonter, Magda; Griffin, Susan; Davies, Robert J; Nunn, Andrew J; Stradling, John R; Riha, Renata L; Morrell, Mary J

    2014-10-01

    -years were similar between the groups (treatment effect 0·01 (95% CI -0·03 to 0·04; p=0·787) and health-care costs were marginally reduced with CPAP (-£35, -390 to 321; p=0·847). CPAP improved objective sleepiness (p=0·024), mobility (p=0·029), total cholesterol (p=0·048), and LDL cholesterol (p=0·042) at 3 months, but these were not sustained at 12 months. Measures of mood, functionality, nocturia, accidents, cognitive function, and cardiovascular events remained unchanged. Systolic blood pressure fell in the BSC group. 37 serious adverse events occurred in the CPAP group, and 22 in BSC group; all were independently classified as being unrelated to the trial and no significant harm was attributed to CPAP use. In older people with OSA syndrome, CPAP reduces sleepiness and is marginally more cost effective over 12 months than is BSC alone. On the basis of these results, we recommend that CPAP treatment should be offered routinely to older patients with OSA syndrome. National Institute of Health Research (NIHR) Health Technology Assessment, NIHR Respiratory Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College London. Copyright © 2014 McMillan et al. Open Access article distributed under the terms of CC BY. Published by .. All rights reserved.

  18. Kinematic Measurement of 12-week Head Control Correlates with 12-month Neurodevelopment in Preterm Infants

    PubMed Central

    Bentzley, Jessica P; Coker-Bolt, Patty; Moreau, Noelle; Hope, Kathryn; Ramakrishnan, Viswanathan; Brown, Truman; Mulvihill, Denise; Jenkins, Dorothea

    2015-01-01

    Background Although new interventions treating neonatal brain injury show great promise, our current ability to predict clinical functional outcomes is poor. Quantitative biomarkers of long-term neurodevelopmental outcome are critically needed to gauge treatment efficacy. Kinematic measures derived from commonly used developmental tasks may serve as early objective markers of future motor outcomes. Aim To develop reliable kinematic markers of head control at 12 weeks corrected gestational age (CGA) from two motor tasks: head lifting in prone and pull-to-sit Study design and subjects Prospective observational study of 22 preterm infants born between 24 and 34 weeks of gestation Outcome measures Bayley Scales of Infant Development III (Bayley) motor scores Results Intrarater and interrater reliability of prone head lift angles and pull-to-sit head angles were excellent. Prone head lift angles at 12 weeks CGA correlated with white matter NAA/Cho, concurrent Test of Infant Motor Performance (TIMP) scores, and 12-month Bayley motor scores. Head angles during pull-to-sit at 12-weeks CGA correlated with TIMP scores. Conclusions Poor ability to lift the head in prone and an inability to align the head with the trunk during the pull-to-sit task were associated with poorer future motor outcome scores. Kinematic measurements of head control in early infancy may serve as reliable objective quantitative markers of future motor impairment and neurodevelopmental outcome. PMID:25621433

  19. Lower cognitive functioning as a predictor of weight gain in bipolar disorder: a 12-month study.

    PubMed

    Bond, D J; Torres, I J; Lee, S S; Kozicky, J-M; Silveira, L E; Dhanoa, T; Lam, R W; Yatham, L N

    2017-03-01

    In cross-sectional studies, elevated body mass index (BMI) is associated with cognitive impairment in bipolar disorder (BD). We investigated the direction of this association by prospectively examining changes in BMI and cognition. We measured BMI and performance in six cognitive domains over 12 months in 80 adolescent and young adult BD patients and 46 healthy comparison subjects (HS). Ninety-three percent of patients received pharmacotherapy and 84% were euthymic. We used repeated-measures ancova and longitudinal mixed models to investigate whether (i) higher BMI and increasing BMI over time predicted lower subsequent cognitive functioning, and (ii) lower cognitive functioning and changes in cognition predicted increasing BMI. Neither baseline BMI nor BMI change predicted lower cognitive functioning. Lower baseline scores in attention, verbal memory, working memory, and a composite measure of global cognition predicted increasing BMI in patients and HS. In patients, lower cognitive functioning remained associated with increasing BMI when clinical and treatment variables were adjusted for. Improvement in working memory predicted a smaller subsequent BMI increase in patients. Lower cognitive functioning in specific domains predicts increasing BMI in patients with BD and healthy young adults. Targeting cognition may be important for minimizing weight gain in BD. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. A 12 month clinical study of bond failures of recycled versus new stainless steel orthodontic brackets.

    PubMed

    Cacciafesta, Vittorio; Sfondrini, Maria Francesca; Melsen, Birte; Scribante, Andrea

    2004-08-01

    The purpose of this prospective longitudinal randomized study was to compare the clinical performance of recycled brackets with that of new stainless steel brackets (Orthos). Twenty patients treated with fixed appliances were included in the investigation. Using a 'split-mouth' design, the dentition of each patient was divided into four quadrants. In 11 randomly selected patients, the maxillary left and mandibular right quadrants were bonded with recycled brackets, and the remaining quadrants with new stainless steel brackets. In the other nine patients the quadrants were inverted. Three hundred and ten stainless steel brackets were examined: 156 were recycled and the remaining 154 were new. All the brackets were bonded with a self-cured resin-modified glass ionomer (GC Fuji Ortho). The number, cause, and date of bracket failures were recorded over 12 months. Statistical analysis was performed by means of a paired t-test, Kaplan-Meier survival estimates, and the log-rank test. No statistically significant differences were found between: (a) the total bond failure rate of recycled and new stainless steel brackets; (b) the upper and lower arches; (c) the anterior and posterior segments. These findings demonstrate that recycling metallic orthodontic brackets can be of benefit to the profession, both economically and ecologically, as long as the orthodontist is aware of the various aspects of the recycling methods, and that patients are informed about the type of bracket that will be used for their treatment.

  1. Efficacy and safety of dienogest in patients with endometriosis: A single-center observational study over 12 months

    PubMed Central

    Park, So Yun; Chae, Hee Dong; Kim, Chung-Hoon; Kang, Byung Moon

    2016-01-01

    Objective To evaluate the efficacy and safety of dienogest treatment in patients who had received dienogest for 12 months or more to treat endometriosis. Methods We analyzed the clinical data of 188 women with endometriosis who had been treated with 2 mg of dienogest once a day for 12 months or more at a single institute. We evaluated changes in endometriosis-associated pain and endometrioma size, recurrence rate, and adverse events following dienogest administration. Bone mineral density (BMD) was measured in patients who were prescribed dienogest for more than 18 months. Results Pain was significantly reduced at 12 months after dienogest medication. In those treated with dienogest due to recurrent endometrioma, the size of the endometrioma was significantly decreased at the 12-month and 18-month follow-ups. We found only one case of sonographic recurrence during dienogest administration among those who were treated postoperatively to prevent recurrence (1 of 114, 0.9%). The most common adverse drug reaction was uterine bleeding (3.2%), and other adverse events were generally tolerable and associated with low discontinuation rates (5.2%). Among the 50 patients in whom BMD was measured, 10 patients (20%) had a Z-score below the expected range for age. Conclusion The administration of dienogest for a year or more seems to be highly effective in preventing recurrence after surgery, reducing endometriosis-associated pain, and decreasing the size of recurrent endometrioma, with a favorable safety and tolerability profile. However, BMD should be checked in patients on long-term medication due to possible bone loss in some women. PMID:28090460

  2. Clinical evaluation of fiber-reinforced composite crowns in pulp-treated primary molars: 12-month results

    PubMed Central

    Mohammadzadeh, Zahra; Parisay, Iman; Mehrabkhani, Maryam; Madani, Azam Sadat; Mazhari, Fatemeh

    2016-01-01

    Objective: The aim of this study was to evaluate the clinical performance of tooth-colored fiber-reinforced composite (FRC) crowns in pulp-treated second primary mandibular teeth. Materials and Methods: This split-mouth randomized, clinical trial performed on 67 children between 3 and 6 years with two primary mandibular second molars requiring pulp treatment. After pulp therapy, the teeth were randomly assigned to stainless steel crown (SSC) or FRC crown groups. Modified United States Public Health Service criteria were used to evaluate marginal integrity, marginal discoloration, and secondary caries in FRC crowns at intervals of 3, 6, and 12 months. Retention rate and gingival health were also compared between the two groups. The data were analyzed using Friedman, Cochran, and McNemar's tests at a significance level of 0.05. Results: Intact marginal integrity in FRC crowns at 3, 6, and 12 months were 93.2%, 94.8%, and 94.2%, respectively. Marginal discoloration and secondary caries were not found at any of the FRC crowns. The retention rates of the FRC crowns were 100%, 98.3%, and 89.7% at 3, 6 and 12 months, respectively, whereas all the SSCs were found to be present and intact after 12 months (P = 0.016). There was no statistically significant difference between the two groups in gingival health. Conclusion: According to the results of this study, it seems that when esthetics is a concern, in cooperative patients with good oral hygiene, FRC crowns can be considered as a valuable procedure. PMID:28042269

  3. Efficacy and safety of dienogest in patients with endometriosis: A single-center observational study over 12 months.

    PubMed

    Park, So Yun; Kim, Sung Hoon; Chae, Hee Dong; Kim, Chung-Hoon; Kang, Byung Moon

    2016-12-01

    To evaluate the efficacy and safety of dienogest treatment in patients who had received dienogest for 12 months or more to treat endometriosis. We analyzed the clinical data of 188 women with endometriosis who had been treated with 2 mg of dienogest once a day for 12 months or more at a single institute. We evaluated changes in endometriosis-associated pain and endometrioma size, recurrence rate, and adverse events following dienogest administration. Bone mineral density (BMD) was measured in patients who were prescribed dienogest for more than 18 months. Pain was significantly reduced at 12 months after dienogest medication. In those treated with dienogest due to recurrent endometrioma, the size of the endometrioma was significantly decreased at the 12-month and 18-month follow-ups. We found only one case of sonographic recurrence during dienogest administration among those who were treated postoperatively to prevent recurrence (1 of 114, 0.9%). The most common adverse drug reaction was uterine bleeding (3.2%), and other adverse events were generally tolerable and associated with low discontinuation rates (5.2%). Among the 50 patients in whom BMD was measured, 10 patients (20%) had a Z-score below the expected range for age. The administration of dienogest for a year or more seems to be highly effective in preventing recurrence after surgery, reducing endometriosis-associated pain, and decreasing the size of recurrent endometrioma, with a favorable safety and tolerability profile. However, BMD should be checked in patients on long-term medication due to possible bone loss in some women.

  4. Incident Vertebral Fractures among Children with Rheumatic Disorders 12 Months Post-Glucocorticoid Initiation: a National Observational Study

    PubMed Central

    Rodd, Celia; Lang, Bianca; Ramsay, Timothy; Alos, Nathalie; Huber, Adam M.; Cabral, David A.; Scuccimarri, Rosie; Miettunen, Paivi M.; Roth, Johannes; Atkinson, Stephanie A.; Couch, Robert; Cummings, Elizabeth A.; Dent, Peter B.; Ellsworth, Janet; Hay, John; Houghton, Kristin; Jurencak, Roman; Larché, Maggie; LeBlanc, Claire; Oen, Kiem; Saint-Cyr, Claire; Stein, Robert; Stephure, David; Taback, Shayne; Lentle, Brian; Matzinger, MaryAnn; Shenouda, Nazih; Moher, David; Rauch, Frank; Siminoski, Kerry; Ward, Leanne M.

    2014-01-01

    Objectives To determine the frequency of incident vertebral fractures (IVF) 12 months after glucocorticoid (GC) initiation in children with rheumatic diseases and to identify children at higher risk. Methods Children with rheumatic diseases initiating GC were enrolled in a prospective observational study. Annual spine radiographs were evaluated using the Genant semi-quantitative method. Spine areal bone mineral density (aBMD) was measured every 6 months. Clinical features, including cumulative GC dose, back pain, disease and physical activity, calcium and vitamin D intake, and spine aBMD Z-scores were analyzed for association with IVF. Results Seven (6%) of 118 children (95% Confidence Interval 2.9 to 11.7) had IVF. Their diagnoses were: juvenile dermatomyositis (n = 2), systemic lupus erythematosus (n = 3), systemic vasculitis (n = 1) and mixed connective tissue disease (n = 1). One child was omitted from the analyses after 4 months because of osteoporosis treatment for symptomatic IVF. Children with IVF received on average 50% more GC than those without (p=0.030), had a greater increase in body mass index (BMI) at 6 months (p=0.010), and had greater decrements in spine aBMD Z-scores in the first 6 months (p=0.048). Four (67%) of 6 children with IVF and data to 12 months had spine aBMD Z-scores less than −2.0 at 12 months compared to 16% of children without IVF (p=0.011). Conclusions The incidence of VF 12 months following GC initiation was 6%; most children were asymptomatic. Children with IVF received more GC, had greater increases in BMI and greater declines in spine aBMD Z-scores in the first 6 months. PMID:22213727

  5. Disturbed intracortical excitability in early Parkinson's disease is l-DOPA dose related: a prospective 12-month paired TMS study.

    PubMed

    Bares, Martin; Kanovský, Petr; Rektor, Ivan

    2007-12-01

    We were interested to know if chronic l-DOPA treatment in Parkinson's disease (PD) patients could restore impairment of the intracortical excitability, when this difference could occur, and if it was related to the total daily dose of l-DOPA. Twelve patients with early PD were studied using paired transcranial magnetic stimulation before the administration of l-DOPA, and then after 3, 6, and 12 months of l-DOPA treatment. The level of disturbed intracortical excitability strongly correlated with the total daily dose of l-DOPA. The level of cortical excitability in PD patients seems to be indirectly related to the nigro-striatal functioning.

  6. [Early prediction of the neurological result at 12 months in newborns at neurological risk].

    PubMed

    Herbón, F; Garibotti, G; Moguilevsky, J

    2015-08-01

    The aim of this study was to evaluate the Amiel-Tison neurological examination (AT) and cranial ultrasound at term for predicting the neurological result at 12 months in newborns with neurological risk. The study included 89 newborns with high risk of neurological damage, who were discharged from the Neonatal Intensive Care of the Hospital Zonal Bariloche, Argentina. The assessment consisted of a neurological examination and cranial ultrasound at term, and neurological examination and evaluation of development at 12 months. The sensitivity, specificity, positive and negative predictor value was calculated. The relationship between perinatal factors and neurodevelopment at 12 month of age was also calculated using logistic regression models. Seventy children completed the follow-up. At 12 months of age, 14% had an abnormal neurological examination, and 17% abnormal development. The neurological examination and the cranial ultrasound at term had low sensitivity to predict abnormal neurodevelopment. At 12 months, 93% of newborns with normal AT showed normal neurological results, and 86% normal development. Among newborns with normal cranial ultrasound the percentages were 90 and 81%, respectively. Among children with three or more perinatal risk factors, the frequency of abnormalities in the neurological response was 5.4 times higher than among those with fewer risk factors, and abnormal development was 3.5 times more frequent. The neurological examination and cranial ultrasound at term had low sensitivity but high negative predictive value for the neurodevelopment at 12 months. Three or more perinatal risk factors were associated with neurodevelopment abnormalities at 12 months of age. Copyright © 2014 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.

  7. Postpartum Varicose Veins: Supplementation with Pycnogenol or Elastic Compression-A 12-Month Follow-Up.

    PubMed

    Belcaro, Gianni; Dugall, Mark; Luzzi, Roberta; Ippolito, Edmondo; Cesarone, M Rosaria

    2017-03-01

    This open registry aimed to evaluate the clinical evolution of postpartum varicose veins (VVs), in healthy women after the second pregnancy, how these veins regain shape and competence, and possible treatments. The registry included two groups of women: (1) those who used elastic compression stockings, and (2) who used an oral venotonic agent (Pycnogenol, 100 mg/d). A total of 12 evaluation targets were established. Minor symptoms were scored in an analogue scale line. A visual analogue scale line evaluated the overall satisfaction relative to elastic compression or Pycnogenol. Overall 133 women completed the registry evaluation with at least 3 months of follow-up. The resulting two registry groups were comparable. At 3 and 6 months in the Pycnogenol group the number of veins and incompetent sites were lower. At 6 months there were 13.3% of patients with edema in controls versus 3.2% in the Pycnogenol group. Spider veins decreased in Pycnogenol patients. Cramps and other minor symptoms were less common in the Pycnogenol group. In both groups there was a significant improvement at 6 months with better results in the Pycnogenol group. The need for treatment was limited with a decreased need for sclerotherapy, surgery, and conservative treatments in the Pycnogenol group. The overall satisfaction was higher among Pycnogenol patients, and compliance was optimal. Re-evaluation at 12 months indicated that the variations in VVs and spider vein clusters and the associated symptoms did not change. Most remodeling appeared to happen within 6 months after the pregnancy. It was concluded that the use of Pycnogenol improves signs/symptoms of postpartum VVs, and venous function and shape seem to return faster to prepartum, physiological pattern with its use.

  8. Eccentric decline squat protocol offers superior results at 12 months compared with traditional eccentric protocol for patellar tendinopathy in volleyball players

    PubMed Central

    Young, M; Cook, J; Purdam, C; Kiss, Z; Alfredson, H

    2005-01-01

    Background: Conservative treatment of patellar tendinopathy has been minimally investigated. Effective validated treatment protocols are required. Methods: This was a prospective randomised controlled trial of 17 elite volleyball players with clinically diagnosed and imaging confirmed patellar tendinopathy. Participants were randomly assigned to one of two treatment groups: a decline group and a step group. The decline group were required to perform single leg squats on a 25° decline board, exercising into tendon pain and progressing their exercises with load. The step group performed single leg squats on a 10 cm step, exercising without tendon pain and progressing their exercises with speed then load. All participants completed a 12 week intervention programme during their preseason. Outcome measures used were the Victorian Institute of Sport Assessment (VISA) score for knee function and 100 mm visual analogue scale (VAS) for tendon pain with activity. Measures were taken throughout the intervention period and at 12 months. Results: Both groups had improved significantly from baseline at 12 weeks and 12 months. Analysis of the likelihood of a 20 point improvement in VISA score at 12 months revealed a greater likelihood of clinical improvements in the decline group than the step group. VAS scores at 12 months did not differ between the groups. Conclusions: Both exercise protocols improved pain and sporting function in volleyball players over 12 months. This study indicates that the decline squat protocol offers greater clinical gains during a rehabilitation programme for patellar tendinopathy in athletes who continue to train and play with pain. PMID:15665207

  9. Depression after stroke at 12-month follow-up: a multicenter study.

    PubMed

    Limampai, Patchara; Wongsrithep, Wanpen; Kuptniratsaikul, Vilai

    2017-10-01

    To study the prevalence of depression at 12 months after stroke and to analyze factors associated with depression. This prospective cross-sectional study was conducted among nine tertiary hospitals in Thailand. Stroke patients from the Thai Stroke Rehabilitation Registry who were admitted in inpatient rehabilitation wards were recruited for evaluation at the 12-month follow-up time point. Hospital Anxiety and Depression Scale (HADS) was used to evaluate depression in stroke. A score of ≥11 was considered as having depression. Univariate and multivariate analysis was used to investigate factors related with depression in stroke. Two hundred stroke patients with a mean age of 62.1±12.5 years were recruited. Approximately 60% were male. The number of stroke patients with depression at the 12-month follow-up was 42 (21.0%, 95%CI 15.9%-27.2%). Mean HADS score at 12-month follow-up was not significantly different from those at discharge. However, 28 (16.5%) stroke patients who did not have depression at discharge developed depression during the 12-month period. From multivariate analysis, complications and urinary incontinence were found to be significantly associated with depression after stroke with adjusted odds ratio of 3.65 (95%CI 1.11-12.06) and 4.82 (95%CI 1.74-13.38), respectively. Depression is a common complication after stroke. This study found one-fifth of stroke survivors developed depression at the 12-month follow-up. Complications at discharge and urinary incontinence were significantly correlated with depression in multivariate analysis. Further study concerning interventions in decreasing depression should be performed in order to improve the quality of life of those stroke patients.

  10. Quality of life in women who use pessaries for longer than 12 months.

    PubMed

    Tenfelde, Sandi; Tell, Dina; Thomas, Tonya Nicole; Kenton, Kimberly

    2015-01-01

    Pessaries are an effective treatment for pelvic organ prolapse and urinary incontinence; however, few data exist describing long-term pessary use. Our aim was to describe symptom bother and quality of life (QoL) in women using pessaries for urinary incontinence and/or prolapse for at least 12 months. Consecutive women who met inclusion criteria were approached for this observational cross-sectional study. Wilson and Cleary's Health-Related Quality of Life Model guided the inclusion of biologic, functional, and individual factors that impact the health-related QoL. Consenting participants completed a generalized QoL index, the Center for Epidemiologic Depression Symptoms, Medical Outcomes Study Social Support Survey, and condition-specific measures; the Pelvic Floor Distress Inventory (PFDI-20-SF) and the Pelvic Floor Impact Questionnaire. Fifty-six women, mean age 74.4 years (range, 47-89 years), completed the survey. Mean length of time for pessary use was 4.5 years (1-15 years). Most of the women (n = 31, 55.4%) returned to the clinic for pessary care every 3 months. There was no difference in generalized QoL nor condition-specific total PFDI-20 in women performing self-care versus routine follow-up. Almost one third (29%) of participants reported complications related to pessary use (eg, vaginal erosion), and 41%were considering surgical repair in the near future. Women who were considering surgery had higher PFDI-20 scores relating to more bothersome prolapse symptoms than those not considering surgery (Pelvic Organ Prolapse Distress Inventory 6, 33.91 vs 24.73, P = 0.03). Pessaries can be used to control pelvic floor symptoms for extended periods. Complication rates in this study were lower than previously reported, even in women not doing self-care. Not surprisingly, women considering surgical intervention reported greater symptom bother despite pessary use.

  11. Spontaneous Course of Biliary Sludge Over 12 Months in Dogs with Ultrasonographically Identified Biliary Sludge.

    PubMed

    DeMonaco, S M; Grant, D C; Larson, M M; Panciera, D L; Leib, M S

    2016-05-01

    Biliary sludge is associated with gallbladder (GB) dysmotility and mucus hypersecretion suggesting a link between biliary sludge and the formation of GB mucoceles (GBM). If biliary sludge progresses to GBM, treatment to reduce the production and progression of sludge is warranted. The objective of this study was to determine the course of biliary sludge in dogs. Seventy-seven healthy, client-owned dogs ≥4 years of age screened for biliary sludge; 45 affected dogs identified. Prospective, observational design. Serial ultrasound examinations were evaluated at 3, 6, 9, and 12 months to monitor degree of sludge based on proportion of GB filled with sludge (mild [0.01-24.4%], moderate [24.5-49.4%], moderate to severe [49.5-74.4%], severe [74.5-100%]), gravity dependency of sludge, and GB dimensions. After 1 year of follow-up, the degree of sludge was mild (34%), moderate (47%), moderate to severe (13%), severe (3%), or absent (3%). There was no significant difference in median degree of sludge over 1 year (P = .36). There were no significant changes in the gravity dependency of sludge over 1 year. A subset of dogs, 24%, with initial gravity-dependent sludge developed a combination of nondependent and dependent sludge. Dogs had resolved (2%), decreased (19%), static (40%), increased (29%), or recurrent (10%) sludge at the conclusion of the study. Biliary sludge was prevalent, affected dogs remained asymptomatic, and it rarely resolves in healthy dogs over a period of 1 year. Some dogs developed nongravity-dependent sludge within 1 year, which might indicate changes in consistency of sludge. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  12. Reinforcement of suspensory ligaments under local anesthesia cures pelvic organ prolapse: 12-month results.

    PubMed

    Sekiguchi, Yuki; Kinjo, Manami; Maeda, Yoshiko; Kubota, Yoshinobu

    2014-06-01

    In 2005, a new minimally invasive procedure, the tissue fixation system (TFS) was reported. Like TVT (tension-free vaginal tape), the TFS works by creating a foreign body collagenous tissue reaction that reinforces a weakened pelvic ligament. The objective was to assess the effectiveness and perioperative safety of TFS in a day surgery clinic for the treatment of pelvic organ prolapse (POP). The TFS tape was applied in a tunnel adjacent to natural ligaments to repair the anterior cervical ring and cardinal ligament, paravaginal tissues and uterosacral ligaments under local anesthesia/sedation. We prospectively studied 60 patients, mean age 67, between October 2008 and February 2010 at Women's Clinic LUNA. Levels of POP were grade 2 (n = 20; 7 %), grade 3 (n = 30; 55 %), and grade 4 (n = 4; 7 %) according to the ICS POPQ classification. Fifty-four patients (90 %) who underwent a total of 162 POP operations presented for review. Follow-up was performed at 12 months. We defined surgical failure according to the ICS POPQ classification. We used prolapse quality of life (P-QOL) questions for QOL measurement. Ninety-eight percent of patients were discharged on the day of surgery. Of the 162 TFS operations reviewed, 157 were successful and 5 failed. The 5 failed operations comprised 4 cystoceles and 1 rectocele. Two patients developed cervical protrusions at the introitus at 6 months with no prolapse of the uterine body. We found 5 cases of erosion in 162 tape insertions. The total number of patients who had no complications, no surgical failures, no erosions, no sensation of bulging, and no cervical protrusions was 47 (87 %). The TFS uses the same surgical principle for repair as the TVT; this principle vastly minimizes the volume of mesh used, erosions, and other complications.

  13. Investigation of the infertile couple: a basic fertility work-up performed within 12 months of trying to conceive generates costs and complications for no particular benefit.

    PubMed

    van der Steeg, Jan W; Steures, Pieternel; Hompes, Peter G A; Eijkemans, Marinus J C; van der Veen, Fulco; Mol, Ben W J

    2005-10-01

    The current approach of the basic fertility work-up has been questioned recently in this journal. Based on new data on human fecundity, the authors advocated starting the fertility work-up after just 6 months of trying to conceive instead of the usual 12 months. In women younger than 39 years and with a regular cycle, there are several arguments why the basic fertility work-up should not be done earlier than after 12 months of child wish. Firstly, 50% of couples who have tried to conceive for 6 months without success will conceive in the next 6 months without any treatment. Secondly, the prevalence of fertility diseases is lower in couples who have been trying to conceive for 6 months as compared with those who have been trying for 12 months. Performance of a fertility work-up at this stage will lead to an increase in false-positive diagnoses compared with performing them at 12 months of subfertility. Thirdly, fertility treatment will have fewer additional effects in couples with good spontaneous conception prospects (6-12 months child wish), compared with subfertile couples who have poor prospects. At present, none of the available fertility treatments have success rates comparable with no intervention in these women, and postponement of treatment in such couples will prevent complications such as ovarian hyperstimulation syndrome and multiple pregnancies. We argue that the fertility work-up should not be offered to couples with a duration of child wish of <12 months, except for women with ovulation disorders and women of 39 years and older.

  14. Vowel Production in 7- to 12-Month-Old Infants with Hearing Loss

    ERIC Educational Resources Information Center

    Nelson, Rebecca; Yoshinaga-Itano, Christine; Rothpletz, Ann; Sedey, Allison

    2007-01-01

    The purpose of this study was to examine vowel production in 7- to 12-month-old infants with hearing loss. Fifty-four infants were divided into three groups according to degree of hearing loss (mild-to-moderate, moderately severe-to-severe, profound), and their vocalizations were phonetically transcribed from 30-minute videotaped samples. These…

  15. Case Study Analyses of Play Behaviors of 12-Month-Old Infants Later Diagnosed with Autism

    ERIC Educational Resources Information Center

    Mulligan, Shelley

    2015-01-01

    Case study research methodology was used to describe the play behaviors of three infants at 12 months of age, who were later diagnosed with an autism spectrum disorder. Data included standardized test scores, and analyses of video footage of semi-structured play sessions from infants identified as high risk for autism, because of having a sibling…

  16. The Flexibility of 12-Month-Olds' Preferences for Phonologically Appropriate Object Labels

    ERIC Educational Resources Information Center

    MacKenzie, Heather K.; Graham, Susan A.; Curtin, Suzanne; Archer, Stephanie L.

    2014-01-01

    We explored 12-month-olds' flexibility in accepting phonotactically illegal or ill-formed word forms in a modified associative-learning task. Sixty-four English-learning infants were presented with a training phase that either clarified the purpose of a sound--object association task or left the task ambiguous. Infants were then habituated to sets…

  17. Religious Involvement and DSM IV 12 Month and Lifetime Major Depressive Disorder among African Americans

    PubMed Central

    Taylor, Robert Joseph; Chatters, Linda M.; Abelson, Jamie M.

    2012-01-01

    This study explores relationships between lifetime and 12 month DSM-IV major depressive disorder and religious involvement within a nationally representative sample of African American adults (n=3,570). MDD was assessed using the DSM-IV World Mental Health Composite International Diagnostic Interview (WMH-CIDI). Multivariate findings indicate that reading religious materials was positively associated with 12 month (OR=1.14, 95% CI=1.001 - 1.29) and lifetime MDD (OR=1.12, 95% CI=1.03 - 1.21), religious service attendance was inversely associated with 12 month and lifetime MDD, and religious coping was inversely associated with 12 month MDD (OR=0.75, 95% CI=.57 - 0.99). Findings are discussed in relation to the role of religion for African American mental health, prior research on the effects of religious involvement on physical and mental health, and theoretical and conceptual models of religion-health connections that specify multiple and often divergent pathways (e.g., prevention, resource mobilization) by which diverse forms of religious involvement impact mental health. PMID:22986280

  18. 12-Month-Old Infants Represent Probable Endings of Motion Events

    ERIC Educational Resources Information Center

    Wagner, Laura; Carey, Susan

    2005-01-01

    This experiment investigated 12-month-old infants' ability to link an event's beginning to its probable ending. Following Csibra, Biro, Koos, and Gergely (2003), infants were habituated to a simple chasing event involving animated balls, and at test saw 2 possible endings: either 1 ball caught the other or failed to do so. Two controls were added…

  19. Biological Motion Displays Elicit Social Behavior in 12-Month-Olds

    ERIC Educational Resources Information Center

    Yoon, Jennifer M. D.; Johnson, Susan C.

    2009-01-01

    To test the hypothesis that biological motion perception is developmentally integrated with important social cognitive abilities, 12-month-olds (N = 36) were shown a display of a human point-light figure turning to observe a target. Infants spontaneously and reliably followed the figure's "gaze" despite the absence of familiar and socially…

  20. Impairments, activity limitations and participation restrictions 6 and 12 months after breast cancer operation.

    PubMed

    Kärki, Anne; Simonen, Riitta; Mälkiä, Esko; Selfe, James

    2005-05-01

    To describe the impairments of upper body and limbs, activity limitations and participation restrictions 6 and 12 months after operation for breast cancer and to examine the impact of impairments on activity limitations. A prospective survey 6 and 12 months after operation. Ninety-six breast cancer patients. A questionnaire for assessing the impairments, activity limitations and participation restrictions was developed. The most common impairments 6 months after operation were breast and axilla scar tightness, axilla oedema and neck-shoulder pain. At 12-month follow-up the breast scar tightness (p=0.008) and axilla oedema (p=0.023) decreased, and limb ache (p=0.005) increased significantly. The most limiting impairments were axilla oedema and limb numbness 6 months after operation, and at 12-month follow-up axilla oedema. Lifting, carrying and reaching out caused worsening of impairments to more than half of the respondents at 6-month follow-up. Regression analysis showed that many impairments together were determinants of activity limitations and sleep impairment. Participation restrictions were constant. Respondents had not given up participation in activities in the home, but some had abandoned leisure activities and felt that their work ability had decreased. Impairments and their impact on activities were frequent and constant. There is an urgent need for developing rehabilitation protocols for breast cancer patients.

  1. Class Matters: 12-Month-Olds' Word-Object Associations Privilege Content over Function Words

    ERIC Educational Resources Information Center

    MacKenzie, Heather; Curtin, Suzanne; Graham, Susan A.

    2012-01-01

    A fundamental step in learning words is the development of an association between a sound pattern and an element in the environment. Here we explore the nature of this associative ability in 12-month-olds, examining whether it is constrained to privilege particular word forms over others. Forty-eight infants were presented with sets of novel…

  2. 12-Month-Olds' Phonotactic Knowledge Guides Their Word-Object Mappings

    ERIC Educational Resources Information Center

    MacKenzie, Heather; Curtin, Suzanne; Graham, Susan A.

    2012-01-01

    This study examined whether 12-month-olds will accept words that differ phonologically and phonetically from their native language as object labels in an associative learning task. Sixty infants were presented with sets of English word-object (N = 30), Japanese word-object (N = 15), or Czech word-object (N = 15) pairings until they habituated.…

  3. Work status and disability trajectories over 12 months after injury among workers in New Zealand.

    PubMed

    Langley, John; Lilley, Rebbecca; Samaranayaka, Ari; Derrett, Sarah

    2014-03-07

    To describe work and disability trajectories over 12 months following injury among workers. Workers injured at work or elsewhere (n=2626) were sourced from the Prospective Outcomes of Injury Study, a longitudinal cohort study in New Zealand, with the primary objective of identifying factors associated with disability following injury. Work and disability status was assessed at 3- and 12-months post injury. The measure of disability was the brief WHODAS II 12-item instrument. Participants were dichotomised into 'disability' or 'no disability' groups based on whether their WHODAS score was greater than, or equal to, 10. In terms of 12-month work status, there are 16 different scenarios. These were grouped into 4 categories: sustained work (SW), delayed return to work (RTW), non-sustained RTW, and sustained off-work. We had complete information for 1975 workers. The largest group (68%) was SW, 32% of which had disability at either time point. The second largest group consisted of 17% of workers who were classified as delayed RTW, 76% of whom were disabled at either time point. Among the non-sustained RTW group (7%), 52% had disability at either time point. Of the sustained off-work group (8%), 80% were disabled at either 3- or 12-months. Although return to work is a useful provider performance indicator of injury compensation and rehabilitation it is inadequate from a wider societal perspective and needs to be complemented by other important outcome measures such as disability status.

  4. FedEx Express Gasoline Hybrid Electric Delivery Truck Evaluation: 12-Month Report

    SciTech Connect

    Barnitt, R.

    2011-01-01

    This report summarizes the data obtained in a 12-month comparison of three gasoline hybrid electric delivery vehicles with three comparable diesel vehicles. The data show that there was no statistical difference between operating cost per mile of the two groups of vehicles. As expected, tailpipe emissions were considerably lower across all drive cycles for the gHEV than for the diesel vehicle.

  5. Atypical Object Exploration at 12 Months of Age Is Associated with Autism in a Prospective Sample

    ERIC Educational Resources Information Center

    Ozonoff, Sally; Macari, Suzanne; Young, Gregory S.; Goldring, Stacy; Thompson, Meagan; Rogers, Sally J.

    2008-01-01

    This prospective study examined object exploration behavior in 66 12-month-old infants, of whom nine were subsequently diagnosed with an autism spectrum disorder. Previous investigations differ on when the repetitive behaviors characteristic of autism are first present in early development. A task was developed that afforded specific opportunities…

  6. Speech Production in 12-Month-Old Children with and without Hearing Loss

    ERIC Educational Resources Information Center

    McGowan, Richard S.; Nittrouer, Susan; Chenausky, Karen

    2008-01-01

    Purpose: The purpose of this study was to compare speech production at 12 months of age for children with hearing loss (HL) who were identified and received intervention before 6 months of age with those of children with normal hearing (NH). Method: The speech production of 10 children with NH was compared with that of 10 children with HL whose…

  7. Maternal cortisol slope at 6 months predicts infant cortisol slope and EEG power at 12 months.

    PubMed

    St John, Ashley M; Kao, Katie; Liederman, Jacqueline; Grieve, Philip G; Tarullo, Amanda R

    2017-09-01

    Physiological stress systems and the brain rapidly develop through infancy. While the roles of caregiving and environmental factors have been studied, implications of maternal physiological stress are unclear. We assessed maternal and infant diurnal cortisol when infants were 6 and 12 months. We measured 12-month infant electroencephalography (EEG) 6-9 Hz power during a social interaction. Steeper 6-month maternal slope predicted steeper 12-month infant slope controlling for 6-month infant slope and breastfeeding. Steeper 6-month maternal slope predicted lower 6-9 Hz power. Six-month maternal area under the cuve (AUCg) was unrelated to 12-month infant AUCg and 6-9 Hz power. Psychosocial, caregiving, and breastfeeding variables did not explain results. At 6 months, maternal and infant slopes correlated, as did maternal and infant AUCg. Twelve-month maternal and infant cortisol were unrelated. Results indicate maternal slope is an informative predictor of infant physiology and suggest the importance of maternal physiological stress in this developmental period. © 2017 Wiley Periodicals, Inc.

  8. Will Any Doll Do? 12-Month-Olds' Reasoning about Goal Objects

    ERIC Educational Resources Information Center

    Spaepen, Elizabet; Spelke, Elizabeth

    2007-01-01

    Infants as young as 5 months of age view familiar actions such as reaching as goal-directed (Woodward, 1998), but how do they construe the goal of an actor's reach? Six experiments investigated whether 12-month-old infants represent reaching actions as directed to a particular individual object, to a narrowly defined object category (e.g., an…

  9. Assessing the Utility of Urine Testing in Febrile Infants Aged 2 to 12 Months With Bronchiolitis.

    PubMed

    Elkhunovich, Marsha A; Wang, Vincent J

    2015-09-01

    The aims of the study were to investigate whether the prevalence of urinary tract infections (UTIs) in febrile infants aged 2 to 12 months with bronchiolitis is higher than the presumed prevalence of asymptomatic bacteriuria (1%) in similarly aged patients and thus to determine whether UTI testing is necessary for these patients. This was a prospective cohort study in which we enrolled a convenience sample of febrile infants aged 2 to 12 months with a clinical diagnosis of bronchiolitis. All patients were seen in the emergency department at a large children's hospital between November 1, 2011 and April 15, 2012, had reported or documented fever higher than 38°C, and had urine collected for determination of the presence of UTI. After the conclusion of enrollment, a chart review was conducted to assess missed cases. Positive urine cultures were found in 6/90 (6.7%) patients (confidence interval, 2.5%-13.9%). The positive urine cultures and urinalysis results were found in 4/90 (4.5%) patients (confidence interval, 1.2%-11%). In our patient population, a significant proportion of infants aged 2 to 12 months who present with bronchiolitis and fever have a concurrent UTI. Obtaining a urine specimen for UTI testing should be considered in infants aged 2 to 12 months with bronchiolitis and fever. A larger multicenter study is needed to further assess the risk factors for UTIs in this patient population.

  10. The Flexibility of 12-Month-Olds' Preferences for Phonologically Appropriate Object Labels

    ERIC Educational Resources Information Center

    MacKenzie, Heather K.; Graham, Susan A.; Curtin, Suzanne; Archer, Stephanie L.

    2014-01-01

    We explored 12-month-olds' flexibility in accepting phonotactically illegal or ill-formed word forms in a modified associative-learning task. Sixty-four English-learning infants were presented with a training phase that either clarified the purpose of a sound--object association task or left the task ambiguous. Infants were then habituated to sets…

  11. Vowel Production in 7- to 12-Month-Old Infants with Hearing Loss

    ERIC Educational Resources Information Center

    Nelson, Rebecca; Yoshinaga-Itano, Christine; Rothpletz, Ann; Sedey, Allison

    2007-01-01

    The purpose of this study was to examine vowel production in 7- to 12-month-old infants with hearing loss. Fifty-four infants were divided into three groups according to degree of hearing loss (mild-to-moderate, moderately severe-to-severe, profound), and their vocalizations were phonetically transcribed from 30-minute videotaped samples. These…

  12. Case Study Analyses of Play Behaviors of 12-Month-Old Infants Later Diagnosed with Autism

    ERIC Educational Resources Information Center

    Mulligan, Shelley

    2015-01-01

    Case study research methodology was used to describe the play behaviors of three infants at 12 months of age, who were later diagnosed with an autism spectrum disorder. Data included standardized test scores, and analyses of video footage of semi-structured play sessions from infants identified as high risk for autism, because of having a sibling…

  13. Change in Sexual Activity 12 Months After ART Initiation Among HIV-Positive Mozambicans

    PubMed Central

    Cassels, Susan; Kurth, Ann E.; Montoya, Pablo; Micek, Mark A.; Gloyd, Stephen S.

    2012-01-01

    We assessed sexual behaviors before and 12-months after ART initiation among 277 Mozambicans attending an HIV clinic. Measured behaviors included the number of sexual partners, condom use, concurrent relationships, disclosure of HIV status, alcohol use, and partners’ serostatus. Compared to before ART initiation, increases were seen 12 months after ART in the proportion of participants who were sexually active (48% vs. 64% respondents, P < 0.001) and the proportion of participants with HIV-negative or unknown serostatus partners (45% vs. 80%, P < 0.001). Almost all (96%) concurrent partnerships reported at 12 months formed after ART initiation. Although reported correct and consist condom use increased, the number of unprotected sexual relationships remained the same (n = 45). Non-disclosure of HIV-serostatus to sexual partners was the only significant predictor of practicing unprotected sex with partners of HIV-negative or unknown serostatus. Sexual activity among HIV-positive persons on ART increased 12 months after ART initiation. Ongoing secondary transmission prevention programs addressing sexual activity with multiple partners, disclosure to partners and consistent condom use with serodisconcordant partners must be incorporated throughout HIV care programs. PMID:21082338

  14. Speech Production in 12-Month-Old Children with and without Hearing Loss

    ERIC Educational Resources Information Center

    McGowan, Richard S.; Nittrouer, Susan; Chenausky, Karen

    2008-01-01

    Purpose: The purpose of this study was to compare speech production at 12 months of age for children with hearing loss (HL) who were identified and received intervention before 6 months of age with those of children with normal hearing (NH). Method: The speech production of 10 children with NH was compared with that of 10 children with HL whose…

  15. Adherence to Glaucoma Medications Over 12 Months in Two US Community Pharmacy Chains

    PubMed Central

    Feehan, Michael; Munger, Mark A.; Cooper, Daniel K.; Hess, Kyle T.; Durante, Richard; Jones, Gregory J.; Montuoro, Jaime; Morrison, Margaux A.; Clegg, Daniel; Crandall, Alan S.; DeAngelis, Margaret M.

    2016-01-01

    This study determined the degree of adherence to medications for glaucoma among patients refilling prescriptions in community pharmacies. Methods: Data abstracted from the dispensing records for 3615 adult patients (18 years or older, predominantly over 45) receiving glaucoma medications from two retail pharmacy chains (64 stores in total) were analyzed. From a 24-month historic data capture period, the 12-month levels of adherence were determined using standard metrics, the proportion of days covered (PDC) and the medication possession ratio (MPR). The overall 12-month mean PDC was only 57%, and the mean MPR was 71%. Using a criterion by which 80% coverage was considered satisfactory adherence, only 30% had satisfactory overall 12-month PDC coverage, and only 37% had satisfactory overall 12-month MPR coverage. Refill adherence increased with age and was highest in the 65-and-older age group (p < 0.001). Differential adherence was found across medication classes, with the highest satisfactory coverage seen for those taking alpha2-adrenergic agonists (PDC = 36.0%; MPR = 47.6%) down to those taking direct cholinergic agonists (PDC = 25.0%; MPR = 31.2%) and combination products (PDC = 22.7%; MPR = 31.0%). Adherence to glaucoma medications in the community setting, as measured by pharmacy refill data, is very poor and represents a critical target for intervention. Community pharmacists are well positioned to monitor and reinforce adherence in this population. PMID:27618115

  16. Auditory Temporal Pattern Perception in 6- and 12-Month-Old Infants.

    ERIC Educational Resources Information Center

    Morrongiello, Barbara A.

    1984-01-01

    A go/no-go conditioned head-turn paradigm was used to examine the abilities of 6- and 12-month-olds to discriminate changes in temporal grouping and their perception of absolute and relative timing information when listening to patterns of white-noise bursts. (Author/RH)

  17. Upper limb module in non-ambulant patients with spinal muscular atrophy: 12 month changes.

    PubMed

    Sivo, Serena; Mazzone, Elena; Antonaci, Laura; De Sanctis, Roberto; Fanelli, Lavinia; Palermo, Concetta; Montes, Jacqueline; Pane, Marika; Mercuri, Eugenio

    2015-03-01

    Recent studies have suggested that in non-ambulant patients affected by spinal muscular atrophy the Upper Limb Module can increase the range of activities assessed by the Hammersmith Functional Motor Scale Expanded. The aim of this study was to establish 12-month changes in the Upper Limb Module in a cohort of non-ambulant spinal muscular atrophy patients and their correlation with changes on the Hammersmith Functional Motor Scale Expanded. The Upper Limb Module scores ranged between 0 and 17 (mean 10.23, SD 4.81) at baseline and between 1 and 17 at 12 months (mean 10.27, SD 4.74). The Hammersmith Functional Motor Scale Expanded scores ranged between 0 and 34 (mean 12.43, SD 9.13) at baseline and between 0 and 34 at 12 months (mean 12.08, SD 9.21). The correlation betweeen the two scales was 0.65 at baseline and 0.72 on the 12 month changes. Our results confirm that the Upper Limb Module can capture functional changes in non-ambulant spinal muscular atrophy patients not otherwise captured by the other scale and that the combination of the two measures allows to capture changes in different subgroups of patients in whom baseline scores and functional changes may be influenced by several variables such as age. Copyright © 2014 Elsevier B.V. All rights reserved.

  18. Change in sexual activity 12 months after ART initiation among HIV-positive Mozambicans.

    PubMed

    Pearson, Cynthia R; Cassels, Susan; Kurth, Ann E; Montoya, Pablo; Micek, Mark A; Gloyd, Stephen S

    2011-05-01

    We assessed sexual behaviors before and 12-months after ART initiation among 277 Mozambicans attending an HIV clinic. Measured behaviors included the number of sexual partners, condom use, concurrent relationships, disclosure of HIV status, alcohol use, and partners' serostatus. Compared to before ART initiation, increases were seen 12 months after ART in the proportion of participants who were sexually active (48% vs. 64% respondents, P < 0.001) and the proportion of participants with HIV-negative or unknown serostatus partners (45% vs. 80%, P < 0.001). Almost all (96%) concurrent partnerships reported at 12 months formed after ART initiation. Although reported correct and consist condom use increased, the number of unprotected sexual relationships remained the same (n = 45). Non-disclosure of HIV-serostatus to sexual partners was the only significant predictor of practicing unprotected sex with partners of HIV-negative or unknown serostatus. Sexual activity among HIV-positive persons on ART increased 12 months after ART initiation. Ongoing secondary transmission prevention programs addressing sexual activity with multiple partners, disclosure to partners and consistent condom use with serodisconcordant partners must be incorporated throughout HIV care programs.

  19. Evidence for a Unitary Goal Concept in 12-Month-Old Infants

    ERIC Educational Resources Information Center

    Biro, Szilvia; Verschoor, Stephan; Coenen, Lot

    2011-01-01

    We investigated whether infants can transfer their goal attribution between situations that contain different types of information about the goal. We found that 12-month-olds who had attributed a goal based on the causal efficacy of a means-end action generated expectations about the actor's action in another scenario in which the actor could…

  20. Skeletal findings in the first 12 months following initiation of glucocorticoid therapy for pediatric nephrotic syndrome

    PubMed Central

    Phan, V; Blydt-Hansen, T; Feber, J; Alos, N; Arora, S; Atkinson, S; Bell, L; Clarson, C; Couch, R; Cummings, EA; Filler, G; Grant, RM; Grimmer, J; Hebert, D; Lentle, B; Ma, J; Matzinger, M; Midgley, J; Pinsk, M; Rodd, C; Shenouda, N; Stein, R; Stephure, D; Taback, S; Williams, K; Rauch, F; Siminoski, K; Ward, LM

    2014-01-01

    Introduction Vertebral fracture (VF) incidence following glucocorticoid (GC) initiation has not been previously reported in pediatric nephrotic syndrome. Methods VF were assessed on radiographs (Genant method); lumbar spine bone mineral density (LS BMD) was evaluated by dual-energy x-ray absorptiometry. Results Sixty-five children were followed to 12 months post-GC initiation (median age: 5.4 years, range 2.3 to 17.9). Three of 54 children with radiographs (6%, 95% CI 2 to 15%) had incident VF at 1 year. The mean LS BMD Z-score was below the healthy average at baseline (mean ± SD −0.5 ± 1.1 p=0.001) and at 3 months (−0.6 ± 1.1 p<0.001), but not at 6 months (−0.3 ± 1.3, p=0.066) or 12 months (−0.3 ± 1.2, p=0.066). Mixed effect modeling showed a significant increase in LS BMD Z-scores between 3 and 12 months (0.22 SD, 95% CI 0.08 to 0.36, p=0.003). A sub-group (N=16; 25%) had LS BMD Z-scores that were ≤ −1.0 at 12 months. In these children, each additional 1000 mg/m2 of GC received in the first 3 months was associated with a decrease in LS BMD Z-score by 0.39 at 12 months (95% CI, −0.71 to −0.07; p=0.017). Conclusions The incidence of VF at 1 year was low and LS BMD Z-scores improved by 12 months in the majority. Twenty-five percent of children had LS BMD Z-scores ≤ −1.0 at 12 months. In these children, LS BMD Z-scores were inversely associated with early GC exposure, despite similar GC exposure compared to the rest of the cohort. PMID:23948876

  1. Neural predictors of 12-month weight loss outcomes following bariatric surgery.

    PubMed

    Holsen, L M; Davidson, P; Cerit, H; Hye, T; Moondra, P; Haimovici, F; Sogg, S; Shikora, S; Goldstein, J M; Evins, A E; Stoeckel, L E

    2017-08-14

    Despite the effectiveness of bariatric surgery, there is still substantial variability in long-term weight outcomes and few factors with predictive power to explain this variability. Neuroimaging may provide a novel biomarker with utility beyond other commonly used variables in bariatric surgery trials to improve prediction of long-term weight-loss outcomes. The purpose of this study was to evaluate the effects of sleeve gastrectomy (SG) on reward and cognitive control circuitry postsurgery and determine the extent to which baseline brain activity predicts weight loss at 12-month postsurgery. Using a longitudinal design, behavioral, hormone and neuroimaging data (during a desire for palatable food regulation paradigm) were collected from 18 patients undergoing SG at baseline (<1 month prior) and 12-month post-SG. SG patients lost an average of 29.0% of their weight (percentage of total weight loss (%TWL)) at 12-month post-SG, with significant variability (range: 16.0-43.5%). Maladaptive eating behaviors (uncontrolled, emotional and externally cued eating) improved (P<0.01), in parallel with reductions in fasting hormones (acyl ghrelin, leptin, glucose, insulin; P<0.05). Brain activity in the nucleus accumbens (NAcc), caudate, pallidum and amygdala during desire for palatable food enhancement vs regulation decreased from baseline to 12 months (P (family-wise error (FWE))<0.05). Dorsolateral and dorsomedial prefrontal cortex activity during desire for palatable food regulation (vs enhancement) increased from baseline to 12 months (P(FWE)<0.05). Baseline activity in the NAcc and hypothalamus during desire for palatable food enhancement was significantly predictive of %TWL at 12 months (P (FWE)<0.05), superior to behavioral and hormone predictors, which did not significantly predict %TWL (P>0.10). Using stepwise linear regression, left NAcc activity accounted for 54% of the explained variance in %TWL at 12 months. Consistent with previous obesity studies, reward

  2. Post-renal transplantation anemia at 12 months: prevalence, risk factors, and impact on clinical outcomes.

    PubMed

    Huang, Zhongli; Song, Turun; Fu, Lei; Rao, Zhengsheng; Zeng, Dongyang; Qiu, Yang; Wang, Xianding; Xie, Libo; Wei, Qiang; Wang, Li; Lin, Tao

    2015-09-01

    To investigate any association between post-transplantation anemia (PTA) and clinical outcomes following living donor kidney transplantation. We retrospectively evaluated 887 patients who received living donor kidney transplantations at our medical center between January 2006 and December 2012 to evaluate whether PTA, defined as serum hemoglobin (Hb) levels of <130 g/l in men and <120 g/l in women, at 12 months is associated with post-transplant outcomes, including graft function, death-censored graft survival, or patient survival. The prevalence of PTA at 1, 3, 6, and 12 months was 84.3, 39.5, 26.2, and 21.6 %, respectively. Donor age [hazard ratio (HR), 1.03; 95 % confidence interval (CI) 1.01-1.05] and acute rejection (HR 2.13; 95 % CI 1.28-3.54) were found to be independent risk factors for PTA at 12 months. Recipient age (HR 0.98; 95 % CI 0.95-1.00), pre-transplantation Hb levels (HR 0.99; 95 % CI 0.98-1.00), and estimated glomerular filtration rates (eGFRs) at 12 months (HR 0.96; 95 % CI 0.94-0.97) were found to confer slight protection against PTA at 12 months. PTA at 12 months was associated with increased graft loss (HR 1.046; 95 % CI 1.045-1.046). For each increase in anemia degree, there was a 2.77-fold greater risk of graft loss (HR 2.77; 95 % CI 1.50-5.13). When stratified according to eGFR, PTA was found to be a predictor of graft loss in patients with an eGFR of <60 ml/min/1.73 m(2) (HR 4.57; 95 % CI 1.98-10.56) but not in patients with an eGFR of >60 ml/min/1.73 m(2) (HR 1.89; 95 % CI 0.13-27.78). PTA was not found to be a predictor of patient survival. Anemia is common after kidney transplantation, and its prevalence declines with time after transplantation. Presence of anemia at 12 months post-transplant was an independent predictor of graft loss, with higher risk of graft loss in patients with anemia and poorer kidney functions.

  3. Physical inactivity at leisure and work: a 12-month study of cardiac patients.

    PubMed

    Rogerson, Michelle C; Murphy, Barbara M; Le Grande, Michael R; Worcester, Marian U C

    2013-01-01

    Physical inactivity has been identified as a distinct health risk. However, little is known about how this can vary at leisure and work in cardiac patients. The aim of this study was to examine the prevalence and predictors of inactivity during leisure and work in the 12 months following a cardiac event in Australian cardiac patients. A total of 346 patients consecutively admitted to hospital with acute coronary syndrome or to undergo coronary artery bypass graft surgery were interviewed in hospital, and 4 and 12 months later. Leisure and occupational physical activity was measured using the Stanford Brief Activity Survey. Sociodemographic, psychosocial, and clinical data were also collected. The prevalence of leisure-time physical inactivity declined over time, with 52% inactive preevent and 29% inactive at 12 months. Approximately 50% of participants were physically inactive in their work, regardless of whether this was measured before or after the cardiac event. Logistic regression revealed that the significant predictors of leisure-time physical inactivity at 12 months were non-home ownership (OR = 2.19; P = .007) and physical inactivity in leisure-time prior to the event (OR = 2.44; P = .001). The significant predictors of occupational physical inactivity at 12 months were white-collar occupation (OR = 3.10; P < .001) and physical inactivity at work prior to the event (OR = 12.99; P < .001). Preevent physical inactivity, socioeconomic, and clinical factors predicted both leisure and work inactivity after an acute cardiac event. Effective interventions could be designed and implemented to target those most at risk of being physically inactive at work or leisure.

  4. Impact of malnutrition on 12-month mortality following acute hip fracture.

    PubMed

    Bell, Jack J; Pulle, Ranjeev C; Crouch, Alisa M; Kuys, Suzanne S; Ferrier, Rebecca L; Whitehouse, Sarah L

    2016-03-01

    Studies investigating the relationship between malnutrition and post-discharge mortality following acute hip fracture yield conflicting results. This study aimed to determine whether malnutrition independently predicted 12-month post-fracture mortality after adjusting for clinically relevant covariates. An ethics approved, prospective, consecutive audit was undertaken for all surgically treated hip fracture inpatients admitted to a dedicated orthogeriatric unit (November 2010-October 2011). The 12-month mortality data were obtained by a dual search of the mortality registry and Queensland Health database. Malnutrition was evaluated using the Subjective Global Assessment. Demographic (age, gender, admission residence) and clinical covariates included fracture type, time to surgery, anaesthesia type, type of surgery, post-surgery time to mobilize and post-operative complications (delirium, pulmonary and deep vein thrombosis, cardiac complications, infections). The Charlson Comorbidity Index was retrospectively applied. All diagnoses were confirmed by the treating orthogeriatrician. A total of 322 of 346 patients were available for audit. Increased age (P = 0.004), admission from residential care (P < 0.001), Charlson Comorbidity Index (P = 0.007), malnutrition (P < 0.001), time to mobilize >48 h (P < 0.001), delirium (P = 0.003), pulmonary embolism (P = 0.029) and cardiovascular complication (P = 0.04) were associated with 12-month mortality. Logistic regression analysis demonstrated that malnutrition (odds ratio (OR) 2.4 (95% confidence interval (CI) 1.3-4.7, P = 0.007)), in addition to admission from residential care (OR 2.6 (95% CI 1.3-5.3, P = 0.005)) and pulmonary embolism (OR 11.0 (95% CI 1.5-78.7, P = 0.017)), independently predicted 12-month mortality. Findings substantiate malnutrition as an independent predictor of 12-month mortality in a representative sample of hip fracture inpatients. Effective strategies to identify and treat malnutrition in hip

  5. Oxidative stress is associated with weight gain in recipients at 12-months following kidney transplantation.

    PubMed

    Cho, Young-Eun; Kim, Hyung-Suk; Lai, Chen; Stanfill, Ansley; Cashion, Ann

    2016-02-01

    Weight gain after kidney transplantation (Tx) is considered a risk factor for poor outcomes. Increased oxidative stress is associated with not only chronic renal disease and Tx, but also obesity and cardiovascular disease. The aim of this pilot study was to test whether oxidative stress is related to weight gain at 12-months after kidney Tx and to obtain preliminary insight into potential mechanisms involved. Recipients (n=33) were classified into two groups; weight loss and weight gain, based on their weight changes at 12-months post-transplant. Total antioxidant capacity (TAOC) and lipid peroxidation (TBARS) were measured to evaluate oxidative stress from plasma at baseline and 12-months. A secondary data analysis was conducted to identify potential gene regulation. Seventeen recipients lost (-6.63±5.52kg), and sixteen recipients gained weight (8.94±6.18kg). TAOC was significantly decreased at 12-months compared to baseline for the total group, however, there was no significant difference between groups at either time point. TBARS was higher in weight gain group, at both time points, and it was significantly higher at 12-months (p=0.012). Gene expression profiling analysis showed that 7 transcripts annotated to reactive oxygen species related genes in adipose tissue were expressed significantly lower in weight gain group at baseline, which might be a negative feedback mechanism to reduce oxidative stress. These results may indicate that elevated oxidative stress (TBARS) is associated with weight gain after kidney Tx and that incorporating early clinical prevention strategies known to decrease oxidative stress could be recommended. Published by Elsevier Inc.

  6. Non-pharmacological, multicomponent group therapy in patients with degenerative dementia: a 12-month randomzied, controlled trial

    PubMed Central

    2011-01-01

    Background Currently available pharmacological and non-pharmacological treatments have shown only modest effects in slowing the progression of dementia. Our objective was to assess the impact of a long-term non-pharmacological group intervention on cognitive function in dementia patients and on their ability to carry out activities of daily living compared to a control group receiving the usual care. Methods A randomized, controlled, single-blind longitudinal trial was conducted with 98 patients (follow-up: n = 61) with primary degenerative dementia in five nursing homes in Bavaria, Germany. The highly standardized intervention consisted of motor stimulation, practice in activities of daily living, and cognitive stimulation (acronym MAKS). It was conducted in groups of ten patients led by two therapists for 2 hours, 6 days a week for 12 months. Control patients received treatment as usual. Cognitive function was assessed using the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog), and the ability to carry out activities of daily living using the Erlangen Test of Activities of Daily Living (E-ADL test) at baseline and after 12 months. Results Of the 553 individuals screened, 119 (21.5%) were eligible and 98 (17.7%) were ultimately included in the study. At 12 months, the results of the per protocol analysis (n = 61) showed that cognitive function and the ability to carry out activities of daily living had remained stable in the intervention group but had decreased in the control patients (ADAS-Cog: adjusted mean difference: -7.7, 95% CI -14.0 to -1.4, P = 0.018, Cohen's d = 0.45; E-ADL test: adjusted mean difference: 3.6, 95% CI 0.7 to 6.4, P = 0.015, Cohen's d = 0.50). The effect sizes for the intervention were greater in the subgroup of patients (n = 50) with mild to moderate disease (ADAS-Cog: Cohen's d = 0.67; E-ADL test: Cohen's d = 0.69). Conclusions A highly standardized, non-pharmacological, multicomponent group intervention conducted

  7. Quality of life in persons living with HIV in Burkina Faso: a follow-up over 12 months.

    PubMed

    Bakiono, Fidèle; Guiguimdé, Patrice Wendpouiré Laurent; Sanou, Mahamoudou; Ouédraogo, Laurent; Robert, Annie

    2015-11-13

    In Burkina Faso, very little is known about the quality of life of persons living with HIV through their routine follow- up. This study aimed to assess the quality of life of persons living with HIV, and its change over a 1-year period. Four hundred and twenty four (424) persons living with HIV were monitored during twelve (12) months from September 2012 to September 2013 in Ouagadougou, the capital city of Burkina Faso. Three interviews were conducted in order to assess the quality of life of patients and its change over time, using the World Health Organization Quality of Life assessment brief scale in patients with Human Immunodeficiency Virus infection (WHOQOL HIV-BREF). The Friedman test was used to assess significant differences in quantitative variables at each of the three follow-up interviews. Groups at baseline, at 6 months and at 12 months were compared using Wilcoxon signed rank test for quantitative data and McNemar test for qualitative variables. Pearson Chi(2) was used when needed. Multivariable logistic regression models were fit to estimate adjusted odds ratio (OR) and 95% confidence intervals (95% CI). Trends in global quality of life score and subgroups (status related to Highly Active Anti Retroviral Treatment (HAART) using univariate repeated measures analysis of variance were assessed. A p-value less than 0.05 was considered significant. At baseline, quality of life scores were highest in the domain of spirituality, religion and personal beliefs (SRPB) and lowest in the environmental domain. This trend was maintained during the 12-month follow-up. The global score increased significantly from the beginning up to the twelfth month of follow-up. Over the 12 months, the baseline factors that were likely to predict an increase in the global quality of life score were: not having support from relatives for medical care (P = 0.04), being under HAART (P = 0.001), being self-perceived as healthy (P = 0.03), and having a global quality of life score

  8. Radiographic Fractal and Clinical Resonance Frequency Analyses of Posterior Mandibular Dental Implants: Their Possible Association With Mandibular Cortical Index With 12-Month Follow-up.

    PubMed

    Tözüm, Tolga F; Dursun, Erhan; Uysal, Serdar

    2016-12-01

    The aim of the present study was to investigate whether the mandibular cortical index (MCI) has a relationship with fractal dimension of bone and/or implant stability, and to justify the possible association between MCI, fractal dimension, and stability. Eighty-two subjects who received dental implants to replace missing mandibular premolar/molar sites were selected. Three months after surgical placement, implants were restored with fixed ceramic fused metal crowns. MCI was evaluated at baseline; fractal dimensions were measured with fractal analysis (FA) and implant stability quotient (ISQ) with resonance frequency analysis immediately after surgery and 12-month follow-up. FA at mesial and distal regions for Class 1, Class 2, and Class 3 MCI resulted with significant increases at 12-month follow-up compared to baseline. The ISQ in patients with Class 2 and Class 3 MCI resulted with a significant decrease compared to Class 1 MCI at baseline and at 12 months. All MCI classes evaluated with ISQ and FA at baseline values resulted with significant increases at 12 months. Significant correlations were considered for all mandibular posterior implants between baseline and 12-month measurements for ISQ and FA evaluations. Fractal analysis may be a useful method for understanding the healing process around implants and implant stability quotient values. Mandibular cortical index evaluations should be considered before implant procedures, which may provide a presurgical treatment plan and may provide information about the mandibular bone quality.

  9. TVT-Secur mini-sling for stress urinary incontinence: a review of outcomes at 12 months.

    PubMed

    Walsh, Colin A

    2011-09-01

    • Synthetic mid-urethral slings (MUSs) are considered the first choice surgical procedure for stress urinary incontinence. Recent publications have raised concerns about the efficacy of third generation single-incision mini-slings. The present paper is a systematic review of studies reporting 12-month outcomes after the TVT-Secur (TVT-S) procedure. • Pubmed/Medline online databases, abstracts from recent International Continence Society and International Urogynecological Association annual scientific meetings and the Clinicaltrials.gov and Controlled-trials.com online trial registries were searched for English-language articles containing the terms 'TVT-Secur', 'TVT Secur' or 'mini-sling'. The primary outcomes were objective and subjective cure rates at 12 months. Secondary outcomes included peri-operative (vaginal perforation, urinary retention, urinary tract infection [UTI]) and postoperative (mesh exposure, de novo overactive bladder (OAB), dyspareunia and return to theatre) complication rates. • Among 1178 women undergoing the TVT-S procedure, from 10 studies, both objective and subjective cure rate at 12 months was 76%, with objective cure significantly higher in women undergoing the 'U-type' approach. Vaginal perforation was a complication in 1.5% of cases, with a 2.4% incidence of mesh exposure in the first year. The incidence of de novo OAB symptoms was 10%. Rates of urinary retention (2.3%), UTI (4.4%), dyspareunia (1%) and return to theatre for complications (0.8%) were low. In the first year after a TVT-S procedure 5% of women required repeat continence surgery. • Longer-term studies and randomized comparisons with more established MUSs are required before TVT-S should be routinely used in the surgical treatment of stress urinary incontinence.

  10. Nasolacrimal duct office probing in children under the age of 12 months: Cure rate and cost evaluation.

    PubMed

    Le Garrec, J; Abadie-Koebele, C; Parienti, J-J; Molgat, Y; Degoumois, A; Mouriaux, F

    2016-02-01

    Controversy exists regarding the treatment of infants with symptomatic nasolacrimal duct obstruction. One philosophy advocates "early" nasolacrimal duct probing, generally in the office - a relatively common approach in France, while others prefer to wait until the age of 12 months to offer a procedure under general anesthesia. The goal of this study is to report results of immediate office probing for congenital nasolacrimal duct obstruction (CNLDO) under age 1 year in terms of efficacy and cost. A retrospective study was performed on 329 patients (443 eyes) treated by probing for CNLDO under the age of 12 months age. A single probing was performed at the first visit in the office under topical anesthesia without sedation. In order to determine the factors associated with failure of probing, univariate analysis was performed using the Student t-test, Pearson's, homogeneity Chi(2) or Fisher's exact tests. For cost evaluation, hypothetical estimates of spontaneous resolution month by month were used according to data in the literature, along with health insurance reimbursement data. The ages of the patients ranged from 2 to 11 months (mean 7.0 ± SD 2.3). The overall success rate for cure by immediate office probing was 76.7%. Unilateral CNLDO had an 80.4% success rate whereas bilateral CNLDO had a 73.2% success rate for each eye (P=0.09). Discharge during probing was associated with failed probing (P=0.02). The cost for the spontaneous resolution strategy was 1.56 times higher than for the immediate probing strategy. A strategy which would apply the spontaneous resolution strategy for children ≤ 5 months and the probing strategy to children>5 months would be the most cost-effective. Immediate office probing between the ages of 5 to 12 months is a safe, effective method to relieve CNLDO and is the most cost-effective. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  11. Peak Oxygen Uptake after Cardiac Rehabilitation: A Randomized Controlled Trial of a 12-Month Maintenance Program versus Usual Care

    PubMed Central

    Madssen, Erik; Arbo, Ingerid; Granøien, Ingrid; Walderhaug, Liv; Moholdt, Trine

    2014-01-01

    Background Exercise capacity is a strong predictor of survival in patients with coronary artery disease (CAD). Exercise capacity improves after cardiac rehabilitation exercise training, but previous studies have demonstrated a decline in peak oxygen uptake after ending a formal rehabilitation program. There is a lack of knowledge on how long-term exercise adherence can be achieved in CAD patients. We therefore assessed if a 12-month maintenance program following cardiac rehabilitation would lead to increased adherence to exercise and increased exercise capacity compared to usual care. Materials and Methods Two-centre, open, parallel randomized controlled trial with 12 months follow-up comparing usual care to a maintenance program. The maintenance program consisted of one monthly supervised high intensity interval training session, a written exercise program and exercise diary, and a maximum exercise test every third month during follow-up. Forty-nine patients (15 women) on optimal medical treatment were included following discharge from cardiac rehabilitation. The primary endpoint was change in peak oxygen uptake at follow-up; secondary endpoints were physical activity level, quality of life and blood markers of cardiovascular risk. Results There was no change in peak oxygen uptake from baseline to follow-up in either group (intervention group 27.9 (±4.7) to 28.8 (±5.6) mL·kg (-1) min (−1), control group 32.0 (±6.2) to 32.8 (±5.8) mL·kg (−1) min (−1), with no between-group difference, p = 0.22). Quality of life and blood biomarkers remained essentially unchanged, and both self-reported and measured physical activity levels were similar between groups after 12 months. Conclusions A maintenance exercise program for 12 months did not improve adherence to exercise or peak oxygen uptake in CAD patients after discharge from cardiac rehabilitation compared to usual care. This suggests that infrequent supervised high intensity interval training sessions are

  12. Gastrointestinal tract development in red deer (Cervus elaphus) calves from 1 to 12 months of age.

    PubMed

    Hammond, K J; Hoskin, S O; Jopson, N B; Mackintosh, C G; Hofstra, G; Thompson, B R; Stevens, D R

    2013-11-01

    This study provides a detailed description of the development of the gastrointestinal tract (GIT) of farmed red deer (Cervus elaphus) calves over the first 12 months of age. GIT development was measured using a combination of computerised tomography (CT) scanning and traditional slaughter plus dissection techniques. Red deer calves of a known birth date were randomly assigned to two treatment groups. A group of five animals were repeatedly CT scanned at 31, 63, 92, 135, 207, 275 and 351 days of age to identify GIT organs and determine their volume. From a group of 20 animals, subsets of four individuals were also scanned at corresponding ages (except 135 days of age). They were immediately euthanised and dissected after CT scanning to compare CT-scanned results with actual anatomical measurements. Individual organ weights were compared with their respective organ volumes determined by CT scanning and were found to have a strong, positive relationship. The combined rumen and reticulum (RR) CT-scanned volume was compared with its volume determined by the water-displacement technique and this also showed good correlation between the two techniques (R = 0.92). The allometric growth rates of organs, relative to animal live weight gains, in descending order, were the rumen, omasum, reticulum, abomasum, caecum blind sac, kidneys, spleen and liver. The red deer GIT was continuing to grow and develop when the last measurement was taken at 351 days of age. The greatest growth of the RR, when expressed in terms of empty weight, was between 31 and 92 days of age. Compared with sheep and cattle, it appears that the red deer have a similar or greater rate of RR development up until approximately 60 to 90 days of age; however, the final increments of GIT maturity in deer may take longer to complete, with the empty weight of the RR gaining 7.5 g/day between 275 and 351 days of age. CT scanning was validated in this study as a viable technique to follow GIT development in the same

  13. New perspective for third generation percutaneous vertebral augmentation procedures: Preliminary results at 12 months.

    PubMed

    Vanni, Daniele; Pantalone, Andrea; Bigossi, Francesco; Pineto, Filippo; Lucantoni, Danilo; Salini, Vincenzo

    2012-07-01

    The prevalence of osteoporotic vertebral fractures (OVF) increased in the last years. Compression fractures promote a progressive spine kyphosis increase, resulting in a weight shift and anterior column overload, with OVF additional risk (domino effect). The aim of this study is to evaluate the OVF treatment outcome using Spine Jack(®), a titanium device for third generation percutaneous vertebral augmentation procedures (PVAPs). From February 2010, a prospective randomized study was performed examining 300 patients who underwent PVAP due to OVF type A1 according to Magerl/AO spine classification. Patients enrolled in the study were divided in two homogenous groups with regards to age (65-85 years), sex, and general clinical findings. Group A included 150 patients who underwent PVAP using Spine Jack(®) system; the second, group B (control group), included 150 patients treated by conventional balloon kyphoplasty. Patients underwent a clinical (visual analogue scale and Oswestry disability index) and radiographic follow-up, with post-operative standing plain radiogram of the spine at 1, 6, and 12 months. The radiographic parameters that were taken into account were: Post-operative anterior vertebral body height, pre-operative anterior vertebral body height, cephalic anterior vertebral body height, and caudal anterior vertebral body height. Compared to the Spine Jack(®) group, the kyphoplasty group required a little longer operation time (an average of 40 min-group A vs. 45 min-group B, P < 0.05) and a greater amount of polymethylmethacrylate (4.0 mL-group A vs. 5.0 mL-group B, P < 0.05;). The post-operative increase in vertebral body height was greater in the Spine Jack(®) group than in the kyphoplasty group (P < 0.05). PVAP are based on the cement injection into the vertebral body. Vertebroplasty does not allow the vertebral body height recovery. Balloon kyphoplasty allows a temporary height restoration. Spine Jack(®) has some new features compared to other

  14. Atypical object exploration at 12 months of age is associated with autism in a prospective sample.

    PubMed

    Ozonoff, Sally; Macari, Suzanne; Young, Gregory S; Goldring, Stacy; Thompson, Meagan; Rogers, Sally J

    2008-09-01

    This prospective study examined object exploration behavior in 66 12-month-old infants, of whom nine were subsequently diagnosed with an autism spectrum disorder. Previous investigations differ on when the repetitive behaviors characteristic of autism are first present in early development. A task was developed that afforded specific opportunities for a range of repetitive uses of objects and was coded blind to outcome status. The autism/ASD outcome group displayed significantly more spinning, rotating, and unusual visual exploration of objects than two comparison groups. The average unusual visual exploration score of the autism/ASD group was over four standard deviations above the mean of the group with no concerns at outcome. Repetitive behaviors at 12 months were significantly related to cognitive and symptomatic status at 36 month outcome. These results suggest that repetitive or stereotyped behaviors may be present earlier than initially thought in very young children developing the autism phenotype.

  15. MOTHER-INFANT INTERACTION AT 12 MONTHS IN PRENATALLY COCAINE-EXPOSED CHILDREN

    PubMed Central

    Ukeje, Ikechukwu; Bendersky, Margaret; Lewis, Michael

    2006-01-01

    This study examined mother-infant interactions of 12-month-old African-American prenatally cocaine-exposed infants and their mothers. Videotaped observations were made during a free-play dyadic interaction, a brief separation, and a reunion period. Videotapes were coded for maternal and child behaviors during each phase of the procedure. Although there were few differences in interactive behaviors between prenatally cocaine-exposed and nonexposed children and their mothers, children who were prenatally exposed to cocaine ignored their mother’s departure (odds ratio [OR] = 3.0, p < .05) during separation significantly more often than nonexposed subjects. In addition, mothers who abused cocaine engaged in significantly more verbal behavior (F(2,104) = 7.00, p < .001) with their children than mothers of nonexposed children. These findings indicate that women who used cocaine during pregnancy may not differ from nonusers in their interactions with their 12-month-old infants. PMID:11417936

  16. Language Differences at 12 Months in Infants Who Develop Autism Spectrum Disorder.

    PubMed

    Lazenby, DeWayne C; Sideridis, Georgios D; Huntington, Noelle; Prante, Matthew; Dale, Philip S; Curtin, Suzanne; Henkel, Lisa; Iverson, Jana M; Carver, Leslie; Dobkins, Karen; Akshoomoff, Natacha; Tagavi, Daina; Nelson, Charles A; Tager-Flusberg, Helen

    2016-03-01

    Little is known about early language development in infants who later develop autism spectrum disorder (ASD). We analyzed prospective data from 346 infants, some of whom were at high risk for developing ASD, to determine if language differences could be detected at 12 months of age in the infants who later were diagnosed with ASD. Analyses revealed lower receptive and expressive language scores in infants who later were diagnosed with ASD. Controlling for overall ability to understand and produce single words, a Rasch analysis indicated that infants who later developed ASD had a higher degree of statistically unexpected word understanding and production. At 12 months of age, quantitative and qualitative language patterns distinguished infants who later developed ASD from those who did not.

  17. Mortality of Kauai residents in the 12-month period following Hurricane Iniki.

    PubMed

    Hendrickson, L A; Vogt, R L

    1996-07-15

    On September 11, 1992, Hurricane Iniki struck Kauai leaving all residents without electricity and telephone services and damaging 70% of the homes. This study examined the hypothesis that Hurricane Iniki increased the mortality of Kauai residents by comparing mortality data for the 5 years preceding Hurricane Iniki with mortality data for the 12 months immediately following. Although the overall mortality rate was increased in the post-Iniki period, the only significant increase was in the rate of diabetes mellitus-related deaths (relative risk = 2.61, 95% confidence interval 1.44-4.74). Hurricane Iniki did not appear to significantly increase the risk of dying of Kauai residents in the 12 months immediately following the disaster.

  18. Lifetime and 12-Month Nonsuicidal Self-Injury and Academic Performance in College Freshmen.

    PubMed

    Kiekens, Glenn; Claes, Laurence; Demyttenaere, Koen; Auerbach, Randy P; Green, Jennifer G; Kessler, Ronald C; Mortier, Philippe; Nock, Matthew K; Bruffaerts, Ronny

    2016-10-01

    We examined whether nonsuicidal self-injury (NSSI) is associated with academic performance in college freshmen, using census-based web surveys (N = 7,527; response = 65.4%). NSSI was assessed with items from the Self-Injurious Thoughts and Behaviors Interview and subsequently linked with the administratively recorded academic year percentage (AYP). Freshmen with lifetime and 12-month NSSI showed a reduction in AYP of 3.4% and 5.9%, respectively. The college environment was found to moderate the effect of 12-month NSSI, with more strongly reduced AYPs in departments with higher-than-average mean departmental AYPs. The findings suggest that overall stress and test anxiety are underlying processes between NSSI membership and academic performance.

  19. The relationship between attention and deferred imitation in 12-month-old infants.

    PubMed

    Zmyj, Norbert; Schölmerich, Axel; Daum, Moritz M

    2017-03-01

    Imitation is a frequent behavior in the first years of life, and serves both a social function (e.g., to interact with others) and a cognitive function (e.g., to learn a new skill). Infants differ in their temperament, and temperament might be related to the dominance of one function of imitation. In this study, we investigated whether temperament and deferred imitation are related in 12-month-old infants. Temperament was measured via the Infant Behavior Questionnaire Revised (IBQ-R) and parts of the Laboratory Temperament Assessment Battery (Lab-TAB). Deferred imitation was measured via the Frankfurt Imitation Test for 12-month-olds (FIT-12). Regression analyses revealed that the duration of orienting (IBQ-R) and the latency of the first look away in the Task Orientation task (Lab-TAB) predicted the infants' imitation score. These results suggest that attention-related processes may play a major role when infants start to imitate.

  20. Quit and Smoking Reduction Rates in Vape Shop Consumers: A Prospective 12-Month Survey

    PubMed Central

    Polosa, Riccardo; Caponnetto, Pasquale; Cibella, Fabio; Le-Houezec, Jacques

    2015-01-01

    Aims: Here, we present results from a prospective pilot study that was aimed at surveying changes in daily cigarette consumption in smokers making their first purchase at vape shops. Modifications in products purchase were also noted. Design: Participants were instructed how to charge, fill, activate and use their e-cigarettes (e-cigs). Participants were encouraged to use these products in the anticipation of reducing the number of cig/day smoked. Settings: Staff from LIAF contacted 10 vape shops in the province of the city of Catania (Italy) that acted as sponsors to the 2013 No Tobacco Day. Participants: 71 adult smokers (≥18 years old) making their first purchase at local participating vape shops were asked by professional retail staff to complete a form. Measurements: Their cigarette consumption was followed-up prospectively at 6 and 12 months. Details of products purchase (i.e., e-cigs hardware, e-liquid nicotine strengths and flavours) were also noted. Findings: Retention rate was elevated, with 69% of participants attending their final follow-up visit. At 12 month, 40.8% subjects could be classified as quitters, 25.4% as reducers and 33.8% as failures. Switching from standard refillables (initial choice) to more advanced devices (MODs) was observed in this study (from 8.5% at baseline to 18.4% at 12 month) as well as a trend in decreasing the e-liquid nicotine strength, with more participants adopting low nicotine strength (from 49.3% at baseline to 57.1% at 12 month). Conclusions: We have found that smokers purchasing e-cigarettes from vape shops with professional advice and support can achieve high success rates. PMID:25811767

  1. A 12-Month Prospective Cohort Study of Symptoms of Common Mental Disorders Among European Professional Footballers.

    PubMed

    Gouttebarge, Vincent; Aoki, Haruhito; Verhagen, Evert A L M; Kerkhoffs, Gino M M J

    2017-09-01

    To determine the 12-month incidence and comorbidity of symptoms of common mental disorders (CMD) among European professional footballers and to explore the association of potential stressors with the health conditions under study among those European professional footballers. Observational prospective cohort study with a follow-up period of 12 months. Male professional footballers from 5 European countries (n = 384 at baseline). Adverse life events, conflicts with trainer/coach, and career dissatisfaction were explored by using validated questionnaires. Symptoms of distress, anxiety/depression, sleep disturbance, and adverse alcohol use were assessed using validated questionnaires. A total of 384 players (mean age of 27 years old; mean career duration of 8 years) were enrolled, of which 262 completed the follow-up period. The incidence of symptoms of CMD were 12% for distress, 37% for anxiety/depression, 19% for sleep disturbance, and 14% for adverse alcohol use. Over the follow-up period of 12 months, approximately 13% of the participants reported 2 symptoms, 5% three symptoms, and 3% four symptoms. Professional footballers reporting recent adverse life events, a conflict with trainer/coach, or career dissatisfaction were more likely to report symptoms of CMD, but statistically significant associations were not found. The 12-month incidence of symptoms of CMD among European professional footballers ranged from 12% for symptoms of distress to 37% for symptoms of anxiety/depression. A professional football team typically drawn from a squad of 25 players can expect symptoms of CMD to occur among at least 3 players in one season.

  2. Factors that can predict pain with walking, 12 months after total knee arthroplasty.

    PubMed

    Lindberg, Maren Falch; Miaskowski, Christine; RustøEn, Tone; Rosseland, Leiv Arne; Cooper, Bruce A; Lerdal, Anners

    2016-12-01

    Background and purpose - Functional limitations after total knee arthroplasty (TKA) are common. In this longitudinal study, we wanted to identify subgroups of patients with distinct trajectories of pain-related interference with walking during the first year after TKA and to determine which demographic, clinical, symptom-related, and psychological characteristics were associated with being part of this subgroup. Patients and methods - Patients scheduled for primary TKA for osteoarthritis (n = 202) completed questionnaires that evaluated perception of pain, fatigue, anxiety, depression, and illness on the day before surgery. Clinical characteristics were obtained from the medical records. Interference of pain with walking was assessed preoperatively, on postoperative day 4, and at 6 weeks, 3 months, and 12 months after TKA. Results - Using growth mixture modeling, 2 subgroups of patients were identified with distinct trajectories of pain-related interference with walking over time. Patients in the Continuous Improvement class (n = 157, 78%) had lower preoperative interference scores and reported a gradual decline in pain-related interference with walking over the first 12 months after TKA. Patients in the Recurrent Interference class (n = 45, 22%) reported a high degree of preoperative pain-related interference with walking, initial improvement during the first 3 months after TKA, and then a gradual increase-returning to preoperative levels at 12 months. Patients in the Recurrent Interference class had higher preoperative pain, fatigue, and depression scores, and poorer perception of illness than the Continuous Improvement class. Interpretation - 1 in 5 patients did not improve in pain-related interference with walking at 12 months after TKA. Future studies should test the efficacy of interventions designed to modify preoperative characteristics.

  3. 6 Minute Walk Test in Duchenne MD Patients with Different Mutations: 12 Month Changes

    PubMed Central

    Pane, Marika; Mazzone, Elena S.; Sormani, Maria Pia; Messina, Sonia; Vita, Gian Luca; Fanelli, Lavinia; Berardinelli, Angela; Torrente, Yvan; D'Amico, Adele; Lanzillotta, Valentina; Viggiano, Emanuela; D'Ambrosio, Paola; Cavallaro, Filippo; Frosini, Silvia; Bello, Luca; Bonfiglio, Serena; Scalise, Roberta; De Sanctis, Roberto; Rolle, Enrica; Bianco, Flaviana; Van der Haawue, Marlene; Magri, Francesca; Palermo, Concetta; Rossi, Francesca; Donati, Maria Alice; Alfonsi, Chiara; Sacchini, Michele; Arnoldi, Maria Teresa; Baranello, Giovanni; Mongini, Tiziana; Pini, Antonella; Battini, Roberta; Pegoraro, Elena; Previtali, Stefano C.; Napolitano, Sara; Bruno, Claudio; Politano, Luisa; Comi, Giacomo P.; Bertini, Enrico; Morandi, Lucia; Gualandi, Francesca; Ferlini, Alessandra; Goemans, Nathalie; Mercuri, Eugenio

    2014-01-01

    Objective In the last few years some of the therapeutical approaches for Duchenne muscular dystrophy (DMD) are specifically targeting distinct groups of mutations, such as deletions eligible for skipping of individual exons. The aim of this observational study was to establish whether patients with distinct groups of mutations have different profiles of changes on the 6 minute walk test (6MWT) over a 12 month period. Methods The 6MWT was performed in 191 ambulant DMD boys at baseline and 12 months later. The results were analysed using a test for heterogeneity in order to establish possible differences among different types of mutations (deletions, duplications, point mutations) and among subgroups of deletions eligible to skip individual exons. Results At baseline the 6MWD ranged between 180 and 560,80 metres (mean 378,06, SD 74,13). The 12 month changes ranged between −325 and 175 (mean −10.8 meters, SD 69.2). Although boys with duplications had better results than those with the other types of mutations, the difference was not significant. Similarly, boys eligible for skipping of the exon 44 had better baseline results and less drastic changes than those eligible for skipping exon 45 or 53, but the difference was not significant. Conclusions even if there are some differences among subgroups, the mean 12 month changes in each subgroup were all within a narrow Range: from the mean of the whole DMD cohort. This information will be of help at the time of designing clinical trials with small numbers of eligible patients. PMID:24421885

  4. Factors that can predict pain with walking, 12 months after total knee arthroplasty

    PubMed Central

    Lindberg, Maren Falch; Miaskowski, Christine; RustøEn, Tone; Rosseland, Leiv Arne; Cooper, Bruce A; Lerdal, Anners

    2016-01-01

    Background and purpose — Functional limitations after total knee arthroplasty (TKA) are common. In this longitudinal study, we wanted to identify subgroups of patients with distinct trajectories of pain-related interference with walking during the first year after TKA and to determine which demographic, clinical, symptom-related, and psychological characteristics were associated with being part of this subgroup. Patients and methods — Patients scheduled for primary TKA for osteoarthritis (n = 202) completed questionnaires that evaluated perception of pain, fatigue, anxiety, depression, and illness on the day before surgery. Clinical characteristics were obtained from the medical records. Interference of pain with walking was assessed preoperatively, on postoperative day 4, and at 6 weeks, 3 months, and 12 months after TKA. Results — Using growth mixture modeling, 2 subgroups of patients were identified with distinct trajectories of pain-related interference with walking over time. Patients in the Continuous Improvement class (n = 157, 78%) had lower preoperative interference scores and reported a gradual decline in pain-related interference with walking over the first 12 months after TKA. Patients in the Recurrent Interference class (n = 45, 22%) reported a high degree of preoperative pain-related interference with walking, initial improvement during the first 3 months after TKA, and then a gradual increase—returning to preoperative levels at 12 months. Patients in the Recurrent Interference class had higher preoperative pain, fatigue, and depression scores, and poorer perception of illness than the Continuous Improvement class. Interpretation — 1 in 5 patients did not improve in pain-related interference with walking at 12 months after TKA. Future studies should test the efficacy of interventions designed to modify preoperative characteristics. PMID:27658970

  5. Gender and relational differences in sensitivity to internal and external cues at 12 months.

    PubMed

    Watson, John S; Futo, Judit; Fonagy, Peter; Gergely, Gyorgy

    2011-03-01

    Gender differences favoring women in relation to awareness of the subjective (internal) world are well demonstrated but their origins are poorly understood. We trained 173 12-month-olds to visually fixate a video image in response to an internal cue (opening own mouth), external cue (seeing a face open its mouth), or both cues. Female infants showed significantly greater sensitivity than males to the internal cues suggesting that prioritization of internally accessible experience is already evident at one year of age.

  6. Effect of exercise on serum estrogens in postmenopausal women: a 12-month randomized clinical trial.

    PubMed

    McTiernan, Anne; Tworoger, Shelley S; Ulrich, Cornelia M; Yasui, Yutaka; Irwin, Melinda L; Rajan, Kumar B; Sorensen, Bess; Rudolph, Rebecca E; Bowen, Deborah; Stanczyk, Frank Z; Potter, John D; Schwartz, Robert S

    2004-04-15

    Elevated circulating estrogens and a sedentary lifestyle increase risk for breast cancer. The effect of exercise on circulating estrogens in sedentary postmenopausal women is unknown. The objective of this study was to examine the effects of a 12-month moderate-intensity exercise intervention on serum estrogens. We randomly assigned 173 sedentary, overweight (body mass index > 24.0 kg/m(2), body fat > 33%), postmenopausal women, ages 50-75 years, not using hormone therapy, living in the Seattle, Washington, area for the next year, and willing to be randomly assigned to an exercise intervention or stretching control group. The exercise intervention included facility and home-based exercise (45 min, 5 days/week moderate intensity sports/recreational exercise). A total of 170 (98.3%) women completed the study with exercisers averaging 171 min/week of exercise. After 3 months, exercisers experienced declines in estrone, estradiol, and free estradiol of 3.8, 7.7, and 8.2%, respectively, versus no change or increased concentrations in controls (P = 0.03, 0.07, and 0.02, respectively). At 12 months, the direction of effect remained the same, although the differences were no longer statistically significant. The effect was limited to women who lost body fat: women whose percentage of body fat [by dual energy x-ray absortiometry (DEXA)] decreased by >/==" BORDER="0">2% had statistically significant (comparing exercisers versus controls) decreases at 12 months of 11.9, 13.7, and 16.7% for serum estrone, estradiol, and free estradiol, respectively. We concluded that a 12-month moderate-intensity exercise intervention in postmenopausal women resulted in significant decreases in serum estrogens. The association between increased physical activity and reduced risk for postmenopausal breast cancer may be partly explained by effects on serum estrogens.

  7. Employment-based Reinforcement of Adherence to Oral Naltrexone in Unemployed Injection Drug Users: 12-month Outcomes

    PubMed Central

    Dunn, Kelly; DeFulio, Anthony; Everly, Jeffrey J.; Donlin, Wendy D.; Aklin, Will M.; Nuzzo, Paul A.; Leoutsakos, Jeannie-Marie S.; Umbricht, Annie; Fingerhood, Michael; Bigelow, George E.; Silverman, Kenneth

    2015-01-01

    Oral naltrexone could be a promising relapse prevention pharmacotherapy for recently detoxified opioid-dependent patients, however interventions are often needed to promote adherence with this treatment approach. We recently conducted a study to evaluate a 26-week employment-based reinforcement intervention of oral naltrexone in unemployed injection drug users (Dunn et al., 2013). Participants were randomly assigned into a Contingency (n=35) group required to ingest naltrexone under staff observation to gain entry into a therapeutic workplace, or a Prescription (n=32) group given a take-home supply of oral naltrexone and access to the workplace without observed ingestion. Monthly urine samples were collected and analyzed for evidence for naltrexone adherence, opioid use, and cocaine use. As previously reported, Contingency participants provided significantly more naltrexone-positive urine samples than Prescription participants during the 26-week intervention period. The goal of this current study is to report the 12-month outcomes, which occurred 6 months after the intervention ended. Results at the 12-month visit showed no between-group differences in naltrexone-positive, opioid-negative, or cocaine-negative urine samples, and no participant self-reported using naltrexone at the follow-up visit. These results show that even after a period of successfully reinforced oral naltrexone adherence longer-term naltrexone use is unlikely to be maintained after reinforcement contingencies are discontinued. PMID:25134047

  8. Employment-based reinforcement of adherence to oral naltrexone in unemployed injection drug users: 12-month outcomes.

    PubMed

    Dunn, Kelly; DeFulio, Anthony; Everly, Jeffrey J; Donlin, Wendy D; Aklin, Will M; Nuzzo, Paul A; Leoutsakos, Jeannie-Marie S; Umbricht, Annie; Fingerhood, Michael; Bigelow, George E; Silverman, Kenneth

    2015-06-01

    Oral naltrexone could be a promising relapse-prevention pharmacotherapy for recently detoxified opioid-dependent patients; however, interventions are often needed to promote adherence with this treatment approach. We recently conducted a study to evaluate a 26-week employment-based reinforcement intervention of oral naltrexone in unemployed injection drug users (Dunn et al., 2013). Participants were randomly assigned into a contingency (n = 35) group required to ingest naltrexone under staff observation to gain entry into a therapeutic workplace or a prescription (n = 32) group given a take-home supply of oral naltrexone and access to the workplace without observed ingestion. Monthly urine samples were collected and analyzed for evidence for naltrexone adherence, opioid use, and cocaine use. As previously reported, contingency participants provided significantly more naltrexone-positive urine samples than prescription participants during the 26-week intervention period. The goal of this current study is to report the 12-month outcomes, which occurred 6 months after the intervention ended. Results at the 12-month visit showed no between-groups differences in naltrexone-positive, opioid-negative, or cocaine-negative urine samples and no participant self-reported using naltrexone at the follow-up visit. These results show that even after a period of successfully reinforced oral naltrexone adherence, longer-term naltrexone use is unlikely to be maintained after reinforcement contingencies are discontinued. (PsycINFO Database Record

  9. [Prevalence of iron deficiency in healthy 12-month-old infants].

    PubMed

    Durá Travé, T; Díaz Vélaz, L

    2002-09-01

    Iron deficiency is the most prevalent nutritional deficiency among infants in industrialized countries. There is ample documentation of both short- and long-term adverse effects of iron deficiency. To study the prevalence of iron deficiency in 12-month-old infants and to investigate the influence of several factors (dietary, growth, etc.) on iron status. A random sample of 94 healthy infants from a basic health district was studied. Maternal and perinatal variables, dietary intake and anthropometry were assessed at regular intervals from birth to the age of 12 months. Hemoglobin, mean corpuscular volume, transferrin saturation and serum ferritin were also evaluated. The prevalence of iron deficiency was 9.6 % and that of iron deficiency anemia was 4.3 %. Of the nine infants with iron deficiency, four had been breast-fed for more than 6 months with late introduction of complementary foods and another had not been fed an iron-fortified formula while the 85 children without iron deficiency had received an appropriate diet (p < 0.05). Weight increase in the first year of life was significantly and positively correlated with hemoglobin and serum ferritin. Iron deficiency is relatively common in 12-month-old-infants but is limited to groups with inadequate feeding practices. Iron deficiency screening should be performed only in children with risk factors and/or inadequate diets.

  10. Depression 12-months after coronary artery bypass graft is predicted by cortisol slope over the day.

    PubMed

    Poole, Lydia; Kidd, Tara; Ronaldson, Amy; Leigh, Elizabeth; Jahangiri, Marjan; Steptoe, Andrew

    2016-09-01

    Alterations in the diurnal profile of cortisol have been associated with depressed mood in patients with coronary heart disease. The relationship between cortisol output and depressed mood has not been investigated prospectively in coronary artery bypass graft (CABG) patients before. We aimed to study the relationship between cortisol measured pre- and post-operatively and depression symptoms measured 12 months after CABG surgery. We analysed data from 171 patients awaiting first-time, elective CABG surgery from the pre-assessment clinic at St. George's Hospital, London. The Beck Depression Inventory (BDI) was used to assess depression symptoms and saliva samples were collected to measure diurnal cortisol. Baseline assessments of depression and cortisol were obtained an average 29days before surgery, short-term follow-up of cortisol occurred 60days after surgery and long-term follow-up of depression was assessed 378days after surgery. Baseline cortisol slope was not associated with depression at 12-month follow-up. However, a steeper cortisol slope measured 60days after surgery predicted reduced odds of depression (BDI≥10) 12 months after surgery (odds ratio 0.661, 95% confidence interval 0.437-0.998, p=0.049) after controlling for covariates. These findings suggest interventions aimed at improving adaptation in the early recovery period may have long-term benefits in this patient group. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. Catheter-based renal denervation for resistant hypertension: 12-month results of the EnligHTN I first-in-human study using a multielectrode ablation system.

    PubMed

    Papademetriou, Vasilios; Tsioufis, Costas P; Sinhal, Ajay; Chew, Derek P; Meredith, Ian T; Malaiapan, Yuvi; Worthley, Matthew I; Worthley, Stephen G

    2014-09-01

    Renal denervation has emerged as a novel approach for the treatment of patients with drug-resistant hypertension. To date, only limited data have been published using multielectrode radiofrequency ablation systems. In this article, we present the 12-month data of EnligHTN I, a first-in-human study using a multielectrode ablation catheter. EnligHTN I enrolled 46 patients (average age, 60±10 years; on average 4.7±1.0 medications) with drug-resistant hypertension. Eligible patients were on ≥3 antihypertensive medications and had a systolic blood pressure (BP) ≥160 mm Hg (≥150 mm Hg for diabetics). Bilateral renal artery ablation was performed using a percutaneous femoral approach and standardized techniques. The average baseline office BP was 176/96 mm Hg, average 24-hour ambulatory BP was 150/83 mm Hg, and average home BP was 158/90 mm Hg. The average reductions (mm Hg) at 1, 3, 6, and 12 months were as follows: office: -28/-10, -27/-10, -26/-10, and -27/-11 mm Hg (P<0.001 for all); 24-hour ambulatory: -10/-5, -10/-5, -10/-6 (P<0.001 for all), and -7/-4 for 12 months (P<0.0094). Reductions in home measurements (based on 2-week average) were -9/-4, -8/-5,-10/-7, and -11/-6 mm Hg (P<0.001 at 12 months). At 12 months, there were no signals of worsening renal function and no new serious or life-threatening adverse events. One patient with baseline nonocclusive renal artery stenosis progressed to 75% diameter stenosis, requiring renal artery stenting. The 12-month data continue to demonstrate safety and efficacy of the EnligHTN ablation system in patients with drug-resistant hypertension. Home BP measurements parallel measurements obtained with 24-hour ambulatory monitoring.

  12. Spatial Habitat Features Derived from Multiparametric Magnetic Resonance Imaging Data Are Associated with Molecular Subtype and 12-Month Survival Status in Glioblastoma Multiforme

    PubMed Central

    Lee, Joonsang; Narang, Shivali; Martinez, Juan; Rao, Ganesh; Rao, Arvind

    2015-01-01

    One of the most common and aggressive malignant brain tumors is Glioblastoma multiforme. Despite the multimodality treatment such as radiation therapy and chemotherapy (temozolomide: TMZ), the median survival rate of glioblastoma patient is less than 15 months. In this study, we investigated the association between measures of spatial diversity derived from spatial point pattern analysis of multiparametric magnetic resonance imaging (MRI) data with molecular status as well as 12-month survival in glioblastoma. We obtained 27 measures of spatial proximity (diversity) via spatial point pattern analysis of multiparametric T1 post-contrast and T2 fluid-attenuated inversion recovery MRI data. These measures were used to predict 12-month survival status (≤12 or >12 months) in 74 glioblastoma patients. Kaplan-Meier with receiver operating characteristic analyses was used to assess the relationship between derived spatial features and 12-month survival status as well as molecular subtype status in patients with glioblastoma. Kaplan-Meier survival analysis revealed that 14 spatial features were capable of stratifying overall survival in a statistically significant manner. For prediction of 12-month survival status based on these diversity indices, sensitivity and specificity were 0.86 and 0.64, respectively. The area under the receiver operating characteristic curve and the accuracy were 0.76 and 0.75, respectively. For prediction of molecular subtype status, proneural subtype shows highest accuracy of 0.93 among all molecular subtypes based on receiver operating characteristic analysis. We find that measures of spatial diversity from point pattern analysis of intensity habitats from T1 post-contrast and T2 fluid-attenuated inversion recovery images are associated with both tumor subtype status and 12-month survival status and may therefore be useful indicators of patient prognosis, in addition to providing potential guidance for molecularly-targeted therapies in

  13. Assessing early communication skills at 12 months: a retrospective study of Autism Spectrum Disorder.

    PubMed

    Swain, Nathaniel Robert; Eadie, Patricia Ann; Prior, Margot Ruth; Reilly, Sheena

    2015-07-01

    Early identification of Autism Spectrum Disorder (ASD) is currently limited by the absence of reliable biological markers for the disorder, as well as the reliability of screening and assessment tools for children aged between 6 and 18 months. Ongoing research has demonstrated the importance of early social communication skills in differentiating children later diagnosed with ASD from their typically developing (TD) peers, but researchers have not yet investigated whether these differences can be detected using community-ascertained systematic observation data as early as 12 months. To investigate whether differences in early social communication skills can be detected at 12 months of age, comparing children later diagnosed with ASD, and TD peers; and to determine whether differences remain when groupings are based on age of subsequent ASD diagnosis. From a prospective community-ascertained sample, we collected data on children in early life, then conducted retrospective analyses for those children who were later diagnosed with ASD by the age of 7 years, compared with matched TD peers. We analysed standardized observational data of early communication skills, collected using the Communication and Symbolic Behavior Scales-Developmental Profile (CSBS-DP) Behavior Sample, when participants were 12 months of age. Children in the ASD group exhibited significantly lower social communication skills than the TD group, including on the Total score and Social and Symbolic Composite scores of the CSBS-DP Behavior Sample. Differences on the Total score and Social Composite were also detected for both early and late ASD diagnosis groups when compared with the TD group. These findings give further support for the importance of social communication in assessing children at risk of ASD as early as 12 months of age. Future research could evaluate the sensitivity and specificity of direct observation of these early communication skills as diagnostic indicators for ASD at 12 months

  14. Postoperative stability for surgery-first approach using intraoral vertical ramus osteotomy: 12 month follow-up.

    PubMed

    Kim, Jun-Young; Jung, Hwi-Dong; Kim, Sang Yoon; Park, Hyung-Sik; Jung, Young-Soo

    2014-07-01

    The aim of this study was to evaluate the postoperative stability of the surgery-first approach using intraoral vertical ramus osteotomy (IVRO). We retrospectively studied a sample derived from the patients who were treated by the surgery-first approach using a LeFort I osteotomy and IVRO for correction of class III dentofacial deformity from 2008 to 2012. Lateral cephalograms taken preoperatively and 2 days, 6 months, and 12 months postoperatively were traced, and the skeletal and dental variables at different time points were analysed. The study sample comprised 37 subjects, mean (SD) age 23 (4) years. The mean (SD) total duration of treatment including postoperative orthodontics was 14 (6) months, and surgical movement of the maxillary A point was 0.75 (1.3)mm anteriorly, and 0.21 (1.79)mm superiorly. The surgical change in the position of the maxillary first molar was 1.01 (1.57)mm superiorly. The mean (SD) movement of mandible was 11.15 (5.4)mm posteriorly at pogonion and 1.02 (1.79)mm inferiorly at menton. There were no significant change in maxillary skeletal variables during the first year postoperative period. The surgical relapse of mandible at pogonion was 0.63 (2.31) mm anteriorly (p=0.01), however, the relapse in superior direction at menton was 2.86 (1.39) mm with statistical significance (p=0.01). The total duration of orthodontic treatment with surgery-first was roughly 5 months shorter than conventional preoperative and postoperative orthodontic treatment. The surgery-first approach using IVRO is effective and predictable, and shortens the overall duration of treatment. Anterior relapse of the mandible was less than 1mm, and increased superior relapse can be compensated for with appropriate preoperative planning to provide a reliable outcome. This study was limited to 12 months' follow-up, and a long term follow-up study is indicated.

  15. Symptomatic response rates to testosterone therapy and the likelihood of completing 12 months of therapy in clinical practice.

    PubMed

    Rhoden, Ernani Luis; Morgentaler, Abraham

    2010-01-01

    Despite increasing medical interest in testosterone therapy (TTh) for men with testosterone deficiency (TD) there is limited information regarding subjective response rates and acceptability of medium- to long-term TTh in routine clinical practice. To evaluate results in a consecutive series of men in clinical practice treated with TTh. A chart review was performed for a consecutive series of men for whom TTh was initiated over 1 year for a clinical diagnosis of TD. A diagnosis of TD was based on the presence of symptoms and on laboratory evaluation indicating total testosterone (<300 ng/dL) or free testosterone (FT) (<1.5 ng/dL). Presenting symptoms were noted at baseline, and improvement was documented in domains of erectile function, libido, energy,and mood. Percentage of men who completed 12 months of TTh, and symptomatic response rates. There were 127 men included in the evaluation. The most common presenting symptoms were the combination of erectile dysfunction (ED) and reduced libido in 82 (64.6%), ED alone in 29 (22.8%), and reduced libido alone in 13 (10.2%). Initial mode of TTh was injections (testosterone enanthate or cypionate) in 70 (55.1%)and transdermal gel (Androgel, Solvay Pharmaceuticals, Marietta, GA, USA) in the remainder. Improvements in erections, libido, energy, and/or mood were reported by 70% of men by 3 months. Eighty men (63%) completed 12 months of TTh with subjective benefit (responders). Treatment was discontinued in 34 (26.8%) who reported no major benefit (non-responders), and 13 (10.2%) were lost to follow-up. Among men who discontinued TTh, 64.7%failed to report benefits by 3 months. Baseline FT was lower among responders than non-responders. One case(1.25%) of prostate cancer was identified after one year of TTh. Approximately two-thirds of men with TD who begin TTh will experience symptomatic benefit and will complete at least 12 months of treatment. Benefit was noted in a majority by 3 months.

  16. Communication development in children who receive a cochlear implant by 12 months of age.

    PubMed

    Leigh, Jaime; Dettman, Shani; Dowell, Richard; Briggs, Robert

    2013-04-01

    Describe the long-term benefits of early cochlear implantation. Provide a comprehensive description of outcomes, including: language, speech production, and speech perception. Compare the communication outcomes for the early implanted children to those of normally hearing children and children who received a cochlear implant at a comparatively older age. Retrospective review of the communication development of 35 children implanted between 6 and 12 months of age and 85 children implanted between 13 and 24 months of age. Audiologic assessments included unaided and aided audiograms, auditory brainstem response (ABR), auditory steady state response (ASSR), and otoacoustic emissons (OAEs). Formal language, speech production, and speech perception measures were administered, preimplant and at 1, 2, 3, and 5 years postimplant. The children who received their cochlear implant by 12 months of age demonstrated language growth rates equivalent to their normally hearing peers and achieved age appropriate receptive language scores 3 years postimplant. The children who received their cochlear implant between 13 and 24 months demonstrated a significant language delay at 3 years postimplant. Speech production development followed a similar pattern to that of normal-hearing children, although was delayed, for both groups of children. Mean open-set speech perception scores were comparable with previous reports for children and adults who use cochlear implants. Children implanted by 12 months of age demonstrate better language development compared with children who receive their cochlear implant between 13 and 24 months. This supports the provision of a cochlear implant within the first year of life to enhance the likelihood that a child with severe-to-profound hearing impairment will commence elementary school with age-appropriate language skills.

  17. Sociodemographic, Perinatal, Behavioral, and Psychosocial Predictors of Weight Retention at 3 and 12 months Postpartum

    PubMed Central

    Siega-Riz, Anna Maria; Herring, Amy H.; Carrier, Kathryn; Evenson, Kelly R.; Dole, Nancy; Deierlein, Andrea

    2010-01-01

    Postpartum weight retention plays an important role in the pathway leading to obesity among women of childbearing age. The objective of this study was to examine predictors of moderate (1–10 pounds) and high (>10 pounds) postpartum weight retention using data from a prospective pregnancy cohort that followed women into the postpartum period; n=688 and 550 women at 3 and 12 months, respectively. Analysis included descriptive statistics and predictive modeling using log-binomial techniques. The average weight retained at 3 and 12 months postpartum in this population was 9.4 lbs (SD=11.4) and 5.7 lbs (SD=13.2) respectively. At 3- months postpartum, prepregnancy weight, gestational weight gain, and hours slept during the night were associated with moderate or high weight retention while having an infant hospitalized after going home and scoring in the upper 75th percentile of the eating attitudes test were associated only with high weight retention. At 12- months postpartum, prepregnancy weight, gestational weight gain and maternal education were associated with moderate weight retention and gestational weight gain, maternal age, race, employment status, and having an infant hospitalized at birth were associated with high weight retention. The results of this study illustrate the importance of prepregnancy weight and gestational weight gain in predicting postpartum weight retention. Furthermore, given the lack of successful intervention studies that exist to date to help women lose weight in the postpartum period, the results of this study may help to inform future interventions that focus on such aspects as hours of sleep, dealing with stress associated with a hospitalized infant, and non-clinical eating disorder symptomatology. PMID:20035283

  18. Language development at 18 months is related to multimodal communicative strategies at 12 months.

    PubMed

    Igualada, Alfonso; Bosch, Laura; Prieto, Pilar

    2015-05-01

    The present study investigated the degree to which an infants' use of simultaneous gesture-speech combinations during controlled social interactions predicts later language development. Nineteen infants participated in a declarative pointing task involving three different social conditions: two experimental conditions (a) available, when the adult was visually attending to the infant but did not attend to the object of reference jointly with the child, and (b) unavailable, when the adult was not visually attending to neither the infant nor the object; and (c) a baseline condition, when the adult jointly engaged with the infant's object of reference. At 12 months of age measures related to infants' speech-only productions, pointing-only gestures, and simultaneous pointing-speech combinations were obtained in each of the three social conditions. Each child's lexical and grammatical output was assessed at 18 months of age through parental report. Results revealed a significant interaction between social condition and type of communicative production. Specifically, only simultaneous pointing-speech combinations increased in frequency during the available condition compared to baseline, while no differences were found for speech-only and pointing-only productions. Moreover, simultaneous pointing-speech combinations in the available condition at 12 months positively correlated with lexical and grammatical development at 18 months of age. The ability to selectively use this multimodal communicative strategy to engage the adult in joint attention by drawing his attention toward an unseen event or object reveals 12-month-olds' clear understanding of referential cues that are relevant for language development. This strategy to successfully initiate and maintain joint attention is related to language development as it increases learning opportunities from social interactions.

  19. Self-Reported Hedonism Predicts 12-Month Weight Loss After Roux-en-Y Gastric Bypass.

    PubMed

    Alfonsson, Sven; Weineland-Strandskov, Sandra; Sundbom, Magnus

    2017-08-01

    Research regarding psychological risk factors for reduced weight loss after bariatric surgery has yielded mixed results, especially for variables measured prior to surgery. More profound personality factors have shown better promise and one such factor that may be relevant in this context is time perspective, i.e., the tendency to focus on present or future consequences. The aim of this study was to investigate the predictive value of time perspective for 12-month weight loss after Roux-en-Y gastric bypass surgery. A total of 158 patients were included and completed self-report instruments prior to surgery. Weight loss was measured after 12 months by medical staff. Background variables as well as self-reported disordered eating, psychological distress, and time perspective were analyzed with regression analysis to identify significant predictors for 12-month weight loss. The mean BMI loss at 12 months was 14 units, from 45 to 30 kg/m(2). Age, sex, and time perspective could significantly predict weight loss but only male sex and self-reported hedonism were independent risk factors for reduced weight loss in the final regression model. In this study, self-reported hedonistic time perspective proved to be a better predictor for 12-month weight loss than symptoms of disordered eating and psychological distress. It is possible that a hedonistic tendency of focusing on immediate consequences and rewards is analogous to the impaired delay discounting seen in previous studies of bariatric surgery candidates. Further studies are needed to identify whether these patients may benefit from extended care and support after surgery.

  20. Socio-demographic inequalities and teeth extraction in the last 12 months in Italy

    PubMed Central

    La Torre, Giuseppe; Romeo, Umberto; Iarocci, Gianluca; Brugnoletti, Orlando; Semyonov, Leda; Galanakis, Alexandros; Barbato, Ersilia

    2014-01-01

    Summary Aims Teeth loss represents a major concern for the global oral health status of a population. The aim of this study was to describe the prevalence of teeth extraction among the Italian adult population, analyzing the association between teeth extraction in the last 12 months and socio-demographic characteristics. Methods This cross-sectional study is based on the national survey ‘Health Conditions and Healthcare Services Use’, carried out by the Italian National Centre of Statistics (ISTAT) in 2005. A univariate analysis was performed to investigate the association between the dependent and the independent variables (teeth extraction Vs socio-demographic characteristics). Multiple logistic regression analysis was conducted to assess the influence on the outcome (teeth extraction Yes/No). Results The present study highlights the relationship between teeth extraction and socio-demographic factors. Out of 128,040 individuals, the sampled population consisted of 124,677 subjects, representing 56,400,323 individuals in the Italian population. The prevalence of teeth extraction in the last 12 months was 8.2%. Subjects who underwent teeth extraction in the last 12 months were prevalent female (8.6%), smokers (10.4%), with a primary education (9.2%), married (9.2%), in poor health conditions (9.3%), age category of 55–64 years (11.1%), from Northeast of Italy (8.5%), with scarce household income (8.4%). The multivariate analysis confirmed most of the results of the univariate analysis. Conclusions Inequalities in health among groups of various socioeconomic status constitute one of the main challenges for public health; these inequalities might be reduced by improving educational opportunities, income distribution, health-related behaviour, or accessibility to health care. PMID:25774248

  1. Effect of omega-3 supplementation on neuropathy in type 1 diabetes: A 12-month pilot trial.

    PubMed

    Lewis, Evan J H; Perkins, Bruce A; Lovblom, Leif E; Bazinet, Richard P; Wolever, Thomas M S; Bril, Vera

    2017-06-13

    To test the hypothesis that 12 months of seal oil omega-3 polyunsaturated fatty acids (ω-3 PUFA) supplementation will stop the known progression of diabetic sensorimotor polyneuropathy (DSP) in type 1 diabetes mellitus (T1DM). Individuals with T1DM and evidence of DSP as determined by a Toronto Clinical Neuropathy Score ≥1 were recruited to participate in a single-arm, open-label trial of seal oil ω-3 PUFA supplementation (10 mL·d(-1); 750 mg eicosapentaenoic acid, 560 mg docosapentaenoic acid, and 1,020 mg docosahexaenoic acid) for 1 year. The primary outcome was the 1-year change in corneal nerve fiber length (CNFL) measured by in vivo corneal confocal microscopy, with sensory and nerve conduction measures as secondary outcomes. Forty participants (53% female), aged 48 ± 14 years, body mass index 28.1 ± 5.8 with diabetes duration of 27 ± 18 years, were enrolled. At baseline, 23 participants had clinical DSP and 17 did not. Baseline CNFL was 8.3 ± 2.9 mm/mm(2) and increased 29% to 10.1 ± 3.7 mm/mm(2) (p = 0.002) after 12 months of supplementation. There was no change in nerve conduction or sensory function. Twelve months of ω-3 supplementation was associated with increase in CNFL in T1DM. NCT02034266. This study provides Class IV evidence that for patients with T1DM and evidence of DSP, 12 months of seal oil omega-3 supplementation increases CNFL. © 2017 American Academy of Neurology.

  2. Performance and Safety of a New Ab Interno Gelatin Stent in Refractory Glaucoma at 12 Months.

    PubMed

    Grover, Davinder S; Flynn, William J; Bashford, Kent P; Lewis, Richard A; Duh, Yi-Jing; Nangia, Rupali S; Niksch, Barbara

    2017-08-04

    To evaluate the intraocular pressure (IOP)-lowering performance and safety of an ab interno gelatin stent (XEN® 45 Gel Stent, Allergan plc), a minimally invasive glaucoma surgery device, in refractory glaucoma. Single-arm, open-label, multicenter clinical study. Following mitomycin pretreatment, the stent was placed ab interno in patients who failed prior filtering/cilioablative procedure or had uncontrolled IOP on maximum-tolerated medical therapy, with medicated IOP ≥20 and ≤35 mmHg and visual field mean deviation ≤-3 dB. Primary performance outcomes: patients (%) achieving ≥20% IOP reduction from baseline on the same or fewer medications and mean IOP change from baseline at month 12. Procedure-related complications and ocular adverse events (AEs) were assessed. Sixty-five patients were implanted (intent-to-treat/safety population). At 12 months, 75.4% (46/61; observed data) reported ≥20% IOP lowering from baseline on the same or fewer medications. Mean IOP change from baseline was -9.1 mmHg (95% CI: -10.7, -7.5) (n=52; observed data) at 12 months, excluding patients with missing data (n=4) and those requiring a glaucoma-related secondary surgical intervention (n=9). Mean medication count decreased from 3.5 (baseline) to 1.7 (12 months). No intraoperative complications or unexpected postoperative AEs were reported. Most AEs were mild/moderate; common AEs included needling (without sight-threatening complications), non-persistent loss of best-corrected visual acuity, and transient hypotony (requiring no surgical intervention). The gelatin stent reduced IOP and medication use without raising unexpected safety concerns, offering a minimally invasive surgical option for refractory glaucoma patients. Copyright © 2017. Published by Elsevier Inc.

  3. Risks and Benefits of Dual Antiplatelet Therapy Beyond 12 Months After Coronary Stenting

    PubMed Central

    Dadjou, Yahya; Safavi, Salar; Kojuri, Javad

    2016-01-01

    Abstract The optimal duration of dual antiplatelet therapy (DAT) after coronary stenting remains poorly define. The aim of this study was to evaluate the impact of longer than 24 months DAT in patients who received drug-eluting and bare-metal stents. A total of 1010 individuals who underwent elective, urgent or emergency coronary angioplasty with intended stent implantation at reference or specialized cardiac hospitals were randomized to receive long-term and short-term DAT to determine the benefits and adverse effects of long-term DAT. Total of 508 patients were randomized to long-term and 502 patients to <1 year DAT, and all of them were followed for more than 36 months for major adverse cardiac and cerebvascular events and bleeding major adverse cardiac and cerebvascular events (MACCE) Mean age of the 1010 patients (364 women and 646 men) was 60 years. Stent reocclusion occurred in 15 patients. Mean Syntax score was 23.00 ± 5.08 for whole samples, 25.00 ± 5.27 in 28 patients with MACCE and 23 ± 5.00 in 982 patients without MACCE (P = 0.057). According to all specified bleeding definitions, clopidogrel therapy for >12 months was not associated with a greater risk of hemorrhage. A regimen of >12 months of clopidogrel therapy in patients who had received drug-eluting or bare-metal stents did not differ significantly from a regimen of <12 months on clopidogrel with regard to MACCE. Long-term DAT might not significantly affect the reduction in the risk of death from any cause, myocardial infarction, or stroke, and not associated with minor or major bleeding events. PMID:27258494

  4. Cumulative traumas and risk thresholds: 12-month PTSD in the World Mental Health (WMH) surveys.

    PubMed

    Karam, Elie G; Friedman, Matthew J; Hill, Eric D; Kessler, Ronald C; McLaughlin, Katie A; Petukhova, Maria; Sampson, Laura; Shahly, Victoria; Angermeyer, Matthias C; Bromet, Evelyn J; de Girolamo, Giovanni; de Graaf, Ron; Demyttenaere, Koen; Ferry, Finola; Florescu, Silvia E; Haro, Josep Maria; He, Yanling; Karam, Aimee N; Kawakami, Norito; Kovess-Masfety, Viviane; Medina-Mora, María Elena; Browne, Mark A Oakley; Posada-Villa, José A; Shalev, Arieh Y; Stein, Dan J; Viana, Maria Carmen; Zarkov, Zahari; Koenen, Karestan C

    2014-02-01

    Clinical research suggests that posttraumatic stress disorder (PTSD) patients exposed to multiple traumatic events (TEs) rather than a single TE have increased morbidity and dysfunction. Although epidemiological surveys in the United States and Europe also document high rates of multiple TE exposure, no population-based cross-national data have examined this issue. Data were analyzed from 20 population surveys in the World Health Organization World Mental Health Survey Initiative (n = 51,295 aged 18+). The Composite International Diagnostic Interview (3.0) assessed 12-month PTSD and other common DSM-IV disorders. Respondents with 12-month PTSD were assessed for single versus multiple TEs implicated in their symptoms. Associations were examined with age of onset (AOO), functional impairment, comorbidity, and PTSD symptom counts. 19.8% of respondents with 12-month PTSD reported that their symptoms were associated with multiple TEs. Cases who associated their PTSD with four or more TEs had greater functional impairment, an earlier AOO, longer duration, higher comorbidity with mood and anxiety disorders, elevated hyperarousal symptoms, higher proportional exposures to partner physical abuse and other types of physical assault, and lower proportional exposure to unexpected death of a loved one than cases with fewer associated TEs. A risk threshold was observed in this large-scale cross-national database wherein cases who associated their PTSD with four or more TEs presented a more "complex" clinical picture with substantially greater functional impairment and greater morbidity than other cases of PTSD. PTSD cases associated with four or more TEs may merit specific and targeted intervention strategies. © 2013 Wiley Periodicals, Inc.

  5. Laser Pulpotomy–An Effective Alternative to Conventional Techniques: A 12 Months Clinicoradiographic Study

    PubMed Central

    Rana, Vivek; Srivastava, Nikhil; Chandna, Preetika

    2015-01-01

    ABSTRACT Background: Vital pulpotomy is a single-stage procedure of surgical amputation of the coronal portion of exposed vital pulp, usually as a means of preserving the vitality and function of the remaining radicular portion. Aims and objectives: The aim of this study was to compare the clinical and radiographic success rates for ferric sulfate (FS), electrosurgery (ES) and laser pulpotomy in human primary molars. Materials and methods: In a randomized clinical trial, 30 primary molars indicated for pulpotomy in children aged 4 to 10 years were treated using either a FS (10 teeth), ES technique (10 teeth) and laser (10 teeth). Following the pulpotomy, the teeth were evaluated for clinical and radiographic success at 3, 6, 9 and 12 months on the basis of the presence of pain, sinus, mobility, internal and external resorption, periapical radiolucency, calcification in the canal and bone loss. Statistical analysis: The data were assessed with Chi-square test. Results: After 12 months of follow-up, both clinical and radiographic success rates were 100% in the laser group but only 80% in both ES and FS groups. There was statistically significant difference between the success rates of three groups (p < 0.05). Conclusion: Laser pulpotomy showed better clinical as well as radiographical results than ES and FS pulpotomy. Laser pulpotomy was also found superior in terms of operating time, patient cooperation, ease of use and pain. Although results of the study showed the failure rates for electrosurgical pulpotomy to be equal to those for FS pulpotomy, electrosurgical pulpotomy being a nonpharmacological technique considered more favorable. Further studies using larger sample size and longer evaluation periods are suggested. How to cite this article: Gupta G, Rana V, Srivastava N, Chandna P. Laser Pulpotomy–An Effective Alternative to Conventional Techniques: A 12 Months Clinicoradiographic Study. Int J Clin Pediatr Dent 2015;8(1):18-21. PMID:26124576

  6. CUMULATIVE TRAUMAS AND RISK THRESHOLDS: 12-MONTH PTSD IN THE WORLD MENTAL HEALTH (WMH) SURVEYS

    PubMed Central

    Karam, Elie G.; Friedman, Matthew J.; Hill, Eric D.; Kessler, Ronald C.; McLaughlin, Katie A.; Petukhova, Maria; Sampson, Laura; Shahly, Victoria; Angermeyer, Matthias C.; Bromet, Evelyn J.; de Girolamo, Giovanni; de Graaf, Ron; Demyttenaere, Koen; Ferry, Finola; Florescu, Silvia E.; Haro, Josep Maria; He, Yanling; Karam, Aimee N.; Kawakami, Norito; Kovess-Masfety, Viviane; Medina-Mora, María Elena; Browne, Mark A. Oakley; Posada-Villa, José A.; Shalev, Arieh Y.; Stein, Dan J.; Viana, Maria Carmen; Zarkov, Zahari; Koenen, Karestan C.

    2014-01-01

    Background Clinical research suggests that posttraumatic stress disorder (PTSD) patients exposed to multiple traumatic events (TEs) rather than a single TE have increased morbidity and dysfunction. Although epidemiological surveys in the United States and Europe also document high rates of multiple TE exposure, no population-based cross-national data have examined this issue. Methods Data were analyzed from 20 population surveys in the World Health Organization World Mental Health Survey Initiative (n 51,295 aged 18+). The Composite International Diagnostic Interview (3.0) assessed 12-month PTSD and other common DSM-IV disorders. Respondents with 12-month PTSD were assessed for single versus multiple TEs implicated in their symptoms. Associations were examined with age of onset (AOO), functional impairment, comorbidity, and PTSD symptom counts. Results 19.8% of respondents with 12-month PTSD reported that their symptoms were associated with multiple TEs. Cases who associated their PTSD with four or more TEs had greater functional impairment, an earlier AOO, longer duration, higher comorbidity with mood and anxiety disorders, elevated hyper-arousal symptoms, higher proportional exposures to partner physical abuse and other types of physical assault, and lower proportional exposure to unexpected death of a loved one than cases with fewer associated TEs. Conclusions A risk threshold was observed in this large-scale cross-national database wherein cases who associated their PTSD with four or more TEs presented a more “complex” clinical picture with substantially greater functional impairment and greater morbidity than other cases of PTSD. PTSD cases associated with four or more TEs may merit specific and targeted intervention strategies. Depression and Anxiety 31:130–142, 2014. PMID:23983056

  7. Sociodemographic, perinatal, behavioral, and psychosocial predictors of weight retention at 3 and 12 months postpartum.

    PubMed

    Siega-Riz, Anna Maria; Herring, Amy H; Carrier, Kathryn; Evenson, Kelly R; Dole, Nancy; Deierlein, Andrea

    2010-10-01

    Postpartum weight retention plays an important role in the pathway leading to obesity among women of childbearing age. The objective of this study was to examine predictors of moderate (1-10 pounds) and high (>10 pounds) postpartum weight retention using data from a prospective pregnancy cohort that followed women into the postpartum period; n = 688 and 550 women at 3 and 12 months, respectively. Analysis included descriptive statistics and predictive modeling using log-binomial techniques. The average weight retained at 3 and 12 months postpartum in this population was 9.4 lb (s.d. = 11.4) and 5.7 lb (s.d. = 13.2), respectively. At 3 months postpartum, prepregnancy weight, gestational weight gain, and hours slept during the night were associated with moderate or high weight retention, whereas having an infant hospitalized after going home and scoring in the upper 75th percentile of the Eating Attitudes Test (EAT) were associated only with high weight retention. At 12 months postpartum, prepregnancy weight, gestational weight gain, and maternal education were associated with moderate weight retention; and gestational weight gain, maternal age, race, employment status, and having an infant hospitalized at birth were associated with high weight retention. The results of this study illustrate the importance of prepregnancy weight and gestational weight gain in predicting postpartum weight retention. Furthermore, given the lack of successful intervention studies that exist to date to help women lose weight in the postpartum period, the results of this study may help to inform future interventions that focus on such aspects as hours of sleep, dealing with stress associated with a hospitalized infant, and nonclinical eating disorder symptomatology.

  8. Relief of postural post dural puncture headache by an epidural blood patch 12 months after dural puncture.

    PubMed

    Klepstad, P

    1999-10-01

    A 20-year-old previously healthy male presented at the pain clinic with chronic headache of about one year duration. Clinical examination revealed no pathological manifestations. During the consultation the patient was drinking Coca-Cola. On direct questioning he told that drinking Coca-Cola gave partial relief from the headache, and that the headache started after he had received two spinal anaesthetics for treatment of a lower leg fracture. Postural post dural puncture headache was now suspected and an epidural blood patch performed. Despite an interval of nearly 12 months since the dural punctures, a single epidural blood patch completely relieved the headache. This case history demonstrates that an epidural blood patch should be tried if a chronic post dural puncture headache is suspected.

  9. The effectiveness of an improved multidisciplinary pain management programme: a 6- and 12-month follow-up study.

    PubMed

    Dysvik, Elin; Kvaløy, Jan Terje; Natvig, Gerd Karin

    2012-05-01

      This article is a report of a Norwegian-revised study on the effectiveness of a follow-up multidisciplinary management programme for chronic pain to investigate the change processes associated with treatment.   Substantial evidence supports the use of Cognitive Behavioural Therapy approaches to chronic pain. As relapse is often reported, follow-up sessions should be included.   A follow-up quasi-experimental design was performed, and a previous control group was used. The study initially included 117 participants, and 104 of the sample completed the 6- and 12-month follow-up programme. The 6-month follow-up consisted of therapeutic dialogue and education combined with physical activity. At the 12-month follow-up, a telephonic consultation was conducted. The data collection period was between September 2006 and January 2008. The statistical and clinical significance were considered.   Findings suggest that this follow-up programme can potentially maintain the positive results of the basic programme in terms of reduced pain perception, improved health-related quality of life, and movement towards self-management.   These results are consistent with the ultimate goal of Cognitive Behavioural Therapy approaches, which is to help patients with chronic pain to cope more effectively and to improve their health-related quality of life and functioning. To maintain treatment improvements and advance nursing, there is a clear need for research that tests the efficacy of follow-up interventions that are designed to prevent drop out and relapse. © 2011 Blackwell Publishing Ltd.

  10. Impact of thulium VapoEnucleation of the prostate on erectile function: a prospective analysis of 72 patients at 12-month follow-up.

    PubMed

    Tiburtius, Christian; Knipper, Sophie; Gross, Andreas J; Netsch, Christopher

    2014-01-01

    To evaluate changes in erectile function after thulium VapoEnucleation of the prostate (ThuVEP) for the treatment of benign prostatic obstruction at 12-month follow-up. We prospectively evaluated 72 patients who underwent ThuVEP between January and July 2011. Preoperative evaluation included maximum urinary flow rate (Qmax), international prostate symptom score (IPSS), quality of life (QoL), postvoiding residual urine (PVR), and the Erectile function domain of the International Index of Erectile Function (IIEF-EF). According to preoperative IIEF-EF score, patients were classified into subgroup A (IIEF-EF ≥19, n = 38) and subgroup B (IIEF-EF <19, n = 34). All complications during the perioperative period were noted and classified according to the modified Clavien classification system. All patients were reassessed at 12-month follow-up by Qmax, IPSS, QoL, PVR, and IIEF-EF score. Patient data were expressed as median (interquartile range). Median patient age was 70 (65-73) years, and the median prostate volume was 52.5 (39.75-72) mL, respectively. At 12-month follow-up, IPSS (20 vs 4), QoL (4 vs 1), Qmax (9.7 vs 22.15 mL/s), and PVR (100 vs 15 mL) improved significantly in comparison with preoperative assessment (P ≤.001) without differences between subgroup A and B. A slight but not statistically significant increase of the IIEF-EF domain score was reported at 12-month follow-up (19.5 vs 20), which could be shown in subgroup A (25 vs 26) and B (6 vs 8). ThuVEP is a safe and effective procedure for the treatment of benign prostatic obstruction. At 12-month follow-up, marginal nonsignificant erectile function improvement was reported after surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. "Cancer Put My Life on Hold": Work-Related Challenges Among Middle-aged Adults 12 Months After a Diagnosis of Colorectal Cancer.

    PubMed

    McGrath, Catherine; Mihala, Gabor; Beesley, Vanessa L; Lynch, Brigid M; Graves, Nicholas; Gordon, Louisa G

    Colorectal cancer affects a wide range of working-age people. Little is known about the consequent work limitations. The aim of this study was to understand the extent and changing nature of work-related limitations of middle-aged (45-64 years) people over the first 12 months of colorectal cancer. Surveys were administered to participants recruited via the Queensland Cancer Registry, at 6 and 12 months after diagnosis. Among those who returned to work, the Work Limitations Questionnaire measured 4 job performance domains (time management, physical, mental-interpersonal, and output demands) and an overall productivity score. Open-ended questions supplemented the Work Limitations Questionnaire, and responses were thematically analyzed. Of 239 participants, 8% did not continue in the study, and 20% left employment by 12 months, leaving 171 participants eligible for this analysis. Open-ended responses for why participants stopped work included bowel problems and stoma, loss of strength, and medication adverse effects. At 12 months, 22% to 39% of participants reported work limitations, but there was no overall significant change in work limitations between 6 and 12 months. Qualitative data highlighted the key work-related issues were changes in work functioning, attitudes of employers and colleagues, financial pressures, and emotional responses. While a significant proportion left work because of treatment-related problems, and the majority of participants did not experience workplace limitations, some reported considerable work-related challenges. Discussions with health professionals about the possible impact of treatment adverse effects on employment, good communication with employers, and workplace flexibility may facilitate return to work for this population.

  12. Testosterone replacement therapy does not promote priapism in hypogonadal men with sickle cell disease: 12-month safety report.

    PubMed

    Morrison, B F; Reid, M; Madden, W; Burnett, A L

    2013-07-01

    Hypogonadism, which is highly prevalent in men with sickle cell disease (SCD), affects quality of life and causes great morbidity. The safety of testosterone replacement therapy (TRT) in SCD in relation to priapism episodes is relatively unknown. Our aim was to monitor the safety of TRT in a cohort of seven hypogonadal men with SCD. Testosterone undecanoate (Nebido) 1 g was administered intramuscularly to adult men with homozygous SCD (Hb SS) having hypogonadism [serum total testosterone ≤12.0 nmol/L (346 ng/dL), reference range 12.5-38.1 nmol/L (360-1098 ng/dL)] for 12 months. Serum total testosterone, haemoglobin, haematocrit, renal and liver function tests, glucose and PSA measurements were done at baseline and 12-month follow-up. Trough serum total testosterone, haemoglobin and haematocrit were measured three monthly. Priapism events and adverse drug events were assessed every 3 months. International Index of Erectile Function (IIEF), Androgen Deficiency in the Ageing Male (ADAM) and World Health Organization Quality of Life (WHOQOL) questionnaires were administered at baseline, 6 and 12 months. Seven men with a mean age of 34.4 years were treated. Median total testosterone increased from 10.6 to 11.2 nmol/L (p = 0.46). Median serum lactate dehydrogenase levels decreased from 1445 to 1143.5 IU/L (p < 0.05), while all other laboratory indices remained stable. Injection site pain was the most frequently reported adverse event, with no increases in painful crises, hypersensitivity or oedema. After TRT, there was no significant increase in priapism frequency. Median questionnaire scores were increased for the IIEF (46-68, p = 0.018), reduced for ADAM (5.0-2.0, p = 0.016) and unchanged for WHOQOL (98-103, p = 0.086). TRT using testosterone undecanoate with eugonadal intent for hypogonadism appears to be safe in men with SCD. This treatment does not appear to promote priapism occurrences and rather it possibly improves sexual function. Future prospective

  13. Replicating Reducing the Risk: 12-Month Impacts of a Cluster Randomized Controlled Trial

    PubMed Central

    Blocklin, Michelle; Layzer, Jean; Price, Cristofer; Juras, Randall; Freiman, Lesley

    2016-01-01

    Objectives. To test the effectiveness of Reducing the Risk, an evidence-based sexual health curriculum designed to help prevent adolescent pregnancy and sexually transmitted infections, on youth sexual behavior and intermediate outcomes thought to lead to these behaviors. Methods. Classes within schools in St. Louis, Missouri; Austin, Texas; and San Diego, California; were randomly assigned to receive Reducing the Risk or “business as usual.” Youths completed Web-based surveys at baseline (preintervention, August 2012–January 2014) and 12 months later (August 2013–January 2015). Intent-to-treat analyses were conducted across sites; we tested for differences in impacts between sites and other subgroups. Results. The program had no overall impact on sexual behaviors. However, at 1 site, program participants were significantly less likely to have engaged in recent sexual intercourse than were control group members. There were positive overall impacts on intermediate outcomes (e.g., knowledge, attitudes). Conclusions. After 12 months, Reducing the Risk was unsuccessful at changing sexual behaviors. Other results were mixed, but promising evidence (e.g., behavioral impacts at 1 site, impacts on intermediate outcomes) suggests potential for more widespread behavioral impacts over a longer term. PMID:27689492

  14. Motor training at 3 months affects object exploration 12 months later.

    PubMed

    Libertus, Klaus; Joh, Amy S; Needham, Amy Work

    2016-11-01

    The development of new motor skills alters how infants interact with objects and people. Consequently, it has been suggested that motor skills may initiate a cascade of events influencing subsequent development. However, only correlational evidence for this assumption has been obtained thus far. The current study addressed this question experimentally by systematically varying reaching experiences in 40 three-month-old infants who were not reaching on their own yet and examining their object engagement in a longitudinal follow-up assessment 12 months later. Results revealed increased object exploration and attention focusing skills in 15-month-old infants who experienced active reaching at 3 months of age compared to untrained infants or infants who only passively experienced reaching. Further, grasping activity after - but not before - reaching training predicted infants' object exploration 12 months later. These findings provide evidence for the long-term effects of reaching experiences and illustrate the cascading effects initiated by early motor skills. © 2015 John Wiley & Sons Ltd.

  15. Correlates of Self-Reported Physical Activity at 3- and 12-Months Postpartum

    PubMed Central

    Vladutiu, Catherine J.; Evenson, Kelly R.; Jukic, Anne Marie; Herring, Amy H.

    2015-01-01

    Background Postpartum women are encouraged to participate in ≥150 minutes/week of moderate-intensity aerobic activity, but few women achieve this recommendation. This study sought to identify factors associated with participation in physical activity following pregnancy. Methods We examined correlates of any self-reported moderate to vigorous physical activity (MVPA) (≥10 minutes/week across all modes) and any recreational MVPA (≥10 minutes/week) among women enrolled in the Pregnancy, Infection, and Nutrition Postpartum study at 3-months (n=667) and 12-months (n=530) postpartum. Potential correlates were identified according to the socio-ecological framework. Results At 3- and 12-months postpartum, lower odds of participation in any MVPA were associated with lower education, breastfeeding, and minimal emotional support. Low exercise self-efficacy, receipt of advice about physical activity, and warmer seasons were associated with higher odds of any MVPA. For recreational MVPA, lower odds of participation were associated with unmarried status, lower education, employment, low income, preeclampsia, and minimal emotional support. Involvement in child/adult care activities, transportation MVPA, and warmer seasons were associated with higher odds of recreational MVPA. Conclusion These findings suggest there are several modifiable intrapersonal and interpersonal factors associated with postpartum MVPA that should be considered when developing interventions to help women maintain or increase MVPA after pregnancy. PMID:25157810

  16. Cost of Living with Parkinson's Disease over 12 Months in Australia: A Prospective Cohort Study.

    PubMed

    Bohingamu Mudiyanselage, Shalika; Watts, Jennifer J; Abimanyi-Ochom, Julie; Lane, Lisa; Murphy, Anna T; Morris, Meg E; Iansek, Robert

    2017-01-01

    Background. Parkinson disease (PD) is a costly chronic condition in terms of managing both motor and nonmotor symptoms. The burden of disease is high for individuals, caregivers, and the health system. The aim of this study is to estimate the annual cost of PD from the household, health system, and societal perspectives. Methods. A prospective cohort study of newly referred people with PD to a specialist PD clinic in Melbourne, Australia. Participants completed baseline and monthly health resource use questionnaires and Medicare data were collected over 12 months. Results. 87 patients completed the 12-month follow-up assessments. The mean annual cost per person to the health care system was $32,556 AUD. The burden to society was an additional $45,000 per annum per person with PD. The largest component of health system costs were for hospitalisation (69% of total costs). The costs for people with moderate to severe disease were almost 4 times those with mild PD ($63,569 versus $17,537 p < 0.001). Conclusion. PD is associated with significant costs to individuals and to society. Costs escalated with disease severity suggesting that the burden to society is likely to grow with the increasing disease prevalence that is associated with population ageing.

  17. Spoken Language Benefits of Extending Cochlear Implant Candidacy Below 12 Months of Age

    PubMed Central

    Nicholas, Johanna G.; Geers, Ann E.

    2013-01-01

    Objective To test the hypothesis that cochlear implantation surgery before 12 months of age yields better spoken language results than surgery between 12–18 months of age. Study Design Language testing administered to children at 4.5 years of age (± 2 months). Setting Schools, speech-language therapy offices, and cochlear implant (CI) centers in the US and Canada. Participants 69 children who received a cochlear implant between ages 6–18 months of age. All children were learning to communicate via listening and spoken language in English-speaking families. Main Outcome Measure Standard scores on receptive vocabulary, expressive and receptive language (includes grammar). Results Children with CI surgery at 6–11 months (N=27) achieved higher scores on all measures as compared to those with surgery at 12–18 months (N=42). Regression analysis revealed a linear relationship between age of implantation and language outcomes throughout the 6–18 month surgery-age range. Conclusion For children in intervention programs emphasizing listening and spoken language, cochlear implantation before 12 months of age appears to provide a significant advantage for spoken language achievement observed at 4.5 years of age. PMID:23478647

  18. Cost of Living with Parkinson's Disease over 12 Months in Australia: A Prospective Cohort Study

    PubMed Central

    Abimanyi-Ochom, Julie; Lane, Lisa; Murphy, Anna T.; Morris, Meg E.; Iansek, Robert

    2017-01-01

    Background. Parkinson disease (PD) is a costly chronic condition in terms of managing both motor and nonmotor symptoms. The burden of disease is high for individuals, caregivers, and the health system. The aim of this study is to estimate the annual cost of PD from the household, health system, and societal perspectives. Methods. A prospective cohort study of newly referred people with PD to a specialist PD clinic in Melbourne, Australia. Participants completed baseline and monthly health resource use questionnaires and Medicare data were collected over 12 months. Results. 87 patients completed the 12-month follow-up assessments. The mean annual cost per person to the health care system was $32,556 AUD. The burden to society was an additional $45,000 per annum per person with PD. The largest component of health system costs were for hospitalisation (69% of total costs). The costs for people with moderate to severe disease were almost 4 times those with mild PD ($63,569 versus $17,537 p < 0.001). Conclusion. PD is associated with significant costs to individuals and to society. Costs escalated with disease severity suggesting that the burden to society is likely to grow with the increasing disease prevalence that is associated with population ageing. PMID:28352490

  19. Long-term memory, forgetting, and deferred imitation in 12-month-old infants

    PubMed Central

    Klein, Pamela J.; Meltzoff, Andrew N.

    2013-01-01

    Long-term recall memory, as indexed by deferred imitation, was assessed in 12-month-old infants. Independent groups of infants were tested after retention intervals of 3 min, 1 week and 4 weeks. Deferred imitation was assessed using the ‘observation-only’ procedure in which infants were not allowed motor practice on the tasks before the delay was imposed. Thus, the memory could not have been based on re-accessing a motor habit, because none was formed in the first place. After the delay, memory was assessed either in the same or a different environmental context from the one in which the adult had originally demonstrated the acts. In Experiments 1 and 3, infants observed the target acts while in an unusual environment (an orange and white polka-dot tent), and recall memory was tested in an ordinary room. In Experiment 2, infants observed the target acts in their homes and were tested for memory in a university room. The results showed recall memory after all retention intervals, including the 4 week delay, with no effect of context change. Interestingly, the forgetting function showed that the bulk of the forgetting occurred during the first week. The findings of recall memory without motor practice support the view that infants as young as 12 months old use a declarative (nonprocedural) memory system to span delay intervals as long as 4 weeks. PMID:25147475

  20. Self-assessment of drinking on the Internet--3-, 6- and 12-month follow-ups.

    PubMed

    Koski-Jännes, Anja; Cunningham, John; Tolonen, Kari

    2009-01-01

    The aim of this work was to report on the results of a pilot study of a web-based self-assessment service (DHT) for Finnish drinkers (www.paihdelinkki.fi/testaa/juomatapatesti). During the 7-month recruitment period in 2004 altogether 22,536 anonymous self-assessments were recorded in the database of this service. The study sample was recruited from the 1598 service users who also participated to a survey evaluating the DHT. Those who consented by providing required baseline data and their e-mail address (n = 343) were sent a message asking them to fill in the follow-up questions 3, 6 and 12 months later. Their self-reported use of alcohol and drinking-related problems served as the main outcome variables in this single-group follow-up study. At 3, 6 and 12 months, 78%, 69% and 61% of the study participants, respectively, responded to the follow-up. The intention-to-treat (ITT) results revealed significant reductions (P < 0.001) in all the outcome measures. The reductions occurred during the first 3 months, after which the changes were non-significant. The results are in line with previous studies with mostly shorter follow-up periods suggesting that Internet-based self-assessment services can be useful tools in reducing excessive drinking. A randomized controlled trial would, however, increase our certainty about the causes of the observed changes.

  1. Predictors of self-rated health: a 12-month prospective study of IT and media workers.

    PubMed

    Hasson, Dan; Arnetz, Bengt B; Theorell, Töres; Anderberg, Ulla Maria

    2006-07-31

    The aim of the present study was to determine health-related risk and salutogenic factors and to use these to construct prediction models for future self-rated health (SRH), i.e. find possible characteristics predicting individuals improving or worsening in SRH over time (0-12 months). A prospective study was conducted with measurements (physiological markers and self-ratings) at 0, 6 and 12 months, involving 303 employees (187 men and 116 women, age 23-64) from four information technology and two media companies. There were a multitude of statistically significant cross-sectional correlations (Spearman's Rho) between SRH and other self-ratings as well as physiological markers. Predictors of future SRH were baseline ratings of SRH, self-esteem and social support (logistic regression), and SRH, sleep quality and sense of coherence (linear regression). The results of the present study indicate that baseline SRH and other self-ratings are predictive of future SRH. It is cautiously implied that SRH, self-esteem, social support, sleep quality and sense of coherence might be predictors of future SRH and therefore possibly also of various future health outcomes.

  2. Does contingency in adults' responding influence 12-month-old infants' social referencing?

    PubMed

    Stenberg, Gunilla

    2016-12-07

    In two experiments we examined the influence of contingent versus non-contingent responding on infant social referencing behavior. EXPERIMENT 1: Forty 12-month-old infants were exposed to an ambiguous toy in a social referencing situation. In one condition an unfamiliar adult who in a previous play situation had responded contingently to the infant's looks gave the infant positive information about the toy. In the other condition an unfamiliar adult who previously had not responded contingently delivered the positive information. EXPERIMENT 2: Forty-eight 12-month-old infants participated in Experiment 2. In this experiment it was examined whether the familiarity of the adult influences infants' reactions to contingency in responding. In one condition a parent who previously had responded contingently to the infant's looks provided positive information about the ambiguous toy, and in the other condition a parent who previously had not responded contingently provided the positive information. The infants looked more at the contingent experimenter in Experimenter 1, and also played more with the toy after receiving positive information from the contingent experimenter. No differences in looking at the parent and in playing with the toy were found in Experiment 2. The results indicate that contingency in responding, as well as the familiarity of the adult, influence infants' social referencing behavior.

  3. Does the Organization of Emotional Expression Change Over Time? Facial Expressivity From 4 to 12 Months

    PubMed Central

    Bendersky, Margaret

    2006-01-01

    Differentiation models contend that the organization of facial expressivity increases during infancy. Accordingly, infants are believed to exhibit increasingly specific facial expressions in response to stimuli as a function of development. This study tested this hypothesis in a sample of 151 infants (83 boys and 68 girls) observed in 4 situations (tickle, sour taste, arm restraint, and masked stranger) at 4 and 12 months of age. Three of the 4 situations showed evidence of increasing specificity over time. In response to tickle, the number of infants exhibiting joy expressions increased and the number exhibiting interest, surprise, and surprise blends decreased from 4 to 12 months. In tasting a sour substance, more infants exhibited disgust and fewer exhibited joy and interest expressions, and fear and surprise blends over time. For arm restraint, more infants exhibited anger expressions and anger blends and fewer exhibited interest and surprise expressions and surprise blends over time. In response to a masked stranger, however, no evidence of increased specificity was found. Overall, these findings suggest that infants increasingly exhibit particular expressions in response to specific stimuli during the 1st year of life. These data provide partial support for the hypothesis that facial expressivity becomes increasingly organized over time. PMID:16906232

  4. Effects of a 12-Month Pedometer-Based Walking Intervention in Women of Low Socioeconomic Status

    PubMed Central

    Hornbuckle, Lyndsey M.; Kingsley, J. Derek; Kushnick, Michael R.; Moffatt, Robert J.; Haymes, Emily M.; Miles, Rebecca; Toole, Tonya; Panton, Lynn B.

    2016-01-01

    This study examined the effects of a 12-month walking intervention in overweight/obese, low socioeconomic women. Forty-six women (48.2 ± 8.0 years) entered the study. Outcomes included weight, waist and hip circumferences, body mass index (BMI), blood pressure, glycosylated hemoglobin, blood lipids, fibrinogen, and high-sensitivity C-reactive protein (hsCRP). Both intention-to-treat analyses in all participants and group analyses in study completers only (3K group = increased steps/day by ≥3,000; No Δ group = did not increase steps/day by ≥3,000) were conducted. Group × time ANOVA was used. In study completers, 3K significantly increased steps/day (6,903 ± 3,328 to 12,323 ± 5,736) compared to No Δ (4,926 ± 3,374 to 5,174 ± 3,095) from baseline to 12 months. There was a significant time effect for weight (P = 0.030), BMI (P = 0.029), and hsCRP (P = 0.044). Low socioeconomic women who adhere to a long-term, pedometer-based walking intervention significantly increased steps/day and may improve body weight, BMI, and hsCRP. This could help reduce health disparities in this population over time. PMID:27746679

  5. Rethinking maternal sensitivity: mothers' comments on infants' mental processes predict security of attachment at 12 months.

    PubMed

    Meins, E; Fernyhough, C; Fradley, E; Tuckey, M

    2001-07-01

    This study investigated predictors of attachment security in a play context using a sample of 71 mothers and their 6-month-old infants. We sought to rethink the concept of maternal sensitivity by focusing on mothers' ability accurately to read the mental states governing infant behaviour. Five categories were devised to assess this ability, four of which were dependent on maternal responses to infant behaviours, such as object-directed activity. The fifth, mothers' Appropriate minded-related comments, assessed individual differences in mothers' proclivity to comment appropriately on their infants' mental states and processes. Higher scores in this fifth category related to a secure attachment relationship at 12 months. Maternal sensitivity and Appropriate mind-related comments were independent predictors of attachment security at 12 months, respectively accounting for 6.5% and 12.7% of its variance. We suggest that these findings are in line with current theorising on internal working models of attachment, and may help to explain security-related differences in mentalising abilities.

  6. 76 FR 63719 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List a Distinct...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-13

    ... Plants; 12-Month Finding on a Petition To List a Distinct Population Segment of the Red Tree Vole as... Plants; 12-Month Finding on a Petition To List a Distinct Population Segment of the Red Tree Vole as... petition to list a distinct population segment of the red tree vole (Arborimus longicaudus) as...

  7. 76 FR 6383 - Endangered and Threatened Species; 12-Month Finding on a Petition To Delist Coho Salmon South of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-04

    ... Species; 12-Month Finding on a Petition To Delist Coho Salmon South of San Francisco Bay AGENCY: National... Service (NMFS), are issuing a 12-month finding on a petition to delist coho salmon (Oncorhynchus kisutch.... Coho salmon populations in this region are currently listed under the ESA as part of the...

  8. The 12-Month Prevalence of DSM-IV Anxiety Disorders among Nigerian Secondary School Adolescents Aged 13-18 Years

    ERIC Educational Resources Information Center

    Adewuya, Abiodun O.; Ola, Bola A.; Adewumi, Tomi A.

    2007-01-01

    Aims: To estimate the 12-month prevalence of DSM-IV-specific anxiety disorders among Nigerian secondary school adolescents aged 13-18 years. Method: A representative sample of adolescents (n=1090) from senior secondary schools in a semi-urban town in Nigeria was assessed for the 12-month prevalence of DSM-IV-specific anxiety. Results: The 12-month…

  9. Fatigue Following Traumatic Brain Injury in Children and Adolescents: A Longitudinal Follow-Up 6 to 12 Months After Injury.

    PubMed

    Crichton, Alison; Anderson, Vicki; Oakley, Ed; Greenham, Mardee; Hearps, Stephen; Delzoppo, Carmel; Beauchamp, Miriam H; Hutchison, James S; Guerguerian, Anne-Marie; Boutis, Kathy; Babl, Franz E

    2017-09-18

    Longitudinal fatigue data in children suffering from traumatic brain injury (TBI) are lacking. To examine the effects of time postinjury (6-12 months) and injury severity on fatigue after childhood TBI. Secondarily, we compared fatigue 12 months postinjury against published control data. Three tertiary children's hospitals across Australia (n = 1) and Canada (n = 2). Parents (n = 109) of children (mean [M] = 9.9 years at injury; range, 1.0-16.9 years) admitted to one of 3 participating hospitals with mild (n = 69) or moderate/severe (n = 37) TBI. Longitudinal prospective study. Primary: Pediatric Quality of Life Multidimensional Fatigue Scale (total, general, sleep/rest, and cognitive), rated by parents 6 and 12 months postinjury. Secondary: Pediatric Injury Functional Outcome Scale (fatigue and sleep items, rated on recruitment and 6 and 12 months postinjury). Demographic and children data were collected at recruitment. Mixed-models analysis demonstrated nonsignificant effects of time (6 vs 12 months postinjury) on multidimensional fatigue scores. Cognitive fatigue worsened over time. Moderate/severe TBI was associated with worse fatigue 12 months postinjury (general, P = .03; cognitive, P = .02). Across all severities, fatigue 12 months postinjury was significantly worse compared with control data (total fatigue, P < .001; all domains, all Ps < .025). Fatigue remains significant at 12 months since injury, particularly for those with moderate/severe TBI.

  10. The 12-Month Prevalence of DSM-IV Anxiety Disorders among Nigerian Secondary School Adolescents Aged 13-18 Years

    ERIC Educational Resources Information Center

    Adewuya, Abiodun O.; Ola, Bola A.; Adewumi, Tomi A.

    2007-01-01

    Aims: To estimate the 12-month prevalence of DSM-IV-specific anxiety disorders among Nigerian secondary school adolescents aged 13-18 years. Method: A representative sample of adolescents (n=1090) from senior secondary schools in a semi-urban town in Nigeria was assessed for the 12-month prevalence of DSM-IV-specific anxiety. Results: The 12-month…

  11. Identification of Infants at Risk for Autism Spectrum Disorder and Developmental Language Delay Prior to 12 Months

    ERIC Educational Resources Information Center

    Samango-Sprouse, Carole A.; Stapleton, Emily J.; Aliabadi, Farhad; Graw, Robert; Vickers, Rebecca; Haskell, Kathryn; Sadeghin, Teresa; Jameson, Robert; Parmele, Charles L.; Gropman, Andrea L.

    2015-01-01

    Studies have shown an increased head circumference and the absence of the head tilt reflex as possible risk factors for autism spectrum disorder, allowing for early detection at 12 months in typically developing population of infants. Our aim was to develop a screening tool to identify infants prior to 12 months at risk for autism spectrum…

  12. Identification of Infants at Risk for Autism Spectrum Disorder and Developmental Language Delay Prior to 12 Months

    ERIC Educational Resources Information Center

    Samango-Sprouse, Carole A.; Stapleton, Emily J.; Aliabadi, Farhad; Graw, Robert; Vickers, Rebecca; Haskell, Kathryn; Sadeghin, Teresa; Jameson, Robert; Parmele, Charles L.; Gropman, Andrea L.

    2015-01-01

    Studies have shown an increased head circumference and the absence of the head tilt reflex as possible risk factors for autism spectrum disorder, allowing for early detection at 12 months in typically developing population of infants. Our aim was to develop a screening tool to identify infants prior to 12 months at risk for autism spectrum…

  13. 76 FR 62503 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Black...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-07

    ... Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Black-footed Albatross as... Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Black-footed Albatross as... petition to list the black-footed albatross (Phoebastria nigripes) as endangered or threatened under the...

  14. Retention of fissure sealants in young permanent molars affected by dental fluorosis: a 12-month clinical study.

    PubMed

    Hasanuddin, S; Reddy, E R; Manjula, M; Srilaxmi, N; Rani, S T; Rajesh, A

    2014-10-01

    To evaluate and compare retention and caries occurance following placement of Clinpro and FUJI VII fissure sealants, by two different techniques simultaneously in unsealed, contralateral young permanent molars of 7- to 10-year-old children affected by mild to moderate dental fluorosis at various recall intervals of 1 week, 1, 3, 6 and 12 months. 80 schoolchildren with mild to moderate dental fluorosis were assigned to Group A and Group B with 40 children in each group. In Group A Clinpro fissure sealant and in Group B Fuji VII fissure sealant was used. In both the groups fissure sealants were applied by conventional fissure sealant technique (CST) on one side and enameloplasty sealant technique (EST) on the other side of the same arch. The applied fissure sealants were evaluated clinically for retention and caries incidence. Clinpro fissure sealant showed a retention rate of 95% when compared with Fuji VII (57.5%) at the end of 12 months, which was statistically significant. Regarding techniques, EST showed better results than CST in both the groups. Comparison of groups with respect to retention and techniques at different time periods was performed using Mann-Whitney U test (p < 0.05). Comparison of different time periods with respect to retention and technique in all the groups was performed using Wilcoxon matched pairs test by ranks (p < 0.05). Clinpro fissure sealant showed better retention at all treatment intervals, when compared with Fuji VII. Further follow-up is required to study the efficacy of the fissure sealant placement techniques.

  15. Do patients with bipolar disorder and subsyndromal symptoms benefit from functional remediation? A 12-month follow-up study.

    PubMed

    Sanchez-Moreno, Jose; Bonnín, Caterina; González-Pinto, Ana; Amann, Benedikt L; Solé, Brisa; Balanzá-Martínez, Vicent; Arango, Celso; Jimenez, Esther; Tabarés-Seisdedos, Rafael; Garcia-Portilla, M Paz; Ibáñez, Angela; Crespo, Jose Manuel; Ayuso-Mateos, Jose Luis; Vieta, Eduard; Martinez-Aran, Anabel; Torrent, Carla

    2017-04-01

    We analyzed the efficacy of functional remediation, in a sample of patients with bipolar disorder who presented with subsyndromal symptoms. From a total sample of 239 patients with bipolar I and II disorder, according to DSM-IV-TR diagnostic criteria, entering a randomized clinical trial, those patients who presented with subsyndromal symptoms were selected based on a method already described by Berk and colleagues was applied. It consists of using the Clinical Global Impression-Bipolar version (CGI-BP) to establish the scores of the Hamilton Depression Rating Scale (HAM-D) and of the Young Mania Rating Scale (YMRS) that correspond with 1 in the CGI-BP. Functional outcome and mood symptoms were assessed at 6 and at 12-month follow-up. A total of 99 patients were selected for this post-hoc analysis, allocated as follows: functional remediation (n=33); psychoeducation (n=37) and treatment as usual (TAU,n=29). The repeated-measures analyses at 12-month follow-up revealed a significant group x time interaction in favour of the patients who received functional remediation when compared to psychoeducation and TAU (F=2.93; p=0.02) at improving psychosocial functioning. Finally, mood symptoms did not significantly change in any of the three groups at any time of follow-up, as shown by the non-significant group x time interaction effect in HAM-D scores (F=1.57; p=0.18) and YMRS scores (F=1.51; p=0.20). Bipolar patients with subsyndromal symptoms improve their functional outcome when exposed to functional remediation regardless of the persistence of mood symptomatology. Copyright © 2017 Elsevier B.V. and ECNP. All rights reserved.

  16. Effect of Improving Dietary Quality on Arterial Stiffness in Subjects with Type 1 and Type 2 Diabetes: A 12 Months Randomised Controlled Trial

    PubMed Central

    Petersen, Kristina S.; Clifton, Peter M.; Lister, Natalie; Keogh, Jennifer B.

    2016-01-01

    People with diabetes have accelerated arterial stiffening. The aim of this study was to determine the effect of increasing fruit, vegetable and dairy intake for 12 months on carotid femoral pulse wave velocity (cfPWV), augmentation index (AIx), and central blood pressure (cBP), compared to a usual diet control, in people with type 1 and type 2 diabetes. In a 12 months randomised controlled trial, cfPWV, AIx and cBP were measured every 3 months. The intervention group received dietary counselling to increase consumption of fruit (+1 serving/day; 150 g/day), vegetables (+2 servings/day; 150 g/day) and dairy (+1 serving/day; 200–250 g/day) at baseline, 1, 3, 6 and 9 months. The control group continued on their usual diet. One hundred and nine participants were randomised and 92 (intervention n = 45; control n = 47) completed. At 3 months, fruit (184 g/day; p = 0.001) and dairy (83 g/day; p = 0.037) intake increased in the intervention group compared with the control group but this increase was not maintained at 12 months. After adjustment for baseline measurements there was no time by treatment effect for central systolic or diastolic BP, AIx or cfPWV. A time effect existed for AIx which modestly increased over time. Peripheral diastolic BP and central pulse pressure were improved in the intervention group compared with the control group at 12 months. In the cohort with type 1 and type 2 diabetes, improving dietary quality by increasing consumption of fruit, vegetables and dairy did not improve cBP, AIx or cfPWV, compared with a control group continuing on their usual diet, after 12 months. PMID:27338467

  17. Changes in health-related quality of life in people with morbid obesity attending a learning and mastery course. A longitudinal study with 12-months follow-up.

    PubMed

    Andenæs, Randi; Fagermoen, May S; Eide, Hilde; Lerdal, Anners

    2012-08-18

    Severe obesity is a complex condition that is associated with a wide range of serious health complications and reduced health-related quality of life (HRQoL). In addition to physiological factors, activity and participation, environmental factors, and personal factors are related to an individual's overall quality of life HRQoL. In Norway, a course based on cognitive behavioral principles is offered to people seeking medical treatment for weight management. The aim is to assist participants to achieve a healthier lifestyle and thereby improve their HRQoL. We therefore investigated changes in HRQoL in participants after they attended this learning and mastery course, and explored how well sociodemographic variables, paid work, social support, personal factors, and surgery predicted HRQoL at 12-month follow-up. A single-group longitudinal study was conducted. Data were collected by self-reported questionnaires. This article reports on those who had completed the questionnaire at the 12-month (n = 69) follow-up. HRQoL was assessed with the EQ-5D. Other standardized instruments measured employment, social support, self-efficacy, and surgery. At the 12-month follow-up, participants scored higher on all dimensions of the EQ-5D and on the EQ-VAS. Generalized linear model showed that having paid work, and social support were statistically significant predictors of HRQoL at the 12-month follow-up. Sex, self-efficacy, and surgery were not statistically significant associated with HRQoL. Participation in paid work, and receiving social support from persons with whom they had a close relationship were strongly related to HRQoL in obese people 12 months after participating in a learning and mastery course. The study is registered in Clinical Trials: NCT01336725.

  18. Impact of methadone with versus without drug abuse counseling on HIV risk: 4- and 12-month findings from a clinical trial.

    PubMed

    Kelly, Sharon M; Schwartz, Robert P; Oʼgrady, Kevin E; Gandhi, Devang; Jaffe, Jerome H

    2012-06-01

    Human immunodeficiency virus (HIV)-risk behaviors were examined at 4- and 12-month follow-up for 230 newly admitted methadone patients randomly assigned to receive either methadone only (n = 99) or methadone with drug abuse counseling (n = 131) in the first 4 months of treatment. The AIDS Risk Assessment was administered at baseline (treatment entry) and at 4- and 12-month follow-up. Linear mixed model analysis examined changes in HIV drug- and sex-risk behaviors over the 12 months in the total sample, drug-risk behaviors in the subsample that reported injecting drugs at baseline (n = 110), and sex-risk behaviors in the subsample that reported engaging in unprotected sex at baseline (n = 130). Significant decreases over time were found in the frequencies of injecting, injecting with other injectors, and sharing cooker, cotton, or rinse water in the total sample and the injector subsample (P < 0.05). Decreases were also found in the frequencies of having sex without a condom either with someone who was not a spouse or primary partner or while high (P < 0.05) in the total sample and the frequencies of having sex without a condom and having sex without a condom while high in the unprotected-sex subsample (P < 0.05). No significant treatment group main effects or Treatment Group × Time interaction effects were found in any of the HIV-risk behaviors in the total sample or either subsample (P > 0.05). During the first 12 months of treatment, providing drug abuse counseling with methadone compared with providing methadone alone was not associated with significant changes in HIV-risk behaviors for methadone maintenance patients.

  19. Predicting Outcome 12 Months after Mild Traumatic Brain Injury in Patients Admitted to a Neurosurgery Service.

    PubMed

    Hellstrøm, Torgeir; Kaufmann, Tobias; Andelic, Nada; Soberg, Helene L; Sigurdardottir, Solrun; Helseth, Eirik; Andreassen, Ole A; Westlye, Lars T

    2017-01-01

    Accurate outcome prediction models for patients with mild traumatic brain injury (MTBI) are key for prognostic assessment and clinical decision-making. Using multivariate machine learning, we tested the unique and added predictive value of (1) magnetic resonance imaging (MRI)-based brain morphometric and volumetric characterization at 4-week postinjury and (2) demographic, preinjury, injury-related, and postinjury variables on 12-month outcomes, including global functioning level, postconcussion symptoms, and mental health in patients with MTBI. A prospective, cohort study of patients (n = 147) aged 16-65 years with a 12-month follow-up. T1-weighted 3 T MRI data were processed in FreeSurfer, yielding accurate cortical reconstructions for surface-based analyses of cortical thickness, area, and volume, and brain segmentation for subcortical and global brain volumes. The 12-month outcome was defined as a composite score using a principal component analysis including the Glasgow Outcome Scale Extended, Rivermead Postconcussion Questionnaire, and Patient Health Questionnaire-9. Using leave-one-out cross-validation and permutation testing, we tested and compared three prediction models: (1) MRI model, (2) clinical model, and (3) MRI and clinical combined. We found a strong correlation between observed and predicted outcomes for the clinical model (r = 0.55, p < 0.001). The MRI model performed at the chance level (r = 0.03, p = 0.80) and the combined model (r = 0.45, p < 0.002) were slightly weaker than the clinical model. Univariate correlation analyses revealed the strongest association with outcome for postinjury factors of posttraumatic stress (Posttraumatic Symptom Scale-10, r = 0.61), psychological distress (Hospital Anxiety and Depression Scale, r = 0.52), and widespread pain (r = 0.43) assessed at 8 weeks. We found no added predictive value of MRI-based measures of brain cortical morphometry and subcortical volumes

  20. Severity of 12-Month DSM-IV Disorders in the National Comorbidity Survey Replication Adolescent Supplement

    PubMed Central

    Kessler, Ronald C.; Avenevoli, Shelli; Costello, Jane; Green, Jennifer Greif; Gruber, Michael J.; McLaughlin, Katie A.; Petukhova, Maria; Sampson, Nancy A.; Zaslavsky, Alan M.; Merikangas, Kathleen Ries

    2012-01-01

    Context Estimates of DSM-IV disorder prevalence are high; stringent criteria to define need for services are desired. Objective To present US national data on the prevalence and sociodemographic correlates of 12-month serious emotional disturbance (SED), defined by the US Substance Abuse and Mental Health Services Administration, from the National Comorbidity Survey Replication Adolescent Supplement. Design The National Comorbidity Survey Replication Adolescent Supplement is a national survey of DSM-IV anxiety, mood, behavior, and substance disorders among US adolescents. Setting Dual-frame household and school samples of US adolescents. Participants Total of 6483 pairs of adolescents aged 13 to 17 (interviews) and parents (questionnaires). Main Outcome Measures The DSM-IV disorders were assessed with the World Health Organization Composite International Diagnostic Interview and validated with blinded clinical interviews based on the Schedule for Affective Disorders and Schizophrenia for School-Age Children. Serious emotional disturbance was operationalized as a DSM-IV/Composite International Diagnostic Interview disorder with a score of 50 or less on the Children’s Global Assessment Scale (ie, moderate impairment in most areas of functioning or severe impairment in at least 1 area). Concordance of Composite International Diagnostic Interview SED diagnoses with blinded Schedule for Affective Disorders and Schizophrenia for School-Age Children diagnoses was good. Results The estimated prevalence of SED was 8.0%. Most SEDs were due to behavior (54.5%) or mood (31.4%) disorders. Although respondents with 3 or more disorders made up only 29.0% of those with 12-month DSM-IV/Composite International Diagnostic Interview disorders, they constituted 63.5% of SEDs. Predictive effects of high comorbidity were significantly greater than the product of their disorder-specific odds ratios and consistent across disorder types. Associations of sociodemographic variables with SED

  1. Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial

    PubMed Central

    Münch, Andreas; Bohr, Johan; Miehlke, Stephan; Benoni, Cecilia; Olesen, Martin; Öst, Åke; Strandberg, Lars; Hellström, Per M; Hertervig, Erik; Armerding, Peter; Stehlik, Jiri; Lindberg, Greger; Björk, Jan; Lapidus, Annika; Löfberg, Robert; Bonderup, Ole; Avnström, Sören; Rössle, Martin; Dilger, Karin; Mueller, Ralph; Greinwald, Roland; Tysk, Curt; Ström, Magnus

    2016-01-01

    Objective This 1-year study aimed to assess low-dose budesonide therapy for maintenance of clinical remission in patients with collagenous colitis. Design A prospective, randomised, placebo-controlled study beginning with an 8-week open-label induction phase in which patients with histologically confirmed active collagenous colitis received budesonide (Budenofalk, 9 mg/day initially, tapered to 4.5 mg/day), after which 92 patients in clinical remission were randomised to budesonide (mean dose 4.5 mg/day; Budenofalk 3 mg capsules, two or one capsule on alternate days) or placebo in a 12-month double-blind phase with 6 months treatment-free follow-up. Primary endpoint was clinical remission throughout the double-blind phase. Results Clinical remission during open-label treatment was achieved by 84.5% (93/110 patients). The median time to remission was 10.5 days (95% CI (9.0 to 14.0 days)). The maintenance of clinical remission at 1 year was achieved by 61.4% (27/44 patients) in the budesonide group versus 16.7% (8/48 patients) receiving placebo (treatment difference 44.5% in favour of budesonide; 95% CI (26.9% to 62.7%), p<0.001). Health-related quality of life was maintained during the 12-month double-blind phase in budesonide-treated patients. During treatment-free follow-up, 82.1% (23/28 patients) formerly receiving budesonide relapsed after study drug discontinuation. Low-dose budesonide over 1 year resulted in few suspected adverse drug reactions (7/44 patients), all non-serious. Conclusions Budesonide at a mean dose of 4.5 mg/day maintained clinical remission for at least 1 year in the majority of patients with collagenous colitis and preserved health-related quality of life without safety concerns. Treatment extension with low-dose budesonide beyond 1 year may be beneficial given the high relapse rate after budesonide discontinuation. Trial registration numbers http://www.clinicaltrials.gov (NCT01278082) and http

  2. [Angioplasty of the renal arteries. Our experience with a 12-month follow-up].

    PubMed

    Simonetti, G; Rossi, P; Passariello, R; Pesce, B; Rovasio, S S; Urigo, F; Canalis, G C; Tomiselli, A

    1983-09-01

    We have treated 56 stenoses of renal arteries in 50 patients in which a renin assay indicated renovascular hypertension. In this paper we refer only to 40 cases of renal arteries angioplasty in 37 patients (3 cases of bilateral stenoses) with a clinical follow-up of 12 months. 25 lesions were of arteriosclerotic nature, while 15 were due to fibromuscular displasia. Results demonstrated that angioplasty resolved hypertensive conditions (either with or without medical therapy) in 82% of the cases of arteriosclerotic lesions and in 86% of the stenoses due to fibromuscular displasia. Although extremely rare, the complications that may occur with this procedure are very serious (arterial rupture, acute thrombosis, peripheral embolization). Out of utmost importance is a close collaboration with a vascular surgeon. Without doubt angioplasty will bring about radical changes in the preparation of therapeutical protocol and in some selected cases to improve renal function.

  3. Proteomic characterization of human milk fat globule membrane proteins during a 12 month lactation period.

    PubMed

    Liao, Yalin; Alvarado, Rudy; Phinney, Brett; Lönnerdal, Bo

    2011-08-05

    The milk fat globule membrane (MFGM) contains proteins which have been implicated in a variety of health benefits. Milk fat globule membrane proteins were isolated from human milk during a 12 month lactation period and subjected to in-solution digestion and liquid chromatography tandem mass spectrometry analysis. Data were pooled, and our results showed that 191 proteins were identified. Relative quantification of the identified MFGM proteins during the course of lactation was performed by label free spectral counting and differentiation expression analysis, which showed some proteins decreasing during the course of lactation whereas some increased or remained at a relatively constant level. The human MFGM proteins are distributed between intracellular, extracellular, and membrane-associated proteins, and they are mainly involved in cell communication and signal transduction, immune function, metabolism and energy production. This study provides more insights into the dynamic composition of human MFGM proteins, which in turn will enhance our understanding of the physiological significance of MFGM proteins.

  4. 77 FR 60509 - Endangered and Threatened Wildlife and Plants; 12-Month Finding for the Lemmon Fleabane...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-03

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list as an endangered or threatened species Erigeron lemmonii (Lemmon fleabane). After a review of the best available scientific information we find that listing the Lemmon fleabane as an endangered or threatened species is no longer warranted, and therefore we are removing this species from the candidate list. We propose to list Echinomastus erectocentrus var. acunensis (acu[ntilde]a cactus) and Pediocactus peeblesianus var. fickeiseniae (Fickeisen plains cactus) as an endangered species, and we propose to designate critical habitat for both cactus species under the Endangered Species Act of 1973, as amended (Act). If finalized, the effect of these regulations would be to add acu[ntilde]a cactus and Fickeisen plains cactus to the List of Endangered and Threatened Plants and to designate critical habitat for these species.

  5. Gender and discipline in 5-12-month-old infants: a longitudinal study.

    PubMed

    Ahl, Richard Evan; Fausto-Sterling, Anne; García-Coll, Cynthia; Seifer, Ronald

    2013-04-01

    We examined the effects of infant age and gender on the behaviors of infants and mothers during discipline interactions using longitudinal, naturalistic, home-based, taped observations of 16 mother-infant dyads (eight males and eight females). These observations were conducted between the child ages of 5 and 12 months and used a devised Maternal Discipline Coding System to code for the occurrence of discipline events. During discipline interactions, mothers vocalized longer, used harsher tones, and used more explanations with older compared to younger infants. Male infants were more likely than female infants to cry or whine during discipline events. Mothers of male infants used longer vocalizations, more words, and more affectionate terms than mothers of female infants. Male infants were more difficult during discipline interactions than female infants, but it appeared that mothers of males responded to this difficulty by using milder discipline techniques.

  6. Factors associated with parental perception of child vulnerability 12 months after abnormal newborn screening results.

    PubMed

    Tluczek, Audrey; McKechnie, Anne Chevalier; Brown, Roger L

    2011-10-01

    We identified factors associated with elevated parental perceptions of child vulnerability (PPCV) 12 months after newborn screening (NBS) of 136 children: healthy, normal results (H, n = 37), cystic fibrosis carriers (CF-C, n = 40), congenital hypothyroidism (CH, n = 36), and cystic fibrosis (CF, n = 23). Controlling for infant and parent characteristics, mixed logit structural equation modeling showed direct paths to elevated PPCV included parent female sex, CF diagnosis, and high documented illness frequency. PPCV was positively associated with maternal parenting stress. Infants with CF and CF carriers had significantly more documented illness frequency than H group infants. The CH group did not differ significantly from the H group and had no paths to PPCV. Unexpectedly high documented illness frequency among infants who are CF carriers warrants further investigation.

  7. Pointing as Epistemic Request: 12-month-olds Point to Receive New Information.

    PubMed

    Kovács, Ágnes M; Tauzin, Tibor; Téglás, Ernő; Gergely, György; Csibra, Gergely

    2014-11-01

    Infants start pointing systematically to objects or events around their first birthday. It has been proposed that infants point to an event in order to share their appreciation of it with others. In the current study, we tested another hypothesis, according to which infants' pointing could also serve as an epistemic request directed to the adult. Thus, infants' motivation for pointing could include the expectation that adults would provide new information about the referent. In two experiments, an adult reacted to 12-month-olds' pointing gestures by exhibiting 'informing' or 'sharing' behavior. In response, infants pointed more frequently across trials in the informing than in the sharing condition. This suggests that the feedback that contained new information matched infants' expectations more than mere attention sharing. Such a result is consistent with the idea that not just the comprehension but also the production of early communicative signals is tuned to assist infants' learning from others.

  8. The role of verbal labels on flexible memory retrieval at 12-months of age.

    PubMed

    Taylor, Gemma; Liu, Hao; Herbert, Jane S

    2016-11-01

    The provision of verbal labels enhances 12-month-old infants' memory flexibility across a form change in a puppet imitation task (Herbert, 2011), although the mechanisms for this effect remain unclear. Here we investigate whether verbal labels can scaffold flexible memory retrieval when task difficulty increases and consider the mechanism responsible for the effect of language cues on early memory flexibility. Twelve-month-old infants were provided with English, Chinese, or empty language cues during a difficult imitation task, a combined change in the puppet's colour and form at the test (Hayne et al., 1997). Imitation performance by infants in the English language condition only exceeded baseline performance after the 10-min delay. Thus, verbal labels facilitated flexible memory retrieval on this task. There were no correlations between infants' language comprehension and imitation performance. Thus, it is likely that verbal labels facilitate both attention and categorisation during encoding and retrieval.

  9. Centile reference charts for total energy expenditure in infants from 1 to 12 months.

    PubMed

    Reichman, C A; Davies, P S W; Wells, J C K; Atkin, L-M; Cleghorn, G; Shepherd, R W

    2003-09-01

    A knowledge of energy expenditure in infancy is required for the estimation of recommended daily amounts of food energy, for designing artificial infant feeds, and as a reference standard for studies of energy metabolism in disease states. The objectives of this study were to construct centile reference charts for total energy expenditure (TEE) in infants across the first year of life. Repeated measures of TEE using the doubly labeled water technique were made in 162 infants at 1.5, 3, 6, 9 and 12 months. In total, 322 TEE measurements were obtained. The LMS method with maximum penalized likelihood was used to construct the centile reference charts. Centiles were constructed for TEE expressed as MJ/day and also expressed relative to body weight (BW) and fat-free mass (FFM). TEE increased with age and was 1.40,1.86, 2.64, 3.07 and 3.65 MJ/day at 1.5, 3, 6, 9 and 12 months, respectively. The standard deviations were 0.43, 0.47, 0.52,0.66 and 0.88, respectively. TEE in MJ/kg increased from 0.29 to 0.36 and in MJ/day/kg FFM from 0.36 to 0.48. We have presented centile reference charts for TEE expressed as MJ/day and expressed relative to BW and FFM in infants across the first year of life. There was a wide variation or biological scatter in TEE values seen at all ages. We suggest that these centile charts may be used to assess and possibly quantify abnormal energy metabolism in disease states in infants.

  10. Lateral wedge insoles for medial knee osteoarthritis: 12 month randomised controlled trial

    PubMed Central

    Bowles, Kelly-Ann; Payne, Craig; Cicuttini, Flavia; Williamson, Elizabeth; Forbes, Andrew; Hanna, Fahad; Davies-Tuck, Miranda; Harris, Anthony; Hinman, Rana S

    2011-01-01

    Objective To assess the effect of lateral wedge insoles compared with flat control insoles on improving symptoms and slowing structural disease progression in medial knee osteoarthritis. Design Randomised controlled trial. Setting Community in Melbourne, Australia. Participants 200 people aged 50 or more with clinical and radiographic diagnosis of mild to moderately severe medial knee osteoarthritis. Interventions Full length 5 degree lateral wedged insoles or flat control insoles worn inside the shoes daily for 12 months. Main outcome measures Primary symptomatic outcome was change in overall knee pain (past week) measured on an 11 point numerical rating scale. Primary structural outcome was change in volume of medial tibial cartilage from magnetic resonance imaging scans. Secondary clinical outcomes included changes in measures of pain, function, stiffness, and health related quality of life. Secondary structural outcomes included progression of medial cartilage defects and bone marrow lesions. Results Between group differences did not differ significantly for the primary outcomes of change in overall pain (−0.3 points, 95% confidence intervals −1.0 to 0.3) and change in medial tibial cartilage volume (−0.4 mm3, 95% confidence interval −15.4 to 14.6), and confidence intervals did not include minimal clinically important differences. None of the changes in secondary outcomes showed differences between groups. Conclusion Lateral wedge insoles worn for 12 months provided no symptomatic or structural benefits compared with flat control insoles. Trial registration Australian New Zealand Clinical Trials Registry ACTR12605000503628 and ClinicalTrials.gov NCT00415259. PMID:21593096

  11. Randomized Controlled Trial of BASICS for Heavy Drinking Mandated and Volunteer Undergraduates: 12-Month Outcomes

    PubMed Central

    Terlecki, Meredith A.; Buckner, Julia D.; Larimer, Mary E.; Copeland, Amy L.

    2014-01-01

    This is the first randomized trial testing whether heavy drinking undergraduates mandated to the Brief Alcohol Screening and Intervention for College Students (BASICS) program following a campus alcohol violation would benefit as much as heavy drinking volunteers up to one year post-intervention using control groups with high-risk drinkers to model disciplinary-related and naturalistic changes in drinking. Participants (61% male; 51% mandated; 84% Caucasian; Mage = 20.14 years) were screened for heavy drinking and randomized to BASICS (n = 115) or assessment-only control (n = 110). Outcome measures (drinking, alcohol problems) were collected at baseline, 4 weeks, 3, 6, and 12 months post-intervention. At 4 weeks post-intervention, intent-to-treat multilevel longitudinal models showed that regardless of referral group (mandated or volunteer) BASICS significantly decreased weekly drinking, typical drinks, and peak drinks relative to controls (ds = .41-.92). BASICS had a large effect on decreases in alcohol problems (d = .87). At 12 months post-intervention, BASICS participants (regardless of referral group) reported significantly fewer alcohol problems (d = .56) compared to controls. Significant long-term intervention gains for peak and typical drinks were sustained in both referral groups relative to controls (ds = .42; .11). Referral group had no significant main effect and did not interact with intervention condition to predict outcomes. Given that BASICS was associated with less drinking and fewer alcohol problems (even among heavier drinking mandated students up to one year post-intervention), provision of BASICS-style programs within disciplinary settings may help reduce heavy and problematic drinking among at-risk students. PMID:25844834

  12. Poor histological healing of a femoral fracture following 12 months of oestrogen deficiency in rats.

    PubMed

    Oliver, R A; Yu, Y; Yee, G; Low, A K; Diwan, A D; Walsh, W R

    2013-10-01

    Fractures in post-menopausal osteoporosis cause significant morbidity; however, animal models for post-menopausal fracture healing lack the effect of ageing. Therefore, we developed a model using aged animals with chronic oestrogen deficiency, which demonstrates inferior fracture repair (decreased healing histologically, bone mineral density and content and strength). This novel model may help develop molecular strategies for osteoporotic fracture repair. The femur is susceptible to damage by both systemic conditions such as osteoporosis and locally by traumatic injury. The capacity for fracture repair decreases with age, while the risk of fracture increases. As studies of osteoporotic fracture healing in rats traditionally use a period of 3 months or less of oestrogen deficiency prior to fracturing, we aimed to establish a osteoporosis model in rats with chronic oestrogen deficiency by 12 months to better mimic human female osteoporosis. Seventy female Sprague-Dawley rats (10 weeks old) were ovariectomised or sham operated and housed for 12 months. The right femur was fractured by way of an open osteotomy and fixed with an intramedullary Kirschner wire. Animals were sacrificed at 1, 3 and 6 weeks for radiography, dual-energy X-ray absorptiometry, tensile testing and histology. Bone mineral density and bone mineral content were lower by 60 and 63 %, respectively, (p < 0.05) in the bilaterally ovariectomized (OVX) groups than those in the sham groups at 6 weeks in the right fractured femurs. Maximum breaking force of the OVX group was lower than that of the sham group, with the greatest difference seen at 6 weeks following osteotomy. Histologically, the OVX groups demonstrated a delay in cellular differentiation within the fracture callus and the presence of bone resorption. The sham animals had a superior histological healing pattern with an Allen score of 4 at 6 weeks compared to a score of 1 for the OVX groups (p < 0.01). Long-term ovariectomy has a

  13. Weight loss effects from vegetable intake: a 12-month randomised controlled trial

    PubMed Central

    Tapsell, L C; Batterham, M J; Thorne, R L; O'Shea, J E; Grafenauer, S J; Probst, Y C

    2014-01-01

    Background/Objectives: Direct evidence for the effects of vegetable intake on weight loss is qualified. The study aimed to assess the effect of higher vegetable consumption on weight loss. Subjects/Methods: A single blind parallel controlled trial was conducted with 120 overweight adults (mean body mass index=29.98 kg/m2) randomised to two energy deficit healthy diet advice groups differing only by doubling the serving (portion) sizes of vegetables in the comparator group. Data were analysed as intention-to-treat using a linear mixed model. Spearmans rho bivariate was used to explore relationships between percentage energy from vegetables and weight loss. Results: After 12 months, the study sample lost 6.5±5.2 kg (P<0.001 time) with no difference between groups (P>0.05 interaction). Both groups increased vegetable intake and lost weight in the first 3 months, and the change in weight was significantly correlated with higher proportions of energy consumed as vegetables (rho=–0.217, P=0.024). Fasting glucose, insulin and triglyceride levels decreased (P<0.001 time) and high-density lipoprotein cholesterol levels increased (P<0.001 time), with no difference between groups. Weight loss was sustained for 12 months by both groups, but the comparator group reported greater hunger satisfaction (P=0.005). Conclusions: Advice to consume a healthy low-energy diet leads to sustained weight loss, with reductions in cardiovascular disease risk factors regardless of an emphasis on more vegetables. In the short term, consuming a higher proportion of the dietary energy as vegetables may support a greater weight loss and the dietary pattern appears sustainable. PMID:24667750

  14. Association Between Blood Transfusions and 12-Month Mortality After Transcatheter Aortic Valve Implantation.

    PubMed

    Kleczynski, Pawel; Dziewierz, Artur; Bagienski, Maciej; Rzeszutko, Lukasz; Sorysz, Danuta; Trebacz, Jaroslaw; Sobczynski, Robert; Tomala, Marek; Stapor, Maciej; Dudek, Dariusz

    2017-02-07

    Blood transfusions are considered as an important predictor of adverse outcome in patients with severe aortic (AS) undergoing transcatheter aortic valve implantation (TAVI). We sought to investigate the association between blood transfusions and mortality after TAVI. We enrolled 101 consecutive patients with severe AS undergoing TAVI. Patients who required transfusion were defined as patients in whom at least one unit of packed red blood cells (PRBCs) was transfused in the perioperative period. Twelve-month outcomes were assessed based on Valve Academic Research Consortium definitions. A total of 28 (27.7%) patients required blood transfusion after TAVI. Baseline characteristics of the patients with and without a transfusion were similar. Median amount of PRBCs was 2 (interquartile range, 2-4). Twelvemonth all-cause mortality was higher in patients with than without a blood transfusion (39.3% versus 9.6%; P = 0.001). Importantly, the need for a blood transfusion after TAVI was an independent predictor of higher mortality rates after 12 months (hazard ratio (HR) 2.84 95%CI (1.06-7.63); P = 0.039; (HR for incomplete coronary revascularization 10.86, 95%CI 3.72-31.73; P < 0.001; HR for a history of stroke/TIA 3.93, 95%CI 1.39-11.07; P < 0.001). The duration of inhospital stay was longer in patients requiring transfusion (16.0 (14.0-22.0) versus 7.0 (7.0-11.5) days; P = 0.014). In conclusion, blood transfusions after TAVI were associated with higher mortality rates after 12 months, longer in-hospital stay, and were identified as an independent predictor of impaired clinical outcome.

  15. Covariation of Adolescent Physical Activity and Dietary Behaviors over 12-Months

    PubMed Central

    Rosenberg, Dori; Norman, Gregory J.; Sallis, James F.; Calfas, Karen J.; Patrick, Kevin

    2007-01-01

    Purpose This study examined covariation among changes in dietary, physical activity, and sedentary behaviors over 12 months among adolescents participating in a health behavior intervention. Evidence of covariation among behaviors would suggest multi-behavior interventions could have synergistic effects. Methods Prospective analyses were conducted with baseline and 12 month assessments from a randomized controlled trial to promote improved diet, physical activity and sedentary behaviors (experimental condition) or SUN protection behaviors (comparison condition). Participants were adolescent girls and boys (N = 878) aged 11 to 15 years on entry. The main outcomes were: diet, based on multiple 24-hour recalls (total fat, grams of fiber, servings of fruit and vegetables, total calories); average daily energy expenditure (kcals/kg) based on 7-Day physical activity recall interviews; daily minutes of moderate-vigorous physical activity minutes from accelerometery; and self-reported daily hours of sedentary behavior. Results Covariation was found between fat and calories (r = .16), fiber and calories (r = .53), fiber and fruit/vegetables (r = .53), calories and fruit/vegetables (r = .34), and fruit and vegetables and sedentary behavior (r = -.12) for the total sample (all p < .01). The pattern of findings was similar for most subgroups defined by sex and study condition. Conclusions The strongest covariation was observed for diet variables that are inherently related (calories and fat, fiber, and fruit/vegetables). Little covariation was detected within or between other diet, physical activity and sedentary behavior domains suggesting that interventions to improve these behaviors in adolescents need to include specific program components for each target behavior of interest. PMID:17950167

  16. Mild pituitary phenotype in 3- and 12-month-old Aip-deficient male mice.

    PubMed

    Lecoq, Anne-Lise; Zizzari, Philippe; Hage, Mirella; Decourtye, Lyvianne; Adam, Clovis; Viengchareun, Say; Veldhuis, Johannes D; Geoffroy, Valérie; Lombès, Marc; Tolle, Virginie; Guillou, Anne; Karhu, Auli; Kappeler, Laurent; Chanson, Philippe; Kamenický, Peter

    2016-10-01

    Germline mutations in the aryl hydrocarbon receptor-interacting protein (AIP) gene predispose humans to pituitary adenomas, particularly of the somatotroph lineage. Mice with global heterozygous inactivation of Aip (Aip(+/-)) also develop pituitary adenomas but differ from AIP-mutated patients by the high penetrance of pituitary disease. The endocrine phenotype of these mice is unknown. The aim of this study was to determine the endocrine phenotype of Aip(+/-) mice by assessing the somatic growth, ultradian pattern of GH secretion and IGF1 concentrations of longitudinally followed male mice at 3 and 12 months of age. As the early stages of pituitary tumorigenesis are controversial, we also studied the pituitary histology and somatotroph cell proliferation in these mice. Aip(+/-) mice did not develop gigantism but exhibited a leaner phenotype than wild-type mice. Analysis of GH pulsatility by deconvolution in 12-month-old Aip(+/-) mice showed a mild increase in total GH secretion, a conserved GH pulsatility pattern, but a normal IGF1 concentration. No pituitary adenomas were detected up to 12 months of age. An increased ex vivo response to GHRH of pituitary explants from 3-month-old Aip(+/-) mice, together with areas of enlarged acini identified on reticulin staining in the pituitary of some Aip(+/-) mice, was suggestive of somatotroph hyperplasia. Global heterozygous Aip deficiency in mice is accompanied by subtle increase in GH secretion, which does not result in gigantism. The absence of pituitary adenomas in 12-month-old Aip(+/-) mice in our experimental conditions demonstrates the important phenotypic variability of this congenic mouse model.

  17. Toxicological Emergencies in the Resuscitation Area of a Pediatric Emergency Department: A 12-Month Review.

    PubMed

    Beauchamp, Gillian A; Kerrey, Benjamin T; Mittiga, Matthew R; Rinderknecht, Andrea S; Yin, Shan

    2017-10-01

    Few studies of children with toxicological emergencies describe those undergoing acute resuscitation, and most describe exposures to single agents. We describe a 12-month sample of patients evaluated in the resuscitation area of a pediatric emergency department (ED) for a toxicological emergency. We conducted a retrospective chart review of patients in a high-volume, academic pediatric ED. We identified patients evaluated in the ED resuscitation area for toxicological exposure and conducted structured chart reviews to collect relevant data. For all variables of interest, we calculated standard descriptive statistics. Of 2999 patients evaluated in the resuscitation area through 12 months (March 2009 to April 2010), we identified 80 (2.7%) whose primary ED diagnosis was toxicological. The mean age was 11.4 years. Eighty-six percent of patients were triaged to the resuscitation area for significantly altered mental status. The most frequent single exposures were ethanol (25%), clonidine (10%), and acetaminophen (5%). At least 1 laboratory test was performed for almost all patients (97%). Interventions performed in the resuscitation area included intravenous access placement (97%), activated charcoal (20%), naloxone (19%), and endotracheal intubation (12%). Eighty-two percent of patients were admitted to the hospital; 37% to the intensive care unit. No patients studied in this sample died and most received only supportive care. In a high-volume pediatric ED, toxicological emergencies requiring acute resuscitation were rare. Ethanol and clonidine were the most frequent single exposures. Most patients received diagnostic testing and were admitted. Further studies are needed to describe regional differences in pediatric toxicological emergencies.

  18. The origins of 12-month attachment: a microanalysis of 4-month mother-infant interaction.

    PubMed

    Beebe, Beatrice; Jaffe, Joseph; Markese, Sara; Buck, Karen; Chen, Henian; Cohen, Patricia; Bahrick, Lorraine; Andrews, Howard; Feldstein, Stanley

    2010-01-01

    A microanalysis of 4-month mother-infant face-to-face communication revealed a fine-grained specification of communication processes that predicted 12-month insecure attachment outcomes, particularly resistant and disorganized classifications. An urban community sample of 84 dyads were videotaped at 4 months during a face-to-face interaction, and at 12 months during the Ainsworth Strange Situation. Four-month mother and infant communication modalities of attention, affect, touch, and spatial orientation were coded from split-screen videotape on a 1 s time base; mother and infant facial-visual "engagement" variables were constructed. We used contingency measures (multi-level time-series modeling) to examine the dyadic temporal process over time, and specific rates of qualitative features of behavior to examine the content of behavior. Self-contingency (auto-correlation) measured the degree of stability/lability within an individual's own rhythms of behavior; interactive contingency (lagged cross-correlation) measured adjustments of the individual's behavior that were correlated with the partner's previous behavior. We documented that both self- and interactive contingency, as well as specific qualitative features, of mother and infant behavior were mechanisms of attachment formation by 4 months, distinguishing 12-month insecure, resistant, and disorganized attachment classifications from secure; avoidant were too few to test. All communication modalities made unique contributions. The separate analysis of different communication modalities identified intermodal discrepancies or conflict, both intrapersonal and interpersonal, that characterized insecure dyads. Contrary to dominant theories in the literature on face-to-face interaction, measures of maternal contingent coordination with infant yielded the fewest associations with 12-month attachment, whereas mother and infant self-contingency, and infant contingent coordination with mother, yielded comparable numbers

  19. The Origins of 12-Month Attachment: A Microanalysis of 4-Month Mother-Infant Interaction

    PubMed Central

    Beebe, Beatrice; Jaffe, Joseph; Markese, Sara; Buck, Karen; Chen, Henian; Cohen, Patricia; Bahrick, Lorraine; Andrews, Howard; Feldstein, Stanley

    2013-01-01

    A detailed microanalysis of 4-month mother-infant face-to-face communication revealed a fine-grained specification of essential communication processes that predicted 12-month insecure attachment outcomes, particularly resistant and disorganized classifications. An urban community sample of 84 dyads were videotaped at 4 months during a face-to-face interaction, and at 12 months during the Ainsworth Strange Situation. Four-month mother and infant communication modalities of attention, affect, touch, and spatial orientation were coded from split-screen videotape on a 1s time base; mother and infant facial-visual “engagement” variables were constructed. We used contingency measures (multi-level time-series modeling) to examine the dyadic temporal process over time, and specific rates of qualitative features of behavior to examine the content of behavior. Self-contingency (auto-correlation) measured the degree of stability/lability within an individual’s own rhythms of behavior; interactive contingency (lagged cross-correlation) measured adjustments of the individual’s behavior that were correlated with the partner’s previous behavior. We documented that both self- and interactive contingency, as well as specific qualitative features, of mother and infant behavior were mechanisms of attachment formation by 4 months, distinguishing 12-month insecure, resistant, and disorganized attachment classifications from secure; avoidant were too few to test. All communication modalities made unique contributions. The separate analysis of different communication modalities identified intermodal discrepancies or conflict, both intrapersonal and interpersonal, that characterized insecure dyads. Contrary to dominant theories in the literature on face-to-face interaction, measures of maternal contingent coordination with infant yielded the fewest associations with 12-month attachment, whereas mother and infant self-contingency, and infant contingent coordination with mother

  20. Prevalence, correlates, and comorbidity of 12-Month tobacco dependence among ever-smokers in South Korea, during 1984-2001.

    PubMed

    Jeon, Hong Jin; Hahm, Bong-Jin; Lee, Hae-Woo; Hong, Jin Pyo; Bae, Jae-Nam; Park, Jong Ik; Kim, Jang-Kyu; Bae, Ahn; Park, Jong Han; Chung, Eun-Kee; Shin, Jong-Ho; Choi, Yong-Seoung; Chung, In-Won; Lee, Hyo Jung; Cho, Maeng Je

    2008-04-01

    The rate of dependence among ever-users of a drug indicates the risk of developing dependence once an individual has been exposed to the drug. This is the first study to investigate 12-month tobacco dependence (TD) among ever-smokers in a community-based population. Analyses were based on two national studies of representative samples aged 18-64 in 1984 (n=5,025) and in 2001 (n=6,275), conducted with household visits and face-to-face interviews. The rates of 12-month TD among ever-smokers in men showed no significant difference between 51.6% in 1984 and 50.6% in 2001. On the contrary, the rates in women significantly increased from 33.3% in 1984 to 52.8% in 2001. After adjusting for the sociodemographic variables, 'male gender' was significantly associated with 12-month TD among eversmokers in 1984, but not in 2001. 'Unmarried' was significantly associated in 2001 but not in 1984. 'Alcohol dependence' was the only psychiatric disorder associated with 12-month TD in both study years. In conclusion, 12-month TD was found in about 50% of ever-smokers, and gender differences between the rates of 12-month TD which was observed in 1984 disappeared in 2001. Individuals with 12-month TD showed higher comorbidity with alcohol dependence than ever-smokers without TD.

  1. Agoraphobia and Follicle-Stimulating Hormone Levels between Tamoxifen and Goserelin versus Tamoxifen Alone in Premenopausal Hormone Receptor-Positive Breast Cancer: A 12-Month Prospective Randomized Study.

    PubMed

    Heo, Jung-Yoon; Yi, Hawoo; Fava, Maurizio; Mischoulon, David; Kim, Kiwon; Yoon, Sechang; Jeon, Hong Jin; Lee, Jeong Eon

    2017-07-01

    Tamoxifen is an estrogen receptor antagonist used to prevent recurrence of breast cancer, which may provoke depression and anxiety and increase follicle-stimulating hormone (FSH) to patients. We compared anxiety and depression symptoms and FSH levels who received conventional tamoxifen alone and combination treatment of goserelin, a gonadotropin-releasing hormone (GnRH) analogue, with tamoxifen. Sixty-four premenopausal women with hormone receptor-positive early-stage breast cancer were included and were assigned randomly to receive either tamoxifen and goserelin combination or tamoxifen alone for 12 months. The participants were evaluated blindly using the Hamilton Depression and Anxiety Rating Scale, the Beck Depression Rating Scale, and the Albany Panic and Phobia Questionnaire (APPQ). Blood FSH levels were assessed at baseline, 6 and 12 months. A significant time×group difference was detected in the agoraphobia trends subscale of the APPQ and in FSH levels. The combination group showed significantly less increases in agoraphobia subscale of APPQ and greater decreases in FSH level than those in the tamoxifen-alone group from baseline to 12 months of treatment. No significant differences for age, tumor grade, body mass index, or family history were found at baseline between the two groups. Our results suggest that the combination treatment of tamoxifen and goserelin resulted in less agoraphobia than tamoxifen alone in premenopausal women with breast cancer, which may associated with FSH suppression of goserelin.

  2. Agoraphobia and Follicle-Stimulating Hormone Levels between Tamoxifen and Goserelin versus Tamoxifen Alone in Premenopausal Hormone Receptor-Positive Breast Cancer: A 12-Month Prospective Randomized Study

    PubMed Central

    Heo, Jung-Yoon; Yi, Hawoo; Fava, Maurizio; Mischoulon, David; Kim, Kiwon; Yoon, Sechang

    2017-01-01

    Objective Tamoxifen is an estrogen receptor antagonist used to prevent recurrence of breast cancer, which may provoke depression and anxiety and increase follicle-stimulating hormone (FSH) to patients. We compared anxiety and depression symptoms and FSH levels who received conventional tamoxifen alone and combination treatment of goserelin, a gonadotropin-releasing hormone (GnRH) analogue, with tamoxifen. Methods Sixty-four premenopausal women with hormone receptor-positive early-stage breast cancer were included and were assigned randomly to receive either tamoxifen and goserelin combination or tamoxifen alone for 12 months. The participants were evaluated blindly using the Hamilton Depression and Anxiety Rating Scale, the Beck Depression Rating Scale, and the Albany Panic and Phobia Questionnaire (APPQ). Blood FSH levels were assessed at baseline, 6 and 12 months. Results A significant time×group difference was detected in the agoraphobia trends subscale of the APPQ and in FSH levels. The combination group showed significantly less increases in agoraphobia subscale of APPQ and greater decreases in FSH level than those in the tamoxifen-alone group from baseline to 12 months of treatment. No significant differences for age, tumor grade, body mass index, or family history were found at baseline between the two groups. Conclusion Our results suggest that the combination treatment of tamoxifen and goserelin resulted in less agoraphobia than tamoxifen alone in premenopausal women with breast cancer, which may associated with FSH suppression of goserelin. PMID:28845177

  3. Telemedicine vs. in-person delivery of intensive short-term dynamic psychotherapy for patients with medically unexplained pain: A 12-month randomized, controlled trial.

    PubMed

    Chavooshi, Behzad; Mohammadkhani, Parvaneh; Dolatshahee, Behrouz

    2017-01-01

    Introduction This study examined the effectiveness of telemedicine in providing psychotherapy to patients with medically unexplained pain (MUP) who may not have access to in-person treatment. The impact of Internet-delivered intensive short-term dynamic psychotherapy (ID-ISTDP) was investigated for MUP via video teleconferencing (Skype™). Methods A randomized, controlled trial of ISTDP, an evidence-based intervention for MUP, was conducted to compare delivery modalities on variations in MUP symptoms. Eighty-one participants with MUP were randomized to either ID-ISTDP ( n = 39) or in-person ISTDP ( n = 42). Outcome variables included the Numeric Pain Rating Scale, Depression Anxiety Stress Scale-21, Emotion Regulation Questionnaire, Mindful Attention Awareness Scale and the Quality of Life Inventory. In addition, exploratory analyses were used to examine acceptability, satisfaction and compliance in both conditions. Participants were assessed prior to intervention, immediately following the intervention, and 12 months after. Results In the intention-to-treat analysis, in-person ISTDP participants had significantly lower pain intensity than ID-ISTDP participants, both immediately following the intervention ( d = 0.97) and at the 12-month follow-up ( d = 0.82). Moreover, there were significant decreases in depression, anxiety and stress as well as a greater increase in emotion regulation functioning, mindfulness and quality of life observed in the in-person ISTDP group at the end of the intervention and 12 months after the treatment when compared to the ID-ISTDP group. Participants rated both treatment conditions as equally credible and satisfying. Conclusion ISTDP seems most effective when delivered in person in treating MUP patients with highly comorbid conditions with benefits maintained over 12 months.

  4. The influence of maternal optimality and infant temperament on parenting stress at 12 months among mothers with substance abuse and psychiatric problems.

    PubMed

    Siqveland, Torill S; Olafsen, Kåre S; Moe, Vibeke

    2013-10-01

    The present prospective longitudinal study aimed to investigate the long-term impact of maternal optimality assessed during pregnancy on parenting stress at infant age 12 months. In this study the concept of optimality was utilized to investigate maternal variations regarding resources during pregnancy in relation to later parenting stress, among three different groups of mothers that were recruited from substance abuse treatment, psychiatric outpatient treatment and well-baby clinics respectively. The influence of infant temperament on parenting stress was also examined. All mothers were interviewed during pregnancy. At 12 months, infant temperament (Colorado Childhood Temperament Inventory; Rowe & Plomin, 1977) and stress in the parent and child domain (Parenting Stress Index; Abidin, 1955) were assessed. Results demonstrated higher levels of parenting stress among mothers in the clinical groups, compared to the non-clinical group. Furthermore, it was the maternal psychiatric optimality index in combination with child temperament characteristics (child emotionality) that contributed uniquely to stress in the parent domain, while stress in the child domain was significantly associated only with child temperament characteristics (both child emotionality and soothability). The association between maternal psychiatric optimality assessed in pregnancy, infant temperament and parenting stress when the infants were 12 months old, points to the importance of simultaneously addressing the mothers' own psychological distress, and to support positive mother-infant interactions. Each woman's individual optimality profile may be used to display needs of follow-up in order to prevent enduring effects of non-optimality on parenting stress. © 2013 The Scandinavian Psychological Associations.

  5. [Previous abstinence time as a predictive factor at 12 months follow-up in a multi-component smoking cessation program].

    PubMed

    Moreno-Arnedillo, J J; Morante-Benadero, M E; Sánchez-Vegazo-Sánchez, E

    2014-01-01

    The objective of this study is to analyze the length of the longest period of previous abstinence time as a predictor of the results of a smoking cessation program at 12 months follow-up. A cross-sectional study was conducted on a sample of 475 smokers who had participated in a multi-component smoking cessation group therapy program. The independent variable is the longest abstinence time passed, measured in weeks, before the current treatment. Success was defined as self-reported abstinence. Bivariate analyses were applied to the independent variable and to other variables in order to determine the factors that would be part of a logistic regression model using contrasts Student t or χ(2) comparisons, as appropriate. Those that showed statistical significance were entered into a multivariate logistic regression model. Within the studied variables, previous abstinence time and sex were the only predictive variables of success at 12 month follow-up. The probability of being abstinent at 12 months follow-up was significantly associated with the length of the previous longest period of abstinence, and this is the best of the predictors considered. Successful cessation programs depend more on the relationship with the consumer biographical aspects than with biological factors. The history of previous attempts is a more valuable source of information for designing treatments than others traditionally considered. Copyright © 2013 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España. All rights reserved.

  6. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence.

    PubMed

    Bradshaw, Catriona S; Morton, Anna N; Hocking, Jane; Garland, Suzanne M; Morris, Margaret B; Moss, Lorna M; Horvath, Leonie B; Kuzevska, Irene; Fairley, Christopher K

    2006-06-01

    We wished to determine recurrences of bacterial vaginosis (BV) after treatment over the course of 12 months and to establish factors associated with recurrence. Women with symptomatic BV (a Nugent score [NS] of 7-10 or of 4-6 with >or=3 Amsel criteria) were enrolled. BV was treated with 400 mg of oral metronidazole twice a day for 7 days. Participants completed a questionnaire and vaginal swabs were collected at 1, 3, 6, and 12 months; the study end point was an NS of 7-10. A total of 121 (87%) women with an NS of 7-10 and 18 (13%) with an NS of 4-6 and >or=3 Amsel criteria were enrolled; 130 (94%) returned >or=1 vaginal samples. Sixty-eight women (58% [95% confidence interval {CI}, 49%-66%]) had a recurrence of BV (NS 7-10), and 84 (69% [95% CI, 61%-77%]) had a recurrence of abnormal vaginal flora (NS 4-10) by 12 months. A past history of BV, a regular sex partner throughout the study, and female sex partners were significantly associated with recurrence of BV and abnormal vaginal flora by multivariate analysis; the use of hormonal contraception had a negative association with recurrence. Current recommended treatment is not preventing the recurrence of BV or abnormal vaginal flora in the majority of women; factors associated with recurrence support a possible role for sexual transmission in the pathogenesis of recurrent BV.

  7. Influence of chlorhexidine concentration on the durability of etch-and-rinse dentin bonds: a 12-month in vitro study

    PubMed Central

    Breschi, Lorenzo; Cammelli, Federica; Visintini, Erika; Mazzoni, Annalisa; Vita, Francesca; Carrilho, Marcela; Cadenaro, Milena; Foulger, Stephen; Tay, Franklin R; Pashley, David; Di Lenarda, Roberto

    2013-01-01

    Objective To investigate the effect of 0.2% and 2% chlorhexidine (CHX) used as a therapeutic primer on the long-term bond strengths of two etch-and-rinse adhesive systems. Methods Adper Scotchbond 1XT (SB1) and XP-Bond (XPB) were evaluated. Etched dentin substrates were assigned to six treatment groups: (1) 0.2% CHX + SB1; (2) 2% CHX + SB1; (3) SB1 (control); (4) 0.2% CHX + XPB; (5) 2% CHX + XPB; (6) XPB (control). Composite build-ups were made and beams prepared for microtensile bond strength test. Beams were divided in three subgroups and either immediately pulled to failure or stored in artificial saliva for 6 or 12 months prior to testing. Data were evaluated by three-way ANOVA. Additional adhesive interfaces were prepared to investigate nanoleakage expression by TEM. Results SB1 and XPB showed similar immediate bond strength values with or without CHX pre-treatment (p>0.05). After 12 months, bonds fell from 43.9 ± 9.5 MPa to 20.1 ± 5.4 MPa and from 39.6 ± 9.4 MPa to 14.2 ± 5.0 MPa in control specimens for SB1 and XPB respectively, while bond fell only from 41.9±9.6MPa to 33.2 ± 8.3 MPa and 38.3 ± 8.9 MPa to 26.5 ± 10.9 (for SB1 and XPB respectively) when 0.2% CHX was previously used. CHX concentration did not affect bond strength values (0.2% vs 2%, p>.05). Nanoleakage increased during aging in controls, but reduced silver deposits were found in CHX-treated specimens. Conclusions Chlorhexidine significantly reduced the loss of bond strength seen in control bonds. Since no bacterial growth was present in the aging conditions, the results of this study suggest that endogenous factors thought to degrade the adhesive interface can be inhibited by CHX. Further in vivo trials should confirm the role of CHX in bond durability. PMID:19603582

  8. A 12-month follow-up study of people with dementia referred to general hospital liaison psychiatry services.

    PubMed

    Sheehan, Bart; Lall, Ranjit; Gage, Heather; Holland, Caroline; Katz, Jeanne; Mitchell, Kate

    2013-11-01

    new services for patients with dementia in general hospitals are being widely developed. Little is known of outcomes after hospital for such patients. to establish outcomes for patients with dementia referred to general hospital psychiatric services. prospective cohort study. two UK general hospitals. referrals with dementia to liaison psychiatric services. eligible referrals (n = 112), and their carers, were assessed during admission, and at 6 and 12 months, using battery of health measurements. mortality at 6 months was 31% and at 12 months 40%. At baseline, 13% lived in a care home, rising to 84% by 6 months. Quality of life scores remained stable over 12 months, while carer stress fell significantly. Baseline clinical and demographic variables did not predict quality of life or carer stress at 6 and 12 months. dementia liaison services in general hospitals currently focus on poor outcome cases.

  9. Clinical and genetic features of Argentinian children with diabetes-onset before 12months of age: Successful transfer from insulin to oral sulfonylurea.

    PubMed

    Taberner, Patricia; Flanagan, Sarah E; Mackay, Deborah J; Ellard, Sian; Taverna, Mariano J; Ferraro, Mabel

    2016-07-01

    Neonatal diabetes mellitus (NDM) is a rare monogenic disorder, reported to affect less than 2 cases per 100,000 infants. There are two types, permanent (PNDM) and transient (TNDM). We describe our clinical experience in determining and comparing the genetic basis of diabetes in children with onset before 6months versus those diagnosed between 6 and 12months of age. We reviewed medical records of children with diabetes diagnosed before 12months of age. Genetic testing was performed in all cases. 12 patients were diagnosed with diabetes before 6months of age (PNDM=6; TNDM=6), and 11 patients between 6 and 12months (all with permanent diabetes). Among children with PNDM, we identified three different KCNJ11 mutations in 5 patients, and one novel ABCC8 mutation in a single patient. Among children with TNDM, we detected a KCNJ11 and ABCC8 mutation each in a single patient and methylation abnormalities at chromosome 6q24 in 4 patients. Among children with diabetes diagnosed between 6 and 12months, 1 patient had an INS mutation and one patient was homozygous for an SLC19A2 mutation which confirmed a diagnosis of thiamine-responsive megaloblastic anaemia syndrome. Five of the patients with an ABCC8 or KCNJ11 mutation have successfully transferred from insulin to glibenclamide whist 1 child demonstrated a partial response to sulfonylurea treatment. Investigating the underlying genetic basis of diabetes in children with onset before 1year is useful for choosing the most efficient treatment, the basis of Personalized Medicine. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  10. Conventional vs. Daylight Photodynamic Therapy for patients with actinic keratosis on face and scalp: 12-month follow-up results of a randomized, intraindividual comparative analysis.

    PubMed

    Sotiriou, Elena; Evagelou, George; Papadavid, Evangelia; Apalla, Zoe; Vrani, Fotini; Vakirlis, Efstratios; Panagiotou, Maro; Stefanidou, Maria; Pombou, Tsampikos; Krasagakis, Konstantinos; Rigopoulos, Dimitrios; Ioannides, Demetrios

    2017-10-03

    Daylight PDT (DLPDT) is a new PDT procedure. Several trials demonstrate that DLPDT achieves similar response rates with conventional PDT (CPDT) in the treatment of nonhyperkeratotic actinic keratoses (AKs) in a nearly painless way. It seems that DLPDT represents a more convenient and equally effective treatment modality. Data on long-term efficacy of DLPDT are limited. To compare short- and long-term efficacy, safety and tolerability of DLPDT with that of CPDT in face and scalp AKs. The study, an intraindividual right-left comparison study, was conducted in 3 centers in North, Center and South Greece. Eligible patients received either DLPDT or CPDT randomly allocated to alternate sides of face or scalp. Patients were evaluated at baseline, 3 and 12 months after treatment. Assessments included lesion response at 3 and 12 months, PDT associated pain during PDT session, local skin reactions 3 days after treatment as well as patients' preference 3 months after treatment. A total of 46 patients completed the study. Three months after treatment the overall lesion complete response rate was 78% for DLPDT and 80.6% for CPDT. At the 12-months follow-up response rate decreased to 71.8% and 73.7% for DLPDT and CPDT accordingly. Regarding response based on lesion grade, response rates obtained in grade I lesions were higher with DLPDT, while treatment with CPDT resulted to higher rates of cured grade II lesions at both follow-up visits. Results were not supported by statistical significance. DLPDT was associated with significantly lower pain and reduced severity of local skin reactions. Patients' preference favored DLPDT. Our study demonstrated that DLPDT is similar to CPDT in terms of long-term efficacy and recurrence rates in the treatment of face and scalp AKs. DLPDT demonstrated a better tolerability profile as it was associated with lower pain and less severe adverse events. This article is protected by copyright. All rights reserved. This article is protected by

  11. Efficacy and safety of ingenol mebutate 0.015% gel after cryosurgery of actinic keratosis: 12-month results.

    PubMed

    Berman, Brian; Goldenberg, Gary; Hanke, C William; Tyring, Stephen K; Werschler, Wm Philip; Knudsen, Kim Mark; Larsson, Thomas; Swanson, Neil

    2014-06-01

    Recurrence rates of actinic keratosis (AK) lesions after cryosurgery are high, and this treatment does not address field cancerization. We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following cryosurgery. In this phase 3, randomized, double-blind, vehicle-controlled study (NCT01541553), patients ≥18 years with four to eight clinically typical, visible, discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015% or vehicle gel for 3 consecutive days. Endpoints included complete clearance at week 11 and safety and efficacy over 12 months. In 329 randomized patients, complete clearance rates were greater with ingenol mebutate than vehicle (week 11: 60.5% vs 49.4%; P=.04; month 12: 30.5% vs 18.5%; P=.01). Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle (38.9% vs 51.9%; P =.02). At month 12, mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle (68.2% vs 54.1%; P =.002). The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel: 78% vs 68% at 6 months; 64% vs 57% at 9 months; 55% vs 40% at month 12, respectively. Ingenol mebutate 0.015% gel was well tolerated and no unexpected adverse events occurred; all adverse events resolved within 2 weeks of starting treatment. Field treatment with ingenol mebutate 0.015% gel following cryosurgery significantly enhanced clearance of baseline lesions, and was well tolerated. Furthermore, ingenol mebutate 0.015% gel following cryosurgery reduced development of new lesions in the treated field.

  12. A web-based preventive intervention program for bipolar disorder: outcome of a 12-months randomized controlled trial.

    PubMed

    Barnes, Caryl W; Hadzi-Pavlovic, Dusan; Wilhelm, Kay; Mitchell, Philip B

    2015-03-15

    The Internet is used to deliver information on many psychiatric disorders such as bipolar disorder. This paper reports on the results of a 12-months randomised controlled trial, which examined the efficacy of an Internet-based preventive program for bipolar disorder, adjunctive to usual pharmacological management. Participants were recruited by completing an online screening questionnaire accessed through the Black Dog Institute and Sentiens websites based in Australia. The treatment was predominantly psycho-educational with cognitive behavioral therapy optional elements. The attention control treatment comprised directing subjects to a variety of websites focused on 'healthy living'. Time to recurrence was determined using Kaplan-Meier survival analysis. The main outcome measures were recurrence as defined by: (i) depressive and/or hypomanic symptomatology and functional capacity (using Beck Depression Inventory, Internal State Scale and Sheehan Disability Scale) and (ii) hospitalization. Two-hundred-and-thirty-three subjects were randomized to the active or control treatment groups. There were no significant differences between the active and control treatment groups on any of the definitions of recurrence. Reliance on an online self-report tool to confirm diagnosis and hospitalization rates may have potentially allowed for inclusion of individuals with other diagnoses such as borderline personality disorder. The 'attention control' treatment may have included more 'active' components than intended. This is the first report examining the efficacy of a randomized controlled web-based psychological intervention in a large sample of subjects with bipolar disorder. The potential reasons for failing to demonstrate a significant difference compared to the active control are discussed. Copyright © 2014 Elsevier B.V. All rights reserved.

  13. Neural signatures of recognition memory in 10- to 12-month-old infants.

    PubMed

    Linnert, Szilvia; Tóth, Brigitta; Nagy, Márton; Parise, Eugenio; Király, Ildikó

    2017-08-19

    Understanding memory mechanisms is crucial in the study of infant social and cognitive development. Here, we show that the Nc ERP component, known to reflect frequency-related attentional and/or memory processes, is a good candidate to investigate infant recognition memory. Previous paradigms have only investigated the effect of frequency during on-line stimulus presentation, but not during stimulus encoding. In this paper, we present a novel method for measuring the neural correlates of recognition memory and the 'degree' of familiarity in 10- to 12-month-old infants. During a familiarization phase, two images were presented frequently, while another two images were presented infrequently to the infants. In the test phase, the infrequent familiar, the frequent familiar, and the novel stimuli, were all presented with equal probability. We found larger Nc amplitudes following the familiar stimuli compared to the novel ones. The 'degree' of familiarity, on the other hand, did not modulate the Nc amplitude. These results can only be explained with memory-related processes, since in our paradigm the on-line presentation frequency did not vary. Furthermore, the lack of familiarization frequency effect suggests that the Nc might be a neural correlate of declarative memory. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Unexpected arrest-related deaths in america: 12 months of open source surveillance.

    PubMed

    Ho, Jeffrey D; Heegaard, William G; Dawes, Donald M; Natarajan, Sridhar; Reardon, Robert F; Miner, James R

    2009-05-01

    Sudden, unexpected arrest-related death (ARD) has been associated with drug abuse, extreme delirium or certain police practices. There is insufficient surveillance and causation data available. We report 12 months of surveillance data using a novel data collection methodology. We used an open-source, prospective method to collect 12 consecutive months of data, including demographics, behavior, illicit substance use, control methods used, and time of collapse after law enforcement contact. Descriptive analysis and chi-square testing were applied. There were 162 ARD events reported that met inclusion criteria. The majority were male with mean age 36 years, and involved bizarre, agitated behavior and reports of drug abuse just prior to death. Law enforcement control techniques included none (14%); empty-hand techniques (69%); intermediate weapons such as TASER((R)) device, impact weapon or chemical irritant spray (52%); and deadly force (12%). Time from contact to subject collapse included instantaneous (13%), within the first hour (53%) and 1-48 hours (35%). Significant collapse time associations occurred with the use of certain intermediate weapons. This surveillance report can be a foundation for discussing ARD. These data support the premise that ARDs primarily occur in persons with a certain demographic and behavior profile that includes middle-aged males exhibiting agitated, bizarre behavior generally following illicit drug abuse. Collapse time associations were demonstrated with the use of TASER devices and impact weapons. We recommend further study in this area to validate our data collection method and findings.

  15. Unexpected Arrest-Related Deaths in America: 12 Months of Open Source Surveillance

    PubMed Central

    Ho, Jeffrey D.; Heegaard, William G.; Dawes, Donald M.; Natarajan, Sridhar; Reardon, Robert F.; Miner, James R.

    2009-01-01

    Introduction: Sudden, unexpected arrest-related death (ARD) has been associated with drug abuse, extreme delirium or certain police practices. There is insufficient surveillance and causation data available. We report 12 months of surveillance data using a novel data collection methodology. Methods: We used an open-source, prospective method to collect 12 consecutive months of data, including demographics, behavior, illicit substance use, control methods used, and time of collapse after law enforcement contact. Descriptive analysis and chi-square testing were applied. Results: There were 162 ARD events reported that met inclusion criteria. The majority were male with mean age 36 years, and involved bizarre, agitated behavior and reports of drug abuse just prior to death. Law enforcement control techniques included none (14%); empty-hand techniques (69%); intermediate weapons such as TASER® device, impact weapon or chemical irritant spray (52%); and deadly force (12%). Time from contact to subject collapse included instantaneous (13%), within the first hour (53%) and 1–48 hours (35%). Significant collapse time associations occurred with the use of certain intermediate weapons. Conclusion: This surveillance report can be a foundation for discussing ARD. These data support the premise that ARDs primarily occur in persons with a certain demographic and behavior profile that includes middle-aged males exhibiting agitated, bizarre behavior generally following illicit drug abuse. Collapse time associations were demonstrated with the use of TASER devices and impact weapons. We recommend further study in this area to validate our data collection method and findings. PMID:19561821

  16. Social looking, social referencing and humor perception in 6- and-12-month-old infants.

    PubMed

    Mireault, Gina C; Crockenberg, Susan C; Sparrow, John E; Pettinato, Christine A; Woodard, Kelly C; Malzac, Kirsten

    2014-11-01

    Social referencing refers to infants' use of caregivers as emotional referents in ambiguous situations (Walden, 1993). Studies of social referencing typically require ambulation, thereby over-looking younger, non-ambulatory infants (i.e., ≤8-months) and resulting in a widespread assumption that young infants do not employ this strategy. Using a novel approach that does not require mobility, we found that when parents provided unsolicited affective cues during an ambiguous-absurd (i.e., humorous) event, 6-month-olds employ one component of social referencing, social looking Additionally, 6-month-olds who did not laugh at the event were significantly more likely to look toward parents than their counterparts who found the event funny. Sequential analyses revealed that, following a reference to a smiling parent, 6-month olds were more likely to smile at the parent, but by 12 months were more likely to smile at the event suggesting that older infants are influenced by parental affect in humorous situations. The developmental implications of these findings are discussed, as well as the usefulness of studying humor for understanding important developmental phenomena.

  17. Perievent panic attacks and panic disorder after mass trauma: a 12-month longitudinal study.

    PubMed

    Wood, Cristina M; Salguero, José M; Cano-Vindel, Antonio; Galea, Sandro

    2013-06-01

    Panic attacks frequently lead to psychopathological disorders, including panic disorder. Even though panic disorder is a highly comorbid and disabling mental health problem associated with stressful life or traumatic events, perievent panic attacks and their association with panic disorder have hardly been investigated as a central topic after mass trauma. Using data from a longitudinal population-based assessment of Madrid residents after the March 11, 2004 train bombings (N = 1,589), with assessments conducted 1, 6, and 12 months after the attacks, the rate of perievent panic attacks was 10.9%. Level of exposure, previous life stressors, and negative emotionality were associated with perievent panic attacks (β = .12, .15, and .10, respectively), which in turn mediated the relationship between exposure to the terrorist event and panic disorder in the following year. Previous life stressors (β = .15) and low social support (β = -.14) were directly associated with panic disorder during the subsequent year. The most vulnerable individuals who experienced perievent panic attacks were 3.7 times, 95% confidence interval [CI] = [2.1, 6.4], more likely to suffer from panic disorder in the following year. Results suggest that early identification of perievent panic attacks following mass trauma may be helpful for reducing panic disorder. Copyright © 2013 International Society for Traumatic Stress Studies.

  18. Indexical and linguistic processing by 12-month-olds: Discrimination of speaker, accent and vowel differences

    PubMed Central

    Bonn, Cory D.; Chládková, Kateřina; Aslin, Richard N.; Escudero, Paola

    2017-01-01

    Infants preferentially discriminate between speech tokens that cross native category boundaries prior to acquiring a large receptive vocabulary, implying a major role for unsupervised distributional learning strategies in phoneme acquisition in the first year of life. Multiple sources of between-speaker variability contribute to children’s language input and thus complicate the problem of distributional learning. Adults resolve this type of indexical variability by adjusting their speech processing for individual speakers. For infants to handle indexical variation in the same way, they must be sensitive to both linguistic and indexical cues. To assess infants’ sensitivity to and relative weighting of indexical and linguistic cues, we familiarized 12-month-old infants to tokens of a vowel produced by one speaker, and tested their listening preference to trials containing a vowel category change produced by the same speaker (linguistic information), and the same vowel category produced by another speaker of the same or a different accent (indexical information). Infants noticed linguistic and indexical differences, suggesting that both are salient in infant speech processing. Future research should explore how infants weight these cues in a distributional learning context that contains both phonetic and indexical variation. PMID:28520762

  19. Determinants of return to work 12 months after total hip and knee arthroplasty

    PubMed Central

    Tilbury, C; Kuijer, PPFM; Verdegaal, SHM; Wolterbeek, R; Nelissen, RGHH; Frings-Dresen, MHW; Vliet Vlieland, TPM

    2016-01-01

    Introduction A substantial number of patients undergoing total hip or knee arthroplasty (THA or TKA) do not or only partially return to work. This study aimed to identify differences in determinants of return to work in THA and TKA. Methods We conducted a prospective, observational study of working patients aged <65 years undergoing THA or TKA for osteoarthritis. The primary outcome was full versus partial or no return to work 12 months postoperatively. Factors analysed included preoperative sociodemographic and work characteristics, alongside the Hip Disability and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS), and Oxford Hip and Knee Scores. Results Of 67 THA and 56 TKA patients, 9 (13%) and 10 (19%), respectively, returned partially and 5 (7%) and 6 (11%), respectively, did not return to work 1 year postoperatively. Preoperative factors associated with partial or no return to work in THA patients were self-employment, absence from work and a better HOOS Activities of Daily Living (ADL) subscale score, whereas only work absence was relevant in TKA patients. Type of surgery modified the impact of ADL scores on return to work. Conclusions In both THA and TKA, absence from work affected return to work, whereas self-employment and better preoperative ADL subscale scores were also associated in THA patients. The impact of ADL scores on return to work was modified by type of surgery. These results suggest that strategies aiming to influence modifiable factors should consider THA and TKA separately. PMID:27138849

  20. Background frequency of Bacillus species at the Canberra Airport: A 12 month study.

    PubMed

    Gahan, Michelle E; Thomas, Rory; Rossi, Rebecca; Nelson, Michelle; Roffey, Paul; Richardson, Michelle M; McNevin, Dennis

    2015-12-01

    Anthrax, caused by Bacillus anthracis, is a naturally occurring disease in Australia. Whilst mainly limited to livestock in grazing regions of Victoria and New South Wales, movement of people, stock and vehicles means B. anthracis could be present outside this region. Of particular interest is the "background" prevalence of B. anthracis at transport hubs including airports. The aim of this study was to determine the background frequency of B. anthracis and the commonly used hoax agent Bacillus thuringiensis at the Canberra Airport over a 12 month period. Samples were collected daily for seven days each month from August 2011-July 2012 and analyzed using species specific real-time polymerase chain reaction. Fourteen samples (of a total of 575) were positive for the B. anthracis PL3 genomic marker, 24 for the cya (pXO1) plasmid marker and five for the capB (pXO2) plasmid marker. Whilst five samples were positive for both PL3 and cya, no samples were positive for all three markers hence there is no evidence to suggest the presence of pathogenic B. anthracis strains. B. anthracis targets were detected primarily in February 2012 and B. thuringiensis peaked in October and November 2011 and again in April and May 2012. This study provides a rapid method to screen for, and differentiate, Bacillus species. Armed with this information investigators will be able to discriminate a "threat" from "background" frequencies should the need arise. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  1. A pandemic influenza vaccine in India: from strain to sale within 12 months.

    PubMed

    Dhere, Rajeev; Yeolekar, Leena; Kulkarni, Prasad; Menon, Ravi; Vaidya, Vivek; Ganguly, Milan; Tyagi, Parikshit; Barde, Prajakt; Jadhav, Suresh

    2011-07-01

    In the event of a highly pathogenic influenza pandemic, the Indian subcontinent would need 1.2 billion doses of vaccine to immunize its entire population, double if two doses were required to assure immunity. Serum Institute of India Limited (SII) thus became one of six initial grantees of the World Health Organization (WHO) technology transfer initiative to create capacity in developing countries to manufacture H5N1 pandemic influenza vaccine. At the outbreak of the A(H1N1) 2009 influenza pandemic, experience gained from the H5N1 project was used to develop a live attenuated influenza vaccine (LAIV), since this was the only option for the level of surge capacity required for a large-scale immunization campaign in India. SII took <12 months to develop and market its LAIV intranasal vaccine from receipt of the seed strain from WHO. As of November 2010, over 2.5 million persons have been vaccinated with Nasovac(®) with no serious adverse reactions or vaccine failure after 3 months' post-marketing surveillance. The product has been submitted for prequalification by WHO for purchase by United Nations agencies. In parallel, SII also developed an inactivated influenza vaccine, and is currently looking to ensure the sustainability of its influenza vaccine manufacturing capacity.

  2. Language skills of children during the first 12 months after stuttering onset.

    PubMed

    Watts, Amy; Eadie, Patricia; Block, Susan; Mensah, Fiona; Reilly, Sheena

    2017-03-01

    To describe the language development in a sample of young children who stutter during the first 12 months after stuttering onset was reported. Language production was analysed in a sample of 66 children who stuttered (aged 2-4 years). The sample were identified from a pre-existing prospective, community based longitudinal cohort. Data were collected at three time points within the first year after stuttering onset. Stuttering severity was measured, and global indicators of expressive language proficiency (length of utterances and grammatical complexity) were derived from the samples and summarised. Language production abilities of the children who stutter were contrasted with normative data. The majority of children's stuttering was rated as mild in severity, with more than 83% of participants demonstrating very mild or mild stuttering at each of the time points studied. The participants demonstrated developmentally appropriate spoken language skills comparable with available normative data. In the first year following the report of stuttering onset, the language skills of the children who were stuttering progressed in a manner that is consistent with developmental expectations. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Naps promote flexible memory retrieval in 12-month-old infants.

    PubMed

    Konrad, Carolin; Seehagen, Sabine; Schneider, Silvia; Herbert, Jane S

    2016-11-01

    Flexibility in applying existing knowledge to similar cues is a corner stone of memory development in infants. Here, we examine the effect of sleep on the flexibility of memory retrieval using a deferred imitation paradigm. Forty-eight 12-month-old infants were randomly assigned to either a nap or a no-nap demonstration condition (scheduled around their natural daytime sleep schedule) or to a baseline control condition. In the demonstration conditions, infants watched an experimenter perform three target actions on a hand puppet. Immediately afterwards, infants were allowed to practice the target actions three times. In a test session 4-hr later, infants were given the opportunity to reproduce the actions with a novel hand puppet differing in color from the puppet used during the demonstration session. Only infants in the nap-condition performed significantly more target actions than infants in the baseline control condition. Furthermore, they were faster to carry out the first target action than infants in the no-nap condition. We conclude that sleep had a facilitative effect on infants' flexibility of memory retrieval. © 2016 Wiley Periodicals, Inc.

  4. Social Looking, Social Referencing and Humor Perception in 6-and-12-month-old Infants

    PubMed Central

    Mireault, Gina C.; Crockenberg, Susan C.; Sparrow, John E.; Pettinato, Christine A.; Woodard, Kelly C.; Malzac, Kirsten

    2014-01-01

    Social referencing refers to infants' use of caregivers as emotional referents in ambiguous situations (Walden, 1993). Studies of social referencing typically require ambulation, thereby over-looking younger, non-ambulatory infants (i.e., ≤ 8-mos) and resulting in a widespread assumption that young infants do not employ this strategy. Using a novel approach that does not require mobility, we found that when parents provided unsolicited affective cues during an ambiguous-absurd (i.e., humorous) event, 6-month-olds employ one component of social referencing, social looking Additionally, 6-month-olds who did not laugh at the event were significantly more likely to look toward parents than their counterparts who found the event funny. Sequential analyses revealed that, following a reference to a smiling parent, 6-month olds were more likely to smile at the parent, but by 12 months were more likely to smile at the event suggesting that older infants are influenced by parental affect in humorous situations. The developmental implications of these findings are discussed, as well as the usefulness of studying humor for understanding important developmental phenomena. PMID:25061893

  5. UNC-Emory Infant Atlases for Macaque Brain Image Analysis: Postnatal Brain Development through 12 Months

    PubMed Central

    Shi, Yundi; Budin, Francois; Yapuncich, Eva; Rumple, Ashley; Young, Jeffrey T.; Payne, Christa; Zhang, Xiaodong; Hu, Xiaoping; Godfrey, Jodi; Howell, Brittany; Sanchez, Mar M.; Styner, Martin A.

    2017-01-01

    Computational anatomical atlases have shown to be of immense value in neuroimaging as they provide age appropriate reference spaces alongside ancillary anatomical information for automated analysis such as subcortical structural definitions, cortical parcellations or white fiber tract regions. Standard workflows in neuroimaging necessitate such atlases to be appropriately selected for the subject population of interest. This is especially of importance in early postnatal brain development, where rapid changes in brain shape and appearance render neuroimaging workflows sensitive to the appropriate atlas choice. We present here a set of novel computation atlases for structural MRI and Diffusion Tensor Imaging as crucial resource for the analysis of MRI data from non-human primate rhesus monkey (Macaca mulatta) data in early postnatal brain development. Forty socially-housed infant macaques were scanned longitudinally at ages 2 weeks, 3, 6, and 12 months in order to create cross-sectional structural and DTI atlases via unbiased atlas building at each of these ages. Probabilistic spatial prior definitions for the major tissue classes were trained on each atlas with expert manual segmentations. In this article we present the development and use of these atlases with publicly available tools, as well as the atlases themselves, which are publicly disseminated to the scientific community. PMID:28119564

  6. Determinants of return to work 12 months after total hip and knee arthroplasty.

    PubMed

    Leichtenberg, C S; Tilbury, C; Kuijer, Ppfm; Verdegaal, Shm; Wolterbeek, R; Nelissen, Rghh; Frings-Dresen, Mhw; Vliet Vlieland, Tpm

    2016-07-01

    Introduction A substantial number of patients undergoing total hip or knee arthroplasty (THA or TKA) do not or only partially return to work. This study aimed to identify differences in determinants of return to work in THA and TKA. Methods We conducted a prospective, observational study of working patients aged <65 years undergoing THA or TKA for osteoarthritis. The primary outcome was full versus partial or no return to work 12 months postoperatively. Factors analysed included preoperative sociodemographic and work characteristics, alongside the Hip Disability and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS), and Oxford Hip and Knee Scores. Results Of 67 THA and 56 TKA patients, 9 (13%) and 10 (19%), respectively, returned partially and 5 (7%) and 6 (11%), respectively, did not return to work 1 year postoperatively. Preoperative factors associated with partial or no return to work in THA patients were self-employment, absence from work and a better HOOS Activities of Daily Living (ADL) subscale score, whereas only work absence was relevant in TKA patients. Type of surgery modified the impact of ADL scores on return to work. Conclusions In both THA and TKA, absence from work affected return to work, whereas self-employment and better preoperative ADL subscale scores were also associated in THA patients. The impact of ADL scores on return to work was modified by type of surgery. These results suggest that strategies aiming to influence modifiable factors should consider THA and TKA separately.

  7. Knowledge and beliefs concerning early childhood caries from mothers of children ages zero to 12 months.

    PubMed

    Azevedo, Marina Sousa; Romano, Ana Regina; Dos Santos, Iná da Silva; Cenci, Maximiliano Sergio

    2014-01-01

    This study's purpose was to assess mothers' knowledge and beliefs about early childhood caries (ECC) etiology and prevention. This cross-sectional study targeted mothers (N=277) of zero- to 12-month-olds visiting 12 public health care centers in Pelotas, Rio Grande do Sul, Brazil. Information on causes of and recommendations to prevent ECC, as well as socioeconomic and demographic variables, was collected. Chi-square, univariate, and multiple logistic regression analyses were performed (P<.05). Sugar intake and lack of oral hygiene were the most frequently mentioned causes of caries. Ninety percent of the mothers were aware of the need to begin tooth-brushing during their children's first year. Mothers who had more children and were in lower socioeconomic positions were more likely to not know the correct age for the first dental visit. Our findings showed that mothers do not know all the factors that can influence caries in their children. None reported the role of micro-organisms and lack of fluoride in the caries etiology. These findings highlight the importance of providing preventive orientation to the mothers regarding early childhood caries. Information on age of first dental visit should be emphasized, especially among mothers with more than one child and low-income families.

  8. Indexical and linguistic processing by 12-month-olds: Discrimination of speaker, accent and vowel differences.

    PubMed

    Mulak, Karen E; Bonn, Cory D; Chládková, Kateřina; Aslin, Richard N; Escudero, Paola

    2017-01-01

    Infants preferentially discriminate between speech tokens that cross native category boundaries prior to acquiring a large receptive vocabulary, implying a major role for unsupervised distributional learning strategies in phoneme acquisition in the first year of life. Multiple sources of between-speaker variability contribute to children's language input and thus complicate the problem of distributional learning. Adults resolve this type of indexical variability by adjusting their speech processing for individual speakers. For infants to handle indexical variation in the same way, they must be sensitive to both linguistic and indexical cues. To assess infants' sensitivity to and relative weighting of indexical and linguistic cues, we familiarized 12-month-old infants to tokens of a vowel produced by one speaker, and tested their listening preference to trials containing a vowel category change produced by the same speaker (linguistic information), and the same vowel category produced by another speaker of the same or a different accent (indexical information). Infants noticed linguistic and indexical differences, suggesting that both are salient in infant speech processing. Future research should explore how infants weight these cues in a distributional learning context that contains both phonetic and indexical variation.

  9. Resistance training and functional plasticity of the aging brain: a 12-month randomized controlled trial.

    PubMed

    Liu-Ambrose, Teresa; Nagamatsu, Lindsay S; Voss, Michelle W; Khan, Karim M; Handy, Todd C

    2012-08-01

    Maintaining functional plasticity of the cortex is essential for healthy aging and aerobic exercise may be an effective behavioral intervention to promote functional plasticity among seniors. Whether resistance training has similar benefits on functional plasticity in seniors has received little investigation. Here we show that 12 months of twice-weekly resistance training led to functional changes in 2 regions of cortex previously associated with response inhibition processes-the anterior portion of the left middle temporal gyrus and the left anterior insula extending into lateral orbital frontal cortex-in community-dwelling senior women. These hemodynamic effects co-occurred with improved task performance. Our data suggest that resistance training improved flanker task performance in 2 ways: (1) an increased engagement of response inhibition processes when needed; and (2) a decreased tendency to prepare response inhibition as a default state. However, we highlight that this effect of resistance training was only observed among those who trained twice weekly; participants of the once-weekly resistance training did not demonstrate comparable response profiles, both in behavioral performance and hemodynamic activity in cortex. In sum, our findings suggest that twice-weekly resistance training in seniors can positively impact functional plasticity of response inhibition processes in cortex, and that it does so in a manner that complements the effects on selective attention that have previously been ascribed to aerobic exercise in seniors.

  10. The Impact of Vaccine Refusal on Physician Office Visits During the Subsequent 12 Months.

    PubMed

    Jones, Milissa U; Carter, Cassandra G; Cameron, Kenneth L; Smith, Tyler K

    2017-09-01

    We hypothesized that families who are nonadherent to the routine vaccination schedule (RVS) present less frequently for physician visits. We conducted a retrospective chart review to compare the number of visits made over the subsequent 12-month period by families that refused the RVS versus those who were adherent. Subjects were aged 0 to 4 years, enrolled to Keller Army Hospital, and had a diagnosis indicating the RVS was refused. Age-matched controls, who were adherent to the RVS, were randomly chosen for each case. Subjects made significantly more total visits than CASES: 7 (interquartile range [IQR] = 1-20) versus 6 (IQR = 2-17), p = 0.0049. When each visit type was compared independently, there was no significant difference in the number of acute (p = 0.494) or emergency department (p = 0.077) visits between groups. However, subjects who refused to follow the RVS made significantly fewer routine care visits during the 1-year follow-up period compared to those that adhered to the RVS (p < 0.001). Reprint & Copyright © 2017 Association of Military Surgeons of the U.S.

  11. Post-thoracotomy pain syndrome and sensory disturbances following thoracotomy at 6- and 12-month follow-ups.

    PubMed

    Hetmann, Fredrik; Kongsgaard, Ulf E; Sandvik, Leiv; Schou-Bredal, Inger

    2017-01-01

    Persistent pain affects a large proportion of patients after thoracotomy and is associated with sensory disturbances. The objective of this prospective study was to investigate the time course of pain and sensory disturbances over a 12-month period. Patients scheduled for thoracotomy were recruited. Data were collected on the day before surgery, including baseline characteristics and the presence of any preoperative pain. At 6- and 12-month follow-ups, data on pain were collected using the Brief Pain Inventory-Short Form, and perceived sensory disturbances around the thoracotomy scar were recorded from a self-exploration test. At 12 months after surgery, 97 patients had complete data including baseline and 6-and 12-month measurements. Almost half of the patients reported post-thoracotomy pain at the follow-ups. However, 20% of the patients not reporting post-thoracotomy pain at 6 months did report it at 12 months. Between 40% and 60% of patients experienced some kind of sensory disturbance at 6 months. A small decline in some kind of sensory disturbance was reported by 20%-50% of patients at 12 months. A proportion of patients experienced either resolved or delayed onset of pain. Sensory changes were strongly associated with post-thoracotomy pain syndrome, but were also present in a large proportion of patients without it.

  12. [Study of motor function development at 8 and 12 months of age in preterm and at term children].

    PubMed

    Mancini, Marisa C; Teixeira, Silvana; de Araújo, Louise G; Paixão, Maria Lúcia; Magalhães, Lívia de Castro; Coelho, Zélia Araújo Cotta; Gontijo, Ana Paula Benseman; Furtado, Sheyla Rossana Cavalcanti; Sampaio, Rosana Ferreira; da Fonseca, Sérgio Teixeira

    2002-12-01

    To compare the development of motor function in children born preterm with those born at term, at 8 and 12 months of age. To investigate the relation of motor function quality at the age of 8 months with motor ability at 12 months. Thirty-two children participated in this study: 16 were born preterm (risk group) and 16 were born at term (control group). The spontaneous movements of the children were assessed at 8 months and their mobility skills and independence were assessed at 12 months (corrected ages for the preterm group), using standardized developmental tests (AIMS and PEDI, respectively). Data were analysed using independent t-tests (between-group comparison) and Pearson correlation coefficients (within-group comparison). There was no significant difference in motor function, between those born preterm with those born at term, either at 8 or at 12 months of age. In the control group, there was significant association (r=0.67; p=0.004) between movement at 8 months and mobility skills at 12 months. In the risk group, there was significant relationship between skills and independence in mobility, at 12 months corrected age (r=0.80; p=0.0001). Preterm born children, without other disorders and with age correction, might show a similar motor development as those born at term. The path for the acquisition of motor abilities in preterm born children appears to differ among those infants.

  13. Post-thoracotomy pain syndrome and sensory disturbances following thoracotomy at 6- and 12-month follow-ups

    PubMed Central

    Hetmann, Fredrik; Kongsgaard, Ulf E; Sandvik, Leiv; Schou-Bredal, Inger

    2017-01-01

    Background Persistent pain affects a large proportion of patients after thoracotomy and is associated with sensory disturbances. The objective of this prospective study was to investigate the time course of pain and sensory disturbances over a 12-month period. Methods Patients scheduled for thoracotomy were recruited. Data were collected on the day before surgery, including baseline characteristics and the presence of any preoperative pain. At 6- and 12-month follow-ups, data on pain were collected using the Brief Pain Inventory-Short Form, and perceived sensory disturbances around the thoracotomy scar were recorded from a self-exploration test. Results At 12 months after surgery, 97 patients had complete data including baseline and 6-and 12-month measurements. Almost half of the patients reported post-thoracotomy pain at the follow-ups. However, 20% of the patients not reporting post-thoracotomy pain at 6 months did report it at 12 months. Between 40% and 60% of patients experienced some kind of sensory disturbance at 6 months. A small decline in some kind of sensory disturbance was reported by 20%–50% of patients at 12 months. Conclusion A proportion of patients experienced either resolved or delayed onset of pain. Sensory changes were strongly associated with post-thoracotomy pain syndrome, but were also present in a large proportion of patients without it. PMID:28356766

  14. Clinical outcomes and immune reconstitution in 103 advanced AIDS patients undergoing 12-month highly active antiretroviral therapy.

    PubMed

    Dai, Yi; Qiu, Zhi-feng; Li, Tai-sheng; Han, Yang; Zuo, Ling-yan; Xie, Jing; Ma, Xiao-jun; Liu, Zheng-yin; Wang, Ai-xia

    2006-10-20

    Highly active antiretroviral therapy (HAART) produces profound suppression of HIV replication, substantial increase in CD4(+) T cells, and partial reconstitution of the immune system. However, the numbers of subjects were small in previous Chinese studies. This study evaluated the efficacy and side effects of HAART in Chinese advanced AIDS patients. One hundred and three antiretroviral drug naive AIDS patients were enrolled in this study and were divided into two groups by their baseline CD4(+) count: < 100 cells/microl or > or = 100 cells/microl. Clinical, virological and immunological outcomes were monitored at baseline and at 1, 3, 6, 9 and 12 months during the course of treatment with HAART. One patient died and another was lost from the follow-up. For the remaining 101 HIV/AIDS patients at the 12th month during the HAART, the plasma viral load (VL) was reduced to (3.2 +/- 0.7) lg copies/ml, the CD4(+) count increased to (168 +/- 51) cells/microl [among which the naive phenotype (CD45RA(+)CD62L(+)) increased to (49 +/- 27) cells/microl and the memory phenotype (CD45RA(-)) increased to (119 +/- 55) cells/microl], and the percentage of CD4(+)CD28(+) cells increased. At the same time, there was a significant reduction of CD8(+) T cell activation. In the 69 patients with the baseline CD4(+) count < 100 cells/microl, 37 had a VL < 50 copies/ml; while in the 34 patients with the baseline CD4(+) count > or = 100 cells/microl, 25 had a VL < 50 copies/ml, the difference between the two groups was statistically significant. The CD4(+) T cell count showed a two-phase increase during HAART and a significant positive correlation was shown between the change of CD4(+) count and plasma VL. Over 12 months of HAART, 10 patients had gastrointestinal side effects, 13 peripheral neuritis, 7 hepatic lesions, 8 hematological side effects, 8 skin rashes, 10 lipodystrophy and 1 renal calculus. Immune reconstitution as well as the significantly improved clinical outcomes is observed in

  15. Controlled clinical trial addressing teeth whitening with hydrogen peroxide in adolescents: a 12-month follow-up

    PubMed Central

    Pinto, Marcelo Mendes; Gonçalves, Marcela Leticia Leal; da Mota, Ana Carolina Costa; Deana, Alessandro Melo; Olivan, Silvia Regina; Bortoletto, Carolina; de Godoy, Camila Haddad Leal; Vergilio, Katia Lumi Tanikawa; Altavista, Olga Maria; Motta, Lara J; Bussadori, Sandra Kalil

    2017-01-01

    OBJECTIVES: To evaluate the colorimetric change in incisors and canines of adolescents aged 12 to 20 years submitted to at-home whitening and to evaluate satisfaction, sensitivity and discomfort during the procedures through a questionnaire. METHOD: Thirty adolescents were randomly assigned to the following groups: 1) 6.0% hydrogen peroxide (White Class with calcium – FGM); 2) 7.5% hydrogen peroxide (White Class with calcium - FGM); 3) 10% hydrogen peroxide (Oral B 3D White – Oral-B); 4) Control group – placebo. Assessments were performed prior to treatment as well as at 7, 30, 180 and 360 days after treatment. Friedman’s ANOVA was used to analyze color. The Kruskal-Wallis test followed by Dunn’s post hoc test was used to compare the groups at the different evaluation times. Answers on the questionnaires were ranked, and non-parametrical tests were employed. The groups were compared in each period using the Kruskal-Wallis test followed by the Student-Newman-Keuls test. Categorical data were analyzed using Fisher's exact test, and the Wilcoxon test was used for the analysis of different periods. P-values were corrected using the Hyan-Holm step-down Bonferroni procedure. Clinicaltrials.gov: NCT01998386. RESULTS: Similar results were obtained one month after treatment with both tooth whitening gels and whitening strips. Patients were partially satisfied with the treatment after the first and second weeks and would recommend it. All products demonstrated color stability after 12 months of follow-up. CONCLUSIONS: The bleaching procedure was efficient, and the patients could perceive its result. Further investigations are needed to determine the effects of bleaching on young teeth. PMID:28355362

  16. Controlled clinical trial addressing teeth whitening with hydrogen peroxide in adolescents: a 12-month follow-up.

    PubMed

    Pinto, Marcelo Mendes; Gonçalves, Marcela Leticia Leal; Mota, Ana Carolina Costa da; Deana, Alessandro Melo; Olivan, Silvia Regina; Bortoletto, Carolina; Godoy, Camila Haddad Leal de; Vergilio, Katia Lumi Tanikawa; Altavista, Olga Maria; Motta, Lara J; Bussadori, Sandra Kalil

    2017-03-01

    To evaluate the colorimetric change in incisors and canines of adolescents aged 12 to 20 years submitted to at-home whitening and to evaluate satisfaction, sensitivity and discomfort during the procedures through a questionnaire. Thirty adolescents were randomly assigned to the following groups: 1) 6.0% hydrogen peroxide (White Class with calcium - FGM); 2) 7.5% hydrogen peroxide (White Class with calcium - FGM); 3) 10% hydrogen peroxide (Oral B 3D White - Oral-B); 4) Control group - placebo. Assessments were performed prior to treatment as well as at 7, 30, 180 and 360 days after treatment. Friedman's ANOVA was used to analyze color. The Kruskal-Wallis test followed by Dunn's post hoc test was used to compare the groups at the different evaluation times. Answers on the questionnaires were ranked, and non-parametrical tests were employed. The groups were compared in each period using the Kruskal-Wallis test followed by the Student-Newman-Keuls test. Categorical data were analyzed using Fisher's exact test, and the Wilcoxon test was used for the analysis of different periods. P-values were corrected using the Hyan-Holm step-down Bonferroni procedure. Clinicaltrials.gov: NCT01998386. Similar results were obtained one month after treatment with both tooth whitening gels and whitening strips. Patients were partially satisfied with the treatment after the first and second weeks and would recommend it. All products demonstrated color stability after 12 months of follow-up. The bleaching procedure was efficient, and the patients could perceive its result. Further investigations are needed to determine the effects of bleaching on young teeth.

  17. Reducing child conduct disordered behaviour and improving parent mental health in disadvantaged families: a 12-month follow-up and cost analysis of a parenting intervention.

    PubMed

    McGilloway, Sinead; NiMhaille, Grainne; Bywater, Tracey; Leckey, Yvonne; Kelly, Paul; Furlong, Mairead; Comiskey, Catherine; O'Neill, Donal; Donnelly, Michael

    2014-09-01

    The effectiveness of the Incredible Years Basic parent programme (IYBP) in reducing child conduct problems and improving parent competencies and mental health was examined in a 12-month follow-up. Pre- to post-intervention service use and related costs were also analysed. A total of 103 families and their children (aged 32-88 months), who previously participated in a randomised controlled trial of the IYBP, took part in a 12-month follow-up assessment. Child and parent behaviour and well-being were measured using psychometric and observational measures. An intention-to-treat analysis was carried out using a one-way repeated measures ANOVA. Pairwise comparisons were subsequently conducted to determine whether treatment outcomes were sustained 1 year post-baseline assessment. Results indicate that post-intervention improvements in child conduct problems, parenting behaviour and parental mental health were maintained. Service use and associated costs continued to decline. The results indicate that parent-focused interventions, implemented in the early years, can result in improvements in child and parent behaviour and well-being 12 months later. A reduced reliance on formal services is also indicated.

  18. The management of lichen sclerosus in a genitourinary medicine setting: a 12-month retrospective case-notes review.

    PubMed

    Challenor, Rachel

    2015-04-01

    A retrospective case-notes review was undertaken of all women with lichen sclerosus seen during a 12-month period to review their characteristics and care. A total of 273 case-notes were reviewed. The mean age was 61 years (range, 14-94), and the mean duration of symptoms was 6.4 years (range, 1-50). The mean age at diagnosis was 55 years (range, 7-92). Sixty-two (23%) had at least one other autoimmune condition. Autoimmune conditions were seven times more frequent overall compared with United Kingdom prevalences. On-going symptoms were reported as none/minimal in 196 (72%), moderate in 65 (24%) and severe in 12 (4%). A total of 233 women (85%) had on-going treatment with clobetasol propionate (Dermovate) ointment with a mode of eight applications per month (range, 0-30). Forty-three women (16%) reported sexual dysfunction and 13 (5%) had needed at least one surgical procedure to restore sexual function. Eighty-six (32%) had undergone at least one biopsy. Nine squamous cell cancers (3%) had been diagnosed in six women (2%). These patients were managed in line with all current guidance. It is surprising that there is still no evidence to direct long-term management.

  19. Improved asthma control in patients with severe, persistent allergic asthma after 12 months of nightly temperature-controlled laminar airflow: an observational study with retrospective comparisons

    PubMed Central

    Schauer, Uwe; Bergmann, Karl-Christian; Gerstlauer, Michael; Lehmann, Sylvia; Gappa, Monika; Brenneken, Amelie; Schulz, Christian; Ahrens, Peter; Schreiber, Jens; Wittmann, Michael; Hamelmann, Eckard

    2015-01-01

    Introduction Continuous or episodic allergen exposure is a major risk factor of frequent symptoms and exacerbations for patients with allergic asthma. It has been shown that temperature-controlled laminar airflow (TLA) significantly reduced allergen exposure and airway inflammation and improved quality of life of patients with poorly controlled allergic asthma. Objective The objective was to evaluate the effects of nighttime TLA when used during real-life conditions for 12 consecutive months in addition to the patients’ regular medication. Methods This multicenter, pre- and postretrospective observational study included patients with inadequately controlled moderate-to-severe allergic asthma who received add-on treatment with TLA for 12 consecutive months. Data on medication use, asthma control, asthma symptoms, lung function, use of hospital resources, and exacerbations were collected after 4 and 12 months and compared with corresponding data collected retrospectively from medical records during the year prior to inclusion in the study. Results Data from 30 patients (mean age 28; range 8–70) completing 4 months and 27 patients completing 12 months of TLA use are presented. The mean number of exacerbations was reduced from 3.6 to 1.3 (p<0.0001), and the ratio of asthma-related emergency room visits or hospitalizations diminished from 72.4 to 23.3% (p=0.001) or from 44.8 to 20.0% (p<0.05), respectively, after 12 months of TLA use. The Asthma Control Test index increased from 14.1 to 18.5 (p<0.0001). After 4 months of TLA use, clear improvements can be shown for most variables in line with the data collected after 12 months. Conclusions The addition of TLA to the patients’ regular medication significantly reduced exacerbations, asthma symptoms, and the utilization of hospital resources. The data support that TLA may be an important new non-pharmacological approach in the management of poorly controlled allergic asthma. PMID:26557252

  20. Beneficial effects of multisensory and cognitive stimulation in institutionalized elderly: 12-months follow-up.

    PubMed

    de Macedo, Liliane Dias E Dias; De Oliveira, Thaís Cristina Galdino; Soares, Fernanda Cabral; Bento-Torres, João; Bento-Torres, Natáli Valim Oliver; Anthony, Daniel Clive; Picanço-Diniz, Cristovam Wanderley

    2015-01-01

    We previously demonstrated the beneficial effects of a multisensory and cognitive stimulation program, consisting of 48 sessions, twice a week, to improve the cognition of elderly subjects living either in long-term care institutions (institutionalized - I) or in communities with their families (noninstitutionalized - NI). In the present study, we evaluated these subjects after the end of the intervention and compared the rate of age-related cognitive decline of those living in an enriched community environment (NI group, n=15, 74.1±3.9 years old) with those living in the impoverished environment of long-term care institutions (I group, n=20, 75.1±6.8 years old). Both groups participated fully in our stimulation program. Over 1 year, we conducted revaluations at five time points (2 months, 4 months, 6 months, 8 months, and 12 months) after the completion of the intervention. Both elderly groups were evaluated with the mini-mental state examination and selected language tests. Progressive cognitive decline was observed in both groups over the period. Indeed, it took only 4-6 months after the end of the stimulation program for significant reductions in language test scores to become apparent. However, earlier reductions in test scores were mainly associated with I group, and linguistic prosody test scores were significantly affected by institutionalization and time, two variables that interacted and reduced these scores. Moreover, I group reduced the Montréal cognitive assessment battery language tests scores 4 months before NI group. It remains to be investigated what mechanisms may explain the earlier and more intense language losses in institutionalized elderly.

  1. Beneficial effects of multisensory and cognitive stimulation in institutionalized elderly: 12-months follow-up

    PubMed Central

    Dias E Dias de Macedo, Liliane; De Oliveira, Thaís Cristina Galdino; Soares, Fernanda Cabral; Bento-Torres, João; Bento-Torres, Natáli Valim Oliver; Anthony, Daniel Clive; Picanço-Diniz, Cristovam Wanderley

    2015-01-01

    We previously demonstrated the beneficial effects of a multisensory and cognitive stimulation program, consisting of 48 sessions, twice a week, to improve the cognition of elderly subjects living either in long-term care institutions (institutionalized – I) or in communities with their families (noninstitutionalized – NI). In the present study, we evaluated these subjects after the end of the intervention and compared the rate of age-related cognitive decline of those living in an enriched community environment (NI group, n=15, 74.1±3.9 years old) with those living in the impoverished environment of long-term care institutions (I group, n=20, 75.1±6.8 years old). Both groups participated fully in our stimulation program. Over 1 year, we conducted revaluations at five time points (2 months, 4 months, 6 months, 8 months, and 12 months) after the completion of the intervention. Both elderly groups were evaluated with the mini-mental state examination and selected language tests. Progressive cognitive decline was observed in both groups over the period. Indeed, it took only 4–6 months after the end of the stimulation program for significant reductions in language test scores to become apparent. However, earlier reductions in test scores were mainly associated with I group, and linguistic prosody test scores were significantly affected by institutionalization and time, two variables that interacted and reduced these scores. Moreover, I group reduced the Montréal cognitive assessment battery language tests scores 4 months before NI group. It remains to be investigated what mechanisms may explain the earlier and more intense language losses in institutionalized elderly. PMID:26316730

  2. Frequency of cardiovascular risk factors before and 6 and 12 months after bariatric surgery.

    PubMed

    Silva, Maria Alayde Mendonça da; Rivera, Ivan Romero; Barbosa, Emília Maria Wanderley de Gusmão; Crispim, Maria Angélica Correia; Farias, Guilherme Costa; Fontan, Alberto Jorge Albuquerque; Bezerra, Rodrigo Azavedo; Sá, Larissa Gabriella de Souza

    2013-01-01

    To compare the frequency of cardiovascular risk factors (CVRFs) in obese patients of the Brazilian Unified Health System (Sistema Único de Saúde - SUS) with indication of bariatric surgery during the preoperative period and after the sixth month and the first year of the procedure. An observational, longitudinal, prospective, and analytical study was performed, with consecutive selection of obese patients with indication for surgery referred to preoperative cardiac evaluation. The protocol consisted of: medical history, physical examination, electrocardiogram, echocardiogram, and biochemical analysis. This study analyzed the following variables: weight, body mass index (BMI), waist circumference (WC), systemic arterial hypertension (SAH), diabetes mellitus type 2(DM), dyslipidemia (high LDL cholesterol; low HDL cholesterol; hypertriglyceridemia), and metabolic syndrome (MS). The chi-squared test and the Tukey-Kramer method were used for statistical analysis. The sample was composed of 96 obese people, among which 86 were women, aged between 18 and 58 years old (median 35 years old). At the end of six months, significant reductions of 88%, 95%, 71%, 89%, and 80% in the frequency of SAH, high LDL cholesterol, hypertriglyceridemia, DM, and MS could already be observed. A significant and small reduction in the frequency of low HDL cholesterol (24%) and abnormal WC (31%) was observed only at the end of 12 months. After six months and one year, weight and BMI experienced reductions of 33.4kg and 44.3kg, and 13.1kg/m(2) and 17.2kg/m(2), respectively. The positive impact on weight loss and the reduction in BMI, WC, and in the frequency of CVRFs are already extremely significant after six months and remain so one year after bariatric surgery. Copyright © 2013 Elsevier Editora Ltda. All rights reserved.

  3. Do electronic cigarettes increase cigarette smoking in UK adolescents? Evidence from a 12-month prospective study.

    PubMed

    Conner, Mark; Grogan, Sarah; Simms-Ellis, Ruth; Flett, Keira; Sykes-Muskett, Bianca; Cowap, Lisa; Lawton, Rebecca; Armitage, Christopher J; Meads, David; Torgerson, Carole; West, Robert; Siddiqi, Kamran

    2017-08-17

    In cross-sectional surveys, increasing numbers of adolescents report using both electronic cigarettes (e-cigarettes) and cigarettes. This study assessed whether adolescent e-cigarette use was associated prospectively with initiation or escalation of cigarette use. Data were from 2836 adolescents (aged 13-14 years at baseline) in 20 schools in England. At baseline, breath carbon monoxide levels, self-reported e-cigarette and cigarette use, sex, age, friends and family smoking, beliefs about cigarette use and percentage receiving free school meals (measure of socioeconomic status) were assessed. At 12-month follow-up, self-reported cigarette use was assessed and validated by breath carbon monoxide levels. At baseline, 34.2% of adolescents reported ever using e-cigarettes (16.0% used only e-cigarettes). Baseline ever use of e-cigarettes was strongly associated with subsequent initiation (n=1726; OR 5.38, 95% CI 4.02 to 7.22; controlling for covariates, OR 4.06, 95% CI 2.94 to 5.60) and escalation (n=318; OR 1.91, 95% CI 1.14 to 3.21; controlling for covariates, this effect became non-significant, OR 1.39, 95% CI 0.97 to 1.82) of cigarette use. This is the first study to report prospective relationships between ever use of e-cigarettes and initiation and escalation of cigarette use among UK adolescents. Ever use of e-cigarettes was robustly associated with initiation but more modestly related to escalation of cigarette use. Further research with longer follow-up in a broader age range of adolescents is required. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  4. Effect of bariatric surgery on microvascular dysfunction associated to metabolic syndrome: a 12-month prospective study.

    PubMed

    Martín-Rodríguez, J F; Cervera-Barajas, A; Madrazo-Atutxa, A; García-Luna, P P; Pereira, J L; Castro-Luque, J; León-Justel, A; Morales-Conde, S; Castillo, J R; Leal-Cerro, A; Cano, D A

    2014-11-01

    To prospectively evaluate the effect of weight loss after bariatric surgery on microvascular function in morbidly obese patients with and without metabolic syndrome (MetS). A cohort of morbidly obese patients with and without MetS was studied before surgery and after 12 months of surgery. Healthy lean controls were also examined. Microvascular function was assessed by postocclusive reactive hyperemia (PORH) at forearm skin evaluated by laser Doppler flowmetry (LDF). Cutaneous vascular conductance (CVC) was calculated from laser-Doppler skin blood flow and blood pressure. Regression analysis was performed to assess the contribution of different clinical, metabolic and biochemical parameters to microvascular function. Before surgery, 62 obese patients, 39 with MetS and 23 without MetS, and 30 lean control subjects were analyzed. The absolute area under the hyperemic curve (AUC(H)) CVC of PORH was significantly decreased in obese patients compared with lean control subjects. One year after surgery, AUC(H) CVC significantly increased in patients free of MetS, including patients that had MetS before surgery. In contrast, AUC(H) CVC did not significantly change in patients in whom MetS persisted after surgery. Stepwise multivariate regression analysis showed that only changes in HDL cholesterol (HDL-C) and oxidized LDL (oxLDL) independently predicted improvement of AUC(H) after surgery. These two variables together accounted for 40.9% of the variability of change in AUC(H) CVC after surgery. Bariatric surgery could significantly improve microvascular dysfunction in obese patients, but only in patients free of MetS after surgery. Improvement of microvascular dysfunction is strictly associated to postoperative increase in HDL-C levels and decrease in oxLDL levels.

  5. The Closed Equilibrated Biological Aquatic System: A 12 months Test of an Artificial Aquatic Ecosystem

    NASA Astrophysics Data System (ADS)

    Blüm, V.; Andriske, M.; Ludwig, Ch.; Paaßen, U.; Voeste, D.

    1999-01-01

    The ``Closed Equilibrated Biological Aquatic System'' (C.E.B.A.S.) is finally disposed for long-term multi-generation experiments with aquatic organisms in a space station. Therefore a minimum operation time of three month is required. It is verified in three versions of laboratory prototypes. The third one passed successfully a 12 months mid-term test in 1995/96 thus demonstrating its high biological stability. The third version of the C.E.B.A.S. consists of a 100 l animal tank, two plant cultivators with a volume of 15 l each with independent illuminations, a 3.0 l semibiological ``mechanical'' filter, a 3.0 l bacteria filter, a heating/cooling device and a dummy filter unit. The live-bearing teleost Xiphophorus helleri is the vertebrate and the pulmonate water snail Biomphalaria glabrata the invertebrate experimental animal in the system. The rootless higher water plant Ceratophyllum demersum is the producer organism. Ammonia oxidizing bacteria and other microorganisms settle in the filters. A simple data acquisition is combined with temperature and plant illumination control. Besides of the space aspects the C.E.B.A.S. proved to be an extremely suitable tool to investigate the organism and subcomponent interactions in a well defined terrestrial aquatic closed ecosystem by providing physical, chemical and biological data which allow an approach to a comprehensive system analysis. Moreover the C.E.B.A.S. is the base for the development of innovative combined animal-plant aquaculture systems for human nutrition on earth which could be implemented into bioregenerative life support systems with a higher degree of complexity suitable for lunar or planetary bases.

  6. The closed equilibrated biological aquatic system: a 12 months test of an artificial aquatic ecosystem.

    PubMed

    Blum, V; Andriske, M; Ludwig, C h; Paassen, U; Voeste, D

    1999-01-01

    The Closed Equilibrated Biological Aquatic System" (C.E.B.A.S.) is finally disposed for long-term multi-generation experiments with aquatic organisms in a space station. Therefore a minimum operation time of three months is required. It is verified in three versions of laboratory prototypes. The third one passed successfully a 12 months mid-term test in 1995/96 thus demonstrating its high biological stability. The third version of the C.E.B.A.S. consists of a 100 l animal tank, two plant cultivators with a volume of 15 l each with independent illuminations, a 3.0 l semibiological "mechanical" filter, a 3.0 l bacteria filter, a heating/cooling device and a dummy filter unit. The live-bearing teleost Xiphophorus helleri is the vertebrate and the pulmonate water snail Biomphalana glabrata the invertebrate experimental animal in the system. The rootless higher water plant Ceratophyllum demersum is the producer organism. Ammonia oxidizing bacteria and other microorganisms settle in the filters. A sample data acquisition is combined with temperature and plant illumination control. Besides of the space aspects the C.E.B.A.S. proved to be an extremely suitable tool to investigate the organism and subcomponent interactions in a well defined terrestrial aquatic closed ecosystem by providing physical, chemical and biological data which allow an approach to a comprehensive system analysis. Moreover the C.E.B.A.S. is the base for the development of innovative combined animal-plant aquaculture systems for human nutrition on earth which could be implemented into bioregenerative life support systems with a higher degree of complexity suitable for lunar or planetary bases.

  7. Three-dimensional analysis of cranial growth from 6 to 12 months of age.

    PubMed

    Meyer-Marcotty, P; Böhm, H; Linz, C; Kochel, J; Stellzig-Eisenhauer, A; Schweitzer, T

    2014-10-01

    The aim of this study was to generate three-dimensional data of the physiological growth of the infant's cranium in the significant growth phase from 6 to 12 months of age. In a longitudinal observational study non-invasive 3D data using an optical surface scanner were generated of the entire head of 52 Caucasian infants (27 females and 25 males) between the ages of 6 (T1) and 12 (T2) months. The circumference of the head increased by 6.51 per cent (from 43.50 to 46.33cm). Analysis of width and length showed that the head grows 2.84 per cent more in length, resulting in a decrease in the cranial index of 2.52 per cent (from 83.87 to 81.76 per cent). The highest increment observed was in the total volume of the cranium, with an increase of 18.76 per cent (from 1229.01 to 1459.57cm(3)). Comparison of the left and right sides of the head by measuring the diagonal symmetry difference showed a difference of only 0.37cm. Overall, the symmetry-related parameters showed an almost symmetric development of the cranium in infants. The findings should provide valuable information on physiological growth and development of the infant's cranium. Therefore the high growth rate of the cranium in the first year of life suggests that this period is a critical period in which the disruption of developmental processes may have long-lasting effects on the morphology of the cranium with a prognostically unfavourable effect of the further growth of the viscerocranium.

  8. Child and Adolescent Emergency and Urgent Mental Health Delivery Through Telepsychiatry: 12-Month Prospective Study.

    PubMed

    Roberts, Nasreen; Hu, Tina; Axas, Nicholas; Repetti, Leanne

    2017-10-01

    The significant gap between children and adolescents presenting for emergency mental healthcare and the shortage of child and adolescent psychiatrists constitutes a major barrier to timely access for psychiatric assessment for rural and remote areas. Unlike remote areas, urban emergency departments have in-house psychiatric consultation. Telepsychiatry may be a solution to ensure the same service for remote areas. However, there is a paucity of studies on the use of telepsychiatry for child and adolescent emergency consults. Thus, the aim of our study was to (1) assess patient satisfaction with telepsychiatry and (2) compare clinical characteristics and outcome of telepsychiatry with face-to-face emergency child and adolescent assessments. This is a prospective study of telepsychiatry emergency assessments of children and adolescents referred by emergency physicians. The comparison group was age- and gender-matched patients seen for face-to-face urgent assessments. Data were gathered on demographic and clinical variables. Telepsychiatry satisfaction was assessed using a questionnaire. Descriptive statistics and chi-square tests were used to assess group differences for each variable. Logistic regression was used to assess impact of the variables on outcome after the consult. A p value <0.05 was used to determine statistical significance. Sixty (n = 60) assessments were conducted through telepsychiatry in 12 months. Among the telepsychiatry group, Aboriginal patients were over-represented (50% vs. 6.7%, p < 0.001), a higher proportion received a diagnosis of adjustment disorder (22% vs. 8.3%, p = 0.004) or no diagnosis (27% vs. 6.7%, p = 0.004) compared with controls. There was no statistically significant difference between groups on other clinical variables. Patients reported a high degree of satisfaction with telepsychiatry. Telepsychiatry is acceptable to patients and families for safe emergency assessment and follow-up, reducing unnecessary travel

  9. Outcome of anthroposophic medication therapy in chronic disease: A 12-month prospective cohort study

    PubMed Central

    Hamre, Harald J; Witt, Claudia M; Glockmann, Anja; Ziegler, Renatus; Kienle, Gunver S; Willich, Stefan N; Kiene, Helmut

    2008-01-01

    Background Anthroposophic medications (AMED) are prescribed in 56 countries. Objective To study clinical outcomes in patients prescribed AMED for chronic disease. Design Prospective cohort study. Setting 110 medical practices in Germany. Participants 665 consecutive outpatients aged 1–71 years, prescribed AMED for mental, respiratory, musculoskeletal, neurological, genitourinary, and other chronic diseases. Main outcomes Disease and Symptom Scores (physicians’ and patients’ assessment, 0–10) and SF-36. Results During the first six months, an average of 1.5 AMED per patient was used, in total 652 different AMED. Origin of AMED was mineral (8.0% of 652 AMED), botanical (39.0%), zoological (7.2%), chemically defined (13.0%), and mixed (33.0%). From baseline to six-month-follow-up, all outcomes improved significantly: Disease Score improved by mean 3.15 points (95% confidence interval 2.97–3.34, p < 0.001), Symptom Score by 2.43 points (2.23–2.63, p < 0.001), SF-36 Physical Component Summary by 3.04 points (2.16–3.91, p < 0.001), and SF-36 Mental Component Summary by 5.75 points (4.59–6.92, p < 0.001). All improvements were maintained at 12-month follow-up. Improvements were similar in adult men and women, in children, and in patients not using adjunctive therapies. Conclusion Outpatients using AMED for chronic disease had long-term reduction of disease severity and improvement of quality of life. PMID:19920891

  10. Recovery in knee range of motion reaches a plateau by 12 months after total knee arthroplasty.

    PubMed

    Zhou, Zhihong; Yew, Khye Soon Andy; Arul, Earnest; Chin, Pak-Lin; Tay, Keng Jin Darren; Lo, Ngai-Nung; Chia, Shi-Lu; Yeo, Seng Jin

    2015-06-01

    The primary aim of this study was to identify the time point at which improvements in knee range of motion reach a plateau, if any. The secondary aim of this study was to investigate the correlation between the improvements in knee range of motion and patient-reported outcomes [Oxford knee score (OKS) and SF-36]. The hypothesis is that there is a time point at which the recovery in the knee range of motion after total knee arthroplasty (TKA) plateaus. A prospective study of 145 patients who underwent TKA was conducted. All TKAs were performed by the same surgeon. OKS and SF-36 scores were measured preoperatively and at 6, 12, and 24 months. Range of motion was measured preoperatively and at 1, 3, 6, 12, and 24 months postoperatively. This study shows that for surgeon/therapist reported range of motion, a plateau in recovery was reached at 12 months after TKA. It was also found that range of extension is significantly correlated with OKS, whereas range of flexion was not significantly correlated with OKS. Knowledge of when patients fully recover after TKA will allow appropriate counseling of patients during preoperative consultation. Also, this knowledge will enable surgeons/therapists to better monitor the rehabilitation progress of TKA patients, and make adjustments to the rehabilitation protocol. In addition, our study shows that objective surgeon-/therapist-measured outcome (range of motion) has a significant correlation with subjective patient-reported outcomes (OKS). Hence, both outcome measures should be employed in the postoperative monitoring of patient progress. Prospective case series, Level IV.

  11. A 12-month evaluation of health-related quality of life outcomes of methadone maintenance program in a rural Malaysian sample.

    PubMed

    Lua, Pei Lin; Talib, Nor Samira

    2012-08-01

    This paper focuses on the evaluation of addiction program effectiveness which involves changes in health-related quality of life (HRQoL) profile. This study was conducted from 2007 until 2010 at a rural methadone maintenance treatment center in Malaysia to assess HRQoL outcomes before and after treatment. Fifty-seven respondents completed the WHOQOL-BREF at baseline, 6 months, and 12 months postintervention. Data were analyzed using nonparametric techniques (SPSS 15). Significant and positive HRQoL impacts were demonstrated. Future studies with larger sample are encouraged. This study was supported by the Ministry of Health Malaysia.

  12. Validity of 12-Month Falls Recall in Community-Dwelling Older Women Participating in a Clinical Trial.

    PubMed

    Sanders, Kerrie M; Stuart, Amanda L; Scott, David; Kotowicz, Mark A; Nicholson, Geoff C

    2015-01-01

    Objectives. To compare 12-month falls recall with falls reported prospectively on daily falls calendars in a clinical trial of women aged ≥70 years. Methods. 2,096 community-dwelling women at high risk of falls and/or fracture completed a daily falls calendar and standardised interviews when falls were recorded, for 12 months. Data were compared to a 12-month falls recall question that categorised falls status as "no falls," "a few times," "several," and "regular" falls. Results. 898 (43%) participants reported a fall on daily falls calendars of whom 692 (77%) recalled fall(s) at 12 months. Participants who did not recall a fall were older (median 79.3 years versus 77.8 years, P = 0.028). Smaller proportions of fallers who sustained an injury or accessed health care failed to recall a fall (all P < 0.04). Among participants who recalled "no fall," 85% reported zero falls on daily calendars. Few women selected falls categories of "several times" or "regular" (4.1% and 0.4%, resp.) and the sensitivity of these categories was low (30% to 33%). Simply categorising participants into fallers or nonfallers had 77% sensitivity and 94% specificity. Conclusion. For studies where intensive ascertainment of falls is not feasible, 12-month falls recall questions with fewer responses may be an acceptable alternative.

  13. The "Surprise Question" Asked of Emergency Physicians May Predict 12-Month Mortality among Older Emergency Department Patients.

    PubMed

    Ouchi, Kei; Jambaulikar, Guru; George, Naomi R; Xu, Wanlu; Obermeyer, Ziad; Aaronson, Emily L; Schuur, Jeremiah D; Schonberg, Mara A; Tulsky, James A; Block, Susan D

    2017-08-28

    Identification of older adults with serious illness (life expectancy less than one year) who may benefit from serious illness conversations or other palliative care interventions in the emergency department (ED) is difficult. To assess the performance of the "surprise question (SQ)" asked of emergency physicians to predict 12-month mortality. We asked attending emergency physician "Would you be surprised whether this patient died in the next 12 months?" regarding patients ≥65 years old that they had cared for that shift. We prospectively obtained death records from Massachusetts Department of Health Vital Records. An urban, university-affiliated ED. Twelve-month mortality. We approached 38 physicians to answer the SQ, and 86% participated. The mean age of our cohort was 76 years, 51% were male, and 45% had at least one serious illness. Out of 207 patients, the physicians stated that they "would not be surprised" if the patient died in the next 12 months for 102 of the patients (49%); 44 of the 207 patients (21%) died within 12 months. The SQ demonstrated sensitivity of 77%, specificity of 56%, positive predictive value of 32%, and negative predictive value of 90%. When combined with other predictors, the model sorted the patient who lived from the patient who died correctly 72% of the time (c-statistic = 0.72). Use of the SQ by emergency physicians may predict 12-month mortality in older ED patients and may help emergency physicians identify older adults in need of palliative care interventions.

  14. Comparison of measures of comorbidity for predicting disability 12-months post-injury

    PubMed Central

    2013-01-01

    Background Understanding the factors that impact on disability is necessary to inform trauma care and enable adequate risk adjustment for benchmarking and monitoring. A key consideration is how to adjust for pre-existing conditions when assessing injury outcomes, and whether the inclusion of comorbidity is needed in addition to adjustment for age. This study compared different approaches to modelling the impact of comorbidity, collected as part of the routine hospital episode data, on disability outcomes following orthopaedic injury. Methods 12-month Glasgow Outcome Scale – Extended (GOS-E) outcomes for 13,519 survivors to discharge were drawn from the Victorian Orthopaedic Trauma Outcomes Registry, a prospective cohort study of admitted orthopaedic injury patients. ICD-10-AM comorbidity codes were mapped to four comorbidity indices. Cases with a GOS-E score of 7–8 were considered “recovered”. A split dataset approach was used with cases randomly assigned to development or test datasets. Logistic regression models were fitted with “recovery” as the outcome and the performance of the models based on each comorbidity index (adjusted for injury and age) measured using calibration (Hosmer-Lemshow (H-L) statistics and calibration curves) and discrimination (Area under the Receiver Operating Characteristic (AUC)) statistics. Results All comorbidity indices improved model fit over models with age and injuries sustained alone. None of the models demonstrated acceptable model calibration (H-L statistic p < 0.05 for all models). There was little difference between the discrimination of the indices for predicting recovery: Charlson Comorbidity Index (AUC 0.70, 95% CI: 0.68, 0.71); number of ICD-10 chapters represented (AUC 0.70, 95% CI: 0.69, 0.72); number of six frequent chronic conditions represented (AUC 0.70, 95% CI: 0.69, 0.71); and the Functional Comorbidity Index (AUC 0.69, 95% CI: 0.68, 0.71). Conclusions The presence of ICD-10 recorded comorbid

  15. Risk factors for wheeze in the last 12 months in preschool children.

    PubMed

    Quah, B S; Mazidah, A R; Simpson, H

    2000-06-01

    Most children with asthma develop their symptoms before the age of 5 years and many preschool wheezers continue to wheeze in the early school years. It is thus important to investigate the factors that predispose young children to wheeze. The objective of this study was to investigate the relevant environmental and family influences on recent wheeze (wheeze within the last 12 months) in preschool children. A cross-sectional study was conducted in five primary health clinics in the district of Kota Bharu from April to October 1998. Nurses from these clinics distributed Bahasa Malaysia questionnaires containing questions on asthma symptoms, environmental risk factors, family's social status and family history of atopy and wheeze to preschool children aged 1-5 years during their home visits. The respondents were parent(s) or carer(s) of the children. A total of 2,524 (87.7%) complete questionnaires were available for analysis of risk factors. One hundred and fifty six (6.2%) children had current wheeze. Significant risk factors associated with current wheeze were a family history of asthma (O.R. = 6.36, 95% C.I. = 4.45-9.09), neonatal hospital admission (O.R. = 2.38, 95% C.I. = 1.51 - 3.75), and a maternal (O.R. = 2.12, 95% C.I. = 1.31-3.41) or paternal (O.R. = 1.52, 95% C.I. = 0.95-2.43) history of allergic rhinitis. Among environmental factors examined, namely, household pets, carpeting in bedroom, use of fumigation mats, mosquito coils and aerosol insect repellents, maternal and paternal smoking, and air conditioning, none were associated with an increased risk of wheeze. In conclusion, the strongest association with current wheeze was a family history of asthma. Also significant were neonatal hospital admission and a history of allergic rhinitis in either the mother or father. None of the environmental factors studied were related to current wheeze in preschool children.

  16. Antireflux Transoral Incisionless Fundoplication Using EsophyX: 12-Month Results of a Prospective Multicenter Study

    PubMed Central

    Buset, Michel; Muls, Vinciane; Rajan, Amin; Rösch, Thomas; Eckardt, Alexander J.; Weerts, Joseph; Bastens, Boris; Costamagna, Guido; Marchese, Michele; Louis, Hubert; Mana, Fazia; Sermon, Filip; Gawlicka, Anna K.; Daniel, Michael A.; Devière, Jacques

    2008-01-01

    Background A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial. Methods Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm. Results The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2–6 cm) and 230° (160°–300°). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with ≥50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation. Conclusion The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients. PMID:18443855

  17. Drug resistance mutations after the first 12 months on antiretroviral therapy and determinants of virological failure in Rwanda.

    PubMed

    Ndahimana, Jean d'Amour; Riedel, David J; Mwumvaneza, Mutagoma; Sebuhoro, Dieudone; Uwimbabazi, Jean Claude; Kubwimana, Marthe; Mugabo, Jules; Mulindabigwi, Augustin; Kirk, Catherine; Kanters, Steve; Forrest, Jamie I; Jagodzinski, Linda L; Peel, Sheila A; Ribakare, Muhayimpundu; Redfield, Robert R; Nsanzimana, Sabin

    2016-07-01

    To evaluate HIV drug resistance (HIVDR) and determinants of virological failure in a large cohort of patients receiving first-line tenofovir-based antiretroviral therapy (ART) regimens. A nationwide retrospective cohort from 42 health facilities was assessed for virological failure and development of HIVDR mutations. Data were collected at ART initiation and at 12 months of ART on patients with available HIV-1 viral load (VL) and ART adherence measurements. HIV resistance genotyping was performed on patients with VL ≥1000 copies/ml. Multiple logistic regression was used to determine factors associated with treatment failure. Of 828 patients, 66% were women, and the median age was 37 years. Of the 597 patients from whom blood samples were collected, 86.9% were virologically suppressed, while 11.9% were not. Virological failure was strongly associated with age <25 years (adjusted odds ratio [aOR]: 6.4; 95% confidence interval [CI]: 3.2-12.9), low adherence (aOR: 2.87; 95% CI: 1.5-5.0) and baseline CD4 counts <200 cells/μl (aOR 3.4; 95% CI: 1.9-6.2). Overall, 9.1% of all patients on ART had drug resistance mutations after 1 year of ART; 27% of the patients who failed treatment had no evidence of HIVDR mutations. HIVDR mutations were not observed in patients on the recommended second-line ART regimen in Rwanda. The last step of the UNAIDS 90-90-90 target appears within grasp, with some viral failures still due to non-adherence. Nonetheless, youth and late initiators are at higher risk of virological failure. Youth-focused programmes could help prevent further drug HIVDR development. © 2016 John Wiley & Sons Ltd.

  18. Objectively measured physical activity and 12-month trajectories of neck-shoulder pain in workers: A prospective study in DPHACTO.

    PubMed

    Hallman, David M; Birk Jørgensen, Marie; Holtermann, Andreas

    2017-05-01

    This study aimed to investigate the association between objectively measured physical activity at work and leisure and the intensity (mean level and time course) of neck-shoulder pain (NSP) over 12 months among male and female blue collar workers. Data were obtained from 625 blue collar workers from the Danish cohort DPHACTO. Physical activity was measured objectively at baseline using accelerometers. The percentage of time spent in physical activity (walking, climbing stairs, running and cycling) was calculated for both work and leisure time. Longitudinal data on the intensity of NSP (numerical rating scale 0-10) were collected using text messages every fourth week over 12 months. Linear mixed models were used to investigate the associations between occupational physical activity (OPA) and leisure time physical activity (LTPA) and the trajectories of the intensity of NSP, adjusted for individual, biomechanical and psychosocial factors, and baseline pain. OPA was not associated with the mean intensity of NSP over 12 months. LTPA was negatively associated with the mean intensity of NSP both among men ( B=-0.71, 95% CI -1.31 to -0.11) and women ( B=-0.85, 95% CI -1.57 to -0.13). Sex interactions on the 12-month trajectories of NSP showed that higher physical activity was associated with a slower reduction in NSP among men for OPA only ( B=0.03, 95% CI 0.01-0.05) and women for LTPA only ( B=0.05, 95% CI 0.00-0.09). We found that more time in LTPA was associated with a lower overall intensity of NSP over 12 months among blue collar workers. However, depending on sex and domain, high physical activity had an unfavourable effect on the course of NSP over 12 months.

  19. Histological analysis and identification of spermatogenesis-related genes in 2-, 6-, and 12-month-old sheep testes.

    PubMed

    Bai, Man; Sun, Limin; Zhao, Jia; Xiang, Lujie; Cheng, Xiaoyin; Li, Jiarong; Jia, Chao; Jiang, Huaizhi

    2017-09-25

    Testis development and spermatogenesis are vital factors that influence male animal fertility. In order to identify spermatogenesis-related genes and further provide a theory basis for finding biomarkers related to male sheep fertility, 2-, 6-, and 12-month-old Small Tail Han Sheep testes were selected to investigate the dynamic changes of sheep testis development. Hematoxylin-eosin routine staining and RNA-Seq technique were used to perform histological and transcriptome analysis for these testes. The results showed that 630, 102, and 322 differentially expressed genes (DEGs) were identified in 2- vs 6-month-old, 6- vs 12-month-old, and 2- vs 12-month-old testes, respectively. GO and KEGG analysis showed the following: DEGs in 2- vs 6-month-old testes were mainly related to the GO terms of sexual maturation and the pathways of multiple metabolism and biosynthesis; in 6- vs 12-month-old testes, most of the GO terms that DEGs involved in were related to metabolism and translation processes; the most significantly enriched pathway is the ribosome pathway. The union of DEGs in 2- vs 6-month-old, 6- vs 12-month-old, and 2- vs 12-month-old testes was categorized into eight profiles by series cluster. Subsequently, the eight profiles were classified into four model profiles and four co-expression networks were constructed based on the DEGs in these model profiles. Finally, 29 key regulatory genes related to spermatogenesis were identified in the four co-expression networks. The expression of 13 DEGs (CA3, APOH, MYOC, CATSPER4, SYT6, SERPINA10, DAZL, ADIPOR2, RAB13, CEP41, SPAG4, ODF1, and FRG1) was validated by RT-PCR.

  20. The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye.

    PubMed

    Blackie, Caroline A; Coleman, Christy A; Holland, Edward J

    2016-01-01

    To evaluate the sustained effect (up to 1 year) of a single, 12-minute vectored thermal pulsation (VTP) treatment in improving meibomian gland function and dry eye symptoms in patients with meibomian gland dysfunction and evaporative dry eye. The prospective, multicenter, open-label clinical trial included 200 subjects (400 eyes) who were randomized to a single VTP treatment (treatment group) or twice-daily, 3-month, conventional warm compress and eyelid hygiene therapy (control group). Control group subjects received crossover VTP treatment at 3 months (crossover group). Effectiveness measures of meibomian gland secretion (MGS) and dry eye symptoms were evaluated at baseline and 1, 3, 6, 9, and 12 months. Subjects with inadequate symptom relief could receive additional meibomian gland dysfunction therapy after 3 (treatment group) and 6 months (crossover group). At 3 months, the treatment group had greater mean improvement in MGS (P<0.0001) and dry eye symptoms (P=0.0068), compared to controls. At 12 months, 86% of the treatment group had received only one VTP treatment, and sustained a mean improvement in MGS from 6.4±3.7 (baseline) to 17.3±9.1 (P<0.0001) and dry eye symptoms from 44.1±20.4 to 21.6±21.3 (P<0.0001); 89% of the crossover group had received only one VTP treatment with sustained mean improvement in MGS from 6.3±3.6 to 18.4±11.1 (P<0.0001) and dry eye symptoms from 49.1±21.0 to 24.0±23.2 (P<0.0001). Greater mean improvement in MGS was associated with less severe baseline MGS (P=0.0017) and shorter duration of time between diagnosis and treatment (P=0.0378). A single VTP treatment can deliver a sustained mean improvement in meibomian gland function and mean reduction in dry eye symptoms, over 12 months. A single VTP treatment provides significantly greater mean improvement in meibomian gland function and dry eye symptoms as compared to a conventional, twice-daily, 3-month regimen. Early VTP intervention for meibomian gland dysfunction is

  1. Possible clinical effects of molecular hydrogen (H2) delivery during hemodialysis in chronic dialysis patients: Interim analysis in a 12 month observation

    PubMed Central

    Nakayama, Masaaki; Itami, Noritomo; Suzuki, Hodaka; Hamada, Hiromi; Osaka, Naoyuki; Yamamoto, Ryo; Tsunoda, Kazumasa; Nakano, Hirofumi; Watanabe, Kimio; Zhu, Wan-Jun; Maruyama, Yukio; Terawaki, Hiroyuki; Kabayama, Shigeru; Nakazawa, Ryoichi; Miyazaki, Mariko; Ito, Sadayoshi

    2017-01-01

    Background and aim It is supposed that enhanced oxidative stress and inflammation are involved with the poor clinical outcomes in patients on chronic dialysis treatment. Recent studies have shown that molecular hydrogen (H2) is biologically active as an anti-inflammatory agent. Thus, we developed a novel hemodialysis (E-HD) system which delivers H2 (30 to 80 ppb)-enriched dialysis solution, to conduct a prospective observational study (UMIN000004857) in order to compare the long-term outcomes between E-HD and conventional-HD (C-HD) in Japan. The present interim analysis aimed to look at potential clinical effects of E-HD during the first 12 months observation. Subjects and method 262 patients (140, E-HD; 122, C-HD) were subjected for analysis for comprehensive clinical profiles. They were all participating in the above mentioned study, and they had been under the respective HD treatment for 12 consecutive months without hospitalization. Collected data, such as, physical and laboratory examinations, medications, and self-assessment questionnaires on subjective symptoms (i.e., fatigue and pruritus) were compared between the two groups. Results In a 12-month period, no clinical relevant differences were found in dialysis-related parameters between the two groups. However, there were differences in the defined daily dose of anti-hypertensive agents, and subjective symptoms, such as severe fatigue, and pruritus, which were all less in the E-HD group. Multivariate analysis revealed E-HD was an independent significant factor for the reduced use of anti-hypertensive agents as well as the absence of severe fatigue and pruritus at 12 months after adjusting for confounding factors. Conclusion The data indicates E-HD could have substantial clinical benefits beyond conventional HD therapy, and support the rationale to conduct clinical trials of H2 application to HD treatment. PMID:28902900

  2. Effects of low calcium dialysate on the progression of coronary artery calcification in hemodialysis patients: An open-label 12-month randomized clinical trial.

    PubMed

    Kim, Soo Jin; Lee, Young-Ki; Oh, Jieun; Cho, AJin; Noh, Jung Woo

    2017-09-15

    The association between the dialysate calcium level and coronary artery calcification (CAC) has not yet been evaluated in hemodialysis patients. The objective of this study was to determine whether lowering the dialysate calcium levels would decrease the progression of coronary artery calcification (CAC) compared to using standard calcium dialysate. We conducted an open-label randomized trial with parallel groups. The patients were randomly assigned to either 12-month treatment with low calcium dialysate (LCD; 1.25mmol/L, n=36) or standard calcium dialysate (SCD; 1.5mmol/L, n=40). The primary outcome was the change in the CAC scores assessed by 64-slice multidetector computed tomography after 12months. During the treatment period, CAC scores increased in both groups, especially significant in LCD group (402.5±776.8, 580.5±1011.9, P=0.004). When we defined progressors as patients at second and third tertiles of CAC changes, progressor group had a higher proportion of LCD-treated patients than SCD-treated patients (P=0.0229). In multivariate analysis, LCD treatment is a significant risk factor for increase in CAC scores (odds ratio=5.720, 95% CI: 1.219-26.843, P=0.027). Use of LCD may accelerate the progression of CAC in patients with chronic hemodialysis over a 12-month period. Clinical Research Information Service [Internet]; Osong (Chungcheongbuk-do): Korea Centers for Disease Control and Prevention, Ministry of Health and Welfare (Republic of Korea), 2010: KCT0000942. Available from: https://cris.nih.go.kr/cris/search/search_result_st01_kren.jsp?seq=3572&sLeft=2&type=my. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  3. Possible clinical effects of molecular hydrogen (H2) delivery during hemodialysis in chronic dialysis patients: Interim analysis in a 12 month observation.

    PubMed

    Nakayama, Masaaki; Itami, Noritomo; Suzuki, Hodaka; Hamada, Hiromi; Osaka, Naoyuki; Yamamoto, Ryo; Tsunoda, Kazumasa; Nakano, Hirofumi; Watanabe, Kimio; Zhu, Wan-Jun; Maruyama, Yukio; Terawaki, Hiroyuki; Kabayama, Shigeru; Nakazawa, Ryoichi; Miyazaki, Mariko; Ito, Sadayoshi

    2017-01-01

    It is supposed that enhanced oxidative stress and inflammation are involved with the poor clinical outcomes in patients on chronic dialysis treatment. Recent studies have shown that molecular hydrogen (H2) is biologically active as an anti-inflammatory agent. Thus, we developed a novel hemodialysis (E-HD) system which delivers H2 (30 to 80 ppb)-enriched dialysis solution, to conduct a prospective observational study (UMIN000004857) in order to compare the long-term outcomes between E-HD and conventional-HD (C-HD) in Japan. The present interim analysis aimed to look at potential clinical effects of E-HD during the first 12 months observation. 262 patients (140, E-HD; 122, C-HD) were subjected for analysis for comprehensive clinical profiles. They were all participating in the above mentioned study, and they had been under the respective HD treatment for 12 consecutive months without hospitalization. Collected data, such as, physical and laboratory examinations, medications, and self-assessment questionnaires on subjective symptoms (i.e., fatigue and pruritus) were compared between the two groups. In a 12-month period, no clinical relevant differences were found in dialysis-related parameters between the two groups. However, there were differences in the defined daily dose of anti-hypertensive agents, and subjective symptoms, such as severe fatigue, and pruritus, which were all less in the E-HD group. Multivariate analysis revealed E-HD was an independent significant factor for the reduced use of anti-hypertensive agents as well as the absence of severe fatigue and pruritus at 12 months after adjusting for confounding factors. The data indicates E-HD could have substantial clinical benefits beyond conventional HD therapy, and support the rationale to conduct clinical trials of H2 application to HD treatment.

  4. 12-month intravascular ultrasound observations from BiOSS® first-in-man studies.

    PubMed

    Gil, Robert J; Bil, Jacek; Costa, Ricardo A; Gil, Katarzyna E; Vassiliev, Dobrin

    2016-09-01

    The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5 % vs 73.9 % (P < 0.05) and 0 % vs 39.1 % (P < 0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7 ± 7.5 % vs 19.4 ± 8.6 %, P < 0.05) as well as in main vessel (22.8 ± 5.6 % vs 16.9 ± 6.1 %, P < 0.05) and main branch (36.1 ± 6.5 % vs 27.6 ± 8.7 %, P < 0.05), but not at the level of bifurcation (15.1 ± 3.8 % vs 13.6 ± 5.4 %, P = NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 ± 0.09 mm vs 0.32 ± 0.14 mm, P < 0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 ± 3.9 % vs 18.9 ± 4.45 %, P < 0.05) as well as at the bifurcation site (12.6 ± 4.1 % vs 14.1 ± 2.4 %, P < 0.05). The

  5. Northern Eurasia Earth Science Partnership Initiative in the past 12 months: An Update

    NASA Astrophysics Data System (ADS)

    Groisman, Pavel; Lowford, Richard

    2013-04-01

    Eight years ago Northern Eurasia Earth Science Partnership Initiative (NEESPI) was launched with the release of its Science Plan (http://neespi.org). Gradually, the Initiative was joined by numerous international projects launched in EU, Russia, the United States, Canada, Japan, and China. Throughout its duration, NEESPI served and is serving as an umbrella for more than 155 individual international research projects. Currently, the total number of the ongoing NEESPI projects (as on January 2013) is 48 and has changed but slightly compared to its peak (87 in 2008). The past 12 months (from the previous EGU Assembly) were extremely productive in the NEESPI outreach. We organized three Open Science Sessions at the three major Geoscience Unions/Assembly Meetings (JpGU, AGU, and this EGU Session) and three International NEESPI Workshops. The programs of two of these Workshops (in Yoshkar Ola and Irkutsk, Russia) included Summer Schools for early career scientists. More than 150 peer-reviewed papers, books, and/or book chapters were published in 2012 or are in press (this list was still incomplete at the time of preparation of this abstract). In particular, a suite of 25 peer-reviewed NEESPI articles was published in the Forth Special NEESPI Issue of "Environmental Research Letters" (ERL) http://iopscience.iop.org/1748-9326/focus/NEESPI3 (this is the third ERL Issue). In December 2012, the next Special ERL NEESPI Issue was launched http://iopscience.iop.org/1748-9326/focus/NEESPI4. Northern Eurasia is a large study domain. Therefore, it was decided to describe the latest findings related to its environmental changes in several regional monographs in English. Three books on Environmental Changes in the NEESPI domain were published by the University of Helsinki (Groisman et al. 2012), "Akademperiodyka" (Groisman and Lyalko 2012), and Springer Publishing House (Groisman and Gutman 2013) being devoted to the high latitudes of Eurasia, to Eastern Europe, and to Siberia

  6. Infections in Infants during the First 12 Months of Life: Role of Placental Malaria and Environmental Factors

    PubMed Central

    Le Port, Agnès; Watier, Laurence; Cottrell, Gilles; Ouédraogo, Smaila; Dechavanne, Célia; Pierrat, Charlotte; Rachas, Antoine; Bouscaillou, Julie; Bouraima, Aziz; Massougbodji, Achille; Fayomi, Benjamin; Thiébaut, Anne; Chandre, Fabrice; Migot-Nabias, Florence; Martin-Prevel, Yves; Garcia, André; Cot, Michel

    2011-01-01

    Background The association between placental malaria (PM) and first peripheral parasitaemias in early infancy was assessed in Tori Bossito, a rural area of Benin with a careful attention on transmission factors at an individual level. Methodology Statistical analysis was performed on 550 infants followed weekly from birth to 12 months. Malaria transmission was assessed by anopheles human landing catches every 6 weeks in 36 sampling houses and season defined by rainfall. Each child was located by GPS and assigned to the closest anopheles sampling house. Data were analysed by survival Cox models, stratified on the possession of insecticide-treated mosquito nets (ITNs) at enrolment. Principal Findings Among infants sleeping in a house with an ITN, PM was found to be highly associated to first malaria infections, after adjusting on season, number of anopheles, antenatal care (ANC) visits and maternal severe anaemia. Infants born from a malaria infected placenta had a 2.13 fold increased risk to present a first malaria infection than those born from a non infected placenta ([1.24–3.67], p<0.01) when sleeping in a house with an ITN. The risk to present a first malaria infection was increased by 3.2 to 6.5, according to the level of anopheles exposure (moderate or high levels, compared to the absence of anopheles). Conclusions First malaria infections in early childhood can be attributed simultaneously to both PM and high levels of exposure to infected anopheles. Protective measures as Intermittent Preventive Treatment during pregnancy (IPTp) and ITNs, targeted on both mothers and infants should be reinforced, as well as the research on new drugs and insecticides. In parallel, investigations on placental malaria have to be strengthened to better understand the mechanisms involved, and thus to protect adequately the infants high risk group. PMID:22096588

  7. Predictors of outcome after 6 and 12 months following anthroposophic therapy for adult outpatients with chronic disease: a secondary analysis from a prospective observational study

    PubMed Central

    2010-01-01

    Background Anthroposophic medicine is a physician-provided complementary therapy system involving counselling, artistic and physical therapies, and special medications. The purpose of this analysis was to identify predictors of symptom improvement in patients receiving anthroposophic treatment for chronic diseases. Methods 913 adult outpatients from Germany participated in a prospective cohort study. Patients were starting anthroposophic treatment for mental (30.4% of patients, n = 278/913), musculoskeletal (20.2%), neurological (7.6%), genitourinary (7.4%) or respiratory disorders (7.2%) or other chronic indications. Stepwise multiple linear regression analysis was performed with the improvement of Symptom Score (patients' assessment, 0: not present, 10: worst possible) after 6 and 12 months as dependent variables. 61 independent variables pertaining to socio-demographics, life style, disease status, co-morbidity, health status (SF-36), depression, and therapy factors were analysed. Results Compared to baseline, Symptom Score improved by average 2.53 points (95% confidence interval 2.39-2.68, p < 0.001) after six months and by 2.49 points (2.32-2.65, p < 0.001) after 12 months. The strongest predictor for improvement after six months was baseline Symptom Score, which alone accounted for 25% of the variance (total model 32%). Improvement after six months was also positively predicted by better physical function, better general health, shorter disease duration, higher education level, a diagnosis of respiratory disorders, and by a higher therapy goal documented by the physician at baseline; and negatively predicted by the number of physiotherapy sessions in the pre-study year and by a diagnosis of genitourinary disorders. Seven of these nine variables (not the two diagnoses) also predicted improvement after 12 months. When repeating the 0-6 month analysis on two random subsamples of the original sample, three variables (baseline Symptom Score, physical function

  8. Additive effects of nutritional supplementation, together with bisphosphonates, on bone mineral density after hip fracture: a 12-month randomized controlled study

    PubMed Central

    Flodin, Lena; Sääf, Maria; Cederholm, Tommy; Al-Ani, Amer N; Ackermann, Paul W; Samnegård, Eva; Dalen, Nils; Hedström, Margareta

    2014-01-01

    Background After a hip fracture, a catabolic state develops, with increased bone loss during the first year. The aim of this study was to evaluate the effects of postoperative treatment with calcium, vitamin D, and bisphosphonates (alone or together) with nutritional supplementation on total hip and total body bone mineral density (BMD). Methods Seventy-nine patients (56 women), with a mean age of 79 years (range, 61–96 years) and with a recent hip fracture, who were ambulatory before fracture and without severe cognitive impairment, were included. Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly) for 12 months (B; n=28), treatment with bisphosphonates along with nutritional supplementation (40 g protein, 600 kcal daily) for the first 6 months (BN; n=26), or to controls (C; n=25). All participants received calcium (1,000 mg) and vitamin D3 (800 IU) daily. Total hip and total body BMD were assessed with dual-energy X-ray absorptiometry at baseline, 6, and 12 months. Marker of bone resorption C-terminal telopeptide of collagen I and 25-hydroxy vitamin D were analyzed in serum. Results Analysis of complete cases (70/79 at 6 months and 67/79 at 12 months) showed an increase in total hip BMD of 0.7% in the BN group, whereas the B and C groups lost 1.1% and 2.4% of BMD, respectively, between baseline and 6 months (P=0.071, between groups). There was no change in total body BMD between baseline and 12 months in the BN group, whereas the B group and C group both lost BMD, with C losing more than B (P=0.009). Intention-to-treat analysis was in concordance with the complete cases analyses. Conclusion Protein-and energy-rich supplementation in addition to calcium, vitamin D, and bisphosphonate therapy had additive effects on total body BMD and total hip BMD among elderly hip fracture patients. PMID:25045257

  9. Validity of the Fine Motor Area of the 12-Month Ages and Stages Questionnaire in Infants Following Major Surgery

    ERIC Educational Resources Information Center

    Smith, Cally; Wallen, Margaret; Walker, Karen; Bundy, Anita; Rolinson, Rachel; Badawi, Nadia

    2012-01-01

    The Ages and Stages Questionnaires (ASQ) are parent-report screening tools to identify infants at risk of developmental difficulties. The purpose of this study was to examine validity and internal reliability of the fine motor developmental area of the ASQ, 2nd edition (ASQ2-FM) for screening 12-month-old infants following major surgery. The…

  10. Video Analysis of Sensory-Motor Features in Infants with Fragile X Syndrome at 9-12 Months of Age

    ERIC Educational Resources Information Center

    Baranek, Grace T.; Danko, Cassandra D.; Skinner, Martie L.; Donald B., Jr.; Hatton, Deborah D.; Roberts, Jane E.; Mirrett, Penny L.

    2005-01-01

    This study utilized retrospective video analysis to distinguish sensory-motor patterns in infants with fragile X syndrome (FXS) (n=11) from other infants [i.e., autism (n=11), other developmental delay (n=10), typical (n=11)] at 9-12 months of age. Measures of development, autistic features, and FMRP were assessed at the time of entry into the…

  11. 75 FR 30338 - Endangered and Threatened Wildlife and Plants; 12-month Finding on a Petition to List the White...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-01

    ... Finding on a Petition to List the White-tailed Prairie Dog as Endangered or Threatened AGENCY: Fish and... Wildlife Service announce a 12-month finding on a petition to list the white-tailed prairie dog (Cynomys... dog is not warranted at this time. However, we ask the public to submit to us any new information that...

  12. 77 FR 19597 - Listing Endangered and Threatened Species; 12-Month Finding on a Petition To List Chinook Salmon...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ...We, NMFS, announce a 12-month finding on a petition to list the Chinook salmon (Oncorhynchus tshawytscha) in the Upper Klamath and Trinity Rivers Basin (UKTR) as threatened or endangered and designate critical habitat under the Endangered Species Act (ESA). We have reviewed the status of the UKTR Chinook salmon Evolutionarily Significant Unit (ESU) and considered the best scientific and......

  13. Structural neural correlates of impaired mobility and subsequent decline in executive functions: A 12-month prospective study

    PubMed Central

    Hsu, Chun Liang; Best, John R.; Chiu, Bryan K.; Nagamatsu, Lindsay S; Voss, Michelle W.; Handy, Todd C.; Bolandzadeh, Niousha; Liu-Ambrose, Teresa

    2016-01-01

    Impaired mobility, such as falls, may be an early biomarker of subsequent cognitive decline and is associated with subclinical alterations in both brain structure and function. In this 12-month prospective study, we examined whether there are volumetric differences in gray matter and subcortical regions, as well as cerebral white matter, between older fallers and non-fallers. In addition, we assessed whether these baseline volumetric differences are associated with changes in cognitive function over 12 months. A total of 66 community-dwelling older adults were recruited and categorized by their falls status. Magnetic resonance imaging occurred at baseline and participants’ physical and cognitive performances were assessed at baseline and 12-months. At baseline, fallers showed significantly lower volumes in gray matter, subcortical regions, and cerebral white matter compared with non-fallers. Notably, fallers had significantly lower left lateral orbitofrontal white matter volume. Moreover, lower left lateral orbitofrontal white matter volume at baseline was associated with greater decline in set-shifting performance over 12 months. Our data suggest that falls may indicate subclinical alterations in regional brain volume that are associated with subsequent decline in executive functions. PMID:27079333

  14. Child-Centered Behaviors of Caregivers with 12-Month-Old Infants: Associations with Passive Joint Engagement and Later Language

    ERIC Educational Resources Information Center

    Trautman, Carol Hamer; Rollins, Pamela Rosenthal

    2006-01-01

    This study investigates three aspects of social communication in 12-month-old infants and their caregivers: (a) caregiver conversational style, (b) caregiver gesture, and (c) infant engagement. Differences in caregiver behavior during passive joint engagement were associated with language outcomes. Although total mean duration of infant time in…

  15. 76 FR 47133 - Endangered and Threatened Wildlife and Plants; 90-Day Finding and 12-Month Determination on a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-04

    ... Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; 90-Day Finding... AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of 90-day petition finding and notice of 12-month determination. SUMMARY: We, the U.S. Fish and Wildlife Service (Service), announce our...

  16. 76 FR 48777 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Nueces...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the Nueces River shiner (Cyprinella sp.) and plateau shiner (Cyprinella lepida) as threatened or endangered and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). After review of all available scientific and commercial information, we find that listing the......

  17. 76 FR 62165 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Texas...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list five mussel species in Texas as threatened or endangered and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). The five species are Texas fatmucket (Lampsilis bracteata), golden orb (Quadrula aurea), smooth pimpleback (Q. houstonensis), Texas pimpleback......

  18. 76 FR 42631 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Pinus...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list Pinus albicaulis (whitebark pine) as threatened or endangered and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). After review of all available scientific and commercial information, we find that listing P. albicaulis as threatened or endangered is......

  19. 75 FR 78029 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the North...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the North American wolverine (Gulo gulo luscus) as an endangered or threatened species under the Endangered Species Act of 1973, as amended (Act). After review of all available scientific and commercial information, we find that the North American wolverine occurring in the contiguous United......

  20. The Role of Intersensory Redundancy in the Emergence of Social Referencing in 5 1/2-Month-Old Infants

    ERIC Educational Resources Information Center

    Vaillant-Molina, Mariana; Bahrick, Lorraine E.

    2012-01-01

    Early evidence of social referencing was examined in 5 1/2-month-old infants. Infants were habituated to 2 films of moving toys, one toy eliciting a woman's positive emotional expression and the other eliciting a negative expression under conditions of bimodal (audiovisual) or unimodal visual (silent) speech. It was predicted that intersensory…

  1. Indirect zirconia-reinforced lithium silicate ceramic CAD/CAM restorations: Preliminary clinical results after 12 months.

    PubMed

    Zimmermann, Moritz; Koller, Christina; Mehl, Albert; Hickel, Reinhard

    2017-01-01

    No clinical data are available for the new computer-aided design/computer-assisted manufacture (CAD/CAM) material zirconia-reinforced lithium silicate (ZLS) ceramic. This study describes preliminary clinical results for indirect ZLS CAD/CAM restorations after 12 months. Indirect restorations were fabricated, using the CEREC method and intraoral scanning (CEREC Omnicam, CEREC MCXL). Sixty-seven restorations were seated adhesively (baseline). Sixty restorations were evaluated after 12 months (follow-up), using modified FDI criteria. Two groups were established, according to ZLS restorations' post-processing procedure prior to adhesive seating: group I (three-step polishing, n = 32) and group II (fire glazing, n = 28). Statistical analysis was performed with Mann-Whitney U test and Wilcoxon test (P < .05). The success rate of indirect ZLS CAD/CAM restorations after 12 months was 96.7%. Two restorations clinically failed as a result of bulk fracture (failure rate 3.3%). No statistically significant differences were found for baseline and follow-up criteria (Wilcoxon test, P > .05). Statistically significant differences were found for criteria surface gloss for group I and group II (Mann-Whitney U test, P < .05). This study demonstrates ZLS CAD/CAM restorations have a high clinical success rate after 12 months. A longer clinical evaluation period is necessary to draw further conclusions.

  2. 77 FR 29077 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To Downlist Three...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-16

    ... 12-month finding on a petition to reclassify San Clemente Island bush mallow is not warranted at this... (San Clemente Island bush mallow), Acmispon (previously listed as Lotus) dendroideus var. traskiae... clementinus (San Clemente Island Bush Mallow) Our review does not support a conclusion that the threats have...

  3. Acoustic Properties of Cries in 12-Month Old Infants at High-Risk of Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Unwin, Lisa M.; Bruz, Ildiko; Maybery, Murray T.; Reynolds, Victoria; Ciccone, Natalie; Dissanayake, Cheryl; Hickey, Martha; Whitehouse, Andrew J. O.

    2017-01-01

    There is preliminary evidence that infant siblings of children with Autism Spectrum Disorder (ASD) have an atypical pattern of cry, characterized by higher fundamental frequency and increased dysphonation. This prospective study collected multiple cry samples of 12-month old siblings of children with ASD (n = 22, "high-risk" group) and…

  4. 76 FR 62722 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Amoreuxia...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-11

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list Amoreuxia gonzalezii (Santa Rita yellowshow), Astragalus hypoxylus (Huachuca milk-vetch), and Erigeron piscaticus (Fish Creek fleabane) as endangered or threatened with critical habitat under the Endangered Species Act of 1973, as amended (Act). After review of the best scientific and commercial......

  5. Validity of the Fine Motor Area of the 12-Month Ages and Stages Questionnaire in Infants Following Major Surgery

    ERIC Educational Resources Information Center

    Smith, Cally; Wallen, Margaret; Walker, Karen; Bundy, Anita; Rolinson, Rachel; Badawi, Nadia

    2012-01-01

    The Ages and Stages Questionnaires (ASQ) are parent-report screening tools to identify infants at risk of developmental difficulties. The purpose of this study was to examine validity and internal reliability of the fine motor developmental area of the ASQ, 2nd edition (ASQ2-FM) for screening 12-month-old infants following major surgery. The…

  6. The First Year Inventory: A Longitudinal Follow-Up of 12-Month-Old to 3-Year-Old Children

    ERIC Educational Resources Information Center

    Turner-Brown, Lauren M.; Baranek, Grace T.; Reznick, J Steven; Watson, Linda R.; Crais, Elizabeth R.

    2013-01-01

    The First Year Inventory is a parent-report measure designed to identify 12-month-old infants at risk for autism spectrum disorder. First Year Inventory taps behaviors that indicate risk in the developmental domains of sensory--regulatory and social--communication functioning. This longitudinal study is a follow-up of 699 children at 3 years of…

  7. 12-Month and Lifetime Prevalence of Suicide Attempts among Black Adolescents in the National Survey of American Life

    ERIC Educational Resources Information Center

    Joe, Sean; Baser, Raymond S.; Neighbors, Harold W.; Caldwell, Cleopatra H.; Jackson, James S.

    2009-01-01

    The data from the National Survey of American life on the suicidal behavior of 1,170 African American and Caribbean black adolescents aged 13 to 17 shows that black adolescents report having a lifetime prevalence of 7.5 percent for suicidal ideation and 2.7 percent for attempts. The 12-month prevalence of suicidal ideation is 3.2 percent and…

  8. Correlation of serum KL-6 and CC16 levels with neurodevelopmental outcome in premature infants at 12 months corrected age

    PubMed Central

    Zhang, Zhiqun; Lu, Hui; Zhu, Yunxia; Xiang, Junhua; Huang, Xianmei

    2015-01-01

    The aim of this study was to evaluate KL-6 and CC16 levels and their correlation with neurodevelopmental outcome among very low birth weight pre-term infants at 12 months corrected age. This prospective cohort study was performed from 2011 to 2013 by enrolling pre-term neonates of gestational age ≤ 32 weeks and birth weight ≤ 1500 g. Serum KL-6 and CC16 levels were determined 7 days after birth and their correlation with neurodevelopment was evaluated using Gesell Mental Developmental Scales. Of the 86 eligible pre-term infants, 63 completed follow-up, of which 15 had bronchopulmonary dysplasia. At 12 months corrected age, 49 infants had favorable outcomes and 14 infants had poor neurodevelopmental outcome. KL-6 levels were higher and CC16 levels were lower in infants with poor neurodevelopmental outcome compared with those infants who had favourable neurodevelopmental outcome. Serum KL-6 levels less than 90.0 ng/ml and CC16 levels greater than 320.0 pg/ml at 7 days of life were found to be predictive of a favourable outcome at 12 months corrected age. These biological markers could predict neurodevelopmental outcome at 12 months corrected age in very low birth weight premature infants, and help the clinician plan early therapeutic interventions to minimize or avoid poor neurodevelopmental outcome. PMID:25631862

  9. Social and Object Mastery Play in 12-Month Olds with Depressed and Non-Depressed Mothers: Developmental Changes and Correlates.

    ERIC Educational Resources Information Center

    Popper, Sally D.; And Others

    As part of a longitudinal study of postpartum adjustment and infant development, this study examined whether securely attached 12-month-old infants show greater object mastery motivation and social-object mastery motivation than do insecurely attached infants. Object mastery relates to infants' goal-directed behavior that is oriented toward…

  10. Disruptions in Brain Networks of Older Fallers Are Associated with Subsequent Cognitive Decline: A 12-Month Prospective Exploratory Study

    PubMed Central

    Hsu, Chun Liang; Voss, Michelle W.; Handy, Todd C.; Davis, Jennifer C.; Nagamatsu, Lindsay S.; Chan, Alison; Boland