Science.gov

Sample records for 3-5 months treatment

  1. Immunogenicity of Infanrix™ hexa administered at 3, 5 and 11 months of age.

    PubMed

    Van Der Meeren, Olivier; Kuriyakose, Sherine; Kolhe, Devayani; Hardt, Karin

    2012-04-05

    A pooled analysis of data from four vaccination studies conducted in Europe was undertaken to assess the immunogenicity of Infanrix™ hexa (DTPa-HBV-IPV/Hib, GlaxoSmithKline Biologicals) when administered in a total of 702 healthy infants at 3, 5 and 11-12 months of age. One month after dose 2, between 96.3% and 100% of subjects had seroprotective antibodies against diphtheria, tetanus, hepatitis B and poliovirus types 1, 2 and 3; 91.7% against Hib and ≥99.0% were seropositive for each pertussis antigen. One month after the third dose, 98.9-100% of subjects were seroprotected/seropositive for all vaccine antigens. Geometric mean antibody concentrations/titres for each vaccine antigen increased by 6.7-52.9 fold after the third vaccine dose. No serious adverse events in DTPa-HBV-IPV/Hib recipients were vaccine related. Infanrix™ hexa induces an adequate immune response after 2-dose primary plus booster doses when administered according to a 3, 5 and 11 months schedule.

  2. Impact on respiratory tract infections of heptavalent pneumococcal conjugate vaccine administered at 3, 5 and 11 months of age.

    PubMed

    Esposito, Susanna; Lizioli, Alessandro; Lastrico, Annalisa; Begliatti, Enrica; Rognoni, Alessandro; Tagliabue, Claudia; Cesati, Laura; Carreri, Vittorio; Principi, Nicola

    2007-02-21

    Medical and public health importance of pneumococcal infections justifies the implementation of measures capable of reducing their incidence and severity, and explains why the recently marketed heptavalent pneumococcal conjugate vaccine (PCV-7) has been widely studied by pediatricians. This study was designed to evaluate the impact of PCV-7 administered at 3, 5 and 11 months of age on respiratory tract infections in very young children. A total of 1,571 healthy infants (910 males) aged 75-105 days (median 82 days) were enrolled in this prospective cohort trial to receive a hexavalent vaccine (DTaP/IPV/HBV/Hib) and PCV-7 (n = 819) or the hexavalent vaccine alone (n = 752) at 3, 5 and 11 months of age. Morbidity was recorded for the 24 months following the second dose by monthly telephone interviews conducted by investigators blinded to the study treatment assignment using standardised questionnaires. During these interviews, the caregivers and the children's pediatricians were questioned about illnesses and the use of antibiotics since the previous telephone call. All of the data were analysed using SAS Windows v.12. Among the 1,555 subjects (98.9%) who completed the study, analysis of the data by the periods of follow-up demonstrated that radiologically confirmed community-acquired pneumonia (CAP) was significantly less frequent in the PCV-7 group during the follow-up as a whole and during the last period of follow-up. Moreover, there were statistically significant between-group differences in the incidence of acute otitis media (AOM) in each half-year period of follow-up except the first, with significantly lower number of episodes in children receiving PCV-7 than in controls. Furthermore, the antibiotic prescription data showed that the probability of receiving an antibiotic course was significantly lower in the PCV-7 group than in the control group. Our findings show the effectiveness of the simplified PCV-7 schedule (three doses administered at 3, 5 and 11

  3. Impact on respiratory tract infections of heptavalent pneumococcal conjugate vaccine administered at 3, 5 and 11 months of age

    PubMed Central

    Esposito, Susanna; Lizioli, Alessandro; Lastrico, Annalisa; Begliatti, Enrica; Rognoni, Alessandro; Tagliabue, Claudia; Cesati, Laura; Carreri, Vittorio; Principi, Nicola

    2007-01-01

    Background Medical and public health importance of pneumococcal infections justifies the implementation of measures capable of reducing their incidence and severity, and explains why the recently marketed heptavalent pneumococcal conjugate vaccine (PCV-7) has been widely studied by pediatricians. This study was designed to evaluate the impact of PCV-7 administered at 3, 5 and 11 months of age on respiratory tract infections in very young children. Methods A total of 1,571 healthy infants (910 males) aged 75–105 days (median 82 days) were enrolled in this prospective cohort trial to receive a hexavalent vaccine (DTaP/IPV/HBV/Hib) and PCV-7 (n = 819) or the hexavalent vaccine alone (n = 752) at 3, 5 and 11 months of age. Morbidity was recorded for the 24 months following the second dose by monthly telephone interviews conducted by investigators blinded to the study treatment assignment using standardised questionnaires. During these interviews, the caregivers and the children's pediatricians were questioned about illnesses and the use of antibiotics since the previous telephone call. All of the data were analysed using SAS Windows v.12. Results Among the 1,555 subjects (98.9%) who completed the study, analysis of the data by the periods of follow-up demonstrated that radiologically confirmed community-acquired pneumonia (CAP) was significantly less frequent in the PCV-7 group during the follow-up as a whole and during the last period of follow-up. Moreover, there were statistically significant between-group differences in the incidence of acute otitis media (AOM) in each half-year period of follow-up except the first, with significantly lower number of episodes in children receiving PCV-7 than in controls. Furthermore, the antibiotic prescription data showed that the probability of receiving an antibiotic course was significantly lower in the PCV-7 group than in the control group. Conclusion Our findings show the effectiveness of the simplified PCV-7 schedule

  4. Face Gender Influences the Looking Preference for Smiling Expressions in 3.5-Month-Old Human Infants

    PubMed Central

    Bayet, Laurie; Quinn, Paul C.; Tanaka, James W.; Lee, Kang; Gentaz, Édouard; Pascalis, Olivier

    2015-01-01

    Young infants are typically thought to prefer looking at smiling expressions. Although some accounts suggest that the preference is automatic and universal, we hypothesized that it is not rigid and may be influenced by other face dimensions, most notably the face’s gender. Infants are sensitive to the gender of faces; for example, 3-month-olds raised by female caregivers typically prefer female over male faces. We presented neutral versus smiling pairs of faces from the same female or male individuals to 3.5-month-old infants (n = 25), controlling for low-level cues. Infants looked longer to the smiling face when faces were female but longer to the neutral face when faces were male, i.e., there was an effect of face gender on the looking preference for smiling. The results indicate that a preference for smiling in 3.5-month-olds is limited to female faces, possibly reflective of differential experience with male and female faces. PMID:26068460

  5. Face Gender Influences the Looking Preference for Smiling Expressions in 3.5-Month-Old Human Infants.

    PubMed

    Bayet, Laurie; Quinn, Paul C; Tanaka, James W; Lee, Kang; Gentaz, Édouard; Pascalis, Olivier

    2015-01-01

    Young infants are typically thought to prefer looking at smiling expressions. Although some accounts suggest that the preference is automatic and universal, we hypothesized that it is not rigid and may be influenced by other face dimensions, most notably the face's gender. Infants are sensitive to the gender of faces; for example, 3-month-olds raised by female caregivers typically prefer female over male faces. We presented neutral versus smiling pairs of faces from the same female or male individuals to 3.5-month-old infants (n = 25), controlling for low-level cues. Infants looked longer to the smiling face when faces were female but longer to the neutral face when faces were male, i.e., there was an effect of face gender on the looking preference for smiling. The results indicate that a preference for smiling in 3.5-month-olds is limited to female faces, possibly reflective of differential experience with male and female faces.

  6. Degradation kinetics of malvidin-3-glucoside and malvidin-3,5-diglucoside exposed to microwave treatment.

    PubMed

    Zhao, Mengyao; Li, Yuan; Xu, Xiayang; Wu, Jihong; Liao, Xiaojun; Chen, Fang

    2013-01-16

    Understanding the factors that contribute to the degradation of bioactive compounds during microwave treatment is meaningful for the practical application of this novel technology. The influence of microwave power, energy density, temperature, pH value, and initial concentration of anthocyanins (Acys) on the degradation behavior of malvidin-3-glucoside (Mv-3-glu) and malvidin-3,5-diglucoside (Mv-3,5-diglu) was investigated in this study. Results showed that the degradation of both Acys was accelerated with the increase of microwave power, energy density, temperature, pH value, and initial concentration of Acys. The degradation process of both Acys followed the first-order kinetics model (R² > 0.94), whereas the relationship between Acys degradation and energy density fitted to the logistic model well (R² > 0.98). In addition, Mv-3-glu was more susceptible to the microwave treatment than Mv-3,5-diglu. Compared with heating in a 98 ± 2 °C water bath, both Acys degraded more rapidly under microwave treatment at 100 °C, indicating the occurrence of microwave effect. The results provide a guide for the scientific application of microwave treatment.

  7. Immunological persistence in 5 y olds previously vaccinated with hexavalent DTPa-HBV-IPV/Hib at 3, 5, and 11 months of age.

    PubMed

    Silfverdal, Sven A; Assudani, Deepak; Kuriyakose, Sherine; Van Der Meeren, Olivier

    2014-01-01

    The combined diphtheria-tetanus-acellular pertussis-hepatitis B-poliomyelitis/Haemophilus influenza vaccine (DTPa-HBV-IPV/Hib: Infanrix™ hexa, GlaxoSmithKline Vaccines) is used for primary vaccination of infants in a range of schedules world-wide. Antibody persistence after 4 DTPa-HBV-IPV/Hib doses in the first 2 y of life has been documented, but long-term persistence data following the 3, 5, 11-12 months (3-5-11) infant vaccination schedule, employed for example in Nordic countries, are limited. We assessed antibody persistence in 57 5-year-old children who had received either DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (Infanrix™-IPV/Hib, GlaxoSmithKline Vaccines) in the 3-5-11 schedule. Among DTPa-HBV-IPV/Hib recipients, 7/12 retained seroprotective antibody concentrations for diphtheria, 10/12 for tetanus, 5/12 for hepatitis and 10/12 for Hib. Detectable antibodies were observed for 0/12 children for pertussis toxin (PT), 12/12 for filamentous haemagglutinin (FHA) and 8/12 for pertactin (PRN). Among DTPa-IPV/Hib recipients, 28/45 retained seroprotective anti-diphtheria concentrations, 34/44 for tetanus and 40/45 for Hib. Detectable antibodies were observed for 9/45 children for PT, 41/45 for FHA and 34/45 for PRN. Antibody persistence in DTPa-HBV-IPV/Hib and DTPa-IPV/Hib-vaccinees appeared similar in 5 y olds to that previously observed in children of a similar age who had received 4 prior doses of DTPa-HBV-IPV/Hib (or DTPa-IPV/Hib). As in subjects primed with 4 prior doses, we observed that antibodies markedly declined by 5 y of age, calling for the administration of a pre-school booster dose in order to ensure continued protection against pertussis.

  8. Initiation of GnRH agonist treatment on 3-5 days postoperatively in endometriosis patients: a randomized controlled trial.

    PubMed

    Gong, Lili; Zhang, Shaofen; Han, Yi; Long, Qiqi; Zou, Shien; Cao, Yuankui

    2015-08-01

    Seventy patients with stage III or IV endometriosis were randomly assigned to 2 groups after conservative surgery. Group O (n = 35) received 3 cycles of a 28-day gonadotropin-releasing hormone agonist (GnRH-a) treatment (goserelin, 3.6 mg) starting 3-5 days postoperatively. Group M (n = 35) received the same treatment starting on days 1-5 of menstruation. Groups were further subdivided according to add-back treatment. Pre- and posttreated levels of estradiol (E2 ), follicle stimulating hormone (FSH), and luteinizing hormone (LH) and visual analog scale (VAS), Kupperman menopausal index (KMI), and bone mineral density (BMD) scores were recorded. The incidence of uterine bleeding was assessed. In both groups, serum levels of E2 , FSH, and LH and VAS scores decreased significantly after treatment. Spotting was the most frequent bleeding pattern. During cycle 1, the bleeding time in group M was much longer that than that in group O (P =.001), and the bleeding rate in group M was significantly higher than that in group O (P =.024, RR = 1.185). In patients with stage III or IV endometriosis, the efficacy of GnRH-a initiated 3-5 days postoperatively was equivalent to that of GnRH-a initiated on days 1-5 of menstruation. Female patients who initiated GnRH-a treatment 3-5 days postoperatively experienced less uterine bleeding during the first cycle of treatment.

  9. Dental caries and their treatment needs in 3-5 year old preschool children in a rural district of India.

    PubMed

    Gupta, Devanand; Momin, Rizwan K; Mathur, Ayush; Srinivas, Kavuri Teja; Jain, Ankita; Dommaraju, Neelima; Dalai, Deepak Ranjan; Gupta, Rajendra Kumar

    2015-04-01

    Dental problems in the preschool children are neglected by their parents as the deciduous teeth are going to shed off, and hence considered to be of no importance and more of economic burden if attended to them. This study was to determine the caries prevalence in preschool children (3-5-year-old) of rural Moradabad district, to analyze the specific pattern of dental caries experience in this population and to assess the treatment needs among them. Children within the age group of 3-5 years attending Anganwadi centers of rural Moradabad district were included in the study. Caries diagnosis was based on decayed, extracted, filled surface (defs) and the treatment needs were recorded using World Health Organization (WHO) oral health assessment form 1997. Out of 1,500 children examined, 48.7% males and 52.6% females did not require any treatment. The mean decayed, extracted, filled teeth (deft) value was found to be significantly high in 5-year-old participants when compared to 3-year-old participants (P < 0.01). Majority of the children required one surface filling followed by two surface fillings, caries arresting sealant care, extraction, crown bridge element, pulp care, and space maintainer. The most common pattern was pit and fissure, then maxillary anterior pattern, posterior proximal pattern, and posterior buccal lingual smooth surface pattern. The mean deft value was higher in males as compared to females. There is a greater need for oral health education among parents and teachers.

  10. Dental Caries and Their Treatment Needs in 3-5 Year Old Preschool Children in a Rural District of India

    PubMed Central

    Gupta, Devanand; Momin, Rizwan K; Mathur, Ayush; Srinivas, Kavuri Teja; Jain, Ankita; Dommaraju, Neelima; Dalai, Deepak Ranjan; Gupta, Rajendra Kumar

    2015-01-01

    Background: Dental problems in the preschool children are neglected by their parents as the deciduous teeth are going to shed off, and hence considered to be of no importance and more of economic burden if attended to them. Aims: This study was to determine the caries prevalence in preschool children (3-5-year-old) of rural Moradabad district, to analyze the specific pattern of dental caries experience in this population and to assess the treatment needs among them. Material and Methods: Children within the age group of 3-5 years attending Anganwadi centers of rural Moradabad district were included in the study. Caries diagnosis was based on decayed, extracted, filled surface (defs) and the treatment needs were recorded using World Health Organization (WHO) oral health assessment form 1997. Results: Out of 1,500 children examined, 48.7% males and 52.6% females did not require any treatment. The mean decayed, extracted, filled teeth (deft) value was found to be significantly high in 5-year-old participants when compared to 3-year-old participants (P < 0.01). Majority of the children required one surface filling followed by two surface fillings, caries arresting sealant care, extraction, crown bridge element, pulp care, and space maintainer. Conclusion: The most common pattern was pit and fissure, then maxillary anterior pattern, posterior proximal pattern, and posterior buccal lingual smooth surface pattern. The mean deft value was higher in males as compared to females. There is a greater need for oral health education among parents and teachers. PMID:25973401

  11. Radiofrequency Ablation Combined with Renal Arterial Embolization for the Treatment of Unresectable Renal Cell Carcinoma Larger Than 3.5 cm: Initial Experience

    SciTech Connect

    Yamakado, Koichiro Nakatsuka, Atsuhiro; Kobayashi, Shigeki; Akeboshi, Masao; Takaki, Haruyuki; Kariya, Zentaro; Kinbara, Hiroyuki; Arima, Kiminobu; Yanagawa, Makoto; Hori, Yasuhide; Kato, Hiromi; Sugimura, Yoshiki; Takeda, Kan

    2006-06-15

    The purpose of the study was to evaluate the feasibility, safety, and therapeutic effects of the combination of renal arterial embolization and radiofrequency (RF) ablation to reinforce the anticancer effect on renal cell carcinomas (RCCs) measuring 3.5 cm or larger. This study was undertaken to evaluate this combined therapy on large RCCs-based tumor geometry. Eleven patients with 12 RCCs 3.5 cm or larger in diameter (3.5-9.0 cm) underwent combined therapy. Two were exophytic tumors, and the remaining 10 tumors had components extending into the renal sinus fat. Tumor vessels were selectively embolized in nine patients and the renal artery was completely embolized in two patients with polyvinyl alcohol or ethanol mixed with iodized oil. RF ablation was percutaneously done under the computed tomographic (CT)-fluoroscopic guidance. Response to treatment was evaluated by dynamic contrast-enhanced CT and magnetic resonance (MR) imaging. Tumor enhancement was eliminated after a single RF session in nine tumors (75%), after two sessions in two tumors (17%), and after four sessions in one tumor (8%). Both exophytic tumors (100%) and 7 of 10 tumors having components in the renal sinus fat (70%) were completely ablated with a single RF session. All tumors remained controlled during a mean follow-up period of 13 months and showed significant reduction in tumor sizes (5.2 {+-} 1.7 cm to 3.6 {+-} 1.4 cm, p < 0.001). A delayed abscess developed in the ablated lesion in a patient, which was percutaneously drainaged. Combined therapy as described in this report is a feasible, relatively safe, and promising treatment method for large RCCs regardless of tumor geometry.

  12. Predictive value of subclinical autistic traits at age 14-15 months for behavioural and cognitive problems at age 3-5 years.

    PubMed

    Möricke, Esmé; Swinkels, Sophie H N; Beuker, Karin T; Buitelaar, Jan K

    2010-08-01

    It is unclear whether subclinical autistic traits at very young age are transient or stable, and have clinical relevance. This study investigated the relationship between early subclinical autistic traits and the occurrence of later developmental and behavioural problems as well as problems in cognitive and language functioning. Parents of infants aged 14-15 months from the general population completed the Early Screening of Autistic Traits Questionnaire (ESAT). Three groups of children with high, moderate, and low ESAT-scores (total n = 103) were selected. Follow-up assessments included the CBCL 1(1/2)-5 at age 3 years, and the SCQ, the ADI-R, the ADOS-G, an on-verbal intelligence test, and language tests for comprehension and production at age 4-5 years. None of the children met criteria for autism spectrum disorder at follow-up. Children with high ESAT-scores at 14-15 months showed significantly more internalizing and externalizing problems at age 3 years and scored significantly lower on language tests at age 4-5 years than children with moderate or low ESAT-scores. Further, significantly more children with high ESAT-scores (14/26, 53.8%) than with moderate and low ESAT-scores (5/36, 13.9% and 1/41, 2.4%, respectively) were in the high-risk/clinical range on one or more outcome domains (autistic symptoms, behavioural problems, cognitive and language abilities). Subclinical autistic traits at 14-15 months predict later behavioural problems and delays in cognitive and language functioning rather than later ASD-diagnoses. The theoretical implications of the findings lie in the pivotal role of early social and communication skills for the development of self-regulation of emotions and impulses. The practical implications bear on the early recognition of children at risk for behavioural problems and for language and cognitive problems.

  13. Fabrication, Tuning, Treatment and Testing of Two 3.5 Cell Photo-Injector Cavities for the ELBE Linac

    SciTech Connect

    Arnold, A.; Murcek, P.; Teichert, J.; Xiang, R.; Eremeev, G. V.; Kneisel, P.; Stirbet, M.; Turlington, L.

    2011-07-01

    As part of a CRADA (Cooperative Research and Development Agreement) between Helmholtz-Zentrum Dresden-Rossendorf (HZDR) and Thomas Jefferson Lab National Accelerator Facility (TJNAF) we have fabricated and tested two 1.3 GHz 3.5 cell photo-injector cavities from polycrystalline RRR niobium and large grain RRR niobium, respectively. The cavity with the better performance will replace the presently used injector cavity in the ELBE linac. The cavities have been fabricated and pre-tuned at TJNAF, while the more sophisticated final field tuning, the adjustment of the external couplings and the field profile measurement of transverse electric modes for RF focusing was done at HZDR. The following standard surface treatment and the vertical test was carried out at TJNAF's production facilities. A major challenge turned out to be the rinsing of the cathode cell, which has small opening (O-slash10mm) to receive the cathode stalk. Another unexpected problem encountered after etching, since large visible defects appeared in the least accessible cathode cell. This contribution reports about our experiences, initial results and the on-going diagnostic work to understand and fix the problems.

  14. PTCA (1H-pyrrole-2,3,5-tricarboxylic acid) as a marker for oxidative hair treatment.

    PubMed

    Petzel-Witt, Silvana; Meier, Sylvia I; Schubert-Zsilavecz, Manfred; Toennes, Stefan W

    2017-09-20

    Hair analysis for the assessment of alcohol or drug abstinence became a routine procedure in forensic toxicology. Hair coloration leading to loss of incorporated xenobiotics and to false negative results turned out to be a major problem. Currently only colored extracts provide hints of manipulations but not bleaching. A liquid chromatographic-mass spectrometric (LC-MSMS) method was developed and validated to determine 1H-pyrrole-2,3,5-tricarboxylic acid (PTCA), a major oxidation product of melanin. PTCA was determined in natural hair samples (n=21) after treatment with 3% hydrogen peroxide (H2 O2 ) for 30 or 40 min with concentrations up to 12% for 40 min. In another series, 12 natural hair samples were submitted to different coloration procedures (henna, tinting, semi-permanent and permanent dyeing, bleaching) and the changes in PTCA content were determined. A significant increase in the PTCA content was found for both incubation times and increasing H2 O2 concentrations. Coloration with henna or tinting had no influence on PTCA levels detected, but a significant increase was observed after semi-permanent and permanent dyeing and bleaching. As PTCA concentrations in natural hair were found to be in a range of <2.1 - 16.4 ng/mg (8.4±3.8 ng/mg, mean±SD, n=33), a cut-off of 20 ng/mg is recommended for the distinction between natural vs. excessively oxidized hair. In case of naturally low melanin content (lightblond or white hair), no marked increase in PTCA may occur. The present study demonstrated that PTCA is formed during oxidative treatment of melanin in hair, which can be used to detect previous hair coloration including oxidation. This article is protected by copyright. All rights reserved.

  15. Month

    NASA Astrophysics Data System (ADS)

    Murdin, P.

    2000-11-01

    A unit of time based on the motion of the Moon around the Earth. The synodic (or lunar) month is the mean time interval between two successive new moons (i.e. the time taken for the Moon to pass through its cycle of phases) and is equal to 29.53059 mean solar days. Because the synodic month (the basis of the lunar calendar) is not equal to a whole number of days, the calendar month is rounded to ...

  16. Bilingual children with primary language impairment: 3 months after treatment.

    PubMed

    Pham, Giang; Ebert, Kerry Danahy; Kohnert, Kathryn

    2015-01-01

    Evidence on the treatment effectiveness for bilingual children with primary language impairment (PLI) is needed to advance both theory and clinical practice. Of key interest is whether treatment effects are maintained following the completion of short-term intense treatments. To investigate change in select language and cognitive skills in Spanish-English bilingual children with PLI 3 months after children have completed one of three experimental treatment conditions. There are two main study aims. First, to determine if skills in Spanish, English and cognitive processing decline, improve or are maintained after treatment has been completed. Second, to determine if differential rates of change are a function of the type of treatment children received. Participants were 48 children, aged 5:6-11:3, who spoke Spanish and English and were diagnosed with moderate to severe PLI. Participants received 6 weeks of treatment focused on English only (EO), bilingual skills in Spanish and English (BI) or nonlinguistic cognitive processing (NCP). Treatment effects reported in a previous study were determined by comparing pre- and post-treatment performance on a variety of language and cognitive measures. Here we re-administered each measure 3 months after completion of the experimental treatments. Hierarchical linear models were calculated for each measure using pre-, post- and follow-up testing scores to estimate change trajectories and compare outcomes between treatment conditions. Participants in all three treatment conditions either maintained skills or showed improvement even after treatment was discontinued for 3 months. Main findings included (1) comparable, positive rates of change on all English language outcomes for EO and BI conditions; (2) maintenance of Spanish language skills, and (3) modest improvements in NCP following the discontinuation of treatment. This study is the first to examine longer-term treatment effects for bilingual school-age children with PLI

  17. Evaluation of an 18-month commercial multidisciplinary obesity treatment programme.

    PubMed

    Aller, E E J G; van Baak, M A

    2016-02-01

    The treatment of obesity is an often studied subject. Although reductions in weight and improvements in cardiometabolic risk factors are important aims of obesity treatment, improvements in quality of life and eating behaviour are also relevant outcomes. In this practice-based study, we evaluated an 18-month commercial multidisciplinary obesity treatment programme and report on treatment results for weight, cardiometabolic risk factors, eating behaviour and quality of life. From a local commercial obesity treatment centre, 426 subjects (65% female; 45.4 ± 12.2 years; body mass index 40.0 ± 6.6 kg m(-2)) were recruited. Measurements of body weight, height, body composition, waist circumference and blood pressure were scheduled at baseline and every 3 months, whereas fasting blood collections were scheduled at baseline and every 6 months. At the same time points, participants were asked to fill in questionnaires on dietary intake, eating behaviour and quality of life. After 18 months of treatment programme, average weight change [mean (95% confidence interval)] was -10.9 kg (-14.8 to -7.0; P < 0.001) for the completers (n = 181) and -10.8 kg (-14.2 to -7.4; P < 0.001) for the intention-to-treat population (n = 426). Waist circumference (mean ± standard error of the mean) (-0.13 ± 0.01 cm; P < 0.001), fat mass (-7.8 ± 1.3 kg; P < 0.001) systolic (-11.4 ± 2.0; P < 0.001) and diastolic (-7.0 ± 1.3; P < 0.001) blood pressure, triglycerides (-0.4 ± 0.1; P = 0.004) and plasma glucose (-0.6 ± 0.2; P = 0.001) were significantly reduced. The PCS scale of the SF-36 and all three scales of the three-factor eating questionnaire improved significantly over the 18-month treatment period. All collected data in this study provide evidence that a multidisciplinary treatment programme based on lifestyle modification results in significant weight loss and improvements in cardiometabolic

  18. 3,5-Diarylpyrazole Derivatives Obtained by Ammonolysis of the Total Flavonoids from Chrysanthemum indicum Extract Show Potential for the Treatment of Alzheimer's Disease.

    PubMed

    Wu, Taizong; Jiang, Cheng; Wang, Ling; Morris-Natschke, Susan L; Miao, Hui; Gu, Lianquan; Xu, Jun; Lee, Kuo-Hsiung; Gu, Qiong

    2015-07-24

    Four new 3,5-diarylpyrazole analogues (1-4) were isolated from an extract of the flowers of Chrysanthemun indicum using a combination of ammonolysis of the total flavonoid extract and an Aβ aggregation inhibitory activity guided purification procedure. All four compounds (1-4) showed moderate to potent activity against Aβ aggregation with EC50 values of 4.3, 15.8, 1.3, and 2.9 μM, respectively. Moreover, compound 3 showed low cytotoxicity and significant neuroprotective activity against Aβ-induced cytotoxicity in the SH-SY5Y cell line. This report is the first to show that 3,5-diarylpyrazole analogues can inhibit Aβ aggregation and exhibit neuroprotective activity with potential for the treatment of Alzheimer's disease. Taken together, the method presented here offers an alternative approach to yield bioactive compounds.

  19. 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

  20. Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy.

    PubMed

    Zanetti, Alessandro; Desole, Maria Giuseppina; Romanò, Luisa; d'Alessandro, Antonio; Conversano, Michele; Ferrera, Giuseppe; Panico, Maria Grazia; Tomasi, Alberto; Zoppi, Giorgio; Zuliani, Massimo; Thomas, Stéphane; Soubeyrand, Benoît; Eymin, Cécile; Lockhart, Stephen

    2017-07-13

    The strategy of vaccinating infants to prevent hepatitis B virus infection in adolescence or adulthood requires durable immunity. This study investigated responses to a challenge dose of monovalent hepatitis B vaccine in children primed with three doses of either Hexavac® or Infanrix hexa® 10years earlier during infancy. This open-label, controlled, multicentre study conducted in Italy, enrolled 751 healthy pre-adolescents (aged 11-13years) who were given either Hexavac (n=409) or Infanrix hexa (n=342) at 3, 5 and 11months of life. All participants received a challenge dose of a monovalent hepatitis B vaccine (HBVaxPro® 5µg). The concentrations of antibodies to hepatitis B surface antigen (anti-HBs) were measured before and 1month after the challenge dose. The analysis was descriptive and no formal hypothesis was tested. One month post-challenge, 331 participants in the Hexavac cohort [83.6%, 95% CI: 79.6; 87.1] and 324 in the Infanrix hexa cohort [96.4%, 95% CI: 93.8; 98.1] had anti-HBs concentrations ≥10mIU/mL. Before the challenge dose, an anti-HBs concentration of ≥10mIU/mL was found in 94 children in the Hexavac cohort [23.9%, 95% CI: 19.7; 28.4] and in 232 children in the Infanrix hexa cohort [69%, 95% CI: 63.8; 74.0]. Among children with a pre-challenge anti-HBs concentration of <10mIU/mL, 236 [78.7%, 95% CI: 73.6; 83.2] in the Hexavac cohort and 92 [88.5%, 95% CI: 80.7; 93.9] in the Infanrix hexa cohort achieved protective anti-HBs antibody concentrations. No evidence of active hepatitis B disease was observed in either group, and the HBVaxPro challenge dose was well tolerated. These data confirm that immune memory persists in a high percentage of children (>80%) at least 10years after a two-dose primary and booster vaccination schedule with a hexavalent vaccine (Hexavac or Infanrix hexa). EudraCT Number: 2013-001602-28; clinicaltrials.gov: NCT02012998. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Biological Activities of 2,3,5,4′-Tetrahydroxystilbene-2-O-β-D-Glucoside in Antiaging and Antiaging-Related Disease Treatments

    PubMed Central

    2016-01-01

    2,3,5,4′-Tetrahydroxystilbene-2-O-β-D-glucoside (THSG) is active component of the Chinese medicinal plant Polygonum multiflorum Thunb. (THSG). Pharmacological studies have demonstrated that THSG exhibits numerous biological functions in treating atherosclerosis, lipid metabolism, vascular and cardiac remodeling, vascular fibrosis, cardiac-cerebral ischemia, learning and memory disorders, neuroinflammation, Alzheimer and Parkinson diseases, diabetic complications, hair growth problems, and numerous other conditions. This review focuses on the biological effects of THSG in antiaging and antiaging-related disease treatments and discusses its molecular mechanisms. PMID:27413420

  2. Effects of Ultra-Fast Cooling After Hot Rolling and Intercritical Treatment on Microstructure and Cryogenic Toughness of 3.5%Ni Steel

    NASA Astrophysics Data System (ADS)

    Wang, Meng; Liu, Zhenyu

    2017-07-01

    A novel process comprised of ultra-fast cooling after control rolling, intercritical quenching and tempering (UFC-LT) was applied to 3.5%Ni steel. In addition, quenching and tempering (QT) treatment was conducted in comparison. The present study focuses on the relationship between the microstructure and cryogenic toughness of 3.5%Ni steel. Results show that the microstructure of steel treated by UFC-LT consisted of tempered martensite, intercritical ferrite and two types of reversed austenite (RA) (needle shape and blocky). Compared to the QT sample, the UFC-LT sample's ultimate tensile strength decreased slightly, while its elongation increased from 32.3 to 35.7%, and its Charpy absorption energy at -135 °C increased from 112 to 237 J. The ductile-brittle transition temperature of UFC-LT sample was lower than that of the QT sample by 18 °C. The superior cryogenic toughness after UFC-LT compared to QT treatment can be attributed to the dissolution of cementite, approximately 3.0% increase in RA and the decrease in effective grain size.

  3. Immunogenicity and reactogenicity of two diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccines administered at 3, 5 and 11-12 months of age.

    PubMed

    Kilpi, Terhi M; Silfverdal, Sven Arne; Nilsson, Lennart; Syrjänen, Ritva; Belloni, Cesare; Desole, Maria; Triban, Chiara; Storsaeter, Jann; Soila, Maaria; Jacquet, Jeanne-Marie

    2009-01-01

    The use of combination vaccines in the routine childhood program reduces distress to the recipients and is likely to improve uptake rates and timeliness of vaccination but requires careful evaluation and surveillance. The aim of this study was to evaluate the immunogenicity and reactogenicity of two commercial diphtheria-tetanus- acellular pertussis-hepatitis b-inactivated polio virus-Haemophilus influenzae type b (DTaP-HBV-IPV/Hib) combination vaccines when administered to infants at 3, 5 and 11-12 months of age. A total of 494 infants were randomized to receive three doses of either Infanrix hexa (GlaxoSmithKline Biologicals; N = 246) or Hexavac (Sanofi Pasteur MSD; N = 248) in 10 centers in Italy, Finland and Sweden. After the third dose, antibodies to diphtheria, tetanus, polio and Hib were at the protective level in nearly all infants in both groups whereas the proportion of subjects who had achieved the protective concentration of >or=10 mIU/ml to hepatitis B surface antigen was 99.1% (95% CI 96.7-99.9) in the Infanrix hexa group as compared to 94.4% (95% CI 90.4.97.1) in the Hexavac group. Antibody titers to all three polio antigens were highest in Italy and lowest in Finland. Clinically relevant general reactions (such as fever of >39.5 degrees C) were mostly reported in less than 5% of the vaccinees. Three doses of DTaP-HBV-IPV/Hib combination vaccines produced sufficient immune responses in nearly all vaccinees.

  4. Treatment of intrabony pockets with Emdogain: results at 36 months.

    PubMed

    Parodi, Renato; Santarelli, Giorgio A E; Gasparetto, Bruno

    2004-02-01

    This study reports the results obtained 36 months after treating deep periodontal defects with amelogenins. Results at 12 months have already been published. Sixteen of 21 patients completed the 3-year recall program. This study confirms after 3 years the results obtained at 1 year: Probing pocket depth decreased from 7.87 +/- 2.03 mm to 2.93 +/- 2.19 mm; recession increased from 2.20 +/- 1.42 mm to 2.93 +/- 1.87 mm; and attachment level decreased from 10.07 +/- 2.28 to 5.87 +/- 2.59 mm. No statistically significant difference was found between the data collected at 12 and 36 months. The standardized radiographs, digitized and analyzed with purpose-developed software, did not show any appreciable increase in bone volume, but only improved mineralization of the preexisting bone after 3 years using Emdogain without grafts.

  5. Bilingual Children with Primary Language Impairment: 3 Months after Treatment

    ERIC Educational Resources Information Center

    Pham, Giang; Ebert, Kerry Danahy; Kohnert, Kathryn

    2015-01-01

    Background: Evidence on the treatment effectiveness for bilingual children with primary language impairment (PLI) is needed to advance both theory and clinical practice. Of key interest is whether treatment effects are maintained following the completion of short-term intense treatments. Aims: To investigate change in select language and cognitive…

  6. Bilingual Children with Primary Language Impairment: 3 Months after Treatment

    ERIC Educational Resources Information Center

    Pham, Giang; Ebert, Kerry Danahy; Kohnert, Kathryn

    2015-01-01

    Background: Evidence on the treatment effectiveness for bilingual children with primary language impairment (PLI) is needed to advance both theory and clinical practice. Of key interest is whether treatment effects are maintained following the completion of short-term intense treatments. Aims: To investigate change in select language and cognitive…

  7. Low Rates of Treatment Failure in Children Aged 2–59 Months Treated for Severe Pneumonia: A Multisite Pooled Analysis

    PubMed Central

    Fox, Matthew P.; Thea, Donald M.; Sadruddin, Salim; Bari, Abdul; Bonawitz, Rachael; Hazir, Tabish; Bin Nisar, Yasir; Qazi, Shamim A.

    2013-01-01

    Background. Despite advances in childhood pneumonia management, it remains a major killer of children worldwide. We sought to estimate global treatment failure rates in children aged 2–59 months with World Health Organization–defined severe pneumonia. Methods. We pooled data from 4 severe pneumonia studies conducted during 1999–2009 using similar methodologies. We defined treatment failure by day 6 as death, danger signs (inability to drink, convulsions, abnormally sleepy), fever (≥38°C) and lower chest indrawing (LCI; days 2–3), LCI (day 6), or antibiotic change. Results. Among 6398 cases of severe pneumonia from 10 countries, 564 (cluster adjusted: 8.5%; 95% confidence interval [CI], 5.9%–11.5%) failed treatment by day 6. The most common reasons for clinical failure were persistence of fever and LCI or LCI or fever alone (75% of failures). Seventeen (0.3%) children died. Danger signs were uncommon (<1%). Infants 6–11 months and 2–5 months were 2- and 3.5-fold more likely, respectively, to fail treatment (adjusted OR [AOR], 1.8 [95% CI, 1.4–2.3] and AOR, 3.5 [95% CI, 2.8–4.3]) as children aged 12–59 months. Failure was increased 7-fold (AOR, 7.2 [95% CI, 5.0–10.5]) when comparing infants 2–5 months with very fast breathing to children 12–59 months with normal breathing. Conclusions. Our findings demonstrate that severe pneumonia case management with antibiotics at health facilities or in the community is associated with few serious morbidities or deaths across diverse geographic settings and support moves to shift management of severe pneumonia with oral antibiotics to outpatients in the community. PMID:23264361

  8. Electrochemical evaluation of the effect of heat treatment and stress on the corrosion characteristics of 7050 aluminum in 3. 5% NaCl solution

    SciTech Connect

    Glass, R.S.; Estill, J.C.

    1985-11-01

    Potentiodynamic polarization curves have been used to evaluate (in a survey mode) the effect of heat treatment and stress on the corrosion behavior of 7050-XX aluminum in deaerated 3.5% NaCl solutions. Specimens, which were machined from extruded ring material, were examined in the as-received condition and following heat treatment at 580/sup 0/F for 0.5 min. The stress levels used in this study ranged from 40 to 90% of the 0.2% offset yield strength. Results indicate that within this stress range, using the given experimental method, medium, and timescales, that there is no significant trend for the effect of stress on the electrochemical-corrosion behavior for the materials examined. The heat-treated specimens have lower uniform corrosion rates than the as-received forms, but are more susceptible to pitting. However, pitting is not spontaneous for either material in this environment. In addition to investigating the variables of stress and heat treatment, we have also compared the behavior of specimens machined from three different orientations within extruded ring material. Generally, the longitudinal and circumferentially oriented specimens were more similar electrochemically than specimens obtained from the radial orientation. The radial specimens generally showed lower uniform corrosion rates and appeared to be less susceptible to pitting.

  9. Efficacy of Slimming Cream Containing 3.5% Water-Soluble Caffeine and Xanthenes for the Treatment of Cellulite: Clinical Study and Literature Review

    PubMed Central

    Byun, Sang-Young; Kwon, Soon-Hyo; Heo, Su-Hak; Shim, Jae-Seong; Du, Mi-Hee

    2015-01-01

    Background Cellulite is a 'cottage cheese-like' cutaneous change caused by subcutaneous fat bulging into the dermis that usually leads to cosmetic problems. Slimming cream containing 3.5% water-soluble caffeine and xanthenes exhibits a lipolytic effect with penetration into the dermis. Objective To evaluate the efficacy and safety of slimming cream for the treatment of cellulite. Methods Fifteen subjects with cellulite applied slimming cream to the thighs and inner side of the upper arms twice daily for 6 weeks. Efficacy was assessed using a standard visual scale, changes in the circumferences of the thighs and upper arms, and patient satisfaction by a questionnaire at baseline, week 3, and week 6. Safety was assessed by inquiring about adverse events through questionnaires. Results The standard visual scale score improved significantly by 0.49 points (19.8%) at week 6. Thigh and upper-arm circumferences decreased by 0.7 cm (1.7%) and 0.8 cm (2.3%), respectively, at week 6. Slight itching and transient flushing were commonly reported, but no serious adverse event occurred. Conclusion The slimming cream tested appears to be effective for the treatment of cellulitis without serious adverse effects. However, additional large clinical trials are required to confirm the efficacy and safety of slimming cream for the treatment of cellulitis. PMID:26082579

  10. Sub-micrometre holotomographic characterisation of the effects of solution heat treatment on an AlMg7.3Si3.5 alloy

    PubMed Central

    Tolnai, D.; Requena, G.; Cloetens, P.; Lendvai, J.; Degischer, H.P.

    2012-01-01

    A strip cast AlMg7.3Si3.5 alloy is investigated by sub-micrometre holotomographic analysis achieving a voxel size of (60 nm)3 by cone beam magnification of the focused synchrotron beam using Kirkpatrick–Baez mirrors. The three-dimensional microstructure of the same specimen volume in the as-cast state is compared with that after exposure to 540 °C for 30 min resolving microstructural features down to 180 nm. The three-dimensional analysis of the architecture of the eutectic Mg2Si and the Fe-aluminides reveals how the as-cast microstructure changes during the solution treatment. The alloy in the as-cast condition contains a highly interconnected seaweed-like Mg2Si eutectic. The level of three-dimensional interconnectivity of the Mg2Si eutectic phase decreases by only partial disintegration during the heat treatment correcting the two-dimensional metallographic impression of isolated round particles. Statistical analyses of the particle distribution, sphericity, mean curvatures and Gaussian curvatures describe quantitatively the architectural changes of the Mg2Si phase. This explains the decrease of the high temperature strength of the alloy by the solution treatment tested in hot compression. PMID:23483521

  11. Efficacy of Slimming Cream Containing 3.5% Water-Soluble Caffeine and Xanthenes for the Treatment of Cellulite: Clinical Study and Literature Review.

    PubMed

    Byun, Sang-Young; Kwon, Soon-Hyo; Heo, Su-Hak; Shim, Jae-Seong; Du, Mi-Hee; Na, Jung-Im

    2015-06-01

    Cellulite is a 'cottage cheese-like' cutaneous change caused by subcutaneous fat bulging into the dermis that usually leads to cosmetic problems. Slimming cream containing 3.5% water-soluble caffeine and xanthenes exhibits a lipolytic effect with penetration into the dermis. To evaluate the efficacy and safety of slimming cream for the treatment of cellulite. Fifteen subjects with cellulite applied slimming cream to the thighs and inner side of the upper arms twice daily for 6 weeks. Efficacy was assessed using a standard visual scale, changes in the circumferences of the thighs and upper arms, and patient satisfaction by a questionnaire at baseline, week 3, and week 6. Safety was assessed by inquiring about adverse events through questionnaires. The standard visual scale score improved significantly by 0.49 points (19.8%) at week 6. Thigh and upper-arm circumferences decreased by 0.7 cm (1.7%) and 0.8 cm (2.3%), respectively, at week 6. Slight itching and transient flushing were commonly reported, but no serious adverse event occurred. The slimming cream tested appears to be effective for the treatment of cellulitis without serious adverse effects. However, additional large clinical trials are required to confirm the efficacy and safety of slimming cream for the treatment of cellulitis.

  12. Nine Months of Multicomponent Behavioral Treatment for ADHD and Effectiveness of MTA Fading Procedures

    ERIC Educational Resources Information Center

    Arnold, L. Eugene; Chuang, Shirley; Davies, Mark; Abikoff, Howard B.; Conners, C. Keith; Elliott, Glen R.; Greenhill, Laurence L.; Hechtman, Lily; Hinshaw, Stephen P.; Hoza, Betsy; Jensen, Peter S.; Kraemer, Helena C.; Langworthy-Lam, Kristen S.; March, John S.; Newcorn, Jeffrey H.; Pelham, William E.; Severe, Joanne B.; Swanson, James M.; Vitiello, Benedetto; Wells, Karen C.; Wigal, Timothy

    2004-01-01

    We examined 9-month data from the 14-month NIMH Multimodal Treatment Study of Children with ADHD (the MTA) as a further check on the relative effect of medication (MedMgt) and behavioral treatment (Beh) for attention-deficit/hyperactivity disorder (ADHD) while Beh was still being delivered at greater intensity than at 14-month endpoint, and…

  13. 3,3',5-Triiodo-L-thyronine-like activity in effluents from domestic sewage treatment plants detected by in vitro and in vivo bioassays

    SciTech Connect

    Murata, Tomonori; Yamauchi, Kiyoshi

    2008-02-01

    Thyroid system-disrupting activity in effluents from municipal domestic sewage treatment plants was detected using three in vitro assays and one in vivo assay. Contaminants in the effluents were extracted by solid-phase extraction (SPE) and eluted stepwise with different organic solvents. The majority of the thyroid system-disrupting activity was detected in the dichloromethane/methanol (1/1) fraction after SPE in all three in vitro assays: competitive assays of 3,3',5-[{sup 125}I]triiodo-L-thyronine ([{sup 125}I]T{sub 3}) binding to the plasma protein transthyretin (TTR assay) and thyroid hormone receptor (TR assay) and T{sub 3}-dependent luciferase assay (Luc assay). Subsequent reverse-phase high-performance liquid chromatography (RP-HPLC) of the dichloromethane/methanol (1/1) fraction separated contaminants potent in the TR and Luc assays from those potent in the TTR assay. The contaminants potent in the TR and Luc assays were also potent in an in vivo short-term gene expression assay in Xenopus laevis (Tadpole assay). The present study demonstrated that the effluents from domestic sewage treatment plants contain contaminants with T{sub 3}-like activity of {approx} 10{sup -10} M T{sub 3}-equivalent concentration (T{sub 3}EQ) and that the TR and Luc assays are powerful in vitro bioassays for detecting thyroid system-disrupting activity in effluents. The availability and applicability of these bioassays for screening contaminants with thyroid system-disrupting activity in the water environment are discussed.

  14. In vitro and in vivo evaluation of resveratrol and 3,5-dihydroxy-4′-acetoxy-trans-stilbene in the treatment of human prostate carcinoma and melanoma

    PubMed Central

    Osmond, Gregory W.; Masko, Elizabeth M.; Tyler, Douglas S.; Freedland, Stephen J.; Pizzo, Salvatore

    2013-01-01

    Background Resveratrol (RESV) is a naturally occurring compound that may possess anti-cancer capabilities in both prostate carcinoma and melanoma. Methods The in vitro and in vivo cytotoxic activity of RESV and 3,5-dihydroxy-4′-acetoxy-trans-stilbene (4-ACE) was tested using cellular assays and a xenograft model. Five prostate carcinoma cell lines were used for in vitro evaluation. A melanoma cell line (Duke melanoma 738 [DM738]) and the prostate carcinoma line CWR22 were used for in vivo experiments. Mice were randomized to osmotic mini pumps with 200 μL of RESV (250 mg/mL), 4-ACE (335 mg/mL), or vehicle (50% dimethyl sulfoxide, 50% polyethylene glycol). Serum drug and metabolite levels were calculated by high-performance liquid chromatography with diode-array detection. Western blots were performed on treated tumors. Results were analyzed using a student’s t-test, analysis of variance, and the Mann–Whitney rank sum test. Results RESV and 4-ACE were cytotoxic in a time- and dose-dependent manner in all prostate carcinoma cell lines tested. Enhanced growth compared with controls was seen at the 24 h time point in four lines treated with RESV and two lines treated with 4-ACE (Ps < 0.048). In vivo, no difference in either tumor growth or postmortem tumor weight was detected in either DM738 (P = 0.555, P = 0.562) or CWR22 (P = 0.166, P = 0.811) xenografts treated with either drug. Serum drug levels did not correlate with tumor growth rates for any treatment group (all Ps > 0.11). Treated tumors demonstrated protein changes by western blot. Conclusion Although in vitro data were promising, RESV and 4-ACE have limited potential as single agents in the treatment of prostate carcinoma and melanoma. PMID:22482756

  15. Critical appraisal of 3-monthly paliperidone depot injections in the treatment of schizophrenia

    PubMed Central

    Carpiniello, Bernardo; Pinna, Federica

    2016-01-01

    Aims Three-monthly injections of paliperidone palmitate (PP-3M) represent a new and recently introduced long-acting antipsychotic therapeutic option. This review focuses on available data relating to the efficacy and safety of PP-3M and its position in the current therapeutic scenario. Method An analysis of PubMed, Scopus, and ISI Web of Knowledge databases was conducted, and all available papers on PP-3M, including poster presentations, were selected and considered for the purpose of the present review. Findings: to date, three full papers have been published, the first, a Phase 1 randomized, open label study investigating the pharmacokinetics, safety, and tolerability of the drug; the second, a Phase 3 double blind study vs placebo focusing on efficacy and tolerability; and the last relating to the practical use of PP-3M. The five posters identified describe data reported in the above-cited papers. Overall, the pharmacokinetic findings obtained in these studies highlight the feasibility of administering PP-3M on a 3-monthly basis, subsequent to the administration of four 1-monthly injections of PP at doses 3.5 times higher than the stabilized dose of 1-monthly injections of PP (ie, 175, 300, 450, and 525 mgs). The published studies highlight a significantly longer time to relapse compared to placebo, and significantly better results compared to placebo for all secondary end-points (Positive and Negative Syndrome Scale, Clinical Global Impression-Severity Scale, Personal and Social Performance Scale scores), in addition to reasonably good safety and tolerability profiles. Conclusion PP-3M emerges as a potential candidate for use as a first-line long-acting agent in the maintenance treatment of patients with schizophrenia. Further studies should however be conducted to confirm this expectation. In view of its efficacy, tolerability, and safety, together with the longer timespan between injections, PP-3M currently represents one of the best available options, and

  16. Shortening Treatment in Adults with Noncavitary Tuberculosis and 2-Month Culture Conversion

    PubMed Central

    Johnson, John L.; Hadad, David Jamil; Dietze, Reynaldo; Noia Maciel, Ethel Leonor; Sewali, Barrett; Gitta, Phineas; Okwera, Alphonse; Mugerwa, Roy D.; Alcaneses, Mary Rose; Quelapio, Maria Imelda; Tupasi, Thelma E.; Horter, Libby; Debanne, Sara M.; Eisenach, Kathleen D.; Boom, W. Henry

    2009-01-01

    Rationale: Cavitary disease and delayed culture conversion have been associated with relapse. Combining patient characteristics and measures of bacteriologic response might allow treatment shortening with current drugs in some patients. Objectives: To assess whether treatment could be shortened from 6 to 4 months in patients with noncavitary tuberculosis whose sputum cultures converted to negative after 2 months. Methods: This study was a randomized, open-label equivalence trial. HIV-uninfected adults with noncavitary tuberculosis were treated daily with isoniazid, rifampin, pyrazinamide, and ethambutol for 2 months, followed by 2 months of isoniazid and rifampin. After 4 months, patients with drug-susceptible TB whose sputum cultures on solid media were negative after 8 weeks of treatment were randomly assigned to continue treatment for 2 more months or to stop treatment. Patients were followed for relapse for 30 months after beginning treatment. Measurements and Main Results: Enrollment was stopped by the safety monitoring committee after 394 patients were enrolled due to apparent increased risk for relapse in the 4-month arm. A total of 370 patients were eligible for per protocol analysis. Thirteen patients in the 4-month arm relapsed, compared with three subjects in the 6-month arm (7.0 vs. 1.6%; risk difference, 0.054; 95% confidence interval with Hauck-Anderson correction, 0.01–0.10). Conclusion: Shortening treatment from 6 to 4 months in adults with noncavitary disease and culture conversion after 2 months using current drugs resulted in a greater relapse rate. The combination of noncavitary disease and 2-month culture conversion was insufficient to identify patients with decreased risk for relapse. PMID:19542476

  17. 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…

  18. 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…

  19. Six-Month Response to Delamanid Treatment in MDR TB Patients.

    PubMed

    Hewison, Cathy; Ferlazzo, Gabriella; Avaliani, Zaza; Hayrapetyan, Armen; Jonckheere, Sylvie; Khaidarkhanova, Zarema; Mohr, Erika; Sinha, Animesh; Skrahina, Alena; Vambe, Debrah; Vasilyeva, Irina; Lachenal, Nathalie; Varaine, Francis

    2017-10-01

    Delamanid, recently available for the treatment of multidrug-resistant tuberculosis (MDR TB), has had limited use outside clinical trials. We present the early treatment results for 53 patients from 7 countries who received a delamanid-containing treatment for MDR TB. Results show good tolerability and treatment response at 6 months.

  20. Ranibizumab 0.5 mg for Diabetic Macular Edema with Bimonthly Monitoring after a Phase of Initial Treatment: 18-Month, Multicenter, Phase IIIB RELIGHT Study.

    PubMed

    Pearce, Ian; Banerjee, Sanjiv; Burton, Ben J L; Chakravarthy, Usha; Downey, Louise; Gale, Richard P; Gibson, Jonathan; Pagliarini, Sergio; Patel, Jignesh; Sivaprasad, Sobha; Andrews, Chris; Brittain, Christopher; Warburton, James

    2015-09-01

    To evaluate ranibizumab 0.5 mg using bimonthly monitoring and individualized re-treatment after monthly follow-up for 6 months in patients with visual impairment due to diabetic macular edema (DME). A phase IIIb, 18-month, prospective, open-label, multicenter, single-arm study in the United Kingdom. Participants (N = 109) with visual impairment due to DME. Participants received 3 initial monthly ranibizumab 0.5 mg injections (day 0 to month 2), followed by individualized best-corrected visual acuity (BCVA) and optical coherence tomography-guided re-treatment with monthly (months 3-5) and subsequent bimonthly follow-up (months 6-18). Laser was allowed after month 6. Mean change in BCVA from baseline to month 12 (primary end point), mean change in BCVA and central retinal thickness (CRT) from baseline to month 18, gain of ≥10 and ≥15 letters, treatment exposure, and incidence of adverse events over 18 months. Of 109 participants, 100 (91.7%) and 99 (90.8%) completed the 12 and 18 months of the study, respectively. The mean age was 63.7 years, the mean duration of DME was 40 months, and 77.1% of the participants had received prior laser treatment (study eye). At baseline, mean BCVA was 62.9 letters, 20% of patients had a baseline BCVA of >73 letters, and mean baseline CRT was 418.1 μm, with 32% of patients having a baseline CRT <300 μm. The mean change in BCVA from baseline to month 6 was +6.6 letters (95% confidence interval [CI], 4.9-8.3), and after institution of bimonthly treatment the mean change in BCVA at month 12 was +4.8 letters (95% CI, 2.9-6.7; P < 0.001) and +6.5 letters (95% CI, 4.2-8.8) at month 18. The proportion of participants gaining ≥10 and ≥15 letters was 24.8% and 13.8% at month 12 and 34.9% and 19.3% at month 18, respectively. Participants received a mean of 6.8 and 8.5 injections over 12 and 18 months, respectively. No new ocular or nonocular safety findings were observed during the study. The BCVA gain achieved in the initial 6-month

  1. Botulinum toxin in the treatment of trigeminal neuralgia: 6-Month follow-up.

    PubMed

    Türk Börü, Ülkü; Duman, Arda; Bölük, Cem; Coşkun Duman, Sanem; Taşdemir, Mustafa

    2017-09-01

    Botulinum toxin type-A (BTX-A) has been successfully utilized to treat trigeminal neuralgia. In this study, through the use of a new technique, the efficacy of the injection of BTX-A to the maxillary and mandibular nerves was evaluated. A total of 27 patients were injected with 100 Units of BTX-A to the maxillary and mandibular nerves. Visual analogue scale score and pain frequency were assessed before treatment and at the first week, second month, and sixth month after treatment. Patients with ≥50% reduction in mean pain score at the second and sixth month were defined as responders. A total of 27 patients were included in the study. BTX-A significantly reduced pain intensity and pain attack frequency at the first week, second month, and sixth month after treatment. At the second month, 74.1% of patients, at the sixth month, 88.9% of patients responded to treatment. Forty-four percent of patients did not experience any pain at the sixth month. The mean recurrence period was 87.7 ± 20.4. BTX-A was well tolerated and showed few treatment-related adverse events. Injection to the maxillary and mandibular roots seems to be a highly effective method. In the event of recurrence, after each injection, the pain severity and attack frequency decreased.

  2. Pivotal Response Treatment Parent Training for Autism: Findings from a 3-Month Follow-Up Evaluation

    ERIC Educational Resources Information Center

    Gengoux, Grace W.; Berquist, Kari L.; Salzman, Emma; Schapp, Salena; Phillips, Jennifer M.; Frazier, Thomas W.; Minjarez, Mendy B.; Hardan, Antonio Y.

    2015-01-01

    This study's objective was to assess maintenance of treatment effects 3 months after completion of a 12-week Pivotal Response Treatment (PRT) parent education group. Families who completed the active treatment (N = 23) were followed for an additional 12 weeks to measure changes in language and cognitive skills. Results indicated a significant…

  3. Pivotal Response Treatment Parent Training for Autism: Findings from a 3-Month Follow-Up Evaluation

    ERIC Educational Resources Information Center

    Gengoux, Grace W.; Berquist, Kari L.; Salzman, Emma; Schapp, Salena; Phillips, Jennifer M.; Frazier, Thomas W.; Minjarez, Mendy B.; Hardan, Antonio Y.

    2015-01-01

    This study's objective was to assess maintenance of treatment effects 3 months after completion of a 12-week Pivotal Response Treatment (PRT) parent education group. Families who completed the active treatment (N = 23) were followed for an additional 12 weeks to measure changes in language and cognitive skills. Results indicated a significant…

  4. Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study.

    PubMed

    Fleischhacker, W Wolfgang; Sanchez, Raymond; Perry, Pamela P; Jin, Na; Peters-Strickland, Timothy; Johnson, Brian R; Baker, Ross A; Eramo, Anna; McQuade, Robert D; Carson, William H; Walling, David; Kane, John M

    2014-08-01

    Long-acting injectable formulations of antipsychotics are treatment alternatives to oral agents. To assess the efficacy of aripiprazole once-monthly compared with oral aripiprazole for maintenance treatment of schizophrenia. A 38-week, double-blind, active-controlled, non-inferiority study; randomisation (2:2:1) to aripiprazole once-monthly 400 mg, oral aripiprazole (10-30 mg/day) or aripiprazole once-monthly 50 mg (a dose below the therapeutic threshold for assay sensitivity). ( clinicaltrials.gov, NCT00706654.) A total of 1118 patients were screened, and 662 responders to oral aripiprazole were randomised. Kaplan-Meier estimated impending relapse rates at week 26 were 7.12% for aripiprazole once-monthly 400 mg and 7.76% for oral aripiprazole. This difference (-0.64%, 95% CI -5.26 to 3.99) excluded the predefined non-inferiority margin of 11.5%. Treatments were superior to aripiprazole once-monthly 50 mg (21.80%, P < or = 0.001). Aripiprazole once-monthly 400 mg was non-inferior to oral aripiprazole, and the reduction in Kaplan-Meier estimated impending relapse rate at week 26 was statistically significant v. aripiprazole once-monthly 50 mg. Royal College of Psychiatrists.

  5. N-Methylprotoporphyrin IX: chemical synthesis and identification as the green pigment produced by 3,5-diethoxycarbonyl-1,4-dihydrocollidine treatment.

    PubMed Central

    Ortiz de Montellano, P R; Beilan, H S; Kunze, K L

    1981-01-01

    The hepatic pigment accumulated in 3,5-diethoxycarbonyl-1,4-dihydrocollidine-treated rats, which has been reported to inhibit ferrochelatase, has been isolated and purified. The pigment has been resolved into one major, one minor, and two trace components, all of which appear to be isomeric porphyrins. The major fraction has been unambiguously identified by spectroscopic methods as the isomer of N-methylprotoporphyrin IX (isolated as the dimethyl ester) in which vinyl-substituted pyrrole ring A is methylated. The minor product appears to be an isomer of the same porphyrin with the N-methyl group on propionic acid-substituted ring C, and the trace components have the same high-pressure liquid chromatography retention times as the other two possible isomers of the porphyrin. The four isomers of N-methylprotoporphyrin IX have been chemically synthesized, independently characterized, and used to confirm the structures of the biologically products. PMID:6940170

  6. Nightguard vital bleaching of tetracycline-stained teeth: 90 months post treatment.

    PubMed

    Leonard, Ralph H; Van Haywood, B; Caplan, Daniel J; Tart, Natile D

    2003-01-01

    The purpose of this longitudinal whitening study was to determine the stability, post-treatment side effects, and patient satisfaction at 90 months post treatment after 6 months of active treatment of tetracycline-stained teeth with 10% carbamide peroxide. Fifteen of 21 participants enrolled in the study (71%) were contacted and asked to participate in a survey concerning their whitening experience. Participants were asked whether there had been any change in the shade of their teeth after treatment and if they had experienced any side effects that they believed were treatment related. Eight of the 15 participated in a clinical examination. Nine participants (60%) reported no obvious shade change or only a slight darkening not noticed by others. None reported darkening back to the original shade; however, four had re-treated their teeth. Examiners were in agreement with the participants' perception of shade change upon comparing pretreatment and post-treatment photographs and Vita shade (Vita Zahnfabrik D-79713, Bad Sackingen, Germany) values. The degree of improvement over the pretreatment shade was significant for the 90-month post-treatment shade (p < .01). All respondents (n = 15) denied having to have a crown or root canal or tooth sensitivity that they believed was treatment related. The results of this study of nightguard vital bleaching indicate that tetracycline-stained teeth can be whitened successfully using extended treatment time and that shade stability may last at least 90 months post treatment (range 84-100 mo). Patients participating in this study were over-whelmingly positive about the procedure in terms of shade retention and lack of post-treatment side effects.

  7. Nightguard vital bleaching of tetracycline-stained teeth: 54 months post treatment.

    PubMed

    Leonard, R H; Haywood, V B; Eagle, J C; Garland, G E; Caplan, D J; Matthews, K P; Tart, N D

    1999-01-01

    The purpose of this longitudinal whitening study was to determine the stability, post-treatment side effects, and patient satisfaction after 6 months of active treatment of tetracycline-stained teeth with 10% carbamide peroxide at 0 and 54 months post treatment. Twelve patients who completed the study (80%) were contacted and asked to participate in a survey concerning their whitening experience. Subjects were asked whether there had been any change in the shade of their teeth after treatment, and if they had experienced any side effects that they believed were treatment-related. Eight of the twelve patients underwent clinical examination. Ten patients (83%) reported no obvious shade change or only a slight darkening not noticed by others. Two (17%) reported a slight darkening that is probably noticeable by other people, but no one reported moderate darkening or significant darkening back to original shade. All respondents (n = 12) denied having to have a crown or root canal that they believed was treatment-related. Examiners who compared preoperative and post-treatment photographs and Vita shade values were in agreement with the patient's perceptions of shade change. The degree of improvement was significant for both the immediate (0 mo) and the 54-month post-treatment comparison with the pretreatment shade (p < .005 and p < .01 respectively). Results of this nightguard vital bleaching study indicate that tetracycline-stained teeth can be whitened successfully using extended treatment time, and that shade stability may last at least 54 months after treatment. Patients who participated in this study were overwhelmingly positive about the procedure in terms of shade retention and lack of post-treatment side effects.

  8. Evaluation of anxiety level changes during the first three months of orthodontic treatment.

    PubMed

    Yıldırım, Ersin; Karacay, Seniz

    2012-08-01

    To determine the changes in dental anxiety, state anxiety, and trait anxiety levels of patients and their parents after 3 months of active orthodontic treatment. We evaluated 120 patients and one parent of each patient. State Anxiety (STAI-S), Trait Anxiety (STAI-T), and Corah's Dental Anxiety Scale (DAS) were administered before orthodontic treatment (T1) and after 3 months of treatment (T2). Differences in scores between T1 and T2 were compared using paired-sample t-tests and the relationship between the scores of the DAS and the STAI were analyzed using a bivariate two-tailed Pearson correlation test. Dental anxiety and state anxiety levels decreased among the patients after adjustment to orthodontic treatment (p < 0.001). However, 3 months of treatment was not sufficient to decrease the anxiety levels of parents (p > 0.05). Patient trait anxiety affected patient state anxiety and dental anxiety (p < 0.01). Additionally, a significant correlation was found between patient dental anxiety and parent dental anxiety (p < 0.05). Dental anxiety and state anxiety levels decrease after patients become familiar with their orthodontist and they became accustomed to orthodontic treatment. However, 3 months is not a sufficient length of time to decrease parental anxiety levels.

  9. Intravitreal bevacizumab as primary treatment for retinal angiomatous proliferation: twelve-month results.

    PubMed

    Gharbiya, Magda; Allievi, Francesca; Recupero, Vincenzo; Martini, Delia; Mazzeo, Luigi; Gabrieli, Corrado Balacco

    2009-06-01

    To evaluate the short-term efficacy and safety of intravitreal bevacizumab for the treatment of retinal angiomatous proliferation. Seventeen eyes from 16 patients with newly diagnosed retinal angiomatous proliferation underwent intravitreal injections of bevacizumab, 1.25 mg. The patients were scheduled for three monthly bevacizumab injections. Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity, central macular thickness on optical coherence tomography, and fluorescein angiographic findings were examined before and after treatment. Patients were followed-up for 12 months. The mean best-corrected visual acuity (+/- standard deviation [SD]) at baseline was 39.53 (+/-10.40) letters (Snellen equivalent: 20/42). At 12 months after treatment the mean best-corrected visual acuity (+/-SD) improved significantly (P = 0.0000001) to 47.88 (+/-11.78) letters (Snellen equivalent: 20/28). Best-corrected visual acuity improved 3 ETDRS lines or more in 3 (17.65%) of 17 treated eyes, 14 (82.35%) eyes were stable, and 15 (88.23%) eyes gained 1 or more ETDRS lines. The mean central macular thickness (+/-SD) at baseline was 297 (+/-60.72) microm. At 12 months after treatment, the mean central macular thickness (+/-SD) reduced significantly (P = 0.00001) to 237 (+/-28.80) microm. At the 12-month follow-up, absence of fluorescein leakage was demonstrated in 14 (82%) of 17 treated eyes. No ocular or systemic adverse effects from treatment were encountered. The 12-month results of intravitreal bevacizumab for retinal angiomatous proliferation are very promising with no apparent short-term safety concerns. Treated eyes had a significant functional and anatomical improvement. Further studies will be needed to better determine long-term efficacy and safety.

  10. 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

  11. 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.

  12. Pivotal Response Treatment Parent Training for Autism: Findings from a 3-Month Follow-Up Evaluation.

    PubMed

    Gengoux, Grace W; Berquist, Kari L; Salzman, Emma; Schapp, Salena; Phillips, Jennifer M; Frazier, Thomas W; Minjarez, Mendy B; Hardan, Antonio Y

    2015-09-01

    This study's objective was to assess maintenance of treatment effects 3 months after completion of a 12-week Pivotal Response Treatment (PRT) parent education group. Families who completed the active treatment (N = 23) were followed for an additional 12 weeks to measure changes in language and cognitive skills. Results indicated a significant improvement in frequency of functional utterances, with maintenance at 3-month follow-up [F(2, 21): 5.9, p = .009]. Children also made significant gains on the Vineland Communication Domain Standard Score [F(2, 12):11.74, p = .001] and the Mullen Scales of Early Learning Composite score [F(1, 20) = 5.43, p = .03]. These results suggest that a brief PRT parent group intervention can lead to improvements in language and cognitive functioning that are maintained 12 weeks post treatment.

  13. Should routine pelvic osteotomy be added to the treatment of DDH after 18 months?

    PubMed

    Arslan, Hüseyin; Sucu, Ekim; Ozkul, Emin; Gem, Mehmet; Kişin, Biülent

    2014-06-01

    The treatment of developmental dysplasia of the hip (DDH) between ages 1-3 years is controversial. Particularly controversial is the age after which pelvic osteotomy should be added to the treatment. In the present study, the outcomes of DDH patients aged 1-3 years treated with anterior open reduction alone were evaluated, and the relationship between inadequate acetabular development, the need for secondary pelvic osteotomy, and age was investigated. A total of 53 patients (70 hips) who had begun walking, who had undergone open reduction through an anterolateral approach, who had a follow-up period of at least 2 years, and who had Tönnis grade III and IV hip dysplasia were included in the study. They were grouped according to treatment age (pre-18 months: Group I; post-18 months: Group II), and the two groups were compared with regard to radiological and functional outcomes and the need for a secondary acetabular procedure. In Group I there were 29 hips (mean age: 16.09 months) and in group II there were 41 hips (mean age: 23.1 months), and the mean follow-up period was 48.9 months. According to the modified Trevor score, in Group I outcomes were excellent in 23 hips (79.3%) and good in 6 hips (20.7%), while in group II outcomes were excellent in 30 hips (73.2%), good in 10 hips (24.4%), and fair in 1 hip (2.1%). The difference between outcomes was not significant (P > 0.05). Inadequate acetabular development was determined in 11 hips in group I (37.9%) and in 16 hips in group II (39%). There was no difference between groups in terms of inadequate acetabular development or the need for acetabular prodecures (p > 0.05). No significant difference was determined between DDH patients treated before 18 months and those treated after 18 months with regard to unsatisfactory acetabular development or the need for secondary acetabular procedures. According to these results, reduction prior to 18 months does not always achieve satisfactory acetabular development, and

  14. Lasting immune memory against hepatitis B following challenge 10-11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11-12 months of age.

    PubMed

    Avdicova, Mária; Crasta, Priya D; Hardt, Karin; Kovac, Martina

    2015-05-28

    The combined hexavalent diphtheria-tetanus-pertussis-hepatitis B-inactivated poliomyelitis - Haemophilus influenzae type b conjugate vaccine (Infanrix hexa™; DTPa-HBV-IPV/Hib: GlaxoSmithKline Vaccines) induces robust responses to the HBV component when administered at 3, 5 and 11-12 months of age. We assessed long term HBV antibody persistence 10-11 years after primary vaccination in infancy. Antibody persistence and immune memory were assessed post-primary vaccination at 3, 5, 11-12 months with DTPa-HBV-IPV/Hib, or monovalent HBV vaccine (Engerix™ B, GlaxoSmithKline Vaccines) co-administered with DTPa-IPV/Hib (Infanrix™-IPV/Hib, GlaxoSmithKline Vaccines) in 185 children aged 11-12 years. Blood samples were collected before and 1 month after a challenge dose of Engerix™ B (10μg dose). 10-11 years after primary vaccination the percentage of subjects with persisting anti-HBs antibody concentrations ≥10mIU/ml was 48.4% in the DTPa-HBV-IPV/Hib group and 58.4% in the DTPa-IPV/Hib+HBV group. After the HBV challenge dose, the percentage with anti-HBs ≥100mIU/ml increased from 14.7% to 93.6% in the DTPa-HBV-IPV/Hib group and 19.1% to 94.4% in the DTPa-IPV/Hib+HBV group. Anti-HBs GMCs increased by at least 187-fold in each group. An anamnestic response (≥4-fold increase in initially seropositive or anti-HBs concentration ≥10mIU/ml in initially seronegative subjects) was observed in 96.8% and 96.6% of subjects in the DTPa-HBV-IPV/Hib and DTPa-IPV/Hib+HBV groups, respectively. No serious adverse events occurred that were considered related to challenge vaccination. Administration of HBV as part of a combination vaccine or as a monovalent vaccine induced long lasting immune memory against HBV in children primed at 3, 5 and 11 months of age. Antibody persistence and immune memory were similar, suggesting that protection afforded by DTPa-HBV-IPV/Hib and monovalent HBV vaccines, is likely to be of similar duration. The administration of HBV challenge dose 10

  15. AMS INSIGHT--absorbable metal stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis.

    PubMed

    Bosiers, Marc; Peeters, Patrick; D'Archambeau, Olivier; Hendriks, Jeroen; Pilger, Ernst; Düber, Christoph; Zeller, Thomas; Gussmann, Andreas; Lohle, Paul N M; Minar, Erich; Scheinert, Dierk; Hausegger, Klaus; Schulte, Karl-Ludwig; Verbist, Jürgen; Deloose, Koen; Lammer, J

    2009-05-01

    Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients "crossed over" to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (>50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of <15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower (p = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels.

  16. Survivorship After Prostate Cancer Treatment: Spouses’ Quality of Life at 36 Months

    PubMed Central

    Harden, Janet; Sanda, Martin G.; Wei, John Thomas; Yarandi, Hossein N.; Hembroff, Larry; Hardy, Jill; Northouse, Laurel

    2014-01-01

    Purpose/Objectives: To determine the long-term effects of prostate cancer treatment on spouse quality of life (QOL) at 36 months following treatment. Design: Descriptive-exploratory; community-based study. Setting: Telephone interviews. Sample: 95 female spouses of men treated for early-stage prostate cancer. Methods: A computer-assisted telephone interview was used to evaluate QOL among spouses of prostate cancer survivors at 36 months after initial prostate cancer treatment. Main Research Variables: Quality of life, dyadic adjustment, sexual satisfaction, appraisal of caregiving, and demographic information. Findings: Spouses who had more negative appraisal of caregiving had lower sexual satisfaction, poorer cancer-specific QOL, and poorer mental QOL. Spouses who perceived bother related to the patient’s sexual or hormone function reported more threatening appraisals of caregiving, less sexual satisfaction, and poorer QOL. Conclusions: Spouses continued to experience negative appraisal of caregiving, which affected QOL 36 months after their husbands’ treatment for prostate cancer. Additional studies related to factors that influence spouse QOL during survivorship will help guide clinical practice. Implications for Nursing: Healthcare providers must help spouses find strategies that promote positive coping and lessen negative appraisal. Giving caregivers information early in the treatment process will help them understand what to expect over time. Supporting caregivers and helping them manage stress will enhance QOL during survivorship. Knowledge Translation: Spouses who experienced more bother related to urinary, sexual, and hormonal function experience more stress and worse QOL at 36 months post-treatment. Spouse appraisal can have a significant effect on QOL. Offering counseling to couples following treatment for prostate cancer may improve QOL by helping couples manage relationship intimacy. PMID:24161635

  17. Survivorship after prostate cancer treatment: spouses' quality of life at 36 months.

    PubMed

    Harden, Janet; Sanda, Martin G; Wei, John Thomas; Yarandi, Hossein N; Hembroff, Larry; Hardy, Jill; Northouse, Laurel

    2013-11-01

    To determine the long-term effects of prostate cancer treatment on spouse quality of life (QOL) at 36 months following treatment. Descriptive-exploratory; community-based study. Telephone interviews. 95 female spouses of men treated for early-stage prostate cancer. A computer-assisted telephone interview was used to evaluate QOL among spouses of prostate cancer survivors at 36 months after initial prostate cancer treatment. Lymphedema, demographic information, self-reported comorbid diseases or medical issues, and medication usage. Spouses who had more negative appraisal of caregiving had lower sexual satisfaction, poorer cancer-specific QOL, and poorer mental QOL. Spouses who perceived bother related to the patient's sexual or hormone function reported more threatening appraisals of caregiving, less sexual satisfaction, and poorer QOL. Spouses continued to experience negative appraisal of caregiving, which affected QOL 36 months after their husbands' treatment for prostate cancer. Additional studies related to factors that influence spouse QOL during survivorship will help guide clinical practice. Healthcare providers must help spouses find strategies that promote positive coping and lessen negative appraisal. Giving caregivers information early in the treatment process will help them understand what to expect over time. Supporting caregivers and helping them manage stress will enhance QOL during survivorship. Spouses who experienced more bother related to urinary, sexual, and hormonal function experience more stress and worse QOL at 36 months post-treatment. Spouse appraisal can have a significant effect on QOL. Offering counseling to couples following treatment for prostate cancer may improve QOL by helping couples manage relationship intimacy.

  18. Monthly CERA treatment maintains stable hemoglobin levels in routine clinical practice of peritoneal dialysis patients.

    PubMed

    González, M Teresa; Ramos, Rosa; Vera, Manel; Barbosa, Francesc; Garcia, Carmen; Garcia, Isabel; González-Segura, Carlota; Cuxart, Marc; Teixidó, Josep; José de la Cruz, Juan

    2013-01-01

    Data on routine use of continuous erythropoietin receptor activator (CERA) in peritoneal dialysis patients are scarce. This study aimed to assess the efficacy of CERA administered once monthly in maintaining stable Hb levels in patients on peritoneal dialysis under routine medical practice. This was a 12-month, observational, prospective and multicenter study. A total of 83 patients with anemia secondary to chronic kidney disease (CKD) on peritoneal dialysis for more than 3 months, on once-monthly subcutaneous CERA treatment, were followed up over a period of 1 year. Efficacy evaluation included Hb levels, mean time in which the Hb level was maintained within target range, CERA doses and number of dose changes. Median Hb level (interquartile range [IQR]) remained stable during the evaluation period [11.8 ± 1.4 g/dL at baseline, 11.8 ± 1.4 g/dL at month 6 and 11.8 ± 1.5 g/dL at month 12 (p > 0.05)]. The median (IQR) time of Hb level maintained within target range (11-13 mg/dL) was 6 (4-10) months. Ferritin, transferrin saturation index, and Fe were also stable and well maintained during the 12 months (p > 0.05). CERA mean dose (SD) was [115.4 (56.2) μg baseline; 117.2 (58.5) μg 6 months; 126.0 (65.9) μg 12 months (p = 0.127)]. The mean number of CERA dose changes per patient during the study was 1.6 (SD 1.3). Serious adverse events were not related to CERA treatment. The results suggest that once-monthly CERA successfully corrects anemia and maintains stable Hb levels within the recommended target range on peritoneal dialysis under routine medical practice.

  19. Biopsychosocial determinants of treatment outcome for mood and anxiety disorders up to 8 months postpartum.

    PubMed

    Misri, Shaila; Albert, Gillian; Abizadeh, Jasmin; Kendrick, Kristin; Carter, Diana; Ryan, Deirdre; Oberlander, Tim F

    2012-08-01

    Little is known about the biopsychosocial determinants that predict postpartum treatment outcome for mood and anxiety disorders. Postpartum mood and anxiety symptoms and psychosocial/biological variables were recorded for 8 months of 22 women treated with antidepressants during pregnancy. Depression scores decreased by 58%, whereas anxiety scores decreased by 35%. Family history of psychiatric illness and prior psychiatric illness unrelated to pregnancy predicted depressive treatment outcome, and sexual abuse history and prior psychiatric illness unrelated to pregnancy predicted anxiety outcome. Biological and psychosocial variables predicted pharmacological treatment outcome in postpartum-depressed and anxious women.

  20. 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.

  1. 18-Month study of intravenous immunoglobulin for treatment of mild Alzheimer disease.

    PubMed

    Relkin, Norman R; Szabo, Paul; Adamiak, Basia; Burgut, Tuna; Monthe, Carmen; Lent, Richard W; Younkin, Steven; Younkin, Linda; Schiff, Richard; Weksler, Marc E

    2009-11-01

    Intravenous immunoglobulin (IVIg) has been proposed as a potential agent for Alzheimer's disease (AD) immunotherapy because it contains antibodies against beta-amyloid (Abeta). We carried out an open label dose-ranging study in 8 mild AD patients in which IVIg was added to approved AD therapies for 6 months, discontinued, and then resumed for another 9 months. Infusions were generally well-tolerated. Anti-Abeta antibodies in the serum from AD patients increased in proportion to IVIg dose and had a shorter half-life than anti-hepatitis antibodies and total IgG. Plasma Abeta levels increased transiently after each infusion. Cerebrospinal fluid Abeta decreased significantly at 6 months, returned to baseline after washout and decreased again after IVIg was re-administered for an additional 9 months. Mini-mental state scores increased an average of 2.5 points after 6 months, returned to baseline during washout and remained stable during subsequent IVIg treatment. Our findings confirm and extend those obtained by Dodel et al. [Dodel, R.C., Du, Y., Depboylu, C., Hampel, H., Frolich, L., Haag, A., Hemmeter, U., Paulsen, S., Teipel, S.J., Brettschneider, S., Spottke, A., Nolker, C., Moller, H.J., Wei, X., Farlow, M., Sommer, N., Oertel, W.H., 2004. Intravenous immunoglobulins containing antibodies against beta-amyloid for the treatment of Alzheimer's disease. J. Neurol. Neurosurg. Psychiatry 75, 1472-1474] from a 6-month trial of IVIg in 5 AD patients and justify further studies of IVIg for treatment of AD.

  2. 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

  3. Effects of the Start For Life treatment on physical activity in primarily African American preschool children of ages 3-5 years.

    PubMed

    Annesi, James J; Smith, Alice E; Tennant, Gisèle A

    2013-01-01

    In U.S. children of ages 2-5 years, combined overweight and obesity has increased to 21%, with African American children of this age range highest at 26%. Lack of physical activity is highly predictive of overweight and obesity in children. Preschools may be a useful point for intervention. An innovative preschool physical activity treatment (Start For Life) was developed based on principles of social cognitive and self-efficacy theory. It incorporated 30 minutes daily of highly structured physical activity with behavioral and self-regulatory skills training (e.g. goal setting, self-monitoring, productive self-talk) interspersed. Data obtained from accelerometry was used to contrast physical activity outputs during the preschool day in the Start For Life condition (n = 202) with a usual-care control condition (n = 136). After controlling for age and sex of the primarily African American participants (M age = 4.7 years), changes over eight weeks in moderate-to-vigorous and vigorous physical activity were significant, and significantly more favorable in the Start For Life group; F(1, 344) = 4.98, p = .026 and F(1, 344) = 3.60, p = .058, respectively. Start For Life was associated with a weekly increase in moderate-to-vigorous physical activity of approximately 40 minutes. After sufficient replications that better account for different sample types, parental effects and physical activity outside of the school day, and long-term effects, widespread dissemination may be considered.

  4. 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.

  5. Data analysis of 87 tic patients for 6 months' treatment in a Korean medicine clinic.

    PubMed

    Chun, Young-Ho; Kim, Won-Ill; Kim, Bo-Kyung

    2013-10-01

    This study was carried out to investigate the relationship between the therapeutic effects of treatment for tic disorder and Korean medicine clinical tests, including body mass index (BMI) and heart variability rate (HRV). This study was not a clinical trial, but a data analysis of 87 tic patients who were treated for 6 months during the time period from Nov. 2010 to Jan. 2012. The clinical evaluation of the symptoms was recorded using the Korean version of the Yale Global Tic Severity Scale (YGTSS). The BMI and the HRV were measured according to a schedule, and various kinds of statistical methods were used. Among the 87 patients, the number of males was 3.34 times the number of females, and 58 patients (66.7%) had been suffering for more than 12 months. The onset age of the males was significantly lower than that of the females, and males had the symptoms longer than females had. Also, males with a family history of tics were 2.5 times as many as females, and their onset ages were substantially lower. At the first medical examinations, the average score on the YGTSS was 34.08, and it decreased linearly as the treatment progressed. After 4 and 6 months of treatment, it had decreased significantly. The YGTSS score and the period of suffering correlated positively. At the first visit, each HRV datum was in the normal range. After the 6 months' treatment, Ln (TP), Ln (LF), and Ln (HF) had dropped substantially in the normal range while Ln (VLF) and the LF/HF ratio had not changed in a meaningful way. During the treatment period, the BMI stayed relatively constant without any meaningful changes.

  6. Temperament, personality, and treatment outcome in major depression: a 6-month preliminary prospective study

    PubMed Central

    Kudo, Yuka; Nakagawa, Atsuo; Wake, Taisei; Ishikawa, Natsumi; Kurata, Chika; Nakahara, Mizuki; Nojima, Teruo; Mimura, Masaru

    2017-01-01

    Background Despite available treatments, major depression is a highly heterogeneous disorder, which leads to problems in classification and treatment specificity. Previous studies have reported that personality traits predict and influence the course and treatment response of depression. The Temperament and Personality Questionnaire (T&P) assesses eight major constructs of personality traits observed in those who develop depression. The aim of this study was to investigate the influence of T&P’s eight constructs on the treatment outcome of depressed patients. Patients and methods A preliminary 6-month prospective study was conducted with a sample of 51 adult patients with a diagnosis of major depressive disorder (MDD) without remarkable psychomotor disturbance using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. All patients received comprehensive assessment including the T&P at baseline. We compared each T&P construct score between patients who achieved remission and those who did not achieve remission after 6 months of treatment for depression using both subjective and objective measures. All 51 (100%) patients received the 6-month follow-up assessment. Results This study demonstrated that higher scores on T&P personal reserve predicted poorer treatment outcome in patients with MDD. Higher levels of personal reserve, rejection sensitivity, and self-criticism correlated with higher levels of depression. Higher levels of rejection sensitivity and self-criticism were associated with non-remitters; however, when we controlled for baseline depression severity, this relationship did not show significance. Conclusion Although the results are preliminary, this study suggests that high scores on T&P personal reserve predict poorer treatment outcome and T&P rejection sensitivity and self-criticism correlate with the severity of depression. Longer follow-up studies with large sample sizes are required to improve the understanding of these

  7. 1,3,5-Trinitrobenzene

    Integrated Risk Information System (IRIS)

    1,3,5 - Trinitrobenzene ; CASRN 99 - 35 - 4 Human health assessment information on a chemical substance is included in the IRIS database only after a comprehensive review of toxicity data , as outlined in the IRIS assessment development process . Sections I ( Health Hazard Assessments for Noncarcino

  8. Six-month compliance with antidepressant medication in the treatment of major depressive disorder.

    PubMed

    Demyttenaere, Koen; Adelin, Albert; Patrick, Mesters; Walthère, Dewé; Katrien, De Bruyckere; Michèle, Sangeleer

    2008-01-01

    The investigation of compliance in patients with major depressive disorder (in drop-outs versus completers and in first episode versus recurrent episode patients). A total of 85 outpatients with major depressive disorder were followed for 6 months. Different dimensions of compliance were investigated: drop-outs versus completers and their medication adherence (with electronic monitoring). General linear mixed models were applied to examine the time courses of adherence. Drop-out rates were higher in younger patients and in patients with a lower initial depression severity. The adherence during 6 months of treatment with selective serotonin reuptake inhibitors was above 80 in 70% of the patients. The adherence decreased by 2.5% per month and decreased more than three times more rapidly in drop-outs (from baseline to time of drop-out). A medical visit resulted in a temporary increase in pill intake. General linear mixed model analysis showed that the predicted outcome was worse in drop-outs than in completers and worse in recurrent episode patients than in first episode patients (the former showing a higher adherence). Adherence decreases with time during 6 months of treatment with antidepressants and is influenced by demographic and clinical variables. Completers show a higher adherence than drop-outs. The outcome was worse in recurrent episode patients than first episode patients although they had a higher adherence.

  9. Randomized, controlled, multicenter study of the immunogenicity and safety of a fully liquid combination diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and haemophilus influenzae type b (Hib) vaccine compared with a DTaP3-IPV/Hib vaccine administered at 3, 5, and 12 months of age.

    PubMed

    Vesikari, Timo; Silfverdal, Sven Arne; Boisnard, Florence; Thomas, Stéphane; Mwawasi, Grace; Reynolds, Donna

    2013-10-01

    This study compared the levels of immunogenicity and safety of diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP(5)), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) (DTaP(5)-IPV-Hib) and DTaP(3)-IPV/Hib vaccines for study participants 3, 5, and 12 months of age. Post-dose 3 noninferiority criteria comparing DTaP(5)-IPV-Hib to DTaP(3)-IPV/Hib using rates of seroprotection were demonstrated against diphtheria, tetanus, and polio types 1 to 3, but not for polyribosylribitol phosphate (PRP). While PRP did not meet noninferiority criteria, the seroprotection rate and geometric mean concentration (GMC) were high, indicating a clinically robust immune response. GMCs or titers for other antigens (including pertussis) and the safety profiles were generally similar between groups. Fully liquid DTaP(5)-IPV-Hib can be administered using the 3-, 5-, and 12-month vaccination schedule. (This study has been registered at ClinicalTrials.gov under registration no. NCT00287092.).

  10. Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of a Fully Liquid Combination Diphtheria–Tetanus Toxoid–Five-Component Acellular Pertussis (DTaP5), Inactivated Poliovirus (IPV), and Haemophilus influenzae Type b (Hib) Vaccine Compared with a DTaP3-IPV/Hib Vaccine Administered at 3, 5, and 12 Months of Age

    PubMed Central

    Silfverdal, Sven Arne; Boisnard, Florence; Thomas, Stéphane; Mwawasi, Grace; Reynolds, Donna

    2013-01-01

    This study compared the levels of immunogenicity and safety of diphtheria–tetanus toxoid–five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) (DTaP5-IPV-Hib) and DTaP3-IPV/Hib vaccines for study participants 3, 5, and 12 months of age. Post-dose 3 noninferiority criteria comparing DTaP5-IPV-Hib to DTaP3-IPV/Hib using rates of seroprotection were demonstrated against diphtheria, tetanus, and polio types 1 to 3, but not for polyribosylribitol phosphate (PRP). While PRP did not meet noninferiority criteria, the seroprotection rate and geometric mean concentration (GMC) were high, indicating a clinically robust immune response. GMCs or titers for other antigens (including pertussis) and the safety profiles were generally similar between groups. Fully liquid DTaP5-IPV-Hib can be administered using the 3-, 5-, and 12-month vaccination schedule. (This study has been registered at ClinicalTrials.gov under registration no. NCT00287092.) PMID:23966556

  11. CaF2 in enamel biopsies 6 weeks and 18 months after fluoride treatment.

    PubMed

    Caslavska, V; Gron, P; Kent, R L; Joshipura, K; DePaola, P F

    1991-01-01

    Fluoride concentrations were studied in enamel biopsies from maxillary central incisors 6 weeks and 18 months after fluoride treatment. In the short-term study biopsies were obtained prior to and after treatment with acidic sodium or ammonium fluoride. The findings showed that large amounts of fluoride were deposited in enamel from NH4F treatment (mean concentration 84,723 ppm), indicating substantial CaF2 formation. NaF treatment resulted in mean fluoride concentrations of 7,818 ppm. In the 18-month study, biopsies from 58 placebo-treated teeth were analyzed for total fluoride (mean 1,733 ppm). Twenty-five additional biopsies from placebo-treated and 58 from NH4F-treated teeth were analyzed for KOH-soluble (CaF2) and KOH-nonsoluble (apatitic) fluoride. The mean values for total fluoride were 1,669 and 2,085 ppm in the placebo-treated and in the NH4F-treated groups, respectively. The corresponding mean values for KOH-nonsoluble fluoride were 1,467 and 1,731 ppm and for KOH-soluble fluoride 202 and 354 ppm, respectively. The increase in enamel fluoride after fluoride treatment was only marginally significant. Biopsies from the ammonium fluoride treated group were significantly more likely to have high (30 vs. 8%) and moderate (28 vs. 16%) CaF2 levels and less likely to have low levels than biopsies of placebo-treated teeth (chi-square = 8.0 with 2 d.f.; p = 0.018). It is concluded that very substantial amounts of CaF2 are present in enamel 6 weeks after treatment, and small amounts may persist in the surface enamel for as long as 18 months.

  12. Risedronate once monthly: a potential new regimen for the treatment of postmenopausal osteoporosis

    PubMed Central

    Moro-Álvarez, María J; Díaz-Curiel, Manuel

    2008-01-01

    Postmenopausal osteoporosis increases susceptibility to low-trauma fractures due to reduced bone volume and microarchitectural deterioration. Daily nitrogen-containing bisphosphonates have shown antifracture efficacy in many studies and are the most commonly prescribed treatment for women with postmenopausal osteoporosis. However, optimal efficacy is often not achieved due to poor patient adherence to medication. Current dosing schedules are often inconvenient or impractical for patients. Poor adherence increases risk of fracture, which itself increases morbidity, healthcare costs and, potentially, mortality. Although weekly rather than daily dosing of bisphosphonates has improved adherence, significant problems remain. Efforts to reduce dosing frequency as a possible means for further improving adherence (compliance and persistence), and therefore treatment outcomes, are ongoing. Risedronate, a third-generation bisphosphonate, has been shown in multiple clinical trials to reduce fracture risk and improve bone mineral density in postmenopausal women with osteoporosis. Risedronate has a specific structure and set of characteristics that enable less frequent dosing. This paper reviews the structure of risedronate, and how this translates into high antiresorptive potency, favorable bone binding, persistence in bone, and good tolerability that permits less frequent dosing. The paper also reviews the clinical evidence for risedronate, demonstrating the viability of less frequent dosing, with its potential benefits for patient convenience and adherence to therapy. Two equivalence or non-inferiority bridging studies have demonstrated the option of novel risedronate dosing regimens. These studies are reviewed to demonstrate the efficacy and safety of two different monthly regimens of risedronate in the treatment of postmenopausal osteoporosis: 75 mg on 2 consecutive days a month and 150 mg once a month. Data for oral risedronate 150 mg once a month are limited to 1 year

  13. Pressure sore and skin tear prevention and treatment during a 10-month program.

    PubMed

    Brillhart, Barbara

    2005-01-01

    This article reports the results of a 10-month skin care program for 30 clients on a residential Alzheimer's disease unit. The majority (n = 26) of the clients were free of pressure sores and skin tears through preventive care during this study. Four clients with Stage I pressure sores and/or skin tears were successfully identified by consistent assessment and healed quickly due to rapidly initiated treatments. This skin care program's success was attributed to consistent education, preventive care, assessment, documentation, and treatment executed by the entire care team under the leadership of nurse practitioners, one of whom was certified as a rehabilitation nurse.

  14. Repairing the Brain by SCF+G-CSF Treatment at 6 Months Postexperimental Stroke

    PubMed Central

    Cui, Lili; Wang, Dandan; McGillis, Sandra; Kyle, Michele

    2016-01-01

    Stroke, a leading cause of adult disability in the world, is a severe medical condition with limited treatment. Physical therapy, the only treatment available for stroke rehabilitation, appears to be effective within 6 months post-stroke. Here, we have mechanistically determined the efficacy of combined two hematopoietic growth factors, stem cell factor (SCF) and granulocyte-colony stimulating factor (G-CSF; SCF + G-CSF), in brain repair 6 months after cortical infarct induction in the transgenic mice carrying yellow fluorescent protein in Layer V pyramidal neurons (Thy1-YFP-H). Using a combination of live brain imaging, whole brain imaging, molecular manipulation, synaptic and vascular assessments, and motor function examination, we found that SCF + G-CSF promoted mushroom spine formation, enlarged postsynaptic membrane size, and increased postsynaptic density-95 accumulation and blood vessel density in the peri-infarct cavity cortex; and that SCF + G-CSF treatment improved motor functional recovery. The SCF + G-CSF-enhanced motor functional recovery was dependent on the synaptic and vascular regeneration in the peri-infarct cavity cortex. These data suggest that a stroke-damaged brain is repairable by SCF + G-CSF even 6 months after the lesion occurs. This study provides novel insights into the development of new restorative strategies for stroke recovery. PMID:27511907

  15. Time to treatment response in first episode schizophrenia: should acute treatment trials last several months?

    PubMed Central

    Gallego, Juan A.; Robinson, Delbert G.; Sevy, Serge M.; Napolitano, Barbara; McCormack, Joanne; Lesser, Martin L.; Kane, John M.

    2010-01-01

    Objectives Response patterns may differ between patients with first episode and multi-episode schizophrenia. This analysis explored trial duration with first episode patients and whether early limited improvement predicts ultimate lack of treatment response with first episode patients as it does with multi-episode patients. Methods 112 subjects (mean age=23.3 years [SD=5.1]) who presented between November 1998 and October 2004 with a first episode of psychosis and had a DSM-IV diagnosis of schizophrenia, schizophreniform or schizoaffective disorder, were randomly assigned to treatment with olanzapine or risperidone for 16 weeks. Treatment response, the primary outcome measure, was defined as a rating of mild or better on all of the positive symptom items on the SADS-C + PD. Response rates were calculated for each study week. A logistic regression analysis examined the association between percent reduction in symptom severity scores from baseline values at weeks 2, 4 or 8 and response by week 16. Results The estimated cumulative response rate by week 8 was 39.59% (95% CI: 29.77% – 49.41%) and 65.19% (95% CI: 55.11% – 75.27%) by week 16. The confidence intervals for estimated response at weeks 10, 12, 14 and 16 were not distinct. Response rates increased approximately 5 to 6 percentage points each 2 week interval between week 10 and 16. Percent reduction in symptom severity score at week 4 (but not 2 or 8) was associated (Chi-square = 3.96; df = 1, p<0.05) with responder status at week 16 (odds ratio: 1.03; 95% CI: 1.00;1.05). However, receiver operating characteristic curves did not suggest any level of percent symptom reduction that would be clinically useful as a predictor of response by week 16. Conclusions Many first episode patients respond between weeks 8 and 16 of treatment with a single antipsychotic medication. Limited early symptom improvement does not identify with enough accuracy to be clinically useful those first episode patients who will not

  16. Three-month treatment response and exacerbation in chronic obstructive pulmonary disease.

    PubMed

    Lee, Jung Su; Rhee, Chin Kook; Yoo, Kwang Ha; Lee, Ji-Hyun; Yoon, Ho Il; Kim, Tae-Hyung; Kim, Woo Jin; Lee, JinHwa; Lim, Seong Yong; Park, Tai Sun; Lee, Jae Seung; Lee, Sei Won; Lee, Sang-Do; Oh, Yeon-Mok

    2015-01-01

    The aim of this study was to investigate relationships between acute exacerbation and Forced Expiratory Volume 1 second (FEV1) improvement after treatment with combined long-acting beta-agonist (LABA) and inhaled corticosteroid (ICS) in patients with chronic obstructive pulmonary disease (COPD). A total of 137 COPD patients were classified as responders or nonresponders according to FEV1 improvement after 3 months of LABA/ICS treatment in fourteen referral hospitals in Korea. Exacerbation occurrence in these two subgroups was compared over a period of 1 yr. Eighty of the 137 COPD patients (58.4%) were classified as responders and 57 (41.6%) as nonresponders. Acute exacerbations occurred in 25 patients (31.3%) in the responder group and in 26 patients (45.6%) in the nonresponder group (P=0.086). FEV1 improvement after LABA/ICS treatment was a significant prognostic factor for fewer acute exacerbations in a multivariate Cox proportional hazard model adjusted for age, sex, FEV1, smoking history, 6 min walk distance, body mass index, exacerbation history in the previous year, and dyspnea scale.Three-month treatment response to LABA/ICS might be a prognostic factor for the occurrence of acute exacerbation in COPD patients.

  17. Perspectives of the Breast Cancer Survivorship Continuum: Diagnosis through 30 Months Post-Treatment

    PubMed Central

    Hulett, Jennifer M.; Armer, Jane M.; Stewart, Bob R.; Wanchai, Ausanee

    2015-01-01

    This study explored breast cancer survivors’ perspectives regarding their experiences of the survivorship continuum from diagnosis through 30 months post-treatment. The sample included women (N = 379) with newly-diagnosed breast cancer undergoing treatment at a Midwestern university-affiliated cancer center. Semi-structured interviews were conducted using the Lymphedema and Breast Cancer Questionnaire at time of diagnosis, post-operatively, quarterly during the first year, and then semi-annually thereafter through 30 months post-treatment. A mixed-methodology was used to analyze participants’ comments. Themes central to long-term survivorship experiences included social support, positive worldviews, breast cancer and lymphedema health literacy, religious/spiritual beliefs, self-empowerment, and recovery expectations. These themes were consistent with a psychoneuroimmunological model of health in which psychosocial variables mediate stress and influence health outcomes. Qualitative data showed that social support and positive worldviews were the two themes with the most significant impact on long-term breast cancer survivorship experiences. Survivors expressed a need to advance their health care literacy in order to share ownership of breast cancer and lymphedema treatment decisions. Since breast cancer is an immune-mediated disease, long-term survivorship planning should address psychosocial factors that influence the long-term psychological distress associated with immune dysfunction. PMID:26030800

  18. Clinical effectiveness of basic root canal treatment after 24 months: a randomized controlled trial.

    PubMed

    Jordan, Rainer A; Holzner, Anna L; Markovic, Ljubisa; Brueckner, Inga; Zimmer, Stefan

    2014-04-01

    The purpose of this study was to investigate the effectiveness of basic root canal treatment (BRT) with tactile working length determination in terms of radiographic and clinical outcome parameters compared with endodontic treatment with standard radiographic working length control. This was a clinical, multicenter, controlled, open-label trial to evaluate BRT effectiveness after 24 months. The primary end point was the apical extension score of the radiographic quality parameter of root canal fillings. The secondary radiographic end point was the periapical index, and the secondary clinical end point was tooth tender to percussion. The safety end point was tooth loss as a consequence of endodontic failure. Statistical analyses of binary and categoric data were calculated using cross tables and the chi-square test. BRT with tactile working length determination compared with standard radiographic working length control did not significantly differ in terms of radiographic and clinical outcomes after 24 months. The apical extension of the root canal fillings and the periapical anatomic structures showed no significant differences according to radiographic analyses (P = .5). Corresponding results were found in clinical aspects of tooth tender to percussion (P = .6) and tooth loss (P = .7). Tactile working length determination in BRT resulted in comparable treatment outcomes compared with standard endodontic treatment with radiographic working length control and turned out to be an accurate method in BRT. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  19. Significantly enhanced magnetic properties of a powder of amorphous Fe70MnxMo3Cr4-6W8-10Si4-5B3-5 particles achieved by annealing treatments below the crystallization temperature

    NASA Astrophysics Data System (ADS)

    Zhang, Jiliang; Zheng, Zhigang; Shek, Chan Hung

    2014-06-01

    Annealing treatments below crystallization temperature were conducted on commercial Fe70MnxMo3Cr4-6W8-10Si4-5B3-5 (x = balance) amorphous powder. It was found that such treatment could significantly improve the soft magnetic properties of the powder especially at a higher frequency. Saturation magnetization increased to a maximum and hysteresis loop decreased to a minimum after the powder was annealed at 800 K for 30 min. Magnetic force microscopy observation indicated that the size of domain structure was not changed but the phase contrast became obvious after annealing. The enhancements of soft magnetic properties were explained in terms of structural relaxation and nanocrystallization as well as the Bethe-Slater curve. Moreover, a characteristic frequency at which the a.c. susceptibility exhibits a drastic change is found and that frequency changes with the annealing treatment.

  20. Association of AGTR1 with 18-month treatment outcome in late-life depression.

    PubMed

    Kondo, Douglas G; Speer, Marcy C; Krishnan, K Ranga; McQuoid, Douglas R; Slifer, Susan H; Pieper, Carl F; Billups, Ashley V; Steffens, David C

    2007-07-01

    Converging lines of evidence implicate vascular factors in late-life depression, and argue that late-life depression is a distinct entity among the mood disorders. The A1166C polymorphism in the angiotensin II receptor, vascular type 1 (AGTR1) gene has been associated with a range of vascular diseases. This study investigated the association of AGTR1 genotype on 18-month treatment outcome in late-life depression. In a large, prospective cohort study, patients with late-life depression received individualized treatment using a standardized algorithm. The authors genotyped participants at the AGTR1 A1166C single nucleotide polymorphism (SNP) using standardized methodology, then used survival analysis to estimate the impact of A1166C and demographic variables on time to remission during 18 months of follow-up. The hazard ratio for AGTR1 homozygous C/C status was 0.37. The A1166C SNP showed evidence for genotypic and allelic association in a comparison of remitted and unremitted/censored subjects. Consistent with its association with numerous vascular disorders, AGTR1 is associated with treatment outcome in late-life depression. Further studies are needed to replicate this finding, and to investigate the impact of other genetic markers of vascular disease on late-life depression outcome.

  1. Clinical Characteristics of Rheumatoid Arthritis Patients Achieving Functional Remission with Six Months of Biological DMARDs Treatment.

    PubMed

    Miwa, Yusuke; Takahashi, Ryo; Ikari, Yuzo; Maeoka, Airi; Nishimi, Shinichiro; Oguro, Nao; Hayashi, Tomoki; Hatano, Mika; Isojima, Sakiko; Yanai, Ryo; Kasama, Tsuyoshi; Toyoshima, Yoichi; Inagaki, Katsunori; Sanada, Kenji

    2017-01-01

    Objective Although previous studies have reported the prognostic factors for functional remission, no reports have cited the predictive factors. Our aim was to study the predictive factors for functional remission, which is a treatment goal in rheumatoid arthritis (RA), after receiving biological disease-modifying antirheumatic drugs (bDMARDs) treatment for six months. Methods The study consisted of 333 RA patients treated with bDMARDs for six months. The following patient characteristics were investigated: age, gender, disease duration, type of bDMARDs, baseline steroid and methotrexate dosage, and levels of serum rheumatoid factor, matrix metalloprotease, anti-cyclic citrullinated peptides antibody, tumor necrosis factor-α, and interleukin-6. In our evaluation, we used the Simplified Disease Activity Index (SDAI) for RA disease activity, health assessment questionnaire disability index (HAQ-DI) for activity of daily living, Short Form (SF)-36 for quality of life, and Hamilton Depression Rating Scale (HAM-D) or Self-rating Depression Scale (SDS) to determine the patients' depression status. The subjects were divided into two groups: patients with HAQ-DI≤0.5 and HAQ-DI>0.5 at 6 months. Results A univariate analysis comparing a group of RA patients without functional remission (n=68) showed that the patients with functional remission (n=164) had the following in common compared with those without remission: younger age, shorter disease duration, lower baseline steroid dosage, lower SDAI, lower HAQ-DI, higher SF-36, and lower HAM-D. Only lower HAQ-DI scores and "mental health" score on the SF-36 were detected using a logistic regression analysis. Conclusion These findings suggested that RA patients with lower HAQ-DI and lower depression scores at baseline were more likely to achieve functional remission using bDMARDs treatment than those without these variables.

  2. Efficacy and safety of piascledine 300 versus chondroitin sulfate in a 6 months treatment plus 2 months observation in patients with osteoarthritis of the knee.

    PubMed

    Pavelka, Karel; Coste, Philippe; Géher, Pál; Krejci, Gerhard

    2010-06-01

    To investigate that a 6-month treatment with avocado soybean unsaponifiable (Piascledine 300 mg) once daily is as effective as with chondroitin sulfate 400 mg three times daily in femorotibial gonarthrosis, and also the carry-over effect for two more months is comparable. Patients were randomized (1:1) to the treatment groups. They received for 6 months 3 capsules chondroitin sulfate per day or one capsule of avocado soybean unsaponifiable (ASU) in a double-dummy technique. A 2-month post-treatment period followed to determine the carry-over effect. Primary efficacy criterion was the change of the WOMAC-index from study begin to end of treatment. Secondary criteria were the changes in Lequesne-index, pain on active movement and at rest, global assessment of efficacy. Three hundred sixty-four patients have been taken up into the trial. Three hundred sixty one patients were eligible for evaluation. One hundred eighty three received ASU 300 mg once daily, one hundred seventy eight chondroitin sulfate three times daily. The WOMAC-index decreased in both groups for approx. 50% to the end of therapy. During the post-treatment observation there was a further slight improvement. There was no statistical significant difference between the treatment groups during the entire observation. All other observed parameters showed the same pattern. The daily intake of rescue medication was reduced continuously. Overall efficacy has been rated excellent and good in more than 80% of the patients in both groups. Both drugs were safe and well tolerated. The first direct comparison between avocado soybean unsaponifiable 300 mg once daily and chondroitin sulfate three times daily reveiled no difference in efficacy or safety aspects between 1 capsule ASU 300 mg per day and 3 capsules chondroitin sulfate per day. It can be assumed that the once daily intake of ASU will lead to a better compliance in routine therapy.

  3. Evaluation of different treatment protocols for dentin hypersensitivity: an 18-month randomized clinical trial.

    PubMed

    Lopes, Anely Oliveira; de Paula Eduardo, Carlos; Aranha, Ana Cecília Correa

    2017-07-01

    This randomized and longitudinal in vivo study aimed to assess different protocols for the treatment of dentin hypersensitivity with low-power laser (with different doses), high-power laser, and a desensitizing agent, for a period of 12 and 18 months. The lesions from 32 patients (117 lesions), who were submitted to the inclusion and exclusion criteria, were divided into nine groups (n = 13): G1: Gluma Desensitizer (Heraeus Kulzer), G2: low-power laser with low dose (three points of irradiation in vestibular portion and an apical point 30 mW, 10 J/cm(2), 9 s per point with the wavelength of 810 nm, with three sessions with an interval of 72 h), G3: low-power laser with high dose (one point in the cervical area, and one apical point 100 mW, 40 J/cm(2), 11 s per point with the wavelength of 810 nm in three sessions with an interval of 72 h), G4: low-power laser with low dose + Gluma Desensitizer, G5: low-power laser with high dose + Gluma Desensitizer, G6: Nd:YAG laser (Power Laser™ ST6, Research® in contact 1.0 W, 10 Hz and 100 mJ, ≈85 J/cm(2), with the wavelength of 1064 nm), G7: Nd:YAG laser + Gluma Desensitizer, G8: low-power laser with low dose + Nd:YAG laser, and G9: low-power laser with high dose + Nd:YAG laser. The level of sensitivity of each volunteer was assessed by visual analog scale of pain (VAS) with the aid of air from the triple syringe and exploration probe, 12 and 18 months after treatment. All analyses were performed separately for air and probe stimulus. The level of significance was considered for values of p < 0.05. After statistical analysis, all treatments were shown to be effective in reducing dentinal hypersensitivity, and the results were considered not statistically different from those at 12 months. Therefore, until the 18-month evaluation, it could be said that no statistical differences were observed in the sensitivity levels for all treatments.

  4. Treatment of persistent trophoblastic disease later than 6 months after diagnosis of molar pregnancy

    PubMed Central

    Gillespie, A M; Kumar, S; Hancock, B W

    2000-01-01

    Of 4257 patients with gestational trophoblastic disease (GTD) registered between 1986 and 1996 with the Trophoblastic Screening and Treatment Centre, Sheffield, 231 women required chemotherapy; 28 were treated 24 weeks or more after the initial evacuation of products of conception. In 18 patients late treatment was a result of a predetermined watch and wait policy on the part of the Centre; these patients formed the study group. Patients were identified from the Centre's computer database. The time interval from first evacuation (diagnosis) to start of chemotherapy was calculated for each patient. Hospital records were reviewed when the interval of observation was 24 weeks or greater to determine patient characteristics, treatment and outcome. Eighteen women were treated ‘late’ (according to Centre policy), with a median age of 30 years (range 21–57 years). The interval from diagnosis to treatment ranged from 24 to, in one case, 56 weeks (median 33 weeks). Fourteen of 18 women had complete moles, 3/18 had partial moles and one had unclassified disease. All women had low-risk disease and were treated with single-agent methotrexate; 17 were cured with this regimen, one also required salvage chemotherapy. In conclusion, where a successful surveillance programme is in operation for GTD, a wait and watch policy can be adopted without compromising patients whose definitive treatment is commenced more than 6 months after the initial diagnosis. © 2000 Cancer Research Campaign PMID:10780516

  5. 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.

  6. Prospective evaluation of the psychosocial impact of the first 6 months of orthodontic treatment with fixed appliance among young adults.

    PubMed

    Prado, Renata França; Ramos-Jorge, Joana; Marques, Leandro Silva; de Paiva, Saul Martins; Melgaço, Camilo Aquino; Pazzini, Camila Alessandra

    2016-07-01

    To evaluate the psychosocial impact of the first 6 months of orthodontic treatment with a fixed appliance among young adults and compare the results with those of a control group of patients awaiting treatment for malocclusion. A study was conducted with a sample of 120 patients on a waiting list for orthodontic treatment at a university. The participants were allocated to an experimental group submitted to treatment and a control group awaiting treatment. The groups were matched for sex and age. All participants were instructed to answer the Brazilian version of the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) at baseline and after 6 months. Statistical analysis involved the Wilcoxon test for the total PIDAQ score and the score of each subscale. All patients participated until the end of the study. Significant differences between baseline and the 6-month evaluation were found for the total PIDAQ score as well as the dental self-confidence and social impact subscales in both groups. No differences between baseline and the 6-month evaluation were found regarding the psychological impact or esthetic concern subscales in the control group. The patients in the experimental group reported greater esthetic impact 6 months after beginning treatment (P < .001). The first 6 months of orthodontic treatment seem to improve psychosocial impact. The first 6 months of orthodontic treatment seem to improve the psychosocial impact of malocclusion. The patients analyzed in the present study reported a greater esthetic impact and less psychological impact after 6 months of using an orthodontic appliance.

  7. Biodegradation of hexahydro-1,3,5-trinitro-1,3,5-triazine

    SciTech Connect

    McCormick, N.G.; Cornell, J.H.; Kaplan, A.M.

    1981-11-01

    Biodegradation of the explosive hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) occurs under anaerobic conditions, yielding a number of products, including: hexahydro-1-nitroso-3,5-dinitro-1,3,5-triazine, hexahydro-1,3-dinitroso-5-nitro-1,3,5-triazine, hexahydro-1,3,5-trinitroso-1,3,5-triazine, hydrazine, 1,1-dimethylhydrazine, 1,2-dimethylhydrazine, formaldehyde, and methanol. A scheme for the biodegradation of RDX is poposed which proceeds via successive reduction of the nitro groups to a point where destabilization and fragmentation of the ring occurs. The noncyclic degradation products arise via subsequent reduction and rearrangement reactions of the fragments. The scheme suggests the presence of several additional compounds, not yet identified. Several of the products are mutagenic or carcinogenic or both. Anaerobic treatment of RDX wastewaters, which also contain high nitrate levels, would permit the denitrification to occur, with concurrent degradation of RDX ultimately to a mixture of hydrazines and methanol. The feasibility of using an aerobic mode in the further degradation of these products is discussed.

  8. Biodegradation of Hexahydro-1,3,5-Trinitro-1,3,5-Triazine

    PubMed Central

    McCormick, N. G.; Cornell, J. H.; Kaplan, A. M.

    1981-01-01

    Biodegradation of the explosive hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) occurs under anaerobic conditions, yielding a number of products, including: hexahydro-1-nitroso-3,5-dinitro-1,3,5-triazine, hexahydro-1,3-dinitroso-5-nitro-1,3,5-triazine, hexahydro-1,3,5-trinitroso-1,3,5-triazine, hydrazine, 1,1-dimethyl-hydrazine, 1,2-dimethylhydrazine, formaldehyde, and methanol. A scheme for the biodegradation of RDX is proposed which proceeds via successive reduction of the nitro groups to a point where destabilization and fragmentation of the ring occurs. The noncyclic degradation products arise via subsequent reduction and rearrangement reactions of the fragments. The scheme suggests the presence of several additional compounds, not yet identified. Several of the products are mutagenic or carcinogenic or both. Anaerobic treatment of RDX wastewaters, which also contain high nitrate levels, would permit the denitrification to occur, with concurrent degradation of RDX ultimately to a mixture of hydrazines and methanol. The feasibility of using an aerobic mode in the further degradation of these products is discussed. PMID:16345884

  9. One-year monthly monitoring of Torque teno virus (TTV) in wastewater treatment plants in Japan.

    PubMed

    Haramoto, Eiji; Katayama, Hiroyuki; Oguma, Kumiko; Yamashita, Hiromasa; Nakajima, Eiichiro; Ohgaki, Shinichiro

    2005-05-01

    Torque teno virus (TTV) is a novel hepatitis virus which is considered to be transmitted by the fecal-oral route. Wastewater samples were collected monthly from eight wastewater treatment plants in Japan for 1 year, from July 2003 to June 2004, and tested for the presence of TTV by TaqMan PCR. TTV was detected in 97% (93/96) of influent samples, implying that TTV is epidemic in Japan. TTV was also isolated in 18% (17/96) of secondary effluent samples before chlorination and in 24% (23/95) of final effluent samples after chlorination. There was no significant difference between the concentration of total coliform in TTV-positive final effluents and that in TTV-negative final effluents, which indicates that total coliform cannot be used as an indicator of TTV. No TTV was detected in 24 effluents for reuse from two wastewater treatment plants using sand filtration and ozonation.

  10. Preparation of 1,3,5-triamino-2,4,6-trinitrobenzene from 3,5-dichloroanisole

    DOEpatents

    Ott, D.G.; Benziger, T.M.

    1991-03-05

    Preparation of 1,3,5-triamino-2,4,6-trinitrobenzene (TATB) from 3,5-dichloroanisole is described. Nitration of 3,5-dichloroanisole under relatively mild conditions gave 3,5-dichloro-2,4,6-trinitroanisole in high yield and purity. Ammonolysis of this latter compound gave the desired TATB. Another route to TATB was through the treatment of the 3,5-dichloro-2,4,6-trinitroanisole with thionyl chloride and dimethylformamide to yield 1,3,5-trichloro-2,4,6-trinitrobenzene. Ammonolysis of this product produced TATB. 8 figures.

  11. Preparation of 1,3,5-triamino-2,4,6-trinitrobenzene from 3,5-dichloroanisole

    DOEpatents

    Ott, Donald G.; Benziger, Theodore M.

    1991-01-01

    Preparation of 1,3,5-triamino-2,4,6-trinitrobenzene (TATB) from 3,5-dichloroanisole. Nitration of 3,5-dichloroanisole under relatively mild conditions gave 3,5-dichloro-2,4,6-trinitroanisole in high yield and purity. Ammonolysis of this latter compound gave the desired TATB. Another route to TATB was through the treatment of the 3,5-dichloro-2,4,6-trinitroanisole with thionyl chloride and dimethylformamide to yield 1,3,5-trichloro-2,4,6-trinitrobenzene. Ammonolysis of this product produced TATB.

  12. Preparation of 1,3,5-triamino-2,4,6-trinitrobenzene from 3,5-dichloranisole

    DOEpatents

    Ott, Donald G.; Benziger, Theodore M.

    1990-01-01

    Preparation of 1,3,5-triamino-2,4,6-trinitrobenzene (TATB) from 3,5-dichloroanisole. Nitration of 3,5-dichloroanisole under relatively mild conditions gave 3,5-dichloro-2,4,6-trinitroanisole in high yield and purity. Ammonolysis of this latter compound gave the desired TATB. Another route to TATB was through the treatment of the 3,5-dichloro-2,4,6-trinitroanisole with thionyl chloride and dimethylformamide to yield 1,3,5-trichloro-2,4,6-trinitrobenzene. Ammonolysis of this product produced TATB.

  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. [Effectiveness of an integrated treatment for severe personality disorders. A 36-month pragmatic follow-up].

    PubMed

    Lana, Fernando; Sánchez-Gil, Carmen; Ferrer, Laia; López-Patón, Nuria; Litvan, Lia; Marcos, Susana; Sierra, Ana C; Soldevilla, Joan M; Feixas, Guillem; Pérez, Víctor

    2015-01-01

    Over the past 25 years, several studies have shown the efficacy of a number of psychological interventions for severe personality disorders. However, the generalizability of these positive results from long traditional research settings to more ordinary ones has been questioned, requiring a need for replication in pragmatic studies. This pragmatic study compares hospitalizations and Emergency Room visits before and during a 6-month therapeutic program for severe personality disorders, and at 36 months after starting it. The therapeutic program, which integrates several specific interventions within a coherent framework, was carried out in an ordinary clinical setting. Fifty-one patients, evaluated according DSM-IV criteria by using the Spanish version of the Structured Clinical Interview for Personality Disorders (SCID-II), were included. The clinical characteristics showed a group of severely disturbed patients, of which 78.4% met criteria for borderline personality disorder. The percentage of patients hospitalized and visiting the Emergency Room, as well as the number of days of hospitalization and Emergency Room visits was significantly reduced during the treatment, and this improvement was maintained throughout. An integrated treatment for severe personality disorders could be effective in preventing reliance on readmissions, or prolonged hospital stays, when it is implemented by clinicians in ordinary clinical settings. Copyright © 2014 SEP y SEPB. Published by Elsevier España. All rights reserved.

  15. Functional Outcome at 6 Months in Surgical Treatment of Spontaneous Supratentorial Intracerebral Haemorrhage

    PubMed Central

    Ghani, Abdul Rahman Izaini; John, John Tharakan Kalappurakkal; Idris, Zamzuri; Ghazali, Mazira Mohamad; Murshid, Nur-Leem; Musa, Kamarul Imran

    2008-01-01

    A prospective cohort study was done to evaluate the role of surgery in patients with spontaneous supratentorial intracerebral haemorrhage (SICH) and to identify predictors of outcome including the use of invasive regional cortical cerebral blood flow (rCoBF) and microdialysis. Surgery consisted of craniotomy or decompressive craniectomy. The ventriculostomy for intracranial pressure (ICP) monitoring and drainage and regional cortical cerebral blood flow (rCoBF) and microdialysis were performed in all subjects. Pre and post operative information on subjects were collected. The study end points was functional outcome at 6 months based on a dichotomised Glasgow Outcome Scale (GOS).The selected clinical, radiological, biochemical and treatment factors that may influence the functional outcome were analysed for their significance. A total of 36 patients were recruited with 27(75%) patients had Glasgow Coma Score (GCS) between 5 to 8 on admission and 9(25%) were admitted with GCS of 9. At 6 months, 86 % had a poor or unfavourable outcome (GOS I–III) and 14% had good or favourable outcome (GOS IV–V). The mortality rate at 6 months was 55%. Univariate analysis for the functional outcome identified 2 significant variables, the midline shift (p=0.013) and mean lactate:pyruvate ratio (p=0.038). Multivariate analysis identified midline shift as the single significant independent predictor of functional outcome (p=0.013).Despite aggressive regional cortical cerebral blood flow (rCoBF) and microdialysis study for detection of early ischemia, surgical treatment for spontaneous intracerebral haemorrhage only benefited a small number of patients in terms of favourable outcome (14%) and in the majority of patients (86%), the outcome was unfavourable. Patients with midline shift > 5mm has almost 21 times higher chances (adj) OR 20.8 of being associated with poor outcome (GOS I–III). PMID:22589638

  16. Femtosecond-lentotomy treatment: six-month follow-up of in vivo treated rabbit lenses

    NASA Astrophysics Data System (ADS)

    Schumacher, S.; Fromm, M.; Oberheide, U.; Bock, P.; Imbschweiler, I.; Hoffmann, H.; Beineke, A.; Gerten, G.; Wegener, A.; Lubatschowski, H.

    2009-07-01

    Presbyopia is an age related effect which affects every human at the age of about 40 years. So far reading glasses are the conventional treatment. According to Helmholtz' theory of accommodation one of the mayor reasons for the development of presbyopia is the increasing sclerosis of the lens. In contrast to that the ciliary muscle and the lens capsule remain mostly active and elastic the whole life. So a possible treatment could be the increase of the flexibility of the lens by creating gliding planes with fs-laser pulses inside the lens tissue. In former studies it was shown that fs-laser pulses were able to increase the flexibility of ex vivo porcine lenses as well as ex vivo human donor lenses. Our current aim was to evaluate the effect of the fs-laser pulses on the crystalline lens of living rabbit eyes due to the fs-lentotomy treatment. The main focus of the evaluation was the exclusion of possible side effects of the treatment like cataract formation or retina damage. The treated eyes were monitored using optical coherence tomography (OCT) and Scheimpflug imaging for localizing and studying the tissue effects of the incisions. Furthermore histological sections of the lens and retina were prepared. The rabbits were investigated pre operatively and up to six months post operatively. The fs-laser induced micro incisions were successfully applied to the left lens of each rabbit. The micro incisions within the crystalline lens were detectable with OCT and Scheimpflug imaging up to six month. The imaging within the lens showed a progressive fading of the incisional opacities generated by the femtosecond laser during the six months and no indication of cataract formation was found. OCT and Scheimpflug images emphasize themselves as necessary tools to monitor the micro incisions over time. Histopathological sections of the lens tissue support the findings of the non invasive imaging techniques. Also the histopathological sections of the retina show no thermal

  17. Predictors of Treatment Failure 24 Months After Surgery For Stress Urinary Incontinence

    PubMed Central

    Richter, Holly E.; Diokno, Ananias; Kenton, Kimberly; Norton, Peggy; Albo, Michael; Kraus, Stephen; Moalli, Pamela; Chai, Toby C.; Zimmern, Philippe; Litman, Heather; Tennstedt, Sharon

    2009-01-01

    Purpose Identify baseline demographic and clinical factors associated with treatment failure after surgical treatment of stress urinary incontinence (SUI). Materials & Methods Data were obtained from 655 women randomized to Burch colposuspension or autologous rectus sling. Of those, 543 (83%) had stress failure status assessed at 24 months (269 Burch, 274 sling). Stress failure (n=261) was defined by any of the following: self-report of SUI by the Medical, Epidemiological, and Social Aspects of Aging (MESA) questionnaire, positive stress test, or re-treatment for SUI. Non-stress failure (n=66) was defined as positive 24-hr pad test (>15 ml) or any incontinent episodes by 3-day voiding diary with none of the three criteria for stress failure. Subjects not meeting any failure criteria were considered a treatment success (n=185). Adjusting for surgical treatment group and clinical site, logistic regression models were developed to predict the probability of treatment failure. Results Severity of urge incontinence symptoms (p=0.041), prolapse stage (p=0.013), and being post-menopausal without hormone therapy (p=0.023) were significant predictors for stress failure. Odds of non-stress failure quadrupled for every 10-point increase in MESA urge score (OR:3.93, CI:1.45,10.65) and decreased over 2 times for every 10-point increase in stress score (OR:0.36, CI:0.16,0.84). The associations of risk factors and failure remained similar regardless of surgical group. Conclusion Two years after surgery, risk factors for stress failure are similar after Burch and sling procedures and include greater baseline urge incontinence symptoms, more advanced prolapse, and menopausal not on HRT. Higher urge scores predicted failure by non stress-specific outcomes. PMID:18206917

  18. Utility of second generation line probe assay (Hain MTBDRplus) directly on 2-month sputa specimens to monitor tuberculosis treatment response.

    PubMed

    Rockwood, Neesha; Wojno, Justyna; Ghebrekristos, Yonas; Nicol, Mark P; Meintjes, Graeme; Wilkinson, Robert J

    2017-03-01

    The utility of line probe assay (Genotype MTBDRplus) performed directly on 2-month sputa to monitor tuberculosis treatment response is unknown. We assessed if direct testing of 2-month sputa with MTBDRplus can predict 2-month culture conversion and long-term treatment outcome. Xpert® MTB/RIF-confirmed rifampicin-susceptible tuberculosis cases were recruited at tuberculosis diagnosis and followed up at 2 and 5-6 months. MTBDRplus was performed directly on 2-month sputa and on all positive culture isolates at 2 and 5-6 months. We also investigated the association of a positive direct MTBDRplus at 2 months with subsequent unsuccessful tuberculosis treatment outcome (failure/death during treatment or subsequent disease recurrence).279 cases (62% HIV-1 co-infected) were recruited. Direct MTBDRplus at 2 months had a sensitivity of 78%(95%CI 65-87) and specificity of 80%(95%CI 74-84) to predict culture positivity at 2 months with a high negative predictive value of 93%(95%CI 89-96). Inconclusive genotypic susceptibility for both rifampicin and isoniazid were seen in 26% of MTDDRplus tests performed directly on sputum. When compared to a reference of MTBDRplus performed on positive cultures, the false positive resistance rate for direct testing of MTBDRplus on sputa was 4% for rifampicin and 2% for isoniazid. Whilst a positive 2-month smear was not significantly associated with an unsuccessful treatment outcome, (aOR 2.69, 95% CI 0.88-8.21), a positive direct MTBDRplus at 2 months was associated with an unsuccessful outcome (aOR 2.87, 95%CI 1.11-7.42). There is moderate utility of direct 2-month MTBDRplus to predict culture conversion at 2 months and also to predict an unfavorable outcome.

  19. Immunogenicity, safety, and antibody persistence at 3, 5, and 10 years postvaccination in adolescents randomized to booster immunization with a combined tetanus, diphtheria, 5-component acellular pertussis, and inactivated poliomyelitis vaccine administered with a hepatitis B virus vaccine concurrently or 1 month apart.

    PubMed

    Embree, Joanne; Law, Barbara; Voloshen, Tim; Tomovici, Antigona

    2015-03-01

    An understanding of the antibody persistence elicited by a combined tetanus, diphtheria, 5-component acellular pertussis, and inactivated poliovirus vaccine (Tdap-IPV) after adolescent vaccination is important to optimize booster dosing intervals. Our objectives were to compare the safety and immunogenicity of Tdap-IPV coadministered with hepatitis B vaccine (HepB) and sequential administration and evaluate humoral immunity at 3, 5, and 10 years after Tdap-IPV vaccination in adolescents. This phase II randomized, controlled, and open-label study enrolled 280 11- to 14-year-old adolescents with up to 10 years postvaccination follow-up. Group 1 (n = 145) received Tdap-IPV, followed by a HepB dose 1 month later, and group 2 (n = 135) received both vaccines simultaneously. No consistent increases in solicited reactions or unsolicited adverse events occurred with coadministration. All vaccinees attained seroprotective antibody levels at ≥0.01 IU/ml for diphtheria and tetanus, at a ≥1:8 dilution for poliovirus (serotypes 1, 2, and 3), and ≥10 mIU/ml for hepatitis B at 1 month postvaccination. Clinically relevant immunologic interactions did not occur with coadministration. For pertussis, all participants achieved seropositivity levels (at or above the lower limit of quantitation), and 72.7% to 95.8% had 4-fold increases in pertussis antibodies at 1 month postvaccination. At 10 years postvaccination, the remaining participants (62.8% of the original cohort) maintained seroprotective levels of ≥0.01 IU/ml for diphtheria and tetanus, a ≥1:8 dilution for all 3 poliovirus serotypes, and 74.1% to 98.2% maintained pertussis seropositivity levels depending on the antigen tested. There were no differences between the groups. These results support the coadministration of Tdap-IPV and HepB to adolescents and suggest that vaccination with Tdap-IPV can offer protection for 10 years after an adolescent booster vaccination.

  20. Immunogenicity, Safety, and Antibody Persistence at 3, 5, and 10 Years Postvaccination in Adolescents Randomized to Booster Immunization with a Combined Tetanus, Diphtheria, 5-Component Acellular Pertussis, and Inactivated Poliomyelitis Vaccine Administered with a Hepatitis B Virus Vaccine Concurrently or 1 Month Apart

    PubMed Central

    Embree, Joanne; Law, Barbara; Voloshen, Tim

    2014-01-01

    An understanding of the antibody persistence elicited by a combined tetanus, diphtheria, 5-component acellular pertussis, and inactivated poliovirus vaccine (Tdap-IPV) after adolescent vaccination is important to optimize booster dosing intervals. Our objectives were to compare the safety and immunogenicity of Tdap-IPV coadministered with hepatitis B vaccine (HepB) and sequential administration and evaluate humoral immunity at 3, 5, and 10 years after Tdap-IPV vaccination in adolescents. This phase II randomized, controlled, and open-label study enrolled 280 11- to 14-year-old adolescents with up to 10 years postvaccination follow-up. Group 1 (n = 145) received Tdap-IPV, followed by a HepB dose 1 month later, and group 2 (n = 135) received both vaccines simultaneously. No consistent increases in solicited reactions or unsolicited adverse events occurred with coadministration. All vaccinees attained seroprotective antibody levels at ≥0.01 IU/ml for diphtheria and tetanus, at a ≥1:8 dilution for poliovirus (serotypes 1, 2, and 3), and ≥10 mIU/ml for hepatitis B at 1 month postvaccination. Clinically relevant immunologic interactions did not occur with coadministration. For pertussis, all participants achieved seropositivity levels (at or above the lower limit of quantitation), and 72.7% to 95.8% had 4-fold increases in pertussis antibodies at 1 month postvaccination. At 10 years postvaccination, the remaining participants (62.8% of the original cohort) maintained seroprotective levels of ≥0.01 IU/ml for diphtheria and tetanus, a ≥1:8 dilution for all 3 poliovirus serotypes, and 74.1% to 98.2% maintained pertussis seropositivity levels depending on the antigen tested. There were no differences between the groups. These results support the coadministration of Tdap-IPV and HepB to adolescents and suggest that vaccination with Tdap-IPV can offer protection for 10 years after an adolescent booster vaccination. PMID:25540274

  1. A combined Haemophilus influenzae type B Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when coadministered with diphtheria, tetanus, acellular pertussis hepatitis B-inactivated poliovirus at 3, 5 and 11 months of age: results of an open, randomized, controlled study.

    PubMed

    Vesikari, Timo; Forstén, Aino; Desole, Maria Guiseppina; Ferrera, Giuseppe; Caubet, Magalie; Mesaros, Narcisa; Boutriau, Dominique

    2013-05-01

    This study evaluated the immunogenicity, reactogenicity and safety of the combined Haemophilus influenzae type B Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) coadministered with diphtheria, tetanus, acellular pertussis hepatitis B-inactivated poliovirus (DTPa-HBV-IPV) as 2 primary and 1 booster doses at 3, 5 and 11 months of age. In this phase III open study (NCT00327184), 709 infants were randomized in 2 parallel groups (1:1) to receive either Hib-MenC-TT coadministered with DTPa-HBV-IPV or control vaccines (MenC-TT coadministered with DTPa-HBV-IPV/Hib). Serum bactericidal activity for MenC (rSBA-MenC) and antibody concentrations against polyribosylribitol phosphate from Hib (anti-PRP) and hepatitis B (anti-HBs) were measured at 1 month after dose 2, before booster and 1 month after booster dose. Solicited (local/general) and unsolicited symptoms were assessed up to 4 and 31 days, respectively, after each vaccination. Serious adverse events were recorded throughout the study. One month after dose 2, high percentages of infants in both groups had rSBA-MenC titers ≥ 8 (≥ 99.1%), anti-PRP concentrations ≥ 0.15 μg/mL (≥ 96.5%) and anti-HBs concentrations ≥ 10 mIU/mL (≥ 95.3%), which persisted up to the booster vaccination (≥ 94.5%, ≥ 86.1%, ≥ 94.2%) and increased again after the booster dose (100%, 100%, ≥ 99%). Exploratory analyses indicated that rSBA-MenC geometric mean titers were lower and anti-PRP geometric mean concentrations were higher in the infants vaccinated with Hib-MenC-TT compared with the control vaccines at all time points. The safety profiles of the coadministered vaccines were similar in both groups. The Hib-MenC-TT and DTPa-HBV-IPV vaccines are immunogenic with a clinically acceptable safety profile when coadministered as 2 primary doses during infancy and 1 booster dose at 11 months of age.

  2. Three month treatment of reactive arthritis with azithromycin: a EULAR double blind, placebo controlled study

    PubMed Central

    Kvien, T; Gaston, J; Bardin, T; Butrimiene, I; Dijkmans, B; Leirisalo-Repo, M; Solakov, P; Altwegg, M; Mowinckel, P; Plan, P; Vischer, T

    2004-01-01

    Objective: To determine the efficacy of weekly treatment with oral azithromycin for 13 weeks on the severity and resolution of reactive arthritis (ReA). Methods: 186 patients from 12 countries were enrolled in a randomised, double blind, placebo controlled trial. Inclusion criteria were inflammatory arthritis of ⩽6 swollen joints, and disease duration of ⩽2 months. All patients received a single azithromycin dose (1 g) as conventional treatment for possible Chlamydia infection, and were then randomly allocated to receive weekly azithromycin or placebo. Clinical assessments were made at 4 week intervals for 24 weeks. Results: 152 patients were analysable (34 failed entry criteria), with a mean (SD) age of 33.8 (9.4) and duration of symptoms 30.7 (17.5) days. Mean C reactive protein (CRP) was 48 mg/l, and ∼50% of those typed were HLA-B27+, suggesting that the inclusion criteria successfully recruited patients with acute ReA. Treatment and placebo groups were well matched for baseline characteristics. There were no statistical differences for changes in any end point (swollen and tender joint count, joint pain, back pain, heel pain, physician and patient global assessments, and CRP) between the active treatment and placebo groups, analysed on an intention to treat basis or according to protocol completion. The time to resolution of arthritis and other symptoms or signs by life table analyses was also not significantly different. Adverse events were generally mild, but were more commonly reported in the azithromycin group. Conclusions: This large trial has demonstrated that prolonged treatment with azithromycin is ineffective in ReA. PMID:15308521

  3. Aripiprazole once-monthly long-acting injectable for the treatment of schizophrenia.

    PubMed

    Potkin, Steven G; Preda, Adrian

    2016-01-01

    Patient non-adherence increases the risk for relapse and the long-term care of schizophrenia. Long-acting injectable (LAI) antipsychotics can decrease this risk by ensuring adherence. An extended formulation, aripiprazole 400 mg once-monthly (AOM 400) LAI (AOM LAI), received regulatory approval in the year 2013 for the treatment of schizophrenia. AOM LAI is the first dopamine D2 partial agonist available in a long-acting formulation for the treatment of schizophrenia. This review covers data on the efficacy and tolerability/safety of AOM LAI. AOM LAI is a lyophilized powder of aripiprazole, with an elimination half-life of 29.9 - 46.5 days, allowing for a 4-week injection interval. Antipsychotic efficacy was documented in a 12-week double-blind trial (n = 340) and in two maintenance-of-effect trials: a 38-week trial (n = 662) and a 52-week trial (n = 403). The side effect profile is similar to that of oral aripiprazole. Adverse events (≥5% and at least twice that for placebo) were typically mild or moderate and did not lead to discontinuation: increased weight, akathisia, injection site pain and sedation. The 400 mg dose is tolerated by >90% of patients. Injection does not require additional training of health personnel or post-injection observation. AOM LAI is an efficacious and well-tolerated antipsychotic treatment for schizophrenia.

  4. 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

  5. Cost-effectiveness of 3-month paliperidone treatment for chronic schizophrenia in Spain.

    PubMed

    Einarson, Thomas R; Bereza, Basil G; Garcia Llinares, Ignacio; González Martín Moro, Beatriz; Tedouri, Fadi; Van Impe, Kristel

    2017-10-01

    A 3-month long treatment of paliperidone palmitate (PP3M) has been introduced as an option for treating schizophrenia. Its cost-effectiveness in Spain has not been established. To compare the costs and effects of PP3M compared with once-monthly paliperidone (PP1M) from the payer perspective in Spain. This study used the recently published trial by Savitz et al. as a core model over 1 year. Additional data were derived from the literature. Costs in 2016 Euros were obtained from official lists and utilities from Osborne et al. The authors conducted both cost-utility and cost-effectiveness analyses. For the former, the incremental cost per quality-adjusted life-year (QALY) gained was calculated. For the latter, the outcomes were relapses and hospitalizations avoided. To assure the robustness of the analyses, a series of 1-way and probability sensitivity analyses were conducted. The expected cost was lower with PP3M (4,780€) compared with PP1M (5,244€). PP3M had the fewest relapses (0.080 vs 0.161), hospitalizations (0.034 v.s 0.065), and emergency room visits (0.045 v.s 0.096) and the most QALYs (0.677 v.s 0.625). In both cost-effectiveness and cost-utility analyses, PP3M dominated PP1M. Sensitivity analyses confirmed base case findings. For the primary analysis (cost-utility), PP3M dominated PP1M in 46.9% of 10,000 simulations and was cost-effective at a threshold of 30,000€/QALY gained. PP3M dominated PP1M in all analyses and was, therefore, cost-effective for treating chronic relapsing schizophrenia in Spain. For patients who require long-acting therapy, PP3M appears to be a good alternative anti-psychotic treatment.

  6. Administration of 3,5-diiodothyronine (3,5-T2) causes central hypothyroidism and stimulates thyroid-sensitive tissues.

    PubMed

    Padron, Alvaro Souto; Neto, Ruy Andrade Louzada; Pantaleão, Thiago Urgal; de Souza dos Santos, Maria Carolina; Araujo, Renata Lopes; de Andrade, Bruno Moulin; da Silva Leandro, Monique; de Castro, João Pedro Saar Werneck; Ferreira, Andrea Claudia Freitas; de Carvalho, Denise Pires

    2014-06-01

    In general, 3,5-diiodothyronine (3,5-T2) increases the resting metabolic rate and oxygen consumption, exerting short-term beneficial metabolic effects on rats subjected to a high-fat diet. Our aim was to evaluate the effects of chronic 3,5-T2 administration on the hypothalamus-pituitary-thyroid axis, body mass gain, adipose tissue mass, and body oxygen consumption in Wistar rats from 3 to 6 months of age. The rats were treated daily with 3,5-T2 (25, 50, or 75 μg/100 g body weight, s.c.) for 90 days between the ages of 3 and 6 months. The administration of 3,5-T2 suppressed thyroid function, reducing not only thyroid iodide uptake but also thyroperoxidase, NADPH oxidase 4 (NOX4), and thyroid type 1 iodothyronine deiodinase (D1 (DIO1)) activities and expression levels, whereas the expression of the TSH receptor and dual oxidase (DUOX) were increased. Serum TSH, 3,3',5-triiodothyronine, and thyroxine were reduced in a 3,5-T2 dose-dependent manner, whereas oxygen consumption increased in these animals, indicating the direct action of 3,5-T2 on this physiological variable. Type 2 deiodinase activity increased in both the hypothalamus and the pituitary, and D1 activities in the liver and kidney were also increased in groups treated with 3,5-T2. Moreover, after 3 months of 3,5-T2 administration, body mass and retroperitoneal fat pad mass were significantly reduced, whereas the heart rate and mass were unchanged. Thus, 3,5-T2 acts as a direct stimulator of energy expenditure and reduces body mass gain; however, TSH suppression may develop secondary to 3,5-T2 administration. © 2014 The authors.

  7. Aripiprazole once-monthly as treatment for psychosis in Turner syndrome: literature review and case report.

    PubMed

    Carlone, Cristiano; Pompili, Enrico; Silvestrini, Cristiana; Nicolò, Giuseppe

    2016-01-01

    Turner syndrome (TS) is a neurogenetic disorder characterized by partial or complete monosomy-X, usually resulting of a sporadic chromosomal nondisjunction. It is one of the most common sex chromosome abnormalities, affecting approximately 1 in 2,000 live born females. There are sporadic few case reports of concomitant TS with schizophrenia worldwide. No defined psychiatric condition has been traditionally related to TS, and it is not mentioned in DSM-IV. Although it is not associated with any psychiatric syndrome, several case reports in the literature describe a similar constellation of symptoms in TS that may represent a biologically-based entity. Aripiprazole once-monthly is a second generation antipsychotic recently developed. Its efficacy and non-inferiority to oral aripiprazole have been demonstrated in preventing relapse in patients with schizophrenia. Experience with oral aripiprazole and the current availability of the long-acting formulation suggest a potential benefit in a variety of clinical scenarios and therefore consideration as a treatment option in the treatment of schizophrenia and psychotic symptoms in several disease like TS.

  8. Aripiprazole Once-Monthly in the Treatment of Acute Psychotic Episodes in Schizophrenia

    PubMed Central

    Ismail, Zahinoor; Peters-Strickland, Timothy; Miguelez, Maia; Baker, Ross A.; Hertel, Peter; Eramo, Anna; Jin, Na; Perry, Pamela; Sanchez, Raymond; McQuade, Robert D.; Kane, John M.

    2017-01-01

    Abstract Background Long-acting injectable antipsychotics are treatment options for acute and long-term treatment of patients with schizophrenia. In a previously published 12-week randomized, double-blind, placebo-controlled clinical trial of patients with schizophrenia experiencing an acute psychotic episode, aripiprazole once-monthly 400 mg (AOM 400) produced significantly greater improvement than placebo on the primary endpoint, Positive and Negative Syndrome Scale (PANSS) total score at week 10. Methods To examine the efficacy of AOM 400 across a broader representation of schizophrenia symptoms, including agitation, a post hoc analysis of this trial was carried out to assess the change in PANSS Marder factor domains (positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression) and the PANSS excited component (equivalent to Marder factor domain uncontrolled hostility/excitement plus the tension item) by comparing differences in change from baseline between AOM 400 and placebo using a mixed model for repeated measures. Results The differences between treatment and placebo for all factors were statistically significant, with improvements seen as early as week 1 or 2, and maintained through week 12. Thus, AOM 400, supplemented with oral aripiprazole in the first 2 weeks, showed significantly greater efficacy versus placebo in acutely ill patients with schizophrenia in all 5 Marder illness domains, as well as in agitation as conceptualized by the PANSS excited component score. Conclusions These findings indicate that AOM 400 is efficacious across the spectrum of schizophrenia symptoms in acutely ill patients, with implications for both short-term and, by extension, long-term patient outcomes. PMID:28383362

  9. Treatment Outcomes of Primary Molars Direct Pulp Capping after 20 Months: A Randomized Controlled Trial

    PubMed Central

    Fallahinejad Ghajari, Masoud; Asgharian Jeddi, Tahereh; Iri, Sonay; Asgary, Saeed

    2013-01-01

    Introduction The aim of this randomized controlled trial was to compare the radiographic and clinical success rates of direct pulp capping (DPC) using ProRoot mineral trioxide aggregate (MTA) or calcium enriched mixture (CEM). Methods and Materials A total of 42 symptom-free carious vital primary molars (21 pairs) were selected in this split mouth trial and randomly pulpotomized in two experimental groups. Pinpoint pulp exposures were covered by the same blinded operator with MTA or CEM, and then restored by amalgam. Radiographic and clinical successes were evaluated at 20 month follow-up. Data were statistically analyzed using McNemar test. Results Nineteen patients were available for 20-month follow-up; only one failed tooth was extracted in the CEM group. All available teeth were symptom-free, however, the final evaluated success rate was 89% in CEM (CI 95%: 0.82-0.96) and 95% in MTA (CI 95%: 0.85-1) groups without statistical difference (P=0.360). Worst case scenario was applied for missing value analysis; assuming that the 2 lost cases in CEM group had failed and the only lost case in MTA group was due to treatment success, as a result the success of CEM and MTA were 81% (CI 95%: 0.72-0.90) and 95% (CI 95%:0.85-1), respectively, with no statistical difference (P=0.078). In the reverse scenario, the success of MTA and CEM were 86% (CI 95%: 0.78-0.94) and 90% (CI 95%: 0.82-0.98), respectively; again with no statistical difference (P=0.479). Conclusion Effectiveness of MTA and CEM biomaterials for primary molars’ DPC was similar; CEM can be a suitable alternative for MTA. PMID:24171019

  10. Cost-effectiveness of aripiprazole once-monthly compared with paliperidone palmitate once-monthly injectable for the treatment of schizophrenia in the United States.

    PubMed

    Citrome, Leslie; Kamat, Siddhesh A; Sapin, Christophe; Baker, Ross A; Eramo, Anna; Ortendahl, Jesse; Gutierrez, Benjamin; Hansen, Karina; Bentley, Tanya G K

    2014-08-01

    To develop a decision-analytic model to estimate the cost-effectiveness of initiating maintenance treatment with aripiprazole once-monthly (AOM) vs paliperidone long-acting injectable (PLAI) once-monthly among patients with schizophrenia in the US. A decision-analytic model was developed to evaluate a hypothetical cohort of patients initiating maintenance treatment with AOM or PLAI. Rates of relapse, adverse events (AEs), and direct medical costs were estimated for 1 year. Patients either remained on initial treatment or discontinued treatment due to lack of efficacy, AEs, or other reasons, including non-adherence. Data from placebo-controlled pivotal trials and product prescribing information (PI) were used to estimate treatment efficacy and AEs. Analyses were performed assuming dosing of clinical trials, real-world practice, PIs, and highest therapeutic dose available, because of variation in practice settings. The main outcome of interest was incremental cost per schizophrenia hospitalization averted with AOM vs PLAI. Based on placebo-controlled pivotal trials' dosing, AOM improved clinical outcomes by reducing schizophrenia relapses vs PLAI (0.181 vs 0.277 per person per year [pppy]) at an additional cost of US$1276 pppy, resulting in an incremental cost-effectiveness ratio (ICER) of US$13,280/relapse averted. When PI dosing was assumed, this ICER increased to US$19,968/relapse averted. When real-world dosing and highest available dosing were assumed, AOM was associated with fewer relapses and lower overall treatment costs vs PLAI. AOM consistently provided favorable clinical benefits. Under various dosing scenarios, AOM results indicated fewer relapses at lower overall costs or a reasonable cost-effectiveness threshold (i.e., less than the cost of a hospitalization relapse) vs PLAI. Given the heterogeneous nature of schizophrenia and variability in treatment response, health plans may consider open access for treatments like AOM. Since model inputs were based

  11. Administration of 3,5-diiodothyronine (3,5-T2) causes central hypothyroidism and stimulates thyroid-sensitive tissues

    PubMed Central

    Padron, Alvaro Souto; Neto, Ruy Andrade Louzada; Pantaleão, Thiago Urgal; de Souza dos Santos, Maria Carolina; Araujo, Renata Lopes; de Andrade, Bruno Moulin; da Silva Leandro, Monique; de Castro, João Pedro Saar Werneck; Ferreira, Andrea Claudia Freitas; de Carvalho, Denise Pires

    2014-01-01

    In general, 3,5-diiodothyronine (3,5-T2) increases the resting metabolic rate and oxygen consumption, exerting short-term beneficial metabolic effects on rats subjected to a high-fat diet. Our aim was to evaluate the effects of chronic 3,5-T2 administration on the hypothalamus–pituitary–thyroid axis, body mass gain, adipose tissue mass, and body oxygen consumption in Wistar rats from 3 to 6 months of age. The rats were treated daily with 3,5-T2 (25, 50, or 75 μg/100 g body weight, s.c.) for 90 days between the ages of 3 and 6 months. The administration of 3,5-T2 suppressed thyroid function, reducing not only thyroid iodide uptake but also thyroperoxidase, NADPH oxidase 4 (NOX4), and thyroid type 1 iodothyronine deiodinase (D1 (DIO1)) activities and expression levels, whereas the expression of the TSH receptor and dual oxidase (DUOX) were increased. Serum TSH, 3,3′,5-triiodothyronine, and thyroxine were reduced in a 3,5-T2 dose-dependent manner, whereas oxygen consumption increased in these animals, indicating the direct action of 3,5-T2 on this physiological variable. Type 2 deiodinase activity increased in both the hypothalamus and the pituitary, and D1 activities in the liver and kidney were also increased in groups treated with 3,5-T2. Moreover, after 3 months of 3,5-T2 administration, body mass and retroperitoneal fat pad mass were significantly reduced, whereas the heart rate and mass were unchanged. Thus, 3,5-T2 acts as a direct stimulator of energy expenditure and reduces body mass gain; however, TSH suppression may develop secondary to 3,5-T2 administration. PMID:24692290

  12. Upper Airway Stimulation for Obstructive Sleep Apnea: Durability of the Treatment Effect at 18 Months

    PubMed Central

    Strollo, Patrick J.; Gillespie, M. Boyd; Soose, Ryan J.; Maurer, Joachim T.; de Vries, Nico; Cornelius, Jason; Hanson, Ronald D.; Padhya, Tapan A.; Steward, David L.; Woodson, B. Tucker; Verbraecken, Johan; Vanderveken, Olivier M.; Goetting, Mark G.; Feldman, Neil; Chabolle, Frédéric; Badr, M. Safwan; Randerath, Winfried; Strohl, Kingman P.

    2015-01-01

    Objective: To determine the stability of improvement in polysomnographic measures of sleep disordered breathing, patient reported outcomes, the durability of hypoglossal nerve recruitment and safety at 18 months in the Stimulation Treatment for Apnea Reduction (STAR) trial participants. Design: Prospective multicenter single group trial with participants serving as their own controls. Setting: Twenty-two community and academic sleep medicine and otolaryngology practices. Measurements: Primary outcome measures were the apnea-hypopnea index (AHI) and the 4% oxygen desaturation index (ODI). Secondary outcome measures were the Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire (FOSQ), and oxygen saturation percent time < 90% during sleep. Stimulation level for each participant was collected at three predefined thresholds during awake testing. Procedure- and/or device-related adverse events were reviewed and coded by the Clinical Events Committee Results: The median AHI was reduced by 67.4% from the baseline of 29.3 to 9.7/h at 18 mo. The median ODI was reduced by 67.5% from 25.4 to 8.6/h at 18 mo. The FOSQ and ESS improved significantly at 18 mo compared to baseline values. The functional threshold was unchanged from baseline at 18 mo. Two participants experienced a serious device-related adverse event requiring neurostimulator repositioning and fixation. No tongue weakness reported at 18 mo. Conclusion: Upper airway stimulation via the hypoglossal nerve maintained a durable effect of improving airway stability during sleep and improved patient reported outcomes (Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire) without an increase of the stimulation thresholds or tongue injury at 18 mo of follow-up. Citation: Strollo PJ, Gillespie MB, Soose RJ, Maurer JT, de Vries N, Cornelius J, Hanson RD, Padhya TA, Steward DL, Woodson BT, Verbraecken J, Vanderveken OM, Goetting MG, Feldman N, Chabolle F, Badr MS, Randerath W

  13. Effect of 1% sodium alendronate in the non-surgical treatment of periodontal intraosseous defects: a 6-month clinical trial.

    PubMed

    Dutra, Bernardo Carvalho; Oliveira, Alcione Maria Soares Dutra; Oliveira, Peterson Antônio Dutra; Manzi, Flavio Ricardo; Cortelli, Sheila Cavalca; Cota, Luís Otávio de Miranda; Costa, Fernando Oliveira

    2017-01-01

    Few studies have evaluated the effect of the topical application of sodium alendronate (ALN) on the treatment of intrabuccal bone defects, especially those caused by periodontitis. This 6-month randomized placebo controlled clinical trial aimed at evaluating the effect of non-surgical periodontal treatment associated with the use of 1% ALN, through clinical evaluations and cone-beam computed tomography (CBCT). Twenty individuals with chronic periodontitis underwent periodontal examination at the baseline as well as 3 and 6 months after periodontal treatment, registering clinical attachment level (CAL), periodontal probing depth (PPD), and bleeding on probing (BOP) as the clinical outcomes. After manual scaling and root planing, 40 bilateral sites with interproximal vertical bone defects were randomly treated with either 1% ALN gel or a placebo. Bone defects were evaluated through CBCT at the baseline and 6 months post-treatment. The clinical and CBCT parameters were compared using the Wilcoxon and Friedman tests (p<0.05). Although ALN produced a greater CAL gain when compared to the placebo at 6 months post-treatment (p=0.021), both treatments produced similar effects on the PPD, BOP, and bone height. Significant differences in bone fill were observed only in patients of the ALN group (4.5 to 3.8 mm; p=0.003) at 6 months post-treatment. Topical application of 1% ALN might be a beneficial adjuvant to non-surgical periodontal therapy.

  14. Effect of 1% sodium alendronate in the non-surgical treatment of periodontal intraosseous defects: a 6-month clinical trial

    PubMed Central

    DUTRA, Bernardo Carvalho; OLIVEIRA, Alcione Maria Soares Dutra; OLIVEIRA, Peterson Antônio Dutra; MANZI, Flavio Ricardo; CORTELLI, Sheila Cavalca; COTA, Luís Otávio de Miranda; COSTA, Fernando Oliveira

    2017-01-01

    Abstract Background and objectives Few studies have evaluated the effect of the topical application of sodium alendronate (ALN) on the treatment of intrabuccal bone defects, especially those caused by periodontitis. This 6-month randomized placebo controlled clinical trial aimed at evaluating the effect of non-surgical periodontal treatment associated with the use of 1% ALN, through clinical evaluations and cone-beam computed tomography (CBCT). Material and Methods Twenty individuals with chronic periodontitis underwent periodontal examination at the baseline as well as 3 and 6 months after periodontal treatment, registering clinical attachment level (CAL), periodontal probing depth (PPD), and bleeding on probing (BOP) as the clinical outcomes. After manual scaling and root planing, 40 bilateral sites with interproximal vertical bone defects were randomly treated with either 1% ALN gel or a placebo. Bone defects were evaluated through CBCT at the baseline and 6 months post-treatment. The clinical and CBCT parameters were compared using the Wilcoxon and Friedman tests (p<0.05). Results Although ALN produced a greater CAL gain when compared to the placebo at 6 months post-treatment (p=0.021), both treatments produced similar effects on the PPD, BOP, and bone height. Significant differences in bone fill were observed only in patients of the ALN group (4.5 to 3.8 mm; p=0.003) at 6 months post-treatment. Conclusions Topical application of 1% ALN might be a beneficial adjuvant to non-surgical periodontal therapy. PMID:28678950

  15. Intragastric balloon for obesity treatment: results of a multicentric evaluation for balloons left in place for more than 6 months.

    PubMed

    Genco, Alfredo; Maselli, Roberta; Frangella, Francesca; Cipriano, Massimiliano; Forestieri, Pietro; Delle Piane, Daniela; Furbetta, Francesco; Micheletto, Giancarlo; Ciampaglia, Franco; Granelli, Paola; Zilli, Maurizio; Lorenzo, Michele; Di Rocco, Giorgio; Giannotti, Domenico; Redler, Adriano

    2015-08-01

    Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months. A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected. Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded. Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.

  16. Controlled clinical trials of cell therapy in stroke: Meta-analysis at six months after treatment.

    PubMed

    Detante, Olivier; Moisan, Anaïck; Hommel, Marc; Jaillard, Assia

    2017-10-01

    Background Cell therapy is promising in experimental studies and has been assessed only in a few studies on humans. Aims To evaluate the effect of cell therapy in humans. Methods We included clinical trials with a control group that reported safety and efficacy six months following treatment. Quality was evaluated and clinical scales data were extracted. Quantitative analysis was based on the standardized means difference (SMD). Among 28 trials published from 1995 to 2016, nine studies (194 patients; 191 controls) were eligible. Publication biases were assessed with the funnel plot and pre-specified explanatory variables were tested with a group analysis and a meta-regression. Results The overall quality was moderate. Cell therapy had a positive effect on the outcome (SMD: 0.57, 95% CI: 0.22-0.92; p = 0.002). The sensitivity analysis showed an upper level of effect size of 0.81 (95% CI: 0.34-1.27; p = 0.001) and a lower level of 0.455 (95% CI: 0.04-0.87; p = 0.03). None of the pre-specified explanatory variable was significantly correlated to outcome: age, ratio infarction/hemorrhage, delay from stroke to treatment, route of administration, cell type, randomization, and blinded outcome assessment. The significant heterogeneity (p = 0.03) was not explained by publication biases (p = 0.09) and was more likely due to methodological and quality differences between the trials. Conclusions This result suggests that cell therapy is beneficial in stroke and is expected to help in the designing of stem cells controlled clinical trials (CCT) in large populations.

  17. Monthly survey of N-nitrosamine yield in a conventional water treatment plant in North China.

    PubMed

    Wang, Chengkun; Liu, Shuming; Wang, Jun; Zhang, Xiaojian; Chen, Chao

    2015-12-01

    A sampling campaign was conducted monthly to investigate the occurrence of N-nitrosamines at a conventional water treatment plant in one city in North China. The yield of N-nitrosamines in the treated water indicated precursors changed greatly after the source water switching. Average concentrations of N-nitrosodimethylamine (NDMA), N-nitrosomorpholine (NMOR), and N-nitrosopyrrolidine (NPYR) in the finished water were 6.9, 3.3, and 3.1ng/L, respectively, from June to October when the Luan River water was used as source water, while those of NDMA, N-nitrosomethylethylamine (NMEA), and NPYR in the finished water were 10.1, 4.9, and 4.7ng/L, respectively, from November to next April when the Yellow River was used. NDMA concentration in the finished water was frequently over the 10ng/L, i.e., the notification level of California, USA, which indicated a considerable threat to public health. Weak correlations were observed between N-nitrosamine yield and typical water quality parameters except for the dissolved organic nitrogen.

  18. [The drug of the month: everolimus (Afinitor) for the treatment of metastatic breast cancer].

    PubMed

    Jerusalem, G; Rorive, A; Collignon, J

    2014-09-01

    Sequential endocrine treatments are recommended for estrogen receptor (ER) positive human epidermal growth factor receptor 2 (HER 2) negative metastatic breast cancers except in the case of symptomatic visceral disease. However, patients who suffer from disease progression while receiving a non-steroidal aromatase inhibitor (NSAI) have a very poor prognosis with standard endocrine therapy alone. Recently, based onthe results of the BOLERO 2 trial, the mammalian target of rapamycin (mTOR) inhibitor everolimus, combined with exemestane, a steroidal aromatase inhibitor, has been approved in Europe and the US for patients suffering from ER positive HER2 negative advanced breast cancer previously treated by a NSAI. The median progression-free survival (PFS) increased from 3.2 to 7.8 months in patients receiving everolimus and exemestane compared to placebo and exemestane. The magnitude of benefit was consistent in all pre-specified subgroups. Side effects were manageable and the quality of life was at least maintained. Everolimus has also beenrecently studied in HER2 positive locally advanced or metastatic disease in heavily pretreated patients (BOLERO 3 trial). This trial met its primary endpoint. The median PFS was increased in patients receiving trastuzumab, vinorelbine and everolimus compared to patients receiving trastuzumab, vinorelbine and placebo. We review pharmacological data and side effects of the drug. We also review the most important clinical trials leading to reimbursement of everolimus in metastatic breast cancer.

  19. Occipital nerve stimulation for the treatment of chronic cluster headache - lessons learned from 18 months experience.

    PubMed

    Mueller, O M; Gaul, C; Katsarava, Z; Diener, H C; Sure, U; Gasser, T

    2011-05-01

    Neuromodulation has been recognized as a valuable surgical treatment option for patients with refractory chronic cluster headache (CCH). Due to the small number of afflicted individuals, the knowledge about this specific therapy is limited. In this study, we present our experiences with bilateral occipital nerve stimulation (ONS) in patients with CCH focusing on patient selection, pre- and postoperative evaluation, surgical procedures, and outcome. Since December 2008, 10 patients with CCH have been treated with ONS at our department. Patients were recruited and clinically followed by a neurologist and a neurosurgeon. Baseline data records on frequency, intensity, and duration of attacks as well as the use of medication were assessed with a 30-day diary. Standardized questionnaires were used pre- and postoperatively and during the follow-up on a regular basis. Surgical procedure and stimulation parameters were standardized for all patients. Lead implantation was followed by a test period of 30 days prior to implantation of the permanent generator. Mean follow-up time was 12 months (range 3-18). All patients responded to the stimulation treatment. Frequency, duration, and severity of the cluster attacks were reduced in 90% of the patients. One patient had a significant reduction of his concomitant tension headache. 70 % of the patients needed less medication during the attacks. All patients reported an improvement in their quality of life. The SF-36 showed a tendency toward objective improvement in the field of psychological comfort. As a major adverse event, one generator had to be exchanged due to a local infection. Another patient had to be reoperated due to a scar tissue formation around the thoracic connector. ONS is a valuable tool in the treatment of patients with refractory CCH. According to our data, the potential side effects and complication rates of the operation are small. With a meticulous selection of patients by an interdisciplinary team, CCH can

  20. Delinquent Behavior and Emerging Substance Use in the MTA at 36 Months: Prevalence, Course, and Treatment Effects

    ERIC Educational Resources Information Center

    Molina, Brooke S. G.; Flory, Kate; Hinshaw, Stephen P.; Greiner, Andrew R.; Arnold, L. Eugene; Swanson, James M.; Hechtman, Lily; Jensen, Peter S.; Vitiello, Benedetto; Hoza, Betsy; Pelham, William E.; Elliott, Glen R.; Wells, Karen C.; Abikoff, Howard B.; Gibbons, Robert D.; Marcus, Sue; Conners, C. Keith; Epstein, Jeffery N.; Greenhill, Laurence L.; March, John S.; Newcorn, Jeffrey H.; Severe, Joanne B.; Wigal, Timothy

    2007-01-01

    Objective: To compare delinquent behavior and early substance use between the children in the Multimodal Treatment Study of Children With ADHD (MTA; N = 487) and those in a local normative comparison group (n = 272) at 24 and 36 months postrandomization and to test whether these outcomes were predicted by the randomly assigned treatments and…

  1. Delinquent Behavior and Emerging Substance Use in the MTA at 36 Months: Prevalence, Course, and Treatment Effects

    ERIC Educational Resources Information Center

    Molina, Brooke S. G.; Flory, Kate; Hinshaw, Stephen P.; Greiner, Andrew R.; Arnold, L. Eugene; Swanson, James M.; Hechtman, Lily; Jensen, Peter S.; Vitiello, Benedetto; Hoza, Betsy; Pelham, William E.; Elliott, Glen R.; Wells, Karen C.; Abikoff, Howard B.; Gibbons, Robert D.; Marcus, Sue; Conners, C. Keith; Epstein, Jeffery N.; Greenhill, Laurence L.; March, John S.; Newcorn, Jeffrey H.; Severe, Joanne B.; Wigal, Timothy

    2007-01-01

    Objective: To compare delinquent behavior and early substance use between the children in the Multimodal Treatment Study of Children With ADHD (MTA; N = 487) and those in a local normative comparison group (n = 272) at 24 and 36 months postrandomization and to test whether these outcomes were predicted by the randomly assigned treatments and…

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. A Six-Month Randomized Controlled Trial of Exercise and Pyridostigmine in the Treatment of Fibromyalgia

    PubMed Central

    Jones, K. D.; Burckhardt, C. S.; Deodhar, A. A.; Perrin, N. A.; Hanson, G. C.; Bennett, R. M.

    2008-01-01

    Objective A subset of fibromyalgia (FM) patients have a dysfunctional hypothalamic–pituitary–insulin-like growth factor 1 (IGF-1) axis, as evidenced by low serum levels of IGF-1 and a reduced growth hormone (GH) response to physiologic stimuli. There is evidence that pyridostigmine (PYD) improves the acute response of GH to exercise in FM patients. The purpose of this study was to evaluate the clinical effectiveness of 6 months of PYD and group exercise on FM symptoms. Methods FM patients were randomized to 1 of the following 4 groups: PYD plus exercise, PYD plus diet recall but no exercise, placebo plus exercise, and placebo plus diet recall but no exercise. The primary outcome measures were the visual analog scale (VAS) score for pain, tender point count, and total myalgic score. Secondary outcome measures were the total score on the Fibromyalgia Impact Questionnaire (FIQ) and FIQ VAS scores for individual symptoms (fatigue, poor sleep, stiffness, and anxiety), as well as quality of life (QOL) and physical fitness (lower body strength/endurance, upper and lower body flexibility, balance, and time on the treadmill). Results A total of 165 FM patients completed baseline measurements; 154 (93.3%) completed the study. The combination of PYD and exercise did not improve pain scores. PYD groups showed a significant improvement in sleep and anxiety in those who completed the study and in QOL in those who complied with the therapeutic regimen as compared with the placebo groups. Compared with the nonexercise groups, the 2 exercise groups demonstrated improvement in fatigue and fitness. PYD was generally well tolerated. Conclusion Neither the combination of PYD plus supervised exercise nor either treatment alone yielded improvement in most FM symptoms. However, PYD did improve anxiety and sleep, and exercise improved fatigue and fitness. We speculate that PYD may have improved vagal tone, thus benefiting sleep and anxiety; this notion warrants further study. PMID

  8. 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.

  9. Upper Airway Stimulation for Obstructive Sleep Apnea: Durability of the Treatment Effect at 18 Months.

    PubMed

    Strollo, Patrick J; Gillespie, M Boyd; Soose, Ryan J; Maurer, Joachim T; de Vries, Nico; Cornelius, Jason; Hanson, Ronald D; Padhya, Tapan A; Steward, David L; Woodson, B Tucker; Verbraecken, Johan; Vanderveken, Olivier M; Goetting, Mark G; Feldman, Neil; Chabolle, Frédéric; Badr, M Safwan; Randerath, Winfried; Strohl, Kingman P

    2015-10-01

    To determine the stability of improvement in polysomnographic measures of sleep disordered breathing, patient reported outcomes, the durability of hypoglossal nerve recruitment and safety at 18 months in the Stimulation Treatment for Apnea Reduction (STAR) trial participants. Prospective multicenter single group trial with participants serving as their own controls. Twenty-two community and academic sleep medicine and otolaryngology practices. Primary outcome measures were the apnea-hypopnea index (AHI) and the 4% oxygen desaturation index (ODI). Secondary outcome measures were the Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire (FOSQ), and oxygen saturation percent time < 90% during sleep. Stimulation level for each participant was collected at three predefined thresholds during awake testing. Procedure- and/or device-related adverse events were reviewed and coded by the Clinical Events Committee. The median AHI was reduced by 67.4% from the baseline of 29.3 to 9.7/h at 18 mo. The median ODI was reduced by 67.5% from 25.4 to 8.6/h at 18 mo. The FOSQ and ESS improved significantly at 18 mo compared to baseline values. The functional threshold was unchanged from baseline at 18 mo. Two participants experienced a serious device-related adverse event requiring neurostimulator repositioning and fixation. No tongue weakness reported at 18 mo. Upper airway stimulation via the hypoglossal nerve maintained a durable effect of improving airway stability during sleep and improved patient reported outcomes (Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire) without an increase of the stimulation thresholds or tongue injury at 18 mo of follow-up. © 2015 Associated Professional Sleep Societies, LLC.

  10. An 18-month follow-up study after randomized treatment of phimosis in boys with topical steroid versus placebo.

    PubMed

    Lund, L; Wai, K H; Mui, L M; Yeung, C K

    2005-01-01

    To evaluate the treatment of phimosis using topical steroid. This was a follow-up study after a prospective, randomized, double-blind study. A total of 137 boys with phimosis were randomly assigned to either betamethasone treatment or placebo for 4 weeks, with application of the cream twice daily. Non-responders to treatment were offered steroid treatment for a further 4 weeks. All patients were invited to a follow-up examination after 18 months. The mean pre-treatment phimosis grades in the steroid and control groups were 5.08+/-0.66 and 4.97+/-0.70, respectively. At the 4-week follow-up, 49 boys (74%) in the steroid group were cured, compared to only 31 (44%) in the control group. Fourteen boys were circumcised after another 4 weeks of treatment; 43 of the remaining 57 boys (17 in the steroid group; 40 in the control group) had been cured. After a total of 92 boys took part in the 18-month follow-up study: 79 had been cured and 13 had suffered a relapse. Twenty-six patients did not took part in the follow-up investigation. No side-effects were noted. When treatment is necessary for phimosis, we recommend application of topical steroid as first-line treatment because surgery can then be avoided in 85% of cases. This first randomized, double-blind, follow-up study shows that the treatment effect persists for at least 18 months.

  11. The effects of continuous antidepressant treatment during the first 6 months on relapse or recurrence of depression.

    PubMed

    Kim, Kyoung-Hoon; Lee, Seung-Mi; Paik, Jong-Woo; Kim, Nam-Soon

    2011-07-01

    To examine whether continuous antidepressant treatment during the first 6 month reduces the risk of relapse/recurrence of depression in South Korea. We used National Health Insurance Data covering the period from 2001 through 2004. The study population consisted of 117,087 adult patients who received antidepressants after being diagnosed with depression. The continuous antidepressant was defined as evidence of antidepressant prescriptions for 75% of the first 6 months of treatment. Relapse or recurrence during the next 18-month period was defined by evidence of a new episode requiring antidepressant treatment, psychiatric hospitalization, electroconvulsive therapy, emergency department visit or attempted suicide. We compared the relapse/recurrence rate during the 18-month follow-up period in patients receiving continuous treatment and those who discontinued early using a Cox's proportional hazard model. Patients receiving continuous antidepressant treatment experienced a lower risk of relapse/recurrence (Hazard ratio: 0.42, 95% CI: 0.40-0.44). Three or more follow-up visits in the first 3 months also reduced the risk of relapse/recurrence. Factors associated with a significant increase of relapse/recurrence were comorbid medical illness, anxiety disorder, and alcohol abuse. The small benefit of SSRIs was appeared only in the early discontinued treatment subgroup, not in the continuous treatment subgroup. We were not able to consider the antidepressant utilization pattern. Continuous antidepressant treatment and frequent follow-up visits during the acute phase were associated with a significant reduction in the likelihood of relapse or recurrence of depression. Our results provide important evidence on the effectiveness of antidepressant treatment in South Korea. Copyright © 2011 Elsevier B.V. All rights reserved.

  12. 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.

  13. Endovascular treatment of bifurcation intracranial aneurysms with the WEB SL/SLS: 6-month clinical and angiographic results.

    PubMed

    Bozzetto Ambrosi, Patricia; Gory, Benjamin; Sivan-Hoffmann, Rotem; Riva, Roberto; Signorelli, Francesco; Labeyrie, Paul-Emile; Eldesouky, Islam; Sadeh-Gonike, Udi; Armoiry, Xavier; Turjman, Francis

    2015-08-01

    The WEB device is a recent intrasaccular flow disruption technique developed for the treatment of wide-necked intracranial aneurysms. To date, a single report on the WEB Single-Layer (SL) treatment of intracranial aneurysms has been published with 1-months' safety results. The aim of this study is to report our experience and 6-month clinical and angiographic follow-up of endovascular treatment of wide-neck aneurysm with the WEB SL. Ten patients with 10 unruptured wide-necked aneurysms were prospectively enrolled in this study. Feasibility, intraoperative and postoperative complications, and outcomes were recorded. Immediate and 6-month clinical and angiographic results were evaluated. Failure of WEB SL placement occurred in two cases. Eight aneurysms were successfully treated using one WEB SL without additional treatment. Three middle cerebral artery, four anterior communicating artery, and one basilar artery aneurysms were treated. Average dome width was 7.5 mm (range 5.4-10.7 mm), and average neck size was 4.9 mm (range 2.6-6.5 mm). No periprocedural complication was observed, and morbi-mortality at discharge and 6 months was 0.0%. Angiographic follow-up at 6 months demonstrated complete aneurysm occlusion in 2/8 aneurysms, neck remnant in 5/8 aneurysms, and aneurysm remnant in 1/8 aneurysm. From this preliminary study, treatment of bifurcation intracranial aneurysms using WEB SL is feasible. WEB SL treatment seems safe at 6 months; however, the rate of neck remnants is not negligible due to compression of the WEB SL. Further technical improvements may be needed in order to ameliorate the occlusion in the WEB SL treatment. © The Author(s) 2015.

  14. Endovascular treatment of bifurcation intracranial aneurysms with the WEB SL/SLS: 6-month clinical and angiographic results

    PubMed Central

    Bozzetto Ambrosi, Patricia; Sivan-Hoffmann, Rotem; Riva, Roberto; Signorelli, Francesco; Labeyrie, Paul-Emile; Eldesouky, Islam; Sadeh-Gonike, Udi; Armoiry, Xavier; Turjman, Francis

    2015-01-01

    Background The WEB device is a recent intrasaccular flow disruption technique developed for the treatment of wide-necked intracranial aneurysms. To date, a single report on the WEB Single-Layer (SL) treatment of intracranial aneurysms has been published with 1-months' safety results. The aim of this study is to report our experience and 6-month clinical and angiographic follow-up of endovascular treatment of wide-neck aneurysm with the WEB SL. Methods Ten patients with 10 unruptured wide-necked aneurysms were prospectively enrolled in this study. Feasibility, intraoperative and postoperative complications, and outcomes were recorded. Immediate and 6-month clinical and angiographic results were evaluated. Results Failure of WEB SL placement occurred in two cases. Eight aneurysms were successfully treated using one WEB SL without additional treatment. Three middle cerebral artery, four anterior communicating artery, and one basilar artery aneurysms were treated. Average dome width was 7.5 mm (range 5.4–10.7 mm), and average neck size was 4.9 mm (range 2.6–6.5 mm). No periprocedural complication was observed, and morbi-mortality at discharge and 6 months was 0.0%. Angiographic follow-up at 6 months demonstrated complete aneurysm occlusion in 2/8 aneurysms, neck remnant in 5/8 aneurysms, and aneurysm remnant in 1/8 aneurysm. Conclusions From this preliminary study, treatment of bifurcation intracranial aneurysms using WEB SL is feasible. WEB SL treatment seems safe at 6 months; however, the rate of neck remnants is not negligible due to compression of the WEB SL. Further technical improvements may be needed in order to ameliorate the occlusion in the WEB SL treatment. PMID:26111987

  15. 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

  16. Treatment as Required versus Regular Monthly Treatment in the Management of Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis

    PubMed Central

    Schmucker, Christine M.; Rücker, Gerta; Sommer, Harriet; Virgili, Gianni; Loke, Yoon K.; Oeller, Patrick; Agostini, Hansjuergen; Ehlken, Christoph

    2015-01-01

    Background To investigate whether treatment as required ‘pro re nata’ (PRN) versus regular monthly treatment regimens lead to differences in outcomes in neovascular age-related macular degeneration (nAMD). Regular monthly administration of vascular endothelial growth factor (VEGF) inhibitors is an established gold standard treatment, but this approach is costly. Replacement of monthly by PRN treatment can only be justified if there is no difference in patient relevant outcomes. Methods Systematic review and meta-analysis. The intervention was PRN treatment and the comparator was monthly treatment with VEGF-inhibitors. Four bibliographic databases were searched for randomised controlled trials comparing both treatment regimens directly (head-to-head studies). The last literature search was conducted in December 2014. Risk of bias assessment was performed after the Cochrane Handbook for Systematic Reviews of Interventions. Findings We included 3 head-to-head studies (6 reports) involving more than 2000 patients. After 2 years, the weighted mean difference in best corrected visual acuity (BCVA) was 1.9 (95% CI 0.5 to 3.3) ETDRS letters in favour of monthly treatment. Systemic adverse events were higher in PRN treated patients, but these differences were not statistically significant. After 2 years, the total number of intravitreal injections required by the patients in the PRN arms were 8.4 (95% CI 7.9 to 8.9) fewer than those having monthly treatment. The studies were considered to have a moderate risk of bias. Conclusions PRN treatment resulted in minor but statistically significant decrease in mean BCVA which may not be clinically meaningful. There is a small increase in risk of systemic adverse events for PRN treated patients. Overall, the results indicate that an individualized treatment approach with anti-VEGF using visual acuity and OCT-guided re-treatment criteria may be appropriate for most patients with nAMD. PMID:26368921

  17. Beneficial effects of intravenous pamidronate treatment in children with osteogenesis imperfecta under 24 months of age.

    PubMed

    Kusumi, Kirsten; Ayoob, Rose; Bowden, Sasigarn A; Ingraham, Susan; Mahan, John D

    2015-09-01

    Osteogenesis imperfecta (OI) is an inherited disorder characterized by bone fragility and low bone mass. Low bone density and fracture is a cause of morbidity. Limited data exists on bisphosphonate treatment in patients under 24 months of age. The objective of the study was to examine the safety and efficacy of pamidronate in children under 24 months with OI. To do so, we carried out a retrospective chart review and analysis of OI patients started on intravenous pamidronate under 24 months of age. Pamidronate was administered in three-day cycles. Growth, the number of fractures, and lumbar bone mineral densities were recorded both prior to and after treatment initiation. A total of 18 patients were reviewed. Five were classified as OI type I, seven were type III, and six were type IV. The mean age at treatment initiation was 12 months (range 11 days to 23 months). The mean lumbar z score at baseline was -3.63, which improved to -1.53 at one year (P < 0.01) and 0.79 (P < 0.01) at the end of the study. The fracture rate improved from 68 fractures in 209 months (0.32 fractures/patient-month) before treatment to 41 fractures in 1,248 months (0.03 fractures/patient-month) post-treatment (P < 0.05). Height standard deviation score (SDS) was conserved from baseline to end of study (-2.12 ± 2.45 vs. -2.45 ± 2.73) (P = 0.05) with an average follow-up of 73 months. The only adverse effect recorded in six infants was fever during the initial pamidronate infusion. Treatment with intravenous pamidronate is safe, significantly improves lumbar bone mineral density (L-BMD), and reduces fracture rates in young infants with OI while preserving linear growth.

  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. 43 CFR 3.5 - Application.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 1 2013-10-01 2013-10-01 false Application. 3.5 Section 3.5 Public Lands: Interior Office of the Secretary of the Interior PRESERVATION OF AMERICAN ANTIQUITIES § 3.5 Application. Each application for a permit should be filed with the Secretary having jurisdiction, and must be...

  20. 43 CFR 3.5 - Application.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Application. 3.5 Section 3.5 Public Lands: Interior Office of the Secretary of the Interior PRESERVATION OF AMERICAN ANTIQUITIES § 3.5 Application. Each application for a permit should be filed with the Secretary having jurisdiction, and must be...

  1. 43 CFR 3.5 - Application.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 1 2012-10-01 2011-10-01 true Application. 3.5 Section 3.5 Public Lands: Interior Office of the Secretary of the Interior PRESERVATION OF AMERICAN ANTIQUITIES § 3.5 Application. Each application for a permit should be filed with the Secretary having jurisdiction, and must be...

  2. Your Child's Development: 3-5 Days

    MedlinePlus

    ... 2-Year-Old Your Child’s Development: 3-5 Days KidsHealth > For Parents > Your Child’s Development: 3-5 Days Print A A A en español El desarrollo ... hijo: 3-5 días Though only a few days old, your baby already is able to interact ...

  3. Effects of Concurrent Topotecan and Radiation on 6-Month Progression-Free Survival in the Primary Treatment of Glioblastoma Multiforme

    SciTech Connect

    Grabenbauer, Gerhard G. Gerber, Klaus-Dieter; Ganslandt, Oliver; Richter, Andrea M.S.; Klautke, Gunther; Birkmann, Josef; Meyer, Martin

    2009-09-01

    Purpose: To report a prospective, randomized, Phase II trial of radiotherapy with and without topotecan for the treatment of glioblastoma. Patients and Methods: Inclusion criteria were histology of glioblastoma, age <60 years, and Eastern Cooperative Oncology Group status 0-2. Patients were stratified according to recursive partitioning analysis class, center, and enzyme-inducing antiepileptic medication. Magnetic resonance imaging scans, neurologic examinations, and quality of life assessments were done every 3 months. The primary endpoint was the progression-free survival rate at 6 months (6-m-PFS). This trial was designed as an exploratory, randomized, Phase II trial with an accrual of 140 patients to detect a difference of 15-20% in 6-m-PFS. An interim analysis was scheduled after 60 patients. Median follow-up was 14 months (range, 1-50 months). Results: The 6-m-PFS was 56% and 40% for patients with and without topotecan, respectively. This benefit disappeared within 2 months. Mean (range) progression-free survival time was 8 (5-10.9) months and 6.7 (4-9.5) months for patients with and without topotecan, respectively. The corresponding 2-year-overall survival rates were 28% vs. 22% (nonsignificant difference), and mean (range) survival time was 20.7 (13.9-27.5) months vs. 18.9 (13.5-24.4) months (nonsignificant difference). Conclusions: A slight but measurable increase of 16% was detected in 6-m-PFS for patients receiving topotecan with radiation as compared with patients having radiotherapy alone. These data might support further investigations into topotecan for the treatment of glioblastoma.

  4. Effects of fixed orthodontic treatment on hair nickel and chromium levels: a 6-month prospective preliminary study.

    PubMed

    Amini, Fariborz; Mollaei, Mobina; Harandi, Saghar; Rakhshan, Vahid

    2015-03-01

    Although nickel and chromium are known as allergen and cytotoxic orthodontic metals, very few and controversial studies have assessed the effect of orthodontic treatment on their systemic levels reflected by their best biomarker of exposure, hair. This prospective preliminary study was conducted to evaluate hair nickel and chromium levels in fixed orthodontic patients. Scalp hair nickel/chromium concentrations of 12 female and 12 male fixed orthodontic patients were measured before treatment and 6 months later, using atomic absorption spectrophotometry. The effects of treatment, gender, and age on hair ions were analyzed statistically (α = 0.05). The patients' mean age was 18.38 ± 3.98 years. The mean nickel levels were 0.1380 ± 0.0570 and 0.6715 ± 0.1785 μg/g dry hair mass, respectively, in the baseline and sixth month of treatment. Chromium concentrations were 0.1455 ± 0.0769 and 0.1683 ± 0.0707 μg/g dry hair mass, respectively. After 6 months, nickel increased for 387 % (paired t test P = 0.0000) and chromium increased for 16 % (P = 0.0002). No significant correlations were observed between any ion levels with age or gender (Spearman P > 0.2). Within the limitations of this preliminary study, it seems that 6 months of fixed orthodontic treatment might increase levels of hair nickel and chromium. Future larger studies are necessary to validate these results.

  5. Enhanced clinical outcome with manual massage following cryolipolysis treatment: a 4-month study of safety and efficacy.

    PubMed

    Boey, Gerald E; Wasilenchuk, Jennifer L

    2014-01-01

    Cryolipolysis procedures have been shown to safely and effectively reduce the thickness of fat in a treated region. This study was conducted to determine whether the addition of post-treatment manual massage would improve efficacy while maintaining the safety profile of the original cryolipolysis treatment protocol. The study population consisted of an efficacy group (n = 10) and a safety group (n = 7). Study subjects were treated on each side of the lower abdomen with a Cooling Intensity Factor of 42 (-72.9 mW/cm(2) ) for 60 minutes. One side of the abdomen was massaged post-treatment and the other side served as the control. Immediately post-treatment, the massage side was treated for 1 minute using a vigorous kneading motion followed by 1 minute of circular massage using the pads of the fingers. For the efficacy group, photos and ultrasound measurements were taken at baseline, 2 months, and 4 months post-treatment. For the safety group, histological analysis was completed at 0, 3, 8, 14, 30, 60, and 120 days post-treatment to examine the effects of massage on subcutaneous tissue over time. Post-treatment manual massage resulted in a consistent and discernible increase in efficacy over the non-massaged side. At 2 months post-treatment, mean fat layer reduction was 68% greater in the massage side than in the non-massage side as measured by ultrasound. By 4 months, mean fat layer reduction was 44% greater in the massage side. Histological results showed no evidence of necrosis or fibrosis resulting from the massage. Post-treatment manual massage is a safe and effective technique to enhance the clinical outcome from a cryolipolysis procedure. © 2013 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

  6. Correlates of Nine-Month Retention following Interim Buprenorphine-Naloxone Treatment in Opioid Dependence: A Pilot Study.

    PubMed

    Håkansson, A; Widinghoff, C; Abrahamsson, T; Gedeon, C

    2016-01-01

    Interim medication-only treatment has been suggested for the initiation of opioid maintenance treatment (OMT) in opioid-dependent subjects, but this rarely has been studied using buprenorphine instead of methadone. Following a pilot trial assessing interim buprenorphine-naloxone treatment in order to facilitate transfer into OMT, we here aimed to study retention, and potential correlates of retention, in full-scale treatment. Thirty-six patients successfully referred from a waiting list through an interim treatment phase were followed for nine months in OMT. Baseline characteristics, as well as urine analyses during the interim phase and during full-scale OMT, were studied as potential correlates of retention. The nine-month retention in OMT was 83 percent (n = 30). While interim-phase urine samples positive for benzodiazepines did not significantly predict dropout from full-scale OMT (p = 0.09), urine samples positive for benzodiazepines within full-scale OMT were significantly associated with dropout (p < 0.01), in contrast to other substances and baseline characteristics. Retention remained high through nine months in this pilot study sample of patients referred through buprenorphine-naloxone interim treatment, but use of benzodiazepines is problematic, and the present data suggest that it may be associated with treatment dropout.

  7. [PERSIRIS study: observational study, postmarketing, prospective, to evaluate the persistence to treatment with monthly risedronate in women with osteoporosis].

    PubMed

    Sitjar Martínez de Sas, Salvador; Aguilera de la Fuente, María Teresa; Combalía Romera, Josep; Menacho Pascual, Ignacio; González Martínez, Susana; Altés Boronat, Andreu

    2016-05-01

    To assess the persistence of treatment with monthly risedronate and know the reasons of persistence and nontherapeutic persistence and the profile of the non-persistent patients. Observational, postmarketin and prospective study. Primary care, traumatology, rheumatology, gynecology and geriatrics of Catalonia. Women with osteoporosis treated with monthly risedronate that previously had abandoned weekly bisphosphonate therapy. Percentage of patients on persistent monthly risedronate year of their prescription, reasons for persistent and non persistent and profile of non persistent patients in relation to biodemographic data, clinical data and risk factors for fracture. 289 evaluable patients with a mean age of 68.3. At 12 months of initiation with monthly risedronate, 58.1% of patients remained on treatment. Most frequent reasons for leaving: fear of having side effects and belief that the disease is typical of the age. Reasons remarkable persistence: comfort/ease and dosage. Significant differences were observed between persistent and non-persistent patients relative to: employment status, number of concomitant therapy and height; however the results of possible associated factors must be contextualized within the study characteristics and the difference in size does not seem clinically relevant. The administration of therapeutic patterns more comfortable as monthly risedronate in osteoporosis, could facilitate persistence in patients improving the effectiveness of the drug. However in that persistence can also influence biodemographic and clinical variables and diverse of various kinds. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  8. 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.

  9. 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.

  10. Diabetes mellitus and tuberculosis: pattern of tuberculosis, two-month smear conversion and treatment outcomes in Guangzhou, China.

    PubMed

    Mi, Fengling; Tan, Shouyong; Liang, Li; Harries, Anthony D; Hinderaker, Sven G; Lin, Yan; Yue, Wentao; Chen, Xi; Liang, Bing; Gong, Fang; Du, Jian

    2013-11-01

    There is a high burden of both diabetes (DM) and tuberculosis (TB) in China. We evaluated the association between DM and the pattern of disease, 2-month sputum smear conversion and treatment outcomes of patients with TB in Guangzhou, China. All patients registered with TB from September 2011 to June 2012 were screened for DM and assessed for treatment outcomes in relation to presence or absence of DM and quality of DM control using patient registers, treatment cards and electronic record systems. There were 1589 patients with TB of whom 189 (12%) had DM. Among those with DM, there was a significantly higher proportion of men, persons aged 35 years and older and persons with smear-positive pulmonary tuberculosis (PTB) (P < 0.01). In patients with DM and new smear-positive PTB, there was a higher proportion who had positive sputum smears at 2 months (21.7% vs. 5.6%, RR 3.85, 95%CI 2.24-6.63), who were lost-to-follow-up (5.2% vs. 1.7%, RR 3.23, 95%CI 1.08-9.63) and who failed treatment (10.3% vs. 2.3%, RR 4.46, 95%CI 1.96-10.18) compared with patients who had no DM. There was no significant association between these adverse outcomes and DM control as measured by 2 and 6-month fasting blood glucose. Diabetes mellitus in new smear-positive patients with PTB was associated with failure to sputum smear convert at 2 months and adverse treatment outcomes of loss-to-follow-up and failure. Further research is needed to understand the reasons for these findings and to determine whether the current length of treatment of 6 months is adequate. © 2013 John Wiley & Sons Ltd.

  11. Weight changes in obese adults 6-months after discontinuation of double-blind zonisamide or placebo treatment

    PubMed Central

    Shin, J.H.; Gadde, K.M.; Øtbye, T.; Bray, Bray

    2014-01-01

    We evaluated weight changes in obese patients at 6-months after they ended participation in a 12-month randomized controlled trial in which they received daily placebo, zonisamide 200 mg, or zonisamide 400 mg, in addition to lifestyle counseling. Of the originally randomized 225 patients, 218 completed month-12 when study interventions were discontinued. For the 154 patients who returned for 6-month follow-up off-treatment, weight changes between month-12 and month-18 for placebo (n=53), zonisamide 200 mg (n=49), and zonisamide 400 mg groups (n=52) were 0.5 kg (95% CI, −0.8 to 1.8; 0.7%), 1.5 kg (0.2 to 2.8; 1.6%; p=0.26 vs placebo) and 2.4 kg (1.1 to 3.7; 2.6%; p=0.04 vs placebo), respectively. Our results suggest that although zonisamide 400 mg daily for 12-months resulted in greater weight loss than with placebo, weight regain after discontinuation of interventions was greater in the zonisamide 400 mg group than placebo group. PMID:25123600

  12. Impact of single annual treatment and four-monthly treatment for hookworm and Ascaris lumbricoides, and factors associated with residual infection among Kenyan school children.

    PubMed

    Kepha, Stella; Mwandawiro, Charles S; Anderson, Roy M; Pullan, Rachel L; Nuwaha, Fred; Cano, Jorge; Njenga, Sammy M; Odiere, Maurice R; Allen, Elizabeth; Brooker, Simon J; Nikolay, Birgit

    2017-02-09

    School-based deworming is widely implemented in various countries to reduce the burden of soil-transmitted helminths (STHs), however, the frequency of drug administration varies in different settings. In this study, we compared the impact of a single annual treatment and 4-monthly treatment over a follow-up among Kenyan school children, and investigated the factors associated with residual infection. We performed a secondary analysis of data from a randomized trial investigating whether deworming for STHs alters risk of acquiring malaria. Children received either a single treatment or 4-monthly albendazole treatments were followed longitudinally from February 2014 to October 2014. The relative impact of treatment and factors associated with residual infections were investigated using mixed-effects regression models. Predisposition to infection was assessed based on Spearman's rank and Kendall's Tau correlation coefficients. In the 4-monthly treatment group, the proportion of children infected with hookworm decreased from 59.9 to 5.7%, while Ascaris lumbricoides infections dropped from 55.7 to 6.2%. In the single treatment group, hookworm infections decreased over the same time period from 58.7 to 18.3% (12.6% absolute difference in reduction, 95% CI: 8.9-16.3%), and A. lumbricoides from 56.7 to 23.3% (17.1% absolute difference in reduction, 95% CI: 13.1-21.1%). There was strong evidence for predisposition to both STH types. Residual hookworm infection among children on 4-monthly treatment were associated with male sex and baseline nutritional status, whereas A. lumbricoides infection was associated with individual and school-level infection at baseline, latrine cleanliness at schools. This study found that 4-monthly treatment w more effective than single annual treatment. Repeated treatments led to dramatic reductions in the intensities of STHs, but did not completely clear infections among school children in Kenya, a presumed reflection of reinfection in a setting

  13. Alcoholics Anonymous and Relapse Prevention as Maintenance Strategies After Conjoint Behavioral Alcohol Treatment for Men: 18-Month Outcomes

    ERIC Educational Resources Information Center

    McCrady, Barbara S.; Epstein, Elizabeth E.; Kahler, Christopher W.

    2004-01-01

    Ninety men with alcohol problems and their female partners were randomly assigned to 1 of 3 outpatient conjoint treatments: alcohol behavioral couples therapy (ABCT), ABCT with relapse prevention techniques (RP/ABCT), or ABCT with interventions encouraging Alcoholics Anonymous (AA) involvement (AA/ABCT). Couples were followed for 18 months after…

  14. 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.

  15. 34 CFR 674.40 - Treatment of loan repayments where cancellation, loan repayments, and minimum monthly repayments...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... repayments, and minimum monthly repayments apply. 674.40 Section 674.40 Education Regulations of the Offices... FEDERAL PERKINS LOAN PROGRAM Terms of Loans § 674.40 Treatment of loan repayments where cancellation, loan... be cancelled, the amount due on the uncancelled loan is the amount established in § 674.31(b)...

  16. 34 CFR 674.40 - Treatment of loan repayments where cancellation, loan repayments, and minimum monthly repayments...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... repayments, and minimum monthly repayments apply. 674.40 Section 674.40 Education Regulations of the Offices... FEDERAL PERKINS LOAN PROGRAM Terms of Loans § 674.40 Treatment of loan repayments where cancellation, loan... be cancelled, the amount due on the uncancelled loan is the amount established in § 674.31(b)...

  17. Treatment retention, drug use and social functioning outcomes in those receiving 3 months versus 1 month of supervised opioid maintenance treatment. Results from the Super C randomized controlled trial.

    PubMed

    Holland, Richard; Maskrey, Vivienne; Swift, Louise; Notley, Caitlin; Robinson, Angela; Nagar, Jess; Gale, Tim; Kouimtsidis, Christos

    2014-04-01

    Supervised consumption of opioid maintenance treatment (OMT) is standard in many drug centres reducing drug diversion, but is costly. We aimed to determine whether supervised consumption of OMT improved retention and other measures of drug use. Pragmatic randomized controlled trial comparing 3 months of daily supervised consumption of OMT with 1 month or less of daily supervised OMT, then daily unsupervised consumption. Four community drug services in the United Kingdom. A total of 293 opioid-dependent patients entering OMT. retention in treatment at 12 weeks. Secondary: retention at 6 months; illicit drug use [Maudsley Addiction Profile (MAP)]; quality of life (SF-12 and MAP); criminality (MAP); and social functioning. No significant between-group difference was observed for the primary outcome: 69% (100 of 145) supervised and 74% (109 of 148) unsupervised were retained [odds ratio (OR) = 0.74, 95% confidence interval (CI) = 0.43-1.27]. Per protocol survival analysis suggested that supervised patients were less well retained (hazard ratio for retention = 0.71, 95% CI = 0.51-1.00). Illicit opioid use reduced in both groups and, while not statistically significant by intention-to-treat analysis, favoured unsupervised patients in per protocol analysis (odds of positive opioid screen for supervised versus unsupervised = 2.07, 95% CI = 1.05-4.06). Data on criminal activity also favoured unsupervised patients with 21% supervised patients committing crime versus 9% unsupervised (OR = 3.37, 95% CI = 1.28-8.86). There was no evidence of a difference in treatment retention or opioid use rates between patients whose consumption of opioid maintenance treatment was supervised for 3 months daily (except Saturdays) compared with supervision for 1 month. There was some evidence that longer periods of supervised consumption were associated with higher levels of criminality. © 2013 Society for the Study of Addiction.

  18. Treatment for Tuberculosis Infection With 3 Months of Isoniazid and Rifapentine in New York City Health Department Clinics.

    PubMed

    Stennis, Natalie L; Burzynski, Joseph N; Herbert, Cheryl; Nilsen, Diana; Macaraig, Michelle

    2016-01-01

    Completion of treatment for tuberculosis infection (TBI) with 9 months of self-administered daily isoniazid (9H) has historically been low (<50%) among New York City (NYC) Health Department tuberculosis clinic patients. Treatment of TBI with 3 months of once-weekly isoniazid and rifapentine (3HP) administered under directly observed therapy (DOT) might increase treatment acceptance and completion. The study population included patients diagnosed with TBI at 2 NYC Health Department tuberculosis clinics from January 2013 through November 2013. Treatment acceptance and completion with 3HP were compared with historical estimates. Treatment outcomes, side effects, and reasons for refusing 3HP were described. Among 631 patients eligible for TBI treatment, 503 (80%) were offered 3HP; 302 (60%) accepted, 92 (18%) chose other treatment, and 109 (22%) refused treatment. The most common reason for refusing 3HP was the clinic-based DOT requirement. Forty (13%) patients treated with 3HP experienced side effects--9 were restarted on 3HP, 18 switched treatment regimens, and 13 discontinued. Although treatment acceptance did not differ from historical estimates (78% vs 79%, P = .75), treatment completion increased significantly (65% vs 34%, P < .01). Implementation of 3HP in 2 NYC Health Department tuberculosis clinics increased TBI treatment completion by 31 percentage points compared with historical estimates. More flexible DOT options may improve acceptance of 3HP. Wider use of 3HP may substantially improve TBI treatment completion in NYC and advance progress toward tuberculosis elimination. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  19. A pragmatic analysis comparing once-monthly paliperidone palmitate versus daily oral antipsychotic treatment in patients with schizophrenia.

    PubMed

    Alphs, Larry; Mao, Lian; Lynn Starr, H; Benson, Carmela

    2016-02-01

    Persons with schizophrenia often come in contact with the criminal justice system (CJS). This analysis of subjects with schizophrenia and a history of contact with the CJS estimated and compared mean cumulative function (MCF) of treatment failure events when treated with paliperidone palmitate (PP) or oral antipsychotics (OAs). All events identified during the full study period of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) trial were evaluated. Subjects were randomly assigned to flexibly dosed, monthly, injectable PP (78-234 mg) or daily OA in a 15-month prospective, open-label, multicenter US study (May 5, 2010-December 9, 2013). Subjects could continue participation after a treatment failure event. Multiple treatment failures in individual subjects were analyzed as recurrent events. Analyses estimated MCF of treatment failure events and MCF of institutionalizations (arrests, incarcerations, or psychiatric hospitalizations) during the 15-month study period. The ITT population included 226 (PP) and 218 (OA) subjects, of whom 41.2% and 40.4%, respectively, completed 15 months of follow-up. The MCF of treatment failures and institutionalizations differed significantly in favor of PP compared with OA (P=0.007 and P=0.005, respectively). Overall, TEAEs were reported by 86.3% of subjects in the PP group and 81.7% in the OA group. This pragmatic analysis suggests that, compared with OA, PP is not only more effective in delaying median time to treatment failure, but it also reduces the number of treatment failures and institutionalizations per person-year follow-up. Clinicaltrials.gov identifier: NCT01157351. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

  20. Three-month sustained-release triptorelin (11.25 mg) in the treatment of central precocious puberty.

    PubMed

    Carel, Jean-Claude; Blumberg, Joëlle; Seymour, Christine; Adamsbaum, Catherine; Lahlou, Najiba

    2006-01-01

    Depot GnRH agonists are commonly used in the treatment of central precocious puberty (CPP). The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP. This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly. Children with a clinical onset of pubertal development before the age of 8 years (girls) or 9 years (boys), pubertal response of LH to GnRH > or = 7 IU/l, advanced bone age > 1 year, enlarged uterus (> or = 36 mm) and testosterone level > or = 0.5 ng/ml (boys), were included. Suppression of gonadotropic activation, as determined from serum LH, FSH, estradiol or testosterone, and pubertal signs were assessed at Months 3, 6 and 12. GnRH-stimulated peak LH < or = 3 IU/l, the main efficacy criterion, was met in 53 out of 62 (85%), 60 out of 62 (97%) and 56 out of 59 (95%) of the children at Months 3, 6 and 12 respectively. Serum FSH and sex steroids were also significantly reduced, while pubertal development regressed in most patients. Mean residual triptorelin levels were stable from Month 3 through to Month 12. The triptorelin 3-month depot was well tolerated. Severe injection pain was experienced in only one instance. Five girls experienced mild-to-moderate or severe (one girl) withdrawal bleeding. The triptorelin 3-month depot efficiently suppresses the pituitary-gonadal axis and pubertal development in children with CPP. This formulation allows a 3-fold reduction, over the once-a-month depot, in the number of i.m. injections required each year.

  1. Treatment of lupus nephritis with total lymphoid irradiation. Observations during a 12-79-month followup

    SciTech Connect

    Strober, S.; Farinas, M.C.; Field, E.H.; Solovera, J.J.; Kiberd, B.A.; Myers, B.D.; Hoppe, R.T.

    1988-07-01

    Seventeen patients with intractable lupus nephritis and nephrotic syndrome were treated with total lymphoid irradiation. Statistically significant improvement in mean renal disease and serologic activity parameters occurred within 3 months and persisted for at least 3 years. Although there was a marked reduction of T helper cell numbers and function after total lymphoid irradiation, recovery of these parameters was not associated with a return of disease activity. Risks of sterility, severe infections, and hematologic malignancy appeared to be lower than with alkylating agents.

  2. 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

  3. Twelve months outcome after percutaneous mechanical thrombectomy for treatment of acute femoropopliteal bypass occlusion.

    PubMed

    Lichtenberg, Michael; Stahlhoff, Wilhelm; Boese, Dirk; Hailer, Birgit

    2013-04-01

    Acute and subacute ischemia of the legs in acute and subacute femoropopliteal bypass occlusion is a dramatic situation that endangers the survival of the limbs, depending on the severity of the ischemia. Different therapy options like percutaneous mechanical thrombectomy procedures, which include rotational thrombectomy, have become available in recent years in addition to local lysis and surgical thrombectomy. Rotational thrombectomy with the Straub Rotarex(®) System as an endovascular therapy option has demonstrated promising results leading to amputation-free survival in multiple studies. We recently provided data of 22 patients with acute femoropopliteal bypass occlusion where we examined the feasibility of the Rotarex(®) System in this indication. A technical success rate of 82% was demonstrated. During a follow-up period of 6 months, no reinterventions in these patients had to be performed. We now provide patency rates in 21 patients of our study group after a follow-up period of 12 months. The average ABI after 12 months was 0.80 ± 0.1. One patient showed a hemodynamic restenosis in a Nitinolstent distal to the femoropopliteal bypass which was implanted in the index procedure. No reocclusion of the femoropopliteal bypasses occurred in all patients.

  4. Impact of a timed-release FSH treatment from 2 to 6 months of age in bulls I: Endocrine and testicular development of beef bulls.

    PubMed

    Harstine, B R; Cruppe, L H; Abreu, F M; Rodrigues, A D; Premanandan, C; DeJarnette, J M; Day, M L

    2017-09-21

    In prepubertal males, FSH facilitates Sertoli cell proliferation and testis maturation. The study aimed to determine the effect of an exogenous FSH treatment on hormone secretion and testis development in Angus bulls. Bulls (n = 22) weaned at 53 ± 3.8 days of age were randomized into two treatment groups based on age and pedigree. Beginning at Day 59, bulls were injected im every 3.5 days with either 30 mg FSH (Folltropin-V; NIH-FSH-P1 units) in a 2% hyaluronan solution (FSH-HA, n = 11) or saline (control, n = 11) until Day 167.5. Blood samples to assess FSH, activin A, and testosterone were collected prior to each treatment. To determine how FSH profiles surrounding treatment were affected, three intensive blood sampling periods, each encompassing two treatment administrations, began at Day 66, 108, and 157, and blood was collected at 0, 6, 12, 18, 24, 36, 60, and 84 h respective to time of treatment. Scrotal circumference (SC) and BW were measured monthly. Bulls were castrated at Day 170 to measure testis size, seminiferous tubule diameter, and the number of Sertoli and germ cells per tubule cross-section. During intensive FSH sampling, FSH-HA bulls experienced an increase (P < 0.05) in FSH over control bulls for at least 18 h post-injection in all instances. In blood collected every 3.5 days, FSH concentrations in FSH-HA bulls were increased (P < 0.05) over initial Day 59 concentration from Day 97.5-167.5. FSH concentrations did not differ between treatments from Day 59-90.5, but were greater (P < 0.05) in FSH-HA from Day 94-167.5. Concentrations of activin A assessed for Day 59, 83.5, 94, 129, and 167.5 were greater (P < 0.05) in FSH-HA than control bulls on Day 83.5 and 94. The treatments did not differ (P > 0.1) in testosterone, BW, SC, testis size, tubule diameter, or number of germ cells per tubule. However, the number of Sertoli cells per tubule was greater in FSH-HA than control bulls (45.2 ± 1.4 vs. 41.6 ± 0.9 cells, P < 0

  5. 12 CFR 3.5 - Applicability.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... written agreement or a temporary or final order pursuant to 12 U.S.C. 1818 (b) or (c), or as a condition... 12 Banks and Banking 1 2011-01-01 2011-01-01 false Applicability. 3.5 Section 3.5 Banks and... Office determines, pursuant to the procedures set forth in subpart C, that different minimum...

  6. 12 CFR 3.5 - Applicability.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... written agreement or a temporary or final order pursuant to 12 U.S.C. 1818 (b) or (c), or as a condition... 12 Banks and Banking 1 2013-01-01 2013-01-01 false Applicability. 3.5 Section 3.5 Banks and... Office determines, pursuant to the procedures set forth in subpart C, that different minimum...

  7. Your Child's Development: 3-5 Days

    MedlinePlus

    ... Feeding Your 1- to 2-Year-Old Your Child’s Development: 3-5 Days KidsHealth > For Parents > Your Child’s Development: 3-5 Days A A A Though only ... the sole of the foot Social and Emotional Development soothed by a ... When to Talk to Your Doctor Every child develops at his or her own pace, but ...

  8. Lipid based nutrient supplements (LNS) for treatment of children (6 months to 59 months) with moderate acute malnutrition (MAM): A systematic review.

    PubMed

    Gera, Tarun; Pena-Rosas, Juan Pablo; Boy-Mena, Evelyn; Sachdev, Harshpal S

    2017-01-01

    Moderate acute malnutrition is a major public health problem affecting children from low- and middle-income countries. Lipid nutrient supplements have been proposed as a nutritional intervention for its treatment. To evaluate the effectiveness and safety of LNS for the treatment of MAM in infants and children 6 to 59 months of age. Systematic review of randomized-controlled trials and controlled before-after studies. Data from nine trials showed that use of LNS, in comparison to specially formulated foods, improved the recovery rate (RR 1.08; 95% CI 1.02-1.14, 8 RCTs, 8934 participants, low quality evidence); decreased the chances of no recovery (RR 0.70; 95% CI 0.58-0.85, 7 RCTs, 8364 participants, low quality evidence) and the risk of deterioration into severe acute malnutrition (RR 0.87; 95% CI 0.73-1.03, 6 RCTs, 6788 participants, low quality evidence). There was little impact on mortality (RR 0.94, 95% CI 0.54-1.52, 8 RCTs, 8364 participants, very-low- quality evidence) or default rate (RR 1.32; 95% CI 0.73-2.4, 7 studies, 7570 participants, low quality evidence). There was improvement in weight gain, weight-for-height z-scores, height-for-age z-scores and mid-upper arm circumference. Subset analyses suggested higher recovery rates with greater amount of calories provided and with ready-to-use therapeutic foods, in comparison to ready-to-use supplementary foods. One study comparing LNS with nutritional counselling (very low quality evidence) showed higher chance of recovery, lower risk of deteriorating into severe acute malnutrition and lower default rate, with no impact on mortality, and no recovery. Evidence restricted to the African regions suggests that LNS may be slightly more effective than specially formulated fortified foods or nutritional counselling in recovery from MAM, lowering the risk of deterioration into SAM, and improving weight gain with little impact on mortality or default rate.

  9. Lipid based nutrient supplements (LNS) for treatment of children (6 months to 59 months) with moderate acute malnutrition (MAM): A systematic review

    PubMed Central

    Pena-Rosas, Juan Pablo; Boy-Mena, Evelyn; Sachdev, Harshpal S.

    2017-01-01

    Background Moderate acute malnutrition is a major public health problem affecting children from low- and middle-income countries. Lipid nutrient supplements have been proposed as a nutritional intervention for its treatment. Objectives To evaluate the effectiveness and safety of LNS for the treatment of MAM in infants and children 6 to 59 months of age. Study design Systematic review of randomized-controlled trials and controlled before-after studies. Results Data from nine trials showed that use of LNS, in comparison to specially formulated foods, improved the recovery rate (RR 1.08; 95% CI 1.02–1.14, 8 RCTs, 8934 participants, low quality evidence); decreased the chances of no recovery (RR 0.70; 95% CI 0.58–0.85, 7 RCTs, 8364 participants, low quality evidence) and the risk of deterioration into severe acute malnutrition (RR 0.87; 95% CI 0.73–1.03, 6 RCTs, 6788 participants, low quality evidence). There was little impact on mortality (RR 0.94, 95% CI 0.54–1.52, 8 RCTs, 8364 participants, very-low- quality evidence) or default rate (RR 1.32; 95% CI 0.73–2.4, 7 studies, 7570 participants, low quality evidence). There was improvement in weight gain, weight-for-height z-scores, height-for-age z-scores and mid-upper arm circumference. Subset analyses suggested higher recovery rates with greater amount of calories provided and with ready-to-use therapeutic foods, in comparison to ready-to-use supplementary foods. One study comparing LNS with nutritional counselling (very low quality evidence) showed higher chance of recovery, lower risk of deteriorating into severe acute malnutrition and lower default rate, with no impact on mortality, and no recovery. Conclusions Evidence restricted to the African regions suggests that LNS may be slightly more effective than specially formulated fortified foods or nutritional counselling in recovery from MAM, lowering the risk of deterioration into SAM, and improving weight gain with little impact on mortality or default

  10. β2-microglobulin Normalization Within 6 months of Ibrutinib-based Treatment is Associated with Superior PFS in CLL

    PubMed Central

    Thompson, Philip A.; O’Brien, Susan M.; Xiao, Lianchun; Wang, Xuemei; Burger, Jan A.; Jain, Nitin; Ferrajoli, Alessandra; Estrov, Zeev; Keating, Michael J.; Wierda, William G.

    2016-01-01

    High pre-treatment β2-microglobulin (B2M) level is associated with inferior survival outcomes. However, the prognostic and predictive significance of changes in B2M during treatment have not been reported. We analyzed 83 patients treated with ibrutinib-based regimens (66 relapsed/refractory) and 198 treatment-naïve (TN) patients treated with combined fludarabine, cyclophosphamide and rituximab (FCR) to characterize change in B2M and their relationship to clinical outcomes. B2M rapidly fell during treatment with ibrutinib; in multivariable analysis (MVA), patients who received FCR [OR 0.40 (0.18–0.90), p=0.027] were less likely to normalize B2M at 6 months than patients treated with ibrutinib. On univariable analysis, normalization of B2M was associated with superior progression-free survival (PFS) from the 6-month landmark in patients treated with ibrutinib-based regimens and FCR. On MVA, failure to normalize B2M at 6 months of treatment was associated with inferior PFS [HR 16.9 (1.3–220.0), p=0.031] for ibrutinib-treated patients, after adjusting for the effects of baseline B2M, stage, fludarabine-refractory disease and del(17p). In contrast, in FCR-treated patients, bone marrow MRD-negative status was the only variable significantly associated with superior PFS [HR 0.28 (0.12–0.67), p=0.004]. Normalization of B2M at 6 months in ibrutinib-treated patients thus was a useful predictor of subsequent PFS and may assist clinical decision-making. PMID:26588193

  11. On the treatment of evapotranspiration, soil moisture accounting, and aquifer recharge in monthly water balance models.

    USGS Publications Warehouse

    Alley, W.M.

    1984-01-01

    Several two- to six-parameter regional water balance models are examined by using 50-year records of monthly streamflow at 10 sites in New Jersey. These models include variants of the Thornthwaite-Mather model, the Palmer model, and the more recent Thomas abcd model. Prediction errors are relatively similar among the models. However, simulated values of state variables such as soil moisture storage differ substantially among the models, and fitted parameter values for different models sometimes indicated an entirely different type of basin response to precipitation.-from Author

  12. 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.

  13. The effect of risedronate treatment on serum cytokines in postmenopausal osteoporosis: a 6-month randomized and controlled study.

    PubMed

    Dundar, Umit; Kavuncu, Vural; Ciftci, Ihsan H; Evcik, Deniz; Solak, Ozlem; Cakir, Tuncay

    2009-01-01

    There is much evidence suggesting that the decline in ovarian function after menopause is associated with spontaneous increases in proinflammatory cytokines. Treatment with risedronate is accompanied by significant changes in bone turnover and bone mineral density. The objective of this study was to determine the effects of risedronate treatment on the level of serum cytokines including receptor activator of nuclear factor-kappaB ligand (RANKL) and osteoprotegerin among postmenopausal women with osteoporosis. The study group consisted of 61 postmenopausal women with osteoporosis. Patients were randomly divided in two groups: In group 1 (n = 41) postmenopausal women received oral risedronate (35 mg/week), calcium (1,000 mg/day), and vitamin D (400 IU/day) for 12 months. In group 2 (control group; n = 20) patients received only oral calcium (1,000 mg/day) and vitamin D (400 IU/day). Bone mineral density (BMD) of lumbar spine (L1-L4) and proximal femur were determined using dual X-ray absorptiometry at baseline and after one year. Venous blood samples were obtained for determination of serum cytokines including interleukin-1beta (IL-1beta), tumor necrosis factor-alpha (TNF-alpha), RANKL, osteoprotegerin, and markers of bone formation and resorption. Levels of serum cytokines were measured before therapy and after three and 6 months. Markers of bone metabolism were studied before therapy and after 6 months. In group 1 (risedronate plus calcium/vitamin D-treated patients), serum levels of RANKL and IL-1beta significantly decreased and the level of osteoprotegerin significantly increased after three and 6 months, but no significant difference was found in TNF-alpha level. In group 2, however, the level of serum cytokines did not change after three and 6 months. In cases of bone turnover, both markers of bone resorption and formation significantly decreased after 6 months in group 1. In conclusion risedronate could improve osteoporosis by increasing osteoprotegerin and

  14. Microbial Interactions with Several Munitions Compounds: 1,3-Dinitrobenzene, 1,3,5-Trinitrobenzene, and 3,5-Dinitroaniline.

    DTIC Science & Technology

    1982-05-01

    of both 1,3-DNB and 1,3,5-TNB have been noted following their treatment in a two-stage aerated reactor composed of Azotobacter agilis in the first...3,5-DiNA Biosorption studies were conducted with 3-day Standard Methods broth cultures of Azotobacter beijerinckii (ATCC19366), Bacillus cereus...Escherichia coli, Bacillus cereus, Serratia marcescens, and Azotobacter beijerinckil. Bacterial cells were washed by repeated centrifuga- tion and resuspension

  15. Treatment of allergic conjunctivitis: results of a 1-month, single-masked randomized study.

    PubMed

    Figus, Michele; Fogagnolo, Paolo; Lazzeri, Stefano; Capizzi, Federica; Romagnoli, Mariachiara; Canovetti, Annalisa; Iester, Michele; Ferreras, Antonio; Rossetti, Luca; Nardi, Marco

    2010-01-01

    To compare the effects of topical antiallergic eyedrops in relieving the signs and symptoms of patients with allergic conjunctival pathology. In this multicenter, single-masked, randomized study, 240 patients with signs and symptoms of allergic conjunctivitis were randomized to receive 1 of the following 8 treatments twice daily: cromolyn sodium/chlorpheniramine maleate, diclofenac, epinastine, fluorometholone, ketotifen, levocabastine, naphazoline/antazoline, and olopatadine. Clinical signs and symptoms were evaluated by a masked operator using a 10-point scale at the moment of enrollment (day 0) and at weeks 1, 2, and 4. The percentage of patients achieving at least a small (at least 50% reduction of the total scale score) or a good (at least 75%) improvement of signs and symptoms was calculated at each visit. Tolerability was also evaluated as the duration of discomfort after instillation. All drugs gave some improvement in symptoms in more than 85% of cases. Epinastine and olopatadine obtained at least a good relief of symptoms in 37% and 33% of cases at week 1. At the end of the study, good improvement of symptoms was obtained in at least 70% of patients by epinastine, ketotifen, fluorometholone, and olopatadine, whereas a 75% improvement for signs was obtained only by fluorometholone and ketotifen. Naphazoline/antazoline induced higher discomfort compared to the other study treatments (p<0.0001). The efficacy of epinastine, ketotifen, and olopatadine in the treatment of allergic conjunctivitis was comparable to fluorometholone. Naphazoline/antazoline had lower tolerability than the other study treatments.

  16. Double-Blind 18-Month Trial of Lithium Versus Divalproex Maintenance Treatment in Pediatric Bipolar Disorder.

    ERIC Educational Resources Information Center

    Findling, Robert L.; McNamara, Nora K.; Youngstrom, Eric A.; Stansbrey, Robert; Gracious, Barbara L.; Reed, Michael D.; Calabrese, Joseph R.

    2005-01-01

    Objective: To determine whether divalproex sodium (DVPX) was superior to lithium carbonate ([Li.sup.+]) in the maintenance monotherapy treatment of youths diagnosed with bipolar disorder who had been previously stabilized on combination [Li.sup.+] and DVPX ([Li.sup.+]/DVPX) pharmacotherapy. Method: Youths ages 5-17 years with bipolar I or II…

  17. Matching Treatment Focus to Patient Social Investment and Support: 18-Month Follow-up Results.

    ERIC Educational Resources Information Center

    Longabaugh, Richard; And Others

    1995-01-01

    Randomly assigned outpatients to one of three treatments: brief broad-spectrum (BBS), extended relationship enhancement (ERE), or extended cognitive-behavioral (ECB). Results suggest that the intensity of focus on relationship enhancement should be calibrated to the anticipated difficulty in dealing with problems in the patient's relationship to…

  18. Double-Blind 18-Month Trial of Lithium Versus Divalproex Maintenance Treatment in Pediatric Bipolar Disorder.

    ERIC Educational Resources Information Center

    Findling, Robert L.; McNamara, Nora K.; Youngstrom, Eric A.; Stansbrey, Robert; Gracious, Barbara L.; Reed, Michael D.; Calabrese, Joseph R.

    2005-01-01

    Objective: To determine whether divalproex sodium (DVPX) was superior to lithium carbonate ([Li.sup.+]) in the maintenance monotherapy treatment of youths diagnosed with bipolar disorder who had been previously stabilized on combination [Li.sup.+] and DVPX ([Li.sup.+]/DVPX) pharmacotherapy. Method: Youths ages 5-17 years with bipolar I or II…

  19. Predictors of adherence to occlusion therapy three months after cataract extraction in the Infant Aphakia Treatment Study

    PubMed Central

    Drews-Botsch, Carolyn D.; Hartmann, E. Eugenie; Celano, Marianne

    2012-01-01

    Background Little information is available on factors that predict adherence to patching in infants. We evaluated data from the Infant Aphakia Treatment Study (IATS), a randomized clinical trial of treatment for infants with unilateral congenital cataracts, to investigate factors associated with successful adherence to patching protocols. Subjects and Methods In the IATS, patching was prescribed 1 hour daily per month of age until 8 months of age and 50% of waking hours thereafter. A centrally located staff member inquired about adherence to patching in a phone interview with the primary caregiver. Analyses used χ2 tests of independence and logistic regression to identify predictors of reported adherence and of achieving adherence rates of at least 75% (“good”) and 90% (“excellent”). Results A total of 104 caregivers provided data on patching 3 months after surgery, at which time 60% reported patching at least 75% of the prescribed time. Reported adherence was not associated with the type of treatment (P = 0.73) but was better in children with private insurance (P = 0.01) and for children with mothers reporting lower levels of parenting stress (P = 0.03). Conclusions Most caregivers reported being able to adhere to prescribed patching shortly after extraction of a unilateral congenital cataract. The type of correction (IOL vs contact lens) was not associated with the amount of patching achieved, whereas family socioeconomic status and maternal stress appeared to play a role. PMID:22525171

  20. Six-month treatment outcomes of cocaine-dependent patients with and without PTSD in a multisite national trial.

    PubMed

    Najavits, Lisa M; Harned, Melanie S; Gallop, Robert J; Butler, Stephen F; Barber, Jacques P; Thase, Michael E; Crits-Christoph, Paul

    2007-05-01

    This study examined 6-month treatment outcomes among 428 cocaine-dependent outpatients with (n = 34) and without (n = 394) posttraumatic stress disorder (PTSD) in a randomized controlled multisite clinical trial of manual-based psychotherapies for substance use disorder (SUD). Assessments were completed at baseline and monthly during the 6-month treatment. With longitudinal mixed-effects models, we compared outcomes between SUD-PTSD and SUD-only patients and also examined rates of within-group change. Results indicated a highly consistent pattern: the SUD-PTSD patients were more impaired to begin with and remained so across time compared with SUD-only patients (with the exception of substance use and addiction-related legal and employment problems, which did not differ between groups). Also, the SUD-PTSD patients improved less than SUD-only patients in alcohol use and the majority of addiction-related psychosocial problems. However, the two groups did not differ significantly in improvement over time on drug use or global psychological severity. The greater impairment and relative lack of improvement of SUD-PTSD patients, compared with those with SUD-only, suggest a need for dual-diagnosis treatments that more directly target their areas of difficulty.

  1. A Spiderless Arachnophobia Therapy: Comparison between Placebo and Treatment Groups and Six-Month Follow-Up Study

    PubMed Central

    Granado, Laura Carmilo; Ranvaud, Ronald; Peláez, Javier Ropero

    2007-01-01

    We describe a new arachnophobia therapy that is specially suited for those individuals with severe arachnophobia who are reluctant to undergo direct or even virtual exposure treatments. In this therapy, patients attend a computer presentation of images that, while not being spiders, have a subset of the characteristics of spiders. The Atomium of Brussels is an example of such an image. The treatment group (n = 13) exhibited a significant improvement (time × group interaction: P = .0026) when compared to the placebo group (n = 12) in a repeated measures multivariate ANOVA. A k-means clustering algorithm revealed that, after 4 weeks of treatment, 42% of the patients moved from the arachnophobic to the nonarachnophobic cluster. Six months after concluding the treatment, a follow-up study showed a substantial consolidation of the recovery process where 92% of the arachnophobic patients moved to the nonarachnophobic cluster. PMID:17713595

  2. Adaptive multimodal treatment for children with attention-deficit-/hyperactivity disorder: an 18 month follow-up.

    PubMed

    Döpfner, Manfred; Ise, Elena; Wolff Metternich-Kaizman, Tanja; Schürmann, Stephanie; Rademacher, Christiane; Breuer, Dieter

    2015-02-01

    The Cologne Adaptive Multimodal Treatment (CAMT) study demonstrated that adaptive and individually tailored multimodal treatment for attention-deficit/hyperactivity disorder (ADHD) [consisting of behavior therapy (BT) and/or stimulant medication] is highly effective. This study reports findings of the 18 month follow-up assessment. Parents and teachers completed broad range behavior scales (Child Behavior Checklist/Teacher Report Form) and standardized ADHD and oppositional defiant disorder/conduct disorder symptom rating scales. Children that used medication to treat ADHD at follow-up (N = 32) and those that did not (N = 34) were analyzed separately. Parents did not report significant changes in child behavior from posttest to follow-up. Teacher ratings revealed some aggravation of ADHD symptoms in children that received medication, but this was not significant after Bonferroni correction. The initial advantage of combined treatment over BT was no longer evident. It can be concluded that treatment for ADHD that is tailored to the assessed needs of children results in large treatment effects that are maintained for at least 18 months.

  3. 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.

  4. Completion Rate and Side-Effect Profile of Three-Month Isoniazid and Rifapentine Treatment for Latent Tuberculosis Infection in an Urban County Jail.

    PubMed

    Juarez-Reyes, Maria; Gallivan, Mark; Chyorny, Alexander; O'Keeffe, Linda; Shah, Neha S

    2016-01-01

    In an urban jail population, 3 months of isoniazid and rifapentine (3HP) was associated with an 85% latent tuberculosis infection treatment completion rate compared with 18% in a standard 9-month isoniazid treatment group. Among the 91 patients who started 3HP therapy, there were 2 treatment discontinuations from adverse drug reactions.

  5. Completion Rate and Side-Effect Profile of Three-Month Isoniazid and Rifapentine Treatment for Latent Tuberculosis Infection in an Urban County Jail

    PubMed Central

    Juarez-Reyes, Maria; Gallivan, Mark; Chyorny, Alexander; O'Keeffe, Linda; Shah, Neha S.

    2016-01-01

    In an urban jail population, 3 months of isoniazid and rifapentine (3HP) was associated with an 85% latent tuberculosis infection treatment completion rate compared with 18% in a standard 9-month isoniazid treatment group. Among the 91 patients who started 3HP therapy, there were 2 treatment discontinuations from adverse drug reactions. PMID:26885547

  6. Patterns of sustained heroin abstinence amongst long-term, dependent heroin users: 36 months findings from the Australian Treatment Outcome Study (ATOS).

    PubMed

    Darke, Shane; Ross, Joanne; Mills, Katherine L; Williamson, Anna; Havard, Alys; Teesson, Maree

    2007-09-01

    To determine patterns of past month, 12 month and sustained 36 month heroin abstinence. As part of a longitudinal cohort study, 429 heroin users re-interviewed at 36 month follow-up for the Australian Treatment Outcome Study (ATOS). The proportion who had sustained heroin abstinence since baseline declined from 14% at 12 months to 8% at 36 months. The proportion who reported abstinence over the preceding 12 months, however, increased significantly from 14% at 12 months to 40% at 36 months. There were no significant gender differences in the proportions reporting sustained 36 month abstinence. Females, however, were significantly more likely to have maintained abstinence over the 12 months preceding 36 month follow-up. Independent predictors of sustained abstinence over 36 months were fewer treatment episodes since baseline, not committing crime at baseline and higher levels of global psychological distress. Despite a decline in the proportion who had maintained complete heroin abstinence over 36 months, there were substantial increases in 12 month abstinence patterns. The results illustrate the importance of stable treatment retention.

  7. 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

  8. TBI Patient, Injury, Therapy, and Ancillary Treatments Associated with Outcomes at Discharge and 9 Months Post-discharge

    PubMed Central

    Horn, Susan D.; Corrigan, John D.; Beaulieu, Cynthia L.; Bogner, Jennifer; Barrett, Ryan S.; Giuffrida, Clare G.; Ryser, David K.; Cooper, Kelli; Carroll, Deborah M.; Deutscher, Daniel

    2015-01-01

    Objective To examine associations of patient and injury characteristics, inpatient rehabilitation therapy activities, and neurotropic medications with outcomes at discharge and 9 months post-discharge for patients with traumatic brain injury (TBI) Design Prospective, longitudinal observational study Setting 10 inpatient rehabilitation centers (9 US, 1 Canada) Participants Consecutive patients (n=2130) enrolled between 2008 and 2011, admitted for inpatient rehabilitation after an index TBI injury Interventions Not applicable Main Outcome Measures Rehabilitation length of stay, discharge to home, and Functional Independence Measure (FIM) at discharge and 9 months post-discharge Results The admission FIM Cognitive score was used to create 5 relatively homogeneous subgroups for subsequent analysis of treatment outcomes. Within each subgroup, significant associations were found between outcomes and patient and injury characteristics, time spent in therapy activities, and medications used. Patient and injury characteristics explained on average 35.7% of the variation in discharge outcomes and 22.3% in 9-month outcomes. Adding time spent and level of effort in therapy activities, as well as percent of stay using specific medications, explained approximately 20.0% more variation for discharge outcomes and 12.9% for 9-month outcomes. After patient, injury, and treatment characteristics were used to predict outcomes, center differences added only approximately 1.9% additional variance explained. Conclusions At discharge, greater effort during therapy sessions, time spent in more complex therapy activities, and use of specific medications were associated with better outcomes for patients in all admission FIM Cognitive subgroups. At 9 months post-discharge, similar but less pervasive associations were observed for therapy activities, but not classes of medications. Further research is warranted to examine more specific combinations of therapy activities and medications that

  9. Neuropsychologic function in children with brain tumors. III. Interval changes in the six months following treatment

    SciTech Connect

    Mulhern, R.K.; Kun, L.E.

    1985-01-01

    Twenty-six children with primary brain tumors were studied prospectively with regard to their sensorimotor, intellectual, academic, and emotional status. Serial evaluations were conducted after surgery (pre-irradiation) and six months after the completion of radiation therapy. The timing of the second evaluation was chosen so as to antedate the late effects of irradiation. Children over 6 years old displayed significant improvement of intellectual function over time, with only 11% exhibiting deterioration on one or more cognitive parameters. In contrast, 68% of younger children clinically deteriorated in one or more areas of intellectual functioning, with prominent difficulties in memory and selective attention for age. Children under 6 years old with supratentorial tumors were less likely than those with posterior fossa tumors to improve their cognitive performance. At the second evaluation, 23% of the patients were functioning below normal (IQ less than 80) intellectually, with 50% of the younger children and 11% of the older children receiving special educational assistance. Approximately 40-50% of the patients manifested emotional adjustment problems at each evaluation. The results are discussed in terms of the clinical need to follow similar patient populations with formal psychological assessments over time, and in terms of the difficulties involved in defining factors that determine the functional status of children surviving brain tumors.

  10. Multipotent drugs with cholinergic and neuroprotective properties for the treatment of Alzheimer and neuronal vascular diseases. I. Synthesis, biological assessment, and molecular modeling of simple and readily available 2-aminopyridine-, and 2-chloropyridine-3,5-dicarbonitriles.

    PubMed

    Samadi, Abdelouahid; Marco-Contelles, José; Soriano, Elena; Alvarez-Pérez, Mónica; Chioua, Mourad; Romero, Alejandro; González-Lafuente, Laura; Gandía, Luis; Roda, José M; López, Manuela G; Villarroya, Mercedes; García, Antonio G; Ríos, Cristóbal de Los

    2010-08-15

    The synthesis, molecular modeling, and pharmacological analysis of new multipotent simple, and readily available 2-aminopyridine-3,5-dicarbonitriles (3-20), and 2-chloropyridine-3,5-dicarbonitriles (21-28), prepared from 2-amino-6-chloropyridine-3,5-dicarbonitrile (1) and 2-amino-6-chloro-4-phenylpyridine-3,5-dicarbonitrile (2) is described. The biological evaluation showed that some of these molecules were modest inhibitors of acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE), in the micromolar range. The 2-amino (3, 4), and 2-chloro derivatives 21-23, 25, 26 were AChE selective inhibitors, whereas 2-amino derivatives 5, 14 proved to be selective for BuChE. Only inhibitor 24 was equipotent for both cholinesterases. Kinetic studies on compound 23 showed that this compound is a mixed-type inhibitor of AChE showing a K(i) of 6.33 microM. No clear SAR can be obtained form these data, but apparently, compounds bearing small groups such as the N,N'-dimethylamino or the pyrrolidino, regardless of the presence of a 2-amino, or 6-chloro substituent in the pyridine ring, preferentially inhibit AChE. Molecular modeling on inhibitors 4, 5, 22, and 23 has been carried out to give a better insight into the binding mode on the catalytic active site (CAS), and peripheral anionic site (PAS) of AChE. The most important differences in the observed binding relay on the modifications of the group at C2, as the amino group forms two hydrogen bonds that direct the binding mode, while in the case of compounds with a chlorine atom, this is not possible. The neuroprotective profile of these molecules has been investigated. In the LDH test, only compounds 26, 3, 22, and 24 showed neuroprotection with values in the range 37.8-31.6% in SH-SY5Y neuroblastoma cells stressed with a mixture of oligomycin-A/rotenone, but in the MTT test only compound 17 (32.9%) showed a similar profile. Consequently, these compounds can be considered as attractive multipotent therapeutic molecules on

  11. Comparison of clinical features and 3-month treatment response among three different choroidal thickness groups in polypoidal choroidal vasculopathy.

    PubMed

    Kong, Mingui; Kim, Sung Min; Ham, Don-Il

    2017-01-01

    Eyes with polypoidal choroidal vasculopathy (PCV) were recently reported to have various choroidal thickness, and choroidal thickness might be associated with visual outcome in the treatment of many retinal disorders. The range of subfoveal choroidal thickness (SFCT), clinical features, and 3-month treatment response among three groups having different range of SFCT were investigated in PCV eyes. In 78 treatment-naïve eyes with PCV, SFCT was measured using optical coherence tomography. Eyes were classified into thin, medium, and thick groups, using mean and one standard deviation of SFCT. Clinical features and imaging findings were compared among the three groups. Some eyes were treated with three consecutive monthly injection of anti-vascular endothelial growth factor (VEGF) as an initial treatment. They were also classified into three thickness groups, and the short-term post-treatment improvement in visual acuity and central retinal thickness were compared among groups. The mean SFCT was 271.9 ± 135.6 μm. Twelve, 53, and 13 eyes were classified into thin (<136.3 μm), medium (136.3-407.5 μm), and thick (>407.5 μm) groups, respectively. The thin group showed older age, lower visual acuity, and a higher prevalence of fundus tessellation than the other two groups (P <0.05). In multiple linear regression analyses, baseline BCVA was correlated with baseline SFCT. Forty-six eyes completed three consecutive anti-VEGF treatments. The thin group showed no visual improvement after treatment (P = 0.141), unlike the other two groups showing visual improvement (P<0.05). Eyes with PCV have a broad range of SFCT, and PCV eyes with a thin choroid manifest worse visual function than eyes with a medium or thick choroid.

  12. Treatment of fibromyalgia at the Maharishi Ayurveda Health Centre in Norway. A six-month follow-up study.

    PubMed

    Rasmussen, L B; Mikkelsen, K; Haugen, M; Pripp, A H; Førre, Ø T

    2009-01-01

    Treatments offered at the Maharishi Ayurveda Health Centre in Norway are based on Maharishi Vedic medicine, which is also known as Maharishi Ayurveda. It is a consciousness based revival of the ancient Ayurvedic medicine tradition in India and is established by Maharishi Mahesh Yogi, the founder of the Transcendental Meditation (TM) technique. To conduct a pilot study of the effect of the treatment program at the Health Centre on fibromyalgia patients. Thirty-one women with diagnosed fibromyalgia received an individually designed Maharishi Vedic physiological purification therapy. All subjects received personal advice on diet based on Ayurvedic principles, including a novel approach to food into-lerance, and daily routines. In addition they were offered instruction in TM (for stress and pain management and personal development) (four subjects started), and recommended Ayurvedic herbal food products for home treatment. A modified Fibromyalgia Impact Questionnaire included a visual analogue scale for each of the seven outcomes: working ability, generalised pain, tiredness, stiffness, tiredness on arising, anxiety and depression. Pre-treatment scores were compared with scores at six-month follow-up for levels of statistical significance. Twenty-eight subjects (90%) completed the follow-up. The outcome measures were reduced by 25 to 46% by the study's endpoint: working ability (p<0.002), pain (p<0.001), tiredness (p<0.001), morning tiredness (p<0.001), stiffness (p<0.005), anxiety (p<0.136), and depression (p<0.001). A group of five excellent responders including all four participants who started to practise TM, had almost no symptoms by the endpoint. Compared to the non-meditating control group the TM-subgroup showed statistically significant improvements for all outcome measures except depression. In this pilot study fibromyalgia patients undergoing treatment at Maharishi Ayurveda Health Centre in Norway showed significant improvements six months post treatment

  13. Safety and efficacy of oral slow release morphine for maintenance treatment in heroin addicts: a 6-month open noncomparative study.

    PubMed

    Vasilev, Georgi N; Alexieva, Daniela Z; Pavlova, Rositsa Z

    2006-01-01

    This open-label, noncomparative, single-center trial evaluated the safety and efficacy of once-daily treatment with slow release oral morphine (SROM) capsules for the maintenance treatment of 20 outpatients with heroin dependency over 6 months at the National Institute for Addictions in Sofia, Bulgaria. Doses were individually titrated up to a mean daily maintenance dose of 760 mg (range 440-1,200 mg). SROM was effective in significantly reducing the signs and symptoms of opioid withdrawal and craving for heroin, with stabilization generally evident within two weeks. Nineteen patients completed 6 months of treatment and illicit opioid use was virtually eliminated. One patient withdrew voluntarily at 22 weeks. Validated questionnaires and tests indicated improvements in patients' well-being from baseline assessments. These included significant improvements with regard to suicidal depression (85%), anxiety and dysphoria (66%), general illness (58%), social dysfunction (54%), sense of hopelessness (34%), attention (25%), and self-reported typical depressive (27%) and disease-related (11%) symptoms. No deaths, serious adverse events, or withdrawals due to adverse events occurred. Five episodes of constipation and one episode of sweating (all nonserious and of mild or moderate severity) were reported. Vital signs were unaffected by SROM and no weight change was evident over the study period. The observations made in this study indicate a promising role for once-daily treatment with SROM in the clinical management of heroin dependency. Copyright 2006 S. Karger AG, Basel.

  14. An Exploration of Smoking Among People Attending Residential Substance Abuse Treatment: Prevalence and Outcomes at Three Months Post-Discharge.

    PubMed

    Ingram, Isabella; Kelly, Peter J; Deane, Frank P; Baker, Amanda L; Lyons, Geoff; Blackman, Russell

    2017-01-01

    Smoking continues to be a major health concern for people with a history of alcohol or other substance use problems. The current research is aimed to (1) describe the prevalence of smoking in residential addictions treatment services and (2) compare characteristics of people who had or had not quit smoking. Participants were attending residential substance abuse treatment provided by the Australian Salvation Army. These programs are up to 10 months in length and offer a range of low-intensity smoking cessation supports. Measures of smoking, substance use, and clinical characteristics were collected from 2008 to 2015 at baseline and three months post-discharge from treatment (N = 702). At baseline, 86% of people were smokers (n = 606). At follow-up, only 48 participants who were smokers at baseline (7%) had quit smoking. Participants who had quit smoking at follow-up also reported higher rates of abstinence from alcohol or other substances at follow-up (72%) than people who had not quit smoking (46%; OR = 2.95, 95% CI [1.52, 5.74]). There is potential for smoking cessation to be better addressed as part of routine care in substance abuse treatment settings. Future research should evaluate the provision of more systematic smoking cessation interventions within these settings.

  15. Internet screening for anxiety disorders: Treatment-seeking outcomes in a three-month follow-up study.

    PubMed

    Van Ameringen, Michael; Simpson, William; Patterson, Beth; Turna, Jasmine

    2015-12-15

    Although many people use the internet to diagnose mental health problems, little is known about the relationship between internet self-diagnosis and treatment-seeking. The MACSCREEN (a validated, self-report screening tool for anxiety and depression) was posted on our clinic homepage and respondents were invited to take an anxiety test. Three months after completing the MACSREEN and a variety of symptom severity scales, respondents were emailed a follow up questionnaire asking about treatment-seeking behaviours. Of the 770 MACSCREEN respondents, 103 completed the follow-up questionnaire. Of these, 100% met criteria for at least one anxiety or mood disorder diagnosis and 51% sought treatment after completing the MACSCREEN. In the 49% who did not seek treatment, fear of medication (57%), discomfort talking to their doctor about anxiety (28%) and the belief that symptoms were not severe enough (28%) were cited as barriers. Compared to non-seekers, treatment-seekers were significantly more likely to meet screening criteria for Generalized Anxiety Disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder and Depression. Higher Sheehan Disability Scale scores and being married (versus single) significantly increased the odds of treatment-seeking, suggesting that functional impairment and disease burden on the family may be stronger predictors of treatment seeking than overall severity of symptoms.

  16. Predictors of Six-month Change in the Voice Handicap Index in a Treatment-seeking Population.

    PubMed

    Moore, Jaime; Greenberg, Caprice; Thibeault, Susan L

    2017-01-01

    To evaluate predictors of longitudinal change in patient-perceived voice impact as determined by the Voice Handicap Index (VHI). Prospective, survey study. Patients consented to the University of Wisconsin Voice and Swallow Clinics Outcomes Database with voice, concerns with a baseline clinic visit from November 2012 to January 2014 were eligible for the study. The VHI was sent to patients 6 months post clinic visit to determine change in voice handicap from baseline. General health was screened using the 12-item Short Form Health Survey, using physical component summary and mental component summary scores. Predictor variables included treatment (medical and/or behavioral); dysphonia sub-diagnosis; grade, roughness, breathiness, asthenia, and strain rating; age; sex; socioeconomic factors; smoking history; and comorbidity score. Two hundred thirty-seven patients met study criteria and were followed longitudinally. Eighty-two patients returned 6-month surveys. The VHI was significantly correlated with mental component summary scores. Patients with a higher grade in baseline grade, roughness, breathiness, asthenia, and strain score were more likely to receive voice intervention (P = 0.04). Six-month improvement in VHI score was associated with both higher initial VHI score and higher educational level in both univariate (P < 0.01, P = 0.04) and multivariate analyses (P < 0.01, P = 0.02). Voice treatment (medical and/or behavioral) was not a significant factor for improvement in VHI score. Our results suggest that it is important to consider baseline self-perceived voice impact measures and educational level in setting expectations for voice treatment. Future studies examining the relationship between treatment patterns and voice-related patient outcomes are warranted. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  17. Nortriptyline versus fluoxetine in the treatment of major depressive disorder: a six-month, double-blind clinical trial

    PubMed Central

    Hashemi, SN; Shirazi, HR Ghafarian; Mohammadi, A; Zadeh-Bagheri, GH; Noorian, KH; Malekzadeh, M

    2012-01-01

    Background Depression is a common psychiatric disorder worldwide, including in Iran, and is estimated to affect 10%–15% of the population. Antidepressant drugs can have multiple side effects, so a good choice of drug is important for successful treatment. This study compared the efficacy of nortriptyline with that of fluoxetine in the treatment of patients with major depressive disorder and assessed related factors, including age, gender, and level of education. Methods The study was a double-blind, randomized clinical trial with a six-month follow-up period. Participants were 120 patients aged 15–60 years with a diagnosis of major depressive disorder based on a psychiatry interview and the Beck depression rating scale, which were performed at the beginning, middle, and end of the study. The patients were treated with nortriptyline or fluoxetine. The paired t-test, independent t-test, and the k chi-square test were used to analyze the data. Results Twenty-three patients dropped out and 97 remained in the trial. Before intervention, the mean depression score was 32.85 ± 6.23 in the nortriptyline group and 33.12 ± 6.50 in the fluoxetine group. The results of the independent t-test showed a significant difference between depression score means before and after treatment in both groups. Changes at the end of the trial compared with baseline scores were 13.4 ± 4.68 and 16.96 ± 4.96 for nortriptyline and fluoxetine, respectively. Paired t-testing showed a significant difference in the mean depression score for both the nortriptyline and fluoxetine groups. Age, gender, and level of education had no significant effects on the outcome of treatment in the two groups. Conclusion The present study suggests that both nortriptyline and fluoxetine were effective in the treatment of depression, but that fluoxetine was more effective than nortriptyline after 3 and 6 months of treatment. PMID:22359466

  18. Tuberculosis treatment outcomes of six and eight month treatment regimens in districts of Southwestern Ethiopia: a comparative cross-sectional study.

    PubMed

    Asres, Abyot; Jerene, Degu; Deressa, Wakgari

    2016-11-08

    A switch of continuation phase tuberculosis (TB) treatment regimen from Ethambutol (E) and Isoniazid (H) combination for 6 months (6EH) to Rifampicin (R) and Isoniazid (H) combination for 4 months (4RH) was recommended. However, the effect of the regimen switch in Ethiopian setting is not known. A comparative cross-sectional study among 790 randomly selected new cases of TB (395 each treated with 4RH and 6EH during the continuation phase) was conducted in nine health centers and one hospital in three zones in southwestern Ethiopia. Data were abstracted from the standard unit TB register composed of standard case and treatment outcome definitions. Data were analyzed using STATA version 13 where binary logistic regression was fitted to identify independent predictors of unsuccessful treatment outcomes at 5 % significance level. Over all, 695 (88 %) of the patients had a successful treatment outcome with statistically significant difference (85.3 % vs 90.6 %, p = 0.02) among the 6HE and 4RH regimens, respectively. After adjusting for confounders, 4RH continuation phase treatment regimen adjusted odds ratio (AOR) [(95 % confidence interval (CI)) 0.55 (0.34,0.89)], age [AOR (95 % CI 1.02 (1.001,1.022)], rural residence [AOR (95 % CI) 2.1 (1.18,3.75)] Human Immunodeficiency virus (HIV) positives [AOR (95 % CI) 2.39 (1.12,5.07)] and increased weight at the end of the second month [AOR (95 % CI 0.28 (0.11,0.72)] independently predicted treatment outcome. The switch of continuation phase TB treatment regimen from 6EH to 4RH has brought better treatment outcomes which imply applicability of the recommendation in high prevalent and resource constrained settings. Therefore, it should be maintained and augmented through further studies on its impact among the older, rural residents and HIV positives.

  19. Simplified Disease Activity Index remission at month 6 is an independent predictor of functional and structural remissions at month 12 during abatacept treatment in patients with rheumatoid arthritis: A multi-center, prospective cohort study in Japan.

    PubMed

    Yamazaki, Hayato; Hirano, Fumio; Takeuchi, Tsutomu; Amano, Koichi; Kikuchi, Jun; Kihara, Mari; Yokoyama, Waka; Sugihara, Takahiko; Nagasaka, Kenji; Hagiyama, Hiroyuki; Nonomura, Yoshinori; Sakai, Ryoko; Tanaka, Michi; Koike, Ryuji; Nanki, Toshihiro; Kohsaka, Hitoshi; Miyasaka, Nobuyuki; Harigai, Masayoshi

    2017-09-01

    To evaluate association of clinical remission at month 6 with functional and structural remissions at month 12 during abatacept treatment in patients with rheumatoid arthritis (RA). This 12-month prospective, multicenter cohort study enrolled 168 patients with RA who started abatacept. Outcomes were assessed using composite measures, quality of life indices, and the van der Heijde-modified total Sharp score (mTSS). The logistic regression analysis was applied to identify factors associated with outcomes and their odds ratios (OR) with 95% confidence interval (95% CI). At month 6 and 12, 21.4% and 26.2% of the patients achieved Simplified Disease Activity Index (SDAI) remission (SDAI <3.3), and 40.6% and 41.7% achieved Health Assessment Questionnaire-Disability Index (HAQ-DI <0.5) remission. Among 129 patients whose mTSS progression was evaluated at month 12, 83 (64.3%) achieved structural remission (ΔmTSS ≤0.5 for 12 months). SDAI remission at month 6 was identified as a significant predictor of both functional (OR, 3.732; 95% CI, 1.328-10.489) and structural remissions (OR, 4.301; 95% CI, 1.298-14.243) at month 12 after adjusting for covariates. Aiming for SDAI remission at month 6 is an appropriate strategy to obtain good functional and structural outcomes at month 12.

  20. Sertraline and fluoxetine treatment of obsessive-compulsive disorder: results of a double-blind, 6-month treatment study.

    PubMed

    Bergeron, Richard; Ravindran, Arun V; Chaput, Yves; Goldner, Elliot; Swinson, Richard; van Ameringen, Michael A; Austin, Carol; Hadrava, Vratislav

    2002-04-01

    The purpose of this study was to evaluate the comparative efficacy and tolerability of sertraline and fluoxetine in the treatment of obsessive-compulsive disorder (OCD). Outpatients meeting DSM-IV criteria for OCD, with a Yale-Brown Obsessive-Compulsive (Y-BOCS) total score >or= 17, an NIMH Global Obsessive-Compulsive (NIMH-OC) scale score >or= 7, and a CGI-Severity score >or= 4 were randomized to 24 weeks of double-blind treatment with sertraline (N = 77) or fluoxetine (N = 73). Primary efficacy measures consisted of the Y-BOCS, the NIMH-OC scale, and the CGI-Severity (CGI-S) and Improvement (CGI-I) scales. Equivalent and significant (p < 0.001) improvement was found at week 24 in Y-BOCS and NIMH-OC scale scores for sertraline and fluoxetine. After 12 weeks, 49.2% of patients on sertraline were rated on the CGI-S scale as being mildly ill or not ill compared to 24.6% on fluoxetine (p < 0.01). A Cox analysis found patients on sertraline to have a statistically nonsignificant 42% greater likelihood of achieving a response by week 12 (CGI-I, much or very much improved; 95% CI, 0.85, 2.38; p = 0.18). Sertraline treatment also resulted in a higher proportion of remissions than fluoxetine (defined as a CGI-I treatment of outpatients with moderate to severe OCD with the subjects treated with sertraline showing a greater likelihood of remission as well as an earlier improvement on some but not all efficacy measures

  1. Treatment of Rheumatoid Arthritis with Marine and Botanical Oils: An 18-Month, Randomized, and Double-Blind Trial

    PubMed Central

    Reed, George W.; Leung, Katherine; Rossetti, Ronald G.; VanBuskirk, Susan; Sharp, John T.; Zurier, Robert B.

    2014-01-01

    Objective. To determine whether a combination of borage seed oil rich in gamma linolenic acid (GLA) and fish oil rich in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) is superior to either oil alone for treatment of rheumatoid arthritis (RA). Methods. Patients were randomized into a double-blind, 18-month trial. Mixed effects models compared trends over time in disease activity measures. Results. No significant differences were observed in changes in disease activity among the three randomized groups. Each group exhibited significant reductions in disease activity (DAS28) at 9 months (fish: −1.56[−2.16, −0.96], borage: −1.33[−1.83, −0.84], combined: −1.18[−1.83, −0.54]) and in CDAI (fish: −16.95[−19.91, −13.98], borage: −11.20[−14.21, −8.19], and combined: −10.31[−13.61, −7.01]). There were no significant differences in change of RA medications among the three groups. Reduced disease activity in study patients was similar to matched patients from an RA registry, and reduction in DMARD use was greater (P < 0.03) in study patients. Conclusion. All 3 treatment groups exhibited similar meaningful clinical responses after 9 months, improvements which persisted for 18 months, and a response similar to matched patients from an RA registry. Study patients were able to reduce DMARD therapy given in combination with TNF antagonists to a greater extent than registry patients. This paper is dedicated to the memory of Dr. John T. Sharp, M.D., a pioneer and innovator in the field of musculoskeletal radiology PMID:24803948

  2. 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.

  3. Evaluation of leptin levels among fibromyalgia patients before and after three months of treatment, in comparison with healthy controls

    PubMed Central

    Ablin, Jacob N; Aronov, Natalia; Shimon, Ilan; Kanety, Hannah; Pariente, Clara; Aloush, Valerie; Elkayam, Ori; Levartovsky, David

    2012-01-01

    BACKGROUND: Leptin, an adipocyte-produced cytokine, interacts with various hormones, including those of the hypothalamic-pituitary-adrenal axis. Fibromyalgia is a syndrome characterized by widespread pain accompanied by tenderness. The pathogenesis involves a disturbance in pain processing and transmission by the central nervous system, leading to a general increase in pain perception. OBJECTIVES: To analyze potential changes in leptin levels among female fibromyalgia patients compared with healthy controls, and to evaluate the changes in leptin levels during treatment. METHODS: Sixteen female fibromyalgia patients were recruited. Patients underwent clinical evaluation, physical examination, including manual dolorimetry, and were evaluated regarding quality of life, pain, fatigue, anxiety and depression. Plasma leptin levels were determined by ELISA. Patients were offered standard treatment for fibromyalgia. Clinical evaluation and leptin determination were repeated after three months. RESULTS: No significant difference was observed between leptin levels among fibromyalgia patients and controls; no significant correlation was observed between leptin levels and clinical parameters reflecting fibromyalgia severity; and no significant change was observed in leptin levels over three months of treatment. These results did not change after adjustment of leptin levels for body mass index values. CONCLUSIONS: The results of the present study do not support the existence of a significant relationship between leptin and fibromyalgia pathogenesis. Increasing the sample size or examining the interaction between leptin and additional hormones/mediators of metabolism and body weight control may yet uncover significant information in this field. PMID:22518370

  4. Evaluation of leptin levels among fibromyalgia patients before and after three months of treatment, in comparison with healthy controls.

    PubMed

    Ablin, Jacob Nadav; Aronov, Natalya; Shimon, Ilan; Kanety, Hannah; Pariente, Clara; Aloush, Valerie; Elkayam, Ori; Levartovsky, David

    2012-01-01

    Leptin, an adipocyte-produced cytokine, interacts with various hormones, including those of the hypothalamic-pituitary-adrenal axis. Fibromyalgia is a syndrome characterized by widespread pain accompanied by tenderness. The pathogenesis involves a disturbance in pain processing and transmission by the central nervous system, leading to a general increase in pain perception. To analyze potential changes in leptin levels among female fibromyalgia patients compared with healthy controls, and to evaluate the changes in leptin levels during treatment. Sixteen female fibromyalgia patients were recruited. Patients underwent clinical evaluation, physical examination, including manual dolorimetry, and were evaluated regarding quality of life, pain, fatigue, anxiety and depression. Plasma leptin levels were determined by ELISA. Patients were offered standard treatment for fibromyalgia. Clinical evaluation and leptin determination were repeated after three months. No significant difference was observed between leptin levels among fibromyalgia patients and controls; no significant correlation was observed between leptin levels and clinical parameters reflecting fibromyalgia severity; and no significant change was observed in leptin levels over three months of treatment. These results did not change after adjustment of leptin levels for body mass index values. The results of the present study do not support the existence of a significant relationship between leptin and fibromyalgia pathogenesis. Increasing the sample size or examining the interaction between leptin and additional hormones⁄mediators of metabolism and body weight control may yet uncover significant information in this field.

  5. Improved adherence with PTH(1–84) in an extension trial for 24 months results in enhanced BMD gains in the treatment of postmenopausal women with osteoporosis

    PubMed Central

    Bilezikian, J. P.; Greenspan, S. L.; Wüster, C.; Muñoz-Torres, M.; Bone, H. G.; Rosen, C. J.; Andersen, H. S.; Hanley, D. A.

    2016-01-01

    Summary The purpose of this study is to examine the effect of PTH(1–84) treatment over 24 months followed by 12 months discontinuation on BMD, bone turnover markers, fractures and the impact of adherence on efficacy. Introduction There is limited information about the effect of PTH(1-84) after 18 months and limited data about the impact of compliance on response to anabolic therapy. Methods Seven hundred and eighty-one subjects who received active PTH(1–84) in the Treatment of Osteoporosis with Parathyroid hormone trial for approximately 18 months were entered into a 6-month open-label extension. Thereafter, they were followed for 12 additional months after discontinuation of treatment. Endpoints examined included changes in BMD and biochemical markers. Results PTH(1–84) treatment over 24 months increased BMD at the lumbar spine by 6.8 % above baseline (p < 0.05). The total corresponding BMD increases at the hip and femoral neck were 1.1 and 2.2% above baseline. Larger increases in spine BMD were observed in participants with ≥80 % adherence to daily injections of PTH(1–84) (8.3% in adherent vs 4.9 % in poorly adherent patients). Total hip BMD gains were 1.7 % in adherent vs 0.6 % in poorly adherent participants. Markers of bone turnover (BSAP and NTx) peaked 6 months after starting PTH(1–84) treatment and declined slowly but remained above baseline at 24 months. After discontinuation of PTH(1–84) treatment (at 24 months), bone turnover markers returned to near baseline levels by 30 months. The adherent group sustained significantly fewer fractures than the poorly adherent group. Conclusions PTH(1–84) treatment over 24 months results in continued increases in lumbar spine BMD. Adherence to treatment with PTH(1–84) for up to 24 months is also associated with greater efficacy. PMID:22930240

  6. A New Implanted Posterior Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome: 3-Month Results of a Novel Therapy at a Single Center.

    PubMed

    van Breda, Hendrikje M K; Martens, Frank M J; Tromp, Johnny; Heesakkers, John P F A

    2017-07-01

    This study was designed to investigate the safety and performance of a new implantable system for tibial nerve stimulation for overactive bladder symptoms. A battery-free stimulation device for tibial nerve stimulation (BlueWind Medical, Herzliya, Israel) was implanted in 15 patients. Safety and efficacy assessments were done at 3 months after activation with a 3-day bladder diary, a 24-hour pad test and 2 quality of life questionnaires. Two males and 13 females were enrolled in the study. Mean age was 54 years (range 19 to 72). Five of 15 patients were previously treated with percutaneous tibial nerve stimulation and 12 experienced urgency urinary incontinence. Median operative time was 34 minutes. At 3 months of followup a significant change was seen in 24-hour frequency from a mean ± SD of 11.8 ± 3.5 to 8.1 ± 2.0 times per day (p = 0.002), the number of severe urinary urgency episodes from 6.5 ± 5.1 to 2.0 ± 2.1 times per day (p = 0.002), the number of severe incontinence episodes from 2.8 ± 5.2 to 0.3 ± 0.4 episodes per day (p = 0.017), urinary loss per day from 243 ± 388 to 39 ± 55 gm (p = 0.038) and improvement in quality of life. After implantation, 3 patients received prolonged antibiotic treatment and 3 received pain medication for 1 week. In 1 patient the device was explanted due to pain and swelling suspicious for infection, although tissue cultures did not reveal a bacterial infection. This novel posterior tibial nerve stimulator is safe and easy to implant with good clinical results. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  7. 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

  8. 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.

  9. Traumatic dissecting aneurysm at the vertebrobasilar junction in a 3-month-old infant: evaluation and treatment strategies. Case report.

    PubMed

    Wang, Huan; Orbach, Darren B

    2008-05-01

    Intracranial aneurysms in young infants are extremely rare, with few published reports on the etiology, evaluation, treatment strategies, and follow-up of this condition in this population. The authors report the case of a traumatic dissecting aneurysm at the vertebrobasilar junction (VBJ) in a 3-month-old infant caused by nonaccidental trauma. Therapeutic occlusion of the VBJ was contemplated, but coil embolization of the main aneurysm sac proved feasible, and anticoagulation and antiplatelet agents were initiated. The patient made a full neurological recovery, and follow-up studies demonstrated stable aneurysm occlusion. Management and follow-up strategies for this challenging condition are discussed.

  10. Reversible cerebral vasoconstriction syndrome associated with fingolimod treatment in relapsing-remitting multiple sclerosis three months after childbirth.

    PubMed

    Kraemer, Markus; Weber, Ralph; Herold, Michèle; Berlit, Peter

    2015-10-01

    Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by acute thunderclap headache, evidence of vasoconstriction in conventional angiography or magnetic resonance angiography and reversibility of these phenomena within 12 weeks. Some triggering factors, for example drugs such as selective serotonin reuptake inhibitors, sumatriptan, tacrolimus, cyclophosphamide and cocaine, or states such as pregnancy, puerperium or migraine have been described. We describe the case of a 29-year-old woman with RCVS associated with fingolimod three months after childbirth. This case represents the first report of RCVS in fingolimod treatment. © The Author(s), 2015.

  11. A randomized, double-blind trial comparing sertraline and fluoxetine 6-month treatment in obese patients with Binge Eating Disorder.

    PubMed

    Leombruni, Paolo; Pierò, Andrea; Lavagnino, Luca; Brustolin, Annalisa; Campisi, Stefania; Fassino, Secondo

    2008-08-01

    Previous studies support the use of selective serotonin reuptake inhibitors (SSRIs), in overweight patients with Binge Eating Disorder (BED), but results are far from conclusive. Sertraline has been studied less extensively, and there have been a few studies concerning SSRIs that report follow-up data at more than 12 weeks of follow-up. The present study assesses the effectiveness of sertraline and fluoxetine over a period of 24 weeks in obese patients with BED (DSM-IV-TR). Forty-two obese outpatients were randomized and assigned to one of two different drug treatments: 22 were treated with sertraline (dose range: 100-200 mg/day) and 20 with fluoxetine (dose range: 40-80 mg/day). Subjects were assessed at baseline and at 8, 12, and 24 weeks of treatment for binge frequency, weight loss, and severity of psychopathology. No significant differences were found between the two treatments. After 8 weeks of treatment a significant improvement in the Binge Eating Scale score and a significant weight loss emerged. These results were maintained by responders (weigh loss of at least 5% of baseline weight) over 24 weeks. The results suggest that a 6-month treatment with SSRI may be an effective option to treat patients with BED.

  12. Decrease of HCVRNA after three days of daily interferon treatment is predictive of the virological response at one month.

    PubMed

    Magalini, A; Puoti, M; Putzolu, V; Quiros-Roldan, E; Forleo, M A; Rossi, S; Zaltron, S; Spinetti, A; Zanini, B; Zonaro, A; Solfrini, R; Carosi, G

    2000-01-01

    Early monitoring of HCVRNA during interferon treatment may allow clinicians to obtain important information that could help them to adopt therapeutic decisions in individual cases. The hepatitis C virus infection is highly dynamic and a daily high dose of IFN may induce a decline of viremia of 95+/-10% of baseline value after 24 to 48 hours of treatment. The importance of this early antiviral efficacy has not been understood. We have measured HCVRNA levels in 47 patients with chronic hepatitis C infection during interferon treatment to study HCVRNA kinetics and evaluate the predictive value of the early decay of viremia on the virological response after one month of treatment. Sixty percent of treated patients showed early virological response (EVR) and it was significantly associated with low HCVRNA levels and a genotype other than 1b. Finally, the absence of an 85% decline in HCVRNA levels after 3 days of treatment observed in 11 out of 45 patients (24%) was an absolute and very early predictor of the absence of EVR in the study population.

  13. Pseudotumor Cerebri in a Child with Idiopathic Growth Hormone Insufficiency Two Months after Initiation of Recombinant Human Growth Hormone Treatment

    PubMed Central

    Loukianou, Eleni; Tasiopoulou, Anastasia; Demosthenous, Constantinos; Brouzas, Dimitrios

    2016-01-01

    Purpose. To report a rare case of pseudotumor cerebri (PTC) in a child two months after receiving treatment with recombinant human growth hormone (rhGH) and to emphasize the need of close collaboration between ophthalmologists and pediatric endocrinologists in monitoring children receiving rhGH. Methods. A 12-year-old boy with congenital hypothyroidism started treatment with rhGH on a dose of 1,5 mg/daily IM (4.5 IU daily). Eight weeks later, he was complaining of severe headache without any other accompanying symptoms. The child was further investigated with computed tomography scan and lumbar puncture. Results. Computed tomography scan showed normal ventricular size and lumbar puncture revealed an elevated opening pressure of 360 mm H2O. RhGH was discontinued and acetazolamide 250 mg per os twice daily was initiated. Eight weeks later, the papilledema was resolved. Conclusions. There appears to be a causal relationship between the initiation of treatment with rhGH and the development of PTC. All children receiving rhGH should have a complete ophthalmological examination if they report headache or visual disturbances shortly after the treatment. Discontinuation of rhGH and initiation of treatment with acetazolamide may be needed and regular follow-up examinations by an ophthalmologist should be recommended. PMID:26966604

  14. Brief Report: Six Months Continuation Treatment in Naltrexone-Responsive Children with Autism: An Open-Label Case-Control Design.

    ERIC Educational Resources Information Center

    Willemsen-Swinkels, Sophie H. N.; Buitelaar, Jan K.; van Berckelaer-Onnes, Ina A.; van Engeland, Herman

    1999-01-01

    This paper reports on a six-month continuation treatment with naltrexone of six children with autism, previously found to be responsive to naltrexone in a four-week trial. Results indicated the moderate hyperactivity-reducing effect of naltrexone was maintained during the six-month continuation treatment but no additional gains in the domains of…

  15. Water Sourcebook. Grades 3-5.

    ERIC Educational Resources Information Center

    Tennessee Valley Authority, Knoxville.

    The goal of this supplemental activity guide for elementary students in grades 3-5 is to develop awareness, knowledge, and skills for sound water use decisions. Materials developed for the program are compatible with existing curriculum standards established by State Boards of Education throughout the United States and teach concepts included in…

  16. Synthesis of deoxyribonucleotidyl(3'5')arabinonucleosides

    SciTech Connect

    Gray, S.H.; Ainsworth, C.F.; Bell, C.L.; Danyluk, S.S.; MacCoss, M.

    1983-01-01

    Two different synthetic routes using phosphotriester methodology have been utilized to prepare deoxyribonucleotidyl(3'-5)arabinonucleosides containing 9-..beta..-D-arabinofuranosyladenine (ara-A vidarabine) and 1-..beta..-D-arabinofuranosylcytosine (ara-C, cytarabine) at the 3'-terminus in amounts and purity (greater than 95%) suitable for NMR analysis.

  17. 12 CFR 3.5 - Applicability.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Banking COMPTROLLER OF THE CURRENCY, DEPARTMENT OF THE TREASURY MINIMUM CAPITAL RATIOS; ISSUANCE OF DIRECTIVES Minimum Capital Ratios § 3.5 Applicability. This subpart is applicable to all banks unless the... ratios are appropriate for an individual bank based upon its particular circumstances, or...

  18. 12 CFR 3.5 - Applicability.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Banking COMPTROLLER OF THE CURRENCY, DEPARTMENT OF THE TREASURY MINIMUM CAPITAL RATIOS; ISSUANCE OF DIRECTIVES Minimum Capital Ratios § 3.5 Applicability. This subpart is applicable to all banks unless the... ratios are appropriate for an individual bank based upon its particular circumstances, or...

  19. Impact of a timed-release FSH treatment from 2 to 6 months of age in bulls II: Endocrinology, puberty attainment, and mature sperm production in Holstein bulls.

    PubMed

    Harstine, B R; Cruppe, L H; Abreu, F M; Rodrigues, A D; DeJarnette, J M; Day, M L

    2017-09-21

    The use of genomic testing in the cattle industries has renewed an interest in hastening bull puberty. In prepubertal males, FSH facilitates Sertoli cell proliferation and testis maturation. The aim of this study was to determine the effect of prepubertal administration of a timed-release FSH (delivered in a hyaluronan solution) on hormone secretion, puberty attainment, and mature sperm production in Holstein bulls in an AI center. Bulls (n = 29) were randomly assigned to one of two treatment groups based on birth date and pedigree. Beginning at 62 days of age (Day 62), bulls were injected im every 3.5 days with either 30 mg FSH (Folltropin-V; NIH-FSH-P1 units) in a 2% hyaluronan solution (FSH-HA, n = 17) or saline (control, n = 12) until Day 170.5. Blood samples to assess FSH, activin A, and testosterone were collected prior to each treatment. Scrotal circumference (SC) and BW were measured monthly. Puberty assessment (ability to ejaculate 5 × 10(7) sperm, 10% motile) was initiated at Day 244. Average mature daily sperm production (3× wk collection, combined 2 ejaculates) was assessed from Day 571-627. In blood collected every 3.5 days, FSH concentrations within FSH-HA bulls were increased (P < 0.05) over initial Day 62 concentration from Day 93.5-170.5. Concentrations of FSH did not differ between treatments from Day 62-93.5, but were greater (P < 0.05) in FSH-HA than control bulls from Day 97-170.5. Concentrations of activin A assessed for Day 62, 86.5, 107.5, 139, and 170.5 were greater (P < 0.05) in FSH-HA than control bulls on Day 86.5 and 107.5. Treatments did not differ (P > 0.1) in testosterone, BW, or SC. FSH-HA bulls attained puberty at a younger age than control bulls (278 ± 7.7 vs. 303 ± 9.1 days of age, P < 0.05), but mature daily sperm production was not different when measured from Day 571-627 (average 5.84 ± 0.11 billion cells/day, P = 0.5). In summary, FSH administration every 3.5 days from Day 62-170.5 resulted in

  20. Effect of one-month treatment with vaginal promestriene on serum estrone sulfate levels in cancer patients: a pilot study.

    PubMed

    Del Pup, L; Postruznik, D; Corona, G

    2012-05-01

    Vaginal promestriene was tested in gynecological cancer patients who suffered from severe vaginal dryness and dyspareunia. This form of estrogen has a low level of vaginal absorption and proved to be effective for vaginal atrophy. 17 patients were treated with a 10mg soft vaginal suppository daily for one month. Plasma levels of estrone sulfate (E1S), used as the marker of overall estrogenicity, were measured by liquid chromatography in combination with mass spectrometry. Mean E1S levels changed from 533 (22-2920) to 374 (81-856) pg/ml (p=0.39). In highly symptomatic gynecological cancer patients the level of circulating estrone sulfate was not significantly affected by vaginal promestriene treatment overall, but a wide range of levels was noted pre and post treatment in individual patients. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  1. A reinforcement-based therapeutic workplace for the treatment of drug abuse: six-month abstinence outcomes.

    PubMed

    Silverman, K; Svikis, D; Robles, E; Stitzer, M L; Bigelow, G E

    2001-02-01

    This study evaluated a novel drug abuse treatment, the Therapeutic Workplace. In this treatment, patients are paid to perform jobs or to participate in job training. Salary is linked to abstinence by requiring patients to provide drug-free urine samples to gain access to the workplace. Pregnant and postpartum drug abuse patients (N = 40) were randomly assigned to a Therapeutic Workplace or usual care control group. Therapeutic Workplace participants were invited to work 3 hr every weekday for 6 months and could earn up to $4,030 in vouchers for abstinence, workplace attendance, and performance. On average, 45% of participants attended the workplace per day. Relative to controls, the Therapeutic Workplace nearly doubled patients' abstinence from opiates and cocaine (33% vs. 59% of thrice-weekly urine samples drug negative, respectively, p < .05). The Therapeutic Workplace can effectively treat heroin and cocaine abuse in pregnant and postpartum women.

  2. [Total atalectasis of the left lung developing during the third month of treatment in a case of pulmonary tuberculosis].

    PubMed

    Dalar, L; Karasulu, L; Sökücü, S; Düger, M; Altın, S

    2011-11-01

    Pulmonary tuberculosis and lung cancer are still important public health problems and can occur simultaneously. In this article, we present the case of a 38-year-old patient treated for smear positive pulmonary tuberculosis. During the third month of treatment, the patient developed respiratory distress and was found to have total atelectasis of the left lung. At rigid bronchoscopy, a lesion obstructing the left main bronchus was removed with a diode laser. Oncological treatment was started following the histological diagnosis of small cell bronchial carcinoma. Pulmonary tuberculosis and bronchial carcinoma can occur at the same time and cause diagnostic confusion. The possibility should be considered in situations where both diseases are endemic. Copyright © 2011. Published by Elsevier Masson SAS.

  3. 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.

  4. Individualized Treatment for Tobacco Dependence in Addictions Treatment Settings: The Role of Current Depressive Symptoms on Outcomes at 3 and 6 Months.

    PubMed

    Zawertailo, Laurie A; Baliunas, Dolly; Ivanova, Anna; Selby, Peter L

    2015-08-01

    Individuals with concurrent tobacco dependence and other addictions often report symptoms of low mood and depression and as such may have more difficulty quitting smoking. We hypothesized that current symptoms of depression would be a significant predictor of quit success among a group of smokers receiving individualized treatment for tobacco dependence within addiction treatment settings. Individuals in treatment for other addictions were enrolled in a smoking cessation program involving brief behavioral counseling and individualized dosing of nicotine replacement therapy. The baseline assessment included the Patient Health Questionnaire (PHQ9) for depression. Smoking cessation outcomes were measured at 3 and 6 months post-enrollment. Bivariate associations between cessation outcomes and PHQ9 score were analyzed. Of the 1,196 subjects enrolled to date, 1,171 (98%) completed the PHQ9. Moderate to severe depression (score >9) was reported by 28% of the sample, and another 29% reported mild depression (score between 5 and 9). Contrary to the extant literature and other findings by our own group, there was no association between current depression and cessation outcome at either 3 months (n = 1,171) (17.0% in those with PHQ9 > 9 vs. 19.8% in those with PHQ9 < 5, p = .32) or 6 months (n = 834) (17.8% vs. 18.9%, p = .74). Contrary to our hypothesis, depression severity as measured by the PHQ9 did not predict cessation outcome in this clinical population. A possible explanation may be the individualized treatment and supportive environment of an addictions treatment setting. These data indicate that patients in an addictions treatment setting can successfully quit smoking regardless of current depressive symptoms. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  5. Successful Treatment of Passive Fecal Incontinence in an Animal Model Using Engineered Biosphincters: A 3-Month Follow-Up Study.

    PubMed

    Bohl, Jaime L; Zakhem, Elie; Bitar, Khalil N

    2017-09-01

    Fecal incontinence (FI) is the involuntary passage of fecal material. Current treatments have limited successful outcomes. The objective of this study was to develop a large animal model of passive FI and to demonstrate sustained restoration of fecal continence using anorectal manometry in this model after implantation of engineered autologous internal anal sphincter (IAS) biosphincters. Twenty female rabbits were used in this study. The animals were divided into three groups: (a) Non-treated group: Rabbits underwent IAS injury by hemi-sphincterectomy without treatment. (b) Treated group: Rabbits underwent IAS injury by hemi-sphincterectomy followed by implantation of autologous biosphincters. (c) Sham group: Rabbits underwent IAS injury by hemi-sphincterectomy followed by re-accessing the surgical site followed by immediate closure without implantation of biosphincters. Anorectal manometry was used to measure resting anal pressure and recto-anal inhibitory reflex (RAIR) at baseline, 1 month post-sphincterectomy, up to 3 months after implantation and post-sham. Following sphincterectomy, all rabbits had decreased basal tone and loss of RAIR, indicative of FI. Anal hygiene was also lost in the rabbits. Decreases in basal tone and RAIR were sustained more than 3 months in the non-treated group. Autologous biosphincters were successfully implanted into eight donor rabbits in the treated group. Basal tone and RAIR were restored at 3 months following biosphincter implantation and were significantly higher compared with rabbits in the non-treated and sham groups. Histologically, smooth muscle reconstruction and continuity was restored in the treated group compared with the non-treated group. Results in this study provided promising outcomes for treatment of FI. Results demonstrated the feasibility of developing and validating a large animal model of passive FI. This study also showed the efficacy of the engineered biosphincters to restore fecal continence as demonstrated

  6. Endoscopic, deep mural implantation of Enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial.

    PubMed

    Johnson, David A; Ganz, Robert; Aisenberg, James; Cohen, Lawrence B; Deviere, Jacques; Foley, T Raymond; Haber, Gregory B; Peters, Jeffrey H; Lehman, Glen A

    2003-02-01

    This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD. Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score < or = 11 on PPI and > or = 20 off PPI, and 24-hour PH probe with > or = 5% total time at PH < or = 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period. At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p < 0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p < 0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation. The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.

  7. Safety and efficacy of levetiracetam for the treatment of partial onset seizures in children from one month of age

    PubMed Central

    Cormier, Justine; Chu, Catherine J

    2013-01-01

    Epilepsy is a common neurological disorder in the pediatric population, affecting up to one percent of children, and for which the mainstay of treatment is anticonvulsant medication. Despite the frequent use of anticonvulsant drugs, remarkably little is known about the safety and efficacy of most of these medications in the pediatric epilepsy population. Of 34 anticonvulsants currently approved for use by the US Food and Drug Administration (FDA), only 13 have been approved for use in children. Although infants and young children are disproportionately affected by epilepsy, there are currently only three anticonvulsant medications that have been specifically evaluated and approved for use in children younger than 2 years of age. In 2012, the FDA approved levetiracetam as an adjunctive treatment for partial onset seizures in infants and children from one month of age. Here we review the available data on levetiracetam in the pediatric epilepsy population. We first discuss the pharmacological profile of levetiracetam, including its mechanism of action, formulations and dosing, and pharmacokinetics in children. We then review the available efficacy, safety, and tolerability data in children from one month of age with partial onset seizures. We conclude that the current data leading to the approval of levetiracetam for use in infants and children with partial onset seizures is encouraging, although more work needs to be done before definitive conclusions can be drawn about the efficacy of levetiracetam across different pediatric age groups. PMID:23458993

  8. Reduction in injection-related HIV risk after 6 months in a low-threshold methadone treatment program.

    PubMed

    Millson, Peggy; Challacombe, Laurel; Villeneuve, Paul J; Strike, Carol J; Fischer, Benedikt; Myers, Ted; Shore, Ron; Hopkins, Shaun

    2007-04-01

    This study assessed injection-related HIV risk behavioral changes among opioid users 6 months after enrollment in low-threshold (harm reduction based) metha-done maintenance treatment (MMT) programs within needle exchange services in Kingston and Toronto, Ontario, Canada. Changes were assessed for all participants (whole cohort), participants who continued to use illicit drugs by any route (drug-using subcohort); and those who continued to inject drugs (injecting subcohort). In this prospective observational cohort study, an interviewer-administered questionnaire examining injection-related HIV risk behaviors was administered to 183 study participants at entry to treatment and 6 months later. Changes in risk behaviors were analyzed using conditional logistic regression which took into account the paired nature of the data. We found that the proportion of participants injecting drugs, sharing needles, sharing drug equipment, indirectly sharing and using shooting galleries declined with follow-up for the whole cohort. Within the drug-using subcohort, there was a decrease in the proportion of individuals who injected drugs, while within the injecting subcohort the sharing of injection equipment and the use of shooting galleries declined. Our findings suggest that low-threshold MMT programs can reduce the risk of HIV without the enforcement of abstinence-based policies.

  9. Elimination of Dirofilaria (syn. Nochtiella) repens microfilariae in dogs with monthly treatments of moxidectin 2.5%/imidacloprid 10% (Advocate, Bayer) spot-on.

    PubMed

    Fok, Eva; Jacsó, Olga; Szebeni, Zsolt; Gyorffy, András; Sükösd, László; Lukács, Zoltán; Schaper, Roland

    2010-04-01

    Elimination of microfilaria in dogs infected with zoonotic Dirofilaria repens would be desirable to reduce further spread. Moxidectin has demonstrated efficacy against microfilariae and safety in dogs infected with Dirofilaria immitis and could be an option for controlling D. repens microfilariae. A field study with 64 dogs previously confirmed positive for D. repens microfilaria was conducted in Hungary, in which a spot-on product (Advocate, Bayer) was tested. Treatments were applied to 44 dogs once a month for 3 months (five dogs) or 6 months (22 dogs), alternatively every 2 weeks for 6 months (17 dogs). Twenty dogs remained untreated. Microfilaria counts were performed once a month and for a further 6 months following the last treatment. Two weeks after the first treatment, 38 of 44 dogs were microfilaria negative. Four weeks after the initial treatment, one dog still showed a low microfilaria count. Following the second treatment, all treated dogs were negative. This status was maintained during the 6-month observation period after the last treatment. These data demonstrate the successful long-lasting elimination of microfilariae. Moreover, it may be supposed that adult D. repens were killed based on the observation that no further microfilariae were seen up to 6 months after the end of the treatment period.

  10. Benefit–risk assessment of paliperidone oral extended-release tablet versus monthly injectable for maintenance treatment of schizophrenia

    PubMed Central

    Markowitz, Michael; Turkoz, Ibrahim; Fu, Dong-Jing; Gopal, Srihari; Alphs, Larry

    2016-01-01

    The purpose of this study was to conduct a post-hoc benefit–risk assessment of paliperidone palmitate once-monthly (PP1M) injectable versus oral paliperidone extended-release (ER) in schizophrenia maintenance treatment. The Benefit–Risk Action Team framework was used to structure the analysis based on patient-level data from two similar, double-blind, placebo-controlled relapse studies. Efficacy outcomes were relapse, psychiatric hospitalization, Clinical Global Impression–Severity scale, Personal and Social Performance (PSP) scale, and Positive and Negative Syndrome Scale (PANSS). Safety outcomes were extrapyramidal symptom–related adverse events, weight gain, prolactin-related adverse events, somnolence, orthostatic hypotension, anticholinergic use, fasting plasma glucose, and total cholesterol/high–density lipoprotein. For the first 8 weeks of maintenance treatment, most efficacy outcomes significantly favored PP1M compared with paliperidone ER. Per 1000 patients, there would be 165, 115, 85, and 53 fewer cases of PSP worsening, relapse, PANSS worsening, and hospitalizations, respectively. For the first 40 weeks, PSP worsening significantly favored PP1M (140 fewer cases). Relapse, PANSS, hospitalizations, and Clinical Global Impression–Severity scale showed a consistent pattern favoring PP1M but were not significant. Safety outcomes for both 8-week and 40-week periods demonstrated no statistically significant differences between groups. These analyses suggest a benefit–risk profile favoring PP1M over oral paliperidone ER throughout 40 weeks of treatment, particularly in early treatment. PMID:27434314

  11. A six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia

    PubMed Central

    Chappell, Amy S; Bradley, Laurence A; Wiltse, Curtis; Detke, Michael J; D’Souza, Deborah N; Spaeth, Michael

    2008-01-01

    Objective: Assess the efficacy of duloxetine 60/120 mg (N = 162) once daily compared with placebo (N = 168) in the treatment of patients with fibromyalgia, during six months of treatment. Methods: This was a phase-III, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of duloxetine. Results: There were no significant differences between treatment groups on the co-primary efficacy outcome measures, change in the Brief Pain Inventory (BPI) average pain severity from baseline to endpoint (P = 0.053) and the Patient’s Global Impressions of Improvement (PGI-I) at endpoint (P = 0.073). Duloxetine-treated patients improved significantly more than placebo-treated patients on the Fibromyalgia Impact Questionnaire pain score, BPI least pain score and average interference score, Clinical Global Impressions of Severity scale, area under the curve of pain relief, Multidimensional Fatigue Inventory mental fatigue dimension, Beck Depression Inventory-II total score, and 36-item Short Form Health Survey mental component summary and mental health score. Nausea was the most common treatment-emergent adverse event in the duloxetine group. Overall discontinuation rates were similar between groups. Conclusions: Although duloxetine 60/120 mg/day failed to demonstrate significant improvement over placebo on the co-primary outcome measures, in this supportive study, duloxetine demonstrated significant improvement compared with placebo on numerous secondary measures. PMID:20428412

  12. Twelve-month treatment with Liraglutide ameliorates Visceral Adiposity Index and common cardiovascular risk factors in type 2 diabetes outpatients.

    PubMed

    Russo, G T; Labate, A M; Giandalia, A; Romeo, E L; Villari, P; Alibrandi, A; Perdichizzi, G; Cucinotta, D

    2015-01-01

    In addition to the effects on glycemic control and body weight, GLP-1 receptor agonists may favorably affect other major cardiovascular disease (CVD) risk factors, although currently available data are still sparse. In this retrospective study, we evaluated the effects of 12-month treatment with liraglutide on major CVD risk factors in 115 type 2 diabetes outpatients (60 men and 55 women), on stable hypoglycemic, anti-hypertensive and/or lipid-lowering therapy. Clinical and anthropometric data, metabolic and lipid profile, as well as the Visceral Adiposity Index (VAI), an obesity-related CVD risk factor, were measured in all participants at baseline and after 12-month treatment. Treatment with liraglutide was associated with a significant reduction from baseline values of fasting blood glucose (-42.1 mg/dl, P < 0.05), HbA1c (-1.5 %, -17 mmol/mol, P < 0.05), body weight (-7.1 kg, P < 0.05), waist circumference (-6.8 cm, P < 0.001), total-cholesterol (-27.4 mg/dl, P < 0.05), LDL-cholesterol (-25.4 mg/dl, P < 0.05), triglycerides (-56.1 mg/dl, P < 0.05), and non-HDL-C (-36.6 mg/dl, P < 0.05) and an increase of HDL-cholesterol concentrations (+9.3 mg/dl, P < 0.001), a significant reduction in both systolic and diastolic blood pressure (-14.7 mmHg, P < 0.001 and -9.0 mmHg, P < 0.05, respectively) and a decrease of VAI values (-1.6, P < 0.001). All these differences were independent of changes in BMI and comparable in men and women. In conclusion, 12-month treatment with liraglutide in add-on to on-going hypoglycemic therapy significantly ameliorates all major CVD risk factors and reduces cardiometabolic risk, as estimated by VAI values.

  13. Prospective evaluation of free radicals and antioxidant activity following 6-month risedronate treatment in patients with postmenopausal osteoporosis.

    PubMed

    Zinnuroglu, Murat; Dincel, Aylin Sepici; Kosova, Funda; Sepici, Vesile; Karatas, Gulcin Kaymak

    2012-04-01

    In addition to the well-described implications of estrogen deficiency in postmenopausal osteoporosis (PMO), free radicals are also effective on bone metabolism. The antioxidant vitamins C and E play an important role in the production of collagen, mesenchymal cell differentiation into osteoblasts, and bone mineralization. Therefore, the incidence of osteoporosis and the risk of fractures were decreased with vitamin C and E. It was proposed that free oxygen radicals are responsible for biological aging, atherosclerosis, carcinogenesis, and osteoclastic activity via their negative effects on the cell and DNA. In this study, we aimed to investigate and compare the levels of free radicals and serum antioxidant activity in patients with PMO and healthy subjects before and after six-month treatment with risedronate, which is an inhibitor of bone resorption. Twenty-three postmenopausal patients aged between 52-83 (mean [± standard deviation] 67.6 ± 8.17) with T scores below -2.5 in femur neck or L1-L4, and 23 postmenopausal healthy subjects were enrolled into the study. Patients who had received any medications within the last 6 months that could alter bone metabolism were excluded. Serum malondialdehyde (MDA), superoxide dismutase (SOD), and glutathione peroxidase (GPx) levels were analyzed in both groups. The patients with PMO were commenced on 5 mg of risedronate, 1,200 mg of calcium, and 800 IU of vitamin D daily. The patients were reevaluated at the end of the sixth month. MDA and SOD levels were similar in patients with PMO when compared to the healthy group before the treatment, while the GPx levels were lower in patients with PMO (P = 0.014). GPx (P = 0.028) and MDA (P = 0.04) levels were increased in patients with PMO after the treatment. In contrast, SOD levels were decreased when compared to the initial levels (P = 0.006). There may be an insufficiency in different steps of the enzymatic antioxidant systems in patients with PMO without treatment. We observed

  14. 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

  15. Percutaneous left atrial appendage occlusion - treatment outcomes and 6 months of follow-up - a single-center experience.

    PubMed

    Karczewski, Michał; Woźniak, Sebastian; Skowronek, Radomir; Burysz, Marian; Fischer, Marcin; Anisimowicz, Lech; Demkow, Marcin; Konka, Marek; Ogorzeja, Wojciech

    2016-06-01

    To present the results of treatment and evaluate 6 months of follow-up in a group of patients with non-valvular atrial fibrillation, who underwent the procedure of percutaneous left atrial appendage occlusion (PLAAO). Percutaneous left atrial appendage occlusion was performed in 34 patients with non-valvular atrial fibrillation and contraindications for oral anticoagulation therapy. The risk of thromboembolic and bleeding complications was determined based on the CHA2DS2VASc and HAS-BLED scales. The Amplatzer Amulet system from St. Jude Medical was used. On the first postoperative day, all patients were started on double antiplatelet therapy with 75 mg/day of acetylsalicylic acid (ASA) and 75 mg/day of clopidogrel (CLO). On the 30(th) postoperative day, the efficacy of the antiplatelet therapy was assessed with impedance aggregometry using a Multiplate analyzer (Roche). Echocardiographic examinations were performed intraoperatively and on the first postoperative day; subsequently, follow-up examinations were conducted 1 and 6 months after the implantation. In all patients, proper occluder position was observed throughout the follow-up. No leakage or thrombi around the implants were found. No strokes or bleeding complications associated with the antiplatelet therapy were observed. Multiplate assessment of platelet activity was conducted in 20 out of 34 patients. The efficacy of ASA treatment was demonstrated in all patients; no response to clopidogrel treatment was observed in 5 out of 20 patients. One patient suffered from cardiac tamponade, which required the performance of full sternotomy. Local complications (hematomas of the inguinal region) were observed in 3 patients. One of the patients died for reasons unrelated to the procedure. Percutaneous left atrial appendage occlusion is an effective procedure in patients with non-valvular atrial fibrillation and contraindications for chronic anticoagulation therapy. Further observation is necessary to evaluate the

  16. Exploratory study describing 6 month outcomes for young children with autism who receive treatment as usual in Italy

    PubMed Central

    Muratori, Filippo; Narzisi, Antonio

    2014-01-01

    Background In the last few years, the results of different studies have confirmed, in different ways, the importance of early intervention for autism. This study aims to evaluate the role of early “as usual” interventions in the outcome of toddlers diagnosed with autism spectrum disorder (ASD). Method Seventy children with ASD aged between 24 and 48 months were recruited at different centers in Italy. They were evaluated by blind researchers at baseline and after 6 months of using Autism Diagnostic Observation Schedule-Generic (ADOS-G), Griffiths Mental Developmental Scales, and Vineland Adaptive Behavior scales. Parents filled out the MacArthur Inventory, Social Communication Questionnaire, and Child Behavior Check List. All children were referred to community providers for available interventions. Results At the endpoint, most of the children were still classified as having an ADOS-G classification of ASD. However, 21 (34.2%) passed from autism to autism spectrum, and 3 (4.2%) passed from autism spectrum to no spectrum. Treatment effects were obtained for cognitive functioning, language, adaptive behavior, and child behavior without differences between development-oriented and behavior-oriented interventions. Parent involvement was a mediator for the best clinical outcome. Baseline low impairments of communication, language comprehension, and gesture were predictors of positive outcome. Conclusion Treatment as usual, composed of individual therapy plus school-supported inclusion, may be an effective intervention in ASD. Better initial levels of communication in child and parent involvement during treatment have an important role for a positive outcome. PMID:24748794

  17. Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons.

    PubMed

    Sterling, Timothy R; Scott, Nigel A; Miro, Jose M; Calvet, Guilherme; La Rosa, Alberto; Infante, Rosa; Chen, Michael P; Benator, Debra A; Gordin, Fred; Benson, Constance A; Chaisson, Richard E; Villarino, M Elsa

    2016-06-19

    Compare the effectiveness, tolerability, and safety of 3 months of weekly rifapentine and isoniazid under direct observation (3HP) versus 9 months of daily isoniazid (9H) in HIV-infected persons. Prospective, randomized, and open-label noninferiority trial. The United States , Brazil, Spain, Peru, Canada, and Hong Kong. HIV-infected persons who were tuberculin skin test positive or close contacts of tuberculosis cases. 3HP versus 9H. The effectiveness endpoint was tuberculosis; the noninferiority margin was 0.75%. The tolerability endpoint was treatment completion; the safety endpoint was drug discontinuation because of adverse drug reaction. Median baseline CD4 cell counts were 495 (IQR 389-675) and 538 (IQR 418-729) cells/μl in the 3HP and 9H arms, respectively (P = 0.09). In the modified intention-to-treat analysis, there were two tuberculosis cases among 206 persons [517 person-years (p-y) of follow-up] in the 3HP arm (0.39 per 100 p-y) and six tuberculosis cases among 193 persons (481 p-y of follow-up) in the 9H arm (1.25 per 100 p-y). Cumulative tuberculosis rates were 1.01 versus 3.50% in the 3HP and 9H arms, respectively (rate difference: -2.49%; upper bound of the 95% confidence interval of the difference: 0.60%). Treatment completion was higher with 3HP (89%) than 9H (64%) (P < 0.001), and drug discontinuation because of an adverse drug reaction was similar (3 vs. 4%; P = 0.79) in 3HP and 9H, respectively. Among HIV-infected persons with median CD4 cell count of approximately 500 cells/μl, 3HP was as effective and safe for treatment of latent Mycobacterium tuberculosis infection as 9H, and better tolerated.

  18. A six month randomized controlled trial of long acting injectable risperidone 50 and 100mg in treatment resistant schizophrenia.

    PubMed

    Meltzer, H Y; Lindenmayer, J-P; Kwentus, J; Share, D B; Johnson, R; Jayathilake, K

    2014-04-01

    It has been suggested that atypical antipsychotic drugs (A-APDs) other than clozapine may be effective to improve positive symptoms in some patients with treatment resistant schizophrenia (TRS), if both the dose is higher, and the duration of the trial longer, than those which have been ineffective in non-TRS (NTRS) patients. This hypothesis was tested with long acting injectable risperidone (Risperdal Consta®, RLAI). One hundred sixty TRS patients selected for persistent moderate-severe delusions or hallucinations, or both, were randomized to RLAI, 50 or 100mg biweekly, in a six month, outpatient, double-blind, multicenter trial. We hypothesized that RLAI, 100mg, would be more effective than RLAI, 50mg. However, both doses produced clinically significant and equivalent improvement in PANSS Total, Positive, and Negative subscale scores, as well as key cognitive, global and functional measures, with increasing response during the course of the study, confirming the value of longer clinical trial duration for patients with TRS, but not superiority of the higher dose. The overall response rate was comparable to that previously reported for clozapine and high dose olanzapine, another A-APD, in TRS. Both doses of RLAI were equally well tolerated, producing minimal extrapyramidal side effects and few drop outs. Plasma levels of the active moiety, risperidone+9-hydroxyrisperidone, during treatment with RLAI 100mg, were comparable to those for 6-8 mg/day oral risperidone, which have not been effective in TRS. Further study of RLAI, ≥ 50-100mg biweekly, should compare it with clozapine and oral risperidone in TRS, with duration of treatment ≥ six months.

  19. Survey of the utility of once-monthly bisphosphonate treatment for improvement of medication adherence in osteoporosis patients in Japan.

    PubMed

    Makita, Kazuya; Okano, Hiroya; Furuya, Takefumi; Urano, Tomohiko; Hirabayashi, Hisashi; Kumakubo, Takami; Iwamoto, Jun

    2015-01-01

    Prescription of a bisphosphonate (BP) with monthly dosing has recently been approved in Japan. The value of this approach for improvement of medication adherence was investigated in patients undergoing drug therapy for osteoporosis. A questionnaire was distributed to patients receiving treatment for osteoporosis at 8 medical facilities (5 orthopedic, 2 gynecology, and one internal medicine). Responses were collected from 1,300 patients. After exclusion of those who missed an item on the questionnaire or took drugs other than oral drugs, responses from 1,151 patients were analyzed. The most frequently used drug for treatment of osteoporosis was a once-weekly BP. Of the 1,151 patients, 38.4 % reported forgetting to take their current drug. The most frequent concern was 'I cannot feel an effect', but 73.2 % answered 'I have no concerns'. Regarding the most appropriate dosing regimen for long-term treatment, 60.3 % selected once-weekly and 24 % selected once every 4 weeks. Based on a recommendation by a physician of a drug to be taken monthly, 32.5 % wanted to switch, 31.8 % were undecided, and 35.7 % wanted to continue with their current drug. The desire for a change was higher among patients currently taking a once-weekly BP (52.3 %) than among patients taking a daily BP (29.5 %) or a SERM (19.4 %). This survey revealed patients' preferences in osteoporosis drug therapy. It is important to select a drug for osteoporosis based on the efficacy and the drug regimen preferred by the individual patient.

  20. Three-month treatment with triptorelin, letrozole and ulipristal acetate before hysteroscopic resection of uterine myomas: prospective comparative pilot study.

    PubMed

    Bizzarri, Nicolò; Ghirardi, Valentina; Remorgida, Valentino; Venturini, Pier Luigi; Ferrero, Simone

    2015-09-01

    To compare the usefulness of preoperative treatment with triptorelin, letrozole or ulipristal acetate or no treatment before hysteroscopic removal of uterine submucosal myomas. Single center prospective non-randomized comparative pilot study. The study included consecutive premenopausal patients undergoing hysteroscopic resection of myomas graded as type 0, type 1 or type 2 according to the FIGO classification with diameter between 20 and 35 mm. Exclusion criteria were: associated polyps, associated non-hysteroscopic surgical procedures, >2 myomas requiring hysteroscopic resection. This study enrolled patients who underwent either direct surgery (group S; n=23) or 3-month preoperative treatment with triptorelin (3.75 mg every 28 days; group T; n=20), letrozole (2.5 mg/day; group L; n=11) or ulipristal acetate (5 mg/day; group U; n=7). Patients underwent hysteroscopic resection of the myomas. All medical treatments caused a significant decrease in the volume of myomas (group T, p<.001; group L, p<.001; group U, p=.006); however, the percentage decrease in myoma volume was lower in group U than in group T (p=.001) and in group L (p=.010). The hysteroscopy time was higher in group S than in group T (p<.001) and in group L (p=.001); there was no significant difference in the hysteroscopy time between group S and group U (p=.206). Fluid absorption was lower in group T than in group S (p=.002) and in group L than in group S (p=.048); fluid absorption was similar in group S and group U (p=.110). Intra- and postoperative complications, postoperative pain, and patient satisfaction were similar in the four study groups. Surgeon's evaluation of operative difficulty was better in group T than in group S (p<.005). Preoperative treatment with triptorelin and letrozole decreases the hysteroscopy time and the volume of fluid absorbed during hysteroscopic resection of uterine submucosal myomas. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  1. Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX)

    Integrated Risk Information System (IRIS)

    Hexahydro - 1,3,5 - trinitro - 1,3,5 - triazine ( RDX ) ; CASRN 121 - 82 - 4 Human health assessment information on a chemical substance is included in the IRIS database only after a comprehensive review of toxicity data , as outlined in the IRIS assessment development process . Sections I ( Health

  2. Octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine (HMX)

    Integrated Risk Information System (IRIS)

    Octahydro - 1,3,5,7 - tetranitro - 1,3,5,7 - tetr . . . ( HMX ) ; CASRN 2691 - 41 - 0 Human health assessment information on a chemical substance is included in the IRIS database only after a comprehensive review of toxicity data , as outlined in the IRIS assessment development process . Sections I

  3. Dermal Sensitization of 1-Acetyloctahydro-3,5,7-Trinitro-1,3,5,7-Tetrazocine.

    DTIC Science & Technology

    1984-08-08

    tetrazocine (SEX) in guinea pigs MATERIALS Test Substance Chemical name: 1-Acetyloctahydro-3,5,7-Trinitro-I,3,5,7- Tetrazocine (SEX) Chemical Abstract Service...exist as a contaminant in P.DX/HMX manufacturing process. The characteristics of SEX are as follows: Chemical Abstract Service Registry No.: 13980-00-2

  4. Long-term safety and tolerability of aripiprazole once-monthly in maintenance treatment of patients with schizophrenia.

    PubMed

    Fleischhacker, W Wolfgang; Sanchez, Raymond; Johnson, Brian; Jin, Na; Forbes, Robert A; McQuade, Robert; Baker, Ross A; Carson, William; Kane, John M

    2013-07-01

    The aim of this study was to evaluate the safety and tolerability of aripiprazole once-monthly (ARI-OM) for the maintenance treatment of schizophrenia. This long-term, pivotal study had four phases: oral conversion (phase 1, 4-6 weeks); oral stabilization (phase 2, 4-12 weeks); ARI-OM stabilization with coadministration of oral aripiprazole in the first 2 weeks (phase 3, 12-36 weeks); and a 52-week, randomized [phase 4, ARI-OM vs. placebo (2 : 1)], double-blind, maintenance phase. Safety was assessed across study phases by the time of first onset of adverse events, as were objective measures of extrapyramidal symptoms, fasting metabolic parameters, and body weight. Patient enrollment was phase 1=633; phase 2=710, of whom 210 entered phase 2 directly; phase 3=576; and phase 4=403 (ARI-OM, n=269; placebo, n=134). Adverse events (>5%) in any phase were insomnia, headache, anxiety, akathisia, increase in weight, injection-site pain, and tremor. Headache, somnolence, and nausea had a peak first onset within 4 weeks of treatment initiation. The incidence of extrapyramidal symptoms was similar in all phases. There were no unexpected changes in weight or shifts in fasting metabolic parameters across all study phases. ARI-OM had a safety and tolerability profile comparable with oral aripiprazole in maintenance treatment of schizophrenia.

  5. Multicomponent, one-pot sequential synthesis of 1,3,5- and 1,3,5,5-substituted barbiturates.

    PubMed

    Volonterio, Alessandro; Zanda, Matteo

    2008-10-03

    Carbodiimides and malonic acid monoethylesters readily react to afford N-acylurea derivatives that could be cyclized in situ by addition of a suitable base. This process represents a general and straightforward one-pot sequential synthesis of 1,3,5-trisubstituted barbiturates in very mild conditions (organic solvent/2 N NaOH aqueous solution, 20 degrees C). Performing the reaction in the presence of an electrophile resulted in the formation of fully substituted (namely, 1,3,5,5-tetrasubstituted) barbiturates through a three-component one-pot sequential process. The latter, however, occurred only with highly reactive electrophiles, such as benzyl and, in some instances, allyl halides. In order to expand the scope of the process, we sought to develop a general method for the C-alkylation of 1,3,5-trisubstituted barbiturates. We found that C-alkylation occurred upon treatment of 1,3,5-trisubstituted barbiturates with an alkyl halide in CH3CN at 120 degrees C in the presence of anhydrous K2CO3 affording the target 1,3,5,5-tetrasubstituted barbiturates in good yields. The multicomponent process was accomplished by combining the three steps in a one-pot sequential fashion, i.e., the condensation of carbodiimides with malonic acid monoethylesters, the cyclization of the resulting N-acylureas, and the C-alkylation of the resulting 1,3,5-substituted barbiturates. A detailed study of the influence of the structure of the reactants on the reaction outcome and mechanism is presented. By selective N'-deprotection of 1,3,5,5-tetrasubstituted barbiturates, the corresponding 1,5,5-trisubstituted barbiturates were also prepared.

  6. The effect of three-monthly albendazole treatment on malarial parasitemia and allergy: a household-based cluster-randomized, double-blind, placebo-controlled trial.

    PubMed

    Wiria, Aprilianto E; Hamid, Firdaus; Wammes, Linda J; Kaisar, Maria M M; May, Linda; Prasetyani, Margaretta A; Wahyuni, Sitti; Djuardi, Yenny; Ariawan, Iwan; Wibowo, Heri; Lell, Bertrand; Sauerwein, Robert; Brice, Gary T; Sutanto, Inge; van Lieshout, Lisette; de Craen, Anton J M; van Ree, Ronald; Verweij, Jaco J; Tsonaka, Roula; Houwing-Duistermaat, Jeanine J; Luty, Adrian J F; Sartono, Erliyani; Supali, Taniawati; Yazdanbakhsh, Maria

    2013-01-01

    Helminth infections are proposed to have immunomodulatory activities affecting health outcomes either detrimentally or beneficially. We evaluated the effects of albendazole treatment, every three months for 21 months, on STH, malarial parasitemia and allergy. A household-based cluster-randomized, double-blind, placebo-controlled trial was conducted in an area in Indonesia endemic for STH. Using computer-aided block randomization, 481 households (2022 subjects) and 473 households (1982 subjects) were assigned to receive placebo and albendazole, respectively, every three months. The treatment code was concealed from trial investigators and participants. Malarial parasitemia and malaria-like symptoms were assessed in participants older than four years of age while skin prick test (SPT) to allergens as well as reported symptoms of allergy in children aged 5-15 years. The general impact of treatment on STH prevalence and body mass index (BMI) was evaluated. Primary outcomes were prevalence of malarial parasitemia and SPT to any allergen. Analysis was by intention to treat. At 9 and 21 months post-treatment 80.8% and 80.1% of the study subjects were retained, respectively. The intensive treatment regiment resulted in a reduction in the prevalence of STH by 48% in albendazole and 9% in placebo group. Albendazole treatment led to a transient increase in malarial parasitemia at 6 months post treatment (OR 4.16(1.35-12.80)) and no statistically significant increase in SPT reactivity (OR 1.18(0.74-1.86) at 9 months or 1.37 (0.93-2.01) 21 months). No effect of anthelminthic treatment was found on BMI, reported malaria-like- and allergy symptoms. No adverse effects were reported. The study indicates that intensive community treatment of 3 monthly albendazole administration for 21 months over two years leads to a reduction in STH. This degree of reduction appears safe without any increased risk of malaria or allergies. Controlled-Trials.com ISRCTN83830814.

  7. [Treatment and indication of botulinum toxin type A for limb spasticity - can we break the 6 months barrier?].

    PubMed

    Miyashiro, Ai

    2012-01-01

    It is common knowledge that recovery of motor function is limited at 6 months after the onset of stroke. But there are some reports that motor functions are improved with using botulinum toxin type A for limb spasticity in the maintenance stage of stroke. Though it has been thought that botulinum toxin type A works in the peripheral nerves so far, Caleo showed botulinum toxin can affect the central nervous system. We suspected botulinum toxin type A affected the spinal cord directly following retrograde transynaptic transport from our experiments and his reports. So, we deduce the abnormal stretch reflex is made a modification by affecting the spinal cord, not only the injected muscle is relaxed, but also motor function is improved. Botulinum toxin type A shows sustained activity up to only 3 months, so we think we should use sufficient dose of botulinum toxin which may cause weakness. Rehabilitation with injected muscles contractions is important soon after botulinum toxin treatment, because botulinum toxin has a specific affinity to cleave certain proteins involved in the mechanism of acetylcholine exocytosis. The new botuslinum toxins type A which decrease the risk of production of antibodies and diffusion of noninjected muscles are under development.

  8. Remarkable Improvement of Nail Changes in Alopecia Areata Universalis with 10 Months of Treatment with Tofacitinib: A Case Report

    PubMed Central

    Ferreira, Sineida Berbert; Scheinberg, Morton; Steiner, Denise; Steiner, Tatiana; Bedin, Gustavo Longhi; Ferreira, Rachel Berbert

    2016-01-01

    Alopecia areata (AA) is a chronic, autoimmune disease. The main symptom is massive hair loss, localized or diffuse, in the scalp and the whole body. However, nails may also be involved, and brittleness, fragility and pitting can be signs of nail dystrophy in AA patients. Here, we report the case of a male patient with AA refractory to various treatments, including oral, topical and intralesional corticosteroids, immunosuppressants, cyclosporin and PUVA (oxoralen plus ultraviolet light), all interrupted due to side effects. The patient's nails had erythematous blotches (striated lunulae) with regular and superficial pitting as well as fragility (trachyonychia), and he could no longer play the guitar because of these symptoms. With patient consent, we introduced tofacitinib (5 mg twice daily), which resulted in remarkable improvements not only regarding hair regrowth but also nail changes, with function recovery within 10 months. PMID:28101018

  9. 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.

  10. Community treatment orders and social outcomes for patients with psychosis: a 48-month follow-up study.

    PubMed

    Vergunst, Francis; Rugkåsa, Jorun; Koshiaris, Constantinos; Simon, Judit; Burns, Tom

    2017-09-12

    Community treatment orders (CTOs) are widely used internationally despite a lack of evidence supporting their effectiveness. Most effectiveness studies are relatively short (12-months or less) and focus on clinical symptoms and service data, while a little attention is given to patients' social outcomes and broader welfare. We tested the association between the duration of CTO intervention and patients' long-term social outcomes. A sub-sample (n = 114) of community-based patients from the Oxford Community Treatment Order Evaluation Trial (OCTET) were interviewed 48 months after randomisation. Multivariate regression models were used to examine the association between the duration of the CTO intervention and social outcomes as measured by the social network schedule, Objective Social Outcomes Index, Euro-Qol EQ-5D-3L (EQ-5D), and Oxford Capabilities Questionnaire for Mental Health. No significant association was found between the duration of CTO intervention and social network size (IRR = 0.996, p = .63), objective social outcomes (B = -0.003, p = .77), health-related quality of life (B = 0.001, p = .77), and capabilities (B = 0.046, p = .41). There were no between-group differences in social outcomes when outcomes were stratified by original arm of randomisation. Patients had a mean of 10.2 (SD = 5.9) contacts in their social networks, 42% of whom were relatives. CTO duration was not associated with improvements in patients' social outcomes even over the long term. This study adds to growing concerns about CTO effectiveness and the justification for their continued use.

  11. Cost per median overall survival month associated with abiraterone acetate and enzalutamide for treatment of patients with metastatic castration-resistant prostate cancer.

    PubMed

    Pilon, Dominic; Queener, Marykay; Lefebvre, Patrick; Ellis, Lorie A

    2016-08-01

    To calculate costs per median overall survival (OS) month in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate plus prednisone (AA + P) or enzalutamide. Median treatment duration and median OS data from published Phase 3 clinical trials and prescribing information were used to calculate costs per median OS month based on wholesale acquisition costs (WACs) for patients with mCRPC treated with AA + P or enzalutamide. Sensitivity analyses were performed to understand how variations in treatment duration and treatment-related monitoring recommendations influenced cost per median OS month. Cost-effectiveness estimates of other Phase 3 trial outcomes were also explored: cost per month of chemotherapy avoided and per median radiographic progression-free survival (rPFS) month. The results demonstrated that AA + P has a lower cost per median OS month than enzalutamide ($3231 vs 4512; 28% reduction), based on the following assumptions: median treatment duration of 14 months for AA + P and 18 months for enzalutamide, median OS of 34.7 months for AA + P and 35.3 months for enzalutamide, and WAC per 30-day supply of $8007.17 for AA + P vs $8847.98 for enzalutamide. Sensitivity analyses showed that accounting for recommended treatment-related monitoring costs or assuming identical treatment durations for AA + P and enzalutamide (18 months) resulted in costs per median OS month 8-27% lower for AA + P than for enzalutamide. Costs per month of chemotherapy avoided were $4448 for AA + P and $5688 for enzalutamide, while costs per month to achieve median rPFS were $6794 for AA + P and $7963 for enzalutamide. This cost-effectiveness analysis demonstrated that costs per median OS month, along with costs of other Phase 3 trial outcomes, were lower for AA + P than for enzalutamide. The findings were robust to sensitivity analyses. These results have important implications

  12. Twelve-month longitudinal parasitological assessment of lymphatic filariasis-positive individuals: impact of a biannual treatment with ivermectin and albendazole.

    PubMed

    Kanamitie, John N; Ahorlu, Collins S; Otchere, Joseph; Aboagye-Antwi, Fred; Kwansa-Bentum, Bethel; Boakye, Daniel A; Biritwum, Nana-Kwadwo; Wilson, Michael D; de Souza, Dziedzom K

    2017-09-11

    Mass drug administration (MDA) for the control of lymphatic filariasis (LF), in Ghana, started in the year 2000. While this had great success in many implementation units, there remain areas with persistent transmission, after more than 10 years of treatment. A closer examination of the parasite populations could help understand the reasons for persistent infections and formulate appropriate strategies to control LF in these areas of persistent transmission. In a longitudinal study, we assessed the prevalence of microfilaraemia (mf) in two communities with 12 years of MDA in Ghana. In baseline surveys 6 months after the National MDA in 2014, 370 consenting individuals were tested for antigenaemia using immunochromatographic test (ICT) cards and had their mf count determined through night blood surveys. 48 ICT positives, of whom, 17 were positive for mf, were treated with 400 μg/kg ivermectin + 400 mg albendazole and subsequently followed for parasitological assessment at 3-month intervals for 1 year. This overlapped with the National MDA in 2015. There was a 68% parasite clearance 3 months after treatment. The pre-treatment mf count differed significantly from the post-treatment mf counts at 3 months (P = 0.0023), 6 months (P = 0.0051), 9 months (P = 0.0113) and 12 months (P = 0.0008). In these settings with persistent LF transmission, twice-yearly treatment may help accelerate LF elimination. Further large-scale evaluations are required to ascertain these findings. © 2017 John Wiley & Sons Ltd.

  13. Efficacy of an unsupervised 8-month rifampicin-containing regimen for the treatment of pulmonary tuberculosis in HIV-infected adults

    PubMed Central

    Johnson, J. L.; Okwera, A.; Nsubuga, P.; Nakibali, J. G.; Whalen, C. C.; Hom, D.; Cave, M. D.; Yang, Z. H.; Mugerwa, R. D.; Ellner, J. J.

    2010-01-01

    SUMMARY SETTING National Tuberculosis Treatment Centre, Mulago Hospital, Kampala, Uganda. OBJECTIVE To assess the efficacy of a daily, self-administered 8-month rifampicin-containing regimen for the treatment of pulmonary tuberculosis (TB) in human immunodeficiency virus (HIV) infected adults. DESIGN Treatment outcomes in patients with pulmonary TB treated with a single 8-month regimen and followed in a prospective epidemiological study. RESULTS Two hundred and sixty-five HIV-infected and 26 non-HIV-infected adults with initial episodes of pulmonary tuberculosis were treated with 2 months of daily isoniazid (INH), rifampicin (RMP), ethambutol and pyrazinamide followed by 6 months of daily INH + RMP. Median follow-up was 17.8 months. Ninety-five per cent of the HIV-infected and all of the non-HIV-infected patients who had sputum examined were sputum culture negative after 2 months of treatment. Twenty-two HIV-infected and no non-HIV-infected patients died during treatment. Relapse rates were 8.4% (5.9 per 100 person-years of observation [PYO], 95%CI 3.2–8.6) among HIV-infected patients and 4.5% (2.1/100 PYO, 95%CI 0–7.8) for non-HIV-infected patients. Adverse drug reactions occurred in 37% of the HIV-infected patients; most were minor and self-limiting. CONCLUSION An 8-month RMP-containing regimen was well tolerated and effective in the treatment of HIV-infected adults with initial episodes of pulmonary TB. Relapse rates were similar to those reported with 6-month short-course regimens in HIV-infected individuals. Decisions about the duration of anti-tuberculosis treatment for HIV-infected adults must balance programme resources and the likelihood of poor compliance with longer regimens with the potential for a modest decrease in relapses with longer treatment. PMID:11092715

  14. IRIS Toxicological Review of Hexahydro-1,3,5-Trinitro-1,3,5 ...

    EPA Pesticide Factsheets

    EPA is developing an Integrated Risk Information System (IRIS) assessment of hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) and has released the draft assessment for public comment. When final, the assessment will appear on the IRIS database. EPA is undertaking an update of the Integrated Risk Information System (IRIS) health assessment for RDX. The outcome of this project is an updated Toxicological Review and IRIS Summary for RDX that will be entered into the IRIS database.

  15. Safety of non-ablative fractional laser for acne scars within 1 month after treatment with oral isotretinoin: A randomized split-face controlled trial.

    PubMed

    Saluja, Sandeep S; Walker, Matthew L; Summers, Erika M; Tristani-Firouzi, Payam; Smart, David R

    2017-08-29

    Based on reports of poor wound healing and scarring, it is currently recommended that patients wait 6 months after completion of oral isotretinoin therapy before the safe initiation of laser treatment. Our aim was to evaluate the safety of non-ablative fractional laser (NAFL) treatment for acne scars within 1 month after isotretinoin therapy. This was a randomized split-face controlled trial involving 10 patients with acne scars who had completed isotretinoin treatment. All patients received three treatments each spaced 4 weeks apart with an erbium-doped 1550 nm NAFL on one side of the face within 1 month after isotretinoin therapy. The untreated side acted as a control. Wound healing and adverse effects as well as acne scar improvement were evaluated by two blinded dermatologists. All patients demonstrated normal wound healing post NAFL treatments, and neither hypertrophic scars nor keloids were observed. Acne scar improvement was satisfactory. NAFL treatment for acne scarring appears to be well tolerated within 1 month of completing isotretinoin treatment. Dermatologists should reevaluate the current recommendation to wait 6 months after isotretinoin treatment for acne scar revision with lasers. Other larger studies are necessary to further challenge this dogma. Lasers Surg. Med. XX:XX-XX, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  16. 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.

  17. Cost-effectiveness Analysis of Aripiprazole Once-Monthly for the Treatment of Schizophrenia in the UK.

    PubMed

    Tempest, Michael; Sapin, Christophe; Beillat, Maud; Robinson, Paul; Treur, Maarten

    2015-12-01

    Schizophrenia is a severe and debilitating psychiatric disorder. Pharmacological interventions aim to ameliorate symptoms and reduce the risk of relapse and costly hospitalisation. Despite the established efficacy of antipsychotic medication, compliance to treatment is poor, particularly with oral formulation. The emergence of long acting injectable (LAI) antipsychotic formulations in recent years has aimed to counteract the poor compliance rates observed and optimise long term patient outcomes. To estimate the cost-effectiveness of aripiprazole once-monthly 400mg (AOM 400) vs. risperidone long acting injectable (RLAI), paliperidone long acting injectable (PLAI) and olanzapine long acting injectable (OLAI) in the maintenance treatment of chronic, stable schizophrenia patients in the United Kingdom. A Markov model was developed to emulate the treatment pathway of a hypothetical cohort of patients initiating maintenance treatment with LAI antipsychotics. The economic analysis was conducted from a National Health Service (NHS) and Personal Social Services (PSS) perspective over a 10 year time horizon. Efficacy and safety probabilities were derived from mixed treatment comparisons (MTCs) where possible. Analyses were conducted assuming pooled dosing from randomised clinical trials included in the MTCs. The model estimates that AOM 400 improves clinical outcomes by reducing relapses per patient comparative to other LAIs over the model time horizon (2.38, 2.53, 2.70, and 2.67 for AOM 400, RLAI, PLAI and OLAI respectively). In the deterministic analysis, AOM 400 dominated PLAI and OLAI; an incremental cost-effectiveness ratio (ICER) of GBP 3,686 per QALY gained was observed against RLAI. Results from the univariate sensitivity analyses highlighted the probability and cost of relapse as main drivers for cost-effectiveness. In the probabilistic sensitivity analysis, AOM 400 demonstrated a marginally higher probability of being cost-effective (51%) than RLAI, PLAI and OLAI

  18. 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

  19. 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

  20. A One Month Review of the Types of Medical Emergencies and their Treatment Outcomes at Two Urban Public Health Clinics.

    PubMed

    Chew, B H; Than, T L; Chew, K S; Jamaludin, N K; Hassan, H

    2012-12-01

    Our study was to examine prevalence and treatment outcomes of medical emergencies at two urban public health clinics in the Petaling district, Selangor, Malaysia. A prospective universal sampling was employed to recruit all emergencies over one month period (12 April to 11 May 2011). A structured case record form was used to capture demographic data, whether the index case was selfpresenting or decided by health care workers as a medical emergency, presenting complaints, diagnoses, concurrent chronic diseases and their treatment outcomes at the clinic level. Emergency presentations and diagnoses were classified according to the International Classification of Primary Care, revised second edition (ICPC-2-R). A total of 125 medical emergencies with 276 presenting complaints were recorded. The mean age was 30.7 years old (SD 19.9). The prevalence of medical emergency was 0.56% (125/22,320). Chief complaints were mainly from ICPC-2-R chapter R (respiratory system) and chapter A (general and unspecified), 40.0% and 28.0% respectively. The most common diagnosis was acute exacerbation of bronchial asthma (34.6%). Forty percent were referred to hospitals. After adjusting for age and gender, patients who presented with painful emergency (OR 4.9 95% CI 2.0 to 11.7), cardiovascular emergency (OR 63.4 95% CI 12.9 to 310.4) and non-respiratory emergency were predictors of hospital referral (OR 4.6 95% CI 1.1 to 19.1). There was about one medical emergency for every 200 patients presenting to these urban public polyclinics which were mainly acute asthma. More than half were discharged well and given a follow-up.

  1. Fracture Incidence, Quality of Life, and Back Pain during 18-Months Treatment with Teriparatide in Greek Postmenopausal Women with Osteoporosis: Results from the European Forsteo Observational Study.

    PubMed

    Aloumanis, K; Karras, D; Drossinos, V; Korelis, E; Polydorakis, A

    2011-01-01

    Objective. To evaluate fracture incidence, effects on health-related quality of life(QoL), back pain (BP) occurrence and treatment compliance in Greek post-menopausal osteoporotic women treated with teriparatide (TPTD) for up to 18 months, in a naturalistic setting. Methods. 301 patients provided baseline information on demographic characteristics, fracture history, osteoporosis-related medication and risk factors. During treatment, QoL and BP severity were evaluated. Results. Mean (SD) age was 69.5 (±8.5) years. Fracture history was reported by 92.5% of patients. Incidence of fractures (per 10,000 patients/years) ranged from 402 during 0-6 months of treatment, to 346 during 12-18 months. All 5 dimensions of QoL showed improvement. At baseline and 18 months, BP was reported by 93.2% and 64.2% of patients, respectively. BP and limitation of activities were quantified as moderate or severe by 89.9% and 62.3% of patients at baseline versus 32.4% and 14.8% at 18 months. Patients on treatment at 6, 12, 17, and 18 months were 92.6%, 88.3%, 79.6%, and 36.5%, respectively. Conclusions. In the Greek EFOS study cohort, patients prescribed TPTD were severely osteoporotic, with considerable health-related problems. Significant improvements in QoL and BP together with low fracture rates and high compliance have been recorded during treatment.

  2. 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

  3. Cognitive skill learning in healthy older adults after 2 months of double-blind treatment with piribedil.

    PubMed

    Peretti, Charles S; Gierski, Fabien; Harrois, Sophie

    2004-11-01

    Cognitive skill learning, as assessed by repeated testing on the Tower of Toronto (TT) task, has been found to be impaired in normal aging. There is evidence that this impairment might be accounted for by the well-documented, age-dependent decline of dopamine D2-like receptor availability. This study was an investigation of whether the D2/D3 dopaminergic agonist piribedil improves cognitive skill learning in older adults. Healthy elderly volunteers were assessed using the TT paradigm. Subjects were evaluated at baseline, and after 2 months of a placebo or piribedil (50 mg daily) treatment in a double-blind, crossover design. Two components of cognitive skill learning were considered--the ability to learn to solve the puzzle and the acquisition of a problem-solving routine. Piribedil showed a beneficial effect on the acquisition of a problem-solving routine, depending on the age of subjects, as revealed by solution reliability indexes measures. The effect of piribedil on the ability to learn to solve the puzzle was found to be dependent on the subject's working memory capacities. The present results suggest that piribedil is likely to enhance cognitive skill learning in healthy older adults and give further evidence that age-related dopamine decline plays an important role in cognitive impairment occurring in normal aging.

  4. A single LipiFlow® Thermal Pulsation System treatment improves meibomian gland function and reduces dry eye symptoms for 9 months.

    PubMed

    Greiner, Jack V

    2012-04-01

    To evaluate the effect of a single treatment with the LipiFlow(®) Thermal Pulsation System on signs of meibomian gland dysfunction (MGD) and dry eye symptoms over a 9-month period. Patients (n = 42 eyes, 21 subjects) diagnosed with MGD and dry eye symptoms were recruited for a non-significant risk, prospective, open-label, 1-month clinical trial. Patients received a single 12-minute treatment using the LipiFlow(®) Thermal Pulsation System on each eye. The LipiFlow(®) device applies heat to the conjunctival surfaces of the upper and lower inner eyelids while simultaneously applying pulsatile pressure to the outer eyelid surfaces to express the meibomian glands. Patient symptoms were evaluated using the Ocular Surface Disease Index (OSDI) and Standard Patient Evaluation for Eye Dryness (SPEED) dry eye questionnaires; tear break-up time was measured with the dry eye test (DET™); and meibomian gland function was evaluated using a standardized diagnostic expression technique. Data are presented for patient's pre-treatment (baseline) and at 1-month and 9-month post-treatment. Meibomian gland secretion scores improved significantly from baseline (4.4 ± 4.0) to 1-month post-treatment (11.3 ± 6.2; p < 0.0001) and this improvement was maintained with no significant regression at 9 months (11.7 ± 5.9). Similarly, baseline tear break-up time (4.8 ± 3.2) was significantly increased at 1 month (9.6 ± 7.6; p < 0.001) and this increase was maintained with no significant regression at 9 months (7.1 ± 5.6). Symptom scores on both OSDI and SPEED questionnaires improved significantly at 1 month (p < 0.0001) and this improvement was maintained at 9 months. With such prolonged improvement in signs and symptoms of dry eye disease, the LipiFlow(®) Thermal Pulsation System offers a technological advancement for the treatment of dry eye disease secondary to meibomian gland dysfunction. A single 12-minute LipiFlow(®) treatment results in up to 9

  5. 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

  6. 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

  7. 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…

  8. 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…

  9. IRIS Toxicological Review of Hexahydro-1,3,5-Trinitro-1,3,5 ...

    EPA Pesticide Factsheets

    The IRIS Toxicological Review of Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) was released for external peer review in September 2016. The EPA’s Science Advisory Board’s (SAB) Chemical Assessment Advisory Committee (CAAC) will conduct a peer review of the scientific basis supporting the RDX assessment and release a final report of their review. Information regarding the peer review can be found on the SAB website. EPA is undertaking an update of the Integrated Risk Information System (IRIS) health assessment for RDX. The outcome of this project is an updated Toxicological Review and IRIS Summary for RDX that will be entered into the IRIS database.

  10. IRIS Toxicological Review of Hexahydro-1,3,5-Trinitro-1,3,5 ...

    EPA Pesticide Factsheets

    The IRIS Toxicological Review of Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) was released for external peer review in September 2016. The EPA’s Science Advisory Board’s (SAB) Chemical Assessment Advisory Committee (CAAC) will conduct a peer review of the scientific basis supporting the RDX assessment and release a final report of their review. Information regarding the peer review can be found on the SAB website. EPA is undertaking an update of the Integrated Risk Information System (IRIS) health assessment for RDX. The outcome of this project is an updated Toxicological Review and IRIS Summary for RDX that will be entered into the IRIS database.

  11. 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

  12. Novel dinuclear dimethylamido-3,5-dimethylpyrazolato and tetranuclear dimethylamido-3,5-dimethylpyrazolato-polyoxo zirconium(IV) complexes. Synthesis and structural characterisation.

    PubMed

    Sanz, Martial; Mosquera, Marta E G; Cuenca, Tomás

    2009-04-14

    The dinuclear dimethylamido-tris(3,5-dimethylpyrazolato)-zirconium(IV) complex [Zr(3,5-Me2Pz)3(NMe2)]2 1 is prepared by treatment of [Zr(NMe2)4] with 3 equivalents of 3,5-dimethylpyrazole (3,5-Me2PzH) with elimination of dimethylamine. When [Zr(NMe2)4] reacted with 2 equivalents of 3,5-Me2PzH, the bis(dimethylamido)-bis(3,5-dimethylpyrazolato)zirconium(IV) compound [Zr(3,5-Me2Pz)2(NMe2)2]2 2 is obtained. Hydrolysis of [Zr(3,5-Me2Pz)3(NMe2)]2 in wet toluene affords the tetranuclear oxo compound [Zr4(eta2-3,5-Me2Pz)4(NMe2)2(mu3-O)2(mu2-3,5-Me2Pz)4(mu2-NMe2)2] . All synthesised compounds are characterised by NMR spectroscopic and analytical methods. Single crystal X-ray diffraction analysis has established the molecular structures of 1 and 4.

  13. 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.

  14. Independence, institutionalization, death and treatment costs 18 months after rehabilitation of older people in two different primary health care settings

    PubMed Central

    2012-01-01

    Background The optimal setting and content of primary health care rehabilitation of older people is not known. Our aim was to study independence, institutionalization, death and treatment costs 18 months after primary care rehabilitation of older people in two different settings. Methods Eighteen months follow-up of an open, prospective study comparing the outcome of multi-disciplinary rehabilitation of older people, in a structured and intensive Primary care dedicated inpatient rehabilitation (PCDIR, n=202) versus a less structured and less intensive Primary care nursing home rehabilitation (PCNHR, n=100). Participants: 302 patients, disabled from stroke, hip-fracture, osteoarthritis and other chronic diseases, aged ≥65years, assessed to have a rehabilitation potential and being referred from general hospital or own residence. Outcome measures: Primary: Independence, assessed by Sunnaas ADL Index(SI). Secondary: Hospital and short-term nursing home length of stay (LOS); institutionalization, measured by institutional residence rate; death; and costs of rehabilitation and care. Statistical tests: T-tests, Correlation tests, Pearson’s χ2, ANCOVA, Regression and Kaplan-Meier analyses. Results Overall SI scores were 26.1 (SD 7.2) compared to 27.0 (SD 5.7) at the end of rehabilitation, a statistically, but not clinically significant reduction (p=0.003 95%CI(0.3-1.5)). The PCDIR patients scored 2.2points higher in SI than the PCNHR patients, adjusted for age, gender, baseline MMSE and SI scores (p=0.003, 95%CI(0.8-3.7)). Out of 49 patients staying >28 days in short-term nursing homes, PCNHR-patients stayed significantly longer than PCDIR-patients (mean difference 104.9 days, 95%CI(0.28-209.6), p=0.05). The institutionalization increased in PCNHR (from 12%-28%, p=0.001), but not in PCDIR (from 16.9%-19.3%, p= 0.45). The overall one year mortality rate was 9.6%. Average costs were substantially higher for PCNHR versus PCDIR. The difference per patient was 3528€ for

  15. IRIS Toxicological Review of Hexahydro-1,3,5-Trinitro-1,3,5 ...

    EPA Pesticide Factsheets

    On March 10, 2016, the public comment draft Toxicological Review of Hexahydro-1,3,5-trinitro-1,3,5-triazine and the draft charge to external peer reviewers were released for public review and comment. The Toxicological Review and charge were reviewed internally by EPA and by other federal agencies and White House Offices before public release. Consistent with the May 2009 IRIS assessment development process, all written comments on IRIS assessments submitted by other federal agencies and White House Offices are made publicly available. Accordingly, interagency comments and the interagency science consultation materials provided to other agencies, including interagency review drafts of the IRIS Toxicological Review of Hexahydro-1,3,5-trinitro-1,3,5-triazine and the charge to external peer reviewers, are posted on this site. EPA is undertaking an update of the Integrated Risk Information System (IRIS) health assessment for RDX. The outcome of this project is an updated Toxicological Review and IRIS Summary for RDX that will be entered into the IRIS database.

  16. The Effect of Three-Monthly Albendazole Treatment on Malarial Parasitemia and Allergy: A Household-Based Cluster-Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Kaisar, Maria M. M.; May, Linda; Prasetyani, Margaretta A.; Wahyuni, Sitti; Djuardi, Yenny; Ariawan, Iwan; Wibowo, Heri; Lell, Bertrand; Sauerwein, Robert; Brice, Gary T.; Sutanto, Inge; van Lieshout, Lisette; de Craen, Anton J. M.; van Ree, Ronald; Verweij, Jaco J.; Tsonaka, Roula; Houwing-Duistermaat, Jeanine J.; Luty, Adrian J. F.; Sartono, Erliyani; Supali, Taniawati; Yazdanbakhsh, Maria

    2013-01-01

    Background Helminth infections are proposed to have immunomodulatory activities affecting health outcomes either detrimentally or beneficially. We evaluated the effects of albendazole treatment, every three months for 21 months, on STH, malarial parasitemia and allergy. Methods and Findings A household-based cluster-randomized, double-blind, placebo-controlled trial was conducted in an area in Indonesia endemic for STH. Using computer-aided block randomization, 481 households (2022 subjects) and 473 households (1982 subjects) were assigned to receive placebo and albendazole, respectively, every three months. The treatment code was concealed from trial investigators and participants. Malarial parasitemia and malaria-like symptoms were assessed in participants older than four years of age while skin prick test (SPT) to allergens as well as reported symptoms of allergy in children aged 5–15 years. The general impact of treatment on STH prevalence and body mass index (BMI) was evaluated. Primary outcomes were prevalence of malarial parasitemia and SPT to any allergen. Analysis was by intention to treat. At 9 and 21 months post-treatment 80.8% and 80.1% of the study subjects were retained, respectively. The intensive treatment regiment resulted in a reduction in the prevalence of STH by 48% in albendazole and 9% in placebo group. Albendazole treatment led to a transient increase in malarial parasitemia at 6 months post treatment (OR 4.16(1.35–12.80)) and no statistically significant increase in SPT reactivity (OR 1.18(0.74–1.86) at 9 months or 1.37 (0.93–2.01) 21 months). No effect of anthelminthic treatment was found on BMI, reported malaria-like- and allergy symptoms. No adverse effects were reported. Conclusions The study indicates that intensive community treatment of 3 monthly albendazole administration for 21 months over two years leads to a reduction in STH. This degree of reduction appears safe without any increased risk of malaria or allergies. Trial

  17. Water Filtration. Grades 3-5.

    ERIC Educational Resources Information Center

    Rushton, Erik; Ryan, Emily; Swift, Charles

    One of our most valuable and often overlooked resources is water. We can survive for a couple of weeks without food but only a few days without water. Having clean water to drink is a luxury. The water that comes out of our faucets does not always start off safe to drink. Most often it has visited a treatment plant prior to reaching our glasses.…

  18. EFFICACY AND SAFETY OF RANIBIZUMAB FOR THE TREATMENT OF CHOROIDAL NEOVASCULARIZATION DUE TO UNCOMMON CAUSE: Twelve-Month Results of the MINERVA Study.

    PubMed

    Lai, Timothy Y Y; Staurenghi, Giovanni; Lanzetta, Paolo; Holz, Frank G; Melissa Liew, Shiao Hui; Desset-Brethes, Sabine; Staines, Harry; Hykin, Philip G

    2017-07-12

    To evaluate the efficacy and safety of ranibizumab 0.5 mg in adult patients with choroidal neovascularization because of an uncommon cause enrolled in the 12-month MINERVA study. In this Phase III, double-masked study, adult (≥18 years) patients (N = 178) were randomized 2:1 to receive either ranibizumab (n = 119) or sham (n = 59) at baseline and, if needed, at Month 1 and open-label individualized ranibizumab from Month 2. Best-corrected visual acuity change from baseline to Month 2 (primary endpoint) and Month 12, treatment exposure, and safety over 12 months were reported. Subgroup analysis was conducted on five predefined choroidal neovascularization etiologies (angioid streak, postinflammatory, central serous chorioretinopathy, idiopathic, and miscellaneous). Ranibizumab showed superior efficacy versus sham from baseline to Month 2 (adjusted least-squares mean best-corrected visual acuity: +9.5 vs. -0.4 letters; P < 0.001). At Month 12, the mean best-corrected visual acuity change was +11.0 letters (ranibizumab) and +9.3 letters (sham). Across the 5 subgroups, the treatment effect ranged from +5.0 to +14.6 letters. The mean number of ranibizumab injections was 5.8 (ranibizumab arm) with no new ocular or nonocular adverse events. Ranibizumab 0.5 mg resulted in clinically significant treatment effect versus sham at Month 2. Overall, ranibizumab was effective in treating choroidal neovascularization of various etiologies with no new safety findings.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

  19. 1,3,5-Hydroxybenzene structures in mosses

    USGS Publications Warehouse

    Wilson, M.A.; Sawyer, J.; Hatcher, P.G.; Lerch, H. E.

    1989-01-01

    A number of mosses from widely different families have been studied by cross polarization solid state 13C NMR spectroscopy. Although polysaccharide-type materials dominate the NMR spectra, significant amounts of aromatic carbons are observed in some mosses. Some of this material can be removed by ultrasonic bath treatment, and is lignin derived, probably from impurities from fine root material from associated higher plants. However other material is truly moss-derived and appears to be from 1,3,5-hydroxybenzene structures. This is inconsistent with lignin as being a component of mosses, and suggests a tannin or hydroxybenzofuran polymer is responsible for moss rigidity. ?? 1989.

  20. 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.

  1. Adherence to Occlusion Therapy in the First Six Months of Follow-Up and Visual Acuity among Participants in the Infant Aphakia Treatment Study (IATS)

    PubMed Central

    Drews-Botsch, Carolyn D.; Celano, Marianne; Kruger, Stacey; Hartmann, E. Eugenie

    2012-01-01

    Purpose. Achieving good vision in infants born with a unilateral cataract is believed to require early surgery and consistent occlusion of the fellow eye. This article examines the relationship between adherence to patching and grating acuity. Methods. Data came from the Infant Aphakia Treatment Study, a randomized clinical trial of treatment for unilateral congenital cataract. Infants were either left aphakic (n = 53) or had an intraocular lens implanted (n = 55). Patching was prescribed 1 hour per day per month of age until 8 months of age and 50% of waking hours thereafter. Adherence was measured as the mean percentage of prescribed patching reported in a 7-day diary completed 2 months after surgery, and 48-hour recall interviews conducted 3 and 6 months after surgery. Grating visual acuity was measured within 1 month of the infant's first birthday (n = 108) using Teller Acuity Cards by a tester masked to treatment. Nonparametric correlations were used to examine the relationship with grating acuity. Results. On average, caregivers reported patching 84.3% (SD = 31.2%) of prescribed time and adherence did not differ by treatment (t = −1.40, df = 106, p = 0.16). Adherence was associated with grating acuity (rSpearman = −0.27, p < 0.01), but more so among pseudophakic (rSpearman = −0.41, p < 0.01) than aphakic infants (rSpearman = −0.10, p = 0.49). Conclusions. This study empirically has shown that adherence to patching during the first 6 months after surgery is associated with better grating visual acuity at 12 months of age after treatment for unilateral cataract and that implanting an intraocular lens is not associated with adherence. (ClinicalTrials.gov number, NCT00212134.) PMID:22491410

  2. 3.5 D temperature model of a coal stockpile

    SciTech Connect

    Ozdeniz, A.H.; Corumluoglu, O.; Kalayci, I.; Sensogut, C.

    2008-07-01

    Overproduced coal mines that are not sold should remain in coal stock sites. If these coal stockpiles remain at the stock yards over a certain period of time, a spontaneous combustion can be started. Coal stocks under combustion threat can cost too much economically to coal companies. Therefore, it is important to take some precautions for saving the stockpiles from the spontaneous combustion. In this research, a coal stock which was 5 m wide, 10 m long, and 3 m in height, with a weight of 120 tons, was monitored to observe internal temperature changes with respect to time under normal atmospheric conditions. Internal temperature measurements were obtained at 20 points distributed all over the two layers in the stockpile. Temperatures measured by a specially designed mechanism were then stored into a computer every 3 h for a period of 3 months. Afterward, this dataset was used to delineate 3.5 D temporal temperature distribution models for these two levels, and they were used to analyze and interpret what was seen in these models to derive some conclusions. It was openly seen, followed, and analyzed that internal temperature changes in the stockpile went up to 31{sup o}C by 3.5 D models created for this research.

  3. Biodegradation of 1,3,5-trinitro-1,3,5-triazine (RDX).

    PubMed

    Lee, Sheng-Yih; Brodman, Bruce W

    2004-01-01

    Two bacteria were isolated from 1,3,5-trinitro-1,3,5-triazine (RDX) contaminated soil at Picatinny Arsenal, New Jersey. These organisms were subsequently identified as Rhiziobium rhizogenes BL and Burkholderia sp.BL by the Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH (DSMZ, German Collection of Microorganisms and Cell Cultures). In addition a fungus, identified as Cladosporium cladosporioides by DSMZ, was found to be growing on water wet RDX. All of these organisms were found to degrade RDX. The two bacteria were found to represent new species that have not been reported before. It was found that these organisms along with an added carbon source could degrade RDX to simple gaseous products. Data are presented that elucidate the mechanisms of RDX biodegradation for these organisms.

  4. Tomographic ventilation/perfusion lung scintigraphy in the monitoring of the effect of treatment in pulmonary embolism: serial follow-up over a 6-month period.

    PubMed

    Begic, Amela; Jögi, Jonas; Hadziredzepovic, Amra; Kucukalic-Selimović, Elma; Begovic-Hadzimuratovic, Sadzida; Bajc, Marika

    2011-06-01

    Pulmonary embolism (PE) is a severe condition with nonspecific symptoms. Diagnosis relies on medical imaging but follow-up is currently based on clinical symptoms and general risk factors. The duration of anticoagulant treatment after an acute episode of PE is still subject to debate and the best method of identifying the risk of recurrence in individual patients is undefined. Tomographic lung scintigraphy [ventilation/perfusion single photon emission computed tomography (V/P SPECT)] has improved the diagnostic accuracy with regard to PE but has not been evaluated for PE follow-up. The aim of this prospective study was to quantitatively follow the natural history of treated PE using V/P SPECT, which could prove helpful in defining an anticoagulant treatment regime for individual patients. Of 83 consecutive patients with clinically suspected PE examined with V/P SPECT, 23 patients with confirmed PE were followed by serial V/P SPECT examinations over a 6-month period. All patients were also followed clinically. The mean relative decrease in PE extent compared with the time of diagnosis was 54±26% at 2 weeks, 79±30% at 3 months, and 82±30% at 6 months. Significant resolution of mismatched perfusion defects occurred between V/P SPECT controls within the first 3 months of anticoagulation (P<0.001) but not thereafter. V/P SPECT identified four patients with chronic PE, even though all patients were free from symptoms at 3-month follow-up. Follow-up of PE with V/P SPECT is feasible to evaluate treatment effectiveness in individual patients and to identify patients that develop chronic PE. This study also confirms that resolution of perfusion defects after PE occurs within the first 3 months of treatment. It is therefore recommended that V/P SPECT follow-up should be considered at 3 months after diagnosis.

  5. Caregiver-reported antiretroviral therapy non-adherence during the first week and after a month of treatment initiation among children diagnosed with HIV in Ethiopia.

    PubMed

    Biru, Mulatu; Jerene, Degu; Lundqvist, Pia; Molla, Mitikie; Abebe, Workeabeba; Hallström, Inger

    2017-04-01

    To achieve optimal virologic suppression for children undergoing antiretroviral therapy (ART), adherence must be excellent. This is defined as taking more than 95% of their prescribed doses. To our knowledge, no study in Ethiopia has evaluated the level of treatment adherence at the beginning of the child's treatment. Our aim was therefore to evaluate caregiver-reported ART non-adherence among children and any predictors for this during the early course of treatment. We conducted a prospective cohort study of 306 children with HIV in eight health facilities in Ethiopia who were registered at ART clinics between 20 December 2014 and 20 April 2015. The adherence rate reported by caregivers during the first week and after a month of treatment initiation was 92.8% and 93.8%, respectively. Our findings highlight important predictors of non-adherence. Children whose caregivers were not undergoing HIV treatment and care themselves were less likely to be non-adherent during the first week of treatment (aOR = 0.17, 95% CI: 0.04, 0.71) and the children whose caregivers did not use a medication reminder after one month of treatment initiation (aOR = 5.21, 95% CI: 2.23, 12.16) were more likely to miss the prescribed dose. Moreover, after one month of the treatment initiation, those receiving protease inhibitor (LPV/r) or ABC-based treatment regimens were more likely to be non-adherent (aOR = 12.32, 95% CI: 3.25, 46.67). To promote treatment adherence during ART initiation in children, particular emphasis needs to be placed on a baseline treatment regimen and ways to issue reminders about the child's medication to both the health care system and caregivers. Further, large scale studies using a combination of adherence measuring methods upon treatment initiation are needed to better define the magnitude and predictors of ART non-adherence in resource-limited settings.

  6. 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

  7. Diabetes mellitus and its influence on sputum smear positivity at the 2nd month of treatment among pulmonary tuberculosis patients in Kuala Lumpur, Malaysia: A case control study.

    PubMed

    Shariff, Noorsuzana Mohd; Safian, Nazarudin

    2015-12-01

    Many studies have suggested that sputum smear conversion after 2 months of antituberculosis treatment is an important determinant of treatment success and can be a predictor for relapse. The objective of this study is to determine the factors that influence sputum smear conversion after 2 months of treatment among pulmonary tuberculosis patients receiving treatment in the Institute of Respiratory Medicine in Kuala Lumpur, Malaysia. A total of 75 cases and 75 controls were interviewed, and their medical records were retrieved in order to extract the information needed. All analyses were conducted using SPSS version 17, and binary logistic regression analysis was used to determine the predictors of sputum smear nonconversion. Results showed that the following factors were associated with sputum smear positivity after 2 months of intensive treatment: diabetes mellitus (p=.013, odds ratio [OR]=2.59, 95% confidence interval [CI] 1.27-5.33), underweight body mass index (p=.025, OR=1.67, 95% CI 0.80-3.49), nonadherent to tuberculosis treatment (p=.024, OR=2.85, 95% CI 1.21-6.74), and previous history of tuberculosis (p=.043, OR=2.53, 95% CI 1.09-5.83). Multivariable analysis identified diabetes mellitus (p=.003, OR=4.01, 95% CI 1.61-9.96) as being independently associated with the risk of persistent sputum smear positivity after 2 months of intensive treatment. Based on the findings, identification of these factors is valuable in strengthening the management and treatment of tuberculosis in Malaysia in the future. This study emphasizes the importance of diabetes screening and integration of diabetic controls among tuberculosis patients in achieving better treatment outcome. Copyright © 2015 Asian-African Society for Mycobacteriology. Published by Elsevier Ltd. All rights reserved.

  8. Treatment of Helicobacter pylori in functional dyspepsia resistant to conventional management: a double blind randomised trial with a six month follow up

    PubMed Central

    Koelz, H R; Arnold, R; Stolte, M; Fischer, M; Blum, A L

    2003-01-01

    Background: Previous studies on the treatment of Helicobacter pylori infection in functional dyspepsia have shown little, if any, effect on dyspeptic symptoms. However, whether such treatment might be of benefit in patients resistant to acid inhibitors has not been formally tested. Aim: The present study investigated the effect of H pylori treatment in patients with functional dyspepsia resistant to conventional treatment. Patients: A total of 181 H pylori positive patients with chronic functional dyspepsia who had not responded to a one week antacid run-in and two week double blind antisecretory or placebo treatment were included. Methods: Patients were randomised to two weeks of treatment with omeprazole 40 mg twice daily combined with amoxicillin 1 g twice daily or omeprazole 20 mg once daily alone. The primary outcome variable (“response”) was defined as no need for further therapy or investigations for dyspeptic symptoms 4–6 months after treatment. Results: H pylori infection was healed in 10% of patients after omeprazole and in 52% after omeprazole plus amoxicillin. The respective “response” rates were 66% and 62% (NS). H pylori treatment and cure of H pylori infection had no effect on complete resolution of all dyspeptic symptoms, individual symptoms, or various aspects of quality of life. Conclusion: In functional dyspepsia, H pylori treatment and cure of H pylori are no more effective for symptoms over six months than short term acid inhibition. These results do not support treatment of H pylori in functional dyspepsia. PMID:12477757

  9. Evaluation and comparison of a flumethrin-imidacloprid collar and repeated monthly treatments of fipronil/(s)-methoprene to control flea, Ctenocephalides f. felis, infestations on cats for eight months.

    PubMed

    Dryden, Michael W; Smith, Vicki; Davis, Wendell L; Settje, Terry; Hostetler, Joe

    2016-05-17

    This controlled laboratory study was designed to evaluate the efficacy of the 10 % imidacloprid/4.5 % flumethrin collar (Seresto®, Bayer Animal Health) against fleas (Ctenocephalides f. felis) on cats, when compared to fipronil (9.8 %w/w)/(s)-methoprene (11.8 % w/w) topical spot-on formulation (Frontline® Plus for Cats and Kittens, Merial). Thirty cats were randomized into three groups of ten animals based on pre-treatment flea counts: Group 1: imidacloprid/flumethrin collar; Group 2: fipronil/(s)-methoprene topical spot-on and Group 3: non-treated controls. The imidacloprid/flumethrin collars were applied one time on Day 0, while the fipronil/(s)-methoprene spot-on was administered every 30 days from Day 0 through Day 210. Cats were infested with 100 fleas on study days 0, 7, 14, 29, 59, 89, 119, 149, 179, 209 and 239. All flea counts were conducted by combing to remove fleas on post-treatment days 2, 8, 15, 30, 60, 90, 120, 150, 180, 210 and 240. The efficacy of the imidacloprid/flumethrin collar ranged from 98.2 to 100 % for eight months. The efficacy of fipronil/(s)-methoprene spot-on ranged from 68.2 to 99.9 %. Efficacy was < 85 % for fipronil/(s)-methoprene on Days 90, 150 and 210. The flea counts in both treatment groups were significantly fewer than those in the non-treated control group at every post-treatment study day (P < 0.0001). In addition, there were significantly fewer fleas in the imidacloprid/flumethrin collar group when compared to the fipronil/(s)-methoprene group on Days 90, 150 and 210 (P < 0.0001). This study demonstrated that the imidacloprid/flumethrin collar (Seresto®, Bayer Animal Health) maintained excellent ( > 98.2 %) efficacy against fleas on cats for the entire 8 month study. Monthly applications of fipronil/(s)-methoprene (Frontline® Plus for Cats and Kittens, Merial) generally had high, but variable (68.2 to 99.9 %) efficacy over the course of the eight month study. Based on the very high residual

  10. Efficacy, safety, and tolerability of a 24-month treatment regimen including delamanid in a child with extensively drug-resistant tuberculosis

    PubMed Central

    Esposito, Susanna; Bosis, Samantha; Tadolini, Marina; Bianchini, Sonia; Migliori, Giovanni Battista; Principi, Nicola

    2016-01-01

    Abstract Rational: Multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) are emerging problems in several countries. These infections require long and expensive treatment regimens. Recently, 2 new drugs, bedaquiline and delamanid, have been approved in several countries for use in adults with severe, difficult-to-treat MDR-TB, and it has been suggested that they could also be administered to children with MDR-TB and limited treatment options. However, no study has been completed on their efficacy. Patient concerns: This report describes a 12-year-old child with XDR-TB who was cured after a 24-month therapy regimen, which included delamanid. Diagnoses: The patient showed progressive clinical deterioration after 5 months of treatment with the majority of anti-TB drugs available on the market. Interventions: After unsuccessfull treatment with several anti-TB drugs for 5 months, he was treated with a regimen including for 24 months. Outcomes: Direct smear microscopy of the gastric aspirates and gastric aspirate cultures for Mycobacterium tuberculosis became negative after only 1 week and remained persistently negative. During the 24-month treatment, all blood test results remained within the normal range, no adverse events were reported, and corrected QT interval was always normal. A clinical and laboratory control was performed 3 months after discontinuation of delamanid, and the other drugs did not reveal any modification of both general conditions as well as laboratory and radiological findings. The patient was considered cured. Lessons: The positive outcome associated with the favorable safety and tolerability profile showed that long-term therapy with delamanid can significantly contribute to treating apparently hopeless XDR-TB cases in children. PMID:27861363

  11. 1H NMR for quantifying sulfide trapping efficiency by using 1,3,5-tris(2-hydroxyethyl)-1,3,5-triazinane.

    PubMed

    Canuto, André V S; Echevarria, Aurea

    2014-07-01

    Hydrogen sulfide (H2S) is an extremely toxic colourless gas; it is corrosive and denser than air. It usually happens in oil and natural gas fields, refineries, coal mines, and in some industrial effluent treatment systems. This work presents an alternative method of monitoring and quantifying H2S trapping efficiency by using 1,3,5-tris(2-hydroxyethyl)-1,3,5-triazinane as a sequestering agent, and sodium sulfide as a source of sulfide ion, through (1)H NMR spectroscopy. The results proved that the reaction occurs very quickly at 20 °C at pH 7 and 10. 3,5-di(2-hydroxyethyl)-1,3,5-thiodiazinane and 5-(2-hydroxyethyl)-1,3,5-dithiozinane were observed and quantified; it was evidenced that (1)H NMR spectroscopy can be applied as a fast and effective method to quantify H2S trapping efficiency. Copyright © 2014 John Wiley & Sons, Ltd.

  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. [Effectiveness of donepezil at six months in the treatment of cognition deterioration in patients with Alzheimer-type dementia].

    PubMed

    López-Pousa, S; Vilalta-Franch, J; Garre-Olmo, J; Turón-Estrada, A; Hernández-Ferrándiz, M; Cruz-Reina, M L

    We compared two groups of patients with cognitive deterioration secondary to Alzheimer's disease (AD) of minimal and slight degree (CAMDEX criteria), one treated with donepezil and the other without this drug (a case history sample) over a period of six months. Both groups received the CAMCOG battery of neuropsychological tests at basal (pretreatment) time and six months later. Those in the study sample who received donepezil (5-10 mg/day) were 91 patients (average age: 75.25, standard deviation = 6.01) of whom 28.6% were men. The control group, who did not receive anticholinesterase drugs (case history sample) consisted of 84 persons (average age: 75.98, standard deviation = 5.01) with 29.8% men. There were no significant differences with regard to age, sex, basal CAMCOG score or period of time between the two CAMCOG determinations. The averages of the differences between the basal CAMCOG scores and those six months later in the two groups was statistically significant (-1.5275 +/- 7.8458 against -6.7143 +/- 6.1234; p < 0.001). Multivariate analysis of repeat measurements corroborates these findings since significant differences were found between the two groups (p < 0.001) in the results of CAMCOG after six months. Donepezil was seen to be effective in that it delayed cognitive deterioration after six months in patients with minimal and slight degrees of AD.

  14. The impact of managed care on publicly funded outpatient adolescent substance abuse treatment: service use and six-month outcomes in Oregon and Washington.

    PubMed

    Carlson, Matthew J; Gabriel, Roy M; Deck, Dennis D; Laws, Katherine E; D'Ambrosio, Ryan

    2005-06-01

    This study assessed the impact of managed care on publicly funded adolescent substance abuse treatment by comparing differences in service utilization and outcomes across prospective samples from two states: Oregon, which uses managed care practices in service financing and delivery, and Washington, which does not. One hundred and six adolescents from Washington and 94 from Oregon, who entered outpatient substance abuse treatment in 1998 and 1999, completed self-report surveys about their substance use before and after receiving treatment (follow-up rate = 75 percent). In addition, clinical chart reviews conducted at the 6-month follow-up assessed the type and amount of treatment these adolescents received during the study period. It was found that service utilization and treatment outcomes were comparable across the two state samples. The evidence presented here suggests that managed care is capable of delivering substance abuse treatment services of comparable quality to state-administered substance abuse treatment services.

  15. Outcomes after 18 Months of Eliglustat Therapy in Treatment-Naïve Adults with Gaucher Disease Type 1: The Phase 3 ENGAGE Trial.

    PubMed

    Mistry, Pramod K; Lukina, Elena; Ben Turkia, Hadhami; Shankar, Suma P; Baris, Hagit; Ghosn, Marwan; Mehta, Atul; Packman, Seymour; Pastores, Gregory; Petakov, Milan; Assouline, Sarit; Balwani, Manisha; Danda, Sumita; Hadjiev, Evgueniy; Ortega, Andres; Gaemers, Sebastiaan J M; Tayag, Regina; Peterschmitt, M Judith

    2017-08-01

    Eliglustat, an oral substrate reduction therapy, is a first-line treatment for adults with Gaucher disease type 1 (GD1) who are poor, intermediate, or extensive CYP2D6 metabolizers (>90% of patients). In the primary analysis of the Phase 3 ENGAGE trial (NCT00891202), eliglustat treatment for 9 months resulted in significant reductions in spleen and liver volumes and increases in hemoglobin concentration and platelet count compared with placebo. We report 18-month outcomes of patients who entered the trial extension period, in which all patients received eliglustat. Of 40 trial patients, 39 entered the extension period and 38 completed 18 months. Absolute values and percent change over time were determined for spleen and liver volume, hemoglobin concentration, platelet count, bone mineral density, bone marrow burden, and Gaucher disease biomarkers. For patients randomized to eliglustat in the double-blind period, continuing treatment with eliglustat for 9 more months resulted in incremental improvement of all disease parameters. For patients randomized to placebo in the double-blind period, eliglustat treatment during the 9-month, open-label period resulted in significant decrease of spleen and liver volumes and significant increase of hemoglobin and platelets, with a similar rate of change to patients who had received eliglustat in the double-blind period. Eliglustat treatment was also associated with improvement in bone marrow burden score, bone mineral density and established biomarkers of Gaucher disease, including reduction of the bioactive lipid, glucosylsphingosine. These findings underscore the efficacy of eliglustat in treatment-naive patients. Eliglustat was well-tolerated, and there were no new safety concerns with longer-term exposure. This article is protected by copyright. All rights reserved. © 2017 Wiley Periodicals, Inc.

  16. 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.

  17. 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.

  18. HIV-free survival at 12-24 months in breastfed infants of HIV-infected women on antiretroviral treatment.

    PubMed

    Chikhungu, Lana Clara; Bispo, Stephanie; Rollins, Nigel; Siegfried, Nandi; Newell, Marie-Louise

    2016-07-01

    To provide estimates of HIV-free survival at 12-24 months in breastfed children by maternal ART (6 months or lifelong) to inform WHO HIV and Infant Feeding guidelines. Eighteen studies published 2005-2015 were included in a systematic literature review (1295 papers identified, 156 abstracts screened, 55 full texts); papers were analysed by narrative synthesis and meta-analysis of HIV-free survival by maternal ART regimen in a random effects model. We also grouped studies by feeding modality. Study quality was assessed using a modified Newcastle-Ottawa Scale (NOS) and GRADE. The pooled estimates for 12-month HIV-free survival were 89.8% (95% confidence interval, CI: 86.5%, 93.2%) for infants of mothers on ART for 6 months post-natally (six studies) and 91.4% (95% CI 87.5%, 95.4%) for infants of mothers on lifelong ART (three studies). Eighteen-month HIV-free survival estimates were 89.0% (95% CI 83.9%, 94.2%) with 6 months ART (five studies) and 96.1% (95% CI 92.8%, 99.0%) with lifelong ART (three studies). Twenty-four-month HIV-free survival for infants whose mothers were on ART to 6 months post-natally (two studies) was 89.2% (95% CI 79.9%, 98.5%). Heterogeneity was considerable throughout. In four studies, HIV-free survival in breastfed infants ranged from 87% (95% CI 78%, 92%) to 96% (95% CI 91%, 98%) and in formula-fed infants from 67% (95% CI 35.5%, 87.9%) to 97.6% (95% CI 93.0%, 98.2%). Our results highlight the importance of breastfeeding for infant survival and of ART in reducing the risk of mother-to-child HIV transmission and support the WHO recommendation to initiate ART for life immediately after HIV diagnosis. © 2016 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

  19. Thirty-sixth-month follow-up of first-in-human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence.

    PubMed

    Almeida, Jose I; Javier, Julian J; Mackay, Edward G; Bautista, Claudia; Cher, Daniel J; Proebstle, Thomas M

    2017-09-01

    The objective of this study was to evaluate the long-term safety and effectiveness of endovenous cyanoacrylate (CA)-based closure of incompetent great saphenous veins. This was a prospective, single-arm, single-center feasibility study conducted at the Canela Clinic (La Romana, Dominican Republic) to assess the effectiveness and safety of a CA-based adhesive for great saphenous vein closure at 36 months after treatment. Thirty-eight subjects were treated by injection of small boluses of CA under ultrasound guidance and without the use of perivenous tumescent anesthesia or postprocedure graduated compression stockings. Periodic scheduled follow-up was performed during 36 months. At month 36, there were 29 subjects who were available for follow-up. Complete occlusion of the treated veins was confirmed by duplex ultrasound in all subjects with the exception of two subjects showing recanalization at month 1 and month 3. Kaplan-Meier analysis revealed an occlusion rate at month 36 of 94.7% (95% confidence interval, 87.9%-100%). The mean Venous Clinical Severity Score (VCSS) improved from 6.1 ± 2.7 at baseline to 2.2 ± 0.4 at month 36 (P < .0001). Pain, edema, and varicosities (VCSS subdomains) improved in 75.9%, 62.1%, and 41.4% of subjects, respectively, at month 36. Overall adverse events were mild or moderate and self-limited. CA adhesive appears to be an effective and safe treatment for saphenous vein closure, with long-term occlusion rates comparable to those of other thermal and nonthermal methods and with no reported serious adverse events. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

  20. Changes in BDNF serum levels in patients with major depression disorder (MDD) after 6 months treatment with sertraline, escitalopram, or venlafaxine.

    PubMed

    Matrisciano, Francesco; Bonaccorso, Stefania; Ricciardi, Angelo; Scaccianoce, Sergio; Panaccione, Isabella; Wang, Lily; Ruberto, Amedo; Tatarelli, Roberto; Nicoletti, Ferdinando; Girardi, Paolo; Shelton, Richard C

    2009-01-01

    Recent studies have implicated brain-derived neurotrophic factor (BDNF) in the pathophysiology of depression and the activity of antidepressant drugs. Serum BDNF levels are lower in depressed patients, and increase in response to antidepressant medication. However, how BDNF responds to different classes of antidepressant drugs is unknown. We assessed serum BDNF levels in 21 patients with major depressive episode treated with sertraline, escitalopram, or venlafaxine and 20 healthy controls. Serum samples were collected between 10 a.m. and 12 p.m. at baseline, 5 weeks, and 6 months of treatment. BDNF levels were measured via immunoassay. The severity of symptoms and response to treatment were assessed by the Hamilton rating scales for depression (HRSD). Baseline serum BDNF levels were significantly lower in depressed patients compared to controls. Sertraline increased BDNF levels after 5 weeks and 6 months of treatment. Venlafaxine increased BDNF levels only after 6 months. Escitalopram did not affect BDNF levels at either time point. A significant negative association was found between percentage increase in BDNF levels and percentage decreased in HRSD scores after 6 months of treatment. In conclusion, these results suggest that different antidepressant drugs have variable effects on serum BDNF levels. This is true even though the three different drugs were equally effective in relieving symptoms of depression and anxiety.

  1. A preliminary 6-month prospective study examining self-reported religious preference, religiosity/spirituality, and retention at a Jewish residential treatment center for substance-related disorders.

    PubMed

    Parhami, Iman; Davtian, Margarit; Collard, Michael; Lopez, Jean; Fong, Timothy W

    2014-07-01

    Although there is a substantial amount of research suggesting that higher levels of religiosity/spirituality (R/S) are associated with better treatment outcomes of substance-related disorders, no studies have explored this relationship at a faith-based residential treatment center. The objective of this prospective study is to explore the relationship between R/S, self-reported religious preference, and retention at a Jewish residential treatment center for substance-related disorders. Using the Daily Spiritual Experience Scale, R/S levels were assessed for 33 subjects at baseline, 1 month, 3 months, and 6 months. Results demonstrated a significant relationship between baseline R/S level and retention at 6 months, while R/S levels were unchanged during the course of treatment. Notably, no relationship was found between self-reported religious affiliation and retention. This study demonstrates that patients' R/S level, rather than religious affiliation, is a possible predictor for better outcome at faith-based residential centers for substance-related disorders.

  2. A Preliminary 6-Month Prospective Study Examining Self-reported Religious Preference, Religiosity/Spirituality, and Retention at a Jewish Residential Treatment Center for Substance-Related Disorders

    PubMed Central

    Davtian, Margarit; Collard, Michael; Lopez, Jean; Fong, Timothy W.

    2012-01-01

    Although there is a substantial amount of research suggesting that higher levels of religiosity/spirituality (R/S) are associated with better treatment outcomes of substance-related disorders, no studies have explored this relationship at a faith-based residential treatment center. The objective of this prospective study is to explore the relationship between R/S, self-reported religious preference, and retention at a Jewish residential treatment center for substance-related disorders. Using the Daily Spiritual Experience Scale, R/S levels were assessed for 33 subjects at baseline, 1 month, 3 months, and 6 months. Results demonstrated a significant relationship between baseline R/S level and retention at 6 months, while R/S levels were unchanged during the course of treatment. Notably, no relationship was found between self-reported religious affiliation and retention. This study demonstrates that patients’ R/S level, rather than religious affiliation, is a possible predictor for better outcome at faith-based residential centers for substance-related disorders. PMID:22460083

  3. Treatment for preventing tuberculosis in children and adolescents: a randomized clinical trial of a 3-month, 12-dose regimen of a combination of rifapentine and isoniazid.

    PubMed

    Villarino, M Elsa; Scott, Nigel A; Weis, Stephen E; Weiner, Marc; Conde, Marcus B; Jones, Brenda; Nachman, Sharon; Oliveira, Ricardo; Moro, Ruth N; Shang, Nong; Goldberg, Stefan V; Sterling, Timothy R

    2015-03-01

    Three months of a once-weekly combination of rifapentine and isoniazid for treatment of latent tuberculosis infection is safe and effective for persons 12 years or older. Published data for children are limited. To compare treatment safety and assess noninferiority treatment effectiveness of combination therapy with rifapentine and isoniazid vs 9 months of isoniazid treatment for latent tuberculosis infection in children. A pediatric cohort nested within a randomized, open-label clinical trial conducted from June 11, 2001, through December 17, 2010, with follow-up through September 5, 2013, in 29 study sites in the United States, Canada, Brazil, Hong Kong (China), and Spain. Participants were children (aged 2-17 years) who were eligible for treatment of latent tuberculosis infection. Twelve once-weekly doses of the combination drugs, given with supervision by a health care professional, for 3 months vs 270 daily doses of isoniazid, without supervision by a health care professional, for 9 months. We compared rates of treatment discontinuation because of adverse events (AEs), toxicity grades 1 to 4, and deaths from any cause. The equivalence margin for the comparison of AE-related discontinuation rates was 5%. Tuberculosis disease diagnosed within 33 months of enrollment was the main end point for testing effectiveness. The noninferiority margin was 0.75%. Of 1058 children enrolled, 905 were eligible for evaluation of effectiveness. Of 471 in the combination-therapy group, 415 (88.1%) completed treatment vs 351 of 434 (80.9%) in the isoniazid-only group (P = .003). The 95% CI for the difference in rates of discontinuation attributed to an AE was -2.6 to 0.1, which was within the equivalence range. In the safety population, 3 of 539 participants (0.6%) who took the combination drugs had a grade 3 AE vs 1 of 493 (0.2%) who received isoniazid only. Neither arm had any hepatotoxicity, grade 4 AEs, or treatment-attributed death. None of the 471 in the combination

  4. Water quality criteria for hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX)

    SciTech Connect

    Etnier, E.L.

    1989-04-01

    The occurrence of the munitions compound hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) in groundwater surrounding Army ammunition plants may result in contamination of local drinking water supplies. RDX exerts its primary toxic effect in humans on the central nervous system, but also involves gastrointestinal and renal effects. Symptomatic effects following acute exposure include hyperirritability, nausea, vomiting, generalized epileptiform seizures, and prolonged postictal confusion and amnesia. Health effects data were analyzed for RDX, and although no controlled human studies exist concerning the acute or chronic toxic effects of exposure to RDX, sufficient animal toxicity data are available to derive an ambient water quality criterion for the protection of human health. This paper summarizes the available literature on metabolism of RDX and human and animal toxicity. Based on noncarcinogenic mammalian toxicity data, and following the methodologies of the U.S. Environmental Protection Agency, an ambient water quality criterion for the protection of human health of 103 micrograms/liter is proposed for ingestion of drinking water and aquatic foodstuffs. A criterion of 105 micrograms/liter is proposed for ingestion of drinking water alone.54 references.

  5. Water quality criteria for hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX).

    PubMed

    Etnier, E L

    1989-04-01

    The occurrence of the munitions compound hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) in groundwater surrounding Army ammunition plants may result in contamination of local drinking water supplies. RDX exerts its primary toxic effect in humans on the central nervous system, but also involves gastrointestinal and renal effects. Symptomatic effects following acute exposure include hyperirritability, nausea, vomiting, generalized epileptiform seizures, and prolonged postictal confusion and amnesia. Health effects data were analyzed for RDX, and although no controlled human studies exist concerning the acute or chronic toxic effects of exposure to RDX, sufficient animal toxicity data are available to derive an ambient water quality criterion for the protection of human health. This paper summarizes the available literature on metabolism of RDX and human and animal toxicity. Based on noncarcinogenic mammalian toxicity data, and following the methodologies of the U.S. Environmental Protection Agency, an ambient water quality criterion for the protection of human health of 103 micrograms/liter is proposed for ingestion of drinking water and aquatic foodstuffs. A criterion of 105 micrograms/liter is proposed for ingestion of drinking water alone.

  6. [Effect of botulinum toxin A injection in the treatment of gastrocnemius spasticity in children aged 9-36 months with cerebral palsy: a prospective study].

    PubMed

    Zhu, Deng-Na; Wang, Ming-Mei; Wang, Jun; Zhang, Wei; Li, He-Zhou; Yang, Po; Xiong, Hua-Chun; Niu, Guo-Hui; Li, San-Song; Zhao, Yun-Xia

    2016-02-01

    To investigate the long-term clinical efficacy and adverse effects of botulinum toxin-A (BTX-A) injection in the treatment of gastrocnemius spasticity in children aged 9-36 months with cerebral palsy. Eighty children aged 9-36 months with cerebral palsy and gastrocnemius spasticity were selected and randomly divided into a BTX-A injection group and a conventional treatment group (n=40 each). The children in the BTX-A injection group received injections of BTX-A guided by color Doppler ultrasound and 4 courses of rehabilitation training after injection. Those in the conventional treatment group received 4 courses of the same rehabilitation training alone. Before treatment and at 1, 2, 3, and 6 months after treatment, the modified Tardieu scale (MTS) was applied to assess the degree of gastrocnemius spasticity, the values in the passive state measured by surface electromyography (sEMG) were applied to evaluate muscle tension, and the Gross Motor Function Measure (GMFM) was used to evaluate gross motor function. Compared with the conventional treatment group, the BTX-A injection group had significantly greater reductions in MTS score and the values in the passive state measured by sEMG (P<0.05), as well as significantly greater increases in joint angles R1 and R2 in MTS and gross motor score in GMFM (P<0.05). No serious adverse reactions related to BTX-A injection were found. BTX-A injection is effective and safe in the treatment of gastrocnemius spasticity in children aged 9-36 months with cerebral palsy.

  7. Muscle strength and function of shoulders with Bankart lesion after successful arthroscopic treatment: interlimb comparison 24 months after surgery.

    PubMed

    Tahta, Mesut; Akmeşe, Ramazan; Özberk, Zekiye Nisa; Coşkun, Ozlem Oner; Işik, Çetin; Korkusuz, Feza; Bozkurt, Murat

    2013-12-01

    The purpose of this study was to examine outcomes following arthroscopic Bankart repair with the focus on strength after the repair. 56 shoulders with Bankart lesion were operated on arthroscopically. Gender, mechanism of the first dislocation, number of dislocations, dominant side, operated side and the number of anchors used for surgery were recorded. DASH and Oxford instability scoring systems were applied preoperatively and compared to scores at the 24-month follow-up. The scoring systems were also applied to contralateral shoulders at the 24th month of follow-up. Range of motion was measured with a goniometer. Muscle strength was analyzed with a dynamometer simultaneously with the muscle activity of four perishoulder muscles. The data were recorded with surface EMG. Range of motion, muscle strength and activity were evaluated according to the contralateral shoulder at the 24th month of follow-up. Male/female ratio was 42/14 with a mean age of 32 years. The mean number of dislocations was 3 ± 1 and all were traumatic dislocations. The number of mean anchors used was 3.1 and the mean follow-up period was 24 months. In clinical evaluation, the preoperative and postoperative results of the DASH and Oxford instability scores of the unstable shoulders were significantly different. In the comparison between the operated and contralateral shoulders, there was no significant difference in DASH and Oxford instability scores at the 24th month of follow-up. There was no significant loss of range of motion. Only internal rotation strength was significantly reduced and there was no significant change in the EMG patterns. Although good clinical results can be achieved, internal rotation strength is reduced after arthroscopic surgery, but daily activities are not affected. There is no guarantee for patients of excellent recovery. Level III cohort study.

  8. Twelve-month prevalence and treatment gap for common mental disorders: Findings from a large-scale epidemiological survey in India.

    PubMed

    Sagar, Rajesh; Pattanayak, Raman Deep; Chandrasekaran, R; Chaudhury, Pranit K; Deswal, Balbir S; Lenin Singh, R K; Malhotra, Savita; Nizamie, S Haque; Panchal, Bharat N; Sudhakar, T P; Trivedi, J K; Varghese, Mathew; Prasad, Jagdish; Chatterji, Somnath

    2017-01-01

    Common mental disorders, such as mood, anxiety, and substance use disorders, are significant contributors to disability globally, including India. Available research is, however, limited by methodological issues and heterogeneities. The present paper focuses on the 12-month prevalence and 12-month treatment for anxiety, mood, and substance use disorders in India. As part of the World Health Organization World Mental Health (WMH) Survey Initiative, in India, the study was conducted at eleven sites. However, the current study focuses on the household sample of 24,371 adults (≥18 years) of eight districts of different states, covering rural and urban areas. Respondents were interviewed face-to-face using the WMH Composite International Diagnostic Interview after translation and country-specific adaptations. Diagnoses were generated as per the International Classification of Diseases, 10(th) edition, Diagnostic Criteria for Research. Nearly 49.3% of the sample included males. The 12-month prevalence of common mental disorders was 5.52% - anxiety disorders (3.41%), mood disorders (1.44%), and substance use disorders (1.18%). Females had a relatively higher prevalence of anxiety and mood disorders, and lower prevalence of substance use disorders than males. The 12-month treatment for people with common mental disorders was 5.09% (range 1.66%-11.55% for individual disorders). The survey revealed a huge treatment gap of 95%, with only 5 out of 100 individuals with common mental disorders receiving any treatment over the past year. The survey provides valuable data to understand the mental health needs and treatment gaps in the Indian population. Despite the 12-month prevalence study being restricted to selected mental disorders, these estimates are likely to be conservative due to under-reporting or inadequate detection due to cultural factors.

  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. A randomised controlled out-patient trial of cognitive-behavioural treatment for children and adolescents with depression: 9-month follow-up.

    PubMed

    Vostanis, P; Feehan, C; Grattan, E; Bickerton, W L

    1996-09-09

    Nine-month outcome data of a randomized controlled out-patient trial of cognitive-behavioural treatment (CBT) for children and adolescents with depression are presented. CBT was compared with a non-focussed intervention (NFI) in 56 subjects. At 9 months after thr termination of the trial, 21 children (37.5%) fulfilled criteria for a psychiatric disorder (DSM-III-R), out of whom 15 (26.8%) had a depressive illness. However, 25 subjects (45%) reported depressive symptoms of significant severity to suggest a depressive episode during the previous 9-month period. Both treatment groups maintained a significant improvement on all psychosocial measures since the post-treatment assessment. No significant treatment effect was established. Low self-esteem at the time of referral, predicted presence of psychiatric disorder, and child-reported scores of depressive symptoms and low self-esteem at follow-up. The research and clinical implications for the treatment of depressive disorders in young life are discussed.

  11. Treatment of post-traumatic stress disorder with eye movement desensitization and reprocessing: outcome is stable in 35-month follow-up.

    PubMed

    Högberg, Göran; Pagani, Marco; Sundin, Orjan; Soares, Joaquim; Aberg-Wistedt, Anna; Tärnell, Berit; Hällström, Tore

    2008-05-30

    Post-traumatic stress disorder (PTSD) is an anxiety disorder that may follow major psychological trauma. The disorder is longstanding, even chronic, and there is a need for effective treatment. The most effective short-term treatments are cognitive behavioural therapy and eye movement desensitization and reprocessing (EMDR). Twenty subjects with chronic PTSD following occupational health hazards from "person under train" accidents or assault at work were treated with five sessions of EMDR. They were assessed with psychometric scales and diagnostic interviews before treatment, directly after treatment, at 8 months, and at 35 months after the end of Therapy. The primary outcome variable was full diagnosis of PTSD according to the DSM-IV diagnostic criteria. Results from interview-based and self-evaluation psychometric scales were used as secondary outcome variables. Immediately following treatment, the patients were divided up into two groups, initial remitters (12 of 20) and non-remitters (8 of 20). There were no drop-outs during therapy, but three patients withdrew during follow-up. The initial result was maintained at the 35-month follow-up. The secondary outcome variables also showed a significant immediate change towards normality that was stable during the long-term follow-up. After 3 years of follow-up, 83% of the initial remitters had full working capacity.

  12. [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.

  13. Treatment of fibromyalgia at the Maharishi Ayurveda Health Centre in Norway II--a 24-month follow-up pilot study.

    PubMed

    Rasmussen, Lars Bjørn; Mikkelsen, Knut; Haugen, Margaretha; Pripp, Are H; Fields, Jeremy Z; Førre, Øystein T

    2012-05-01

    Treatments offered at the Maharishi Ayurveda Health Centre in Norway are based on Maharishi Vedic Medicine (MVM). MVM is a consciousness-based revival by Maharishi Mahesh Yogi, the founder of the Transcendental Meditation (TM) program of the ancient Ayurvedic medicine tradition in India. To extend from 6 to 24 months, a pilot study of the effects of the treatment program at the Health Centre on fibromyalgia. Retesting 2 years after a clinical trial. In this intention to treat study, 31 women with a diagnosis of fibromyalgia received an individually tailored program of (1) physiological purification therapy (Maharishi Panchakarma) and (2) Ayurvedic recommendations regarding daily routine and diet including a novel approach to food intolerance. Five subjects chose to learn TM for stress reduction, pain management and personal development. All were recommended Ayurvedic herbal products for follow-up treatment. A modified Fibromyalgia Impact Questionnaire (FIQ) that included seven dimensions. Scores at 24 months follow-up were compared with pre-treatment scores. At 24-months follow-up, there were significant reductions (26% to 44%) in six of the seven fibromyalgia dimensions: impairment of working ability, pain, tiredness, morning tiredness, stiffness and anxiety. The 7th, depression, decreased 32% (borderline significant). At 24 months, the four subjects who continued practising TM, had almost no symptoms and significantly lower FIQ change scores (-92% to 97%) than the non-meditators on all outcomes. This pilot study suggests that the treatments and health promotion programs offered at the Maharishi Ayurveda Health Centre in Norway lead to long-term reductions in symptoms of fibromyalgia, which is considered a treatment-resistant condition, and further studies are warranted.

  14. Effect of Bone Marrow-Derived Mononuclear Cell Treatment, Early or Late After Acute Myocardial Infarction: Twelve Months CMR and Long-Term Clinical Results.

    PubMed

    Sürder, Daniel; Manka, Robert; Moccetti, Tiziano; Lo Cicero, Viviana; Emmert, Maximilian Y; Klersy, Catherine; Soncin, Sabrina; Turchetto, Lucia; Radrizzani, Marina; Zuber, Michel; Windecker, Stephan; Moschovitis, Aris; Bühler, Ines; Kozerke, Sebastian; Erne, Paul; Lüscher, Thomas F; Corti, Roberto

    2016-07-22

    Intracoronary delivery of autologous bone marrow-derived mononuclear cells (BM-MNC) may improve remodeling of the left ventricle (LV) after acute myocardial infarction (AMI). To demonstrate long-term efficacy of BM-MNC treatment after AMI. In a multicenter study, we randomized 200 patients with large AMI in a 1:1:1 pattern into an open-labeled control and 2 BM-MNC treatment groups. In the BM-MNC groups, cells were either administered 5 to 7 days (early) or 3 to 4 weeks (late) after AMI. Cardiac magnetic resonance imaging was performed at baseline and after 12 months. The current analysis investigates the change from baseline to 12 months in global LV ejection fraction, LV volumes, scar size, and N-terminal pro-brain natriuretic peptide values comparing the 2 treatment groups with control in a linear regression model. Besides the complete case analysis, multiple imputation analysis was performed to address for missing data. Furthermore, the long-term clinical event rate was computed. The absolute change in LV ejection fraction from baseline to 12 months was -1.9±9.8% for control (mean±SD), -0.9±10.5% for the early treatment group, and -0.7±10.1% for the late treatment group. The difference between the groups was not significant, both for complete case analysis and multiple imputation analysis. A combined clinical end point occurred equally in all the groups. Overall, 1-year mortality was low (2.25%). Among patients with AMI and LV dysfunction, treatment with BM-MNC either 5 to 7 days or 3 to 4 weeks after AMI did not improve LV function at 12 months, compared with control. The results are limited by an important drop out rate. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00355186. © 2016 American Heart Association, Inc.

  15. In vivo reference point indentation reveals positive effects of raloxifene on mechanical properties following 6 months of treatment in skeletally mature beagle dogs.

    PubMed

    Aref, Mohammad; Gallant, Maxime A; Organ, Jason M; Wallace, Joseph M; Newman, Christopher L; Burr, David B; Brown, Drew M; Allen, Matthew R

    2013-10-01

    Raloxifene treatment has been shown previously to positively affect bone mechanical properties following 1 year of treatment in skeletally mature dogs. Reference point indentation (RPI) can be used for in vivo assessment of mechanical properties and has been shown to produce values that are highly correlated with properties derived from traditional mechanical testing. The goal of this study was to use RPI to determine if raloxifene-induced alterations in mechanical properties occurred after 6 months of treatment. Twelve skeletally mature female beagle dogs were treated for 6 months with oral doses of saline vehicle (VEH, 1 ml/kg/day) or a clinically relevant dose of raloxifene (RAL, 0.5 mg/kg/day). At 6 months, all animals underwent in vivo RPI (10N force, 10 cycles) of the anterior tibial midshaft. RPI data were analyzed using a custom MATLAB program, designed to provide cycle-by-cycle data from the RPI test and validated against the manufacturer-provided software. Indentation distance increase (IDI), a parameter that is inversely related to bone toughness, was significantly lower in RAL-treated animals compared to VEH (-16.5%), suggesting increased bone toughness. Energy absorption within the first cycle was significantly lower with RAL compared to VEH (-21%). These data build on previous work that has documented positive effects of raloxifene on material properties by showing that these changes exist after 6 months.

  16. In vivo reference point indentation reveals positive effects of raloxifene on mechanical properties following 6 months of treatment in skeletally mature beagle dogs

    PubMed Central

    Aref, Mohammad; Gallant, Maxime A.; Organ, Jason M.; Wallace, Joseph M; Newman, Christopher L.; Burr, David B.; Brown, Drew M.; Allen, Matthew R.

    2013-01-01

    Raloxifene treatment has been shown previously to positively affect bone mechanical properties following 1 year of treatment in skeletally mature dogs. Reference point indentation (RPI) can be used for in vivo assessment of mechanical properties and has been shown to produce values that are highly correlated with properties derived from traditional mechanical testing. The goal of this study was to use RPI to determine if raloxifene-induced alterations in mechanical properties occurred after 6 months of treatment. Twelve skeletally mature female beagle dogs were treated for 6 months with oral doses of saline vehicle (VEH, 1 ml/kg/day) or a clinically relevant dose of raloxifene (RAL, 0.5 mg/kg/day). At 6 months, all animals underwent in vivo RPI (10 N force, 10 cycles) of the anterior tibial midshaft. RPI data were analyzed using a custom MATLAB program, designed to provide cycle-by-cycle data from the RPI test and validated against the manufacturer-provided software. Indentation distance increase (IDI), a parameter that is inversely related to bone toughness, was significantly lower in RAL-treated animals compared to VEH (− 16.5%), suggesting increased bone toughness. Energy absorption within the first cycle was significantly lower with RAL compared to VEH (− 21%). These data build on previous work that has documented positive effects of raloxifene on material properties by showing that these changes exist after 6 months. PMID:23871851

  17. Long-term efficacy and tolerability of 4-monthly versus yearly botulinum toxin type A treatment for lower-limb spasticity in children with cerebral palsy.

    PubMed

    Kanovský, Petr; Bares, Martin; Severa, Stanislav; Richardson, Alan

    2009-06-01

    In this study, we compared the long-term efficacy and tolerability of two dosage regimens of the potent botulinum toxin type A (BoNT-A; Dysport; Ipsen Ltd, Slough, UK) in children with cerebral palsy (CP) and lower-limb spasticity. Children aged 1 to 8 years with diplegic CP who were able to walk (aided or unaided) were randomized (1:1) to 30 LD(50) units/kg total body weight of BoNT-A (injected into gastrocnemius muscles) every 4 months or once yearly for 2 years in this multicentre, assessor-blinded, parallel-group study. In the 4-monthly group (n=110, 39 males, 71 females), mean age was 3 years 8 months (SD 1 y 6 mo, range 1-8 y). In the yearly group (n=104, 47 males, 57 females), mean age was 4 years 4 months (SD 1 y 6 mo, range 2-8 y). Both treatment groups had similar baseline Gross Motor Function Measure scores. At month 28 (primary endpoint; intention-to-treat group), median maximum passive ankle dorsiflexion was 12.00 degrees in the 4-monthly and 11.00 degrees in the yearly group. Between-group difference of 1.67 degrees was not statistically significant (p=0.055). Other efficacy endpoints showed no significant difference between the regimens. The results of the study do not allow a clear conclusion of the preferred injection regimen.

  18. Transformation of hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) by permanganate.

    PubMed

    Chokejaroenrat, Chanat; Comfort, Steve D; Harris, Clifford E; Snow, Daniel D; Cassada, David; Sakulthaew, Chainarong; Satapanajaru, Tunlawit

    2011-04-15

    The chemical oxidant permanganate (MnO(4)(-)) has been shown to effectively transform hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) at both the laboratory and field scales. We treated RDX with MnO(4)(-) with the objective of quantifying the effects of pH and temperature on destruction kinetics and determining reaction rates. A nitrogen mass balance and the distribution of reaction products were used to provide insight into reaction mechanisms. Kinetic experiments (at pH ∼ 7, 25 °C) verified that RDX-MnO(4)(-) reaction was first-order with respect to MnO(4)(-) and initial RDX concentration (second-order rate: 4.2 × 10(-5) M(-1) s(-1)). Batch experiments showed that choice of quenching agents (MnSO(4), MnCO(3), and H(2)O(2)) influenced sample pH and product distribution. When MnCO(3) was used as a quenching agent, the pH of the RDX-MnO(4)(-) solution was relatively unchanged and N(2)O and NO(3)(-) constituted 94% of the N-containing products after 80% of the RDX was transformed. On the basis of the preponderance of N(2)O produced under neutral pH (molar ratio N(2)O/NO(3) ∼ 5:1), no strong pH effect on RDX-MnO(4)(-) reaction rates, a lower activation energy than the hydrolysis pathway, and previous literature on MnO(4)(-) oxidation of amines, we propose that RDX-MnO(4)(-) reaction involves direct oxidation of the methylene group (hydride abstraction), followed by hydrolysis of the resulting imides, and decarboxylation of the resulting carboxylic acids to form N(2)O, CO(2), and H(2)O.

  19. Baseline characteristics and treatment patterns of patients with schizophrenia initiated on once-every-three-months paliperidone palmitate in a real-world setting.

    PubMed

    Joshi, Kruti; Lafeuille, Marie-Hélène; Brown, Brianne; Wynant, Willy; Emond, Bruno; Lefebvre, Patrick; Tandon, Neeta

    2017-10-01

    Since May 2015, adult patients with schizophrenia adequately treated with once monthly paliperidone palmitate (PP1M) may be transitioned to once-every-three-months paliperidone palmitate (PP3M). This study aims to describe baseline characteristics and treatment patterns of patients with schizophrenia initiated on PP3M in a real-world setting. Pharmacy and medical claims from May 2014 to September 2016 for adult patients with schizophrenia initiated on PP3M (index date) in the Symphony Health Solutions database were analyzed. The cohort consisting of all patients and the one restricted to those transitioning from PP1M as per prescribing guideline recommendations were considered. Baseline characteristics were assessed during the 12 month baseline period. PP1M treatment patterns, proportion of days covered (PDC) by mental-health-related medications, and healthcare resource utilization (HRU) patterns were evaluated for each baseline quarter. PP3M treatment patterns were assessed post-index. Among the 1545 adult patients initiated on PP3M who formed the first cohort, 68.8% transitioned from PP1M based on prescribing guidelines and on an adaptation of the strict clinical trial protocol for PP1M to PP3M transition, forming the second cohort. In both cohorts, the proportion of patients with a PDC ≥80% for antipsychotics, antidepressants, anxiolytics, and mood stabilizers increased while the proportion of patients with ≥1 emergency room, inpatient, or outpatient visit decreased in baseline quarters closer to PP3M initiation. Among patients with ≥4 months of follow-up after the first dose, 85-88% had a second dose. Similarly, among those with ≥4 months of follow-up after the second dose, 87-90% received a third dose. Patients initiated on PP3M demonstrated decreased HRU and increased adherence in quarters closer to PP3M initiation, and were persistent on their PP3M treatment.

  20. 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

  1. Separation of 1,3,5,7-tetranitro-1,3,5,7-tetraazacyclooctane and 1,3,5-trinitro-1,3,5- triazacyclohexane by molecularly imprinted solid-phase extraction.

    PubMed

    Wang, Jian; Meng, Zi-Hui; Xue, Min; Qiu, Li-Li; Zhang, Chen-Fan

    2017-03-01

    Synthesis of 1,3,5,7-tetranitro-1,3,5,7-tetraazacyclooctane and 1,3,5-trinitro-1,3,5-triazacyclohexane by the Bachmann process leads to a mixture of both. The separation of 1,3,5,7-tetranitro-1,3,5,7-tetraazacyclooctane and 1,3,5-trinitro-1,3,5-triazacyclohexane from their mixture is difficult because the sizes and physical properties of these homologous compounds are similar. For this purpose, seven molecularly imprinted polymers have been synthesized for each explosive, and a selective solid-phase extraction procedure has been developed. A molecularly imprinted polymer, synthesized with 1,3,5,7-tetranitro-1,3,5,7-tetraazacyclooctane as the template, methacrylic acid as the monomer and trimethylolpropane trimethacrylate as the cross-linking agent in a molar ratio of 1:8:8 showed the best separation capability. A packed cartridge containing this polymer can be reused for 23 solid-phase extraction cycles without repacking, and the total separation capability toward 1,3,5,7-tetranitro-1,3,5,7-tetraazacyclooctane reached 6.81 mg per gram of polymer. 1,3,5-Trinitro-1,3,5-triazacyclohexane was not detected in the separated 1,3,5,7-tetranitro-1,3,5,7-tetraazacyclooctane by high-performance liquid chromatography and vice versa. This newly developed method had the advantages of high recovery (100%) and purity, environmental friendliness, and room temperature operability. This study showed that some molecularly imprinted polymers that cannot absorb target analytes well in the solvent in which the polymers were polymerized might have high-binding capacity for the analytes and show imprinting effects in other solvents.

  2. 45 CFR 1210.3-5 - Preparation for appeal.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Preparation for appeal. 1210.3-5 Section 1210.3-5... Termination § 1210.3-5 Preparation for appeal. (a) Entitlement to Representation. A Volunteer may be... because of conflict of position. (b) Time for Preparation and Presentation. (1) A...

  3. 45 CFR 1210.3-5 - Preparation for appeal.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 4 2012-10-01 2012-10-01 false Preparation for appeal. 1210.3-5 Section 1210.3-5... Termination § 1210.3-5 Preparation for appeal. (a) Entitlement to Representation. A Volunteer may be... because of conflict of position. (b) Time for Preparation and Presentation. (1) A...

  4. 45 CFR 1210.3-5 - Preparation for appeal.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 4 2013-10-01 2013-10-01 false Preparation for appeal. 1210.3-5 Section 1210.3-5... Termination § 1210.3-5 Preparation for appeal. (a) Entitlement to Representation. A Volunteer may be... because of conflict of position. (b) Time for Preparation and Presentation. (1) A...

  5. Endodontic Treatment of a Maxillary Lateral Incisor with Two Roots; A Case Report with 6 Months Follow-Up

    PubMed Central

    Hoseini, Atefeh; Abbaszadegan, Abbas

    2014-01-01

    Maxillary lateral incisors are widely known to be single rooted with one root canal. Although rare cases with root canal variations are being reported in many populations, the reports regarding Iranian population is extremely limited. In this report, we are presenting the endodontic treatment of a double rooted maxillary lateral incisor. These rare root-canal variations should be considered in pretreatment evaluations by clinicians who perform endodontic treatments. PMID:25469361

  6. Computerized tomography-guided sphenopalatine ganglion pulsed radiofrequency treatment in 16 patients with refractory cluster headaches: Twelve- to 30-month follow-up evaluations.

    PubMed

    Fang, Luo; Jingjing, Lu; Ying, Shen; Lan, Meng; Tao, Wang; Nan, Ji

    2016-02-01

    Sphenopalatine ganglion percutaneous radiofrequency thermocoagulation treatment can improve the symptoms of cluster headaches to some extent. However, as an ablation treatment, radiofrequency thermocoagulation treatment also has side effects. To preliminarily evaluate the efficacy and safety of a non-ablative computerized tomography-guided pulsed radiofrequency treatment of sphenopalatine ganglion in patients with refractory cluster headaches. We included and analysed 16 consecutive cluster headache patients who failed to respond to conservative therapy from the Pain Management Center at the Beijing Tiantan Hospital between April 2012 and September 2013 treated with pulsed radiofrequency treatment of sphenopalatine ganglion. Eleven of 13 episodic cluster headaches patients and one of three chronic cluster headaches patient were completely relieved of the headache within an average of 6.3 ± 6.0 days following the treatment. Two episodic cluster headache patients and two chronic cluster headache patients showed no pain relief following the treatment. The mean follow-up time was 17.0 ± 5.5 months. All patients enrolled in this study showed no treatment-related side effects or complications. Our data show that patients with refractory episodic cluster headaches were quickly, effectively and safely relieved from the cluster period after computerized tomography-guided pulsed radiofrequency treatment of sphenopalatine ganglion, suggesting that it may be a therapeutic option if conservative treatments fail. © International Headache Society 2015.

  7. 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

  8. The Effects of Six-Month L-Thyroxine Treatment on Cognitive Functions and Event-Related Brain Potentials in Children with Subclinical Hypothyroidism

    PubMed Central

    Sangün, Özlem; Demirci, Serpil; Dündar, Nihal; Pirgon, Özgür; Koca, Tuğba; Doğan, Melike; Dündar, Bumin

    2015-01-01

    Objective: The aim of this study was to investigate the cognitive status of children with subclinical hypothyroidism (SH) before and after L-thyroxine (L-T4) treatment using event-related potentials (ERPs) and neuropsychological tests. Methods: This prospective study was conducted on a series of 20 children with mild SH (free T4 normal and thyroid-stimulating hormone level within 5-10 µIU/L) who underwent clinical and cognitive assessment before L-T4 treatment and 6 months afterwards. The recordings of ERPs were done at the time of diagnosis and after 6 months of euthyroid state. Neuropsychiatric tests for attention, perception, close and remote memory were performed on all patients and on the control group which consisted of 20 healthy children of normal intelligence. Results: While pretreatment verbal memory (VM) and verbal recall (VR) scores of the SH group were significantly lower than those of the control group (p=0.004 and 0.012, respectively), no significant differences between the post-treatment and control groups were found in these scores after 6 months of L-T4 treatment. Post-treatment VM and VR scores were significantly higher than the pretreatment scores in the SH group (p=0.008 and p=0.0001). There were no significant differences between the pre-and post-treatment values of electrophysiological evaluation in N1, P2, P3 latencies or P3 amplitude (p>0.05), although there was a significant decrease in N2 latency in the post-treatment group (p=0.03). Conclusion: SH affects cognition in children and L-T4 replacement therapy leads to normalization of cognitive functions. Neuropsychological tests can be used as complementary measures in the evaluation of children with SH. Determining the association between ERPs and SH would contribute to the comprehensive evaluation of these children. PMID:26316431

  9. Sleep in children with attention-deficit/hyperactivity disorder (ADHD) before and after 6-month treatment with methylphenidate: a pilot study.

    PubMed

    Vigliano, Piernanda; Galloni, Giovanni Battista; Bagnasco, Irene; Delia, Giuliana; Moletto, Alessandra; Mana, Mauro; Cortese, Samuele

    2016-05-01

    Children with ADHD may present with sleep disturbances that add to the impairment of the disorder. The long-term sleep effects of the first-line pharmacological treatment for ADHD, i.e., psychostimulants, are unclear. In this pilot study, we compared polysomnographic variables in children with ADHD (n = 11, aged 6-15 years), before pharmacological treatment, and in children without ADHD (n = 22, aged 5-14 years); we also assessed polysomnographic changes in children with ADHD (n = 7) after a 6-month treatment with methylphenidate immediate-release (once or twice daily). Compared to children without ADHD, those with ADHD at baseline presented with significantly increased duration of awakenings (p = 0.02), reduction in sleep efficiency (p = 0.03), and increase in stage I (N1) (p < 0.01) and reduction in stage II (N2) (p = 0.02) and stage III-IV (N3) percentages. Methylphenidate treatment did not significantly change any parameter of sleep architecture. Preliminary evidence from this pilot study shows that, compared to children without ADHD, those with ADHD presented a more fragmented and less effective sleep at baseline and that the 6-month methylphenidate treatment did not further negatively impact on sleep architecture. • Children with ADHD may present with subjectively reported and/or objectively confirmed disturbances of sleep. • The long-term effects on sleep of the first-line pharmacological treatment for ADHD, i.e., psychostimulants, are not clear. What is new: • Our study showed that the 6-month continuous treatment with methylphenidate did not further negatively impact on sleep architecture in children with ADHD.

  10. 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.

  11. 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.

  12. After six months of anti-psychotic treatment: Is the improvement in mental health at the expense of physical health?

    PubMed

    Martín Otaño, Leire; Barbadillo Izquierdo, Laura; Galdeano Mondragón, Ander; Alonso Pinedo, Marta; Querejeta Ayerdi, Imanol

    2013-01-01

    The morbidity and mortality due to cardiovascular causes in patients with schizophrenia is higher than in the general population, a fact that has been observed more since second generation anti-psychotics came into general use. To determine the incidence of metabolic syndrome in patients with a previously untreated first psychotic episode, as well as the prospective changes in the parameters that define the criteria of metabolic syndrome. An observational study with a prospective cohort design including patients who were admitted to the Acute Unit of Donostia Hospital. A total of 21 patients were included in the study, of which 19 completed it. Just over one-quarter (26.3%) of the patients developed a metabolic syndrome at six months. Statistically significant differences were observed in the following parameters: 1) abdominal perimeter measurement with an increase of 14.6 cm at six months (P=.001); 2) triglyceride levels with a mean increase over the initial measurement of 48.99 mg/dl (P=.039); and 3) fasting blood glucose levels with a mean increase of 10.72 mg/dl (P=.001). Significant changes were observed in metabolic parameters in a short period with the subsequent risk of associated cardiovascular events in a group of young patients. Actions are required directed at ensuring appropriate monitoring of these patients in order to measures to minimise the risks. Copyright © 2012 SEP y SEPB. Published by Elsevier Espana. All rights reserved.

  13. Patients with Cheyne-Stokes respiration and heart failure: patient tolerance after three-month discontinuation of treatment with adaptive servo-ventilation.

    PubMed

    Hetland, Arild; Lerum, Tøri Vigeland; Haugaa, Kristina H; Edvardsen, Thor

    2017-02-11

    The recent SERVE HF study concluded that patients with chronic heart failure (CHF) and Cheyne-Stokes respiration (CSR) have increased mortality when treated with adaptive servo-ventilation (ASV). We, therefore, wanted to explore if these patients tolerated discontinuation of ASV treatment. The study was a prospective post-ASV treatment observational design with a 3-month follow-up period. 14 patients from our outpatient clinic, all male, were originally diagnosed with CHF and Cheyne-Stokes respiration, which is a clinical form of central sleep apnea. Left ventricular ejection fraction (LVEF) was ≤45% when ASV treatment was initiated. Median machine use was 68 (42-78) months when the patients were instructed to terminate ASV treatment. The patients were then followed during conventional CHF treatment for 3 months. Study baseline was set the last ASV treatment day. Sleep data were collected from the machine the last day of use. Apnea-hypopnea index (AHI), LVEF, 6-min walk test and 24-h ambulatory electrocardiogram recordings were performed at baseline and at study end. Life quality data were obtained using The Minnesota Living with Heart Failure Questionaire (MLHFQ). New York Heart Association Functional Classification (NYHA) was registered. An ambulatory sleep screening was performed at study end. AHI increased significantly after 3 months without ASV treatment [from 1.6 (0.8-3.2) to 39.2 (24.3-44.1, p = 0.001)]. Quality of life (QOL) decreased significantly: 30 (13-54) at discontinuation of ASV vs. 46 (24-67) (MLHFQ) at study end, p = 0.04. Though there was no significant change in NYHA functional class, patients especially reported increased shortness of breath, reduced concentration and reduced memory after discontinuation of ASV treatment. There were no significant differences in LVEF, heart rhythm data and physical capacity. Left ventricular function was preserved indicating that discontinuation of ASV in heart failure patients does not affect cardiac

  14. Surgical treatment of cholelithiasis and choledocholithiasis in a 2-month-old premature and low birth weight infant.

    PubMed

    Chang, Jeong Hwan; Kim, Kyung Jong; Moon, Kyung Rye

    2005-05-01

    Detection rates of cholelithiasis and choledocholithiasis in infants and children have increased since the introduction of ultrasonography, and surgical treatment is gradually tending to increase. However, for cholelithiasis and choledocholithiasis, controversies over etiology, diagnostic means, operation time, and operating method remain. Using ultrasonogram and magnetic resonance cholangiopancreatography (MRCP), we diagnosed cholelithiasis and choledocholithiasis in a premature and low birth weight infant who was admitted to the hospital with complaints of obstructive jaundice and alcoholic feces. We report the successful treatment of this infant by cholecystectomy and T-tube drainage.

  15. Monthly errors

    EPA Pesticide Factsheets

    The 2006 monthly average statistical metrics for 2m Q (g kg-1) domain-wide for the base and MODIS WRF simulations against MADIS observations. This dataset is associated with the following publication:Ran, L., J. Pleim, R. Gilliam, F. Binkowski, C. Hogrefe, and L. Band. Improved meteorology from an updated WRF/CMAQ modeling system with MODIS vegetation and albedo. JOURNAL OF GEOPHYSICAL RESEARCH-ATMOSPHERES. American Geophysical Union, Washington, DC, USA, 121(5): 2393-2415, (2016).

  16. The United Kingdom Infantile Spasms Study (UKISS) comparing hormone treatment with vigabatrin on developmental and epilepsy outcomes to age 14 months: a multicentre randomised trial.

    PubMed

    Lux, Andrew L; Edwards, Stuart W; Hancock, Eleanor; Johnson, Anthony L; Kennedy, Colin R; Newton, Richard W; O'Callaghan, Finbar J K; Verity, Christopher M; Osborne, John P

    2005-11-01

    Infantile spasms is a severe infantile seizure disorder that is difficult to treat and has a high morbidity. Absence of spasms on days 13 and 14 after randomisation is more common in infants allocated hormone treatments than in those allocated vigabatrin. We sought to assess whether early control of spasms is associated with improved developmental or epilepsy outcomes. Infants enrolled in the United Kingdom Infantile Spasms Study (UKISS) were randomly assigned hormone treatment (n=55) or vigabatrin (n=52) and were followed up until clinical assessment at 12-14 months of age. We assessed neurodevelopment with the Vineland adaptive behaviour scales (VABS) at 14 months of age on an intention to treat basis. Of 107 infants enrolled, five died and 101 survivors reached both follow-up assessments. Absence of spasms at final clinical assessment (hormone 41/55 [75%] vs vigabatrin 39/51 [76%]) was similar in each treatment group (difference 1.9%, 95% CI -18.3% to 14.4%; chi(2)=0.05; p=0.82). Mean VABS score did not differ significantly (hormone 78.6 [SD 16.8] vs vigabatrin 77.5 [SD 12.7]; difference 1.0, 95% CI -4.9 to 7.0; t(99)=0.35, p=0.73). In infants with no identified underlying aetiology, the mean VABS score was higher in those allocated hormone treatment than in those allocated vigabatrin (88.2 [17.3] vs 78.9 [14.3]; difference 9.3, 95% CI 1.2 to 17.3; t(95)=2.28, p=0.025). Hormone treatment controls spasms better than does vigabatrin initially, but not at 12-14 months of age. Better initial control of spasms by hormone treatment in those with no identified underlying aetiology may lead to improved developmental outcome.

  17. A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management: preliminary results of the impact of diet at 6 months--PREFER study.

    PubMed

    Burke, Lora E; Styn, Mindi A; Steenkiste, Ann R; Music, Edvin; Warziski, Melanie; Choo, Jina

    2006-11-01

    The PREFER study objectives were to examine potential differences in weight loss during a standard behavioral intervention between subjects assigned to one of two calorie- and fat-restricted diets [standard behavior treatment (SBT) and lacto-ovo-vegetarian ([SBT+LOV)], with or without regard to their preferred dietary treatment. This article reports the differences in outcomes between diet groups after the first 6 months of the intervention. The study used a four-group design. Subjects (n = 182) were randomized to a treatment preference group and then to a dietary treatment group. For this report, preference groups were combined to permit comparisons by dietary treatment only (SBT, n = 98; SBT+LOV, n = 84). Additional analyses compared SBT+LOV subjects who were 100% adherent (did not consume any meat, fish, or poultry, n = 47) to those who were <100% adherent (n = 24). Significant differences were seen in the baseline to 6-month change scores between the two groups for carbohydrate consumption (p = 0.013), protein consumption (p < 0.001), polyunsaturated-to-saturated fat ratio (p = 0.009), and low-density lipoprotein-cholesterol (LDL-C) level (p = 0.013). Among SBT+LOV subjects, those who were 100% adherent experienced greater reductions in weight (p < 0.001), total cholesterol (p = 0.026), LDL-C (p = 0.034), and glucose (p = 0.002) and consumed less fat (p = 0.030) compared with those who were <100% adherent. Differences between dietary treatment groups at 6 months were minimal, most likely because one-third of the SBT+LOV group did not follow the vegetarian diet and because both groups had the same calorie and fat restrictions. SBT+LOV subjects who were 100% adherent were more successful at both weight loss and cholesterol reduction than those who were <100% adherent, suggesting that vegetarian diets are efficacious for weight and cholesterol control.

  18. Suicide Behavior Before and After the Start with Antidepressants: A High Persistent Risk in the First Month of Treatment Among the Young.

    PubMed

    Termorshuizen, Fabian; Palmen, Saskia J M; Heerdink, Eibert R

    2015-07-18

    A causal relationship between antidepressants (ADs) and a high risk of suicidal behavior at a young age has been suggested. We analyzed the rates of suicide attempts during treatment with AD in comparison with the rates before treatment initiation for different ages. Claims of insurance company Achmea were linked to the population registry of Statistics Netherlands. Episodes of AD use were defined for those with their first registered prescription in 2006-2011 (n = 66,196). Rates were analyzed in a Poisson model. Correlates of attempts in the first month of AD use were assessed in a logistic model. Among those aged <25 years, a high rate of suicide attempts during the month before the start of ADs was found (376.3/10 000 person yrs). A non-significant increase in the first month (p = 0.212) was found and a non-significant trend to lower values was determined thereafter (p = 0.3050). Among those ≧ 25 years, a clear decrease to lower rates immediately after the start was observed (p < 0.025). The highest rates of suicide were found among those >40 years during the first month. Female gender was, but treatment characteristics were not, associated with early attempts at a young age. Among young AD users, a high pre-treatment risk of suicide attempts was present and persisted during the early phases after the start. This contrasted with the clear decrease in risk among those aged ≧ 25 years, suggesting lower effectiveness of ADs to prevent suicidal behavior at young ages. Caution should be exercised to infer a causal relationship or to use data on attempts to predict risk of suicide during AD use. © The Author 2015. Published by Oxford University Press on behalf of CINP.

  19. Six-month preoperative octreotide treatment in unselected, de novo patients with acromegaly: effect on biochemistry, tumour volume, and postoperative cure.

    PubMed

    Carlsen, Sven M; Svartberg, Johan; Schreiner, Thomas; Aanderud, Sylvi; Johannesen, Oivind; Skeie, Svein; Lund-Johansen, Morten; Fougner, Stine L; Bollerslev, Jens

    2011-06-01

    Treatment with somatostatin analogues is the primary medical treatment of acromegaly. Controversies still exist whether acute octreotide effect predicts long-term biochemical effects, tumour regression or surgical cure. This prospective study investigates effect of 6-month treatment with octreotide long-acting repeatable (LAR) on insulin-like growth factor-1 (IGF-1) and growth hormone (GH) levels, pituitary function, tumour regression and postoperative cure in de novo acromegalic patients. After a baseline evaluation including fasting hormone levels, MRI scan and an acute 50 μg octreotide test, 32 patients were treated with octreotide LAR 20 mg every 28th day for 6 months before surgery. Treatment effects on IGF-1 and GH levels, serum hormone levels and tumour volume were monitored. Surgical cure was evaluated 3 months postoperatively. Mean tumour volume reduction was 35%, in one-third of the patients more than 50%, while approximately one-third achieved biochemical remission evaluated by normalized IGF-1 levels. The GH reduction following an acute octreotide test was 81 ± 19% and associated with long-term GH reduction (r = 0·78, P < 0·0005). However, neither acute (r = 0·29, P = 0·12) nor the long-term octreotide effect (r = 0·11, P = 0·58) on GH levels was associated with tumour volume reduction and did not predict subsequent surgical cure. Six months of long-acting octreotide using a fixed dose, 1/3 of the patients came in biochemical remission, while 2/3 had significant tumour reduction. Moreover, an acute effect of octreotide seemed to be a prerequisite for long-term effect. © 2011 Blackwell Publishing Ltd.

  20. Rational emotive behavior therapy, cognitive therapy, and medication in the treatment of major depressive disorder: a randomized clinical trial, posttreatment outcomes, and six-month follow-up.

    PubMed

    David, Daniel; Szentagotai, Aurora; Lupu, Viorel; Cosman, Doina

    2008-06-01

    A randomized clinical trial was undertaken to investigate the relative efficacy of rational-emotive behavior therapy (REBT), cognitive therapy (CT), and pharmacotherapy in the treatment of 170 outpatients with nonpsychotic major depressive disorder. The patients were randomly assigned to one of the following: 14 weeks of REBT, 14 weeks of CT, or 14 weeks of pharmacotherapy (fluoxetine). The outcome measures used were the Hamilton Rating Scale for Depression and the Beck Depression Inventory. No differences among treatment conditions at posttest were observed. A larger effect of REBT (significant) and CT (nonsignificant) over pharmacotherapy at 6 months follow-up was noted on the Hamilton Rating Scale for Depression only.

  1. High (18)F-FDG uptake by the remaining adrenal gland four months after surgery and initiation of mitotane treatment in two patients with adrenocortical carcinoma.

    PubMed

    Mpanaka, Ioanna; Lyra, Vassiliki D; Kaltsas, Gregory; Chatziioannou, Sofia N

    2011-01-01

    Two men, one 42 and the other 35 years old were both subjected to adrenalectomy for adrenocortical carcinoma (ACC). Adjuvant treatment with mitotane [o,p΄-dichloro-diphenyl-dichloroethane, (o,p΄-DDD)], was initiated following surgery. Mitotane is the only agent available at present for treatment in ACC because of a late-onset specific adrenocortical cell toxicity. Both patients underwent a (18)F-FDG-PET/CT scan, which revealed 4 months after starting treatment with mitotane significantly high (18)F-FDG uptake in the contralateral adrenal gland. Both patients underwent magnetic resonance imaging, while one had a laparotomy, because of an abcess at the site of previous adrenalectomy. No metastasis or size increase of the remaining adrenal glands were found suggesting that their hypermetabolic state could be attributed to mitotane treatment. Beside its cytotoxic delayed-effect, mitotane has an early -onset effect on steroid metabolism. In conclusion, an abnormal high (18)F-FDG uptake was observed in the contralateral adrenal gland in both our adrenalectomized ACC patients, 4 months after starting mitotane treatment, probably related to mitotane's effect on steroid metabolism, not yet fully understood.

  2. Long-term efficacy and safety results of taliglucerase alfa up to 36 months in adult treatment-naïve patients with Gaucher disease.

    PubMed

    Zimran, Ari; Durán, Gloria; Mehta, Atul; Giraldo, Pilar; Rosenbaum, Hanna; Giona, Fiorina; Amato, Dominick J; Petakov, Milan; Muñoz, Eduardo Terreros; Solorio-Meza, Sergio Eduardo; Cooper, Peter A; Varughese, Sheeba; Chertkoff, Raul; Brill-Almon, Einat

    2016-07-01

    Taliglucerase alfa is an intravenous enzyme replacement therapy approved for treatment of type 1 Gaucher disease (GD), and is the first available plant cell-expressed recombinant therapeutic protein. Herein, we report long-term safety and efficacy results of taliglucerase alfa in treatment-naïve adult patients with GD. Patients were randomized to receive taliglucerase alfa 30 or 60 U/kg every other week, and 23 patients completed 36 months of treatment. Taliglucerase alfa (30 U/kg; 60 U/kg, respectively) resulted in mean decreases in spleen volume (50.1%; 64.6%) and liver volume (25.6%; 24.4%) with mean increases in hemoglobin concentration (16.0%; 35.8%) and platelet count (45.7%; 114.0%), and mean decreases in chitotriosidase activity (71.5%; 82.2%). All treatment-related adverse events were mild to moderate in intensity and transient. The most common adverse events were nasopharyngitis, arthralgia, upper respiratory tract infection, headache, pain in extremity, and hypertension. These 36-month results of taliglucerase alfa in treatment-naïve adult patients with GD demonstrate continued improvement in disease parameters with no new safety concerns. These findings extend the taliglucerase alfa clinical safety and efficacy dataset. www.clinicaltrials.gov identifier NCT00705939. Am. J. Hematol. 91:656-660, 2016. © 2016 Wiley Periodicals, Inc.

  3. 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

  4. 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

  5. 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

  6. REO Monthly

    SciTech Connect

    Walker, Howard Andrew

    2010-12-31

    A spreadsheet written in Microsoft Excel that evaluates combinations of renewable energy technologies at a site and identifies the combination that minimizes life cycle cost. Constraints on the optimization such as percent of energy from renewable, available land area; available investment capital, etc make the optimization more useful. Inputs to the model include building location, number of square feet and floors; monthly energy use and cost for electric and any other fuels. Outputs include size of each RE technology total investment, utility costs, O&M costs; percent renewable; life cycle cost; rate of return; CO2 savings.

  7. Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later.

    PubMed

    Madras, Bertha K; Compton, Wilson M; Avula, Deepa; Stegbauer, Tom; Stein, Jack B; Clark, H Westley

    2009-01-01

    Alcohol screening and brief interventions in medical settings can significantly reduce alcohol use. Corresponding data for illicit drug use is sparse. A Federally funded screening, brief interventions, referral to treatment (SBIRT) service program, the largest of its kind to date, was initiated by the Substance Abuse and Mental Health Services Administration (SAMHSA) in a wide variety of medical settings. We compared illicit drug use at intake and 6 months after drug screening and interventions were administered. SBIRT services were implemented in a range of medical settings across six states. A diverse patient population (Alaska Natives, American Indians, African-Americans, Caucasians, Hispanics), was screened and offered score-based progressive levels of intervention (brief intervention, brief treatment, referral to specialty treatment). In this secondary analysis of the SBIRT service program, drug use data was compared at intake and at a 6-month follow-up, in a sample of a randomly selected population (10%) that screened positive at baseline. Of 459,599 patients screened, 22.7% screened positive for a spectrum of use (risky/problematic, abuse/addiction). The majority were recommended for a brief intervention (15.9%), with a smaller percentage recommended for brief treatment (3.2%) or referral to specialty treatment (3.7%). Among those reporting baseline illicit drug use, rates of drug use at 6-month follow-up (4 of 6 sites), were 67.7% lower (p<0.001) and heavy alcohol use was 38.6% lower (p<0.001), with comparable findings across sites, gender, race/ethnic, age subgroups. Among persons recommended for brief treatment or referral to specialty treatment, self-reported improvements in general health (p<0.001), mental health (p<0.001), employment (p<0.001), housing status (p<0.001), and criminal behavior (p<0.001) were found. SBIRT was feasible to implement and the self-reported patient status at 6 months indicated significant improvements over baseline, for

  8. Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: Comparison at intake and six months

    PubMed Central

    Madras, Bertha K.; Compton, Wilson M.; Avula, Deepa; Stegbauer, Tom; Stein, Jack B.; Clark, H. Westley

    2009-01-01

    Objectives Alcohol screening and brief interventions in medical settings can significantly reduce alcohol use. Corresponding data for illicit drug use is sparse. A Federally funded Screening, Brief Intervention, Referral to Treatment (SBIRT) service program, the largest of its kind to date, was initiated by the Substance Abuse and Mental Health Services Administration (SAMHSA) in a wide variety of medical settings. We compared illicit drug use at intake and six months after drug screening and interventions were administered. Design SBIRT services were implemented in a range of medical settings across six states. A diverse patient population (Alaska Natives, American Indians, African-Americans, Caucasians, Hispanics), was screened and offered score-based progressive levels of intervention (brief intervention, brief treatment, referral to specialty treatment). In this secondary analysis of the SBIRT service program, drug use data was compared at intake and at a six month follow-up, in a sample of a randomly selected population (10%) that screened positive at baseline. Results Of 459,599 patients screened, 22.7% screened positive for a spectrum of use (risky/problematic, abuse/addiction). The majority were recommended for a brief intervention (15.9%), with a smaller percentage recommended for brief treatment (3.2%) or referral to specialty treatment (3.7%). Among those reporting baseline illicit drug use, rates of drug use at 6 month follow-up (4 of 6 sites), were 67.7% lower (p < 0.001) and heavy alcohol use was 38.6% lower (p < 0.001), with comparable findings across sites, gender, race/ethnic, age subgroups. Among persons recommended for brief treatment or referral to specialty treatment, self-reported improvements in general health (p < 0.001), mental health (p < 0.001), employment (p < 0.001), housing status (p < 0.001), and criminal behavior (p < 0.001) were found. Conclusions SBIRT was feasible to implement and the self-reported patient status at six months

  9. Comparison of treatment outcomes in severe personality disorder patients with or without substance use disorders: a 36-month prospective pragmatic follow-up study

    PubMed Central

    Lana, Fernando; Sánchez-Gil, Carmen; Adroher, Núria D; Pérez, Víctor; Feixas, Guillem; Martí-Bonany, Josep; Torrens, Marta

    2016-01-01

    Background Concurrent personality disorder (PD) and substance use disorder (SUD) are common in clinical practice. However, SUD is the main criterion for study exclusion in most psychotherapeutic studies of PD. As a result, data on treatment outcomes in patients with concurrent PD/SUD are scarce. Methods The study sample consisted of 51 patients diagnosed with severe PD and admitted for psychotherapeutic treatment as a part of routine mental health care. All patients were diagnosed with PD according to the Structured Clinical Interview for PD. Patients were further assessed (DSM-IV diagnostic criteria) to check for the presence of concurrent SUD, with 28 patients diagnosed with both disorders (PD-SUD). These 28 cases were then compared to the 23 patients without SUD (PD-nSUD) in terms of psychiatric hospitalizations and psychiatric emergency room (ER) visits before and during the 6-month therapeutic intervention and every 6 months thereafter for a total of 36 months. Results The baseline clinical characteristics correspond to a sample of PD patients (78% met DSM-IV criteria for borderline PD) with poor general functioning and a high prevalence of suicide attempts and self-harm behaviors. Altogether, the five outcome variables – the proportion and the number of psychiatric inpatient admissions, the number of days hospitalized, and the proportion and the number of psychiatric ER visits – improved significantly during the treatment period, and this improvement was maintained throughout the follow-up period. Although PD-SUD patients had more psychiatric hospitalizations and ER visits than PD-nSUD patients during follow-up, the differences between these two groups remained stable over the study period indicating that the treatment was equally effective in both groups. Conclusion Specialized psychotherapy for severe PD can be effectively applied in patients with concurrent PD-SUD under usual practice conditions. These findings suggest that exclusion of patients with

  10. Treatment and outcomes of an Australian cohort of outpatients with bipolar I or schizoaffective disorder over twenty-four months: implications for clinical practice

    PubMed Central

    2012-01-01

    Background The Bipolar Comprehensive Outcomes Study (BCOS) is a 2-year, prospective, non-interventional, observational study designed to explore the clinical and functional outcomes associated with ‘real-world’ treatment of participants with bipolar I or schizoaffective disorder. All participants received treatment as usual. There was no study medication. Methods Participants prescribed either conventional mood stabilizers (CMS; n = 155) alone, or olanzapine with, or without, CMS (olanzapine ± CMS; n = 84) were assessed every 3 months using several measures, including the Young Mania Rating Scale, 21-item Hamilton Depression Rating Scale, Clinical Global Impressions Scale – Bipolar Version, and the EuroQol Instrument. This paper reports 24-month longitudinal clinical, pharmacological, functional, and socioeconomic data. Results On average, participants were 42 (range 18 to 79) years of age, 58%; were female, and 73%; had a diagnosis of bipolar I. Polypharmacy was the usual approach to pharmacological treatment; participants took a median of 5 different psychotropic medications over the course of the study, and spent a median proportion of time of 100%; of the study on mood stabilizers, 90%; on antipsychotics, 9%; on antidepressants, and 5%; on benzodiazepines/hypnotics. By 24 months, the majority of participants had achieved both symptomatic and syndromal remission of both mania and depression. Symptomatic relapse rates were similar for both the CMS alone (65%;) and the olanzapine ± CMS (61%;) cohorts. Conclusions Participants with bipolar I or schizoaffective disorder in this study were receiving complex medication treatments that were often discordant with recommendations made in contemporary major treatment guidelines. The majority of study participants demonstrated some clinical and functional improvements, but not all achieved remission of symptoms or syndrome. PMID:23244301

  11. Polydeoxyribonucleotide Injection in the Treatment of Chronic Supraspinatus Tendinopathy: A Case-Controlled, Retrospective, Comparative Study With 6-Month Follow-Up.

    PubMed

    Yoon, Young Chun; Lee, Doo-Hyung; Lee, Michael Young; Yoon, Seung-Hyun

    2017-05-01

    To determine the efficacy of polydeoxyribonucleotide (PDRN) injection for rotator cuff disease (RCD). Case-controlled, retrospective, comparative study. Outpatient clinic at a university-affiliated tertiary care hospital. Patients (N=106) with chronic nontraumatic refractory RCD who were unresponsive to at least 1 month of conservative treatment: 55 patients received PDRN injection (PDRN group) and 51 continued conservative treatment (control group). Not applicable. Shoulder Pain and Disability Index, score on a visual analog scale of the average shoulder pain level, number of analgesic ingestions per day, isometric strength of shoulder abductor, active range of motion (flexion, abduction, internal rotation, external rotation), and maximal tear size of tendon on ultrasonography at pretreatment and 3 and 6 months postinjection. There was no significant difference between the 2 groups in terms of age, sex, shoulder affected, duration of symptoms, and ultrasonographic findings at pretreatment. Compared with the control group, the treatment group showed a significant improvement in Shoulder Pain and Disability Index, visual analog scale score, and number of analgesic ingestions per day. However, there was no difference in isometric strength, active range of motion, and maximal tear size of tendon. No adverse events were reported. To our knowledge, this is the first study to assess the efficacy of PDRN injection for patients with RCD. The PDRN injection group showed improvement in pain and subjective disability in patients with RCD and continued to show improvement for 3 months thereafter; the PDRN injection can be an optional treatment for patients with chronic RCD who show no response to other treatments. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  12. Mid-Treatment Sleep Duration Predicts Clinically Significant Knee Osteoarthritis Pain reduction at 6 months: Effects From a Behavioral Sleep Medicine Clinical Trial.

    PubMed

    Salwen, Jessica K; Smith, Michael T; Finan, Patrick H

    2017-02-01

    To determine the relative influence of sleep continuity (sleep efficiency, sleep onset latency, total sleep time [TST], and wake after sleep onset) on clinical pain outcomes within a trial of cognitive behavioral therapy for insomnia (CBT-I) for patients with comorbid knee osteoarthritis and insomnia. Secondary analyses were performed on data from 74 patients with comorbid insomnia and knee osteoarthritis who completed a randomized clinical trial of 8-session multicomponent CBT-I versus an active behavioral desensitization control condition (BD), including a 6-month follow-up assessment. Data used herein include daily diaries of sleep parameters, actigraphy data, and self-report questionnaires administered at specific time points. Patients who reported at least 30% improvement in self-reported pain from baseline to 6-month follow-up were considered responders (N = 31). Pain responders and nonresponders did not differ significantly at baseline across any sleep continuity measures. At mid-treatment, only TST predicted pain response via t tests and logistic regression, whereas other measures of sleep continuity were nonsignificant. Recursive partitioning analyses identified a minimum cut-point of 382 min of TST achieved at mid-treatment in order to best predict pain improvements 6-month posttreatment. Actigraphy results followed the same pattern as daily diary-based results. Clinically significant pain reductions in response to both CBT-I and BD were optimally predicted by achieving approximately 6.5 hr sleep duration by mid-treatment. Thus, tailoring interventions to increase TST early in treatment may be an effective strategy to promote long-term pain reductions. More comprehensive research on components of behavioral sleep medicine treatments that contribute to pain response is warranted.

  13. Association of blood eosinophils and plasma periostin with FEV1 response after 3-month inhaled corticosteroid and long-acting beta2-agonist treatment in stable COPD patients

    PubMed Central

    Park, Hye Yun; Lee, Hyun; Koh, Won-Jung; Kim, Seonwoo; Jeong, Ina; Koo, Hyeon-Kyoung; Kim, Tae-Hyung; Kim, Jin Woo; Kim, Woo Jin; Oh, Yeon-Mok; Sin, Don D; Lim, Seong Yong; Lee, Sang-Do

    2016-01-01

    Background COPD patients with increased airway eosinophilic inflammation show a favorable response to inhaled corticosteroids (ICS) in combination with a long-acting bronchodilator. Recent studies have demonstrated a significant correlation of sputum eosinophilia with blood eosinophils and periostin. We investigated whether high blood eosinophils and plasma periostin were associated with an improvement in forced expiratory volume in 1 second (FEV1) after 3-month treatment with ICS/long-acting beta2-agonist (LABA) in stable COPD patients. Patients and methods Blood eosinophils and plasma periostin levels were measured in 130 stable COPD subjects selected from the Korean Obstructive Lung Disease cohort. Subjects began a 3-month ICS/LABA treatment after washout period. Results High blood eosinophils (>260/µL, adjusted odds ratio =3.52, P=0.009) and high plasma periostin (>23 ng/mL, adjusted odds ratio =3.52, P=0.013) were significantly associated with FEV1 responders (>12% and 200 mL increase in FEV1 from baseline after treatment). Moreover, the addition of high blood eosinophils to age, baseline positive bronchodilator response, and FEV1 <50% of the predicted value significantly increased the area under the curve for prediction of FEV1 responders (from 0.700 to 0.771; P=0.045). Conclusion High blood eosinophils and high plasma periostin were associated with improved lung function after 3-month ICS/LABA treatment. In particular, high blood eosinophils, in combination with age and baseline lung function parameters, might be a possible biomarker for identification of COPD patients with favorable FEV1 improvement in response to ICS/LABA treatment. PMID:26730185

  14. 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

  15. Clinical and radiographic features of hybrid surgery for the treatment of skip-level cervical degenerative disc disease: A minimum 24-month follow-up.

    PubMed

    Wu, Ting-Kui; Wang, Bei-Yu; Cheng, Ding; Rong, Xin; Lou, Ji-Gang; Hong, Ying; Liu, Hao

    2017-02-25

    We describe the radiographic changes of IS and investigate the safety and feasibility of hybrid surgery (HS) coupling cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) for the treatment of skip-level cervical degenerative disc disease (CDDD). Twenty-seven patients who received HS were retrospectively reviewed. Clinical evaluation based on the Japanese Orthopedic Association (JOA) and Neck Disability Index (NDI) and Visual Analog Scale (VAS) scores. Radiographic parameters included cervical alignment (CA), functional spine unite (FSU) angle of intermediated segment (IS), range of motion (ROM) and intervertebral disc height (IDH). Data regarding radiographic changes at IS were collected. The mean follow-up duration of 30.10months. Compared with preoperative value, JOA, NDI and VAS scores significantly improved after surgery (p<0.05). The CA was recovered significantly after surgery (p<0.05). There was no significant difference in the FSU angle and the IDH of IS between before and at 24months postoperatively (p>0.05). The ROM of IS significantly decreased at the first week after surgery (p<0.05), was similar to preoperative value at 3months postoperatively and significantly increased after 6months (p<0.05). Radiographic changes at IS were observed in 2 patients and Class II Heterotopic ossification (HO) was detected in 2 patients. HS is a safe and feasible alternative procedure for the treatment of skip-level CDDD. It preserved the IS intact and achieved satisfactory clinical and radiographic outcomes over a 24-month follow-up.

  16. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial

    PubMed Central

    Carrera, Fernando; Lok, Charmaine E.; de Francisco, Angel; Locatelli, Francesco; Mann, Johannes F.E.; Canaud, Bernard; Kerr, Peter G.; Macdougall, Iain C.; Besarab, Anatole; Villa, Giuseppe; Kazes, Isabelle; Van Vlem, Bruno; Jolly, Shivinder; Beyer, Ulrich; Dougherty, Frank C.

    2010-01-01

    Background. Several studies with erythropoiesis-stimulating agents claim that maintenance therapy of renal anaemia may be possible at extended dosing intervals; however, few studies were randomized, results varied, and comparisons between agents were absent. We report results of a multi-national, randomized, prospective trial comparing haemoglobin maintenance with methoxy polyethylene glycol-epoetin beta and darbepoetin alfa administered once monthly. Methods. Haemodialysis patients (n = 490) on stable once-weekly intravenous darbepoetin alfa were randomized to methoxy polyethylene glycol-epoetin beta once monthly or darbepoetin alfa every 2 weeks for 26 weeks, with dose adjustment for individual haemoglobin target (11–13 g/dL; maximum decrease from baseline 1 g/dL). Subsequently, patients entered a second 26-week period of once-monthly methoxy polyethylene glycol-epoetin beta and darbepoetin alfa. The primary endpoint was the proportion of patients who maintained average haemoglobin ≥10.5 g/dL, with a decrease from baseline ≤1 g/dL, in Weeks 50–53; the secondary endpoint was dose change over time. The trial is registered at www.ClinicalTrials.gov, number NCT00394953. Results. Baseline characteristics were similar between groups. One hundred and fifty-seven of 245 patients treated with methoxy polyethylene glycol-epoetin beta and 99 of 245 patients with darbepoetin alfa met the response definition (64.1% and 40.4%; P < 0.0001). Doses increased by 6.8% with methoxy polyethylene glycol-epoetin beta and 58.8% with darbepoetin alfa during once-monthly treatment. Death rates were equal between treatments (5.7%). Most common adverse events included hypertension, procedural hypotension, nasopharyngitis and muscle spasms, with no differences between groups. Conclusions. Methoxy polyethylene glycol-epoetin beta maintained target haemoglobin more successfully than darbepoetin alfa at once-monthly dosing intervals despite dose increases with darbepoetin alfa

  17. Early BCR-ABL1 Transcript Decline after 1 Month of Tyrosine Kinase Inhibitor Therapy as an Indicator for Treatment Response in Chronic Myeloid Leukemia.

    PubMed

    El Missiry, Mohamed; Hjorth-Hansen, Henrik; Richter, Johan; Olson-Strömberg, Ulla; Stenke, Leif; Porkka, Kimmo; Kreutzman, Anna; Mustjoki, Satu

    2017-01-01

    In chronic myeloid leukemia (CML), early treatment prediction is important to identify patients with inferior overall outcomes. We examined the feasibility of using reductions in BCR-ABL1 transcript levels after 1 month of tyrosine kinase inhibitor (TKI) treatment to predict therapy response. Fifty-two first-line TKI-treated CML patients were included (imatinib n = 26, dasatinib n = 21, nilotinib n = 5), and BCR-ABL1 transcript levels were measured at diagnosis (dg) and 1, 3, 6, 12, 18, 24, and 36 months. The fold change of the BCR-ABL1 transcripts at 1 month compared to initial BCR-ABL1 transcript levels was used to indicate early therapy response. In our cohort, 21% of patients had no decrease in BCR-ABL1 transcript levels after 1 month and were classified as poor responders. Surprisingly, these patients had lower BCR-ABL1 transcript levels at dg compared to responders (31% vs. 48%, p = 0.0083). Poor responders also significantly more often had enlarged spleen (55% vs. 15%; p<0.01) and a higher percentage of Ph+ CD34+CD38- cells in the bone marrow (91% vs. 75%, p<0.05). The major molecular response rates were inferior in the poor responders (at 12m 18% vs. 64%, p<0.01; 18m 27% vs. 75%, p<0.01; 24m 55% vs. 87%, p<0.01). In conclusion, early treatment response analysis defines a biologically distinct patient subgroup with inferior long-term outcomes.

  18. Efficacy of memantine in the treatment of fibromyalgia: A double-blind, randomised, controlled trial with 6-month follow-up.

    PubMed

    Olivan-Blázquez, Bárbara; Herrera-Mercadal, Paola; Puebla-Guedea, Marta; Pérez-Yus, Mari-Cruz; Andrés, Eva; Fayed, Nicolas; López-Del-Hoyo, Yolanda; Magallon, Rosa; Roca, Miquel; Garcia-Campayo, Javier

    2014-12-01

    Fibromyalgia (FM) is a prevalent and disabling chronic disease. Recent studies have found elevated levels of glutamate in several brain regions, leading to hypotheses about the usefulness of glutamate-blocking drugs such as memantine in the treatment of FM. The aim of this study was to evaluate the efficacy of memantine in the treatment of pain and other clinical variables (global function, clinical impression, depression, anxiety, quality of life) in FM patients. A double-blind, parallel randomised controlled trial was developed. A total of 63 patients diagnosed with FM were recruited from primary health care centres in Zaragoza, Spain. Memantine was administered at doses of 20mg/d after 1 month of titration. Assessments were carried out at baseline, posttreatment, and 3- and 6-month follow-up. Compared with a placebo group, memantine significantly decreased ratings on a pain visual analogue scale (Cohen's d=1.43 at 6 months) and pain measured with a sphygmomanometer (d=1.05). All other secondary outcomes except anxiety also improved, with moderate-to-large effect sizes at 6 months. Compared with placebo, the absolute risk reduction obtained with memantine was 16.13% (95% confidence interval=2.0% to 32.6%), and the number needed to treat was 6.2 (95% confidence interval=3 to 47). Tolerance was good, with dizziness (8 patients) and headache (4 patients) being the most frequent side effects of memantine. Although additional studies with larger sample sizes and longer follow-up times are needed, this study provides preliminary evidence of the utility of memantine for the treatment of FM.

  19. Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease

    PubMed Central

    Müller-Hülsbeck, Stefan; Keirse, Koen; Zeller, Thomas; Schroë, Herman; Diaz-Cartelle, Juan

    2016-01-01

    Purpose: To report the 12-month results of the MAJESTIC clinical study of the self-expanding Eluvia paclitaxel-eluting stent in the treatment of femoropopliteal lesions. Methods: The prospective, single-arm, multicenter trial (clinicaltrials.gov identifier NCT01820637) enrolled 57 patients (mean age 69±9 years; 47 men) with chronic lower limb ischemia referable to de novo or restenotic lesions in the native superficial femoral and/or proximal popliteal arteries. A third of the patients had diabetes. Mean lesion length was 70.8±28.1 mm, and diameter stenosis was 86.3%±16.2%; 26 (46%) lesions were occluded. Primary patency was defined as duplex ultrasound peak systolic velocity ratio ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Major adverse events (MAEs) included all-cause death through 1 month and target limb major amputation and TLR through 12 months. Results: All 57 patients had a single Eluvia stent implanted, employing pre- and postdilation in 93% (53/57) and 95% (54/57) of cases, respectively. Technical success was 97% (55/57; 2 failures due to residual stenosis >30%). At 12 months, primary patency was 96% (49/51) and the MAE rate was 4% (2/53); both MAEs were TLRs. No stent fractures were identified. There were no major amputations. One death occurred 368 days postprocedure, unrelated to the device or procedure. Improvements in the Rutherford category were sustained through 1 year, with 81% (43/53) exhibiting no symptoms (category 0) and 13% (7/53) presenting with mild claudication (category 1). Mean ABI improved from 0.73±0.22 at baseline to 1.02±0.20 at 12 months. Conclusion: MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent sustained high patency and low MAE rates through 12 months. PMID:27193308

  20. Effect of one month ketoconazole treatment on GH, cortisol and ACTH release after ghrelin, GHRP-6 and GHRH administration in patients with Cushing's disease.

    PubMed

    Correa-Silva, Silvia R; Nascif, Sérgio O; Silva, Marcos R; Molica, Patrícia; Lengyel, Ana-Maria J

    2007-10-01

    GH responses to ghrelin, GHRP-6, and GHRH in Cushing's disease (CD) are markedly blunted. There is no data about the effect of reduction of cortisol levels with steroidogenesis inhibitors, like ketoconazole, on GH secretion in CD. ACTH levels during ketoconazole treatment are controversial. The aims of this study were to compare the GH response to ghrelin, GHRP-6, and GHRH, and the ACTH and cortisol responses to ghrelin and GHRP-6 before and after one month of ketoconazole treatment in 6 untreated patients with CD. Before treatment peak GH (microg/L; mean +/- SEM) after ghrelin, GHRP-6, and GHRH administration was 10.0 +/- 4.5; 3.8 +/- 1.6, and 0.6 +/- 0.2, respectively. After one month of ketoconazole there was a significant decrease in urinary cortisol values (mean reduction: 75%), but GH responses did not change (7.0 +/- 2.0; 3.1 +/- 0.8; 0.9 +/- 0.2, respectively). After treatment, there was a significant reduction in cortisol (microg/dL) responses to ghrelin (before: 30.6 +/- 5.2; after: 24.2 +/- 5.1). No significant changes in ACTH (pg/mL) responses before (ghrelin: 210.9 +/- 69.9; GHRP-6: 199.8 +/- 88.8) and after treatment (ghrelin: 159.7 +/- 40.3; GHRP-6: 227 +/- 127.2) were observed. In conclusion, after short-term ketoconazole treatment there are no changes in GH or ACTH responses, despite a major decrease of cortisol levels. A longer period of treatment might be necessary for the recovery of pituitary function.

  1. Treatment of menopausal symptoms with three low-dose continuous sequential 17β-estradiol/progesterone parenteral monthly formulations using novel non-polymeric microsphere technology

    PubMed Central

    Cortés-Bonilla, Manuel; Bernardo-Escudero, Roberto; Alonso-Campero, Rosalba; Francisco-Doce, María T.; Hernández-Valencia, Marcelino; Celis-González, Cuauhtémoc; Márquez-Oñate, Ricardo; Chedraui, Peter; Uribe, Juan A.

    2015-01-01

    Abstract Objective: To analyze the short-term efficacy and safety over menopausal symptoms of three low-dose continuous sequential 17β-estradiol (E)/progesterone (P) parental monthly formulations using novel non-polymeric microspheres. Methods: This was a multicenter, randomized, single blinded study in which peri- and postmenopausal women were assigned to receive a monthly intramuscular injection of 0.5 mg E + 15 mg P (Group A, n = 34), 1 mg E + 20 mg P (Group B, n = 24) or 1 mg E + 30 mg P (Group C, n = 26) for 6 months. Primary efficacy endpoints included mean change in the frequency and severity of hot flushes and the effect over urogenital atrophy symptoms at 3 and 6 months. Safety variables included changes in the rate of amenorrhea, endometrial thickness and histopathology, and local and systemic adverse events. Results: Compared to baseline at month 6, the three treatment schemes significantly decreased the rate of urogenital atrophy symptoms and the frequency (mean number per day) and severity (mean number graded as moderate and severe per month) of hot flushes. No differences in studied efficacy parameters were observed between studied groups at baseline or at the end of the study. For all groups the most frequent adverse event was pain at the injection site; however they were all rated as mild. At the end of the study peri- and postmenopausal women displayed no significant changes in endometrial thickness or histopathology in all treated groups. The rate of amenorrhea at the end of the study decreased for all studied groups yet was less evident among postmenopausal women as compared to perimenopausal ones. Conclusions: The three low-dose continuous sequential intramuscular monthly treatments of E/P using novel microsphere technology were effective at reducing menopausal symptoms at short-term with a low rate of adverse events. More long-term and comparative research is warranted to support our positive findings

  2. [Six-month follow-up study of drug treatment for cannabis addiction: comparison study of four drugs].

    PubMed

    Shoenfeld, Netta; Bodnik, Dana; Rosenberg, Oded; Kotler, Moshe; Dannon, Pinhas

    2011-12-01

    Marijuana addiction is one of the most common forms of addiction worldwide. A variety of reasons for use exist, however, there are only a few tested treatments with frequent relapses. In this study, we examined the efficacy of four pharmacotherapy agents for the treatment of marijuana addiction: naltrexone, bupropion, escitalopram and bromazepam. A total of 59 patients were randomly assigned into four groups. Each group received one of the pharmacological agents for 120 days. Four types of questionnaires were employed: The Hamilton Rating Scale for Depression--21 items, the Hamilton Rating Scale for Anxiety, the Global Assessment of Functioning and a Visual Analogue Scale for perceived need of the drug. In addition, random urine tests were performed to detect tetrahydrocannabinol [THC). Naltrexone proved to be the most efficacious of the four agents, with only four dropouts. Other agents proved less efficacious with six, seven and eights dropouts for bupropion, bromazepam and escitalopram, respectively. In addition, naltrexone was most efficacious in reducing anxiety and depression rates, and increasing functioning and perceived need for drug use. Out of four pharmacological agents, naltrexone proved to be most efficacious in treating marijuana addiction and related disorders. Further studies are needed to confirm our results.

  3. Cognitive and psychomotor effects of three months of escitalopram treatment in elderly patients with major depressive disorder.

    PubMed

    Beheydt, Lieve Lia; Schrijvers, Didier; Docx, Lise; Bouckaert, Filip; Hulstijn, Wouter; Sabbe, Bernard

    2015-12-01

    Although psychomotor retardation (PR) and cognitive disfunctioning are essential symptoms of elderly depressed patients, the differential effect of treatment with an SSRI in the elderly on these symptoms has hardly got any attention in studies with objective experimental measures. Since effects appear relatively slower in elderly, this study evaluates the effect on cognitive and psychomotor functioning as compared to mood, on four points during a twelve week follow up of monotreatment with escitalopram. 28 non-demented elderly unipolar depressive patients on 5-20mg escitalopram were compared to 20 matched healthy elderly. All participants underwent a test battery containing clinical depression measures, cognitive measures of processing speed, executive function and memory, clinical ratings of PR, and objective computerized fine motor skill-tests at the start and after 2, 6 and 12 weeks. Statistical analysis consisted of a General Linear Model (GLM) repeated measures multivariate analysis of variance of completers to compare the psychomotor and cognitive outcomes of the two groups. Although, apart from the significant mood effect, no interaction effects were found for the psychomotor and cognitive tasks, the means in general show a trend of differential effects in cognitive and psychomotor functions, with smaller effects and delayed timeframes and with presence of subgroups compared to mood effects. Longer follow up studies are necessary to evaluate differential long term effects. In elderly, moderate effects of SSRI treatment on mood precede slow or limited effects on cognition and psychomotor retardation. Copyright © 2015 Elsevier B.V. All rights reserved.

  4. Long-term oxandrolone treatment increases muscle protein net deposition via improving amino acid utilization in pediatric patients 6 months after burn injury

    PubMed Central

    Tuvdendorj, D.; Chinkes, DL.; Zhang, XJ.; Suman, OE.; Aarsland, A.; Ferrando, A.; Kulp, GA; Jeschke, MG.; Wolfe, RR.; Herndon, DN.

    2011-01-01

    Background We recently showed that mechanisms of protein turnover in skeletal muscle are unresponsive to amino acid (AA) infusion in severely burned pediatric patients at 6 months postinjury. In the current study, we evaluated if oxandrolone treatment affects mechanisms of protein turnover in skeletal muscle and whole-body protein breakdown in pediatric burn patients 6 months postinjury. Methods At the time of admission, patients were randomized to control or oxandrolone treatments. The treatment regimens were continued until 6 months postinjury, at which time patients (n = 26) underwent study with a stable isotope tracer infusion to measure muscle and whole-body protein turnover. Results Protein kinetics in leg muscle were expressed in nmol/min/100 ml leg volume (mean±SE). During AA infusion, rates of protein synthesis in leg muscle were increased (p < .05) in both groups (Basal vs. AA: control, 51±8 vs. 86±21; oxandrolone, 56±7 vs. 96±12). In the control group, there was also a simultaneous increase in breakdown (Basal vs. AA: 65±10 vs. 89±25), which resulted in no change in the net balance of leg muscle protein (Basal vs. AA: − 15±4 vs. − 2±10). In the oxandrolone group, protein breakdown did not change (Basal vs. AA: 80±12 vs. 77±9), leading to increased net balance (Basal vs. AA: − 24±7 vs. 19±7, p < .05). Protein breakdown at the whole-body level was not different between the groups. Conclusion Long-term oxandrolone treatment increased net deposition of leg muscle protein during AA infusion by attenuating protein breakdown, but did not affect whole-body protein breakdown. PMID:21333314

  5. Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia.

    PubMed

    Naber, Dieter; Hansen, Karina; Forray, Carlos; Baker, Ross A; Sapin, Christophe; Beillat, Maud; Peters-Strickland, Timothy; Nylander, Anna-Greta; Hertel, Peter; Andersen, Henrik Steen; Eramo, Anna; Loze, Jean-Yves; Potkin, Steven G

    2015-10-01

    To directly compare aripiprazole once-monthly 400mg (AOM 400) and paliperidone palmitate once-monthly (PP) on the Heinrichs-Carpenter Quality-of-Life Scale (QLS), a validated health-related quality of life and functioning measure in schizophrenia. This 28-week, randomized, non-inferiority, open-label, rater-blinded, head-to-head study (QUALIFY) of AOM 400 and PP in adult patients (18-60 years) comprised oral conversion, initiation of AOM 400 or PP treatment, and continuation with intramuscular injections every 4weeks. The primary endpoint assessed non-inferiority and superiority on QLS total score analyzed using a mixed model for repeated measurements. Of 295 randomized patients, 100/148 (67.6%) of AOM 400 and 83/147 (56.5%) of PP patients completed 28weeks of treatment. A statistically significant least squares mean difference in change from baseline to week 28 on QLS total score (4.67 [95%CI: 0.32;9.02], p=0.036) confirmed non-inferiority and established superiority of AOM 400 vs PP. There were also significant improvements in Clinical Global Impression - Severity scale and the Investigator's Assessment Questionnaire for AOM 400 vs PP, and pre-defined sub-group analyses revealed a consistent pattern of significance favoring AOM 400 in patients ≤35years. Common treatment-emergent adverse events in the treatment continuation phase were more frequent with PP vs AOM 400, and adverse events were the most frequent reason for discontinuation (27/137 [19.7%] for PP and 16/144 [11.1%] for AOM 400). All-cause discontinuation was numerically lower with AOM 400. Superior improvements on clinician-rated health-related quality of life and a favorable tolerability profile suggest greater overall effectiveness for aripiprazole once-monthly vs paliperidone palmitate. ClinicalTrials.gov identifier:NCT01795547. Copyright © 2015. Published by Elsevier B.V.

  6. Forensic Assertive Community Treatment in a Continuum of Care for Male Internees in Belgium: Results After 33 Months.

    PubMed

    Marquant, Thomas; Sabbe, Bernard; Van Nuffel, Meike; Verelst, Rudy; Goethals, Kris

    2017-08-08

    Non-forensic or regular assertive community treatment (ACT) has positive effects on non-forensic outcomes but has poor effects on forensic outcome measures. In this study, we examined non-forensic and forensic outcome measures of a forensic adaptation of ACT (ForACT) within a continuum of care for internees. Data were collected retrospectively from files of 70 participants in the ForACT group who had been released from a forensic hospital. The control group comprised internees who had left prison and entered community-based care (n = 56). The ForACT group demonstrated significantly better outcomes on forensic measures, such as arrests and incarcerations, and had better community tenure. However, this group showed high hospitalization rates. The findings indicate that this type of community-based care can be beneficial for such internees; however, internees continue to experience difficulties reintegrating into society.

  7. Ovine ruminal microbes are capable of biotransforming hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX).

    PubMed

    Eaton, H L; De Lorme, M; Chaney, R L; Craig, A M

    2011-08-01

    Bioremediation is of great interest in the detoxification of soil contaminated with residues from explosives such as hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX). Although there are numerous forms of in situ and ex situ bioremediation, ruminants would provide the option of an in situ bioreactor that could be transported to the site of contamination. Bovine rumen fluid has been previously shown to transform 2,4,6-trinitrotoluene (TNT), a similar compound, in 4 h. In this study, RDX incubated in whole ovine rumen fluid was nearly eliminated within 4 h. Whole ovine rumen fluid was then inoculated into five different types of media to select for archaeal and bacterial organisms capable of RDX biotransformation. Cultures containing 30 μg mL(-1) RDX were transferred each time the RDX concentration decreased to 5 μg mL(-1) or less. Time point samples were analyzed for RDX biotransformation by HPLC. The two fastest transforming enrichments were in methanogenic and low nitrogen basal media. After 21 days, DNA was extracted from all enrichments able to partially or completely transform RDX in 7 days or less. To understand microbial diversity, 16S rRNA-gene-targeted denaturing gradient gel electrophoresis (DGGE) fingerprinting was conducted. Cloning and sequencing of partial 16S rRNA fragments were performed on both low nitrogen basal and methanogenic media enrichments. Phylogenetic analysis revealed similar homologies to eight different bacterial and one archaeal genera classified under the phyla Firmicutes, Actinobacteria, and Euryarchaeota. After continuing enrichment for RDX degraders for 1 year, two consortia remained: one that transformed RDX in 4 days and one which had slowed after 2 months of transfers without RDX. DGGE comparison of the slower transforming consortium to the faster one showed identical banding patterns except one band. Homology matches to clones from the two consortia identified the same uncultured Clostridia genus in both; Sporanaerobacter

  8. Clinical efficacy and treatment persistence of monthly minodronate for osteoporotic patients unsatisfied with, and shifted from, daily or weekly bisphosphonates: the BP-MUSASHI study.

    PubMed

    Sakai, A; Ikeda, S; Okimoto, N; Matsumoto, H; Teshima, K; Okazaki, Y; Fukuda, F; Arita, S; Tsurukami, H; Nagashima, M; Yoshioka, T

    2014-09-01

    This multi-center, prospective, open-label, observational study evaluated the effects of once-monthly minodronate (50 mg) on treatment persistence, bone turnover markers, bone mineral density, low back pain, and upper gastrointestinal symptoms in outpatients with osteoporosis previously treated with daily or weekly bisphosphonate products. The purposes of this study were to investigate the effects of once-monthly oral minodronate (MIN 50 mg) on bone turnover markers and bone mineral density, low back pain, and upper gastrointestinal symptoms, as well as preference for and treatment persistence of MIN 50 mg among Japanese osteoporosis patients currently treated with daily or weekly bisphosphonates. Study patients were allocated based on their preference to either the Switch group (patients willing to switch over to MIN 50 mg) or the Continue group (patients wanting to continue their current therapies). Patients' treatment persistence and satisfaction levels with the therapies were assessed using a self-administered questionnaire. The study endpoints were serum TRACP-5b, serum P1NP, bone mineral density, upper gastrointestinal symptoms, and low back pain. In total, 264 and 133 patients were allocated into the Switch and Continue groups, respectively. Approximately, 65 % of patients were willing to switch to MIN 50 mg, with the predominant reason being "less frequent dosing more convenient." Treatment persistence was significantly higher in the Switch group (MIN 50 mg) than the Continue group. Almost all patients with abnormal bone metabolism markers demonstrated normalization after switchover. MIN 50 mg alleviated low back pain and upper gastrointestinal symptoms induced by prior bisphosphonate use. MIN 50 mg alleviates low back pain, reduces bone turnover markers and increases bone density, and induces fewer upper gastrointestinal symptoms after switchover from prior bisphosphonate products, and therefore, it may provide patients with a more convenient

  9. Fluorouracil cream 0.5% for the treatment of actinic keratoses on the face and anterior scalp: interim results of an 18-month open-label study.

    PubMed

    Stough, Dow; Bucko, Alicia D; Vamvakias, George; Rafal, Elyse S; Davis, Steven A

    2008-07-01

    This study further assessed the long-term safety and efficacy of fluorouracil cream 0.5% in patients with multiple actinic keratosis (AK) on the face/anterior scalp and other body sites. This 18-month, prospective, open-label, multicenter study comprised two treatment cycles separated by 12 months. Cycle 1 included treatment of AK lesions on the face, anterior scalp, posterior scalp, ears, neck, lips, arms, and/or hands. Once-daily fluorouracil cream 0.5% was applied for four weeks as tolerated, followed by four weeks of follow-up in each treatment cycle. Adults (N=277) with five or more visible and/or palpable AK lesions on the face/anterior scalp and five or more lesions on the posterior scalp, ears, neck, lips, arms, and/or hands were enrolled. Main outcome measures included adverse events (AEs) and reduction/clearance of AK lesions on the face/anterior scalp after four weeks of treatment. RESULTS for treatment of AK lesions on the face/anterior scalp for Cycle 1 are reported. All 277 patients were treated during Cycle 1. Besides anticipated application-site reactions (67.9% and 19.1% of patients experiencing mild-to-moderate and severe events, respectively) and eye irritation, overall incidence of treatment-emergent AEs was low. No individual AE appeared in greater than four percent of patients. At the end of Cycle 1, significant reductions were noted in lesion counts on the face/anterior scalp (84.8%; P<0.0001). Clearance rate for lesions on the face and anterior scalp was 39.8 percent at eight weeks. RESULTS indicate that fluorouracil cream 0.5% is safe and effective for patients with multiple AK lesions on the face/anterior scalp.

  10. The 3.5 Meter at Apache Point Observatory

    NASA Astrophysics Data System (ADS)

    York, Donald G.

    1995-05-01

    As of November 1, 1994, the 3.5 meter telescope at Apache Point is in regular science operation. About 15% of the time is still used for engineering. The performance is still being improved. At present, we achieve 4 arc second rms absolute pointing from 20 to 89 degrees above the horizon. Image sizes are one arc second on a regular basis. The best open loop tracking achieved is 0.1 arc sec. errors over 10 minutes, though it can be worse. Closed loop tracking is better than 0.1 arc seconds. No aberrations from the mirror supports have been detected. The honeycomb primary mirror is kept at ambient temperature during the night time. Temperature non-uniformities in the back and front plates are controlled to be the same to 0.1 degrees centigrade. The telescope is regularly used with an infrared imager, a medium resolution spectrograph, and a large format, drift scan CCD camera. An echelle spectrograph, a high angular resolution camera, and an adaptive optics system are being integrated into the system. Instrument changes can be made in less than 20 minutes, at night. All instruments are operational and can be mounted by one person at any time. The observatory is operated by a full time staff of 6.6 individuals. Remote operations are possible from all ARC campuses. Over 70% of the observing is carried out this way, with site visits by astronomers only for mounting visitor instruments or for training purposes. Observing functions, including complete telescope control, instrument control, and data retrieval are carried out by the remote observer. The telescope is scheduled on an hourly basis, two months in advance of the actual runs. The individual university members of the project control their own time allocations and intra-institutional trades of time. The project partners are the University of Chicago, New Mexico State University, Princeton University, the University of Washington, and Washington State University.

  11. Response of vascular pigment epithelium detachment due to age-related macular degeneration to monthly treatment with ranibizumab: the prospective, multicentre RECOVER study.

    PubMed

    Clemens, Christoph R; Wolf, Armin; Alten, Florian; Milojcic, Carolin; Heiduschka, Peter; Eter, Nicole

    2017-01-13

    To assess the effects of monthly intravitreal ranibizumab injections in patients with vascularized pigment epithelium detachment (vPED) secondary to age-related macular degeneration (AMD). A total of 40 patients were prospectively observed and treated monthly with 0.5 mg ranibizumab injections (ClinicalTrials.gov Ident. NCT00976222). Inclusion criterion was a treatment-naïve vPED lesion with a minimum height of ≥200 μm. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography (SD-OCT) were evaluated at all visits. Fluorescein angiography and indocyanine green angiography were performed at baseline and quarterly. Lesions were differentiated between serous vascular PED (svPED, group A, 29 patients) and fibrovascular PED (fPED, group B, 11 patients). Primary outcome was the effectivity of continuous monthly treatment during a 12-month period as measured in change in BCVA. Secondary outcomes were change in PED height and PED greatest linear diameter (GLD). Further secondary outcomes were the presence of subretinal fluid and prognostic markers of an impending retinal pigment epithelium (RPE) tear: PED lesion height and diameter, ratio of choroidal neovascularization (CNV) size to PED size, hyperreflective lines in near-infrared images, microrips and subretinal cleft. Mean BCVA was 56.9 ± 11.5 letters (A: 55.4 ± 10.8; B: 59.1 ± 13.4) at baseline and 55.1 ± 15.9 (A: 53.7 ± 17.0; B: 58.9 ± 12.7) at 12-month follow-up. Excluding the RPE tear patients, the svPED group showed an increase in BCVA from 56.1 ± 10.3 at baseline to 62.4 ± 10.2 at 12-month follow-up (p = 0.048). Best-corrected visual acuity in patient who developed a RPE tear was 55.8 ± 12.5 at baseline and 37.1 ± 14.9 at 12-month follow-up. The mean change in PED height was -242.1 μm ± 285.5 (A: -427.3 μm ± 299.7; B: -51.6 μm ± 99.5). The mean decrease in PED GLD was -471.8 μm ± 727.6 (A: -738.9 μm ± 788.2; B: -10.4

  12. Endodontic treatment of trauma-induced necrotic immature teeth using a tricalcium silicate-based bioactive cement. A report of 3 cases with 24-month follow-up.

    PubMed

    Martens, L; Rajasekharan, S; Cauwels, R

    2016-03-01

    Pulp necrosis is the second most common complication after traumatic dental injuries and occurs mostly within the first 6-24 months of follow-up period, depending on the type of dental trauma. Three cases with endodontic treatment scenarios of trauma-induced necrosis in immature permanent anterior teeth. All cases were treated by full canal obturation with Biodentine (Septodont, Saint Maur des Fosses, France) and documented for a follow-up period of 24 months. Copious irrigation of the root canal, minimal mechanical preparation, use of calcium hydroxide for a short period of time and complete obturation of these immature teeth with a bioactive cement with superior mechanical properties such as Biodentine were the prominent reasons attributed to the success of these three cases.

  13. Photoablation using the turbo-booster and excimer laser for in-stent restenosis treatment: twelve-month results from the PATENT study.

    PubMed

    Schmidt, Andrej; Zeller, Thomas; Sievert, Horst; Krankenberg, Hans; Torsello, Giovanni; Stark, Matthew A; Scheinert, Dierk

    2014-02-01

    To evaluate the performance of the Turbo Elite laser catheter in combination with the Turbo-Booster guiding catheter for the treatment of femoropopliteal in-stent restenosis (ISR). The PATENT study (Photoablation Using the Turbo-Booster and Excimer Laser for In-Stent Restenosis Treatment) was a multicenter prospective industry-sponsored registry involving 5 European centers. Patients with symptomatic femoropopliteal ISR (Rutherford categories 2-5) and an ankle-brachial index ≤0.8 were treated with excimer laser atherectomy (ELA). Ninety patients (65 men; mean age 69.5±9.3 years) were enrolled. The majority of patients were Rutherford category 3 (63, 71.6%), and 32 (35.6%) patients had previous treatment for ISR. The average lesion length was 123±95.9 mm, and 30 (34.1%) lesions were total occlusions. The main efficacy outcome was primary patency at 12 months as measured by duplex ultrasonography. The primary safety outcome was freedom from major adverse events (MAE) during hospitalization and at 30-day follow-up to include all death, unplanned major amputation, or target lesion revascularization (TLR). The Turbo Elite laser catheter created a pilot channel in 87 (96.7%) of 90 lesions, with a mean of 1.5 passes, followed by the Turbo Booster with a mean of 5.7 passes. Adjunctive balloon dilation was performed in 79 (87.8%) lesions. Procedure success (<30% residual stenosis without stenting) was 96.7%. The mean percentage stenosis improved from a baseline of 87.0% to 32.3% after laser atherectomy and to 7.4% after final treatment. The MAE rate through 30 days was 2.2%. Nine (10.0%) patients experienced distal embolization. Estimates of freedom from TLR at 6 and 12 months were 87.8% and 64.4%, respectively. Primary patency at 6 and 12 months was 64.1% and 37.8%, respectively. Only a history of prior intervention for ISR (p<0.01) was a predictor of TLR at 12 months. The PATENT study has established excimer laser atherectomy as safe for the treatment of

  14. Preparation of 3,5-disubstituted pyrazoles and isoxazoles from terminal alkynes, aldehydes, hydrazines, and hydroxylamine.

    PubMed

    Harigae, Ryo; Moriyama, Katsuhiko; Togo, Hideo

    2014-03-07

    The reaction of terminal alkynes with n-BuLi, and then with aldehydes, followed by the treatment with molecular iodine, and subsequently hydrazines or hydroxylamine provided the corresponding 3,5-disubstituted pyrazoles or isoxazoles in good yields with high regioselectivity, through the formations of propargyl secondary alkoxides and α-alkynyl ketones. The present reactions are one-pot preparation of 3,5-disubstituted pyrazoles from terminal alkynes, aldehydes, molecular iodine, and hydrazines, and 3,5-disubstituted isoxazoles from terminal alkynes, aldehydes, molecular iodine, and hydroxylamine.

  15. 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.

  16. 43 CFR 9269.3-5 - Timber management.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Timber management. 9269.3-5 Section 9269.3-5 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT... Timber management. (a) Sales of forest products; general. (b) Non-sale disposals;...

  17. 43 CFR 9269.3-5 - Timber management.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Timber management. 9269.3-5 Section 9269.3-5 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT... Timber management. (a) Sales of forest products; general. (b) Non-sale disposals;...

  18. 43 CFR 9269.3-5 - Timber management.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Timber management. 9269.3-5 Section 9269.3-5 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT... Timber management. (a) Sales of forest products; general. (b) Non-sale disposals;...

  19. 43 CFR 9269.3-5 - Timber management.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Timber management. 9269.3-5 Section 9269.3-5 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT... Timber management. (a) Sales of forest products; general. (b) Non-sale disposals; general—(1...

  20. 43 CFR 4120.3-5 - Assignment of range improvements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... MANAGEMENT, DEPARTMENT OF THE INTERIOR RANGE MANAGEMENT (4000) GRAZING ADMINISTRATION-EXCLUSIVE OF ALASKA Grazing Management § 4120.3-5 Assignment of range improvements. The authorized officer shall not approve... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Assignment of range improvements. 4120.3-5...

  1. 43 CFR 4120.3-5 - Assignment of range improvements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... MANAGEMENT, DEPARTMENT OF THE INTERIOR RANGE MANAGEMENT (4000) GRAZING ADMINISTRATION-EXCLUSIVE OF ALASKA Grazing Management § 4120.3-5 Assignment of range improvements. The authorized officer shall not approve... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Assignment of range improvements. 4120.3-5...

  2. 43 CFR 4120.3-5 - Assignment of range improvements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... MANAGEMENT, DEPARTMENT OF THE INTERIOR RANGE MANAGEMENT (4000) GRAZING ADMINISTRATION-EXCLUSIVE OF ALASKA Grazing Management § 4120.3-5 Assignment of range improvements. The authorized officer shall not approve... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Assignment of range improvements. 4120.3-5...

  3. 43 CFR 4120.3-5 - Assignment of range improvements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Assignment of range improvements. 4120.3-5... MANAGEMENT, DEPARTMENT OF THE INTERIOR RANGE MANAGEMENT (4000) GRAZING ADMINISTRATION-EXCLUSIVE OF ALASKA Grazing Management § 4120.3-5 Assignment of range improvements. The authorized officer shall not...

  4. Serum disposition of sertraline, N-desmethylsertraline and paroxetine: a pharmacokinetic evaluation of repeated drug concentration measurements during 6 months of treatment for major depression.

    PubMed

    Reis, Margareta; Aberg-Wistedt, Anna; Agren, Hans; Höglund, Peter; Akerblad, Ann-Charlotte; Bengtsson, Finn

    2004-07-01

    Sertraline and paroxetine are frequently prescribed SSRIs for long-term treatment of major depression. Nevertheless, continuous follow-ups of drug concentrations prevailing in patients during the whole treatment period are not available. Hence, in a large phase IV clinical trial, a total of 353 patients with major depression were enrolled for a 6-month comparison of sertraline (50-150 mg daily) and paroxetine (20-60 mg daily). The present study reports the pharmacokinetic results of up to eight serum samples per patient. 1. A profound variability was found in the interindividual steady state and trough serum levels of sertraline, desmethylsertraline and paroxetine: the coefficient of variation (CV) was 59% for sertraline, 51% for desmethylsertraline, 27% for the ratio desmethylsertraline/sertraline (50 mg/day), and 71% for paroxetine (20 mg/day). The intraindividual CV for the ratio desmethylsertraline/sertraline was only 19%, indicating intraindividual metabolizing stability over time. Both sertraline and paroxetine displayed sex differences in the dose-concentration correlation. 2. It was possible to predict sertraline, but not paroxetine, steady state levels. 3. The terminal elimination t(1/2) for both drugs after 6 months of treatments was similar to data previously reported from short-term withdrawal studies. 4. No correlation between serum drug concentrations and clinical effect was detected for either sertraline or paroxetine. For the future, continuous efforts are warranted to perform PK investigations in the natural clinical setting in which the drugs are usually prescribed.

  5. Comparison of daily and monthly pyrantel treatment in yearling thoroughbreds and the protective effect of strategic medication of mares on their foals.

    PubMed

    Herd, R P; Majewski, G A

    1994-10-01

    Studies on a Thoroughbred breeding farm in Ohio were done to: (1) compare the effects of daily administration of pyrantel tartrate feed pellets with monthly administration of a pyrantel pamoate paste to yearling horses (21 January-3 September); (2) assess the effects of daily pyrantel tartrate given strategically in spring/summer to foaling mares (1 April-16 August) and given for a prolonged period to barren mares (21 January-3 September); (3) determine if strategic medication of foaling mares with daily pyrantel tartrate protected their foals until weaning. There were no differences in cyathostome egg counts, pasture larval counts, body condition scores, or body weights of yearlings treated with daily pyrantel tartrate or monthly pyrantel pamoate. Both treatments failed to maintain fecal egg counts of yearlings below 100 eggs per gram (epg), and mean counts exceeded 400 epg (pyrantel pamoate) and 700 epg (pyrantel tartrate) in August and September, resulting in a sharp, but moderate increase in pasture infectivity in October. By contrast, prolonged or strategic use of daily pyrantel tartrate in mature horses were each highly effective in reducing pasture contamination and infectivity with cyathostome eggs and larvae respectively. Strategic medication of foaling mares provided protection of their foals until weaning and first treatment of foals was delayed until after weaning when mean strongyle counts exceeded 100 epg. Treatment of weanlings with pyrantel pamoate had little effect on egg counts. A comparative anthelmintic study with ivermectin, oxibendazole, and pyrantel pamoate confirmed earlier studies showing reduced efficacy of anthelmintics in young horses.

  6. 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.

  7. Improved adherence with PTH(1-84) in an extension trial for 24 months results in enhanced BMD gains in the treatment of postmenopausal women with osteoporosis.

    PubMed

    Black, D M; Bilezikian, J P; Greenspan, S L; Wüster, C; Muñoz-Torres, M; Bone, H G; Rosen, C J; Andersen, H S; Hanley, D A

    2013-04-01

    The purpose of this study is to examine the effect of PTH(1-84) treatment over 24 months followed by 12 months discontinuation on BMD, bone turnover markers, fractures and the impact of adherence on efficacy. There is limited information about the effect of PTH(1-84) after 18 months and limited data about the impact of compliance on response to anabolic therapy. Seven hundred and eighty-one subjects who received active PTH(1-84) in the Treatment of Osteoporosis with Parathyroid hormone trial for approximately 18 months were entered into a 6-month open-label extension. Thereafter, they were followed for 12 additional months after discontinuation of treatment. Endpoints examined included changes in BMD and biochemical markers. PTH(1-84) treatment over 24 months increased BMD at the lumbar spine by 6.8% above baseline (p<0.05).The total corresponding BMD increases at the hip and femoral neck were 1.1 and 2.2% above baseline. Larger increases in spine BMD were observed in participants with ≥80% adherence to daily injections of PTH(1-84) (8.3% in adherent vs 4.9% in poorly adherent patients). Total hip BMD gains were 1.7% in adherent vs 0.6% in poorly adherent participants. Markers of bone turnover (BSAP and NTx) peaked 6 months after starting PTH(1-84) treatment and declined slowly but remained above baseline at 24 months. After discontinuation of PTH(1-84) treatment (at 24 months), bone turnover markers returned to near baseline levels by 30 months. The adherent group sustained significantly fewer fractures than the poorly adherent group. PTH(1-84) treatment over 24 months results in continued increases in lumbar spine BMD. Adherence to treatment with PTH(1-84) for up to 24 months is also associated with greater efficacy.

  8. First-line analysis of the effects of treatment on progression of structural changes in knee osteoarthritis over 24 months: data from the osteoarthritis initiative progression cohort.

    PubMed

    Martel-Pelletier, Johanne; Roubille, Camille; Abram, François; Hochberg, Marc C; Dorais, Marc; Delorme, Philippe; Raynauld, Jean-Pierre; Pelletier, Jean-Pierre

    2015-03-01

    To determine, using data from participants enrolled in the progression cohort of the OAI, the effects of conventional osteoarthritis (OA) pharmacological treatment and those of the combination of glucosamine and chondroitin sulfate (Glu/CS) on knee structural changes. Six hundred patients with knee OA were stratified based on whether or not they received for 24 consecutive months the OA conventional pharmacological treatment and/or Glu/CS. The main outcomes were knee structural changes, including the loss of joint space width (JSW) and of cartilage volume measured by quantitative MRI. Participants reported taking (+) (n=300) or not taking (-) (n=300) OA treatment (analgesic/NSAIDs). The +analgesic/NSAIDs participants had higher Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores (p<0.001) and smaller JSW (p=0.01), reflecting more severe disease at baseline. In the -analgesic/NSAIDs group, participants taking Glu/CS had significantly reduced loss of cartilage volume at 24 months in the medial central plateau (p=0.007). Further subdivision revealed that this effect of Glu/CS occurred in participants with a higher severity of the disease (JSW≤median). In the +analgesic/NSAIDs group, those taking Glu/CS had significantly reduced loss of cartilage volume in the global plateau at 12 months (p=0.05), and in the central plateau at 24 months (p=0.05). These effects occurred in participants with less disease severity (JSW>median). By contrast, no significant reduction in JSW was found between all groups. In +analgesic/NSAIDs groups and -analgesic/NSAIDs groups, participants who took Glu/CS had reduced loss of cartilage volume over 24 months in subregions when assessed with qMRI, arguing for a disease-modifying effect of Glu/CS which could not be identified by X-rays. 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.

  9. Safety, tolerability, and efficacy of azilsartan medoxomil with or without chlorthalidone during and after 8 months of treatment for hypertension.

    PubMed

    Kipnes, Mark S; Handley, Alison; Lloyd, Eric; Barger, Bruce; Roberts, Andrew

    2015-03-01

    A phase 3, 26-week, open-label, titrate-to-target study (n=418) assessed the safety of azilsartan medoxomil (AZL-M) alone and with chlorthalidone (CLD), followed by a 6-week, double-blind, placebo-controlled reversal phase with change in clinic diastolic blood pressure (DBP) as the primary endpoint. Target blood pressure (BP) was <140/90 mm Hg (<130/80 mm Hg with diabetes/chronic kidney disease). AZL-M was initiated at 40 mg once a day (QD), force-titrated to 80 mg at week 4. CLD 25 mg QD could be added (weeks 8-22), if required, to reach target, followed by additional antihypertensives from week 12. At the end of the open-label phase, mean change in systolic BP (SBP)/DBP from baseline was -23/-16 mm Hg. The most common adverse events, irrespective of treatment, were dizziness (8.9%) and headache (7.2%). Serious AEs were reported in eight patients (1.9%). Consecutive creatinine elevations ≥50% with values exceeding the upper limit of normal (ULN) were reported in nine (2.2%) patients. All returned to below the 50% threshold; most also returned to below the ULN after drug discontinuation. Mean DBP was maintained through the reversal phase in patients receiving AZL-M, but increased with placebo (difference: -7.8 mm Hg, 95% confidence interval, -9.8 to -5.8; P<.001). AZL-M alone or with CLD showed good long-term safety and stable BP improvements in a titrate-to-target approach. BP improvements caused by AZL-M therapy were safely reversible upon AZL-M withdrawal. © 2015 Wiley Periodicals, Inc.

  10. 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

  11. Double blind study on efficacy and safety of single doses of ivermectin and diethylcarbamazine for treatment of Polynesian Wuchereria bancrofti carriers. Results at six months.

    PubMed

    Cartel, J L; Spiegel, A; Nguyen, L; Genelle, B; Roux, J F

    1991-03-01

    In 1989, a double-blind trial was implemented in Tahiti to compare both efficacy and tolerability of single doses of ivermectin and diethylcarbamazine (DEC) for treatment of Wuchereria bancrofti carriers. Of 58 carriers, in whom microfilarial (mf) density was greater than or equal to 100 mf/ml, 23, 24 and 11 were randomly allocated to treatment with respectively ivermectin 100 mcg/kg, DEC 3 and DEC 6 mg/kg. One week after treatment, clearance of microfilaremia was complete in 22 of the 23 carriers treated with ivermectin and in one only of the 35 treated with DEC. Adjusted geometric mean for mf densities was significantly lower (p less than 0.001) in carriers treated with ivermectin than in those treated with DEC at one, but neither at 3 (p = 0.26) nor at 6 months (p = 0.63). At 3 and 6 months, mf levels were 14 and 28%, 21.6 and 19.4%, and 10.2 and 8.4% of pretreatment mf levels in carriers treated respectively with ivermectin 100 mcg/kg, DEC 3 and DEC 6 mg/kg. Side effects were experienced by 51 carriers (88%) of whom only 8 (14%) suffered a grade 3 reaction. Onset and intensity of side effects were significantly associated (p less than 0.01) with both pretreatment mf densities and peripheral blood parasite clearance. Efficacy of ivermectin single dose was superior to that of DEC single dose in terms of immediate mf clearance but not in terms of sustained mf decrease at 6 months.

  12. Fractional Erbium laser in the treatment of photoaging: randomized comparative, clinical and histopathological study of ablative (2940nm) vs. non-ablative (1540nm) methods after 3 months*

    PubMed Central

    Borges, Juliano; Cuzzi, Tullia; Mandarim-de-Lacerda, Carlos Alberto; Manela-Azulay, Mônica

    2014-01-01

    BACKGROUND Fractional non-ablative lasers keep the epidermis intact, while fractional ablative lasers remove it, making them theoretically more effective. OBJECTIVES To evaluate the clinical and histological alterations induced by fractional photothermolysis for treating photoaging, comparing the possible equivalence of multiple sessions of 1540nm Erbium, to one session of 2940nm Erbium. METHODS Eighteen patients (mean age 55.9) completed the treatment with three sessions of 1540nm fractional Erbium laser on one side of the face (50 mJ/mB, 15ms, 2 passes), and one session of 2940nm on the other side (5mJ/mB, 0.25ms, 2 passes). Biopsies were performed before and 3 months after treatment. Clinical, histological and morphometric evaluations were carried out. RESULTS All patients presented clinical improvement with no statistically significant difference (p> 0.05) between the treated sides. Histopathology revealed a new organization of collagen and elastic fibers, accompanied by edema, which was more evident with the 2940nm laser. This finding was confirmed by morphometry, which showed a decrease in collagen density for both treatments, with a statistical significance for the 2940nm laser (p > 0.001). CONCLUSIONS Three 1540nm sessions were clinically equivalent to one 2940nm session. The edema probably contributed to the positive results after three months, togheter with the new collagen and elastic fibers organization. The greater edema after the 2940nm session indicates that dermal remodeling takes longer than with 1540nm. It is possible that this histological superiority relates to a more prolonged effect, but a cohort longer than three months is needed to confirm that supposition. PMID:24770501

  13. Results of fractional ablative facial skin resurfacing with the erbium:yttrium-aluminium-garnet laser 1 week and 2 months after one single treatment in 30 patients.

    PubMed

    Trelles, Mario A; Mordon, Serge; Velez, Mariano; Urdiales, Fernando; Levy, Jean Luc

    2009-03-01

    The erbium:yttrium-aluminium-garnet (Er:YAG) laser has recently been used in the fractional resurfacing of photo-aged skin. Our study evaluated the results after one single session of fractional resurfacing with Er:YAG. Thirty women participated in the study, with an average age of 46 years, skin types from II to IV, and wrinkle grades I to III. The 2,940 nm Er:YAG system used (Pixel, Alma Laser, Israel) had variable pulse durations (1 ms to 2 ms) and energy densities (800 mJ/cm(2) to 1,400 mJ/cm(2)) which, together with the number of passes (four to eight), were selected as a function of wrinkle severity. All patients received only one treatment. Postoperative side effects were evaluated. The number of wrinkles was documented with clinical photography and was scored. Histological assessment was carried out on two patients before and 2 months after treatment. All patients completed the study. Of the patients, 93% reported good or very good improvement of the degree of their wrinkles, with a satisfaction index of 83%. Pain was not a problem during treatment, and there were no side effects except for in one phototype IV patient, who had hyperpigmentation. Histology 2 months after the single treatment demonstrated younger morphology of both the epidermis and dermis, with improvement of the pretreatment typical elastotic appearance. At the parameters used in our study, only one treatment session of Er:YAG laser could achieve effective skin rejuvenation, with effects recognized in both the dermis and, more importantly, the epidermis. This regimen offers an interesting alternative to the conventional approach of multi-session fractional resurfacing.

  14. 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.

  15. PDE5 inhibitor treatment persistence and adherence in Brazilian men: post-hoc analyses from a 6-month, prospective, observational study.

    PubMed

    Cairoli, Carlos; Reyes, Luis Antonio; Henneges, Carsten; Sorsaburu, Sebastian

    2014-01-01

    Characterize persistence and adherence to phosphodiesterase type - 5 inhibitor (PDE5I) on-demand therapy over 6 months among Brazilian men in an observational, non-interventional study of Latin American men naïve to PDE5Is with erectile dysfunction (ED). Men were prescribed PDE5Is per routine clinical practice. Persistence was defined as using ≥ 1 dose during the previous 4 - weeks, and adherence as following dosing instructions for the most recent dose, assessed using the Persistence and Adherence Questionnaire. Other measures included the Self - Esteem and Relationship (SEAR) Questionnaire, and International Index of Erectile Function (IIEF). Multivariate logistic regression was used to identify factors associated with persistence/adherence. 104 Brazilian men were enrolled; mean age by treatment was 53 to 59 years, and most presented with moderate ED (61.7%). The prescribed PDE5I was sildenafil citrate for 50 (48.1%), tadalafil for 36 (34.6%), vardenafil for 15 (14.4%), and lodenafil for 3 patients (2.9%). Overall treatment persistence was 69.2% and adherence was 70.2%; both were numerically higher with tadalafil (75.0%) versus sildenafil or vardenafil (range 60.0% to 68.0%). Potential associations of persistence and/or adherence were observed with education level, ED etiology, employment status, and coronary artery disease. Improvements in all IIEF domain scores, and both SEAR domain scores were observed for all treatments. Study limitations included the observational design, brief duration, dependence on patient self - reporting, and limited sample size. Approximately two-thirds of PDE5I-naive, Brazilian men with ED were treatment persistent and adherent after 6 months. Further study is warranted to improve long-term outcomes of ED treatment.

  16. Artemether-lumefantrine versus artemisinin-naphthoquine in Papua New Guinean children with uncomplicated malaria: a six months post-treatment follow-up study.

    PubMed

    Laman, Moses; Benjamin, John M; Moore, Brioni R; Salib, Mary; Tawat, Somoyang; Davis, Wendy A; Siba, Peter M; Robinson, Leanne J; Davis, Timothy M E

    2015-03-21

    In a recent trial of artemisinin-naphthoquine (artemisinin-NQ) and artemether-lumefantrine (AM-LM) therapy in young children from Papua New Guinea (PNG), there were no treatment failures in artemisinin-NQ-treated children with Plasmodium falciparum or Plasmodium vivax compared with 2.2% and 30.0%, respectively, in AM-LM-treated children during 42 days of follow-up. To determine whether, consistent with the long elimination half-life of NQ, this difference in efficacy would be more durable, clinical episodes of malaria were assessed in a subset of trial patients followed for six months post-treatment. For children completing trial procedures and who were assessable at six months, all within-trial and subsequent clinical malaria episodes were ascertained, the latter by clinic attendances and/or review of hand-held health records. Presentations with non-malarial illness were also recorded. Differences between allocated treatments for pre-specified endpoints were determined using Kaplan-Meier survival analysis. Of 247 children who were followed to Day 42, 176 (71.3%) were included in the present sub-study, 87 allocated to AM-LM and 89 to artemisinin-NQ. Twenty children in the AM-LM group (32.8%) had a first episode of clinical malaria within six months compared with 10 (16.4%) in the artemisinin-NQ group (P = 0.033, log rank test). The median (interquartile range) time to first episode of clinical malaria was 64 (50-146) vs 116 (77-130) days, respectively (P = 0.20). There were no between-group differences in the incidence of first presentation with non-malarial illness (P = 0.31). The greater effectiveness of artemisinin-NQ over conventional AM-LM extends to at least six months post-treatment for clinical malaria but not non-malarial illness. Australian New Zealand Clinical Trials Registry ACTRN12610000913077 .

  17. Double-blind, placebo-controlled study of three-month treatment with lymecycline in reactive arthritis, with special reference to Chlamydia arthritis.

    PubMed

    Lauhio, A; Leirisalo-Repo, M; Lähdevirta, J; Saikku, P; Repo, H

    1991-01-01

    We conducted a double-blind, placebo-controlled, randomized study of 3-month treatment with lymecycline, a form of tetracycline, in reactive arthritis (ReA). Lymecycline therapy significantly decreased the duration of the illness in patients with Chlamydia trachomatis-triggered ReA, but not in other ReA patients. In 2 ReA patients, C trachomatis was found in the throat, an uncommon locale for this organism. Our results suggest that it is important to verify the triggering microbe and that it is beneficial to treat Chlamydia arthritis patients with a prolonged course of tetracycline.

  18. The impact of 12 months treatment with ivacaftor on Scottish paediatric patients with cystic fibrosis with the G551D mutation: a review.

    PubMed

    Dryden, Carol; Wilkinson, Jane; Young, David; Brooker, Richard John

    2016-06-10

    We reviewed the impact of ivacaftor on Scottish paediatric patients with cystic fibrosis ≥6 years of age after 12 months of treatment. Statistically significant improvements in FEV1 and body mass index and a reduction in sweat chloride, all comparable with previously published data were observed. The findings also suggested reduced use of intravenous antibiotics and oral antibiotics. No significant adverse effects were observed but a possible association with cataract formation could not be excluded. This review suggests that, in the short term at least, ivacaftor is effective and safe in paediatric patients ≥6 years of age with G551D.

  19. 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.

  20. Clinical, histologic, and bacteriologic findings in dairy cows with digital dermatitis (footwarts) one month after topical treatment with lincomycin hydrochloride or oxytetracycline hydrochloride.

    PubMed

    Berry, Steven L; Read, Deryck H; Walker, Richard L; Famula, Thomas R

    2010-09-01

    To compare the effectiveness of lincomycin and oxytetracycline for treatment of digital dermatitis (DD) in dairy cows through gross visual examination, histologic evaluation, and bacteriologic evaluation. Randomized controlled clinical trial. 25 cows with DD lesions from a commercial Holstein dairy herd. Cows with DD lesions were randomly assigned to 1 of 3 groups: topical treatment with 10 g of lincomycin hydrochloride (n = 11), topical treatment with 10 g of oxytetracycline hydrochloride (11), and no treatment (3) on days 1 and 2 (d1). Biopsy specimens were obtained for histologic examination from DD lesions prior to treatment and 28 or 31 days (d30) after treatment for histologic examination. Cows were clinically examined on d1, days 12 or 14 (d14), and d30. No difference was evident in clinical responses to lincomycin and oxytetracycline, so data were pooled; at d30, 8 of 11 of lincomycin-treated lesions and 7 of 11 oxytetracycline-treated lesions appeared visually healed, respectively. Gross visual examination suggested 73% (16/22) of treated cows were healed at d14 and 68% (15/22) of treated cows were healed on d30. Of the 15 lesions that appeared healed on d30, 7 of 15 were classified histologically as active (ulceration and bacterial invasion; 2/15) or incipient (5/15). Clinical responses to lincomycin and oxytetracycline did not differ. Agreement was good between gross visual and histologic assessments of DD lesions before treatment; agreement 1 month after treatment was variable. Histologic evaluation could not distinguish incomplete healing from lesion recurrence.

  1. 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.

  2. Three-month treatment with pioglitazone reduces circulating C1q-binding adiponectin complex to total-adiponectin ratio, without changes in body mass index, in people with type 2 diabetes.

    PubMed

    Nakatsuji, Hideaki; Kishida, Ken; Kobayashi, Hironori; Funahashi, Tohru; Shimomura, Iichiro

    2013-01-01

    We measured circulating C1q-binding adiponectin (C1q-APN) levels before and after 3-month treatment with pioglitazone in people with type 2 diabetes. The results indicate 3-month treatment with pioglitazone reduces circulating levels of C1q-APN/total-adiponectin ratio without changes in body mass index.

  3. Is treatment in a day hospital step-down program superior to outpatient individual psychotherapy for patients with personality disorders? 36 months follow-up of a randomized clinical trial comparing different treatment modalities.

    PubMed

    Gullestad, Frida Slagstad; Wilberg, Theresa; Klungsøyr, Ole; Johansen, Merete Selsbakk; Urnes, Oyvind; Karterud, Sigmund

    2012-01-01

    Despite increasing interest in the development of effective treatments for patients with PDs, there is still no consensus about the optimal treatment setting for this group of patients. This study reports the 36 months follow-up of the Ullevål Personality Project (UPP) (n=113), a randomized clinical trial comparing two treatment modalities for patients with PDs: an intensive long-term step-down treatment program, consisting of short-term day hospital treatment followed by combined group and individual psychotherapy organized in a hospital setting, with "ordinary" outpatient individual psychotherapy in private practice for patients with moderate to severe PDs. Patients in both treatment groups showed improvements in several clinical measures after 36 months. However, contrary to our expectations, patients in the outpatient treatment setting improved significantly more. Possible explanations for this surprising finding are discussed. The study cannot exclude the possibility that treatment aspects other than differences in modalities could explain some of the differential effectiveness (e.g. differences between therapists).

  4. IRIS Toxicological Review of Hexahydro-1,3,5-Trinitro-1,3,5-Triazine (Rdx) (External Review Draft)

    EPA Science Inventory

    The IRIS Toxicological Review of Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) was released for external peer review in September 2016. The EPA’s Science Advisory Board’s (SAB) Chemical Assessment Advisory Committee (CAAC) will conduct a peer review of the scientific basis suppor...

  5. IRIS Toxicological Review of Hexahydro-1,3,5-Trinitro-1,3,5-Triazine (Rdx) (Interagency Science Consultation Draft)

    EPA Science Inventory

    On March 10, 2016, the public comment draft Toxicological Review of Hexahydro-1,3,5-trinitro-1,3,5-triazine and the draft charge to external peer reviewers were released for public review and comment. The Toxicological Review and charge were reviewed internally by EPA and by othe...

  6. IRIS Toxicological Review of Hexahydro-1,3,5-Trinitro-1,3,5-Triazine (Rdx) (Interagency Science Consultation Draft)

    EPA Science Inventory

    On March 10, 2016, the public comment draft Toxicological Review of Hexahydro-1,3,5-trinitro-1,3,5-triazine and the draft charge to external peer reviewers were released for public review and comment. The Toxicological Review and charge were reviewed internally by EPA and by othe...

  7. IRIS Toxicological Review of Hexahydro-1,3,5-Trinitro-1,3,5-Triazine (Rdx) (Public Comment Draft)

    EPA Science Inventory

    EPA is developing an Integrated Risk Information System (IRIS) assessment of hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) and has released the draft assessment for public comment. When final, the assessment will appear on the IRIS database.

  8. IRIS Toxicological Review of Hexahydro-1,3,5-Trinitro-1,3,5-Triazine (Rdx) (Public Comment Draft)

    EPA Science Inventory

    EPA is developing an Integrated Risk Information System (IRIS) assessment of hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) and has released the draft assessment for public comment. When final, the assessment will appear on the IRIS database.

  9. Identification of ovine ruminal microbes capable of biotransforming hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX)

    USDA-ARS?s Scientific Manuscript database

    Bioremediation is of great interest in the detoxification of soil contaminated with residues from explosives such as hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX). Although there are numerous forms of in situ and ex situ bioremediation, ruminants would provide the option of an in situ bioreactor tha...

  10. IRIS Toxicological Review of Hexahydro-1,3,5-Trinitro-1,3,5-Triazine (Rdx) (External Review Draft)

    EPA Science Inventory

    The IRIS Toxicological Review of Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) was released for external peer review in September 2016. The EPA’s Science Advisory Board’s (SAB) Chemical Assessment Advisory Committee (CAAC) will conduct a peer review of the scientific basis suppor...

  11. 21 CFR 176.230 - 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...-thione. 3,5-Dimethyl-1,3,5,2H-tetrahydrothi-adiazine-2-thione may safely be used as a preservative in the... as a preservative for substances added to the pulp suspension prior to the sheet-forming operation provided that the preservative is volatilized by heat in the drying and finishing of the paper and...

  12. No changes of cardiometabolic and body composition parameters after 6-month add-on treatment with sarcosine in patients with schizophrenia.

    PubMed

    Strzelecki, Dominik; Kałużyńska, Olga; Szyburska, Justyna; Wlazło, Agata; Wysokiński, Adam

    2015-12-15

    This study was undertaken with the purpose to determine if there are changes in metabolic parameters during 6-month add-on treatment with sarcosine in patients with schizophrenia. This was a randomized double blind, placebo-controlled and parallel group study. Eligible participants were randomly assigned to receive 2g of sarcosine (n=30) or placebo (n=29). Sarcosine was administered as supplementation to the ongoing antipsychotic treatment. Augmentation with sarcosine had no effect on any of the analyzed cardiometabolic parameters. Also, augmentation with sarcosine had no effect on any of the analyzed body composition parameters. This is the first randomized placebo-controlled study to examine the metabolic safety of sarcosine in patients with schizophrenia. Clinically, this observation is of high importance considering how prevalent are metabolic abnormalities in patients with schizophrenia.

  13. Real-Life Experience with Aflibercept and Ranibizumab in the Treatment of Newly Diagnosed Neovascular Age-Related Macular Degeneration over 24 Months.

    PubMed

    Garweg, Justus G; Gerhardt, Christin; Kodjikian, Laurent; Pfister, Isabel B

    2017-09-01

    Comparative data appertaining to the long-term effects of Aflibercept or Ranibizumab in newly diagnosed cases of neovascular age-related macular degeneration (nAMD) over follow-up periods exceeding 12 months in clinical routine are scarce. In this retrospective comparative analysis, a case series of patients with treatment-naïve nAMD and requiring anti-vascular endothelial growth factor (VEGF) therapy in a routine clinical setting were treated with either Aflibercept [Afl (n = 106)] or Ranibizumab [Ran (n = 47)]. During the drug-loading phase, 3 monthly injections were administered. Thereafter, a treat-and-extend protocol was pursued for a maximum of 24 months. Ran was administered predominantly in eyes with classical lesions; Afl was administered in all others. The primary outcome parameters included anatomical and functional stability after 24 months. Patients were comparable regarding age, gender distribution, and lens status. Fewer patients presented with intraretinal fluid in the Afl- than in the Ran group at diagnosis (46.2% vs. 67.4%; P = 0.02), but not after the drug-loading phase. After the drug-loading phase, visual acuity [-4.2 letters (Afl) vs. -4.5 letters (Ran); P = 0.78] and the central foveal thickness remained stable. Linked to the lesion type, the number of scheduled clinical visits during the course of 24 months was higher for the Ran- than for the Afl group [11.9 ± 4.7 visits (Ran) vs. 8.4 ± 3.1 visits (Afl); P = 0.0005]. However, the total number of injections was similar [10.5 ± 2.8 (Ran) vs. 11.7 ± 3.6 (Afl); P = 0.06]. Based on tailoring according to the lesion type in cases of nAMD, the anatomical and the functional outcomes of treatment with either Afl or Ran were comparable for a maximum of 2 years.

  14. Six-month healing success rates after endodontic treatment using the novel GentleWave™ System: The pure prospective multi-center clinical study

    PubMed Central

    Le, Khang T.; Woo, Stacey M.; Rassoulian, Shahriar A.; McLachlan, Kimberly; Abbassi, Farah; Garland, Randy W.

    2016-01-01

    Background This prospective multi-center (PURE) clinical study evaluated healing rates for molars after root canal treatment employing the GentleWave® System (Sonendo, Inc., Laguna Hills, CA). Material and Methods Eighty-nine patients met the inclusion criteria and consented for this clinical study after referral for a root canal treatment. All enrolled patients were treated with the GentleWave System. Five endodontists performed the clinical procedures and follow-up evaluations. Pre-operative, intra-operative, and post-operative 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 tooth radiographs for apical periodontitis using the periapical index (PAI). The teeth classified as healing or healed were considered as a success and composed of a cumulative success rate of healing. Statistical analysis was performed by using the Fisher’s exact test, Pearson correlation, and multivariate logistic regression analyses of the pre-operative prognostic factors at 0.05 significance level. Results Seventy-seven patients were evaluated at six months with a follow-up rate of 86.5%. The cumulative success rate of healing was 97.4%. Eleven prognostic factors were identified using bivariate analyses. Using logistic analyses, the two prognostic significant variables that were directly correlated to healing were the pre-operative presence of periapical index (p value=0.016), and single treatment visits (p value=0.024). Conclusions In this six-month PURE clinical study, the cumulative success rate of healing was 97.4% when patients were treated with the GentleWave® System. Key words:Healing rate, root canal treatment, molar, GentleWave™, Sonendo®, Multisonic Ultracleaning™ . PMID:27398180

  15. Treatment of renal anaemia with erythropoiesis-stimulating agents in predialysis chronic kidney disease patients: Haemoglobin profile during the 6 months before initiation of dialysis.

    PubMed

    Kawahara, Kazuhiko; Minakuchi, Jun; Yokota, Narushi; Suekane, Hiroto; Tsuchida, Kenji; Kawashima, Shu

    2015-12-01

    Erythropoiesis-stimulating agents (ESAs) are all effective for renal anaemia in patients with chronic kidney disease (CKD). However, it was reported that the haemoglobin (Hb) concentration decreases to 8.4 g/dL during the initial phase of dialysis despite treatment with recombinant human erythropoietin (rHuEPO). This study compared Hb at the initiation of dialysis among patients treated with three different ESAs (rHuEPO, darbepoetin alfa [DA], and a continuous erythropoietin receptor activator [CERA]). The subjects were 82 CKD patients who started dialysis at Kawashima Hospital between 1 January 2009 and 28 February 2015 and who received only one kind of ESA for at least 6 months before initiation of dialysis. Baseline characteristics and laboratory data at initiation of dialysis were compared among the three groups. Then changes of the Hb, ESA dose, and erythropoiesis resistance index were assessed over time during the 6 months before initiation of dialysis. Differences of Hb at the initiation of dialysis were also assessed. Among the 82 patients, 36 received rHuEPO, 13 received DA, and 33 received CERA. Baseline characteristics and laboratory data of the patients showed no significant differences among the three groups. The monthly Hb decreased gradually during the 6-month period before initiation of dialysis in all three groups. Hb was significantly higher in the CERA group than the rHuEPO group at the initiation of dialysis. Long-acting ESAs may be more useful for predialysis patients with CKD because they do not attend hospital frequently, unlike haemodialysis patients. © 2015 Asian Pacific Society of Nephrology.

  16. 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).

  17. 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

  18. Paliperidone palmitate 3-month treatment results in symptomatic remission in patients with schizophrenia: a randomized, multicenter, double-blind, and noninferiority study.

    PubMed

    Savitz, Adam J; Xu, Haiyan; Gopal, Srihari; Nuamah, Isaac; Hough, David; Mathews, Maju

    2017-08-11

    The current analysis assessed symptomatic and functional remission achieved following paliperidone palmitate 3-month (PP3M) versus 1-month (PP1M) treatment in patients (age: 18-70 years) with schizophrenia, previously stabilized on PP1M. Following a less than or equal to 3-week screening, and a 17-week, flexible-dosed, open-label phase [PP1M: day 1 (150 mg eq. deltoid), day 8 (100 mg eq. deltoid), weeks 5, 9, and 13 (50, 75, 100, or 150 mg eq., deltoid/gluteal)], clinically-stable patients were randomized (1 : 1) to PP3M (fixed-dose, 175, 263, 350, or 525 mg eq. deltoid/gluteal) or PP1M (fixed-dose, 50, 75, 100, or 150 mg eq. deltoid/gluteal) in 48-week double-blind (DB) phase. Symptomatic remission was assessed using Andreasen's criteria. Functional remission was assessed using Personal and Social Performance scale (PSP). More than 50% patients in both groups achieved symptomatic remission (PP3M: 50.3%; PP1M: 50.8%) during last 6 months of DB phase. Similar percentage of patients of both groups achieved functional remission (defined as PSP score>70, PP3M: 42.5%; PP1M: 43.9%) and combined remission (symptomatic and functional remission, PP3M: 25.1%; PP1M: 26.6%) during last 6 months of DB phase. Most patients who achieved remission at DB baseline maintained their remission status throughout the DB phase. PP3M and PP1M achieved comparable symptomatic and functional remissions during the DB phase.

  19. Removing dentine caries in deciduous teeth with Carisolv: a randomised, controlled, prospective study with six-month follow-up, comparing chemomechanical treatment with drilling.

    PubMed

    Bergmann, Jørgen; Leitão, Jorge; Kultje, Christina; Bergmann, Dorte; Clode, Maria João

    2005-01-01

    Dental fear is often associated with experience of pain, unpleasant sounds and uncomfortable vibrations caused by dental drills. Therefore patients welcome alternative, less painful excavating methods such as lasers, sandblasters and chemomechanical systems. The aim of this study was to compare a chemomechanical caries removal system (Carisolv) to traditional drilling with regard to patient acceptance and time consumption as well as the six-month success rate of fillings. Ninety-two primary teeth in 46 children were included in the study. From this study, the following conclusions can be drawn: patient acceptance of Carisolv-treatment compared to drilling is excellent, since 65% would choose Carisolv and no one drilling when treated next time. The dentists rated patients' degree of pain significantly lower in Carisolv situations than in drill situations. Time consumption is significantly higher when excavating with Carisolv (6.7 min.) than with drill (3.3 min.). The durability of fillings six months after treatment is equal in the two groups.

  20. [Efficacy of a program for tobacco use cessation with a combined substitution treatment of nicotine (patches plus chewing gum) at 6 months of follow-up].

    PubMed

    Toral, J; Ortega, F; Cejudo, P; Güalberto, M R; Sánchez, H; Montemayor, T

    1998-06-01

    Our aim was to assess the efficacy after 6 months of combined smoking cessation therapy using nicotine substitution with both chewing gum and patches. Sixty-six (25 women, 41 men) heavy smokers (38.04 packs/year and 8.42 mean score on Fagerström test) were followed between September 1995 and March 1997. Most patients were referred by respiratory, cardiology or ear-nose-and-throat outpatient clinics. The patients were prescribed 24-hour nicotine substitution therapy with 21 mg patches, plus chewing gum providing 2 mg of nicotine (3 to 10 per day) for a minimum of 8 weeks and a maximum of 12, with gradually decreasing doses. The patients were checked 1, 2, 4, 8, 12 and 24 weeks after enrollment. Expired air carbon monoxide was measured to confirm abstinence at each checkup and a simple questionnaire was filled in to assess abstinence syndrome and detect the presence of treatment side effects. Rate of abstinence achieved with this protocol after six months of follow-up was 37.9%. The failure rate was highest in the first week (33%) but gradually decreased until week 12. No patients had to abandon treatment due to side effects.

  1. 2' Derivatives of guanosine and inosine cyclic 3',5'-phosphates. Synthesis, enzymic activity, and the effect of 8-substituents.

    PubMed

    Miller, J P; Boswell, K H; Mian, A M; Meyer, R B; Robins, R K; Khwaja, T A

    1976-01-13

    A series of representative derivatives of guanosine cyclic 3',5'-phosphate (cGMP) and inosine cyclic 3',5'-phosphate (cIMP) which contained modifications in either the 2' position or the 8 and 2' positions were synthesized. Three types of derivatives were investigated: (1) derivatives in which the 2' position has been altered to produce a 2'-deoxynucleoside cyclic 3',5'-phosphate or a 9-beta-D-arabinofuranosylpurine cyclic 3',5'-phosphate; (2) 2'-omicron-acyl derivatives; and (3) doubly modified derivatives containing a 2' modification [as in (1) and (2)] and an 8-substitution. 2'-Deoxyinosine cyclic 3',5'-phosphate and 9-beta-D-arabinofuranosylhypoxanthine cyclic 3',5'-phosphate were obtained by HNO2 deamination of 2'-deoxyadenosine cyclic 3',5'-phosphate and 9-beta-D-arabinofuranosyladenine cyclic 3',5'-phosphate (ara-cAMP), respectively. Treatment of 8-bromo-2'-omicron-(p-toluenesulfonyl) adenosine cyclic 3',5'-phosphate with NaSH yielded the intermediate 8,2'-anhydro-9-beta-D-arabinofuranosyl-8-mercaptoadenine cyclic 3',5-phosphate, which was converted directly to 2'-deoxyadenosine cyclic 3',5'-phosphate (dcAMP) by treatment with Raney nickel. 8-Bromo-2'-omicron-(p-toluenesulfonyl) guanosine cyclic 3',5'-phosphate was converted to 8,2'-anhydro-9-beta-D-arabinofuranosyl-8-mercaptoguanine cyclic 3',5'-phosphate, and the latter was desulfurized with Raney nickel to give 2-deoxyguanosine cyclic 3',5'-phosphate. Ara-cAMP, 9-beta-D-arabinofuranosylguanine cyclic 3',5'-phosphate, and 9-beta-D-arabinofuranosyl-8-mercaptoguanine cyclic 3',5'-phosphate have been previously reported (Mian et al. (1974), J. Med. Chem. 17, 259). 8-Bromo-2'-omicron-acetylinosine cyclic 3',5'-phosphate and 8-[(p-chlorophenyl)thio]-2'-omicron-acetylinosine cyclic 3',5'-phosphate were produced by acylation of 8-bromoinosine cyclic 3',5'-phosphate and 8-[(p-chlorophenyl)thio]inosine cyclic 3',5'-phosphate, respectively; while 8-bromo-2'-omicron-butyrylguanosine cyclic 3',5'-phosphate was

  2. Protocol for the effect evaluation of independent medical evaluation after six months sick leave: a randomized controlled trial of independent medical evaluation versus treatment as usual in Norway.

    PubMed

    Husabo, Elisabeth; Monstad, Karin; Holmås, Tor Helge; Oyeflaten, Irene; Werner, Erik L; Maeland, Silje

    2017-06-14

    It has been discussed whether the relationship between a patient on sick leave and his/her general practitioner (GP) is too close, as this may hinder the GP's objective evaluation of need for sick leave. Independent medical evaluation involves an independent physician consulting the patient. This could lead to new perspectives on sick leave and how to follow-up the patient. The current study is a randomized controlled trial in a Norwegian primary care context, involving an effect evaluation, a cost/benefit analysis, and a qualitative evaluation. Independent medical evaluation will be compared to treatment as usual, i.e., the physicians' and social insurance agencies' current management of long-term sick-listed patients. Individuals aged 18-65 years, sick listed by their GP and on full or partial sick leave for the past 6 months in Hordaland county will be included. Exclusion criteria are pregnancy, cancer, dementia or an ICD-10 diagnosis. A total sample of 3800 will be randomly assigned to either independent medical evaluation or treatment as usual. Official register data will be used to measure the primary outcome; change in sickness benefits at 7, 9 and 12 months. Sick listed in other counties will serve as a second control group, if appropriate under the "common trend" assumption. The Norwegian effect evaluation of independent medical evaluation after 6 months sick leave is a large randomized controlled trial, and the first of its kind, to evaluate this type of intervention as a means of getting people back to work after long-term sickness absence. ClinicalTrials.gov NCT02524392 . Registered June 23, 2015.

  3. Neurocognitive performance and behavioral symptoms in patients with attention-deficit/hyperactivity disorder during twenty-four months of treatment with methylphenidate.

    PubMed

    Wang, Liang-Jen; Chen, Chih-Ken; Huang, Yu-Shu

    2015-04-01

    This study investigated the trends in neurocognitive function and behavioral symptoms among patients with attention-deficit/hyperactivity disorder (ADHD) during 24 months of treatment with methylphenidate in a clinical setting. Study participants consisted of 181 ADHD patients with a mean age of 13.4±2.5 years (ages ranged from 8 to 18 years; 151 boys and 30 girls) who were prescribed oral short-acting methylphenidate two or three times daily, with each dose ranging between 0.3 and 1.0 mg/kg. At baseline and 6, 12, 18, and 24 months from baseline, neurocognitive function was assessed using the Test of Variables of Attention (TOVA) on the day the patient was off medication, and behavioral symptoms were evaluated using the Swanson, Nolan, and Pelham Version IV Scale for ADHD (SNAP-IV) parent form, the SNAP-IV teacher form, and the ADHD-Rating Scale (completed by a child psychiatrist). Of the 181 ADHD patients at the initial visit, 103 (56.9%) completed the study. During the 24-month methylphenidate treatment, only the commission errors in TOVA significantly improved; however, the omission errors, response time, response time variability, response sensitivity, and ADHD score did not. The behavioral symptoms of ADHD, observed by various informants, all declined substantially, and were significantly correlated with each other during the long-term follow-up. The severity of teacher ratings was lower than that of parent and psychiatrist ratings. However, the teacher-rated inattention symptoms showed the strongest correlations with TOVA performance. Findings suggest that neurocognitive deficits in ADHD patients, except inhibition ability, might be long lasting in realistic settings. In addition, obtaining behavior profile assessments from multiple informants, especially from teachers, is vital for establishing a complete understanding of ADHD patients.

  4. 3.5 cm artificial urinary sphincter cuff erosion occurs predominantly in irradiated patients.

    PubMed

    Simhan, Jay; Morey, Allen F; Singla, Nirmish; Tausch, Timothy J; Scott, J Francis; Lemack, Gary E; Roehrborn, Claus G

    2015-02-01

    We analyzed our initial 100-case experience with the 3.5 cm artificial urinary sphincter cuff to identify risk factors for cuff erosion. We reviewed the records of a single surgeon, consecutive series of patients treated with 3.5 cm artificial urinary sphincter cuff placement from September 2009 to August 2013. Each patient underwent single perineal cuff placement via standardized technique. Preoperative characteristics, technical considerations and postoperative outcomes were analyzed and compared to those in a cohort of patients in whom a larger (4.0 cm or greater) artificial urinary sphincter cuff was placed during the same period. We identified clinical factors associated with an increased risk of 3.5 cm artificial urinary sphincter cuff erosion. Of the 176 men who met study inclusion criteria during the 4-year period 100 (57%) received the 3.5 cm artificial urinary sphincter cuff and 76 (43%) received a larger cuff (4.0 cm or greater). The continence rate (83% vs 80%, p = 0.65) and mean followup (32 vs 25 months, p = 0.14) were similar in the 2 groups. Erosion developed in 16 of the 176 patients (9%) during the study period, of whom 13 had the 3.5 cm cuff. Of the 100 patients with the 3.5 cm cuff 52 (52%) had a history of radiation, including 11 (21%) with erosion. Cuff erosion developed only rarely in nonirradiated men (2 of 48 or 4%, p = 0.01). A history of radiation was the only significant risk factor associated with 3.5 cm cuff erosion (OR 6.2, 95% CI 1.3-29.5). Men with a history of radiation who underwent placement of a 3.5 cm artificial urinary sphincter cuff experienced an increased (21%) risk of cuff erosion. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  5. Postural and Balance Disorders in Patients with Parkinson's Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment

    PubMed Central

    Santamato, Andrea; Ranieri, Maurizio; Cinone, Nicoletta; Stuppiello, Lucia Anna; Valeno, Giovanni; De Sanctis, Jula Laura; Fortunato, Francesca; Solfrizzi, Vincenzo; Greco, Antonio; Seripa, Davide; Panza, Francesco

    2015-01-01

    Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson's disease (PD) to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy) for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients. PMID:26798551

  6. Postural and Balance Disorders in Patients with Parkinson's Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment.

    PubMed

    Santamato, Andrea; Ranieri, Maurizio; Cinone, Nicoletta; Stuppiello, Lucia Anna; Valeno, Giovanni; De Sanctis, Jula Laura; Fortunato, Francesca; Solfrizzi, Vincenzo; Greco, Antonio; Seripa, Davide; Panza, Francesco

    2015-01-01

    Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson's disease (PD) to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy) for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients.

  7. Characteristics and treatment interests among individuals with substance use disorders and a history of past six-month violence: findings from an emergency department study.

    PubMed

    Chermack, Stephen T; Murray, Regan; Kraus, Shane; Walton, Maureen A; Cunningham, Rebecca M; Barry, Kristen L; Booth, Brenda M; Blow, Frederic C

    2014-01-01

    The study examined clinical characteristics and treatment interests of individuals identified to have substance use disorders (SUDs) in an urban emergency department (ED) who reported past six-month history of violence or victimization. Specifically, participants were 1441 ED patients enrolled in a randomized controlled trial of interventions designed to link those with SUDs to treatment. To examine factors related to violence type, four groups based on participants' reports of violence toward others were created: no violence (46.8%), partner violence only (17.3%), non-partner violence only (20.2%), and both partner and non-partner violence (15.7%). Four groups based on participants' reports of victimization were also created: no violence (42.1%), victimization from partner only (18.7%), victimization from non-partner only (20.2%), and both partner and non-partner victimization (17.7%). Separate multinomial logistic regression analyses were conducted to examine which variables distinguished the violence and victimization groups from those reporting no violence or victimization. For violence toward others, demographic variables, alcohol and cocaine disorders, and rating treatment for psychological problems were higher for violence groups, with some differences depending on the type of violence. For victimization, demographic variables, having an alcohol disorder, and rating treatment for family/social problems were higher for violence groups, also with some differences depending on the type of violence. Findings from the present study could be useful for designing effective brief interventions and services for ED settings. © 2013.

  8. Comprehensive treatment for co-occurring child maltreatment and parental substance abuse: outcomes from a 24-month pilot study of the MST-Building Stronger Families program.

    PubMed

    Schaeffer, Cindy M; Swenson, Cynthia Cupit; Tuerk, Elena Hontoria; Henggeler, Scott W

    2013-08-01

    This manuscript presents outcomes from a pilot study of Multisystemic Therapy-Building Stronger Families (MST-BSF), an integrated treatment model for the co-occurring problem of parental substance abuse and child maltreatment among families involved in the child welfare system. Participants were 25 mother-youth dyads who participated in MST-BSF and an additional 18 families with similar demographic and case characteristics who received Comprehensive Community Treatment (CCT). At post-treatment, mothers who received MST-BSF showed significant reductions in alcohol use, drug use, and depressive symptoms; they also significantly reduced their use of psychological aggression with the youth. Youth reported significantly fewer anxiety symptoms following MST-BSF treatment. Relative to families who received CCT, mothers who received MST-BSF were three times less likely to have another substantiated incident of maltreatment over a follow-up period of 24 months post-referral. The overall number of substantiated reabuse incidents in this time frame also was significantly lower among MST-BSF families, and youth who received MST-BSF spent significantly fewer days in out-of-home placements than did their CCT counterparts. These promising preliminary outcomes support the viability of a more rigorous (i.e., randomized) evaluation of the MST-BSF model.

  9. Characteristics and treatment interests among individuals with substance use disorders and a history of past six-month violence: Findings from an emergency department study

    PubMed Central

    Chermack, Stephen T.; Murray, Regan; Kraus, Shane; Walton, Maureen A.; Cunningham, Rebecca M.; Barry, Kristen L.; Booth, Brenda M.; Blow, Frederic C.

    2014-01-01

    The study examined clinical characteristics and treatment interests of individuals identified to have substance use disorders (SUDs) in an urban emergency department (ED) who reported past six-month history of violence or victimization. Specifically, participants were 1441 ED patients enrolled in a randomized controlled trial of interventions designed to link those with SUDs to treatment. To examine factors related to violence type, four groups based on participants’ reports of violence toward others were created: no violence (46.8%), partner violence only (17.3%), non-partner violence only (20.2%), and both partner and non-partner violence (15.7%). Four groups based on participants’ reports of victimization were also created: no violence (42.1%), victimization from partner only (18.7%), victimization from non-partner only (20.2%), and both partner and non-partner victimization (17.7%). Separate multinomial logistic regression analyses were conducted to examine which variables distinguished the violence and victimization groups from those reporting no violence or victimization. For violence toward others, demographic variables, alcohol and cocaine disorders, and rating treatment for psychological problems were higher for violence groups, with some differences depending on type of violence. For victimization, demographic variables, having an alcohol disorder, and rating treatment for family/social problems were higher for violence groups, also with some differences depending on type of violence. Findings from the present study could be useful for designing effective brief interventions and services for ED settings. PMID:24148140

  10. Impact of a timed-release follicle-stimulating hormone treatment from one to three months of age on endocrine and testicular development of prepubertal bulls.

    PubMed

    Harstine, B R; Cruppe, L H; Abreu, F M; Utt, M D; Cipriano, R S; Lemes, A; Premanandan, C; DeJarnette, J M; Day, M L

    2017-04-01

    In prepubertal bulls, FSH facilitates testis maturation and a transient proliferation of Sertoli cells. Two experiments examined the effects of exogenous FSH on hormone secretion and testis development in Angus bulls. Exogenous FSH treatment consisted of an intramuscular injection (i.m.) of 30 mg FSH (Folltropin-V) in a 2% hyaluronic acid solution (FSH-HA). In Exp. 1,