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Adverse Experiences (adverse + experience)
Selected AbstractsAPVMA's Annual Report of Adverse Experiences for Veterinary Medicines 2003AUSTRALIAN VETERINARY JOURNAL, Issue 9 2004PJ Dagg No abstract is available for this article. [source] Morning cortisol Levels in preschool-aged foster children: Differential effects of maltreatment type,DEVELOPMENTAL PSYCHOBIOLOGY, Issue 1 2009Jacqueline Bruce Abstract Maltreated foster children are subjected to a range of early adverse experiences, including neglect, abuse, and multiple caregiver disruptions. Research suggests that such disturbances alter the development and subsequent functioning of the hypothalamic-pituitary-adrenocortical system. The current study was designed to investigate morning cortisol levels in 117 foster children and 60 low-income, nonmaltreated children. Maltreatment and foster care placement experiences were coded from official records. Analyses revealed that the foster children were significantly more likely than the nonmaltreated children to have low morning cortisol levels. Additionally, specific maltreatment experiences were significantly associated with the foster children's morning cortisol levels. Foster children with low morning cortisol levels experienced more severe physical neglect than the other foster children. In contrast, foster children with high morning cortisol levels experienced more severe emotional maltreatment. These results suggest that specific early adverse experiences have differential effects on the functioning of the hypothalamic-pituitary-adrenocortical system. © 2008 Wiley Periodicals, Inc. Dev Psychobiol 51: 14,23, 2009 [source] Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetesDIABETES OBESITY & METABOLISM, Issue 2 2010T. Vilsbøll Objective: To evaluate the efficacy and tolerability of sitagliptin when added to insulin therapy alone or in combination with metformin in patients with type 2 diabetes. Methods: After a 2 week placebo run-in period, eligible patients inadequately controlled on long-acting, intermediate-acting or premixed insulin (HbA1c , 7.5% and , 11%), were randomised 1:1 to the addition of once-daily sitagliptin 100 mg or matching placebo over a 24-week study period. The study capped the proportion of randomised patients on insulin plus metformin at 75%. Further, the study capped the proportion of randomised patients on premixed insulin at 25%. The metformin dose and the insulin dose were to remain stable throughout the study. The primary endpoint was HbA1c change from baseline at week 24. Results: Mean baseline characteristics were similar between the sitagliptin (n = 322) and placebo (n = 319) groups, including HbA1c (8.7 vs. 8.6%), diabetes duration (13 vs. 12 years), body mass index (31.4 vs. 31.4 kg/m2), and total daily insulin dose (51 vs. 52 IU), respectively. At 24 weeks, the addition of sitagliptin significantly (p < 0.001) reduced HbA1c by 0.6% compared with placebo (0.0%). A greater proportion of patients achieved an HbA1c level < 7% while randomised to sitagliptin as compared with placebo (13 vs. 5% respectively; p < 0.001). Similar HbA1c reductions were observed in the patient strata defined by insulin type (long-acting and intermediate-acting insulins or premixed insulins) and by baseline metformin treatment. The addition of sitagliptin significantly (p < 0.001) reduced fasting plasma glucose by 15.0 mg/dl (0.8 mmol/l) and 2-h postmeal glucose by 36.1 mg/dl (2.0 mmol/l) relative to placebo. A higher incidence of adverse experiences was reported with sitagliptin (52%) compared with placebo (43%), due mainly to the increased incidence of hypoglycaemia (sitagliptin, 16% vs. placebo, 8%). The number of hypoglycaemic events meeting the protocol-specified criteria for severity was low with sitagliptin (n = 2) and placebo (n = 1). No significant change from baseline in body weight was observed in either group. Conclusion: In this 24-week study, the addition of sitagliptin to ongoing, stable-dose insulin therapy with or without concomitant metformin improved glycaemic control and was generally well tolerated in patients with type 2 diabetes. [source] Cumulative adversity and drug dependence in young adults: racial/ethnic contrastsADDICTION, Issue 3 2003R. Jay Turner ABSTRACT Aims To study cumulative exposure to stressors as a risk factor for drug dependence, and evaluate whether group differences in exposure contribute to differences in prevalence. Design Cross-sectional community survey of life-time adverse experiences and substance and psychiatric disorders. Setting Data collected between 1997 and 2000 in Miami,Dade County, USA. Participants A total of 1803 former Miami,Dade public school students, 93% between ages 19 and 21 years when interviewed. Males and females of Cuban origin, other Caribbean basin Hispanics, African-Americans and non-Hispanic whites are represented equally. Measurements Drug dependence disorder assessed by DSM-IV criteria using the Composite International Diagnostic Interview, and a 41-item checklist of life-time exposure to major and potentially traumatic experiences. Both measures include age at time of first occurrence. Findings Life-time rate of drug dependence disorder (total 14.3%) did not vary significantly (P > 0.05) by socio-economic group. Male rate (17.6%) was significantly greater than female rate (10.9%). The African-American rate (6.5%) was dramatically lower than non-Hispanic white (17.0%), Cuban (18.1%) and non-Cuban Hispanic (16.0%) rates despite their dramatically higher exposure to adversity. Twenty-eight of 33 individual adversities were associated with the subsequent onset of drug dependence (P < 0.05). Cumulative life-time exposure was greatest for males and for African-Americans, and was associated inversely with socio-economic level. Multivariate discrete-time event history analysis revealed significant independent effects of distal (>1 year earlier) and proximal (previous year) exposure to adverse events (P < 0.05), controlling for childhood conduct disorder, attention deficit hyperactive disorder and previous psychiatric disorder. Conclusions Life-time cumulative exposure to distant as well as more recent adversity predicts risk of subsequent drug dependence, although it does not explain ethnic group differences in risk. [source] Infliximab in the treatment of severe, steroid-refractory ulcerative colitis: A pilot studyINFLAMMATORY BOWEL DISEASES, Issue 2 2001Dr. Bruce E. Sands Abstract We report the experience of 11 patients (of 60 planned patients) enrolled in a double-blind, placebo-controlled clinical trial of infliximab in patients with severe, active steroid-refractory ulcerative colitis. The study was terminated prematurely because of slow enrollment. Patients having active disease for at least 2 weeks and receiving at least 5 days of intravenous corticosteroids were eligible to receive a single intravenous infusion of infliximab at 5, 10, or 20 mg/kg body weight. The primary endpoint used in this study was treatment failure at 2 weeks after infusion. Treatment failure was defined as 1) unachieved clinical response as defined by a modified Truelove and Witts severity score, 2) increase in corticosteroid dosage, 3) addition of immunosuppressants, 4) colectomy, or 5) death. Safety evaluations included physical examination, clinical chemistry and hematology laboratory tests, and occurrence of adverse experiences. Four of 8 patients (50%) who received infliximab were considered treatment successes at 2 weeks, compared with none of 3 patients who received placebo. Improvement in erythrocyte sedimentation rates and serum concentrations of C-reactive protein and interleukin-6 correlated with the clinical response observed in patients receiving infliximab. Infusion with infliximab produced no significant adverse events. Infliximab was well tolerated and may provide clinical benefit for some patients with steroid-refractory ulcerative colitis. [source] Safety and Immunogenicity Profile of the Concomitant Administration of ZOSTAVAX and Inactivated Influenza Vaccine in Adults Aged 50 and OlderJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 10 2007Boris Kerzner MD OBJECTIVES: To evaluate the safety and immunogenicity of ZOSTAVAX administered concomitantly with inactivated influenza vaccine or sequentially in adults aged 50 and older. DESIGN: Randomized, blinded, placebo-controlled study. SETTING: Thirteen U.S. and seven European study sites. PARTICIPANTS: Three hundred eighty-two concomitantly, 380 sequentially vaccinated subjects. INTERVENTION: The concomitant vaccination group received influenza vaccine and ZOSTAVAX at separate injection sites on Day 1 and placebo at Week 4. The nonconcomitant vaccination group received influenza vaccine and placebo at separate injection sites on Day 1 and ZOSTAVAX at Week 4. MEASUREMENTS: Primary safety endpoints: vaccine-related serious adverse experiences (AEs) within 28 days postvaccination (PV); and diary card,prompted local and systemic AEs. Primary immunogenicity endpoints: geometric mean titer (GMT) and geometric mean fold rise (GMFR) from baseline of varicella-zoster virus (VZV) antibody (Ab) at 4 weeks PV according to glycoprotein enzyme-linked immunosorbent assay (gpELISA) and GMT of influenza Ab for the three vaccine strains (2005,2006 influenza season) at 4 weeks PV according to hemagglutination inhibition assay. Secondary immunogenicity endpoint: influenza seroconversion rates (SCRs). RESULTS: No serious AEs related to ZOSTAVAX were observed during the study. VZV Ab GMTs 4 weeks PV for the concomitant and sequential groups were 554 and 597 gpELISA U/mL, respectively. The estimated VZV Ab GMT ratio was 0.9 (95% confidence interval (CI)=0.8,1.0), indicating noninferior (P<.001 for the null hypothesis of GMT ratio <0.67) responses. Estimated VZV Ab GMFR from baseline in the concomitant group was 2.1 (95% CI=2.0,2.3), indicating acceptable fold rise. Estimated GMT ratios (concomitant/sequential) for influenza strains A(H1N1), A(H3N2), and B were 0.9 (95% CI=0.8,1.1), 1.1 (95% CI=0.9,1.3), and 0.9 (95% CI=0.8,1.1), respectively, and SCRs were comparable across both groups, with more than 85% achieving titers of 1:40 or greater, meeting regulatory criteria. CONCLUSION: ZOSTAVAX and influenza vaccine given concomitantly are generally well tolerated in adults aged 50 and older. Ab responses were similar whether ZOSTAVAX and influenza vaccine were given concomitantly or sequentially. [source] The Influence of Anger-arousal Level on Attribution of Hostile Intent and Problem Solving Capability in an Individual with a Mild Intellectual Disability and a History of Difficulties with AggressionJOURNAL OF APPLIED RESEARCH IN INTELLECTUAL DISABILITIES, Issue 1 2006Kenneth M. A. MacMahon Background, Recent studies have suggested that cognitive biases may play an important mediating role in aggressive outbursts from people with mild intellectual disabilities (IDs). Essentially, some individuals may frequently perceive other people as acting towards them in a hostile fashion. This biased perception may develop through repeated adverse experiences, and may make them more likely to respond, likewise, in an aggressive manner. These studies have led to the development of a cognitive behavioural model of aggression, incorporating factors both intrinsic and extrinsic to the individual. This study aimed to explore one facet of this model: a putative relationship between anger-arousal level, problem-solving ability and perception of hostile intent in others. Method, Single-case methodology was utilized, and a 44-year-old man with a mild ID and a history of difficulties with aggression participated. A series of vignettes, containing potentially provocative social interactions, were read to the participant. His perception of hostile intent, and suggestions of possible behavioural responses were recorded as dependent variables. Anger-arousal was manipulated, through autobiographical recall, as a dependent variable. Results, Although not conclusive, results indicate that anger-arousal may act in an interactive fashion to increase perception of hostile intent. No effect of anger-arousal was observed on problem-solving ability; however, floor-effects in the task used may provide an explanation for this. Conclusions, A high level of anger-arousal may exacerbate the probability of a frequently aggressive individual perceiving others as acting in a hostile manner. However, future research should take the limitations of this study into account, and continue development of a cognitive model of frequent aggression in those with a mild ID. [source] Two-Year Results of Once-Weekly Administration of Alendronate 70 mg for the Treatment of Postmenopausal OsteoporosisJOURNAL OF BONE AND MINERAL RESEARCH, Issue 11 2002R Rizzoli Abstract The aim of this study was to provide confirmation that once-weekly dosing with 70 mg of alendronate (seven times the daily oral dose) and twice-weekly dosing with 35 mg is equivalent to the 10-mg once-daily regimen and to gain more extensive safety experience with this new dosing regimen. Twelve hundred fifty-eight postmenopausal women (aged 42,95 years) with osteoporosis (bone mineral density [BMD] of either lumbar spine or femoral neck at least 2.5 SDs below peak young adult mean or prior vertebral or hip fracture) were assigned to receive oral once-weekly alendronate, 70 mg (n = 519); twice-weekly alendronate, 35 mg (n = 369); or daily alendronate 10 mg (n = 370) for a total of 2 years of double-blind experience. Mean BMD increases from baseline (95% CI) at 24 months in the once-weekly, twice-weekly, and daily treatment groups, respectively, were 6.8% (6.4, 7.3), 7.0% (6.6, 7.5), and 7.4% (6.9, 7.8) at the lumbar spine and 4.1% (3.8, 4.5), 4.3% (3.9, 4.7), and 4.3% (3.9, 4.7) at the total hip. These increases in BMD as well as the BMD increases at the femoral neck, trochanter, and total body and the reductions of biochemical markers of bone resorption (urinary cross-linked N-telopeptides of type I collagen [NTx]) and bone formation (serum bone-specific alkaline phosphatase [BSAP]) were similar for the three dosing regimens. All treatment regimens were well tolerated with a similar incidence of upper gastrointestinal (GI) adverse experiences. The incidence rates of clinical fractures, captured as adverse experiences, were similar among the groups. The 2-year results confirm the conclusion reached after 1 year that once-weekly alendronate is therapeutically equivalent to daily dosing, providing patients with a more convenient dosing option that may potentially enhance adherence to therapy. [source] Use of yttrium-90 microspheres (TheraSphere®) in a patient with unresectable hepatocellular carcinoma leading to liver transplantation: A case reportLIVER TRANSPLANTATION, Issue 9 2005Laura M. Kulik Prior to therapy, model for end stage liver disease (MELD) scoring, diagnostic imaging and tumor staging were performed in a patient with T3 HCC. The patient received an orthotopic liver transplant (OLT) 42 days after treatment. The explant specimen showed complete necrosis of the target tumor. Follow-up of this patient has demonstrated no evidence of recurrence. There was no life threatening or fatal adverse experiences related to treatment. This case report documents the natural course, history and outcome of a patient treated with yttrium-90 for unresectable HCC. The patient was downstaged from T3 to T2 and was subsequently transplanted. (Liver Transpl 2005;11:1127,1131.) [source] Differences Between Mistimed and Unwanted Pregnancies Among Women Who Have Live BirthsPERSPECTIVES ON SEXUAL AND REPRODUCTIVE HEALTH, Issue 5 2004Denise V. D'Angelo CONTEXT: Mistimed and unwanted pregnancies that result in live births are commonly considered together as unintended pregnancies, but they may have different precursors and outcomes METHODS: Data from 15 states participating in the 1998 Pregnancy Risk Assessment Monitoring System were used to calculate the prevalence of intended, mistimed and unwanted conceptions, by selected variables. Associations between unintendedness and women's behaviors and experiences before, during and after the pregnancy were assessed through unadjusted relative risks. RESULTS: The distribution of intended, mistimed and unwanted pregnancies differed on nearly every variable examined; risky behaviors and adverse experiences were more common among women with mistimed than intended pregnancies and were most common among those whose pregnancies were unwanted. The likelihood of having an unwanted rather than mistimed pregnancy was elevated for women 35 or older (relative risk, 2.3) and was reduced for those younger than 25 (0.8); the pattern was reversed for the likelihood of mistimed rather than intended pregnancy (0.5 vs. 1.7,2.7). Parous women had an increased risk of an unwanted pregnancy (2.1,4.0) but a decreased risk of a mistimed one (0.9). Women who smoked in the third trimester, received delayed or no prenatal care, did not breastfeed, were physically abused during pregnancy, said their partner had not wanted a pregnancy or had a low-birth-weight infant had an increased risk of unintended pregnancy; the size of the increase depended on whether the pregnancy was unwanted or mistimed CONCLUSION: Clarifying the difference in risk between mistimed and unwanted pregnancies may help guide decisions regarding services to women and infants [source] Reproductive traits following a parent,child separation trauma during childhood: A natural experiment during World War IIAMERICAN JOURNAL OF HUMAN BIOLOGY, Issue 3 2008Anu-Katriina Pesonen Given the ethical limitations of exposing children to experimentally manipulated adverse experiences, evidence of the effects of childhood traumas on subsequent life history are based mostly on women's retrospective reports and animal studies. Only a few prospective studies have assessed the life-long consequences of childhood trauma. We asked whether a traumatic separation from both parents during childhood is associated with reproductive and marital traits later in life, measured by age of onset of menarche, timing of menopause, period of fertile years, age at first childbirth, birth spacing, number of children, and history of divorce. We studied members of the 1934,1944 Helsinki Birth Cohort, including 396 former war evacuees from varying socioeconomic backgrounds, who were sent unaccompanied by their parents to temporary foster families in Sweden and Denmark, and 503 participants who had no separation experiences. Data on separation experiences, number of children, and divorces experienced came from national registers, and the remaining data from a survey among the participants aged 61.6 years (SD = 2.9). Former evacuees had earlier menarche, earlier first childbirth (men), more children by late adulthood (women), and shorter interbirth intervals (men), than the non-separated. A traumatic experience in childhood is associated with significant alterations in reproductive and marital traits, which characterize both women and men. The implications are relevant to the 9.2 million child refugees living throughout the world today. Am. J. Hum. Biol., 2008. © 2008 Wiley-Liss, Inc. [source] Cumulative Adversity and Posttraumatic Stress Disorder: Evidence From a Diverse Community Sample of Young AdultsAMERICAN JOURNAL OF ORTHOPSYCHIATRY, Issue 4 2003Donald A. Lloyd PhD The authors hypothesized that a history of adversities, whether they were objectively traumatic or not, predicts risk for 1st onset of PTSD. Survival analysis in a community sample of 1,803 young adults revealed that risk is associated with retrospectively reported adverse experiences that occurred in years prior to the focal traumatic event. Analyses control for clustering of events proximal to onset. Implications for etiology and preventive intervention are noted. [source] Effects of policosanol treatment on the susceptibility of low density lipoprotein (LDL) isolated from healthy volunteers to oxidative modification in vitroBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 3 2000Roberto Menéndez Aims The aim of this study was to investigate the effect of policosanol on the susceptibility of LDL-C to in vitro lipid peroxidation in human healthy volunteers. Methods The effect of policosanol (5 and 10 mg day,1) on LDL-C oxidation was studied in a double-blind, randomized, placebo-controlled trial conducted in 69 subjects. LDL-C samples isolated at baseline and after 8 weeks were subjected to in vitro tests of LDL-C oxidation. We tested the susceptibility of LDL-C to lipid peroxidation in a cell-free system by the addition of copper ions as well as in a more physiological system, macrophage-mediated oxidation. Results At baseline all groups were well matched regarding all variables. After 8 weeks of therapy policosanol administered at 5 and 10 mg, significantly and in a dose-dependent manner increased the lag phase of conjugated diene generation (mean ± s.d.) from 83.79 ± 29.16 min to 94.90 ± 25.50 min (5 mg day,1) and from 82.74 ± 17.16 min to 129.89 ± 35.71 min (10 mg day,1), while in the placebo group LDL-C oxidation did not change significantly. Policosanol (10 mg day,1), but not placebo, significantly decreased the rate of conjugated diene generation. Comparison with placebo after therapy also showed significant differences. Macrophage mediated-oxidation was also inhibited by policosanol as evident by measuring thiobarbituric acid reactive substances (TBARS). Policosanol (10 mg day,1) significantly lowered malondialdehyde (MDA) generation from 8.50 ± 0.91 to 5.76 ± 1.01 nmol mg,1 protein. Comparison with placebo after 5 and 10 mg day,1 showed significant differences. Policosanol significantly lowered total cholesterol by 10.5% (5 mg day,1) and 12.4% (10 mg day,1) and LDL-C by 16.7% and 20.2%, respectively. Also, policosanol (10 mg day,1) increased HDL-C by 15.2%. Five subjects withdrew from the study, none because of adverse experiences. No clinical or blood biochemical drug-related disturbances were found. Conclusions The present study demonstrated that policosanol administered within its therapeutic dosage for lowering cholesterol (5 and 10 mg day,1), decreased the susceptibility of LDL-C to lipid peroxidation in vitro. [source] Are perceptions of parenting and interpersonal functioning related in those with personality disorder?CLINICAL PSYCHOLOGY AND PSYCHOTHERAPY (AN INTERNATIONAL JOURNAL OF THEORY & PRACTICE), Issue 3 2001Evidence from patients detained in a high secure setting We explored the widely-held assumption that dysfunctional interpersonal behaviour, a key characteristic of personality disorder, is associated with adverse experiences in childhood in a sample of patients detained in high secure care. We obtained Parental Bonding Inventory (PBI) and Chart of Interpersonal Relations in Closed Living Environment (CIRCLE) data from 79 patients detained at a high secure hospital. This comprised 48 with the legal classification (1983 Mental Health Act) of Psychopathic Disorder (PD) and 31 with the legal classification of Mental Illness (MI). On the PBI, the PD group had significantly lower care scores and increased protection scores compared with the MI group; the latter reported care and protection scores similar to those from published norms. The CIRCLE scores also demonstrated significantly different interpersonal functioning between the PD and MI groups, with each group typically plotted in opposing halves of the interpersonal circle (IPC). Although the PDs showed abnormalities in both the PBI and CIRCLE in the expected direction, there were no clear associations between aspects of abnormal parenting and adult dysfunctional interpersonal behaviour within this group. This finding did not confirm our hypothesis and we discuss possible explanations. Copyright © 2001 John Wiley & Sons, Ltd. [source] | ||||||||||