nils-herrmann/clean_scirepeval huggingface dataset:
Atomoxetine hydrochloride in the treatment of children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder: A placebo-controlled Italian study

The primary aim of this study was to assess the efficacy of atomoxetine in improving ADHD and ODD symptoms in paediatric patients with ADHD and comorbid oppositional defiant disorder (ODD), non-responders to previous psychological intervention with parent support.



This was a multicentre, randomised, placebo-controlled trial conducted in patients aged 6-15 years, with ADHD and ODD diagnosed according to the DSM-IV criteria by a structured clinical interview (K-SADS-PL). Only subjects who are non-responders to a 6-week standardized parent training were randomised to atomoxetine (up to 1.2 mg/kg/day) or placebo (in a 3:1 ratio) for the following 8-week double blind phase.



Only 2 of the 156 patients enrolled for the parent support phase (92.9% of males; mean age: 9.9 years), improved after the parent training program; 139 patients were randomised for entering in the study and 137 were eligible for efficacy analysis. At the end of the randomised double blind phase, the mean changes in the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV) ADHD subscale were -8.1+/-9.2 and -2.0+/-4.7, respectively in the atomoxetine and in the placebo group (p<0.001 between groups); changes in the ODD subscale were -2.7+/-4.1 and -0.3+/-2.6, respectively in the two groups (p=0.001 between groups). The CGI-ADHD-S score decreased in the atomoxetine group (median change at endpoint: -1.0) compared to no changes in the placebo group (p<0.001 between groups). Statistically significant differences between groups, in favour of atomoxetine, were found in the CHIP-CE scores for risk avoidance domain, emotional comfort and individual risk avoidance subdomains. An improvement in all the subscales of Conners Parents (CPRS-R:S) and Teacher (CTRS-R:S) subscales was observed with atomoxetine, except in the cognitive problems subscale in the CTRS-R:S. Only 3 patients treated with atomoxetine discontinued the study due to adverse events. No clinically significant changes of body weight, height and vital signs were observed in both groups.



Treatment with atomoxetine of children and adolescents with ADHD and ODD, who did not initially respond to parental support, was associated with improvements in symptoms of ADHD and ODD, and general health status. Atomoxetine was well tolerated.
Effects of pravastatin on mortality in patients with and without coronary heart disease across a broad range of cholesterol levels. The Prospective Pravastatin Pooling project.

To assess the effects of pravastatin on all-cause mortality and cause-specific mortality and to compare the effects for patients with prior coronary heart disease with those for patients without, using pooled data from the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) study, the Cholesterol and Recurrent Events (CARE) study, and the West of Scotland Coronary Prevention Study (WOSCOPS).



13 173 patients with coronary heart disease and 6595 men with elevated cholesterol and no prior coronary disease received pravastatin, 40 mg daily, or placebo for an average of 5 to 6 years. Data were analysed according to a pre-specified, 27%, P<0.0001). Active treatment was associated with a reduction in coronary mortality (24%, 95% CI 14-33%). Larger reductions in absolute risk were estimated in those with prior coronary heart disease than in those without.



Treatment with pravastatin over 5 years reduces all-cause mortality and coronary mortality in patients with and those without a history of coronary heart disease. The size of the benefit was related principally to the baseline risk.
Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial

The non-nucleoside reverse transcriptase inhibitor (NNRTI), rilpivirine (TMC278; Tibotec Pharmaceuticals, County Cork, Ireland), had equivalent sustained efficacy to efavirenz in a phase 2b trial in treatment-naive patients infected with HIV-1, but fewer adverse events. We aimed to assess non-inferiority of rilpivirine to efavirenz in a phase 3 trial with common background nucleoside or nucleotide reverse transcriptase inhibitors (N[t]RTIs).



We undertook a 96-week, phase 3, randomised, double-blind, double-dummy, non-inferiority trial in 98 hospitals or medical centres in 21 countries. We enrolled adults (≥18 years) not previously given antiretroviral therapy and with a screening plasma viral load of 5000 copies per mL or more and viral sensitivity to background N(t)RTIs. We randomly allocated patients (1:1) using a computer-generated interactive web-response system to receive oral rilpivirine 25 mg once daily or efavirenz 600 mg once daily; all patients received an investigator-selected regimen of background N(t)RTIs (tenofovir-disoproxil-fumarate plus emtricitabine, zidovudine plus lamivudine, or abacavir plus lamivudine). The primary outcome was non-inferiority (12% margin on logistic regression analysis) at 48 weeks in terms of confirmed response (viral load <50 copies per mL, defined by the intent-to-treat time to loss of virologic response [TLOVR] algorithm) in all patients who received at least one dose of study drug. 
From May 22, 2008, we screened 947 patients and enrolled 340 to each group. 86% of patients (291 of 340) who received at least one dose of rilpivirine responded, compared with 82% of patients (276 of 338) who received at least one dose of efavirenz (difference 3.5% [95% CI -1.7 to 8.8]; p(non-inferiority)<0.0001). Increases in CD4 cell counts were much the same between groups. 7% of patients (24 of 340) receiving rilpivirine had a virological failure compared with 5% of patients (18 of 338) receiving efavirenz. 4% of patients (15) in the rilpivirine group and 7% (25) in the efavirenz group discontinued treatment due to adverse events. Grade 2-4 treatment-related adverse events were less common with rilpivirine (16% [54 patients]) than they were with efavirenz (31% [104]; p<0.0001), as were rash and dizziness (p<0.0001 for both) and increases in lipid levels were significantly lower with rilpivirine than they were with efavirenz (p<0.0001).



Despite a slightly increased incidence of virological failures, a favourable safety profile and non-inferior efficacy compared with efavirenz means that rilpivirine could be a new treatment option for treatment-naive patients infected with HIV-1.
A simple method to assess freezing of gait in Parkinson's disease patients.

Freezing of gait (FOG) can be assessed by clinical and instrumental methods. Clinical examination has the advantage of being available to most clinicians; however, it requires experience and may not reveal FOG even for cases confirmed by the medical history. Instrumental methods have an advantage in that they may be used for ambulatory monitoring. The aim of the present study was to describe and evaluate a new instrumental method based on a force sensitive resistor and Pearson's correlation coefficient (Pcc) for the assessment of FOG. Nine patients with Parkinson's disease in the "on" state walked through a corridor, passed through a doorway and made a U-turn. We analyzed 24 FOG episodes by computing the Pcc between one "regular/normal" step and the rest of the steps. The Pcc reached ±1 for "normal" locomotion, while correlation diminished due to the lack of periodicity during FOG episodes. Gait was assessed in parallel with video. FOG episodes determined from the video were all detected with the proposed method. The computed duration of the FOG episodes was compared with those estimated from the video. The method was sensitive to various types of freezing; although no differences due to different types of freezing were detected. The study showed that Pcc analysis permitted the computerized detection of FOG in a simple manner analogous to human visual judgment, and its automation may be useful in clinical practice to provide a record of the history of FOG.
Short-term methotrexate could reduce early immune reactions and improve outcomes in umbilical cord blood transplantation for adults

Post transplant immune disorders are problematic in cord blood transplantation (CBT) for adult patients, and optimal prophylaxis has not been established. We investigated whether intensive graft-versus-host disease (GVHD) prophylaxis using short-term methotrexate (MTX) has a prognostic impact on CBT. Post-CBT immune reactions were classified according to time course as pre-engraftment immune reaction (PIR), engraftment syndrome (ES) or acute GVHD. Between March 2001 and November 2005, a total of 77 patients underwent CBT at eight transplantation centers. Median age was 48 years (range, 18–69 years). Preparative regimens comprised myeloablative (n=31) or reduced-intensity (n=46). Acute GVHD prophylaxis included cyclosporine alone (n=23), tacrolimus alone (n=12), cyclosporine plus MTX (n=17), tacrolimus plus short-term MTX (n=23) or cyclosporine plus methylprednisolone (n=2). Cumulative incidences of PIR, ES and grade II–IV GVHD were 36, 12 and 23%, respectively. Short-term MTX exerted significant favorable effects on post-CBT immune reactions (hazard ratio, 0.55; 95% confidence interval (95% CI), 0.31–0.98; P=0.04) in multivariate analysis. Overall survival rates for patients with and without short-term MTX at day 180 were 59% (95% CI, 42–73%) and 16% (95% CI, 6.6–30%) (P=0.0001), respectively. Short-term MTX could offer one optimal regimen to reduce immune reactions and improve outcomes in CBT.
Clearing clinical barriers: enhancing social support using a patient navigator for asthma care.

Patients with moderate or severe asthma, particularly those who are minority or poor, often encounter significant personal, clinical practice, and health system barriers to accessing care.



To explore the ideas of patients and providers for potentially feasible, individualized, cost-effective ways to reduce obstacles to care by providing social support using a patient advocate or navigator.



The authors conducted four focus groups of adults with moderate or severe asthma. Participants were recruited from clinics serving low-income and minority urban neighborhoods. Data from these patient focus groups were shared with two additional focus groups, one of nurses and one of physicians. Researchers independently coded and agreed upon themes from all focus groups, which were categorized by types of social support: instrumental (physical aid), informational (educational), emotional (empathizing), validation (comparisons to others).



Patients and providers agreed that a patient navigator could help patients manage asthma by giving social support. Both groups found instrumental and informational support most important. However, patients desired more instrumental help whereas providers focused on informational support. Physicians stressed review of medical information whereas patients wanted information to complete administrative tasks. Providers and patients agreed that the patient navigator's role in asthma would need to address both short-term care of exacerbations and enhance long-term chronic self-management by working with practice personnel.



Along with medical information, there is a need for providers to connect patients to instrumental support relevant to acute and long-term asthma-self-management.
Generalizability and durability of treatment effects in an intervention program for coronary-prone (type A) managers

To test the reliability and durability of positive treatment effects obtained in a type A intervention project for healthy managers, the analysis was extended to data available from a third treatment group (a special behavior therapy group for participants eliminated from the main sample because of manifestations of clinical CHD) and to measures obtained 6 months following the end of treatment. Immediately after treatment all three groups showed a similar pattern of improvement, although the two behavior therapy groups did show a greater decrease in serum cholesterol levels. Six months after treatment the sample as a whole showed good maintenance of treatment effects, but the differences between groups had become somewhat sharper, with the special behavior therapy group faring best, the regular behavior therapy group intermediate, and the psychotherapy group worst. The logical consistency of these findings increases our confidence in the initial treatment results, as well as permitting cautious optimism concerning the possibility of developing effective intervention programs for coronary-prone (type A) behavior.
Effects of acute administration of gallopamil on left ventricular relaxation and filling dynamics in acute myocardial infarction assessed by doppler echocardiography

The purpose of this study was to assess the acute effect of an intravenous bolus of the calcium antagonist gallopamil on left ventricular diastolic function using Doppler echocardiography. Fifteen patients with acute myocardial infarction in the first Killip class and sinus rhythm were randomized to an intravenous bolus of gallopamil (50 μg/kg over 5 minutes) or placebo in a crossover sequence. Doppler echocardiography was performed at baseline and 15 minutes after each bolus. No patients had received calcium antagonists or beta blockers before the study; all patients received nitroglycerin, which was withdrawn at least 2 hours before the baseline Doppler echocardiogram. The following Doppler parameters were calculated: the early (E) and late (A) peak filling velocities, the velocities ratio (E/A), the diastolic filling time-velocity integral (TVI), the peak filling rate normalized to the mitral stroke volume (nMPFR), the isovolumic relaxation time (IVRT), and the systolic flow velocity integral (SFVI). Expressing the parameters measured after a gallopamil bolus as the percent change of those measured after placebo, E, E/A, and nMPFR increased by 25.5±11.5%, 30.6±15.5%, and 19.0±12.2%, respectively (p<0.001); IVRT decreased by 13.5±7.0% (p<0.001); and TVI increased mildly by 6.9±9.9% (p=0.01). SFVI and A did not change significantly. Negligible differences were observed between placebo and baseline values. Heart rate, mean blood pressure, and left ventricular and atrial diameters did not change significantly. It was concluded that gallopamil infusion improves early left ventricular filling and relaxation in patients with acute myocardial infarction. Considering the unchanged loading conditions, this indicates an improvement in left ventricular diastolic performance.
Validation of the Totaled Health Risks In Vascular Events (THRIVE) score for outcome prediction in endovascular stroke treatment.

We recently developed the Totaled Health Risks In Vascular Events (THRIVE) score to predict outcomes after endovascular stroke treatment. The THRIVE score, which incorporates age, National Institutes of Health Stroke Scale score, and three medical comorbidities (hypertension, diabetes mellitus, and atrial fibrillation), was developed using data from the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) and Multi MERCI trials.



We set out to perform external validation of the THRIVE score using data from the largest registry of endovascular stroke treatment performed to date, the Merci Registry.



We compared the performance of the THRIVE score in two different data sets: the development cohort (the MERCI and Multi MERCI trials, n = 305) and a validation cohort (the Merci Registry, a prospective multicenter registry of patients undergoing endovascular stroke treatment, n = 1000). We examined the predictive utility of the THRIVE score across the range of clinical outcomes and used receiver-operator characteristics curve analysis to compare score performance in the two data sets.



The THRIVE score predicted good outcome, death, and the full range of the modified Rankin Scale in a similar fashion between the MERCI trials and the Merci Registry. Receiver-operator characteristics curve comparisons showed no statistically significant difference in the performance of the THRIVE score between the two data sets: for good outcome, the receiver-operator characteristics area under the curve was 0·293 for the MERCI trials and 0·266 for the Merci Registry (P = 0·47) and for death, the receiver-operator characteristics area under the curve was 0·692 for the MERCI trials and 0·717 for the Merci Registry (P = 0·48). The THRIVE score and vessel recanalization were also found to be independent and unrelated predictors of clinical outcome.



The THRIVE score reliably predicts outcomes after endovascular stroke treatment and may be useful as a clinical prognostic tool and to perform severity adjustments in stroke clinical research.
Estrogen Metabolizing Polymorphisms and Breast Cancer Risk Among Older White Women

To investigate breast cancer risk according to metabolizing genes polymorphisms in older women.  A subset (43.8%) of 4248 older, white women from the Study of Osteoporotic Fractures (SOF) were genotyped for the catechol-O-methyltransferase (COMT) Val108Met polymorphism and the CYP1A1*2C locus. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for the associations between genotypes and breast cancer while controlling for potential confounders.  During a mean follow up of 12.4 years, 252 women (5.9%) developed breast cancer. The HR (95% CI) for breast cancer was 1.24 (0.87–1.75) for COMT Val/Met and 1.35 (0.93–1.97) for COMT Met/Met . No interactions with lifestyle and reproductive factors were found. The HR associated with the CYP1A1*2C Val allele was 0.80 (0.46, 1.39) with little evidence for interactions with lifestyle or reproductive factors.   Among older white women, neither the COMT Val108/158Met polymorphism nor the CYP1A*2C Val allele plays a major role in breast cancer risk either alone or in combination with lifestyle and reproductive factors.
Associations of ECP (eosinophil cationic protein)-gene polymorphisms to allergy, asthma, smoke habits and lung function in two Estonian and Swedish sub cohorts of the ECRHS II study

The Eosinophil Cationic Protein (ECP) is a potent multifunctional protein. Three common polymorphisms are present in the ECP gene, which determine the function and production of the protein. The aim was to study the relationship of these ECP gene polymorphisms to signs and symptoms of allergy and asthma in a community based cohort (The European Community Respiratory Health Survey (ECRHS)).



Swedish and Estonian subjects (n = 757) were selected from the larger cohort of the ECRHS II study cohort. The prevalence of the gene polymorphisms ECP434(G>C) (rs2073342), ECP562(G>C) (rs2233860) and ECP c.-38(A>C) (rs2233859) were analysed by DNA sequencing and/or real-time PCR and related to questionnaire-based information of allergy, asthma, smoking habits and to lung functions.



Genotype prevalence showed both ethnic and gender differences. Close associations were found between the ECP434(G>C) and ECP562(G>C) genotypes and smoking habits, lung function and expression of allergic symptoms. Non-allergic asthma was associated with an increased prevalence of the ECP434GG genotype. The ECP c.-38(A>C) genotypes were independently associated to the subject being atopic.



Our results show associations of symptoms of allergy and asthma to ECP-genotypes, but also to smoking habits. ECP may be involved in impairment of lung functions in disease. Gender, ethnicity and smoking habits are major confounders in the evaluations of genetic associations to allergy and asthma.
Endocrine therapy for advanced breast cancer.

The demonstrated efficacy of pharmacologic antiestrogen therapy in treating hormone receptor-positive breast cancer has changed the landscape of treatment for the majority of women with metastatic disease, providing them with a well-tolerated therapeutic alternative to surgical oophorectomy and chemotherapy. A multitude of clinical trials have evaluated the various endocrine agents alone or in combination. Studies have established ovarian suppression as key for the management of premenopausal metastatic breast cancer patients, and aromatase inhibitor therapy as first-line treatment for their postmenopausal counterparts. Fulvestrant (Faslodex, AstraZeneca) has also been found to be efficacious and has been studied in the first-line and second-line settings. De novo and acquired endocrine therapy resistance represent a major challenge to the ongoing treatment of patients with hormone receptor-positive disease; strategies to circumvent or delay resistance, including the use of combination endocrine therapy and endocrine therapy with agents targeting various growth-factor signaling pathways, represent an active area of investigation. This review provides a summary of the various landmark trials that have established our current standards of practice in the management of patients with hormone receptor-positive metastatic breast cancer. A discussion of future directions and ongoing studies is also provided.
Impact of noncancer pain on health-related quality of life.

While the economic costs of pain have been documented, the impact of noncancer pain on quality of life has not been studied extensively.



To estimate the influence of noncancer pain on quality of life measures.



Prospective, multicenter, observational nonrandomized patient pain registry.



Outpatient settings.



Patients with acute episodes of noncancer pain requiring treatment with a prescription medication containing oxycodone immediate-release on an as-needed basis for at least 5 days (n = 629).



The modified Brief Pain Inventory and the 12-item Short Form Health Survey (SF-12) was measured at baseline when oxycodone immediate-release began and days 7, 14, 21, and 28. Repeated measures mixed models provided estimates of impact of pain on the physical component summary score (PCS) and mental health component summary score (MCS) of the SF-12.



Patterns indicating pain oscillation over the 28-day window were common (Range: 44.3% back/neck pain cohort to 61.2% postoperative cohort). After adjustment for sociodemographics, concomitant medications and gastrointestinal symptoms, worst pain in 24 hours was associated with a 13.9 point PCS reduction (adjusted PCS for pain = 10: 31.1; adjusted PCS for pain = 0: 45.0) and a 7.2 point MCS reduction (adjusted MCS for pain = 10: 44.1; adjusted MCS for pain = 0: 51.3). Similar clinically relevant differences were observed among patients with arthritis, back/neck pain, injury/trauma, postoperative pain, neuropathic pain and fibromyalgia, although statistical significance was not observed in the latter 2 groups.



Among outpatients with various underlying causes of pain, the negative impact of pain on physical and mental health-related quality of life is significant.