nils-herrmann/clean_scirepeval huggingface dataset:
Randomized trial of buprenorphine for treatment of concurrent opiate and cocaine dependence.

Buprenorphine is a partial mu-opiate agonist and kappa-opiate antagonist with established efficacy in the treatment of opiate dependence. Its efficacy for cocaine dependence is uncertain. This study evaluated buprenorphine for the treatment of concomitant cocaine and opiate dependence.



Two hundred outpatients currently dependent on both cocaine and opiates were randomly assigned to double-blind groups receiving a sublingual solution of buprenorphine (2, 8, or 16 mg daily, or 16 mg on alternate days, or placebo), plus weekly individual drug abuse counseling, for 13 weeks. The chief outcome measures were urine concentrations of opiate and cocaine metabolites (quantitative) and proportion of urine samples positive for opiates or cocaine (qualitative). Group differences were assessed by use of mixed regression modeling.



The target dose of buprenorphine was achieved in 179 subjects. Subjects receiving 8 or 16 mg buprenorphine daily showed statistically significant decreases in urine morphine levels (P =.0135 for 8 mg and P <.001 for 16 mg) or benzoylecgonine concentrations (P =.0277 for 8 mg and P =.006 for 16 mg) during the maintenance phase of the study. For the 16-mg group, mean benzoylecgonine concentrations fell from 3715 ng/mL during baseline to 186 ng/mL during the withdrawal phase; mean morphine concentrations fell from 3311 ng/mL during baseline to 263 ng/mL during withdrawal. For the 8-mg group, mean benzoylecgonine concentrations fell from 6761 ng/mL during baseline to 676 ng/mL during withdrawal; mean morphine concentrations fell from 3890 ng/mL during baseline to 661 ng/mL during withdrawal. Qualitative urinalysis showed a similar pattern of results. Subjects receiving the highest dose showed concomitant decreases in both urine morphine and benzoylecgonine concentrations. There were no significant group differences in treatment retention or adverse events.



A sublingual buprenorphine solution at 16 mg daily is well tolerated and effective in reducing concomitant opiate and cocaine use. The therapeutic effect on cocaine use appears independent of that on opiate use.
Paranoid personality disorder in the United States: the role of race, illicit drug use, and income.

Differential rates of schizophrenia and paranoia symptoms have been found for Black and White individuals. Paranoid personality disorder shares symptoms with schizophrenia, yet has received minimal attention with regard to potential racial differences. In a sample consisting of 180 substance use disorder treatment-seeking individuals, the association between the diagnosis of paranoid personality disorder and the variables of race, cannabis use disorder, and income were examined.  extended previous findings to paranoid personality disorder, supporting the hypothesis that Black individuals would be diagnosed with higher rates of paranoid personality disorder. Cannabis use disorder status and income did not predict paranoid personality disorder diagnoses.
Separate and combined effects of methylphenidate and a behavioral intervention on disruptive behavior in children with mental retardation.

We investigated the separate and combined effects of a behavioral intervention and methylphenidate (Ritalin) on disruptive behavior and task engagement in 3 children with severe to profound mental retardation. The behavioral intervention involved differential reinforcement of appropriate behavior and guided compliance. All 3 children demonstrated decreased disruptive behavior and improved task engagement in response to the response to the behavioral intervention. Two of the 3 children demonstrated similar improvement in response to methylphenidate. Although both interventions were highly effective for these 2 participants, the relative efficacy of the interventions varied between the 2 children. There was no evidence of an additive or synergistic effect of the two interventions, but the high efficacy of each intervention alone limited our ability to detect such effects.
Sealing of Postoperative Axillary Leakage After Axillary Lymphadenectomy Using a Fibrin Glue Coated Collagen Patch: a Prospective Randomised Study

Seroma formation after axillary lymphadenectomy in women with breast cancer remains a problem despite many efforts to reduce surgery-related morbidity. In a prospective, randomised, open, parallel-group, controlled clinical trial we evaluated the effect of a fibrin-glue coated collagen patch (TachoComb H®, Nycomed Pharma AS, Denmark) on volume and duration of postoperative axillary drainage, duration of hospital stay, and procedural safety. Sixty patients were included in the study. Patients did not differ with respect to general characteristics, such as age, body mass index, treatment modality, and tumor stage distribution. In 29 patients, a fibrin-glue coated collagen patch was applied from the apex axillae to the thoracic longus nerve and half a patch was applied to the lateral border of the axillary nerve-vessel bundle. Thirty-one patients were randomised to standard closure of the axillary lymphadenectomy area. The mean duration of axillary drainage was 3.8±1.9 days in the fibrin-glue treatment group and 3.9±1.8 days in the control group (p=NS). The mean total drainage volume was 338.5±251.8ml in the fibrin-glue treatment group and 370.8±314.6ml in the standard closure group (p=NS). The mean length of post-operative hospital stay was 9.1±2.7 days in the fibrin-glue treatment group and 9.3±3.6 days in the standard closure group (p=NS). Seven patients (25%) and eight patients (25%) were diagnosed with local inflammation in the fibrin-glue treatment group and the standard closure group, respectively (p=NS). Seroma formation after drain removal was found in 11 patients (39%) in the fibrin-glue treatment group and in 13 patients (42%) in the standard closure group (p=NS). In summary, we observed no statistically significant differences with respect to axillary drainage time, drainage volume, length of hospital stay, local inflammation, and seroma formation after drainage removal.
Montelukast, a leukotriene receptor antagonist, in combination with loratadine, a histamine receptor antagonist, in the treatment of chronic asthma.

Montelukast sodium, a potent, oral, specific leukotriene-receptor antagonist, has demonstrated clinical efficacy in the treatment of chronic asthma. Loratadine, a selective histamine type 1 (H(1))-receptor antagonist, has demonstrated antiallergic properties. Leukotriene-receptor antagonists given concomitantly with H(1)-receptor antagonists have been shown to have additive effects in the prevention of bronchospasm in antigen-challenge models.



To determine whether montelukast plus loratadine provides improved efficacy to montelukast alone in the treatment of chronic asthma.



The efficacy of montelukast alone vs montelukast-loratadine was studied in a 10-week, multicenter, randomized, double-blind, 2 x 2 crossover study. After a 2-week placebo run-in period, patients received montelukast sodium (10 mg) plus loratadine (20 mg), or montelukast sodium (10 mg) plus placebo once daily for 2 weeks. After a 2-week placebo washout period, patients were crossed over to receive 2 weeks of the other active treatment regimen, followed by another 2-week placebo washout period.



Montelukast given concomitantly with loratadine caused significant improvement in percentage of change from baseline in forced expiratory volume in 1 second (FEV(1)) compared with montelukast alone (13.86% vs 9.72%; P =.001). The average additional effect of loratadine (least square mean difference in percentage of change from baseline in FEV(1)) was 4.15% (95% confidence interval, 1.65%-6.65%). Key secondary end points (mean daily beta-agonist use, daytime and nighttime symptom scores, morning and evening peak expiratory flow rate, and the Patient Global Evaluation) all showed significant improvement with montelukast-loratadine (P<.05).



Montelukast-loratadine significantly improved end points of asthma control during a 2-week treatment period.
Clinicoradiological factors influencing the reversibility of posterior reversible encephalopathy syndrome: a multicenter study

The aim of this retrospective study was to clarify the relation between the reversibility of posterior reversible encephalopathy syndrome (PRES) with three factors: the anatomical region of the brain involved, the background clinical cause, and the diffusion weighted image (DWI) intensity of PRES lesions. This multicenter study, conducted by the PRES Study Group of the Neuroradiology Workshop, involved 52 cases from 28 institutions. Initial and follow-up magnetic resonance imaging were compared regarding the reversibility of PRES lesions according to anatomical location and clinical background. Initial DWI and apparent diffusion coefficient (ADC) maps were reviewed in 20 cases. Reversibility was significantly lower (P < 0.01) in the brain stem (44%) and deep white matter (47%) compared to the other cortical and subcortical areas (76%–91%). The reversibility was greater in the eclampsia subgroup followed by the hypertension and chemotherapy subgroups. DWI, even with ADC maps, had limitations in predicting the outcome of PRES lesions. The typical cortical and subcortical PRES lesions showed reversibility, whereas the brain stem and deep white matter lesions showed less reversibility. PRES due to eclampsia showed maximum reversibility compared to hypertension- and drug-related PRES. DWI, even with ADC maps, had limitations in predicting the course of PRES.
Continuous subcutaneous insulin infusion and multiple daily injection therapy are equally effective in type 2 diabetes: a randomized, parallel-group, 24-week study.

Compare the efficacy, safety, and patient satisfaction of continuous subcutaneous insulin infusion (CSII) therapy with multiple daily injection (MDI) therapy for patients with type 2 diabetes.



A total of 132 CSII-naive type 2 diabetic patients were randomly assigned (1:1) to CSII (using insulin aspart) or MDI therapy (bolus insulin aspart and basal NPH insulin) in a multicenter, open-label, randomized, parallel-group, 24-week study. Efficacy was assessed with HbA(1c) and eight-point blood glucose (BG) profiles. Treatment satisfaction was determined with a self-administered questionnaire. Safety assessments included adverse events, hypoglycemic episodes, laboratory values, and physical examination findings.



HbA(1c) values decreased similarly for both groups from baseline (8.2 +/- 1.37% for CSII, 8.0 +/- 1.08% for MDI) to end of study (7.6 +/- 1.22% for CSII, 7.5 +/- 1.22% for MDI). The CSII group showed a trend toward lower eight-point BG values at most time points (only significant 90 min after breakfast; 167 +/- 48 vs. 192 +/- 65 mg/dl for CSII and MDI, respectively; P = 0.019). A total of 93% of CSII-treated subjects preferred the pump to their previous injectable insulin regimen for reasons of convenience, flexibility, ease of use, and overall preference. Safety assessments were comparable for both treatment groups.



Insulin aspart in CSII therapy provided efficacy and safety comparable to MDI therapy for type 2 diabetes. Patients with type 2 diabetes can be trained as outpatients to use CSII and prefer CSII to injections, indicating that pump therapy should be considered when initiating intensive insulin therapy for type 2 diabetes.
Effect of cat and daycare exposures on the risk of asthma in children with atopic dermatitis

Atopic dermatitis (AD) in young children is often followed by the development of asthma (atopic march). The role of environmental exposures is unclear in this high-risk population. We aimed to determine the predictive relationship between indoor allergen exposures, particularly pets, rodents, and cockroaches, to the development of asthma in a prospective pediatric cohort. Children with AD and a family history of allergy were followed prospectively with questionnaire ascertainment of environmental exposure to cats, dogs, cockroaches, rats, and mice. Asthma was diagnosed by study physicians based on caregiver reports of symptoms continually assessed over the course of the study period. Fifty-five of the 299 children developed asthma by the end of the study. Cat exposure had a strong and independent effect to reduce the risk of developing asthma across all analyses (odds ratio [OR], 0.16; 95% confidence interval [CI], 0.05-0.53). Dog, mouse, rat, and cockroach exposures did not significantly influence the development of asthma. Daycare exposure had the largest risk reduction for the development of asthma (OR, 0.08; 95% CI, 0.03-0.19). Maternal asthma (OR, 2.93; 95% CI, 1.29-6.67), baseline body mass index (OR, 1.23; 95% CI, 1.08-1.42), and specific immunoglobulin E to house-dust mix at 3 years were each independent risk factors for the development of asthma. In children with AD, cat and daycare exposure may reduce the risk of developing early childhood asthma.
Comparison of initial versus delayed introduction of a treat-to-target strategy in patients with recent-onset rheumatoid arthritis: results of the T-4 3-year study.

We investigated whether a delayed treat-to-target strategy introduction was disadvantageous compared with the clinical, radiological, and functional efficacy of initial introduction on early rheumatoid arthritis (RA) after a 3-year follow-up (T-4 3-year) study. Between August 2008 and April 2010, 243 early RA patients (symptom duration <3 years) were randomly allocated to one of four strategy groups; we focus here on the routine care (R group) and the disease activity score in 28 joints (DAS28) plus matrix metalloproteinase (MMP)-3-driven therapy (T group) . The T-4 3-year study followed a 1-year study. At 56 weeks, all subjects were allocated to the T group (R→T, RT group; T→T, TT group, etc.), and visits were every 4 weeks; the clinical variable assessment, each physician’s articular examination and DAS28 calculations were every 12 weeks and at baseline. During the T-4 1-year study, the R group’s therapy was changed as per physicians’ judgement. If the DAS28 or MMP-3
Efficacy and safety of deferasirox in β-thalassemia major patients in Iran: a prospective study from a single referral center in Iran.

Herein, the results of a prospective study evaluating the efficacy and safety of treatment with deferasirox are studied in iron-overloaded patients with β-thalassemia major during an 18-month trial.



Thirty patients who were previously chelated with deferoxamine with/without deferiprone, and fulfilled the inclusion criteria were recruited. Patients received an initial dose of 10-30 mg/kg/day. Liver and cardiac MRI T2* were evaluated before and after the trial. In addition, serum ferritin level was assessed every 3 months. Primary endpoint was regarded as significant improvement in the severity of liver and cardiac iron overload in severe and moderate cases, in addition to improvement or maintenance of the grade of severity in patients with mild iron overload or normal iron accumulation. Therapy was considered effective if primary endpoint was met in >50%.



Liver MRI values improved significantly (P = .002), achieving a 73.33% success rate. A successful outcome regarding myocardial iron overload was observed in 80%. Finally, an overall of 66.66% of patients met the success criteria. Secondary endpoint, regarded as safety and tolerability was reached by 93.33%. The most common adverse events were skin rash and gastrointestinal disturbance. A dose between 30 and 40 mg/kg/day, tailored to each patient was considered the optimal dose.



Deferasirox proved as an efficient and safe chelating agent in our patients, specifically in mild to moderate iron overloaded patients.
A clinical trial of methysergide and lithium in mania

Six manic patients were studied in an open sequential drug trial of placebo and the serotonin antagonist methysergide; lithium was then substituted double-blind. No dramatic change occurred in individual manic item scores or in mean daily mania ratings after 48 hours or seven days of methysergide, although several of the patients showed slight trends toward improvement. However, after a mean duration of 10.3 days of lithium treatment, all manic item scores improved dramatically and significantly, so that complete clinical remission was evident in all patients. In view of the discrepancy between these essentially negative findings and several recent positive reports on the efficacy of methysergide in the treatment of mania, the authors feel that the indolealkylamine hypothesis of affective disorders should be further investigated.
Effect of interactive metronome training on children with ADHD.

The purpose of this study was to determine the effects of a specific intervention, the Interactive Metronome, on selected aspects of motor and cognitive skills in a group of children with attention deficit hyperactivity disorder (ADHD).



The study included 56 boys who were 6years to 12 years of age and diagnosed before they entered the study as having ADHD. The participants were pretested and randomly assigned to one of three matched groups. A group of 19 participants receiving 15 hr of Interactive Metronome training exercises were compared with a group receiving no intervention and a group receiving training on selected computer video games.



A significant pattern of improvement across 53 of 58 variables favoring the Interactive Metronome treatment was found. Additionally, several significant differences were found among the treatment groups and between pretreatment and posttreatment factors on performance in areas of attention, motor control, language processing, reading, and parental reports of improvements in regulation of aggressive behavior.



The Interactive Metronome training appears to facilitate a number of capacities, including attention, motor control, and selected academic skills, in boys with ADHD.
Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial.

Treating hypertension decreases mortality and disability from cardiovascular disease, but most hypertension remains inadequately controlled.



To determine if a new model of care that uses patient Web services, home blood pressure (BP) monitoring, and pharmacist-assisted care improves BP control.



A 3-group randomized controlled trial, the Electronic Communications and Home Blood Pressure Monitoring study was based on the Chronic Care Model. The trial was conducted at an integrated group practice in Washington state, enrolling 778 participants aged 25 to 75 years with uncontrolled essential hypertension and Internet access. Care was delivered over a secure patient Web site from June 2005 to December 2007.



Participants were randomly assigned to usual care, home BP monitoring and secure patient Web site training only, or home BP monitoring and secure patient Web site training plus pharmacist care management delivered through Web communications.



Percentage of patients with controlled BP (<140/90 mm Hg) and changes in systolic and diastolic BP at 12 months.



Of 778 patients, 730 (94%) completed the 1-year follow-up visit. Patients assigned to the home BP monitoring and Web training only group had a nonsignificant increase in the percentage of patients with controlled BP (<140/90 mm Hg) compared with usual care (36% [95% confidence interval {CI}, 30%-42%] vs 31% [95% CI, 25%-37%]; P = .21). Adding Web-based pharmacist care to home BP monitoring and Web training significantly increased the percentage of patients with controlled BP (56%; 95% CI, 49%-62%) compared with usual care (P < .001) and home BP monitoring and Web training only (P < .001). Systolic BP was decreased stepwise from usual care to home BP monitoring and Web training only to home BP monitoring and Web training plus pharmacist care. Diastolic BP was decreased only in the pharmacist care group compared with both the usual care and home BP monitoring and Web training only groups. Compared with usual care, the patients who had baseline systolic BP of 160 mm Hg or higher and received home BP monitoring and Web training plus pharmacist care had a greater net reduction in systolic BP (-13.2 mm Hg [95% CI, -19.2 to -7.1]; P < .001) and diastolic BP (-4.6 mm Hg [95% CI, -8.0 to -1.2]; P < .001), and improved BP control (relative risk, 3.32 [95% CI, 1.86 to 5.94]; P<.001).



Pharmacist care management delivered through secure patient Web communications improved BP control in patients with hypertension.
Lenalidomide and low-dose dexamethasone (Rd) versus bortezomib, melphalan, prednisone (VMP) in elderly newly diagnosed multiple myeloma patients: A comparison of two prospective trials.

There are currently no direct head-to-head clinical trials evaluating bortezomib-melphalan-prednisone (VMP) versus lenalidomide and low-dose dexamethasone (Rd). VMP (257 cases) and Rd (222 cases) arms of two randomized phase III trials were employed to assess the treatment influence on outcome in untreated elderly MM patients. Progression free survival (PFS) and overall survival (OS) were the primary and secondary end-points, respectively, and were investigated according to treatments administered over a 60-months follow-up period. While VMP significantly reduced the disease progression rate between enrolment and 12 months of follow-up, no difference between the two schedules was found between 12 and 32 months. After 32 months, Rd-treated patients had a lower incidence of disease progression. A statistically significant higher OS rate was seen in the VMP arm, which was maintained after data adjustment for potential confounders. Both approaches showed acceptable toxicity profiles. The profound tumor reduction by VMP over Rd justifies the initial higher PFS rate in favor of the bortezomib schedule, while the Rd regimen overcomes this evident initial drawback in reducing the tumor burden by long-term drug administration, gaining a subsequent improved disease control. VMP is associated with a significant reduced risk of death. This study may help physicians make a more informed therapy choice.
ABO mismatch is associated with increased nonrelapse mortality after allogeneic hematopoietic cell transplantation.

We evaluated ABO associated outcomes in 1737 patients who underwent allogeneic hematopoietic cell transplantation (allo-HCT) at Stanford University between January 1986 and July 2011. Grafts were 61% ABO matched, 18% major mismatched (MM), 17% minor MM, and 4% bidirectional MM. Median follow-up was 6 years. In multivariate analysis, overall survival (OS) was inferior in minor MM hematopoietic cell transplantations (median 2.1 versus 6.3 years; hazard ratio [HR], 1.56; 95% confidence interval [CI], 1.19 to 2.05; P = .001) in comparison with ABO-matched grafts. ABO minor MM was associated with an increase in early nonrelapse mortality (NRM) (18% versus 13%; HR, 1.48; 95% CI, 1.06 to 2.06; P = .02). In an independent Center for International Blood and Marrow Transplant Research (CIBMTR) analysis of 435 lymphoma patients receiving mobilized peripheral blood grafts, impairment of OS (HR, 1.55; 95% CI, 1.07 to 2.25; P = .021) and increased NRM (HR, 1.72; 95% CI, 1.11 to 2.68; P = .03) were observed in recipients of ABO minor-MM grafts. A second independent analysis of a CIBMTR data set including 5179 patients with acute myeloid leukemia and myelodysplastic syndrome identified a nonsignificant trend toward decreased OS in recipients of ABO minor-MM grafts and also found ABO major MM to be significantly associated with decreased OS (HR, 1.19; 95% CI, 1.08 to 1.31; P < .001) and increased NRM (HR, 1.23; 95% CI, 1.08 to 1.4; P = .002). ABO minor and major MM are risk factors for worse transplantation outcomes, although the associated hazards may not be uniform across different transplantation populations. Further study is warranted to determine which patient populations are at greatest risk, and whether this risk can be modified by anti-B cell therapy or other peri-transplantation treatments.