nils-herrmann/clean_scirepeval huggingface dataset:
Pilot study of a preliminary criterion standard for prescription opioid misuse.

Multidisciplinary experts created a behaviorally defined preliminary criterion standard definition of probable prescription opioid misuse (PPOM) that could be rated from material found in administrative, pharmacy, and electronic health record databases. They then derived a scoring system to identify PPOM patients requiring referral to a specialist. Experts next rated cases of misuse and nonmisuse. Rater no. 1 correctly differentiated 37 of 40 cases (92.5%); kappa coefficient was .79 (CI: .57, 1.00). Rater no. 2 correctly identified 39 of 40 cases (97.5%); kappa was .94 (CI: .81, 1.00). Kappa for comparing raters was .73 (CI: .49, .98). This preliminary study demonstrates that multidisciplinary raters can use behaviorally based criteria to identify patients with known PPOM from health plan databases.
A waitlist-controlled trial of behavioral parent training for fathers of children with ADHD.

Fathers, in general, have been underrepresented in studies of parent training outcome for children with attention deficit hyperactivity disorder (ADHD), and the present study aimed to investigate the efficacy of a behavioral parent training program developed expressly for fathers. The present investigation randomly assigned 55 fathers of children ages 6 to 12 with ADHD to the Coaching Our Acting-out Children: Heightening Essential Skills (COACHES) program or a waitlist control group. Outcomes for the study included objective observations of parent behaviors and parent ratings of child behavior. Results indicated that fathers in the COACHES group reduced their rates of negative talk and increased rates of praise as measured in parent-child observations, and father ratings of the intensity of problem behaviors were reduced, relative to the waitlist condition. Groups did not differ on observations of use of commands or father ratings of child behavior problems. Untreated mothers did not significantly improve on observational measures or behavioral ratings. This study provides preliminary evidence for the efficacy of the COACHES parenting program for fathers of children with ADHD. Results are cast in light of the larger literature on behavioral parent training for ADHD as well as how to best work with fathers of children with ADHD in treatment contexts.
Does stage of illness impact treatment response in bipolar disorder? Empirical treatment data and their implication for the staging model and early intervention.

The staging model suggests that early stages of bipolar disorder respond better to treatments and have a more favourable prognosis. This study aims to provide empirical support for the model, and the allied construct of early intervention.



Pooled data from mania, depression, and maintenance studies of olanzapine were analyzed. Individuals were categorized as having had 0, 1-5, 6-10, or >10 prior episodes of illness, and data were analyzed across these groups.



Response rates for the mania and maintenance studies ranged from 52-69% and 10-50%, respectively, for individuals with 1-5 previous episodes, and from 29-59% and 11-40% for individuals with >5 previous episodes. These rates were significantly higher for the 1-5 group on most measures of response with up to a twofold increase in the chance of responding for those with fewer previous episodes. For the depression studies, response rates were significantly higher for the 1-5 group for two measures only. In the maintenance studies, the chance of relapse to either mania or depression was reduced by 40-60% for those who had experienced 1-5 episodes or 6-10 episodes compared to the >10 episode group, respectively. This trend was statistically significant only for relapse into mania for the 1-5 episode group (p=0.005).



Those individuals at the earliest stages of illness consistently had a more favourable response to treatment. This is consistent with the staging model and underscores the need to support a policy of early intervention.
Chemotherapy for mobilisation of Ph-negative progenitor cells from patients with CML: impact of different mobilisation regimens

Mobilised peripheral blood stem cells are widely used for autografting in patients with chronic myeloid leukaemia (CML) and it is generally thought that a high proportion of Ph-negative progenitor cells in the graft is desirable. We report here the results of 91 stem cell mobilisations performed with various chemotherapy regimens followed by G-CSF. We show that mobilisation of Ph-negative cells is possible after diagnosis as well as in advanced stages of the disease. The yield of Ph-negative cells is highly dependent on the chemotherapy regimen: while the combination of idarubicin and cytarabin for 3–5 days (IC3–5) mobilised Ph-negative cells in most patients, high-dose cyclophosphamide was ineffective. Mobilisation of Ph-negative progenitor cells after IC3 was at least as effective as after IC5; however, less apheresis sessions were required, and toxicity was much reduced after IC3. Compared to historical controls, IC was equally effective as the widely used ICE/minilCE (idarubicin, cytarabin, etoposide) protocol. No correlation was found between graft quality and the cytogenetic response to subsequent treatment with interferon-α. We conclude that IC3 is an effective and well-tolerated regimen for mobilising Ph-negative cells that compares well with more aggressive approaches such as IC5 and ICE/minilCE. Bone Marrow Transplantation (2001) 27, 1125–1132.
Hepatitis Delta Virus Infection in Romania: Prevalence and Risk Factors.

Hepatitis delta virus (HDV) infection is associated with accelerated progression of fibrosis, early occurrence of hepatic decompensation and an increased risk for hepatocellular carcinoma. Epidemiological data on hepatitis delta virus (HDV) in Romania are still lacking.



To assess the prevalence, virological, clinical and epidemiological features of HDV infection in Romanian patients.



We conducted a multicenter study in 10 centers. Data on sociodemographic characteristics and potential risk factors were collected through a questionnaire. Virological markers of HBV and HDV infection, biochemical and clinical features of liver disease were evaluated.



The study population comprised 2,761 HBsAg(+) patients with a mean age of 43.8+/-13.8 years, out of whom 5.2% were HBeAg(+) and 55.7% were males. Liver cirrhosis was detected in 17.9% of patients, while 80.4% had chronic hepatitis. The prevalence of IgG anti-HDV(+) patients was 23.1%, out of whom 16.4% were HDV RNA positive. The highest prevalence of HDV infection was encountered in patients aged 50-59 years (28.9%) and patients aged >/= 60 (24.8%) (p=0.0001). Seroprevalence of HDV was significantly higher in AgHBs(+) cirrhotics vs. noncirrhotics (43.4% vs 19.0%, p=0.0001). Risk factors for HDV infection were: occupational hazard, no HCV chronic infection, lack of anti-HBV vaccination, presence of blood transfusions, any previous surgery, frequent hospitalization or endoscopies, tattoos, body piercing, use of glass syringes, number of female sexual partners.



HBsAg(+) population in Romania is characterized by a high prevalence of HBeAg(-) HBV infection as well as HDV co-infection. A cohort phenomenon for HDV prevalence is also observed similar to that of HCV/HBV monoinfections.
A multicenter randomized controlled trial of a nutrition intervention program in a multiethnic adult population in the corporate setting reduces depression and anxiety and improves quality of life: the GEICO study.

To determine whether a plant-based nutrition program in a multicenter, corporate setting improves depression, anxiety, and productivity.



A quasi-experimental study examined the impact of diet on emotional well-being and productivity.



The study was conducted in 10 corporate sites of a major U.S. insurance company.



There were 292 participants (79.8% women, 20.2% men), with body mass index ≥25 kg/m(2) and/or previous diagnosis of type 2 diabetes.



Either weekly instruction in following a vegan diet or no instruction was given for 18 weeks.



Depression and anxiety were measured using the Short Form-36 questionnaire. Work productivity was measured using the Work Productivity and Activity Impairment questionnaire.



Baseline characteristics were examined by t-test for continuous variables and χ(2) test for categorical variables. Analysis of covariance models were adjusted for baseline covariates. Paired t-tests were used to determine within-group changes and t-tests for between-group differences.



In an intention-to-treat analysis, improvements in impairment because of health (p < .001), overall work impairment because of health (p = .02), non-work-related activity impairment because of health (p < .001), depression (p = .02), anxiety (p = .04), fatigue (p < .001), emotional well-being (p = .01), daily functioning because of physical health (p = .01), and general health (p = 0.02) in the intervention group were significantly greater than in the control group. Results were similar for study completers.



A dietary intervention improves depression, anxiety, and productivity in a multicenter, corporate setting.
Optimal Design for Model Discrimination and Parameter Estimation for Itraconazole Population Pharmacokinetics in Cystic Fibrosis Patients

Optimal sampling times are found for a study in which one of the primary purposes is to develop a model of the pharmacokinetics of itraconazole in patients with cystic fibrosis for both capsule and solution doses. The optimal design is expected to produce reliable estimates of population parameters for two different structural PK models. Data collected at these sampling times are also expected to provide the researchers with sufficient information to reasonably discriminate between the two competing structural models
Effects of protease inhibitors on the course of CMV retinitis in relation to CD4+ lymphocyte responses in HIV+ patients.

To gain insight into the course of CMV retinitis (CMVR) in AIDS patients receiving protease inhibitors (PI), and to evaluate whether certain patterns of CD4 response are indicative of the clinical outcome and the risk of recurrence.



15 consecutive AIDS patients receiving maintenance therapy for CMVR were included in a prospective observational cohort study at the university hospital between July and October 1996. Patients were evaluated for signs of CMVR activity and intraocular inflammation. CMVR recurrence was defined as the primary clinical endpoint. Follow up was performed until July 1997. No patient was lost to follow up. Clinical outcome was related to CD4+ lymphocyte counts, which were monitored every 6 weeks. Highly active antiretroviral treatment regimen including PI was started at study entry.



All recurrences (n = 7) were in patients who failed to have a sustained increase in CD4 counts, whereas CMVR remained inactive during a follow up of 42-52 weeks in those who were able permanently to restore their CD4 values to 100 x 10(6)/l or more (n = 5). The remaining three patients died after 12, 16, and 50 weeks, respectively, without recurrences. All relapses of CMVR were seen after 6-16 weeks, and at CD4 counts well below 100 x 10(6)/l.



The beneficial effects of PI treatment correlate with the pattern of CD4 response. Sustained increases in CD4 counts achieved in the first 16 weeks of treatment are associated with a prolonged period of CMVR quiescence. Poor initial response is associated with a high risk of CMVR recurrence.
Association between bone indices assessed by DXA, HR-pQCT and QCT scans in post-menopausal women

Quantitative computed tomography (QCT), high-resolution peripheral QCT (HR-pQCT) and dual X-ray absorptiometry (DXA) scans are commonly used when assessing bone mass and structure in patients with osteoporosis. Depending on the imaging technique and measuring site, different information on bone quality is obtained. How well these techniques correlate when assessing central as well as distal skeletal sites has not been carefully assessed to date. One hundred and twenty-five post-menopausal women aged 56–82 (mean 63) years were studied using DXA scans (spine, hip, whole body and forearm), including trabecular bone score (TBS), QCT scans (spine and hip) and HR-pQCT scans (distal radius and tibia). Central site measurements of areal bone mineral density (aBMD) by DXA and volumetric BMD (vBMD) by QCT correlated significantly at the hip (r = 0.74, p < 0.01). Distal site measurements of density at the radius as assessed by DXA and HR-pQCT were also associated (r = 0.74, p < 0.01). Correlations between distal and central site measurements of the hip and of the tibia and radius showed weak to moderate correlation between vBMD by HR-pQCT and QCT (r = −0.27 to 0.54). TBS correlated with QCT at the lumbar spine (r = 0.35) and to trabecular indices of HR-pQCT at the radius and tibia (r = −0.16 to 0.31, p < 0.01). There was moderate to strong agreement between measuring techniques when assessing the same skeletal site. However, when assessing correlations between central and distal sites, the associations were only weak to moderate. Our data suggest that the various techniques measure different characteristics of the bone, and may therefore be used in addition to rather than as a replacment for imaging in clinical practice.
Erratum to: The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma

Previous studies have shown disparities between Black and Hispanic patients compared with other populations in response to asthma medications.



The aim of this analysis was to assess the effect of budesonide/formoterol pressurized metered-dose inhaler (BUD/FM pMDI) and BUD on predefined criteria for asthma worsening, an asthma control metric generally aligned with definitions of moderate asthma exacerbations, across four different populations.



Data were from four 12-week, randomized, double-blind, US studies of BUD/FM pMDI treatment in patients aged 12 years or older with varying asthma severities and of varying races. Predefined asthma events and withdrawals due to predefined events were assessed as secondary study endpoints. Study I (NCT00651651) includes data from predominantly White patients with mild to moderate asthma who were randomized to BUD/FM pMDI 160/9 μg twice daily (bid; n = 123) or BUD pMDI 160 μg bid (n = 121). Study II (NCT00652002) includes data from predominantly White patients with moderate to severe asthma who were randomized to BUD/FM pMDI 320/9 μg bid (n = 124) or BUD pMDI 320 μg bid (n = 109). Study III (NCT00702325) included self-reported Black patients with moderate to severe asthma who were randomized to BUD/FM pMDI 320/9 μg bid (n = 153) or BUD dry powder inhaler 360 μg bid (n = 148).  (NCT00419757) included self-reported Hispanic patients with moderate to severe asthma who were randomized to BUD/FM pMDI 320/9 μg bid (n = 127) or BUD pMDI 320 μg bid (n = 123). Patients were to be withdrawn from the studies if they developed an asthma event, as determined by predefined criteria, except for night-time awakenings, where withdrawal was left to the study physician's judgment.



Overall, fewer patients in the studies (study I, II, III, and IV, respectively) experienced ≥1 asthma event in the BUD/FM group (18.7%, 29.8%, 37.3%, 25.2%) versus the BUD group (21.5%, 44.0%, 45.3%, 31.7%); only study II results showed a statistically significant difference between treatments. Fewer patients with moderate to severe asthma (studies II, III, and IV) were withdrawn due to ≥1 asthma event in the BUD/FM group (10.5%, 11.8%, 3.1%, respectively) than in the BUD group (20.2%, 18.9%, 6.5%, respectively); however, percentages were similar in the BUD/FM (7.3%) and BUD (6.6%) groups in patients with mild to moderate asthma (study I).



Predefined asthma event rates were numerically or significantly lower for patients with asthma receiving BUD/FM pMDI versus BUD, regardless of race or disease severity. Differences between the BUD/FM pMDI and BUD groups were smaller in patients with mild to moderate asthma than in those with moderate to severe asthma, most likely because patients with milder disease had lower asthma event rates. Overall, these findings support the efficacy of BUD/FM pMDI in achieving asthma control in patients with moderate to severe asthma.
Regional Arterial Infusion Chemotherapy improves the Pathological Response rate for advanced gastric cancer with Short-term Neoadjuvant Chemotherapy

To identify clinicopathologic and treatment variables that could predict pathologic tumor response to short-term neoadjuvant chemotherapy (NAC) for patients with locally advanced gastric cancer. A retrospective analysis was conducted of 178 patients who underwent short-term NAC with EOX regimen followed by surgery from January 2008 to December 2010. Neoadjuvant treatment response was evaluated using tumor regression grade. Relationships between pathologic tumor response and clinicopathological factors were evaluated using logistic regression analysis. The benefits of regional arterial infusion chemotherapy were investigated separately. The postoperative pathological response rate was 46.1% (82/178) and 4 patients (2.2%) had complete pathological remission. Pathological response was significantly associated with tumor differentiation (P = 0.008), abnormal a-fetoprotein levels (P = 0.01) and administration approach to chemotherapy (intravenous versus regional arterial infusion chemotherapy) (P = 0.018). Most bone marrow toxicities, vomiting, nausea, alopecia, and fatigue were acceptable. Grade 3/4 toxicities were not commonly observed. The 3-year overall survival (OS) and recurrence free survival (RFS) were 67.0% and 53.0%, respectively. Regional arterial infusion NAC group had significantly better median RFS (48.0 versus 34.0 months) than the intravenous NAC group (P = 0.049). In conclusion, regional arterial infusion NAC can improve the pathological response rate of advanced gastric cancer treated with EOX regimen.
High-dose methotrexate toxicity in elderly patients with primary central nervous system lymphoma.

The dose of high-dose methotrexate (HDMTX) in elderly patients often has to be reduced, resulting in a loss of treatment efficacy. We evaluated HDMTX-related toxicity with special regard to age distribution in patients with primary central nervous system lymphoma (PCNSL) in a phase IV multicenter trial.



One hundred and fifty-four patients (median age 61 years; 89 patients >60 years old, 21 patients >70 years old) received 619 HDMTX cycles. Toxicity was evaluated prospectively using the WHO classification. Unless a reduced dose was required after calculating a decreased glomerular filtration rate (GFR), the patients received 4 g/m(2) HDMTX followed by leucovorin rescue.



Toxicity was generally mild with toxicities of WHO grade > or =3 usually <10%. The differences in the incidence and severity of toxicity were not statistically significant between patients >60 years and < or =60 years old. The same was true for therapy termination owing to MTX toxicity and for delayed serum MTX clearance. Dose reduction significantly differed between patients < or =60 years and those >60 years old (18% versus 44%; P = 0.001).



HDMTX is a safe treatment for PCNSL patients regardless of age, with adherence to dose reduction determined by calculating the GFR before each treatment cycle.
Shared decision-making in breast cancer: discrepancy between the treatment efficacy required by patients and by physicians

Several factors can influence individual perceptions of the expected benefit of recommended adjuvant treatment for breast cancer. This study investigated differences between patients and physicians with regard to the required efficacy of treatment and the factors influencing patients’ and physicians’ willingness to accept different therapeutic options. A total of 9,000 questionnaires were distributed to patients with breast cancer, and 6,938 questionnaires were distributed to physicians treating breast cancer patients. The patients were asked for personal information and about their medical history and experiences during treatment. The physicians were asked about personal information and their specialty and work environment. The treatment efficacy required by the two groups was assessed using six virtual cases of breast cancer and the treatment regimens proposed, with specific benefits and side effects. A total of 2,155 patients and 527 physicians responded to the questionnaire (return rates of 23.9 and 7.6 %). Significantly different ratings between patients and physicians with regard to the expected benefit of certain treatment options were observed. The differences were noted not only for chemotherapy but also for antihormonal and antibody treatments. Whereas physicians had a quite realistic view of the expected treatment benefits, the patients’ expectations were varied. Approximately one-fifth of the patients were willing to accept treatment regimens even with marginal anticipated benefits, whereas one-third required unrealistic treatment benefits. Several influencing factors that were significantly associated with the quality rating of treatment regimens in the groups of breast cancer patients and physicians were also identified. In contrast to physicians, many breast cancer patients required treatment benefits beyond what was realistically possible, although a large group of patients were also satisfied with minimal benefits. Individual factors were also identified in both groups that significantly influence thresholds for accepting adjuvant treatment, independently of risk estimates and therapy guidelines.
Phase I dose escalation clinical trial of phenylbutyrate sodium administered twice daily to patients with advanced solid tumors

Phenylbutyrate (PBA), and its metabolite phenylacetate (PAA), induce growth inhibition and cellular differentiation in multiple tumor models. However, despite their potential anti-cancer properties, several pharmacodynamic aspects remain unknown.  We conducted a dose escalating trial to evaluate twice-daily intravenous PBA infusions for two consecutive weeks (Monday through Friday) every month at five dose levels (60–360 mg/kg/day). Twenty-one patients with the following malignancies were treated: colon carcinoma 4, non-small cell lung carcinoma 4; anaplastic astrocytoma 3, glioblastoma multiforme 3, bladder carcinoma 2, sarcoma 2, and ovarian carcinoma, rectal hemangiopericytoma, and pancreatic carcinoma 1 each.  Conversion of PBA to PAA and phenylacetylglutamine (PAG) was documented without catabolic saturation. Plasma content of PBA ≥1 mM was documented for only 3 h following each dose at the top two dosages. The therapy was well tolerated overall. Common adverse effects included grade 1 nausea/vomiting, fatigue, and lightheadedness. Dose limiting toxicities were short-term memory loss, sedation, confusion, nausea, and vomiting. Two patients with anaplastic astrocytoma and a patient with glioblastoma remained stable without tumor progression for 5, 7, and 4 months respectively.  Administration of PBA in a twice-daily infusion schedule is safe. The maximum tolerated dose is 300 mg/kg/day. Study designs with more convenient treatment schedules and specific molecular correlates may help to further delineate the mechanism of action of this compound. Future studies evaluating PBA's ability to induce histone acetylation and cell differentiation alone or in combination with other anti-neoplastics are recommended.