nils-herrmann/clean_scirepeval huggingface dataset:
A tailored minimal self-help intervention to promote condom use in young women: results from a randomized trial.

To evaluate the efficacy of a theory-based tailored minimal self-help intervention to increase condom use among young women at risk for HIV/sexually transmitted disease (STD).



Randomized controlled trial on an intent-to-treat basis in two managed care plans, in Washington state and North Carolina, with follow-up at 3 and 6 months.



A proactively recruited sample of 1210 heterosexually active, non-monogamous, non-pregnant women, aged 18-24 years recruited June 1999-April 2000; 85% completed the 6-month follow-up.



Arm 1 received usual care. Arm 2 received a mailed computer-generated self-help magazine, individually tailored on survey items including stage of readiness to use condoms, barriers to condom use, partner type; condom samples and a condom-carrying case were included in the packet; this was followed 3 months later by a tailored 'booster' newsletter. The a priori 6-month main outcomes were percentage of women using condoms during the previous 3 months (overall and by partner type) and proportion of total episodes of intercourse during which condoms were used in the previous 3 months.



Relative to usual care, intervention group women reported significantly more condom use overall [adjusted odds ratio (OR), 1.86; 95% confidence interval (CI), 1.32-2.65; P = 0.0005] and with recent primary partners (OR, 1.97; 95% CI, 1.37-2.86; P = 0.0003). They also reported using condoms for a higher proportion of intercourse episodes (52.7% versus 47.9%; P = 0.05). Significantly more intervention women carried condoms, discussed condoms with partners, and had higher self-efficacy to use condoms with primary partners.



Tailored cognitive/behavioral minimal self-help interventions hold promise as HIV/STD prevention strategies for diverse populations of young at-risk women.
Economic issues involved in integrating genomic testing into clinical care: the case of genomic testing to guide decision-making about chemotherapy for breast cancer patients

The use of taxanes to treat node-positive (N+) breast cancer patients is associated with heterogeneous benefits as well as with morbidity and financial costs. This study aimed to assess the economic impact of using gene expression profiling to guide decision-making about chemotherapy, and to discuss the coverage/reimbursement issues involved. Retrospective data on 246 patients included in a randomised trial (PACS01) were analyzed. Tumours were genotyped using DNA microarrays (189-gene signature), and patients were classified depending on whether or not they were likely to benefit from chemotherapy regimens without taxanes. Standard anthracyclines plus taxane chemotherapy (strategy AT) was compared with the innovative strategy based on genomic testing (GEN). Statistical analyses involved bootstrap methods and sensitivity analyses. The AT and GEN strategies yielded similar 5-year metastasis-free survival rates. In comparison with AT, GEN was cost-effective when genomic testing costs were less than 2,090€. With genomic testing costs higher than 2,919€, AT was cost-effective. Considering a 30% decrease in the price of docetaxel (the patent rights being about to expire), GEN was cost-effective if the cost of genomic testing was in the 0€–1,139€ range; whereas AT was cost-effective if genomic testing costs were higher than 1,891€. The use of gene expression profiling to guide decision-making about chemotherapy for N+ breast cancer patients is potentially cost-effective. Since genomic testing and the drugs targeted in these tests yield greater well-being than the sum of those resulting from separate use, questions arise about how to deal with extra well-being in decision-making about coverage/reimbursement.
Comparison of bleeding in patients with nonvalvular atrial fibrillation treated with ximelagatran or warfarin: assessment of incidence, case-fatality rate, time course and sites of bleeding, and risk factors for bleeding.

Ximelagatran is a novel direct thrombin inhibitor that can be administered as a fixed oral dose, without the need for anticoagulant monitoring.



We undertook a pooled analysis of 7329 patients with nonvalvular atrial fibrillation from the Stroke Prevention Using Oral Thrombin Inhibitor in Atrial Fibrillation III and V trials to compare bleeding outcomes in patients who received ximelagatran, 36 mg twice daily, or warfarin sodium (target international normalized ratio, 2.0-3.0). We determined annual risk of bleeding (any, major), case-fatality rate, time course and anatomic sites of major bleeding, and risk factors for major bleeding with ximelagatran and warfarin treatment.



Annual incidence of any bleeding was 31.75% with ximelagatran and 38.82% with warfarin (relative risk reduction, 18.2%; 95% confidence interval [CI], 13.0-23.1; P<.001). Annual incidence of major bleeding was 2.01% with ximelagatran and 2.68% with warfarin (relative risk reduction, 25.1%; 95% CI, 3.2-42.1; P = .03). Case-fatality rate of bleeding was comparable in ximelagatran- and warfarin-treated patients (8.16% vs 8.09%; P = .98). Cumulative incidence of major bleeding was higher with warfarin than ximelagatran after 24 months of treatment (4.7% vs 3.7%; P = .04). Anatomic sites of bleeding were comparable with both treatments. Risk factors for bleeding with ximelagatran were as follows (hazard ratios and 95% CIs in parentheses): diabetes mellitus (1.81; 1.19-2.77; P = .006), previous stroke or transient ischemic attack (1.78; 1.16-2.73; P = .008), age 75 years or greater (1.70; 1.33-2.18; P<.001), and aspirin use (1.68; 1.08-2.59; P = .02). Risk factors for bleeding in warfarin-treated patients were previous liver disease (4.88; 1.55-15.39; P = .007); aspirin use (2.41; 1.69-3.43; P<.001); and age 75 years or greater (1.26; 1.03-1.52; P = .02).



Treatment with ximelagatran, 36 mg twice daily, is associated with a lower risk of bleeding than warfarin in patients with nonvalvular atrial fibrillation. Aspirin use and increasing age were associated with an increased risk of bleeding in ximelagatran- and warfarin-treated patients.
Incidence and correlates of hepatitis C virus infection in a large cohort of prisoners who have injected drugs

Hepatitis C virus (HCV) infection is common among prisoners, particularly those with a history of injecting drug use (IDU). Incarcerated people who inject drugs frequently report high-risk injecting practices both in prison and in the community. In spite of rising morbidity and mortality, utilisation of HCV-related services in Australia has been persistently low. This study aimed to describe the incidence, prevalence and correlates of HCV seropositivity in a large cohort of prisoners who have injected drugs, and to identify correlates of receiving confirmation of active infection.



Data-linkage to a State-wide statutory notifiable diseases surveillance system was used to investigate the incidence of notified HCV seropositivity, seroconversion and confirmed HCV infection in a cohort of 735 prisoners with a history of IDU, over 14 years of follow up. Hepatitis C test results from prison medical records were used to identify correlates of testing positive in prison.



The crude incidence of HCV notification was 5.1 cases per 100 person-years. By the end of follow up, 55.1% of the cohort had been the subject of a HCV-related notification, and 47.4% of those tested in prison were HCV seropositive. In multivariable analyses, injecting in prison was strongly associated with HCV seropositivity, as was opioid use compared to injection of other drugs. The rate of reported diagnostic confirmation among those with notified infections was very low, at 6.6 confirmations per 100 seropositive participants per year.



Injecting drugs in prison was strongly associated with HCV seropositivity, highlighting the need for increased provision of services to mitigate the risk of transmission within prisons. Once identified as seropositive through screening, people with a history of IDU and incarceration may not be promptly receiving diagnostic services, which are necessary if they are to access treatment. Improving access to HCV-related services will be of particular importance in the coming years, as HCV-related morbidity and mortality is increasing, and next generation therapies are becoming more widely available.
Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment.

We compared an aprepitant regimen with a control regimen of ondansetron + dexamethasone given for 4 days.



Patients scheduled to receive cisplatin > or =70 mg/m(2) were randomized to either the aprepitant regimen (aprepitant, ondansetron and dexamethasone on day 1; aprepitant and dexamethasone on days 2-3; dexamethasone on day 4) or control regimen (ondansetron + dexamethasone on days 1-4). Patients recorded vomiting, nausea and rescue therapy use. The primary end point was complete response (no vomiting and no use of rescue therapy) in the overall phase (days 1-5 post-cisplatin).



Complete response rates were higher in the aprepitant than control group in the overall (72% versus 61%; P = 0.003), acute (day 1; 88% versus 79%; P = 0.005) and delayed phases (days 2-5; 74% versus 63%; P = 0.004), as were rates of no vomiting (overall 77% versus 62%, P < or = 0.001; acute 89% versus 81%, P = 0.004; delayed 79% versus 64%, P < or = 0.001). Rates of no rescue therapy were similar between groups.



Compared with an antiemetic regimen in which ondansetron + dexamethasone were given for 4 days, the aprepitant regimen was superior in the acute, delayed and overall phases of chemotherapy-induced nausea and vomiting. The aprepitant regimen should be considered a new standard of antiemetic therapy for cisplatin-treated patients.
Predictors of short-term neurocognitive outcome following coronary revascularisation (CABG) depending on the use of cardiopulmonary bypass.

The purpose of our study was to investigate the association between perioperative cerebral microembolization, expressed as high-intensity transient signals (HITS) and postoperative dynamics of the neuromarker S100P in patients operated using cardiopulmonary bypass, and to assess their impact upon the neurocognitive function in the early postoperative stage. The study involved 62 consecutive male patients aged 60 or above, alls scheduled for elective aortocoronary bypass. The patients were recruited from two groups with respect to the use of CPB: on-pump group (CPB+, N = 30) and off-pump group (CPB-, N = 32). In all patients we performed intraoperative monitoring of cerebral haemodynamics using transcranial Doppler, with the goal of quantifying perioperative cerebral microembolization. The serum levels of the neuromarker S100l were measured immediately after surgery, and then 12, 24 and 48 hours after the surgery. Neurocognitive status was assessed before and after the surgery and in three cognitive domains. Results of the study have shown that with respect to the short-term postoperative neurocognitive outcome there is no significant difference between the on-pump and off-pump surgical technique of coronary revascularization'. Perioperative cerebral microembolization was significantly more pronounced in the on-pump group yet it did not affect early postoperative neurocognitive function, while the increase in the neuromarker S100beta serum level 48 hours after surgery may have prognostic value as a predictor of postoperative neurocognitive dysfunction.
Duration of untreated symptoms in common mental disorders: association with outcomes: International study.

Studies have assessed the association between a longer duration of untreated symptoms and outcome for psychoses in specialist care. We investigated the effect of longer duration on the outcome of common psychiatric disorders in primary care, where most patients are treated. Patients presenting to primary care for new episodes in 10 countries were recruited into a prospective cohort study. Information on duration of untreated symptoms and psychosocial status was collected for 351 individuals using standardised instruments and this was repeated 1 year later. At 1-year follow-up, longer duration was associated with worse psychiatric outcome even after controlling for potential confounders.
Phase II study of vinorelbine (alternating intravenous and oral) in combination with docetaxel as first-line chemotherapy in metastatic breast cancer

Combination of intravenous (i.v.) vinorelbine and docetaxel was shown to be feasible and effective in metastatic breast cancer (MBC). In an effort to improve patient convenience, we investigated in first-line treatment a regimen alternating i.v. and oral vinorelbine in combination with docetaxel. Forty-nine patients (median age, 53 years) with MBC received a maximum of 6 cycles consisting of i.v. vinorelbine 20 mg/m² plus docetaxel 60 mg/m² given on day 1, and oral vinorelbine 60 mg/m² on day 15 every 3 weeks in an open-label, multicentre phase II study (recommended dose established in phase I study ). Sixty-three percent of the patient had received prior adjuvant chemotherapy and 78% presented visceral involvement. Twenty-four responses were documented and validated by an independent panel review, yielding response rates of 49% (95% CI: 34–64) in the 49 enrolled patients and 55.8% (95% CI: 40–71) in the 43 evaluable patients. Median duration of response was 9.4 months. Median progression-free survival and median overall survival were 5.5 and 33.2 months, respectively. Neutropenia was the main dose-limiting toxicity but complications were uncommon, four patients having experienced febrile neutropenia and one having developed neutropenic infection. Other frequently reported adverse events included alopecia, fatigue, stomatitis, constipation, diarrhoea and nausea, which were rarely severe. This regimen alternating oral and i.v. vinorelbine in combination with docetaxel is effective and manageable. Vinorelbine i.v. per oral day 1 per day 15-docetaxel day 1 every 3 weeks represents a convenient option to combine docetaxel and vinorelbine for the palliative treatment of MBC.
Appropriate Use Criteria for Coronary Revascularization and Trends in Utilization, Patient Selection, and Appropriateness of Percutaneous Coronary Intervention.

Appropriate Use Criteria for Coronary Revascularization were developed to critically evaluate and improve patient selection for percutaneous coronary intervention (PCI). National trends in the appropriateness of PCI have not been examined.



To examine trends in PCI utilization, patient selection, and procedural appropriateness following the introduction of Appropriate Use Criteria.



Multicenter, longitudinal, cross-sectional analysis of patients undergoing PCI between July 1, 2009, and December 31, 2014, at hospitals continuously participating in the National Cardiovascular Data Registry CathPCI registry over the study period.



Proportion of nonacute PCIs classified as inappropriate at the patient and hospital level using the 2012 Appropriate Use Criteria for Coronary Revascularization.



A total of 2.7 million PCI procedures from 766 hospitals were included. Annual PCI volume of acute indications was consistent over the study period (377,540 in 2010; 374,543 in 2014), but the volume of nonacute PCIs decreased from 89,704 in 2010 to 59,375 in 2014. Among patients undergoing nonacute PCI, there were significant increases in angina severity (Canadian Cardiovascular Society grade III/IV angina, 15.8% in 2010 and 38.4% in 2014), use of antianginal medications prior to PCI (at least 2 antianginal medications, 22.3% in 2010 and 35.1% in 2014), and high-risk findings on noninvasive testing (22.2% in 2010 and 33.2% in 2014) (P < .001 for all), but only modest increases in multivessel coronary artery disease (43.7% in 2010 and 47.5% in 2014, P < .001). The proportion of nonacute PCIs classified as inappropriate decreased from 26.2% (95% CI, 25.8%-26.6%) to 13.3% (95% CI, 13.1%-13.6%), and the absolute number of inappropriate PCIs decreased from 21,781 to 7921. Hospital-level variation in the proportion of PCIs classified as inappropriate persisted over the study period (median, 12.6% [interquartile range, 5.9%-22.9%] in 2014).



Since the publication of the Appropriate Use Criteria for Coronary Revascularization in 2009, there have been significant reductions in the volume of nonacute PCI. The proportion of nonacute PCIs classified as inappropriate has declined, although hospital-level variation in inappropriate PCI persists.
Once- vs twice-daily budesonide/formoterol in 6- to 15-year-old patients with stable asthma.

To assess efficacy/tolerability of once-daily budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus budesonide pMDI (primary) and twice-daily budesonide/formoterol (secondary) in children/adolescents with asthma stabilized with twice-daily budesonide/formoterol.



This 12-week multicenter, double-blind randomized controlled study (www.clinicaltrials.gov identifier NCT00646321) included 521 patients aged 6 to 15 years with mild/moderate persistent asthma. Patients stabilized during a 4- to 5-week run-in with twice-daily budesonide/formoterol pMDI 40/4.5 microgx2 inhalations (160/18 microg daily) received twice-daily budesonide/formoterol pMDI 40/4.5 microgx2 inhalations (160/18 microg daily), once-daily budesonide/formoterol pMDI 80/4.5 microgx2 inhalations (160/9 microg daily; evening), or once-daily budesonide pMDI 80 microgx2 inhalations (160 microg daily; evening).



Once- or twice-daily budesonide/formoterol was more effective than budesonide for evening peak expiratory flow (primary variable) at the end of the 24-hour once-daily dosing interval (P<or=.027). Twice-daily budesonide/formoterol demonstrated better efficacy versus once-daily treatments for evening predose forced expiratory volume in 1 second (P<or=.011), versus budesonide for daytime/nighttime rescue medication (P<or=.023), and versus once-daily budesonide/formoterol for daytime rescue medication (last 12 hours of once-daily dosing) (P=.032). There were no significant between-group differences for daytime/nighttime asthma symptoms, nighttime awakenings attributed to asthma, or health-related quality of life. Fewer patients experienced asthma worsening (predefined criteria) with twice-daily budesonide/formoterol (8.2%) versus once-daily budesonide (15.5%) (P=.036) or once-daily budesonide/formoterol (19.6%) (P=.002). All treatments were well tolerated.



Once-daily budesonide/formoterol demonstrated significantly better efficacy than once-daily budesonide for most pulmonary-function variables. Twice-daily budesonide/formoterol (160/18 microg daily) maintenance therapy was generally more effective than stepping down to once-daily dosing (160/9 microg daily). Treatments were well tolerated, and there was no evident safety benefit for once- versus twice-daily dosing.
Validation of the short version of the 10/66 dementia diagnosis in multiethnic Asian older adults in Singapore

To validate the short version of the 10/66 dementia diagnosis against the standard version of the 10/66 dementia diagnosis and clinical diagnosis and examine concurrent validity with the World Health Organisation Disability Assessment schedule and care needs in a multiethnic Asian older adult population in Singapore.



Data from the Well-being of the Singapore Elderly study, a nationally representative survey of the older Singapore Resident population aged 60 years and above was used. The validity of the short version of the 10/66 dementia diagnostic criteria derived from the Community Screening Instrument for Dementia, the modified Consortium to Establish a Registry of Alzheimer's Disease 10-word list delayed recall and the EURO-D depression screen were examined against the standard version of the 10/66 dementia diagnosis and clinician diagnosis as a gold standard. Concurrent validity was tested by examining the relationships between the short version 10/66 dementia diagnosis, disability and care needs.



A total of 2373 respondents who had completed data on the short version diagnosis were included in this study. The majority (82.63%) of respondents were of Chinese descent, 9.86% were Malays, 6.12% were of Indian descent and 1.39% belonged to other ethnic group. We found the short version 10/66 dementia diagnosis showed almost perfect agreement with the standard version 10/66 dementia diagnosis (kappa = 0.90, AUC = 0.96) and substantial agreement with clinical diagnosis (kappa = 0.70, AUC = 0.87). The weighted prevalence of dementia in the population was slightly higher based on the short version diagnosis than the standard version diagnosis (10.74% vs. 10.04%). We also found that those with the short version 10/66 dementia were significantly associated with higher disability (β = 28.90, 95% CI = 23.62, 9.62) and needed care occasionally (OR =35.21, 95% CI = 18.08, 68.59) or much of the time (OR = 9.02, 95% CI = 5.21, 15.61).



The study found that the short version 10/66 dementia diagnosis has excellent validity to diagnose dementia in a multiethnic Asian population in Singapore. Further research is required to determine the usefulness of this diagnosis in clinical practice or institutional settings to aid early detection and intervention for dementia.
Randomized Trial of Treat and Extend Ranibizumab with and without Navigated Laser for Diabetic Macular Edema: TREX-DME 1 Year Outcomes.

To compare monthly dosing with a treat and extend algorithm using ranibizumab 0.3 mg with and without angiography-guided macular laser photocoagulation for center-involving diabetic macular edema (DME).



Multicenter, prospective, randomized clinical trial.



A total of 150 eyes from 116 subjects were randomized into 3 cohorts: Monthly (n = 30), TReat and EXtend without macular laser photocoagulation (TREX; n = 60), and treat and extend with angiography-GuIded macular LAser photocoagulation (GILA; n = 60).



Monthly cohort eyes received ranibizumab 0.3 mg every 4 weeks. Eyes in the TREX and GILA cohorts received 4 monthly injections of ranibizumab 0.3 mg followed by a treat and extend algorithm based on disease activity. Eyes in the GILA cohort also received angiography-guided macular laser photocoagulation at month 1 and again every 3 months for microaneurysm leakage.



Change in mean best-corrected visual acuity (BCVA), mean central retinal thickness (CRT), number of injections from baseline to 1 year, and percentage gaining/losing 2 and 3 lines of vision.



Baseline demographics were well balanced among the cohorts. A total of 137 eyes (91%) completed the 1-year end point visit. At 1 year, the mean BCVA improved by 8.6, 9.6, and 9.5 letters in the Monthly, TREX, and GILA cohorts, respectively (P = 0.8). There was no significant difference between the cohorts in the percentage gaining/losing 2 and 3 lines of vision. The CRT improved by 123 μm, 146 μm, and 166 μm in the Monthly, TREX, and GILA cohorts, respectively (P = 0.47). The mean number of macular laser treatments in the GILA cohort at 1 year was 2.9 (range, 1-4). The number of injections was significantly reduced in both the TREX (10.7) and GILA (10.1) cohorts compared with the Monthly cohort (13.1, P < 0.001). There were no cases of endophthalmitis, and the total incidence of Anti-Platelet Trialists' Collaboration events was 4.7%.



This prospective, randomized trial found that treat and extend dosing of ranibizumab 0.3 mg with and without angiography-guided macular laser photocoagulation significantly decreased the number of injections given while providing similar visual and anatomic outcomes compared with monthly dosing at 1 year. Adding angiography-guided laser photocoagulation to this dosing algorithm did not significantly improve outcomes at 1 year.