nils-herrmann/clean_scirepeval huggingface dataset:
Adherence to blood pressure telemonitoring in a cluster-randomized clinical trial.

Hypertension is a leading cause of cardiovascular disease and death worldwide. Advances in technology have added telemedicine as a tool for managing hypertension. The effectiveness of telemedicine depends on patients' ability to adhere to schedules of home monitoring and case management. Participants with uncontrolled hypertension in the intervention arm of a randomized trial who completed 6 months of follow-up were included in this analysis. They were asked to measure their blood pressure (BP) a minimum of 6 times per week using a telemonitor that transmitted the readings to their pharmacist case manager. Hypertensive patients in this study had high adherence to telemonitoring (73% took at least 6 BP readings per week) and phone visits (88% of expected visits were attended). In a multivariate analysis, older age, male sex, and some college education predicted better telemonitoring adherence. White non-Hispanic race/ethnicity predicted better adherence to phone visits with pharmacist case managers. Telemonitoring adherence and phone adherence were highly correlated; participants who did not send readings on schedule were more likely to skip at least one phone visit with their pharmacist case manager. The findings from this analysis indicate that hypertensive patients in this study were able to achieve and maintain high adherence to both the telemonitoring and the phone case management visits.
Inter-individual Variability in the Pre-clinical Drug Cardiotoxic Safety Assessment—Analysis of the Age–Cardiomyocytes Electric Capacitance Dependence

Electrical phenomena located within the plasma membrane of the mammalian cardiac cells are connected with the cells' main physiological functions--signals processing and contractility. They were extensively studied and described mathematically in so-called Hodgkin-Huxley paradigm. One of the physiological parameters, namely cell electric capacitance, has not been analyzed in-depth. The aim of the study was to validate the mechanistic model describing the capacitive properties of cells, based on a collected experimental dataset which describes the electric capacitance of human ventricular myocytes. The gathered data was further utilized for developing an empirical correlation between a healthy individual's age and cardiomyocyte electric capacitance.
Results of a phase II double-blinded randomized clinical trial of difluoromethylornithine for cervical intraepithelial neoplasia grades 2 to 3.

Our purpose was to conduct a double-blinded randomized trial of difluoromethylornithine (DFMO) at 0.125, 0.5 gm/m2, versus placebo in the treatment of cervical intraepithelial neoplasia (CIN) grades 2 to 3. A promising phase I study has shown histopathologic responses at these dose levels.



Patients with histopathologically confirmed CIN 2-3 lesions were recruited from a colposcopy clinic and underwent Papanicolaou testing, human papillomavirus testing, and colpophotography. They took oral contraception and DFMO or placebo elixir for 28 days and filled out the National Cancer Institute common toxicity calendars. They returned for follow-up and a repeat Papanicolaou smear, colpophotograph, and loop excision of the cervix.



There were no statistically significant differences among the arms in histopathologic response. This could no be explained by any biases in risk factors. The prominent toxicities were diarrhea, dizziness, nausea, and headaches. There were no differences in the toxicities among arms. The Papanicolaou smear was a poor biomarker of response and correlated poorly with the histopathology.



DFMO is no active at 0.125 and 0.5 gm/m2 for 28 days when given orally in CIN 2-3. Higher oral doses or longer administration is necessary, supporting data from breast trials. Alternatively, a trial of topical DFMO might merit attention as activity has been noted in trials of actinic keratoses.
A phase II study of neoadjuvant chemotherapy with docetaxel, cisplatin and trastuzumab for T2 breast cancers

Preclinical data indicate that the combination of docetaxel, cisplatin and trastuzumab (TCH) may have the potential for clinically significant activity against breast cancers that overexpress the her2/neu gene (HER2). An open-label phase II trial was designed to investigate the response rate and toxicity profile of TCH in breast cancer patients with a primary tumor 2–5 cm in diameter (T2) in its original size. Thirty breast cancer patients with HER2-overexpressing tumors were enrolled. Patients received 6 cycles of docetaxel at 60 mg/m2 and cisplatin at 50 mg/m2 given on day 1 and then every 21 days. Trastuzumab was given on day 1, cycle 1 (4 mg/kg), and then continued weekly at 2 mg/kg for 1 year or until disease progression. Tumor measurements were obtained at baseline as well as after 3 and 6 cycles of chemotherapy. We identified 29 breast cancer patients in Taiwan, of whom 13 (44.8%) had pathological complete responses. No cardiac toxicity was observed. Hematologic grade 4 or 3 toxicities were observed in 1 of 28 patients. Non-hematologic grade 4 or 3 toxicities with a reverse pattern were observed in 6 of 29 patients. The results of our study indicate that TCH neoadjuvant chemotherapy is feasible and active in T2 HER2-overexpressing breast cancer patients in terms of pathological complete response rate, complete response, partial response and manageable toxicities.
Robotic right colectomy with intracorporeal anastomosis compared with laparoscopic right colectomy with extracorporeal and intracorporeal anastomosis: a retrospective multicentre study

Growing evidence suggests that the intracorporeal fashioning of an anastomosis after a laparoscopic right colectomy may offer several advantages. However, due to the difficulty of the intracorporeal technique, laparoscopic extracorporeal confectioning of the anastomosis remains the most widely adopted technique. Although the purpose of the robotic approach was to overcome the limitations of the laparoscopic technique and to simplify the most demanding surgical procedures, such as performing an intracorporeal anastomosis, evidence is lacking that compares the robotic right colectomy with intracorporeal anastomosis (RRCIA) technique with both the conventional laparoscopic right colectomy with extracorporeal anastomosis (LRCEA) and the laparoscopic right colectomy with intracorporeal anastomosis confectioning (LRCIA) techniques. This study aims to compare the intraoperative and postoperative outcomes of the RRCIA to those of both the LRCEA and the LRCIA. A retrospective review of a prospectively maintained database of two Italian centres was performed on the data on patients undergoing an RRCIA, LRCEA or LRCIA for cancer or adenomas. Two hundred and thirty-six patients (RRCIA = 102, LRCEA = 94, LRCIA = 40) met the criteria for inclusion in the study. The three groups were comparable in their demographic and baseline characteristics. No significant differences were found in the conversion to open rates, intraoperative blood loss, 30-day morbidity and mortality, number of lymphnodes harvested and other pathological characteristics. Compared with the LRCEA, the RRCIA required a longer operative time (P < 0.0001) but had better recovery outcomes, such as a shorter length of hospital stay (P < 0.0001). Compared with the LRCIA, the RRCIA had a shorter time to first flatus (P < 0.0001) but offered no advantages in terms of the length of the hospital stay. Performing the RRCIA offers significantly better perioperative recovery outcomes compared with the LRCEA, with a substantial reduction in the length of the hospital stay. The RRCIA does not offer the same advantages compared with the LRCIA.
Teaching tobacco dependence treatment and counseling skills during medical school: rationale and design of the Medical Students helping patients Quit tobacco (MSQuit) group randomized controlled trial.

Physician-delivered tobacco treatment using the 5As is clinically recommended, yet its use has been limited. Lack of adequate training and confidence to provide tobacco treatment is cited as leading reasons for limited 5A use. Tobacco dependence treatment training while in medical school is recommended, but is minimally provided. The MSQuit trial (Medical Students helping patients Quit tobacco) aims to determine if a multi-modal and theoretically-guided tobacco educational intervention will improve tobacco dependence treatment skills (i.e. 5As) among medical students.



10 U.S. medical schools were pair-matched and randomized in a group-randomized controlled trial to evaluate whether a multi-modal educational (MME) intervention compared to traditional education (TE) will improve observed tobacco treatment skills. MME is primarily composed of TE approaches (i.e. didactics) plus a 1st year web-based course and preceptor-facilitated training during a 3rd year clerkship rotation. The primary outcome measure is an objective score on an Objective Structured Clinical Examination (OSCE) tobacco-counseling smoking case among 3rd year medical students from schools who implemented the MME or TE.



MSQuit is the first randomized to evaluate whether a tobacco treatment educational intervention implemented during medical school will improve medical students' tobacco treatment skills. We hypothesize that the MME intervention will better prepare students in tobacco dependence treatment as measured by the OSCE. If a comprehensive tobacco treatment educational learning approach is effective, while also feasible and acceptable to implement, then medical schools may substantially influence skill development and use of the 5As among future physicians.
No Signs of Inflammation during Knee Surgery with Ischemia: A Study Involving Inhaled Nitric Oxide

Nitric oxide donors and inhaled nitric oxide (iNO) may decrease ischemia/reperfusion injury as reported in animal and human models. We investigated whether the attenuation of reperfusion injury, seen by others, in patients undergoing knee arthroplasty could be reproduced when patients had spinal anesthesia. 45 consecutive patients were randomized into three groups (n = 15). Groups 1 and 3 were receiving iNO 80 ppm or placebo (nitrogen, N2) throughout the entire operation, and group 2 only received iNO in the beginning and at the end of the operation. Blood samples were collected before surgery, at the end of the surgery, and 2 hours postoperatively. Muscle biopsies were taken from quadriceps femoris muscle before and after ischemia. There were no increases in plasma levels of soluble adhesion molecules: ICAM, VCAM, P-selectin, E-selectin, or of HMGB1, in any of the groups. There were low numbers of CD68+ macrophages and of endothelial cells expression of ICAM, VCAM, and P-selectin in the muscle analyzed by immunohistochemistry, prior to and after ischemia. No signs of endothelial cell activation or inflammatory response neither systemically nor locally could be detected. The absence of inflammatory response questions this model of ischemia/reperfusion, but may also be related to the choice of anesthetic method EudraCTnr.
Determining the Basic Psychometric Properties of the Greek KDQOL-SF TM

The aim of this study was to determine the basic psychometric properties, i.e. reliability and validity, of the Greek version of the Kidney Disease Quality of Life Short Form (KDQOL-SF TM). The instrument was self-administered to a homogenous group of 665 end stage renal disease patients in 20 dialysis units throughout Greece and the overall response rate was 72.6%. Reliability was demonstrated by Cronbach’s alpha exceeding the recommended minimum value of 0.70 in all, except one, scales. Tests of item-internal consistency, after correction for overlap, resulted in correlations between items and their hypothesized scales, which exceeded the 0.40 standard in 94.5% of the cases. Item discriminant validity tests indicated 100% scaling success for six out of eight generic and disease-targeted scales. Validity was supported by the confirmation of expected correlations between scales and the overall health-rating item included in the instrument and with sociodemographic and self-reported health variables. Multiple stepwise linear regression analysis demonstrated that all disease-targeted scales were important predictors of SF-36 general health scales and the variance explained ranged from 37% to 57%. Overall, the psychometric properties of the KDQOL-SF TM , resulting from this first-time administration of the instrument to a Greek dialysis population, were good and the disease targeted scales were informative and of high internal consistency reliability. Cross-sectional construct validity is demonstrated, despite the lack of external validity criteria based on clinical ratings of severity. The results support administering the Greek KDQOL-SF TM in studies evaluating dialysis therapy and contribute to transnational comparison of findings.
Prevention of exacerbations in patients with COPD and vitamin D deficiency through vitamin D supplementation (PRECOVID): a study protocol

Vitamin D is well known for its function in calcium homeostasis and bone mineralisation, but is increasingly studied for its potential immunomodulatory properties. Vitamin D deficiency is a common problem in patients with COPD. Previous studies have not demonstrated a beneficial effect of vitamin D on exacerbation rate in COPD patients. However, subgroup analyses suggested protective effects in vitamin D deficient patients. Our objective is to assess the effect of vitamin D supplementation on exacerbation rate specifically in vitamin D deficient COPD patients.



We will perform a randomised, multi-center, double-blind, placebo-controlled intervention study. The study population consists of 240 COPD patients aged 40 years and older with vitamin D deficiency (25-hydroxyvitamin D concentration < 50 nmol/L). Participants will be recruited after an exacerbation and will be randomly allocated in a 1:1 ratio to receive vitamin D3 16800 IU or placebo orally once a week during 1 year. Participants will receive a diary card to register the incidence of exacerbations and changes in medication during the study period. Visits will be performed at baseline, at 6 months and at 12 months after randomisation. Participants will undergo spirometry, measurement of total lung capacity and assessment of maximal respiratory mouth pressure. Several physical performance and hand grip strength tests will be performed, questionnaires on quality of life and physical activity will be filled in, a nasal secretion sample and swab will be obtained and blood samples will be taken. The primary outcome will be exacerbation rate.



This study will be the first RCT aimed at the effects of vitamin D supplementation on exacerbation rate in vitamin D deficient COPD patients. Also, in contrast to earlier studies that used infrequent dosing regimens, our trial will study effects of a weekly dose of vitamin D supplementation. Secondly, the immunomodulatory effects of vitamin D on host immune response of COPD patients and underlying mechanisms will be studied. Finally, the effects on physical functioning will be examined.
Tapering off long-term benzodiazepine use with or without group cognitive-behavioural therapy: three-condition, randomised controlled trial.

Benzodiazepine withdrawal programmes have never been experimentally compared with a nonintervention control condition.



To evaluate the efficacy and feasibility of tapering off long-term benzodiazepine use in general practice, and to evaluate the value of additional group cognitive-behavioural therapy (CBT).



A 3-month randomised, 3-month controlled trial was conducted in which 180 people attempting to discontinue long-term benzodiazepine use were assigned to tapering off plus group CBT, tapering off alone or usual care.



Tapering off led to a significantly higher proportion of successful discontinuations than usual care (62% nu. 21%). Adding group CBT did not increase the success rate (58% v. 62%). Neither successful discontinuation nor intervention type affected psychological functioning. Both tapering strategies showed good feasibilityin general practice.



Tapering off is a feasible and effective way of discontinuing long-term benzodiazepine use in general practice. The addition of group CBT is of limited value.
Cost-effectiveness analyses for mirtazapine and sertraline in dementia: randomised controlled trial.

Depression is a common and costly comorbidity in dementia. There are very few data on the cost-effectiveness of antidepressants for depression in dementia and their effects on carer outcomes.



To evaluate the cost-effectiveness of sertraline and mirtazapine compared with placebo for depression in dementia.



A pragmatic, multicentre, randomised placebo-controlled trial with a parallel cost-effectiveness analysis (trial registration: ISRCTN88882979 and EudraCT 2006-000105-38). The primary cost-effectiveness analysis compared differences in treatment costs for patients receiving sertraline, mirtazapine or placebo with differences in effectiveness measured by the primary outcome, total Cornell Scale for Depression in Dementia (CSDD) score, over two time periods: 0-13 weeks and 0-39 weeks. The secondary evaluation was a cost-utility analysis using quality-adjusted life years (QALYs) computed from the Euro-Qual (EQ-5D) and societal weights over those same periods.



There were 339 participants randomised and 326 with costs data (111 placebo, 107 sertraline, 108 mirtazapine). For the primary outcome, decrease in depression, mirtazapine and sertraline were not cost-effective compared with placebo. However, examining secondary outcomes, the time spent by unpaid carers caring for participants in the mirtazapine group was almost half that for patients receiving placebo (6.74 v. 12.27 hours per week) or sertraline (6.74 v. 12.32 hours per week). Informal care costs over 39 weeks were £1510 and £1522 less for the mirtazapine group compared with placebo and sertraline respectively.



In terms of reducing depression, mirtazapine and sertraline were not cost-effective for treating depression in dementia. However, mirtazapine does appear likely to have been cost-effective if costing includes the impact on unpaid carers and with quality of life included in the outcome. Unpaid (family) carer costs were lower with mirtazapine than sertraline or placebo. This may have been mediated via the putative ability of mirtazapine to ameliorate sleep disturbances and anxiety. Given the priority and the potential value of supporting family carers of people with dementia, further research is warranted to investigate the potential of mirtazapine to help with behavioural and psychological symptoms in dementia and in supporting carers.
Discriminative aspects of two generic and two asthma-specific instruments: relation with symptoms, bronchodilator use and lung function in patients with mild asthma

The objective of this study was to compare the two most frequently used asthma-specific quality of life (QOL) questionnaires and two generic QOL questionnaires with clinical data in order to establish their ability to discriminate in asthma severity, also referred to as cross-sectional construct validity. We conducted a multicentre, randomized, placebo-controlled study investigating the long-term effects of the long-acting ß2-agonist formoterol in asthma patients using inhaled corticosteroids and short-acting ß2-agonists. Before randomization, the peak expiratory flow (PEF) and use of ß2-agonists for relief of symptoms were recorded twice daily for 1 month. At the end of the run-in period, the forced expiratory volume in 1s (FEV1), airway hyper-responsiveness (PC20 methacholine) and QOL were measured, using two asthma-specific questionnaires, the Asthma Quality of Life Questionnaire (AQLQ) and the Living with Asthma Quality of Life Questionnaire (LWAQ), as well as two generic questionnaires, the Short Form 36 (SF-36) and the Psychological General Well Being (PGWB) index. The quality of life of the patients (n=110) was only mildly impaired. The mean symptom score was 3.6 on a scale of 0-21 and the mean FEV1 was 65% of that predicted. The correlations between the QOL parameters and objective measures of asthma severity, such as the FEV1, PEF and PC20, were low (0.01-0.37). The correlations between the QOL parameters and subjective measures of asthma severity, such as symptom scores (range 0.26-0.65) and ß2-agonist use for the relief of symptoms (0.09-0.39), were higher. The correlations of the activity and symptoms domains of the AQLQ with diary-obtained symptom scores were r=0.50 (p[lessthan]0.0001) and r=0.65 (p[lessthan]0.0001), respectively. The correlation between the physical construct of the LWAQ and symptom scores was r=0.42 (p[lessthan]0.001) and that between the physical sumscore of the SF-36 and symptom scores was r=0.50 (p[lessthan]0.001). The correlation between the PGWB and symptom scores was r=0.41 (p[lessthan]0.001). The relation between the FEV1, PEF and PC20 and QOL was very low. The QOL measurements related well to the symptom scores. The AQLQ had a better cross-sectional construct validity than the LWAQ. The cross-sectional construct validity of the SF-36 was surprisingly high for this group of patients and the SF-36 performed better than the PGWB and LWAQ.
Pharmacokinetics of fosamprenavir plus ritonavir in human immunodeficiency virus type 1-infected adult subjects with hepatic impairment.

The effect of hepatic impairment on fosamprenavir/ritonavir pharmacokinetics was investigated. Sixty human immunodeficiency virus type 1-infected subjects, including 13, 20, and 10 subjects with mild, moderate, and severe hepatic impairment, respectively, and a comparator group of 17 subjects with normal hepatic function, were enrolled. Subjects with normal hepatic function received fosamprenavir at 700 mg plus ritonavir at 100 mg twice daily, whereas subjects with hepatic impairment received adjusted doses in anticipation of increased exposures. For subjects with mild hepatic impairment, the studied regimen of fosamprenavir 700 mg twice daily plus ritonavir 100 mg once daily delivered 17% higher values for the maximum plasma amprenavir concentration at the steady state (C(max)), 22% higher values for the area under the plasma concentration versus time curve over the dosing interval at the steady state [AUC(0-tau)], similar values for the concentration at the end of the dosing interval (C(tau)), and 114% higher unbound C(tau) values. For subjects with moderate hepatic impairment, the studied dosage regimen of fosamprenavir at 300 mg twice daily plus ritonavir at 100 mg once daily delivered 27% lower plasma amprenavir C(max) values, 27% lower AUC(0-24) values, 57% lower C(tau) values, and 21% higher unbound amprenavir C(tau) values. For subjects with severe hepatic impairment, the studied dosage regimen of fosamprenavir at 300 mg twice daily plus ritonavir at 100 mg once daily delivered 19% lower plasma amprenavir C(max) values, 23% lower AUC(0-24) values, 38% lower C(tau) values, and similar unbound amprenavir C(tau) values. With a reduced ritonavir dosing frequency of 100 mg once daily, the plasma ritonavir AUC(0-24) values were 39% lower, similar, and 40% higher for subjects with mild, moderate, and severe hepatic impairment, respectively. The results of the study support the use of reduced fosamprenavir/ritonavir doses or dosing frequencies in the treatment of patients with hepatic impairment. No significant safety issues were identified; however, plasma amprenavir and ritonavir exposures were more variable in subjects with hepatic impairment, and those patients should be closely monitored for safety and virologic response.