nils-herrmann/clean_scirepeval huggingface dataset:
High Medication Adherence During Periconception Periods Among HIV-1–Uninfected Women Participating in a Clinical Trial of Antiretroviral Pre-exposure Prophylaxis

Pre-exposure prophylaxis (PrEP) may be an important safer conception strategy for HIV-1-uninfected women with HIV-1-infected partners. Understanding medication adherence in this population may inform whether PrEP is a feasible safer conception strategy.



We evaluated predictors of pregnancy and adherence to study medication among HIV-1-uninfected women enrolled in a randomized placebo-controlled trial of PrEP among African HIV-1-serodiscordant couples. Participants were counseled on HIV-1 risk reduction, contraception, and adherence and tested for pregnancy at monthly study visits. Pill counts of dispensed drug were performed and, at a subset of visits, plasma was collected to measure active drug concentration.



Among 1785 women, pregnancy incidence was 10.2 per 100 person-years. Younger age, not using contraception, having an additional sexual partner, and reporting unprotected sex were associated with increased likelihood of pregnancy. Monthly clinic pill counts estimated that women experiencing pregnancy took 97% of prescribed doses overall, with at least 80% pill adherence for 98% of study months, and no difference in adherence in the periconception period compared with previous periods (P = 0.98). Tenofovir was detected in plasma at 71% of visits where pregnancy was discovered. By multiple measures, adherence was similar for women experiencing and not experiencing pregnancy (P ≥ 0.1).



In this clinical trial of PrEP, pregnancy incidence was 10% per year despite excellent access to effective contraception. Women experiencing pregnancy had high medication adherence, suggesting that PrEP may be an acceptable and feasible safer conception strategy for HIV-1-uninfected women with HIV-1-serodiscordant partners.
Relations between endogenous androgens and estrogens in postmenopausal women with suspected ischemic heart disease.

Because androgens are obligatory precursors of estrogens, it is reasonable to assume that their serum concentrations would exhibit positive correlations. If so, then epidemiologic studies that examine the association between androgens and pathological processes should adjust the results for the independent effect of estrogens.



The objective of the study was to examine the interrelationships among testosterone (T), androstenedione, estradiol (E2), estrone, and SHBG in postmenopausal women.



This was a cross-sectional study of women participating in the National Heart, Blood, and Lung Institute-sponsored Women's Ischemia Syndrome Evaluation study.



The study was conducted at four academic medical centers.



A total of 284 postmenopausal women with chest pain symptoms or suspected myocardial ischemia.



Post hoc analysis of the relationships among sex steroid hormones with insulin resistance, body mass index (BMI), and presence or absence of coronary artery disease as determined by coronary angiography.



BMI was significantly associated with insulin resistance, total E2, free E2, bioavailable E2, and free T. Highly significant correlations were found for total T, free T, and androstenedione with total E2, free E2, bioavailable E2, and estrone and persisted after adjustment for BMI and insulin resistance. A significant relationship was present between total and free T and the presence of coronary artery disease after adjustment for the effect of E2.



Serum levels of androgens and estrogens track closely in postmenopausal women referred for coronary angiography for suspected myocardial ischemia. Epidemiological studies that relate sex steroid hormones to physiological or pathological processes need to control for the independent effect of both estrogens and androgens.
Clinical correlates of response to DST. The Dexamethasone Suppression test in depression: a World Health Organisation collaborative study.

From 9 centres 293 patients took part in the WHO-collaborative study on Dexamethasone-Suppression-Test (DST) in depression to examine the relationship of psychopathological and psychiatric history information to cortisol-levels and suppression/non-suppression status. Differences between the centres were large and significant on nearly all of the measures. The predictor analyses generally suffered from numerically weak correlations with many variables correlating to sex and age. Therefore analyses of the data were adjusted for centre-, sex-, and age-influences. The best predicting features of cortisol were 'fitful, restless sleep', 'change of bodyweight' and 'affective disorders in blood relatives'. The last 2 items together with 'hypersomnia' and 'ideas of insufficiency' were the best predictors of suppression/nonsuppression status. However, statistical evidence did not seem to be strong enough to describe a typical symptom profile of a depressive cortisol suppressor or nonsuppressor.
Cognitive-motor intervention in Alzheimer's disease: long-term results from the Maria Wolff trial.

Little is known about the long-term acceptance and effects of cognitive and motor stimulation interventions (CMSI) in Alzheimer's disease (AD).



To evaluate a replicable CMSI program for mild cognitive impairment (MCI) and mild-to-moderate AD persons.



Eighty-four non-institutionalized subjects with AD were randomized to receive either CMSI, administered by a single care provider, or standard support. Cognition, activities of daily living (ADL), mood, and study partner's subjective burden were assessed by blinded raters. Data on institutionalization, psychiatric medications, and demise were collected by the study physicians. Random effects model and survival analyses were conducted, after 2 and 3 years of study.



Three-year assessments could be performed by the physician in 85% and by the blinded rater in 66% of subjects. Significant benefits were observed in basic ADL at the 2- and 3-year assessments, whereas instrumental ADL showed benefits only up to the second year of intervention (p < 0.05).



Long-term cognitive-motor stimulation is well accepted and produces functional benefits in subjects with AD, with no extra subjective burden in the partner.
Progressive preclinical interstitial lung disease in rheumatoid arthritis.

Early detection and treatment for interstitial lung disease (ILD) in patients with rheumatoid arthritis (RA) may ameliorate disease progression. The objective of this study was to identify asymptomatic lung disease and potential therapeutic targets in patients having RA and preclinical ILD (RA-ILD).



Sixty-four adults with RA and 10 adults with RA and pulmonary fibrosis (RAPF) were referred to the National Institutes of Health, Bethesda, Maryland, and underwent high-resolution computed tomography (HRCT) and pulmonary physiology testing. Proteins capable of modulating fibrosis were quantified in alveolar fluid.



Twenty-one of 64 patients (33%) having RA without dyspnea or cough had preclinical ILD identified by HRCT. Compared with patients without lung disease, patients with RA-ILD had statistically significantly longer histories of cigarette smoking (P< .001), increased frequencies of crackles (P= .02), higher alveolar-arterial oxygen gradients (P= .004), and higher HRCT scores (P< .001). The HRCT abnormalities progressed in 12 of 21 patients (57%) with RA-ILD. The alveolar concentrations of platelet-derived growth factor-AB and platelet-derived growth factor-BB were statistically significantly higher in patients having RA-ILD (mean [SE], 497.3 [78.6] and 1473  pg/mL, respectively) than in patients having RA without ILD (mean [SE], 24.9 [42.4] and 792.7 [195.0] pg/mL, respectively) (P< .001 and P=.047, respectively). The concentrations of interferon gamma and transforming growth factor beta(2) were statistically significantly lower in patients having RAPF (mean [SE], 5.59 [1.11] pg/mL and 0.94 [0.46] ng/mL, respectively) than in patients having RA without ILD (mean [SE], 14.1 [1.9] pg/mL and 2.30 [0.39] ng/mL, respectively) (P=.001 and P=.006, respectively) or with preclinical ILD (mean [SD], 11.4 [2.6] pg/mL and 3.63 [0.66] ng/mL, respectively) (P=.04 and P=.007, respectively). Compared with patients having stable RA-ILD, patients having progressive RA-ILD had statistically significantly higher frequencies of treatment using methotrexate and higher alveolar concentrations of interferon gamma and transforming growth factor beta(1) (P=.046, P=.04, and P=.04, respectively).



Asymptomatic preclinical ILD, which is detectable by HRCT, may be prevalent and progressive among patients having RA. Cigarette smoking seems to be associated with preclinical ILD in patients having RA, and treatment using methotrexate may be a risk factor for progression of preclinical ILD. Quantification of alveolar proteins indicates that potential pathogenic mechanisms seem to differ in patients having RA-ILD and symptomatic RAPF.
Association between endogenous complement inhibitor and myocardial salvage in patients with myocardial infarction.

Many pathogenic processes and diseases are the result of an erroneous activation of the complement cascade and a number of inhibitors of complement have thus been examined for anti-inflammatory actions. It was recently demonstrated that supraphysiological concentrations of the endogenous complement inhibitor MAp44 (also denoted MAP1) protect against myocardial reperfusion injury. In the present study, we examined the association between outcome after acute myocardial infarction (MI) and the plasma levels of MAp44 and its related proteins MASP-1 and MASP-3 in patients with first-time MI. In addition, we compared plasma levels of MAp44, MASP-1, and MASP-3 in MI patients to levels in a healthy control group.



A total of 192 MI patients and 140 control persons were included. Plasma samples were obtained and analysed with time-resolved immunofluorometric assays determining the plasma levels of MAp44, MASP-1, and MASP-3. The myocardial outcomes (salvage index and final infarct size) were measured by gated single-photon emission CT.



MI patients had 18 % higher plasma levels of MAp44 (IQR 11-25%) as compared to the healthy control group (p<0.001. However, neither salvage index (Spearman rho -0.1, p=0.28) nor final infarct size (Spearman rho 0.02, p=0.83) correlated with plasma levels of MAp44. Likewise, MASP-1 and MASP-3 were elevated in MI patients (p=0.002 and p<0.001), but the levels were not correlated to outcome.



Plasma levels of MAp44, MASP-1, and MASP-3 are significantly higher in patients with MI compared to healthy control persons, but are not associated with short-term outcome measured as salvage index and final infarct.
Short term prognosis of patients with acute coronary syndromes: the level of cardiac troponin T elevation corresponding to the "old" WHO definition of myocardial infarction.

T raditionally, myocardial infarction (MI) has been diagnosed according to the World Health Organization criteria, which emphasises the importance of the clinical syndrome, electrocardiographic changes, and elevation of long standing but relatively non-specific markers of myocardial damage such as creatine kinase (CK). In 2000, a Joint European Society of Cardiology ( This has led to the inclusion of patients with lower levels of myocardial damage than was previously detectable. As a result future epidemiological studies will inevitably be skewed by the ‘‘new’’ definition with an increase in the numbers of patients diagnosed with MI, and an apparent improvement in overall prognosis likely to be related to a smaller proportion of patients with large transmural infarctions being exposed to the hazards of ventricular remodelling and heart failure. This has important implications for patients who may be unjustifiably concerned by information concerning their prognosis obtained from historical studies and unjustifiably penalised by financial institutions. For these reasons it is important to try and establish the level of troponin elevation that corresponds in terms of prognosis to the ‘‘old’’ WHO definition of MI so that patients and physicians can compare old and new data from registries and clinical trials.
Validity of a Novel Method for Estimation of Low-Density Lipoprotein Cholesterol Levels in Diabetic Patients

Low-density lipoprotein cholesterol (LDL-C) is routinely estimated using the Friedewald equation [LDL-C(F)]. A novel method for LDL-C [LDL-C(M)] estimation recently proposed by Martin et al. was reported to be more accurate than the Friedewald formula in subjects in the United States. The validity of LDL-C(M) in different races and patients with diabetes mellitus (DM) has not been elucidated. The purpose of this study was to validate the LDL-C(M) estimates in Japanese population with type 2 DM by comparing with LDL-C(F) and directly measured LDL-C [LDL-C(D)].



Both LDL-C(M) and LDL-C(F) levels were compared against LDL-C(D) measured by selective solubilization method in 1,828 Japanese patients with type 2 DM.



On linear regression analysis, LDL-C(M) showed a stronger correlation than that shown by LDL-C(F) (R=0.979 vs. R=0.953, respectively) with LDL-C(D). We further analyzed the effect of serum triglyceride (TG) concentrations on the accuracy of LDL-C(F) and LDL-C(M). Although LDL-C levels showed a positive correlation with TG levels, the LDL-C(F) levels tended to show a greater divergence from LDL-C(D) levels than that shown by LDL-C(M) with changes in TG levels.



We for the first time demonstrated a more useful measurement of LDL-C levels estimated by Martin's method than that estimated by the Friedewald equation in Japanese patients with DM.
Different sequential approaches of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in treating ovarian cancer with malignant ascites

Treatment for malignant ascites in advanced ovarian cancer (OC) patients remains controversial. The objective of this study was to investigate the efficacy of combined continuous circulatory hyperthermic intraperitoneal chemotherapy (HIPEC) preceded or followed by cytoreductive surgery (CRS) for malignant ascites in OC patients. Female OC patients (n = 32) with malignant ascites were divided based on stable (n = 17) or unstable (n = 15) vital signs. Stable patients were treated with CRS immediately followed by HIPEC (CRS + HIPEC). Unstable patients were treated using B-mode ultrasound-guided HIPEC followed by delayed CRS upon vital sign stability (HIPEC + dCRS). All patients were followed up until death or until December 2012. Median follow-up was 29 months. All patients showed ascite regression [objective remission rates (ORR) = 100 %]. Among stable patients, CRS + HIPEC was successful in 14/17 (83.4 %). Among unstable patients, HIPEC + dCRS was successful in 13/15 (86.7 %). Median survival times were 19 and 17 months in the stable and unstable groups, respectively. No significant differences in CRS rates, ascites ORR, Karnofsky performance status scores, or survival rates were observed between groups (P > 0.05). Cytoreductive surgery with immediate HIPEC and HIPEC with dCRS, determined by vital sign stability, may lead to similar outcomes in OC patients with malignant ascites.
AMG 416 (velcalcetide) is a novel peptide for the treatment of secondary hyperparathyroidism in a single-dose study in hemodialysis patients.

AMG 416 (velcalcetide), a novel peptide agonist of the calcium-sensing receptor, lowers plasma parathyroid hormone in preclinical uremic animal models and in normal healthy individuals. Here, we studied its efficacy in hemodialysis patients suffering from secondary hyperparathyroidism. Major inclusion criteria were hemodialysis for at least 3 months, serum parathyroid hormone over 300 pg/ml, a corrected serum calcium of 9.0 mg/dl or more, and stable doses of vitamin D analogs for at least 3 weeks prior to screening. Twenty-eight patients were enrolled in one of five cohorts (5, 10, 20, 40, 60 mg). Cohorts 1-3 (four patients each) were treated in a two-period crossover design, while cohorts 4 and 5 (eight patients each) were randomized 1:1 to AMG 416 or placebo. Patients were admitted to a clinical research unit following hemodialysis and studied for 3 days prior to discharge for hemodialysis. Single intravenous doses of AMG 416 from 5 to 60 mg were well tolerated, and plasma levels increased in a dose-related manner. AMG 416 treatment was associated with significant, dose-dependent reductions in serum parathyroid hormone and fibroblast growth factor 23. Compared with placebo, all dose groups of 10 mg or more were associated with attenuation in the rise in serum phosphate during the interdialytic period. Dose-dependent reductions in serum calcium were observed and were well tolerated. Thus, AMG 416 represents a novel therapeutic approach for the treatment of secondary hyperparathyroidism in hemodialysis patients.
Hippocampal function during associative learning in patients with posttraumatic stress disorder.

In the last decade several studies have shown memory deficits in patients with posttraumatic stress disorder (PTSD) which have been associated with a reduced hippocampus volume. However, until now we do not know how or whether these structural abnormalities turn into functional abnormalities. Thus, the primary purpose of the present study was the investigation of the hippocampal function using functional magnet resonance imaging (fMRI). We compared PTSD patients and healthy control participants using an associative learning paradigm consisting of two encoding and one retrieval condition. During fMRI scanning participants had to learn face-profession pairs. Afterwards only faces were presented as cue stimuli for associating the category of the prior learned target profession and the participants had to decide whether this face belonged to a scientific or an artistic profession. Additionally, cognitive functioning, i.e. memory and attention, was examined using neuropsychological standard tests. During encoding PTSD patients showed stronger hippocampal and weaker prefrontal activation compared to healthy control participants. During retrieval the two groups did not differ neither in hippocampus activation nor in accuracy of retrieval. PTSD patients however showed a reduced activation in the left parahippocampal gyrus and other memory-related brain regions. We did not find any significant memory differences between PTSD patients and healthy control participants. The results suggest that PTSD has an effect on memory-related brain function despite intact memory functioning. In particular the hippocampal/parahippocampal regions and the prefrontal cortex show functional alterations during associative learning and memory.
Moderators of the mediated effect of intentions, planning, and saturated-fat intake in obese individuals.

The present study aimed to advance our understanding of health-related theory, that is, the alleged intention-behavior gap in an obese population. It examined the mediating effects of planning on the intention-behavior relationship and the moderated mediation effects of age, self-efficacy and intentions within this relationship.



The study was conducted over a five-week period. Complete data from 571 obese participants were analyzed. The moderated mediation hypothesis was conducted using multiple-regression analysis. To test our theoretical model, intentions (Week 2), action self-efficacy (Week 2), maintenance self-efficacy (Week 5), planning (Week 5), and saturated-fat intake (Weeks 1 and 5) were measured by self-report.



As hypothesized, planning mediated the intention-behavior relationship for perceived (two-item scale) and percentage-saturated-fat intake (measured by a food frequency questionnaire). Age, self-efficacy, and intention acted as moderators in the above mediation analysis. In specific, younger individuals, those with stronger intention, and people with higher levels of maintenance self-efficacy at higher levels of planning showed greater reductions in their perceived saturated-fat intake.



For successful behavior change, knowledge of its mediators and moderators is needed. Future interventions targeting planning to change saturated-fat intake should be guided by people's intentions, age, and self-efficacy levels.
Theoretical simulation of tumour oxygenation and results from acute and chronic hypoxia.

The tumour microenvironment is considered to be responsible for the outcome of cancer treatment and therefore it is extremely important to characterize and quantify it. Unfortunately, most of the experimental techniques available now are invasive and generally it is not known how this influences the results. Non-invasive methods on the other hand have a geometrical resolution that is not always suited for the modelling of the tumour response. Theoretical simulation of the microenvironment may be an alternative method that can provide quantitative data for accurately describing tumour tissues. This paper presents a computerized model that allows the simulation of the tumour oxygenation. The model simulates numerically the fundamental physical processes of oxygen diffusion and consumption in a two-dimensional geometry in order to study the influence of the different parameters describing the tissue geometry. The paper also presents a novel method to simulate the effects of diffusion-limited (chronic) hypoxia and perfusion-limited (acute) hypoxia. The results show that all the parameters describing tissue vasculature are important for describing tissue oxygenation. Assuming that vascular structure is described by a distribution of inter-vessel distances, both the average and the width of the distribution are needed in order to fully characterize the tissue oxygenation. Incomplete data, such as distributions measured in a non-representative region of the tissue, may not give relevant tissue oxygenation. Theoretical modelling of tumour oxygenation also allows the separation between acutely and chronically hypoxic cells, a distinction that cannot always be seen with other methods. It was observed that the fraction of acutely hypoxic cells depends not only on the fraction of collapsed blood vessels at any particular moment, but also on the distribution of vessels in space as well. All these suggest that theoretical modelling of tissue oxygenation starting from the basic principles is a robust method that can be used to quantify the tissue oxygenation and to provide input parameters for other simulations.
Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients.

The stool softener docusate is widely used in the management of constipation in hospice patients. There is little experimental evidence to support this practice, and no randomized trials have been conducted in the hospice setting.



To assess the efficacy of docusate in hospice patients.



This was a 10-day, prospective, randomized, double-blind, placebo-controlled trial of docusate and sennosides vs. placebo and sennosides in hospice patients in Edmonton, Alberta. Patients were included if they were age 18 years or older, able to take oral medications, did not have a gastrointestinal stoma, and had a Palliative Performance Scale score of 20% or more. The primary outcome measures were stool frequency, volume, and consistency. Secondary outcomes were patient perceptions of bowel movements (difficulty and completeness of evacuation) and bowel-related interventions.



A total of 74 patients were randomized into the study (35 to the docusate group and 39 to the placebo group). There were neither significant differences between the groups in stool frequency, volume, or consistency, nor in difficulty or completeness of evacuation. On the Bristol Stool Form Scale, more patients in the placebo group had Type 4 (smooth and soft) and Type 5 (soft blobs) stool, whereas in the docusate group, more had Type 3 (sausage like) and Type 6 (mushy) stool (P=0.01).



There was no significant benefit of docusate plus sennosides compared with placebo plus sennosides in managing constipation in hospice patients. Docusate use should be considered on an individual basis.