nils-herrmann/clean_scirepeval huggingface dataset:
Salivary cortisol levels are associated with outcomes of weight reduction therapy in obese Japanese patients.

Dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis can increase the risk of cardiovascular disease (CVD). However, the detailed relationships of HPA axis activity with weight reduction and CVD risk factors in obese patients have not been examined. This study was designed to elucidate the associations of salivary cortisol levels with weight reduction and CVD risk factors in obese patients. As a marker of HPA axis activity, we measured the morning salivary cortisol levels of 83 obese Japanese outpatients. We also examined metabolic parameters, inflammatory markers, and indicators of arterial stiffness, that is, the pulse wave velocity and cardio-ankle vascular index. All 83 obese patients underwent 3-month weight reduction therapy with lifestyle modification. At the baseline, multivariate regression analysis revealed that only logarithmic transformation of C-reactive protein (β = 0.258, P < .05) and cardio-ankle vascular index (β = 0.233, P < .05) were independent determinants of the salivary cortisol levels. However, other metabolic parameters were not significantly associated with the salivary cortisol levels. In addition, lower salivary cortisol levels and higher body weight at the baseline were the only independent determinants of successful weight loss through the weight reduction therapy (P < .01). The present study demonstrates that the baseline morning salivary cortisol levels are significantly associated with the levels of an inflammatory marker, arterial stiffness, and successful weight reduction in obese patients. Therefore, salivary cortisol could be a useful marker for assessing and managing body weight and CVD risk factors in obese patients.
Sentinel node biopsy after primary chemotherapy in breast cancer: a note of caution from results of ABCSG-14.

Over the past years, experience has been increasing with lymphatic mapping and sentinel node biopsy (SNB) after preoperative chemotherapy for breast cancer, with a wide range of results reported in the literature and final conclusions on the diagnostic value and clinical consequences of this sequential approach still missing. Between 1999 and 2002, the Austrian Breast and Colorectal Cancer Study Group (ABCSG) conducted a prospective randomized multicenter trial comparing three versus six preoperative cycles of epirubicin/docetaxel + granulocyte colony-stimulating factor for operable breast cancer. Of the 292 patients recruited to the trial overall, 111 were enrolled in a prospective subprotocol for performing LM and SNB in addition to obligatory axillary lymph node dissection (ALND) after PC. SNB after PC identified at least one sentinel node in 100 of 111 patients (identification rate 90%). In six cases, a false-negative SN was identified, resulting in a false-negative rate of 13% (6 of 47). We only found little correlation between patients and tumor characteristics and the identification rate or false-negative rate. Lymphatic mapping and SNB after primary chemotherapy failed to predict histologic infiltration of the sentinel node with sufficient sensitivity. The routine use of SNB after primary chemotherapy should therefore be discouraged.
Genetic and environmental influence on lung function impairment in Swedish twins

The understanding of the influence of smoking and sex on lung function and symptoms is important for understanding diseases such as COPD. The influence of both genes and environment on lung function, smoking behaviour and the presence of respiratory symptoms has previously been demonstrated for each of these separately. Hence, smoking can influence lung function by co-varying not only as an environmental factor, but also by shared genetic pathways. Therefore, the objective was to evaluate heritability for different aspects of lung function, and to investigate how the estimates are affected by adjustments for smoking and respiratory symptoms.



The current study is based on a selected sample of adult twins from the Swedish Twin Registry. Pairs were selected based on background data on smoking and respiratory symptoms collected by telephone interview. Lung function was measured as FEV1, VC and DLco. Pack years were quantified, and quantitative genetic analysis was performed on lung function data adjusting stepwise for sex, pack years and respiratory symptoms.



Fully adjusted heritability for VC was 59% and did not differ by sex, with smoking and symptoms explaining only a small part of the total variance. Heritabilities for FEV1 and DLco were sex specific. Fully adjusted estimates were 10 and 15% in men and 46% and 39% in women, respectively. Adjustment for smoking and respiratory symptoms altered the estimates differently in men and women. For FEV1 and DLco, the variance explained by smoking and symptoms was larger in men. Further, smoking and symptoms explained genetic variance in women, but was primarily associated with shared environmental effects in men.



Differences between men and women were found in how smoking and symptoms influence the variation in lung function. Pulmonary gas transfer variation related to the menstrual cycle has been shown before, and the findings regarding DLco in the present study indicates gender specific environmental susceptibility not shown before. As a consequence the results suggest that patients with lung diseases such as COPD could benefit from interventions that are sex specific.
A disease-specific psychosocial questionnaire for Parkinson’s disease caregivers

To evaluate the “Belastungsfragebogen Parkinson Angehörigen—kurzversion” (BELA-A-k), a questionnaire for measuring psychosocial problems and need for help in Parkinson’s disease (PD) caregivers. The “Belastungsfragebogen Parkinson Angehörigen—kurzversion” was translated into Dutch. It consists of 15 items with a “Bothered by” (Bb) and a “Need for Help” (NfH) score. The BELA-A-k was tested for cultural differences, relevance and feasibility in a pilot (n = 10). We determined the psychometric properties in a validation study (n = 50) and compared the BELA-A-k with the Sickness Impact Profile, the COOP/WONCA Functional Health Assessment Charts and the Loneliness Questionnaire (de Jong-Gierveld). All questionnaires were administered in person at home, in a prescribed order. The BELA-A-k was completed by 60 PD-caregivers. The internal-consistency reliability coefficients for the total ”Bothered by” (0.90) and “Need for Help” (0.92) scales were excellent. The internal consistency of the subscales exceeded the 0.70 standard except for the “Bothered by” and “Need for Help” Social functioning scale (Bb = 0.62; NfH = 0.65) and the Partner-bonding/Family scale (NfH = 0.69). Almost all BELA-A-k subscales correlated highly (P < 0.001) with the corresponding scales of the standard quality of life indices. The BELA-A-k is a relevant, reliable and valid measure for assessing psychosocial problems and need for help of PDcaregivers.
[Development and validation of the Social Functioning Scale, short version, in schizophrenia for its use in the clinical practice].

The Social Functioning Scale (SFS) was designed to evaluate social functioning essential to schizophrenic patients. Its length may be difficult to use in clinical practice. The objective of this study was to develop and validate a short version of the SFS.



Data from 445 patients with schizophrenia who came from two separate studies, one longitudinal (n=250) and one cross-sectional (n=195), were used to produce and validate the short form of the SFS. The two samples were combined and then randomly split into two subsamples. In the first subsample (n = 223), items were eliminated using classical, modern (item response theory) psychometric criteria, as well as clinimetric criteria. The short version was independently validated using data from the other subsample (n = 222), by comparing the level of association (correlation and Area Under the ROC Curve [AUC]) with the EQ-5D VAS and the Clinical Global Impression (CGI), with the original scale.



The original 78 items were reduced initially to 19 and 13 items (respectively using classic and modern psychometric criteria) and then to 15, since 2 items related with the employment capacity were added for clinometric criteria. The short form of the SFS had a Cronbach's alpha of 0.76. Spearman correlation coefficients with the EQ-5D VAS and with the CGI score (0.46 and 0.42, respectively) were similar or even higher for the short version than for the original version. The AUC of the SFS and the dichotomous CGI were practically the same for both the original (AUC: 0.74) and the short (AUC: 0.73) versions.



The short version of the SFS proved to be reliable and valid. It could be adequate for use in clinical practice.
Effects of Action Observational Training Plus Brain-Computer Interface-Based Functional Electrical Stimulation on Paretic Arm Motor Recovery in Patient with Stroke: A Randomized Controlled Trial.

The purpose of this study was to investigate whether action observational training (AOT) plus brain-computer interface-based functional electrical stimulation (BCI-FES) has a positive influence on motor recovery of paretic upper extremity in patients with stroke. This was a hospital-based, randomized controlled trial with a blinded assessor. Thirty patients with a first-time stroke were randomly allocated to one of two groups: the BCI-FES group (n = 15) and the control group (n = 15). The BCI-FES group administered to AOT plus BCI-FES on the paretic upper extremity five times per week during 4 weeks while both groups received conventional therapy. The primary outcomes were the Fugl-Meyer Assessment of the Upper Extremity, Motor Activity Log (MAL), Modified Barthel Index and range of motion of paretic arm. A blinded assessor evaluated the outcomes at baseline and 4 weeks. All baseline outcomes did not differ significantly between the two groups. After 4 weeks, the Fugl-Meyer Assessment of the Upper Extremity sub-items (total, shoulder and wrist), MAL (MAL-Activity of Use and Quality of Movement), Modified Barthel Index and wrist flexion range of motion were significantly higher in the BCI-FES group (p < 0.05). AOT plus BCI-based FES is effective in paretic arm rehabilitation by improving the upper extremity performance. The motor improvements suggest that AOT plus BCI-based FES can be used as a therapeutic tool for stroke rehabilitation. The limitations of the study are that subjects had a certain limited level of upper arm function, and the sample size was comparatively small; hence, it is recommended that future large-scale trials should consider stratified and lager populations according to upper arm function.
Thrombolysis in brain ischemia (TIBI) transcranial Doppler flow grades predict clinical severity, early recovery, and mortality in patients treated with intravenous tissue plasminogen activator.

TIMI angiographic classification measures coronary residual flow and recanalization. We developed a Thrombolysis in Brain Ischemia (TIBI) classification by using transcranial Doppler (TCD) to noninvasively monitor intracranial vessel residual flow signals. We examined whether the emergent TCD TIBI classification correlated with stroke severity and outcome in patients treated with intravenously administered tPA (IV-tPA).



TCD examination occurred acutely and on day 2. TIBI flows were determined at distal MCA and basilar artery depths, depending on occlusion site. TIBI waveforms were graded as follows: 0, absent; 1, minimal; 2, blunted; 3, dampened; 4, stenotic; and 5, normal. National Institutes of Health Stroke Scale (NIHSS) scores were obtained at baseline and 24 hours after administration of tPA.



One hundred nine IV tPA patients were studied. Mean+/-SD age was 68+/-16 years; median NIHSS score before administration of tPA (pre-tPA) was 17.5. The tPA bolus was administered 143+/-58 minutes and the TCD examination 141+/-57 minutes after symptom onset. Pre-tPA NIHSS scores were higher in patients with TIBI grade 0 than TIBI grade 4 or 5 flow. TIBI flow improvement to grade 4 or 5 occurred in 35% of patients (19/54) with an initial grade of 0 or 1 and in 52% (12/23) with initial grade 2 or 3. The 24-hour NIHSS scores were higher in follow-up in patients with TIBI grade 0 or 1 than those with TIBI grade 4 or 5 flow. TIBI flow recovery correlated with NIHSS score improvement. Lack of flow recovery predicted worsening or no improvement. In-hospital mortality was 71% (5/7) for patients with posterior circulation occlusions; it was 22% (11/51) for patients with pre-tPA TIBI 0 or 1 compared with 5% (1/19) for those with pre-tPA TIBI 2 or 3 anterior circulation occlusions.



Emergent TCD TIBI classification correlates with initial stroke severity, clinical recovery, and mortality in IV-tPA-treated stroke patients. A flow-grade improvement correlated with clinical improvement.
A pilot, open label, clinical trial using hydroxyzine in multiple sclerosis.

Multiple sclerosis (MS) is an autoimmune disorder of myelin destruction. Blood-brain-barrier (BBB) disruption precedes pathological or clinical findings and could involve mediators from perivascular brain mast cells, such as histamine and vascular endothelial growth factor (VEGF). Mast cells could be activated by many triggers, including acute stress that has been correlated with MS exacerbations. We considered that the histamine-1 (H1) receptor antagonist hydroxyzine, which also partially inhibits brain mast cells and has anxiolytic properties, may reduce MS symptoms. This open label, pilot, clinical trial investigated the effect on MS of an oral solution of hydroxyzine (100 mg per day), together with caffeine (200 mg per day) to reduce sedation. Twenty patients (8 males; 12 females) with relapsing-remitting or relapsing-progressive MS completed the study (12 +/- 1 months) and were evaluated using disability scales. Most patients on hydroxyzine (75%) remained stable or improved neurologically and all but one showed improved mood. Hydroxyzine could be used as an adjuvant in MS, but the small number of patients enrolled and the short duration of the study precludes any definitive conclusions. A double-blind, placebo-controlled study is warranted.
An experimental assessment of the influence of exercise versus social implementation intentions on physical activity during and following pulmonary rehabilitation

Techniques to increase physical activity among pulmonary rehabilitation patients outside of the rehabilitation context are warranted. Implementation intentions are a strategy used to initiate goal-directed behaviour, and have been found to be useful in other populations. This study compared the long-term effects of exercise and social implementation intentions interventions on objectively measured physical activity in 40 pulmonary rehabilitation patients randomly assigned to condition. Repeated measures ANOVAs found that those in the exercise implementation intentions group took more steps (p = .007) at the end of pulmonary rehabilitation than those in the social implementation intentions group. Improvements attained by the exercise group during the intervention were not maintained 6-months following rehabilitation. Implementation intentions targeting physical activity appear to have positive short term effects on physical activity, although the long term effects are less consistent. This may be due in part to methods used to assess physical activity behaviour.
Profound suppression of plasma estrogens by megestrol acetate in postmenopausal breast cancer patients.

Twelve postmenopausal women suffering from advanced breast cancer had plasma estrogens, androgens, cortisol, and gonadotropins determined before therapy and during treatment with megestrol acetate (MA) in oral doses escalated from 40 to 160 mg. The plasma clearance and production rate of estrone and estrone sulfate were determined before treatment and after 4 weeks of therapy with 160 mg MA. Treatment with MA suppressed plasma levels of dehydroepiandrosterone sulfate, androstenedione, and cortisol in a dose-dependent manner to <10% of pretreatment values. Plasma testosterone, estradiol, estrone, and estrone sulfate were suppressed to 18-29% of pretreatment values, whereas the gonadotropins were suppressed to 35-52%. The plasma clearance rates of estrone and estrone sulfate were increased by a mean value of 23.7% (P < 0.01) and 23.5% (P < 0.025), whereas the production rates were reduced by 76.7% (P < 0.0005) and 76.1% (P < 0.0005), respectively. Our findings indicate that MA causes profound suppression of adrenal steroid production but in addition suppresses ovarian secretion of androgens in postmenopausal breast cancer patients. The reduction in plasma estrogens is comparable to values obtained with commonly used aromatase inhibitors and may be responsible for its antitumor effects in breast cancer.
Does short-term androgen deprivation substitute for radiation dose in the treatment of high-risk prostate cancer?

Randomized trials have corroborated the clinical benefit of adding androgen deprivation (AD) to radiotherapy (RT) in the treatment of high-risk prostate cancer. Another competing strategy is to escalate the RT dose using three-dimensional conformal RT (3D-CRT). In this analysis, we asked whether the addition of short-term AD (STAD) (<or=6 months) to RT in the treatment of high-risk (prostate-specific antigen >20 ng/mL, Gleason score 8-10, or T3-4) prostate cancer is an effective substitute for dose escalation.



Between March 1, 1990 and November 30, 1998, 296 high-risk prostate cancer patients were treated with 3D-CRT alone (n = 206) or in combination with STAD (n = 90). The patient characteristics were median age 68 years, median follow-up 58 months, pretreatment initial prostate-specific antigen 21.8 ng/mL, RT dose 75 Gy, STAD duration 3 months, and time off STAD 64 months. The impact of STAD with respect to dose was examined using univariate analysis for dose ranges of <75 Gy and >or=75 Gy. Stepwise Cox proportional hazards regression multivariate analysis was performed to determine independent correlates of freedom from biochemical failure (bNED), freedom from distant metastasis (FDM), and overall survival. In a separate matched-pair analysis (n = 44 per group), those treated to <75 Gy + STAD (Group A) were compared with those who received >or=75 Gy alone (Group B).



On univariate analysis, the addition of STAD had no impact on bNED, FDM, or overall survival in either dose group. On multivariate analysis, initial prostate-specific antigen level, palpation T stage, and RT dose were significant correlates of bNED. For FDM and overall survival, the significant covariates were palpation T stage and Gleason score, respectively. Finally, in matched-pair analysis, the higher RT dose group had a significantly greater bNED rate at 5 years (Group A 35% vs. Group B 57%, p = 0.0190).



Our data suggest that STAD, as used here (median 3 months), is not a substitute for RT dose in the treatment of high-risk prostate cancer. RT dose is an essential element in the treatment of high-risk prostate cancer.
Spiritual direction in addiction treatment: two clinical trials.

Spirituality has long been regarded as an important component of recovery from addiction. This article reports the findings of two controlled trials of spiritual direction as an adjunct in addiction treatment. In Study 1, 60 participants were randomly assigned to receive or not receive a 12-session manual-guided spiritual guidance (SG) intervention during and after inpatient treatment, in addition to treatment as usual (TAU). In Study 2, two cohorts of 40 each received TAU without or with SG during their inpatient stay. In both trials, contrary to prediction, SG had no effect on spiritual practices or substance use outcomes at any follow-up point. At the first follow-up in Study 1 only, those randomly assigned to spiritual direction unexpectedly showed significantly less improvement on depression and anxiety, relative to TAU controls. Limitations and implications for treatment are discussed.
Experimental knee joint pain during strength training and muscle strength gain in healthy subjects: a randomized controlled trial.

Knee joint pain and reduced quadriceps strength are cardinal symptoms in many knee pathologies. In people with painful knee pathologies, quadriceps exercise reduces pain, improves physical function, and increases muscle strength. A general assumption is that pain compromises muscle function and thus may prevent effective rehabilitation. This study evaluated the effects of experimental knee joint pain during quadriceps strength training on muscle strength gain in healthy individuals.



Twenty-seven healthy untrained volunteers participated in a randomized controlled trial of quadriceps strengthening (3 times per week for 8 weeks). Participants were randomized to perform resistance training either during pain induced by injections of painful hypertonic saline (pain group, n = 13) or during a nonpainful control condition with injection of isotonic saline (control group, n = 14) into the infrapatellar fat pad. The primary outcome measure was change in maximal isokinetic muscle strength in knee extension/flexion (60, 120, and 180 degrees/second).



The group who exercised with pain had a significantly larger improvement in isokinetic muscle strength at all angular velocities of knee extension compared to the control group. In knee flexion there were improvements in isokinetic muscle strength in both groups with no between-group differences.



Experimental knee joint pain improved the training-induced gain in muscle strength following 8 weeks of quadriceps training. It remains to be studied whether knee joint pain has a positive effect on strength gain in patients with knee pathology.
Prostacyclin influences the pressure reactivity in patients with severe traumatic brain injury treated with an ICP-targeted therapy.

This prospective consecutive double-blinded randomized study investigated the effect of prostacyclin on pressure reactivity (PR) in severe traumatic brain injured patients. Other aims were to describe PR over time and its relation to outcome.



Blunt head trauma patients, Glasgow coma scale ≤8, age 15-70 years were included and randomized to prostacyclin treatment (n = 23) or placebo (n = 25). Outcome was assessed using the extended Glasgow outcome scale (GOSE) at 3 months. PR was calculated as the regression coefficient between the hourly mean values of ICP versus MAP. Pressure active/stable was defined as PR ≤0.



Mean PR over 96 h (PRtot) was 0.077 ± 0.168, in the prostacyclin group 0.030 ± 0.153 and in the placebo group 0.120 ± 0.173 (p < 0.02). There was a larger portion of pressure-active/stable patients in the prostacyclin group than in the placebo group (p < 0.05). Intra-individual changes over time were common. PRtot correlated negatively with GOSE score (p < 0.04). PRtot was 0.117 ± 0.182 in the unfavorable (GOSE 1-4) and 0.029 ± 0.140 in the favorable outcome group (GOSE 5-8). Area under the curve for prediction of death (ROC) was 0.742 and for favorable outcome 0.628.



Prostacyclin influenced the PR in a direction of increased pressure stability and a lower PRtot was associated with improved outcome. The individual PR varied substantially over time. The predictive value of PRtot for outcome was not solid enough to be used in the clinical situation.