nils-herrmann/clean_scirepeval huggingface dataset:
Effects of typical and atypical antipsychotics on glucose–insulin homeostasis and lipid metabolism in first-episode schizophrenia

Glucose and lipid metabolism dysfunction is a significant side effect associated with antipsychotics. Although there are many studies about the linkages between drugs and metabolic dysfunction, most of these studies have compared the effects of two antipsychotics on only one metabolic measure: either glucose or lipid metabolism. The present study aimed to investigate the effects of clozapine, olanzapine, risperidone, and sulpiride on glucose and lipid metabolism in first-episode schizophrenia. One hundred twelve schizophrenics were assigned randomly to receive clozapine, olanzapine, risperidone, or sulpiride for 8 weeks. Planned assessments included body mass index (BMI), waist-to-hip ratio, fasting glucose, insulin, C-peptide, insulin resistance index (IRI), cholesterol, and triglyceride. All measures were collected at baseline and at the end of the 8-week treatment. After treatment, insulin, C-peptide, and IRI were significantly increased in the four groups, but not fasting glucose levels. Cholesterol and triglyceride levels were significantly increased in the clozapine and olanzapine groups. Patients treated with clozapine and olanzapine had higher fasting insulin, C-peptide, and IRI levels than those treated with risperidone and sulpiride. Among the four antipsychotics, the increases of mean BMI from high to low were as follows: clozapine, olanzapine, sulpiride, and risperidone. This study confirmed that the four antipsychotic drugs were associated with an increase of insulin, C-peptide, and IRI. It was found that clozapine and olanzapine were associated with an increase in cholesterol and triglyceride levels. The effects of clozapine and olanzapine on the glucose and lipid metabolism outweighed those of risperidone and sulpiride.
Tea polyphenols decrease serum levels of prostate-specific antigen, hepatocyte growth factor, and vascular endothelial growth factor in prostate cancer patients and inhibit production of hepatocyte growth factor and vascular endothelial growth factor in vitro.

The purpose of this study was to determine the effects of short-term supplementation with the active compounds in green tea on serum biomarkers in patients with prostate cancer. Twenty-six men with positive prostate biopsies and scheduled for radical prostatectomy were given daily doses of Polyphenon E, which contained 800 mg of (-)-epigallocatechin-3-gallate (EGCG) and lesser amounts of (-)-epicatechin, (-)-epigallocatechin, and (-)-epicatechin-3-gallate (a total of 1.3 g of tea polyphenols), until time of radical prostatectomy. Serum was collected before initiation of the drug study and on the day of prostatectomy. Serum biomarkers hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF)-I, IGF binding protein-3 (IGFBP-3), and prostate-specific antigen (PSA) were analyzed by ELISA. Toxicity was monitored primarily through liver function enzymes. Changes in serum components were analyzed statistically using the Wilcoxon signed rank test. Cancer-associated fibroblasts were treated with EGCG, and HGF and VEGF protein and mRNA levels were measured. HGF, VEGF, PSA, IGF-I, IGFBP-3, and the IGF-I/IGFBP-3 ratio decreased significantly during the study. All of the liver function tests also decreased, five of them significantly: total protein, albumin, aspartate aminotransferase, alkaline phosphatase, and amylase. The decrease in HGF and VEGF was confirmed in prostate cancer-associated fibroblasts in vitro. Our results show a significant reduction in serum levels of PSA, HGF, and VEGF in men with prostate cancer after brief treatment with EGCG (Polyphenon E), with no elevation of liver enzymes. These findings support a potential role for Polyphenon E in the treatment or prevention of prostate cancer.
Dehydroepiandrosterone in the treatment of erectile dysfunction in patients with different organic etiologies

In 1994 the Massachusetts Male Aging Study described an inverse correlation of the serum levels of dehydroepiandrosterone sulfate (DHEAS) and the incidence of erectile dysfunction (ED). The positive results of a pilot study in the treatment in patients with no organic etiology prompted a detailed investigation on the efficacy of DHEA therapy for ED in patients with different organic etiologies, in a prospective study. The inclusion criteria included ED, a normal physical condition, normal serum levels of testosterone, prolactin and PSA and a serum DHEAS level <1.5 µmol/l. The study patients comprised 27 patients (group 1) with hypertension, 24 patients (group 2) with diabetes mellitus, six patients with neurological disorders (group 3) and 28 patients (group 4) with no organic etiology were treated with 50 mg DHEA p.o. for 6 months. We assessed efficacy by using the responses to question 3 (frequency of penetration) and question 4 (maintenance of erections after penetration) of the 15-question International Index of Erectile Function (IIEF). DHEA treatment was associated with statistically significantly higher mean scores compared to baseline values for question 3 and question 4 of the IIEF in groups 1 and 4 after a period of 24 weeks. The differences between the mean scores of groups 2 and 3 and the baseline values were not statistically significant. Our results suggest that oral DHEA-treatment may be of benefit to patients with ED who have hypertension or to patients with ED without organic etiology. There was no impact of DHEA therapy on patients with diabetes mellitus or with neurological disorders.
The use of ultrasound in determining the initiation of treatment in instability of the hip in neonates.

We have evaluated the effect of the use of ultrasound in determining the initiation of treatment in neonatal instability of the hip. A total of 99 newborn infants (1.5% of all live births) with neonatal hip instability did not have treatment from birth, but were re-examined at eight to 15 days. In the 31 who had persisting clinical instability and ultrasound abnormality, treatment was then started with a Frejka pillow. The hips in the remaining 68 infants showed spontaneous clinical stabilisation and improvement of the ultrasound findings. Treatment was therefore withheld. There was a marked trend towards normal development in mildly unstable hips, whereas no hips with severe instability did so spontaneously. Further follow-up showed normal development in all the hips which had been treated, and in all except five of the 68 untreated infants. These five infants showed persistent hip dysplasia on both ultrasound and radiological examination at four to five months of age. Treatment with an abduction splint was then started and their hips developed normally. Ultrasound is very useful in deciding on treatment if the examiners have adequate experience with the method. Its use substantially reduces the rate of treatment. Spontaneous resolution occurred in more than half of the unstable hips. Since five of the untreated infants developed hip dysplasia a strict follow-up is essential to identify and treat these cases.
Airway epithelial gene expression in the diagnostic evaluation of smokers with suspect lung cancer

Lung cancer is the leading cause of death from cancer in the US and the world. The high mortality rate (80–85% within 5 years) results, in part, from a lack of effective tools to diagnose the disease at an early stage. Given that cigarette smoke creates a field of injury throughout the airway, we sought to determine if gene expression in histologically normal large-airway epithelial cells obtained at bronchoscopy from smokers with suspicion of lung cancer could be used as a lung cancer biomarker. Using a training set (n = 77) and gene-expression profiles from Affymetrix HG-U133A microarrays, we identified an 80-gene biomarker that distinguishes smokers with and without lung cancer. We tested the biomarker on an independent test set (n = 52), with an accuracy of 83% (80% sensitive, 84% specific), and on an additional validation set independently obtained from five medical centers (n = 35). Our biomarker had ∼90% sensitivity for stage 1 cancer across all subjects. Combining cytopathology of lower airway cells obtained at bronchoscopy with the biomarker yielded 95% sensitivity and a 95% negative predictive value. These findings indicate that gene expression in cytologically normal large-airway epithelial cells can serve as a lung cancer biomarker, potentially owing to a cancer-specific airway-wide response to cigarette smoke.
Phase I trial of inhaled natural interleukin 2 for treatment of pulmonary malignancy: toxicity, pharmacokinetics, and biological effects.

Safety, local and systemic immunomodulation, and tumor response to treatment with aerosolized natural interleukin 2 (nIL-2) applied five times a day were studied in a Phase I trial in 16 patients with pulmonary malignancies refractory to conventional therapy. The toxicity of inhaled nIL-2 was different from that observed after systemic administration. Reversible airway irritation causing a nonproductive cough represented the dose-limiting toxicity. Mild to moderate reduction of the vital capacity and forced expiratory volume (FEV1) with minor effects on relative FEV1, peak expiratory flow, airway resistance, and PaO2 was experienced by individual patients. In 14 patients suffering from pulmonary metastases due to renal cell cancer, one durable complete response, one partial response, and one mixed response were observed. Inhalation of nIL-2 aerosol resulted in a dose-dependent expansion of pulmonary immunocompetent cells in bronchoalveolar lavage fluid. Posttreatment bronchoalveolar lavage showed an activated lymphocyte phenotype with increased HLA-DR expression. The only systemic biological effect detectable in peripheral blood was a marked increase of soluble interleukin 2 receptor serum levels. We conclude that treatment with aerosolized nIL-2 is an effective means for site-specific immunomodulation and deserves further investigation for the treatment of malignant and inflammatory lung disease.
What contributes to good patient outcomes in the home treatment of the severely mentally ill: study protocol of a multi-centre analysis

While evidence is available that home treatment could be effective for treating severe mental illness, there is a lack of evidence on what exactly makes home treatment effective. The study presented here aims to develop recommendations for structures and processes in home treatment that are necessary for its effectiveness.



14 provider networks of home treatment for severe mental illness will be analyzed and compared according to their structures, processes and patient-related outcomes. Data will be drawn from health care claims data, routine assessments of psychosocial functioning, and from questionnaires on structures and processes. The primary outcome will be psychosocial functioning; secondary outcomes, quality of life and days spent in hospital. The relation between structures and processes on one hand side and outcomes on the other side will be identified by multilevel analysis. In addition, focus groups with patients, relatives and network staff will be held to add further insight into relevant processes. All networks will receive individual quality reports, providing them with feedback on the results of this research and benchmarking them against the average. Based on this research, recommendations for processes and structures of home treatment will be developed.



The research will use longitudinal data on outcomes routinely assessed since 2009 and claims data. Routine data is also used for the assessment of structures and processes. By way of additional questionnaires developed in discussion with providers, further relevant factors can be included. The approach of this study becomes more comprehensive by conducting focus groups with patients, relatives and providers and by having the chance to evaluate the results with the networks by providing feedback of results. Several factors such as outcomes related to regional availability of hospital beds or size of networks might limit this study.
To tell or not to tell: South African women's disclosure of HIV status during pregnancy.

HIV-positive pregnant women often do not disclose their serostatus to their partners, family and friends, creating potential barriers to preventing sexual transmission to partners and mother-to-child transmission through breastfeeding. This research explores recently diagnosed HIV-positive pregnant women's reasons for disclosure and non-disclosure of serostatus to various members of their social networks, as well as the consequences of their disclosure. Data were collected through open-ended questions as part of a semi-structured interview with 293 recently diagnosed HIV-positive pregnant women recruited from antenatal clinics in two townships in Tshwane, South Africa. A content analysis of responses showed that women weighed fear of abandonment and discrimination against their desire to raise risk awareness and their need for support. Partners most often responded to disclosure with disbelief and shock, whereas parents frequently exhibited emotional distress, but were still supportive, as were other relatives and friends. The women subsequently experienced low levels of adverse consequences after disclosure. The results can assist healthcare providers in understanding the complexity of pregnant women's decisions to disclose to various members of their social networks and emphasize the need for continued counselling and support.
Vincristine with high-dose etoposide in advanced breast cancer: a phase II trial of the Piedmont Oncology Association

Vincristine (VCR) and etoposide (VP-16) have been shown to be synergistic in a murine model, and this combination was studied in a phase II trial. Eligibility required measurable disease, a performance status of 0–2, a life expectancy of ≥2 months, an interval of at least 3 weeks since the receipt of previous radiation therapy or chemotherapy and recovery from related toxicity, no prior treatment with VCR or VP-16, and no more than two prior chemotherapy regimens (only one for treatment of metastatic disease). Treatment consisted of 0.5 mg i.v. (bolus) VCR followed by 200 mg/m2 VP-16 given over 2 h. Both drugs were given daily for 3 consecutive days every 3 weeks (total dose: VCR, 1.5 mg; VP-16, 600 mg/m2). A total of 18 patients with metastatic breast cancer were accured; 14 had adjuvant chemotherapy and 8 had chemotherapy for advanced disease. As judged by International Union Against Cancer (UICC) criteria, one complete response (CR) and three partial responses (PR) were obtained, for a CR+PR rate of 22% (95% confidence interval, 6%–48%). All responders had soft-tissue involvement only. Six patients had stable disease and 8 showed progression. The median time to treatment failure was 3.5 months, and the median survival from study entry was 8.3 months. The major toxicity was myelosuppression, with 9 patients (50%) experiencing a total WBC of <1,000/mm3. Grade 2–3 neurologic toxicity was noted in 6 patients (33%) and grade 3 nausea and vomiting was noted in 5 (28%). The combination of VCR and VP-16 is active in advanced breast cancer but is not convincingly superior to either of these agents used alone.
The discontent degree in relations with the proximal social environment and adolescent personality features in Timis County, Romania.

In our study we investigated whether there is a relation between the degree of discontent in relations with the proximal social environment (family and peer groups) and adolescent personality features. The study was conducted on a statistical representative and homogenous sample consisting of 2908 teenagers (51.5% girls and 48.5 % boys, aged between 15 and 19 years). It was an observational (case) study and it consisted in 2 questionnaires applying: Freiburg Personality Inventory (212 items) and CORT 2004 questionnaire (116 items, 6 referring to the discontent levels created by proximal social environment). Cronbach's alpha index was 0.802 for FPI and 0,910 for CORT 2004. Statistical analysis was performed by SPSS 16 program applying Chi square (χ2) and gamma (γ) correlation.



Depression and Emotional lability correlated positively and powerfully with q15 (discontent degree of relations with present friend-peers) (γ = 0.471, Sig. 0.000, and γ = 0.383, Sig. 0.000, respectively) and q5 (discontent degree of the relation with parents) (γ = 0.380, Sig. 0.000, and γ = 0.337, Sig. 0.000, respectively). Sociability and calm correlated negative with q5 (γ = -0.14, Sig. 0.000, and γ = -0.35, Sig. 0.000, respectively), q15 (γ = -0.33, Sig. 000 and γ = -0.18, Sig. 000, respectively). In conclusion, there is direct proportional relation between the discontent degree of relations with friend-peers and parents and depression and emotional lability, and inverse proportional relation of friend-peers and parents with sociability and calm.
Subjective effects of narcotic antagonists cyclazocine and nalorphine on the Addiction Research Center Inventory (ARCI)

The subjective effects of two doses of cyclazocine (0.6 mg and 1.2 mg/70 kg), nalorphine (16 and 32 mg/70 kg), no-drug and placebo were compared with 32 opiate addicts using drug sensitive scales of the Addiction Research Center Inventory (ARCI) items. The effects of these narcotic antagonists were highly similar on ARCI scales and items. Both drugs produced a general drug effect, difficulty in focusing eyes, physical weakness, tiredness, poor motivation, moodiness, misery, anxiety, tension, hallucinations, changes in sensation and perception, and inefficiency of physical, cognitive and social functions. Cyclazocine was 15–26 times more potent than nalorphine. The effects of cyclazocine and nalorphine were differentiated from the effects of other drugs such as morphine, pentobarbital and LSD when the overall pattern of effect was considered.
Four-year incidence and progression of visual impairment in a South Indian population with diabetes

The aim of this study is to investigate the 4-year incidence and progression of visual impairment (VI) and the associated risk factors for incident VI in a South Indian population with type 2 diabetes.



A total of 634 participants with type 2 diabetes were found eligible after 4 years. Visual acuity (VA) was estimated using the modified Early Treatment Diabetic Retinopathy Study protocol. VA in the better eye was considered for the assessment of VI based on the World Health Organization criteria. Mild VI was defined as VA <20/40 but up to 20/60, moderate VI as VA <20/60 but up to 20/200, severe VI as VA <20/200 but up to 10/200, and blindness as VA worse than 10/200.



The 4-year incidence of any VI, mild VI, moderate VI, severe VI, and blindness was 21.7%, 18.3%, 3.4%, 0.0%, and 0.0%, respectively; of the 13 participants with VI at baseline, 12 (92%) showed worsening/progression of VI on follow-up. Multiple logistic regression showed that nuclear cataract of grades >4.0 (odds ratio [OR]: 2.612 [1.148-5.942], P = 0.022) and lower socioeconomic score (OR: 0.965 [95% confidence interval, (0.933-0.998)], P = 0.040) were associated with the risk of future incident VI. Refractive error (47%) and cataract (30%) were identified as the leading causes of incident VI at follow-up.



VI seems to be a significant problem among diabetic participants in the South Indian population. Refractive error and cataract are the leading but treatable causes of incident VI in this population and would benefit from intervention.
Pedometers to enhance physical activity in COPD: a randomised controlled trial

Physical inactivity is a cardinal feature of chronic obstructive pulmonary disease (COPD), and is associated with increased morbidity and mortality. Pedometers, which have been used in healthy populations, might also increase physical activity in patients with COPD. COPD patients taking part in a 3-month individualised programme to promote an increase in their daily physical activity were randomised to either a standard programme of physical activity encouragement alone, or a pedometer-based programme. Assessments were performed by investigators blinded to treatment allocation. Change in average 1-week daily step count, 6-min walking distance (6MWD), modified Medical Research Council scale, St George's respiratory questionnaire (SGRQ) and COPD assessment test (CAT) were compared between groups. 102 patients were recruited, of whom 97 completed the programme (pedometer group: n=50; control group: n=47); 60.8% were male with a mean±sd age of 68.7±8.5 years, and forced expiratory volume in 1 s (FEV1) 66.1±19.4% and FEV1/forced vital capacity 55.2±9.5%. Both groups had comparable characteristics at baseline. The pedometer group had significantly greater improvements in: physical activity 3080±3254 steps·day(-1) versus 138.3±1950 steps·day(-1) (p<0.001); SGRQ -8.8±12.2 versus -3.8±10.9 (p=0.01); CAT score -3.5±5.5 versus -0.6±6.6 (p=0.001); and 6MWD 12.4±34.6 versus -0.7±24.4 m (p=0.02) than patients receiving activity encouragement only. A simple physical activity enhancement programme using pedometers can effectively improve physical activity level and quality of life in COPD patients.
The 68Ga/177Lu theragnostic concept in PSMA targeting of castration-resistant prostate cancer: correlation of SUVmax values and absorbed dose estimates

A targeted theragnostic approach based on increased expression of prostate-specific membrane antigen (PSMA) on PC cells is an attractive treatment option for patients with metastatic castration-resistant prostate cancer (mCRPC). Ten consecutive mCRPC patients were selected for 177Lu-PSMA617 therapy on the basis of PSMA-targeted 68Ga-PSMA-HBED-CC PET/CT diagnosis showing extensive and progressive tumour load. Following dosimetry along with the first therapy cycle restaging (68Ga-PSMA-HBED-CC and 18F-NaF PET/CT) was performed after 2 and 3 therapy cycles (each 6.1 ± 0.3 GBq, range 5.4–6.5 GBq) given intravenously over 30 minutes, 9 ± 1 weeks apart. PET/CT scans were compared to 177Lu-PSMA617 24-hour whole-body scans and contrast-enhanced dual-phase CT. Detailed comparison of SUVmax values and absorbed tumour doses was performed. 177Lu-PSMA617 dosimetry indicated high tumour doses for skeletal (3.4 ± 1.9 Gy/GBq; range 1.1–7.2 Gy/GBq), lymph node (2.6 ± 0.4 Gy/GBq; range 2.3–2.9 Gy/GBq) as well as liver (2.4 ± 0.8 Gy/GBq; range 1.7–3.3 Gy/GBq) metastases whereas the dose for tissues/organs was acceptable in all patients for an intention-to-treat activity of 18 ± 0.3 GBq. Three patients showed partial remission, three mixed response, one stable and three progressive disease. Decreased 177Lu-PSMA617 and 68Ga-PSMA-HBED-CC uptake (mean SUVmax values 20.2 before and 15.0 after 2 cycles and 11.5 after 3 cycles, p < 0.05) was found in 41/54 skeletal lesions, 12/13 lymph node metastases, 3/5 visceral metastases and 4/4 primary PC lesions. Due to substantial individual variance, dosimetry is mandatory for a patient-specific approach following 177Lu-PSMA617 therapy. Higher activities and/or shorter treatment intervals should be applied in a larger prospective study.