nils-herrmann/clean_scirepeval huggingface dataset:
A controlled clinical trial testing two potentially non-cross-resistant chemotherapeutic regimens in small-cell carcinoma of the lung.

With the objectives of improving response rate, duration of response, and survival in small-cell carcinoma of the lung, 39 patients were randomized to remission-induction with either one of two potentially non-cross-resistant drug combinations: APE (consisting of adriamycin, 35 mg/m2 IV, D1 Q 3 weeks; procarbazine, 60 mg/m2 PO, D1-10 Q 3 weeks; and the epipodophyllotoxin (VP16-213), 130 mg/m2 IV, D8, 15 Q 3 weeks) or MOCC (composed of methotrexate, 15 mg/m2 IV (with [vincristine] Oncovin) or PO twice weekly D8-21 Q 3 weeks; Oncovin, 1.5 mg/m2 IV, D8, 15 Q 3 weeks; cyclophosphamide, 600 mg/m2 IV, D1 Q 3 weeks, and CCNU, 60 mg/m2 PO Q 6 weeks). A fixed crossover to the alternate regimen occurred at three months. Radiotherapy was delivered to the primary tumor (locoregional disease only) by a split course technique (1,750 rads for five days with a three-week split, followed by 3,400 rads over 17 days). The median survival including both arms was 11 months for regional and nine months for extensive disease. The chemotherapeutic activity of both regimens was comparable, with 15/17 (88 percent) of the patients responding to APE (including six complete) and 14/17 (82 percent) responding to MOCC (including five complete). The median survival for the complete responders was 11.7 months, while the partial responders survived for a median of 9.7 months. There were 2/9 (22 percent) responders to the alternate regimen at progressive disease. The overall incidence of CNS progression was 17 percent. The toxicity of the regimens was moderate, except for one instance of granulocytopenic death. This study establishes two equipotent drug combinations for the treatment of small-cell carcinoma of the lung.
Prognostic value of pretreatment serum beta 2 microglobulin in myeloma: a Southwest Oncology Group Study.

Six hundred twelve eligible, previously untreated patients with active multiple myeloma and at least some data available for analysis were entered into a randomized trial (Southwest Oncology Group [SWOG] Phase III myeloma study 8229/30), in which the prognostic significance of pretreatment serum beta 2 microglobulin levels was evaluated. Because there was no statistically significant survival difference between the alternating and syncopating VMCP/VBAP regimens, it was possible to evaluate serum beta 2 microglobulin for the total population all together. The serum beta 2 microglobulin measurements showed the highest significance of any prognostic factor, both in the bivariate and multivariate regression analyses. The median survival was 36 months for the 322 patients with pretreatment serum beta 2 microglobulin values of less than 6 micrograms/mL, as compared with a median survival of 23 months for the 225 patients with a beta 2 level of greater than or equal to 6 mcg/mL (P less than .0001). The stepwise multiple regression model first contained serum beta 2 microglobulin, followed by serum albumin, serum calcium, age, and serum creatinine. Serum beta 2 microglobulin was highly correlated with stage: median values ranged from 3.7 micrograms/mL for stage IA, to 10.1 for stage IIIB. It was possible to stratify myeloma patients based on combinations of serum beta 2 microglobulin with both albumin and age, producing excellent separation of patients into low-, intermediate-, and high-risk categories. It is concluded that serum beta 2 microglobulin is the most powerful prognostic factor currently available for multiple myeloma and that it can be used alone or in combination with other variables for pretreatment stratification.
Increased release of dopamine in the striata of young adults with hearing impairment and its relevance for the social defeat hypothesis of schizophrenia.

An increased risk for psychosis is observed in people with hearing impairment. According to the social defeat hypothesis, the long-term experience of exclusion leads to enhanced baseline activity and/or sensitization of the dopamine system and puts the individual at increased risk for psychosis.



To investigate whether young adults with severe hearing impairment (SHI) experience more feelings of social defeat, show greater dopamine release in response to dexamphetamine, and report a stronger subjective reaction to this substance than normal-hearing young adults and to examine whether dopamine release is associated with both self-reported social exclusion and dexamphetamine-induced psychotic experiences.



A sample of 19 participants with SHI and 19 smoking-, age-, and sex-matched healthy controls underwent single-photon emission computed tomography with iodine 123-labeled iodobenzamide as a radiotracer before and after an amphetamine challenge at an academic hospital.



Dexamphetamine sulfate (0.3 mg/kg) administered intravenously.



Baseline D2/3 receptor binding and endogenous dopamine release.



The participants with SHI reported experiencing more feelings of social defeat (U=109, z=-2.09, P=.04) and loneliness (U=87.5, z=-2.72, P=<.001) than did healthy controls, but they did not differ from healthy controls with regard to baseline psychotic symptoms (U=156.5, z=-0.70, P=.48). There were no significant group differences in baseline D2/3 receptor binding. However, repeated-measures multivariate analysis of covariance with age (in months) and tobacco smoking (in pack-years) as covariates showed that there was a greater amphetamine-induced striatal dopamine release among the participants with SHI than among the healthy controls (F1,34=4.55, P=.04). After amphetamine administration, the participants with SHI reported more changes in affect than the healthy controls, but not a greater increase in psychotic symptoms. Likewise, reports of social exclusion and an increase in psychotic symptoms were not associated with dopamine release.



Our study presents preliminary evidence of dopamine sensitization in a socially excluded group of people with hearing impairment. If replicated by future studies in other excluded groups, this finding may have major implications for our understanding of the underlying mechanism and for prevention of psychotic disorders.
Once-Daily Pefloxacin + Teicoplanin vs Netilmicin + Teicoplanin in Empirical Therapy for Fever and Neutropenia

There have been several reports of teicoplanin in combination with various antibacterials such as ciprofloxacin, ceftazidime, aztreonam and amikacin,lI,2] However, studies of once-daily regimens are rare, and treatment with a once-daily quinolone in combination with teicoplanin has not been previously reported. This trial compared two oncedaily regimens using teicoplanin with either netilmicin (an aminoglycoside) or pefloxacin (a quinolone).
Sitagliptin/Metformin Versus Insulin Glargine Combined With Metformin in Obese Subjects With Newly Diagnosed Type 2 Diabetes

To compare the therapeutic effects of different regimens in Chinese obese type 2 diabetic mellitus (T2DM) patients. From October 2013 to July 2014, a total of 166 T2DM outpatients who attended the Shanghai Changhai Hospital and the Yijishan Hospital of Wannan Medical College were randomly assigned into an experimental sitagliptin/metformin combined with low caloric diet group (n = 115) and an insulin glargine combined with metformin control group (n = 51). Inclusion criteria were body mass index (BMI) ≥ 25 kg/m and diagnosed with T2DM with glycosylated hemoglobin (glycated hemoglobin A1C [HbA1c]) >9%. Main outcome parameters were fasting plasma glucose, postprandial plasma glucose, BMI, HbA1c, fasting C-peptide, 2-h postprandial C-peptide, triglyceride (TG), total cholesterol (TC), high-density cholesterol (HDL-C), and low-density cholesterol (LDL-C), which were determined by the 75 g steamed-bun meal tolerance test before and 4, 8, 12, and 24 weeks after the treatment started. Treatment costs and life quality were also assessed. BMI, HbA1C, TG, TC, and LDL were significantly more reduced (P < 0.000) and HbA1c significantly better improved in the experimental group than in the control group (<6.5% in 24 [20.87%] vs 2 [3.92%], P < 0.001; <7% in 65 [56.52%] vs 12 [23.53%], P < 0.001). Quality of life scores in the experimental group increased more than in the control group (P < 0.001). The costs for the experimental group medication were less than for other regimens. For obese T2DM patients diagnosed with a glycosylated hemoglobin level >9%, oral sitagliptin/metformin combined with a low caloric diet effectively and economically maintained glycemic control and significantly improved life quality.
Telehealth behavior therapy for the management of type 1 diabetes in adolescents.

Poor management of type 1 diabetes mellitus (T1DM) may result in serious medical complications. Psychological intervention may improve adherence to medical regimens; however, access to trained professionals is limited, particularly in rural communities. Telehealth interventions may address this by allowing families to access services at home; however, little is known about the efficacy of such services.



This study presents results from a pilot trial of a randomized waitlist controlled trial of Telehealth Behavioral Therapy (TBT) for youths with T1DM. Primary outcome measures were adherence to the diabetes regimen, glycemic control, and level of family discord. Thirty-two youths (23 female) with T1DM (aged 9 to 17 years) and one parent or caregiver participated. Telehealth Behavioral Therapy sessions were conducted thrice weekly for 12 weeks by phone and lasted an average of 15 min each.



Results indicated that youths in treatment decreased their hemoglobin A1c by 0.74 compared to 0.09 in the waitlist, though this was not statistically significant. Youths in treatment reported increased unsupportive and decreased caring parental behaviors.



Telehealth Behavioral Therapy improves access to knowledgeable providers and results in a clinically significant improvement in glycemic control. Despite some youths experiencing an increase in unsupportive parental behaviors, TBT is a promising method of service delivery that warrants further investigation.
Trends in cardiovascular mortality and hospitalisations, and potential contribution of inhospital case-fatality rates to changes in national mortality in the Czech Republic 1994-2009.

To analyse trends in cardiovascular disease (CVD) mortality and hospitalisations in the Czech Republic in 1994-2009 and to assess the contribution of inhospital case-fatality rates (CFR) to changes in national CVD mortality.



National hospitalisation and mortality registers were used to estimate rates of hospital admissions and mortality for hypertension, angina pectoris, acute myocardial infarction (AMI), chronic ischaemic heart disease chronic (IHD), heart failure and stroke.



All hospitalisations and deaths from CVD during 1994-2009.



Average annual relative changes in age-standardised mortality, hospital admission and inhospital CFR.



Between 1994 and 2009, 5 409 407 hospital admissions and 930 659 deaths from CVD were recorded. The age-standardised CVD mortality rate fell from 561 to 357 per 100 000 population (mean annual decline 3.1%) but hospitalisation rates remained relatively stable, with 2800 admissions per 100 000 per year (annual decline 0.7%). Inhospital CFR decreased significantly in all examined diagnoses but most rapidly for AMI (by 5.5% per year) and stroke (4.2% per year). The improvements were larger in the younger population than in elderly persons. Calculations based on unlinked mortality and hospitalisation data suggest that a decline in inhospital CFR may explain approximately 24%, 41% and 61% of the decline in national deaths from IHD, AMI and stroke, respectively.



During the study period, the overall CVD hospitalisation rates remained high but inhospital CFR declined considerably. The improved case-fatality seems to have made a substantial contribution to the decline in the national CVD mortality, particularly for AMI and stroke.
Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder.

Despite the persistence of attention-deficit/hyperactivity disorder (ADHD) into adolescence, little is known about the efficacy and tolerability of stimulant medications in this age group.



To report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system (OROS) methylphenidate.



Adolescents (N = 220) having a confirmed Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylphenidate that improved symptoms to predefined criteria. Subjects successfully completing the dose titration phase (n = 177) (ie, tolerated and responded to treatment and adhered to the protocol) were randomized to receive 2 weeks' treatment with their individualized dosage of OROS methylphenidate (18, 36, 54, or 72 mg once daily) or placebo. Treatment effectiveness was measured using investigator, parent, and adolescent assessments of ADHD.



A significant reduction from baseline in the investigator-rated ADHD Rating Scale, the primary efficacy measure, was found with OROS methylphenidate treatment compared with placebo. Similar findings were noted with parent- and adolescent-report measures. Based on a Clinical Global Impression improvement subscale score of much or very much improved, 52% of subjects in the OROS methylphenidate group improved compared with 31% receiving placebo. Thirty-seven percent of subjects required the maximum dosage of 72 mg/d. The incidence of drug-related adverse events was similar between the 2 study groups.



In adolescents, once-daily OROS methylphenidate significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d.
Comparison of long-term outcomes between children with aplastic anemia and refractory cytopenia of childhood who received immunosuppressive therapy with antithymocyte globulin and cyclosporine.

The 2008 World Health Organization classification proposed a new entity in childhood myelodysplastic syndrome, refractory cytopenia of childhood. However, it is unclear whether this morphological classification reflects clinical outcomes. We retrospectively reviewed bone marrow morphology in 186 children (median age 8 years; range 1-16 years) who were enrolled in the prospective study and received horse antithymocyte globulin and cyclosporine between July 1999 and November 2008. The median follow-up period was 87 months (range 1-146 months). Out of 186 patients, 62 (33%) were classified with aplastic anemia, 94 (49%) with refractory cytopenia of childhood, and 34 (18%) with refractory cytopenia with multilineage dysplasia. Aplastic anemia patients received granulocyte colony-stimulating factor more frequently and for longer durations than other patients (P<0.01). After six months, response rates to immunosuppressive therapy were not significantly different among the 3 groups. Acquisition of chromosomal abnormalities was observed in 5 patients with aplastic anemia, 4 patients with refractory cytopenia of childhood, and 3 patients with refractory cytopenia with multilineage dysplasia. Although the cumulative incidence of total clonal evolution at ten years was not significantly different among the 3 groups, the cumulative incidence of monosomy 7 development was significantly higher in aplastic anemia than in the other groups (P=0.02). Multivariate analysis revealed that only granulocyte colony-stimulating factor administration duration of 40 days or more was a significant risk factor for monosomy 7 development (P=0.02). These findings suggest that even the introduction of a strict morphological distinction from hypoplastic myelodysplastic syndrome cannot eradicate clonal evolution in children with aplastic anemia.
Calcium imaging and selective computed tomography angiography in comparison to functional testing for suspected coronary artery disease: the multicentre, randomized CRESCENT trial.

To compare the effectiveness and safety of a cardiac computed tomography (CT) algorithm with functional testing in patients with symptoms suggestive of coronary artery disease (CAD).



Between April 2011 and July 2013, 350 patients with stable angina, referred to the outpatient clinic of four Dutch hospitals, were prospectively randomized between cardiac CT and functional testing (2 : 1 ratio). The tiered cardiac CT protocol included a calcium scan followed by CT angiography if the Agatston calcium score was between 1 and 400. Patients with test-specific contraindications were not excluded from study participation. By 1 year, fewer patients randomized to cardiac CT reported anginal complaints (P = 0.012). The cumulative radiation dose was slightly higher in the CT group (6.6 ± 8.7 vs. 6.1 ± 9.3 mSv; P < 0.0001). After 1.2 years, event-free survival was 96.7% for patients randomized to CT and 89.8% for patients randomized to functional testing (P = 0.011). After CT, the final diagnosis was established sooner (P < 0.0001), and additional downstream testing was required less frequently (25 vs. 53%, P < 0.0001), resulting in lower cumulative diagnostic costs (€369 vs. €440; P < 0.0001).



For patients with suspected stable CAD, a tiered cardiac CT protocol offers an effective and safe alternative to functional testing. Incorporating the calcium scan into the diagnostic workup was safe and lowered diagnostic expenses and radiation exposure.
Increased α-linolenic acid intake lowers C-reactive protein, but has no effect on markers of atherosclerosis

To investigate the effects of increased alpha-linolenic acid (ALA)-intake on intima–media thickness (IMT), oxidized low-density lipoprotein (LDL) antibodies, soluble intercellular adhesion molecule-1 (sICAM-1), C-reactive protein (CRP), and interleukins 6 and 10.Design: Randomized double-blind placebo-controlled trial.Subjects: Moderately hypercholesterolaemic men and women (55±10 y) with two other cardiovascular risk factors ( Participants were assigned to a margarine enriched with ALA (fatty acid composition 46% LA, 15% ALA) or linoleic acid (LA) (58% LA, 0.3% ALA) for 2 y. Dietary ALA intake was 2.3 en% among ALA users, and 0.4 en% among LA users. The 2-y progression rate of the mean carotid IMT (ALA and LA: +0.05 mm) and femoral IMT (ALA:+0.05 mm; LA:+0.04 mm) was similar, when adjusted for confounding variables. After 1 and 2 y, ALA users had a lower CRP level than LA users (net differences −0.53 and −0.56 mg/l, respectively, P<0.05). No significant effects were observed in oxidized LDL antibodies, and levels of sICAM-1, interleukins 6 and 10.Conclusions: A six-fold increased ALA intake lowers CRP, when compared to a control diet high in LA. The present study found no effects on markers for atherosclerosis. The Dutch ‘Praeventiefonds’.
Characterization of apoptosis and autophagy through Bcl-2 and Beclin-1 immunoexpression in gestational trophoblastic disease

The pathogenesis of Gestational Trophoblastic Disease (GTD) is not clearly known.



In this study, immunoexpression of proteins Bcl-2 and Beclin-1 in trophoblastic lesions and normal trophoblastic tissue was conducted to study the mechanism of apoptotic and autophagic cell death that is expected to complete the study of GTD pathogenesis.



Bcl-2 and Beclin-1 immunoexpression were studied on complete hydatidiform mole, partial hydatidiform mole, invasive mole, choriocarcinoma and normal placenta slides.



The average total scores of Bcl-2 immunoexpression had a decreasing value, starting from partial hydatidiform mole (3.09), complete hydatidiform mole (2.36), invasive mole (1.18) to choriocarcinoma (0) when compared to normal placenta (6). The results showed no significant difference in Beclin-1 immunoexpression total score between complete hydatidiform mole, partial hydatidiform mole and invasive mole, namely that the value of the average total score of Beclin-1 was low (2.27, 2.45 and 2.36), but on the contrary choriocarcinoma showed an increasing strong Beclin-1 expression with the average total score of 4.57.



Bcl-2 expression decreases in line with the excessive proliferation of trophoblast cells in hydatidiform mole and leads to malignancy in invasive mole and choriocarcinoma. The decreased expression of Beclin-1 that leads to autophagy defects in complete hydatidiform mole, partial hydatidiform mole and invasive mole shows the role of autophagy as tumor suppressor, whereas strong Beclin-1 expression shows the survival role of autophagy in choriocarcinoma. The change of Bcl-2 activity as antiapoptosis and Beclin-1 as proautophagy plays a role in pathogenesis of GTD.
Intraoperative solumedrol helps prevent postpneumonectomy pulmonary edema.

Postpneumonectomy pulmonary edema and pneumonia are life threatening and seemingly unavoidable complications after pneumonectomy. We theorized that an intraoperative dose of intravenous steroids (as a prophylactic measure to reduce pulmonary injury to the remaining lung) just before pulmonary artery ligation might decrease this problem.



Seventy-two patients (52 men) who had pneumonectomy during two time periods were studied prospectively. Thirty-five patients received 250 mg of methylprednisolone sodium succinate (Solumedrol; Upjohn, Kalamazoo, MI) just before pulmonary artery ligation (S group) and 37 did not (non-S group). Groups were matched for known or suspected preoperative, intraoperative, and postoperative risk factors for postpneumonectomy pulmonary edema.



The incidence of postpneumonectomy pulmonary edema or adult respiratory distress syndrome was less in the S group (0 of 35, 0% versus 5 of 37, 13.5%, p = 0.049), the overall major complication rate was less in the S group (7 of 35, 20% versus 16 of 37, 43%, p = 0.04), and the length of hospital stay was shorter in the S group (6.1 days versus 11.9 days, p = 0.02). In addition, there were no bronchopleural fistulas in the S group compared with two (both right-sided) in the non-S group.



The intraoperative intravenous administration of 250 mg of methylprednisolone sodium succinate just before pulmonary artery ligation during pneumonectomy may reduce the incidence of postpneumonectomy pulmonary edema and adult respiratory distress syndrome as well as decrease other major complications and shorten the hospital stay. It does not seem to increase the incidence of bronchopleural fistula. Further randomized trials are needed.
Changes in perceived health between one and five years after stroke: A randomized controlled trial of early supported discharge with continued rehabilitation at home versus conventional rehabilitation

Early supported discharge with continued rehabilitation at home (ESD) for patients with mild to moderate impairments has been compared to conventional rehabilitation in a randomized controlled trial. The aim of this study was to explore changes over time in perceived health status over the five years after stroke onset.



Of 83 patients enrolled in a randomized controlled trial of ESD compared to conventional rehabilitation, 50 (home rehabilitation group, n=28, conventional rehabilitation group, n=22) were followed up at one and five years after stroke with regard to perceived health using the Sickness Impact Profile. The Mann Whitney U-test was employed for statistical analysis of differences between the groups at one and five years, and the Wilcoxon sign test for differences within each group between one and five years.



There was no difference in perceived health between the groups at one or five years after stroke with regard to SIP total and the physical and psychosocial dimensions. Perceived health did not change significantly between one and five years in the home rehabilitation group whereas it had deteriorated significantly in the conventional rehabilitation group (p=0.05).



We conclude that the long term outcome with regard to perceived health status is more favourable after ESD than after conventional rehabilitation. Our results suggest that the environment is a key component to be considered in the rehabilitation process of stroke patients.