nils-herrmann/clean_scirepeval huggingface dataset:
Treatment of generalized social phobia: results at long-term follow-up.

This study investigated the long-term follow-up effectiveness of (cognitive-) behavioural group and individual treatments for generalized social phobia. Patients were reassessed 18 months after they had finished one of the following treatment packages: (1) exposure in vivo; (2) cognitive therapy followed by exposure in vivo; or (3) a cognitive-behavioural treatment in which both strategies were integrated from the start. Half of the patients were individually treated, the other half in a group. Self-report assessments were held before and after treatment and at 3-month and 18-month follow-ups. Repeated measures MANOVAs on the patients who completed the long-term follow-up (n = 50) demonstrated significant time effects, indicating lasting improvement compared with the pretest. Between the posttest and the 18-month follow-up no significant changes were observed. ANCOVAs either with the pretest or the posttest as covariate showed a significant interaction at 18-month follow-up between treatment package and treatment modality on three of the four compound outcome variables. The group treatment with exposure in vivo alone had been the most effective in the longer term, the integrated group treatment the least effective, while the individual treatments had given improvements in-between. Results are qualified in view of numbers of dropouts, additional treatments in the respective treatment conditions, and clinical relevance.
Effect of Child Development Centre model early stimulation among at risk babies--a randomized controlled trial.

To study the effectiveness of Child Development Centre (CDC) model early stimulation therapy done in the first year of postnatal life, in improving the developmental outcome of at-risk neonates at one and two years of age.



Randomized controlled trial.



The study participants included a consecutive sample of 800 babies discharged alive from the level II nursery of Medical College, Thiruvananthapuram.



The control group received routine postnatal check-up as per hospital practice. Intervention group in addition received CDC model early stimulation therapy (home-based).



The intervention group of babies had a statistically significant higher score for mental developmental index (MDI) and psychomotor developmental index (PDI) at one and two years of age. After adjusting all significant risk factors for development, the babies who had intervention had significantly higher Bayley scores, 5.8 units at one year and 2.8 units at two year, as compared to control babies.



Early stimulation therapy was effective at one year. The beneficial effect also persisted at two years, without any additional interventions in the second year.
Postanaesthesia pulmonary complications after use of muscle relaxants in Europe: Study protocol of the POPULAR study.

From the Department of Anesthesiology, Surgical Services and Intensive Care, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden (MJF, LIE); Department of Anesthesiology, Technische Universität München, Munich, Germany (HF, EB, MB); Department of Medical Statistics and Epidemiology, Technische Universität München, Munich, Germany (KU); Department of Anesthesiology, Academic Medical Centre, Amsterdam University, Amsterdam, The Netherlands (MH); Department of Anesthesiology, University of Nancy, Nancy, France (CM); Department of Musculoskeletal Biology, Institute of Ageing and Chronic Disease, Liverpool University, Liverpool, UK (JMH); and Research department, European Society of Anaesthesiology, Brussels, Belgium (BL, SD)
The "MESACA" study: methylsulfonylmethane and boswellic acids in the treatment of gonarthrosis.

Osteoarthritis is a chronic rheumatoid disease mediated by metalloproteinases and inflammatory cytokines. Methylsulfonylmethane (MSM) and boswellic acids (BA) each show promise in the treatment of inflammatory processes, but the efficacy of combined treatment with these substances in the treatment of arthritis has not yet been studied.



In this prospective randomized clinical trial, MESACA (for "methylsulfonylmethane and boswellic acids in the treatment of knee arthritis"), 60 subjects affected by arthritis of the knee were randomly assigned to an experimental group treated for 60 days with 5 g of MSM and 7.2 mg of BA daily, or a control group which was administered a placebo. At 2 and 6 months follow-up (FU), the efficacy of combined treatment with these two dietary supplements was assessed using the visual analog pain scale (VAS) and the Lequesne index (LI) for joint function, as well as monitoring the use of anti-inflammatory drugs (nonsteroidal anti-inflammatory drugs and anti-cyclooxygenase-2).



Pain, assessed with the VAS scale, was worse in the group treated with MSM and BA as compared with the placebo group at 2 months FU (3.8 vs. 2.7; P=0.04), whereas no difference between the two groups was observed at 6 months FU (2.7 vs. 3.6; P=0.2). No statistically significant differences were found in the LI between the two groups at either FU (2 months: 4.8 vs. 4.2; P=0.51; 6 months: 4.4 vs. 4.5; P=0.91). By contrast, a statistically significant difference in patients need for anti-inflammatory drugs was seen in the experimental as compared to the placebo group, even by 2 months FU (0.2 vs. 0.6 tablets/day; P<0.0001), that persisted up to the end of the study (0.1 vs. 0.6 tablets/day; P<0.0001).



Although the combined administration of MSM and BA in the treatment of gonarthrosis was not shown to be more efficacious than placebo in the management of the clinical and functional picture, it significantly reduced patients need for anti-inflammatory drugs.
Psychometric characteristics of the Spanish version of instruments to measure neck pain disability

The NDI, COM and NPQ are evaluation instruments for disability due to NP. There was no Spanish version of NDI or COM for which psychometric characteristics were known. The objectives of this study were to translate and culturally adapt the Spanish version of the Neck Disability Index Questionnaire (NDI), and the Core Outcome Measure (COM), to validate its use in Spanish speaking patients with non-specific neck pain (NP), and to compare their psychometric characteristics with those of the Spanish version of the Northwick Pain Questionnaire (NPQ).



Translation/re-translation of the English versions of the NDI and the COM was done blindly and independently by a multidisciplinary team. The study was done in 9 primary care Centers and 12 specialty services from 9 regions in Spain, with 221 acute, subacute and chronic patients who visited their physician for NP: 54 in the pilot phase and 167 in the validation phase. Neck pain (VAS), referred pain (VAS), disability (NDI, COM and NPQ), catastrophizing (CSQ) and quality of life (SF-12) were measured on their first visit and 14 days later. Patients' self-assessment was used as the external criterion for pain and disability. In the pilot phase, patients' understanding of each item in the NDI and COM was assessed, and on day 1 test-retest reliability was estimated by giving a second NDI and COM in which the name of the questionnaires and the order of the items had been changed.



Comprehensibility of NDI and COM were good. Minutes needed to fill out the questionnaires [median, (P25, P75)]: NDI. 4 (2.2, 10.0), COM: 2.1 (1.0, 4.9).  NDI: 0.88 (0.80, 0.93). COM: 0.85 (0.75,0.91). Sensitivity to change: Effect size for patients having worsened, not changed and improved between days 1 and 15, according to the external criterion for disability: NDI: -0.24, 0.15, 0.66; NPQ: -0.14, 0.06, 0.67; COM: 0.05, 0.19, 0.92.



Results of NDI, NPQ and COM were consistent with the external criterion for disability, whereas only those from NDI were consistent with the one for pain. Correlations with VAS, CSQ and SF-12 were similar for NDI and NPQ (absolute values between 0.36 and 0.50 on day 1, between 0.38 and 0.70 on day 15), and slightly lower for COM (between 0.36 and 0.48 on day 1, and between 0.33 and 0.61 on day 15). Correlation between NDI and NPQ: r = 0.84 on day 1, r = 0.91 on day 15. Correlation between COM and NPQ: r = 0.63 on day 1, r = 0.71 on day 15.



Although most psychometric characteristics of NDI, NPQ and COM are similar, those from the latter one are worse and its use may lead to patients' evolution seeming more positive than it actually is. NDI seems to be the best instrument for measuring NP-related disability, since its results are the most consistent with patient's assessment of their own clinical status and evolution. It takes two more minutes to answer the NDI than to answer the COM, but it can be reliably filled out by the patient without assistance.
Effects of nedocromil sodium in the treatment of non-allergic subjects with chronic obstructive pulmonary disease.

Nedocromil sodium, a nonsteroidal anti-inflammatory drug, is effective in the treatment of asthma. Its efficacy in the treatment of chronic obstructive pulmonary disease (COPD) has not been investigated.



Fifty four non-allergic patients with COPD were randomised to 10 weeks of treatment with placebo or nedocromil sodium (4 x 8 mg/day) in a double blind study.



Nedocromil sodium treatment had no effect on airway responsiveness to histamine, methacholine, and adenosine-5'-monophosphate, pulmonary function, and symptom scores. Both patients and clinicians favoured treatment with nedocromil sodium, however, and the number of dropouts (because of exacerbations) was fewer during treatment with the drug.



Longer trials will be necessary to assess if nedocromil sodium can reduce the frequency of exacerbations and the decrease in pulmonary function, eventually leading to a better quality of life in patients with COPD.
Defining nicotine dependence for genetic research: evidence from Australian twins.

Whether current criteria used to define nicotine dependence are informative for genetic research is an important empirical question. The authors used items of the DSM-IV and of the Heaviness of Smoking Index to characterize the nicotine dependence phenotype and to identify salient symptoms in a genetically informative community sample of Australian young adult female and male twins.



Phenotypic and genetic factor analyses were performed on nine dependence symptoms (the seven DSM-IV substance dependence criteria and the two Heaviness of Smoking Index (HSI) items derived from the Fagerström Tolerance Questionnaire, time to first cigarette in the morning and number of cigarettes smoked per day). Phenotypic and genetic analyses were restricted to ever smokers.



Phenotypic nicotine dependence symptom covariation was best captured by two factors with a similar pattern of factor loadings for women and men. In genetic factor analysis item covariation was best captured by two genetic but one shared environmental factor for both women and men; however, item factor loadings differed by gender. All nicotine dependence symptoms were substantially heritable, except for the DSM-IV criterion of 'giving up or reducing important activities in order to smoke', which was weakly familial.



The salient behavioral indices of nicotine dependence are similar for women and men. DSM-IV criteria of tolerance, withdrawal, and experiencing difficulty quitting and HSI items time to first cigarette in the morning and number of cigarettes smoked per day may represent the most highly heritable symptoms of nicotine dependence for both women and men.
Epoetin alfa in patients with advanced-stage Hodgkin's lymphoma: results of the randomized placebo-controlled GHSG HD15EPO trial.

To determine whether epoetin alfa reduces anemia-related fatigue, improves other aspects of health-related patient-recorded outcomes (PROs), reduces the number of RBC transfusions, and has an impact on freedom from treatment failure (FFTF) and overall survival (OS) in patients with advanced-stage Hodgkin's lymphoma (HL).



The prospectively randomized HD15EPO study performed by the German Hodgkin Study Group investigated epoetin alfa administered at doses of 40,000 U weekly during and after chemotherapy (six to eight cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone [BEACOPP]) in a double-blind, placebo-controlled setting. The study accrued 1,379 patients, of whom 1,328 were assessable for safety, 1,303 were assessable for clinical outcome, and 930 were assessable for PROs.



PROs were not different in patients receiving placebo or epoetin alfa, both after the end of chemotherapy and 6 months thereafter. There was no difference between patients treated with epoetin alfa or placebo with respect to FFTF and OS. There were also no differences in the numbers of deaths, progressions, relapses, and thromboembolic events. The median number of RBC transfusions was reduced from four per patient in the placebo group to two per patient in the epoetin alfa group (P < .001), with 27.4% of patients needing no RBC transfusion in the placebo group compared with 36.7% of patients in the epoetin alfa group (P < .001).



Epoetin alfa administered at 40,000 U weekly parallel to BEACOPP chemotherapy was safe in patients with advanced-stage HL and reduced the number of RBC transfusions but had no impact on fatigue and other PRO domains.
Examining the link between information processing speed and executive functioning in multiple sclerosis.

Slowed information processing speed (IPS) is frequently reported in those with multiple sclerosis (MS), and at least 20% are compromised on some aspect of executive functioning also. However, any relationship between these two processes has not been examined. The Sternberg Memory Scanning Test, Processing Speed Index (WAIS-III), Delis Kaplan Executive Function System (D.KEFS), and Working Memory Index (WMS-III) were administered to 90 participants with MS. Their performance on the PSI was significantly below the normative scores but no deficits in memory scanning speed were evident. The initial response speed of the Sternberg and the PSI were more closely related to D.KEFS performance, particularly in timed tasks with a high cognitive demand (switching tasks). In contrast, memory scanning speed was related to working memory. This study reinforces the link between IPS and working memory in MS, and supports the suggestion that IPS is not a unitary construct.
Helicobacter pylori Eradication Lowers Serum Asymmetric Dimethylarginine Levels

Microbial pathogens, one of them is Helicobacter pylori (H. pylori), have frequently been implicated in the atherogenesis. Endothelium-derived nitric oxide (NO) is synthesized from L-arginine by nitric oxide synthase (NOS) and plays a pivotal role in the regulation of vascular tone. Asymmetric dimethylarginine (ADMA) is the most potent endogenous NOS inhibitor. Elevated levels of ADMA have been reported in many circumstances associated with a high cardiovascular risk. The aim of the present study was to investigate whether the eradication of H. pylori infection affects serum ADMA levels.



Forty-two H. pylori-positive patients were enrolled in the study. Triple therapy for 14 days were given to all patients. Serum ADMA levels were measured at baseline and 2 months after therapy.



Eradication was achieved in 34 (81%) patients. The mean serum ADMA levels before and after therapy were 1, 77 ± 0, 30 and 1, 67 ± 0, 29 ng/mL in the group with H. pylori eradicated and 1, 63 ± 0, 28 and 1, 56 ± 0, 32 ng/mL in the noneradicated, respectively. We detected statistically significant decreased serum ADMA levels after therapy in H. pylori eradicated group.



These findings have indicated that eradication of H. pylori infection may decrease the risk of atherosclerosis and cardiovascular events.
Ristocetin-Induced Platelet Aggregation for Monitoring of Bleeding Tendency in CLL Treated with Ibrutinib

Bleeding because of impaired platelet function is a major side effect of the Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib. We quantitatively assessed ristocetin-induced platelet aggregation (RIPA) in 64 patients with chronic lymphocytic leukemia (CLL) under ibrutinib at 287 time points. Eighty-seven bleeding episodes in 39 patients were registered (85 Common Toxicity Criteria (CTC) grade 1 or 2, 2 CTC grade 3) during a median observation period of 10.9 months. At times of bleeding, RIPA values were significantly lower (14 vs 28 U; P<0.0001). RIPA was impaired in patients receiving concomitant antiplatelet therapy or anticoagulation (14 vs 25 U, P=0.005). A gradual decline of median RIPA values was observed with increasing bleeding severity. Importantly, no CTC grade 2 or 3 bleeding were observed with RIPA values of >36 U. Sequential monitoring indicated a decrease of RIPA values from a median of 17 to 9 U within 2 weeks after initiation of treatment as well as an increase above the critical threshold of 36 U within 7 days when ibrutinib was paused. Low RIPA values were similar during treatment with another BTK inhibitor, CC292. Quantitative assessment of platelet function is a practical tool to monitor bleeding tendency under BTK-inhibitor therapy.
Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial

Severe traumatic brain injury (TBI) has been increasing with greater incidence of injuries from traffic or sporting accidents. Although there are a number of animal models of TBI using progesterone for head injury, the effects of progesterone on neurologic outcome of acute TBI patients remain unclear. The aim of the present clinical study was to assess the longer-term efficacy of progesterone on the improvement in neurologic outcome of patients with acute severe TBI.



A total of 159 patients who arrived within 8 hours of injury with a Glasgow Coma Score </= 8 were enrolled in the study. A prospective, randomized, placebo-controlled trial of progesterone was conducted in the Neurotrauma Center of our teaching hospital. The patients were randomized to receive either progesterone or placebo. The primary endpoint was the Glasgow Outcome Scale score 3 months after brain injury. Secondary efficacy endpoints included the modified Functional Independence Measure score and mortality. In a follow-up protocol at 6 months, the Glasgow Outcome Scale and the modified Functional Independence Measure scores were again determined.



Of the 159 patients randomized, 82 received progesterone and 77 received placebo. The demographic characteristics, the mechanism of injury, and the time of treatment were compared for the two groups. After 3 months and 6 months of treatment, the dichotomized Glasgow Outcome Scale score analysis exhibited more favorable outcomes among the patients who were given progesterone compared with the control individuals (P = 0.034 and P = 0.048, respectively). The modified Functional Independence Measure scores in the progesterone group were higher than those in the placebo group at both 3-month and 6-month follow-up (P < 0.05 and P < 0.01). The mortality rate of the progesterone group was significantly lower than that of the placebo group at 6-month follow-up (P < 0.05). The mean intracranial pressure values 72 hours and 7 days after injury were lower in the progesterone group than in the placebo group, but there was no statistical significance between the two groups (P > 0.05). Instances of complications and adverse events associated with the administration of progesterone were not found.



Our data suggest that acute severe TBI patients with administration of progesterone hold improved neurologic outcomes for up to 6 months. These results provide information important for further large and multicenter clinical trials on progesterone as a promising neuroprotective drug.
Community-based lifestyle modification of cardiovascular disease risks in middle-aged Japanese: a 27-month update.

Lifestyle modification is the cornerstone of preventive management for people with cardiovascular disease risks, such as obesity, hypertension, dyslipidemia and diabetes. This study investigated the effect of a 27-month community-based lifestyle intervention on the reduction of cardiovascular disease risks in middle-aged Japanese. Of 549 participants with cardiovascular disease risk factors of overweight, hypertension, dyslipidemia or diabetes enrolled in this non-randomized controlled study, 397 participants aged 39-71 years old completed all 3 serial surveys at baseline, 15 months and 27 months. For the intervention group (39 males and 174 females), 31 specific interventions including individual counselling and group sessions were conducted. The control group (64 males and 120 females) only received 7 newsletters providing health information and results of health checkups. Multiple logistic regression analysis adjusted for sex, each baseline risk category and age category showed that the proportion of those who were overweight or showed dyslipidemia risk were significantly lower in the intervention group only at 27 months [Odds ratio (OR): 0.43 (95% CI 0.20-0.94), OR: 0.43 (95% CI 0.21-0.87), respectively] and the proportion of those showing diabetes risk was significantly lower in the intervention group at both 15 months [OR: 0.42 (95% CI 0.18-0.97)] and 27 months [OR: 0.56 (95% CI 0.32-0.99)]. In conclusion, the 27-month community-based lifestyle modification of cardiovascular disease risks shows significant reductions in risks of diabetes, overweight and dyslipidemia in middle-aged Japanese.
Can concept sorting provide a reliable, valid and sensitive measure of medical knowledge structure?

Evolution from novice to expert is associated with the development of expert-type knowledge structure. The objectives of this study were to examine reliability and validity of concept sorting (ConSort) as a measure of static knowledge structure and to determine the relationship between concepts in static knowledge structure and concepts used during diagnostic reasoning.



ConSort was used to identify static knowledge concepts and analysis of think-aloud protocols was used to identify dynamic knowledge concepts (used during diagnostic reasoning). Intra- and inter-rater reliability, and correlation across cases, were evaluated. Construct validity was evaluated by comparing proportions of nephrologists and students with expert-type knowledge structure. Sensitivity and specificity of static knowledge concepts as a predictor of dynamic knowledge concepts were estimated.



Thirteen first-year medical students and 19 nephrologists participated. Intra- and inter-rater agreement for determination of static knowledge concepts were 1.0 and 0.90, respectively. Reliability across cases was 0.45. The proportions of nephrologists and students identified as having expert-type knowledge structure were 82.9% and 55.8%, respectively (p=0.001). Sensitivity and specificity of ConSort((c)) in predicting concepts that were used during diagnostic reasoning were 96.8% and 27.8% for nephrologists and 87.2% and 55.1% for students.



ConSort is a reliable, valid and sensitive tool for studying static knowledge structure. The applicability of tools that evaluate static knowledge structure should be explored as an addition to existing tools that evaluate dynamic tasks such as diagnostic reasoning.