nils-herrmann/clean_scirepeval huggingface dataset:
A prospective, randomized, double-blind and placebo-controlled study to assess the efficacy of paracervical block in the pain relief during egg collection in IVF.

The role of paracervical block in the pain relief during egg collection in in-vitro fertilization (IVF) is still not confirmed. In this prospective, double-blind and placebo-controlled study, 135 patients undergoing egg collection in their first IVF cycle were randomized to receive 10 ml of 1.5% lignocaine (group A) or normal saline (group B) in the paracervical block and no local injection (group C). No differences were seen among the groups in the demographic data, the ovarian response, the duration of egg collection, the number of follicles punctured, the pregnancy rates and the pain levels related to blood taking, scanning and insertion of an i.v. cannula. All patients experienced similar pain scores for vaginal puncture but patients in group A experienced significantly less abdominal pain during egg collection, compared with those in group B and group C (P = 0.009 and P = 0.001 respectively; Mann-Whitney U-test). When lignocaine was used, the abdominal pain scores were reduced by 38.9 and 51.4% compared with placebo and no local injection respectively. We recommend that paracervical block with lignocaine should be used in conjunction with i.v. sedation/analgesia during egg collection performed through the transvaginal route under ultrasound guidance (TUGOR) to reduce the pain of the procedure.
A pilot study of plasma metabolomic patterns from patients treated with ketamine for bipolar depression: evidence for a response-related difference in mitochondrial networks.

(R,S)-ketamine produces rapid and significant antidepressant effects in approximately 65% of patients suffering from treatment-resistant bipolar depression (BD). The genetic, pharmacological and biochemical differences between ketamine responders and non-responders have not been identified. The purpose of this study was to employ a metabolomics approach, a global, non-targeted determination of endogenous metabolic patterns, to identify potential markers of ketamine response and non-response.



Plasma samples from 22 BD patients were analyzed to produce metabolomic patterns. The patients had received ketamine in a placebo-controlled crossover study and the samples were obtained 230 min post-administration at which time the patients were categorized as responders or non-responders. Matching plasma samples from the placebo arm of the study were also analysed. During the study, the patients were maintained on either lithium or valproate.



The metabolomic patterns were significantly different between the patients maintained on lithium and those maintained on valproate, irrespective of response to ketamine. In the patients maintained on lithium, 18 biomarkers were identified. In responders, lysophosphatidylethanolamines (4) and lysophosphatidylcholines (9) were increased relative to non-responders.



The results indicate that the differences between patients who respond to ketamine and those who do not are due to alterations in the mitochondrial β-oxidation of fatty acids. These differences were not produced by ketamine administration. The data indicate that pretreatment metabolomics screening may be a guide to the prediction of response and a potential approach to the individualization of ketamine therapy.
Postoperative chemotherapy including intraperitoneal and intradermal administration of the streptococcal preparation OK-432 for patients with gastric cancer and peritoneal dissemination: a prospective randomized study

We studied the effects on survival time of postoperative immuno-chemotherapy, including the streptococcal preparation OK-432, in patients with gastric cancer and synchronous peritoneal dissemination. The patients were prospectively randomized and a valid statistical assessment could be made for 109. Patients randomized to group B received therapy that is widely used in Japan to treat patients with gastric cancer: mitomycin C (MMC) and UFT, a combination of tegafur and uracil in a molar ratio of 1∶4, for 1 year. Patients randomized to group A received the same drugs as were given to group B patients plus OK-432 i.p. for 7 days, beginning on postoperative day 0, and OK-432 by intradermal injection for 1 year, at 2-week intervals. There were no differences between the two groups in any known prognostic factor or in the dose of any drug administered except for OK-432. There was no difference in the toxicity rate between the groups. In this negative trial, there was no improvement in survival time with the addition of OK-432 to MMC and UFT for patients with gastric cancer and peritoneal dissemination.
Positive affect and incidence of frailty in elderly women caregivers and noncaregivers: results of Caregiver-Study of Osteoporotic Fractures.

To determine whether positive affect is associated with a lower incidence of frailty over 2 years in elderly community-dwelling women and to test the stress-buffering hypothesis by evaluating whether these associations differed in caregivers and noncaregivers.



Prospective cohort study with three annual interviews conducted in four U.S. communities between 1999 and 2004.



Home-based interviews.



Three hundred thirty-seven caregiver and 617 noncaregiver participants from the Caregiver-Study of Osteoporotic Fractures (Caregiver-SOF) who were not frail at the baseline Caregiver-SOF interview.



High and low positive affect and depressive symptoms were derived from the baseline 20-item Center for Epidemiologic Studies Depression Scale. Frailty was the development of three or more indicators (weight loss, exhaustion, slow walking speed, or weak grip strength) at the first or second follow-up interview.



Respondents' mean age was 81.2. Caregivers and noncaregivers had similar levels of positive affect (56.3% vs 58.3%) and frailty incidence (15.4% vs 15.9%) but differed in perceived stress (mean Perceived Stress Scale score 16.7 vs 14.8, P<.001). Frailty risk was lower in respondents with high positive affect than in those with low positive affect in the total sample (adjusted hazard ratio (HR)=0.49, 95% confidence interval (CI)=0.35-0.70), caregivers (adjusted HR=0.44, 95% CI=0.24-0.80) and noncaregivers (adjusted HR=0.50, 95% CI=0.32-0.77).



These findings add to the evidence that positive affect protects against health decline in older adults, although it had no additional stress-buffering effect on health in elderly caregivers.
Resistance training concomitant to radiotherapy of spinal bone metastases – survival and prognostic factors of a randomized trial

To compare the effects of resistance training versus passive physical therapy on bone survival in the metastatic bone during radiation therapy (RT) as combined treatment in patients with spinal bone metastases. Secondly, to evaluate overall survival and progression-free-survival (PFS) as well as to quantify prognostic factors of bone survival after combined treatment.



In this randomized trial 60 patients were allocated from September 2011 until March 2013 into one of the two groups: resistance training (group A) or passive physical therapy (group B) with thirty patients in each group during RT. We estimated patient survival using Kaplan-Meier survival method. The Wald-test was used to evaluate the prognostic importance of pathological fracture, primary site, Karnofsky performance status, localization of metastases, number of metastases, and cerebral metastases.



Median follow-up was 10 months (range 2-35). Bone survival showed no significant difference between groups (p = .303). Additionally no difference between groups could be detected in overall survival (p = .688) and PFS (p = .295). Local bone progression was detected in 16.7 % in group B, no irradiated bone in group A showed a local progression over the course (p = 0.019). In univariate analysis breast cancer, prostate cancer, and the presence of cerebral metastases had a significant impact on bone survival in group B, while no impact could be demonstrated in group A.



In this group of patients with spinal bone metastases we were able to show that guided resistance training of the paravertebral muscles had no essential impact on survival concomitant to RT. Importantly, no local bone progression in group A was detected, nevertheless no prognostic factor for combined treatment could be evaluated.
Three-month cumulative incidence of thromboembolism and bleeding after periprocedural anticoagulation management of arterial vascular bypass patients

The objective of this study was to determine 3-month cumulative incidence of peri-procedural thromboembolism (TE) including graft occlusion, and peri-procedural bleeding for chronically anticoagulated vascular bypass graft (BG) patients requiring temporary warfarin interruption for an invasive procedure. Appropriate peri-procedural management of patients receiving chronic warfarin therapy to preserve lower extremity arterial BG patency is unknown. In a protocol driven, cohort study design, all BG patients referred to the Mayo Clinic Thrombophilia Center for peri-procedural anticoagulation (1997–2007) were followed forward in time to estimate the 3-month cumulative incidence of TE and bleeding. Decisions to provide “bridging” low molecular weight heparin (LMWH) were individualized based on estimated risk of TE and bleeding. There were 78 BG patients (69 ± 10 years; 38 % women), of whom 73 % had a distal autogenous and 53 % had prosthetic BG; 45 % received antiplatelet therapy. Peri-procedural LMWH was prescribed for 77 % of patients and did not vary by BG distal anastomosis location or type. The 3-month cumulative incidence of TE was 5.1 % (95 % CI 1.4–12.6), including two BG occlusions, one DVT, and one myocardial infarction. Major bleeding occurred in 1 patient (1.28 %, 95 % CI 0.0–6.94). One patient died due to heart failure. TE and bleeding did not differ by bridging status. The 3-month cumulative incidence of TE among BG patients in whom warfarin is temporarily interrupted for an invasive procedure may be higher than in other “bridging” populations (atrial fibrillation, prosthetic heart valve, venous thromboembolism). This finding underscores the often tenuous nature of distal bypass grafts necessitating an aggressive approach to peri-procedural anticoagulation management.
Cascading verification: an integrated method for domain-specific model checking

Model checking is an established method for verifying behavioral properties of system models. But model checkers tend to support low-level modeling languages that require intricate models to represent even the simplest systems. Modeling complexity arises in part from the need to encode domain knowledge at relatively low levels of abstraction. 
 In this paper, we demonstrate that formalized domain knowledge can be reused to raise the abstraction level of model and property specifications, and hence the effectiveness of model checking. We describe a novel method for domain-specific model checking called cascading verification that uses composite reasoning over high-level system specifications and formalized domain knowledge to synthesize both low-level system models and their behavioral properties for verification. In particular, model builders use a high-level domain-specific language (DSL) based on YAML to express system specifications that can be verified with probabilistic model checking. Domain knowledge is encoded in the Web Ontology Language (OWL), the Semantic Web Rule Language (SWRL) and Prolog, which are used in combination to overcome their individual limitations. A compiler then synthesizes models and properties for verification by the probabilistic model checker PRISM. We illustrate cascading verification for the domain of uninhabited aerial vehicles (UAVs), for which we have constructed a prototype implementation. An evaluation of this prototype reveals nontrivial reductions in the size and complexity of input specifications compared to the artifacts synthesized for PRISM.
Fine-tuning risperidone dosage for acutely exacerbated schizophrenia: clinical determinants

Risperidone doses for acute schizophrenia were rather high in most recent studies. We tested a hypothesis that fine-tuning risperidone dosage to relieve side effects still yields efficacy. Clinical factors influencing the dosing were also determined. One hundred and forty-six schizophrenia inpatients with acute exacerbation entered a prospective, 6-week, repeated measures study. Risperidone doses were titrated to 6 mg/day (if tolerable) within 7 days, but were lowered thereafter if adverse reactions appeared. Efficacy and safety were measured biweekly. Forty-eight patients tolerated the 6-mg/day target dose well, while the other 98 received lower final doses (mean±SD=3.4±0.9 mg/day) to curtail adverse effects. At endpoint, 64.3% of the low-dose patients and 43.8% of the high-dose subjects responded to treatment [≥20% reduction in the Positive and Negative Syndrome Scale (PANSS) total score] (P=0.018). In detail, the low-dose individuals were significantly superior in percentage changes in the PANSS total and general-subscale scores at endpoint. The low-dose group also tended to improve more (albeit statistically insignificantly) in the PANSS positive and negative subscales and other efficacy measures. Compared to the patients with undifferentiated subtype, those with disorganized subtype received higher dosage by 0.90 mg/day, after controlling for other variables (P=0.008). Paranoid subtype was similar to undifferentiated subtype in drug doses. Patients with longer illness duration also showed a trend to use higher dosage (P=0.078). These findings suggest that dosage adjustment to diminish side effects does not compromise risperidone response and that disorganized patients and perhaps patients with longer illness duration are prone to receive larger doses.
Substance use and substance use disorders in recently deployed and never deployed soldiers.

Military studies investigating the prevalence of substance use (SU) and substance use disorders (SUD) and the relation between SU and mental disorders often lack a comprehensive assessment of SU, SUD and mental disorders and comparable groups of deployed and non-deployed personnel. There is also limited data regarding SU and SUD in the German military to date.



Cross-sectional examination of n=1483 soldiers recently deployed in Afghanistan and 889 never deployed soldiers using a fully-standardized diagnostic interview (MI-CIDI) including a comprehensive substance section.



Across both groups, 12-months prevalence of DSM-IV alcohol use disorders was 3.1%, 36.9% reported binge drinking, 13.9% heavy drinking, 1.3% illegal drug use. 55.1% were regular smokers, 10.9% nicotine dependent. Although recently deployed soldiers revealed slightly higher rates in some measures, there were no significant differences to the never deployed regarding SU und SUD except that recently deployed soldiers smoked more cigarettes per day. The association of SU with mental mental disorders was substantially different though, revealing significant associations between SU and mental disorders only among recently deployed soldiers.



We do not find remarkable differences in the prevalence of SU and SUD between recently deployed and never deployed soldiers. Especially binge drinking and regular smoking were prevalent across both samples indicating needs for improved interventions. The finding that SU and mental disorders are only associated in recently deployed soldiers might have implications for improved screening and prevention and suggests that deployment might promote different pathways and mechanisms involved in the evolution of SU and mental disorders.
Development of immunity following financial incentives for hepatitis B vaccination among people who inject drugs: A randomized controlled trial.

People who inject drugs (PWID) are at risk of hepatitis B virus (HBV) but have low rates of vaccination completion. The provision of modest financial incentives increases vaccination schedule completion, but their association with serological protection has yet to be determined.



To investigate factors associated with vaccine-induced immunity among a sample of PWID randomly allocated to receive AUD$30 cash following receipt of doses two and three ('incentive condition') or standard care ('control condition') using an accelerated 3-dose (0,7,21 days) HBV vaccination schedule.



A randomised controlled trial among PWID attending two inner-city health services and a field site in Sydney, Australia, assessing vaccine-induced immunity measured by hepatitis B surface antibodies (HBsAb ≥ 10 mIU/ml) at 12 weeks. The cost of the financial incentives and the provision of the vaccine program are also reported.



Just over three-quarters of participants - 107/139 (77%)--completed the vaccination schedule and 79/139 (57%) were HBsAb ≥ 10 mIU/ml at 12 weeks. Vaccine series completion was the only variable significantly associated with vaccine-induced immunity in univariate analysis (62% vs 41%, p<0.035) but was not significant in multivariate analysis. There was no statistically discernible association between group allocation and series completion (62% vs 53%). The mean costs were AUD$150.5, (95% confidence interval [CI]: 142.7-158.3) and AUD$76.9 (95% CI: 72.6-81.3) for the intervention and control groups respectively.



Despite increasing HBV vaccination completion, provision of financial incentives was not associated with enhanced serological protection. Further research into factors which affect response rates and the optimal vaccination regimen and incentive schemes for this population are needed.
A Phase II trial of autologous stem cell transplantation followed by mini-allogeneic stem cell transplantation for the treatment of multiple myeloma: an analysis of Eastern Cooperative Oncology Group ECOG E4A98 and E1A97.

Conventional allogeneic hematopoietic stem cell transplantation (HSCT) for multiple myeloma is associated with high transplantation-related mortality (TRM). Nonmyeloablative allogeneic transplantation (NST) uses the well-known graft-versus-myeloma (GVM) effect to eradicate minimal residual disease. The Eastern Cooperative Oncology Group conducted a Phase II trial of autologous HSCT followed by NST to provide maximal tumor cytoreduction to allow for a subsequent GVM effect. Patients received melphalan 200 mg/m(2) with autologous HSCT, followed by fludarabine 30 mg/m(2) in 5 daily doses and cyclophosphamide 1 g/m(2) in 2 daily doses with matched sibling donor NST. Graft-versus-host disease (GVHD) prophylaxis included cyclosporine and corticosteroids. The primary endpoints were TRM, graft failure, acute GVHD, progression-free survival (PFS), and overall survival (OS). Thirty-two patients were enrolled into the study; 23 patients completed both transplantations (72%). Best responses post-NST were 7 (30%) complete remission (CR), 11 (48%) partial remission (PR), 2 (9%) no response, and 3 (13%) not evaluable. Acute grade III-IV GVHD was observed in 4 patients (17%), and chronic GVHD was seen in 13 patients (57%; 7 limited, 6 extensive). Chronic GVHD resulted in the following responses: 3 (23%) CR, 1 continuing CR, and 6 (46%) PR. Two patients (8.7%) had early TRM. With a median follow up of 4.6 years, the median PFS was 3.6 years, and the 2-year OS was 78%. Our findings indicate that autologous HSCT followed by NST is feasible, with a low early TRM in a cooperative group setting. The overall response rate was 78%, including 30% CR, similar to other reports for autologous HSCT-NST. Because a plateau in PFS or OS was not observed with this treatment approach even in patients achieving CR, we suggest that future studies use posttransplantation maintenance therapy.
Glycaemic control and self-management behaviours in Type 2 diabetes: results from a 1-year longitudinal cohort study.

To better understand the associations between changes in self-management behaviours and glycaemic control.



We conducted a prospective observational study of 295 adult patients with Type 2 diabetes evaluated at baseline, 6 and 12 months. Four self-management behaviours were evaluated using the Summary of Diabetes Self-Care Activities instrument, which assesses healthy diet, physical activity, medication taking and self-monitoring of blood glucose. Using hierarchical linear regression models, we tested whether changes in self-management behaviours were associated with short-term (6-month) or long-term (12-month) changes in glycaemic control, after controlling for demographic and clinical characteristics.



Improved diet was associated with a decrease in HbA1c level, both at 6 and 12 months. Improved medication taking was associated with short-term improvement in glycaemic control, while increased self-monitoring of blood glucose frequency was associated with a 12-month improvement in HbA1c . Completely stopping exercise after being physically active at baseline was associated with a rise in HbA1c level at 6-month follow-up. Interaction analysis indicated that a healthy diet benefitted all participant subgroups, but that medication taking was associated with glycaemic control only for participants living in poverty and more strongly for those with lower educational levels. Finally, a higher self-monitoring of blood glucose frequency was associated with better glycaemic control only in insulin-treated participants.



Even after adjusting for potential confounders (including baseline HbA1c ), increased frequency of healthy diet, medication taking and self-monitoring of blood glucose were associated with improved HbA1c levels. These self-management behaviours should be regularly monitored to identify patients at risk of deterioration in glycaemic control. Barriers to optimum self-management should be removed, particularly among socio-economically disadvantaged populations.
Image rejects in general direct digital radiography

The number of rejected images is an indicator of image quality and unnecessary imaging at a radiology department. Image reject analysis was frequent in the film era, but comparably few and small studies have been published after converting to digital radiography. One reason may be a belief that rejects have been eliminated with digitalization.



To measure the extension of deleted images in direct digital radiography (DR), in order to assess the rates of rejects and unnecessary imaging and to analyze reasons for deletions, in order to improve the radiological services.



All exposed images at two direct digital laboratories at a hospital in Norway were reviewed in January 2014. Type of examination, number of exposed images, and number of deleted images were registered. Each deleted image was analyzed separately and the reason for deleting the image was recorded.



Out of 5417 exposed images, 596 were deleted, giving a deletion rate of 11%. A total of 51.3% were deleted due to positioning errors and 31.0% due to error in centering. The examinations with the highest percentage of deleted images were the knee, hip, and ankle, 20.6%, 18.5%, and 13.8% respectively.



The reject rate is at least as high as the deletion rate and is comparable with previous film-based imaging systems. The reasons for rejection are quite different in digital systems. This falsifies the hypothesis that digitalization would eliminates rejects. A deleted image does not contribute to diagnostics, and therefore is an unnecessary image. Hence, the high rates of deleted images have implications for management, training, education, as well as for quality.