nils-herrmann/clean_scirepeval huggingface dataset:
The effect of prior bisphosphonate therapy on the subsequent therapeutic effects of strontium ranelate over 2 years

Many osteoporotic women prescribed strontium ranelate have previously received bisphosphonates. Prior bisphosphonate use blunted the spinal bone mineral density (BMD) response for 6 months. Hip BMD was blunted to a degree for 2 years, although there was an overall increase in hip BMD in contrast to the heel where BMD did not increase. Many osteoporotic women commenced on strontium ranelate have already received treatment with bisphosphonates. This study investigates whether prior bisphosphonate use impairs the subsequent therapeutic response to strontium ranelate. Women were recruited who were either bisphosphonate naïve or currently receiving a bisphosphonate. All women received strontium ranelate and were followed up for 2 years. One hundred and twenty women were recruited. After 2 years, the bisphosphonate-naïve group had significant BMD increases of 8.9%, 6.0% and 6.4% at the spine, hip and heel, respectively. In the prior bisphosphonate group, BMD increased significantly at the spine (4.0%) and hip (2.5%) but not at the heel. At all time points at all sites, the BMD increase was greater in the bisphosphonate-naïve group. BMD at the spine did not increase during the first 6 months in the prior bisphosphonate group but then increased in parallel with the bisphosphonate-naïve group. In contrast, the difference between the two groups in hip BMD continued to increase throughout the 2 years. P1NP was suppressed in the prior bisphosphonate group for the first 6 months. After bisphosphonate exposure, the BMD response to strontium ranelate is blunted for only 6 months at the spine. At the hip, a degree of blunting was observed over 2 years, although there was an overall increase in hip BMD in contrast to the heel where no increase in BMD was observed.
Voxel-based morphometric multisite collaborative study on schizophrenia.

Regional gray matter (GM) abnormalities are well known to exist in patients with chronic schizophrenia. Voxel-based morphometry (VBM) has been previously used on structural magnetic resonance images (MRI) data to characterize these abnormalities. Two multisite schizophrenia studies, the Functional Biomedical Informatics Research Network and the Mind Clinical Imaging Consortium, which include 9 data collection sites, are evaluating the efficacy of pooling structural imaging data across imaging centers. Such a pooling of data could yield the increased statistical power needed to elucidate effects that may not be seen with smaller samples. VBM analyses were performed to evaluate the consistency of patient versus control gray matter concentration (GMC) differences across the study sites, as well as the effects of combining multisite data. Integration of data from both studies yielded a large sample of 503 subjects, including 266 controls and 237 patients diagnosed with schizophrenia, schizoaffective or schizophreniform disorder. The data were analyzed using the combined sample, as well as analyzing each of the 2 multisite studies separately. A consistent pattern of reduced relative GMC in schizophrenia patients compared with controls was found across all study sites. Imaging center-specific effects were evaluated using a region of interest analysis. Overall, the findings support the use of VBM in combined multisite studies. This analysis of schizophrenics and controls from around the United States provides continued supporting evidence for GM deficits in the temporal lobes, anterior cingulate, and frontal regions in patients with schizophrenia spectrum disorders.
Prasugrel Use in Real Life: A Report From the Outpatient Setting in France.

The objective of this study was to provide descriptive statistics on patterns of prasugrel usage in the outpatient setting in France. This retrospective study was conducted to describe treatment patterns for prasugrel in the outpatient setting in France using the Intercontinental Marketing Services (IMS) Disease Analyzer database, which collates electronic medical records updated by a nationally representative database of 1200 French general practitioners (GPs). Anonymous data were collected prospectively at each follow-up visit. The study population consisted of patients with ≥1 prescription for prasugrel in the outpatient setting from its launch date to 3 years post-launch. Patients were followed up from the date of the first prescription for prasugrel recorded in the database until they died, changed GP, or reached the end of the study, whichever came first. In France, the IMS Disease Analyzer included 1052 patients receiving ≥1 prescription of prasugrel from January 2010 until October 2012. Eighty-five percent of the population was male. The mean age was 58 years; 94.3% were age <75 years, and 95.0% weighed ≥60 kg. Of the total, 99.8% of patients were prescribed a daily maintenance dose of 10 mg, and 0.2% had a history of transient ischemic attack/stroke. Concomitant medications were antiplatelet agents (100%; aspirin, 93.7%), lipid-lowering agents (90.1%), β-blockers (83.7%), angiotensin-converting enzyme inhibitors (62.2%), and anti-ulcer medications (55.1%). The results reflect good usage of prasugrel by French GPs in the outpatient setting, with excellent implementation of the Prasugrel European Summary Product Characteristics.
Hand splinting for poststroke spasticity: a randomized controlled trial.

To determine the effect of volar and dorsal splinting on the spasticity of the wrist flexor muscles in patients who had stroke.



Thirty-nine subjects were prospectively randomized to use a dorsal or volar splint or no splint (control group). All the patients underwent home-based exercise program, and the experimental groups used either dorsal or volar hand splints according to their distribution. The primary outcome measure was spasticity assessed clinically by the Modified Ashworth Scale (MAS) and electrophysiologically by H latency and Hmax:Mmax ratio of flexor carpi radialis. Secondary outcome measure was passive range of motion (PROM) of wrist extension.



Spasticity parameters (MAS, H latency, Hmax:Mmax ratio) and wrist PROM were not significantly different among the groups.



This study failed to demonstrate any statistically significant difference in spasticity or in wrist PROM of both the volar and dorsal splint groups. These splints could be recommended as part of an integrative approach without expecting a major clinical effect rather than as an alternative to other treatment.
Psychophysiological interactions between smoking and stress coping?

Earlier studies with different types of stressors suggested that cigarette smoking might selectively dampen physiological stress reactions in passive rather than in active coping situations. This hypothesis was tested in the present study using the same task for both types of coping, but with two different instructions. Twenty-four female regular smokers were assigned either to a group requiring active coping or to a group requiring passive coping with ongoing electric shocks, and tested in two sessions where they performed a pre- and a postsmoking/non-smoking trial of the rapid information processing task (RIP). Smoking increased RIP task performance, cardiovascular and electrocortical arousal, and reduced anxiety throughout the session. Active coping, as compared to passive coping, produced greater increases in heart rate and blood pressure, a greater pre- to post-treatment decrease in reaction time and higher pain ratings of the electrical shocks. However, interactions between the effects of smoking and the type of coping were few and did not suggest a plausible concept. Thus, it was concluded that, although the typical effects of smoking as well as the differentiation between active and passive coping seen earlier with the same paradigm were confirmed, cigarette smoking did not affect the effects of the two coping conditions in a differential way.
Comparison of haemodynamic changes in patients undergoing unilateral and bilateral spinal anaesthesia.

To assess the haemodynamic changes in patients receiving unilateral and bilateral spinal anaesthesia with their pre-anaesthesia recordings.



Quasi-experimental study.


PLACE AND DURATION OF STUDY
Main Operation Theater, Liaquat National Hospital, Karachi, from May 2006 to February 2007.



Sixty patients meeting the inclusion criteria were randomly allocated in two groups of 30 patients each. One and a half ml of 0.75% hyperbaric bupivacaine was injected with free flow of cerebrospinal fluid using a 23 gauge quincke needle. Lumbar puncture was performed in the sitting position at 3 - 4 or 4 - 5 lumbar interspace. Patients were then assigned to the supine or lateral decubitus position for 10 minutes. Heart rate, systolic, mean and diastolic blood pressures of patients were recorded with their pre-anaesthesia readings in the 1st, 5th, 15th, 30th and then at every 15th minute till the end of procedure. Recovery room readings were also taken.



The systolic, mean and diastolic blood pressure changes were significant in both groups. But from 1st minute to recovery room, statistically significant difference (p < 0.05) was found at each time interval, the unilateral groups (group A) being more stable with respect to pre-anaesthesia readings. The decrease in heart rate was comparable in both groups.



Unilateral spinal anaesthesia was associated with a more stable cardiovascular profile, therefore, it is a valuable technique for high risk patients.
Distinct HLA associations by stroke subtype in children with sickle cell anemia.

Children with sickle cell anemia (SCA) carry a 200-fold increased risk for cerebral infarction. Stroke can be the result of small-vessel (SV) or large-vessel (LV) disease. However, it is unknown whether these subtypes result from the same pathophysiologic processes. Complete HLA genotyping was performed on 231 eligible children previously enrolled in the Cooperative Study of Sickle Cell Disease (CSSCD). Cerebral infarction on magnetic resonance imaging (MRI) was documented in 71 patients, and 160 patients had negative findings on MRI. Based on MRI/magnetic resonance angiography (MRA) findings, infarct size, and location, 36 patients were classified as having LV stroke and 35 as having SV stroke. When comparing the total MRI+ group with the MRI- group, HLA DPB1*0401 was associated with increased stroke risk (P =.01), whereas DPB1*1701 (P =.02) conferred protection from stroke. These DPB1 associations with stroke were attributed to the SV stroke group, in whom DPB1*0401 was associated with susceptibility (P =.003) and DPB1*1701 with protection from stroke (P =.06). In the LV stroke subgroup, HLA-A*0102 (P =.02) and -A*2612 (P =.007) conferred susceptibility, whereas -A*3301(P =.04) protected from stroke. These results suggest that specific HLA alleles influence stroke risk and appear to contribute differently to SV and LV stroke subtypes. The distinct HLA associations with SV and LV stroke suggest that different pathologic processes may be involved in the development of stroke in children with SCA. If these results are confirmed in a larger study, HLA type may serve as a useful marker for the early identification of SCA patients at high risk for stroke.
Value of debriefing during simulated crisis management: oral versus video-assisted oral feedback.

The debriefing process during simulation-based education has been poorly studied despite its educational importance. Videotape feedback is an adjunct that may enhance the impact of the debriefing and in turn maximize learning. The purpose of this study was to investigate the value of the debriefing process during simulation and to compare the educational efficacy of two types of feedback, oral feedback and videotape-assisted oral feedback, against control (no debriefing).



Forty-two anesthesia residents were enrolled in the study. After completing a pretest scenario, participants were randomly assigned to receive no debriefing, oral feedback, or videotape-assisted oral feedback. The debriefing focused on nontechnical skills performance guided by crisis resource management principles. Participants were then required to manage a posttest scenario. The videotapes of all performances were later reviewed by two blinded independent assessors who rated participants' nontechnical skills using a validated scoring system.



Participants' nontechnical skills did not improve in the control group, whereas the provision of oral feedback, either assisted or not assisted with videotape review, resulted in significant improvement (P < 0.005). There was no difference in improvement between oral and video-assisted oral feedback groups.



Exposure to a simulated crisis without constructive debriefing by instructors offers little benefit to trainees. The addition of video review did not offer any advantage over oral feedback alone. Valuable simulation training can therefore be achieved even when video technology is not available.
Prospective analysis of creatine kinase muscle-brain fraction and comparison with troponin T to predict cardiac risk and benefit of an invasive strategy in patients with non-ST-elevation acute coronary syndromes.

We sought to determine whether elevation of plasma creatine kinase muscle-brain fraction (CK-MB) would be useful to triage patients with acute coronary syndromes (ACS) to early angiography/revascularization.



It is unknown whether the measurement of CK-MB is effective for triage to an aggressive management strategy.



Patients in the Treat Angina With Aggrastat and Determine Cost of Therapy With an Invasive or Conservative Strategy (TACTICS-TIMI) 18 study received aspirin, heparin, and tirofiban for treatment of ACS, were randomized to an invasive or a conservative strategy (angiography/revascularization between 4 and 48 h), and were followed up for a composite end point of death, myocardial infarction, or rehospitalization for ACS. Of 2,220 patients, CK-MB was elevated in 826 (37%). Of the patients with negative CK-MB, troponin T was elevated in 361 (31.2%). Event rates at 30 and 180 days were twice as high in patients with elevated CK-MB than in patients without elevated CK-MB. Both groups had similar benefit from an invasive strategy; there was no evidence of interaction between CK-MB elevation and strategy on the composite end point at 30 or 180 days. When patients were stratified according to both CK-MB and troponin status, there was evidence of a benefit in the invasive strategy among patients who were CK-negative but troponin-positive (odds ratios [95% confidence interval]: 0.13 [0.04 to 0.39] at 30 days and 0.29 [0.16 to 0.52] at 180 days).



Patients with minimal amounts of recent onset myonecrosis but elevated risk as indicated by CK-MB and troponin, respectively, benefit most from invasive management. Determination of troponin levels yielded significant information regarding triage to an invasive strategy, particularly in CK-MB-negative patients.
Prospective evaluation of skin and nipple-areola sensation and patient satisfaction after nipple-sparing mastectomy.

Sensation and quality of life (QOL) before and after nipple sparing mastectomy (NSM) are poorly understood.



Women electing mastectomy with immediate reconstruction and eligible for NSM were prospectively enrolled in a sensation and satisfaction/QOL study. Women self-selected skin-sparing mastectomy (SSM) or NSM. Skin sensation testing using Semmes Weinstein monofilaments and patient satisfaction/QOL surveys were administered preoperatively and at 1 year postoperatively.



53 patients were enrolled (n = 38, 72% NSM and n = 15, 28% SSM). Both groups had significant reduction in postoperative skin sensation. For NSM, measurable NAC sensation was preserved in both NAC for 26% of patients and in one NAC for 68%. QOL and satisfaction was similar between groups. Neither group was satisfied with sexual arousal with breast or nipple stimulation after surgery.



Patients undergoing SSM and NSM have considerable loss in skin and NAC sensation following surgery. Satisfaction and QOL did not differ between groups.
Brief treatment for elementary school children with disaster-related posttraumatic stress disorder: a field study.

Effective psychological intervention is needed to help children recover from disaster-related posttraumatic stress disorder (PTSD). This controlled study evaluated the effectiveness of a brief intervention for disaster-related PTSD. At one-year follow-up of a prior intervention for disaster-related symptoms, some previously treated children were still suffering significant trauma symptoms. Using a randomized lagged-groups design, we provided three sessions of Eye Movement Desensitization and Reprocessing (EMDR) treatment to 32 of these children who met clinical criteria for PTSD. The Children's Reaction Inventory (CRI) was the primary measure of the treatment's effect on PTSD symptoms. Associated symptoms were measured using the Revised Children's Manifest Anxiety Scale (RCMAS) and the Children's Depression Inventory (CDI). Treatment resulted in substantial reductions in both groups' CRI scores and in significant, though more modest, reductions in RCMAS and CDI scores. Gains were maintained at six-month follow-up. Health visits to the school nurse were significantly reduced following treatment. Psychosocial intervention appears useful for children suffering disaster-related PTSD. Conducting controlled studies of children's treatment in the postdisaster environment appears feasible.
Iron therapy in the pediatric hemodialysis population

Iron therapy maintains iron stores and optimizes the response to recombinant human erythropoietin (r-HuEPO) in patients with end-stage renal failure. Information is limited, however, regarding the preferential route of iron administration in pediatric patients receiving hemodialysis. Therefore, we prospectively randomized 35 iron-replete patients (aged >1 to <20 years) to receive up to 16 weeks of maintenance IV (n=17) or daily oral (n=18) iron. Eligible patients had received hemodialysis for >2 months, had a baseline transferrin saturation [TSAT] >20%, and were receiving maintenance r-HuEPO. Treatment arms were evenly distributed with respect to baseline demographic and clinical characteristics, with no statistically significant differences in baseline hemoglobin (Hb), hematocrit (Hct), reticulocyte Hb content (CHr), serum ferritin (SF), TSAT, or r-HuEPO dose. In the 35 patients, IV iron dextran and not oral iron was associated with a significant increase (138.5 to 259.1 ng/ml, P=0.003) in SF. A comparison of the change in SF between the IV iron group and the oral iron group was also significant (P=0.001). Whereas only IV iron was associated with a significant decrease in the dose of r-HuEPO (234.0 to 157.6 U/kg per week, P=0.046) and an increase of the CHr (29.2 to 30.1 pg, P=0.049), these changes were not significantly different from those experienced by patients in the oral iron group. In both groups, the Hct remained stable and in neither group was there a significant change in the TSAT. In summary, although both oral and IV iron maintained patients in an iron-replete state in this short-term study, only IV therapy allowed for a significant improvement in iron stores.
Antiviral response and resistance analysis of treatment-naïve HCV-infected patients receiving single and multiple doses of GS-9190.

GS-9190 is a NS5B non-nucleoside analogue with demonstrated effectiveness in a Phase 1 monotherapy study and in combination with other DAAs for treatment of chronic HCV infection. Here, the resistance profile of GS-9190 monotherapy in a Phase 1b study was investigated. Resistance analysis was performed by population sequencing and allele-specific PCR (AS-PCR) for Y448H with an assay cut-off of 0.5%. Phenotypic susceptibility analyses were performed on patient isolates as well as site-directed mutagenesis of mutations selected during monotherapy. No resistance-associated variants were observed in patients before or after receiving single doses of GS-9190 by population sequencing. In contrast, in patients who received GS-9190 for 8 days, mutations Y448H and Y452H in NS5B were observed by population sequencing in 21/36 (58%) and 2/36 (5.6%) patients, respectively, at Day 8 or Day 14. Among the remaining 15 patients who had no detectable Y448H at Day 8 or Day 14 by population sequencing, low frequencies of Y448H ranging from 1.3 to 9.7% were detected in 14 of 15 patients by AS-PCR. By AS-PCR, Y448H remained detectable at reduced frequency in the majority of patients analysed through 4-6 months of follow-up. Chimeric HCV replicons constructed with the NS5B sequence from patients with Y448H and Y448H + Y452H/Y demonstrated 27-fold and 78.5-fold reduced susceptibility to GS-9190. In conclusion, Y448H was rapidly selected in the majority of patients receiving multiple doses of GS-9190 as monotherapy, despite undetectable levels in pretreatment samples. Y448H confers reduced susceptibility to GS-9190 and other NNIs and persisted in most patients for months post-treatment.
Lack of sensitivity to readmission: a grounded theory study for explaining the process of readmitting patients suffering from congestive heart failure.

Readmission due to congestive heart failure is a global problem during the recent decades; however, little is known about the process of readmission in these patients.



To clarify the readmission process of patients suffering from congestive heart failure in two large referral hospitals in Tehran, Iran.



A grounded theory approach was utilized. 42 experienced patients, families, nurses and cardiologists participated in the study. Data analysis was carried out over a period of 12months (November 2007 to November 2008).



The main concern of participants was "managing the acute problems" of disease. The process of readmission begins with "concentrating on the concern". So, all the participants neglected the patient readmission. Having managed the acute problems, the patients were discharged without a "comprehensive context oriented discharge planning" leading to their return to community without preparation or supporting system. This results in "traditional self-treatment" owing to unhealthy behaviors which brings about the readmission of patients. Neglecting or "lack of sensitivity to readmission" was presented as the core variable.



In order to control readmission, we recommend those in charge of policy-making for public health to pay particular attention to this variable and taking step such as sensitizing people concerned.