nils-herrmann/clean_scirepeval huggingface dataset:
Risk Factors for Long-Term Mortality after Hospitalization for Community-Acquired Pneumonia: A 5-Year Prospective Follow-Up Study

Contributors to long-term mortality in patients with community-acquired pneumonia (CAP) remain unclear, with little attention paid to pneumonia etiology. We examined long-term survival, causes of death, and risk factors for long-term mortality in adult patients who had been hospitalized for CAP, with emphasis on demographic, clinical, laboratory, and microbiological characteristics.



Two hundred and sixty-seven consecutive patients admitted in 2008-2011 to a general hospital with CAP were prospectively recruited and followed up. Patients who died during hospital stay were excluded. Demographic, clinical, and laboratory data were collected within 48 hours of admission. Extensive microbiological work-up was performed to establish the etiology of CAP in 63% of patients. Mortality data were obtained from the Norwegian Cause of Death Registry. Cox regression models were used to identify independent risk factors for all-cause mortality.



Of 259 hospital survivors of CAP (median age 66 years), 79 (30.5%) died over a median of 1,804 days (range 1-2,520 days). Cumulative 5-year survival rate was 72.9% (95% CI 67.4-78.4%). Standardized mortality ratio was 2.90 for men and 2.05 for women. The main causes of death were chronic obstructive pulmonary disease (COPD), vascular diseases, and malignancy. Independent risk factors for death were the following (hazard ratio, 95% CI): age (1.83 per decade, 1.47-2.28), cardiovascular disease (2.63, 1.61-4.32), COPD (2.09, 1.27-3.45), immunocompromization (1.98, 1.17-3.37), and low serum albumin level at admission (0.75 per 5 g/L higher, 0.58-0.96), whereas active smoking was protective (0.32, 0.14-0.74); active smokers were younger than non-smokers (P < 0.001). Microbial etiology did not predict mortality.



Results largely confirm substantial comorbidity-related 5-year mortality after hospitalization for CAP and the impact of several well-known risk factors for death, and extend previous findings on the prognostic value of serum albumin level at hospital admission. Pneumonia etiology had no prognostic value, but this remains to be substantiated by further studies using extensive diagnostic microbiological methods in the identification of causative agents of CAP.
Effect of diltiazem, a moderate CYP3A inhibitor, on the pharmacokinetics of anacetrapib, a potent cholesteryl ester transfer protein inhibitor, in healthy subjects.

A (MK-0859) is a potent and selective inhibitor of cholesteryl ester transfer protein (CETP) currently undergoing development as an oral drug for the treatment of primary hypercholesterolemia and mixed hyperlipidemia. A midazolam probe study demonstrated that anacetrapib neither induces nor inhibits CYP3A activity. A drug interaction study performed with ketoconazole as a potent CYP3A inhibitor suggested that anacetrapib is a moderately sensitive CYP3A substrate. Specifically, the exposure to anacetrapib was increased by ketoconazole; the geometric mean ratio (anacetrapib with ketoconazole/anacetrapib alone) for area under the plasma concentration vs. time curve from zero to infinity (AUC0-∞) and peak maximal concentration (Cmax) were 4.58 and 2.37 with 90% confidence interval of 3.68 to 5.71 and 2.02 to 2.78, respectively. Because a number of cardiovascular drugs widely used for the treatment of dyslipidemia are moderate CYP3A inhibitors, it is of interest to understand whether the interaction with diltiazem, a probe moderate CYP3A inhibitor, will be clinically meaningful. Therefore, the effect of diltiazem, a moderate CYP3A inhibitor, on the pharmacokinetic parameters of anacetrapib was studied. Specifically, the goal of this study was to establish that the concomitant use of moderate CYP3A4 inhibitors does not alter the pharmacokinetic and safety profile of anacetrapib to a clinically meaningful extent.
Effects of Acute Tryptophan Depletion on Mood and Cortisol Release in First-degree Relatives of Type I and Type II Bipolar Patients and Healthy Matched Controls

Biological vulnerability for bipolar disorders (BD) in relatives of BD patients has not as yet been established. Serotonergic vulnerability was studied, using acute tryptophan depletion (ATD), in healthy first-degree relatives of BD patients and healthy controls. The effects of ATD on mood and cortisol release in 30 healthy adult, lifetime symptom free, unaffected first-degree relatives of BD patients (Family History; FH) were compared with effects in 15 healthy matched controls in a placebo-controlled, double-blind, crossover design. During ATD and placebo, salivary cortisol response was also assessed during a stress-inducing speech task (SIST). First-degree relatives of type II BD patients (FH II) showed an elevation of mood, whereas control subjects and relatives of type I BD patients (FH I) showed a lowering of mood after ATD. ATD was followed by a decrease in cortisol level in both FH subgroups, but not in the controls. The results suggest serotonergic vulnerability that affected mood in FH II subjects and cortisol release in both FH I and FH II subjects.
Changes in pain perception after pelvis manipulation in women with primary dysmenorrhea: a randomized controlled trial.

This study aims to evaluate the immediate effect of a global pelvic manipulation (GPM) technique, bilaterally applied, on low back pelvic pain in women with primary dysmenorrhea (PD).



A prospective, randomized, double-blind, controlled trial.



Faculty of Nursing, Physiotherapy and Podiatry. University of Sevilla, Spain.



The sample group included 40 women (30 ± 6.10 years) that were divided into an experimental group (EG) (N = 20) who underwent a bilateral GPM technique and a control group (CG) (N = 20) who underwent a sham (placebo) intervention. Evaluations were made of self-reported low back pelvic pain (visual analog scale), pressure pain threshold (PPT) in sacroiliac joints (SIJs), and the endogenous response of the organism to pain following catecholamines and serotonin release in blood levels.



The intragroup comparison showed a significant improvement in the EG in the self-perceived low back pelvic pain (P = 0.003) and in the mechanosensitivity in both SIJs (P = 0.001). In the between-group comparison, there was a decrease in pain perception (P = 0.004; F(1,38) = 9.62; R(2) = 0.20) and an increase in the PPT of both SIJs, in the right side (P = 0.001; F(1,38) = 21.29; R(2) = 0.35) and in the left side (P = 0.001; F(1,38) = 20.63; R(2) = 0.35). There were no intergroup differences for catecholamines plasma levels (adrenaline P = 0.123; noradrenaline P = 0.281; dopamine P = 0.173), but there were for serotonin levels (P = 0.045; F(1,38) = 4.296; R(2) = 0.10).



The bilateral GPM technique improves in a short term the self-perceived low back pelvic pain, the PPT in both SIJs, and the serotonin levels in women with PD. It shows no significant differences with a sham intervention in catecholamines plasma levels.
Immunomodulatory effects of total intravenous and balanced inhalation anesthesia in patients with bladder cancer undergoing elective radical Cystectomy: preliminary results

Although surgery and anesthesia induce immunesuppression, remains largely unknown whether various anesthetic techniques have different immunosuppressive effects on cancer patients. Therefore, the aim of this study was to investigate the influence of total intravenous anesthesia with target-controlled infusion (TIVA-TCI) and balanced inhalation anesthesia (BAL) on the peri-operative levels of inflammatory cytokines and regulatory T cells (Tregs) in patients with bladder cancer undergoing surgery.



Twenty eight consecutive patients with bladder cancer who underwent radical cystectomy were prospectively randomized into two groups to receive TIVA-TCI (n = 14) or BAL (n = 14). Before the induction of anesthesia (T0), 6-8 hours (T1) post-surgery, and 5 days post-surgery (T2), Tregs and serum levels of interleukin -1beta (IL-1β), interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), interleukin -2 (IL-2), interleukin -6 (IL-6), and interleukin -10 (IL-10) were measured.



In the peri-operative period all cancer patients showed a marked and significant increase in IL-6. Moreover, TIVA-TCI patients also showed a higher increase in IFN-γ, whereas in BAL patients Tregs were reduced by approximately 30% during surgery. The incidence of infections, metastases, and death was similar in both groups.



The increase in the Th1 response in the TIVA-TCI group and the reduction in Tregs in the BAL group seem to balance the immunosuppressive effect induced by IL-6. Therefore TIVA-TCI and BAL can be both used in major surgery in patients with bladder cancer without worsening the outcome.
Arterial stiffness is regulated by nitric oxide and endothelium-derived hyperpolarizing factor during changes in blood flow in humans.

Cytochrome-derived epoxyeicosatrienoic acids may be important endothelium-derived hyperpolarizing factors, opening calcium-activated potassium channels, but their involvement in the regulation of arterial stiffness during changes in blood flow in humans is unknown. In healthy volunteers, we measured arterial pressure, radial artery diameter, wall thickness, and flow (NIUS02) during hand skin heating in the presence of saline or inhibitors of NO synthase (N(G)-monomethyl-L-arginine), calcium-activated potassium channels (tetraethylammonium), and cytochrome epoxygenases (fluconazole). Arterial compliance and elastic modulus were calculated and fitted as functions of midwall stress to suppress the confounding influence of geometric changes. Under saline infusion, heating induced an upward shift of the compliance-midwall stress curve and a downward shift of the modulus-midwall stress curve demonstrating a decrease in arterial tone and stiffness when blood flow increases. These shifts were reduced by N(G)-monomethyl-L-arginine and abolished by the combinations of N(G)-monomethyl-L-arginine+tetraethylammonium and N(G)-monomethyl arginine+fluconazole. In parallel, in isolated mice coronary arteries, fluconazole and tetraethylammonium reduced the relaxations to acetylcholine. However, fluconazole did not affect the relaxations to the openers of calcium-activated potassium channels of small- and intermediate-conductance NS309 and of large-conductance NS1619 excluding a direct effect on these channels. Moreover, tetraethylammonium reduced the relaxations to NS1619 but not to NS309, suggesting that the endothelium-derived hyperpolarizing factor involved mainly acts on large-conductance calcium-activated potassium channels. These results show in humans that, during flow variations, arterial stiffness is regulated by the endothelium through the release of both NO and cytochrome-related endothelium-derived hyperpolarizing factor.
Individual active treatment combined with group exercise for acute and subacute low back pain.

Randomized controlled trial.



To compare two fast-access evidence-based interventions for the treatment of simple low back pain.



People aged 18-65 with a new episode of simple back pain causing them to be off work or on modified work for less than 1 year.



A district general hospital using a consultation/treatment room and a rehabilitation gym.



One group received a back advice booklet and one session of advice and then followed the normal route of care as directed by their general practitioner. The other group received the back booklet and one session of advice and also a back program. The back program consisted of a full assessment, immediately followed by one individual treatment, and then exercise classes over 1 to 2 weeks.



(1) Rate of return to work, (2) pain scores and health status, and (3) cost effectiveness of interventions versus the financial cost to the individual or employer.



On average, those receiving the individual treatment and group exercise took 7 days less off work. This represented a 35% reduction in the amount of time taken off work since study entry. The estimated cost saving of providing the extra service of a simple back program ranged between 250 pound (367 US dollars, 300 euro) and 578 pound (850 US dollars, 694 euro) for each patient.



The results indicate that the costs of this active back program are more than reimbursed as a consequence of earlier return to work.
Comparison of measurement properties of the P4 pain scale and disease specific pain measures in patients with knee osteoarthritis.

To compare measurement properties of the P4 pain scale, Western Ontario and McMaster Universities Arthritis Index pain subscale (WOMAC-pain), and Intermittent and Constant Osteoarthritis Pain (ICOAP) measure in patients with knee osteoarthritis (OA).



A secondary analysis from a randomized controlled trial included participants (n = 156) with knee OA that were consulting with a surgeon regarding knee arthroplasty. They completed pain measures (P4, WOMAC-pain, ICOAP) and WOMAC-function subscale (WOMAC-function) at baseline and 2 weeks. Measurement properties assessed in various subgroups included floor/ceiling effects, test-retest reliability using intraclass correlation coefficients (ICC2,1), internal consistency using Cronbach's ɑ, factorial structure of each pain measure combined with WOMAC-function using principal component analysis, and responsiveness using standardized response mean (SRM).



P4 had low floor and ceiling effects (<1%). P4 test-retest reliability (ICC2,1 = 0.72), internal consistency (Chronbach's ɑ = 0.91), and responsiveness (SRM = 0.56) were similar to the values for WOMAC-pain and ICOAP. Factorial structure of P4 and ICOAP were separate from WOMAC-function items. WOMAC-pain and WOMAC-function items loaded on similar factors. ICOAP-constant subscale had a large floor effect (33%).



P4 should be used to measure pain in patients with knee OA. It had acceptable measurement properties which is comparable to more widely used pain measures. WOMAC-pain shared a factorial structure with WOMAC-function indicating these measures might be capturing the same construct, questioning its validity to measure pain separately from function. ICOAP had acceptable properties. More work should compare pain measures in less severely affected OA populations.
Occupational Exposures and Mycosis Fungoides. A European Multicentre Case–control Study (Europe)

Mycosis Fungoides (MF) is a rare disease with an occurrence indicating that occupational exposures may play a role. To estimate the association between MF and occupational exposures as measured by means of an job-exposure matrix (JEM).  A European multicenter case–control study was conducted from 1995 to 1997 and included seven rare cancers, one of which was MF. Patients between 35 and 69 years of age, diagnosed with MF (n=140), were recruited and the diagnoses were checked by a reference pathologist who classified 83 cases as definite, 35 cases as possible and 22 cases as not accepted. Among the 118 accepted cases, 104 cases were interviewed, of which 76 were definite cases. We selected population controls and colon cancer controls to serve all seven case groups. Altogether 833 colon cancer controls and 2071 population controls were interviewed. Based on the reported occupational experiences, a team of industrial hygiene specialists identified five potential exposures and developed an JEM. This JEM was used to estimate the odds ratios (OR) for MF as a function of these exposures. The JEM included aromatic and/or halogenated hydrocarbons (AAHs), chrome (VI) and its salts, electromagnetic radiations, silica and pesticides.  Exposures to AHHs (OR 6.3, C.I 2.4–16.7 for male) were associated with a high MF risk.  The study supports the hypothesis that some MFs have an occupational etiology but only a small fraction of exposed workers are apparently susceptible since the disease is so rare.
The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study

Stroke significantly affects thousands of individuals annually, leading to considerable physical impairment and functional disability. Gait is one of the most important activities of daily living affected in stroke survivors. Recent technological developments in powered robotics exoskeletons can create powerful adjunctive tools for rehabilitation and potentially accelerate functional recovery. Here, we present the development and evaluation of a novel lower limb robotic exoskeleton, namely H2 (Technaid S.L., Spain), for gait rehabilitation in stroke survivors. H2 has six actuated joints and is designed to allow intensive overground gait training. An assistive gait control algorithm was developed to create a force field along a desired trajectory, only applying torque when patients deviate from the prescribed movement pattern. The device was evaluated in 3 hemiparetic stroke patients across 4 weeks of training per individual (approximately 12 sessions). The study was approved by the Institutional Review Board at the University of Houston. The main objective of this initial pre-clinical study was to evaluate the safety and usability of the exoskeleton. A Likert scale was used to measure patient’s perception about the easy of use of the device. Three stroke patients completed the study. The training was well tolerated and no adverse events occurred. Early findings demonstrate that H2 appears to be safe and easy to use in the participants of this study. The overground training environment employed as a means to enhance active patient engagement proved to be challenging and exciting for patients. These results are promising and encourage future rehabilitation training with a larger cohort of patients. The developed exoskeleton enables longitudinal overground training of walking in hemiparetic patients after stroke. The system is robust and safe when applied to assist a stroke patient performing an overground walking task. Such device opens the opportunity to study means to optimize a rehabilitation treatment that can be customized for individuals.
Thrombus aspiration during ST-segment elevation myocardial infarction.

The clinical effect of routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) is uncertain. We aimed to evaluate whether thrombus aspiration reduces mortality.



We conducted a multicenter, prospective, randomized, controlled, open-label clinical trial, with enrollment of patients from the national comprehensive Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and end points evaluated through national registries. A total of 7244 patients with STEMI undergoing PCI were randomly assigned to manual thrombus aspiration followed by PCI or to PCI only. The primary end point was all-cause mortality at 30 days.



No patients were lost to follow-up. Death from any cause occurred in 2.8% of the patients in the thrombus-aspiration group (103 of 3621), as compared with 3.0% in the PCI-only group (110 of 3623) (hazard ratio, 0.94; 95% confidence interval [CI], 0.72 to 1.22; P=0.63). The rates of hospitalization for recurrent myocardial infarction at 30 days were 0.5% and 0.9% in the two groups, respectively (hazard ratio, 0.61; 95% CI, 0.34 to 1.07; P=0.09), and the rates of stent thrombosis were 0.2% and 0.5%, respectively (hazard ratio, 0.47; 95% CI, 0.20 to 1.02; P=0.06). There were no significant differences between the groups with respect to the rate of stroke or neurologic complications at the time of discharge (P=0.87). The results were consistent across all major prespecified subgroups, including subgroups defined according to thrombus burden and coronary flow before PCI.



Routine thrombus aspiration before PCI as compared with PCI alone did not reduce 30-day mortality among patients with STEMI. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT01093404.).
Distributed health data networks: a practical and preferred approach to multi-institutional evaluations of comparative effectiveness, safety, and quality of care.

Comparative effectiveness research, medical product safety evaluation, and quality measurement will require the ability to use electronic health data held by multiple organizations. There is no consensus about whether to create regional or national combined (eg, "all payer") databases for these purposes, or distributed data networks that leave most Protected Health Information and proprietary data in the possession of the original data holders.



Demonstrate functions of a distributed research network that supports research needs and also address data holders concerns about participation. Key design functions included strong local control of data uses and a centralized web-based querying interface.



We implemented a pilot distributed research network and evaluated the design considerations, utility for research, and the acceptability to data holders of methods for menu-driven querying. We developed and tested a central, web-based interface with supporting network software. Specific functions assessed include query formation and distribution, query execution and review, and aggregation of results.



This pilot successfully evaluated temporal trends in medication use and diagnoses at 5 separate sites, demonstrating some of the possibilities of using a distributed research network. The pilot demonstrated the potential utility of the design, which addressed the major concerns of both users and data holders. No serious obstacles were identified that would prevent development of a fully functional, scalable network.



Distributed networks are capable of addressing nearly all anticipated uses of routinely collected electronic healthcare data. Distributed networks would obviate the need for centralized databases, thus avoiding numerous obstacles.
Testing the feasibility, acceptability and effectiveness of a 'decision navigation' intervention for early stage prostate cancer patients in Scotland--a randomised controlled trial.

Does decision navigation (DN) increase prostate cancer patients' confidence and certainty in treatment decisions, while reducing regret associated with the decisions made?



Two hundred eighty-nine newly diagnosed prostate cancer patients were eligible. 123 consented and were randomised to usual care (n = 60) or navigation (n = 63). The intervention involved a 'navigator' guiding the patient in creating a personal question list for a consultation and providing a CD and typed summary of the consultation to patients, the general practitioner and physician. The primary outcome was decisional self efficacy. Secondary outcomes included decisional conflict (DCS) and decisional regret (RS). Measures of mood (Hospital Anxiety and Depression Scale) and adjustment (Mental Adjustment to Cancer Scale) were included to detect potential adverse effects of the intervention.



ANOVA showed a main effect for the group (F = 7.161, df 1, p = 0.009). Post hoc comparisons showed significantly higher decisional self efficacy in the navigated patients post-consultation and 6 months later. Decisional conflict was lower for navigated patients initially (t = 2.005, df = 105, p = 0.047), not at follow-up (t = 1.969, df = 109, p = 0.052). Regret scores were significantly lower in the navigation group compared to the controls 6 months later (t = -2.130, df = 100, p = 0.036). There was no impact of the intervention on mood or adjustment.



Compared to control patients, navigated patients were more confident in making decisions about cancer treatment, were more certain they had made the right decision after the consultation and had less regret about their decision 6 months later. Decision navigation was feasible, acceptable and effective for newly diagnosed prostate cancer patients in Scotland.