nils-herrmann/clean_scirepeval huggingface dataset:
Effects of hyperbaric oxygenation therapy on cerebral metabolism and intracranial pressure in severely brain injured patients.

OBJECT
Hyperbaric oxygenation (HBO) therapy has been shown to reduce mortality by 50% in a prospective randomized trial of severely brain injured patients conducted at the authors' institution. The purpose of the present study was to determine the effects of HBO on cerebral blood flow (CBF), cerebral metabolism, and intracranial pressure (ICP), and to determine the optimal HBO treatment paradigm.



Oxygen (100% O2, 1.5 atm absolute) was delivered to 37 patients in a hyperbaric chamber for 60 minutes every 24 hours (maximum of seven treatments/patient). Cerebral blood flow, arteriovenous oxygen difference (AVDO2), cerebral metabolic rate of oxygen (CMRO2), ventricular cerebrospinal fluid (CSF) lactate, and ICP values were obtained 1 hour before and 1 hour and 6 hours after a session in an HBO chamber. Patients were assigned to one of three categories according to whether they had reduced, normal, or raised CBF before HBO. In patients in whom CBF levels were reduced before HBO sessions, both CBF and CMRO2 levels were raised 1 hour and 6 hours after HBO (p < 0.05). In patients in whom CBF levels were normal before HBO sessions, both CBF and CMRO2 levels were increased at 1 hour (p < 0.05), but were decreased by 6 hours after HBO. Cerebral blood flow was reduced 1 hour and 6 hours after HBO (p < 0.05), but CMRO2 was unchanged in patients who had exhibited a raised CBF before an HBO session. In all patients AVDO2 remained constant both before and after HBO. Levels of CSF lactate were consistently decreased 1 hour and 6 hours after HBO, regardless of the patient's CBF category before undergoing HBO (p < 0.05). Intracranial pressure values higher than 15 mm Hg before HBO were decreased 1 hour and 6 hours after HBO (p < 0.05). The effects of each HBO treatment did not last until the next session in the hyperbaric chamber.



The increased CMRO2 and decreased CSF lactate levels after treatment indicate that HBO may improve aerobic metabolism in severely brain injured patients. This is the first study to demonstrate a prolonged effect of HBO treatment on CBF and cerebral metabolism. On the basis of their data the authors assert that shorter, more frequent exposure to HBO may optimize treatment.
Altruism motivates participation in a therapeutic HIV vaccine trial (CTN 173).

This is the first study examining motivation to participate in an HIV therapeutic vaccine trial of Remune and ALVAC.  Trial participants also reported high levels of existential well-being (e.g., "I believe there is some real purpose for my life"). Results suggest that HIV therapeutic vaccine trial participants are highly motivated by altruism and that participating in research may contribute meaning to living with HIV. Fostering altruism and responsibly promoting the societal benefits of research may facilitate trial participation.
A phase I clinical and pharmacokinetic study of capecitabine (Xeloda®) and irinotecan combination therapy (XELIRI) in patients with metastatic gastrointestinal tumours

Capecitabine is a highly active oral fluoropyrimidine that is an attractive alternative to 5-fluorouracil in colorectal cancer treatment. The current study, undertaken in 27 patients with gastrointestinal tumours, aimed to assess the toxicity and potential for significant pharmacokinetic interactions of a combination regimen incorporating capecitabine with 3-weekly irinotecan (XELIRI). Irinotecan (200 and 250 mg m−2) was administered as a 90-min infusion on day 1 in combination with escalating capecitabine doses (700–1250 mg m−2 twice daily) administered on days 2–15 of a 3-week treatment cycle. Pharmacokinetics were characterised on days 1 and 2 of the first two cycles. A total of 103 treatment cycles were administered. The principal dose-limiting toxicities were diarrhoea and neutropenia. Capecitabine 1150 mg m−2 twice daily with irinotecan 250 mg m−2 was identified as the maximum-tolerated dose and capecitabine 1000 mg m−2 with irinotecan 250 mg m−2 was identified as the recommended dose for further study. Analyses confirmed that there were no significant pharmacokinetic interactions between the two agents. The combination was clinically active, with complete and partial responses achieved in heavily pretreated patients. This study indicates that XELIRI is a potentially feasible and clinically active regimen in patients with advanced gastrointestinal cancer.
Small but important errors in cardiovascular risk calculation by practice nurses: a cross-sectional study in randomised trial setting.

Practice nurses play an increasingly important role in the prevention of cardiovascular diseases but we do not have evidence about the accuracy of their cardiovascular risk assessments during real practice consultations.



To examine how nurses perform with regard to absolute 10-year cardiovascular risk assessment in actual practice.



Cross-sectional study.



This study was nested in the IMPALA study, a clustered randomised controlled trial involving 24 general practices in The Netherlands.



24 practice nurses, trained in 10-year cardiovascular risk assessment, calculated the risk of a total of 421 patients without established cardiovascular diseases but eligible for cardiovascular risk assessment.



The main outcome measure was the accuracy of risk assessments, defined as (1) the difference between the 10-year cardiovascular risk percentage calculated by nurses and an independent assessor, and (2) the agreement between the treatment categories assigned by the nurses (low, moderate or high risk) and those assigned by the independent assessor.



Thirty-one (7.4%) of the calculated risk percentages differed by more than our preset limits, 25 (81%) being underestimations. Elderly patients (OR 1.1, 95% CI 1.0-1.1), male patients (vs. female OR 3.1, 95% CI 1.2-7.3), and smoking patients (vs. non-smoking OR 3.8, 95% CI 1.7-8.9) were more likely to have their cardiovascular risk miscalculated. Ten (28%) of the 36 patients who should be assigned to the high-risk treatment category according to the independent calculation, were missed as high-risk patients by the practice nurses.



The overall standard of accuracy of cardiovascular risk assessment by trained practice nurses in actual practice is high. However, a significant number of high-risk patients were misclassified, with the probability that it led to missed opportunities for risk-reducing interventions. As cardiovascular risk assessments are frequently done by nurses in general practice, further specific training should be considered to prevent undertreatment.
Eff ect of improved tuberculosis screening and isoniazid preventive therapy on incidence of tuberculosis and death in patients with HIV in clinics in Rio de Janeiro , Brazil : a stepped wedge , cluster-randomised trial

We did a stepped wedge, cluster-randomised trial with patients actively enrolled in 29 HIV clinics in Rio de Janeiro. Clinic staff were trained in tuberculosis screening, use of tuberculin skin tests, and use of isoniazid preventive therapy. Clinics were randomly allocated a date to begin the intervention period, with two clinics beginning the intervention every 2 months starting from Sept 1, 2005. The primary outcome was tuberculosis incidence alone or combined with death in the control versus intervention periods until Aug 31, 2009.
Intention to leave the workplace among nurses working with cancer patients in acute care hospitals in Sweden.

To examine associations between perceived leadership and intention to leave the workplace due to job dissatisfaction among registered nurses (RNs) who care for patients with cancer. We also examine intention to leave in relation to proportion of cancer patients, length of time in practice, perceived adequacy of cancer care education, and burnout.



The data originated from the Swedish component of RN4CAST, based on a survey of RNs working with in-patient care in all acute care hospitals in Sweden. The 7412 RNs reporting ≥10% patients with cancer on their unit were included in this analysis. Data were collected on perceptions of work environment, burnout, future employment intentions, and demographic characteristics. Additional questions related to cancer care.



About 1/3 of all RNs intended to leave their workplace within the next year. Intention to leave was more prevalent among RNs reporting less favourable perceptions of leadership, who had worked ≤ two years as RN, who reported having inadequate cancer care education, and with higher burnout scores. Associations between leadership and intention to leave were stronger among RNs in the profession > two years, who reported having adequate cancer care education, and with lower burnout scores.



Perception of leadership is strongly associated with intention to leave among RNs in both specialized and general cancer care. This suggests a crucial area for improvement in order to reduce turnover rates.
Clinical efficacy and safety of abatacept in methotrexate-naive patients with early rheumatoid arthritis and poor prognostic factors

To assess the efficacy and safety of abatacept in methotrexate-naive patients with early rheumatoid arthritis (RA) and poor prognostic factors.



In this double-blind, phase IIIb study, patients with RA for 2 years or less were randomly assigned 1 : 1 to receive abatacept (approximately 10 mg/kg) plus methotrexate, or placebo plus methotrexate. Patients were methotrexate-naive and seropositive for rheumatoid factor (RF), anti-cyclic citrullinated protein (CCP) type 2 or both and had radiographic evidence of joint erosions. The co-primary endpoints were the proportion of patients achieving disease activity score in 28 joints (DAS28)-defined remission (C-reactive protein) and joint damage progression (Genant-modified Sharp total score; TS) at year 1. Safety was monitored throughout.



At baseline, patients had a mean DAS28 of 6.3, a mean TS of 7.1 and mean disease duration of 6.5 months; 96.5% and 89.0% of patients were RF or anti-CCP2 seropositive, respectively. At year 1, a significantly greater proportion of abatacept plus methotrexate-treated patients achieved remission (41.4% vs 23.3%; p<0.001) and there was significantly less radiographic progression (mean change in TS 0.63 vs 1.06; p = 0.040) versus methotrexate alone. Over 1 year, the frequency of adverse events (84.8% vs 83.4%), serious adverse events (7.8% vs 7.9%), serious infections (2.0% vs 2.0%), autoimmune disorders (2.3% vs 2.0%) and malignancies (0.4% vs 0%) was comparable for abatacept plus methotrexate versus methotrexate alone.



In a methotrexate-naive population with early RA and poor prognostic factors, the combination of abatacept and methotrexate provided significantly better clinical and radiographic efficacy compared with methotrexate alone and had a comparable, favourable safety profile.
Outcomes with nifedipine GITS or Co-amilozide in hypertensive diabetics and nondiabetics in Intervention as a Goal in Hypertension (INSIGHT).

To investigate the impact of treatment on cardiovascular mortality and morbidity, we assessed outcomes in patients with hypertension and diabetes who received co-amilozide or nifedipine in the International Nifedipine GITS Study: Intervention as a Goal in Hypertension. Participants had to be 55 to 80 years of age, with hypertension (> or =150/95 or > or =160 mm Hg) and at least one additional cardiovascular risk factor. Patients received 30 mg nifedipine once daily or co-amilozide (25 mg hydrochlorothiazide and 2.5 mg amiloride) daily. Doses were doubled if target blood pressures (<140/90 mm Hg) were not achieved. Primary (composite of cardiovascular death, myocardial infarction, heart failure, and stroke) and secondary outcomes (composite of primary outcomes, including all-cause mortality and death from vascular and nonvascular causes) were assessed by means of intent-to-treat analyses. There was no significant difference in the incidence of primary outcomes between nifedipine-treated and co-amilozide-treated patients with diabetes at baseline (n=1302) (8.3% versus 8.4%; relative risk, 0.99, 95% CI, 0.69 to 1.42; P=1.00). A significant benefit for nifedipine-treated patients was seen for the composite secondary outcome (14.2% versus 18.7%; relative risk, 0.76, 95% CI, 0.59 to 0.97; P=0.03). Among patients without diabetes at baseline (n=5019), there was a significant difference in the incidence of new diabetes (nifedipine 4.3% versus co-amilozide 5.6%, P=0.023). Nifedipine GITS once daily is as effective as diuretic therapy in reducing cardiovascular complications in hypertensive diabetics. Nifedipine-treated patients were also less likely to have diabetes or have secondary events (a composite of all-cause mortality, death from a vascular cause, and death from a nonvascular cause) than co-amilozide recipients. Our results suggest that nifedipine could be considered as first-line therapy for hypertensive diabetics.
Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer

In pre-clinical studies, the anti-tumor activity of T-DM1 was enhanced when combined with taxanes or pertuzumab. This phase 1b/2a study evaluated the safety/tolerability of T-DM1 + paclitaxel ± pertuzumab in HER2-positive advanced breast cancer. In phase 1b (n = 60), a 3 + 3 dose-escalation approach was used to determine the maximum tolerated dose (MTD) of T-DM1 + paclitaxel ± pertuzumab. The primary objective of phase 2a was feasibility, with 44 patients randomized to T-DM1 + paclitaxel ± pertuzumab at the MTD identified in phase 1b. The MTD was T-DM1 3.6 mg/kg every three weeks (q3w) or 2.4 mg/kg weekly + paclitaxel 80 mg/m2 weekly ± pertuzumab 840 mg loading dose followed by 420 mg q3w. Phase 2a patients had received a median of 5.0 (range: 0–10) prior therapies for advanced cancer. In phase 2a, 51.2 % received ≥12 paclitaxel doses within 15 weeks, and 14.0 % received 12 paclitaxel doses by week 12. Common all-grade adverse events (AEs) were peripheral neuropathy (90.9 %) and fatigue (79.5 %). A total of 77.3 % experienced grade ≥3 AEs, most commonly neutropenia (25.0 %) and peripheral neuropathy (18.2 %). Among the 42 phase 2a patients with measurable disease, the objective response rate (ORR) was 50.0 % (95 % confidence interval (CI) 34.6–65.4); the clinical benefit rate (CBR) was 56.8 % (95 % CI 41.6–71.0). No pharmacokinetic interactions were observed between T-DM1 and paclitaxel. This regimen showed clinical activity. Although there is potential for paclitaxel to be added to T-DM1 ± pertuzumab, peripheral neuropathy was common in this heavily pretreated population.
Latino values in the context of palliative care: illustrative cases from the Family Focused Grief Therapy trial.

Clinicians meet a variety of ethnicities among patients and families in hospice programs. This article focuses on Latino families.



Within a controlled trial of family therapy in the context of palliative care, 17 families identified as Hispanic. Five were examined qualitatively herein.



A synopsis of each family's narrative is presented here. Patterns of strong family loyalty (Familismo), the gender roles of Machismo and Marianismo, the importance of family tradition, expectations about caregiving, and the place of faith and religion emerged as prominent and able potentially to impact on the therapy.



Family therapists need to be thoughtful about cultural issues as they strive to support families.
Shared genetic contributions to anxiety disorders and pathological gambling in a male population.

Pathological gambling (PG) frequently co-occurs with anxiety disorders. However, the extent to which the co-occurrence is related to genetic or environmental factors across PG and anxiety disorders is not known.



Data from the Vietnam Era Twin Registry (n=7869, male twins) were examined in bivariate models to estimate genetic and shared and unique environmental contributions to PG and generalized anxiety disorder (GAD) and PG and panic disorder (PD).



While both genetic and unique environmental factors contributed individually to PG, GAD, and PD, the best fitting model indicated that the relationship between PG and GAD was attributable predominantly to shared genetic contributions (r(A)=0.53). In contrast, substantial correlations were observed between both the genetic (r(A)=0.34) and unique environmental (r(E)=0.31) contributions to PG and PD.



Results may be limited to middle aged males.



The existence of shared genetic contributions between PG and both GAD and PD suggests that specific genes, perhaps those involved in affect regulation or stress responsiveness, contribute to PG and anxiety disorders. Overlapping environmental contributions to the co-occurrence of PG and PD suggest that common life experiences (e.g., early life trauma) contribute to both PG and PD. Conversely, the data suggest that distinct environmental factors contribute to PG and GAD (e.g., early onset of gambling in PG). Future studies should examine the relationship between PG and anxiety disorders amongst other populations (women and adolescents) to identify specific genetic and environmental influences that account for the manifestation of these disorders and their co-occurrences.
A double-blind, placebo-controlled trial of fish oil concentrate (MaxEpa) in stroke patients.

The feeding of large amounts of fish or fish oils to healthy volunteers has been shown to reduce plasma triglycerides and platelet aggregation, and prolong the skin bleeding time. To determine whether a commercially available marine oil (MaxEpa) would have similar effect in stroke patients, we performed a double-blind, placebo-controlled study in 11 patients (7 men, 4 women) with completed stroke (7) or transient ischemic attacks (TIA's) (4). Ten 1 ml opaque capsules containing either MaxEpa or olive oil were given daily for 6 weeks, and then the patients were crossed-over. Aspirin was avoided during the trial. The data were analyzed by paired-sample t-tests. A significant reduction was found in serum triglycerides, but total serum cholesterol and HDL cholesterol were unaffected. The bleeding time was modestly prolonged after 3 weeks of treatment, but the differences between MaxEpa and olive oil treatments were not significant at 6 weeks. Aside from an increase in collagen-stimulated malondialdehyde formation no other statistically significant changes in hemostatic factors were observed. We conclude that the ingestion of up to 10 MaxEpa capsules daily for 6 weeks has little influence on such established risk factors as cholesterol concentration and platelet function in patients with stroke or TIA's.
Cumulative iron dose and resistance to erythropoietin.

Optimizing anemia treatment in hemodialysis (HD) patients remains a priority worldwide as it has significant health and financial implications. Our aim was to evaluate in a large cohort of chronic HD patients in Fresenius Medical Care centers in Spain the value of cumulative iron (Fe) dose monitoring for the management of iron therapy in erythropoiesis-stimulating agent (ESA)-treated patients, and the relationship between cumulative iron dose and risk of hospitalization.



Demographic, clinical and laboratory parameters from EuCliD(®) (European Clinical Dialysis Database) on 3,591 patients were recorded including ESA dose (UI/kg/week), erythropoietin resistance index (ERI) [U.I weekly/kg/gr hemoglobin (Hb)] and hospitalizations. Moreover the cumulative Fe dose (mg/kg of bodyweight) administered over the last 2 years was calculated. Univariate and multivariate analyses were performed to identify the main predictors of ESA resistance and risk of hospitalization. Patients belonging to the 4th quartile of ERI were defined as hypo-responders.



The 2-year iron cumulative dose was significantly higher in the 4th quartile of ERI. In hypo-responders, 2-year cumulative iron dose was the only iron marker associated with ESA resistance. At case-mix adjusted multivariate analysis, 2-year iron cumulative dose was an independent predictor of hospitalization risk.



In ESA-treated patients cumulative Fe dose could be a useful tool to monitor the appropriateness of Fe therapy and to prevent iron overload. To establish whether the associations between cumulative iron dose, ERI and hospitalization risk are causal or attributable to selection bias by indication, clinical trials are necessary.
Leisure-time physical activity and type 2 diabetes during a 28 year follow-up in twins

The study aimed to investigate whether baseline physical activity protects against the occurrence of type 2 diabetes during a 28 year follow-up, after controlling for childhood environment and genetic predisposition. At baseline in 1975 same-sex twin pairs born in Finland before 1958 were sent a questionnaire including questions on physical activity. The participants (20,487 individuals, including 8,182 complete twin pairs) were divided into quintiles by leisure-time physical activity metabolic equivalent (MET) index (MET h/day). Type 2 diabetes was determined from nationwide registers for the follow-up period (1 January 1976–31 December 2004). Individual and pairwise Cox proportional hazard models were used. During follow-up, 1,082 type 2 diabetes cases were observed. Among all individuals, participants in MET quintiles (Q) III–V had significantly decreased risk for type 2 diabetes compared with sedentary individuals (QI). The pairwise analysis on pairs discordant for physical activity showed that participants in MET QII to V had significantly lower hazard ratios (0.61, 0.59, 0.61, 0.61) compared with sedentary participants. These findings from the pairwise analysis persisted after adjusting for BMI. In the pairwise analysis, the BMI-adjusted hazard ratio for type 2 diabetes was lower for physically active members of twin pairs (combined QII–V) than for inactive co-twins (HR 0.54; 95% CI 0.37–0.78). Similar results were obtained for both dizygotic and monozygotic pairs, as well as for the subgroup of twin pairs defined as free of co-morbidities in 1981 (HR 0.36; 95% CI 0.17–0.76). Leisure-time physical activity protects from type 2 diabetes after taking familial and genetic effects into account.
Seven consecutive successful clinical islet isolations with pancreatic ductal injection.

Inconsistent islet isolation is one of the issues of clinical islet transplantation. In the current study, we applied ductal injection to improve the consistency of islet isolation. Seven islet isolations were performed with the ductal injection of ET-Kyoto solution (DI group) and eight islet isolations were performed without the ductal injection (standard group) using brain-dead donor pancreata. Isolated islets were evaluated based on the Edmonton protocol for transplantation. The DI group had significantly higher islet yields (588,566 +/- 64,319 vs. 354,836 +/- 89,649 IE, p < 0.01) and viability (97.3 +/- 1.2% vs. 92.6 +/- 1.2%, p < 0.02) compared with the standard group. All seven isolated islet preparations in the DI group (100%), versus only three out of eight isolated islet preparations (38%) in the standard group met transplantation criteria. The islets from the DI group were transplanted into three type 1 diabetic patients and all three patients became insulin independent. Ductal injection significantly improved quantity and quality of isolated islets and resulted in high success rate of clinical islet transplantation. This simple modification will reduce the risk of failure of clinical islet isolation.