nils-herrmann/clean_scirepeval huggingface dataset:
The CAM-S: development and validation of a new scoring system for delirium severity in 2 cohorts.

Quantifying the severity of delirium is essential to advancing clinical care by improved understanding of delirium effect, prognosis, pathophysiology, and response to treatment.



To develop and validate a new delirium severity measure (CAM-S) based on the Confusion Assessment Method.



Validation analysis in 2 independent cohorts.



Three academic medical centers.



The first cohort included 300 patients aged 70 years or older scheduled for major surgery. The second included 919 medical patients aged 70 years or older.



A 4-item short form and a 10-item long form were developed. Association of the maximum CAM-S score during hospitalization with hospital and posthospital outcomes related to delirium was evaluated.



Representative results included adjusted mean length of stay, which increased across levels of short-form severity from 6.5 days (95% CI, 6.2 to 6.9 days) to 12.7 days (CI, 11.2 to 14.3 days) (P for trend < 0.001) and across levels of long-form severity from 5.6 days (CI, 5.1 to 6.1 days) to 11.9 days (CI, 10.8 to 12.9 days) (P for trend < 0.001). Representative results for the composite outcome of adjusted relative risk of death or nursing home residence at 90 days increased progressively across levels of short-form severity from 1.0 (referent) to 2.5 (CI, 1.9 to 3.3) (P for trend < 0.001) and across levels of long-form severity from 1.0 (referent) to 2.5 (CI, 1.6 to 3.7) (P for trend < 0.001).



Data on clinical outcomes were measured in an older data set limited to patients aged 70 years or older.



The CAM-S provides a new delirium severity measure with strong psychometric properties and strong associations with important clinical outcomes.
An open-label, sequential, dose-finding study of peginesatide for the maintenance treatment of anemia in chronic hemodialysis patients

Peginesatide is a peptide-based erythropoiesis-stimulating agent that was designed and engineered to stimulate specifically the erythropoietin receptor dimer that governs erythropoiesis. The primary objective of this phase 2 dose-finding study was to determine the once-monthly peginesatide dosing strategy that would maintain hemoglobin within ±1.0 g/dL of baseline values after conversion from epoetin alfa; the safety of peginesatide was evaluated concurrently.



Chronic hemodialysis patients on stable regimens of epoetin alfa were sequentially assigned to cohorts that differed on (1) how the peginesatide starting dose was determined (using a single epoetin alfa-to-peginesatide dose conversion ratio or a tiered, weight-based or absolute-dose conversion table) and on (2) whether or not a 1-week erythropoiesis-stimulating agent-free interval was used. Peginesatide doses were titrated to maintain hemoglobin levels within ±1.0 g/dL from baseline.



A total of 164 patients were enrolled and received intravenous peginesatide every 4 weeks for up to 6 doses; the duration of the study including follow-up was ≤29 weeks. Overall, the proportion of patients with hemoglobin levels within ±1.0 g/dL of baseline increased over the course of the study from 39% (Weeks 2-13) to 54% (Weeks 18-25). Cohorts that used tiered dose conversion tables trended towards having more stable peginesatide doses than did those cohorts that used a single dose conversion ratio. Moreover, cohorts that used an erythropoiesis-stimulating agent-free interval did not have the substantial initial increase in hemoglobin levels that was seen in those cohorts that did not use such an interval. In this study, the safety profile of peginesatide was consistent with those of marketed erythropoiesis-stimulating agents.



The results of this study were used to guide the dosing regimens used subsequently in phase 3 studies. Once-monthly peginesatide is feasible in hemodialysis patients.
Landiolol attenuates cardiovascular response at induction of general anesthesia for cesarean delivery

General anesthesia for cesarean delivery is frequently associated with hypertension and tachycardia caused by tracheal intubation, which may lead to cardiac ischemia in susceptible patients or may cause harm due to increased intracranial pressure. To prevent these adverse events, we investigated the efficacy and safety of single-dose intravenous administration of landiolol, a short-acting selective β1 receptor blocker, just prior to intubation. Patients scheduled for cesarean delivery under general anesthesia were randomized into two groups: landiolol (group L, n = 32); and nontreated (group N, n = 32) patients. After patients entered the operating room, blood pressure (BP), heart rate (HR), and fetal heart beats were monitored to ensure no problems were present, then thiopental 5 mg/kg and rocuronium 0.9 mg/kg were given. In addition, group L received a single dose of landiolol 0.2 mg/kg. After tracheal intubation, anesthesia was maintained in both groups using sevoflurane. From before starting anesthesia to the time of delivery, BP, HR, need for additional treatment with uterotonic or vasopressor agents, and neonatal Apgar scores were recorded. Data were compared between groups. Group L showed significantly lower percentage changes in BP and HR than group N (p < 0.05 each). Intraoperative blood loss, frequency of decreased uterine contraction, and fetal Apgar scores did not differ significantly between groups. In our study, landiolol reduced BP and HR changes during anesthesia induction, whereas no adverse effects on uterine contraction or the fetus were seen. These findings suggest landiolol provides adequate hemodynamic regulation during general anesthesia induction in patients undergoing cesarean delivery.
Gender-related safety and efficacy of cardiac resynchronization therapy.

Cardiac resynchronization therapy (CRT) is an established therapy for patients with chronic heart failure (CHF) and a broad QRS complex. Gender-related safety and efficacy data are necessary for informed patient decision-making for female patients with CHF. The aim of the study was to assess the effects of gender on the outcome of CRT in highly symptomatic heart failure patients.



Gender may have an effect on the outcome of heart failure patients undergoing cardiac resynchronisation therapy.



The study analyzed the 2-year follow-up of 393 New York Heart Association (NYHA) class III/IV patients with a class I CRT indication enrolled in the Management of Atrial Fibrillation Suppression in AF-HF Comorbidity Therapy (MASCOT) study.



In female patients (n = 82), compared with male patients (n = 311), CHF was more often due to dilated cardiomyopathy (74% vs 44%, respectively; P < 0.0001). Females also had a more impaired quality-of-life score and a smaller left ventricular end-diastolic diameter (LVEDD). Women were less likely than men to have received a CRT defibrillator (35% vs 61%, respectively; P < 0.0001). After 2 years, the devices had delivered more biventricular pacing in women than in men (96% ± 13% vs 94% ± 13%, respectively; P < 0.0004). Women had a greater reduction in LVEDD than did men (-8.2 mm ± 11.1 mm vs -1.1 mm ± 22.1 mm, respectively; P < 0.02). Both genders improved similarly in NYHA functional class. Women reported greater improvement than men in quality-of-life score (-21.1 ± 26.5 vs -16.2 ± 22.1, respectively; P < 0.0001). After adjustment for cardiovascular history, women had lower all-cause mortality (P = 0.0007), less cardiac death (P = 0.04), and fewer hospitalizations for worsening heart failure (P = 0.01).



Females exhibited a better response to CRT than did males. Because females have such impressive benefits from CRT, improved screening and advocacy for CRT implantation in women should be considered.
Peptide vaccination induces profound changes in the immune system in patients with B-cell chronic lymphocytic leukemia.

Although the immune status of chronic lymphocytic leukemia (CLL) patients is mostly characterized by immunosuppression, there is an accumulation of in vivo (graft-versus-leukemia effect) and in vitro (spontaneous remissions after infections) data that indicates that CLL might be effectively targeted by T-cell based immunotherapy. Recently, we characterized receptor for hyaluronic acid mediated motility (RHAMM) as a preferential target for immunotherapy of CLL. We also completed a RHAMM-derived peptide vaccination phase I/II clinical trial in CLL. Here, we present a detailed immunological analysis of six CLL patients vaccinated with HLA-A2 restricted RHAMM-derived epitope R3 (ILSLELMKL). Beside effective induction of R3-specific cytotoxic T-cells, peptide vaccination caused profound changes in different T-cell subsets as well as cytokines. We present longitudinal analyses of Th17, CD8(+)CD103(+), CD8(+)CD137(+) and IL-17 producing CD8(+) T cells (CD8(+)IL- -17(+)) as well as important cytokines involved in regulation of immune response such as TGF-β, IL-10, IL-2 and TNF throughout the peptide vaccination period.
Interactions of familial and hormonal risk factors for large bowel cancer in women.

Family history of colorectal cancer has been consistently associated with an increased personal risk of this disease. Since evidence suggests that hormones are related to colon cancer risk in women, the effect of family history on large bowel incidence may be modified according to endogenous and exogenous hormone levels.



We analysed data from a population-based case-control study of female colorectal cancer to evaluate family history and cancer risk. Cases (n = 702) were female residents of Wisconsin with a new diagnosis of colorectal cancer, identified through a statewide tumour registry. Controls (n = 2274) were randomly selected from lists of licensed drivers and from rosters of Medicare beneficiaries. All relative risks (RR) were adjusted for age, body mass index, smoking and alcohol history, education, and use of hormone replacement therapy.



Compared with women who reported no history of cancer in a first degree relative, women with a family history had an RR of 2.07 (95% confidence interval [CI]: 1.60-2.68). Regardless of which parent was affected, risks were increased about twofold, while sibling history was associated with about a 50% increase in risk. Risk was greater if more than one family member was affected (RR 3.65, 95% CI: 1.81-7.37). The association between family history and risk was stronger for colon cancer than for rectal cancer. There were no indications that exogenous hormonal factors, notably hormone replacement use, modified these risks. There was a suggestion that high parity attenuated the risks associated with family history (P = 0.07).



These results confirm that family history of colorectal cancer is associated with a doubling of risk for large bowel cancer in women; some histories were associated with greater risk. This relation was not substantially different among subgroups of women with varying exogenous and endogenous hormone exposures.
Palliative pelvic radiotherapy for symptomatic incurable prostate cancer – A prospective multicenter study.

Radiotherapy is used to palliate pelvic symptoms of castration resistant prostate cancer (CRPC). However, magnitude and time course of effects and toxicities are poorly documented. Study aims were to evaluate changes in patient-reported target symptoms (TS), health-related quality of life (HRQOL) and toxicity following palliative pelvic radiotherapy (PPRT) of CRPC.



47 patients with CRPC and a symptomatic pelvic mass prescribed PPRT with 30-39 Gy were prospectively included. Primary endpoint was patient-reported improvement or complete resolution of the TS twelve weeks after PPRT. HRQOL changes were explored. Toxicity was physician-evaluated.



Lower urinary tract symptoms (LUTS) (45%), hematuria (26%) and pain (19%) were the most common TS. In the 40 evaluable patients, overall TS response twelve weeks after PPRT was 70%. TS responses were 8/18 for LUTS, 11/12 for hematuria, and 7/9 for pain. Global HRQOL improved transiently. The most common toxicity was grade 1 or 2 diarrhea (50%). There was no grade 4 toxicity.



In the majority of patients with CRPC and a symptomatic pelvic tumor, PPRT with 30-39 Gy contributes to relief of hematuria, pain and other pelvic symptoms, with acceptable toxicity. Future studies should investigate whether PPRT regimens can be simplified.
Dexamethasone for morbidity after subdural electrode insertion--a randomized controlled trial.

Invasive monitoring with subdural electrodes (SDE) for investigation of medically intractable epilepsy may be associated with undesirable immediate postoperative morbidity such as headache, nausea, vomiting, fever, and meningism. We undertook to evaluate the potential beneficial role of perioperative dexamethasone in reducing these symptoms.



In a double-blind placebo controlled clinical trial 30 patients undergoing SDE insertion were randomized to receive either placebo or a course of dexamethasone beginning one hour prior to surgery and tapering to discontinue over 72 hours postoperatively. Pain, pain relief, nausea, nausea relief, temperature, and meningism were assessed regularly in the postoperative period, and analgesic, antipyretic, and antiemetic drug requirements were tabulated.



One patient was withdrawn from the dexamethasone group due to lack of data. With regards to postoperative pain, the direction of benefit favoured dexamethasone but a significant treatment by time interaction prevented further analysis of treatment effect. The dexamethasone group did have significantly lower temperatures and higher nausea relief scores. There was no statistically significant difference between the groups with regards to pain relief, nausea, and meningism scores. The beneficial effects of dexamethasone were delayed in onset, of limited duration, and not uniform over the observation period.



Dexamethasone appears to have a role in reducing immediate morbidity following SDE insertion but its effect is not uniform in the postoperative period; it appears to be delayed in onset, and of limited duration. Further study is necessary to determine the ideal dosing schedule.
Breast cancer awareness of rural women in Malaysia: is it the same as in the cities?

Breast cancer is the most common cancer among women globally. This study was conducted to compare the awareness of breast cancer and the practice of breast self-examination (BSE), clinical breast examination (CBE) and mammography screening among rural females in Pahang and Perak. A cross-sectional study was carried out in five selected rural districts of Pahang and Perak. Two hundred and fifty households were randomly selected and interviewed face to face using a semi-structured questionnaire. The majority of residents from both states were Malay, aged between 50 and 60 years and had a secondary level of education. Malay women aged 40-49 years and women with a higher level of education were significantly more aware of breast cancer (p<0.05). About half of these women practiced BSE (60.7%) and CBE (56.1%), and 7% had underwent mammography screening. The results of this study suggest that women in Pahang and Perak have good awareness of breast cancer and that more than half practice BSE and CBE. The women's level of education appears to contribute to their level of knowledge and health behaviour. However, more effort is needed to encourage all women in rural areas to acquire further knowledge on breast cancer.
Effectiveness of massage therapy as co-adjuvant treatment to exercise in osteoarthritis of the knee: a randomized control trial.

The effectiveness of exercise therapy in the treatment of osteoarthritis of the knee (KOA) is widely evidenced. The current study aims to compare the effectiveness of massage therapy as a co-adjuvant treatment for KOA.



A blind, randomized controlled trial design was used. Eighteen women were randomly allocated to two different groups. Group A was treated with massage therapy and an exercise program, and Group B was treated with the exercise program alone. The intervention lasted for 6 weeks. Outcomes were assessed using a verbal analogue scale (VAS), the WOMAC index, and the Get-Up and Go test. Baseline, post-treatment, and 1- and 3- month follow-up data were collected. Values were considered statistically significant at a p < 0.05. The Mann-Whitney U test was applied in order to find out the differences between groups, and to verify the existence of such differences, the Friedman Test for repeated measures complemented with multiple comparisons tests was carried out.



In both groups, significant differences were found in the three variables between the baseline measurement and three months after treatment, with the exception of the WOMAC variable in group B (p=0.064) No significant differences were found between both groups in the WOMAC index (p=0.508) and VAS (p=0.964) variables and the Get-Up and Go test (p=0.691).



Combining exercise-based therapy with massage therapy may lead to clinical improvement in patients with KOA. The use of massage therapy combined with exercise as a treatment for gonarthrosis does not seem to have any beneficial effects.
Development and implementation of a clinical survey for cancer-related fatigue assessment.

In recent years, fatigue has been recognized as a prevalent and often debilitating symptom for patients with cancer. Despite the increased recognition of cancer-related fatigue (CRF), it often is not assessed adequately in the clinical setting. This article reports the results of a feasibility test to evaluate the utility and relevance of the Quick Fatigue Assessment Survey (QFAS), a brief fatigue assessment technique for determining the onset, intensity, and duration of fatigue and for identifying known factors that contribute to the experience and severity of fatigue. Patients from four outpatient oncology clinics, with a variety of cancer diagnoses, participated in the test of the QFAS. The overwhelming majority (96%) of patients who completed the QFAS reported experiencing CRF. The nurses who administered the survey subsequently evaluated its utility in clinical practice. Ninety-six percent of the nurses found the QFAS helpful in providing a quick assessment of patient fatigue. The majority (92%) also believed that the QFAS helped identify contributing factors associated with CRF, and 74% responded that the QFAS assisted them in planning for interventions to minimize CRF. A fatigue assessment technique that is relevant and useful in the clinical setting may be a helpful first step in addressing the problem of CRF.
Termination of malignant ventricular arrhythmias with an implanted automatic defibrillator in human beings.

The development of a clinically applicable, automatic, implantable defibrillator has been described previously.1 This electronic device is designed to monitor cardiac electrical activity, to recognize ventricular fibrillation and ventricular tachyarrhythmias with a sinusoidal wave form, and then to deliver corrective defibrillatory discharges. It is intended to protect patients at particularly high risk of sudden death whenever and wherever they are stricken by these lethal arrhythmias.
FLAIR vascular hyperintensities and dynamic 4D angiograms for the estimation of collateral blood flow in posterior circulation occlusion

The objectives of this paper are to assess collateral blood flow in posterior circulation occlusion by MRI-based approaches (fluid-attenuated inversion recovery (FLAIR) vascular hyperintensities (FVHs), collateralization on dynamic 4D angiograms) and investigate its relation to ischemic lesion size and growth. In 28 patients with posterior cerebral artery (PCA) and 10 patients with basilar artery (BA) occlusion, MRI findings were analyzed, with emphasis on distal FVH and collateralization on dynamic 4D angiograms. In PCA occlusion, distal FVH was observed in 18/29 (62.1 %), in BA occlusion, in 8/10 (80 %) cases. Collateralization on dynamic 4D angiograms was graded 1 in 8 (27.6 %) patients, 2 in 1 (3.4 %) patient, 3 in 12 (41.4 %) patients, and 4 in 8 (27.6 %) patients with PCA occlusion and 0 in 1 (10 %) patient, 2 in 3 (30 %) patients, 3 in 1 (10 %) patient, and 4 in 5 (50 %) patients with BA occlusion. FVH grade showed neither correlation with initial or follow-up diffusion-weighted image (DWI) lesion size nor DWI–perfusion-weighted imaging (PWI) mismatch ratio. Collateralization on dynamic 4D angiograms correlated inversely with initial DWI lesion size and moderately with the DWI–(PWI) mismatch ratio. The combination of distal FVH and collateralization grade on dynamic 4D angiograms correlated inversely with initial as well as follow-up DWI lesion size and highly with the DWI–PWI mismatch ratio. In posterior circulation occlusion, FVH is a frequent finding, but its prognostic value is limited. Dynamic 4D angiograms are advantageous to examine and graduate collateral blood flow. The combination of both parameters results in an improved characterization of collateral blood flow and might have prognostic relevance.
Effects of valsartan compared with enalapril on blood pressure and cognitive function in elderly patients with essential hypertension

This prospective, randomised, open-label, blinded-endpoint study was to compare the effects of the angiotensin II (Ang II) AT1 receptor antagonist valsartan with those of the ACE inhibitor enalapril on blood pressure (BP) and cognitive functions in elderly hypertensive patients. One hundred and forty-four patients aged 61–80 years with mild to moderate essential hypertension (DBP ≥95 mmHg and ≤110 mmHg at the end of a 2-week placebo run-in period) were randomly assigned to once daily (o.d.) treatment with valsartan 160 mg (n=73) or enalapril 20 mg (n=71) for 16 weeks. The patients were examined every 4 weeks during the study, with pre-dose BP (standard mercury sphygmomanometer, Korotkoff I and V) and heart rate (pulse palpation) being recorded at each visit. Cognitive function was evaluated at the end of the wash-out period and after 16 weeks of active treatment by means of five tests (verbal fluency, the Boston naming test, word list memory, word list recall and word list recognition). Both valsartan and enalapril had a clear antihypertensive effect, but the former led to a slightly greater reduction in SBP/DBP at 16 weeks (18.6±4.6/13.7±4.0 mmHg vs 15.6±5.1/10.9±3.9 mmHg; P<0.01). Enalapril did not induce any significant changes in any of the cognitive function test scores; valsartan significantly increased the word list memory score (+11.8%; P<0.05 vs baseline and P<0.01 vs enalapril) and the word list recall score (+18.7%; P<0.05 vs baseline and P<0.01 vs enalapril), but not those of the other tests. These findings indicate that, in elderly hypertensive patients, 16 weeks of treatment with valsartan 160 mg o.d. is more effective than enalapril 20 mg o.d. in reducing BP, and (unlike enalapril) improves some of the components of cognitive function, particularly episodic memory.