nils-herrmann/clean_scirepeval huggingface dataset:
Readmission to an Acute Care Hospital During Inpatient Rehabilitation for Traumatic Brain Injury.

To assess the incidence of, causes for, and factors associated with readmission to an acute care hospital (RTAC) during inpatient rehabilitation for traumatic brain injury (TBI).



Prospective observational cohort.



Inpatient rehabilitation.



Individuals with TBI admitted consecutively for inpatient rehabilitation (N=2130).



Not applicable.



RTAC incidence, RTAC causes, rehabilitation length of stay (RLOS), and rehabilitation discharge location.



A total of 183 participants (9%) experienced RTAC for a total of 210 episodes. Of 183 participants, 161 patients experienced 1 RTAC episode, 17 had 2, and 5 had 3. The mean time from rehabilitation admission to first RTAC was 22±22 days. The mean duration in acute care during RTAC was 7±8 days. Eighty-four participants (46%) had ≥1 RTAC episodes for medical reasons, 102 (56%) had ≥1 RTAC episodes for surgical reasons, and 6 (3%) participants had RTAC episodes for unknown reasons. Most common surgical RTAC reasons were neurosurgical (65%), pulmonary (9%), infection (5%), and orthopedic (5%); most common medical reasons were infection (26%), neurological (23%), and cardiac (12%). Any RTAC was predicted as more likely for patients with older age, history of coronary artery disease, history of congestive heart failure, acute care diagnosis of depression, craniotomy or craniectomy during acute care, and presence of dysphagia at rehabilitation admission. RTAC was less likely for patients with higher admission FIM motor scores and education less than high school diploma. RTAC occurrence during rehabilitation was significantly associated with longer RLOS and smaller likelihood of discharge home.



Approximately 9% of patients with TBI experienced RTAC episodes during inpatient rehabilitation for various medical and surgical reasons. This information may help inform interventions aimed at reducing interruptions in rehabilitation for RTAC. RTACs were associated with longer RLOS and discharge to an institutional setting.
Antidepressant dose and treatment response in bipolar depression: Reanalysis of the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) data.

The aim of this study is to evaluate whether an adjunct antidepressant therapy at a higher dose to a mood stabilizer would make a difference in the treatment of bipolar depression. This is a post-hoc analysis of the data from the randomized treatment for acute depression of the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), in which patients with bipolar depression were randomly assigned to treatment with a mood stabilizer plus adjunctive antidepressant drugs or placebo. According to the highest dose received in the course of treatment, the subjects were divided into one of the following three groups: high-dose, low-dose and placebo groups. The primary and secondary outcomes were durable recovery (which was operationally defined as eight consecutive weeks with </ = 2 symptoms) and treatment-emergent affective switch (i.e. transition to mania or hypomania), respectively. In the evaluable 333 subjects, subjects in both the high-dose (n = 102) and placebo groups (n = 169) more significantly achieved durable recovery than the low-dose group (n = 62) (odds ratio = 3.013 [p = 0.009], 2.899 [p = 0.008], respectively). No significant association was found between the dose status and treatment-emergent affective switch (p = 0.614). The allocation to either high- and low-dose antidepressants was not randomized and the dose was guided by a case-by-case decision, which hampers to draw a firm conclusion on dose-response issues and renders the findings as preliminary. Nevertheless, higher doses of adjunctive antidepressant drugs seem to have potential for yielding greater clinical improvement without increasing any risk of manic switch compared to lower doses, at least in carefully selected patients. THE CLINICALTRIALS.


GOV IDENTIFIER
NCT00012558.
Six- versus 12-h conversion method from intravenous to transdermal fentanyl in chronic cancer pain: a randomized study

The objective of the present prospective study was to compare the safety and efficacy of a 12-h method to a 6-h method in chronic cancer pain management. Randomized, prospective clinical trial was conducted between December 2007 and June 2009, enrolling 90 patients with chronic cancer pain. Patients with chronic cancer pain were randomly assigned to the conversion from continuous intravenous infusion to transdermal fentanyl using two-step taper of the continuous intravenous infusion in 12 h (12-h method) or the conversion in 6 h (6-h method). The parameters assessed in the present study included pain intensity (on a scale of 0 to 10) and bolus use frequency, and the adverse effects were assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 3. Pain intensity and the number of boluses during conversion remained stable in both arms. The incidence of adverse events was 25.6% in the 12-h method group and 2.3% in the 6-h method group (95% confidence interval, 0.01–0.55; p = 0.002). Adverse events occurred in four patients at 6–12 h, five patients at 12–18 h, two patients at 18–24 h, and one patient at 24–48 h after application. Excellent safety profile and sustained efficacy are shown for the 6-h conversion method.
The relationship between coping strategies, quality of life, and mood in patients with incurable cancer.

Patients with incurable cancer face many physical and emotional stressors, yet little is known about their coping strategies or the relationship between their coping strategies, quality of life (QOL), and mood.



As part of a randomized trial of palliative care, this study assessed baseline QOL (Functional Assessment of Cancer Therapy-General), mood (Hospital Anxiety and Depression Scale), and coping (Brief COPE) in patients within 8 weeks of a diagnosis of incurable lung or gastrointestinal cancer and before randomization. To examine associations between coping strategies, QOL, and mood, we used linear regression, adjusting for patients' age, sex, marital status, and cancer type.



There were 350 participants (mean age, 64.9 years), and the majority were male (54.0%), were married (70.0%), and had lung cancer (54.6%). Most reported high utilization of emotional support coping (77.0%), whereas fewer reported high utilization of acceptance (44.8%), self-blame (37.9%), and denial (28.2%). Emotional support (QOL: β = 2.65, P < .01; depression: β = -0.56, P = .02) and acceptance (QOL: β = 1.55, P < .01; depression: β = -0.37, P = .01; anxiety: β = -0.34, P = .02) correlated with better QOL and mood. Denial (QOL: β = -1.97, P < .01; depression: β = 0.36, P = .01; anxiety: β = 0.61, P < .01) and self-blame (QOL: β = -2.31, P < .01; depression: β = 0.58, P < .01; anxiety: β = 0.66, P < .01) correlated with worse QOL and mood.



Patients with newly diagnosed, incurable cancer use a variety of coping strategies. The use of emotional support and acceptance coping strategies correlated with better QOL and mood, whereas the use of denial and self-blame negatively correlated with these outcomes. Interventions to improve patients' QOL and mood should seek to cultivate the use of adaptive coping strategies. Cancer 2016;122:2110-6.
Angiotensin-converting enzyme inhibitor trandolapril does not affect C-reactive protein levels in myocardial infarction patients.

Not Affect C-Reactive Protein Levels in Myocardial Infarction Patients  Recently, Wang et al1 reported a direct effect of C-reactive protein (CRP) on the angiotensin system. Their findings add to the accumulating evidence that CRP is not only an indirect risk marker for cardiovascular disease but also causally contributes to the precipitation of the disease. An association between CRP and the angiotensin system also raises the question of what the effect is of angiotensin-converting enzyme (ACE) inhibitors on CRP, given that the ACE inhibitors are often used after coronary events. We studied the effect of the ACE inhibitor, trandolapril, on CRP levels in 80 patients who participated in the TRAndolapril Cardiac Evaluation (TRACE) study,2 randomized to treatment (0.5 mg daily) or placebo. Citrated blood was collected from these patients during hospitalization after a myocardial infarction but before randomization, and after 1, 3, 6, 9, and 12 months of treatment. CRP was measured in the plasma using a highsensitivity enzyme immunoassay with polyclonal antibodies to human CRP as catching and tagging antibodies (Dako). The effect of treatment on CRP was analyzed using repeatedmeasures ANOVA on logarithmically transformed CRP levels. CRP levels were elevated after the myocardial infarction (geometric mean at randomization, 34.1 mg/L [coefficient of variation {CV}, 1.36]) and had returned to normal levels after 1 month, both in the treated group and in the placebo group (2.50 mg/L [CV 1.20] and 3.20 mg/L [CV 1.53], respectively; NS). The levels were not significantly different at any time point during the treatment period. The results of our study suggest that the association between CRP and the angiotensin system does not include lowering of CRP by ACE inhibitors but may be limited to an effect of CRP on angiotensin I receptor expression as reported by Wang et al.1 In conclusion, CRP levels after a myocardial infarction and the beneficial effect of ACE-inhibitor treatment of patients after a myocardial infarction do not seem to include a reduction of levels of the inflammatory marker CRP.
Influence of life-style choices on locomotor disability, arthritis and cardiovascular disease in older women: prospective cohort study.

many chronic conditions have their roots in modifiable health-related behaviours.



a total of 4,286 women aged 60-79 in the British Women's Heart and Health Study are followed up for incident cardiovascular disease (CVD), arthritis and locomotor disability over 7 years. Self-reported smoking, alcohol consumption, exercise and fruit intake at baseline is also available. Associations between these and each outcome, plus a composite outcome, are investigated in those without prevalent disease at baseline using logistic regression with multiple imputation.



ex-smokers and current smokers showed increased odds of locomotor disability, CVD and the combined outcome. Less regular exercisers had increased odds of all outcomes, particularly locomotor disability. There was no evidence that alcohol or fruit intake was associated with any outcome. Population attributable fractions (PAFs) suggest in addition to the influence of smoking and alcohol, exercise accounts for 9% of incident locomotor disability, 5% of CVD and 4% of arthritis. All four lifestyle factors combined account for 17% of incident locomotor disability and 9% of incident conditions combined.



never smokers and regular exercisers had substantially reduced odds of 7-year disability onset. Low PAFs suggest changes in health-related behaviours in older women would result in only modest reductions in common chronic conditions.
Tai chi exercise for patients with chronic obstructive pulmonary disease: a pilot study.

To determine the feasibility of a randomized controlled trial of the effect of a tai chi program on quality of life and exercise capacity in patients with COPD.



We randomized 10 patients with moderate to severe COPD to 12 weeks of tai chi plus usual care (n = 5) or usual care alone (n = 5). The tai chi training consisted of a 1-hour class, twice weekly, that emphasized gentle movement, relaxation, meditation, and breathing techniques. Exploratory outcomes included disease-specific symptoms and quality-of-life, exercise capacity, pulmonary function tests, mood, and self-efficacy. We also conducted qualitative interviews to capture patient narratives regarding their experience with tai chi.



The patients were willing to be randomized. Among 4 of the 5 patients in the intervention group, adherence to the study protocol was excellent. The cohort's baseline mean ± SD age, percent-of-predicted FEV₁, and ratio of FEV₁ to forced vital capacity were 66 ± 6 y, 50 ± 12%, and 0.63 ± 0.14, respectively. At 12 weeks there was significant improvement in Chronic Respiratory Questionnaire score among the tai chi participants (1.4 ± 1.1), compared to the usual-care group (-0.1 ± 0.4) (P = .03). There were nonsignificant trends toward improvement in 6-min walk distance (55 ± 47 vs -13 ± 64 m, P = .09), Center for Epidemiologic Studies Depression Scale (-9.0 ± 9.1 vs -2.8 ± 4.3, P = .20), and University of California, San Diego Shortness of Breath score (-7.8 ± 3.5 vs -1.2 ± 11, P = .40). There were no significant changes in either group's peak oxygen uptake.



A randomized controlled trial of tai chi is feasible in patients with moderate to severe COPD. Tai chi exercise as an adjunct to standard care warrants further investigation.
Effect of furosemide on angiotensin II-mediated prostaglandin I2 production in hypertensive subjects

The role of angiotensin II (AII) in Prostaglandin I2 (PGI2) production following furosemide has been examined in a placebo-controlled, cross-over study. Furosemide 20 mg was injected intravenously in eight hypertensive subjects already treated with oral captopril 25 mg or a matching placebo. Urinary excretion of 6-keto-PGF1α (a metabolite of PGI2) and PGE2, PRA and AII was increased following furosemide without captopril pretreatment. The rises in urinary 6-keto-PGF1α and PGE2, and plasma AII after furosemide were prevented by the captopril pretreatment. Urinary volume, sodium and furosemide were not affected by captopril. The data indicate that the effect of furosemide on PGI2 production, as reflected by the urinary excretion of 6-keto-PGF1α, was mediated by an action of AII.
Evaluation of 0.6% sodium alginate as a submucosal injection material in endoscopic submucosal dissection for early gastric cancer.

We have focused on sodium alginate (SA) solution as a potential submucosal injection material for endoscopic submucosal dissection (ESD). A previous SA solution had high viscosity and problems such as difficult handling. After its properties were adjusted, SA solution was examined in vitro and its clinical safety was evaluated.



With 0.4% sodium hyaluronate (SH) solution as a control, catheter injectability and mucosa-elevating capacity of 0.3-0.8% SA solutions were evaluated. Next, 0.6% SA solution was used for ESD in 10 patients with early gastric cancer in a prospective clinical study.



Compared with 0.4% SH solution, 0.6% SA solution exhibited no significant difference in catheter injectability but significant superiority in mucosa-elevating capacity. In the clinical study, no adverse events were observed in any patient.



The safety of 0.6% SA solution as a submucosal injection material was confirmed and it is suggested that its efficacy should be investigated in a larger number of cases.
Drug-Eluting Nitinol Stent Treatment of the Superficial Femoral Artery and Above-the-Knee Popliteal Artery (The Zilver PTX Single-Arm Clinical Study): A Comparison Between Diabetic and Nondiabetic Patients

To describe the 1-year results of drug-eluting nitinol stent placement in the femoropopliteal artery of diabetic and nondiabetic patients. All patients enrolled in this prospective, multicenter study underwent paclitaxel-eluting stent placement for de novo or restenotic lesions of the superficial femoral and/or popliteal artery. Baseline and follow-up walking impairment questionnaire (WIQ) scores, Rutherford classifications, and ankle–brachial index (ABI) measurements were obtained. Follow-up was completed at 1, 6, and 12 months. There were 285 diabetic patients and 502 nondiabetic patients treated. There were no significant differences in mean lesion length or lesion calcification between patient groups. Procedural success in both treatment groups was >97 %. There were no significant differences between diabetic and nondiabetic groups in Kaplan–Meier estimates of patency, event-free survival (EFS), or freedom from target lesion revascularization (TLR) at 6 and 12 months. Both groups experienced a significant increase in ABI and WIQ values after treatment, and these improvements were sustained to 12-month follow-up; however, nondiabetic patients had significantly greater 6- and 12-month WIQ scores compared with diabetic patients. Based on covariate analysis, the only factors shown to be significant and to negatively influence patency were longer lesion length (p = 0.009), higher Rutherford classification (p = 0.02), and lack of hypertension (p = 0.02); diabetic status was not found to be a significant factor. Diabetic and nondiabetic patients had similar estimates of primary patency, EFS, and freedom from TLR; however, diabetic patients showed less improvement in WIQ scores compared with nondiabetic patients.
CHAPTER 2 Improved Control of Oral Anticoagulant Dosing : A Randomized Controlled Trial Comparing Two Computer Algorithms

Efforts to improve dosing quality in oral anticoagulant control include the use of computer algorithms. Since current algorithms are simplistic and give dosage proposals in a small fraction of patients, we developed an algorithm based on principles of system and control engineering that gives proposals in nearly all patients.  We evaluated the new algorithm in clinical practice.  We conducted a double-blind randomized controlled trial among 712 patients with an indication for long-term anticoagulant treatment at the Leiden Anticoagulation Clinic. We compared oral anticoagulant dosing supported by the new algorithm (ICAD) with the standard algorithm (TRODIS).  The percentage of time spent in therapeutic range was similar for the new and standard algorithm group, 79.8% versus 80.2% (Diff 0.4%, 95%CI –1.7% to 2.6%). The new algorithm produced a dosage proposal in 97.5% of visits and the standard algorithm in 60.8% (Diff 36.7%, 95%CI 35.4%-38.0%). 79.3 % of proposals of the new algorithm were accepted by the physician versus 90.9% for the standard algorithm (Diff 11.6%, 95%CI 10.2%-13.0%). This implies that the new algorithm gave an acceptable proposal in 77.4% of all patient visits versus 55.3% for the standard algorithm (Diff 22.1%, 95%CI 20.4%-23.8%).  Substantially more dosage proposals were generated and accepted with the new than with the standard algorithm, and the new algorithm will therefore improve the efficiency of anticoagulant monitoring without loss of quality. Comparison of two anticoagulant dosing algorithms 21
Impact of treatment with oral calcitriol on glucose indices in type 2 diabetes mellitus patients.

Type 2 diabetes is a major public health problem. Recent epidemiological evidence also points to a potential association of vitamin D insufficiency with adverse metabolic risks, including that for type 2 diabetes.



A double-blind randomized placebo-controlled trial was carried out. Seventy subjects with type 2 diabetes, age 30-75 years old, were randomly assigned in a double-blind fashion to two groups. One group received two capsules of calcitriol (0.25 μg 1,25-dihydroxy cholecalciferol per each capsule) per day. The second group received placebo tablets. At the beginning, middle and the end of the 12 week supplementation trial, serum glucose, insulin, calcium and phosphorous, HbA1c and 25(OH) vitamin D were measured.



There was no significant difference between two groups at baseline. At the end of the study, fasting plasma glucose increased in the control group (p=0.038), while it remained unchanged in calcitriol group. Level of insulin and HbA1c increased significantly in both groups (p=0.013 and 0.0004 in treatment and control group). Regarding insulin resistance indices, there was a significant change in HOMA-IR and QUICKI in both groups (p=0.023 and 0.002 in treatment and 0.001 and <0.001 in control group respectively). Insulin secretion as assessed by HOMA-%β, remained relatively unchanged in the control group, while it increased significantly in the treatment group at the end of study (p=0.009).



Vitamin D supplementation attenuated the increase in glycemia, and increased insulin secretion, but had no effect on insulin resistance.
Therapist empathy, combined behavioral intervention, and alcohol outcomes in the COMBINE research project.

Common factors such as therapist empathy play an important role in treatment for addictive behaviors. The present study was a secondary analysis designed to evaluate the relation between therapist empathy and alcohol treatment outcomes in data from a large, multisite, randomized controlled trial.



Audio-recorded psychotherapy sessions for 38 therapists and 700 clients had been randomly selected for fidelity coding from the combined behavioral intervention condition of Project COMBINE. Sessions were evaluated by objective raters for both specific content (coping with craving, building social skills, and managing negative mood) and relational components (empathy level of the therapist). Multilevel modeling with clients nested within therapists evaluated drinks per week at the end of treatment.



Approximately 11% of the variance in drinking was accounted for by therapists. A within-therapist effect of empathy was detected (B = -0.381, SE = 0.103, p < .001); more empathy than usual was associated with subsequent decreased drinking. The Social and Recreational Counseling module (B = -0.412, SE = 0.124, p < .001), Coping with Cravings and Urges module (B = -0.362, SE = 0.134, p < .01), and the Mood Management module (B = -0.403, SE = 0.138, p < .01) were also associated with decreased drinking. No between-therapist effect was detected, and the Empathy × Module Content interactions were not significant.



The results of the study appear consistent with the hypothesis that skills building and therapist empathy are independent contributions to the overall benefit derived from the combined behavioral intervention.
Heterogeneity in response to interferon beta in patients with multiple sclerosis: a 3-year monthly imaging study.

To investigate the heterogeneity in magnetic resonance image (MRI) patterns of response to interferon beta across patients with multiple sclerosis or within an individual patient over time.



Fifteen patients with relapsing-remitting multiple sclerosis underwent monthly MRIs and clinical examinations (6-month pretherapy phase and 36-month therapy phase) and bimonthly neutralizing antibody tests. On each MRI, the total number of contrast-enhancing lesions was noted. Therapy MRI responders were defined as those with a reduction of 60% or more in the total number of contrast-enhancing lesions during each semester of therapy.



Subcutaneous administration of interferon beta-1b, 250 microg, every other day for 3 years.



Reduction in the number of contrast-enhancing lesions.



Eight patients (53.3%) were MRI responders and 7 (46.7%) were nonresponders. Of those 7, 3 (20.0%) had only an initial optimal reduction of the total number of contrast-enhancing lesions, 2 (13.3%) never reached an optimal response, and 2 (13.3%) had a delayed optimal response. No clear association between neutralizing antibody profile and MRI response was evident.



Multiple MRI evaluations disclose that approximately only half of the patients treated with interferon beta achieve and maintain a full response to the drug over time, although an additional small number of individuals may still restore an optimal response to the drug after an initial failure.