nils-herrmann/clean_scirepeval huggingface dataset:
Chronic disease self-management and exercise in COPD as pulmonary rehabilitation: a randomized controlled trial

Both exercise and self-management are advocated in pulmonary rehabilitation for people with chronic obstructive pulmonary disease (COPD). The widely used 6-week, group-based Chronic Disease Self-Management Program (CDSMP) increases self-reported exercise, despite supervised exercise not being a program component. This has been little explored in COPD. Whether adding supervised exercise to the CDSMP would add benefit is unknown. We investigated the CDSMP in COPD, with and without a formal supervised exercise component, to address this question.



Adult outpatients with COPD were randomized to the CDSMP with or without one hour of weekly supervised exercise over 6 weeks. The primary outcome measure was 6-minute walk test distance (6MWD). Secondary outcomes included self-reported exercise, exercise stage of change, exercise self-efficacy, breathlessness, quality of life, and self-management behaviors. Within- and between-group differences were analyzed on an intention-to-treat basis.



Of 84 subjects recruited, 15 withdrew. 6MWD increased similarly in both groups: CDSMP-plus-exercise (intervention group) by 18.6±46.2 m; CDSMP-alone (control group) by 20.0±46.2 m. There was no significant difference for any secondary outcome.



The CDSMP produced à small statistically significant increase in 6MWD. The addition of a single supervised exercise session did not further increase exercise capacity. Our findings confirm the efficacy of a behaviorally based intervention in COPD, but this would seem to be less than expected from conventional exercise-based pulmonary rehabilitation, raising the question of how, if at all, the small gains observed in this study may be augmented.
The efficacy of standard laxative use for the prevention and treatment of opioid induced constipation during oxycodone use: a small Dutch observational pilot study.

Dutch clinical guidelines recommend that a standard laxative treatment (SLT) should be prescribed concomitantly when starting opioid treatment to prevent opioid-induced constipation (OIC).



Clinical evidence for SLT in the treatment of OIC is lacking, therefore an observational pilot study was performed to explore the efficacy and tolerability of SLT on OIC in patients treated with the opioid oxycodone.



Twenty-four patients (58% female, median (range) age 65 (39-92)) were included in this pilot study. The analysis showed that 9 out of 21 patients (43%) were non-responders to SLT. When also taking into consideration patients tending to develop diarrhea 75% of patients are non-responsive to SLT.



This pilot study indicates that optimal laxative therapy (SLT) might not be effective and feasible for the prevention and treatment of OIC.
Uric acid: association with rate of renal function decline and time until start of dialysis in incident pre-dialysis patients

In patients with chronic kidney disease (CKD) hyperuricemia is common. Evidence that hyperuricemia might also play a causal role in vascular disease, hypertension and progression of CKD is accumulating. Therefore, we studied the association between baseline uric acid (UA) levels and the rate of decline in renal function and time until start of dialysis in pre-dialysis patients.



Data from the PREPARE-2 study were used. The PREPARE-2 study is an observational prospective cohort study including incident pre-dialysis patients with CKD stages IV-V in the years between 2004 and 2011. Patients were followed for a median of 14.9 months until start of dialysis, kidney transplantation, death, or censoring. Main outcomes were the change in the rate of decline in renal function (measured as estimated glomerular filtration rate (eGFR)) estimated using linear mixed models, and time until start of dialysis estimated using Cox proportional hazards models.



In this analysis 131 patients were included with a baseline UA level (mean (standard deviation (SD)) of 8.0 (1.79) mg/dl) and a mean decline in renal function of -1.61 (95% confidence interval (CI), -2.01; -1.22) ml/min/1.73 m2/year. The change in decline in GFR associated with a unit increase in UA at baseline was -0.14 (95% CI -0.61;0.33, p=0.55) ml/min/1.73 m2/year. Adjusted for demography, comorbidities, diet, body mass index (BMI), blood pressure, lipids, proteinuria, diuretic and/or allopurinol usage the change in decline in eGFR did not change. The hazard ratio (HR) for starting dialysis for each mg/dl increase in UA at baseline was 1.08 (95% CI, 0.94;1.24, p=0.27). After adjustment for the same confounders the HR became significant at 1.26 (95% CI, 1.06;1.49, p=0.01), indicating an earlier start of dialysis with higher levels of UA.



Although high UA levels are not associated with an accelerated decline in renal function, a high serum UA level in incident pre-dialysis patient is a risk factor for an earlier start of dialysis.
Multicenter study on hemorrhagic risk of heparin bridging therapy for periendoscopic thromboprophylaxis

For endoscopic interventions, heparin bridging therapy is recommended in patients who are at high risk from interruption of antithrombotic therapy. Although heparin bridging has been reported to be effective in preventing thrombosis, several reports have raised concerns about increased risk of bleeding. The aim of this study was to clarify complications of hepari bridging therapy in therapeutic endoscopy.



A nationwide multicenter survey using questionnaire was performed about patients undergoing therapeutic endoscopy with heparin bridging. Patients who underwent therapeutic endoscopy without heparin bridging therapy were considered as controls. Compliance scores of heparin bridging therapy guideline were employed, and association was analyzed between the score and occurrence of post-procedural bleeding.



The incidence of post-procedural bleeding was significantly higher (13.5%, 33/245) in the heparin group compared with the control group (2.7%, 299/11102)(p < 0.001). Thrombosis occurred in 1 patient each in the two groups. In the heparin group, post-procedural bleeding was more likely to be delayed bleeding. Dose adjustment of heparin was a significant factor contributing to bleeding. The compliance score of heparin bridging therapy guideline was significantly higher in those who suffered bleeding.



Heparin bridging therapy significantly increased the risk of post-procedural bleeding compared with the control. The bleeding risk was associated with greater adherence with guidelines for heparin bridging therapy.
Risk-taking propensity as a predictor of induction onto naltrexone treatment for opioid dependence.

Heroin addiction is a chronic relapsing disorder that has devastating social, medical, and economic consequences. Naltrexone is an antagonist that blocks opioid effects and could be an effective medication for the treatment of opioid dependence. However, its clinical utility has been limited partly because of poor adherence and acceptability. Given the importance of compliance to naltrexone treatment for opioid dependence, the goal of the current study was to examine predictors involved in successful induction onto naltrexone treatment.



Parametric and nonparametric statistical tests were performed on data from a sample of 64 individuals entering treatment who met DSM-IV criteria for opioid dependence. The relationship between naltrexone induction (ie, inducted vs not inducted onto naltrexone) and risk-taking propensity, as indexed by riskiness on the Balloon Analogue Risk Task (BART), was examined. Participants were recruited from local detoxification programs, inpatient drug treatment, and other Baltimore programs that provided services to opioid-dependent adults (eg, Baltimore Needle Exchange Program) during the period from August 2007 to September 2008.



Positive association was shown between risk-taking propensity and odds of naltrexone induction. Specifically, each 5-point increase in the total BART score was associated with a 25% decrease in odds of naltrexone induction (OR = 0.76; 95% CI, 0.58-0.99; P = .041). This association remained statistically significant, even after adjusting for potential confounds, including injection drug use and cocaine positive urine results (P = .05). After adjusting for the covariates, each 5-point increase in BART score was associated with 28% decrease in the odds of achieving the maintenance dose (adjusted OR = 0.73; 95% CI, 0.54-0.99; P = .046).



Risk-taking propensity was predictive of induction onto naltrexone treatment, above and beyond injection drug use and cocaine-positive urine samples.
Relationship between postoperative clopidogrel use and subsequent angiographic and clinical outcomes following coronary artery bypass grafting

Dual antiplatelet therapy with both aspirin and clopidogrel is increasingly used after coronary artery bypass grafting (CABG); however, little is known about the safety or efficacy. We sought to determine the relationship between postoperative clopidogrel and clinical and angiographic outcomes following CABG. We evaluated 3,014 patients from PREVENT IV who underwent CABG at 107 US sites. Postoperative antiplatelet therapy was left to physician discretion. Risk-adjusted angiographic and clinical outcomes were compared in patients taking and not taking clopidogrel 30 days post-CABG. At 30 days, 633 (21 %) patients were taking clopidogrel. Clopidogrel users were more likely to have peripheral vascular (15 vs. 11 %) and cerebrovascular disease (17 vs. 11 %), prior myocardial infarction (MI) (46 vs. 41 %), and off-pump surgery (33 vs. 18 %). Clopidogrel use was associated with statistically insignificant higher graft failure (adjusted odds ratio 1.3; 95 % confidence interval [CI] [1.0, 1.7]; P = 0.05). At 5-year follow-up, clopidogrel use was associated with similar composite rates of death, MI, or revascularization (27 vs. 24 %; adjusted hazard ratio 1.1; 95 % CI [0.9, 1.4]; P = 0.38) compared with those not using clopidogrel. There was an interaction between use of cardiopulmonary bypass and clopidogrel with a trend toward lower 5-year clinical events with clopidogrel in patients undergoing off-pump CABG. In this observational analysis, clopidogrel use was not associated with better 5-year outcomes following CABG. There may be better outcomes with clopidogrel among patients having off-pump surgery. Adequately powered randomized clinical trials are needed to determine the role of dual antiplatelet therapy after CABG.
Bortezomib Induced Tumor Lysis Syndrome in Multiple Myeloma

The tumor lysis syndrome (TLS) commonly occurs in the lymphoproliferative disorder, either spontaneously or in response to therapy. TLS is uncommon in multiple myeloma. However, with the use of bortezomib in the treatment of multiple myeloma, cases of TLS have been reported. We report here threepatients who presented with TLS after the administration of bortezomib. Two of them presented mild symptoms and recovered with hydration only. However, death of the other patient was associated with TLS. We should monitor patients who had high tumor burden, especially in early phase of bortezomib therapy and appropriate prophylaxis for high risk patient is also needed.
P05.31. Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis

Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials.



The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists' clinical judgment and maintaining consistency with a prior pilot study.



The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated.



The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings.
Therapist-reported alliance: Is it really a predictor of outcome?

Most of the literature on the alliance-outcome association is based exclusively on differences between patient reports on alliance. Much less is known about the unique contribution of the therapist's report to this association across treatment, that is, the association between therapist-reported alliance and outcome over the course of treatment, after controlling for the patient's contribution. The present study is the first to examine the unique contribution of the therapist-reported alliance to outcome, accounting for reverse causation (symptomatic levels predicting alliance), at several time points in the course of treatment. Of 156 patients randomized to dynamic supportive-expressive psychotherapy, antidepressant medication with clinical management, and placebo with clinical management, 149 were included in the present study. Alliance was assessed from the perspective of both the patient and the therapist. Outcome measures included the patients' self-reported and diagnostician-rated depressive symptoms. Overall, the findings demonstrate that the therapists' contribution to the alliance-outcome association was explained mainly by prior symptomatic levels. However, when a time lag of several sessions was introduced between alliance and symptoms, a positive association emerged between alliance at 1 time point and symptomatic distress assessed several sessions later in the treatment, controlling for previous symptomatic level. The findings were similar whether or not we controlled for the patient's perspective on the alliance. Taken together, the findings attest to the importance of improving therapists' ability to detect deterioration in the alliance.
Severe ADC decreases do not predict irreversible tissue damage in humans.

A mismatch between diffusion- and perfusion-weighted MRI is thought to define tissue at risk of infarction. This concept is based on the assumption that diffusion slowing of and decreases in the apparent diffusion coefficient (ADC) serve as indicator of tissue proceeding to infarction. We tested this hypothesis.



MRI (diffusion weighted, perfusion weighted, MRA, T2 weighted) was performed in 15 patients with acute stroke within 2.9+/-0.8 hours (mean+/-SD) of onset and on days 1 and 7. After intraindividual realignment of the ADC maps, the development of ADC range volumes and ADC values was determined.



An increase (354%, group A1) in the total ADC-based lesion volume below a threshold of < 80% occurred in 4 patients on day 1, persisting on day 7 with a pronounced increase of ADC range volumes with low ADC values. An increase in total ADC-based lesion volume (201%, group A2) followed by a secondary drop to day 7 was found in 7 patients. A significant reduction in total ADC-based lesion volume (14%, group B) was found in 4 patients. ADC-based lesion volume increase was associated with persistent vessel occlusion in group A, whereas recanalization in group B resulted in ADC volume decrease. ADC normalization was observed independently from the degree of the initial ADC decrease on days 1 and 7 in group B.



In line with results from animal experiments, ADC decreases do not reliably indicate tissue infarction Even severely decreased ADC values may normalize in human stroke, and it seems likely that ADC normalization depends on the duration and severity of ischemia rather than the absolute value.
Treatment of postnasal drip with proton pump inhibitors: a prospective, randomized, placebo-controlled study.

Patients commonly present with complaints of postnasal drainage (PND) without objective evidence to support a sinonasal or infectious etiology. PND has been attributed to extra-esophageal reflux (EER), and an empiric trial of antireflux medication often is used to treat PND and associated symptoms. This study was performed to (1) evaluate the relationship between symptoms of EER and PND and (2) assess the efficacy of proton pump inhibitors (PPIs) in the management of PND.



Patients with a chief complaint of PND without objective evidence of sinonasal inflammatory disease were enrolled in a prospective, double-blinded, randomized placebo-controlled trial using rabeprazole, 20 mg, orally twice daily or placebo for 90 days. Subjects completed two-site 24-hour pharyngeal pH probe monitoring before treatment. Outcome measures included pre- and posttreatment visual analog scales for PND symptoms, reflux symptom index, and reflux finding score (RFS).



Forty-seven patients were enrolled (mean age, 55 years)-21 patients in the PPI group and 26 in the placebo group. Fifty-six percent of subjects had pH probe confirmed EER using a cutoff of pH < 5.0. Baseline symptom measures between subjects with and without EER were not different. Compared with placebo, subjects receiving rabeprazole reported significant reduction in PND frequency (p = 0.0180), hoarseness (p = 0.0164), and chronic cough (p = 0.0204). The RFS decreased slightly in the placebo group (p = 0.1490) whereas it increased slightly in the PPI group (p = 0.5235). This difference between groups was significant (p = 0.0272).



Although 50% of subjects had evidence of EER, there was no difference in baseline symptoms between subjects with and without. Our findings support the potential benefit of PPI therapy for reducing PND frequency, hoarseness, and chronic cough, and confirm a placebo effect for other laryngopharyngeal reflux symptoms. The effect on laryngeal findings is mixed and patients may experience symptomatic improvement before changes in laryngoscopic appearance.
Motivational Interviewing to Increase Postdischarge Antibiotic Adherence in Older Adults with Pneumonia.

To evaluate the impact of a pharmacist-led, motivational interviewing on antibiotic adherence following discharge in older adults with pneumonia.



Inpatient medical wards in a large tertiary academic medical center.



Older adults diagnosed with pneumonia were enrolled from December 1, 2013, to August 1, 2014, at Yale-New Haven Hospital.



Motivational interviewing-a patient-centered method of communication-has gained recognition as a tool that can aid pharmacists in addressing negative health behaviors (e.g., medication adherence, health screenings, substance abuse during counseling sessions). However, the potential role of motivational interviewing in older adults to improve medication adherence during transitions of care is not clear. In this study, in addition to standard discharge care, older adults hospitalized with pneumonia who were randomized to the intervention group received enhanced care: pharmacist-led motivational interviewing.



Evaluation of adherence to prescribed antibiotic regimens and patient satisfaction with the motivational interviewing, enhanced-care session.



Ultimately, 87% of patients in the intervention group (n = 16) compared with 64% of patients in the control group (n = 14) were adherent to their antibiotic regimens. Patient satisfaction with the motivational interviewing intervention was high.



Pharmacist-led motivational interviewing sessions have the potential to positively influence antibiotic adherence rates and patient satisfaction.
Primary prevention implantable cardioverter-defibrillators in older racial and ethnic minority patients.

Racial and ethnic minorities are under-represented in clinical trials of primary prevention implantable cardioverter-defibrillators (ICDs). This analysis investigates the association between primary prevention ICDs and mortality among Medicare, racial/ethnic minority patients.



Data from Get With The Guidelines-Heart Failure Registry and National Cardiovascular Data Registry's ICD Registry were used to perform an adjusted comparative effectiveness analysis of primary prevention ICDs in Medicare, racial/ethnic minority patients (nonwhite race or Hispanic ethnicity). Mortality data were obtained from the Medicare denominator file. The relationship of ICD with survival was compared between minority and white non-Hispanic patients. Our analysis included 852 minority patients, 426 ICD and 426 matched non-ICD patients, and 2070 white non-Hispanic patients (1035 ICD and 1035 matched non-ICD patients). Median follow-up was 3.1 years. Median age was 73 years, and median ejection fraction was 23%. Adjusted 3-year mortality rates for minority ICD and non-ICD patients were 44.9% (95% confidence interval [CI], 44.2%-45.7%) and 54.3% (95% CI, 53.4%-55.1%), respectively (adjusted hazard ratio, 0.79; 95% CI, 0.63-0.98; P=0.034). White non-Hispanic patients receiving an ICD had lower adjusted 3-year mortality rates of 47.8% (95% CI, 47.3%-48.3%) compared with 57.3% (95% CI, 56.8%-57.9%) for those with no ICD (adjusted hazard ratio, 0.75; 95% CI, 0.67%-0.83%; P<0.0001). There was no significant interaction between race/ethnicity and lower mortality risk with ICD (P=0.70).



Primary prevention ICDs are associated with lower mortality in nonwhite and Hispanic patients, similar to that seen in white, non-Hispanic patients. These data support a similar approach to ICD patient selection, regardless of race or ethnicity.
Is addition of angiotensin receptor blockade superior to increasing ACE inhibitor dose in patients with heart failure?

We conducted a prospective, randomised, open-label, blinded end point (PROBE) study examining the relative efficacy of irbesartan 300 mg/day versus maximising dose of ACE inhibitor, additional to background conventional heart failure therapy. Patients with CHF, NYHA Class II-III and a left ventricular ejection fraction <40% were randomised to one of two treatment arms. All patients were receiving ≤ half target dose of ACE inhibitor as background therapy. 44 patients received an increase in their background ACE inhibitor while 45 patients were given irbesartan (target dose 300 mg/day) in addition to their background ACE inhibitor. The primary end-point was change in brain natriuretic peptide (BNP) from baseline to 6 months. Change in hs-CRP level, 6 min walk distance, and Minnesota living with heart failure quality of life questionnaire (MLWHF) from baseline to 6 months were also evaluated. Patients were well matched at baseline for all end-point parameters as well as for age, gender and baseline systolic ventricular function. There was general improvement in clinical status for all patients but no significant difference between increased ACE inhibitor vs added ARB for change in BNP, hs-CRP, NYHA, 6 min walk or MLWHF (all P>0.05). This PROBE study has demonstrated similar clinical responses with increased dose of ACE inhibitor compared to addition of ARB in patients with systolic CHF. These findings suggest that either approach to increasing renin-angiotensin blockade in patients taking low doses of background ACE inhibitor results in similar clinical outcomes.