nils-herrmann/clean_scirepeval huggingface dataset:
Comparison of effectiveness of high-dose intracoronary adenosine versus intravenous administration on the assessment of fractional flow reserve in patients with coronary heart disease.

Intravenous adenosine is considered the drug of choice to obtain maximum hyperemia in the measurement of the fractional flow reserve (FFR). However, comparative studies performed between intravenous and intracoronary administration have not used high doses of intracoronary adenosine. The present study compared the efficacy and safety of high doses of intracoronary adenosine to intravenous administration when calculating the FFR. Intracoronary bolus doses of 60, 180, 300, and 600 μg adenosine were compared to an intravenous administration of 140 μg/kg/min, 200 μg/kg/min, and 140 μg/kg/min plus an intracoronary bolus of 120 μg. All the cases were performed using the radial approach. FFR was assessed in 102 patients with 108 intermediate lesions by an intracoronary pressure wire. The intracoronary dose of 60 μg was associated with a significantly greater FFR compared to the intravenous infusion (0.02 ± 0.03, p = 0.001). The intracoronary doses of 300 (-0.01 ± 0.00; p = 0.006) and 600 μg (-0.02 ± 0.00; p <0.0005) were significantly associated with a smaller FFR compared to the intravenous infusion. An intracoronary dose of 600 μg revealed a significantly greater percentage of lesions with an FFR <0.80 compared to intravenous infusion at 140 μg/kg/min (37.6 vs 31.5%; p <0.05) and 200 μg/kg/min (37.6 vs 32.4%; p <0.05) and compared to intracoronary doses of 60 (26.9%) and 180 μg (31.5%). In conclusion, an intracoronary bolus dose >300 μg can be equal to or more effective than an intravenous infusion of adenosine in achieving maximum hyperemia when calculating the FFR. Its use could simplify these procedures without having an effect on safety.
Linking the Klein-Bell Activities of Daily Living Scale to the International Classification of Functioning, Disability and Health.

The main objective of this study was to link the Klein-Bell activities of daily living (KB) Scale to the International Classification of Functioning, Disability and Health (ICF), in order to validate the KB Scale content-wise.



A qualitative approach was used with directed content analysis.



Concepts in the KB Scale items were linked to ICF categories according to established rules. This was followed by 4 analyses: examination of the linked categories' frequency distribution; comparison of these categories with core sets for spinal cord injury (SCI) and occupational therapists; calculation of content density, content diversity and range of linked categories; and calculation of agreement between two independent linkage versions.



All except one identified KB Scale concept could be linked to ICF categories. The occupational therapists Core Sets were most consistent with linked categories in the KB Scale. Content density, content diversity and range varied between the different KB Scale dimensions. Agreement was reliable for the whole KB Scale and for 5 of 6 dimensions.



The ICF has provided a valuable reference to identify and quantify the concepts in the KB Scale. Furthermore, comparison between the KB Scale and ICF Core Sets provides insights into areas covered by these instruments.
Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand.

Xenotransplantation using pig cells, tissues, or organs may be associated with the transmission of porcine microorganisms and the development of zoonoses. Among all porcine microorganisms porcine endogenous retroviruses (PERVs) represent a special risk because they are integrated in the genome of all pigs and able to infect human cells. In previous preclinical and retrospective clinical trials of xenotransplantation, no transmission of PERV was observed. The first clinical trial of (alginate-encapsulated) porcine islet cell transplantation in New Zealand, which was approved by the New Zealand Government as an open-label phase I/IIa safety/efficacy trial, offers the possibility to analyze microbiological safety in a prospective clinical study.



Before the trial started, a multilevel testing strategy was used to screen for 26 microorganisms in donor pigs of the Auckland Island strain and the islet cell preparations used for treatment. Donor testing was performed using molecular methods including multiplex real-time PCR. Blood samples from 14 pig islet cell recipients were also investigated by molecular biological methods at weeks 1, 4, 8, 12, 24, and 52 post-transplant for the transmission of porcine microorganisms. Sera were also monitored at these time points for antibodies against PERVs.



Beginning in 2009, fourteen patients with severe unaware hypoglycemia were treated with one of four different dosages of alginate-encapsulated porcine islets ranging from 5000-20,000 islet equivalents delivered in a single dose. No transmission of either PERVs or other porcine microorganisms was detected by PCR and immunological methods.



These findings support previous results and strongly indicate the safety of xenotransplantation as performed here.
Effect of Acupressure on Nausea-Vomiting in Patients With Acute Myeloblastic Leukemia.

The aim of this study was to assess the effect of acupressure, applied at P6 (Neiguan) acupuncture point, on chemotherapy-induced nausea and vomiting in patients with acute myeloblastic leukemia. This was a randomized controlled trial conducted on patients with myeloblastic leukemia. A total of 90 patients, who received the same chemotherapy regimen and antiemetic therapy, were included in the study as 30 patients in the control group, 30 patients in the band group, and 30 patients in the pressure group. Although acupressure was applied by placing wristbands at P6 acupuncture point of both wrists in patients of the band group for totally 4 days, acupressure was applied with the use of finger pressure in patients of the pressure group for totally 4 days. No intervention was made in patients of the control group other than the routine antiemetic therapy. The data of the study were collected by using a questionnaire and nausea-vomiting chart. Severity of nausea-vomiting was assessed by using the visual analog scale on this chart. It was determined that the acupressure band applied to the patients included in the study reduced number and severity of nausea-vomiting (P < .05); however, the acupressure applied with pressure did not affect number and severity of nausea-vomiting (P > .05). It was found that the acupressure band was effective for reducing the chemotherapy-induced nausea and vomiting.
Role of Preoperative Magnetic Resonance Imaging in the Surgical Management of Early-Stage Breast Cancer

To examine the role of preoperative magnetic resonance imaging (pMRI) on time to surgery and rates of reoperation and contralateral prophylactic mastectomy (CPM) using a population-based study of New Jersey breast cancer patients. The study included 289 African-American and 320 white women who participated in the Breast Cancer Treatment Disparity Study and underwent breast surgery for newly diagnosed early-stage breast cancer between 2005 and 2010. Patients were identified through rapid case ascertainment by the New Jersey State Cancer Registry. Association between pMRI and time to surgery was examined by using linear regression and, with reoperation and CPM, by using binomial regression. Half (49.9 %) of the study population received pMRI, with higher use for whites compared with African-Americans (62.5 vs. 37.5 %). After adjusting for potential confounders, patients with pMRI versus those without experienced significantly longer time to initial surgery [geometric mean = 38.7 days; 95 % confidence interval (CI) 34.8–43.0; vs. 26.5 days; 95 % CI 24.3–29.0], a significantly higher rate of CPM [relative risk (RR) = 1.82; 95 % CI 1.06–3.12], and a nonsignificantly lower rate of reoperation (RR = 0.76; 95 % CI 0.54–1.08). Preoperative MRI was associated with significantly increased time to surgery and a higher rate of CPM, but it did not affect the rate of reoperation. Physicians and patients should consider these findings when making surgical decisions on the basis of pMRI findings.
Design and participant baseline characteristics of 'A Clinical Trial of IntensiVE Dialysis': the ACTIVE Dialysis Study.

Observational reports suggest extended dialysis hours are associated with improved outcomes. These findings are confounded by better prognostic characteristics among people practising extended hours. The aim of this article is to provide an overview of the methods and baseline characteristics for ACTIVE Dialysis Study participants.



This multicentre, randomized, open-label, blinded endpoint-assessment trial randomized participants receiving maintenance haemodialysis therapy to either extended (≥24 h) or standard (12-18 h) weekly haemodialysis for 12 months. A web-based randomization system used minimization to ensure balanced allocation across regions, dialysis setting and dialysis vintage. The primary outcome is the change in quality of life over 12 months of study treatment assessed by EQ-5D. Secondary outcomes include change in left ventricular mass index assessed by magnetic resonance imaging and safety outcomes including dialysis access events.



A total of 200 participants were recruited between 2009 and 2013 from Australia (29.0%), China (62.0%), Canada (5.5%) and New Zealand (3.5%). Participants had a mean age of 52 (± 12) years and 11.5% were dialysing at home, with a mean duration of 13.9 h per week over a median of three sessions. At baseline, 32.5% had a history of cardiovascular disease and 36.5% had diabetes.



The ACTIVE Dialysis Study has met its planned recruitment target. The participant population are drawn from a range of health service settings in a global context. The study will contribute important evidence on the benefits and harms of extending weekly dialysis hours. The trial is registered at clinicaltrials.gov (NCT00649298).
Responsiveness of the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life Scale (AAQoL)

This study examined responsiveness of the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life Scale (AAQoL), which was developed to assess health-related quality of life (HRQL) among adults with attention-deficit/hyperactivity disorder (ADHD). Adults with ADHD completed the AAQoL, Conners’ Adult ADHD Rating Scale (CAARS), SF-36, and Endicott Work Productivity Scale (EWPS) at baseline and week 8 of a randomized, placebo-controlled trial of atomoxetine. Clinicians rated symptom severity and improvement (CGI-ADHD-S, CGI-ADHD-I). Responsiveness was examined through effect sizes and association with change in the measures listed previously (Spearman correlations, GLMs). Analyses included 328 patients (58.8% male; mean age = 36.9 years). All AAQoL scales reflected significant improvement from baseline to week 8 (P < 0.0001). AAQoL change scores were significantly correlated with change in the CGI-ADHD-S (r = −0.37 to −0.50), EWPS (r = −0.43 to −0.63), and CAARS (r = −0.35 to −0.62) (all P < 0.001). AAQoL change scores significantly discriminated among patients with various levels of symptom improvement. AAQoL effect sizes (−0.67 to −1.11) were larger than effect sizes for the SF-36 (0.15 to −0.39). The AAQoL was responsive to change in symptoms of ADHD, and it appears to be a useful outcome measure for treatments of ADHD in adults.
Acceptability and Preliminary Efficacy of a Tailored Online HIV/STI Testing Intervention for Young Men who have Sex with Men: The Get Connected! Program

Southeast Michigan accounts for over 70 % of all HIV/STI cases in the state, with young men who have sex with men (YMSM) between the ages of 13 and 24 encumbering the largest burden in HIV/STI incidence. Using community-based participatory research principles, we developed and pilot tested a web-based, randomized control trial seeking to promote HIV/STI testing (“Get Connected!”) among YMSM (N = 130; ages 15–24). Randomized participants completed a baseline assessment and shown a test-locator condition (control) or a tailored, personalized site (treatment). At 30-day follow-up, we found high acceptability among YMSM in both conditions, yet higher credibility of intervention content among YMSM in the treatment group (d = .55). Furthermore, 30 participants reported testing by following, with the majority of these participants (73.3 %; n = 22) completing the treatment condition, a clinically meaningful effect (d = .34) suggesting preliminary efficacy for the intervention. These results demonstrate the potential of the intervention, and suggest that a larger efficacy trial may be warranted. El Sudeste de Michigan contiene más del 70 % de todos los casos de VIH/ETS en el estado, con JHCH (jóvenes hombres que tienen sexo con hombres) entre las edades de 13 y 24 sufriendo la mayor incidencia de VIH/ETS. Utilizando los principios de investigación participativa y comunitaria, hemos desarrollado y examinado un proyecto piloto, con diseñode ensayo aleatorizado de control basado en promover la prueba de VIH/ETS (“Get Connected!”) entre JHCH (N = 130 entre los 15 y 24 años). Los JHCH completaron un cuestionario inicial y asignados a una condición control (acceso a un localizador de pruebas) o a un grupo de tratamiento (un sitio web personalizado). A los 30 días de seguimiento, encontramos una alta aceptación a ambas condiciones de la intervención; sin embargo, encontramos una mayor credibilidad al contenido entre los JHCH en el grupo de tratamiento (d = .55). Treinta participantes se reportaron haberse hecho una prueba de VIH/ETS durante el seguimiento, con la mayoría de los participantes (73.3 %, n = 22) siendo parte de la condición de tratamiento, un efecto clínicamente significativo (d = .34) que sugiere la eficacia preliminar de la intervención. Estos resultados demuestran el potencial de laintervención, y sugieren un estudio de eficacia con una muestra más grande de JHCH.
Caregivers' appraisals of patients' involuntary hospital treatment: European multicentre study.

Mental health policies emphasise that caregivers' views of involuntary psychiatric treatment should be taken into account. However, there is little evidence on how caregivers view such treatment.



To explore caregivers' satisfaction with the involuntary hospital treatment of patients and what factors are associated with caregivers' appraisals of treatment.



A multicentre prospective study was carried out in eight European countries. Involuntarily admitted patients and their caregivers rated their appraisal of treatment using the Client Assessment of Treatment Scale 1 month after admission.



A total of 336 patients and their caregivers participated. Caregivers' appraisals of treatment were positive (mean of 8.5 on a scale from 0 to 10) and moderately correlated with patients' views. More positive caregivers' views were associated with greater patients' symptom improvement.



Caregivers' appraisals of involuntary in-patient treatment are rather favourable. Their correlation with patients' symptom improvement may underline their relevance in clinical practice.
Pulmonary hemorrhage: Imaging with a new magnetic resonance blood pool agent in conjunction with breathheld three-dimensional magnetic resonance angiography

To describe the three-dimensional magnetic resonance angiography (3D MRA) imaging appearance of the pulmonary arteries following administration of a superparamagnetic iron oxide blood pool agent to human volunteers, and to demonstrate in an animal model (pigs) how this technique can be used to detect pulmonary parenchymal hemorrhage.  Two volunteers were examined following the intravenous administration of a superparamagnetic iron oxide blood pool agent (NC100150 Injection, Nycomed Amersham Imaging, Wayne, PA, USA). T1-weighted 3D gradient recalled echo (GRE) image sets (TR/TE 5.1/1.4 msec, flip angle 30°) were acquired breathheld over 24 sec. To assess the detectability of pulmonary bleeding with intravascular MR contrast, pulmonary parenchymal injuries were created in two animals under general anesthesia, and fast T1-weighted 3D GRE image sets collected before and after the injury.  Administration of the intravascular contrast in the two volunteers resulted in selective enhancement of the pulmonary vasculature permitting complete visualization and excellent delineation of central, segmental, and subsegmental arteries. Following iatrogenic injury in the two animals, pulmonary hemorrhage was readily detected on the 3D image sets.  The data presented illustrate that ultrafast 3D GRE MR imaging in conjunction with an intravenously administered intravascular blood pool agent can be used to perform high-quality pulmonary MRA as well as to detect pulmonary hemorrhage.
Existential behavioural therapy for informal caregivers of palliative patients: a randomised controlled trial.

Existential behavioural therapy (EBT) was developed to support informal caregivers of palliative patients in the last stage of life and during bereavement as a manualised group psychotherapy comprising six sessions. We tested the effectiveness of EBT on mental stress and quality of life (QOL).



Informal caregivers were randomly assigned (1:1) to EBT or a treatment-as-usual control group using computer-generated numbers in blocks of 10. Primary outcomes were assessed with the Brief Symptom Inventory (subscales somatisation, anxiety and depression), the Satisfaction with Life Scale (SWLS), the WHOQOL-BREF and a numeric rating scale for QOL (QOL-NRS, range 0-10). Data were collected at baseline, pre-treatment, post-treatment and follow-ups after 3 and 12 months. Treatment effects were assessed with a multivariate analysis of covariance.



Out of 160 relatives, 81 were assigned to EBT and 79 to the control group. Participants were 54.5 ± 13.2 years old; 69.9% were female. The multivariate model was significant for the pre-/post-comparison (p=0.005) and the pre-/12-month comparison (p=0.05) but not for the pre-/3-month comparison. Medium to large effects on anxiety and QOL (SWLS, WHOQOL-BREF, QOL-NRS) were found at post-treatment; medium effects on depression and QOL (QOL-NRS) emerged in the 12-month follow-up. No adverse effects of the intervention were observed.



Existential behavioural therapy appears to exert beneficial effects on distress and QOL of informal caregivers of palliative patients. Further longitudinal evidence is needed to confirm these findings.
[Muscle retraining or aerobic endurance training? What will improve the aerobic capacity of patients with coronary disease in the only 4 weeks?].

The aim of this study was to compare the effects of 4 weeks of CT and AT, which training impulse (total external workload and perceived exertion), are similar on power associated at VO2 peak (pVO2 peak) and cardiorespiratory responses of patient with CAD.



Eighteen male with CAD (62 ± 7 years, 175 ± 2 cm, 84 ± 16 kg, fraction of ejection = 0.49 ± 0.16) performed 4 weeks of CT (n = 9) or AT (n = 9). pVO2 peak, maximal and first ventilatory threshold values of oxygen uptake (VO2 peak, VO2-vt) and heart rate (HRmax, HR-vt) were measured before and after training session. Total training impulse (exercise rehabilitation and other paramedical actions) were evaluated and harmonized between AT and CT according to Foster et al. formula (1996)  No significant difference were found in training impulse between AT and CT (3650 ± 220 vs 3497 ± 190 U, P = NS). VO2 pic increased after AT (16.9 ± 4.4 vs 18.9 ± 4.9 mL O2/min/kg, P < 0.05) and remained unchanged after CT (17.7 ± 7.8 vs 17.8 ± 7.2, P = NS). Four weeks of training induced significant increase in pVO2 peak, VO2-vt and FC-vt, expressed in absolute or relative value (P < 0,05), without any difference between AT and CT modalities (P = NS).



Improving pVO2 pic following an exercise training does not necessarily preclude an improvement in coronary VO2 pic. pVO2 peak was not improved with the same cardiorespiratory adaptations between AT and CT. Thus, there seems important to measure gas exchanges of subject with CAD during the incremental test and identify the respective part of muscular and cardiorespiratory functions in exercise exhaustion.
Patient predictors of symptom and functional outcome following cognitive behaviour therapy or befriending in first-episode psychosis

Cognitive behaviour therapy (CBT) is an effective treatment for many, but not all, individuals with psychosis. An important goal is identifying individuals more likely to benefit from CBT to ensure appropriate delivery. The current study aimed to examine patient-related predictors of symptom and functional outcome following CBT and Befriending in first-episode psychosis (FEP).



Our original randomized controlled trial compared 14 weeks of CBT (n=31) and Befriending (n=31) in FEP (Jackson et al. 2008). A series of regressions were conducted separately for each group to examine demographic, cognitive, symptoms/illness and functioning variables in predicting positive symptoms (BPRS Psychotic), negative symptoms (SANS Total) and functioning (SOFAS) at 1-year follow-up.



In the CBT group, higher baseline functioning (SOFAS) predicted lower levels of positive symptoms (R(2)=0.19; p=0.023), higher educational achievement and lower levels of avolition symptoms (SANS Avolition) predicted lower levels of total negative symptoms (R(2)=0.38; p=0.003), and working/studying at baseline predicted higher functional outcome (R(2)=0.35; p=0.004) at 1 year. In the Befriending group, premorbid adjustment (PAS Average) was the only variable that predicted 1-year positive symptom (R(2)=0.26; p=0.010), negative symptom (R(2)=0.35; p=0.016) and functional (R(2)=0.48; p=0.002) outcome.



FEP individuals with higher baseline functioning may benefit more from CBT than those with poorer functioning. Individuals with functional difficulties may benefit from alternative treatments initially, such as supported education or employment.
The effect of single doses of pramlintide on gastric emptying of two meals in men with IDDM

In a previous study we have shown that an intravenous infusion of pramlintide (an analogue of human amylin) delayed gastric emptying, but the dose of pramlintide was supraphysiological in relation to the amylin response to food in non-diabetic subjects. The purpose of this study was to examine the dose response relationship of subcutaneous injections of pramlintide on gastric emptying and to determine whether administration of the drug before one meal has an impact on the subsequent meal. Eleven men with insulin-dependent diabetes mellitus were studied in a double-blind, randomised, four-way crossover design. None had autonomic neuropathy. Euglycaemia was maintained overnight before the study day. At −30 min the patients self-injected their usual morning insulin and at −15 min they injected the study drug (either placebo or 30, 60 or 90 μg pramlintide) subcutaneously. At 0 min they ate a standard meal consisting of a pancake, labelled with 99mTc, and a milkshake containing 3-ortho-methylglucose (3-OMG). Gastric emptying images were obtained for the next 8 h. At 240 min the subjects ate a similar meal, but on this occasion the pancake was labelled with 111In. All three doses of pramlintide delayed emptying of the solid component of the first meal (p < 0.004) with no significant difference between the drug doses. There were no differences between placebo and pramlintide after the second meal. All three doses of pramlintide resulted in a prolongation in the time to peak plasma 3-OMG level (p < 0.0001) after the first meal but there was no difference after the second meal.