nils-herrmann/clean_scirepeval huggingface dataset:
The effects of orlistat on weight and on serum lipids in obese patients with hypercholesterolemia: a randomized, double-blind, placebo-controlled, multicentre study

Assessment of the effects of orlistat 120 mg three times daily vs placebo on weight loss and serum lipids in obese hypercholesterolemic patients. A 24 week multicentre, double-blind, randomized, placebo-controlled trial. After a 2-week single-blind run-in period (placebo+diet (−600 kcal/day; ≤30% of calories as fat)), 294 patients were submitted to the hypocaloric diet and randomly assigned to either orlistat 120 mg or placebo three times daily. Patients who completed the double-blind study (n=255) were eligible for participation in a subsequent 24 week open-label orlistat extension phase. Patients with body mass index (BMI) 27–40 kg/m2 and hypercholesterolemia (low-density-lipoprotein cholesterol, LDL-C, 4.1–6.7 mmol/l).MEASUREMENTS: Efficacy assessments included weight loss, lipid levels, other cardiovascular risk factors and anthropometric parameters. Safety assessments. Weight loss during run-in was similar in both groups. After randomization, orlistat-treated patients lost significantly more weight than placebo recipients: mean percentage weight loss from start of run-in to week 24 was−6.8% in the orlistat group and −3.8% in the placebo group (P<0.001). Moreover, more patients in the orlistat group than in the placebo group achieved clinically meaningful weight loss of ≥5% (64 vs 39%) or ≥10% (23 vs 13%) at week 24. Treatment with orlistat was associated with significantly greater changes in total cholesterol (−11.9% vs −4.0%; P<0.001) and LDL-C (−17.6 vs −7.6%; P<0.001). For any category of weight loss during the double-blind treatment period, change in LDL-C was more pronounced in orlistat-treated patients than in placebo recipients, indicating that orlistat had a direct cholesterol-lowering effect that was independent of weight reduction (P<0.001). Adjunction of orlistat during the extension phase in patients who initially received placebo induced a further decrease in weight, total cholesterol and LDL-C. Orlistat was generally well tolerated with a safety profile comparable to placebo, with the exception of a higher incidence of gastrointestinal events (≥1 event in 64 vs 38% of patients).CONCLUSION: Orlistat as an adjunct to dietary intervention promotes weight loss and reduces LDL-C beyond the effect of weight loss in overweight or obese patients with concomitant hypercholesterolemia.
It ain't what you do, it's the way that you do it: a qualitative study of advice for young cannabis users.

Advice is a widely recommended and practised intervention with young drug users. Study of precisely how advice is given and received in any setting has, however, been limited.



We qualitatively analysed 106 audio-recordings of advice sessions on cannabis use for young people within a randomised trial. Inductive data analysis was guided by a focus on practitioner behaviour which served to engage the active participation of the young drug user in the session.



A cluster of 'Information Management' activities was identified together with an 'Interactive Orientation' evident in a series of specific behaviours. Participants were most successfully engaged when both were combined, understood here as 'Personalised Advice-giving'.



These components identified in this exploratory study might assist further research in rectifying the absence of a solid empirical basis for effective practice in advice giving with young drug users and more widely.
Using Pictures to Evoke Spiritual feelings in Breast Cancer Patients: Development of a New Paradigm for Neuroimaging Studies

This study was designed to develop and validate a method for enhancing spiritual feelings, particularly in women who have received a diagnosis of breast cancer. The protocol specifically was developed to be used in functional magnetic resonance imaging (fMRI) studies. Eighteen breast cancer survivors rated pictures for their ability to enhance feelings of spirituality, happiness, and sadness. Results indicate that presenting carefully selected pictures with spiritual content (e.g., nature scenes, people engaged in contemplative behaviors) can effectively enhance spiritual feelings among breast cancer survivors. Future fMRI studies will explore the use of the protocol developed in this study for investigating neural activity during spiritual feelings and states.
4D-SPECT/CT in orthopaedics: a new method of combined quantitative volumetric 3D analysis of SPECT/CT tracer uptake and component position measurements in patients after total knee arthroplasty

The purpose was to evaluate the intra- and inter-observer reliability of combined quantitative 3D-volumetric single-photon emission computed tomography (SPECT)/CT analysis including size, intensity and localisation of tracer uptake regions and total knee arthroplasty (TKA) position. Tc-99m-HDP-SPECT/CT of 100 knees after TKA were prospectively analysed. The anatomical areas represented by a previously validated localisation scheme were 3D-volumetrically analysed. The maximum intensity was recorded for each anatomical area. Ratios between the respective value and the mid-shaft of the femur as the reference were calculated. Femoral and tibial TKA position (varus–valgus, flexion–extension, internal rotation– external rotation) were determined on 3D-CT. Two consultant radiologists/nuclear medicine physicians interpreted the SPECT/CTs twice with a 2-week interval. The inter- and intra-observer reliability was determined (ICCs). Kappa values were calculated for the area with the highest tracer uptake between the observers. The measurements of tracer uptake intensity showed excellent inter- and intra-observer reliabilities for all regions (tibia, femur and patella). Only the tibial shaft area showed ICCs <0.89. The kappa values were almost perfect (0.856, p < 0.001; 95 % CI 0.778, 0.922). For measurements of the TKA position, there was strong agreement within and between the readings of the two observers; the ICCs for the orientation of TKA components for inter- and intra-observer reliability were nearly perfect (ICCs >0.84). This combined 3D-volumetric standardised method of analysing the location, size and the intensity of SPECT/CT tracer uptake regions (“hotspots”) and the determination of the TKA position was highly reliable and represents a novel promising approach to biomechanics.
Perioperative hepatic functional risk assessed with technetium-99m diethylenetriamine pentaacetic acid-galactosyl human serum albumin liver scintigraphy in patients undergoing pancreaticoduodenectomy complicated by obstructive jaundice.

Liver scintigraphy with technetium-99m diethylenetriamine pentaacetic acid-galactosyl human serum albumin (Tc-GSA) can be used to predict outcome of biliary drainage and hepatic function after pancreaticoduodenectomy in patients with pancreatic, biliary, and ampullary carcinomas complicated by obstructive jaundice.



Preoperative obstructive jaundice has been reported as a crucial risk factor for serious postoperative complications in patients undergoing pancreaticoduodenectomy. The aim of the present study was to investigate whether Tc-GSA liver scintigraphy can assess hepatic functional risk in patients with pancreatic, biliary, and ampullary carcinomas complicated by obstructive jaundice.



Liver scintigraphy was performed before biliary drainage in 18 patients with obstructive jaundice. The maximum removal rate of Tc-GSA (GSA-Rmax; standard normal value > or = 0.60) was calculated. These patients underwent pancreaticoduodenectomy with wide lymphadenectomy. The efficacy of preoperative biliary drainage was assessed with the decrease in serum bilirubin concentration in the first week after biliary drainage. Postoperative liver function was assessed with the increase in serum bilirubin concentration, which was the difference between the immediate preoperative and maximal postoperative bilirubin concentrations.



Serum bilirubin decreased more in the first week after biliary drainage in patients with GSA-Rmax > or = 0.60 (7.64 +/- 1.09 mg/Dl/wk) than in patients with GSA-Rmax < 0.60 (3.56 +/- 1.25 mg/DL/wk, p = 0.042). Postoperative bilirubin increased less in patients with GSA-Rmax > or = 0.60 (0.81 +/- 0.30 mg/dL) than in patients with GSA-Rmax < 0.60 (4.00 +/- 0.69 mg/DL, p = 0.0012). Multivariate analysis showed that GSA-Rmax significantly predicted the postoperative bilirubin increase (p = 0.020).
Chemical arthrodesis of the distal tarsal joints using sodium monoiodoacetate in 104 horses.

To evaluate chemical arthrodesis using sodium monoiodoacetate for treatment of degenerative joint disease of the tarsometatarsal and distal intertarsal joints.



Retrospective clinical study.



Horses were diagnosed with degenerative joint disease of one or more of the tarsometatarsal or distal intertarsal joints based on history, lameness examination, radiographic findings and, in some cases, response to intra-articular anaesthesia or medication. Intra-articular injections of sodium monoiodoacetate were performed using 23 gauge needles in the sedated, standing horse. Positive contrast arthrography of the distal intertarsal joint was performed in all horses to evaluate needle placement and the presence or absence of communication with other synovial structures. The mean intra-articular dose of sodium monoiodoacetate was 192 mg. Horses were subject to a graded exercise program commencing 7 to 10 days after treatment. Where possible, follow up lameness examination and radiography was performed at 3, 6, 12 and 24 months after treatment.



At 3, 6, 12 and 24 months after treatment, respectively, 0/57, 14/55, 41/50, and 29/34 of horses were sound. At 3, 6, 12 and 24 months after treatment, respectively, 5/55, 24/38, 26/30 and 18/18 of horses had radiographic evidence of ankylosis of treated joints. Post injection pain was marked in 6.7% of horses and significant complications requiring further treatment occurred in 3.8% of horses.



Chemical arthrodesis using sodium monoiodoacetate was an effective treatment method for degenerative joint disease of the distal tarsal joints. The technique was performed in the sedated standing horse and required minimal equipment. Results were comparable to those achieved following surgical arthrodesis. The risk of significant complications was minimised through good technique using an appropriate injection volume and concentration.
Controlled trial of hydroxocobalamin and riboflavine in Nigerian ataxic neuropathy.

The results are presented of a double-blind therapeutic trial of hydroxocobalamin and riboflavine in Nigerian patients suffering from a degenerative neuropathy. Although no benefit from either vitamin was demonstrated, this may reflect the inadequacy of the dosages used. The results are discussed in relation to the hypothesis that dietary cyanide and cyanogens are responsible, at least in part, for the occurrence of this disease in a malnourished population.
The effects of observation of walking in a living room environment, on physical, cognitive, and quality of life related outcomes in older adults with dementia: a study protocol of a randomized controlled trial

The number of older adults with dementia is expected to increase. Dementia is not only characterized by a decline in cognition, also other functions, for example, physical functioning change. A possible means to decrease the decline in these functions, or even improve them, could be increasing the amount of physical activity. A feasible way hereto may be activation of the mirror neuron system through action observation. This method has already been shown beneficial for the performance of actions in, for example, stroke patients. The primary aim of this study is to examine the effect of observing videos of walking people on physical activity and physical performance, in older adults with dementia. Secondary, effects on cognition and quality of life related factors will be examined.



A cluster randomized controlled trial is being performed, in which videos are shown to older adults with dementia (also additional eligibility criteria apply) in shared living rooms of residential care facilities. Due to the study design, living rooms instead of individual participants are randomly assigned to the experimental (videos of walking people) or control (videos of nature) condition, by means of drawing pieces of paper. The intervention has a duration of three months, and takes place on weekdays, during the day. There are four measurement occasions, in which physical activity, physical functioning, activities of daily living, cognition, the rest-activity rhythm, quality of life, and depression are assessed. Tests for participants are administered by a test administrator who is blind to the group the participant is in.



This study examines the effect of the observation of walking people on multiple daily life functions and quality of life related factors in older adults with dementia. A strength of this study is that the intervention does not require much time and attention from caregivers or researchers. A challenge of the study is therefore to get to know for how long residents watch the videos. However, the design implies a high feasibility of the study, as well as a high applicability of the intervention into daily care.
Longitudinal outcome 6 years after spinal cord injury

Multicentered follow-up with centralized data collection based on retrospective study. To assess the outcome in a population of patients with spinal cord injury (SCI). The assessed outcomes are mortality, state of health, occupation, mobility, autonomy, social and partner relationships, quality of life (QoL), with the identification of any relation between results and demographic–clinical data. Two rehabilitation centers (Udine and Trevi) and a Spinal Injuries Unit ( A total of 251 patients with SCI discharged after first hospitalization from rehabilitation facilities between 1989 and 1994 were enrolled. A questionnaire was administered by telephone. During the time between discharge and follow-up, 25 out of the 251 patients had died, yielding a mortality rate of 9.96%. A total of 80 patients did not give their consent. The 146 patients' mean interval from discharge from the rehabilitation facility was 6 years. At least 25% has been hospitalized again. The descriptive analysis also shows that 29.5% of patients were working, 48.6% were able to drive, 63.7% would leave their home alone, 61% would leave home every day, 63% reported of a change in their relationships, 48.6% were happy with their love lives. Significant correlations have emerged between certain items and age: those who had a job, who could drive, were more autonomous and had a higher QoL are generally younger.  The injury's completeness and etiology do not exhibit any correlation. QoL is associated with a number of items: a higher QoL is linked to the possibility to work, especially if it is a paid job, to the ability to drive, to a good degree of autonomy, to a lack of change in the social and partner relationships, and to a satisfactory love life. At 6 years after discharge from rehabilitations, the effects of trauma on work and social and partner relationships, domains correlated with autonomy and QoL, are evident. Further investigation by means of a prospective study over the years are therefore necessary.
Subsequent afebrile seizure in children who have a first seizure with fever after 6 years of age.

The objective was to evaluate the risk and the risk factors associated with subsequent afebrile seizures in 31 children who experienced their first seizure with fever after 6 years of age. The children were classified into two groups. Group I comprised children with their first seizure with fever after 6 years of age (n = 15). Group II comprised children who had febrile seizures before 5 years of age and who had recurrent seizures with fever after 6 years of age (n = 16). Of these 31 children, 7 (22.5%) had subsequent afebrile seizure. The cumulative probability of subsequent afebrile seizure was 13.3% at 6 months and 36 months in group I; in group II, the cumulative probability was 12.5% at 6 months, 18.8% at 18 months, 25% at 24 months, and 31.3% at 36 months. There was no significant difference in the risk for subsequent afebrile seizures between the two groups. There were no risk factors associated with an increased risk of subsequent afebrile seizures. If the first seizure with fever occurred after 6 years of age, this was a significant risk for subsequent afebrile seizure; the risk of seizure recurrence in this group appears to be similar to children who have persistent febrile seizures after 6 years of age, but far below that of children with first epileptic seizure.
Systemic effects of inhaled corticosteroids on growth and bone turnover in childhood asthma: a comparison of fluticasone with beclomethasone.

Inhaled steroids are frequently used in childhood asthma, but concerns based on limited objective evidence remain, regarding long-term side-effects. In this study the systemic effects of standard doses of inhaled steroids in childhood asthma were assessed, comparing beclomethasone dipropionate (BDP) with fluticasone propionate (FP). The study was prospective, randomized and double-blind. Twenty-three steroid-naive children with moderately severe asthma, aged 5-10 yrs, were allocated either BDP (400 microg x day(-1) or FP (200 microg x day(-1)) using a metered-dose inhaler with a spacer. Asthma control was assessed at regular intervals over 20 months. Fasting morning blood and overnight urine samples were collected for estimation of serum cortisol, serum 1-carboxyterminal telopeptide (ICTP), serum osteocalcin and urine deoxypyridinoline (DPD). Bone mineral density (BMD) was measured at each visit. None of the markers of bone turnover showed any change during the study period. BMD increased at normal rates with age. Serum cortisol significantly decreased on BDP, but not on FP. A significant difference in growth rates was found between the groups, with a slower rate of growth towards the end of the observation period in the BDP group. In conclusion when taken in a relatively modest dose over a period of time, beclomethasone dipropionate had significant effects on the hypothalamic-pituitary-adrenal axis and statural growth in childhood asthma. These systemic effects were not seen with an equipotent dose of fluticasone propionate.
Risk- and response-based classification of childhood B-precursor acute lymphoblastic leukemia: a combined analysis of prognostic markers from the Pediatric Oncology Group (POG) and Children's Cancer Group (CCG).

The Children's Cancer Group (CCG) and the Pediatric Oncology Group (POG) joined to form the Children's Oncology Group (COG) in 2000. This merger allowed analysis of clinical, biologic, and early response data predictive of event-free survival (EFS) in acute lymphoblastic leukemia (ALL) to develop a new classification system and treatment algorithm. From 11 779 children (age, 1 to 21.99 years) with newly diagnosed B-precursor ALL consecutively enrolled by the CCG (December 1988 to August 1995, n=4986) and POG (January 1986 to November 1999, n=6793), we retrospectively analyzed 6238 patients (CCG, 1182; POG, 5056) with informative cytogenetic data. Four risk groups were defined as very high risk (VHR; 5-year EFS, 45% or below), lower risk (5-year EFS, at least 85%), and standard and high risk (those remaining in the respective National Cancer Institute [NCI] risk groups). VHR criteria included extreme hypodiploidy (fewer than 44 chromosomes), t(9;22) and/or BCR/ABL, and induction failure. Lower-risk patients were NCI standard risk with either t(12;21) (TEL/AML1) or simultaneous trisomies of chromosomes 4, 10, and 17. Even with treatment differences, there was high concordance between the CCG and POG analyses. The COG risk classification scheme is being used for division of B-precursor ALL into lower- (27%), standard- (32%), high- (37%), and very-high- (4%) risk groups based on age, white blood cell (WBC) count, cytogenetics, day-14 marrow response, and end induction minimal residual disease (MRD) by flow cytometry in COG trials.
Hypochloremia, Diuretic Resistance, and Outcome in Patients With Acute Heart Failure.

Chloride plays a role in renal salt sensing, neurohormonal activation, and regulation of diuretic targets, and hypochloremia predicts mortality in acute heart failure (AHF). AHF therapies, such as diuretics, alter chloride homeostasis. We studied the association between (changes in) chloride levels and diuretic responsiveness, decongestion, and mortality in patients with AHF.



Patients hospitalized for AHF in the PROTECT trial (n=2033) with serum chloride levels within 24 hours of admission and 14 days later were studied (n=1960). Hypochloremia was defined as serum chloride <96 mEq/L. Mean baseline chloride was 100.8±5.0 mEq/L. Low baseline chloride was associated with high bicarbonate, poor diuretic response, less hemoconcentration, and worsening heart failure (all P<0.01). Newly developed hypochloremia at day 14 was common and associated with a decline in renal function and an increase in blood urea nitrogen (P<0.01). In multivariable analyses, chloride measured at day 14, but not baseline chloride, was strongly and independently associated with mortality through 180 days (hazard ratio per unit decrease: 1.07 [1.03-1.10]; P<0.001). In comparison, sodium was not significantly associated with mortality after multivariable adjustment at any time point. Hypochloremia at baseline that resolved was not associated with mortality (P=0.55), but new or persistent hypochloremia at day 14 was associated with increased mortality (hazard ratio: 3.11 [2.17-4.46]; P<0.001).



Low serum chloride at AHF hospital admission was strongly associated with impaired decongestion. New or persistent hypochloremia 14 days later was independently associated with reduced survival, whereas hypochloremia that resolved by day 14 was not.
Managing better: children, parents, and asthma.

To evaluate a health education program to improve family management of asthma, 310 children with asthma and their 290 parents were randomly assigned to a program or control group. Program families participated in health education designed to resolve specific management problems and build self-confidence in the ability to manage asthma. Following education, program parents scored better on an asthma self-management index than parents in the control group (+1.57 versus -0.83, P less than 0.0001). Program parents also scored better on two subindices of the self-management index: attack management (+0.87 vs. +0.42, P less than 0.05) and preventive measures (+0.42 vs. -0.35, P less than 0.05). Also, program parents reported significantly more use of guidelines to determine appropriate levels of physical activity for children. Following education, program children reported more use of three management steps than control children: productive cough or postural drainage (59% vs. 35%, P less than 0.004), breathing and relaxation exercises (80% vs. 65%, P less than 0.05), and attempts to stay calm (12% vs. 2%, P less than 0.05). Program children reported significantly less worry than control children about the limitations asthma imposes and about making mistakes at school.