nils-herrmann/clean_scirepeval huggingface dataset:
Paricalcitol- or cinacalcet-centred therapy affects markers of bone mineral disease in patients with secondary hyperparathyroidism receiving haemodialysis: results of the IMPACT-SHPT study.

In this Phase 4 international study, efficacy and safety of paricalcitol-centred therapy were compared with that of cinacalcet-centred therapy for the treatment of chronic kidney disease (CKD)-associated secondary hyperparathyroidism (SHPT) in patients undergoing haemodialysis (ClinicalTrials.gov identifier NCT00977080).



Patients ≥ 18 years of age with Stage 5 CKD and SHPT [intact parathyroid hormone (iPTH) level of 300-800 pg/mL, calcium level of 8.4-10.0 mg/dL and phosphate concentration of ≤ 6.5 mg/dL] who were undergoing haemodialysis were included. Patients were randomized by mode of paricalcitol administration [i.e. intravenous (IV) or oral strata] to receive paricalcitol- or cinacalcet-centred therapy for ≤ 28 weeks. Changes in metabolic markers [total alkaline phosphatase (AP), bone-specific AP and fibroblast growth factor-23 (FGF-23)] and the proportion of patients in each treatment group who achieved an iPTH level of 150-300 pg/mL during Weeks 8, 16 and 21-28 as a composite value were evaluated.



Compared with cinacalcet-centred therapy, levels of both bone turnover markers were significantly reduced from baseline with IV and oral paricalcitol-centred treatment (P < 0.05 for both dosing strata) at Weeks 8, 16 and 28. Levels of FGF-23 were increased with paricalcitol versus cinacalcet-centred treatment. A greater proportion of patients receiving paricalcitol-centred therapy achieved target iPTH levels (i.e. 150-300 pg/mL) throughout the study in the IV and oral dosing strata compared with patients receiving cinacalcet-centred treatment.



In patients with CKD and SHPT undergoing haemodialysis, paricalcitol-centred therapy reduced circulating bone turnover markers and iPTH levels and increased FGF-23 levels compared with cinacalcet-centred treatment.
Trial comparing D-penicillamine and gold in rheumatoid arthritis. Preliminary report.

The Multicentre Trial Group (1973) showed that penicillamine was superior to placebo in a doubleblind trial against placebo. In this trial penicillamine was compared with gold. There are three reasons why a double-blind trial of penicillamine and gold was not attempted; first, gold is given by injection and penicillamine orally;. secondly, both drugs have distinctive side effects which might 'unblind' the observer; and thirdly, because some side effects are potentially dangerous, it is essential that the physician knows which drug his patient is receiving. For these reasons, the patients were treated by their usual physicians who supervised dosage and documented side effects. Before the trial and at 3-monthly intervals after the start of treatment, the patients were seen by a 'blind' observer from another hospital.
Asthma and genes encoding components of the vitamin D pathway

Genetic variants at the vitamin D receptor (VDR) locus are associated with asthma and atopy. We hypothesized that polymorphisms in other genes of the vitamin D pathway are associated with asthma or atopy.



Eleven candidate genes were chosen for this study, five of which code for proteins in the vitamin D metabolism pathway (CYP27A1, CYP27B1, CYP2R1, CYP24A1, GC) and six that are known to be transcriptionally regulated by vitamin D (IL10, IL1RL1, CD28, CD86, IL8, SKIIP). For each gene, we selected a maximally informative set of common SNPs (tagSNPs) using the European-derived (CEU) HapMap dataset. A total of 87 SNPs were genotyped in a French-Canadian family sample ascertained through asthmatic probands (388 nuclear families, 1064 individuals) and evaluated using the Family Based Association Test (FBAT) program. We then sought to replicate the positive findings in four independent samples: two from Western Canada, one from Australia and one from the USA (CAMP).



A number of SNPs in the IL10, CYP24A1, CYP2R1, IL1RL1 and CD86 genes were modestly associated with asthma and atopy (p < 0.05). Two-gene models testing for both main effects and the interaction were then performed using conditional logistic regression. Two-gene models implicating functional variants in the IL10 and VDR genes as well as in the IL10 and IL1RL1 genes were associated with asthma (p < 0.0002). In the replicate samples, SNPs in the IL10 and CYP24A1 genes were again modestly associated with asthma and atopy (p < 0.05). However, the SNPs or the orientation of the risk alleles were different between populations. A two-gene model involving IL10 and VDR was replicated in CAMP, but not in the other populations.



A number of genes involved in the vitamin D pathway demonstrate modest levels of association with asthma and atopy. Multilocus models testing genes in the same pathway are potentially more effective to evaluate the risk of asthma, but the effects are not uniform across populations.
Comparative effects of dried plum and dried apple on bone in postmenopausal women.

Aside from existing drug therapies, certain lifestyle and nutritional factors are known to reduce the risk of osteoporosis. Among the nutritional factors, dried plum or prunes (Prunus domestica L.) is the most effective fruit in both preventing and reversing bone loss. The objective of the present study was to examine the extent to which dried plum reverses bone loss in osteopenic postmenopausal women. We recruited 236 women, 1-10 years postmenopausal, not on hormone replacement therapy or any other prescribed medication known to influence bone metabolism. Qualified participants (n 160) were randomly assigned to one of the two treatment groups: dried plum (100 g/d) or dried apple (comparative control). Participants received 500 mg Ca plus 400 IU (10 μg) vitamin D daily. Bone mineral density (BMD) of lumbar spine, forearm, hip and whole body was assessed at baseline and at the end of the study using dual-energy X-ray absorptiometry. Blood samples were collected at baseline, 3, 6 and 12 months to assess bone biomarkers. Physical activity recall and 1-week FFQ were obtained at baseline, 3, 6 and 12 months to examine physical activity and dietary confounders as potential covariates. Dried plum significantly increased BMD of ulna and spine in comparison with dried apple. In comparison with corresponding baseline values, only dried plum significantly decreased serum levels of bone turnover markers including bone-specific alkaline phosphatase and tartrate-resistant acid phosphatase-5b. The findings of the present study confirmed the ability of dried plum in improving BMD in postmenopausal women in part due to suppressing the rate of bone turnover.
Transient no reflow following primary percutaneous coronary intervention

No reflow following primary percutaneous coronary intervention (PCI) is a serious complication in the treatment of acute myocardial infarction. No reflow in some patients is reversible (transient no reflow), whereas no reflow in others persists until the end of the procedure (persistent no reflow). The aim of this study was to identify clinical features of transient no reflow following primary PCI. Consecutive patients with no reflow (n = 123) were enrolled following primary PCI. Among them, 59 patients were in the transient group and 64 in the persistent group. We compared clinical features and hospital outcomes between the two groups. Multivariate logistic regression analysis was performed to identify the determinants of transient no reflow. The transient group had a lower rate of in-hospital cardiac death than the persistent group (0 vs. 6.4 %, relatively, P = 0.018). There was a trend for a shorter length of hospital stay in the transient group. Multivariate logistic regression analysis identified initial thrombolysis in myocardial infarction (TIMI) flow grade 3 (OR 6.239, 95 % CI 1.727–22.541, P = 0.005) and a higher estimated glomerular filtration rate (OR 1.204, 95 % CI 1.006–1.440, P = 0.042) as independent predictors of transient no reflow. Transient no reflow tended to be associated with TIMI thrombus grade ≤3 (OR 2.879, 95 % CI 0.928–8.931, P = 0.067). In conclusion, initial TIMI flow grade 3 and preserved renal function were associated with recovery from no reflow. Initial angiographic finding such as TIMI flow or TIMI thrombus grade might be an important predictor of recovery from the no-reflow phenomenon.
Left atrial function in congestive heart failure: assessment by transmitral and pulmonary vein Doppler

The relation of transmitral flow patterns and pulmonary venous velocities was analyzed from 50 heart failure patients (28 men, 22 women; mean [±SD] age 61 ± 9 years) with a left ventricular ejection fraction < 40%. Doppler echocardiography was performed in all patients. Transmitral flow measurements included early (E) and atrial (A) velocities and deceleration time of E wave (DT). Patients were assigned to two groups according to E/A ratio, DT, or both: 20 patients in the restrictive group, and 30 patients in the nonrestrictive group. Pulmonary venous flow was obtained by the transthoracic approach. Systolic (S), diastolic (D) and atrial reversal (Ar) velocities were measured. Of the study population, 13 patients had simultaneously determined pulmonary capillary wedge pressure (PCWP).The results showed a lower S (28 ± 11 vs. 51 ± 10 cm/sec, p < 0.01), a higher D (66 ± 13 vs. 44 ± 10 cm/sec, p < 0.01) and a smaller Ar (12 ± 10 vs. 24 ± 9 cm/sec, p < 0.01) in the restrictive group compared with those in nonrestrictive group. In the subgroup of patients undergoing invasive hemodynamic studies, there was no relationship between PCWP and atrial reversal velocity. However, a significant correlation was observed for pulmonary systolic (r = -0.70, p < 0.01) and diastolic (r = 0.76, p < 0.01) velocities to PCWP. These findings suggest a reduction in left atrial compliance and atrial systolic function and both play important roles in heart failure patients with the restrictive transmitral flow pattern.
Concordance between capnography and capnia in adults admitted for acute dyspnea in an ED.

End-tidal carbon dioxide pressure (etCO(2)) is widely used in anaesthesia and critical care in intubated patients. The aim of our preliminary study was to evaluate the feasibility of a simple device to predict capnia in spontaneously breathing patients in an emergency department (ED).



This study was a prospective, nonblind study performed in our teaching hospital ED. We included nonintubated patients with dyspnea (> or =18 years) requiring measurement of arterial blood gases, as ordered by the emergency physician in charge. There were no exclusion criteria. End-tidal CO(2) was measured by an easy-to-use device connected to a microstream capnometer, which gave a continuous measurement and graphical display of the etCO(2) level of a patient's exhaled breath.



A total of 43 patients (48 measurements) were included, and the majority had pneumonia (n = 12), acute cardiac failure (n = 8), asthma (n = 7), or chronic obstructive pulmonary disease exacerbation (n = 6). Using simple linear regression, the correlation between etCO(2) and Paco(2) was good (R = 0.82). However, 18 measurements (38%) had a difference between etCO(2) and Paco(2) of 10 mm Hg or more. The mean difference between the Paco(2) and etCO(2) levels was 8 mm Hg. Using the Bland and Altman matrix, the limits of agreement were -10 to +26 mm Hg.



In our preliminary study, etCO(2) using a microstream method does not seem to accurately predict Paco(2) in patients presenting to an ED for acute dyspnea.
Monitoring IgA multiple myeloma: immunoglobulin heavy/light chain assays.

The use of electrophoresis to monitor monoclonal immunoglobulins migrating in the β fraction may be difficult because of their comigration with transferrin and complement proteins.



Immunoassays specific for IgGκ, IgGλ, IgAκ, IgAλ, IgMκ, and IgMλ heavy/light chain (HLC) were validated for use in the clinical laboratory. We assessed sample stability, inter- and intraassay variability, linearity, accuracy, and reference intervals for all 6 assays. We tested accuracy by verifying that the sum of the concentrations for the HLC-pairs accounted for the total immunoglobulins in each of 129 healthy sera, and that the HLC-pair ratios (rHLCs) were outside the reference interval in 97% of 518 diagnostic multiple myeloma (MM) samples.



We assessed diagnostic samples and posttreatment sera in 32 IgG and 30 IgA patients for HLC concentrations, rHLC, and total immunoglobulins and compared these nephelometry results with serum protein electrophoresis (SPEP) and immunofixation electrophoresis (IFE). In sample sets from patients with IgG MM, the sensitivity of SPEP was almost the same as for rHLC, and no additional advantage was conferred by running HLC assays. In pre- and posttreatment samples from patients with IgA MM, the SPEP, rHLC, and IFE identified clonality in 28%, 56%, and 61%, respectively. In addition, when M-spikes were quantifiable, the concentration of the involved HLC was linearly related to that of the SPEP M-spike, with a slope near 1.



The use of IgA HLC assays for monitoring β-migrating IgA monoclonal proteins can substitute for the combination of SPEP, IFE, and total IgA quantification.
Motivating Latino caregivers of children with asthma to quit smoking: a randomized trial.

Secondhand smoke exposure is associated with asthma onset and exacerbation. Latino children have higher rates of asthma morbidity than other groups. The current study compared the effectiveness of a newly developed smoking cessation treatment with existing clinical guidelines for smoking cessation.



Latino caregivers who smoked (N = 133; 72.9% female; mean age = 36.8 years) and had a child with asthma were randomly assigned to receive 1 of 2 smoking cessation counseling interventions during a home-based asthma program: (a) behavioral action model (BAM; modeled on clinical guidelines for smoking cessation) or (b) precaution adoption model (PAM; feedback on the caregiver's carbon monoxide level and child's secondhand smoke exposure using Motivational Interviewing). Counseling was delivered by a bilingual Latina health educator, and the content was tailored to Latino values and culture. It was not necessary for smokers to want to quit smoking to participate. Smoking cessation was biochemically verified and secondhand smoke exposure was objectively measured through passive nicotine monitors.



Intent-to-treat analyses showed that 20.5% of participants in the PAM condition and 9.1% of those in the BAM condition were continuously abstinent at 2 months posttreatment (OR = 2.54; 95% CI = 0.91-7.10), whereas 19.1% of participants in the PAM condition and 12.3% of those in BAM condition were continuously abstinent at 3 months posttreatment (OR = 1.68; 95% CI = 0.64-4.37). Secondhand smoke exposure decreased only in the BAM condition (p < .001), an effect due to less smoking around the child among nonquitters in this condition. Asthma morbidity showed significant decreases in the posttreatment period for the PAM group only (p < .001).



Results provide support for targeting specific populations with theory-based interventions.
Schizophrenia: a five-year follow-up of patient outcome following psycho-education for caregivers.

There is evidence that psycho-education courses for caregivers of individuals with schizophrenia improve the short-term outcome of the condition. However, most of the outcome studies are limited to two-year follow-up.



This study is a five-year retrospective case-control follow-up of an original cohort of 63 patients and their 101 caregivers who completed a six-week Caregiver Psycho-education Programme (CPP) for schizophrenia and psychosis between 2002 and 2005, and 60 controls, matched for age, gender and severity of their psychotic illness.



Patients whose caregivers learned more from the six-week psycho-education course had a significantly longer time to relapse (P = 0.04) and a significantly shorter length of stay during their first relapse (P < 0.05). Patients whose caregivers attended the six-week psycho-education course (regardless of how much the caregivers learned) had a significantly better outcome than controls. This included a significantly smaller number of relapses (P < 0.01), longer time to relapse (P < 0.01), shorter length of stay during their first relapse (P < 0.01) and smaller number of bed days over five years (P < 0.01). The odds ratio of controls relapsing, although insignificant at one year, was 4.13 (1.85-9.21) at five years. Outcome was not affected by either the numbers of caregivers attending for each patient, or caregiver gender.



This study, which is among the first to examine outcome over five years, supports the efficacy of psycho-education for caregivers in improving outcome for patients. Caregivers should be encouraged to take up psycho-education where it is available.
Improved outcome of adult Burkitt lymphoma/leukemia with rituximab and chemotherapy: report of a large prospective multicenter trial.

This largest prospective multicenter trial for adult patients with Burkitt lymphoma/leukemia aimed to prove the efficacy and feasibility of short-intensive chemotherapy combined with the anti-CD20 antibody rituximab. From 2002 to 2011, 363 patients 16 to 85 years old were recruited in 98 centers. Treatment consisted of 6 5-day chemotherapy cycles with high-dose methotrexate, high-dose cytosine arabinoside, cyclophosphamide, etoposide, ifosphamide, corticosteroids, and triple intrathecal therapy. Patients >55 years old received a reduced regimen. Rituximab was given before each cycle and twice as maintenance, for a total of 8 doses. The rate of complete remission was 88% (319/363); overall survival (OS) at 5 years, 80%; and progression-free survival, 71%; with significant difference between adolescents, adults, and elderly patients (OS rate of 90%, 84%, and 62%, respectively). Full treatment could be applied in 86% of the patients. The most important prognostic factors were International Prognostic Index (IPI) score (0-2 vs 3-5; P = .0005), age-adjusted IPI score (0-1 vs 2-3; P = .0001), and gender (male vs female; P = .004). The high cure rate in this prospective trial with a substantial number of participating hospitals demonstrates the efficacy and feasibility of chemoimmunotherapy, even in elderly patients.
Clinical efficacy of Apomorphine SL in erectile dysfunction of diabetic men

Although subgroup analyses from large randomised premarketing studies have shown that Apomorphine SL enhances the percentage of erections firm enough for sexual intercourse in diabetic men, the clinical role of the drug in this patient population remains to be elucidated. The aim of the present study was to assess the efficacy of Apomorphine SL in diabetic males with erectile dysfunction (ED) and to identify factors predicting those who may benefit from the treatment. A total of 130 diabetic patients were randomised to receive either four tablets of 3 mg Apomorphine or a matching placebo. Assessments of efficacy comprised the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and the one-item global efficacy question (GEQ). Patients with both a positive response to the GEQ and an improvement of at least 5 points in the EF domain of the IIEF were considered responders and subanalysed by several parameters indicative of the severity of both ED and diabetes. Response rate was 17% after placebo and 22% after Apomorphine SL. The EF domain of the IIEF and both questions 3 and 4 scores did not significantly improve in either of the two arms over the baseline. A younger age and a lower Hb1Ac were significantly linked to the status of responder in the Apomorphine arm. Apomorphine SL failed to show a statistically significant benefit over a placebo, but 22% of patients had a clinically significant erectile response. These figures seem to suggest that the drug has a limited use for ED diabetic patients.
Doctors’ views of disulfiram and their response to relapse in alcohol-dependent patients, Free State, 2009

Disulfiram is the oldest and best known drug to prevent relapse after detoxification from alcohol. Effective use of the drug is dependent on stringent monitoring and high levels of external motivation. Doctors' perceptions about the drug have not been investigated extensively.



We investigated the perceptions and practices of doctors involved in relapse prevention in alcoholics with regard to disulfiram and their response to relapse.



The study population consisted of 60 doctors from the Free State Province, involved in the follow-up of alcoholics across various work settings.



A cross-sectional descriptive study design was used, and data collection involved the use of a questionnaire and semi-structured interviews. Quantitative results are presented in figures and percentages to provide a background for the qualitative findings that are clustered in themes.



A quarter of participants did not prescribe disulfiram, another quarter prescribed disulfiram routinely after detoxification, and half of them prescribed it for selected cases only. Subject to affordability, selection of disulfiram was mainly determined by the perceived level of the patient's motivation. External motivation sometimes took the form of threats of bodily harm or death caused by drinking. Some participants regarded relapse as confirmation of poor motivation and even a valid reason for terminating the doctor-patient relationship.



Doctors perceive disulfiram as a psychological tool to induce motivation through creating fear of drinking. Failure and success are perceived as related to the level of motivation. These perceptions could be unfair as biological factors in inter-patient variability in response are ignored.
Patients' Self-Assessed Functional Status in Heart Failure by New York Heart Association Class: A Prognostic Predictor of Hospitalizations, Quality of Life and Death

Clinician-assigned New York Heart Association (NYHA) class is an established predictor of outcomes in heart failure. This study aims to test whether patients' self-assessment of functional status by NYHA class predicts hospital admissions, quality of life, and mortality.



This was an observational study within a randomized controlled trial. A total of 293 adult patients diagnosed with heart failure were recruited after an emergency admission at 3 acute hospitals in Norfolk, UK. Outcome measures included number of emergency admissions over 6 months, self-assessed quality of life measured with the Minnesota Living with Heart Failure questionnaire (MLHFQ) and EQ-5D at 6 months, and deaths up to 20 months' follow-up. Patients were grouped into 3 NYHA groups (I/II, III, and IV) based on patients' self-assigned NYHA class (SA-NYHA). A Poisson model indicated an increased readmission rate associated with higher SA-NYHA class (adjusted rate ratio 1.21; 95% CI 1.04-1.41; P=.02). Higher SA-NYHA class at baseline predicted worse quality of life at 6 months' follow-up (P=.002 for MLHFQ; P=.047 for EQ-5D), and was associated with higher mortality rate (adjusted hazard ratio 1.84; 95% CI 1.10-3.06; P=.02).



SA-NYHA class is predictive of hospitalization, quality of life, and mortality among patients with heart failure.