nils-herrmann/clean_scirepeval huggingface dataset:
Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia: a study protocol

Uncomplicated chronic rachialgia is a highly prevalent complaint, and one for which therapeutic results are contradictory. The aim of the present study is to evaluate the effectiveness and safety of treatment with auriculopressure, in the primary healthcare sector, carried out by trained healthcare professionals via a 30-hour course.



The design consists of a multi-centre randomized controlled trial, with placebo, with two parallel groups, and including an economic evaluation. Patients with chronic uncomplicated rachialgia, whose GP is considering referral for auriculopressure sensory stimulation, are eligible for inclusion. Sampling will be by consecutive selection, and randomised allocation to one of the two study arms will be determined using a centralised method, following a 1:1 plan (true auriculopressure; placebo auriculopressure). The implants (true and placebo) will be replaced once weekly, and the treatment will have a duration of 8 weeks. The primary outcome measure will be the change in pain intensity, measured on a visual analogue scale (VAS) of 100 mm, at 9 weeks after beginning the treatment. A follow up study will be performed at 6 months after beginning treatment. An assessment will also be made of the changes measured in the Spanish version of the McGill Pain Questionnaire, of the changes in the Lattinen test, and of the changes in quality of life (SF-12). Also planned is an analysis of cost-effectiveness and also, if necessary, a cost-benefit analysis.



This study will contribute to developing evidence on the use of auriculotherapy using Semen vaccariae [wang bu liu xing] for the treatment of uncomplicated chronic rachialgia.
Development and initial validation of the medical fear survey-short version.

The present investigation employs item response theory (IRT) to develop an abbreviated medical fear survey (MFS). Application of IRT analyses in study 1 (n = 931) to the original 50-item MFS resulted in a 25-item shortened version. Examination of the location parameters also resulted in a reduction of the Likert-type scaling of the MFS by removing the last response category ("terror"). The five subscales of the original MFS were highly correlated with those of the MFS-short version. The short version also displayed comparable convergent and discriminant validity with the original MFS in relation to measures of fear, disgust, and anxiety. Confirmatory factor analysis in Study 2 revealed that the five-factor structure of the MFS-short form fit the data well in U.S. (n = 283) and Dutch (n = 258) samples. The short form also had comparable convergent and discriminant validity with the original MFS in relation to domains of disgust in both samples. Receiver operating characteristic (ROC) analysis in Study 3 demonstrated that the subscales of the short version were comparable with the original MFS in classifying participants high (n = 40) and low (n = 40) in blood/injection phobia. Last, structural equation modeling in Study 4 (n = 113) revealed that the MFS-short form demonstrated excellent convergent/discriminant validity with strong associations with injection fear and no association with spider fear. These findings suggest that the MFS-short form has considerable strengths, including decreased assessment time, while retaining sound psychometric properties.
A Canadian paediatric brain tumour consortium (CPBTC) phase II molecularly targeted study of imatinib in recurrent and refractory paediatric central nervous system tumours.

To evaluate the safety, efficacy and pharmacokinetics of imatinib in children with recurrent or refractory central nervous system (CNS) tumours expressing KIT and/or PDGFRA.



Nineteen patients aged 2-18 years, with recurrent or refractory CNS tumours expressing either of the target receptors KIT and/or PDGFRA (by immunohistochemistry) were eligible. Participants received imatinib orally at a dose of 440 mg/m(2)/day and toxicities and tumour responses were monitored. Serial blood and cerebrospinal fluid samples for pharmacokinetics were obtained in a subset of consenting patients. Frozen tumour samples were analysed retrospectively for KIT and PDGFRA gene amplification in a subset of patients for whom samples were available.



Common toxicities were lymphopaenia, neutropaenia, leucopaenia, elevated serum transaminases and vomiting. No intratumoural haemorrhages were observed. Although there were no objective responses to imatinib, four patients had long-term stable disease (SD) (38-104 weeks). Our results suggest a possible relationship between KIT expression and maintenance of SD with imatinib treatment; KIT immunopositivity was seen in only 58% (11/19) of study participants overall, but in 100% of patients with SD at 38 weeks. All patient tumours showed PDGFRA expression. Pharmacokinetic data showed a high interpatient variability, but corresponded with previously reported values.



Imatinib at 440 mg/m(2)/day is relatively safe in children with recurrent CNS tumours, but induced no objective responses. Demonstration of SD in previously progressing patients (KIT-expressing) suggests cytostatic activity of imatinib.
Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial

Multiple sclerosis is associated with muscle stiffness, spasms, pain, and tremor. Much anecdotal evidence suggests that cannabinoids could help these symptoms. Our aim was to test the notion that cannabinoids have a beneficial effect on spasticity and other symptoms related to multiple sclerosis.



We did a randomised, placebo-controlled trial, to which we enrolled 667 patients with stable multiple sclerosis and muscle spasticity. 630 participants were treated at 33 UK centres with oral cannabis extract (n=211), Delta9-tetrahydrocannabinol (Delta9-THC; n=206), or placebo (n=213). Trial duration was 15 weeks. Our primary outcome measure was change in overall spasticity scores, using the Ashworth scale. Analysis was by intention to treat.



611 of 630 patients were followed up for the primary endpoint. We noted no treatment effect of cannabinoids on the primary outcome (p=0.40). The estimated difference in mean reduction in total Ashworth score for participants taking cannabis extract compared with placebo was 0.32 (95% CI -1.04 to 1.67), and for those taking Delta9-THC versus placebo it was 0.94 (-0.44 to 2.31). There was evidence of a treatment effect on patient-reported spasticity and pain (p=0.003), with improvement in spasticity reported in 61% (n=121, 95% CI 54.6-68.2), 60% (n=108, 52.5-66.8), and 46% (n=91, 39.0-52.9) of participants on cannabis extract, Delta9-THC, and placebo, respectively.



Treatment with cannabinoids did not have a beneficial effect on spasticity when assessed with the Ashworth scale. However, though there was a degree of unmasking among the patients in the active treatment groups, objective improvement in mobility and patients' opinion of an improvement in pain suggest cannabinoids might be clinically useful.
One-year weight maintenance after significant weight loss in healthy overweight and obese subjects: does diet composition matter?

For many people, maintenance of weight loss is elusive. Whereas high-protein (HP) diets have been found to be superior to high-carbohydrate (HC) diets for weight loss in the short term, their benefits long term are unclear, particularly for weight maintenance. Furthermore, the literature lacks consensus on the long-term effects of an HP diet on cardiovascular disease risk factors.



The objective was to investigate whether macronutrient dietary composition plays a role in weight maintenance and in improvement of cardiovascular disease risk factors.



The study comprised 2 phases. Phase 1 featured a very-low-energy diet for 3 mo. In phase 2, the subjects were randomly assigned to an HP or an HC diet for 12 mo. The diets were isocaloric, tightly controlled, and individually prescribed for weight maintenance. The subjects were overweight or obese but otherwise healthy men and women.



The subjects lost an average of 16.5 kg during phase 1 and maintained a mean (+/-SEM) weight loss of 14.5 +/- 1.2 kg (P < 0.001) during phase 2; no significant differences between groups were observed. By the end of the study, reductions in systolic blood pressure were 14.3 +/- 2.4 mm Hg for the HP group and 7.7 +/- 2.2 mm Hg for the HC group (P < 0.045). Forty-seven percent of the 180 subjects who began the study completed both phases.



The results indicate that the protein or carbohydrate content of the diet has no effect on successful weight-loss maintenance. A general linear model analysis indicated that dietary treatment (HP or HC) was a significant factor in systolic blood pressure change and in favor of the HP diet.
Pharmacist-led medication education in cancer pain control: a multicentre randomized controlled study in Guangzhou, China.

To evaluate clinical pharmacist-led pain-medication education in patients with cancer.



A controlled study was conducted prospectively at six tertiary hospitals in China. In-patients with cancer were randomized to receive conventional treatment plus medication education or no education (controls). Education consisted of access to information booklets and eight 30-min face-to-face counselling sessions given by clinical pharmacists over 4 weeks. Patients completed pain- and analgesic-knowledge assessments and a Brief Pain Inventory, pre- and post-study.



A total of 123 and 114 patients in the education and control groups, respectively, completed follow-up. At the end of the study, patient knowledge regarding cancer pain and pain control was significantly increased in both groups; pain and analgesic knowledge scores were significantly higher in the education group compared with controls. In the control group, the increase in total pain-related knowledge was significantly greater in analgesic-naïve patients compared with those who were using/had used analgesics. Pain intensity scores and pain interference of daily activities were significantly reduced in the education group compared with controls.



Clinical pharmacist-led medication education resulted in improved pain control in patients with cancer.
Effect of Helicobacter pylori eradication on reflux esophagitis therapy: a multi-center randomized control study.

Helicobacter pylori (H. pylori) frequently colonizes the stomach. Gastroesophageal reflux disease (GERD) is a common and costly disease. But the relationship of H. pylori and GERD is still unclear. This study aimed to explore the effect of H. pylori and its eradication on reflux esophagitis therapy.



Patients diagnosed with reflux esophagitis by endoscopy were enrolled; based on rapid urease test and Warth-Starry stain, they were divided into H. pylori positive and negative groups. H. pylori positive patients were randomly given H. pylori eradication treatment for 10 days, then esomeprazole 20 mg bid for 46 days. The other patients received esomeprazole 20 mg bid therapy for 8 weeks. After treatment, three patient groups were obtained: H. pylori positive eradicated, H. pylori positive uneradicated, and H. pylori negative. Before and after therapy, reflux symptoms were scored and compared. Healing rates were compared among groups. The χ2 test and t-test were used, respectively, for enumeration and measurement data.



There were 176 H. pylori positive (with 92 eradication cases) and 180 negative cases. Healing rates in the H. pylori positive eradicated and H. pylori positive uneradicated groups reached 80.4% and 79.8% (P = 0.911), with reflux symptom scores of 0.22 and 0.14 (P = 0.588). Healing rates of esophagitis in the H. pylori positive uneradicated and H. pylori negative groups were, respectively, 79.8% and 82.2% (P = 0.848); reflux symptom scores were 0.14 and 0.21 (P = 0.546).



Based on esomeprazole therapy, H. pylori infection and eradication have no significant effect on reflux esophagitis therapy.
Access to rehabilitation facilities in an unselected hospital population affected by acute stroke

The aim of this study was to evaluate the selection criteria and characteristics of the patients who have access to rehabilitation facilities after having experienced an acute stroke. Between January 1993 and February 1994, 383 patients were recruited in 13 hospitals in Lombardy, and telephonically followed up four months after study entry. The data were collected by members of the Associazione Volontari Ospedalieri (Hospital Volunteers' Association). The 4-month mortality rate was 23%. The primary selection criterion for gaining access to rehabilitation facilities was the degree of disability; the secondary factor was age. Rehabilitation facilities were not available to very severely afflicted or self-sufficient patients, but were preferentially made available to young, partially-dependent patients. A rehabilitative intervention within the first month was made available to fewer than 50% of the patients for whom it was indicated. The absence of care for elderly patients and the delay in its availability for those who actually receive it underline the need for new organisational methods. The data presented here also show that voluntary associations can work as observers of the health service. A more complete study is required in order to understand the real dimensions of the problem and the clinical and social characteristics of the population involved. Lo studio è stato condotto per valutare i criteri di selezione e le caratteristiche dei pazienti che accedono alle risorse riabilitative dopo stroke acuto. Dal gennaio 1993 al febbraio 1994 sono stati reclutati in 13 ospedali lombardi 383 pazienti, seguiti con follow-up telefonico 4 mesi dopo l'ammissione allo studio. I dati sono stati raccolti da appartenenti alla Associazione Volontari Ospedalieri. La mortalità a 4 mesi è risultata del 23%. Fattore di selezione primaria per l'accesso alle risorse riabilitative è risultato essere il livello di disabilità. Fattore di selezione secondaria l'età. Le risorse riabilitative non sono risultate di fatto disponibili per i pazienti molto gravi o autosufficienti, queste vengono attribuite preferenzialmente ai pazienti giovani parzialmente dipendenti. Un intervento riabilitativo entro il primo mese è stato disponibile per meno del 50% dei pazienti in cui l'intervento stesso risulta indicato. Le carenze assistenziali per i pazienti anziani e per i lunghi tempi di intervento sottolineano la necessità di nuove modalità organizzative. I dati del presente lavoro indicano inoltre che associazioni di volontariato possono attuare la loro opera anche come osservatori del servizio sanitario. È necessario uno studio più completo per conoscere le reali dimensioni del problema e le caratteristiche cliniche e sociali della popolazione.
A multi-biomarker risk score improves prediction of long-term mortality in patients with advanced heart failure.

Accurate risk prediction is important for an adequate management of heart failure (HF) patients. We assessed the incremental prognostic ability of a multi-biomarker approach in advanced HF.



In 349 patients with advanced HF (median 75 years, 66% male) we investigated the incremental prognostic value of 12 novel biomarkers involved in different pathophysiological pathways including inflammation, immunological activation, oxidative stress, cell growth, remodeling, angiogenesis and apoptosis.



During a median follow-up of 4.9 years 55.9% of patients died. Using multivariable Cox regression and bootstrap variable-selection age, chronic obstructive pulmonary disease, N-terminal pro-B-type natriuretic peptide (NT-proBNP) and the following 5 novel biomarkers were retained in the best mortality prediction model: the chemokine fractalkine, the angiogenic and mitogenic hepatocyte growth factor (HGF), the growth differentiation factor 15 (GDF-15) influencing cardiac remodeling and apoptosis, and the 2 pro-apoptotic molecules soluble apoptosis-stimulating fragment (sFAS) and soluble tumor necrosis factor-related apoptosis-inducing ligand (sTRAIL). This multi-biomarker score had strong discriminatory power for 5-year mortality (area under the Receiver Operating Characteristic curve [AUC]=0.81) and improved risk prediction beyond the prognostic power of a comprehensive conventional risk score including known clinical predictors and NT-proBNP (AUC=0.77). Net reclassification confirmed a significant improvement of individual risk prediction (p=0.003).



Risk prediction by a multi-biomarker score is superior to a conventional risk score including clinical parameters and NT-proBNP. Additional predictive information from different biological pathways reflects the multisystemic character of HF.
Diuretics and mortality in acute renal failure.

According to recent research, diuretics may increase mortality in acute renal failure patients. The administration of diuretics in such patients has been discouraged. Our objective was to determine the impact of diuretics on the mortality rate of critically ill patients with acute renal failure.



Prospective, multiple-center, multinational epidemiologic study.



Intensive care units from 54 centers and 23 countries.



Patients were 1,743 consecutive patients who either were treated with renal replacement therapy or fulfilled predefined criteria for acute renal failure.



Three distinct multivariate models were developed to assess the relationship between diuretic use and subsequent mortality: a) a propensity score adjusted multivariate model containing terms previously identified to be important predictors of outcome; b) a new propensity score adjusted multivariate model; and c) a multivariate model developed using standard methods, compensating for collinearity.



Approximately 70% of patients were treated with diuretics at study inclusion. Mean age was 68 and mean Simplified Acute Physiology Score II was 47. Severe sepsis/septic shock (43.8%), major surgery (39.1), low cardiac output (29.7), and hypovolemia (28.2%) were the most common conditions associated with the development of acute renal failure. Furosemide was the most common diuretic used (98.3%). Combination therapy was used in 98 patients only. In all three models, diuretic use was not associated with a significantly increased risk of mortality.



Diuretics are commonly prescribed in critically ill patients with acute renal failure, and their use is not associated with higher mortality. There is full equipoise for a randomized controlled trial of diuretics in critically ill patients with renal dysfunction.
Evaluation of Potential Pharmacokinetic Drug-Drug Interaction between Armodafinil and Aripiprazole in Healthy Adults.

Armodafinil, a moderate inducer of cytochrome P450 (CYP) 3A4, has been studied as adjunctive therapy to maintenance medications for major depressive episodes associated with bipolar I disorder. We evaluated the effect of daily dosing with armodafinil on the pharmacokinetics and safety of the CYP3A4 substrate aripiprazole, an atypical antipsychotic used to treat bipolar I disorder.



Healthy adults received 15 mg aripiprazole alone and after armodafinil (250 mg/day) pretreatment. Pharmacokinetic parameters were derived from plasma concentrations of aripiprazole and its active metabolite, dehydro-aripiprazole, obtained over 16 days after each aripiprazole administration. Steady-state pharmacokinetics of armodafinil and its 2 circulating metabolites was assessed.



Of 36 subjects enrolled, 24 were evaluable for pharmacokinetic analysis. Armodafinil reduced systemic exposure to aripiprazole (Cmax, - 8%; AUC0-∞, -34%) and dehydro-aripiprazole, which is both formed and eliminated in part via CYP3A4 (Cmax, - 10%; AUC0-∞, - 32%). Adverse events were generally consistent with known safety profiles of each agent.



Systemic exposure to aripiprazole and dehydro-aripiprazole was moderately reduced following armodafinil pretreatment. The combination was generally well tolerated under the conditions studied.
Association of age and response to androgen-deprivation therapy with or without radiotherapy for prostate cancer: data from CaPSURE.

To assess whether the response to primary androgen-deprivation therapy (PADT) and radiotherapy (RT) plus adjuvant ADT would be muted in older men, as their tumours might already be relatively androgen insensitive, because serum testosterone levels decline with increasing age.



Using the Cancer of the Prostate Strategic Urologic Research Endeavor database, we conducted an observational study evaluating two groups of men treated for prostate cancer from 1995 to 2006. One group of 1748 men was treated with PADT and the second group of 612 men was treated with RT (external beam RT or brachytherapy) with neoadjuvant and/or adjuvant ADT. We tested whether age was a predictor of disease progression in the PADT group and prostate-specific antigen (PSA) recurrence in the RT + ADT group (Phoenix definition). Secondary outcomes were all cause (ACM) and prostate cancer-specific mortality (PCSM).



In both univariate and multivariate analysis stratifying by clinical risk group, age (<65, 65-69, 70-74, and > or =75 years) was not associated with the risk of secondary treatment or PSA recurrence for the PADT and the RT + ADT groups, respectively. Age category had no relationship to increased ACM or PCSM for the RT + ADT group. However, for the PADT group the oldest category (>75 years) had an increased hazard ratio (2.26, 95% confidence interval 1.04-4.88; P = 0.02) for ACM, but a decreased ratio for PCSM (0.29, 0.21-0.42; P < 0.01).



If we assume that age is a valid proxy measure for free available testosterone levels, then these levels do not seem to affect the likelihood of response to ADT, either used alone or combined with RT.
Rates and indications for surgical breast biopsies in a community-based health system.

High rates of surgical breast biopsies in community hospitals have been reported but may misrepresent actual practice.



Patient-level data from 5,757 women who underwent breast biopsies in a large integrated health system were evaluated to determine biopsy types, rates, indications, and diagnoses.



Between 2008 and 2010, 6,047 breast biopsies were performed on 5,757 women. Surgical biopsy was the initial diagnostic procedure in 16% (n = 942) of women overall and in 6% (72 of 1,236) of women with newly diagnosed invasive breast cancer. Invasive breast cancer was diagnosed in 72 women (8%) undergoing surgical biopsy compared with 1,164 (24%) undergoing core needle biopsy (P < .001, age adjusted). Main indications for surgical biopsies included symptomatic abnormalities, technical challenges, and patient choice.



Surgical biopsy was the initial diagnostic procedure in 16% of women with breast abnormalities, comparable with rates at academic centers. Rates could be improved by more careful consideration of indications.