nils-herrmann/clean_scirepeval huggingface dataset:
Idarubicin and intermediate-dose cytarabine for myeloid blast crisis of chronic myelogenous leukemia – results of a phase-II trial

Sixteen patients with Philadelphia chromosome-positive chronic myelogenous leukemia (CML) in myeloid blast crisis were treated with cytarabine (AraC) 600 mg/m2 two times daily for 5 days and idarubicin 12 mg/m2 for 3 days. Patients achieving a second chronic phase received interferon (IFN) alpha 2b 5 mio units/day daily and AraC 20 mg/day subcutaneously 14 days every month. Study end points were remission rate and survival. Four patients (25%) entered a second chronic phase and had a median survival of 31.1 weeks (range 16.1–111 weeks). Nine patients (56%) experienced blast crisis again and had a median survival of 12.9 weeks (range 5.1–59.3 weeks). Three patients (18.8%) died of septic complications during marrow aplasia. The median overall survival was 16.1 weeks (range 2.6–111 weeks) with no significant difference between responders and nonresponding patients. We conclude that AraC/idarubicin is as effective as other intensive regimens in inducing second chronic phase in patients with myeloid blast crisis of CML. Remission duration and survival are comparable to previous results. Further studies to improve survival are required.
Pretreatment prognostic factors for overall survival in primary resistant acute myeloid leukemia.

Primary resistant acute myeloid leukemia has a very poor prognosis. We assessed pretreatment parameters for their significance as prognostic factors in the overall survival (OS) of 53 acute myeloid leukemia (AML) patients who had failed to achieve complete remission (CR) after first-line standard-dose remission-induction therapy.



During the period January 2005-December 2009, 53 with acute myeloid leukemia received two cycles of the 3+7 protocol as a first-line standard-dose remission-induction therapy (ARA-C, days 1-7 and daunorubicin, days 1-3). The HiDAC (5 patients), MiDAC (7 patients), and FLAG-IDA protocols (3 patients) were given as salvage therapy. None of these patients achieved CR. There were 27 (51%) males and 26 (49%) females (median age, 55 years, range 28-76). The median white blood cell count was 53 (range 0.9 -350)×10(9)/L, platelets 44 (range 3-856×10(9)/l) and bone marrow blasts 67%. HCT-IC comorbidity scores were 3 in two (3.8%) patients, 2 in 11 (20.8%), 1 in 12 (22.6%) and 0 in 16 (30.2%) patients. Median OS was 3.9 months (range 1 -20 months). The hepatomegaly, white blood cell count, ECOG PS, serum level of lactate dehydrogenase, dysplastic changes, coexpression of CD64, CD15, CD11b, comorbidities and disease cytogenetics influenced survival.



This single-center study evaluated the significance of pretreatment factors, and found that patient age, comorbidities, ECOG performance status, leukocytosis, hepatomegaly, LDH, and the disease cytogenetics were factors which influenced the outcomes of primary resistant patients with acute myeloid leukemia. An understanding of these factors may help to predict OS in cases where CR has not been achieved and may help when making further treatment decisions.
A double-blind, placebo-controlled trial of i.v. dolasetron mesilate in the prevention of radiotherapy-induced nausea and vomiting in cancer patients

The aim of this work was to measure the safety and efficacy of single i.v. doses of dolasetron mesilate for the control of emesis caused by single high-dose (at least 6 Gy) radiotherapy to the upper abdomen. The double-blind, placebo-controlled, multicenter study stratified patients on the basis of being naive or nonnaive to radiotherapy. Patients with or without a history of previous chemotherapy were enrolled. Patients were randomized to receive placebo or 0.3, 0.6, or 1.2 mg/kg dolasetron mesilate 30 min before radiotherapy, then monitored for 24 h. Antiemetic efficacy was assessed from the time to the first emetic episode or rescue, from whether there was a complete response (0 emetic episodes/no rescue medication) or a complete-plus-major response (0-2 emetic episodes/no rescue medication), from the severity of nausea (rated by patients and the investigator), and from the investigator's assessment of efficacy. Fifty patients completed the study (owing to changing medical practice, enrollment objectives were not met; consequently, no significant linear dose trend was expected). Pooled dolasetron was superior to the placebo in its effect on the time to first emesis or rescue in radiotherapy-nonnaive patients (P=0.015). Dolasetron was statistically superior to the placebo in the overall population on the basis of a complete plus major response:54%, 100%, 93%, and 83% for the placebo and 0.3-, 0.6-, and 1.2-mg/kg doses respectively (P=0.002). The low response in the highest dose group may be due to an imbalance in the number of chemotherapynonnaive patients in that group. Dolasetron was superior to the placebo on the basis of nausea assessed by the investigator (P=0.024) and administration of rescue medication (P=0.006). Complete response at the 0.3-mg/ kg dose was superior to results with the placebo (P=0.050). Treatment-related adverse events were rare, mild to moderate in intensity, and evenly distributed across the four groups. Overall, dolasetron mesilate was effective and well-tolerated in the control of single, high-dose radiotherapy-induced emesis.
Long-term outcomes and costs of an integrated rehabilitation program for chronic knee pain: a pragmatic, cluster randomized, controlled trial.

Chronic joint pain is a major cause of pain and disability. Exercise and self-management have short-term benefits, but few studies follow participants for more than 6 months. We investigated the long-term (up to 30 months) clinical and cost effectiveness of a rehabilitation program combining self-management and exercise: Enabling Self-Management and Coping of Arthritic Knee Pain Through Exercise (ESCAPE-knee pain).



In this pragmatic, cluster randomized, controlled trial, 418 people with chronic knee pain (recruited from 54 primary care surgeries) were randomized to usual care (pragmatic control) or the ESCAPE-knee pain program. The primary outcome was physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] function), with a clinically meaningful improvement in physical function defined as a ≥15% change from baseline. Secondary outcomes included pain, psychosocial and physiologic variables, costs, and cost effectiveness.



Compared to usual care, ESCAPE-knee pain participants had large initial improvements in function (mean difference in WOMAC function -5.5; 95% confidence interval [95% CI] -7.8, -3.2). These improvements declined over time, but 30 months after completing the program, ESCAPE-knee pain participants still had better physical function (difference in WOMAC function -2.8; 95% CI -5.3, -0.2); lower community-based health care costs (£-47; 95% CI £-94, £-7), medication costs (£-16; 95% CI £-29, £-3), and total health and social care costs (£-1,118; 95% CI £-2,566, £-221); and a high probability (80-100%) of being cost effective.



Clinical and cost benefits of ESCAPE-knee pain were still evident 30 months after completing the program. ESCAPE-knee pain is a more effective and efficient model of care that could substantially improve the health, well-being, and independence of many people, while reducing health care costs.
Effect on biopsy technique of the breast imaging reporting and data system (BI-RADS) for nonpalpable mammographic abnormalities.

To determine if the breast imaging reporting and data system (BI-RADS) defines a group of patients with mammographic abnormalities in whom stereotactic core needle biopsy (SCNB) is appropriate.



A blinded retrospective validation sample.



A university-affiliated hospital.



One hundred and nine consecutive patients who underwent fine-wire localization breast biopsy (FWLB) between Jan. 1, 1994, and June 1, 1999, with a known final pathological diagnosis.



Blinded mammographic review and classification using the BI-RADS; review of corresponding pathological findings from FWLBs.



Correlation of pathological findings with each BI-RADS category and analysis of the predictive value of clinical and radiologic features.



BI-RADS findings were as follows: 0 malignant lesions in 10 category 3 cases, 18 malignant lesions (3 in situ, 15 invasive) in 68 category 4 cases and 24 malignant lesions (8 in situ and 16 invasive) in 31 category 5 cases. There was 1 malignant lesion in 22 category 4 cases in women younger than 50 years.



SCNB should be applied to BI-RADS categories 3 and 4 (< 50 yr of age). FWLB should be reserved for category 4 (> 50 yr of age) and category 5 cases. This algorithm will reduce the morbidity and cost of breast biopsies in patients with nonpalpable mammographic abnormalities.
One-year outcome after prehospital intubation.

The aim of physician staffed emergency medical services (EMS) is to supplement other EMS units in the care of prehospital patients. The need for advanced airway management in critical prehospital patients can be considered as one indicator of the severity of the patient's condition. Our primary aim was to study the long-term outcome of critically ill patients (excluding cardiac arrest) who were intubated by EMS physicians in the prehospital setting.



Data of 845 patients, whose airways were secured by the EMS physicians during a 5-year (2007-2011) period, were retrospectively evaluated. After exclusions, the outcome of 483 patients (8.9% of all patients treated by EMS) was studied. Evaluation was based on hospital patient records 1 year after the incident. For assessment of neurological outcome, a modified Glasgow Outcome Score (GOS) was used. Time and cause of death were recorded.



55.3% of the study patients had a good neurological recovery (GOS 4-5) with independent life 1 year after the event. The overall 1-year mortality (GOS 1) was 35.0%. Poor neurological outcome (GOS 2-3) was found in 9.7% of the patients. Patients with intoxication or convulsions survived best, while those with suspected intracranial pathology had the worst prognosis. Of all survivors, 85% recovered well.



The majority of the study patients had a favourable neurological recovery with independent life at 1 year after the incident. More than 80% of all deaths occurred within 30 days of the incident.
Chlamydia and Gonorrhea in HIV-Infected Pregnant Women and Infant HIV Transmission.

Sexually transmitted infections (STIs) such as Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) can lead to adverse pregnancy and neonatal outcomes. The prevalence of STIs and its association with HIV mother-to-child transmission (MTCT) were evaluated in a substudy analysis from a randomized, multicenter clinical trial.



Urine samples from HIV-infected pregnant women collected at the time of labor and delivery were tested using polymerase chain reaction testing for the detection of CT and NG (Xpert CT/NG; Cepheid, Sunnyvale, CA). Infant HIV infection was determined by HIV DNA polymerase chain reaction at 3 months.



Of the 1373 urine specimens, 249 (18.1%) were positive for CT and 63 (4.6%) for NG; 35 (2.5%) had both CT and NG detected. Among 117 cases of HIV MTCT (8.5% transmission), the lowest transmission rate occurred among infants born to CT- and NG-uninfected mothers (8.1%) as compared with those infected with only CT (10.7%) and both CT and NG (14.3%; P = 0.04). Infants born to CT-infected mothers had almost a 1.5-fold increased risk for HIV acquisition (odds ratio, 1.47; 95% confidence interval, 0.9-2.3; P = 0.09).



This cohort of HIV-infected pregnant women is at high risk for infection with CT and NG. Analysis suggests that STIs may predispose to an increased HIV MTCT risk in this high-risk cohort of HIV-infected women.
Preventing diabetes in primary care: a feasibility cluster randomized trial.

To determine the feasibility of implementing a large-scale primary care-based diabetes prevention trial.



A feasibility cluster randomized controlled trial was conducted in British Columbia, Canada, amongst adults with prediabetes using the Facilitated Lifestyle Intervention Prescription (FLIP) vs. usual care. FLIP included lifestyle advice, a pedometer, and telephone support from a lifestyle facilitator for 6 months. Indicators of feasibility included recruitment rates of family practices, participants and facilitators, as well as feasibility and retention rates in the FLIP program and study protocols.



Six family practices participated; 59 patients were enrolled between October 2012 and March 2013. The trial protocol was acceptable to practices and participants and had a 95% participant retention rate over the 6 months (56/59). Adherence to the intervention was high (97%), with 34 of 35 patients continuing to receive telephone calls from the facilitator for 6 months. The mean cost of the intervention was C$144 per person. Compared with control, intervention participants significantly reduced weight by 3.2 kg (95% CI, 1.7 to 4.6); body mass index by 1.2 (95% CI, 0.7 to 1.7) and waist circumference by 3 cm (95% CI, 0.3 to 5.7).



It is feasible to implement FLIP and to conduct a trial to assess effectiveness. A larger trial with longer follow up to assess progression to diabetes is warranted.
Phase I-II trial of weekly bicalutamide in men with elevated prostate-specific antigen and negative prostate biopsies.

Men with elevated prostate-specific antigen (PSA) and negative prostate biopsies are at risk for prostate cancer. The antiandrogen bicalutamide has a prolonged half-life, thus potentially allowing an intermittent administration to retain activity while reducing toxicity. We conducted a phase I-II trial of weekly bicalutamide in men with PSA >4 ng/mL and negative biopsies.



Eighty subjects were nonrandomly assigned to a three-arm trial to either bicalutamide 50 mg/wk (n = 26) or 100 mg/wk (n = 28) or no treatment (n = 26) for 6 months. Blood samples were obtained at 0, 3, and 6 months, and prostate biopsies were repeated after 6 months. The outcome measures were 6-month changes of tissue Ki-67 (primary end point), high-grade prostatic intraepithelial neoplasia (HG-PIN), proliferative inflammatory atrophy, circulating PSA, and sex hormones.



Ki-67 expression was higher in HG-PIN than in normal tissue (10% versus 3%; P < 0.01) but was not modulated by bicalutamide in normal luminal cells. A trend toward an improvement of HG-PIN status was found in treated subjects (26% improved, 60% had no change, 15% worsened) as compared with the no-treatment arm (4% improved, 83% had no change, 13% worsened; P = 0.07). Proliferative inflammatory atrophy prevalence was not reduced by bicalutamide. Bicalutamide reduced PSA by 50% in both arms and raised testosterone and estradiol levels. Asymptomatic breast swelling was noted in 40% of the treated cases.



A weekly administration of bicalutamide seems to be reasonably safe and shows an encouraging signal of activity on HG-PIN prevalence, supporting further studies of this schedule in men at high risk despite the negative primary end-point findings on Ki-67.
Telephone management in substance abuse treatment.

The purpose of this article is to describe the results of a clinical trial in which telephonic case management was evaluated as a supplement to substance abuse treatment. An interactive voice response system (IVR) was developed by the research team for use in the case management of randomly assigned participants in a clinical trial research project. The features of the software program facilitated a double caseload for the case manager as well as real-time data capture. At intake, no significant differences were found between participants in the telecommunication condition and the general project. Thus, the effectiveness of random assignment was supported. An IVR was useful for case management services, was less costly, and showed acceptability to clients. A reduction in time expenditure by using telecommunication occurred within three activity areas. Telecommunication facilitated client interaction and the use of case management, and it reduced provider time expenditure. As an alternative strategy, telecommunication case management can enhance cost effectiveness improvements.
Extra- and Intracranial Cerebral Vasculitis in Giant Cell Arteritis

Recognizing giant cell arteritis (GCA) in patients with stroke may be challenging. We aimed to highlight the clinical spectrum and long-term follow-up of GCA-specific cerebrovascular accidents. Medical charts of all patients followed in a French Department of Internal Medicine for GCA between January 2008 and January 2014 were retrospectively reviewed. Patients with cerebrovascular accidents at GCA diagnosis were included. Diagnosis of GCA was based on American College of Rheumatology criteria. Transient ischemic attacks and stroke resulting from an atherosclerotic or cardioembolic mechanism were excluded. Clinical features, GCA-diagnosis workup, brain imaging, cerebrospinal fluid (CSF) study, treatment, and follow-up data were analyzed. From January 2008 to January 2014, 97 patients have been followed for GCA. Among them, 8 biopsy-proven GCA patients (mean age 70±7.8 years, M/F sex ratio 3/1) had stroke at GCA diagnosis. Six patients reported headache and visual impairment. Brain MR angiography showed involvement of vertebral and/or basilar arteries in all cases with multiple or unique ischemic lesions in the infratentorial region of the brain in all but one case. Intracranial cerebral arteries involvement was observed in 4 cases including 2 cases with cerebral angiitis. Long lasting lesions on diffusion-weight brain MRI sequences were observed in 1 case. All patients received steroids for a mean of 28.1±12.8 months. Side effects associated with long-term steroid therapy occurred in 6 patients. Relapses occurred in 4 patients and required immunosuppressive drugs in 3 cases. After a mean follow-up duration of 36.4±16.4 months, all but 1 patient achieved complete remission without major sequelae. The conjunction of headache with vertebral and basilar arteries involvement in elderly is highly suggestive of stroke associated with GCA. Intracranial cerebral arteries involvement with cerebral angiitis associated with long lasting brain lesions on diffusion-weight brain MRI sequences may occur in GCA. Both frequent relapses and steroid-induced side effects argue for the use of immunosuppressive agents combined with steroids as first-line therapy.
The points for pacing.

In this issue of the Journal, the study by Higgins et al. (1) from the trial of resynchronization therapy provides the opportunity to assess the current status of both the application of biventricular pacing and the construction of trial end points for new therapies in heart failure (HF). The devices used in this trial clearly improved functional capacity in those patients with major functional limitation at baseline, a finding that reinforces the functional benefit seen with similar devices and populations in other trials. The strength and relevance of this emerging evidence stand despite the interposition of an end point that did not show benefit in this trial.
The PROFI study (Prevention of Cerebral Embolization by Proximal Balloon Occlusion Compared to Filter Protection During Carotid Artery Stenting): a prospective randomized trial.

The objective of this study was to compare the cerebral embolic load of filter-protected versus proximal balloon-protected carotid artery stenting (CAS).



Randomized trials comparing filter-protected CAS with carotid endarterectomy revealed a higher periprocedural stroke rate after CAS. Proximal balloon occlusion may be more effective in preventing cerebral embolization during CAS than filters.



Patients undergoing CAS with cerebral embolic protection for internal carotid artery stenosis were randomly assigned to proximal balloon occlusion or filter protection. The primary endpoint was the incidence of new cerebral ischemic lesions assessed by diffusion-weighted magnetic resonance imaging. Secondary endpoints were the number and volume of new ischemic lesions and major adverse cardiovascular and cerebral events (MACCE).



Sixty-two consecutive patients (mean age: 71.7 years, 76.4% male) were randomized. Compared with filter protection (n = 31), proximal balloon occlusion (n = 31) resulted in a significant reduction in the incidence of new cerebral ischemic lesions (45.2% vs. 87.1%, p = 0.001). The number (median [range]: 2 [0 to 13] vs. 0 [0 to 4], p = 0.0001) and the volume (0.47 [0 to 2.4] cm(3) vs. 0 [0 to 0.84] cm(3), p = 0.0001) of new cerebral ischemic lesions were significantly reduced by proximal balloon occlusion. Lesions in the contralateral hemisphere were found in 29.0% and 6.5% of patients (filter vs. balloon occlusion, respectively, p = 0.047). The 30-day MACCE rate was 3.2% and 0% for filter versus balloon occlusion, respectively (p = NS).



In this randomized trial of patients undergoing CAS, proximal balloon occlusion as compared with filter protection significantly reduced the embolic load to the brain.
Prevalence and clinical correlates of pruritus in patients with systemic sclerosis: an updated analysis of 959 patients.

One previous study has estimated the prevalence of pruritus in SSc, but that study had important limitations due to a relatively small sample size. The present study updates the analyses of the previous study using a substantially larger patient sample. The objectives were to (i) document the proportion of patients who experience pruritus on most days overall and by disease duration and (ii) identify clinical correlates of pruritus.



Patients from the Canadian Scleroderma Research Group Registry ≥1 year after registry enrolment were asked on two consecutive annual visits whether they had experienced pruritus in the past month on most days and underwent clinical history and medical examination. Multiple logistic regression was used to assess the association between sociodemographic and clinical variables and pruritus.



Among 959 patients, 42.6% reported pruritus. Of 693 patients with data for both visits, 333 (48%) did not report pruritus at either visit, 209 (30%) reported pruritus at both visits and 151 (22%) reported pruritus at one, but not the other, visit. The presence of pruritus was independently associated with greater skin involvement [odds ratio (OR) = 1.02, 95% CI 1.00, 1.04, P = 0.017] and greater gastrointestinal involvement (OR = 1.24, 95% CI 1.04, 1.48, P = 0.018).



Pruritus is common in SSc across the course of the disease and has small but statistically significant associations with the degree of skin involvement and gastrointestinal system involvement.
Empathic engineering: helping deliver dignity through design

Dignity is a key value within healthcare. Technology is also recognized as being a fundamental part of healthcare delivery, but also a potential cause of dehumanization of the patient. Therefore, understanding how medical devices can be designed to help deliver dignity is important. This paper explores the role of empathy tools as a way of engendering empathy in engineers and designers to enable them to design for dignity. A framework is proposed that makes the link between empathy tools and outcomes of feelings of dignity. It represents a broad systems view that provides a structure for reviewing the evidence for the efficacy of empathy tools and also how dignity can be systematically understood for particular medical devices.