nils-herrmann/clean_scirepeval huggingface dataset:
Increased risk of osteoarthritis after anterior cruciate ligament reconstruction: a 14-year follow-up study of a randomized controlled trial.

The reported prevalence of radiological osteoarthritis (OA) after anterior cruciate ligament (ACL) reconstruction varies from 10% to 90%. Purpose/



To report the prevalence of OA after ACL reconstruction and to compare the OA prevalence between quadrupled semitendinosus tendon (ST) and bone-patellar tendon-bone (BPTB) grafts. The hypothesis was that there would be no difference in OA prevalence between the graft types. The secondary aim was to study whether patient characteristics and additional injuries were associated with long-term outcomes.



Randomized controlled trial; Level of evidence, 1.



Radiological examination results, Tegner activity levels, and Knee injury and Osteoarthritis Outcome Score (KOOS) values were determined in 135 (82%) of 164 patients at a mean of 14 years after ACL reconstruction randomized to an ST or a BPTB graft. Osteoarthritis was defined according to a consensus by at least 2 of 3 radiologists of Kellgren-Lawrence grade ≥2. Using regression analysis, graft type, sex, age, overweight, time between injury and reconstruction, additional meniscus injury, and a number of other variables were assessed as risk factors for OA 14 years after ACL reconstruction.



Osteoarthritis of the medial compartment was most frequent, with 57% of OA cases in the ACL-reconstructed knee and 18% of OA cases in the contralateral knee (P < .001). There was no difference between the graft types: 49% of OA of the medial compartment for BPTB grafts and 65% for ST grafts (P = .073). The KOOS results were lower for patients with OA in all subscales, indicating that OA was symptomatic. No difference in the KOOS between the graft types was found. Meniscus resection was a strong risk factor for OA of the medial compartment (odds ratio, 3.6; 95% CI, 1.4-9.3) in the multivariable logistic regression analysis.



A 3-fold increased prevalence of OA was found after an ACL injury treated with reconstruction compared with the contralateral healthy knee. No differences in the prevalence of OA between the BPTB and quadrupled ST reconstructions were found. An initial meniscus resection was a strong risk factor for OA; the time between injury and reconstruction was not.
A comparison of short-term treatment with inhaled fluticasone propionate and zafirlukast for patients with persistent asthma.

To compare the short-term efficacy and safety of low-dose fluticasone propionate with that of oral zafirlukast therapy for patients previously treated with beta-2-agonists alone, and to evaluate the potential therapeutic benefit of switching from zafirlukast to a low-dose inhaled corticosteroid.



This study consisted of a 4-week randomized, double-blind treatment period followed by a 4-week open-label period. Two hundred ninety-four patients > or =12 years old with asthma previously uncontrolled with beta-2-agonists alone were randomly assigned to treatment with low-dose inhaled fluticasone (88 microg twice daily) or oral zafirlukast (20 mg twice daily). After 4 weeks, all patients discontinued their double-blind therapy and received open-label fluticasone (88 microg twice daily). Outcomes included pulmonary function, asthma symptoms, albuterol use, asthma exacerbations, and adverse events.



During the double-blind treatment period, fluticasone patients had significantly greater improvements in morning peak flow (29.3 L/min vs. 18.3 L/min), percentage of symptom-free days (19.8% vs. 11.6%), and daily albuterol use (-1.8 puffs per day vs. -1.1 puffs per day) compared with zafirlukast patients (P < or =0.025, each comparison). During the open-label treatment period, patients switched from zafirlukast to fluticasone experienced additional improvements in morning peak flow (17.2 L/min), evening peak flow (13.6 L/min), and FEV(1) (0.11 liter) and daily albuterol use (-0.9 puffs daily) compared with values obtained at the end of the double-blind treatment period (P < or =0.001, each comparison).



Low-dose fluticasone was more effective than zafirlukast in improving pulmonary function and symptoms in patients with persistent asthma. In addition, switching patients from zafirlukast to fluticasone further improved clinical outcomes.
Breast cancer in elderly women: a different reality? Results from the NORA study.

The incidence of breast cancer increases with age, and the disease affects many older women; however, attitudes about prevention and treatment of breast cancer vary based on the patient's age. Older women have less access to clinical trials and fewer opportunities for treatment with innovative therapies. The National Oncological Research observatory on Adjuvant therapy in breast cancer (NORA) study was a cohort study designed to obtain information about adjuvant strategies for treatment of breast cancer after surgery, patterns of recurrence, and possible correlations between cancer-related events and biological factors.



This report describes patient characteristics, disease status, and local and systemic adjuvant treatments in a population of breast cancer patients aged >or=65 years. The NORA study consecutively enrolled >3500 patients from 2000 through 2002 at 77 Italian hospitals; of these, 1085 were aged >or=65 years. Data on patient characteristics, cancer presentation, and treatments were analyzed to identify possible relationships between these factors and age.



The findings indicate that age is significantly related to later diagnosis and different patterns of treatment. Choice of adjuvant systemic treatment was primarily related to hormone receptor status and tumor stage but was strongly influenced by the patient's age; there was a proportional relationship between endocrine treatment and increasing age. Cyclophosphamide, methotrexate, and 5-fluorouracil as well as anthracyclines were widely used, but the use of taxanes was limited to a very small percentage of patients.



The findings of the NORA study may help to change attitudes that currently exclude a significant proportion of breast cancer patients from secondary prevention policies, more active treatment strategies, and clinical research trials based on age.
Cemented versus cementless Oxford unicompartmental knee arthroplasty using radiostereometric analysis: a randomised controlled trial.

The most common reasons for revision of unicompartmental knee arthroplasty (UKA) are loosening and pain. Cementless components may reduce the revision rate. The aim of this study was to compare the fixation and clinical outcome of cementless and cemented Oxford UKAs. A total of 43 patients were randomised to receive either a cemented or a cementless Oxford UKA and were followed for two years with radiostereometric analysis (RSA), radiographs aligned with the bone-implant interfaces and clinical scores. The femoral components migrated significantly during the first year (mean 0.2 mm) but not during the second. There was no significant difference in the extent of migration between cemented and cementless femoral components in either the first or the second year. In the first year the cementless tibial components subsided significantly more than the cemented components (mean 0.28 mm (sd 0.17) vs. 0.09 mm (sd 0.19 mm)). In the second year, although there was a small amount of subsidence (mean 0.05 mm) there was no significant difference (p = 0.92) between cemented and cementless tibial components. There were no femoral radiolucencies. Tibial radiolucencies were narrow (< 1 mm) and were significantly (p = 0.02) less common with cementless (6 of 21) than cemented (13 of 21) components at two years. There were no complete radiolucencies with cementless components, whereas five of 21 (24%) cemented components had complete radiolucencies. The clinical scores at two years were not significantly different (p = 0.20). As second-year migration is predictive of subsequent loosening, and as radiolucency is suggestive of reduced implant-bone contact, these data suggest that fixation of the cementless components is at least as good as, if not better than, that of cemented devices.
Safety and feasibility of early hospital discharge in ST-segment elevation myocardial infarction--a prospective and randomized trial in low-risk primary percutaneous coronary intervention patients (the Safe-Depart Trial).

Patients with ST-segment elevation myocardial infarction (STEMI) have traditionally been hospitalized for 5 to 7 days to monitor for serious complications such as heart failure, arrhythmias, reinfarction, and death. The Zwolle Primary Percutaneous Coronary Intervention (PCI) Index is an externally validated risk score that has been used to identify low-risk STEMI patients who have undergone primary PCI and can safely be discharged from hospital within 72 hours. Previous studies have shown that many low-risk patients remain in hospital significantly longer.



We randomly assigned 54 low-risk STEMI patients treated with primary or rescue PCI to 1 of 2 groups. Patients in the intervention group (n = 27) were actively targeted for early hospital discharge (48-72 hours) and received outpatient follow-up with an advanced practice nurse (APN). In the control group (n = 27), discharge planning and follow-up were left to the treating physician, and there was no added nursing intervention. The 2 primary outcomes of this pilot study were to demonstrate feasibility and safety. Secondary outcomes included compliance with medications, smoking cessation, attendance at cardiac rehabilitation, and quality of life, measured in both groups at 6 weeks time.



In the intervention group, 74% of patients were discharged within 72 hours, 100% had follow-up with the APN within 3 days (74% in person, 26% by phone), and 100% had >/= 3 APN follow-ups in total, meeting our prespecified criteria for feasibility. The median length of stay was 55 hours in both groups. There were no deaths in either group, and there was no difference in rehospitalization between patients in the intervention and control groups (8% vs 4%, P = .56). There was no difference in rates of medication compliance, smoking cessation, attendance at cardiac rehabilitation, or quality of life between the 2 groups, although our small pilot study was not powered to detect a difference in these outcomes.



In low-risk STEMI patients treated with primary or rescue PCI, a strategy of early hospital discharge facilitated by close nursing follow-up is feasible. Although our study did not identify differences in compliance or quality of life between the 2 groups, it did provide a functional study design for a larger trial powered to detect these important clinical end points.
Sensor-augmented pump therapy from the diagnosis of childhood type 1 diabetes: results of the Paediatric Onset Study (ONSET) after 12 months of treatment

The value of managing children with type 1 diabetes using a combination of insulin pump and continuous glucose monitoring starting from diagnosis for improving subsequent glycaemic control and preserving residual beta cell function was determined. A total of 160 children (aged 1–16 years, mean ± SD: 8.7 ± 4.4 years; 47.5% girls) were randomised to receive insulin pump treatment with continuous glucose monitoring or conventional self-monitoring blood glucose measurements. The primary outcome was the level of HbA1c after 12 months. Other analyses included fasting C-peptide, glycaemic variability, sensor usage, adverse events, children’s health-related quality of life and parent’s wellbeing. HbA1c was not significantly different between the two groups, but patients with regular sensor use had lower values (mean 7.1%, 95% CI 6.8–7.4%) compared with the combined group with no or low sensor usage (mean 7.6%, 95% CI 7.3–7.9%; p = 0.032). At 12 months, glycaemic variability was lower in the sensor group (mean amplitude of glycaemic excursions 80.2 ± 26.2 vs 92.0 ± 33.7; p = 0.037). Higher C-peptide concentrations were seen in sensor-treated 12- to 16-year-old patients (0.25 ± 0.12 nmol/l) compared with those treated with insulin pump alone (0.19 ± 0.07 nmol/l; p = 0.033). Severe hypoglycaemia was reported only in the group without sensors (four episodes). Sensor-augmented pump therapy starting from the diagnosis of type 1 diabetes can be associated with less decline in fasting C-peptide particularly in older children, although regular sensor use is a prerequisite for improved glycaemic control. ISRCTN.org ISRCTN05450731 Medtronic International Trading Sàrl, Tolochenaz, Switzerland
A threefold dose intensity treatment with ifosfamide, carboplatin, and etoposide for patients with small cell lung cancer: a randomized trial.

The dose intensity of chemotherapy can be increased to the highest possible level by early administration of multiple and sequential high-dose cycles supported by transfusion with peripheral blood progenitor cells (PBPCs). A randomized trial was performed to test the impact of such dose intensification on the long-term survival of patients with small cell lung cancer (SCLC).



Patients who had limited or extensive SCLC with no more than two metastatic sites were randomly assigned to high-dose (High, n = 69) or standard-dose (Std, n = 71) chemotherapy with ifosfamide, carboplatin, and etoposide (ICE). High-ICE cycles were supported by transfusion with PBPCs that were collected after two cycles of treatment with epidoxorubicin at 150 mg/m(2), paclitaxel at 175 mg/m(2), and filgrastim. The primary outcome was 3-year survival. Comparisons between response rates and toxic effects within subgroups (limited or extensive disease, liver metastases or no liver metastases, Eastern Cooperative Oncology Group performance status of 0 or 1, normal or abnormal lactate dehydrogenase levels) were also performed.



Median relative dose intensity in the High-ICE arm was 293% (range = 174%-392%) of that in the Std-ICE arm. The 3-year survival rates were 18% (95% confidence interval [CI] = 10% to 29%) and 19% (95% CI = 11% to 30%) in the High-ICE and Std-ICE arms, respectively. No differences were observed between the High-ICE and Std-ICE arms in overall response (n = 54 [78%, 95% CI = 67% to 87%] and n = 48 [68%, 95% CI = 55% to 78%], respectively) or complete response (n = 27 [39%, 95% CI = 28% to 52%] and n = 24 [34%, 95% CI = 23% to 46%], respectively). Subgroup analyses showed no benefit for any outcome from High-ICE treatment. Hematologic toxicity was substantial in the Std-ICE arm (grade > or = 3 neutropenia, n = 49 [70%]; anemia, n = 17 [25%]; thrombopenia, n = 17 [25%]), and three patients (4%) died from toxicity. High-ICE treatment was predictably associated with severe myelosuppression, and five patients (8%) died from toxicity.



The long-term outcome of SCLC was not improved by raising the dose intensity of ICE chemotherapy by threefold.
Atypical indications for transanal endoscopic microsurgery to avoid major surgery

Transanal endoscopic microsurgery (TEM) was originally designed for the removal of rectal tumors, principally incipient adenomas, and adenocarcinomas up to 20 cm from the anal verge. However, with the evolution of the technique and the increase in surgeons’ experience, new indications have emerged and TEM may now be used in place of other surgical procedures which are associated with higher morbidity. The aim of our study was to evaluate our group’s use of TEM or transanal endoscopic operations (TEO) for conditions other than rectal tumors. An observational study of TEM (using Wolf equipment) or TEO (using Storz equipment) for indications other than excision of rectal tumors was conducted from June 2004 to July 2012. Four hundred twenty-four procedures were performed using TEM/TEO: removal of adenocarcinomas in 148 (34.9 %) patients, adenomas in 236 (55.7 %), post-polypectomy excision in 12 (2.8 %), removal of neuroendocrine tumors in 8 (1.9 %), and atypical indications in 20 (4.7 %). Atypical indications were pelvic abscess (3), benign rectal stenoses (2), rectourethral fistula after prostatectomy (3), gastrointestinal stromal tumor (3), endorectal condylomata acuminata (1), rectal prolapse (2), extraction of impacted fecaloma in the rectosigmoid junction (1), repair of traumatic and iatrogenic perforation of the rectum (2), and presacral tumor (3). The use of TEM/TEO in atypical indications may benefit patients by avoiding surgical procedures associated with greater morbidity.
Genetic variation of CYP2C19 affects both pharmacokinetic and pharmacodynamic responses to clopidogrel but not prasugrel in aspirin-treated patients with coronary artery disease

The metabolic pathways leading to the formation of prasugrel and clopidogrel active metabolites differ. We hypothesized that decreased CYP2C19 activity affects the pharmacokinetic and pharmacodynamic response to clopidogrel but not prasugrel.



Ninety-eight patients with coronary artery disease (CAD) taking either clopidogrel 600 mg loading dose (LD)/75 mg maintenance dose (MD) or prasugrel 60 mg LD/10 mg MD were genotyped for variation in six CYP genes. Based on CYP genotype, patients were segregated into two groups: normal function (extensive) metabolizers (EM) and reduced function metabolizers (RM). Plasma active metabolite concentrations were measured at 30 min, 1, 2, 4, and 6 h post-LD and during the MD period on Day 2, Day 14, and Day 29 at 30 min, 1, 2, and 4 h. Vasodilator-stimulated phosphoprotein (VASP) and VerifyNow P2Y12 were measured predose, 2, and 24 +/- 4 h post-LD and predose during the MD period on Day 14 +/- 3 and Day 29 +/- 3. For clopidogrel, active metabolite exposure was significantly lower (P = 0.0015) and VASP platelet reactivity index (PRI, %) and VerifyNow P2Y(12) reaction unit (PRU) values were significantly higher (P < 0.05) in the CYP2C19 RM compared with the EM group. For prasugrel, there was no statistically significant difference in active metabolite exposure or pharmacodynamic response between CYP2C19 EM and RM. Variation in the other five genes demonstrated no statistically significant differences in pharmacokinetic or pharmacodynamic responses.



Variation in the gene encoding CYP2C19 in patients with stable CAD contributes to reduced exposure to clopidogrel's active metabolite and a corresponding reduction in P2Y(12) inhibition, but has no significant influence on the response to prasugrel.
Why attend a memory clinic? What do patients and their families want and/or expect?

To explore which symptoms led people to seek a memory clinic assessment and what they wanted and expected from that assessment. Did the patient and family want and/or expect diagnostic disclosure and, if so, why?



Patients scheduled for memory clinic appoint-ments received two questionnaires by post prior to clinic attendance - one for the patient, one for the next-of- kin - regarding symptomatology, wants, expectations and rationale.



Ninety-two per cent of patients (n = 47) and 88% (n = 43) of next-of-kin wanted the patient to be informed of the diagnosis; 84% (n = 43) of patients and 86% (n = 42) of next-of-kin expected the patient to be informed. Rationales for diagnostic disclosure were categorised under themes of planning, treatment, information, coping strategies and rights.



Patients and families want diagnostic disclosure in order to plan, receive treatment, receive help and learn strategies to cope. This knowledge is seen as the patient's right.
Entacapone to tolcapone switch: Multicenter double-blind, randomized, active-controlled trial in advanced Parkinson's disease.

This double-blind study examined the efficacy and safety of replacing entacapone with tolcapone in fluctuating Parkinson's disease (PD) patients. Patients receiving entacapone for > or =15 days were randomly assigned to continue entacapone (n = 75) or switch to tolcapone (n = 75) and were followed up for 3 weeks. Efficacy measures included changes in on time (without disabling dyskinesia) and an investigator's global assessment (IGA). The on time increased by > or =1 hour/day (primary efficacy measure) in 43% of entacapone-treated patients and 53% of tolcapone-treated patients, and by > or =3 hours/day in 13% and 25%, respectively. The IGA indicated moderate/marked improvements in 25% of entacapone patients and 39% receiving tolcapone. Response rates (the proportion of patients with > or =1 hour/day increase in on time and improvements on IGA) were 17% with entacapone and 32% with tolcapone. Dyskinesia was the most common adverse event affecting 29% of entacapone and 31% of tolcapone recipients. One patient in each group had elevated liver enzymes, resulting in treatment withdrawal (levels returned to normal thereafter in both cases). In conclusion, within the limits of the protocol, there was a tendency for tolcapone to offer enhanced efficacy in patients with fluctuating PD, despite optimized entacapone therapy. Tolcapone can be considered, therefore, for patients whose motor fluctuations are inadequately controlled by their existing regimen.
A new instrument to measure quality of life of heart failure family caregivers.

Family caregivers of heart failure (HF) patients experience poor physical and mental health leading to poor quality of life. Although several quality-of-life measures exist, they are often too generic to capture the unique experience of this population. The purpose of this study was to evaluate the psychometric properties of the Family Caregiver Quality of Life (FAMQOL) Scale that was designed to assess the physical, psychological, social, and spiritual dimensions of quality of life among caregivers of HF patients.



Psychometric testing of the FAMQOL with 100 HF family caregivers was conducted using item analysis, Cronbach α, intraclass correlation, factor analysis, and hierarchical multiple regression guided by a conceptual model. Caregivers were predominately female (89%), white, (73%), and spouses (62%).



Evidence of internal consistency reliability (α=.89) was provided for the FAMQOL, with item-total correlations of 0.39 to 0.74. Two-week test-retest reliability was supported by an intraclass correlation coefficient of 0.91. Using a 1-factor solution and principal axis factoring, loadings ranged from 0.31 to 0.78, with 41% of the variance explained by the first factor (eigenvalue=6.5). With hierarchical multiple regression, 56% of the FAMQOL variance was explained by model constructs (F8,91=16.56, P<.001). Criterion-related validity was supported by correlations with SF-36 General (r=0.45, P<.001) and Mental (r=0.59, P<.001) Health subscales and Bakas Caregiving Outcomes Scale (r=0.73, P<.001). Evidence of internal and test-retest reliability and construct and criterion validity was provided for physical, psychological, and social well-being subscales.



The 16-item FAMQOL is a brief, easy-to-administer instrument that has evidence of reliability and validity in HF family caregivers. Physical, psychological, and social well-being can be measured with 4-item subscales. The FAMQOL scale could serve as a valuable measure in research, as well as an assessment tool to identify caregivers in need of intervention.