nils-herrmann/clean_scirepeval huggingface dataset:
Prospective randomized controlled trial of robotic versus open radical cystectomy for bladder cancer: perioperative and pathologic results.

In recent years, surgeons have begun to report case series of minimally invasive approaches to radical cystectomy, including robotic-assisted techniques demonstrating the surgical feasibility of this procedure with the potential of lower blood loss and more rapid return of bowel function and hospital discharge. Despite these experiences and observations, at this point high levels of clinical evidence with regard to the benefits of robotic cystectomy are absent, and the current experiences represent case series with limited comparisons to historical controls at best.



We report our results on a prospective randomized trial of open versus robotic-assisted laparoscopic radical cystectomy with regard to perioperative outcomes, complications, and short-term narcotic usage.



A prospective randomized single-center noninferiority study comparing open versus robotic approaches to cystectomy in patients who are candidates for radical cystectomy for urothelial carcinoma of the bladder. Of the 41 patients who underwent surgery, 21 were randomized to the robotic approach and 20 to the open technique.



Radical cystectomy, bilateral pelvic lymphadenectomy, and urinary diversion by either an open approach or by a robotic-assisted laparoscopic technique.



The primary end point was lymph node (LN) yield with a noninferiority margin of four LNs. Secondary end points included demographic characteristics, perioperative outcomes, pathologic results, and short-term narcotic use.



On univariate analysis, no significant differences were found between the two groups with regard to age, sex, body mass index, American Society of Anesthesiologists classification, anticoagulation regimen of aspirin, clinical stage, or diversion type. Significant differences were noted in operating room time, estimated blood loss, time to flatus, time to bowel movement, and use of inpatient morphine sulfate equivalents. There was no significant difference in regard to overall complication rate or hospital stay. On surgical pathology, in the robotic group 14 patients had pT2 disease or higher; 3 patients had pT3/T4 disease; and 4 patients had node-positive disease. In the open group, eight patients had pT2 disease or higher; five patients had pT3/T4 disease; and seven patients had node-positive disease. The mean number of LNs removed was 19 in the robotic group versus18 in the open group. Potential study limitations include the limited clinical and oncologic follow-up and the relatively small and single-institution nature of the study.



We present the results of a prospective randomized controlled noninferiority study with a primary end point of LN yield, demonstrating the robotic approach to be noninferior to the open approach. The robotic approach also compares favorably with the open approach in several perioperative parameters.
Cryosurgery is more effective in the treatment of primary, non-superficial basal cell carcinomas when applied during and not prior to a five week imiquimod course: a randomized, prospective, open-label study.

Combinational cryosurgery during daily imiquimod application ('immunocryosurgery') efficiently cures invading basal cell carcinoma (BCC). Since timing of the cryosurgery is considered crucial for effectiveness, our aim was to compare efficacy of two different timing schemes of the combination of cryosurgery and topical imiquimod: Cryosurgery (a) 2 weeks after (Arm I) vs (b) prior to the initiation of a 5 week daily imiquimod course (Arm II). 16 patients with 21 BCC were recruited in this prospective, randomized, open-label trial. 14 patients with 17 BCC were evaluated (Arm I: 7 patients/10 tumors vs Arm II: 7 patients/7 tumors) during scheduled interim analysis at 6 month follow-up (two patients dropped out, one non-compliant and one lost to follow up). The trial was revoked because study Arm I ('immunocryosurgery') was significantly superior to Arm II (adjuvant imiquimod) in achieving tumor clearance (10/10 vs 3/7 tumors; p=0.0147) and by overall treatment efficacy (9/10 vs 2/7 relapse-free tumors; p=0.0345). The same overall efficacy persisted after at least 18 months follow-up for those patients with tumor clearance after the trial treatment. The timing of cryosurgery during imiquimod application substantially determines the efficacy of this combinational approach in the treatment of BCC.
Antibiotic therapy after acute myocardial infarction: a prospective randomized study.

Infection with Chlamydia pneumoniae is suspected to contribute to the pathogenesis of human atherosclerosis. We investigated whether treatment with the macrolide antibiotic roxithromycin would reduce mortality or morbidity in patients with an acute myocardial infarction.



Eight hundred seventy-two patients with an acute myocardial infarction (AMI) were randomly assigned to receive double-blind treatment with either 300 mg roxithromycin or placebo daily for 6 weeks. Primary end point was total mortality during 12-month follow-up. Four hundred thirty-three patients were treated with roxithromycin and 439 with placebo. With the exception of a higher proportion of patients suffering an anterior wall AMI (48.1% in the roxithromycin group versus 40.2% in the placebo group; P=0.027) and a lower prevalence of chronic obstructive pulmonary disease in the roxithromycin group (3.5% versus 6.9%, P=0.028), baseline characteristics, reperfusion therapy, and medical treatment were well balanced between the two groups. More patients in the roxithromycin group interrupted their study medication before completion of at least 4 weeks of treatment (78 of 433 [18%] versus 48 of 439 [11%]; P=0.003; odds ratio, 1.8; 95% CI, 1.2 to 2.6). Follow-up at 12 months was achieved in 868 of 872 (99.5%) patients. Total mortality at 12 months was 6.5% (28 of 431) in the roxithromycin group compared with 6.0% (26 of 437) in the placebo group (odds ratio, 1.1; 95% CI, 0.6 to 1.9; P=0.739). There were also no differences in the secondary combined end points at 12 months.



Treatment of AMI patients with roxithromycin did not reduce event rates during 12 months of follow-up. Therefore, our findings do not support the routine use of antibiotic treatment with a macrolide in patients with AMI.
Validity of Montreal Cognitive Assessment in non-english speaking patients with Parkinson's disease.

The Montreal Cognitive Assessment is a brief and easy screening tool for accurately testing cognitive dysfunction in Parkinson's disease. We tested its validity for use in non-English (Malayalam) speaking patients with Parkinson's disease.



We developed a Malayalam (a south-Indian language) version of Montreal Cognitive Assessment and applied to 70 patients with Parkinson's disease and 60 age- and education-matched healthy controls. Metric properties were assessed, and the scores were compared with the performance in validated Malayalam versions of Mini Mental Status Examination and Addenbrooke's Cognitive Examination.



The Montreal Cognitive Assessment-Malayalam showed good internal consistency and test-retest reliability and its scores correlated with Mini Mental Status Examination (patients: R = 0.70; P < 0.001; healthy controls: R = 0.26; P = 0.04) and Addenbrooke's Cognitive Examination (patients: R = 0.8; P < 0.001; healthy controls: R = 0.52; P < 0.001) scores.



This study establishes the reliability of cross-cultural adaptation of Montreal Cognitive Assessment for assessing cognition in Malayalam-speaking Parkinson's disease patients for early screening and potential future interventions for cognitive dysfunction.
Little evidence of association between severity of trigonocephaly and cognitive development in infants with single-suture metopic synostosis.

To measure severity of trigonocephaly among infants with single-suture metopic craniosynostosis by using a novel shape descriptor, the trigonocephaly severity index (TSI), and to evaluate whether degree of trigonocephaly correlates with their neurodevelopmental test scores.



We conducted a multicenter cross-sectional and longitudinal study, identifying and recruiting 65 infants with metopic synostosis before their corrective surgery. We obtained computed tomography images for 49 infants and measured the presurgical TSI, a 3-dimensional outline-based cranial shape descriptor. We evaluated neurodevelopment by administering the Bayley Scales of Infant Development, Second Edition, and the Preschool Language Scale, Third Edition, before surgery and at 18 and 36 months of age. We fit linear regression models to estimate associations between test scores and TSI values adjusted for age at testing and race/ethnicity. We fit logistic regression models to estimate whether the odds of developmental delay were increased among children with more severe trigonocephaly.



We observed little adjusted association between neurodevelopmental test scores and TSI values, and no associations that persisted at 3 years. Trigonocephaly was less severe among children referred at older ages.



We observed little evidence of an association between the severity of trigonocephaly among metopic synostosis patients and their neurodevelopmental test scores. Detecting such a relationship with precision may require larger sample sizes or alternative phenotypic quantifiers. Until studies are conducted to explore these possibilities, it appears that although associated with the presence of metopic synostosis, the risk of developmental delays in young children is unrelated to further variation in trigonocephalic shape.
Menstrual and reproductive characteristics and breast density in young women

Breast density is strongly related to breast cancer risk, but determinants of breast density in young women remain largely unknown. Associations of reproductive and menstrual characteristics with breast density measured by magnetic resonance imaging were evaluated in a cross-sectional study of 176 healthy women, 25–29 years old, using linear mixed effects models. Parity was significantly inversely associated with breast density. In multivariable adjusted models that included non-reproductive variables, mean percent dense breast volume (%DBV) decreased from 20.5 % in nulliparous women to 16.0 % in parous women, while mean absolute dense breast volume (ADBV) decreased from 85.3 to 62.5 cm3. Breast density also was significantly inversely associated with the age women started using hormonal contraceptives, whereas it was significantly positively associated with duration of hormonal contraceptive use. In adjusted models, mean %DBV decreased from 21.7 % in women who started using hormones at 12–17 years of age to 14.7 % in those who started using hormones at 22–28 years of age, while mean ADBV decreased from 86.2 to 53.7 cm3. The age at which women started using hormonal contraceptives and duration of hormone use were inversely correlated, and mean %DBV increased from 15.8 % in women who used hormones for not more than 2.0 years to 22.0 % in women who used hormones for more than 8 years, while mean ADBV increased from 61.9 to 90.4 cm3 over this interval. Breast density in young women is inversely associated with parity and the age women started using hormonal contraceptives but positively associated with duration of hormone use.
Glenoid morphology affects the incidence of radiolucent lines around cemented pegged polyethylene glenoid components

Radiolucent lines (RLL) are frequent findings around cemented all-polyethylene glenoid implants. The present study evaluates the frequency, extend and the clinical impact of RLL around a cemented two-pegged glenoid implant with special focus on the influence of preoperative glenoid morphology. Our hypothesis was that glenoid morphology does not affect clinical outcome and RLL in the investigated setting. Between 2003 and 2008, a total of 113 cases of total shoulder arthroplasties (Affinis, Mathys Ltd Bettlach, Switzerland) were performed in three surgical centres using a pegged cemented polyethylene glenoid component. A total of 90 cases could be evaluated clinically and radiographically. Clinical outcome was analysed using the constant score (CS) and range of motion assessment. Radiographic evaluation was performed in true anterior–posterior and axial views with special focus on loosening and RLL. Further, preoperative glenoid morphology was documented and its correlation to radiolucent lines and clinical outcomes was evaluated. At a mean of 58.8 (range 31.2–92.5)-month follow-up the CS improved from 21.5 points preoperatively to 62.3 points postoperatively. Radiolucent lines were found in 76.6 % of cases. If present, RLL were located at the backside of the implant (74.4 %) in the majority of the cases not around the pegs (10 %). There was no significant correlation between RLL and clinical outcome or follow-up time. The amount and extend of RLL were correlated to glenoid morphology with significantly higher values for glenoid types B2 and C according to Walch in comparison to glenoid types A1, A2 and B1. RLL did not affect clinical outcome and did not correlate with the follow-up time. Patients with glenoid morphology types B2 and C showed significantly worse radiographic results.
Ranibizumab and bevacizumab for neovascular age-related macular degeneration.

Clinical trials have established the efficacy of ranibizumab for the treatment of neovascular age-related macular degeneration (AMD). In addition, bevacizumab is used off-label to treat AMD, despite the absence of similar supporting data.



In a multicenter, single-blind, noninferiority trial, we randomly assigned 1208 patients with neovascular AMD to receive intravitreal injections of ranibizumab or bevacizumab on either a monthly schedule or as needed with monthly evaluation. The primary outcome was the mean change in visual acuity at 1 year, with a noninferiority limit of 5 letters on the eye chart.



Bevacizumab administered monthly was equivalent to ranibizumab administered monthly, with 8.0 and 8.5 letters gained, respectively. Bevacizumab administered as needed was equivalent to ranibizumab as needed, with 5.9 and 6.8 letters gained, respectively. Ranibizumab as needed was equivalent to monthly ranibizumab, although the comparison between bevacizumab as needed and monthly bevacizumab was inconclusive. The mean decrease in central retinal thickness was greater in the ranibizumab-monthly group (196 μm) than in the other groups (152 to 168 μm, P=0.03 by analysis of variance). Rates of death, myocardial infarction, and stroke were similar for patients receiving either bevacizumab or ranibizumab (P>0.20). The proportion of patients with serious systemic adverse events (primarily hospitalizations) was higher with bevacizumab than with ranibizumab (24.1% vs. 19.0%; risk ratio, 1.29; 95% confidence interval, 1.01 to 1.66), with excess events broadly distributed in disease categories not identified in previous studies as areas of concern.



At 1 year, bevacizumab and ranibizumab had equivalent effects on visual acuity when administered according to the same schedule. Ranibizumab given as needed with monthly evaluation had effects on vision that were equivalent to those of ranibizumab administered monthly. Differences in rates of serious adverse events require further study. (Funded by the National Eye Institute; ClinicalTrials.gov number, NCT00593450.).
Validation of a simple index (SIisOGTT) of insulin sensitivity in a population of sedentary men.

The ongoing obesity epidemic is associated with numerous health problems related to altered metabolic function. Among these is type 2 diabetes, characterized by lowered insulin sensitivity (IS). Consequently, the development of simple indices to assess IS has research and clinical importance. The SI(is)OGTT, a new index of IS, was recently described by Bastard et al. (Diabetes & Metabolism 2007;33:261-8), and validated in sedentary, non-diabetic, overweight and obese postmenopausal women. The aim of the present study was to validate the index in men.



The data used in this project came from sedentary men (n=36), aged 34-53 years, all of whom underwent a hyperinsulinaemic-euglycaemic clamp and 2-hour oral glucose tolerance test (OGTT). Correlations with M/I (glucose infusion rate [GIR] divided by insulin concentration), GIR and GIR divided by fat-free mass (FFM) were obtained by four well-known indices (HOMA, QUICKI, Cederholm and Matsuda) as well as with the new SI(is)OGTT index. Pearson correlations and Bland-Altman analyses were obtained for every index versus clamp value.



The best correlate of IS in the present study was the SI(is)OGTT (r=0.84, P<0.0001). The agreement of this method with the hyperinsulinaemic-euglycaemic clamp, as assessed by Bland-Altman plots, was similar to those of the other indices and to those previously described in postmenopausal women.



The new index proposed by Bastard et al. is as good a predictor of IS in sedentary men as the other commonly used indices, and appears to be as reliable in this population as it was in the original study of postmenopausal women.
Reliability of the quality of upper extremity skills test for children with cerebral palsy aged 2 to 12 years.

To investigate reliability of the Quality of Upper Extremity Skills Test (QUEST) scores for children with cerebral palsy (CP) aged 2-12 years.



Thirty-one QUESTs from 24 children with CP were rated once by two raters and twice by one rater. Internal consistency of total scores, inter- and intra-rater reliability findings for total, domain, and item scores were calculated.



Total scores inter-rater reliability, Intra-class Correlation Coefficient (ICC) was 0.86, and for intra-rater reliability, ICC was 0.96. Domains had high reliability (ICC > 0.80) within raters and between raters except for grasp (moderate at ICC = 0.67). Item inter-rater reliability was moderate or better for 80% of items; item intra-rater reliability was moderate or better for 87% of items. Total score internal consistency was high (α = 0.97).



The QUEST has proven reliability for children with CP aged 18 months to 8 years. This study demonstrates strong reliability for children aged 2-12 years.
Zinc transporter gene expression and glycemic control in post-menopausal women with Type 2 diabetes mellitus.

Type 2 diabetes mellitus (DM) is associated often with underlying zinc deficiency and nutritional supplements such as zinc may be of therapeutic benefit in the disease. In a randomized, double-blind, placebo-controlled, 12-week trial in postmenopausal women (n=48) with Type 2 DM we investigated the effects of supplementation with zinc (40mg/d) and flaxseed oil (FSO; 2g/d) on the gene expression of zinc transporters (ZnT1, ZnT5, ZnT6, ZnT7, ZnT8, Zip1, Zip3, Zip7, and Zip10) and metallothionein (MT-1A, and MT-2A), and markers of glycemic control (glucose, insulin, glycosylated hemoglobin [HbA1c]). The homeostasis model assessment of insulin resistance (HOMA-IR) was calculated. No significant effects of zinc or FSO supplementation were observed on glycemic marker concentrations, HOMA-IR or fold change over 12 weeks in zinc transporter and metallothionein gene expression. In multivariate analysis, the change over 12 weeks in serum glucose concentrations (P=0.001) and HOMA-IR (P=0.001) predicted the fold change in Zip10. In secondary analysis, marginal statistical significance was observed with the change in both serum glucose concentrations (P=0.003) and HOMA-IR (P=0.007) being predictive of the fold change in ZnT6. ZnT8 mRNA expression was variable; HbA1c levels were higher (P=0.006) in participants who exhibited ZnT8 expression compared to those who did not. The significant predictive relationships between Zip10, ZnT6, serum glucose and HOMA-IR are preliminary, as is the relationship between HbA1c and ZnT8; nevertheless the observations support an association between Type 2 DM and zinc homeostasis that requires further exploration.
Treatment with vaginal progesterone in women with low-grade cervical dysplasia: a phase II trial.

The development of low-grade cervical dysplasia (CIN I) has been linked to a decrease of apoptosis and Langerhans cell (LC) count in the cervical epithelium and to an increase in the expression of various adhesion molecules. Vaginally administered progesterone locally increases apoptosis and the number of LCs, and reduces the expression of various adhesion molecules. We hypothesized that vaginal progesterone would increase the regression rate in women with CIN I.



A non-randomized, open phase II trial with vaginal progesterone as treatment of CIN I was performed. Forty women were treated with vaginal micronized progesterone at 400 mg daily for 10 days/month from menstrual cycle day 16-25 for 6 months. The control group consisted of 96 consecutive women with CIN I treated prior and after the study period. After 3 and 6 months, all women were examined for regression, persistence, or progression of disease. Women were treated according to standard clinical protocols. In cases of progressive disease, a large loop excision of the transformation zone (LLETZ) was performed.



The mean (standard deviation) age of women in the treatment and control groups was 32.0 (7.6) and 32.6 (8.5) years, respectively. A total of 30% and 38.3% of CIN I regressed in the treatment and control group, respectively. In a multivariate model, a higher number of children, a higher lifetime number of sexual partners, a lower age at first intercourse, non-use of condoms as contraception, current smoking, and treatment with vaginal progesterone were associated with a higher probability of having persistent or progressive CIN. Current smoking and treatment with vaginal progesterone were associated with a higher probability of undergoing LLETZ.



Treatment with vaginal progesterone is associated with a lower rate of disease regression and a higher rate of surgical interventions in women with CIN I. We suggest that vaginal progesterone treatment should not be applied in women with known dysplasia.
Renal Phosphate Reabsorption is Correlated with the Increase in Lumbar Bone Mineral Density in Patients Receiving Once-Weekly Teriparatide

In order to assess the changes in serum calcium and phosphate and the changes in renal tubular phosphate reabsorption (TmP/GFR) and to evaluate the association between these indices and the increase in bone mineral density (BMD) with once-weekly intermittent administration of teriparatide (TPTD), the results from the teriparatide once-weekly efficacy research (TOWER) trial were re-analyzed. The TOWER trial studied postmenopausal women and older men with osteoporosis. Patients were randomly assigned to receive TPTD 56.5 μg or placebo for 72 weeks. Of these patients, the present study investigated those whose calcium and phosphate levels and lumbar BMD (L-BMD) were measured (TPTD group, n = 153 and Placebo group, n = 137). The TPTD group had significantly lower serum phosphate, calcium-phosphate product, and TmP/GFR at weeks 4, 24, 48, and 72 and urinary fractional calcium excretion (FECa) at weeks 12, 48, and 72 (p < 0.05). In the TPTD group, the serum phosphate and TmP/GFR during early treatment (4, and 12 weeks) showed a significant positive correlation with the percent change in L-BMD at weeks 48 and 72. Based on multivariate analysis corrected for age, BMI, and L-BMD at the start of treatment, serum phosphate and TmP/GFR at week 4 showed a significant correlation with the percent change in L-BMD. This study suggests that the L-BMD response to once-weekly long-term TPTD treatment is associated with circulating phosphate or with the status of its renal reabsorption. Preventing decrease in serum phosphate levels may be important in acquiring greater L-BMD with once-weekly TPTD.