nils-herrmann/clean_scirepeval huggingface dataset:
The radiological outcomes of patient-specific instrumentation versus conventional total knee arthroplasty

The aim of this study was to investigate the post-operative radiological outcomes of patient-specific instrumentation (PSI) surgery versus conventional total knee arthroplasty (TKA). Sixty patients scheduled for a primary TKA were prospectively divided into PSI or conventional technique. Coronal and sagittal radiographic long limb films were taken post-operatively. The accepted values for normal alignment were 180° ± 3° for hip-knee-ankle angle; 90° ± 3° for coronal femoral component angle or coronal tibia component angle; 0° to 3° flexion for sagittal femoral component angle and 0° to 7° posterior slope for sagittal tibia component angle. For hip-knee-ankle angle, there were 21 % more outliers in the PSI group compared to the conventional group (p = 0.045). Most of these outliers had valgus deformity in the PSI group and varus deformity in the conventional group (p = 0.045). For implant placement, there was no difference in the proportion of outliers between the two groups. There was also no difference in the duration of surgery. This study showed that PSI surgery is associated with a larger proportion of outliers for lower limb alignment. PSI surgery as an alternative to conventional TKA is not advisable. II.
An evaluation of the safety and efficacy of cariprazine in patients with acute exacerbation of schizophrenia: A phase II, randomized clinical trial

Cariprazine is an orally active and potent D3 and D2 partial agonist with preferential binding to D3 receptors in development for the treatment of schizophrenia and bipolar mania. This study (NCT00694707) evaluated the efficacy and safety of cariprazine in patients with acute exacerbation of schizophrenia.



This study was a multinational, double-blind, randomized, placebo- and active-controlled, fixed-dose trial. Patients were randomized to receive placebo, cariprazine 1.5mg/d, cariprazine 3.0mg/d, cariprazine 4.5mg/d, or risperidone 4.0mg/d (for assay sensitivity) for 6 weeks of double-blind treatment and 2 weeks of safety follow-up. Primary and secondary efficacy parameters were change from baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) total and Global Impressions-Severity of Illness (CGI-S) scores, respectively. Safety parameters included adverse events (AEs), vital signs, laboratory measures, and extrapyramidal symptom (EPS) scales.



Of 732 randomized patients, 64% completed the study. PANSS total score improvement at Week 6 was statistically significant versus placebo for cariprazine 1.5mg/d, 3.0mg/d, and 4.5mg/d (least squares mean difference [LSMD]: -7.6, -8.8, -10.4, respectively; p<0.001; LOCF) and risperidone (-15.1, p<0.001; LOCF); significant improvement on CGI-S was demonstrated for all active treatments (p<0.05). The most frequent cariprazine AEs (≥ 5% and at least twice the rate of the placebo group) were insomnia, extrapyramidal disorder, akathisia, sedation, nausea, dizziness, and constipation. Mean changes in metabolic parameters were small and similar between groups.



The results of this study support the efficacy and safety of cariprazine in patients with acute exacerbation of schizophrenia.
Short telomere length in blood leucocytes contributes to the presence of atherothrombotic stroke and haemorrhagic stroke and risk of post-stroke death.

Inter-individual differences in biological aging could affect susceptibility to stroke. To date, the relationship between stroke and telomere shortening remain inconclusive; and sparse data are available for haemorrhagic stroke. A Chinese case-control study was conducted, comprising 1756 cases (767 atherothrombosis, 503 lacunar infarction and 486 haemorrhagic strokes) and 1801 controls. Stroke patients were prospectively followed up for a median of 4.5 (range, 0.1-6.0) years. Individuals with shorter telomere length had a higher presence of atherothrombotic stroke {multivariate OR (odds ratio) 1.37 [95% CI (confidence interval), 1.06-1.77]; P=0.015} or haemorrhagic stroke [multivariate OR 1.48 (95% CI, 1.08-2.02); P=0.016] in comparison of the lowest to highest tertile of telomere length. Particularly, in subjects with a family history of stroke, there was a significant 2.55-fold increased presence of atherothrombotic stroke (95% CI, 1.87-3.48; Ptrend<0.0001) and a 2.33-fold increased presence of haemorrhagic stroke (95% CI, 1.62-3.36; Ptrend<0.0001). During the follow-up, 338 recurrent strokes and 312 deaths (181 from stroke or coronary heart disease and 131 from other causes) were documented. Associations with stroke recurrence were not observed in the follow-up patients, whereas atherothrombotic stroke cases with shorter telomeres had 69% increased risk of post-stroke death [relative risk, 1.69 (95% CI, 1.07-2.67); P=0.02]. Finally, we compared telomere lengths in 12 paired samples of circulating leucocytes and carotid atherosclerotic plaques from patients undergoing carotid endarterectomy; there was a positive correlation between vessel wall tissue and leucocyte telomere length. In conclusion, shorter telomere length may serve as a potential marker for the presence of atherothrombotic and haemorrhagic stroke and for the risk of post-stroke death.
The Use of Functional Data Analysis to Evaluate Activity in a Spontaneous Model of Degenerative Joint Disease Associated Pain in Cats

Accelerometry is used as an objective measure of physical activity in humans and veterinary species. In cats, one important use of accelerometry is in the study of therapeutics designed to treat degenerative joint disease (DJD) associated pain, where it serves as the most widely applied objective outcome measure. These analyses have commonly used summary measures, calculating the mean activity per-minute over days and comparing between treatment periods. While this technique has been effective, information about the pattern of activity in cats is lost. In this study, functional data analysis was applied to activity data from client-owned cats with (n = 83) and without (n = 15) DJD. Functional data analysis retains information about the pattern of activity over the 24-hour day, providing insight into activity over time. We hypothesized that 1) cats without DJD would have higher activity counts and intensity of activity than cats with DJD; 2) that activity counts and intensity of activity in cats with DJD would be inversely correlated with total radiographic DJD burden and total orthopedic pain score; and 3) that activity counts and intensity would have a different pattern on weekends versus weekdays.



Results showed marked inter-cat variability in activity. Cats exhibited a bimodal pattern of activity with a sharp peak in the morning and broader peak in the evening. Results further showed that this pattern was different on weekends than weekdays, with the morning peak being shifted to the right (later). Cats with DJD showed different patterns of activity from cats without DJD, though activity and intensity were not always lower; instead both the peaks and troughs of activity were less extreme than those of the cats without DJD. Functional data analysis provides insight into the pattern of activity in cats, and an alternative method for analyzing accelerometry data that incorporates fluctuations in activity across the day.
Pooled analysis of the CONFIRM registries: impact of gender on procedure and angiographic outcomes in patients undergoing orbital atherectomy for peripheral artery disease.

To compare the acute procedure and angiographic outcomes of peripheral artery disease (PAD) patients treated with orbital atherectomy stratified by gender.



The CONFIRM I, II, and III registries are US multicenter, nonrandomized, all-comers registries of PAD patients who were treated with orbital atherectomy. All patients with gender specified in the registry database were included in the current analysis, which compared the final residual stenosis achieved after atherectomy and the rate of acute complications in female and male patients. The 3 registries included 3131 patients with 4761 lesions: 1261 women (mean age 73.2 ± 10.7 years) with 1874 lesions and 1870 men (mean age 70.4 ± 10.2) with 2887 lesions.



The women were older (p < 0.001) and had a higher but nonsignificant prevalence of critical limb ischemia (p = 0.075). After treatment, the final residual stenosis in women vs. men was 9% ± 11% vs. 11% ± 11%, respectively (p < 0.001). Women had a higher rate of all types of dissection (13.3% vs. 9.9%, p<0.001). However, both genders had similar rates of flow-limiting dissections (1.6% vs. 1.4%, p = 0.61), perforation, slow flow, vessel closure, spasm, embolism, and thrombus formation.



The gender analysis of the CONFIRM registries revealed that there was successful lesion modification with orbital atherectomy in both men and women; however, women had a higher rate of dissection (all types). This difference is likely because of the older age and higher percentage of critical limb ischemia in women in this cohort. These results, however, suggest that additional studies should be completed to further understand the increased risks for women vs. men during endovascular procedures.
Activation of the Nrf2-Keap 1 Pathway in Short-Term Iodide Excess in Thyroid in Rats

Wistar rats were randomly divided into groups of varying iodide intake: normal iodide; 10 times high iodide; and 100 times high iodide on Days 7, 14, and 28. Insignificant changes were observed in thyroid hormone levels (p > 0.05). Urinary iodine concentration and iodine content in the thyroid glands increased after high consumption of iodide from NI to 100 HI (p < 0.05). The urinary iodine concentration of the 100 HI group on Days 7, 14, and 28 was 60-80 times that of the NI group. The mitochondrial superoxide production and expressions of Nrf2, Srx, and Prx 3 all significantly increased, while Keap 1 significantly decreased in the 100 HI group when compared to the NI or 10 HI group on Days 7, 14, and 28 (p < 0.05). Immunofluorescence staining results showed that Nrf2 was localized in the cytoplasm in NI group. Although Nrf2 was detected in both cytoplasm and nucleus in 10 HI and 100 HI groups, a stronger positive staining was found in the nucleus. We conclude that the activation of the Nrf2-Keap 1 antioxidative defense mechanism may play a crucial role in protecting thyroid function from short-term iodide excess in rats.
Drug preference and mood in humans: Preference for d-amphetamine and subject characteristics

Forty-five normal, young, adult volunteers participated in a nine-session experiment. During the first four sessions, they received alternately 5 mg d-amphetamine or placebo. During the next five sessions, they chose between amphetamine and placebo. On the basis of the choice results, subjects retrospectively were divided into the following three groups: (1) five of five drug choices (N=16), (2) four of five drug choices (N=12); and (3) 0–3 of five drug choices (N=17). There was an overall average of 3.76 drug choices per subject. These groups were compared by demographic characteristics, drug use history, and several personality measures, but none predicted drug choice. However, subjects who chose drug on every occasion had significantly higher predrug scores on the anxiety, depression, and confusion subscales of the Profile of Mood States (POMS). The functional relationship between initial dysphoria and consistent amphetamine choosing remains an intriguing question.
Best-practice models that work: the CDC's Racial and Ethnic Adult Disparities Immunization Initiative (READII) Programs.

In this panel discussion, three health leaders provide information on techniques and approaches used to effectively implement the CDC's Racial and Ethnic Adult Disparities Immunization Initiative (READII) Programs. Part 1 offers an overview of READII and information on early results and program accomplishments. In Part 2, the Mississippi READII initiative is explored, with insights on how this program has served 10,000 African Americans in inner-city Jackson, Mississippi as well 23,000 elderly African Americans in 18 rural Delta counties, said to be the poorest counties in the nation. The third segment of this presentation explains challenges and successes found in San Antonio, Texas where READII efforts focused on immunizing the city's elderly Hispanics. Readers will find lessons learned and plans for future expansion to use as models when considering implementation of immunization programs in local communities.
Evaluating adherence to highly active antiretroviral therapy with use of pill counts and viral load measurement in the drug resources enhancement against AIDS and malnutrition program in Mozambique.

Maintaining treatment adherence among the growing number of patients receiving antiretroviral treatment in Africa is a dramatic challenge. The objective of our study was to explore the results of a computerized pill count method and to test the validity, sensitivity, and specificity of this method with respect to viral load measurement in an African setting.



We performed a prospective, observational study involving patients who received first-line highly active antiretroviral therapy in Mozambique from 1 April 2005 through 31 March 2006. Enrolled patients had received treatment for at least 3 months before the study. For defining treatment adherence levels, pill counts were used, and the results were analyzed with viral load measurements at the end of the observation period.



The study involved 531 participants. During the 12 months of observation, 137 patients left the program or discontinued first-line therapy. Of the remaining 394 patients, 284 (72.1%) had >95% treatment adherence; of those 284 patients, 274 (96.5%) had a final viral load <1000 copies/mL. A Cox proportional hazards analysis revealed that the relationship between >95% treatment adherence and the final viral load was closer than that between >90% treatment adherence and viral load.



Treatment adherence >95% maximizes the results of the nonnucleoside reverse-transcriptase inhibitor-based regimen. The pill count method appears to be a reliable and economic tool for monitoring treatment adherence in resource-limited settings.
Effect of supplementation with cholecalciferol and calcium on 2-y bone mass accrual in HIV-infected children and adolescents: a randomized clinical trial.

Skeletal abnormalities have been reported in HIV-infected children and adolescents. Although the etiology is not well understood, vitamin D deficiency may be involved.



The study objective was to evaluate the effect of vitamin D and calcium supplementation on bone mass accrual in HIV-infected youth.



Perinatally HIV-infected children were randomly assigned to receive vitamin D (100,000 IU cholecalciferol given every 2 mo) and calcium (1 g/d) (supplemented group) or double placebo (placebo group) for 2 y. The total-body bone mineral content (TBBMC), total-body bone mineral density (TBBMD), spine bone mineral content (SBMC), and spine bone mineral density (SBMD) were assessed by using dual-energy X-ray absorptiometry at baseline and at 2 annual follow-up visits.



Fifty-nine participants, aged 6-16 y, were randomly assigned to either the supplemented (n = 30) or the placebo (n = 29) group. At enrollment, supplemented and placebo groups did not differ with respect to age, sex, dietary intakes of vitamin D and calcium, mean baseline serum 25-hydroxyvitamin D [25(OH)D] concentration, TBBMC, TBBMD, SBMC, or SBMD. Significant increases in serum 25(OH)D were observed in the supplemented group but not in the placebo group. TBBMC, TBBMD, SBMC, and SBMD increased significantly at 1 and 2 y in both groups. No between-group differences were observed at any time before or after adjustment for stage of sexual maturation by mixed linear model analysis.



One gram of calcium per day and oral cholecalciferol at a dosage of 100,000 IU every 2 mo administered to HIV-infected children and adolescents did not affect bone mass accrual despite significant increases in serum 25(OH)D concentrations.
One-year clinical outcomes of depressed public sector outpatients: a benchmark for subsequent studies

The symptomatic outcomes of a cohort of public mental health sector depressed outpatients treated for 1 year are described to provide a benchmark for future long-term trials. Baseline moderators of outcome were evaluated.



Outpatients with nonpsychotic major depressive disorder (n = 118) scoring >/=30 on the 30-item Inventory of Depressive Symptomatology-Clinician Rating (IDS-C(30)) were treated with a medication algorithm and patient/family education package. Response and remission rates were assessed every 3 months with the IDS-C(30). Logistic regression analyses evaluated several baseline features in relation to outcome.



While response and remission rates increased from 3 to 12 months, the 1-year last observation carried forward (LOCF) response (26.3%) and remission (11.0%) rates were not impressive (sustained response = 14.4%; sustained remission = 5.1%). Younger patients and those with full-time employment (at baseline) were more likely to respond. A shorter length of illness tended to be associated with higher response and remission rates (p <.10). Results are generalizable to public sector patients with substantial socioeconomic, general medical, and educational disadvantages who were sufficiently depressed to recommend a change in antidepressant medication.



Response and remission rates were modest when compared with outcomes in shorter duration efficacy trials in depressed outpatients with less chronicity, fewer concurrent general medical conditions, and less treatment resistance. Results support the need for more powerful treatments and/or the better delivery of available treatments.
Combination of Two Targeted Medications (Bevacizumab Plus Cetuximab) Improve the Therapeutic Response of Pancreatic Carcinoma

The objective of this study is to evaluate the efficacy and safety profiles of the targeted medications, bevacizumab and cetuximab, in combination with cytostatic drugs in patients with locally advanced or metastatic pancreatic cancer. In this retrospective phase 2 study, a total of 59 patients with pancreatic cancer were recruited and received conventional (gemcitabine, cisplatin, and fluorouracil) or targeted regimen (conventional plus bevacizumab and cetuximab for the first cycle) in 2-week intervals for four cycles. The primary end-point for this study was the overall response rate. Secondary end-points were progression-free survival and the safety profiles of the combined therapy. The median time-to-progression and overall survival were 3 and 7 months, respectively, in the conventional treatment group as well as 11 and 13 months, respectively, in the targeted medications treatment group. The most common adverse events in both treatment groups were nausea and vomiting. Moderate (Grade 2) nausea and vomiting were more common in the conventional group than the targeted group but severe (Grade 3) nausea and vomiting were more common in the targeted group. Bevacizumab and cetuximab in combination with gemcitabine, cisplatin, and fluorouracil may help lengthen overall survival up to six months for patients with pancreatic cancer.
Comparison of an Intraoperative Infusion of Dexmedetomidine, Fentanyl, and Remifentanil on Perioperative Hemodynamics, Sedation Quality, and Postoperative Pain Control

We aimed to compare fentanyl, remifentanil and dexmedetomidine with respect to hemodynamic stability, postoperative pain control and achievement of sedation at the postanesthetic care unit (PACU). In this randomized double-blind study, 90 consecutive total laparoscopic hysterectomy patients scheduled for elective surgery were randomly assigned to receive fentanyl (1.0 μg/kg) over 1 minute followed by a 0.4 μg/kg/hr infusion (FK group, n = 30), or remifentanil (1.0 μg/kg) over 1 minute followed by a 0.08 μg/kg/min infusion (RK group, n = 30), or dexmedetomidine (1 μg/kg) over 10 minutes followed by a 0.5 μg/kg/hr infusion (DK group, n = 30) initiating at the end of main procedures of the operation to the time in the PACU. A single dose of intravenous ketorolac (30 mg) was given to all patients at the end of surgery. We respectively evaluated the pain VAS scores, the modified OAA/S scores, the BIS, the vital signs and the perioperative side effects to compare the efficacy of fentanyl, remifentanil and dexmedetomidine. Compared with other groups, the modified OAA/S scores were significantly lower in DK group at 0, 5 and 10 minutes after arrival at the PACU (P < 0.05), whereas the pain VAS and BIS were not significantly different from other groups. The blood pressure and heart rate in the DK group were significantly lower than those of other groups at the PACU (P < 0.05). DK group, at sedative doses, had the better postoperative hemodynamic stability than RK group or FK group and demonstrated a similar effect of pain control as RK group and FK group with patient awareness during sedation in the PACU. (World Health Organization registry, KCT0001524).
Das T1-Blasenkarzinom

Bei der Nachresektion nach T1-Blasentumoren kann eine exakte Relokalisation des ehemaligen infiltrativen Tumorareals wegen reaktiver Veränderungen, multipler Narben oder wechselnder Operateure erschwert sein. In unserer Untersuchung haben wir die Bedeutung der exakten Tumordokumentation und die Lokalisation und Rate der Residualtumore analysiert.  In this study the results of control transurethral resection of the bladder (TURB) after T1 high grade bladder tumors with the focus on localization and importance of standardized exact documentation were analyzed. From July to February 2012 a control resection was performed in 167 patients due to a T1 high grade bladder cancer. The rates of residual tumor tissue and localization were investigated with standardized tumor documentation. Out of 167 patients with T1 bladder cancer who underwent a control resection tumor tissue was found in 58.1 % (97 out of 167) and in 85.6 % (83 out of 97) the primary site was affected (41.2 % only at primary site and 44.3 % additionally at other locations). In 11 patients (11.3 %) residual tumor tissue at the initial site was only detected histologically. Our results indicate that T1 high grade bladder cancers show a relevant rate of residual tumor tissue at control resection which confirms the clinical guidelines of the European Association of Urology (EAU) on mandatory resection. In most cases the primary tumor site is affected. The standardized bladder tumor documetation allows well-directed control resection also in patients with multiple scars and post-TUR alterations, even when performed by a different surgeon.