nils-herrmann/clean_scirepeval huggingface dataset:
Association of vitamin D deficiency, secondary hyperparathyroidism, and heterotopic ossification in spinal cord injury.

Our objective was to explore the relationship between low vitamin D, secondary hyperparathyroidism, and heterotopic ossification (HO) in patients with spinal cord injury (SCI). Ninety-six subjects with acute or chronic motor complete SCI participated. Levels of serum vitamin D25(OH), calcium, and intact parathyroid hormone (PTH) were collected, and information regarding nutritional patterns and fracture history was obtained from subjects. Evidence of current or previous HO was ascertained through chart review. Of the 96 subjects, 12 were found to have developed HO, 11 with serum vitamin D25(OH) between 5 and 17 ng/mL. Nine subjects exhibited secondary hyperparathyroidism in the range of 72 to 169 pg/mL. Only one subject demonstrated HO in the absence of low vitamin D. However, many subjects with low vitamin D (5-31 ng/mL) did not have hyperparathyroidism or HO. Statistical testing demonstrated a correlation between hyperparathyroidism and HO (p < 0.001) as well as hyperparathyroidism and vitamin D deficiency (<20 ng/mL). Direct correlation between HO and low vitamin D was not observed, but hyperparathyroidism may increase this risk. We believe that those patients who demonstrate low vitamin D and elevated PTH should be screened for HO in addition to beginning vitamin supplementation. Initiating early treatment of low vitamin D to restore therapeutic levels may prevent development of HO.
Pharmaceutical care program for patients with uncontrolled hypertension. Report of a double-blind clinical trial with ambulatory blood pressure monitoring.

Pharmaceutical care programs may be an option to improve blood pressure (BP) control in patients with uncontrolled hypertension. The aim of this study was to evaluate the efficacy of pharmaceutical care programs in treating patients with resistant hypertension.



In a double-blind randomized clinical trial, 71 patients with uncontrolled BP were enrolled in a pharmaceutical care program or in a control group and underwent a series of cognitive tests. The primary outcome was change in ambulatory BP (ABP) between the baseline evaluation and the final visit 6 months later. The secondary outcomes were the frequency of drug-related problems and adherence as determined by plasma levels of hydrochlorothiazide.



The delta-values between the intervention and control groups for ABP in the different daily periods, with the corresponding 95% confidence limits, adjusted for age and baseline BP were: 3 (-1 to 5), 2 (-2 to 4), and 5 (-1 to 6) mm Hg for 24 h, daily and nightly systolic BP, respectively. The corresponding values for diastolic BP were 1 (-1 to 3), 0 (-2 to 2), and 3 (-1 to 4) mm Hg, respectively. Hydrochlorothiazide was detected in the plasma in 21 of 27 patients in the intervention group that attended to all appointments and 24 of 30 patients in the control group (P = .904).



The pharmaceutical care program tested in this trial was feasible and showed a trend for better BP control in patients with uncontrolled hypertension.
Prospective multicenter clinical evaluation of AMPLICOR and COBAS AMPLICOR hepatitis C virus tests.

We conducted a multicenter clinical evaluation of the second versions of the manual AMPLICOR and the semiautomated COBAS AMPLICOR tests for hepatitis C virus (HCV) RNA (Roche Molecular Systems, Inc., Pleasanton, Calif.). The performance characteristics of these HCV RNA tests for diagnosis of active viral infection were determined by comparison to anti-HCV serological test results, alanine aminotransferase levels, and liver biopsy histology results. A total of 878 patients with clinical or biochemical evidence of liver disease were enrolled at four hepatology clinics. A total of 1,089 specimens (901 serum and 188 plasma) were tested with the AMPLICOR test. Sensitivity compared to serology was 93.1% for serum and 90.6% for plasma. The specificity was 97% for serum and 93.1% for plasma. A total of 1,084 specimens (896 serum and 188 plasma) were tested with the COBAS test. Sensitivities for serum and plasma were the same as with the AMPLICOR test. The specificity was 97.8% for serum and 96.6% for plasma. Of the 69 specimens with false-positive and false-negative AMPLICOR test results relative to those of serology, alternative primer set (APS) reverse transcription (RT)-PCR analysis showed that the AMPLICOR test provided the correct result relative to the specimens containing HCV RNA in 64 (92.7%) specimens. Similarly, 66 of 67 (98.5%) false-positive and false-negative COBAS test results were determined to be correct by APS RT-PCR analysis. There were no substantive differences in clinical performances between study sites, patient groups, specimen types, storage conditions (-20 to -80 degrees C versus 2 to 8 degrees C), or anticoagulants (EDTA versus acid citrate dextrose) for either test. Both tests showed >99% reproducibility within runs, within sites, and overall. We conclude that these tests can reliably detect the presence of HCV RNA, as evidence of active infection, in patients with clinical or biochemical evidence of liver disease.
Results from the intracarotid amytal procedure in patients with uni or bitemporal lobe epilepsy and mesial sclerosis.

This study discusses the results from the IAP and its lateralizing and prognostic value in patients with temporal lobe epilepsy (TLE) and mesial temporal sclerosis (MTS). Eighteen patients were submitted to the IAP. Fifteen had bitemporal and 3 unitemporal lobe epilepsies. All patients had MTS on MRI and in one there was an unrelated lesion in the contralateral hippocampus. Nine bitemporal patients passed after the injection ipsilateral to the MTS and 4 failed bilaterally. One bitemporal passed bilaterally. Seven of these bitemporal patients passed an injection ipsilateral to MTS and failed on contralateral injection. Two of the unitemporal lobe patients passed the ipsilateral injection and failed the contralateral one. One of the unitemporal lobe patients failed bilaterally the IAP. Overall, 56% of the group disclosed the pass ipsi-/fail contralateral pattern in the IAP. Eight patients were operated, are seizure free and had no additional memory deficit. Many patients with TLE were found to have the pass ipsi-/fail contralateral pattern in the IAP. This might prove to be of lateralizing and prognostic value in such cases.
Metacognitive therapy in treatment-resistant depression: a platform trial.

Patients with treatment-resistant depression received up to 8 sessions of metacognitive therapy (MCT) targeting attentional control, rumination, worry, and metacognitive beliefs. A baseline period was followed by weekly sessions with follow-up assessments at 6 and 12 months post treatment. Large and statistically significant improvements occurred in all symptom measures at post treatment and were maintained over follow-up. Two out of 3 process measures significantly improved at post treatment and all of these measures were improved at follow-up. Treatment was associated with similar response rates on the BDI and Hamilton rating scale. Using liberal criteria 80% of completers were classified as recovered at post treatment and 70% at follow-up on the BDI. In the intention to treat sample 66.6% were recovered at post treatment and 58.3% at follow-up. More stringent criteria showed 60% recovery rates at post treatment and at 12 m. The results suggest that MCT could be a brief and effective treatment and they provide a precedent for more definitive randomized controlled trials.
Preoperative radiotherapy combined with 5 days per week capecitabine chemotherapy in locally advanced rectal cancer

There is increasing evidence supporting the use of preoperative chemoradiotherapy in patients with locally advanced rectal cancer in an attempt to facilitate complete surgical resection with clear margins. We describe our experience of using a 5-day per week regime of preoperative capecitabine chemoradiotherapy. Between November 2004 and September 2006, 70 patients with MRI-defined locally advanced rectal cancer were selected for treatment. Capecitabine was given at a dose of 900 mg m−2 for 5 days per week combined with 45 Gy of radiotherapy in 25 doses. This regime was well tolerated with 89% of our patients receiving the full dose of chemotherapy and 96% receiving the full dose of radiotherapy. Ninety-three per cent proceeded to macroscopically complete surgical resection. The pathological complete response rate was 9.2% with a node-negative rate of 66%. A negative circumferential margin was achieved by 79% of the patients who underwent resection. Compared to studies using a 7-day per week capecitabine schedule, our results show increased compliance and less dose reductions with comparable pathological outcome.
Effect of treatment duration on plasma levels of clozapine andN-desmethylclozapine in men and women

Plasma levels of clozapine and its major metabolites,N-desmethylclozapine and clozapine-N-oxide, were measured in 18 schizophrenic patients at different times (4, 6 and 24 weeks) during the course of treatment with multiple doses of the drug, by using high performance liquid chromatography (HPLC) with UV detection. Plasma levels of clozapine andN-desmethylclozapine were significantly higher in females than in males after 4 and 6 weeks, but not after 24 weeks, of treatment. No sex difference was found at any time with respect to plasma levels of clozapine-N-oxide.
Factors associated with short-term changes in HIV viral load and CD4+ cell count in antiretroviral-naive individuals

Among antiretroviral therapy (ART)-naive individuals, viral load levels tend to increase and CD4(+) cell counts decline over time. We sought to explore the rate of change and influence of other factors associated with these markers of HIV progression.



An observational cohort collaboration study.



A total of 158 385 pairs of consecutive viral load and CD4(+) cell count simultaneously measured from 34 384 ART-naive individuals in the COHERE database were analysed. Annual changes and factors associated with these changes were estimated using generalized estimating equations.



Viral load continued to rise at a mean [95% confidence interval (CI)] rate of 0.091 (0.086-0.096) log10 copies/ml per year. A faster rise in viral load was significantly associated with older age, such that for every 10 years older, it was a mean 0.022 log10 copies/ml per year greater. The mean (95% CI) CD4(+) cell count change was -78.0 (-80.1 to -76.0) cell/μl per year and it was strongly associated with a higher current viral load: for every 1 log10 copies/ml higher, CD4(+) cell count declined by an additional 37.6 cells/μl per year (P < 0.001). Current viral load was a stronger predictor of CD4(+) cell count depletion than baseline viral load. Neither sex, race nor transmission by injecting drug use was associated with change in either the viral load or CD4(+) cell count.



We found that in ART-naive individuals, viral load continues to increase over time and more sharply in those who are older. Our results also suggest that higher current viral load is strongly associated with ongoing rate of CD4(+) cell count depletion.
Response assessment in solid tumours: a comparison of WHO, SWOG and RECIST guidelines.

The primary objective of this study was to evaluate the applicability of World Health Organization (WHO), Southwest Oncology Group (SWOG) and Response Evaluation Criteria in Solid Tumours (RECIST) guidelines when evaluating the response of cytotoxic agents in solid tumours. Patients with a solid tumour who were planned for standard chemotherapy, were aged more than 18 years and had an anticipated life expectancy of at least 12 weeks were included in the study. Patients received chemotherapy using standard protocols and were required to have a pre-treatment evaluation of tumour burden on CT. Subsequent response assessment was performed every two cycles. Each patient was evaluated by all three criteria (WHO, SWOG and RECIST) to check the applicability of a specific criterion during routine clinical practice. In total, 80 patients were included in the study. Out of these, the response criteria displayed discordance in 17 (21%) patients. Of these 17 patients, RECIST criteria were not applicable for 6 patients owing to the small lesion size. The present study shows that a particular guideline may be useful in establishing uniformity of evaluation in a desired study population but may not be the best for that population during routine clinical practice. It also indicates that each of the guidelines has its own applicability and that no guideline can outweigh the other during routine clinical practice.
Surgically modifiable factors measured by computer-navigation together with patient-specific factors predict knee society score after total knee arthroplasty.

The purpose was to investigate whether patient-specific factors (PSF) and surgically modifiable factors (SMF), measured by means of a computer-assisted navigation system, can predict the Knee Society Scores (KSS) after total knee arthroplasty (TKA).



Data from 99 patients collected during a randomized clinical trial were used for this secondary data analysis. The KSS scores of the patients were measured preoperatively and at 4-years follow-up. Multiple regression analyses were performed to investigate which combination of variables would be the best to predict the 4-years KSS scores.



When considering SMF alone the combination of four of them significantly predicted the 4-years KSS-F score (p = 0.009), explaining 18 % of its variation. When considering only PSF the combination of age and body weight significantly predicted the 4-years KSS-F (p = 0.008), explaining 11 % of its variation. When considering both groups of predictors simultaneously the combination of three PSF and two SMF significantly predicted the 4-years KSS-F (p = 0.007), explaining 20 % of its variation.



Younger age, better preoperative KSS-F scores and lower BMI before surgery, a positive tibial component slope and small changes in femoral offset were predictors of better KSS-F scores at 4-years.
Early mobilisation after total hip or knee arthroplasty: A multicentre prospective observational study

Early mobilisation is recommended following total hip arthroplasty (THA) or total knee arthroplasty (TKA) to prevent venous thromboembolism (VTE). We sought to determine the proportions of patients that first mobilised on post-operative day 0 (POD 0) and factors associated with earlier time to mobilisation.



A prospective cohort study was conducted involving patients with hip or knee osteoarthritis who had undergone primary unilateral THA (n = 818) and TKA (n = 989) at 19 Australian hospitals. Patient-related (e.g. age, gender, body mass index), treatment-related (e.g. hospital site, presence of indwelling catheter) and mobilisation-related variables were collected on standardised forms. Time was measured by post-operative days, where POD 0 was defined as the day of surgery ending at midnight. Multivariate Poisson regression analysis identified associations between patient- and treatment-related covariates and time to mobilisation.



Inter-hospital variation was evident, but overall, only 9.4% of THA and 5.6% of TKA patients mobilised on POD 0. For THA patients, earlier time to mobilisation was associated with hospital site and absences of an indwelling catheter and acute complications. For TKA patients, earlier time to mobilisation was associated with hospital site and absence of donor blood transfusion.



Few THA and TKA patients mobilise POD 0, although some hospitals appear more aggressive with their mobilisation attempts than others. Treatment-related factors, not patient-related, are associated with post-operative day of mobilisation, indicating the potentially pivotal role of service providers in promoting early mobilisation to improve health outcomes and reduce rates of VTE.
Treatment of posttraumatic and focal osteoarthritic cartilage defects of the knee with autologous polymer-based three-dimensional chondrocyte grafts: 2-year clinical results

Autologous chondrocyte implantation (ACI) is an effective clinical procedure for the regeneration of articular cartilage defects. BioSeed-C is a second-generation ACI tissue engineering cartilage graft that is based on autologous chondrocytes embedded in a three-dimensional bioresorbable two-component gel-polymer scaffold. In the present prospective study, we evaluated the short-term to mid-term efficacy of BioSeed-C for the arthrotomic and arthroscopic treatment of posttraumatic and degenerative cartilage defects in a group of patients suffering from chronic posttraumatic and/or degenerative cartilage lesions of the knee. Clinical outcome was assessed in 40 patients with a 2-year clinical follow-up before implantation and at 3, 6, 12, and 24 months after implantation by using the modified Cincinnati Knee Rating System, the Lysholm score, the Knee injury and Osteoarthritis Outcome Score, and the current health assessment form (SF-36) of the International Knee Documentation Committee, as well as histological analysis of second-look biopsies. Significant improvement (p < 0.05) in the evaluated scores was observed at 1 and/or 2 years after implantation of BioSeed-C, and histological staining of the biopsies showed good integration of the graft and formation of a cartilaginous repair tissue. The Knee injury and Osteoarthritis Outcome Score showed significant improvement in the subclasses pain, other symptoms, and knee-related quality of life 2 years after implantation of BioSeed-C in focal osteoarthritic defects. The results suggest that implanting BioSeed-C is an effective treatment option for the regeneration of posttraumatic and/or osteoarthritic defects of the knee.
A phase 3 trial evaluating panitumumab plus best supportive care vs best supportive care in chemorefractory wild-type KRAS or RAS metastatic colorectal cancer

We assessed the treatment effect of panitumumab plus best supportive care (BSC) vs BSC on overall survival (OS) in patients with chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer (mCRC) and report the first prospective extended RAS analysis in a phase 3 trial.Patients with wild-type KRAS exon 2 mCRC were randomised 1 : 1 to panitumumab (6 mg kg−1 Q2W) plus BSC or BSC. On-study crossover was prohibited. RAS mutation status was determined by central laboratory testing. The primary endpoint was OS in wild-type KRAS exon 2 mCRC; OS in wild-type RAS mCRC (KRAS and NRAS exons 2, 3, and 4) was a secondary endpoint.Three hundred seventy seven patients with wild-type KRAS exon 2 mCRC were randomised. Median OS was 10.0 months with panitumumab plus BSC vs 7.4 months with BSC (HR=0.73; 95% CI=0.57–0.93; P=0.0096). RAS ascertainment was 86%. In wild-type RAS mCRC, median OS for panitumumab plus BSC was 10.0 vs 6.9 months for BSC (HR=0.70; 95% CI=0.53–0.93; P=0.0135). Patients with RAS mutations did not benefit from panitumumab (OS HR=0.99; 95% CI=0.49–2.00). No new safety signals were observed.Panitumumab significantly improved OS in wild-type KRAS exon 2 mCRC. The effect was more pronounced in wild-type RAS mCRC, validating previous retrospective analyses.
Safety and efficacy of treatment with pegylated interferon alpha-2a with ribavirin in chronic hepatitis C genotype 4.

The hepatitis C virus (HCV) genotype is an important predictive outcome parameter for pegylated interferon plus ribavirin therapy. Most published therapeutic trials to date have enrolled mainly patients with HCV genotypes 1, 2 and 3. Limited studies have focused on genotype 4 patients, who have had a poor representation in pivotal trials. Our aim was to evaluate the efficacy and safety of treatment with standard dose pegylated interferon alfa-2a in combination with weight-based ribavirin in patients with chronic hepatitis C genotype 4. In this prospective observational study, 198 patients with HCV-4 were included in this study from February 2004 to August 2005,188 patients who received at least 1 dose of drugs were included in the ITT analysis and they were treated with pegylated interferon alfa-2a and ribavirin for 48 weeks. Baseline and demographic characteristics, response to treatment at weeks 12, 48 and 72, and the nature and frequency of adverse effects were analyzed. Virological response at week 12 was achieved in 144 patients (76.6%). Virological response at the end of treatment was present in 110 patients (58.5%). At week 72, 99 patients presented SVR (52.7%). The reported adverse events were similar to those found in the literature for treatments of similar dose and duration. In conclusion, combined treatment with pegylated interferon alfa-2a and ribavirin was well tolerated and effective in chronic hepatitis C genotype 4, yielding response rates between those reported for genotype 1 and those of genotypes 2-3.
Cognitive function and oxidative stress after carotid endarterectomy: comparison of propofol to sevoflurane anesthesia.

To examine the antioxidant role of propofol in ischemia-reperfusion during carotid endarterectomy (CEA) and its influence on cognitive dysfunction after CEA.



A randomized prospective study.



Single-center study in a university hospital.



Forty-four patients.



Patients underwent elective CEA under general anesthesia with either sevoflurane (group S, n = 21) or propofol (group P, n = 23).



Cognitive function was assessed with the Mini-Mental State Examination (MMSE) before CEA, 1 hour after CEA, and 24 hours after CEA. Blood samples from the radial artery and the internal jugular vein were drawn before carotid clamping and 5 minutes following unclamping, and peripheral blood was obtained 24 hours postoperatively. Samples were analyzed for lactate, S100B, and P-selectin concentrations and for the antioxidative markers malondialdehyde/low-density lipoprotein ratio and nitrate + nitrite concentrations. Compared with group S, patients in group P exhibited a greater increase in their MMSE values 24 hours postoperatively. Patients who had their MMSE performance reduced at 24 hours also were significantly fewer in group P (13% v 43% in group S, p<0.05). Significantly lower levels of lactate and S100B were observed in arterial and jugular vein samples in group P. In addition, the jugular vein-arterial differences of malondialdehyde-to-low-density lipoprotein ratio and nitrates + nitrites concentrations were lower during propofol anesthesia.



Propofol seemed to improve cognitive performance after CEA. This improvement was associated with decreased indices of ischemic cerebral damage and seemed to be due to antioxidative effect in the ischemic cerebral circulation.