nils-herrmann/clean_scirepeval huggingface dataset:
Effectiveness of Cinacalcet in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Not Receiving Dialysis

Secondary hyperparathyroidism (SHPT) is a common complication in chronic kidney disease (CKD) patients. Cinacalcet could be a therapeutic option although its use is controversial in patients not receiving dialysis. Thus, the aim of this study is to assess the effectiveness and safety of cinacalcet in patients with CKD and SHPT without renal replacement treatment (RRT) and without renal transplantation (RT).



A retrospective observational study was conducted. Patients were included if they had collected cinacalcet, under off-label use, during 2010 and 2011. Patients selected were followed from the beginning of cinacalcet therapy for one year of treatment.



A total of 37 patients were included with CKD stage 3 (38%), 4 (51%) and 5 (11%). Baseline mean PTH value was 400.86 ± 168.60 mg/dl. At 12 months, a 67% of patients achieved at least a 30% reduction in their PTH value (p<0.001; CI 49.7-83.6), and the overall mean reduction of PTH values was 38% (p< 0.001; IC -49.1, -27.5). A 28% of the patients achieved KDOQI PTH goals (p = 0.003, CI 12%-50%). At 12 months, mean serum calcium values decreased by 6% and mean serum phosphorus values increased by 13%. A 19% of patients experienced hypocalcemia episodes while an increase of 24% in hyperphosphatemia episodes was observed. A 25% of patients finished cinacalcet before a year of treatment. Main withdrawal reasons were: gastrointestinal and other discomfort (8%), hypocalcaemia (8%), non-compliance (3%), interactions (3%) and excess of efficacy (3%).



Cinacalcet was effective in patients with CKD and SHPT not receiving dialysis. Electrolytic imbalances could be managed with administration of vitamin D and analogues or phosphate binders.
The Beneficial Effects of the DPP-4 Inhibitor Alogliptin on Hemoglobin A1c and Serum Lipids in Japanese Patients with Type 2 Diabetes.

It has been reported that dipeptidyl peptidase-4 (DPP-4) inhibitors improve hemoglobin A1c (HbA1c) levels in diabetic patients and may also improve the serum lipids. However, few studies have examined relationship between the effects of the DPP-4 inhibitor and the pretreatment HbA1c levels in diabetic patients. Furthermore, it has been reported that prolonged treatment with DPP-4 inhibitors may make glycemic control difficult in some patients. In the present study, we investigated (1) the effect of the DPP-4 inhibitor alogliptin on HbA1c, blood glucose (BG), and serum lipid in Japanese patients with type 2 diabetes, (2) the relationship between the HbA1c levels at baseline and the effects of alogliptin, and (3) the effects of switching of the DPP-4 inhibitor to alogliptin after 12 months' administration of sitagliptin on glycemic control and serum lipids. After 6-months' treatment with alogliptin, we found reductions of HbA1c, BG, and serum total cholesterol, and LDL cholesterol levels. Pretreatment level of HbA1c was well correlated with the degree of reduction of both HbA1c and BG levels after the treatment. Also, alogliptin kept levels of HbA1c and BG reduced by sitagliptin for 12 months, and relapsing of these levels and serum lipids were not observed. This study revealed that alogliptin improved HbA1c, BG, and serum lipid profiles in type 2 diabetic patients, and the effect of alogliptin on HbA1c and BG levels was correlated with HbA1c level at pretreatment. Furthermore, long-term treatment with alogliptin did not cause relapsing of glycemic control and serum lipids.
Combined effects of a valgus knee brace and lateral wedge foot orthotic on the external knee adduction moment in patients with varus gonarthrosis.

To test the hypothesis that a custom-fit valgus knee brace and custom-made lateral wedge foot orthotic will have greatest effects on decreasing the external knee adduction moment during gait when used concurrently.



Proof-of-concept, single test session, crossover trial.



Biomechanics laboratory within a tertiary care center.



Patients (n=16) with varus alignment and knee osteoarthritis (OA) primarily affecting the medial compartment of the tibiofemoral joint (varus gonarthrosis).



Custom-fit valgus knee brace and custom-made full-length lateral wedge foot orthotic. Amounts of valgus angulation and wedge height were tailored to each patient to ensure comfort.



The external knee adduction moment (% body weight [BW]*height [Ht]), frontal plane lever arm (cm), and ground reaction force (N/kg), determined from 3-dimensional gait analysis completed under 4 randomized conditions: (1) control (no knee brace, no foot orthotic), (2) knee brace, (3) foot orthotic, and (4) knee brace and foot orthotic.



The reduction in knee adduction moment was greatest when concurrently using the knee brace and foot orthotic (effect sizes ranged from 0.3 to 0.4). The mean decrease in first peak knee adduction moment compared with control was .36% BW*Ht (95% confidence interval [CI], -.66 to -.07). This was accompanied by a mean decrease in frontal plane lever arm of .59cm (95% CI, -.94 to -.25).



These findings suggest that using a custom-fit knee brace and custom-made foot orthotic concurrently can produce a greater overall reduction in the knee adduction moment, through combined effects in decreasing the frontal plane lever arm.
Reproducibility of the blood flow index as noninvasive, bedside estimation of cerebral blood flow

To investigate the feasibility and reproducibility of the blood flow index (BFI) method for measuring cerebral blood flow.  Prospective functional study in pediatric intensive care.  14 consecutive patients with median age of 2 months (range 1 days–11 years) requiring artificial ventilation, invasive arterial blood pressure monitoring, and central venous access.  The first passage of an intravenous indocyanine green (ICG) bolus through the cerebral vasculature was monitored by noninvasive near-infrared spectroscopy. BFI was calculated by dividing maximal ICG absorption change by rise time. Reproducibility was evaluated by six ICG injections at 5-min intervals.  Of all ICG injections 6% were canceled, and 4% were eliminated due to injection failures. Median BFI of 17 reproducibility determinations was 71 (range 12–213) and median coefficient of variation (CV) of BFI was 10% (4.9–18.5). The quantity of ICG bolus did not affect the CV (0.1 vs. 0.3 mg ICG/kg). Eight reproducibility tests in patients after cardiac surgery had smaller CV than the others, and the eight in newborns had higher CV than in older children. Patient parameters such as arterial blood pressure, endtidal CO2, and percutaneous oxygen saturation were stable and showed CV below 2% during reproducibility determination.  The BFI method allows rapid and repeated measurements of CBF with good feasibility and reproducibility. As a relative but not absolute measure of CBF, BFI seems to be suited for clinical evaluation of intraindividual CBF changes during determination of cerebrovascular reactivities or during therapeutic interventions.
The neglected need for psychological intervention in patients suffering from incidentally discovered intracranial aneurysms

Previous studies demonstrated a conspicuously elevated rate of psychiatric disorders in patients with incidental intracranial aneurysms. This study was designed to analyze the impact of this observation on the post-interventional rates of PTSD, depressions and anxiety disorders in this collective.



Physically unaffected iA patients with an unremarkable medical history were included in this two center study. Pre-interventional psychiatric histories, rates of post-interventional depressions, subjective trauma, PTSD, and pre-interventional fears were determined by questionnaires (Beck Depression Inventory (BDI), Impact of Event Scale (IES), civilian Post-traumatic-Stress-Disorder (PTSD) Check List (PCL-C)). Benign meningioma (M) patients served as controls.



58 M and 45 iA patients were enrolled. Significantly higher rates of PTSD, elevated trauma scores, and moderate/severe depressions (PTSD: p=0.0017; IES: p=0.0038; BDI: p=0.0301) were demonstrated in the iA collective. After excluding patients with a positive pre-interventional psychiatric history those differences were not reproducible. 70% of the iA patients reported an improvement of their unspecific pre-interventional symptoms, while 30% would have rated a psychological consultation as helpful.



The data identifies the early psychological consultation as a relevant and by affected patients accepted treatment modification when trying to improve the outcome after treatment of incidental aneurysms.
Is major pulmonary resection by video-assisted thoracic surgery an adequate procedure in clinical stage I lung cancer?

Although several studies have shown that video-assisted thoracic surgery (VATS) for major pulmonary resection is less invasive than open thoracotomy, VATS for lung cancer has been performed in only a limited number of institutions. We aimed to review our experience of VATS for major pulmonary resections, and to determine its safety and adequacy in stage I lung cancer.



Between August 1999 and March 2003, we performed major pulmonary resection by VATS in 106 patients with lung cancer and preoperatively determined clinical stage I disease. We evaluated the number of procedures converted to open thoracotomy and the reasons for conversion, the intraoperative blood loss, interval between surgery and chest tube removal, length of postoperative hospital stay, postoperative complications, mortality rate, prognoses, and patterns of recurrence.



We successfully performed VATS in 95 patients, whereas in another 11 patients (10%) conversion to open thoracotomy was required. The operative procedures were lobectomy in 86 patients, segmentectomy in 8 patients, and bilobectomy in 1 patient. In 95 patients who underwent VATS, postoperative complications developed in 9 patients (9%), and 1 patient (1%) died from pneumonia. In the 86 patients without complications, the mean postoperative hospital stay was 7.6 days (range, 4 to 15 days). In a mean follow-up period of 25 months (range, 6 to 48 months) in patients with non-small cell lung cancer (NSCLC), including the one perioperative death, the 3-year survival rate was 93% in 82 patients with clinical stage I disease, and 97% in 68 patients with pathologic stage I disease. The 3-year disease-free survival rate was 79% in patients with clinical stage I disease, and 89% in patients with pathologic stage I disease. Local recurrence was observed in six patients (6%): recurrence in mediastinal lymph nodes in five patients, and in the bronchial stump in one patient.



Major pulmonary resection by VATS is acceptable in view of its low perioperative mortality and morbidity, and is an adequate procedure for the achievement of local control and good prognosis in patients with clinical stage I NSCLC.
Clinical response and pharmacokinetics from a phase 1 study of an active dosing schedule of flavopiridol in relapsed chronic lymphocytic leukemia.

We previously reported interim results of a phase 1 trial in patients with chronic lymphocytic leukemia (CLL) whereby flavopiridol was administered intravenously as a 30-minute bolus followed by 4-hour infusion. We now report full pharmacokinetic (PK) data, correlations of PK with clinical outcomes, and final response and progression-free survival (PFS). Twenty-one (40%) of 52 patients with relapsed CLL achieved a partial response (PR) with a median PFS of 12 months. Responders included 17 (40%) of 43 fludarabine refractory patients, 7 (39%) of 18 patients with del(17p13), and 14 (74%) of 19 patients with del(11q22). Six responders received repeat therapy at relapse, and 5 responded again with a second median PFS of 10 months. Noncompartmental analysis and nonlinear mixed effects modeling was used to estimate PK parameters and evaluate covariates. Two-compartment population parameter estimates were 31.4 L/h, 65.8 L, 8.49 L/h, and 157 L for CL, V1, Q, and V2, respectively. Flavopiridol area under the plasma concentration-time curve (AUC) correlated with clinical response and cytokine release syndrome, and glucuronide metabolite AUC correlated with tumor lysis syndrome. These composite results confirm high activity of this pharmacokinetically derived schedule in relapsed, genetically high-risk CLL. Furthermore, PK describes some, but not all, variability in response and toxicity.
Endovascular coil embolization of 435 small asymptomatic unruptured intracranial aneurysms: procedural morbidity and patient outcome.

Whether treatment of small asymptomatic aneurysms is appropriate or not remains controversial. We performed a retrospective study on the procedural morbidity and mortality of coil embolization of small asymptomatic unruptured intracranial aneurysms (UIAs) to obtain a more generalized estimate of procedural risk.



A total of 435 small (maximum diameter < or = 7 mm) asymptomatic UIAs in 370 patients were treated by coil embolization. Aneurysm sizes were determined by using 3D angiograms. We assessed procedure-related morbidity and mortality, immediate postprocedural angiographic results, short-term imaging follow-up results, and clinical outcomes.



Initial aneurysm occlusion was complete in 334 aneurysms, near complete in 78, and incomplete in 22. One internal carotid artery (ICA) aneurysm that ruptured during the procedure was treated with parent artery occlusion. Two hundred wide-neck aneurysms were coiled with the aid of various neck-remodeling techniques. The 44 procedure-related complications were the following: 24 thromboembolisms, 11 coil protrusions or prolapses into the parent vessel, 4 intraprocedural ruptures, 3 device-related complications, and 2 femoral-access complications. We had a total of 44 (10.1%) procedure-related complications with only 1 leading to persistent neurologic deficit. Procedure-related permanent morbidity and mortality were 0.27% (1/370) and 0%, respectively.



In this series of small unruptured asymptomatic aneurysms, endovascular treatment was achieved with good short-term angiographic outcome and low permanent neurologic impairment. The goal of this study was not to provide a conclusion about treatment guidelines for small UIA but rather to help guide future recommendations by presenting a more generalized estimate of endovascular treatment risk than is currently available.
The effect of ketamine on configural facial processing.

Ketamine can induce a transient psychosis via its influence on ionotropic N-methyl-d-aspartate receptors. Unlike dopamine agonists, which specifically mimic the positive symptoms seen in psychotic illnesses such as schizophrenia, ketamine may provide a better model because it is able to induce not only positive symptoms but also schizophrenia-like cognitive and negative symptoms. To test the veracity of the ketamine model further, research is attempting to replicate a range of cognitive deficits associated with schizophrenia in healthy controls under the influence of ketamine. Facial processing is one area that is impaired in schizophrenia. More specifically, research suggests that schizophrenia is associated with a reduced facial inversion effect reflecting abnormalities in configural face processing. The purpose of the current study was to determine whether ketamine would also reduce the facial inversion effect. This study was a double-blind, placebo-controlled repeated-measures design in which data are presented for 14 participants who received ketamine on one occasion and saline on another. The results supported the ketamine model, with the participants demonstrating an intact inversion effect in the placebo condition but no inversion effect under the influence of ketamine. Further, participants' self-reported deficits in visual processing correlated with their inversion score and errors on the faces task. Future studies should examine a wider range of facial processing tasks with a larger sample to confirm the current results and to determine the specificity of ketamine's ability to mimic schizophrenia facial processing deficits. The current study is supportive of the role of glutamate system in the processing of configural face information.
Factors associated with health-related quality of life among hemodialysis patients in the DOPPS

To identify modifiable factors associated with health-related quality of life (HRQOL) among chronic hemodialysis patients. Analysis of baseline data of 9,526 hemodialysis patients from seven countries enrolled in phase I of the Dialysis Outcomes and Practice Patterns Study (DOPPS). Using the Kidney Disease Quality of Life Short Form (KDQOL-SFTM), we determined scores for 8 generic scale summaries derived from these scales, i.e., the physical component summary [PCS] and mental component summary [MCS], and 11 kidney disease-targeted scales. Regression models were used to adjust for differences in comorbidities and sociodemographic and treatment factors. The Benjamin-Hochberg procedure was used to correct P-values for multiple comparisons. Unemployment and psychiatric disease were independently and significantly associated with lower scores for all generic and several kidney disease-targeted HRQOL measures. Several other comorbidities, lower educational level, lower income, and hypoalbuminemia were also independently and significantly associated with lower scores of PCS and/or MCS and several generic and kidney disease-targeted scales. Hemodialysis by catheter was associated with significantly lower PCS scores, partially explained by the correlation with covariates. Associations of poorer HRQOL with preventable or controllable factors support a greater focus on psychosocial and medical interventions to improve the well-being of hemodialysis patients.
Intravenous Amantadine for Freezing of Gait Resistant to Dopaminergic Therapy: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Clinical Trial

Freezing of gait (FOG) is one of the most disabling symptoms in Parkinsonism. Open-label studies have suggested that intravenous (IV) amantadine is effective against FOG resistant to dopaminergic therapy in Parkinson's disease (PD). We evaluated the efficacy of IV amantadine on FOG resistant to dopaminergic therapy.



This was a randomized, double-blind, placebo-controlled, cross-over study on IV amantadine. The placebo (normal saline) and amantadine (400 mg/day) were injected for 2 days with a 52-hour washout period. The instruments for the outcome measures were the Freezing of Gait Questionnaire (FOGQ), Unified Parkinson's disease rating Scale (UPDRS), and the duration of the 4×10 m walking test. The placebo arm was compared to the amantadine arm. Ten patients were enrolled but two patients withdrew, one from each arm. The FOGQ and UPDRS scores and the duration of the 4×10 m walking test improved in both arms compared to the baseline (P<0.05 in all). However, there were no differences in these values between the amantadine arm and placebo arm (P = 0.368, P = 0.583, P = 0.206, respectively). Follow-up measures 2 weeks after discharge in an open-label study showed the beneficial effects of an amantadine tablet on FOG (FOGQ, P = 0.018; UPDRS, P = 0.012 respectively).



This double blind, placebo-controlled study did not show the efficacy of IV amantadine on FOG when compared with the placebo. This study provides Class II evidence due to small sample size for the lack of benefit of IV amantadine on FOG resistant to dopaminergic therapy
Design of the DEFINE trial: determining the EFficacy and tolerability of CETP INhibition with AnacEtrapib.

Residual cardiovascular (CV) risk often remains high despite statin therapy to lower low-density lipoprotein cholesterol (LDL-C). New therapies to raise high-density lipoprotein cholesterol (HDL-C) are currently being investigated. Anacetrapib is a cholesteryl ester transfer protein (CETP) inhibitor that raises HDL-C and reduces LDL-C when administered alone or with a statin. Adverse effects on blood pressure, electrolytes, and aldosterone levels, seen with another drug in this class, have not been noted in studies of anacetrapib to date.



Determining the EFficacy and Tolerability of CETP INhibition with AnacEtrapib (DEFINE) is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety profile of anacetrapib in patients with coronary heart disease (CHD) or CHD risk equivalents (clinical trials.gov NCT00685776). Eligible patients at National Cholesterol Education Program-Adult Treatment Panel III LDL-C treatment goal on a statin, with or without other lipid-modifying medications, are treated with anacetrapib, 100 mg, or placebo for 18 months, followed by a 3-month, poststudy follow-up. The primary end points are percent change from baseline in LDL-C and the safety and tolerability of anacetrapib. Comprehensive preplanned interim safety analyses will be performed at the 6- and 12-month time points to examine treatment effects on key safety end points, including blood pressure and electrolytes. A preplanned Bayesian analysis will be performed to interpret the CV event distribution, given the limited number of events expected in this study.



A total of 2,757 patients were screened at 153 centers in 20 countries, and 1,623 patients were randomized into the trial. Lipid results, clinical CV events, and safety outcomes from this trial are anticipated in 2010.
Standardized assessment of walking capacity after spinal cord injury: the European network approach.

After a spinal cord injury (SCI), walking function is an important outcome measure for rehabilitation and new treatment interventions. The current status of four walking capacity tests that are applied to SCI subjects is presented: the revised walking index for spinal cord injury (WISCI II), the 6 minute walk test (6MinWT), 10 meter walk test (10MWT) and the timed up and go (TUG) test. Then, we investigated which categories of the WISCI II apply to SCI subjects who participated in the European Multicenter Study of Human Spinal Cord Injury (EM-SCI), and the relationship between the 10MWT and the TUG.



In the EM-SCI, the walking tests were applied 2 weeks and 1, 3, 6 and 12 months after SCI. We identified the WISCI II categories that applied to the EM-SCI subjects at each time point and quantified the relationship between the 10MWT and the TUG using Spearman's correlation coefficients (rho) and linear regression.



Five WISCI II categories applied to 71% of the EM-SCI subjects with walking ability, while 11 items applied to 11% of the subjects. The 10MWT correlated excellently with the TUG at each time point (rho>0.80). However, this relationship changed over time. One year after SCI, the time needed to accomplish the TUG was 1.25 times greater than the 10MWT time.



Some categories of the WISCI II appear to be redundant, while some discriminate to an insufficient degree. In addition, there appear to be ceiling effects, which limit its usefulness. The relationship between the 10MWT and TUG is high, but changes over time. We suggest that, at present, the 10MWT appears to be the best tool to assess walking capacity in SCI subjects. Additional valuable information is provided by assessing the needs for walking aids or personal assistance. To ensure comparability of study results, proposals for standardized instructions are presented.