nils-herrmann/clean_scirepeval huggingface dataset:
Rotation in total knee arthroplasty: no difference between patient-specific and conventional instrumentation

It was our hypothesis that patient-specific instrumentation (PSI) can improve the accuracy of the rotational alignment in TKA based on the concept of the system and on the potential to clearly identify pre-operatively during planning the classical anatomical landmarks that serve as references to set-up the rotation both for the femur and tibia. In this prospective comparative randomized study, 40 patients (20 in each group) operated in our institution between September 2012 and January 2013 by the 2 senior authors were included. Randomization of patients into one of the two groups was done by the Hospital Informatics Department with the use of a systematic sampling method. All patients received the same cemented high-flex mobile bearing TKA. In the PSI group, implant position was compared to the planed position using previously validated dedicated software. The position of the implants (frontal and sagittal) was compared in the 2 groups on standard X-rays, and the rotational position was analysed on post-operative CT-scan. 90 % of the patients add <2° or mm of difference between the planned position of the implants and the obtained position, except for the tibial rotation where the variations were much higher. Mean HKA was 179° (171–185) in the PSI group with 4 outliers (2 varus: 171° and 172°:184° and 185°) and 178.3° with 2 outliers (171° and 176°) in the control group. No difference was observed between the two groups concerning the frontal and sagittal position of the implants on the ML and AP X-rays. No significant difference of femoral rotation was observed between the two groups with a mean of 0.4° in the PSI group and 0.2° in the control group (p: n.s). Mean tibial rotation was 8° of internal rotation in the PSI group and 15° of internal rotation in the standard group (p: n.s). Based on our results, we were unable to confirm our hypothesis as PSI cannot improve rotation in TKA. More work needs to be done to more clearly define the place of PSI in TKA, to keep on improving the accuracy of the system and to better define the individual targets in TKA in terms of frontal, sagittal and rotational positioning of the implant for each patient. Prospective comparative randomized study,
Metformin decreases angiogenesis via NF-kappaB and Erk1/2/Erk5 pathways by increasing the antiangiogenic thrombospondin-1.

Polycystic ovary syndrome (PCOS) is associated with insulin resistance (IR), obesity, and cardiovascular complications. Thrombospondin-1 (TSP-1) is a novel antiangiogenic adipokine highly expressed in obese insulin-resistant subjects. We sought to assess TSP-1 levels in adipose tissue (AT) from PCOS women and matched controls. The effects of metformin treatment on circulating TSP-1 levels in PCOS subjects, the effects of serum from normal and PCOS women on in vitro migration and angiogenesis before and after metformin treatment, and ex vivo regulation of AT TSP-1 by D-glucose were also studied.



Serum TSP-1 (ELISA), subcutaneous and omental AT TSP-1 mRNA (reverse transcriptase-polymerase chain reaction), and protein (western blotting) were significantly lower in PCOS women (P < 0.05). Corresponding plasminogen activator inhibitor-1 (PAI-1) and PAI-1 activity were significantly higher (P < 0.01). After 6 months of metformin treatment, there was a significant increase in serum TSP-1 (P < 0.05) and a corresponding decrease in PAI-1 and PAI-1 activity (P < 0.01). In vitro migration and angiogenesis were significantly increased in serum from PCOS women (P < 0.01); these effects were significantly attenuated by metformin treatment (P < 0.01) through the regulation of TSP-1 levels via nuclear factor-kappaB (NF-kappaB), extracellular regulated-signal kinase 1/2 (Erk1/2) and Erk5 pathways. Importantly, changes in the intima media thickness were predictive of changes in serum TSP-1 (P = 0.049). In AT explants, glucose significantly decreased TSP-1 protein production and secretion into conditioned media (ELISA) (P < 0.05, P < 0.001).



TSP-1 levels are lower in PCOS women. Metformin treatment increases serum TSP-1 in these women. Our findings provide novel insights into the relationship between obesity, IR, and angiogenesis.
Niacin extended-release/simvastatin combination therapy produces larger favorable changes in high-density lipoprotein particles than atorvastatin monotherapy

The purpose of this research was to compare the effects of niacin extended-release in combination with simvastatin (NER/S) versus atorvastatin monotherapy on high-density lipoprotein (HDL) particle number and size in patients with hyperlipidemia or dyslipidemia from the SUPREME study.



This was a post hoc analysis of patients (n = 137) who completed the SUPREME study and who had lipid particle number and size measurements at both baseline and at week 12 by nuclear magnetic resonance spectroscopy. Following ≥4 weeks without lipid-modifying therapy (washout period), the patients received NER/S 1000/40 mg/day for 4 weeks followed by NER/S 2000/40 mg/day for 8 weeks, or atorvastatin 40 mg/day for 12 weeks. Median percent changes in HDL particle number and size from baseline to week 12 were compared between the NER/S and atorvastatin treatment groups using the Wilcoxon rank-sum test. Distribution of HDL particle subclasses at week 12 was compared between the treatment groups using the Cochran-Mantel-Haenszel test.



Treatment with NER/S resulted in a significantly greater percent reduction in small HDL particle number at week 12 compared with atorvastatin monotherapy (-1.8% versus 4.2%, P = 0.014), and a numerically greater percent increase in large HDL particle number (102.4% versus 39.2%, P = 0.078) compared with atorvastatin monotherapy. A significantly greater percent increase in HDL particle size from baseline at week 12 was observed with NER/S compared with atorvastatin (6.0% versus 1.3%, P < 0.001). NER/S treatment also resulted in a significant shift in HDL particle size from small and medium at baseline to large at week 12 (P < 0.0001).



Treatment with NER/S resulted in larger favorable changes in number and size of HDL particle subclasses compared with atorvastatin monotherapy, including a numerically greater increase in number of large HDL particles, and a significantly greater decrease in number of small HDL particles compared with atorvastatin monotherapy. In addition, NER/S treatment resulted in a significant change in HDL particle size distribution from small and medium to large.
Fast response temperature measurement and highly reproducible heating methods for 96-well plates.

Hyperthermia, the procedure of exposing cells to a temperature between 42 degrees and 49 degrees C, has been shown to be a promising approach for cancer treatment. To understand the underlying mechanisms of hyperthermic killing of cancer cells, it is critical to have an accurate temperature measurement technique and a heating method with high reproducibility. To this end, we have developed a method using fine thermocouples with fast response time to measure the temperatures in multiple wells of a 96-well plate. The accuracy of temperature measurement was +/- 0.2 degree C. Such a capability allows a complete record of the time and temperature of the treatment procedure and helps define an accurate thermal dose. We have also compared several methods for heating 96-well plates and found that use of copper blocks in contact with the lower surface of the 96-well plate in an incubator provides a highly reproducible heating method. The common method of using water bath to heat cells in vitro resulted in a decrease of cell viability even at the control temperature of 37 degrees C and a decrease in the reproducibility of certain biological assays. In summary, using these improved techniques, proposed thermal dose can be defined more precisely, and highly reproducible heating in vitro can be achieved.
Coronary endothelial function in hyperhomocysteinemia: improvement after treatment with folic acid and cobalamin in patients with coronary artery disease.

We evaluated the effect of therapy with folic acid and cobalamin on coronary endothelial function, expressed as a change in volumetric coronary blood flow (CBF), in hyperhomocysteinemic patients with coronary artery disease (CAD).



Hyperhomocysteinemia is an independent risk factor for CAD. The mechanism responsible for this increased risk is unclear, but it is generally assumed that hyperhomocysteinemia causes endothelial dysfunction. It is unknown whether lowering plasma homocysteine levels with folic acid and cobalamin improves coronary endothelial function in patients with hyperhomocysteinemia and symptomatic CAD.



Fifteen patients scheduled for elective percutaneous transluminal coronary angioplasty (PTCA) with plasma homocysteine levels of >or=16 micromol/l were randomized for six months of treatment with folic acid 5 mg and cobalamin 400 microg daily or placebo. Coronary endothelial function was evaluated in a non-PTCA vessel using acetylcholine infusion in dosages of 10(-8) M, 10(-7) M, and 10(-6) M. Endothelium- dependent CBF is determined using intracoronary Doppler velocity and quantitative coronary angiography at baseline and after six months.



In the folic acid/cobalamin treated group, CBF increased after acetylcholine infusion with 96% (standard deviation 54; 95% confidence interval [CI]: 44% to 154%) compared with a decrease of 16% (standard deviation 35; 95% CI: -20% to +30%) of the CBF in the placebo-treated group (p < 0.005).



This is the first prospective randomized placebo-controlled intervention study evaluating coronary endothelial function in hyperhomocysteinemic patients with CAD. Our results suggest that coronary endothelial function improves after treatment with folic acid and cobalamin.
[Cabazitaxel for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: the TROPIC study in France].

In 2010, results of the TROPIC study demonstrated that, when compared to mitxantrone, the novel taxane cabazitaxel improved median overall survival of patients with metastatic castration-resistant prostate cancer who progressed on or after docetaxel treatment. We report the data on efficacy and toxicity observed in the subgroup of patients included in the French centers. In this phase III randomized international trial, patients received prednisone and were treated with either 25 mg/m(2) cabazitaxel or 12 mg/m(2) mitoxantrone intravenously every three weeks. The primary endpoint was overall survival. The secondary endpoints included progression-free survival (PFS) and safety. Analyses were performed on the intention-to-treat population. Among the 90 patients enrolled in France, the median overall survival was 18 months for the cabazitaxel arm versus 14.3 months for the mitoxantrone arm. An improvement in PFS was also observed, with a median of 1.4 months for the mitoxatrone arm compared to a median of 2.5 months for the cabazitaxel arm. The most common grade ≥ 3 adverse events were hematologic with neutropenia, usually afebrile and digestive with 4 % of patients reporting diarrhea. These results are comparable to those reported for the overall population and the safety profile remains favorable without any toxic death related to cabazitaxel.
Do patients with knee osteoarthritis perform sit-to-stand motion efficiently?

The sit-to-stand motion (STS) is a frequently executed activity that is affected by weakness in the quadriceps femoris muscle and knee joint pain in patients with knee osteoarthritis (OA). We investigated whether patients with knee OA can efficiently perform STS through mechanical energy transfer assessments. Participants were 20 women with knee OA and 17 age-matched asymptomatic controls. The center of mass (COM), segment angles, joint moments, and powers during STS were measured. The negative mechanical work in the proximal portion of the shank, negative mean powers in the distal portion of the pelvis and proximal portion of the shank, and the positive mean power in the proximal and distal portions of the thigh were significantly lower in the knee OA group than in the control group. Patients with knee OA primarily performed thoracic forward lean movement, shifting their COM closer to the base of support provided by the feet alone, in an attempt to achieve stability at and after buttocks-off. However, control ability, which generates and absorbs kinetic energy quickly, was not enhanced in these patients, and their motion was unable to increase absorption of the mechanical energy in hip extensors and reduce the load on knee extensors. Furthermore, STS in patients with knee OA had reduced energy absorption in the knee extensors from the shank forward lean movement after buttocks-off, had reduced knee extensor efficiency, and made greater use of physiological energy. These findings suggest that, from the standpoint of mechanical energy transfer, patients with knee OA do not perform STS efficiently.
Early azathioprine therapy is no more effective than placebo for newly diagnosed Crohn's disease.

A small placebo-controlled trial reported the efficacy of mercaptopurine therapy for children newly diagnosed with Crohn's disease, yet little is known about the efficacy of early thiopurine therapy in adults.



We performed a prospective double-blind trial of adult patients with a recent (<8 weeks) diagnosis of Crohn's disease. Patients were randomly assigned to groups given azathioprine (2.5 mg · kg(-1) · day(-1), n = 68) or placebo (n = 63) at 31 hospitals from February 2006 to September 2009. Corticosteroids but no other concomitant medications were allowed for control of disease activity. The primary measure of efficacy was sustained corticosteroid-free remission.



After 76 weeks of treatment, 30 patients treated with azathioprine (44.1%) and 23 given placebo (36.5%) were in sustained corticosteroid-free remission (difference of 7.6%; 95% confidence interval, -9.2 to 24.4%; P = .48). The rates of relapse (defined as Crohn's Disease Activity Index score >175) and corticosteroid requirements were similar between groups. A post hoc analysis of relapse, defined as a Crohn's Disease Activity Index score >220, showed lower relapse rates in the azathioprine group than in the placebo group (11.8% vs 30.2%; P = .01). Serious adverse events occurred in 14 patients in the azathioprine group (20.6%) and 7 in the placebo group (11.1%) (P = .16). A larger percentage of patients in the azathioprine group had adverse events that led to study drug discontinuation (20.6%) than in the placebo group (6.35%) (P = .02).



In a study of adults with Crohn's disease, early azathioprine therapy was no more effective than placebo to achieve sustained corticosteroid-free remission but was more effective in preventing moderate to severe relapse in a post hoc analysis. EudraCT 2005-001186-34.
Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice: protocol of a pragmatic randomized controlled trial

Insomnia is a highly prevalent disorder causing clinically significant distress and impairment. Furthermore, insomnia is associated with high societal and individual costs. Although cognitive behavioural treatment for insomnia (CBT-I) is the preferred treatment, it is not used often. Offering CBT-I in an online format may increase access. Many studies have shown that online CBT for insomnia is effective. However, these studies have all been performed in general population samples recruited through media. This protocol article presents the design of a study aimed at establishing feasibility, effectiveness and cost-effectiveness of a guided online intervention (i-Sleep) for patients suffering from insomnia that seek help from their general practitioner as compared to care-as-usual.



In a pragmatic randomized controlled trial, adult patients with insomnia disorder recruited through general practices are randomized to a 5-session guided online treatment, which is called "i-Sleep", or to care-as-usual. Patients in the care-as-usual condition will be offered i-Sleep 6 months after inclusion. An ancillary clinician, known as the psychological well-being practitioner who works in the GP practice (PWP; in Dutch: POH-GGZ), will offer online support after every session. Our aim is to recruit one hundred and sixty patients. Questionnaires, a sleep diary and wrist actigraphy will be administered at baseline, post intervention (at 8 weeks), and at 6 months and 12 months follow-up. Effectiveness will be established using insomnia severity as the main outcome. Cost-effectiveness and cost-utility (using costs per quality adjusted life year (QALY) as outcome) will be conducted from a societal perspective. Secondary measures are: sleep diary, daytime consequences, fatigue, work and social adjustment, anxiety, alcohol use, depression and quality of life.



The results of this trial will help establish whether online CBT-I is (cost-) effective and feasible in general practice as compared to care-as-usual. If it is, then quality of care might be increased because implementation of i-Sleep makes it easier to adhere to insomnia guidelines. Strengths and limitations are discussed.
Site of pleural drain insertion and early postoperative pulmonary function following coronary artery bypass grafting with internal mammary artery.

Coronary artery bypass graft (CABG) surgery using the left internal mammary artery (LIMA) impairs postoperative pulmonary function. We studied the changes in pulmonary function and subjective pain relative to the site of chest tube insertion.



Thirty patients undergoing CABG surgery using the LIMA were randomized into two groups. Group A (n = 15) received a left chest tube inserted from the midline (subxyphoid). Group B (n = 15) had a tube placed in the sixth intercostal space at the anterior axillary line. All of the patients underwent bedside pulmonary function testing preoperatively and on postoperative days (PODs) 1, 3, and 5. Pain sensation was quantified by a standardized score (1 to 10).



A significant impairment of pulmonary function parameters was observed in both groups until POD 5. For group A, the decline in percent predicted (+/-SD) in the vital capacity (VC) from before surgery to POD 5 was, respectively, 92.3+/-30.6% to 56.9+/-12.6% (p < 0.001). For group B, the decline in the VC was from 88.0+/-18.2% to 55.5+/-14.8% (p < 0.001). The FEV1 declined concomitantly in group A from 86.2+/-18.2% to 50.8+/-12.1%, and in group B from 83.5+/-16.4% to 53.9+/-12.5% (p < 0.001). On POD 1, a significantly lower decrease in the VC was measured in group A than in group B, respectively: 45.3+/-15.5% vs 28.6+/-8.7% (p < 0.001). A significantly lower decrease in the FEV1 was also seen in group A than in group B, respectively: 36.9+/-12.9% vs 28.0+/-10.6% (p < 0.05). Pain experienced during deep inspiration was also significantly less in group A than in group B, respectively: 1.2+/-1.1 vs 2.5+/-0.9 (p < 0.01).



Subxyphoid insertion of the pleural drain leads to a significantly lower impairment of pulmonary function and less subjective pain than insertion at the intercostal position. The drainage of the left pleural space is equally effective with both techniques.
Phase II trial of carboplatin plus oral etoposide for elderly patients with small-cell lung cancer.

A phase II trial was conducted to evaluate the efficacy and toxicity of the Egorin's carboplatin dosing formula with 14-day oral etoposide in 38 elderly patients with small-cell lung cancer (SCLC). The overall response rate was 81%. Median survival times were 15.1 months for 16 limited-disease (LD) and 8.6 months for 22 extensive-disease (ED) patients. Myelosuppression was the principal side-effect. This regimen is an active regimen in the treatment of elderly SCLC patients.
Olanzapine compared to quetiapine in adolescents with a first psychotic episode

To compare the efficacy, safety, and tolerability of olanzapine and quetiapine in adolescents with first episode psychosis. Fifty adolescents (age 16 ± 1.25) with a first episode of psychosis were randomized to quetiapine or olanzapine in a 6-month open label study. Efficacy and side effect scales, as well as vital signs and laboratory data were recorded at baseline, 7, 15, 30, 90, and 180 days (end of study). Out of the total sample included in the study, 32 patients completed the trial (quetiapine n = 16, olanzapine n = 16). Patients in both treatment groups had a significant reduction in all clinical scales with the exception of the negative scale of the Positive and Negative Symptom Scale (PANSS) for olanzapine and the general psychopathology scale of the PANSS for quetiapine. The only difference between treatment arms on the clinical scales was observed on the patients’ strength and difficulties questionnaire (SDQ) scale, with greater improvement for olanzapine. Patients on olanzapine gained 15.5 kg and patients on quetiapine gained 5.5 kg. Olanzapine and quetiapine reduced psychotic symptoms in this adolescent sample. Patients on olanzapine gained significantly more weight. Side effects with both drugs seemed to be more prevalent than those reported in adult studies.
Adequacy of dialysis and nutrition in continuous peritoneal dialysis: association with clinical outcomes. Canada-USA (CANUSA) Peritoneal Dialysis Study Group.

The objective of the study presented here was to evaluate the relationship of adequacy of dialysis and nutritional status to mortality, technique failure, and morbidity. This was a prospective cohort study of consecutive patients commencing continuous peritoneal dialysis in 14 centers in Canada and the United States. Between September 1, 1990 and December 31, 1992, 680 patients were enrolled. Follow-up was terminated December 31, 1993. There were 90 deaths, 137 transplants, and 118 technique failures. Fifteen withdrew from dialysis. Analysis of the patient and technique survival used the Cox proportional hazards model with adequacy of dialysis and nutritional status as time-dependent covariates. The relative risk (RR) of death increased with increased age, insulin-dependent diabetes mellitus, cardiovascular disease, decreased serum albumin concentration and worsened nutritional status (subjective global assessment and percentage lean body mass). A decrease of 0.1 unit Kt/V per week was associated with a 5% increase in the RR of death; a decrease of 5 L/1.73 m2 creatinine clearance (CCr) per week was associated with a 7% increase in the RR of death. The RR of technique failure was increased with decreased albumin concentration and decreased CCr. Hospitalization was increased with decreased serum albumin concentration, worsened nutrition according to subjective global assessment and decreased CCr. A weekly Kt/V of 2.1 and a weekly CCr of 70 L/1.73 m2 were each associated with an expected 2-yr survival of 78%.
Effects of guided imagery on biobehavioral factors in women with fibromyalgia

Women diagnosed with fibromyalgia (N = 72) participated in a 10-week randomized trial to examine the effectiveness of guided imagery on self-efficacy, perceived stress, and selected biobehavioral factors (FMS symptoms; immune biomarkers). Participants in both guided imagery and usual care control conditions completed measures and donated 3 cc of blood at baseline, 6- and 10-weeks. A mixed effects linear model to test for differences between groups for all behavioral and biologic variables demonstrated that after 10 weeks of daily intervention use, guided imagery participants reported statistically significant increases in self-efficacy and statistically significant decreases in stress, fatigue, pain, and depression. There were no statistically significant changes in biomarker levels, although total group C-reactive protein was elevated at baseline (4.7 mg/L), indicating an inflammatory process. Subsequent studies should be undertaken to more fully elucidate the biobehavioral aspects of nonpharmacological intervention effectiveness.