nils-herrmann/clean_scirepeval huggingface dataset:
What are the important surgical factors affecting the wound healing after primary total knee arthroplasty?

Wound condition after primary total knee arthroplasty (TKA) is an important issue to avoid any postoperative adverse events. Our purpose was to investigate and to clarify the important surgical factors affecting wound score after TKA.



A total of 139 knees in 128 patients (mean 73 years) without severe comorbidity were enrolled in the present study. All primary unilateral or bilateral TKAs were done using the same skin incision line, measured resection technique, and wound closure technique using unidirectional barbed suture. In terms of the wound healing, Hollander Wound Evaluation Score (HWES) was assessed on postoperative day 14. We performed multiple regression analysis using stepwise method to identify the factors affecting HWES. Variables considered in the analysis were age, sex, body mass index (kg/m(2)), HbA1C (%), femorotibial angle (degrees) on plain radiographs, intraoperative patella eversion during the cutting phase of the femur and the tibia in knee flexion, intraoperative anterior translation of the tibia, patella resurfacing, surgical time (min), tourniquet time (min), length of skin incision (cm), postoperative drainage (ml), patellar height on postoperative lateral radiographs, and HWES. HWES was treated as a dependent variable, and others were as independent variables.



The average HWES was 5.0 ± 0.8 point. According to stepwise forward regression test, patella eversion during the cutting phase of the femur and the tibia in knee flexion and anterior translation of the tibia were entered in this model, while other factors were not entered. Standardized partial regression coefficient was as follows: 0.57 in anterior translation of the tibia and 0.38 in patella eversion.



Fortunately, in the present study using the unidirectional barbed suture, major wound healing problem did not occur. As to the surgical technique, intraoperative patella eversion and anterior translation of the tibia should be avoided for quality cosmesis in primary TKA.
Fibromyalgia: a randomised, controlled trial of a treatment programme based on self management.

To evaluate the efficacy of a treatment programme for patients with fibromyalgia (FM) based on self management, using pool exercises and education.



Randomised controlled trial with a 6 month follow up to evaluate an outpatient multidisciplinary programme; 164 patients with FM were allocated to an immediate 6 week programme (n = 84) or to a waiting list control group (n = 80). The main outcomes were changes in quality of life, functional consequences, patient satisfaction and pain, using a combination of patient questionnaires and clinical examinations. The questionnaires included the Fibromyalgia Impact Questionnaire (FIQ), Psychological General Well-Being (PGWB) index, regional pain score diagrams, and patient satisfaction measures.



61 participants in the treatment group and 68 controls completed the programme and 6 month follow up examinations. Six months after programme completion, significant improvements in quality of life and functional consequences of FM were seen in the treatment group as compared with the controls and as measured by scores on both the FIQ (total score p = 0.025; fatigue p = 0.003; depression p = 0.031) and PGWB (total score p = 0.032; anxiety p = 0.011; vitality p = 0.013,). All four major areas of patient satisfaction showed greater improvement in the treatment than the control groups; between-group differences were statistically significant for "control of symptoms", "psychosocial factors", and "physical therapy" No change in pain was seen.



A 6 week self management based programme of pool exercises and education can improve the quality of life of patients with FM and their satisfaction with treatment. These improvements are sustained for at least 6 months after programme completion.
Integrating Mobile health and Physical Activity to reduce the burden of Chronic low back pain Trial (IMPACT): a pilot trial protocol

It is well recognised that low back pain is a significant public health problem and engagement in moderate levels of physical activity is associated with positive outcomes. Conservative active care, such as exercise, is effective in reducing pain and disability associated with chronic low back pain. However, a rapid decline in clinical outcomes is commonly seen after discharge from treatment.



We will conduct a randomised controlled trial to investigate the effectiveness of a mobile health supported physical activity intervention (compared to standard care) in care-seeking, pain and disability in people with chronic low back pain after discharge from treatment. We will recruit 68 patients with chronic low back pain following discharge from an outpatient hospital program, who will be randomly allocated to the physical activity intervention (n = 34) or the standard care group (n = 34) and monitored for 6 months. The physical activity intervention will involve a physical activity advice booklet, a face-to-face health coaching session and 12 fortnightly follow-up telephone-based health coaching sessions. This intervention will be supported by provision of a specifically designed web app and a physical activity monitoring device (FitBit). The standard care group will receive the physical activity advice booklet only.



This pilot trial will investigate a new model to prevent clinical decline in people following conservative treatment for chronic low back pain. If proven to be effective, this approach will constitute a major advance in the management of low back pain. Chronic patients who experience recurrent pain and disability after treatment are prone to seek additional care in the form of physiotherapy, medication, emergency department attendance, specialist consultation or spinal surgery. This model aims to maintain functional levels and reduce care-seeking empowering patients to self-manage their low back pain by offering them a contemporary patient-centred physical activity program with the support of mobile health technology. The outcomes of this trial will have immediate implications for clinical practice.
Attention bias modification for major depressive disorder: Effects on attention bias, resting state connectivity, and symptom change.

Cognitive theories of depression posit that selective attention for negative information contributes to the maintenance of depression. The current study experimentally tested this idea by randomly assigning adults with Major Depressive Disorder (MDD) to 4 weeks of computer-based attention bias modification designed to reduce negative attention bias or 4 weeks of placebo attention training. Findings indicate that compared to placebo training, attention bias modification reduced negative attention bias and increased resting-state connectivity within a neural circuit (i.e., middle frontal gyrus and dorsal anterior cingulate cortex) that supports control over emotional information. Further, pre- to post-training change in negative attention bias was significantly correlated with depression symptom change only in the active training condition. Exploratory analyses indicated that pre- to post-training changes in resting state connectivity within a circuit associated with sustained attention to visual information (i.e., precuenus and middle frontal gyrus) contributed to symptom improvement in the placebo condition. Importantly, depression symptoms did not change differentially between the training groups-overall, a 40% decrease in symptoms was observed across attention training conditions. Findings suggest that negative attention bias is associated with the maintenance of depression; however, deficits in general attentional control may also maintain depression symptoms, as evidenced by resting state connectivity and depression symptom improvement in the placebo training condition.
Can a lifestyle intervention programme improve physical behaviour among adolescents and young adults with spastic cerebral palsy? A randomized controlled trial.

Optimal physical behaviour is important, as physical inactivity contributes to functional deterioration and reduced social participation. Nevertheless, research showed that persons with cerebral palsy (CP) have low physical activity levels. The objective of this study is to evaluate the effectiveness of a lifestyle intervention programme on physical behaviour.



Fifty-seven persons (36 completed the total study) with spastic CP (age range 16 to 25y; 27 males, 30 females), classified as Gross Motor Function Classification System levels I-IV were included in this randomized controlled trial. Twenty-nine participants had a unilateral CP and 27 had a bilateral CP. A 6-month lifestyle intervention consisting of fitness training and counselling on physical behaviour and sports participation was evaluated. Physical behaviour was objectively measured using ambulatory activity monitors. Self-reported physical activity was determined using the Physical Activity Scale for Individuals with Physical Disabilities.



The intervention did not affect the objectively measured physical activity during the intervention (beta=0.34, CI=-1.70 to 2.37) or at follow-up (beta=0.30, CI=-1.99 to 2.59). Self-reported physical activity was positively affected during the intervention period (beta=7.61, CI=0.17-15.05); however, this effect was not present at follow-up (beta=3.65, CI=-3.05 to 10.36).



The lifestyle intervention was ineffective in eliciting a behavioural change towards more favourable physical behaviour in adolescents and young adults with spastic CP.
Association Between 5-HTTLPR Polymorphism and Tics after Treatment with Methylphenidate in Korean Children with Attention-Deficit/Hyperactivity Disorder

The purpose of this study is to examine the relationship between 5-HTTLPR polymorphism (44-bp insertion/deletion polymorphism of serotonin transporter gene) and methylphenidate (MPH) treatment response, as well as the association between the adverse events of MPH treatment and 5-HTTLPR polymorphism in children with attention-deficit/hyperactivity disorder (ADHD).



A total of 114 children with ADHD (mean age 9.08 ± 1.94 years) were recruited from the child psychiatric clinic in a hospital in South Korea. We have extracted the genomic DNA of the subjects from their blood lymphocytes and analyzed 5-HTTLPR polymorphism of the SLC6A4 gene. All children were treated with MPH for 8 weeks, with clinicians monitoring both the improvement of ADHD symptoms and the side effects. We compared the response to MPH treatment and adverse events among those with the genotype of 5-HRRLPR polymorphism.



There was no significant association between the 5-HTTLPR genotype and the response to MPH treatment in children with ADHD. Subjects with the S/L+L/L genotype tended to have tics and nail biting (respectively, p < 0.001, p = 0.017).



The results of this study do not support the association between the 5-HTTLPR polymorphism and treatment response with MPH in ADHD. However, our findings suggest the association between 5-HTTLPR polymorphism and the occurrence of tics and nail-biting as an adverse event of methylphenidate. This may aid in our understanding of the genetic contribution and genetic susceptibility of a particular allele in those ADHD patients with tics or nail biting.
Histamine, mast cells and tumour cell proliferation in breast cancer: does preoperative cimetidine administration have an effect?

Endogenous histamine has been shown to effect growth mechanisms in experimental mammary carcinomas via H2 membrane receptors (Cricco et al, 1994). Both H1 and H2 binding sites are present in human mammary glands but only 75% malignant carcinomas express H2 receptors (Lemos et al, 1995). The presence of mast cells around tumour tissue raises questions concerning the source of histamine in breast tumour tissue. While cimetidine, an H2 antagonist, has been shown to influence the presence of tumour infiltrating lymphocytes (TIL) in colorectal cancer (Adams and Morris, 1994, 1997) that was not found to be the case in breast cancer (Ng et al, 1995). In recent studies tumour cell proliferation, as measured by Ki-67 antibody labelling, has been seen as an additional prognostic indicator in breast cancer (Railo et al, 1993, 1997; Ferno, 1998; Schauer et al, 1998). We investigated the possibility that cimetidine may influence tumour proliferation by blocking the growth-promoting effects of histamine. No relationship between preoperative cimetidine administration and tumour cell proliferation was seen overall. A weak correlation was seen between tissue histamine content and mast cell count which was not influenced by cimetidine. Tumour cell proliferation correlated well with other prognostic indicators such as grade and differentiation.
Large-diameter Delta ceramic-on-ceramic versus common-sized ceramic-on-polyethylene bearings in THA.

The higher failure rate of total hip arthroplasty (THA) in young, active patients remains a challenge for surgeons. Recently, larger-diameter femoral heads combined with an alumina matrix composite ceramic (BIOLOX Delta; CeramTec AG, Plochingen, Germany) articulation was developed to improve implant longevity and meet patients' activity demands while reducing the risk of component-related complications. The purpose of this study was to determine whether this new device may provide advantages for young, active patients. A prospective, randomized, controlled trial was conducted on 93 patients (113 THAs) with more than 3 years of follow-up. Patients were randomly divided into a study group (51 THAs) with a 36-mm Delta ceramic-on-ceramic (COC) articulation and a control group (62 THAs) with a common-sized alumina ceramic head on polyethylene liner (COP) articulation. Clinical and radiographic results were collected to compare the outcomes and complications, including implant-related failures, osteolysis, and noises. The large-diameter Delta COC articulation provided greater range of motion improvement (6.1° more), similar Harris Hip Scores, and similar complication rates compared with the alumina COP articulation. This study suggests that in the short term, the large-diameter Delta COC articulation results in better range of motion with no higher complication rates; however, mid-term (8-10 years) or longer follow-up is necessary to determine its superiority in young, active patients.
Efficacy of a nucleoside-sparing regimen of darunavir/ritonavir plus raltegravir in treatment-naive HIV-1-infected patients (ACTG A5262).

To explore darunavir/ritonavir (DRV/r) plus raltegravir (RAL) combination therapy in antiretroviral-naive patients.



Phase IIb, single-arm, open-label, multicenter study.



One hundred and twelve antiretroviral-naive, HIV-1-infected patients received DRV/r 800/100 mg once daily and RAL 400 mg twice daily. Primary endpoint was virologic failure by week 24. Virologic failure was defined as confirmed viral load of 1000 copies/ml or more at week 12, or an increase of more than 0.5 log(10) copies/ml in viral load from week 4 to 12, or a confirmed viral load of more than 50 copies/ml at or after week 24. Protease and integrase genes were sequenced in patients experiencing virologic failure.



Virologic failure rate was 16% [95% confidence interval (CI) 10-24] by week 24 and 26% (95% CI 19-36) by week 48 in an intent-to-treat analysis. Viral load at virologic failure was 51-200 copies/ml in 17/28 failures. Adjusting for age and sex, virologic failure was associated with baseline viral load of more than 100,000 copies/ml [hazard ratio 3.76, 95% CI (1.52-9.31), P = 0.004] and lower CD4 cell count [0.77 per 100 cells/μl increase (95% CI 0.61-0.98), P = 0.037]. When trough RAL concentrations were included as a time-varying covariate in the analysis, virologic failure remained associated with baseline viral load more than 100,000 copies/ml [hazard ratio = 4.67 (95% CI 1.93-11.25), P < 0.001], whereas RAL level below detection limit in plasma at one or more previous visits was associated with increased hazard [hazard ratio = 3.42 (95% CI 1.41-8.26), P = 0.006]. All five participants with integrase mutations during virologic failure had baseline viral load more than 100,000 copies/ml.



DRV/r plus RAL was effective and well tolerated in most patients, but virologic failure and integrase resistance were common, particularly in patients with baseline viral load more than 100,000 copies/ml.
Migraine and antiphospholipid antibodies: no association found in migraine-discordant monozygotic twins.

Migraine headache (with and without aura) is common in the general population and is known to be influenced by genetic factors with heritability estimates between 34-57%. Antiphospholipid syndrome (APS) is a hypercoagulable state characterized by clinical features including venous and arterial thromboses, pregnancy loss and migraine, and by association with antiphospholipid antibodies (aPL). Numerous small studies have investigated whether aPL are associated with migraine in the general population--with contradictory results. In this study, the question was addressed by studying the prevalence of aPL in members of monozygotic (MZ) twin pairs differing in their migraine status. Such twins provide a unique natural experiment, matched as they are for age, sex and genetic factors, and allow the role of environmental factors, such as aPL, to be determined. Despite 95% power to detect a difference of 0.59 IgG units per litre in anticardiolipin antibody IgG titres, no difference in prevalence of aPL could be detected in migraine-discordant MZ twins.
Downregulation of IFNG in CD4+ T Cells in Lung Cancer through Hypermethylation: A Possible Mechanism of Tumor-Induced Immunosuppression

Tumor survival is significantly correlated with the immune response of patients. IFNG plays an important role in the tumor host response and decreased IFNG expression is often observed in lung cancer. Studies have shown that CpG island hypermethylation plays a critical role in transcriptional silencing of IFNG gene expression. However, there is limited understanding regarding the molecular mechanisms of altered methylation, and whether the tumor microenvironment has any effect on DNA methylation and IFNG production. In the current study, we demonstrate that plasma and intra-cellular IFNG levels are significantly lower in lung cancer patients. Hypermethylation of the IFNG promoter in CD4(+) T cells and plasma IFNG was negatively correlated. CD4(+) T cells from healthy individuals co-cultured with SPC-A1 cells generated lower levels of IFNG after activation, elevated expression of DNA methyltransferases (DNMTs), and exhibited hypermethylation of the IFNG promoter. In conclusion, decreased IFNG expression of CD4(+) T cells co-cultured with lung cancer cell is associated with IFNG promoter hypermethylation. Our study suggests that interaction between lung cancer cells and CD4(+) T cells induces DNMT expression and IFNG promoter hypermethylation in CD4(+) T cell, which may serve as an important mechanism of tumor-induced immunosuppression.
Warfarin prevents venous obstruction after cardiac devices implantation in high-risk patients: partial analysis.

To evaluate the efficacy of prophylactic use of warfarin in patients with high risk of lead-associated thrombosis.



Clinical, prospective, randomized and blinded study, in patients submitted to first transvenous leads implantation with LVEF <0.40 and/or previous ipsilateral temporary pacing. After device implantation, patients were randomly assigned to placebo or warfarin. Periodical clinical and laboratorial evaluations were performed to anticoagulant management. After a six-month period, every patient was submitted to a digital subtraction venography. From February 2004 to November 2006, 101 patients underwent randomization. Baseline characteristics were similar in both groups (P=NS).



Venographic analysis showed 31.4% of venous obstructions in patients assigned to warfarin as compared with 57.1% in patients assigned to placebo (RR= 0.57 [95% CI, 0.33 to 0.98]; P=0.015). In the warfarin group, 72% of the PT/INR tests were in therapeutic INR range. Only one patient required warfarin discontinuation and cross-over to placebo group due to gastrointestinal bleeding.



These preliminary results showed that the anticoagulation therapy has been safe and reduced the frequency of venous thrombosis after transvenous cardiac devices implantation in high risk patients.
Does adenosine prevent myocardial micronecrosis following percutaneous coronary intervention? The ADELINE pilot trial. ADEnosine Limit myocardial Necrosis.

After successful percutaneous coronary intervention (PCI), 24–44% of patients suffer some myocardial damage as indicated by a significant change in the concentrations of cardiospecific troponin or the MB isoenzyme of creatine kinase (CK-MB). 2 Patients with minor increases of these cardiac markers after PCI constitute a population with a worse long term prognosis. Preconditioning of human myocardium can be obtained by intracoronary administration of adenosine, as indicated by attenuation of ischaemia and chest pain in patients undergoing PCI. In the present trial (ADELINE, does ADEnosine Limit myocardial Necrosis), we investigated the effect of intracoronary administration on chest pain and ischaemia during a 90 second balloon inflation during PCI. In addition, we evaluated the release of cardiac markers after angiographically successful coronary intervention.
A twelve month comparison of salmeterol with salbutamol in asthmatic patients. European Study Group.

The efficacy and tolerability of salmeterol, 50 micrograms b.i.d. was compared for three months with salbutamol, 200 micrograms q.i.d., administered from metered-dose inhaler. For the following nine months, safety and clinic lung function was monitored on salmeterol, 50 micrograms b.i.d., compared with salbutamol, 200 micrograms b.i.d. This comparison was made in a multicentre, double-blind, parallel-group study of 667 moderate asthmatics, who had a forced expiratory volume in one second (FEV1) or peak expiratory flow rate (PEFR) > 50% predicted, a 15% reversibility to inhaled salbutamol and who were experiencing symptoms. Throughout the first three month treatment period, both morning and evening PEFR were significantly higher on treatment with salmeterol than salbutamol (mean differences between the treatments 30 l.min-1 for morning, p < 0.001, and 11 l.min-1 for evening, p < 0.01). In addition, the diurnal variation in PEFR, nocturnal and daytime symptoms and use of additional salbutamol were significantly lower in the salmeterol treated group. This improvement was also apparent in the separate subpopulations of patients taking no concurrent glucocorticosteroid or concurrent inhaled and/or oral glucocorticosteroids. Both treatments were well-tolerated throughout the 12 months of treatment. There was a lower incidence of asthma and related events during salmeterol treatment compared to salbutamol treatment subgroups. The results of the study clearly demonstrate that salmeterol, 50 micrograms b.i.d., is well-tolerated and more effective than salbutamol, 200 micrograms q.i.d., in the treatment of moderate asthma.