nils-herrmann/clean_scirepeval huggingface dataset:
Reconstruction of the trapeziometacarpal joint in inflammatory joint disease using interposition of autologous tendon or poly-L-D-lactic acid implants: a prospective clinical trial.

Interposition arthroplasty with bioreplaceable poly-L-D-lactic acid (PLDLA) implants has yielded promising results in reconstruction of rheumatoid hands. In this prospective clinical study we compared the PLDLA implant arthroplasty (n = 17) with that of tendon interposition (n = 12) for destruction of the trapeziometacarpal joint in arthritic patients. There was no significant difference between the two groups preoperatively. At one-year follow-up, the mean pain and function scores were 5 and 13 in the PLDLA group, and 19 and 43 in the tendon interposition group, respectively. At one-year follow-up the visual analogue scale (VAS) for function of the PLDLA group differed significantly from that of the tendon interposition group (p = 0.03). This difference was not found at three months postoperatively, and disappeared again at two-year follow-up. Otherwise, no significant difference was found between the groups in the pain or function scores, functional tests, or range of movement. Bioreplaceable interposition arthroplasty works at least as well as tendon interposition. The operation is easier.
Alcohol-related breast cancer in postmenopausal women – effect of CYP19A1, PPARG and PPARGC1A polymorphisms on female sex-hormone levels and interaction with alcohol consumption and NSAID usage in a nested case-control study and a randomised controlled trial

Alcohol consumption is associated with increased risk of breast cancer (BC), and the underlying mechanism is thought to be sex-hormone driven. In vitro and observational studies suggest a mechanism involving peroxisome proliferator-activated receptor gamma (PPARγ) in a complex with peroxisome proliferator-activated receptor gamma coactivator 1-α (PGC-1α) and interaction with aromatase (encoded by CYP19A1). Use of non-steroidal anti-inflammatory drugs (NSAID) may also affect circulating sex-hormone levels by modifying PPARγ activity. In the present study we assessed whether genetic variation in CYP19A1 is associated with risk of BC in a case-control study group nested within the Danish “Diet, Cancer and Health” cohort (ncases = 687 and ncontrols = 687) and searched for gene-gene interaction between CYP19A1 and PPARGC1A, and CYP19A1 and PPARG, and gene-alcohol and gene-NSAID interactions. Association between the CYP19A1 polymorphisms and hormone levels was also examined among 339 non-HRT users. Incidence rate ratios were calculated based on Cox’ proportional hazards model. Furthermore, we performed a pilot randomised controlled trial to determine the effect of the PPARG Pro12Ala polymorphism and the PPARγ stimulator Ibuprofen on sex-hormone levels following alcohol intake in postmenopausal women (n = 25) using linear regression. Genetic variations in CYP19A1 were associated with hormone levels (estrone: Prs11070844 = 0.009, estrone sulphate: Prs11070844 = 0.01, Prs749292 = 0.004, Prs1062033 = 0.007 and Prs10519297 = 0.03, and sex hormone-binding globulin (SHBG): Prs3751591 = 0.03) and interacted with alcohol intake in relation to hormone levels (estrone sulphate: Pinteraction/rs2008691 = 0.02 and Pinteraction/rs1062033= 0.03, and SHBG: Pinteraction/rs11070844 = 0.03). CYP19A1/rs3751591 was both associated with SHBG levels (P = 0.03) and with risk of BC (Incidence Rate Ratio = 2.12; 95 % Confidence Interval: 1.02–4.43) such that homozygous variant allele carriers had increased levels of serum SHBG and were at increased risk of BC. Acute intake of alcohol decreased blood estrone (P = <0.0001), estrone sulphate (P = <0.0001), and SHBG (P = 0.009) levels, whereas Ibuprofen intake and PPARG Pro12Ala genotype had no effect on hormone levels. Our results suggest that genetically determined variation in CYP19A1 is associated with differences in sex hormone levels. However, the genetically determined differences in sex hormone levels were not convincingly associated with BC risk. The results therefore indicate that the genetically determined variation in CYP19A1 contributes little to BC risk and to alcohol-mediated BC risk. NCT02463383 , June 3, 2015.
Gender-informed, psychoeducational programme for couples to prevent postnatal common mental disorders among primiparous women: cluster randomised controlled trial.

Interventions to prevent postpartum common mental disorders (PCMD) among unselected populations of women have had limited success. The aim was to determine whether What Were We Thinking (WWWT) a gender-informed, psychoeducational programme for couples and babies can prevent PCMD among primiparous women 6 months postpartum.



Cluster-randomised controlled trial.



48 Maternal and Child Health Centres (MCHCs) from 6 Local Government Areas in Melbourne, Australia were allocated randomly to usual care (24) or usual care plus WWWT (24).



English-speaking primiparous women receiving primary care at trial MCHCs were recruited to the intervention (204) and control (196) conditions. Of these, 187 (91.7%) and 177 (90.3%) provided complete data.



WWWT is a manualised programme comprising primary care from a trained nurse, print materials and a face-to-face seminar.



Data sources were standardised and study-specific measures collected in blinded computer-assisted telephone interviews at 6 and 26 weeks postpartum. The primary outcome was PCMD assessed by Composite International Diagnostic Interviews and Patient Health Questionnaire (PHQ) Depression and Generalised Anxiety Disorder modules.



In intention-to-treat analyses the adjusted OR (AOR) of PCMD in the intervention compared to the usual care group was 0.78 (95% CI 0.38 to 1.63, ns), but mild to moderate anxiety symptoms (AOR 0.58, 95% CI 0.35 to 0.97) and poor self-rated health (AOR 0.46, 95% CI 0.22 to 0.97) were significantly lower. In a per protocol analysis, comparing the full (three component) intervention and usual care groups, the AOR of PCMD was 0.36, (95% CI 0.14 to 0.95). The WWWT seminar was appraised as salient, comprehensible and useful by >85% participants. No harms were detected.



WWWT is readily integrated into primary care, enables inclusion of fathers and addresses modifiable risks for PCMD directly. The full intervention appears a promising programme for preventing PCMD, optimising family functioning, and as the first component of a stepped approach to mental healthcare.
The influence of insulin use on glycemic control: How well do adults follow prescriptions for insulin?

The purposes of this study were to determine the relationship between insulin self-management and glycemic control and to identify patient characteristics associated with better control.



A Department of Veterans Affairs regional database was used to identify patients with diabetes on chronic insulin therapy (n = 6,222) with dose defined as number of units and doses. The rate of insulin use during a 2-year period was calculated using pharmacy data. Regression analyses were used 1) to predict compliance with prescribed insulin regimens using demographic variables, HbA1c levels, and a measure of diabetes management intensity and 2) to predict HbA1c levels using demographic variables and rates of insulin use.



Insulin use was 77.44 +/- 17% of prescribed amounts, including wastage; HbA1c levels were 7.98 +/- 1.66%. Concomitant oral hypoglycemic agent use (84.89 +/- 16%) was higher than insulin use (P < 0.0001) but correlated with insulin use (r = 0.189, P < 0.0001). Ordinary least-squares regression showed that race, HbA1c levels, and intensity of diabetes management were significant predictors of insulin use. Age, race, and insulin use were significant predictors of HbA1c levels.



Adults prescribed a specific insulin regimen averaged using 77% of prescribed doses, demonstrating good intention to follow the prescription. However, HbA1c higher than the recommended level suggested that the rate of insulin use, the prescribed regimen, or both were inadequate to achieve good glycemic control in patients with long-term insulin use.
Effects of Group Training Based on the Health Belief Model on Knowledge and Behavior Regarding the Pap Smear Test in Iranian Women: a Quasi-Experimental Study.

The Pap smear test is recommended for early diagnosis of cervical cancer. The aim of this study was to assess knowledge and behavior regarding the Pap smear test based on the Health Belief Model (HBM) in women referred to premarital counseling classes, Hamadan, Iran. This quasi-experimental study was conducted on 330 women, who were allocated randomly to two case and control groups (n=165). Two educational session classes were performed in the case group. Two stages in before and after intervention groups were evaluated. Analysis of data was performed by SPSS/16.0, using t-test, x2, and McNemar's test. P-values <0.05 were regarded as significant. There was no significant difference between the mean scores of the various structures of this model in two groups before the intervention. However, after the intervention there were significant increase in mean score of knowledge and all variables of HBM in the intervention group(<0.001). The findings of this study highlight the important role of education about cervical cancer on changing women's beliefs about cervical screening.
The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial.

Transcranial direct current stimulation (tDCS) trials for major depressive disorder (MDD) have shown positive but mixed results.



To assess the combined safety and efficacy of tDCS vs a common pharmacological treatment (sertraline hydrochloride, 50 mg/d).



Double-blind, controlled trial. Participants were randomized using a 2 × 2 factorial design to sertraline/placebo and active/sham tDCS.



Outpatient, single-center academic setting in São Paulo, Brazil.



One hundred twenty antidepressant-free patients with moderate to severe, nonpsychotic, unipolar MDD.



Six-week treatment of 2-mA anodal left/cathodal right prefrontal tDCS (twelve 30-minute sessions: 10 consecutive sessions once daily from Monday to Friday plus 2 extra sessions every other week) and sertraline hydrochloride (50 mg/d).  In this intention-to-treat analysis, the primary outcome measure was the change in Montgomery-Asberg depression rating scale score at 6 weeks (end point). We considered a difference of at least 3 points to be clinically relevant. The analysis plan was previously published. Safety was measured with an adverse effects questionnaire, the young mania rating scale, and cognitive assessment. Secondary measures were rates of clinical response and remission and scores on other scales.



At the main end point, there was a significant difference in Montgomery-Asberg depression rating scale scores when comparing the combined treatment group (sertraline/active tDCS) vs sertraline only (mean difference, 8.5 points; 95% CI, 2.96 to 14.03; P = .002), tDCS only (mean difference, 5.9 points; 95% CI, 0.36 to 11.43; P = .03), and placebo/sham tDCS (mean difference, 11.5 points; 95% CI, 6.03 to 17.10; P < .001). Analysis of tDCS only vs sertraline only presented comparable efficacies (mean difference, 2.6 points; 95% CI, -2.90 to 8.13; P = .35). Use of tDCS only (but not sertraline only) was superior to placebo/sham tDCS. Common adverse effects did not differ between interventions, except for skin redness on the scalp in active tDCS (P = .03). There were 7 episodes of treatment-emergent mania or hypomania, 5 occurring in the combined treatment group.



In MDD, the combination of tDCS and sertraline increases the efficacy of each treatment. The efficacy and safety of tDCS and sertraline did not differ.
Lack of pharmacokinetic interaction between ropinirole and theophylline in patients with Parkinson's disease

Ropinirole and theophylline have the potential to interact, because they use the same hepatic cytochrome P450 (CYP1A2) as their major metabolic pathway. The present study investigated the effect of steady-state oral theophylline on the pharmacokinetics of ropinirole at steady state and the effect of steady-state ropinirole on the pharmacokinetics of a single intravenous (i.v.) dose of theophylline, both in patients with idiopathic Parkinson's disease (PD).  Pharmacokinetic parameters (AUC and Cmax) for i.v. theophylline were compared before and after a 4-week period of oral treatment with ropinirole (2 mg t.i.d.) in 12 patients with PD. Patients were then maintained at this dose of ropinirole, and oral theophylline was co-administered at doses of up to 300 mg b.i.d. The parameters AUC, Cmax and tmax for ropinirole were compared before, during and after oral theophylline co-treatment.  Co-administration of ropinirole did not significantly change the pharmacokinetics of i.v. theophylline (mean AUC with and without ropinirole: 68.6 μg · h−1 · ml−1 and 70.0 μ· h−1 · ml−1, respectively; mean Cmax with and without ropinirole: 11.07 μ g · ml−1 and 11.83 μg · ml−1, respectively). Similarly, there were no significant changes in ropinirole pharmacokinetics when the drug was co-administered with oral theophylline (mean AUC for ropinirole with and without theophylline: 21.91 ng · h−1 · ml−1 and 22.09 ng · h−1 · ml−1, respectively; mean Cmax for ropinirole with and without theophylline: 5.65 ng · ml−1 and 5.54 ng · ml−1, respectively; median tmax for ropinirole with and without theophylline: 2.0 h and 1.5 h, respectively).  These results suggest a lack of significant pharmacokinetic interaction between the two drugs at current therapeutic doses.
Health-related quality of life and risk of colorectal cancer recurrence and All-cause death among advanced stages of colorectal cancer 1-year after diagnosis

The study aimed to examine the association between health-related quality of life (HRQOL) assessed with overall survival (OS) and recurrence after diagnosis of colorectal cancer (CRC). Overall 160 patients with advanced stage CRC were recruited in an observational study and completed the generic and condition-specific HRQOL questionnaires at the colorectal specialist outpatient clinic in Hong Kong, between 10/2009 and 07/2010. Socio-demographic and clinical characteristics including duration since diagnosis, primary tumor location and treatment modality, were collected to serve as predictor variables in regression models. All-cause death or CRC recurrence was the event of interest. Association between HRQOL with OS was assessed using Cox regression. Association between HRQOL and CRC recurrence was further modeled by competing-risks regression adjusted for the competing-risks of death from any cause. After a median follow-up of 23 months, there were 22 (16.1%) incidents of CRC recurrence and 15 (9.4%) deaths. Decreased physical functioning (hazard ratios, HR = 0.917, 95% CI:0.889-0.981) and general health of domains in SF-12 (HR = 0.846, 95% CI:0.746-0.958) or SF-6D scores (HR = 0.010, 95% CI:0.000-0.573) were associated with an increased risk of death, with adjustment of patients’ characteristics. Increased vitality (HR = 1.151, 95% CI:1.027-1.289) and mental health (HR = 1.128, 95% CI:1.005-1.265) were associated with an increased likelihood of death. In models adjusted for competing-risk of death, those with worse HRQOL was not associated with increased risk of CRC recurrence. Although self-reported HRQOL was not a significant prognostic factor for CRC recurrence, the HRQOL provided independent prognostic value about mortality in patients with advanced stage of CRC.
Validation of a method to replace frozen section during parathyroid exploration by using the rapid parathyroid hormone assay on parathyroid aspirates.

The parathyroid hormone (PTH) content of tissue aspirates is an accurate indicator of parathyroid tissue and can replace frozen section during parathyroid surgery.



Prospective data collection in a tertiary care hospital with a single surgeon.



One hundred sixty-seven consecutive patients completing limited parathyroid explorations.



Parathyroid adenomas removed during limited parathyroid exploration were aspirated through a 22-gauge needle into 0.5 mL isotonic sodium chloride solution and the solution held on ice in a purple-top tube. Aspirates of in situ thyroid tissue were also taken for comparison. Samples were then assessed to monitor the physiologic impact of the surgery.



The PTH content of tissue aspirates was compared with histologic identification of removed putative parathyroid tissue.



Elevated tissue PTH content was associated with the identification of origin as parathyroid in every case. Tissue aspirates from pathologically proven parathyroid tissue had a mean PTH level of at least 1691 pg/mL, with 160 having values exceeding the upper limit of the assay. This measure was significantly higher than values obtained from thyroid aspirates, which had a mean PTH level of 88 pg/mL (P<.01), reflective of blood levels at the time of aspiration. Using the 99% confidence interval of histologically confirmed parathyroid glands as the lower limit of a positive test result at 1610 pg/mL, tissue aspirate PTH assay has a sensitivity of 97% and a specificity of 100%.



Positive identification of removed tissue as parathyroid is necessary adjunct to limited parathyroid exploration, where decreases in false positive blood PTH levels can be a result of operative manipulation of the neck. Analysis of tissue PTH content during the same assay that is being used for assessing blood PTH concentration is an efficient and accurate method for identifying the tissue with certainty. This measure also prevents the occasional ambiguity in frozen sections of parathyroid tissue that apparently contain thyroidlike colloid material.
Early treatment of stroke with monosialoganglioside GM-1. Efficacy and safety results of the Early Stroke Trial.

The Early Stroke Trial (EST) is a randomized, double-blind, placebo-controlled trial to assess the effect of monosialoganglioside GM-1 in improving recovery in patients who experienced an ischemic supratentorial stroke.



Sixteen clinical centers recruited 805 patients, of whom 792 were confirmed to be eligible. Treatment, consisting of a first dose of either 200 mg GM-1 or placebo, was initiated within 5 hours of the onset of stroke; a second dose of either 100 mg GM-1 or placebo was administered 12 hours later. Thereafter, patients received a daily injection of 100 mg GM-1 or placebo intravenously from day 2 through 10 and intramuscularly from day 11 through 21. Patients were followed up for a total of 4 months.



Survival was similar in the two treatment groups. Improvement in neurological status, as measured by the change in Canadian Neurological Scale score between baseline and 4-month assessments, was greater in the group receiving GM-1; the observed difference between treatment groups was 0.22 (P = .06). A post hoc analysis in the subgroup of patients treated within 4 hours showed a statistically significant difference, with Canadian Neurological Scale mean improvement of 0.41 (P = .016). GM-1 use was not associated with differences in frequency, nature, or severity of adverse experiences.



These findings suggest that GM-1 is safe in the dose and treatment schedule used and that its efficacy in ischemic stroke is greater when given soon after onset of stroke.
Colours of fruit and vegetables and 10-year incidence of CHD.

The colours of the edible part of fruit and vegetables indicate the presence of specific micronutrients and phytochemicals. The extent to which fruit and vegetable colour groups contribute to CHD protection is unknown. We therefore examined the associations between fruit and vegetables of different colours and their subgroups and 10-year CHD incidence. We used data from a prospective population-based cohort including 20 069 men and women aged 20-65 years who were enrolled between 1993 and 1997. Participants were free of CVD at baseline and completed a validated 178-item FFQ. Hazard ratios (HR) for the association between green, orange/yellow, red/purple, white fruit and vegetables and their subgroups with CHD were calculated using multivariable Cox proportional hazards models. During 10 years of follow-up, 245 incident cases of CHD were documented. For each 25 g/d increase in the intake of the sum of all four colours of fruit and vegetables, a borderline significant association with incident CHD was found (HR 0·98; 95 % CI 0·97, 1·01). No clear associations were found for the colour groups separately. However, each 25 g/d increase in the intake of deep orange fruit and vegetables was inversely associated with CHD (HR 0·74; 95 % CI 0·55, 1·00). Carrots, their largest contributor (60 %), were associated with a 32 % lower risk of CHD (HR 0·68; 95 % CI 0·48, 0·98). In conclusion, though no clear associations were found for the four colour groups with CHD, a higher intake of deep orange fruit and vegetables and especially carrots may protect against CHD.
Mobilizing social support networks to improve cancer screening: the COACH randomized controlled trial study design

Disadvantaged populations face many barriers to cancer care, including limited support in navigating through the complexities of the healthcare system. Family members play an integral role in caring for patients and provide valuable care coordination; however, the effect of family navigators on adherence to cancer screening has not previously been evaluated. Training and evaluating trusted family members and other support persons may improve cancer outcomes for vulnerable patients. Guided by principles of community based participatory research (CBPR), “Evaluating Coaches of Older Adults for Cancer Care and Healthy Behaviors (COACH)” is a community-based randomized controlled trial to assess the effectiveness of a trained participant-designated coach (support person or care giver) in navigating cancer-screening for older African American adults, 50–74 years old. Participants are randomly assigned as dyads (participant + coach pair) to receiving either printed educational materials only (PEM—control group) or educational materials plus coach training (COACH—intervention group). We defined a coach as family member, friend, or other lay support person designated by the older adult. The coach training is designed as a one-time, 35- to 40-minute training consisting of: 1) a didactic session that covers the role of the coach, basic facts about colorectal, breast and cervical cancers (including risk factors, signs and symptoms and screening modalities), engaging the healthcare provider in cancer screening, insurance coverage for screening, and related healthcare issues, 2) three video skits addressing misconceptions about and planning for cancer screening, and 3) an interactive role-play session with the trainer to reinforce and practice strategies for encouraging the participant to get screened. The primary study outcome is the difference in the proportion of participants completing at least one of the recommended screenings (for breast, cervix or colorectal cancer) between the control and intervention groups. Building on trusted patient contacts to encourage cancer screening, COACH is a highly sustainable intervention in a high-risk population. It has the potential to minimize the effect of mistrust of the medical establishment on screening behaviors by mobilizing participants’ existing support networks. If effective, the intervention could have a high impact on health care disparities research across multiple diseases.