nils-herrmann/clean_scirepeval huggingface dataset:
Effect of large doses of parenteral vitamin D on glycaemic control and calcium/phosphate metabolism in patients with stable type 2 diabetes mellitus: a randomised, placebo-controlled, prospective pilot study.

Vitamin D (D₃) status is reported to correlate negatively with insulin production and insulin sensitivity in patients with type 2 diabetes mellitus (T2DM). However, few placebo-controlled intervention data are available. We aimed to assess the effect of large doses of parenteral D3 on glycosylated haemoglobin (HbA(₁c)) and estimates of insulin action (homeostasis model assessment insulin resistance: HOMA-IR) in patients with stable T2DM.



We performed a prospective, randomised, double-blind, placebo-controlled pilot study at a single university care setting in Switzerland. Fifty-five patients of both genders with T2DM of more than 10 years were enrolled and randomised to either 300,000 IU D₃ or placebo, intramuscularly. The primary endpoint was the intergroup difference in HbA(₁c) levels. Secondary endpoints were: changes in insulin sensitivity, albuminuria, calcium/phosphate metabolism, activity of the renin-aldosterone axis and changes in 24-hour ambulatory blood pressure values.



After 6 months of D₃ supply, there was a significant intergroup difference in the change in HbA(₁c) levels (relative change [mean ± standard deviation] +2.9% ± 1.5% in the D₃ group vs +6.9% ± 2.1% the in placebo group, p = 0.041) as HOMA-IR decreased by 12.8% ± 5.6% in the D₃ group and increased by 10% ± 5.4% in the placebo group (intergroup difference, p = 0.032). Twenty-four-hour urinary albumin excretion decreased in the D₃ group from 200 ± 41 to 126 ± 39, p = 0.021). There was no significant intergroup difference for the other secondary endpoints.



D₃ improved insulin sensitivity (based on HOMA-IR) and affected the course of HbA(₁c) positively compared with placebo in patients with T2DM.
Cardiovascular benefits of acupressure (Jin Shin) following stroke.

Acupressure, a complementary and alternative medicine (CAM) treatment, uses fingertips, rather than needles, to stimulate acupoints on the skin and has been implicated as a successful treatment for a variety of medical disorders. However, acupressure's underlying mechanisms remain unclear. One theory is that acupoint stimulation modulates autonomic nervous system activity. Previous studies have suggested that acupressure may positively affect heart rate and blood pressure. The current study investigated the effects of a type of acupressure, Jin Shin, on cardiovascular function in stroke survivors, a population that could especially benefit from a treatment promoting cardiovascular health. The study tested the hypothesis that active acupressure treatments would reduce heart rate and blood pressure (i.e., induce a greater relaxation response) above and beyond that seen during placebo acupressure treatments.



A randomised, placebo-controlled, single-blind crossover design was utilised, in which 16 participants received 8 weeks of either active or placebo acupressure followed by washout and crossover into the opposite treatment condition. Heart rate and blood pressure measurements were taken throughout treatments.



Active acupressure treatments were associated with a significantly greater (p=.043, eta(2)=.30) and faster (p=.002, eta(2)=.76) reduction in heart rate compared to that seen during placebo treatments. No treatment effect on blood pressure was found.



Active acupressure reduced heart rate significantly more than did placebo acupressure during treatments. Although no treatment effect on blood pressure was found, this could be due to 67% of participants taking antihypertensive medications during the study.
Temporal trends and volume-outcome associations in periampullary cancer patients: a propensity score-adjusted nationwide population-based study.

The purpose of this study was to evaluate temporal trends in the incidence of pancreaticoduodenectomy (PD) with periampullary cancers and the impact of hospital volume and surgeon volume on patient outcomes and to explore predictors of these outcomes.



This population-based cohort study retrospectively analyzed 4,039 PD procedures performed from 1998 to 2009. The odds ratio and 95% confidence interval were calculated to assess the relative change rate. Hierarchical regression models were used to predict these outcomes.



The incidence of PDs per 10(5) persons increased from .97 to 1.89, whereas the length of stay and hospital treatment cost declined. Current treatment in a low-volume hospital and current treatment by a low-volume surgeon showed significant positive associations with these outcomes (P < .001).



The data indicate that analysis and emulation of the treatment strategies used by high-volume hospitals and high-volume surgeons may reduce overall hospital resource use. Because high-volume hospitals and surgeons consistently achieve superior outcomes of PD, their treatment strategies should be carefully analyzed and emulated.
Benefits of ultrasonography in the management of early arthritis: a cross-sectional study of baseline data from the ESPOIR cohort.

To assess ultrasonography's (US) performance to detect the structural damage in the initial evaluation of early arthritis (EA) using the Etude et Suivides Polyarthrites Indifférenciées Récentes (ESPOIR) cohort.



ESPOIR is a French, multi-centric EA cohort. Four centres assessed the structural damage by both X-ray and US examination at baseline. X-rays of hands and feet were read first by the centre's local investigator (usual reading), then in the X-ray coordinating centre (central reading). Four trained examiners performed US blindly from clinical data to detect erosions on the second and fifth MCP (MCP2 and 5) and the fifth MTP (MTP5) joints bilaterally.



Patients' characteristics (n = 126) were: female 78%; mean age 50.3 years; disease duration 103 days; disease activity score on 28 joints 5; CRP level 22.7 mg/l; and 79.4% of the patients fulfilling RA ACR criteria. Twelve patients had missing data for X-rays. US revealed 42 (36.8%) patients with erosive disease, whereas radiography revealed only 30 (26%) with central reading and only 11% with usual reading. US missed erosive disease present in X-rays in 10 (8.8%) patients. Combined technique of both revealed 52 (45.6%) patients with erosive diseases. On the targeted joints, US detected erosion on 75 (11%) joints vs X-rays on only 11 (1.5%). Only three joints with erosion(s) detected on X-rays were missed on US. At baseline, the presence of PD activity was not associated with joint erosions.



US on six joints detected 1.4-fold more patients with erosions (3.3-fold more with the usual reading). In clinical practice, US combined with X-rays is of helpful diagnostic value in EA.
Study protocol for the Integra Initiative to assess the benefits and costs of integrating sexual and reproductive health and HIV services in Kenya and Swaziland

In sub-Saharan Africa (SSA) there are strong arguments for the provision of integrated sexual and reproductive health (SRH) and HIV services. Most HIV transmissions are sexually transmitted or associated with pregnancy, childbirth, and breastfeeding. Many of the behaviours that prevent HIV transmission also prevent sexually transmitted infections and unintended pregnancies. There is potential for integration to increase the coverage of HIV services, as individuals who use SRH services can benefit from HIV services and vice-versa, as well as increase cost-savings. However, there is a dearth of empirical evidence on effective models for integrating HIV/SRH services. The need for robust evidence led a consortium of three organizations - International Planned Parenthood Federation, Population Council and the London School of Hygiene & Tropical Medicine - to design/implement the Integra Initiative. Integra seeks to generate rigorous evidence on the feasibility, effectiveness, cost and impact of different models for delivering integrated HIV/SRH services in high and medium HIV prevalence settings in SSA.



A quasi-experimental study will be conducted in government clinics in Kenya and Swaziland - assigned into intervention/comparison groups. Two models of service delivery are investigated: integrating HIV care/treatment into 1) family planning and 2) postnatal care. A full economic-costing will be used to assess the costs of different components of service provision, and the determinants of variations in unit costs across facilities/service models. Health facility assessments will be conducted at four time-periods to track changes in quality of care and utilization over time. A two-year cohort study of family planning/postnatal clients will assess the effect of integration on individual outcomes, including use of SRH services, HIV status (known/unknown) and pregnancy (planned/unintended). Household surveys within some of the study facilities' catchment areas will be conducted to profile users/non-users of integrated services and demand/receipt of integrated services, before-and-after the intervention. Qualitative research will be conducted to complement the quantitative component at different time points. Integra takes an embedded 'programme science' approach to maximize the uptake of findings into policy/practice.



Integra addresses existing evidence gaps in the integration evaluation literature, building on the limited evidence from SSA and the expertise of its research partners.
The Psychometric Properties of the Chinese Version of the SF-36 Health Survey in Patients with Myocardial Infarction in Mainland China

To test the reliability and validity of the Chinese Mandarin version of the SF-36 health survey (CM:SF-36) in patients with myocardial infarction (MI) in mainland China. Single group, cross-sectional design to test the measurement performance on a convenience sample of 180 Chinese patients with MI, 30 of whom were retested after 2 weeks to establish reliability. Cronbach’s α coefficients exceeded the 0.70 criterion for all subscales except General Health, indicating good internal consistency. Test–retest reliability was adequate (intraclass correlation coefficient >0.70) for all subscales. The significant differences were detected by the presence or absence of co-morbidities and the number of risk factors in most physical subscales indicating good discriminative validity. Principal components factor analysis with varimax rotation confirmed the presence of the eight factors, though the item loadings of the Vitality and Mental Health subscales were found to differ from the original ones of the SF-36. The CM:SF-36 is a psychometrically acceptable instrument for assessing the health status of Chinese patients with myocardial infarction.
Length of carotid stenosis predicts peri-procedural stroke or death and restenosis in patients randomized to endovascular treatment or endarterectomy

The anatomy of carotid stenosis may influence the outcome of endovascular treatment or carotid endarterectomy. Whether anatomy favors one treatment over the other in terms of safety or efficacy has not been investigated in randomized trials.



In 414 patients with mostly symptomatic carotid stenosis randomized to endovascular treatment (angioplasty or stenting; n = 213) or carotid endarterectomy (n = 211) in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS), the degree and length of stenosis and plaque surface irregularity were assessed on baseline intraarterial angiography. Outcome measures were stroke or death occurring between randomization and 30 days after treatment, and ipsilateral stroke and restenosis ≥50% during follow-up.



Carotid stenosis longer than 0.65 times the common carotid artery diameter was associated with increased risk of peri-procedural stroke or death after both endovascular treatment [odds ratio 2.79 (1.17-6.65), P = 0.02] and carotid endarterectomy [2.43 (1.03-5.73), P = 0.04], and with increased long-term risk of restenosis in endovascular treatment [hazard ratio 1.68 (1.12-2.53), P = 0.01]. The excess in restenosis after endovascular treatment compared with carotid endarterectomy was significantly greater in patients with long stenosis than with short stenosis at baseline (interaction P = 0.003). Results remained significant after multivariate adjustment. No associations were found for degree of stenosis and plaque surface.



Increasing stenosis length is an independent risk factor for peri-procedural stroke or death in endovascular treatment and carotid endarterectomy, without favoring one treatment over the other. However, the excess restenosis rate after endovascular treatment compared with carotid endarterectomy increases with longer stenosis at baseline. Stenosis length merits further investigation in carotid revascularisation trials.
Phase III, multicenter, open-label, long-term study of the safety of abatacept in Japanese patients with rheumatoid arthritis and an inadequate response to conventional or biologic disease-modifying antirheumatic drugs

To examine the long-term safety of intravenous (IV) abatacept treatment in Japanese patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX) or other conventional or biologic disease-modifying antirheumatic drugs.



This Phase III, open-label, long-term study (NCT00484289) comprised Japanese patients with RA who had completed abatacept Phase I or Phase II studies, and new patients intolerant to MTX. Patients from Phase I and Phase II studies received a weight-tiered dosing equivalent of 10 mg/kg abatacept, with MTX at doses up to 8 mg/week; newly enrolled patients received weight-tiered 10 mg/kg abatacept monotherapy. Safety and efficacy were assessed.



A total of 217 patients (Phase I, n = 13; Phase II, n = 178; newly enrolled, n = 26) were treated with IV abatacept for a mean of 3 years. Serious adverse events occurred in 67/217 (30.9%) patients. Most adverse events were mild or moderate. For all cohorts combined, American College of Rheumatology 20% response rates ranged from 61.3 to 81.8% for as-observed and last observation carried forward analyses over 192 weeks. Following initial response, clinical and functional outcomes were maintained for up to 3 years.



In Japanese patients with RA, IV abatacept with and without background MTX showed tolerable safety and sustained efficacy over 3 years.
Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial.

Low back pain (LBP) is responsible for more than 2.5 million visits to US emergency departments (EDs) annually. These patients are usually treated with nonsteroidal anti-inflammatory drugs, acetaminophen, opioids, or skeletal muscle relaxants, often in combination.



To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients randomized to a 10-day course of (1) naproxen + placebo; (2) naproxen + cyclobenzaprine; or (3) naproxen + oxycodone/acetaminophen.



This randomized, double-blind, 3-group study was conducted at one urban ED in the Bronx, New York City. Patients who presented with nontraumatic, nonradicular LBP of 2 weeks' duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item questionnaire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment. Beginning in April 2012, a total of 2588 patients were approached for enrollment. Of the 323 deemed eligible for participation, 107 were randomized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen. Follow-up was completed in December 2014.



All participants were given 20 tablets of naproxen, 500 mg, to be taken twice a day. They were randomized to receive either 60 tablets of placebo; cyclobenzaprine, 5 mg; or oxycodone, 5 mg/acetaminophen, 325 mg. Participants were instructed to take 1 or 2 of these tablets every 8 hours, as needed for LBP. They also received a standardized 10-minute LBP educational session prior to discharge.



The primary outcome was improvement in RMDQ between ED discharge and 1 week later.



Demographic characteristics were comparable among the 3 groups. At baseline, median RMDQ score in the placebo group was 20 (interquartile range [IQR],17-21), in the cyclobenzaprine group 19 (IQR,17-21), and in the oxycodone/acetaminophen group 20 (IQR,17-22). At 1-week follow-up, the mean RMDQ improvement was 9.8 in the placebo group, 10.1 in the cyclobenzaprine group, and 11.1 in the oxycodone/acetaminophen group. Between-group difference in mean RMDQ improvement for cyclobenzaprine vs placebo was 0.3 (98.3% CI, -2.6 to 3.2; P = .77), for oxycodone/acetaminophen vs placebo, 1.3 (98.3% CI, -1.5 to 4.1; P = .28), and for oxycodone/acetaminophen vs cyclobenzaprine, 0.9 (98.3% CI, -2.1 to 3.9; P = .45).



Among patients with acute, nontraumatic, nonradicular LBP presenting to the ED, adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up. These findings do not support use of these additional medications in this setting.
Evaluation of patients with head and neck cancer by means of 99mTc-glucarate.

Preliminary findings have suggested that (99m)Tc-glucarate has tumor-seeking properties. The purpose of this study was to explore the potential of this tracer to evaluate malignant head and neck tumors by means of SPECT/CT software fusion imaging.



Eleven male patients with advanced head and neck carcinoma were included in the study: 9 with locally advanced disease and 2 with clinical suspicion of local relapse. Scanning started 3-6 h after the injection of 1,110 MBq of (99m)Tc-glucarate. Planar and SPECT images of the head, neck, and thorax were acquired. Three-dimensional images were also coregistered with CT.



We found (99m)Tc-glucarate uptake in all suspected lesions. SPECT/CT fusion imaging was helpful in all cases for topographically localizing the tracer foci.



(99m)Tc-glucarate can be considered a potential tracer for the evaluation of patients with head and neck tumors.
Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study

The aim of this randomized, crossover study was to determine if transoral fundoplication (TF) could further improve clinical outcomes in partial responders to high-dose (HD) proton-pump inhibitor (PPI) therapy and to evaluate durability of TF.



In seven United States centers, patients with hiatal hernia ≤ 2 cm and abnormal esophageal acid exposure (EAE) were randomized to TF (n = 40) or HD PPIs (n = 23) group. At 6-month follow-up, PPI patients underwent crossover. We assessed clinical outcomes 6-month post TF in crossover patients (COP), as compared to 6-month of HD PPI therapy, and 12-month outcomes in patients initially randomized to TF. The primary outcome was symptom control evaluated by Reflux Disease Questionnaire and Reflux Symptom Index. Secondary outcomes included healing of esophagitis, normalization of EAE and PPI use after TF. We analyzed 21 COP and 39 TF patients. 's test or Fisher exact test was used to compare proportions.



Of 63 randomized patients, 3 were lost to follow-up, leaving 39 TF and 21 COP for analyses. In the COP, TF further improved control of regurgitation and of atypical symptoms achieved after six months of HD PPIs. Of 20 patients with GERD symptoms after six months of high-dose PPI therapy, 65% (13/20) reported global elimination of troublesome regurgitation and atypical symptoms post TF off PPIs; 67% (6/9) reported no troublesome regurgitation. Esophagitis further healed in 75% (6/8) of patients. Seventy-one percent of COP patients were off PPIs six months following TF. Normalization of EAE decreased from 52% after HD PPIs (on PPIs) to 33% after TF (off PPIs), p =0.388. In the original TF group, 12-month post TF, 77% of patients achieved complete symptom control, 82% ceased PPI therapy, 100% healed esophagitis and 45% normalized EAE.



The results of this study indicate that in patients with incomplete symptom control on high-dose PPI therapy TF may provide further elimination of symptoms and esophagitis healing. In the original TF group, the clinical outcomes of TF remained stable between 6- and 12-month follow-up.
One-year treatment with mometasone furoate in chronic obstructive pulmonary disease

Many patients with chronic obstructive pulmonary disease (COPD) are treated with twice daily (BID) inhaled corticosteroids (ICS). This study evaluated whether daily PM mometasone furoate administered via a dry powder inhaler (MF-DPI) was equally effective compared to twice daily dosing.In a 52-week, randomized, double-blind, placebo-controlled study, 911 subjects with moderate-to-severe COPD managed without ICS received MF-DPI 800 microg QD PM, MF-DPI 400 microg BID, or placebo. The change from baseline in postbronchodilator forced expiratory volume in 1 second (FEV1), total COPD symptom scores, and health status as well as the percentage of subjects with a COPD exacerbation were assessed. Adverse events were recorded. Mometasone furoate administered via a dry powder inhaler 800 microg QD PM and 400 microg BID significantly increased postbronchodilator FEV1 from baseline (50 mL and 53 mL, respectively, versus a 19 mL decrease for placebo; P < 0.001). The percentage of subjects exacerbating was significantly lower in the pooled MF-DPI groups than in the placebo group (P = 0.043). Subjects receiving MF-DPI 400 microg BID reported a statistically significant (19%) reduction in COPD symptom scores compared with placebo (P < 0.001). Health status as measured with St. George's Respiratory Questionnaire (SGRQ) improved significantly in all domains (Total, Activity, Impacts, and Symptoms) in the pooled MF-DPI groups versus placebo (P < or = 0.031). MF-DPI treatment was well tolerated.Once-daily MF-DPI improved lung function and health status in subjects with moderate-to-severe COPD and was comparable to BID MF-DPI.
Uptake of faecal occult blood test colorectal cancer screening by different ethnic groups in the Netherlands.

We investigated the participation rates in CRC screening with a FOBT among various ethnic groups in the Netherlands. Individuals (n = 10 054) were invited by mail and grouped by country of birth. Overall participation rate was 49%. Participation among ethnic minority groups was significantly lower than among ethnic Dutch [adjusted OR for participation: Middle- or Central-East 0.25 (0.18-0.34), African 0.48 (0.34-0.67), Surinamese and Antillean 0.51 (0.43-0.61), South- or South-East Asian 0.56 (0.46-0.69) and 'other Western' 0.78 (0.63-0.96)]. Further studies are needed to explore whether ethnic minority groups are not reached or that low uptake is determined by other causes.