nils-herrmann/clean_scirepeval huggingface dataset:
Significance of initial blood pressure and comorbidity for the efficacy of a fixed combination of an angiotensin receptor blocker and hydrochlorothiazide in clinical practice

Two-thirds of all patients with arterial hypertension need drug combinations to achieve blood pressure (BP) goals. Fixed combinations have high efficacy and result in high patient compliance. 300 mg irbesartan plus 25 mg hydrochlorothiazide (HCTZ) has been investigated only in clinical trials but not in daily practice.



A multicenter, noninterventional, noncontrolled observational study with 8123 patients seen by 1604 physicians in daily practice. BP reduction (office measurements), co-morbid disease and tolerability were documented over a 6-month observational period.



At mean baseline BP of 161 +/- 15/94 +/- 10 mmHg, administering of fixed combination resulted in a substantial BP reduction averaging 28 +/- 15/14 +/- 10 mmHg (P < 0.001). Decrease of systolic BP ran parallel with increasing systolic baseline BP (Spearman's Rho -0.731; P < 0.0001; diastolic BP vs diastolic baseline BP Rho 0.740; P < 0.0001), independent from patient characteristics (age, obesity, diabetes or nephropathy) but enhanced with short history of hypertension (P < 0.0001 vs long history), prior beta blockers (P = 0.001 vs prior angiotensin receptor blockers [ARBs]), prior calcium channel blockers (P = 0.046 vs prior ARBs) and no prior medication (P = 0.012 vs prior ARBs). High compliance (>98%) and low incidence of adverse events (0.66%) were documented.



The fixed combination of 300 mg irbesartan with 25 mg HCTZ was efficacious and tolerable in an unselected patient population in primary care.
Pre-Operative Femoral Nerve Block for Hip Arthroscopy: A Randomized Controlled Trial

This open-access article is published and distributed under the Creative Commons Attribution NonCommercial No Derivatives License (http://creativecommons.org/licenses/by-nc-nd/3.0/), which permits the noncommercial use, distribution, and reproduction of the article in any medium, provided the original author and source are credited. You may not alter, transform, or build upon this article without the permission of the Author(s). For reprints and permission queries, please visit SAGE’s Web site at http://www.sagepub.com/journalsPermissions.nav. Pre-Operative Femoral Nerve Block for Hip  A Randomized Controlled Trial
Evaluating holistic needs assessment in outpatient cancer care—a randomised controlled trial: the study protocol

People living with and beyond cancer are vulnerable to a number of physical, functional and psychological issues. Undertaking a holistic needs assessment (HNA) is one way to support a structured discussion of patients' needs within a clinical consultation. However, there is little evidence on how HNA impacts on the dynamics of the clinical consultation. This study aims to establish (1) how HNA affects the type of conversation that goes on during a clinical consultation and (2) how these putative changes impact on shared decision-making and self-efficacy.



The study is hosted by 10 outpatient oncology clinics in the West of Scotland and South West England. Participants are patients with a diagnosis of head and neck, breast, urological, gynaecological and colorectal cancer who have received treatment for their cancer. Patients are randomised to an intervention or control group. The control group entails standard care--routine consultation between the patient and clinician. In the intervention group, the patient completes a holistic needs assessment prior to consultation. The completed assessment is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and preponderance of initiative (PI) within the consultation. The secondary outcome measures are shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater patient participation within the consultation, and that shared decision-making and feelings of self-efficacy will increase as a function of the intervention.


ETHICS AND DISSEMINATION
This study has been given a favourable opinion by the West of Scotland Research Ethics Committee and NHS Research & Development. Study findings will be disseminated through peer-reviewed publications and conference attendance.
Association of the recurrence of vocal leukoplakia with MDM2-309 variants over a 2-year period: a prospective study.

MDM2-309 polymorphism variant genotypes decrease the risk of recurrence in vocal leukoplakia.



The results of a previous study 2 years ago showed the effect of mouse double minute 2 homolog (MDM2) SNP309 polymorphisms in people with laryngeal carcinoma and vocal leukoplakia (a pre-cancerous laryngeal carcinoma lesion). This prospective, clinical trial was performed to assess the relationship between MDM2-309 polymorphism variants and recurrence/cancerization rates in people with vocal leukoplakia over a 2-year period.



A total of 61 post-operative patients with vocal leukoplakia participated in this prospective, observational, 2-year, follow-up study, and were genotyped for the MDM2-309 gene using pyrosequencing. Recurrence and cancerization rates were used to assess the relationship between the clinical outcome and the genotype variants.



The recurrence rate in the GT genotypes group was lower than that in the normal TT genotype group (17.2% vs 50%, p = 0.05) and there was a significantly lower recurrence rate in the GG genotype group than in the normal TT genotype group (10% vs 50%, p = 0.03). However, there was no statistically significant difference in the cancerization rate between the MDM2-309 variant (GT + GG) genotypes group and the normal TT genotype group (12.2% vs 8.3%, p > 0.05) over the 2-year follow-up period.
Topiramate modulates trigeminal pain processing in thalamo-cortical networks in humans after single dose administration

Migraine is the sixth most common cause of disability in the world. Preventive migraine treatment is used to reduce frequency, severity and duration of attacks and therefore lightens the burden on the patients' quality of life and reduces disability. Topiramate is one of the preventive migraine treatments of proven efficacy. The mechanism of action underlying the preventive effect of topiramate in migraine remains largely unknown. Using functional magnetic resonance imaging (fMRI) we examined the central effects of a single dose of topiramate (100mg) on trigeminal pain in humans, compared to placebo (mannitol). In this prospective, within subject, randomized, placebo-controlled and double-blind study, 23 healthy participants received a standardized nociceptive trigeminal stimulation and control stimuli whilst being in the scanner. No differences in the subjective intensity ratings of the painful stimuli were observed between topiramate and placebo sessions. In contrast, topiramate significantly decreased the activity in the thalamus and other pain processing areas. Additionally, topiramate increased functional coupling between the thalamus and several brain regions such as the bilateral precuneus, posterior cingulate cortex and secondary somatosensory cortex. These data suggest that topiramate exhibits modulating effects on nociceptive processing in thalamo-cortical networks during trigeminal pain and that the preventive effect of topiramate on frequent migraine is probably mediated by an effect on thalamo-cortical networks.
Magnetic resonance imaging in early rheumatoid arthritis: a multicenter, prospective study

To identify the magnetic resonance imaging (MRI) features of hands and wrists in early rheumatoid arthritis (RA). A total of 129 early arthritis patients (≤1 year) were enrolled in the study. At presentation, MRI of the hands was performed, with clinical and laboratory analyses. After a 1-year follow-up, clinical diagnosis of early RA or non-RA was confirmed by two rheumatologists. The characteristics of MRI variables at baseline in RA patients not fulfilling ACR 1987 criteria [RA-87(−)] were compared with those fulfilling ACR1987 criteria [RA-87(+)] and non-RA. In the 129 early arthritis patients, 90 were diagnosed with RA in a 1-year follow-up. There were 47.8 % (43/90) of the RA patients not fulfilling ACR 1987 criteria [RA-87(−)]. The scores of synovitis in RA-87(−) patients were similar with those in RA-87(+) [Synovitis score, 14.0 (IQR, 4.0–25.0) vs. 14.0 (IQR, 10.0–25.0), p > 0.05]. Compared with those in non-RA, RA-87(−) patients had higher synovitis scores and occurrence of synovitis in proximal interphalangeal (PIP) joints [synovitis score, 14.0 (IQR, 4.0–25.0) vs. 6.0 (IQR, 2.0–14.5), p = 0.046; occurrence of PIP synovitis: 53.5 vs. 27.3 %, p = 0.02]. There was no significant difference of bone marrow edema, bone erosion, and tenosynovitis between RA-87(−) and non-RA. Synovitis in PIP joints was independent predictor for RA-87(−) [OR, 3.1 (95 %CI 1.2–8.1)]. High synovitis scores and synovitis in PIP joints on MRI were important in early RA, especially those not fulfilling ACR 1987 criteria.
Dose-finding study of weekly 24h continuous infusion of 5-fluorouracil associated with alternating oxaliplatin or irinotecan in advanced colorectal cancer patients

To determine maximum tolerated dose, safety and efficacy of weekly 24 h infusional 5-fluorouracil (5-FU) combined alternately with oxaliplatin and irinotecan.  Advanced colorectal carcinoma patients in firstor second-line chemotherapy received increasing doses of 5-FU (weekly 24 h continuous intravenous infusion without leucovorin) on days 1, 8, 15 and 22, irinotecan days 1 and 15; and oxaliplatin days 8 and 22, every 35 days.  Thirty-four patients received 175 cycles. The median age was 64 years (range 47–78). Eighteen per cent of patients had the primary tumor in the rectum, with a median of one disease site (range one to three), and liver involvement in 88% and lung in 38%. Six (18%) patients had chemotherapy for prior advanced disease. The most frequent grade 3–4 toxicity was neutropenia (41% of patients), but the regimen was well tolerated clinically, with febrile neutropenia in two patients and grade 4 neutropenia lasting >7 days in one; grade 3–4 diarrhea, nausea and vomiting in 6% of patients; grade 3–4 peripheral neuropathy in 9% of patients. Seventeen patients had a partial response (50%; 95% confidence interval 33%–67%), 13 had stable disease and one had progressive disease. Five patients underwent metastatic surgical resection after tumor shrinkage. Median response duration was 14 months (range 4.7–29.2+) and median time to progression was 11.3 months (range 1.1+–30.7+).  This combination three-drug regimen is feasible and well tolerated without toxicity overlap. Preliminary antitumor activity compares well with standard double combinations, with an unusually long median time to progression. The recommended dose is 5-FU 3000 mg/m, weekly for 4 weeks, irinotecan 100 mg/m days 1 and 15, oxaliplatin 80 mg/m days 8 and 22. Further assessment of antitumor activity and safety is warranted.
The relationship between post-stent strut apposition and follow-up strut coverage assessed by a contour plot optical coherence tomography analysis.

This study sought to evaluate the relationship between post-stent strut apposition and follow-up strut coverage using contour plot optical coherence tomographic analysis.



Tracking the fate of interested regions of struts at different time points has not been investigated.



Post-intervention and 6-month follow-up optical coherence tomographic evaluations were performed in 82 patients treated with biolimus- (n = 37) or sirolimus-eluting stents (n = 45). Post-stent apposition was classified as embedded, apposed, or malapposed. For volumetric stent evaluation, the post-intervention strut-artery distance and the neointimal thickness at follow-up were measured as a function of the circumferential arc length and longitudinal stent length. Computer-generated contour plots of the strut-artery distance and neointimal thickness were compared.



The percentages of embedded and malapposed struts after intervention were 1.8% (Interquartile range [IQR]: 0.6% to 6.2%) and 2.3% (IQR: 0.5% to 5.2%), respectively. The percentages of uncovered and malapposed struts at 6 months were 16.0% (IQR: 7.4% to 33.3%) and 0% (IQR: 0% to 0.7%), respectively. The percentage of uncovered struts at 6 months varied significantly with post-stent strut apposition (0% [IQR: 0% to 11.4%] in embedded, 16.3% [IQR: 8.1% to 31.3%] in apposed, and 26.8% [IQR: 0% to 56.3%] in malapposed, p < 0.001 for all pairwise comparisons). In lesions without tissue prolapse, embedded struts were all covered (100% covered struts) compared with those with tissue prolapse (76.8% covered, p < 0.001).



The optical coherence tomography-guided optimization of stent strut apposition enhances strut coverage at follow-up. This comprehensive method for evaluating strut apposition may provide more useful information to understanding the serial changes in strut coverage.
The effects of methylphenidate on prepulse inhibition during attended and ignored prestimuli among boys with attention-deficit hyperactivity disorder

The present study investigated attentional modification of prepulse inhibition of startle among boys with and without attention-deficit hyperactivity disorder (ADHD). Two hypotheses were tested: (1) whether ADHD is associated with diminished prepulse inhibition during attended prestimuli, but not ignored prestimuli, and (2) whether methylphenidate selectively increases prepulse inhibition to attended prestimuli among boys with ADHD.  Participants were 17 boys with ADHD and 14 controls. Participants completed a tone discrimination task in each of two sessions separated by 1 week. ADHD boys were administered methylphenidate (0.3 mg/kg) in one session and placebo in the other session in a randomized, double-blind fashion. During each series of 72 tones (75 dB; half 1200-Hz, half 400-Hz), participants were paid to attend to one pitch and ignore the other. Bilateral eyeblink electromyogram startle responses were recorded in response to acoustic probes (50-ms, 102-dB white noise) presented following the onset of two-thirds of tones, and during one-third of intertrial intervals.  Relative to controls, boys with ADHD exhibited diminished prepulse inhibition 120 ms after onset of attended but not ignored prestimuli following placebo administration. Methylphenidate selectively increased prepulse inhibition to attended prestimuli at 120 ms among boys with ADHD to a level comparable to that of controls, who did not receive methylphenidate.  These data are consistent with the hypothesis that ADHD involves diminished selective attention and suggest that methylphenidate ameliorates the symptoms of ADHD, at least in part, by altering an early attentional mechanism.
Effects of angiotensin converting enzyme and angiotensin II receptor inhibition on impaired fibrinolysis in systemic hypertension.

Abnormalities in fibrinolysis have been reported in hypertension. Angiotensin converting enzyme (ACE) inhibitors have been shown to improve altered fibrinolytic balance in hypertensive patients. It has not been documented, however, whether this is due to a decrease in angiotensin II (Ang-II) generation or is a consequence of elevated local levels of bradykinin. Accordingly, the aim of this study was to determine the effects of an ACE inhibitor (perindopril) and an Ang-II receptor antagonist (losartan) on fibrinolytic kinetics. We have examined the serum levels of the plasminogen activator inhibitor type-1 (PAI-1) antigen and activity, tissue plasminogen activator (t-PA) antigen and activity, soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) before and after reaching the target blood pressure (<140/90 mm Hg) in 13 hypertensive patients receiving perindopril (mean age 40+/-11 years, 6 women, 7 men) and in 12 patients receiving losartan (mean age 38+/-9 years, 6 women, 6 men). We also compared the baseline fibrinolytic activity of hypertensive patients with that of 12 normotensive control persons (mean age 40+/-9 years, 6 women, 6 men). The mean basal plasma levels of PAI-1 antigen, PAI-1 activity, and sTM were significantly higher in the hypertensive patients than in normal controls (P<.005). The values of other analytes were similar in both groups. Increased plasma levels of PAI-1 antigen, PAI-1 activity, and sTM were reduced in patients after they were given perindopril and losartan (P<.005); the reductions in losartan-receiving group were more pronounced (P<.05). There were no significant effects on the plasma levels of t-PA antigen, t-PA activity, and TFPI in patients receiving the two therapeutic regimens (P>.05). In conclusion, chronic hypertension is associated with hypofibrinolysis. The beneficial effect of ACE inhibitors on fibrinolysis seems to be related to the blockade of Ang-II, and increased kinin activity does not appear to play a major role.
European experience with methotrexate treatment in Crohn's disease: a multicenter retrospective analysis.

Methotrexate (MTX) has been utilized for the treatment of Crohn's disease (CD) for decades. Nevertheless, current data provide equivocal evidence on the efficacy of MTX in CD.The aims of this study were to describe the efficacy of MTX for maintenance of remission in CD and to identify the factors associated with the probability of steroid-free clinical remission in a multicenter European referral center cohort.



This was a retrospective cohort analysis. Consecutive patients treated with MTX for CD were included from 11 referral centers. Patients receiving concomitant treatment with tumor necrosis factor inhibitors or thiopurines were excluded. The main outcome was steroid-free clinical remission; the secondary outcomes included the rate of complications leading to MTX discontinuation and duration of relapse-free survival in patients achieving the main outcome.



Between July 1992 and January 2012, 118 patients were identified for inclusion. MTX administration route was oral for induction in 31.4% and for maintenance in 49.1% of the patients. Steroid-free remission was achieved in 44/118 (37.2%) patients and was maintained relapse free by 28/44 (63.6%) for a median of 12 (3.5-18.5) months. At least one adverse effect was reported by 28.9% of the patients. No clinical or demographic factors were associated with either likelihood of achieving a clinical response or duration of relapse-free survival.



MTX treatment induced steroid-free clinical remission in over a third of CD patients and maintained it for a year in almost two-thirds of the responders. MTX should be considered a viable therapeutic option in CD patients refractory to other therapies.
Mobitz type I and II atrioventricular blocks during fingolimod therapy

We investigated patients who showed a second-degree atrioventricular block (S-AVB) after the first fingolimod administration. We observed six patients with S-AVB, three Mobitz type I, and three type II. Monitoring continued on the second day for all patients. Three patients showed persistence of the S-AVB, with resolution on the second or third day. One patient had a persistent S-AVB up to the fourth day when fingolimod was discontinued. We conclude that Mobitz type II S-AVB is possible during fingolimod therapy. Patients with S-AVB could be monitored until resolution of the S-AVBs, as these may persist several days after the first fingolimod administration.
Detection of cytomegalovirus in upper gastrointestinal biopsies from heart transplant recipients: comparison of light microscopy, immunocytochemistry, in situ hybridisation, and nested PCR.

To establish the diagnostic value of in situ hybridisation and the nested polymerase chain reaction (PCR) in detecting clinically relevant cytomegalovirus (CMV) infection in upper gastrointestinal biopsies from heart transplant patients.



Test sensitivity and specificity for detection of CMV early gene RNA by in situ hybridisation and CMV intermediate early gene by PCR were established and then compared with haematoxylin and eosin (H&E) and immunocytochemical detection of CMV in order to establish the best pathological diagnostic approach. All investigations were carried out on formalin fixed, paraffin embedded tissue.



Nested PCR had the highest test sensitivity, followed by in situ hybridisation and immunocytochemistry with the same sensitivity; H&E had the lowest. H&E and immunocytochemistry were the most specific but both had a significant false negative rate which was less of a problem with PCR. However, PCR gave no other diagnostic information, and in situ hybridisation was no better than immunocytochemistry. Both in situ hybridisation and PCR were technically complex and more expensive.



H&E and immunocytochemistry represent the best initial screen for CMV and other diseases in upper gastrointestinal biopsies from heart transplant patients. If H&E and immunocytochemistry were negative, nested PCR could significantly increase the diagnostic yield of clinically relevant CMV infection. In situ hybridisation appeared to have no advantages and some drawbacks compared with immunocytochemistry and PCR.
Pulmonary Vein Antrum Isolation in Patients With Paroxysmal Atrial Fibrillation: More Than a Decade of Follow-Up.

We report the outcome of pulmonary vein (PV) antrum isolation in paroxysmal atrial fibrillation (AF) patients over more than a decade of follow-up.



A total of 513 paroxysmal AF patients (age 54±11 years, 73% males) undergoing catheter ablation at our institutions were included in this analysis. PV antrum isolation extended to the posterior wall between PVs plus empirical isolation of the superior vena cava was performed in all. Non-PV triggers were targeted during repeat procedure(s). Follow-up was performed quarterly for the first year and every 6 to 9 months thereafter. The outcome of this study was freedom from recurrent AF/atrial tachycardia. At 12 years, single-procedure arrhythmia-free survival was achieved in 58.7% of patients. Overall, the rate of recurrent arrhythmia (AF/atrial tachycardia) was 21% at 1 year, 11% between 1 and 3 years, 4% between 3 and 6 years, and 5.3% between 6 and 12 years. Repeat procedure was performed in 74% of patients. Reconnection in the PV antrum was found in 31% of patients after a single procedure and in no patients after 2 procedures. Non-PV triggers were found and targeted in all patients presenting with recurrent arrhythmia after ≥2 procedures. At 12 years, after multiple procedures, freedom from recurrent AF/atrial tachycardia was achieved in 87%.



In patients with paroxysmal AF undergoing extended PV antrum isolation, the rate of late recurrence is lower than what previously reported with segmental or less extensive antral isolation. However, over more than a decade of follow-up, nearly 14% of patients developed recurrence because of new non-PV triggers.