nils-herrmann/clean_scirepeval huggingface dataset:
Effects of mometasone furoate administered via a dry powder inhaler once daily in the evening on nocturnal lung function and sleep parameters in patients with moderate persistent asthma: a randomized, double-blind, placebo-controlled pilot study.

Nocturnal symptoms are common in asthma patients and have the potential for considerable clinical effects due to a lack of sleep and persistent daytime symptoms of somnolence and activity impairment. The primary objective of this investigation was to determine the effect of a 14-day course of once-daily evening administration of mometasone furoate 400 microg administered via a dry powder inhaler (MF-DPI 400 microg qd pm) on the overnight decline in pulmonary function observed in patients with nocturnal asthma.



Eligible enrollees were between the ages of 18 and 60 years and had established mild to moderate asthma, with an improvement in forced expiratory volume in 1 second (FEV(1)) of >15% after administration of inhaled salbutamol (albuterol) 200 microg. All enrolled patients had a history of nocturnal asthma. Enrollees were randomized to receive MF-DPI 400 microg qd pm or placebo administered between 6 pm and 8 pm for 14 days. The primary outcome evaluated in the study was reduction in nocturnal decline in evening (8 pm) to morning (6 am) FEV(1) values. Secondary outcomes included reduction in nocturnal decline in evening to morning peak expiratory flow rate (PEFR), polysomnographic indices of sleep, and psychometric indices (Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire [NRQLQ], 36-item Short Form of the Medical Outcomes Survey [SF-36], and Asthma Quality of Life Questionnaire [AQLQ]).



A total of 20 patients were randomized and completed all phases of the study. No significant differences were observed between treatment groups in the primary outcome of nocturnal decline in FEV(1) from pretreatment to end of treatment. Likewise, there was no significant difference between treatment groups in polysomnographic indices of sleep or quality-of-life assessments. However, there was a trend toward improvement in the activity scale of the AQLQ assessment in the MF-DPI 400 microg qd pm treatment group.



No significant treatment effect on nocturnal pulmonary function, sleep indices or quality of life was observed with 14-day administration of MF-DPI 400 microg qd pm. These findings are limited by the small sample size and the short treatment period evaluated. Future studies are warranted to study the effects of MF-DPI therapy in patients with nocturnal asthma.
High-dose chemotherapy and peripheral blood stem cell support in refractory gestational trophoblastic neoplasia

We present retrospectively our experience in the use of high-dose chemotherapy and haematopoietic stem cell support (HSCS) for refractory gestational trophoblastic neoplasia (GTN) in the largest series so far reported. In all, 11 patients have been treated at three Trophoblast Centres between 1993 and 2004. The conditioning regimens comprised either Carbop-EC-T (carboplatin, etoposide, cyclophosphamide, paclitaxel and prednisolone) or CEM (carboplatin, etoposide and melphalan) or ICE (ifosfamide, carboplatin, etoposide). Two patients had complete human chorionic gonadotrophin responses, one for 4 and the other for 12 months. Three patients had partial tumour marker responses for 1–2 months. High-dose chemotherapy and HSCS for GTN is still unproven. Further studies are needed, perhaps in high-risk patients who fail their first salvage treatment.
Differentiation of prostate cancer and benign prostatic hyperplasia: the clinical value of 201Tl SPECT--a pilot study.

Thallium-201 (201Tl) is a recognized tumor-imaging agent; however, the usefulness of 201Tl in prostate cancer has not been studied. The purpose of this preliminary study was to evaluate the efficacy of 201Tl single-photon emission computed tomography (SPECT) imaging for differentiating prostate cancer from benign prostatic hyperplasia (BPH).



201Tl pelvic SPECT was performed in 10 patients (aged 64-78 years) with biopsy-proven BPH before transurethral resection of the prostate and 15 patients (aged 65-81 years) with biopsy-proven prostate cancer prior to any therapeutic modality or invasive surgical procedures for treatment of their prostate cancer.



From the 15 patients with prostate cancer, 201Tl pelvic SPECT detected prostate cancer in 13 (86.7%) but not in 2 (13.3%) patients with Gleason scores of 5 (2 + 3). In contrast, all 10 patients with BPH (100.0%) had negative results of 201Tl pelvic SPECT.



Our study showed that 201Tl pelvic SPECT scan is very helpful in distinguishing between prostate cancer and BPH.
Risk Perception and Sexual Risk Behaviors Among HIV-Positive Men on Antiretroviral Therapy

There are reports of increased sexual risk behavior among people on highly active antiretroviral therapy (HAART) due to beliefs about risk of HIV transmission when on HAART. In a cross-sectional study (Seropositive Urban Men’s Study), we examined the relationship between risk perception and sexual risk behavior among sexually active, culturally diverse HIV positive men who have sex with men (N = 456). Less than twenty-five percent engaged in unprotected anal sex (either with an HIV negative, or unknown-status partner, or an HIV positive partner) within the past 3 months. Most men believed there was significant health risk (to partner or self) associated with unprotected sex when on HAART. There was no increased risk behavior associated with being on HAART, although the perception of negative health consequences, including HIV transmission, when on HAART was significantly lower for the relatively small subset of men who reported unprotected sex. Prevention strategies need to be tailored to address risk perception associated with HAART.
Relationship between flow-mediated vasodilation and cardiovascular risk factors in a large community-based study

To determine the relationships between flow-mediated vasodilation (FMD) and cardiovascular risk factors, and to evaluate confounding factors for measurement of FMD in a large general population in Japan.



This was a cross-sectional study. A total of 5314 Japanese adults recruited from people who underwent health screening from 1 April 2010 to 31 August 2012 at 3 general hospitals in Japan. Patients' risk factors (age, Body Mass Index, blood pressure, cholesterol parameters, glucose level and HbA1c level) and prevalence of cardiovascular disease (coronary heart disease and cerebrovascular disease) were investigated.



Univariate regression analysis revealed that FMD correlated with age (r=-0.27, p<0.001), Body Mass Index (r=-0.14, p<0.001), systolic blood pressure (r=-0.18, p<0.001), diastolic blood pressure (r=-0.13, p<0.001), total cholesterol (r=-0.07, p<0.001), triglycerides (r=-0.10, p<0.001), high-density lipoprotein cholesterol (r=0.06, p<0.001), low-density lipoprotein cholesterol (r=-0.04, p=0.01), glucose level (r=-0.14, p<0.001), HbA1c (r=-0.14, p<0.001), and baseline brachial artery diameter (r=-0.43, p<0.001) as well as Framingham Risk score (r=-0.29, p<0.001). Multivariate analysis revealed that age (t value=-9.17, p<0.001), sex (t value=9.29, p<0.001), Body Mass Index (t value=4.27, p<0.001), systolic blood pressure (t value=-2.86, p=0.004), diabetes mellitus (t value=-4.19, p<0.001), smoking (t value=-2.56, p=0.01), and baseline brachial artery diameter (t value=-29.4, p<0.001) were independent predictors of FMD.



FMD may be a marker of the grade of atherosclerosis and may be used as a surrogate marker of cardiovascular outcomes. Age, sex, Body Mass Index, systolic blood pressure, diabetes mellitus, smoking and, particularly, baseline brachial artery diameter are potential confounding factors in the measurement of FMD.
Targeted physiotherapy for patellofemoral joint osteoarthritis: A protocol for a randomised, single-blind controlled trial

The patellofemoral joint (PFJ) is one compartment of the knee that is frequently affected by osteoarthritis (OA) and is a potent source of OA symptoms. However, there is a dearth of evidence for compartment-specific treatments for PFJ OA. Therefore, this project aims to evaluate whether a physiotherapy treatment, targeted to the PFJ, results in greater improvements in pain and physical function than a physiotherapy education intervention in people with symptomatic and radiographic PFJ OA.



90 people with PFJ OA (PFJ-specific history, signs and symptoms and radiographic evidence of PFJ OA) will be recruited from the community and randomly allocated into one of two treatments. A randomised controlled trial adhering to CONSORT guidelines will evaluate the efficacy of physiotherapy (8 individual sessions over 12 weeks, as well as a home exercise program 4 times/week) compared to a physiotherapist-delivered OA education control treatment (8 individual sessions over 12 weeks). Physiotherapy treatment will consist of (i) quadriceps muscle retraining; (ii) quadriceps and hip muscle strengthening; (iii) patellar taping; (iv) manual PFJ and soft tissue mobilisation; and (v) OA education. Resistance and dosage of exercises will be tailored to the participant's functional level and clinical state. Primary outcomes will be evaluated by a blinded examiner at baseline, 12 weeks and 9 months using validated and reliable pain, physical function and perceived global effect scales. All analyses will be conducted on an intention-to-treat basis using linear mixed regression models, including respective baseline scores as a covariate, subjects as a random effect, treatment condition as a fixed factor and the covariate by treatment interaction.



This RCT is targeting PFJ OA, an important sub-group of knee OA patients, with a specifically designed conservative intervention. The project's outcome will influence PFJ OA rehabilitation, with the potential to reduce the personal and societal burden of this increasing public health problem.
Allopregnanolone impairs episodic memory in healthy women

Allopregnanolone is an endogenous neuroactive steroid that, through its binding to the γ-aminobutyric acid (GABA) A receptor, has GABA-active properties. Animal studies indicate that allopregnanolone administration results in diminished learning and memory impairment. The aim of the current study was to investigate the effect of intravenously administered allopregnanolone on episodic memory, semantic memory, and working memory in healthy women. Twenty-eight healthy women were included in the study. The participants were scheduled for the memory tests twice in the follicular phase. During the test sessions, an intravenous allopregnanolone and placebo infusion were administered in a double-blinded, randomized order at intervals of 48 h. Before and 10 min after the allopregnanolone/placebo injections, memory tasks were performed. The study demonstrated that allopregnanolone impaired episodic memory in healthy women. There was a significant difference between pre- and postallopregnanolone injection episodic memory scores (p < 0.05), whereas there was no change in episodic memory performance following the placebo injections. There was also a significant difference between allopregnanolone and placebo postinjection episodic memory scores (p < 0.05). There were no effects of allopregnanolone on the semantic memory task or working memory task. Intravenous allopregnanolone impairs episodic memory in healthy women, but there is a high degree of individual variability.
Cardiac resynchronization therapy and cardiac sympathetic function.

Cardiac resynchronization therapy (CRT) is an established therapy for advanced congestive heart failure, improving both survival and hospitalization. The mechanism beneath these improvements still needs to be defined as about one-third of the patients do not benefit from resynchronization. Restoration of sympatho-vagal function can play a significant role in the process, but available data are limited. In this scenario, positron emission tomography scans with (11) C-hydroxyephedrine, a noradrenaline analogous, has the potential to characterize the modifications of the sympathetic nervous system induced by CRT in decompensated patients.



Ten patients (six males, age 68 ± 10 years) with primary dilated cardiomyopathy were studied before and after resynchronization (acutely and after 3 months), from a clinical and echocardiographic point of view. Their cardiac sympathetic nerve activity was evaluated by (11) C-hydroxyephedrine positron emission tomography before resynchronization, at short and medium term after resynchronization.



Responders to CRT (patients showing ≥ 15% decrease in left ventricular end-systolic volume) showed a higher level of left ventricular radiotracer uptake both at baseline and after resynchronization with respect to nonresponders. This was coupled with a progressive improvement in homogeneity in left ventricular tracer uptake mainly in responders.



Cardiac resynchronization therapy improves cardiac sympathetic nerve activity in responders since its activation, while nonresponders do not show any significant change at any time of evaluation. CRT seems to be more effective in those patients with a still structurally preserved, yet functionally impaired, neuroautonomic system.
Reducing glucose variability with continuous subcutaneous insulin infusion increases endothelial progenitor cells in type 1 diabetes: an observational study

Circulating endothelial progenitor cells (EPCs) are involved in the repairing mechanisms of vascular damage. Glucose variability may contribute to the development of chronic vascular complications of diabetes. We evaluated whether reducing glucose variability with continuous subcutaneous insulin infusion (CSII) would increase circulating levels of EPCs in type 1 diabetes. The study population consisted of 106 type 1 diabetic patients: 41 subjects considered eligible for CSII completed a 6-month follow-up. Sixty-five patients on intensified insulin therapy with multiple daily injections served as control group. Seven EPCs phenotypes were assessed by flow cytometry, and glucose variability by mean amplitude of glycemic excursions (MAGE). Both CD34+KDR+ [difference between groups 32.0, 95 % CI (19.6–44.4) number/106 cells, P < 0.001] and CD34+KDR+CD133+ [12.5 (5.5–19.5), P < 0.001)] cell count increased at endpoint in the CSII group, associated with a reduction of MAGE [−1.1 (−2.1 to −0.1), P = 0.026]. No changes occurred in the control group. In multivariate analyses, changes in MAGE were independently associated with changes in both CD34+KDR+ (P = 0.019) and CD34+KDR+CD133+ (P = 0.022) cell count. Reducing glucose variability with CSII in type 1 diabetes increases circulating EPCs levels, suggesting a novel mechanism of vascular damage by oscillating glucose.
Gracilis urethromyoplasty – an autologous urinary sphincter for neurologically impaired patients with stress incontinence

To investigate the effect of a neurovascularly intact gracilis muscle urethral wrap, to be used to restore urinary continence as a transposed urinary sphincter graft, in patients with neurogenic lower urinary tract dysfunction.  Five neurologically impaired men with a denervated and damaged urinary sphincter mechanisms were treated. The etiology of sphincteric insufficiency included sphincter denervation in three patients, external sphincterotomy in one, and urethral trauma due to a chronic indwelling catheter in one. All patients underwent gracilis urethromyoplasty sphincter reconstruction. Two patients also underwent concomitant ileocystoplasty and one patient ileocystostomy because of poor bladder compliance and a bladder capacity of <200 ml.  The gracilis urethromyoplasty functioned as a new autologous sphincter with follow-ups ranging from 6 – 35 months. The surgery was successful in four patients. Three of the four patients were managed with intermittent catheterization, and one managed by ileocystostomy. The fifth patient continued to require an indwelling urethral catheter.  Gracilis urethromyoplasty achieves compression of the urethra using a neurovascularly intact muscle graft. The functional urethral closure, obtained from the gracilis muscle wrap, assures dryness, and permits intermittent self-catheterization. It also avoids the risks of infection, erosion, or malfunction associated with the artificical urinary sphincter. The potential exists for electrical stimulation of this muscle graft to allow volitional control of the neo-sphincter mechanism, and voluntary voiding.
Efficacy and safety of ivabradine in patients with chronic systolic heart failure and diabetes: an analysis from the SHIFT trial.

To evaluate clinical profiles and outcomes in patients with systolic heart failure (HF) with or without diabetes, and the efficacy and safety of ivabradine (heart rate-lowering agent) with respect to diabetic status.



This is a post hoc analysis on patients in SHIFT, a randomized controlled trial in adults in sinus rhythm with systolic HF, left ventricular ejection fraction ≤35%, and resting heart rate ≥70 b.p.m. Patients were randomized to ivabradine (titrated to 7.5 mg bid) or placebo. Diabetic status was established by medical history at baseline. The primary composite endpoint (PCE) was cardiovascular death or hospitalisation for worsening HF. Of 6505 patients, 30% had diabetes, 32% of whom used insulin. The PCE was more frequent in patients with diabetes [adjusted hazard ratio (HR) 1.18, 95% confidence interval (CI) 1.07-1.31; p = 0.001], as was hospitalization for worsening HF (adjusted HR 1.28, 95% CI 1.13-1.44; P < 0.001), and was increased in patients treated with insulin (adjusted HR 1.43, 95% CI 1.23-1.66; P < 0.01 vs. non-diabetics). Ivabradine significantly reduced the PCE in patients with and without diabetes (adjusted HR 0.80, 95% CI 0.68-0.94 and HR 0.84, 95% CI, 0.75-0.95, respectively; interaction P was non-significant) vs. placebo. Adverse events were significantly more frequent in patients with diabetes (78%) than without (74%) (P < 0.001). Regardless of diabetic status, the incidence of serious adverse events was not significantly different between ivabradine and placebo.



Comorbid diabetes in chronic HF worsens the prognosis of systolic HF patients. Irrespective of diabetic status, ivabradine is effective and safe in these patients.
A randomized placebo-controlled study on the effect of nifedipine on coronary endothelial function and plaque formation in patients with coronary artery disease: the ENCORE II study†

Endothelial dysfunction and plaque formation are features of atherosclerosis. Inhibition of L-type calcium channels or HMG-CoA pathway improves endothelial function and reduces plaque size. Thus, we investigated in stable coronary artery disease (CAD) the effects of a calcium antagonist on coronary endothelial function and plaque size.



In 454 patients undergoing PCI, acetylcholine (10(-6) to 10(-4) M) was infused in a coronary segment without significant CAD. Changes in coronary diameter were measured and an intravascular ultrasound examination (IVUS) was performed. On top of statin therapy, patients were randomized in a double-blind fashion to placebo or nifedipine GITS 30-60 mg/day and followed for 18-24 months. Blood pressure was lower on nifedipine than on placebo by 5.8/2.1 mmHg (P < 0.001) as was total and LDL cholesterol (4.8 mg/dL; P = 0.495), while HDL was higher (3.6 mg/dL; P = 0.026). In the most constricting segment, nifedipine reduced vasoconstriction to acetylcholine (14.0% vs. placebo 7.7%; P < 0.0088). The percentage change in plaque volume with nifedipine and placebo, respectively, was 1.0 and 1.9%, ns.



The ENCORE II trial demonstrates in a multi-centre setting that calcium channel blockade with nifedipine for up to 2 years improves coronary endothelial function on top of statin treatment, but did not show an effect of nifedipine on plaque volume.
Blood pressure-lowering effects of angiotensin receptor antagonist monotherapy and in combination with other anti-hypertensive drugs in primary care settings in Japan.

Combination therapy with multiple anti-hypertensives is required to achieve target blood pressure (BP) control and is recommended as the first-line therapy in hypertension. Although angiotensin receptor blockers (ARBs) may be combined with other anti-hypertensives, it is unclear how the effects of ARBs are influenced by co-administered anti-hypertensives. We investigated the effect of olmesartan medoxomil (OLM) when it is given alone (monotherapy) or concomitantly with other anti-hypertensives in 6507 OLM-naive Japanese in "real world" clinical practice. After a 12-week treatment, BP was significantly reduced from baseline in both the monotherapy group and the combination therapy group (P < 0.0001). The BP-lowering efficacy after treatment and achievement rates of target BP were similar in both groups. In the combination therapy group, no significant difference of achieved BP level was detected between patients taking Calcium channel blockers and any other class of anti-hypertensive drugs. This study suggests that ARBs such as OLM-elicits BP-lowering efficacy as either a first- or second-line agent and its effects are minimally influenced by co-administered anti-hypertensives.
Ablation of Stable VTs Versus Substrate Ablation in Ischemic Cardiomyopathy: The VISTA Randomized Multicenter Trial.

Catheter ablation reduces ventricular tachycardia (VT) recurrence and implantable cardioverter defibrillator shocks in patients with VT and ischemic cardiomyopathy. The most effective catheter ablation technique is unknown.



This study determined rates of VT recurrence in patients undergoing ablation limited to clinical VT along with mappable VTs ("clinical ablation") versus substrate-based ablation.



Subjects with ischemic cardiomyopathy and hemodynamically tolerated VT were randomized to clinical ablation (n = 60) versus substrate-based ablation that targeted all "abnormal" electrograms in the scar (n = 58). Primary endpoint was recurrence of VT. Secondary endpoints included periprocedural complications, 12-month mortality, and rehospitalizations.



At 12-month follow-up, 9 (15.5%) and 29 (48.3%) patients had VT recurrence in substrate-based and clinical VT ablation groups, respectively (log-rank p < 0.001). More patients undergoing clinical VT ablation (58%) were on antiarrhythmic drugs after ablation versus substrate-based ablation (12%; p < 0.001). Seven (12%) patients with substrate ablation and 19 (32%) with clinical ablation required rehospitalization (p = 0.014). Overall 12-month mortality was 11.9%; 8.6% in substrate ablation and 15.0% in clinical ablation groups, respectively (log-rank p = 0.21). Combined incidence of rehospitalization and mortality was significantly lower with substrate ablation (p = 0.003). Periprocedural complications were similar in both groups (p = 0.61).



An extensive substrate-based ablation approach is superior to ablation targeting only clinical and stable VTs in patients with ischemic cardiomyopathy presenting with tolerated VT.