nils-herrmann/clean_scirepeval huggingface dataset:
Mometasone furoate nasal spray reduces the ocular symptoms of seasonal allergic rhinitis.

Mometasone furoate nasal spray (MFNS), a potent intranasal corticosteroid with proved efficacy in relieving nasal allergic rhinitis symptoms, has demonstrated effectiveness in improving ocular symptoms associated with seasonal allergic rhinitis (SAR) in retrospective analyses.



We sought to evaluate prospectively the efficacy of MFNS in reducing total ocular symptom scores (TOSSs) and individual ocular symptoms in subjects with SAR.



Subjects 12 years or older (n = 429) with moderate-to-severe baseline symptoms were randomized to MFNS, 200 microg once daily, or placebo in this 15-day, double-blind, parallel-group study. Subjects evaluated morning instantaneous TOSSs and daily reflective TOSSs, total nasal symptom scores (TNSSs; both instantaneous TNSSs and reflective TNSSs, respectively), and individual ocular and nasal symptoms. Mean changes from baseline averaged over days 2 to 15 (instantaneous) and days 1 to 15 (reflective) were calculated. Quality of life was assessed by using the Rhinoconjunctivitis Quality of Life Questionnaire.



MFNS treatment yielded significant reductions from baseline versus placebo in instantaneous TOSSs (-0.34, P = .026, coprimary end point), instantaneous TNSSs (-0.88, P < .001, coprimary end point), reflective TOSSs (-0.44, P = .005), and reflective TNSSs (-1.06, P < .001). Significant decreases in all individual reflective ocular symptoms and instantaneous eye itching/burning and eye watering/tearing were observed for MFNS versus placebo (P < .05). Numeric improvements in instantaneous eye redness were seen but did not reach statistical significance. Improvements in Rhinoconjunctivitis Quality of Life Questionnaire total scores and individual symptom domains were achieved with MFNS treatment versus placebo (P < .001). MFNS was well tolerated.



This prospective study demonstrates that MFNS significantly reduces ocular symptoms in subjects with SAR.
Garlic powder, effect on plasma lipids, postprandial lipemia, low-density lipoprotein particle size, high-density lipoprotein subclass distribution and lipoprotein(a).

To test the hypothesis that a garlic supplement alters plasma lipoproteins, postprandial lipemia, low-density lipoprotein (LDL) size and high-density lipoprotein (HDL) subclass distribution differently in 50 moderately hypercholesterolemic subjects classified as LDL subclass pattern A or B.



Garlic has been variably reported to reduce or not affect plasma cholesterol values. Low-density lipoprotein pattern B is a common inherited disorder of lipoprotein metabolism that has been shown to have a significantly greater response to several lipid lowering treatments including low fat diet when compared with LDL pattern A individuals.



A double blind, randomized, placebo controlled trial in an outpatient lipid research clinic was performed and included fifty moderately hypercholesterolemic subjects (mean LDL cholesterol = 166 +/- 22 mg/dl) classified as LDL subclass pattern A (predominantly large LDL, n = 22) or B (predominantly small LDL, n = 28). Following a two-month stabilization period, subjects were randomly assigned to a placebo or 300 mg three times a day of a standardized garlic tablet for three months.



For all subjects, LDL pattern A and B subjects combined, garlic treatment for three months resulted in no significant change in total cholesterol, LDL cholesterol, HDL cholesterol, HDL subclass distribution, postprandial triglycerides, apolipoprotein B, lipoprotein (a) (Lp[a]), LDL peak particle diameter or LDL subclass distribution. There was no significant difference in response for the same parameters among subjects classified as LDL pattern A or B with the exception of significantly greater (p = 0.01) reduction in mean peak particle diameter in pattern A subjects treated with either garlic or placebo. There was no significant change in LDL subclass distribution.



This investigation confirms that garlic therapy has no effect on major plasma lipoproteins and further, that it has no impact on HDL subclasses, Lp(a), apolipoprotein B, postprandial triglycerides or LDL subclass distribution. Garlic may have a greater effect on LDL particle diameter in LDL pattern A compared with pattern B subjects. This difference was not reflected in other plasma lipid measurements.
Randomised double-blind, positive-controlled trial to assess the efficacy of glucosamine/chondroitin sulfate for the treatment of dogs with osteoarthritis.

Thirty-five dogs were included in a randomised, double-blind, positive controlled, multi-centre trial to assess the efficacy of an orally-administered glucosamine hydrochloride and chondroitin sulfate (Glu/CS) combination for the treatment of confirmed osteoarthritis of hips or elbows. Carprofen was used as a positive control. Dogs were re-examined on days 14, 42 and 70 after initiation of treatment. Medication was then withdrawn and dogs were re-assessed on day 98. Response to treatment was based on subjective evaluation by participating veterinarians who recorded their findings at each visit. Dogs treated with Glu/CS showed statistically significant improvements in scores for pain, weight-bearing and severity of the condition by day 70 (P<0.001). Onset of significant response was slower for Glu/CS than for carprofen-treated dogs. The results show that Glu/CS has a positive clinical effect in dogs with osteoarthritis.
The effect of isometric exercise of the hand on the synovial blood flow in patients with rheumatoid arthritis measured by color Doppler ultrasound

In 90% of patients with rheumatoid arthritis (RA), the joints of the hand are affected. Studies of grip strength training have not indicated a negative effect on disease activity after training. Introduction of ultrasound Doppler (USD) to measure increased blood flow induced by inflammation has made it possible to investigate the direct effect on blood supply in the synovium after training. In this case–control study, 24 patients with RA with USD activity in the wrist joint participated. The USD activity was measured by the color fraction (CF) (CF = colored pixels/total number of pixels in ROI). Twenty-four patients were assigned to an 8-week grip strength training program. At baseline and after 8 weeks of training, an USD examination of the wrist joint was performed. In the training group, we measured grip strength and pain in the wrist joint. Six patients withdrew from the training because of pain or change in medication. Eighteen patients served as control group. There was a modest, not significant, decrease in the CF in response to training (1.86%; P = 0.08). Grip strength increased 8.8% after training (P = 0.055). Pain in motion deceased after training (P = 0.04). No difference in the CF was seen between the training and control groups, neither at baseline nor at follow-up (P = 0.82 and P = 0.48). Patients withdrawing from training had a significantly higher CF than the other patients (P > 0.001). The results in this study might indicate that the flow in the synovium assessed by USD is not affected by grip strength training.
A phase II study on safety and efficacy of high-dose N-acetylcysteine in patients with cystic fibrosis

We conducted a single-centre, randomised, double-blinded, placebo-controlled phase II clinical study to test safety and efficacy of a 12-week therapy with low-dose (700 mg/daily) or high-dose (2800 mg/daily) of NAC.



Twenty-one patients (DeltaF508 homo/heterozygous, FEV1>40% pred.) were included in the study. After a 3-weeks placebo run-in phase, 11 patients received low-dose NAC, and 10 patients received high-dose NAC. Outcomes included safety and clinical parameters, inflammatory (total leukocyte numbers, cell differentials, TNF-alpha, IL-8) measures in induced sputum, and concentrations of extracellular glutathione in induced sputum and blood.



High-dose NAC was a well-tolerated and safe medication. High-dose NAC did not alter clinical or inflammatory parameters. However, extracellular glutathione in induced sputum tended to increase on high-dose NAC.



High-dose NAC is a well-tolerated and safe medication for a prolonged therapy of patients with CF with a potential to increase extracellular glutathione in CF airways.
Olive oil polyphenols decrease blood pressure and improve endothelial function in young women with mild hypertension.

Olive oil polyphenols have been associated with several cardiovascular health benefits. This study aims to examine the influence of a polyphenol-rich olive oil on blood pressure (BP) and endothelial function in 24 young women with high-normal BP or stage 1 essential hypertension.



We conducted a double-blind, randomized, crossover dietary-intervention study. After a run-in period of 4 months (baseline values), two diets were used, one with polyphenol-rich olive oil (∼30 mg/day), the other with polyphenol-free olive oil. Each dietary period lasted 2 months with a 4-week washout between diets. Systolic and diastolic BP, serum or plasma biomarkers of endothelial function, oxidative stress, and inflammation, and ischemia-induced hyperemia in the forearm were measured.



When compared to baseline values, only the polyphenol-rich olive oil diet led to a significant (P < 0.01) decrease of 7.91 mm Hg in systolic and 6.65 mm Hg of diastolic BP. A similar finding was found for serum asymmetric dimethylarginine (ADMA) (-0.09 ± 0.01 µmol/l, P < 0.01), oxidized low-density lipoprotein (ox-LDL) (-28.2 ± 28.5 µg/l, P < 0.01), and plasma C-reactive protein (CRP) (-1.9 ± 1.3 mg/l, P < 0.001). The polyphenol-rich olive oil diet also elicited an increase in plasma nitrites/nitrates (+4.7 ± 6.6 µmol/l, P < 0.001) and hyperemic area after ischemia (+345 ± 386 perfusion units (PU)/sec, P < 0.001).



We concluded that the consumption of a diet containing polyphenol-rich olive oil can decrease BP and improve endothelial function in young women with high-normal BP or stage 1 essential hypertension.
Relationship Between Microvessel Density and Thermographic Hot Areas in Breast Cancer

This study was conducted to evaluate the validity of thermography in breast examination.  We performed contact thermography and measured the direct temperature by inserting a needle-type thermometer into the tissue. The core temperature of the tumor (dTt) and the temperature of the tissue surrounding the tumor (dTs) were compared with normal tissue. The microvessel density (MVD) and the MIB-1 labeling index (MIB-1 LI) of the tumor were examined immunohistochemically. The subjects were 48 women with primary invasive ductal carcinoma. The area of the tumor was diagnosed pathologically, and the hot area was measured using thermography.  The dTt was significantly higher than the dTs. Both the dTt and dTs were significantly higher when the thermographical hot area was positive, or when more than four lymph node metastases were found. The dTs was correlated with MVD. A correlation between MVD and tumor temperature measured directly was also confirmed. A higher dTs was related to the dissociated wide area of the thermogram.  These findings suggested a relationship between dTs and the high-risk group of breast cancer. We also found that abnormalities in temperature were reflected in thermography and that a higher dTs was related to the dissociated wide area of the thermogram.
The Effects of the Number of Rubber Bands Placed at Each Endoscopic Session Upon Variceal Outcomes: A Prospective, Randomized Study

To determine the role of the number of bands placed per session upon patient-related and procedural-related outcomes.Patients were assigned to receive as many bands as could be possibly placed (group 1) or up to a maximum of six bands (group 2) per session. The primary outcome measured was the number of sessions to achieve obliteration. Other outcomes measured included: rebleeding, variceal recurrence, mortality (within 6 wk and within 1 yr), complications, banding and total procedure times, and number of bands misfired.A total of 86 patients were enrolled: 45 in group 1 and 41 in group 2. The two groups had similar age, Child-Pugh scores, grade of varices at entry. The overall proportion of patients achieving obliteration was 56% (53% and 59% for groups 1 and 2, respectively). Despite receiving significantly more mean bands per session, patients in group 1 required similar (mean ± SEM) number of sessions to obliteration (2.9 ± 0.3 vs 3.3 ± 0.3) and total number of bands (20.0 ± 2.4 vs 16.6 ± 1.8) to achieve this goal compared with group 2. The overall proportion of patients with variceal rebleeding was 25%, the 1-yr variceal recurrence 31.3%, and the overall early- and 1-yr mortality were 18.6% and 33.7%, respectively. These proportions were similar in the two groups. Banding and total procedure times were significantly longer and associated with significantly more misfired bands per session in group 1.CONCLUSION:Compared with a maximum of six bands per session, the placement of >6 bands per session was not associated with better patient outcomes but with significantly more prolonged banding and total procedure times and significantly more misfired bands.
Subphenotypes in acute respiratory distress syndrome: latent class analysis of data from two randomised controlled trials.

Subphenotypes have been identified within heterogeneous diseases such as asthma and breast cancer, with important therapeutic implications. We assessed whether subphenotypes exist within acute respiratory distress syndrome (ARDS), another heterogeneous disorder.



We used data from two ARDS randomised controlled trials (ARMA trial and ALVEOLI trial), sponsored by the National Heart, Lung, and Blood Institute. We applied latent class modelling to identify subphenotypes using clinical and biological data. We modelled data from both studies independently. We then tested the association of subphenotypes with clinical outcomes in both cohorts and with the response to positive end-expiratory pressure (PEEP) in the ALVEOLI cohort.



We analysed data for 1022 patients: 473 in the ARMA cohort and 549 in the ALVEOLI cohort. Independent latent class models indicated that a two-class (ie, two subphenotype) model was the best fit for both cohorts. In both cohorts, we identified a hyperinflammatory subphenotype (phenotype 2) that was characterised by higher plasma concentrations of inflammatory biomarkers, a higher prevalence of vasopressor use, lower serum bicarbonate concentrations, and a higher prevalence of sepsis than phenotype 1. Participants in phenotype 2 had higher mortality and fewer ventilator-free days and organ failure-free days in both cohorts than did those in phenotype 1 (p<0·007 for all). In the ALVEOLI cohort, the effects of ventilation strategy (high PEEP vs low PEEP) on mortality, ventilator-free days and organ failure-free days differed by phenotype (p=0·049 for mortality, p=0·018 for ventilator-free days, p=0·003 for organ-failure-free days).



We have identified two subphenotypes within ARDS, one of which is categorised by more severe inflammation, shock, and metabolic acidosis and by worse clinical outcomes. Response to treatment in a randomised trial of PEEP strategies differed on the basis of subphenotype. Identification of ARDS subphenotypes might be useful in selecting patients for future clinical trials.
Magnetic resonance imaging study of hippocampal volume in chronic, combat-related posttraumatic stress disorder

This study used quantitative volumetric magnetic resonance imaging techniques to explore the neuroanatomic correlates of chronic, combat-related posttraumatic stress disorder (PTSD) in seven Vietnam veterans with PTSD compared with seven nonPTSD combat veterans and eight normal nonveterans. Both left and right hippocampi were significantly smaller in the PTSD subjects compared to the Combat Control and Normal subjects, even after adjusting for age, whole brain volume, and lifetime alcohol consumption. There were no statistically significant group differences in intracranial cavity, whole brain, ventricles, ventricle:brain ratio, or amygdala. Subarachnoidal cerebrospinal fluid was increased in both veteran groups. Our finding of decreased hippocampal volume in PTSD subjects is consistent with results of other investigations which utilized only trauma-unexposed control groups. Hippocampal volume was directly correlated with combat exposure, which suggests that traumatic stress may damage the hippocampus. Alternatively, smaller hippocampi volume may be a pre-existing risk factor for combat exposure and/or the development of PTSD upon combat exposure.
Topical photodynamic therapy with 5-aminolevulinic acid for cervical high-risk HPV infection.

To investigate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) for cervical high-risk HPV (HR-HPV) infection.



In this prospective study, a total of 76 patients with persistent cervical HR-HPV infection were randomly divided into two groups. The treatment group (39 patients) received three treatments of ALA-PDT at two-week intervals. The control group (37 patients) received no treatment. All patients were followed up for 9 months. Hybrid Capture HPV DNA Assay and ThinPrep cytology test (TCT) were performed for both groups. Patients with abnormal TCT results received colposcopic biopsy before treatment and during follow-ups.



HR-HPV remission rates were 64.10% (25/39) in the treatment group and 24.32% (9/37) in the control group at 3 month follow-up. Complete remission rates were 76.92% (30/39) and 32.40% (12/37), respectively, in the two groups at 9 month follow-up. There was a statistically significant difference between the two groups (P<0.01). Conversion rates of abnormal TCT results were 81.81% (9/11) in the treatment group and 12.50% (1/8) in the control group at 3 months, and 90.90% (10/11) and 25.00% (2/8), respectively, at 9 months. Five of six patients with CIN I in the treatment group and no patients in the control group achieved complete response at 9 months. There was a statistically significant difference between the two groups (P<0.01).



Topical ALA-PDT is an effective, safe and well tolerated treatment for cervical HR-HPV infection.
Effects of a low-fat meal on the oral bioavailability of UFT and leucovorin in patients with colorectal cancer

UFT is composed of tegafur, a prodrug of 5-fluorouracil, and uracil, at a fixed ratio of 1: 4. UFT is widely used with leucovorin as adjuvant chemotherapy in patients with colon cancer. As reported, UFT/leucovorin should not be taken simultaneously with food because a high fat content will reduce the systemic exposure to the active cytotoxic moiety of UFT. In this single-dose, randomized, two-way crossover study, we investigated the effects of a low-fat Japanese meal on the pharmacokinetics and oral bioavailability of UFT (2 × 100-mg capsules; dose in terms of tegafur) and leucovorin (1 × 25-mg tablet). Patients (n = 12) were randomly assigned to receive both drugs after an overnight fast or 5 min after eating a standard Japanese breakfast (641 kcal), with a 3-day washout period between treatments. Pharmacokinetics (n = 12) were determined for tegafur, 5-fluorouracil, uracil, leucovorin, and 5-methyltetrahydrofolate (an active metabolite of leucovorin). For 5-fluorouracil pharmacokinetics, the maximum plasma concentration and the area under the curve were reduced by 73.7% and 47.4%, respectively, when UFT was taken postprandially, and the maximum plasma concentration and the area under the curve for uracil were reduced by 84.1% and 68.9%, respectively, compared with dosing on an empty stomach. These decreases in the systemic exposure to 5-fluorouracil were quite marked and may have an impact on its antitumor effect. A low-fat meal affects the pharmacokinetics of UFT similarly to a high-fat meal.
Atypical and Conventional Antipsychotic Drugs in Treatment-Naive First-Episode Schizophrenia: A 52-Week Randomized Trial of Clozapine Vs Chlorpromazine

The purported advantages of second-generation or ‘atypical’ antipsychotics relative to first-generation antipsychotics have not been examined in patients with a first episode of schizophrenia. This flexible-dose study examined efficacy and safety in a randomized, double-blind, 52-week trial, comparing chlorpromazine (CPZ) and clozapine (CLZ) in treatment naive patients experiencing their first episode of schizophrenia. In all, 160 inpatients with first-episode schizophrenia or schizophreniform disorder were randomized to CPZ or CLZ and followed them for 52 weeks or until dropout. The primary efficacy measure was time to first remission and proportion of time remaining in remission. The analysis was supplemented by comparisons on a profile of clinical symptoms and side effects. Of these first-episode patients, 80% achieved remission within 1 year (79% CPZ, 81% CLZ). The Kaplan–Meier estimated median time to first remission was 8 weeks for CLZ vs 12 weeks for CPZ (χ2(1)=5.56, p=0.02). Both the rate of first achieving remission and the odds for being in remission during the trial were almost doubled for the CLZ group in comparison with the CPZ group. At 12 weeks, CLZ was superior on many rating scale measures of symptom severity while CPZ was not superior on any. These symptom differences remained significant when controlling for EPS differences. By 52 weeks many of the symptom differences between groups were no longer significantly different. Generally, CLZ produced fewer side effects than CPZ, particularly extrapyramidal side effects. There was no significant difference between treatments in weight change or glucose metabolism. For each prior year of untreated psychosis, there was a 15% decrease in the odds of achieving remission (OR=0.85; CI 0.75–0.95). A high proportion of first-episode patients remitted within 1 year. We detected no difference in the proportion of first-episode patients receiving CLZ or CPZ that achieved remission. However, first-episode patients receiving CLZ remitted significantly faster and remained in remission longer than subjects receiving CPZ. While the CLZ group showed significantly less symptomatology on some measures and fewer side effects at 12 weeks, the two treatment groups seemed to converge by 1 year. Longer duration of untreated psychosis was associated with lower odds of achieving remission.
The Comprehensive ICF core sets for spinal cord injury from the perspective of physical therapists: a worldwide validation study using the Delphi technique

To validate the International Classification of Functioning, Disability and Health (ICF) Core Set for individuals with spinal cord injury (SCI) in the early post-acute and long-term context from the perspective of physical therapists.International.Physical therapists experienced in the treatment of SCI were asked about problems, resources and aspects of the environment treated by them, in a three-round electronic mail survey using the Delphi technique. Responses were linked to the ICF by two researches; κ-coefficient was calculated as statistical measure of agreement.In all, 81 experts from 27 countries named 3694 concepts. They were linked to 187 ICF categories for the early post-acute context. Three ICF categories from the component body function, five ICF categories from the component body structures and two ICF categories from the component activities and participation were not represented in the ICF Core Set for the early post-acute context. In all, 207 ICF categories were linked for the long-term context. Four ICF categories from the component body function, five ICF categories from the component body structures and two ICF categories from the component activities and participation were not represented in the ICF Core Set for the long-term context.Physical therapists addressed a vast variety of problems that they take care of in their interventions in patients with SCI. The Comprehensive ICF Core Sets covered a high percentage of these problems. Further research is necessary on several responses not covered in the ICF.