nils-herrmann/clean_scirepeval huggingface dataset:
Influence of capsaicin infusion on secondary peristalsis in patients with gastroesophageal reflux disease

To determine whether capsaicin infusion could influence heartburn perception and secondary peristalsis in patients with gastroesophageal reflux disease (GERD).



Secondary peristalsis was performed with slow and rapid mid-esophageal injections of air in 10 patients with GERD. In a first protocol, saline and capsaicin-containing red pepper sauce infusions were randomly performed, whereas 2 consecutive sessions of capsaicin-containing red pepper sauce infusions were performed in a second protocol. Tested solutions including 5 mL of red pepper sauce diluted with 15 mL of saline and 20 mL of 0.9% saline were infused into the mid-esophagus via the manometric catheter at a rate of 10 mL/min with a randomized and double-blind fashion. During each study protocol, perception of heartburn, threshold volumes and peristaltic parameters for secondary peristalsis were analyzed and compared between different stimuli.



Infusion of capsaicin significantly increased heartburn perception in patients with GERD (P < 0.001), whereas repeated capsaicin infusion significantly reduced heartburn perception (P = 0.003). Acute capsaicin infusion decreased threshold volume of secondary peristalsis (P = 0.001) and increased its frequency (P = 0.01) during rapid air injection. The prevalence of GERD patients with successive secondary peristalsis during slow air injection significantly increased after capsaicin infusion (P = 0.001). Repeated capsaicin infusion increased threshold volume of secondary peristalsis (P = 0.002) and reduced the frequency of secondary peristalsis (P = 0.02) during rapid air injection.



Acute esophageal exposure to capsaicin enhances heartburn sensation and promotes secondary peristalsis in gastroesophageal reflux disease, but repetitive capsaicin infusion reverses these effects.
Effectiveness and cost-effectiveness of meaning-centered group psychotherapy in cancer survivors: protocol of a randomized controlled trial

Meaning-focused coping may be at the core of adequate adjustment to life after cancer. Cancer survivors who experience their life as meaningful are better adjusted, have better quality of life and psychological functioning. Meaning-Centered Group Psychotherapy for Cancer Survivors (MCGP-CS) was designed to help patients to sustain or enhance a sense of meaning and purpose in their lives. The aim of the proposed study is to evaluate the effectiveness and cost-effectiveness of MCGP-CS.



Survivors diagnosed with cancer in the last 5 years and treated with curative intent, are recruited via several hospitals in the Netherlands. After screening, 168 survivors are randomly assigned to one of the three study arms: 1. Meaning-Centered Group Psychotherapy (MCGP-CS) 2. Supportive group psychotherapy (SGP) 3. Care as usual (CAU). Baseline assessment takes place before randomisation, with follow up assessments post-intervention and at 3, 6 and 12 months follow-up. Primary outcome is meaning making (PMP, PTGI, SPWB). Secondary outcome measures address quality of life (EORTC-30), anxiety and depression (HADS), hopelessness (BHS), optimism (LOT-R), adjustment to cancer (MAC), and costs (TIC-P, EQ-5D, PRODISQ).



Meaning-focused coping is key to adjustment to life after cancer, however, there is a lack of evidence based psychological interventions in this area. Many cancer survivors experience feelings of loneliness and alienation, and have a need for peer support, therefore a group method in particular, can be beneficial for sustaining or enhancing a sense of meaning. If this MCGP-CS is effective for cancer survivors, it can be implemented in the practice of psycho-oncology care.
Effect of a thromboxane A(2) antagonist on sputum production and its physicochemical properties in patients with mild to moderate asthma.

To determine the effects of a specific thromboxane A(2) (TxA(2)) receptor antagonist, seratrodast, on asthma control and airway secretions.



Multicenter, double-blind, randomized, placebo-controlled study.



Forty-five patients with mild to moderate asthma who had been continuously expectorating sputum of > 20 g/d. Patients with a current pulmonary infection or taking oral corticosteroids, antibiotics, or mucolytic agents were excluded from the trial.



Following a 2-week run-in period, while pulmonary function, sputum production, and mucociliary function were assessed, patients were assigned to receive seratrodast, 40 mg/d, or placebo for 6 weeks.



During the treatment period, the changes in FEV(1) and peak expiratory flow (PEF) were not different between the two patient groups, but there were significant reductions in diurnal variation of PEF (p = 0.034), frequency of daytime asthma symptoms (p = 0.030), and daytime supplemental use of beta(2)-agonist (p = 0.032) in the seratrodast group. For sputum analysis, seratrodast treatment decreased the amount of sputum (p = 0.005), dynamic viscosity (p = 0. 007), and albumin concentration (p = 0.028), whereas it had no effect on elastic modulus or fucose concentration. Nasal clearance time of a saccharin particle was shortened in the seratrodast group at week 4 (p = 0.031) and week 6 (p = 0.025), compared with the placebo group.



Blockade of TxA(2) receptor has minimal effects on pulmonary function, but may cause an improvement in mucociliary clearance by decreasing the viscosity of airway secretions.
A double-blind, placebo-controlled study of adjunctive calcitonin nasal spray in acute refractory mania.

Calcitonin, a neuropeptide, has been shown in preliminary double-blind trials to reduce agitation in patients with acute mania. Given that it has effects similar to those of lithium and anticonvulsants on modulation of second-messenger signaling pathways and stabilization of neuronal membranes, this study examined the efficacy of calcitonin nasal spray in treating acute manic symptoms in patients with treatment-resistant mania using a double-blind, placebo-controlled design.



A total of 46 hospitalized patients experiencing either a manic or a mixed episode, who were refractory to treatment with adequate doses of either a mood stabilizer or an antipsychotic, or a mood stabilizer/antipsychotic combination, and had a score of ≥16 on the Young Mania Rating Scale (YMRS), were randomized to receive adjunctive nasal calcitonin 200 IU (n = 24) or saline (n = 22) spray for three weeks. The primary efficacy measure was the change in YMRS scores using the last observation carried forward (LOCF) method.



The clinical and demographic characteristics were similar between the groups. Patients had a mean YMRS score of 26 in the placebo group and a mean score of 25 in the calcitonin group. There were no significant differences in YMRS scores or percentage responders at three weeks between patients who received calcitonin and those who received placebo. There were also no significant differences in change scores on any other scales. Few patients experienced any adverse events.



This study does not support the use of nasal calcitonin in the treatment of treatment-resistant mania.
Ezetimibe effectively lowers LDL-cholesterol in cardiac allograft recipients on stable statin therapy.

We investigated tolerability and efficacy of ezetimibe treatment (10 mg/d) in 25 heart allograft recipients already on stable statin therapy. Total cholesterol (TC), low-density cholesterol (LDL-C), high-density cholesterol (HDL-C), triglycerides (TG), immunosuppressant drug levels, laboratory and clinical parameters were assessed before, four months and one yr after initiation of ezetimibe treatment. Mean equivalent statin dose was 53.5 +/- 12.3 mg of pravastatin, remaining unchanged throughout the study period. Ezetimibe was generally well tolerated, only two patients (8%) discontinued ezetimibe due to stomach pain or headache. Mean TC decreased from 231.8 +/- 6.4 mg/dL before therapy to 202.2 +/- 8.8 mg/dL after four months and 192.9 +/- 7.0 mg/dL after one yr (p < 0.001). Mean LDL-C decreased from 143.1 +/- 5.4 mg/dL to 121.4 +/- 7.9 mg/dL (month 4; p < 0.05) and 107.1 +/- 5.6 mg/dL (one yr; p < 0.001). TG decreased from 182 +/- 14.3 mg/dL to 173.3 +/- 17.5 mg/dL after one yr (p < 0.05), whereas HDL-C was unchanged. Initial LDL-C and cardiac diagnosis before transplantation were identified as predictors of absolute LDL-C reduction. Immunosuppressant drug doses and blood concentrations were unchanged as well as other laboratory and clinical parameters. Ezetimibe appears safe and effective for further reduction of TC and LDL-C in heart allograft recipients already on stable statin therapy. Extent of pre-treatment LDL-C and cardiac disorder prior to transplantation appear to correlate with the efficacy of ezetimibe therapy.
From prediction to experimental validation: desmoglein 2 is a functionally relevant substrate of matriptase in epithelial cells and their reciprocal relationship is important for cell adhesion.

Accurate identification of substrates of a protease is critical in defining its physiological functions. We previously predicted that Dsg-2 (desmoglein-2), a desmosomal protein, is a candidate substrate of the transmembrane serine protease matriptase. The present study is an experimental validation of this prediction. As demanded by our published method PNSAS [Prediction of Natural Substrates from Artificial Substrate of Proteases; Venkatraman, Balakrishnan, Rao, Hooda and Pol (2009) PLoS ONE 4, e5700], this enzyme-substrate pair shares a common subcellular distribution and the predicted cleavage site is accessible to the protease. Matriptase knock-down cells showed enhanced immunoreactive Dsg-2 at the cell surface and formed larger cell clusters. When matriptase was mobilized from intracellular storage deposits to the cell surface there was a decrease in the band intensity of Dsg-2 in the plasma membrane fractions with a concomitant accumulation of a cleaved product in the conditioned medium. The exogenous addition of pure active recombinant matriptase decreased the surface levels of immunoreactive Dsg-2, whereas the levels of CD44 and E-cadherin were unaltered. Dsg-2 with a mutation at the predicted cleavage site is resistant to cleavage by matriptase. Thus Dsg-2 seems to be a functionally relevant physiological substrate of matriptase. Since breakdown of cell-cell contact is the first major event in invasion, this reciprocal relationship is likely to have a profound role in cancers of epithelial origin. Our algorithm has the potential to become an integral tool for discovering new protease-substrate pairs.
Standard laparoscopic versus single-incision laparoscopic colectomy for cancer: early results of a randomized prospective study.

Standard laparoscopic colectomy (SLC) for cancer is a safe, feasible, and oncologically effective procedure with better short-term and similar long-term results of open colectomy. Conversely, owing to technical difficulties in colonic resection and full mesenteric dissection, single-incision laparoscopic colectomy (SILC) has been considered unsuitable for oncologic purposes. We compared the technical feasibility and early clinical outcomes of SLC and SILC for cancer.



In this prospective randomized clinical trial, 16 (50%) patients underwent SLC (10 left and 6 right) and 16 (50%) patients underwent SILC (8 left and 8 right).



Demographics, preoperative data, and characteristics of the tumor were similar. The mean number of resected lymph nodes was 16 ± 5 in the SLC and 18 ± 6 in the SILC group (P = NS). Surgical time was 124 ± 8 minutes and 147 ± 5 minutes, respectively (P = NS). Surgical mortality was nil and the major morbidity rate was 6.3% in both groups.



SILC for cancer is a technically feasible and safe oncologic procedure with short-term results similar to those obtained with a traditional laparoscopic approach.
Switch from 200 to 350 CD4 baseline count: what it means to HIV care and treatment programs in Kenya

With the increasing population of infected individuals in Africa and constrained resources for care and treatment, antiretroviral management continues to be an important public health challenge. Since the announcement of World Health Organization recommendation and guidelines for initiation of antiretroviral Treatment at CD4 count below 350, many developing countries are adopting this strategy in their country specific guidelines to care and treatment of HIV and AIDS. Despite the benefits to these recommendations, what does this switch from 200 to 350 CD4 count mean in antiretroviral treatment demand?



A Multi-centre study involving 1376 patients in health care settings in Kenya. CD4 count was carried out by flow cytometry among the HIV infected individuals in Kenya and results analyzed in view of the In-country and the new CD4 recommendation for initiation of antiretroviral treatment.



Across sites, 32% of the individual required antiretroviral at <200 CD4 Baseline, 40% at <250 baseline count and 58% based on the new criteria of <350 CD4 Count. There were more female (68%) than Male (32%).Different from <200 and <250 CD4 baseline criteria, over 50% of all age groups required antiretroviral at 350 CD4 baseline. Age groups between 41-62 led in demand for ART.



With the new guidelines, demand for ARVs has more than doubled with variations noted within regions and age groups. As A result, HIV Care and Treatment Programs should prepare for this expansion for the benefits to be realized.
Effects of preferred-exercise prescription compared to usual exercise prescription on outcomes for people with non-specific low back pain: a randomized controlled trial [ACTRN12608000524392]

Non-specific chronic low back pain (NSCLBP) has become a significant problem due to high healthcare utilization, rising costs of care and perceived limitations of effectiveness of many current treatments. Systematic reviews have repeatedly concluded that, on average across participants, exercise for NSCLBP appears effective in decreasing pain and improving function. Not all people with NSCLBP benefit from exercise programs and it would assist care-providers and care-seekers if factors that impact on program effectiveness and success were identified.



The study will be a randomised controlled trial comparing an exercise rehabilitation program informed by a participant preferences questionnaire compared to a program without this guideline for patients with chronic low back pain. A sample of 150 patients will be recruited in Melbourne, Australia through community-based healthcare clinics that provide supervised exercise rehabilitation programs for people with non-specific chronic low back pain. Clinicians will be randomly assigned to exercise preferences questionnaire or no questionnaire and participants will be allocated in a concealed manner. A qualitative focus group study of exercise instructor feedback about the exercise preferences instrument will be embedded in the research design. Two qualitative focus group studies will also be conducted for participants in the intervention and the control groups to obtain feedback about participants' experiences of the two types of exercise programs. The primary outcomes will be functional ability, pain, fear avoidance, exercise adherence.



This trial will evaluate the effectiveness of individualised exercise prescription compared to usual exercise prescription for NSCLP and, using feedback following the trial, refine the exercise preferences questionnaire.
Effects of Rosuvastatin and Atorvastatin on LDL and HDL Particle Concentrations in Patients With Metabolic Syndrome

The purpose of this study was to examine the effects of statin therapy on lipoprotein particle concentrations in patients with the metabolic syndrome. Changes in lipoprotein particle concentration may predict the risk of coronary heart disease more accurately than lipoprotein cholesterol levels.



Patients with dyslipidemia and the metabolic syndrome (n = 318) were randomly assigned in a double-blind study comparing 10 mg rosuvastatin (RSV), 10 mg atorvastatin, or placebo daily for 6 weeks. From weeks 6 to 12, patients in the RSV and placebo groups received 20 mg RSV, whereas the ATV group increased their dose to 20 mg daily. Lipoprotein particle concentrations were measured by nuclear magnetic resonance spectroscopy, LDL cholesterol was measured by beta-quantification, and other lipoproteins were measured by standard methods at baseline, 6 weeks, and 12 weeks. Lipoprotein levels were compared by analysis of covariance.



Statins reduced LDL particle concentration less than LDL cholesterol (-30 to -38 vs. -38 to -51%). Reductions were greater with RSV than with ATV (P < 0.05 for LDL particle concentration and P < 0.001 for LDL cholesterol). Most patients attained LDL cholesterol <2.59 mmol/l (100 mg/dl) at 12 weeks (80% with RSV and 59% with ATV; P = 0.003), but only 27% of patients receiving RSV and 19% receiving ATV attained the goal of LDL particle concentration <1,000 nmol/l (P = 0.07).



In patients with the metabolic syndrome, statin-induced changes in LDL cholesterol do not accurately reflect changes in LDL particle concentration. Consequently, despite attainment of LDL cholesterol goals, these patients may retain considerable residual coronary heart disease risk.
Assessment of the psychometric properties of an English version of the cancer dyspnea scale in people with advanced lung cancer.

Dyspnea is a poorly understood subjective sensation. Existing dyspnea measures fail to adequately address its multidimensionality. A Japanese group developed and validated the Cancer Dyspnea Scale (CDS) for assessing dyspnea in patients with advanced lung cancer.



We evaluated the validity and reliability of the English version of the CDS (CDS-E) that has 12 items and takes, on average, 140 seconds for individuals to complete.



Eligible patients had advanced lung cancer, consented, and were fluent in English. Participants completed a 100 mm visual analogue scale (VAS), the modified Borg scale, the CDS-E, the Hospital Anxiety and Depression Scale, and the Functional Assessment of Cancer Therapy--Lung quality-of-life scale. Demographic, radiographic, and treatment information were obtained from patients' medical records.



One hundred twelve participants were enrolled at three sites in the U.S., Australia, and the U.K. Mean age was 64.5 years (SD 11.5); 90% were Caucasian, 68% had Eastern Cooperative Oncology Group performance status 0-1, and 50% had non-small cell carcinoma. All completed the CDS-E independently, without difficulty. The CDS-E had reasonable internal consistency overall (Cronbach's α = 0.71) and for each of the three factors (effort, anxiety, discomfort Cronbach's α = 0.80-0.84). CDS-E scores were significantly correlated with the 100mm VAS (r = 0.82; P < 0.001) and the modified Borg (r = 0.87; P < 0.001). After factor analysis, the CDS-E was revised by removing three items (r-CDS-E).



The CDS-E and r-CDS-E are reliable and valid measures of the sensation and the psychological components of dyspnea, with the shorter version having similar psychometric properties.
Effect of cigarette smoking on gastric emptying of solids in Japanese smokers: a crossover study using the 13C-octanoic acid breath test

Cigarette smoking is associated with an increased risk of peptic ulcer and gastroesophageal reflux disease. Gastric emptying disorders may play a role in the development of these upper gastrointestinal diseases. Thus, studies examining a link between smoking and gastric emptying disorders have clinical relevance. This study was conducted to investigate the effect of smoking on gastric emptying of solids in Japanese smokers. The 13C-octanoic acid breath test was performed in eight male habitual smokers on two randomized occasions (either sham smoking or actively smoking). The time vs 13CO2 excretion rate curve was mathematically fitted to a conventional formula of y (t) = m*k*β*e−k*t*(1 − e−k*t)β−1, and the parameters of k and β were determined: under the crossover protocol, a larger (smaller) β indicates slower (faster) emptying in the early phase, and a larger (smaller) k indicates faster (slower) emptying in the later phase. The half 13CO2 excretion time (t1/2b = −[ln(1 − 2−1/β)]/k) and the time of maximal 13CO2 excretion rate (tmax = [lnβ]/k) were also calculated. Between the two occasions, k, β, t1/2b, and tmax were compared by the Wilcoxon signed-rank test. After smoking, k was significantly increased. No significant differences were found in β, t1/2, and tmax between the two occasions. The increase in k suggests the acceleration of gastric emptying in the later phase. For the first time, this study has revealed that acute smoking speeds the gastric emptying of solids in Japanese habitual smokers.
Efficacy of UVA-1 cold light as an adjuvant therapy for systemic lupus erythematosus.

The assessment of the efficacy of therapy of patients with moderately active systemic lupus erythematosus (SLE) with low doses of UVA-1 cold light.



A double blind, placebo-controlled, cross-over study design was used for the examination of the efficacy of low doses of UVA-1 radiation (12 J/cm2/day for 15 days) in 12 patients.



UVA-1 treatment resulted in a significant decrease of well-validated disease activity indexes [the SLE Activity Measure (SLAM) (P < 0.001) and the SLE Disease Activity Index (SLEDAI) (P = 0.007)], whereas neither score improved significantly during placebo treatment. Furthermore, UVA-1 therapy proved to be more effective [mean decrease 4.8 points) than placebo (mean decrease -1.7 points (i.e. an increase)] when measured by the SLAM (P = 0.001, 95% CI -7.56 to -2.28), but not by the SLEDAI. Two patients had transient skin reactions at the beginning of treatment.



UVA-1 therapy appears to be a useful adjuvant treatment modality for patients suffering from moderately active SLE. Its effect could possibly be explained by reduction of B-cell function or apoptosis of plasma cells.
Comprehensive disease control (CDC): what does achieving CDC mean for patients with rheumatoid arthritis?

This study assessed the impact of simultaneous achievement of clinical, functional and structural efficacy, herein referred to as comprehensive disease control (CDC), on short-term and long-term work-related outcomes, health-related quality of life (HRQoL), pain and fatigue.



Data were pooled from three randomised trials of adalimumab plus methotrexate for treatment of early-stage or late-stage rheumatoid arthritis (RA). CDC was defined as 28-joint Disease Activity Score using C reactive protein <2.6, Health Assessment Questionnaire <0.5 and change from baseline in modified Total Sharp Score ≤0.5. Changes in scores at weeks 26 and 52 for work-related outcomes, Short Form 36 (SF-36) physical (PCS) and mental component scores (MCS), a Visual Analogue Scale measuring pain (VAS-Pain) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were compared between patient groups defined by achievement of CDC at week 26 using linear regression with adjustment for baseline scores.



Patients with RA who achieved CDC at week 26 (n=200) had significantly greater improvements in VAS-Pain (46.9 vs 26.9; p<0.0001), FACIT-F (13.3 vs 7.5; p<0.0001), SF-36 PCS (19.7 vs 8.9; p<0.0001) and SF-36 MCS (8.1 vs 5.0; p=0.0004) than those who did not (n=1267). Results were consistent at week 52 and among methotrexate-naive patients with early RA, methotrexate-experienced patients with late-stage RA and patients with inadequate response to methotrexate.



Patients with RA who achieved CDC at week 26 had improved short-term and long-term HRQoL, pain, fatigue and work-related outcomes compared with patients who do not. These results demonstrate that the joint achievement of all CDC components provides meaningful benefits to patients.