nils-herrmann/clean_scirepeval huggingface dataset:
Formulation and evaluation of diclofenac potassium fast-disintegrating tablets and their clinical application in migraine patients.

The aim of this study was to prepare fast-disintegrating tablets (FDTs) of diclofenac potassium with sufficient integrity as well as a pleasant taste, using two different fillers and binders: Tablettose 70(®) and Di-Pac(®). Tablets were made with direct compression method. Tablet properties such as porosity, hardness, and disintegration time were determined. Diclofenac potassium determinations were carried out using a validated spectrophotometric method for the analysis of drug. Furthermore, in vivo experiments were carried out to compare the analgesic effect and the time to relieve migraine headache between the commercial tablets and FDTs of diclofenac potassium against placebo. Results showed that FDTs of diclofenac potassium with durable structure and desirable taste can be prepared using both fillers and binders but tablets prepared with Di-Pac had a better taste so the tablet formulation containing Di-Pac was chosen for in vivo experiments. Placebo controlled in vivo trial demonstrated that 50 mg diclofenac potassium, administered as a single dose of FDTs or commercial tablets, was effective in relieving the pain and both of them were superior to placebo.
Intraoperative temperature control using the Thermogard system during off-pump coronary artery bypass grafting.

Normothermia during off-pump coronary bypass (OPCAB) grafting reduces metabolic derangements and contributes to improved clinical outcomes. Thus study examined the feasibility and efficacy of intraoperative temperature control using a novel endovascular heating system during OPCAB.



Thirty-eight consecutive patients undergoing OPCAB were prospectively randomized to receive conventional warming (elevated room temperature, warmed intravenous fluids, warming blanket) or the Thermogard system (Alsius Corp, Irvine, CA). The triple-lumen temperature control Icy catheter (Alsius Corp) was inserted percutaneously into the inferior vena cava through common femoral vein. The catheter was removed after all wounds were closed. Temperature measurements (bladder, nasopharyngeal, and blood) were recorded at 5-minute intervals and compared between groups.



Patient demographics did not significantly differ between groups. The 17 Thermogard patients warmed at a significantly faster rate than the 21 control patients (0.28 degrees vs 0.11 degrees C/h, p = 0.03). Furthermore, Thermogard patients received more bypass grafts (3.4 +/- 0.6 vs 2.6 +/- 0.9, p < 0.001) and less intraoperative fluids (1557.0 +/- 547.7 vs 2012.3 +/- 723.1 mL, p = 0.02) despite longer operative times (150.3 +/- 123.4 vs 108.1 +/- 43.7 min; p = 0.12). All catheters were placed successfully on the first attempt, and there were no device-related complications.



Endovascular warming is safe, simple to use, and obviates the need for uncomfortably warm operating room temperatures. The Thermogard system compared favorably with conventional methods for warming during OPCAB.
Validation of a quantitative FFQ for a study of diet and risk of colorectal adenoma among Japanese Brazilians.

To assess the validity of a 161-item quantitative FFQ (QFFQ) that was developed to evaluate dietary risk factors for a colorectal adenoma case–control study.



A cross-sectional validation study of the QFFQ against 4 d food diary using Pearson correlation coefficients, cross-classification, weighted k statistics and Bland–Altman plotting.



Two hospitals in Sa˜o Paulo, Brazil.



Ninety-seven healthy Japanese-Brazilian adults (40–75 years) were recruited. One participant was excluded from the analysis due to unusual energy intake report.



Mean daily nutrient intakes from the QFFQ were higher than from the food diary. The mean Pearson correlation coefficient for nutrient intakes between the QFFQ and the average of the 4 d food diary was 0?43, and increased to 0?45 after correcting correlations for attenuation due to residual day-to-day variation in the food diary measurements. Adjustment for total energy and further adjustment for age and gender decreased the correlation; however, 77% of observations remained in the same or adjacent quartiles with a mean weighted k of 0?22. Bland–Altman plots on loge-transformed data showed no linear trend between the differences and means for energy, fat, protein, total folate and vitamin C. Compared with the food diary, the QFFQ showed consistently reasonable performance for dietary fibre, total folate, retinol, riboflavin and vitamin C.



This investigation supports the relative validity of the QFFQ as a method for assessing long-term dietary intake. The instrument will be a useful tool in the analysis of diet–adenoma associations in the case–control study.
Saline pomphus around scalp arteries can block migraine pain

In our preceding letter , we reported that prolonged compression of scalp arteries can abort a migraine attack. In the attempt to explain the mechanism by which this occurs, we considered the possibility of an inhibitory effect on the periarterial visceral afferent nerve. We took into account the paper by Afridi et al. , who performed a single injection of 3 ml of 2 % lidocaine (plus 80 mg methylprednisolone) around the greater occipital nerve (GON) on 101 patients with primary headache, obtaining long-lasting complete or partial response in 26 of 57 injections in 54 migraineurs. However, they reported that only about half of the injections had an anesthetic effect in the area of the GON. We therefore supposed that the positive effect reported was due not to blocking the GON, but possibly to the involvement of the neighboring occipital artery and its periarterial visceral nervous afferents. On this basis, we decided to try a lidocaine injection around the occipital artery in the hope of aborting a migraine attack. A woman, 48 years old, affected with LETTER TO THE EDITORS
A randomized controlled trial of Koru: a mindfulness program for college students and other emerging adults.

To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults.



Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013.



Randomized controlled trial. It was hypothesized that Koru, compared with a wait-list control group, would reduce perceived stress and sleep problems, and increase mindfulness, self-compassion, and gratitude.



As hypothesized, results showed significant Group (Koru, Wait-List)×Time (Pre, Post) interactions for improvements in perceived stress (F[1, 76.40]=4.50, p=.037, d=.45), sleep problems (F [1, 79.49]=4.71, p=.033, d=.52), mindfulness (F [1, 79.09]=26.80, p<.001, d=95), and self-compassion (F[1, 74.77]=18.08, p<.001, d=.75). All significant effects were replicated in the wait-list group. Significant correlations were observed among changes in perceived stress, sleep problems, mindfulness, and self-compassion.



Results support the effectiveness of the Koru program for emerging adults in the university setting.
Gallopamil slow release: a double blind study of twice daily versus once daily treatment in chronic stable angina

The clinical efficacy of a new slow release preparation of the calcium antagonist gallopamil was assessed in 20 patients by diary cards and treadmill exercise tests. A single blind phase of two week periods of placebo, gallopamil 100 mg o.d. and gallopamil 100 mg b.i.d., blinded to the patient, was followed in 18 patients by a double blind comparison of gallopamil 100 mg od versus 100 mg b.i.d. Angina frequency and trinitrin consumption per week were both significantly less on high dose (2.7 and 1.7) than on low dose (5.4 and 3.4) respectively. Treadmill total exercise time was longer on high dose (523 s) than low dose (449 s). Other exercise test parameters showed similar improvements on high dose treatment. Gallopamil was well tolerated. PR interval correlated best with plasma gallopamil level, while exercise test parameters correlated best with the log plasma level of its major metabolite nor-gallopamil.
Usage of haloperidol for delirium in cancer patients

Although haloperidol is mainly used for the medical treatment of delirium in cancer patients, there are no universally accepted guidelines for its usage. We accordingly assessed the usefulness in managing delirium of a haloperidol treatment regimen in ten delirious cancer patients. The results of this preliminary study suggest that, in the management of delirium, appropriate usage of haloperidol on the first day is important as it affects the dosage thereafter.
Phase II study of docetaxel, capecitabine, and cisplatin as neoadjuvant chemotherapy for locally advanced breast cancer

Docetaxel, capecitabine, and cisplatin are effective chemotherapeutic agents for breast cancer with significant synergistic cytotoxicity demonstrated by in vitro studies. The purpose of this study was to assess the efficacy of a combination of docetaxel, capecitabine, and cisplatin (TXP) in patients diagnosed with locally advanced breast cancer (LABC). Patients (n = 42) with chemotherapy-naïve LABC (stage IIIa or IIIb) were enrolled. The chemotherapeutic regimen consisted of 4–6 cycles of intravenous docetaxel (60 mg/m2) and cisplatin (50 mg/m2) on day 1, plus oral capecitabine (1,800 mg/m2/day) on day 1–14, repeated every 3 weeks. Upon completion of therapy, the primary tumor was resected when not contraindicated. Median patient age was 48.5 years (range 31–66 years). Median tumor size was 6.8 cm (range 2.7–15 cm), 29 patients were node-positive, and 12 patients were hormone receptor positive. A total of 216 cycles (median 5; range 3–6 cycles) were administered without prophylactic G-CSF. The predominant toxicities were grade 3/4 neutropenia (30%/28%) and no grade 3/4 thrombocytopenia, febrile neutropenia, or grade 4 non-hematological toxicities were observed. Grade 3 non-hematological toxicities included hand-foot syndrome (5.6%) and vomiting (0.5%). The overall clinical response rate was 97.6% (41/42). Six of the 42 patients (14.3%) achieved a complete pathological response. Of 22 patients who completed 6 cycles of combination treatment, the complete pathological response was 27.3% (6/22). A combination of TXP can be administered safely without prophylactic G-CSF, and appears to be an effective neoadjuvant regimen in patients with LABC.
Trends in Hospital and Surgeon Volume and Operative Mortality for Cancer Surgery

We measured 13-year trends in operative mortality for six cancer resections. We then examined whether these trends are driven by changes in hospital and surgeon volume or by changes that occurred among all providers, regardless of volume. We analyzed administrative discharge data on patients who received one of six cancer resections in Florida, New Jersey, and New York for three time periods: 1988 to 1991, 1992 to 1996, and 1997 to 2000. Descriptive statistics and nested regression models were used to test for changes in the association between inpatient mortality and annual hospital and annual surgeon volume over time, adjusting for patient and hospital characteristics. Unadjusted inpatient mortality rates for the six cancer resections declined between .8 and 4.0 percentage points between the time periods 1988 to 1991 and 1997 to 2000. Over this time period, annual hospital and surgeon volumes for the six cancer operations increased an average of 24.3% and 24.2%, respectively. The logistic regressions indicated a relatively stable relationship over time between both increased hospital and surgeon volume and lower inpatient mortality. Simulations suggest that increases in hospital and surgeon procedure volume over time led to a reduction in inpatient mortality ranging from .1 percentage points for rectal cancer to 2.3 percentage points for pneumonectomy. Persistence of the volume-outcome relation and increasing hospital and surgeon volumes explain much of the decline over time in inpatient mortality for five of the six cancer operations studied. Concentrating cancer resections among high-volume providers should lead to further reduced inpatient mortality.
Tesetaxel, a new oral taxane, in combination with capecitabine: a phase I, dose-escalation study in patients with advanced solid tumors

This phase I study was conducted primarily to determine the maximum tolerated dose (MTD) of tesetaxel, a novel, orally active, semisynthetic microtubule inhibitor of the taxane class, administered with oral capecitabine to patients with advanced solid tumors. During each 21-day cycle, patients were to receive tesetaxel on Day 1 and capecitabine twice daily on Days 1 through 14. The starting dose was tesetaxel 18 mg/m2 and capecitabine 1,250 mg/m2/day. These doses were increased based on tolerability during the first cycle according to the protocol-specified dose-escalation scheme. Response was evaluated every other treatment cycle according to RECIST. Serial blood samples were collected during the first and second cycles to explore possible pharmacokinetic drug interactions. Twenty-seven patients were enrolled and treated. The most frequently reported dose-limiting toxicities were neutropenia and febrile neutropenia, with individual patients experiencing dose-limiting stomatitis and diarrhea. The MTD for the treatment regimen was defined as tesetaxel 27 mg/m2 and capecitabine 2,500 mg/m2/day. The most common ≥Grade 3 treatment-related adverse events included leukopenia (44% of patients) and neutropenia (41%). Of 22 evaluable patients, the best overall response was stable disease in 82% and progressive disease in 18%. No meaningful pharmacokinetic drug interactions were apparent. The results of this study demonstrate that these two orally active agents can be combined at the individual MTD of each drug with acceptable toxicity. These data further support the continued clinical development of tesetaxel both as a single agent and in combination with other active cancer therapeutics.
Variability in creatinine excretion in adult diabetic, overweight men and women: consequences on creatinine-based classification of renal disease.

It is crucial to estimate renal function in diabetic patients. However, formulas are inadequate in this population whereas creatinine clearance (C(cr)) on a 24-h urine collection may be valuable only if we can improve its reproducibility.



To evaluate in diabetic patients whether standardised procedures of 24-h urine collection improve the day-to-day variability in creatinine urinary excretion and the subsequent precision of the measured C(cr).



The C(cr) from two consecutive 24-h urine collections was measured in 201 consecutive diabetic inpatients. Procedures of 24-h urine collection were standardised, and implementation was supervised at a diabetes clinic.



Pearson's correlation coefficients of the two 24-h creatinine urinary excretion were significant (r(2)=0.64 in women and r(2)=0.65 in men, p<0.0001) but the daily variability in creatinine urinary excretion was high (14.9% in women and 17.4% in men). As a consequence, the agreement between the two consecutive measurements of C(cr) was poor. First, Bland-Altman plots showed large 95% limits of agreement (-34.3 to 34.6 mL/min/1.73 m(2) in women and -39.0 to 52.0 mL/min/1.73 m(2) in men). Secondly, there was a poor agreement for classifying patients according to the National Kidney Foundation classification >90, 60-89.9, 30-59.9, and <30 mL/min/1.73 m(2) (Kappa coefficients=0.61, 0.42, 0.65, and 0.74, respectively).



Despite standardised procedures of 24-h urine collection, day-to-day variability in creatinine urinary excretion in adult diabetic men and women remains important, and may lead to misclassification of renal disease.
Trends in suicidal behaviour in Dutch general practice 1983–2013: a retrospective observational study

To analyse trends in suicidal behaviour as reported by the Dutch sentinel general practices from 1983 to 2013. Second, to examine the relationship between suicidal behaviour and several patient characteristics. Finally, to compare the relationship between suicidal behaviour and patient characteristics before (1983-2007) and after (2008-2013) the start of the crisis.



40 general practices in the Netherlands during the period 1983-2013.



Patients with an ICPC code of P77 (suicide attempt).



Primary outcomes were age-adjusted and gender-specific trends in reported suicides (342) and suicide attempts (1614). Secondary outcomes were the relationship between suicidal behaviour and age, household composition, history of depression, recognition of suicide ideation, treatment before the suicidal behaviour and contact within the past month before suicidal behaviour for the period 1983-2013. Additionally, separate frequencies for the periods 1983-2007 and 2008-2013 were presented.



Join-point analyses revealed a significant rise in male suicides from 2008 (b=0.32, SE=0.1, p=0.008), and an increase in male suicide attempts since 2009 (b=0.19, SE=0.04, p<0.001). Female suicidal behaviour showed a steady decrease from 1989 to 2013(b=-0.03, SE=0.007, p<0.0001 for female suicide, b=-0.02, SE=0.002, p<0.001 for female attempts). Before 2007, a history of depression was reported in 65% (168/257) of the suicides. After the start of the recession, a depression was recognised in 44% (22/50) of the patients who died by suicide.



Since 2008, there was a rise in the male suicide rate while female suicide behaviour has continued to decline. General practitioners less often reported a history of depression within patients who died due to suicide after 2007 than before. Training in the early recognition of suicide ideation in depressive patients might improve suicide prevention in primary care.
Filmed v. live social contact interventions to reduce stigma: randomised controlled trial.

Direct social contact interventions are known to reduce mental health stigma. Filmed social contact may be equally effective and have practical and cost advantages.



To compare the effectiveness of a DVD, a live intervention and a lecture control, in reducing stigma, testing the hypotheses that: (a) DVD and live interventions will be equally effective; and (b) the interventions with social contact (DVD/live) will be more effective than the lecture. Cost-effectiveness, process and acceptability are also assessed.



Student nurses were randomised to: (a) watch a DVD of service users/informal carers talking about their experiences, (b) watch a similar live presentation, or (c) attend a lecture. Primary outcomes were changes in attitudes (using the Mental Illness: Clinicians Attitudes Scale, MICA), emotional reactions (using the Emotional Reactions to Mental Illness Scale, ERMIS), intended proximity (using the Reported and Intended Behaviour Scale, RIBS), and knowledge (using the Social Contact Intended Learning Outcomes, SCILO), immediately after the intervention and at 4-month follow-up.



For the 216 participants, there were no differences between the DVD and live groups on MICA, ERMIS or RIBS scores. The DVD group had higher SCILO (knowledge) scores. The combined social contact group (DVD/live) had better MICA and RIBS scores than the lecture group, the latter difference maintained at 4 months. The DVD was the most cost-effective of the interventions, and the live session the most popular.



Our hypotheses were confirmed. This study supports the wider use of filmed social contact interventions to reduce stigma about mental illness.
Phase I clinical trial of the use of zinc phthalocyanine tetrasulfonate as a photosensitizer for photodynamic therapy in dogs.

To determine the threshold for acute toxicosis of parenterally administered zinc phthalocyanine tetrasulfonate (ZnPcS(4)), a candidate second-generation photosensitizer, in mice and evaluate the compound's safety in a phase I clinical trial of ZnPcS(4)-based photodynamic therapy (PDT) in pet dogs with naturally occurring tumors.



Male Swiss-Webster mice and client-owned dogs with naturally occurring neoplasms.


PROCEDURES
For the study of acute toxicosis, mice were given graded doses of ZnPcS(4). To determine safety, a rapid-titration phase I clinical trial of ZnPcS(4)-based PDT in tumor-bearing dogs was conducted.



In mice, administration of >or= 100 mg of ZnPcS(4)/kg resulted in renal tubular necrosis 24 hours after IP injection. In tumor-bearing dogs, ZnPcS(4) doses <or= 4 mg/kg induced no signs of toxicosis and resulted in partial to complete tumor responses in 10 of 12 dogs 4 weeks after PDT. Tumor remission was observed with ZnPcS(4) doses as low as 0.25 mg/kg.



A conservative starting dose of ZnPcS(4) was arrived at on the basis of mouse toxicosis findings. Zinc phthalocyanine tetrasulfonate-based PDT was tolerated well by all dogs and warrants further study. The identification of the maximum tolerated dose through traditional phase I clinical trials may be unnecessary for evaluating novel PDT protocols.
HE4 and CA125 as a diagnostic test in ovarian cancer: prospective validation of the Risk of Ovarian Malignancy Algorithm

Recently, a Risk of Ovarian Malignancy Algorithm (ROMA) utilising human epididymis secretory protein 4 (HE4) and CA125 successfully classified patients as presenting a high or low risk for epithelial ovarian cancer (EOC). We validated this algorithm in an independent prospective study.Women with a pelvic mass, who were scheduled to have surgery, were enrolled in a prospective study. Preoperative serum levels of HE4 and CA125 were measured in 389 patients. The performance of each of the markers, as well as that of ROMA, was analysed.When all malignant tumours were included, ROMA (receiver operator characteristic (ROC)-area under curve (AUC)=0.898) and HE4 (ROC-AUC)=0.857) did not perform significantly better than CA125 alone (ROC–AUC=0.877). Using a cutoff for ROMA of 12.5% for pre-menopausal patients, the test had a sensitivity of 67.5% and a specificity of 87.9%. With a cutoff of 14.4% for post-menopausal patients, the test had a sensitivity of 90.8% and a specificity of 66.3%. For EOC vs benign disease, the ROC–AUC of ROMA increased to 0.913 and for invasive EOC vs benign disease to 0.957.Conclusion:This independent validation study demonstrated similar performance indices to those recently published. However, in this study, HE4 and ROMA did not increase the detection of malignant disease compared with CA125 alone. Although the initial reports were promising, measurement of HE4 serum levels does not contribute to the diagnosis of ovarian cancer.