nils-herrmann/clean_scirepeval huggingface dataset:
Stents in patients with esophageal cancer before chemoradiotherapy: high risk of complications and no impact on the nutritional status

Preoperative chemoradiotherapy is the standard of care for locally advanced esophageal cancer, causing persistent deterioration in the nutritional status. We performed a prospective study to evaluate the safety and efficacy of esophageal double-covered self-expandable metal stents in patients with esophageal cancer before chemoradiotherapy. The nutritional status and dysphagia were prospectively recorded. Eleven patients were included: eight were moderate and three were severely malnourished. After stent placement, dysphagia improved in all patients. With regard to complications, one patient developed an esophageal perforation that required urgent esophagectomy. Four patients presented stent migration. Three of these patients required enteral nutrition and none was submitted to surgery because of poor nutritional status. Of the other six patients, only four were operated upon. Stent placement presented a high complication rate and did not prevent weight loss or malnutrition. Other alternatives, including naso-gastric tube placement or endoscopic percutaneous gastrostomy or jejunostomy, should be considered.
Report of a phase I evaluation of dose and schedule of interleukin-1 alpha and cyclophosphamide in patients with advanced tumors: An Eastern Cooperative Oncology Group study (PX990) and review of IL-1-based studies of hematopoietic reconstitution.

Interleukin-1 (IL-1) is a cytokine critical to inflammation, immunological activation, response to infection, and bone marrow hematopoiesis. Cyclophosphamide downmodulates immune suppressor cells and is cytotoxic to a variety of tumors. A phase I trial of IL-1 and cyclophosphamide was conducted by the Eastern Cooperative Oncology Group. This study evaluated 3 dose levels and 3 schedules in patients with solid tumors. The goal was to evaluate the hematopoietic supportive care effect and possible antitumor effect. Toxicity was fever, chills, hypotension, nausea/emesis, hepatic, and neutropenia. Toxicity increased with dose increases of interleukin-1. Treatment at all dose levels resulted in significant increases in total white blood cell (WBC) counts above baseline. Nadir WBC and nadir absolute neutrophil counts were not significantly different by dose level of IL-1 or schedule of IL-1. Toxicity due to IL-1 at higher doses prohibited further evaluation of this agent for hematopoietic support, particularly in view of the activity and tolerability of more lineage-specific hematopoietic cytokines. Therapeutic interventions in the role of IL-1 in inflammatory conditions and cancer may be further informed by our definition of its clinical and biological effects in this evaluation of dose and schedule.
The comparative effectiveness of Integrated treatment for Substance abuse and Partner violence (I-StoP) and substance abuse treatment alone: a randomized controlled trial

Research has shown that treatments that solely addressed intimate partner violence (IPV) perpetration were not very effective in reducing IPV, possibly due to neglecting individual differences between IPV perpetrators. A large proportion of IPV perpetrators is diagnosed with co-occurring substance use disorders and it has been demonstrated that successful treatment of alcohol dependence among alcohol dependent IPV perpetrators also led to less IPV. The current study investigated the relative effectiveness of Integrated treatment for Substance abuse and Partner violence (I-StoP) to cognitive behavioral treatment addressing substance use disorders including only one session addressing partner violence (CBT-SUD+) among patients in substance abuse treatment who repeatedly committed IPV. Substance use and IPV perpetration were primary outcome measures.



Patients who entered substance abuse treatment were screened for IPV. Patients who disclosed at least 7 acts of physical IPV in the past year (N = 52) were randomly assigned to either I-StoP or CBT-SUD+. Patients in both conditions received 16 treatment sessions. Substance use and IPV perpetration were assessed at pretreatment, halfway treatment and posttreatment in blocks of 8 weeks. Both completers and intention-to-treat (ITT) analyses were performed.



Patients (completers and ITT) in both conditions significantly improved regarding substance use and IPV perpetration at posttreatment compared with pretreatment. There were no differences in outcome between conditions. Completers in both conditions almost fully abstained from IPV in 8 weeks before the end of treatment.



Both I-StoP and CBT-SUD+ were effective in reducing substance use and IPV perpetration among patients in substance abuse treatment who repeatedly committed IPV and self-disclosed IPV perpetration. Since it is more cost and time-effective to implement CBT-SUD+ than I-StoP, it is suggested to treat IPV perpetrators in substance abuse treatment with CBT-SUD+.
Melbourne Assessment of Unilateral Upper Limb Function: construct validity and correlation with the Pediatric Evaluation of Disability Inventory.

The Melbourne Assessment of Unilateral Upper Limb Function (Melbourne Assessment) is an evaluation tool that objectively measures upper-extremity function in children with cerebral palsy (CP). This study investigates how well performance on the Melbourne Assessment relates to the child's actual performance in functional tasks. Eighteen children with CP (5 to 14 years of age; nine males, nine females) were assessed using the Melbourne Assessment and the Pediatric Evaluation of Disability Inventory (PEDI). Five children had spastic quadriplegia, eight had spastic diplegia, two had spastic hemiplegia and diplegia, two had athetosis, and one had hypotonic quadriplegia with mobile ventilator dependence. Children's performances were statistically correlated using Spearman's rho to establish the relation between these tools. Very high correlation coefficients were calculated between the Melbourne Assessment and self-care (0.939) and mobility domains (0.783) of the PEDI and the overall functional skills section of the PEDI (0.718). The Melbourne Assessment demonstrates excellent construct validity for upper limb functioning.
Low dose nesiritide and the preservation of renal function in patients with renal dysfunction undergoing cardiopulmonary-bypass surgery: a double-blind placebo-controlled pilot study.

Renal insufficiency is associated with increased morbidity and mortality after cardiopulmonary bypass cardiac surgery. B-type natriuretic peptide is a cardiac hormone that enhances glomerular filtration rate and inhibits aldosterone. Cystatin has been shown to be a better endogenous marker of renal function than creatinine.



We performed a double-blinded placebo-controlled proof of concept pilot study in patients (n=40) with renal insufficiency preoperatively (defined as an estimated creatinine clearance of <60 mL/min determined by the Cockroft-Gault formula), undergoing cardiopulmonary bypass cardiac surgery. Patients were randomized to placebo (n=20) or i.v. low dose nesiritide (n=20; 0.005 microg/Kg/min) for 24 hours started after the induction of anesthesia and before cardiopulmonary bypass. Patients in the nesiritide group had an increase of plasma B-type natriuretic peptide and its second messenger cGMP with a decrease in plasma cystatin levels at the end of the 24-hour infusion. These changes were not observed in the placebo group. There was a significant activation of aldosterone in the placebo group at the end of the 24-hour infusion, but not in the nesiritide group. At 48 and 72 hours, there was a decrease in estimated creatinine clearance and an increase in plasma cystatin as compared with end of the 24-hour infusion in the placebo group. In contrast, renal function was preserved in the nesiritide group with no significant change in estimated creatinine clearance and a trend for plasma cystatin to increase as compared with end of the 24-hour infusion.



This proof of concept pilot study supports the conclusion that perioperative administration of low dose nesiritide is biologically active and decreases plasma cystatin in patients with renal insufficiency undergoing cardiopulmonary bypass cardiac surgery. Further studies are warranted to determine whether these physiological observations can be translated into improved clinical outcomes.
β-defensin genomic copy number is associated with HIV load and immune reconstitution in sub-saharan Africans.

AIDS, caused by the retrovirus human immunodeficiency virus (HIV), is the leading cause of death of economically active people (age, 15-59 years) in sub-Saharan Africa. The host genetic variability of immune response to HIV and immune reconstitution following initiation of highly active antiretroviral therapy (HAART) is poorly understood. Here we focused on copy number variation of the β-defensin genes, which have been shown to have anti-HIV activity, and are important chemoattractants for Th17 lymphocytes via the chemokine receptor CCR6. We determined β-defensin gene copy number for 1002 Ethiopian and Tanzanian patients. We show that higher β-defensin copy number variation is associated with increased HIV load prior to HAART (P=.005) and poor immune reconstitution following initiation of HAART (P=.003). We suggest a model where variable amounts of β-defensin expression by mucosal cells, due to gene copy number variation, alters the efficacy of recruitment of Th17 lymphocytes to the site of infection, altering the dynamics of infection.
Preliminary report of a phase I study of combination chemotherapy and humanized A33 antibody immunotherapy in patients with advanced colorectal cancer.

In previous studies, humanized A33 (huA33) demonstrated modest antitumor activity in chemotherapy-resistant colorectal cancer patients. In addition, unexpected major tumor responses were observed in patients treated with a specific chemotherapy regimen [carmustine, vincristine, fluorouracil, and streptozocin (BOF-Strep)] administered after huA33 protocols. We designed the present Phase I, open label, cohort, dose-escalation study of huA33 and a fixed dose of BOF-Strep to (a) determine the maximum tolerated dose of huA33 immunotherapy administered with chemotherapy, (b) determine whether chemotherapy modifies huA33 immunogenicity, and (c) develop preliminary information regarding antitumor activity.



Stage IV fluorouracil/leucovorin and irinotecan-refractory colorectal cancer patients (n = 16) received escalating weekly doses of huA33 (5-40 mg/m(2)) with BOF-Strep chemotherapy.



Four patients requiring radiotherapy or surgery were removed early. Of 12 evaluable patients, grade 3 and 4 neutropenia (n = 2) and grade 3 thrombocytopenia (n = 1) were observed. Seven of 12 (58.3%) patients developed anti-huA33 activity. Three patients had radiographic partial responses for 7.5, 5.5, and 14 months with greater than 85% decline in serum carcinoembryonic antigen levels. One mixed response (4.5 months with a serum carcinoembryonic antigen decline of 38%) was also observed.



huA33 can be safely combined with BOF-Strep chemotherapy. The present report provides compelling evidence supporting our previous observations of major antitumor activity with the combination of huA33 and BOF-Strep chemotherapy. huA33 is still immunogenic when administered with chemotherapy. Future studies to evaluate the immunogenicity of new huA33 antibodies and identify which drugs in the BOF-Strep regimen are critical for enhanced antitumor efficacy are planned.
Brief supportive-expressive group therapy for partners of men with early stage prostate cancer: lessons learned from a negative randomized controlled trial

The purpose of this paper is to report the results of a negative randomized controlled trial, which piloted brief supportive-expressive therapy (SET) for partners of men with prostate cancer, and to discuss lessons learned for future clinical trials. Partners of men with newly diagnosed, non-metastatic prostate cancer were randomized to SET (n = 45) or usual care (n = 32). SET involved six weekly group sessions emphasizing emotional expression, social support, and finding meaning in the cancer experience. Measures of mood disturbance, marital satisfaction, and social support were administered to both partners and patients at baseline, post-program, and at 3- and 6-month follow-up. There were no significant differences between SET and the control group for either patients or their wives on any outcome. Regardless of group membership, partners reported improvements in total mood disturbance (p = .011), tension (p < .001), anger (p = .041), confusion (p < .001), state anxiety (p = .001), and emotional support (p = .037), and patients reported improvements in tension (p = .003), emotional support (p = .047), positive interaction support (p = .004), and overall social support (p = .026). Compared to the natural course of recovery, SET did not improve psychosocial outcomes for either men with prostate cancer or their wives. Methodological challenges experienced in implementing this trial yield valuable lessons for future research, including designing interventions relevant to unique problems faced by specific groups, being closely guided by previous research, and the potential utility of screening for distress as an inclusion criteria in intervention trials.
Prevalence and incidence of human immunodeficiency virus among patients undergoing long-term hemodialysis

20:799-809 3. Brenner RJ, Spring DB, Sebastian A, McSherry E, Gennaut HK, Palubinskas AJ, Morris RC Jr (1982) Incidence of radiographically evident bone disease, nephrocalcinosis and nephrolithiasis in various types of renal tubular acidosis.  307:217 -221 4. Buchanan EU, Komrower GM (1958) The prognosis of idiopathic renal acidosis in infancy with observation on urine acidification and ammonia production in children.  Leumann EP, Steinmarm B (1975) Persistent and transient distal renal acidosis with bicarbonate wasting. Pediatr Res 9:767-773 6. Lather AL, Buruard ED (1950) Idiopathic hyperchloremic acidosis of infants. Q J Med 76: 285301 7. Nash MA, Torrado AD, Greifer I, Spitzer A, Edelman CM (1972) Renal tubular acidosis in infants and children. J Pediatr 80:738-748 8. Barakat AY, Der Kaloustian VM, Mufarrij AM, Birbari AE (1986) The kidney in genetic disease, abnormalities of kidney function, 1st edn. Churchill Livingstone, Edinburgh, pp 50-66
Omega-3 fatty acid treatment, with or without cytidine, fails to show therapeutic properties in bipolar disorder: a double-blind, randomized add-on clinical trial.

This study aimed to test the effects of omega-3 fatty acids (O3FA), given as fish oil capsules, with and without oral cytidine (CYT), a pyrimidine with reported preclinical and clinical antidepressant-like effects, in patients with bipolar disorder (BD).



A total of 45 outpatients with diagnosed BD (type I) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision, were recruited for this 4-month, randomized, double-blind, placebo-controlled, add-on study. Treatment groups were (1) oral CYT + O3FA, (2) placebo + O3FA, and (3) placebo + placebo control. O3FA was given 2 g twice a day and CYT was administered as 1 g twice a day.



There was no statistically significant difference among the groups in the primary outcome: study retention. Clinical measures improved in all treatment groups, and there were no significant differences between groups, including change in probability of symptoms of depression or mania, change in positive ratings of depression or mania, or change in Global Assessment of Functioning scores. Neither CYT + O3FA nor placebo + O3FA treatment was superior to placebo treatment. Rather, there was a statistically nonsignificant trend for both groups treated with O3FA to do worse than the placebo group.



Despite preclinical studies suggesting that the effect of O3FA might be augmented with pyrimidines, add-on CYT did not substantially improve mood symptoms in BD. In addition, although a power analysis indicated that the sample size would be adequate to see beneficial effects similar to those previously reported, O3FA treatment by itself was not superior to placebo for BD.
Sex differences in aortic valve calcification measured by multidetector computed tomography in aortic stenosis.

Aortic valve calcification (AVC) is the intrinsic mechanism of valvular obstruction leading to aortic stenosis (AS) and is measurable by multidetector computed tomography. The link between sex and AS is controversial and that with AVC is unknown.



We prospectively performed multidetector computed tomography in 665 patients with AS (aortic valve area, 1.05±0.35 cm(2); mean gradient, 39±19 mm Hg) to measure AVC and to assess the impact of sex on the AVC-AS severity link in men and women. AS severity was comparable between women and men (peak aortic jet velocity: 4.05±0.99 versus 3.93±0.91 m/s, P=0.11; aortic valve area index: 0.55±0.20 versus 0.56±0.18 cm(2)/m(2); P=0.46). Conversely, AVC load was lower in women versus men (1703±1321 versus 2694±1628 arbitrary units; P<0.0001) even after adjustment for their smaller body surface area or aortic annular area (both P<0.0001). Thus, odds of high-AVC load were much greater in men than in women (odds ratio, 5.07; P<0.0001). Although AVC showed good associations with hemodynamic AS severity in men and women (all r>0.67; P<0.0001), for any level of AS severity measured by peak aortic jet velocity or aortic valve area index, AVC load, absolute or indexed, was higher in men versus women (all P≤0.01).



In this large AS population, women incurred similar AS severity than men for lower AVC loads, even after indexing for their smaller body size. Hence, the relationship between valvular calcification process and AS severity differs in women and men, warranting further pathophysiological inquiry. For AS severity diagnostic purposes, interpretation of AVC load should be different in men and in women.
Relationship of Plasma N‐terminal Pro‐brain Natriuretic Peptide Concentrations to Heart Failure Classification and Cause of Respiratory Distress in Dogs Using a 2nd Generation ELISA Assay

Cardiac biomarkers provide objective data that augments clinical assessment of heart disease (HD).



Determine the utility of plasma N-terminal pro-brain natriuretic peptide concentration [NT-proBNP] measured by a 2nd generation canine ELISA assay to discriminate cardiac from noncardiac respiratory distress and evaluate HD severity.



Client-owned dogs (n = 291).



Multicenter, cross-sectional, prospective investigation. Medical history, physical examination, echocardiography, and thoracic radiography classified 113 asymptomatic dogs (group 1, n = 39 without HD; group 2, n = 74 with HD), and 178 with respiratory distress (group 3, n = 104 respiratory disease, either with or without concurrent HD; group 4, n = 74 with congestive heart failure [CHF]). HD severity was graded using International Small Animal Cardiac Health Council (ISACHC) and ACVIM Consensus (ACVIM-HD) schemes without knowledge of [NT-proBNP] results. Receiver-operating characteristic curve analysis assessed the capacity of [NT-proBNP] to discriminate between dogs with cardiac and noncardiac respiratory distress. Multivariate general linear models containing key clinical variables tested associations between [NT-proBNP] and HD severity.



Plasma [NT-proBNP] (median; IQR) was higher in CHF dogs (5,110; 2,769-8,466 pmol/L) compared to those with noncardiac respiratory distress (1,287; 672-2,704 pmol/L; P < .0001). A cut-off >2,447 pmol/L discriminated CHF from noncardiac respiratory distress (81.1% sensitivity; 73.1% specificity; area under curve, 0.84). A multivariate model comprising left atrial to aortic ratio, heart rate, left ventricular diameter, end-systole, and ACVIM-HD scheme most accurately associated average plasma [NT-proBNP] with HD severity.



Plasma [NT-proBNP] was useful for discriminating CHF from noncardiac respiratory distress. Average plasma [NT-BNP] increased significantly as a function of HD severity using the ACVIM-HD classification scheme.
GnRH Agonist Therapy to Protect Ovarian Function in Young Korean Breast Cancer Patients

The increased survival of patients with breast cancer has given rise to other problems associated with the complications of chemotherapy. One major complication is premature ovarian failure, an especially harmful outcome for women of reproductive age. This study was performed to evaluate the efficacy of GnRH agonist (GnRHa) treatment on protecting ovarian function in young breast cancer patients (30.59+/-5.1 yr) receiving chemotherapy after surgery. Twenty-two women were enrolled and given subcutaneous injections of leuprolide acetate (3.75 mg) every 4 weeks during chemotherapy. Follow-up laboratory tests (luteinizing hormone [LH], follicle stimulating hormone [FSH], and estradiol) were performed 1, 3, and 6 months after chemotherapy. Menstruation patterns and clinical symptoms were followed up for a mean duration of 35.6+/-1.7 months. FSH and LH levels were normal in all patients 6 months after completing chemotherapy (8.0+/-5.3, 4.4+/-2.7 mIU/mL, respectively). During follow-up, none of the patients complained of menopausal symptoms and 81.8% experienced recovery of menstruation. This report is the first trial of GnRHa as a treatment modality to protect ovarian function during adjuvant chemotherapy in young Korean breast cancer patients.
Medical and psychosocial predictors of mechanical circulatory support device implantation and competing outcomes in the Waiting for a New Heart Study.

Medical and psychosocial factors are related to 1-year outcomes in the Waiting for a New Heart Study. With increased use of mechanical circulatory support devices (MCSD) over the course of the study, we can now evaluate these variables as predictors of MCSD in an extended follow-up.



Analyses focused on 313 MCSD-free patients (82% men; aged 53 ± 11 years) newly listed for heart transplantation (HTx). Variables assessed at time of listing included psychosocial risk (depression, social isolation), quality of life, waiting list stress, and medical risk (Heart Failure Survival Score, pulmonary capillary wedge pressure). Cumulative incidence functions and cause-specific Cox models examined the association of medical and psychosocial risk (low: non-depressed and socially integrated; medium: depressed or socially isolated; high: depressed and socially isolated) with time until MCSD, considering covariates and competing outcomes (death, high-urgency transplantation [HU-HTx], elective HTx, and delisting due to clinical improvement or deterioration).



Psychosocial risk groups were comparable regarding demographics, medical parameters, and quality of life, but differed in waiting list-related stressors. During follow-up (median, 326; range, 5-1,849 days), 26 patients received MCSD, 53 died, 144 underwent HTx (103 in HU status), and 53 were delisted (15 deteriorated, 31 improved). Non-depressed and socially integrated patients did not require MCSD. Controlling for medical risk, psychosocial risk significantly contributed to MCSD, HU-HTx, and improvement; medical risk and female gender predicted death (p < 0.05).



Psychosocial risk at time of listing affects the prognosis of HTx candidates beyond medical risk. Psychosocial interventions may help to stabilize patients' health.