nils-herrmann/clean_scirepeval huggingface dataset:
Impact of S-1 in patients with gemcitabine-refractory pancreatic cancer in Japan.

We investigated the impact of S-1 on the prognosis of patients with gemcitabine-refractory pancreatic cancer.



A total of 108 patients with gemcitabine-refractory pancreatic cancer were divided by the time of S-1 introduction in our institution: 47 patients who experienced progressive disease before February 2005 (pre-S-1 group) and 61 patients showed progressive disease after February 2005 (post-S-1 group). Introduction rates of second-line chemotherapy and survival were compared. Prognostic factors for residual survival were analyzed using the Cox proportional hazards model.



Introduction rates of second-line chemotherapy were 12.8% in the pre-S-1 group and 45.9% in the post-S-1 group. Second-line chemotherapy was administered to 34 patients: 29 using S-1, 4 using 5-fluorouracil-based chemoradiation and 1 using 5-fluorouracil. The objective response rate, progression-free survival and overall survival for second-line chemotherapy with S-1 were 17.2%, 2.5 and 7.7 months, respectively. By the introduction of S-1 in our institution, residual survival was prolonged from 3.1 months in the pre-S-1 group to 6.7 months in the post-S-1 group (P < 0.001). Overall survival from the initiation of gemcitabine was 8.8 months in the pre-S-1 group and 11.3 months in the post-S-1 group (P = 0.013). Multivariate analysis identified the post-S-1 group (hazard ratio, 0.43; P = 0.001), gender, performance status, liver metastasis, and lactate dehydrogenase and C-reactive protein levels at progressive disease for gemcitabine to be prognostic factors for residual survival.



The introduction of S-1 might improve the prognosis of patients with gemcitabine-refractory pancreatic cancer.
Efficacy and safety of remifemin compared to tibolone for controlling of perimenopausal symptoms ]

To investigate the efficacy and safety of remifemin (isopropanolic extract of cimicifuga racemosa) treating perimenopausal symptoms in comparison of tibolone. One hundred and eighty postmenopausal women at range of 40 60 years old were enrolled in a multicenter, randomized and double blind study. They were divided into remifemin and tibolone group at ratio 1:1. The therapeutic strategy was remifemin 20 mg bid po for 12 weeks in remifemin group and tibolone 2.5 mg qd po for 12 weeks in tibolone group. To evaluate therapeutic effect, total score of Kupperman menopause index (KMI) was used as the major observed index and single item score of KMI were secondary observed index. Safety warning was determined by laboratory tests and adverse events at timepoint of before, at 4 and 12 weeks treatment. (1) Total score of KMI: it were 24 +/5 in remifemin group and 25 +/6 in tibolone group before treatment. At timepoint of 4 weeks treatment, it were 11 +/6 in remifemin group and 11 +/7 in tibolone group. At timepoint of 12 weeks treatment, it were 7 +/6 in remifemin group and 6 +/5 in tibolone group. Total KMI score between two groups did not show statistical difference at various timepoint (P > 0.05). (2) Single item score of KMI: when compared before, at 4 and 12 weeks treatment, did show remarkable difference (P < 0.05) either in remifemin or in tibolone group. However, those single items of KMI score did not show statistical difference between 4 and 12 weeks timepoint in each treatment group (P > 0.05). (3) Adverse effect: the incidence of adverse effect in remifemin group was significantly lower than that of tibolone group. None case with vaginal bleeding was observed in remifemin group, however, 17 cases with vaginal bleeding occurred in tibolone group (19%, 17/90). The incidence of breast swelling were 16% (14/90) in remifemin group and 36% (32/90) in tibolone group; before treatment, the thickness of endometrium were (2.6 +/1.1) mm in remifemin group and (2.8 +/1.1) mm in tibolone group; at timepoint of 12 weeks treatment, the thickness of endometrium were (2.9 +/1.4) mm in remifemin group and (3.4 +/2.0) mm in tibolone group. In comparison of thickness of endometrium before and at 12 weeks treatment, no remarkable changes was observed in remifemin group, however, endometrium displayed significantly thicker in tibolone group. Our study suggested that remifemin was one effective and safe agent to manage women with climacteric symptom. It has similar therapeutic effect and lower incidence of adverse effect when compared with tibolone.  2009] PubMed NCBI 2/2 www.ncbi.nlm.nih.gov/pubmed/20003788 PMID: 20003788 [PubMed indexed for MEDLINE] Publication Types, MeSH Terms, Substances LinkOut more resources
Intraoperative brief electrical stimulation (BES) for prevention of shoulder dysfunction after oncologic neck dissection: study protocol for a randomized controlled trial

Shoulder pain and dysfunction are common after oncologic neck dissection for head and neck cancer (HNC), due to traction, compression, and devascularization injuries to the spinal accessory nerve (SAN). Shoulder pain and dysfunction can hinder postoperative rehabilitation and hygiene, activities of daily living (ADLs), and return to work after treatment for HNC. Due to the rising incidence of human papillomavirus (HPV)-associated oropharyngeal cancer, patients are often diagnosed in the third or fourth decade of life, leaving many potential working years lost if shoulder dysfunction occurs. Brief electrical stimulation (BES) is a novel technique that has been shown to enhance and accelerate neuronal regeneration after injury through a brain-derived neurotrophic growth factor (BDNF)-driven molecular pathway in multiple peripheral nerves in both humans and animals.



This is a randomized controlled trial testing the effect of intraoperative BES on postoperative shoulder pain and dysfunction. All adult participants with a new diagnosis of HNC undergoing surgery with neck dissection, including Level IIb and postoperative radiotherapy, will be enrolled. Participants will undergo intraoperative BES after completion of neck dissection for 60 min continuously at 20 Hz, 3 to 5 V, in 100-msec pulses. Postoperatively, participants will be evaluated using the Constant-Murley Shoulder Score, a scale that assesses shoulder pain, ADLs, strength, and range of motion. Secondary outcomes measured will include nerve conduction studies (NCS) and electromyographic (EMG) studies, as well as scores on the Oxford Shoulder Score (OSS), the Neck Dissection Impairment Index (NDII), and the University of Washington Quality of Life (UW-QOL) score. Primary and secondary outcomes will be assessed at 6 weeks, 3 months, 6 months, and 12 months.



The objective of this study is to evaluate the effect of BES on postoperative clinical and objective shoulder functional outcomes and pain after oncologic neck dissection. BES has been shown to be successful in accelerating peripheral nerve regeneration in both animal and human participants in multiple different peripheral nerves. If successful, this technique may provide an adjunctive prevention option for shoulder pain and dysfunction in HNC patients.
Symptom Trajectories After an Emergency Department Visit for Potential Acute Coronary Syndrome.

Many patients evaluated for acute coronary syndrome (ACS) in emergency departments (EDs) continue to experience troubling symptoms after discharge-regardless of their ultimate medical diagnosis. However, comprehensive understanding of common post-ED symptom trajectories is lacking.



The aim of this study was to identify common trajectories of symptom severity in the 6 months after an ED visit for potential ACS.



This was a secondary analysis of data from a larger observational, prospective study conducted in five U.S. EDs. Patients (N = 1005) who had electrocardiogram and biomarker testing ordered, and were identified by the triage nurse as potentially having ACS, were enrolled. Symptom severity was assessed in the hospital after initial stabilization and by telephone at 30 days and 6 months using the validated 13-item ACS Symptom Checklist. Growth mixture modeling was used for the secondary analysis. The eight most commonly reported symptoms (chest discomfort, chest pain, chest pressure, light-headedness, shortness of breath, shoulder pain, unusual fatigue, and upper back pain) were modeled across the three study time points. Models with increasing numbers of classes were compared, and final model selection was based on a combination of interpretability, theoretical justification, and statistical fit indices.



The sample was 62.6% male with a mean age of 60.2 years (SD = 14.17 years), and 57.1% ruled out for ACS. Between two and four distinct trajectory classes were identified for each symptom. The seven different types of trajectories identified across the eight symptoms were labeled "tapering off," "mild/persistent," "moderate/persistent," "moderate/worsening," "moderate/improving," "late onset, "and "severe/improving." Trajectories differed on age, gender, and diagnosis.



Research on the individual nature of symptom trajectories can contribute to patient-centered, rather than disease-centered, care. Further research is needed to verify the existence of multiple symptoms trajectories in diverse populations and to assess the antecedents and consequences of individual symptom trajectories.
Factors associated with completion of a behavioral intervention for caregivers of urban children with asthma.

Rates of preventive follow-up asthma care after an acute emergency department (ED) visit are low among inner-city children. We implemented a novel behavioral asthma intervention, Pediatric Asthma Alert (PAAL) intervention, to improve outpatient follow-up and preventive care for urban children with a recent ED visit for asthma.



The objective of this article is to describe the PAAL intervention and examine factors associated with intervention completers and noncompleters.



Children with persistent asthma and recurrent ED visits (N = 300) were enrolled in a randomized controlled trial of the PAAL intervention that included two home visits and a facilitated follow-up visit with the child's primary care provider (PCP). Children were categorized as intervention completers, that is, completed home and PCP visits compared with noncompleters, who completed at least one home visit but did not complete the PCP visit. Using chi-square test of independence, analysis of variance, and multiple logistic regression, the intervention completion status was examined by several sociodemographic, health, and caregiver psychological variables.



Children were African-American (95%), Medicaid insured (91%), and young (aged 3-5 years, 56%). Overall, 71% of children randomized to the intervention successfully completed all home and PCP visits (completers). Factors significantly associated with completing the intervention included younger age (age 3-5 years: completers, 65.4%; noncompleters, 34.1%; p < .001) and having an asthma action plan in the home at baseline (completers: 40%; noncompleters: 21%; p = .02). In a logistic regression model, younger child age, having an asthma action plan, and lower caregiver daily asthma stress were significantly associated with successful completion of the intervention.



The majority of caregivers of high-risk children with asthma were successfully engaged in this home and PCP-based intervention. Caregivers of older children with asthma and those with high stress may need additional support for program completion. Further, the lack of an asthma action plan may be a marker of preexisting barriers to preventive care.
Prognostic Value of Plasma Epstein-Barr Virus DNA for Local and Regionally Advanced Nasopharyngeal Carcinoma Treated With Cisplatin-Based Concurrent Chemoradiotherapy in Intensity-Modulated Radiotherapy Era.

This study aimed to evaluate the prognostic value of plasma Epstein-Barr Virus DNA (EBV DNA) for local and regionally advanced nasopharyngeal carcinoma (NPC) patients treated with concurrent chemoradiotherapy in intensity-modulated radiotherapy (IMRT) era.In this observational study, 404 nonmetastatic local and regionally advanced NPC patients treated with IMRT and cisplatin-based concurrent chemotherapy were recruited. Blood samples were collected before treatment for examination of plasma EBV DNA levels. We evaluated the association of pretreatment plasma EBV DNA levels with progression-free survival rate (PFS), distant metastasis-free survival rate (DMFS), and overall survival rate (OS).Compared to patients with an EBV DNA level < 4000  copies/mL, patients with an EBV DNA ≥ 4000  copies/mL had a lower rate of 3-year PFS (76%, 95% CI [68-84]) versus (93%, 95% CI [90-96], P < 0.001), DMFS (83%, 95% CI [76-89]) versus (97%, 95% CI [94-99], P < 0.001), and OS (85%, 95% CI [78-92]) versus (98%, 95% CI [95-100], P < 0.001). Multivariate analysis showed that pretreatment EBV DNA levels (HR = 3.324, 95% CI, 1.80-6.138, P < 0.001) and clinical stage (HR = 1.878, 95% CI, 1.036-3.404, P = 0.038) were the only independent factor associated with PFS, pretreatment EBV DNA level was the only significant factor to predict DMFS (HR = 6.292, 95% CI, 2.647-14.956, P < 0.001), and pretreatment EBV DNA levels (HR = 3.753, 95% CI, 1.701-8.284, P < 0.001) and clinical stage (HR = 2.577, 95% CI, 1.252-5.050, P = 0.010) were significantly associated with OS. In subgroup analysis, higher plasma EBV DNA levels still predicted a worse PFS, DMFS, and OS for the patients stage III or stage IVa-b, compared with those with low EBV DNA levels.Elevated plasma EBV DNA was still effective prognostic biomarker for local and regionally advanced NPC patients treated with IMRT and cisplatin-based concurrent chemotherapy. Future ramdomized clinical trials are needed to further evaluate whether plasma EBV DNA levels could be applied to guide concurrent chemotherapy regimen for local and regionally advanced NPC patients.
Farnesyltransferase inhibitor tipifarnib is well tolerated, induces stabilization of disease, and inhibits farnesylation and oncogenic/tumor survival pathways in patients with advanced multiple myeloma.

Patients with multiple myeloma (MM) with mutated RAS are less likely to respond to chemotherapy and have a shortened survival. Therefore, targeting RAS farnesylation may be a novel approach to treatment of MM. We evaluated the activity and tolerability of the farnesyltransferase (FTase) inhibitor tipifarnib (Zarnestra) in a phase 2 trial as well as its ability to inhibit protein farnesylation and oncogenic pathways in patients with relapsed MM. Forty-three patients (median age, 62 years [range, 33-82 years]) with a median of 4 (range, 1-6) chemotherapy regimens entered the study. Tipifarnib, 300 mg orally twice daily, was administered for 3 weeks every 4 weeks. The most common toxicity was fatigue occurring in 66% of patients. Other toxicities included diarrhea, nausea, neuropathy, anemia, and thrombocytopenia. Sixty-four percent of the patients had disease stabilization. Treatment with tipifarnib suppressed FTase (but not geranylgeranyltransferase I) in bone marrow and peripheral blood mononuclear cells and also inhibited the farnesylation of HDJ-2 in unfractionated mononuclear cells and purified myeloma cells. Inhibition of farnesylation did not correlate with disease stabilization. Finally, tipifarnib decreased the levels of phosphorylated Akt and STAT3 (signal transducer and activator of transcription 3) but not Erk1/2 (extracellular signal regulated kinase 1 and 2) in bone marrow cells. We conclude that tipifarnib is tolerable, can induce disease stabilization, and can inhibit farnesylation and oncogenic/tumor survival pathways.
Abciximab attenuates coronary microvascular endothelial dysfunction after coronary stenting.

Platelet glycoprotein IIb/IIIa receptor blockade with abciximab decreases ischemic events after percutaneous coronary intervention (PCI); however, the mechanism of this benefit has not been fully elucidated. The present study was designed to assess endothelium-dependent vasomotion after coronary stenting and to determine if abciximab alters this response.



The study group consisted of 48 patients (59+/-10 years of age) with discrete coronary stenoses who underwent stenting alone (n=28) or stenting plus abciximab (n=20). A control group consisted of 31 additional patients who had vasomotor testing on a non-PCI vessel. Coronary blood flow (CBF) was measured (0.014-inch Doppler wire) 30 minutes after uncomplicated PCI and in response to the intracoronary infusion of acetylcholine (Ach) (10(-7), 10(-6) mol/L Ach) and adenosine (24 microg). Ach-mediated increase in CBF was impaired after stent insertion when compared with the control group (41+/-52% versus 70+/-48%; P<0.05). The stenting plus abciximab group demonstrated a superior CBF response to Ach compared with the stenting alone group (83+/-93% versus 41+/-52%; P<0.05), with no difference between groups in the peak flow or percent change in flow to adenosine. By multivariate analysis, concomitant administration of abciximab was strongly predictive of the change in CBF to Ach (P<0.005).



Abciximab preserves the CBF response to Ach after coronary stenting. The preservation of microvascular endothelial function may help explain the beneficial clinical effect of this agent in patients undergoing PCI.
GENOMEVIEWER: An Interactive Genomic Somatic Mutation Visualizer

New Generation Sequencing (NGS) technologies offer new insights to researchers in the field of oncogenomics. These technologies provide valuable genetic information by rapidly detecting and identifying expected mutations to improve clinical treatments. To be used effectively, this large amount of data has to be processed, explored and interpreted carefully and quickly. Meanwhile, cancer research continues to publish new theories and findings based on large-scale collaborative projects that provide publicly available genomic and clinical cancer data. However, researchers have a hard time using the data to its full potential although it's readily available. Between the growing output size and complexity of NGS technologies, and the growing number of publicly available heterogeneous databases, processing and exploring this data can become a challenge for the average researcher. This paper presents GenomeViewer's functionalities, which specializes in visualization of somatic mutations in cancer genomics. This easy to use software will enable cancer researchers to seamlessly compare their data against publicly available resources. GenomeViewer uses "Big Data" technologies such as Spark and Parquet, and is based on the UC Berkeley's Analysis Data Model (ADAM) genomic format for cloud scale computing. Our hope is that GenomeViewer will become the preferred tool for viewing somatic mutations for researchers in cancer genomics.
Capecitabine "metronomic" chemotherapy for palliative treatment of elderly patients with advanced gastric cancer after fluoropyrimidine-based chemotherapy.

We aimed to study the efficacy and safety of metronomic capecitabine in pretreated elderly patients with advanced gastric cancer. Eligible patients with advanced gastric cancer were treated with capecitabine at a fixed dose 1,000 mg daily (days 1-28 continuously, every 5 weeks) until disease progression or significant toxicity. Tumor response was assessed every 10 weeks by computed tomography scan using Response Evaluation Criteria in solid tumors. In total, 45 patients were enrolled, of whom 43 were evaluated for efficacy and 45 for safety. A median of 3 cycles (range 1-12) were administered. Metronomic chemotherapy had a disease control rate (DCR) at 8 weeks of 51.1% (95% CI 25.7-67.8), and the objective response rate was 20.9% (95% CI 13.1-38.5, 9 of 43 assessable patients). The median time-to-progression and median overall survival were 3.6 months (95% CI: 3.2-4.0 months) and 7.6 months (95% CI 7.0-8.2 months), respectively. Grade II neutropenia and thrombocytopenia were observed in 13.3 and 2.2% of patients, respectively. Grade II/III nonhematological toxicities included diarrhea (4.4%), stomatitis (13.4%), and hand-foot syndrome (15.5%). No grade IV toxicity, neutropenic fever or treatment-related deaths occurred. Metronomic capecitabine was effective and well tolerated as palliative treatment in elderly patients with advanced gastric cancer after fluoropyrimidine-based chemotherapy.
Safety, immune lot-to-lot consistency and non-inferiority of a fully liquid pentavalent DTwp-HepB-Hib vaccine in healthy Indian toddlers and infants

Pentavalent combination vaccines are important tools to strengthen the immunization programs in numerous countries throughout the world. A large number of countries have recognized the value of combination vaccines and have introduced whole cell pentavalent vaccines into their immunization programs. A phase III, multi-center, randomized, single blinded study of a fully liquid pentavalent DTwP-HepB-Hib investigational vaccine (Shan5™) was conducted across India in 2 cohorts: 15 toddlers were evaluated for safety and immunogenicity following a single booster dose (Cohort 1) followed by 1085 infants (Cohort 2) evaluated for immunogenicity and safety following 3-dose primary immunization of the investigational vaccine or a locally licensed comparator vaccine (Pentavac SD). Immune consistency analysis among 3 lots of the investigational vaccine, and immune non-inferiority analysis of pooled (3 lots) data of investigational vaccine vs. comparator vaccine were carried out in cohort 2. The vaccines demonstrated comparable safety and immune responses in cohort 1. In cohort 2, equivalent immune consistency among 3 lots was observed for all antigens except whole cell pertussis antigens, where a marginal variation was observed which was linked to the low power of the test and concluded to not have any clinical significance. Immune non-inferiority against the comparator vaccine was demonstrated for all 5 antigens. Safety results were comparable between vaccine groups. This investigational, fully-liquid, whole-cell pertussis (wP) containing new pentavalent vaccine was found to be safe and immunologically non-inferior to the licensed comparator vaccine.