tbuckley/cabot-search huggingface dataset:
Phase I evaluation of thrice-daily intravenous bolus interleukin-4 in patients with refractory malignancy.
Authors: M B Atkins, G Vachino, H J Tilg, D D Karp, N J Robert, K Kappler, J W Mier
Journal: Journal of Clinical Oncology (1992)

PURPOSE A phase I dose-escalation trial of recombinant human interleukin-4 (IL-4) was performed to determine its toxicity, biologic activity, and potential antineoplastic effects. PATIENTS AND METHODS Ten patients with refractory malignancies received IL-4 by bolus intravenous injection every 8 hours on days 1 to 5 and 15 to 19 (maximum, 28 doses) of a 31-day study period. Three patients received 10 micrograms/kg per dose and seven received 15 micrograms/kg per dose of IL-4. RESULTS Toxic symptoms noted at the second dose level included nasal congestion, diarrhea, nausea and vomiting, fatigue, anorexia, headache, dyspnea, and capillary leak syndrome (median weight gain, 6.1%; range, 3.4% to 11.7%). Fever or sustained hypotension sufficient to require pressors did not occur. Decreases in lymphocyte count and serum bicarbonate, sodium, albumin, fibrinogen and immunoglobulin (Ig) levels, and increases in hematocrit, prothrombin time/partial thromboplastin time (PT/PTT), soluble CD23, and, occasionally, serum creatinine and transaminases occurred. All side effects resolved by day 31. Phenotypic analysis of peripheral-blood mononuclear cells (PBMC) showed a decrease in the percentage of circulating CD16 and CD14(+) cells. Plasma tumor necrosis factor (TNF) and IL-1 beta levels were unaffected, whereas serum C-reactive protein (CRP) concentrations increased slightly and plasma IL-1 receptor antagonist (IL-1RA) levels increased markedly. No tumor responses were observed. CONCLUSIONS We conclude that 10 micrograms/kg per dose of IL-4 is the maximum-tolerated dose for this schedule, although 15 micrograms/kg per dose can be tolerated if more intensive, but still non-intensive care unit level care is provided. The results of this study should aid in the design of future phase II trials that involve IL-4 alone or phase I studies that combine IL-4 with other cytokines such as IL-2.
Lymph node staging standards in gastric cancer.
Authors: A M Bunt, P C Hogendoorn, C J van de Velde, J A Bruijn, J Hermans
Journal: Journal of Clinical Oncology (1995)

PURPOSE In tumor-node-metastasis (TNM) staging, no recommendations are provided on the number of lymph nodes to examine per N level. We investigated the relationship between number of nodes examined and probability of detecting metastases, and ultimately staging accuracy. PATIENTS AND METHODS Data from 473 curatively resected gastric cancer patients, from a randomized trial that compared the Western resection with limited and the Japanese resection with extended lymphadenectomy, were used. RESULTS Yields varied between zero to 67 in N1 and zero to 43 in N2. Yields correlated significantly with classification; the more nodes examined, the more likely the classification was N+. Calculating the probability of detecting metastases using either a likelihood-ratio estimate or an exponential model, this probability increased steeply in the lower range and more gradually in the higher range yield. CONCLUSION To standardize treatment results, we emphasize histologic examination of a fixed number of nodes per anatomically defined N level (20 in N1 and 15 in N2), corresponding with a probability to detect metastases of 60% to 65% and 40% to 45%, respectively. These yields are feasible in all resection specimens, while the extra increase in the chance of detecting metastases by examining more nodes does not compensate the effort to increase yields further. Thus, standardization of histologic TNM staging can improve and render comparison of surgical and adjuvant treatment modalities feasible.
Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials.
Authors: N K Aaronson, E Visser-Pol, G H Leenhouts, M J Muller, A C van der Schot, F S van Dam, R B Keus, C C Koning, W W ten Bokkel Huinink, J A van Dongen, R Dubbelman
Journal: Journal of Clinical Oncology (1996)

PURPOSE Here we report the results of a randomized study undertaken to test the efficacy of a supplementary, telephone-based nursing intervention in increasing patients' awareness and understanding of the clinical trials in which they are asked to participate. METHODS During a 12-month period, 180 cancer patients who were approached to participate in a phase II or III clinical trial were randomized to undergo either of the following: (1) standard informed consent procedures based on verbal explanations from the treating physician plus written information (controls); or (2) standard informed consent procedures plus a supplementary, telephone-based contact with an oncology nurse (intervention). For purposes of evaluation, face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed. RESULTS The two groups were comparable with regard to sociodemographic and clinical variables. Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments. The intervention group was significantly (P &lt; .01) better informed about the following: (1) the risks and side effects of treatment; (2) the clinical trial context of the treatment; (3) the objectives of the clinical trial; (4) where relevant, the use of randomization in allocating treatment; (5) the availability of alternative treatments; (6) the voluntary nature of participation; and (7) the right to withdraw from the clinical trial. The intervention did not have any significant effect on patients' anxiety levels or on rates of clinical trial participation. Patients reported high levels of satisfaction with the intervention. CONCLUSION The use of a supplementary, telephone-based nursing intervention is a feasible and effective means to increase cancer patients' awareness and understanding of the salient issues that surround the clinical trials in which they are asked to participate.
Alcohol misuse in patients with psoriasis: identification and relationship to disease severity and psychological distress
Authors: M.A. McAleer, D.L. Mason, S. Cunningham, S.J. O’Shea, P.A. McCormick, C. Stone, P. Collins, S. Rogers, B. Kirby
Journal: British Journal of Dermatology (2011)

Moderate to severe psoriasis is associated with increased alcohol intake and excessive mortality from alcohol-related causes. Alcohol biomarkers provide an objective measure of alcohol consumption. Carbohydrate-deficient transferrin (CDT) is the single most sensitive and specific alcohol biomarker.To assess alcohol consumption in a cohort of patients with moderate to severe psoriasis using standard alcohol screening questionnaires and biomarkers. We investigated whether there was an association between alcohol intake, anxiety, depression and disease severity.Consecutive patients with chronic plaque psoriasis were recruited and completed a range of anonymized assessments. Psoriasis severity, anxiety and depression, and the impact of psoriasis on quality of life were assessed. Alcohol screening questionnaires were administered. Blood specimens were taken and γ-glutamyltransferase (γGT) and CDT were measured.A total of 135 patients completed the study. Using validated questionnaires, between 22% and 32% had difficulties with alcohol. Seven per cent had CDT > 1·6% indicating a heavy alcohol intake. The Alcohol Use Disorders Identification Test (AUDIT) questionnaire was superior to other validated questionnaires in detecting alcohol misuse. There were no significant associations between measures of excessive alcohol consumption and disease severity. Excessive alcohol intake as measured by the CAGE questionnaire was associated with increased depression (P = 0·001) but other measures of alcohol excess did not correlate with psychological distress. Men had significantly more difficulties with alcohol than women (P < 0·001).Alcohol misuse is common in patients with moderate to severe psoriasis. Screening with the AUDIT questionnaire and CDT may allow the identification of patients who are misusing alcohol and allow appropriate intervention.
Irinotecan with 5-FU/FA in advanced biliary tract adenocarcinomas—A two-center phase II trial (GBFiri)
Authors: J. Feisthammel, K. Schoppmeyer, M. Wiedmann, J. Mossner, M. Schulze, K. Caca
Journal: Journal of Clinical Oncology (2006)

14088 Background: The majority of patients with biliary tract cancer present with advanced, unresectable tumors. Irinotecan and 5-Fluorouracil/folinic acid (FOLFIRI) have synergistic activity in gastrointestinal cancers. The aim of this study was to determine the tolerability and activity of systemic chemotherapy with FOLFIRI in patients with intrahepatic cholangiocarcinoma (CCC) or gallbladder cancer (GBC). Methods: This was a prospective, multicenter, non-randomised, open-label, phase II trial. Eligibility criteria: Inoperable adenocarcinoma of the biliary tract, measurable disease, age 18–80 years, ECOG PS 0–2. Patients received irinotecan 80 mg/m 2 as a 30 min infusion, followed by folinic acid 500 mg/m 2 over 2 h and 5-FU 2000 mg/m 2 over 24h weekly × 6 followed by a 2 week rest. Treatment was continued until progression or limiting toxicity. Response to therapy was assessed after every other cycle according to RECIST criteria. Primary end point was response rate, secondary end points were overall survival, progression free survival and toxicity. Results: 30 pts (CCC 17, GBC 13) were enrolled. A total of 387 doses (Median 12.9; 1 to 36) were administered with an overall relative dose intensity of 98%. 30 patients are evaluable for safety. WHO grade 3/4 drug related adverse events occured in 7 patients (23%): Leukopenias in 2, anemia in 1, and diarrhea in 4 patients. 14 patients completed 2 cycles and were evaluable for response. Response rates: CR 0/30, PR 3/30 (10%) and SD 3/30 (10%). 8 patients presented with disease progression at restaging. Median overall survival: CCC 166 days, GBC 327 days. Progression-free-survival: CCC 84 days, GBC 159 days. Conclusions: FOLFIRI is a well tolerated regimen in patients with biliary cancer that can be safely administered on an outpatient basis. FOLFIRI has no substantial activity in CCC and moderate activity in GBC. Further studies are required to define a standard palliative chemotherapy for treatment of biliary cancer. No significant financial relationships to disclose.
Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans.
Authors: L Gianni, C M Kearns, A Giani, G Capri, L Viganó, A Lacatelli, G Bonadonna, M J Egorin
Journal: Journal of Clinical Oncology (1995)

PURPOSE To characterize and model the disposition of paclitaxel in humans and define a pharmacodynamic relationships between paclitaxel disposition and its toxicity and efficacy. PATIENTS AND METHODS Paclitaxel pharmacokinetics were studied in 55 courses of therapy in 30 patients. Paclitaxel was administered at 135 mg/m2 or 175 mg/m2 by either a 3- or a 24-hour infusion schedule to patients with advanced ovarian cancer (n = 15), or at 225 mg/m2 by 3-hour infusion to patients with advanced breast cancer (n = 15). Paclitaxel and 6 alpha-hydroxylpaclitaxel were quantified by high-performance liquid chromatography (HPLC). Pharmacokinetics were assessed by noncompartmental and model-dependent methods. Pharmacodynamic correlations were evaluated statistically and by regression models. RESULTS Paclitaxel disposition is nonlinear in humans and, on the 3-hour schedule, 6 alpha-hydroxylpaclitaxel was identified in the plasma of all patients treated. The plasma disposition of paclitaxel and 6 alpha-hydroxylpaclitaxel was well described by a model that featured multiple nonlinear processes. Neutropenia was not related to the areas under the curves (AUCs) of paclitaxel or 6 alpha-hydroxylpaclitaxel, or to palitaxel peak concentrations (Cmax). Neutropenia was related to the duration that plasma concentrations were &gt; or = 0.05 mumol/L, a relationship that is well described by a sigmoid maximum response (Emax) model. CONCLUSION The disposition of paclitaxel in humans is nonlinear. Paclitaxel metabolism to 6 alpha-hydroxylpaclitaxel is likely an important detoxification pathway. Myelosuppression is related to the duration that plasma paclitaxel concentrations are &gt; or = 0.05 mumol/L. Trials of new doses and schedules of paclitaxel should take into account its nonlinear disposition to rule out adverse clinical consequences, especially if the drug is administered by short infusion. Our pharmacokinetic model should prove to be a powerful tool in predicting paclitaxel disposition, regardless of dose and schedule, and should facilitate further pharmacodynamic investigations.
Long-term Follow-up of Placental Transfusion in Full-term Infants
Authors: Heike Rabe, Debra A. Erickson-Owens, Judith S. Mercer
Journal: JAMA Pediatrics (2015)

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People living close to livestock farms less often see their general practitioner
Authors: Christel van Dijk, Lidwien Smit, Jan-Paul Zoch, Mariette Hooiveld, Inge Wouters, Dick Heederik, Joris Yzermans
Journal: European Respiratory Journal (2014)

Living in the neighbourhood of a high density of livestock farms has been associated with adverse respiratory health effects. Little is known about the effects of livestock farming on health care utilisation. Our aim was to investigate associations between proximity to livestock farms and contacts for respiratory disorders in general practice. Electronic medical records of 54,777 patients of 16 general practices in an area with a high density of livestock farms in the Netherlands were analysed. Outcomes were the total number of contacts in general practice, respiratory contacts, and contacts related to acute respiratory infections. Livestock-related exposures at the home address were defined as i) distance to livestock farms and ii) particulate matter (PM)10 emissions from farms within 500 m. Associations between the number of contacts and livestock-related exposures were evaluated using Poisson multilevel regression analyses adjusted for age, gender, chronic diseases and distance to the general practice. Patients living closer to livestock farms and/or with higher PM10 emissions levels had fewer contacts with their general practitioner. Similar results were found for respiratory contacts and contacts related to acute respiratory infections. Patients living further away from their general practitioner had fewer contacts, but did not confound the association with livestock exposures. We conclude that people living in the proximity of livestock farming less often see their general practitioner. This may reflect a different health care seeking behaviour of these patients, and has important implications for epidemiological studies on proximity to farms and health care utilisation for respiratory problems.
Blood transfusions and immunophenotypic alterations of lymphocyte subsets in sickle cell anemia. The Transfusion Safety Study Group
Authors: Wing Yen Wong, Darleen R. Powars, Eva A. Operskalski, Joseph Hassett, John W. Parker, Sharada Sarnaik, Charles H. Pegelow, Margaret W. Hilgartner, Cage S. Johnson, Yi Zhou, Pei Yu Ku, James W. Mosley
Journal: Blood (1995)
Abstract 15835: Endothelial Cells are Able to Synthesize and Release Catecholamines Both in vitro and in vivo
Authors: Daniela Sorriento, Gaetano Santulli, Carmine Del Giudice, Antonio Anastasio, Bruno Trimarco, Guido Iaccarino
Journal: Circulation (2011)

Recently it has been demonstrated that catecholamines are produced and used by macrophages and mediate immune response. The aim of this study was to verify if endothelial cells (EC), that are of my...
Positive biopsy (bx) rates for prostate cancer (PCA) based on prostate specific antigen (PSA) grouping in a large cancer screening trial: Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO).
Authors: D. Reding, C. McCarty, T. Riley, T. Hickey, W. G. Hocking
Journal: Journal of Clinical Oncology (2010)

4563 Background: PLCO is a large-scale, randomized study to determine whether certain screening tests reduce the number of deaths from these cancers. Methods: PLCO compared certain screening procedures to a control group to determine the sensitivity, specificity and overall mortality reduction of these screening tests. For PCA, digital rectal examination (DRE) and PSA were done at baseline and annually × 5. 38,342 men were randomized to the screening arm. 6,301 men had a PSA >4 and were analyzed for PCA by PSA groupings. Results: Four groups were analyzed. Group 1 (first positive PSA) 2,830 men; Group 2 (prior PSA, first positive PSA) 3,471 men; Group 3 (multiple positive PSA, no bx) 2,350 men; Group 4 (multiple positive PSA, prior negative bx) 1,557 men. Biopsy rates for the groups were: Group 1 1,125/2,830 (39%), Group 2 1,244/3,471 (35%), Group 3 960/2,350 (40%), Group 4 474/1,557 (30.4%). Positive biopsies for PCA were: Group 1 502/1,125 (44.6%), Group 2 472/1,244 (37.9%), Group 3 402/960 (41.8%), Group 4 177/474 (37.3%). Factors were analyzed to determine if demographic factors influenced positive bx rates for cancer. Factors analyzed included PSA, age, prior bx, prostate symptoms, education, race, hypertension, smoking, heart disease, BMI, prior STD's. Chi-squared and logistic regression analyses were used to determine factors. For all groups not controlling for PSA with prostate cancer as an outcome, race (Black) and family history of prostate cancer increased likelihood bx resulted in cancer. Prior negative PSA, prostate problems, decreased likelihood bx resulted in PCA diagnosis. When controlling for log PSA, family history of PCA and race (Black) remained significant factors for positive PCA bx. Factors demonstrating decreased risk for prostate cancer with bx were prostate problem, >1 PSA, education <12 years, race (Asian). Other medical conditions (hypertension, heart disease), BMI, STD did not affect positive bx rates. PCA did not vary significantly by stage of PCA or Gleason score for the groups. Conclusions: Factors influencing positive PCA biopsy rates include family history of PCA and log PSA and race. No significant financial relationships to disclose.
The undertranslated transcriptome reveals widespread translational silencing by alternative 5' transcript leaders.
Authors: G Lynn Law, Kellie S Bickel, Vivian L MacKay, David R Morris
Journal: Genome biology (2006)

Abstract Background Translational efficiencies in Saccharomyces cerevisiae vary from transcript to transcript by approximately two orders of magnitude. Many of the poorly translated transcripts were found to respond to the appropriate external stimulus by recruiting ribosomes. Unexpectedly, a high frequency of these transcripts showed the appearance of altered 5' leaders that coincide with increased ribosome loading. Results Of the detectable transcripts in S. cerevisiae , 8% were found to be underloaded with ribosomes. Gene ontology categories of responses to stress or external stimuli were overrepresented in this population of transcripts. Seventeen poorly loaded transcripts involved in responses to pheromone, nitrogen starvation, and osmotic stress were selected for detailed study and were found to respond to the appropriate environmental signal with increased ribosome loading. Twelve of these regulated transcripts exhibited structural changes in their 5' transcript leaders in response to the environmental signal. In many of these the coding region remained intact, whereas regulated shortening of the 5' end truncated the open reading frame in others. Colinearity between the gene and transcript sequences eliminated regulated splicing as a mechanism for these alterations in structure. Conclusion Frequent occurrence of coordinated changes in transcript structure and translation efficiency, in at least three different gene regulatory networks, suggests a widespread phenomenon. It is likely that many of these altered 5' leaders arose from changes in promoter usage. We speculate that production of translationally silenced transcripts may be one mechanism for allowing low-level transcription activity necessary for maintaining an open chromatin structure while not allowing inappropriate protein production.
Hormone replacement therapy may not always be right choice to prevent cardiovascular disease
Authors: S. Panico, R. Galasso, E. Celentano, L. Frova, R. Capocaccia, F. Berrino
Journal: BMJ (1996)

women using hormone replacement therapy for up to five years but was not significantly increased in women using it for longer.5Neither of these obser- vations is consistent with a causal relation between sex steroid hormones and cancer, such as that so clearly shown between unopposed oestrogens and endometrial cancer.Price and Little also com- pletely ignore a recent population based case- control study that showed no increase in the risk of breast cancer even when hormone replacement therapy was taken for 20 years and more.6While relying uncritically on the report on use of hormone replacement therapy and breast can- cer from the nurses' health study, the authors perfunctorily dismiss the finding from the same cohort of a 50% reduction in the risk of myocar- dial infarction among women using the therapy.We recognise that epidemiology has provided no easy answer to the question of whether use of hormone replacement therapy has an effect on the risk of breast cancer, but we object to the promulgation of any attitude towards hormone replacement therapy, whether positive or nega- tive, that is based on prejudice and a personal agenda.Making an announcement of a new organisation is no excuse for such abuse of the literature.Sadly, it is all too easy for those with no clinical responsibility for hormone replace- ment therapy to present a distorted view, to the detriment of women seeking a balanced assessment of the benefits and risks.