tbuckley/cabot-search huggingface dataset:
Racial and Ethnic Disparities in the Use of Postmastectomy Breast Reconstruction: Results From a Population- Based Study
Authors: Amy K. Alderman, Sarah T. Hawley, Nancy K. Janz, Mahasin S. Mujahid, Monica Morrow, Ann S. Hamilton, John J. Graff, Steven J. Katz
Journal: Journal of Clinical Oncology (2009)

There is concern that minority women have limited access to breast reconstruction. We described patterns of use, experiences with clinicians, and patients' satisfaction with treatment decisions for women of different race/ethnicities.A total of 3,252 patients with breast cancer from Los Angeles and Detroit Surveillance, Epidemiology, and End Results registries were surveyed near the time of diagnosis (n = 2,260, response rate 72.2%). The primary outcomes were receipt of reconstruction, access to information about reconstruction, and decisional satisfaction. The primary independent variable was race/ethnicity (white, African American [AA], highly acculturated Latina [Latina-high], and less acculturated Latina [Latina-low]). Control variables included other sociodemographic and clinical factors. chi(2) and multivariate logistic regression were used for the analyses.Receipt of reconstruction varied significantly by patient race/ethnicity-40.9% of whites, 33.5% of AAs, 41.2% of Latina-high, and only 13.5% of Latina-low (P < .001)-and persisted when we controlled for demographic and clinical factors. Minority women were significantly less likely than whites to see a plastic surgeon before initial surgery and were more likely to desire more information about reconstruction (17.0% of whites v 27.0% of AAs, 30.0% of Latina-high, and 55.9% of Latina-low; P < .001). Decisional satisfaction was lowest among minority women without reconstruction (P < .001).Minority women, particularly less acculturated Latinas, had low receipt of breast reconstruction, which may be related to limited information about the procedure and less access to plastic surgeons. Greater desire for information and lower satisfaction with surgical decisions among these patients motivate greater attention to treatment support for these patients.
Interleukin 10 promoter microsatellite polymorphisms are associated with response to long term treatment with etanercept in patients with rheumatoid arthritis
Authors: H Schotte
Journal: Annals of the Rheumatic Diseases (2004)

To analyse the association of interleukin 10 (IL10) promoter polymorphisms, which have been shown to be related to IL10 secretion capacity, with the response to long term treatment with etanercept in patients with rheumatoid arthritis (RA).Fifty patients with active RA were treated for up to 4 years (median 39 months, range 3-52) with stable doses of etanercept as monotherapy. Treatment response was assessed as defined by the EULAR criteria in an intention to treat analysis, with the last observation carried forward. IL10 promoter microsatellite polymorphisms IL10.R and IL10.G were genotyped by fragment length analysis in patients and 189 healthy controls matched for ethnicity, age, and sex. Haplotypes were reconstructed using a method based on bayesian, coalescent theory with the PHASE software.IL10 microsatellite polymorphisms were not associated with susceptibility to RA. When patients with good treatment response (n = 25) were compared with patients with moderate (n = 17) or no response (n = 8), a significantly different distribution of the prevailing alleles R2, R3 and G9, G13, respectively, became evident. Good treatment response was associated with carriage of the R3 allele or R3-G9 haplotype, whereas the allele G13 and the haplotype R2-G13 predominated in patients with moderate or no response.Genotyping of the IL10 promoter microsatellites may be useful in predicting the clinical response to etanercept in patients with RA. The high prevalence of the presumptive IL10 low producer allele R3 in patients with a favourable response suggests that IL10 promotes disease activity in RA under the specific condition of tumour necrosis factor antagonism.
Coronary Bypass Surgery with or without Surgical Ventricular Reconstruction
Authors: Robert H. Jones, Eric J. Velazquez, Robert E. Michler, George Sopko, Jae K. Oh, Christopher M. O'Connor, James A. Hill, Lorenzo Menicanti, Zygmunt Sadowski, Patrice Desvigne-Nickens, Jean-Lucien Rouleau, Kerry L. Lee
Journal: New England Journal of Medicine (2009)

Surgical ventricular reconstruction is a specific procedure designed to reduce left ventricular volume in patients with heart failure caused by coronary artery disease. We conducted a trial to address the question of whether surgical ventricular reconstruction added to coronary-artery bypass grafting (CABG) would decrease the rate of death or hospitalization for cardiac causes, as compared with CABG alone.Between September 2002 and January 2006, a total of 1000 patients with an ejection fraction of 35% or less, coronary artery disease that was amenable to CABG, and dominant anterior left ventricular dysfunction that was amenable to surgical ventricular reconstruction were randomly assigned to undergo either CABG alone (499 patients) or CABG with surgical ventricular reconstruction (501 patients). The primary outcome was a composite of death from any cause and hospitalization for cardiac causes. The median follow-up was 48 months.Surgical ventricular reconstruction reduced the end-systolic volume index by 19%, as compared with a reduction of 6% with CABG alone. Cardiac symptoms and exercise tolerance improved from baseline to a similar degree in the two study groups. However, no significant difference was observed in the primary outcome, which occurred in 292 patients (59%) who were assigned to undergo CABG alone and in 289 patients (58%) who were assigned to undergo CABG with surgical ventricular reconstruction (hazard ratio for the combined approach, 0.99; 95% confidence interval, 0.84 to 1.17; P=0.90).Adding surgical ventricular reconstruction to CABG reduced the left ventricular volume, as compared with CABG alone. However, this anatomical change was not associated with a greater improvement in symptoms or exercise tolerance or with a reduction in the rate of death or hospitalization for cardiac causes. (ClinicalTrials.gov number, NCT00023595.)
Reversal of Sjogren's-like syndrome in non-obese diabetic mice
Authors: S. D Tran, S. Kodama, B. M Lodde, I. Szalayova, S. Key, S. Khalili, D. L Faustman, E. Mezey
Journal: Annals of the Rheumatic Diseases (2006)

<b>Background:</b> Non-obese diabetic (NOD) mice exhibit autoimmune diabetes and Sjögren's-like syndrome. <b>Objective:</b> To test whether a treatment that reverses end-stage diabetes in the NOD mouse would affect their Sjögren's-like syndrome. <b>Methods:</b> NOD mice have a proteasome defect. Improperly selected naive T cells escape, but can be killed by reintroducing major histocompatibility complex class I self-peptides on matched normal splenocytes. The proteasome defect also impairs nuclear factor kB, a transcription factor in pathogenic memory T cells, increasing their susceptibility to tumour necrosis factor-induced apoptosis stimulated through complete Freund's adjuvant (CFA). The impact of this two-limb therapy (injections of matched normal splenocytes and CFA) on the autoimmune salivary gland disease of the NOD mice was studied. <b>Results:</b> All NOD mice receiving the above treatment had a complete recovery of salivary flow and were protected from diabetes. Restoration of salivary flow could be the result of a combination of rescue and regeneration of the gland, as confirmed by immunohistochemical analysis. All untreated NOD mice showed a continuous decline in salivary flow, followed by hyperglycaemia and death. <b>Conclusion:</b> This study establishes that a brief intervention in NOD mice with Sjögren's-like syndrome can reverse salivary gland dysfunction.
Treatment of Borderline Personality Disorder With Psychoanalytically Oriented Partial Hospitalization: An 18-Month Follow-Up
Authors: Anthony Bateman, Peter Fonagy
Journal: American Journal of Psychiatry (2001)

OBJECTIVE: The aim of this study was to determine whether the substantial gains made by patients with borderline personality disorder following completion of a psychoanalytically oriented partial hospitalization program, in comparison to patients treated with standard psychiatric care, were maintained over an 18-month follow-up period. METHOD: Forty-four patients who participated in the original study were assessed every 3 months after completion of the treatment phase. Outcome measures included frequency of suicide attempts and acts of self-harm, number and duration of inpatient admissions, service utilization, and self-reported measures of depression, anxiety, general symptom distress, interpersonal functioning, and social adjustment. RESULTS: Patients who completed the partial hospitalization program not only maintained their substantial gains but also showed a statistically significant continued improvement on most measures in contrast to the patients treated with standard psychiatric care, who showed only limited change during the same period. CONCLUSIONS: The superiority of psychoanalytically oriented partial hospitalization over standard psychiatric treatment found in a previous randomized, controlled trial was maintained over an 18-month follow-up period. Continued improvement in social and interpersonal functioning suggests that longer-term changes were stimulated.
Early combined immunosuppression for the management of Crohn's disease (REACT): a cluster randomised controlled trial
Authors: Reena Khanna, Brian Bressler, Barrett G Levesque, Guangyong Zou, Larry W Stitt, Gordon R Greenberg, Remo Panaccione, Alain Bitton, Pierre Paré, Séverine Vermeire, Geert D'Haens, Donald MacIntosh, William J Sandborn, Allan Donner, Margaret K Vandervoort, Joan C Morris, Brian G Feagan
Journal: The Lancet (2015)
Transdermal Nicotine for Smoking Cessation
Authors: Arden Christen, Bradley Beiswanger, Melissa Mau, Cheryl Walker, Dorothy Hatsukami, Sharon Allen, Marguerite Huber, Joni Jensen, Stephen Rennard, David Daughton, Ronald Cheney, Kathleen Hatlelid, Austin Thompson, Edward Lichtenstein, Anthony Biglan, Linda Ochs, Scott Heatley, Lawrence Repsher, William Schones, Dara Stlllman, Cheryl Casey, Bonnie Poole, Jennifer Leitch, Stephen Fortmann, Joel Killen, Mark Hansen, L. Rasenick Douss, John Hughes, William Valliere, Laura Solomon, William Wadland, Elbert Glover, Penny Glover, Donna Causey, Mark Knowles, Katherine Voss-Roberts, Della Prather, Nancy Trunnell, Diane Moos, Clyde Rolf, Robert Nowak, Phillip Ackerman, Neil Malone
Journal: JAMA (1991)

Objective.  —To evaluate the efficacy of a new transdermal nicotine system for smoking cessation.  Design.  —Two 6-week, randomized, double-blind, placebo-controlled, parallel group trials were conducted. Successful abstainers from both trials enrolled in a third trial for blinded downtitration from medications (6 weeks) and subsequent off-drug follow-up (12 weeks).  Setting.  —Nine outpatient clinics specializing in the treatment of smoking cessation.  Patients.  —Healthy volunteers who smoked one or more packs of cigarettes daily and wanted to participate in a smoking cessation program.  Intervention.  —Patients were randomly assigned to a transdermal nicotine system delivering nicotine at rates of 21,14, or 7 mg (in trial 1 only) over 24 hours or to placebo. Group counseling sessions were provided to all participants.  Main Outcome Measure.  —Rates of continuous smoking abstinence were determined during 6 weeks of full-dose treatment, a 6-week weaning period (through week 12), and a 3-month follow-up receiving no therapy (through week 24). Abstinence was defined by patient diary reports of no smoking during the designated periods, confirmed by expired-breath carbon monoxide levels of 8 ppm or lower.  Results.  —The centers enrolled 935 patients. Cessation rates during the last 4 weeks of the two 6-week trials (pooled data) were 61%, 48%, and 27% for 21-and 14-mg transdermal nicotine and placebo, respectively ( P ≤.001 for each active treatment vs placebo). Six-month abstinence rates for 21-mg transdermal nicotine and placebo were 26% and 12%, respectively ( P ≤.001). All transdermal nicotine doses significantly decreased the severity of nicotine withdrawal symptoms and significantly reduced cigarette use by patients who did not stop smoking. Compliance was excellent, and no serious systemic adverse effects were reported.  Conclusions.  —Transdermal nicotine systems show considerable promise as an aid to smoking cessation.  ( JAMA . 1991;266:3133-3138)
Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder
Authors: Alexandra Philipsen, Thomas Jans, Erika Graf, Swantje Matthies, Patricia Borel, Michael Colla, Laura Gentschow, Daina Langner, Christian Jacob, Silke Groß-Lesch, Esther Sobanski, Barbara Alm, Martina Schumacher-Stien, Michael Roesler, Wolfgang Retz, Petra Retz-Junginger, Bernhard Kis, Mona Abdel-Hamid, Viola Heinrich, Michael Huss, Catherine Kornmann, Arne Bürger, Evgeniy Perlov, Gabriele Ihorst, Michael Schlander, Mathias Berger, Ludger Tebartz van Elst
Journal: JAMA Psychiatry (2015)

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder with high prevalence in adulthood. There is a recognized need to assess the efficacy of psychotherapy in adult ADHD.To evaluate the efficacy of cognitive behavioral group psychotherapy (GPT) compared with individual clinical management (CM) and that of methylphenidate hydrochloride compared with placebo.Prospective, multicenter, randomized clinical trial of 18- to 58-year-old outpatients with ADHD from 7 German study centers. Patients were recruited between January 2007 and August 2010, treatment was finalized in August 2011, and final follow-up assessments occurred in March 2013.Sessions of GPT and CM were held weekly for the first 12 weeks and monthly thereafter (9 months). Patients received either methylphenidate or placebo for 1 year.The primary outcome was the change in the ADHD Index of the Conners Adult ADHD Rating Scale from baseline to the end of the 3-month intensive treatment (blinded observer ratings). Secondary outcomes included ADHD ratings after 1 year, blinded observer ratings using the Clinical Global Impression Scale, and self-ratings of depression.Among 1480 prescreened patients, 518 were assessed for eligibility, 433 were centrally randomized, and 419 were analyzed as randomized. After 3 months, the ADHD Index all-group baseline mean of 20.6 improved to adjusted means of 17.6 for GPT and 16.5 for CM, with no significant difference between groups. Methylphenidate (adjusted mean, 16.2) was superior to placebo (adjusted mean, 17.9) (difference, -1.7; 97.5% CI, -3.0 to -0.4; P = .003). After 1 year, treatment effects remained essentially stable. Descriptive analyses showed that methylphenidate was superior to placebo in patients assigned to GPT (difference, -1.7; 95% CI, -3.2 to -0.1; P = .04) or CM (difference, -1.7; 95% CI, -3.3 to -0.2; P = .03). Regarding depression, no significant differences were found. In contrast, GPT was superior to CM for all visits in the Clinical Global Impression global assessment of effectiveness.Highly structured group intervention did not outperform individual CM with regard to the primary outcome. Psychological interventions resulted in better outcomes during a 1-year period when combined with methylphenidate as compared with placebo.isrctn.org Identifier: ISRCTN54096201.
Differentiation of bacterial and viral pneumonia in children
Authors: R Virkki
Journal: Thorax (2002)

Background: A study was undertaken to investigate the differential diagnostic role of chest radiographic findings, total white blood cell count (WBC), erythrocyte sedimentation rate (ESR), and serum C reactive protein (CRP) in children with community acquired pneumonia of varying aetiology. Methods: The study population consisted of 254 consecutive children admitted to hospital with community acquired pneumonia diagnosed between 1993 and 1995. WBC, ESR, and CRP levels were determined on admission. Seventeen infective agents (10 viruses and seven bacteria) were searched for. Chest radiographs were retrospectively and separately reviewed by three paediatric radiologists. Results: A potential causative agent was found in 215 (85%) of the 254 cases. Bacterial infection was found in 71% of 137 children with alveolar infiltrates on the chest radiograph, while 72% of the 134 cases with a bacterial pneumonia had alveolar infiltrates. Half of the 77 children with solely interstitial infiltrates on the chest radiograph had evidence of bacterial infection. The proportion of patients with increased WBC or ESR did not differ between bacterial and viral pneumonias, but differences in the CRP levels of &gt;40 mg/l, &gt;80 mg/l, and &gt;120 mg/l were significant although the sensitivity for detecting bacterial pneumonia was too low for use in clinical practice. Conclusions: Most children with alveolar pneumonia, especially those with lobar infiltrates, have laboratory evidence of a bacterial infection. Interstitial infiltrates are seen in both viral and bacterial pneumonias.
Successful Treatment of Ebola Virus–Infected Cynomolgus Macaques with Monoclonal Antibodies
Authors: Xiangguo Qiu, Jonathan Audet, Gary Wong, Stephane Pillet, Alexander Bello, Teresa Cabral, Jim E. Strong, Frank Plummer, Cindy R. Corbett, Judie B. Alimonti, Gary P. Kobinger
Journal: Science Translational Medicine (2012)

Ebola virus (EBOV) is considered one of the most aggressive infectious agents and is capable of causing death in humans and nonhuman primates (NHPs) within days of exposure. Recent strategies have succeeded in preventing acquisition of infection in NHPs after treatment; however, these strategies are only successful when administered before or minutes after infection. The present work shows that a combination of three neutralizing monoclonal antibodies (mAbs) directed against the Ebola envelope glycoprotein (GP) resulted in complete survival (four of four cynomolgus macaques) with no apparent side effects when three doses were administered 3 days apart beginning at 24 hours after a lethal challenge with EBOV. The same treatment initiated 48 hours after lethal challenge with EBOV resulted in two of four cynomolgus macaques fully recovering. The survivors demonstrated an EBOV-GP-specific humoral and cell-mediated immune response. These data highlight the important role of antibodies to control EBOV replication in vivo, and support the use of mAbs against a severe filovirus infection.
Unrelated cord blood transplantation in adults with myelodysplasia or secondary acute myeloblastic leukemia: a survey on behalf of Eurocord and CLWP of EBMT
Authors: M Robin, G F Sanz, I Ionescu, B Rio, A Sirvent, M Renaud, E Carreras, N Milpied, M Mohty, Y Beguin, P Bordigoni, T de Witte, A Picardi, D Purtill, E Gluckman, N Kroger, V Rocha
Journal: Leukemia (2010)
Childhood Acute Lymphoblastic Leukemia With the <i>MLL-ENL</i> Fusion and t(11;19)(q23;p13.3) Translocation
Authors: Jeffrey E. Rubnitz, Bruce M. Camitta, Hazem Mahmoud, Susana C. Raimondi, Andrew J. Carroll, Michael J. Borowitz, Jonathan J. Shuster, Michael P. Link, D. Jeanette Pullen, James R. Downing, Frederick G. Behm, Ching-Hon Pui
Journal: Journal of Clinical Oncology (1999)

PURPOSE: To determine the molecular characteristics, clinical features, and treatment outcomes of children with acute lymphoblastic leukemia (ALL) and the t(11;19)(q23;p13.3) translocation. PATIENTS AND METHODS: A retrospective analysis of leukemic cell karyotypes obtained from patients with new diagnoses of ALL who were treated at St. Jude Children's Research Hospital or by the Pediatric Oncology Group was performed to identify cases with the t(11;19)(q23;p13.3) translocation. Molecular analyses were performed on these cases to determine the status of the MLL gene and the presence of the MLL-ENL fusion transcript. RESULTS: Among 3,578 patients with ALL and successful cytogenetic analysis, we identified 35 patients with the t(11;19)(q23;p13.3) translocation: 13 infants and 11 older children had B-precursor leukemia, whereas 11 patients had a T-cell phenotype. Although all of the cases examined had MLL rearrangements and MLL-ENL fusion transcripts, outcome varied according to age and immunophenotype. Among B-precursor cases, only two of the 13 infants remain in complete remission, compared with six of the 11 older children. Most strikingly, no relapses have occurred among B-precursor patients 1 to 9 years of age or among T-cell patients. CONCLUSION: Although MLL gene rearrangements are generally associated with a dismal outcome in ALL, two distinct subsets with MLL-ENL fusions have an excellent prognosis. Our results suggest that patients with this genetic abnormality who have T-cell ALL or are 1 to 9 years of age should not be considered candidates for hematopoietic stem-cell transplantation during their first remission.
U.S. Food and Drug Administration Inspections of Clinical Investigators: Overview of Results from 1977 to 2009
Authors: Sonia K. Morgan-Linnell, David J. Stewart, Razelle Kurzrock
Journal: Clinical Cancer Research (2014)

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research is responsible for evaluating drug safety and efficacy, including oversight of clinical trials and principal investigators. The FDA Clinical Investigator Inspection List (CIIL) contains online, detailed, relevant information of all FDA inspections. We reviewed FDA inspections of clinical investigators to ascertain their outcome and included all inspections on the list (July 1977 through December 31, 2009; n = 9,481 inspections). Eighty-eight percent of inspections were "data audit" (primary purpose = verification of data), and the rest (12%) were "for cause." The number of inspections each year significantly increased over time (P < 0.0001) and averaged 350 per year in the past decade. No deficiencies were found in only 11.2% of all "data audit" and 5% of all "for cause" inspections. Only 31% of inspections resulted in "no action indicated." About two thirds of inspections resulted in some finding, requiring either voluntary investigator action (61.3% of inspections) or official FDA action (3.9%). The most frequently cited deficiencies were failure to follow investigational plan (34%), inadequate informed consent form (28%), and inadequate/inaccurate records (27%). In conclusion, over the past decade, the FDA has performed approximately 350 inspections per year, with the number increasing over time. The vast majority of FDA inspections yield deficiency findings and, as a result, only about one third of inspections have an outcome of "no action indicated."