Search Results - "Crowe, Brenda J"

Prospective Safety Surveillance of GH-Deficient Adults: Comparison of GH-Treated vs Untreated Patients by Hartman, Mark L, Xu, Rong, Crowe, Brenda J, Robison, Leslie L, Erfurth, Eva Marie, Kleinberg, David L, Zimmermann, Alan G, Woodmansee, Whitney W, Cutler, Gordon B, Chipman, John J, Melmed, Shlomo

“…Context: In clinical practice, the safety profile of GH replacement therapy for GH-deficient adults compared with no replacement therapy is unknown. Objective:…”
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Meta-analysis of clinical trial safety data in a drug development program: Answers to frequently asked questions by Berlin, Jesse A, Crowe, Brenda J, Whalen, Edward, Xia, H Amy, Koro, Carol E, Kuebler, Juergen

“…Background Meta-analyses of clinical trial safety data have risen in importance beyond regulatory submissions. During drug development, sponsors need to…”
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Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team by Crowe, Brenda J, Xia, H. Amy, Berlin, Jesse A, Watson, Douglas J, Shi, Hongliang, Lin, Stephen L, Kuebler, Juergen, Schriver, Robert C, Santanello, Nancy C, Rochester, George, Porter, Jane B, Oster, Manfred, Mehrotra, Devan V, Li, Zhengqing, King, Eileen C, Harpur, Ernest S, Hall, David B

“…Background The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America. Purpose…”
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Genotypes and phenotypes in children with short stature: clinical indicators of SHOX haploinsufficiency by Rappold, Gudrun, Blum, Werner F, Shavrikova, Elena P, Crowe, Brenda J, Roeth, Ralph, Quigley, Charmian A, Ross, Judith L, Niesler, Beate

“…Background: Short stature affects approximately 2% of children, representing one of the more frequent disorders for which clinical attention is sought during…”
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Growth Hormone Is Effective in Treatment of Short Stature Associated with Short Stature Homeobox-Containing Gene Deficiency: Two-Year Results of a Randomized, Controlled, Multicenter Trial by Blum, Werner F., Crowe, Brenda J., Quigley, Charmian A., Jung, Heike, Cao, Dachuang, Ross, Judith L., Braun, LeeAnn, Rappold, Gudrun

“…Background: The short stature homeobox-containing gene, SHOX, located on the distal ends of the X and Y chromosomes, encodes a homeodomain transcription factor…”
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Growth Hormone Treatment of Early Growth Failure in Toddlers with Turner Syndrome: A Randomized, Controlled, Multicenter Trial by Davenport, Marsha L., Crowe, Brenda J., Travers, Sharon H., Rubin, Karen, Ross, Judith L., Fechner, Patricia Y., Gunther, Daniel F., Liu, Chunhua, Geffner, Mitchell E., Thrailkill, Kathryn, Huseman, Carol, Zagar, Anthony J., Quigley, Charmian A.

“…Context: Typically, growth failure in Turner syndrome (TS) begins prenatally, and height sd score (SDS) declines progressively from birth. Objective: This…”
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Effect of Growth Hormone Treatment on Adult Height in Peripubertal Children with Idiopathic Short Stature: A Randomized, Double-Blind, Placebo-Controlled Trial by Leschek, Ellen Werber, Rose, Susan R., Yanovski, Jack A., Troendle, James F., Quigley, Charmian A., Chipman, John J., Crowe, Brenda J., Ross, Judith L., Cassorla, Fernando G., Blum, Werner F., Cutler, Gordon B., Baron, Jeffrey

“…GH is often used to treat children with idiopathic short stature despite the lack of definitive, long-term studies of efficacy. We performed a randomized,…”
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Growth Hormone and Low Dose Estrogen in Turner Syndrome: Results of a United States Multi-Center Trial to Near-Final Height by Quigley, Charmian A., Crowe, Brenda J., Anglin, D. Greg, Chipman, John J.

“…A cardinal clinical feature of Turner syndrome (TS) is linear growth failure resulting in extreme short stature: the median adult height of untreated women…”
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Psychological Adaptation in Children with Idiopathic Short Stature Treated with Growth Hormone or Placebo by Ross, Judith L., Sandberg, David E., Rose, Susan R., Leschek, Ellen Werber, Baron, Jeffrey, Chipman, John J., Cassorla, Fernando G., Quigley, Charmian A., Crowe, Brenda J., Roberts, Kristen, Cutler, Gordon B.

“…The influence of short stature on psychological adaptation in childhood and adolescence is controversial. GH is currently used to treat children with…”
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Safety of Growth Hormone Treatment in Pediatric Patients with Idiopathic Short Stature by Quigley, Charmian A., Gill, Anne M., Crowe, Brenda J., Robling, Kristen, Chipman, John J., Rose, Susan R., Ross, Judith L., Cassorla, Fernando G., Wolka, Anne M., Wit, Jan M., Rekers-Mombarg, Lyset T. M., Cutler, Gordon B.

“…Context: Recombinant human GH was approved by the United States Food and Drug Administration in 2003 for the treatment of idiopathic short stature (ISS)…”
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Comparison of several imputation methods for missing baseline data in propensity scores analysis of binary outcome by Crowe, Brenda J., Lipkovich, Ilya A., Wang, Ouhong

“…We performed a simulation study comparing the statistical properties of the estimated log odds ratio from propensity scores analyses of a binary response…”
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Planning and core analyses for periodic aggregate safety data reviews by Xia, H Amy, Crowe, Brenda J, Schriver, Robert C, Oster, Manfred, Hall, David B

“…Background In 2009, the Safety Planning, Evaluation and Reporting Team gave detailed recommendations for a well-planned and systematic approach for safety data…”
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Comparison of Bayesian and Frequentist Meta-Analytical Approaches for Analyzing Time to Event Data by Bennett, Monica M., Crowe, Brenda J., Price, Karen L., Stamey, James D., Seaman, John W.

“…Using meta-analysis in health care research is a common practice. Here we are interested in methods used for analysis of time-to-event data. Particularly, we…”
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Effect of Growth Hormone Dose on Bone Maturation and Puberty in Children with Idiopathic Short Stature by Crowe, Brenda J., Rekers-Mombarg, Lyset T. M., Robling, Kristen, Wolka, Anne M., Cutler, Gordon B., M., Jan

“…Context: GH at 0.22 mg/kg·wk has been shown to have no effect on pubertal onset or pace, whereas GH at 0.5 mg/kg·wk has been shown to advance pubertal onset…”
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Response to commentaries by Crowe, Brenda J, Berlin, Jesse A, Schriver, Robert C, SPERT

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Which Patients Do Not Require a GH Stimulation Test for the Diagnosis of Adult GH Deficiency? by Hartman, Mark L., Crowe, Brenda J., Biller, Beverly M. K., Ho, Ken K. Y., Clemmons, David R., Chipman, John J.

“…Adult GH deficiency (GHD) is currently diagnosed in patients with either a history of childhood-onset GHD or acquired hypothalamic-pituitary disease by GH…”
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Which patients do not require a GH stimulation test for the diagnosis of adult GH deficiency? by Hartman, Mark L, Crowe, Brenda J, Biller, Beverly M K, Ho, Ken K Y, Clemmons, David R, Chipman, John J

“…Adult GH deficiency (GHD) is currently diagnosed in patients with either a history of childhood-onset GHD or acquired hypothalamic-pituitary disease by GH…”
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Growth hormone and low dose estrogen in Turner syndrome: Results of a United States multi-center trial to near-final height by QUIGLEY, Charmian A, CROWE, Brenda J, ANGLIN, D. Greg, CHIPMAN, John J

“…A cardinal clinical feature of Turner syndrome (TS) is linear growth failure resulting in extreme short stature: the median adult height of untreated women…”
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P-59 THE GROWTH RESPONSE TO GH TREATMENT IN CHILDREN WITH GH DEFICIENCY (GHD) IS NOT DIFFERENT BETWEEN THOSE WHO DO OR DO NOT NORMALIZE THEIR IGF-I LEVELS by Blum, Werner F, Shavrikova, Elena P, Crowe, Brenda J

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OR10-2 GH IS EFFECTIVE IN TREATMENT OF SHORT STATURE ASSOCIATED WITH SHOX DEFICIENCY: RESULTS OF A RANDOMIZED, CONTROLLED, MULTI-CENTER TRIAL by Blum, Werner F, Quigley, Charmian A, Crowe, Brenda J, Cao, Dachuang, Jung, Heike, Ross, Judith L, Rappold, Gudrun

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