Medicine and Health Sciences Commons^™

Stent Placement Compared With Balloon Angioplasty For Obstructed Coronary Bypass Grafts. Saphenous Vein De Novo Trial Investigators., M P Savage, J S Douglas, D L Fischman, C J Pepine, S B King, J A Werner, S R Bailey, P A Overlie, S H Fenton, J A Brinker, M B Leon, S Goldberg

Michael P Savage M.D.

BACKGROUND: Treatment of stenosis in saphenous-vein grafts after coronary-artery bypass surgery is a difficult challenge. The purpose of this study was to compare the effects of stent placement with those of balloon angioplasty on clinical and angiographic outcomes in patients with obstructive disease of saphenous-vein grafts.

METHODS: A total of 220 patients with new lesions in aortocoronary-venous bypass grafts were randomly assigned to placement of Palmaz-Schatz stents or standard balloon angioplasty. Coronary angiography was performed during the index procedure and six months later.

RESULTS: As compared with the patients assigned to angioplasty, those assigned to stenting had a higher rate …

A Randomized Trial Of Heparin And Saline For Maintaining Intravenous Locks In Neonates, J. Heilskov, Charmaine Kleiber, K. Johnson, J. Miller

Charmaine Kleiber

PURPOSE: To determine the effects of saline, heparin 2 units (U) per ml saline, and heparin 10 U/ml saline flush solutions on the duration of intravenous (i.v.) locks and the incidence of i.v. infiltration in neonates. DESIGN: Randomized double-blind experiment. SETTING: Tertiary-care nursery. PARTICIPANTS: Neonates (N = 90) hospitalized at birth in the intensive, intermediate care, or newborn units. MAIN OUTCOME MEASURES: Total hours from the time the i.v. was inserted to the time the i.v. was removed; hours from the time the i.v. was first flushed to the time the i.v. was removed; number of i.vs. removed because of …

A Randomized Trial Of Heparin And Saline For Maintaining Intravenous Locks In Neonates, J. Heilskov, Charmaine Kleiber, K. Johnson, J. Miller

Charmaine Kleiber

PURPOSE: To determine the effects of saline, heparin 2 units (U) per ml saline, and heparin 10 U/ml saline flush solutions on the duration of intravenous (i.v.) locks and the incidence of i.v. infiltration in neonates. DESIGN: Randomized double-blind experiment. SETTING: Tertiary-care nursery. PARTICIPANTS: Neonates (N = 90) hospitalized at birth in the intensive, intermediate care, or newborn units. MAIN OUTCOME MEASURES: Total hours from the time the i.v. was inserted to the time the i.v. was removed; hours from the time the i.v. was first flushed to the time the i.v. was removed; number of i.vs. removed because of …

Telephone Management In Substance Abuse Treatment, J. A. Hall, Diane L. Huber

Diane Huber

The purpose of this article is to describe the results of a clinical trial in which telephonic case management was evaluated as a supplement to substance abuse treatment. An interactive voice response system (IVR) was developed by the research team for use in the case management of randomly assigned participants in a clinical trial research project. The features of the software program facilitated a double caseload for the case manager as well as real-time data capture. At intake, no significant differences were found between participants in the telecommunication condition and the general project. Thus, the effectiveness of random assignment was …

Bladder Inflammatory Transcriptome In Response To Tachykinins: Neurokinin 1 Receptor-Dependent Genes And Transcription Regulatory Elements, Ricardo Saban, Cindy Simpson, Rajanikanth Vadigepalli, Sylvie Memet, Igor Dozmorov, Marcia R. Saban

Rajanikanth Vadigepalli

Background Tachykinins (TK), such as substance P, and their neurokinin receptors which are ubiquitously expressed in the human urinary tract, represent an endogenous system regulating bladder inflammatory, immune responses, and visceral hypersensitivity. Increasing evidence correlates alterations in the TK system with urinary tract diseases such as neurogenic bladders, outflow obstruction, idiopathic detrusor instability, and interstitial cystitis. However, despite promising effects in animal models, there seems to be no published clinical study showing that NK-receptor antagonists are an effective treatment of pain in general or urinary tract disorders, such as detrusor overactivity. In order to search for therapeutic targets that could …

Maternal Genes And Facial Clefts In Offspring: A Comprehensive Search For Genetic Associations In Two Population-Based Cleft Studies From Scandinavia, A. Jugessur, M. Shi, H. K. Gjessing, R. T. Lie, A. J. Wilcox, C. R. Weinberg, K. Christensen, A. L. Boyles, Sandra Daack-Hirsch, T. T. Nguyen, L. Christiansen, A. C. Lidral, J. C. Murray

Sandra Daack-Hirsch

BACKGROUND: Fetal conditions can in principle be affected by the mother's genotype working through the prenatal environment. METHODOLOGY/PRINCIPAL FINDINGS: Genotypes for 1536 SNPs in 357 cleft candidate genes were available from a previous analysis in which we focused on fetal gene effects. After data-cleaning, genotypes for 1315 SNPs in 334 autosomal genes were available for the current analysis of maternal gene effects. Two complementary statistical methods, TRIMM and HAPLIN, were used to detect multi-marker effects in population-based samples from Norway (562 case-parent and 592 control-parent triads) and Denmark (235 case-parent triads). We analyzed isolated cleft lip with or without cleft …

Genetic Determinants Of Facial Clefting: Analysis Of 357 Candidate Genes Using Two National Cleft Studies From Scandinavia, A. Jugessur, M. Shi, H. K. Gjessing, R. T. Lie, A. J. Wilcox, C. R. Weinberg, K. Christensen, A. L. Boyles, Sandra Daack-Hirsch, T. N. Trung, C. Bille, A. C. Lidral, J. C. Murray

Sandra Daack-Hirsch

BACKGROUND: Facial clefts are common birth defects with a strong genetic component. To identify fetal genetic risk factors for clefting, 1536 SNPs in 357 candidate genes were genotyped in two population-based samples from Scandinavia (Norway: 562 case-parent and 592 control-parent triads; Denmark: 235 case-parent triads). METHODOLOGY/PRINCIPAL FINDINGS: We used two complementary statistical methods, TRIMM and HAPLIN, to look for associations across these two national samples. TRIMM tests for association in each gene by using multi-SNP genotypes from case-parent triads directly without the need to infer haplotypes. HAPLIN on the other hand estimates the full haplotype distribution over a set of …

Parent Behavior And Child Distress During Urethral Catheterization, Charmaine Kleiber, Ann Marie Mccarthy

Ann Marie McCarthy

ISSUES AND PURPOSE: Researchers need a clear understanding of the natural behaviors parents use to help their children cope. This study describes the relationships between naturally occurring parent behaviors and child distress behaviors during urethral catheterization. DESIGN AND METHODS: In this descriptive study, researchers videotaped the behaviors of parent-child interactions during urethral catheterization. RESULTS: Parents used distraction to maintain calm behavior during the first part of the procedure and used more reassurance when the children started to become distressed. Seven of the nine children displayed calm behavior at least half the time following distraction. Parental reassurance did not decrease distress …

Medical Sequencing Of Candidate Genes For Nonsyndromic Cleft Lip And Palate, A. R. Vieira, J. R. Avila, Sandra Daack-Hirsch, E. Dragan, T. M. Felix, F. Rahimov, J. Harrington, R. R. Schultz, Y. Watanabe, M. Johnson, J. Fang, S. E. O'Brien, I. M. Orioli, E. E. Castilla, D. R. Fitzpatrick, R. Jiang, M. L. Marazita, J. C. Murray

Sandra Daack-Hirsch

Nonsyndromic or isolated cleft lip with or without cleft palate (CL/P) occurs in wide geographic distribution with an average birth prevalence of 1/700. We used direct sequencing as an approach to study candidate genes for CL/P. We report here the results of sequencing on 20 candidate genes for clefts in 184 cases with CL/P selected with an emphasis on severity and positive family history. Genes were selected based on expression patterns, animal models, and/or role in known human clefting syndromes. For seven genes with identified coding mutations that are potentially etiologic, we performed linkage disequilibrium studies as well in 501 …

Parent Behavior And Child Distress During Urethral Catheterization, Charmaine Kleiber, Ann Marie Mccarthy

Charmaine Kleiber

ISSUES AND PURPOSE: Researchers need a clear understanding of the natural behaviors parents use to help their children cope. This study describes the relationships between naturally occurring parent behaviors and child distress behaviors during urethral catheterization. DESIGN AND METHODS: In this descriptive study, researchers videotaped the behaviors of parent-child interactions during urethral catheterization. RESULTS: Parents used distraction to maintain calm behavior during the first part of the procedure and used more reassurance when the children started to become distressed. Seven of the nine children displayed calm behavior at least half the time following distraction. Parental reassurance did not decrease distress …

A Randomized Trial Of Heparin And Saline For Maintaining Intravenous Locks In Neonates, J. Heilskov, Charmaine Kleiber, K. Johnson, J. Miller

Charmaine Kleiber

PURPOSE: To determine the effects of saline, heparin 2 units (U) per ml saline, and heparin 10 U/ml saline flush solutions on the duration of intravenous (i.v.) locks and the incidence of i.v. infiltration in neonates. DESIGN: Randomized double-blind experiment. SETTING: Tertiary-care nursery. PARTICIPANTS: Neonates (N = 90) hospitalized at birth in the intensive, intermediate care, or newborn units. MAIN OUTCOME MEASURES: Total hours from the time the i.v. was inserted to the time the i.v. was removed; hours from the time the i.v. was first flushed to the time the i.v. was removed; number of i.vs. removed because of …

Telephone Management In Substance Abuse Treatment, J. A. Hall, Diane L. Huber

Diane Huber

The purpose of this article is to describe the results of a clinical trial in which telephonic case management was evaluated as a supplement to substance abuse treatment. An interactive voice response system (IVR) was developed by the research team for use in the case management of randomly assigned participants in a clinical trial research project. The features of the software program facilitated a double caseload for the case manager as well as real-time data capture. At intake, no significant differences were found between participants in the telecommunication condition and the general project. Thus, the effectiveness of random assignment was …

Women In Ict: Guidelines For Evaluating Intervention Programmes, Annemieke Craig, Julie Fisher, Linda Dawson

Associate Professor Linda Dawson

Many intervention programmes to increase the number of women in theInformation and Communications Technology (ICT) profession have been implemented over the last twenty years. Detailed evaluations help us to determine the effectiveness of these programmes yet few comprehensive evaluations appear in the literature.The research reported here describes an investigation of the evaluation of the intervention programmes focusing on increasing the enrolment and retention of females in ICT in Australia. This paper describes an empirical study which explores how evaluation has been and might be conducted and concludes with guidelines for evaluation for those developing programmes for increasing the participation of …

Parent Behavior And Child Distress During Urethral Catheterization, Charmaine Kleiber, Ann Marie Mccarthy

Ann Marie McCarthy

ISSUES AND PURPOSE: Researchers need a clear understanding of the natural behaviors parents use to help their children cope. This study describes the relationships between naturally occurring parent behaviors and child distress behaviors during urethral catheterization. DESIGN AND METHODS: In this descriptive study, researchers videotaped the behaviors of parent-child interactions during urethral catheterization. RESULTS: Parents used distraction to maintain calm behavior during the first part of the procedure and used more reassurance when the children started to become distressed. Seven of the nine children displayed calm behavior at least half the time following distraction. Parental reassurance did not decrease distress …

Parent Behavior And Child Distress During Urethral Catheterization, Charmaine Kleiber, Ann Marie Mccarthy

Charmaine Kleiber

ISSUES AND PURPOSE: Researchers need a clear understanding of the natural behaviors parents use to help their children cope. This study describes the relationships between naturally occurring parent behaviors and child distress behaviors during urethral catheterization. DESIGN AND METHODS: In this descriptive study, researchers videotaped the behaviors of parent-child interactions during urethral catheterization. RESULTS: Parents used distraction to maintain calm behavior during the first part of the procedure and used more reassurance when the children started to become distressed. Seven of the nine children displayed calm behavior at least half the time following distraction. Parental reassurance did not decrease distress …

A Randomized Trial Of Heparin And Saline For Maintaining Intravenous Locks In Neonates, J. Heilskov, Charmaine Kleiber, K. Johnson, J. Miller

Charmaine Kleiber

PURPOSE: To determine the effects of saline, heparin 2 units (U) per ml saline, and heparin 10 U/ml saline flush solutions on the duration of intravenous (i.v.) locks and the incidence of i.v. infiltration in neonates. DESIGN: Randomized double-blind experiment. SETTING: Tertiary-care nursery. PARTICIPANTS: Neonates (N = 90) hospitalized at birth in the intensive, intermediate care, or newborn units. MAIN OUTCOME MEASURES: Total hours from the time the i.v. was inserted to the time the i.v. was removed; hours from the time the i.v. was first flushed to the time the i.v. was removed; number of i.vs. removed because of …

Telephone Management In Substance Abuse Treatment, J. A. Hall, Diane L. Huber

Diane Huber

The purpose of this article is to describe the results of a clinical trial in which telephonic case management was evaluated as a supplement to substance abuse treatment. An interactive voice response system (IVR) was developed by the research team for use in the case management of randomly assigned participants in a clinical trial research project. The features of the software program facilitated a double caseload for the case manager as well as real-time data capture. At intake, no significant differences were found between participants in the telecommunication condition and the general project. Thus, the effectiveness of random assignment was …

Reliability Of The 60+ Functional Fitness Test Battery For Older Adults, K. E. Mobily, Paula R. Mobily

Paula Mobily

The primary purpose of this investigation was to determine the internal consistency of the 60+ functional fitness test battery for older adults. A secondary purpose was to determine whether the number of trials recommended in the testing manual was optimal. Subjects were used from an ongoing study of a fitness program for community-dwelling older adults. Internal consistency coefficients for subtests of flexibility, agility, coordination, and strength were excellent. Post hoc analysis across trials indicated significant differences in means between early trials and later trials. Mean scores stabilized after two or three trials, depending on the subtest of interest. Data provided …

The Effects Of Laropiprant, A Selective Prostaglandin D₂ Receptor 1 Antagonist, On The Antiplatelet Activity Of Clopidogrel Or Aspirin., Aimee Dallob, Wen-Lin Luo, Julie Mabalot Luk, Lisa Ratcliffe, Amy O Johnson-Levonas, Jules I Schwartz, Victor Dishy, Walter K. Kraft, Jan N De Hoon, Anne Van Hecken, Inge De Lepeleire, Waldemar Radziszewski, John A Wagner, Eseng Lai

walter k Kraft

Laropiprant (LRPT) is being developed in combination with Merck's extended-release niacin (ERN) formulation for the treatment of dyslipidemia. LRPT, an antagonist of the prostaglandin PGD₂ receptor DP1, reduces flushing symptoms associated with ERN. LRPT also has affinity for the thromboxane A₂ receptor TP (approximately 190-fold less potent at TP compared with DP1). Aspirin and clopidogrel are two frequently used anti-clotting agents with different mechanisms of action. Since LRPT may potentially be co-administered with either one of these agents, these studies were conducted to assess the effects of steady-state LRPT on the antiplatelet activity of steady-state clopidogrel or aspirin. Bleeding time …

A Glycosylated Recombinant Human Granulocyte Colony Stimulating Factor Produced In A Novel Protein Production System (Avi-014) In Healthy Subjects: A First-In Human, Single Dose, Controlled Study., Roslyn Varki, Ed Pequignot, Mark C Leavitt, Andres Ferber, Walter K Kraft

walter k Kraft

BACKGROUND: AVI-014 is an egg white-derived, recombinant, human granulocyte colony-stimulating factor (G-CSF). This healthy volunteer study is the first human investigation of AVI-014. METHODS: 24 male and female subjects received a single subcutaneous injection of AVI-014 at 4 or 8 mcg/kg. 16 control subjects received 4 or 8 mcg/kg of filgrastim (Neupogen, Amgen) in a partially blinded, parallel fashion. RESULTS: The Geometric Mean Ratio (GMR) (90% CI) of 4 mcg/kg AVI-014/filgrastim AUC(0-72 hr) was 1.00 (0.76, 1.31) and Cmax was 0.86 (0.66, 1.13). At the 8 mcg/kg dose, the AUC(0-72) GMR was 0.89 (0.69, 1.14) and Cmax was 0.76 (0.58, …

Neighborhood Socioeconomic Deprivation And Mortality: Nih-Aarp Diet And Health Study, Jacqueline M. Major, Chyke A. Doubeni, Neal D. Freedman, Yikyung Park, Min Lian, Albert R. Hollenbeck, Arthur Schatzkin, Barry I. Graubard, Rashmi Sinha

Chyke A. Doubeni

PURPOSE: Residing in deprived areas may increase risk of mortality beyond that explained by a person's own SES-related factors and lifestyle. The aim of this study was to examine the relation between neighborhood socioeconomic deprivation and all-cause, cancer- and cardiovascular disease (CVD)-specific mortality for men and women after accounting for education and other important person-level risk factors. METHODS: In the longitudinal NIH-AARP Study, we analyzed data from healthy participants, ages 50-71 years at study baseline (1995-1996). Deaths (n = 33831) were identified through December 2005. Information on census tracts was obtained from the 2000 US Census. Cox models estimated hazard …