Medicine and Health Sciences Commons^™

A Comparative Study Of Cervical Hysteresis Characteristics After Various Osteopathic Manipulative Treatment (Omt) Modalities, Precious Barnes, Francisco Laboy, Lauren Noto-Bell, Veronica Ferencz, Jeffrey Nelson, Michael Kuchera

Michael Kuchera

BACKGROUND: Few objective measures have been used to document change in myofascial tissues after OMT.

HYPOTHESIS: Paraspinal tissues associated with cervical somatic dysfunction (SD) will demonstrate quantifiable change in myofascial hysteresis characteristics after a given OMT technique but not after a Sham intervention.

MATERIALS AND METHODS: 240 subjects were palpated for cervical articular SD. A randomly selected intervention (5 OMT techniques or a Sham) was applied to the cervical SD clinically considered to be most severe. A durometer (SA201(®); Sigma Instruments, Cranberry, PA, USA) objectively measured myofascial structures overlying each cervical spinal segment pre- and post- intervention. Using a …

Development Of Antigen-Specific Memory Cd8+ T Cells Following Live-Attenuated Chimeric West Nile Virus Vaccination, Heidi Smith, Thomas Monath, Pamela Pazoles, Alan Rothman, Diane Casey, Masanori Terajima, Francis Ennis, Farshad Guirakhoo, Sharone Green

Alan Rothman

ChimeriVax-WN02 is a novel live-attenuated West Nile virus (WNV) vaccine containing modified WNV premembrane (prM) and envelope (E) sequences inserted into the yellow fever 17D vaccine genome. We investigated the induction and evolution of CD8(+) T cell responses to a WNV envelope epitope, which is a dominant target in naturally infected HLA-A*02-positive individuals. WNV epitope-specific CD8(+) T cells were detected by HLA tetramer staining in 22 of 23 donors tested, with peak frequencies occurring between days 14 and 28. WNV epitope-specific T cells evolved from an effector phenotype to a long-lived memory phenotype. In the majority of donors, CD8(+) T …

Development Of Antigen-Specific Memory Cd8+ T Cells Following Live-Attenuated Chimeric West Nile Virus Vaccination, Heidi Smith, Thomas Monath, Pamela Pazoles, Alan Rothman, Diane Casey, Masanori Terajima, Francis Ennis, Farshad Guirakhoo, Sharone Green

Sharone Green

ChimeriVax-WN02 is a novel live-attenuated West Nile virus (WNV) vaccine containing modified WNV premembrane (prM) and envelope (E) sequences inserted into the yellow fever 17D vaccine genome. We investigated the induction and evolution of CD8(+) T cell responses to a WNV envelope epitope, which is a dominant target in naturally infected HLA-A*02-positive individuals. WNV epitope-specific CD8(+) T cells were detected by HLA tetramer staining in 22 of 23 donors tested, with peak frequencies occurring between days 14 and 28. WNV epitope-specific T cells evolved from an effector phenotype to a long-lived memory phenotype. In the majority of donors, CD8(+) T …

A Double-Blind Randomized Controlled Trial Of Olanzapine Plus Sertraline Vs Olanzapine Plus Placebo For Psychotic Depression: The Study Of Pharmacotherapy Of Psychotic Depression (Stop-Pd), Barnett Meyers, Alastair Flint, Anthony Rothschild, Benoit Mulsant, Ellen Whyte, Catherine Peasley-Miklus, Eros Papademetriou, Andrew Leon, Moonseong Heo, Paul Appelbaum, Philip Candilis, Nancy Byatt, Kristina Deligiannidis

Philip J. Candilis

CONTEXT: Evidence for the efficacy of combination pharmacotherapy has been limited and without positive trials in geriatric patients with major depression (MD) with psychotic features. OBJECTIVES: To compare remission rates of MD with psychotic features in those treated with a combination of atypical antipsychotic medication plus a serotonin reuptake inhibitor with those treated with antipsychotic monotherapy; and to compare response by age. DESIGN: Twelve-week, double-blind, randomized, controlled trial. SETTING: Clinical services of 4 academic sites. Patients Two hundred fifty-nine subjects with MD with psychotic features randomized by age ( or =60 years) (mean [standard deviation (SD)], 41.3 [10.8] years in …

Treatment Of Premature Labor With Indomethacin., D. Blake, Jennifer Niebyl, R. White, K. Kumor, N. Dubin, J. Robinson, P. Egner

Jennifer R Niebyl

No abstract provided.

A Placebo-Controlled Randomized Trial Of The Terbutaline Pump For Prevention Of Preterm Delivery, K. Wenstrom, C. Weiner, D. Merrill, Jennifer Niebyl

Jennifer R Niebyl

To determine the efficacy of the terbutaline pump for the prevention of preterm delivery, patients in preterm labor defined by progressive cervical change underwent intravenous magnesium sulfate tocolysis (with or without oral indomethacin, as necessary), and once labor was arrested, were randomized to one of three treatment arms: terbutaline by pump, saline by pump (blinded), or oral terbutaline. If recurrent preterm labor occurred despite maximization of therapy, the treatment arm was determined and therapy was changed; saline pump and oral terbutaline were switched to terbutaline pump, terbutaline pump was switched to oral terbutaline. Patients who continued to labor were readmitted …

The Influence Of Aspirin On The Course Of Induced Midtrimester Abortion, Jennifer Niebyl, D. Blake, L. Burnett, T. King

Jennifer R Niebyl

Prostaglandins appear to mediate the uterine contractions of abortion and labor, and aspirin has been shown to be an inhibitor of prostaglandin synthesis. In this double-blind, placebo-controlled, prospective, and randomized study, aspirin was administered orally in doses of 600 mg. every 6 hours to patients undergoing induced midtrimester abortions with hyperosmolar urea and oxytocin augmentation. The mean injection-abortion interval was significantly prolonged by aspirin in nulliparous patients (aspirin 32.3 +/- 3.3 hr. vs. placebo 21.5 +/- 3.5 hr.) and no aspirin-treated nullipara aborted in less than 18 hours. There was no significant difference between treatment groups in the mean injection-abortion …

Treatment Of Premature Labor With Indomethacin, D. Blake, Jennifer Niebyl, R. White, K. Kumor, N. Dubin, J. Robinson, P. Egner

Jennifer R Niebyl

No abstract provided.

The Doctor-Patient Relationship Revisited. An Analysis Of The Placebo Effect., Herbert M. Adler, Md, Van B. Hammett. Md

Herbert M. Adler

An overview of prescientific medicine, evolution, and individual human development is presented in an attempt to discover the generic factors operating in all interpersonal therapies. We hypothesize that the placebo effect rests on the universal human need for a group and, by symbolic extension, a system.

A New Transient Sham Tens Device Allows For Investigator Blinding While Delivering A True Placebo Treatment, Barbara Rakel, N. Cooper, H. Adams, B. Messer, L. Frey Law, D. Dannen, C. Miller, A. Polehna, R. Ruggle, C. Vance, D. Walsh, K. Sluka

Barbara A. Rakel

This study compared a new transient sham transcutaneous electrical nerve stimulation (TENS) that delivers current for 45 seconds to an inactive sham and active TENS to determine the degree of blinding and influence on pain reduction. Pressure-pain thresholds (PPT), heat-pain thresholds (HPT), and pain intensities to tonic heat and pressure were measured in 69 healthy adults before and after randomization. Allocation investigators and subjects were asked to identify the treatment administered. The transient sham blinded investigators 100% of the time and 40% of subjects compared to the inactive sham that blinded investigators 0% of the time and 21% of subjects. …

Ethical Issues Posed By Cluster Randomized Trials In Health Research, Charles Weijer, Jeremy Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Antonio Gallo, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein

Charles Weijer

The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. …

Ethical And Policy Issues In Cluster Randomized Trials: Rationale And Design Of A Mixed Methods Research Study, Monica Taljaard, Charles Weijer, Jeremy Grimshaw, Judith Brown, Ariella Binik, Robert Boruch, Jamie Brehaut, Shazia Chaudhry, Martin Eccles, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein, Allan Donner

Charles Weijer

Background: Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities--rather than individual themselves--are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main …

Research Governance Lessons From The National Placebo Initiative, Heather Sampson, Charles Weijer, Daryl Pullman

Charles Weijer

No abstract provided.

Heads Or Tails: Randomized Placebo-Controlled Trials, Charles Weijer

Charles Weijer

No abstract provided.

When Are Research Risks Reasonable In Relation To Anticipated Benefits?, Charles Weijer, Paul Miller

Charles Weijer

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk in research is required. Component analysis provides such a systematic approach.

The Ethics Of Placebo-Controlled Trials, Charles Weijer

Charles Weijer

No abstract provided.

Rehabilitating Equipoise, Paul Miller, Charles Weijer

Charles Weijer

When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that there exist a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. FE and CE are widely understood …

Is The Use Of Placebo Controls Ethically Permissible In Clinical Trials Of Agents Intended To Reduce Fractures In Osteoporosis?, Baruch Brody, Nancy Dickey, Susan Ellenberg, Robert Heaney, Robert Levine, Richard O'Brien, Ruth Purtilo, Charles Weijer

Charles Weijer

Substantial progress has been made in developing treatments that reduce the risk of fractures in osteoporosis. However, available treatments are only partially effective, they are not widely used, and there is need to search for more effective means of fracture prevention. Currently known effective means of reducing fractures were found using randomized placebo-controlled trials. The use of placebo controls in clinical trials has been a subject of significant controversy in recent years. The Declaration of Helsinki revision of October 2000 caused great concern among clinical investigators about the future use of placebo controls if known effective therapeutic agents are available. …

Placebo Tribulations, Charles Weijer

Charles Weijer

No abstract provided.

Placebo Trials And Tribulations, Charles Weijer

Charles Weijer

No abstract provided.

I Need A Placebo Like I Need A Hole In The Head, Charles Weijer

Charles Weijer

No abstract provided.

The Ethics Of Placebo-Controlled Trials, Charles Weijer, Kathleen Glass

Charles Weijer

No abstract provided.

When Argument Fails, Charles Weijer

Charles Weijer

No abstract provided.

Placebo-Controlled Studies In Schizophrenia: Ethical And Scientific Perspectives. Panel Discussion, T. Lemmens, P. Appelbaum, W. Carpenter, C. Mccarthy, C. Peterson, D. Streiner, Charles Weijer

Charles Weijer

No abstract provided.

Placebo-Controlled Trials In Schizophrenia: Are They Ethical? Are They Necessary?, Charles Weijer

Charles Weijer

The current controversy as to the proper role of the placebo control in the evaluation of new treatments for schizophrenia requires an analysis that is sensitive to both ethical and scientific issues. Clinical equipoise, widely regarded as the moral foundation of the randomized controlled trial (RCT), requires the use of best available treatment as the control in RCT. Scientific criticisms of the use of an active control are examined and none present an insuperable barrier to the use of an active control. Indeed, scrutiny of the most recent argument for the use of placebo controls, 'assay sensitivity', suggests that the …

Consensus-Seeking Roundtable On Placebos In Clinical Research, Charles Weijer

Charles Weijer

No abstract provided.

Reb Review Of Research Proposals Involving Placebo Controls, Charles Weijer

Charles Weijer

No abstract provided.

The Placebo Effect, Charles Weijer

Charles Weijer

No abstract provided.

Ccnp Position Paper On The Use Of Placebos In Psychiatry, William Friend, Charles Weijer

Charles Weijer

No abstract provided.

Placebo Controls Are Not Good Science, Charles Weijer

Charles Weijer

No abstract provided.