A5031001812- Statistical Methods in Clinical Trials
- Health Systems, Economic Evaluations, Quality of Life
- Meta-analysis and systematic reviews
- Ethics in Clinical Research
- Hormonal and reproductive studies
- Vaccine Coverage and Hesitancy
- Biomedical Ethics and Regulation
- Advanced Causal Inference Techniques
- Optimal Experimental Design Methods
- Neuroscience of respiration and sleep
- Pharmaceutical studies and practices
- SARS-CoV-2 and COVID-19 Research
- Obstructive Sleep Apnea Research
- Statistical Methods and Inference
- Muscle metabolism and nutrition
- Sexual function and dysfunction studies
- Pharmacology and Obesity Treatment
- Cardiac, Anesthesia and Surgical Outcomes
- Viral Infections and Outbreaks Research
- Influenza Virus Research Studies
- Sexual Differentiation and Disorders
- COVID-19 Clinical Research Studies
- COVID-19 and healthcare impacts
- Pharmaceutical Economics and Policy
- Hepatitis B Virus Studies
University of Pennsylvania
2016-2025
Brigham and Women's Hospital
2014-2024
AbbVie (United States)
2024
Harvard University
2024
Cleveland Clinic
2024
University of Pittsburgh
2024
University of California, San Francisco
2024
Center for Clinical Research (United States)
2024
Philadelphia University
2024
Institute for Medical Informatics and Biostatistics
2019-2021
Adenotonsillectomy is commonly performed in children with the obstructive sleep apnea syndrome, yet its usefulness reducing symptoms and improving cognition, behavior, quality of life, polysomnographic findings has not been rigorously evaluated. We hypothesized that, syndrome without prolonged oxyhemoglobin desaturation, early adenotonsillectomy, as compared watchful waiting supportive care, would result improved outcomes.
Serum testosterone concentrations decrease as men age, but benefits of raising levels in older have not been established.
About a third of patients with ovarian cancer present localized disease; despite surgical resection, up to half the tumors recur. Since it has not been established whether adjuvant treatment can benefit such patients, we conducted two prospective, randomized national cooperative trials therapy in carcinoma (International Federation Gynecology and Obstetrics Stages Ia IIc). All underwent resection plus comprehensive staging and, 18 months later, re-exploration. In first trial, 81...
<h3>Importance</h3> Recent studies have yielded conflicting results as to whether testosterone treatment increases cardiovascular risk. <h3>Objective</h3> To test the hypothesis that of older men with low slows progression noncalcified coronary artery plaque volume. <h3>Design, Setting, and Participants</h3> Double-blinded, placebo-controlled trial at 9 academic medical centers in United States. The participants were 170 788 aged 65 years or an average 2 serum levels lower than 275 ng/dL (82...
<h3>Importance</h3> As men age, they experience decreased serum testosterone concentrations, bone mineral density (BMD), and increased risk of fracture. <h3>Objective</h3> To determine whether treatment older with low increases volumetric BMD (vBMD) estimated strength. <h3>Design, Setting, Participants</h3> Placebo-controlled, double-blind trial allocation by minimization at 9 US academic medical centers 65 years or 2 concentrations averaging less than 275 ng/L participating in the...
Marcus, Carole L.; Moore, Reneé H.; Rosen, Carol Giordani, Bruno; Garetz, Susan Taylor, H. Gerry; Mitchell, Ron B.; Amin, Raouf; Katz, Eliot S.; Arens, Raanan; Paruthi, Shalini; Muzumdar, Hiren; Gozal, David; Thomas, Nina Hattiangadi; Ware, Janice; Beebe, Dean; Snyder, Karen; Elden, Lisa; Sprecher, Rober C.; Willging, Paul; Jones, Dwight; Bent, John P.; Hoban, Timothy; Chervin, Ronald D.; Ellenberg, Redline, for the Childhood Adenotonsillectomy Trial (CHAT) Author Information
The Testosterone Trials (TTrials) were a coordinated set of seven placebo-controlled, double-blind trials in 788 men with mean age 72 years to determine the efficacy increasing testosterone levels older low testosterone. treatment increased median level from unequivocally at baseline midnormal for young after 3 months and maintained that until month 12. In Sexual Function Trial, sexual activity, desire, erectile function. Physical did not increase distance walked 6 minutes whose walk speed...
<h3>Importance</h3> In one-third of older men with anemia, no recognized cause can be found. <h3>Objective</h3> To determine if testosterone treatment 65 years or unequivocally low levels and unexplained anemia would increase their hemoglobin concentration. <h3>Design, Setting, Participants</h3> A double-blinded, placebo-controlled trial allocation by minimization using 788 who have average less than 275 ng/dL. Of participants, 126 were anemic (hemoglobin ≤12.7 g/dL), 62 whom had known...
<h3>Importance</h3> Most cognitive functions decline with age. Prior studies suggest that testosterone treatment may improve these functions. <h3>Objective</h3> To determine if compared placebo is associated improved verbal memory and other in older men low age-associated impairment (AAMI). <h3>Design, Setting, Participants</h3> The Testosterone Trials (TTrials) were 7 trials to assess the efficacy of levels. Cognitive Function Trial evaluated function all TTrials participants. In 12 US...
The effects of spinal anesthesia as compared with general on the ability to walk in older adults undergoing surgery for hip fracture have not been well studied.
BackgroundTestosterone treatment in men with hypogonadism improves bone density and quality, but trials a sufficiently large sample long duration to determine the effect of testosterone on incidence fractures are needed.MethodsIn subtrial double-blind, randomized, placebo-controlled trial that assessed cardiovascular safety middle-aged older hypogonadism, we examined risk clinical fracture time-to-event analysis. Eligible were 45 80 years age preexisting, or high of, disease; one more...
Placebo controls are commonly used in clinical trials of investigational treatments because they have important advantages. In recent years, some criticized the use placebo-controlled when effective alternative therapy exists, regardless expected effect therapy. part 1 this paper, ethical arguments addressed and interpretive problems inherent active-control equivalence to establish efficacy a new treatment clarified. However, uncertainties may complicate decisions about appropriate placebo...
We evaluated the risk of acute nonlymphocytic leukemia, myelodysplastic syndrome, and preleukemia in 3633 patients with gastrointestinal cancer who were treated nine randomized clinical trials. Among 2067 given semustine (methyl-CCNU) as adjuvant therapy, leukemic disorders developed 14, whereas only one disorder (acute leukemia) occurred among 1566 other therapies (relative = 12.4; 95 per cent confidence interval 1.7 to 250). The six-year cumulative mean (+/- S.E.) acquiring a after...
Each year, over 500,000 adenotonsillectomies (AT), mostly for the treatment of pediatric obstructive sleep apnea (OSA) are performed in US children under 15 years age. No definitive study, however, has been yet conducted that rigorously evaluated effectiveness AT not only improving disordered breathing, but also clinically relevant outcomes, such as neurocognitive function, behavior, and quality life. The Childhood Adenotonsillectomy Trial (CHAT) was designed to assess neuropsychological...
A two-stage design which selects the best of several experimental treatments and compares it to a standard control is proposed. The allows early termination with acceptance global null hypothesis. Optimal sample size cut-off parameters are obtained by minimizing expected total for fixed significance level power.
Premarketing studies of drugs, although large enough to demonstrate efficacy and detect common adverse events, cannot reliably an increased incidence rare events or with significant latency. For most only about 500 3000 participants are studied, for relatively short durations, before a drug is marketed. Systems assessment postmarketing include spontaneous reports, computerized claims medical record databases, formal studies. We briefly review the strengths limitations each. Postmarketing...
In clinical trials where several experimental treatments are of interest, the goal may be viewed as identification best these and comparison that treatment to a standard control therapy. However, it is undesirable commit patients large-scale comparative trial new regimen without evidence its therapeutic success rate acceptably high. We propose two-stage design in which first randomized among treatments, single having highest observed identified. If this falls below fixed cutoff then...