Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation

Search Page

Filters

My NCBI Filters

Results by year

Table representation of search results timeline featuring number of search results per year.

Year Number of Results
1990 1
1991 1
1996 1
1999 1
2001 1
2002 1
2004 1
2005 1
2006 3
2007 1
2008 2
2009 1
2010 1
2011 1
2012 1
2016 2
2017 1
2020 1
2021 2
2022 1
2024 0

Text availability

Article attribute

Article type

Publication date

Search Results

22 results

Results by year

Filters applied: . Clear all
Page 1
Methods for external control groups for single arm trials or long-term uncontrolled extensions to randomized clinical trials.
Seeger JD, Davis KJ, Iannacone MR, Zhou W, Dreyer N, Winterstein AG, Santanello N, Gertz B, Berlin JA. Seeger JD, et al. Among authors: berlin ja. Pharmacoepidemiol Drug Saf. 2020 Nov;29(11):1382-1392. doi: 10.1002/pds.5141. Epub 2020 Oct 4. Pharmacoepidemiol Drug Saf. 2020. PMID: 32964514 Free PMC article. Review.
These internal controls are missing in single arm trials and from long-term extensions (LTE) of trials including only the treatment arm. ...
These internal controls are missing in single arm trials and from long-term extensions (LTE) of trials including only the treatment a …
Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR.
Bissonnette R, Gottlieb AB, Langley RG, Leonardi CL, Papp KA, Pariser DM, Uy J, Lafferty KP, Langholff W, Fakharzadeh S, Berlin JA, Brouwer ES, Greenspan AJ, Strober BE. Bissonnette R, et al. Among authors: berlin ja. Drug Saf. 2021 Jun;44(6):699-709. doi: 10.1007/s40264-021-01065-z. Epub 2021 Jun 2. Drug Saf. 2021. PMID: 34075572 Free PMC article. Review.
OBJECTIVE: The aim of this study was to discuss methodological limitations and post hoc analyses in long-term safety registries using learnings from analyses of a potential safety risk for major adverse cardiovascular events (MACE) in PSOLAR. ...CONCLUSION: Our results, wh …
OBJECTIVE: The aim of this study was to discuss methodological limitations and post hoc analyses in long-term safety registries using …
Baseline characteristics and treatment-emergent risk factors associated with cerebrovascular event and death with risperidone in dementia patients.
Howard R, Costafreda SG, Karcher K, Coppola D, Berlin JA, Hough D. Howard R, et al. Among authors: berlin ja. Br J Psychiatry. 2016 Nov;209(5):378-384. doi: 10.1192/bjp.bp.115.177683. Epub 2016 Jul 7. Br J Psychiatry. 2016. PMID: 27388570 Review.
Interactions between treatment (risperidone or placebo) and characteristic were analysed with a Cox proportional hazards regression model with main effects for treatment and characteristic in addition to the interaction term. RESULTS: Baseline complications of depression ( …
Interactions between treatment (risperidone or placebo) and characteristic were analysed with a Cox proportional hazards regression model wi …
Effects of L-carnitine on dialysis-related hypotension and muscle cramps: a meta-analysis.
Lynch KE, Feldman HI, Berlin JA, Flory J, Rowan CG, Brunelli SM. Lynch KE, et al. Among authors: berlin ja. Am J Kidney Dis. 2008 Nov;52(5):962-71. doi: 10.1053/j.ajkd.2008.05.031. Epub 2008 Aug 15. Am J Kidney Dis. 2008. PMID: 18706751 Review.
SETTING & POPULATION: Adult patients with end-stage renal disease receiving long-term hemodialysis. SELECTION CRITERIA FOR STUDIES: All published English-language reports of randomized placebo-controlled trials of L-carnitine supplementation in adult long-term h …
SETTING & POPULATION: Adult patients with end-stage renal disease receiving long-term hemodialysis. SELECTION CRITERIA FOR STUDIE …
Uncontrolled Extensions of Clinical Trials and the Use of External Controls-Scoping Opportunities and Methods.
Wang CY, Berlin JA, Gertz B, Davis K, Li J, Dreyer NA, Zhou W, Seeger JD, Santanello N, Winterstein AG. Wang CY, et al. Among authors: berlin ja. Clin Pharmacol Ther. 2022 Jan;111(1):187-199. doi: 10.1002/cpt.2346. Epub 2021 Aug 10. Clin Pharmacol Ther. 2022. PMID: 34165790 Free PMC article.
Increased interest in real-world evidence (RWE) for clinical and regulatory decision making and the need to evaluate long-term benefits and risks of pharmaceutical products raise the importance of understanding the use of external controls (ECs) for uncontrolled extensions …
Increased interest in real-world evidence (RWE) for clinical and regulatory decision making and the need to evaluate long-term benefi …
Risk of breast cancer associated with short-term use of oral contraceptives.
Folger SG, Marchbanks PA, McDonald JA, Bernstein L, Ursin G, Berlin JA, Daling JR, Norman SA, Strom BL, Weiss LK, Simon MS, Burkman RT, Malone KE, Spirtas R. Folger SG, et al. Among authors: berlin ja. Cancer Causes Control. 2007 Mar;18(2):189-98. doi: 10.1007/s10552-006-0086-7. Epub 2007 Jan 10. Cancer Causes Control. 2007. PMID: 17216547
OBJECTIVE: To estimate breast cancer risk associated with short-term (<6 months) oral contraceptive use, and explore variation in estimates by use characteristics and medical, menstrual, and reproductive history. ...However, significant interaction between short-term …
OBJECTIVE: To estimate breast cancer risk associated with short-term (<6 months) oral contraceptive use, and explore variation in …
Oral contraceptives and breast cancer. Review and meta-analysis.
Romieu I, Berlin JA, Colditz G. Romieu I, et al. Among authors: berlin ja. Cancer. 1990 Dec 1;66(11):2253-63. doi: 10.1002/1097-0142(19901201)66:11<2253::aid-cncr2820661102>3.0.co;2-g. Cancer. 1990. PMID: 2147122
This risk was predominant among women who used oral contraceptives for at least 4 years before their first term pregnancy (relative risk = 1.72; 95% confidence interval = 1.36 to 2.19). ...
This risk was predominant among women who used oral contraceptives for at least 4 years before their first term pregnancy (relative r …
Hormone replacement therapy regimens and breast cancer risk(1).
Weiss LK, Burkman RT, Cushing-Haugen KL, Voigt LF, Simon MS, Daling JR, Norman SA, Bernstein L, Ursin G, Marchbanks PA, Strom BL, Berlin JA, Weber AL, Doody DR, Wingo PA, McDonald JA, Malone KE, Folger SG, Spirtas R. Weiss LK, et al. Among authors: berlin ja. Obstet Gynecol. 2002 Dec;100(6):1148-58. doi: 10.1016/s0029-7844(02)02502-4. Obstet Gynecol. 2002. PMID: 12468157
Hormone replacement therapy (HRT) has increased in the United States over the past 2 decades in response to reports of long-term health benefits. A relationship between HRT and breast cancer risk has been observed in a number of epidemiological studies. ...Our data suggest …
Hormone replacement therapy (HRT) has increased in the United States over the past 2 decades in response to reports of long-term heal …
The effect of selective serotonin re-uptake inhibitors on the risk of myocardial infarction in a cohort of patients with depression.
Kimmel SE, Schelleman H, Berlin JA, Oslin DW, Weinstein RB, Kinman JL, Sauer WH, Lewis JD. Kimmel SE, et al. Among authors: berlin ja. Br J Clin Pharmacol. 2011 Sep;72(3):514-7. doi: 10.1111/j.1365-2125.2011.04008.x. Br J Clin Pharmacol. 2011. PMID: 21557758 Free PMC article.
RESULTS: SSRI exposure may be associated with a reduced MI risk (OR = 0.77, 95% CI 0.57, 1.03). However, reduced risk was only observed with longer term use (OR = 0.73, 95% CI 0.53, 1.00) and not with shorter term use (OR = 1.15, 95% CI: 0.65, 2.05). CONCLUSIONS: On …
RESULTS: SSRI exposure may be associated with a reduced MI risk (OR = 0.77, 95% CI 0.57, 1.03). However, reduced risk was only observed with …
Analyses of mortality risk in patients with dementia treated with galantamine.
Feldman HH, Pirttila T, Dartigues JF, Everitt B, Van Baelen B, Brashear HR, Berlin JA, Battisti WP, Kavanagh S. Feldman HH, et al. Among authors: berlin ja. Acta Neurol Scand. 2009 Jan;119(1):22-31. doi: 10.1111/j.1600-0404.2008.01047.x. Epub 2008 Jun 1. Acta Neurol Scand. 2009. PMID: 18518863
METHODS: (1) Meta-analysis of mortality data from double-blind, placebo-controlled, randomized trials; and (2) recontact study to collect additional longer term mortality data from previous galantamine trial participants. ...Cox regression analyses were consistent with the …
METHODS: (1) Meta-analysis of mortality data from double-blind, placebo-controlled, randomized trials; and (2) recontact study to collect ad …
22 results