A two-year clinical follow-up study in 80 CADASIL subjects: progression patterns and implications for clinical trials

2004 ◽  
Vol 31 (S 1) ◽  
Author(s):  
J Herzog ◽  
N Peters ◽  
C Opherk ◽  
M Dichgans
Keyword(s):  
Clinical Trials ◽  
Follow Up Study ◽  
Progression Patterns

scholarly journals Intergenerational monitoring in clinical trials of germline gene editing

2019 ◽  
Vol 46 (3) ◽  
pp. 183-187 ◽  
Author(s):  
Bryan Cwik
Keyword(s):  
Clinical Trials ◽  
Gene Editing ◽  
Ethical Issues ◽  
Human Subjects ◽  
Germline Gene ◽  
Ethical Challenges ◽  
Human Subjects Research ◽  
Follow Up Study

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued.

Experience and Reason: Twenty-Year Follow-Up of Protective Immunity of the Oka Strain Live Varicella Vaccine

PEDIATRICS ◽  
1994 ◽  
Vol 94 (4) ◽  
pp. 524-526
Author(s):  
Yoshizo Asano ◽  
Sadao Suga ◽  
Tetsushi Yoshikawa ◽  
Ikuko Kobayashi ◽  
Takehiko Yazaki ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Protective Immunity ◽  
Protective Efficacy ◽  
Varicella Vaccine ◽  
The United States ◽  
Follow Up Study ◽  
Waning Immunity

Since the first report on the development of a live attenuated varicella vaccine in 1974, the vaccine has been studied extensively, with largely favorable results, in both healthy and leukemic children. It is now licensed in Japan, Korea, and some European countries, and is being considered for licensure in the United States. Although various clinical trials have established the safety, immunogenicity, and the efficacy of the vaccine, concern has been expressed that waning immunity in the vaccine recipients might allow the occurrence of more severe varicella later in life. We show data relevant to this concern on the approximately 20-year follow-up study of the vaccine recipients; this work further extends the experience of a long-term protective efficacy of the vaccine.

BRAF inhibitor treatment in classic hairy cell leukemia: a long-term follow-up study of patients treated outside clinical trials

Leukemia ◽  
2019 ◽  
Vol 34 (5) ◽  
pp. 1454-1457
Author(s):  
Nora Liebers ◽  
Tobias Roider ◽  
Jan-Paul Bohn ◽  
Isabella Haberbosch ◽  
Andreas Pircher ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hairy Cell Leukemia ◽  
Braf Inhibitor ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Follow Up Study ◽  
Long Term Follow Up ◽  
Inhibitor Treatment

scholarly journals Lung Cancer–Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results

Diabetes Care ◽  
2019 ◽  
Vol 42 (9) ◽  
pp. 1708-1715 ◽  
Author(s):  
Nicolle M. Gatto ◽  
Daniel O. Koralek ◽  
Michael B. Bracken ◽  
William T. Duggan ◽  
Joanna Lem ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Controlled Clinical Trials ◽  
Inhaled Insulin ◽  
Follow Up Study ◽  
Related Mortality

scholarly journals Estrogen Use and Breast Cancer Increases

2020 ◽  
pp. 1-2
Author(s):  
Ellen C G Grant ◽  
Ellen C G Grant
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Hormone Therapy ◽  
Women's Health ◽  
Women's Health Initiative ◽  
Women’S Health Initiative ◽  
Health Initiative ◽  
Follow Up Study ◽  
The Women’S Health Initiative

The Women’s Health Initiative (WHI) clinical trials 24-year follow-up study found increases in breast cancer and mortality with combined progestin/estrogen hormone therapy (HT) but reduced risks with estrogen-only HT [1]. The latter finding is dubious especially as HT use seems to be unknown during the long follow-up period [1].

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