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ACIP: Flu vaccines for older adults show similar safety profiles

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Mon, 06/08/2020 - 16:30

The two currently available flu vaccines specifically for older adults showed similar safety profiles, based on data from 757 individuals.

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The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.

To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.

Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).

Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.

In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.

The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”

Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.

Dr. Schmader had no financial conflicts to disclose.

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The two currently available flu vaccines specifically for older adults showed similar safety profiles, based on data from 757 individuals.

copyright Wavebreakmedia/Thinkstock

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.

To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.

Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).

Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.

In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.

The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”

Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.

Dr. Schmader had no financial conflicts to disclose.

The two currently available flu vaccines specifically for older adults showed similar safety profiles, based on data from 757 individuals.

copyright Wavebreakmedia/Thinkstock

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.

To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.

Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).

Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.

In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.

The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”

Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.

Dr. Schmader had no financial conflicts to disclose.

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FROM AN ACIP MEETING

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MRI doubles rate of observation in low-risk prostate cancer

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Fri, 01/18/2019 - 17:55

Men who undergo MRI of the prostate around the time of a low-risk prostate cancer diagnosis are nearly twice as likely to be managed with active surveillance as are men who do not get MRI, investigators found.

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The findings suggest that MRI at the time of diagnosis can enhance patient and physician confidence in the decision to choose active surveillance (AS) over immediate surgery or radiation therapy in men with low-risk disease, according to Michael S. Leapman, MD, and his colleagues from Yale University, New Haven, Conn.

“Despite initial high costs associated with obtaining and interpreting MRI studies of the prostate, economic modeling studies imply that MRI would be cost effective if it resulted in increased utilization of AS for low- and very-low-risk PCa [prostate cancer]. The association identified in our study between MRI use and initial observation may serve as an informative basis for examining strategies to improve the quality of PCa care with the anticipated growing use of this technology,” they wrote in Urology.

Although active surveillance is increasingly accepted as an initial management strategy for patients with low-risk (Gleason score 6 or less) localized prostate cancer, the majority of patients with low-risk disease still receive definitive treatment.

“Although longitudinal studies support the safety of AS, uncertainty about the possibility of underestimating an indvidual’s risk of harboring aggressive disease remains a strong motivator to treat,” Dr. Leapman and his associates noted.

To see whether MRI of the prostate may have an effect on the use of active surveillance in men with low-risk disease, the investigators reviewed records from the Surveillance, Epidemiology and End Results (SEER) Medicare database to identify men diagnosed with low-risk prostate cancer during 2010-2013.

They looked at the association between MRI and patient management (ascertained by claims) and evaluated clinical and demographic factors associated with the receipt of MRI.

They identified 8,144 patients with low-risk prostate cancer during the study period, of whom 495 (6.1%) had undergone MRI scans. They found that the use of MRI in patients with low-risk cancer increased from 3.4% in 2010 to 10.5% in 2013.

MRI was performed significantly more frequently among 3,060 patients who were managed with observation, with 265 (8.7%) receiving scans, compared with 230 (4.5%) of the 5,084 patients who underwent treatment within a year of diagnosis.

In multivariable analysis that controlled for demographics, factors significantly associated with increased likelihood of undergoing observation versus definitive therapy included MRI, white vs. nonwhite race, later years of diagnosis, higher income status (by ZIP code), unmarried vs. married, treatment region (more common in the West and Midwest versus Northeast or South), and in referral regions with higher population density of urologists.

In a propensity score–matched analysis designed to smooth out potential confounders, the investigators found that receipt of MRI around the time of diagnosis was associated with a significantly higher likelihood of active surveillance, with an odds ratio of 1.90 (95% confidence interval, 1.56-2.32).

“Efforts to facilitate observational approaches for low-risk PCa are highly valuable to improving the quality of cancer care. Because the use of prostate MRI has grown, and is likely to continue expanding, the cost-effectiveness of MRI-driven pathways are increasingly relevant to the sustainability of the practice,” the authors wrote.

SOURCE: Leapman MS et al. Urology. 2018 Aug 11. doi: 10.1016/j.urology.2018.07.041.

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Men who undergo MRI of the prostate around the time of a low-risk prostate cancer diagnosis are nearly twice as likely to be managed with active surveillance as are men who do not get MRI, investigators found.

roobcio/Thinkstock.com

The findings suggest that MRI at the time of diagnosis can enhance patient and physician confidence in the decision to choose active surveillance (AS) over immediate surgery or radiation therapy in men with low-risk disease, according to Michael S. Leapman, MD, and his colleagues from Yale University, New Haven, Conn.

“Despite initial high costs associated with obtaining and interpreting MRI studies of the prostate, economic modeling studies imply that MRI would be cost effective if it resulted in increased utilization of AS for low- and very-low-risk PCa [prostate cancer]. The association identified in our study between MRI use and initial observation may serve as an informative basis for examining strategies to improve the quality of PCa care with the anticipated growing use of this technology,” they wrote in Urology.

Although active surveillance is increasingly accepted as an initial management strategy for patients with low-risk (Gleason score 6 or less) localized prostate cancer, the majority of patients with low-risk disease still receive definitive treatment.

“Although longitudinal studies support the safety of AS, uncertainty about the possibility of underestimating an indvidual’s risk of harboring aggressive disease remains a strong motivator to treat,” Dr. Leapman and his associates noted.

To see whether MRI of the prostate may have an effect on the use of active surveillance in men with low-risk disease, the investigators reviewed records from the Surveillance, Epidemiology and End Results (SEER) Medicare database to identify men diagnosed with low-risk prostate cancer during 2010-2013.

They looked at the association between MRI and patient management (ascertained by claims) and evaluated clinical and demographic factors associated with the receipt of MRI.

They identified 8,144 patients with low-risk prostate cancer during the study period, of whom 495 (6.1%) had undergone MRI scans. They found that the use of MRI in patients with low-risk cancer increased from 3.4% in 2010 to 10.5% in 2013.

MRI was performed significantly more frequently among 3,060 patients who were managed with observation, with 265 (8.7%) receiving scans, compared with 230 (4.5%) of the 5,084 patients who underwent treatment within a year of diagnosis.

In multivariable analysis that controlled for demographics, factors significantly associated with increased likelihood of undergoing observation versus definitive therapy included MRI, white vs. nonwhite race, later years of diagnosis, higher income status (by ZIP code), unmarried vs. married, treatment region (more common in the West and Midwest versus Northeast or South), and in referral regions with higher population density of urologists.

In a propensity score–matched analysis designed to smooth out potential confounders, the investigators found that receipt of MRI around the time of diagnosis was associated with a significantly higher likelihood of active surveillance, with an odds ratio of 1.90 (95% confidence interval, 1.56-2.32).

“Efforts to facilitate observational approaches for low-risk PCa are highly valuable to improving the quality of cancer care. Because the use of prostate MRI has grown, and is likely to continue expanding, the cost-effectiveness of MRI-driven pathways are increasingly relevant to the sustainability of the practice,” the authors wrote.

SOURCE: Leapman MS et al. Urology. 2018 Aug 11. doi: 10.1016/j.urology.2018.07.041.

Men who undergo MRI of the prostate around the time of a low-risk prostate cancer diagnosis are nearly twice as likely to be managed with active surveillance as are men who do not get MRI, investigators found.

roobcio/Thinkstock.com

The findings suggest that MRI at the time of diagnosis can enhance patient and physician confidence in the decision to choose active surveillance (AS) over immediate surgery or radiation therapy in men with low-risk disease, according to Michael S. Leapman, MD, and his colleagues from Yale University, New Haven, Conn.

“Despite initial high costs associated with obtaining and interpreting MRI studies of the prostate, economic modeling studies imply that MRI would be cost effective if it resulted in increased utilization of AS for low- and very-low-risk PCa [prostate cancer]. The association identified in our study between MRI use and initial observation may serve as an informative basis for examining strategies to improve the quality of PCa care with the anticipated growing use of this technology,” they wrote in Urology.

Although active surveillance is increasingly accepted as an initial management strategy for patients with low-risk (Gleason score 6 or less) localized prostate cancer, the majority of patients with low-risk disease still receive definitive treatment.

“Although longitudinal studies support the safety of AS, uncertainty about the possibility of underestimating an indvidual’s risk of harboring aggressive disease remains a strong motivator to treat,” Dr. Leapman and his associates noted.

To see whether MRI of the prostate may have an effect on the use of active surveillance in men with low-risk disease, the investigators reviewed records from the Surveillance, Epidemiology and End Results (SEER) Medicare database to identify men diagnosed with low-risk prostate cancer during 2010-2013.

They looked at the association between MRI and patient management (ascertained by claims) and evaluated clinical and demographic factors associated with the receipt of MRI.

They identified 8,144 patients with low-risk prostate cancer during the study period, of whom 495 (6.1%) had undergone MRI scans. They found that the use of MRI in patients with low-risk cancer increased from 3.4% in 2010 to 10.5% in 2013.

MRI was performed significantly more frequently among 3,060 patients who were managed with observation, with 265 (8.7%) receiving scans, compared with 230 (4.5%) of the 5,084 patients who underwent treatment within a year of diagnosis.

In multivariable analysis that controlled for demographics, factors significantly associated with increased likelihood of undergoing observation versus definitive therapy included MRI, white vs. nonwhite race, later years of diagnosis, higher income status (by ZIP code), unmarried vs. married, treatment region (more common in the West and Midwest versus Northeast or South), and in referral regions with higher population density of urologists.

In a propensity score–matched analysis designed to smooth out potential confounders, the investigators found that receipt of MRI around the time of diagnosis was associated with a significantly higher likelihood of active surveillance, with an odds ratio of 1.90 (95% confidence interval, 1.56-2.32).

“Efforts to facilitate observational approaches for low-risk PCa are highly valuable to improving the quality of cancer care. Because the use of prostate MRI has grown, and is likely to continue expanding, the cost-effectiveness of MRI-driven pathways are increasingly relevant to the sustainability of the practice,” the authors wrote.

SOURCE: Leapman MS et al. Urology. 2018 Aug 11. doi: 10.1016/j.urology.2018.07.041.

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Key clinical point: MRI at screening or diagnosis of low-risk prostate cancer is associated with a higher likelihood of observation versus immediate definitive therapy.

Major finding: MRI was associated with a near doubling of the likelihood of observation.

Study details: Review of SEER Medicare data on 8,144 men diagnosed with low-risk prostate cancers during 2010-2013.

Disclosures: The study was supported by the National Cancer Institute, California Department of Public Health, and Centers for Disease Control and Prevention. The authors reported no relevant conflicts of interest.

Source: Leapman MS et al. Urology. 2018 Aug 11. doi: 10.1016/j.urology.2018.07.041.
 

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Progeria Research Foundation Scientific Workshop Planned

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Progeria Research Foundation Scientific Workshop Planned

The 9th International Scientific Workshop of the Progeria Research Foundation will take place September 20-22, 2018, in Cambridge, Massachusetts. This event promotes collaboration among basic and clinical scientists toward progress in progeria, cardiovascular disease, and aging research. Information and registration.

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The 9th International Scientific Workshop of the Progeria Research Foundation will take place September 20-22, 2018, in Cambridge, Massachusetts. This event promotes collaboration among basic and clinical scientists toward progress in progeria, cardiovascular disease, and aging research. Information and registration.

The 9th International Scientific Workshop of the Progeria Research Foundation will take place September 20-22, 2018, in Cambridge, Massachusetts. This event promotes collaboration among basic and clinical scientists toward progress in progeria, cardiovascular disease, and aging research. Information and registration.

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Osteogenesis Imperfecta Foundation Plans Conference

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July 13-15, 2018, will be the dates of the biennial conference of the Osteogenesis Imperfecta Foundation. To take place in Baltimore, the program will feature forums with leading experts, practical living advice and research.

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July 13-15, 2018, will be the dates of the biennial conference of the Osteogenesis Imperfecta Foundation. To take place in Baltimore, the program will feature forums with leading experts, practical living advice and research.

July 13-15, 2018, will be the dates of the biennial conference of the Osteogenesis Imperfecta Foundation. To take place in Baltimore, the program will feature forums with leading experts, practical living advice and research.

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One-Day Conference Planned on Effects of Necrotizing Enterocolitis on Premature Infants and Families

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One-Day Conference Planned on Effects of Necrotizing Enterocolitis on Premature Infants and Families

The Morgan Leary Vaughn Fund Inc. is hosting a one-day regional conference in Cromwell, Connecticut, on June 11, 2018, on reducing the devastating effects of necrotizing enterocolitis on premature infants and their families. Online registration is open now for “Speaking of NEC: Unplugged.”

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The Morgan Leary Vaughn Fund Inc. is hosting a one-day regional conference in Cromwell, Connecticut, on June 11, 2018, on reducing the devastating effects of necrotizing enterocolitis on premature infants and their families. Online registration is open now for “Speaking of NEC: Unplugged.”

The Morgan Leary Vaughn Fund Inc. is hosting a one-day regional conference in Cromwell, Connecticut, on June 11, 2018, on reducing the devastating effects of necrotizing enterocolitis on premature infants and their families. Online registration is open now for “Speaking of NEC: Unplugged.”

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MDS Foundation Hosts Family/Caregiver Forums

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MDS Foundation Hosts Family/Caregiver Forums

The MDS Foundation hosts forums at locations around the U.S. for newly diagnosed patients, long-term survivors, or caregivers affected by myelodysplastic syndromes. Medical experts present information on treatment options and strategies for living with MDS. View the dates and locations.

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The MDS Foundation hosts forums at locations around the U.S. for newly diagnosed patients, long-term survivors, or caregivers affected by myelodysplastic syndromes. Medical experts present information on treatment options and strategies for living with MDS. View the dates and locations.

The MDS Foundation hosts forums at locations around the U.S. for newly diagnosed patients, long-term survivors, or caregivers affected by myelodysplastic syndromes. Medical experts present information on treatment options and strategies for living with MDS. View the dates and locations.

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National Tissue Biobank Established for Coats Disease

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National Tissue Biobank Established for Coats Disease

The Jack McGovern Coats’ Disease Foundation has established a national tissue biobank at the Wilmer Eye Institute of Johns Hopkins Medicine to facilitate research on the causes of, and most effective treatments for, Coats’ disease. This rare disorder affects the retina and has been diagnosed in children as young as four months. More.

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The Jack McGovern Coats’ Disease Foundation has established a national tissue biobank at the Wilmer Eye Institute of Johns Hopkins Medicine to facilitate research on the causes of, and most effective treatments for, Coats’ disease. This rare disorder affects the retina and has been diagnosed in children as young as four months. More.

The Jack McGovern Coats’ Disease Foundation has established a national tissue biobank at the Wilmer Eye Institute of Johns Hopkins Medicine to facilitate research on the causes of, and most effective treatments for, Coats’ disease. This rare disorder affects the retina and has been diagnosed in children as young as four months. More.

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Opioid Epidemic Impacts Patients With Sarcoidosis

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Opioid Epidemic Impacts Patients With Sarcoidosis

The Foundation for Sarcoidosis Research has issued a press release about a survey on chronic pain, neuropathy, and medications for sarcoidosis patients. The survey provides information related to chronic pain experienced by those living with sarcoidosis and the opioid epidemic. Read the press release.

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The Foundation for Sarcoidosis Research has issued a press release about a survey on chronic pain, neuropathy, and medications for sarcoidosis patients. The survey provides information related to chronic pain experienced by those living with sarcoidosis and the opioid epidemic. Read the press release.

The Foundation for Sarcoidosis Research has issued a press release about a survey on chronic pain, neuropathy, and medications for sarcoidosis patients. The survey provides information related to chronic pain experienced by those living with sarcoidosis and the opioid epidemic. Read the press release.

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Alpha-1 Foundation Awards John Walsh Translational Research Award

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Alpha-1 Foundation Awards John Walsh Translational Research Award

The John W. Walsh Translational Research Award has been granted to Joseph Kaserman, MD, Instructor of Medicine at Boston University School of Medicine and a physician in Pulmonary, Allergy, Sleep, and Critical Care Medicine at Boston Medical Center. The award was established in memory of John Walsh, co-founder of the foundation who dedicated his life to seeking a cure for alpha-1 antitrypsin deficiency. More.

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The John W. Walsh Translational Research Award has been granted to Joseph Kaserman, MD, Instructor of Medicine at Boston University School of Medicine and a physician in Pulmonary, Allergy, Sleep, and Critical Care Medicine at Boston Medical Center. The award was established in memory of John Walsh, co-founder of the foundation who dedicated his life to seeking a cure for alpha-1 antitrypsin deficiency. More.

The John W. Walsh Translational Research Award has been granted to Joseph Kaserman, MD, Instructor of Medicine at Boston University School of Medicine and a physician in Pulmonary, Allergy, Sleep, and Critical Care Medicine at Boston Medical Center. The award was established in memory of John Walsh, co-founder of the foundation who dedicated his life to seeking a cure for alpha-1 antitrypsin deficiency. More.

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Abstracts Being Accepted for Cornelia de Lange Syndrome Foundation Symposium

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Abstracts are currently being accepted for the Cornelia de Lange Syndrome Foundation’s 8th Biennial Scientific and Education Symposium. The meeting will take place June 27-28, 2018, in Minneapolis. Attendees include physicians in various clinical disciplines, genetic counselors, and research scientists. The meeting encourages interactions between basic and clinical scientists.

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Abstracts are currently being accepted for the Cornelia de Lange Syndrome Foundation’s 8th Biennial Scientific and Education Symposium. The meeting will take place June 27-28, 2018, in Minneapolis. Attendees include physicians in various clinical disciplines, genetic counselors, and research scientists. The meeting encourages interactions between basic and clinical scientists.

Abstracts are currently being accepted for the Cornelia de Lange Syndrome Foundation’s 8th Biennial Scientific and Education Symposium. The meeting will take place June 27-28, 2018, in Minneapolis. Attendees include physicians in various clinical disciplines, genetic counselors, and research scientists. The meeting encourages interactions between basic and clinical scientists.

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