scholarly journals DESIGNING DRUG TRIALS FOR SARCOPENIA IN OLDER ADULTS WITH HIP FRACTURE – A TASK FORCE FROM THE INTERNATIONAL CONFERENCE ON FRAILTY AND SARCOPENIA RESEARCH (ICFSR)

2014 ◽  
pp. 1-6
Author(s):  
B. VELLAS ◽  
R. FIELDING ◽  
R. MILLER ◽  
Y. ROLLAND ◽  
S. BHASIN ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hip Fracture ◽  
Diagnostic Criteria ◽  
Task Force ◽  
National Institutes Of Health ◽  
Pharmaceutical Companies ◽  
Working Definition ◽  
Age Related ◽  
Increased Risk ◽  
Definition Of

In May 2012, a Sarcopenia Consensus Summit was convened by the Foundation of the National Institutes of Health (FNIH), National Institute of Aging (NIA), and the U.S. Food and Drug Administration (FDA); and co-sponsored by five pharmaceutical companies. At this summit, sarcopenia experts from around the world worked to develop agreement on a working definition of sarcopenia, building on the work of previous efforts to generate a consensus. With the ultimate goal of improving function and independence in individuals with sarcopenia, the Task Force focused its attention on people at greatly increased risk of muscle atrophy as a consequence of hip fracture. The rationale for looking at this population is that since hip fracture is a recognized condition, there is a clear regulatory path forward for developing interventions. Moreover, patients with hip fracture may provide an appropriate population to advance understanding of sarcopenia, for example helping to define diagnostic criteria, develop biomarkers, understand the mechanisms that underlie the age-related loss of muscle mass and strength, and identify endpoints for clinical trials that are reliable, objective, and clinically meaningful. Task Force members agreed that progress in treating sarcopenia will require strengthening of partnerships between academia, industry, and government agencies, and across continents to reach consensus on diagnostic criteria, optimization of clinical trials design, and identification of improved treatment and preventive strategies. In this report, the main results of the Task Force discussion are presented.

scholarly journals The 2020 “Padua Criteria” for Diagnosis and Phenotype Characterization of Arrhythmogenic Cardiomyopathy in Clinical Practice

2022 ◽  
Vol 11 (1) ◽  
pp. 279
Author(s):  
Francesca Graziano ◽  
Alessandro Zorzi ◽  
Alberto Cipriani ◽  
Manuel De Lazzari ◽  
Barbara Bauce ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Diagnostic Criteria ◽  
Tissue Characterization ◽  
Task Force ◽  
Positive Family History ◽  
Standard Test ◽  
Arrhythmogenic Cardiomyopathy ◽  
Increased Risk ◽  
Criteria For Diagnosis ◽  
The Right

Arrhythmogenic Cardiomyopathy (ACM) is a heredo-familial cardiac disease characterized by fibro-fatty myocardial replacement and increased risk of sudden cardiac death. The diagnosis of ACM can be challenging due to the lack of a single gold-standard test: for this reason, it is required to satisfy a combination of multiple criteria from different categories including ventricular morpho-functional abnormalities, repolarization and depolarization ECG changes, ventricular arrhythmias, tissue characterization findings and positive family history/molecular genetics. The first diagnostic criteria were published by an International Task Force (ITF) of experts in 1994 and revised in 2010 with the aim to increase sensitivity for early diagnosis. Limitations of the 2010 ITF criteria include the absence of specific criteria for left ventricle (LV) involvement and the limited role of cardiac magnetic resonance (CMR) as the use of the late gadolinium enhancement technique for tissue characterization was not considered. In 2020, new diagnostic criteria (“the Padua criteria”) were proposed. The traditional organization in six categories of major/minor criteria was maintained. The criteria for identifying the right ventricular involvement were modified and a specific set of criteria for identifying LV involvement was created. Depending on the combination of criteria for right and LV involvement, a diagnosis of classic (right dominant) ACM, biventricular ACM or left-dominant ACM is then made. The article reviews the rationale of the Padua criteria, summarizes the main modifications compared to the previous 2010 ITF criteria and provides three examples of the application of the Padua criteria in clinical practice.

scholarly journals Peripheral IL-6 Levels but not Sarcopenia Are Predictive of 1-Year Mortality After Hip Fracture in Older Patients

2020 ◽  
Vol 75 (10) ◽  
pp. e130-e137
Author(s):  
Paloma Bermejo-Bescós ◽  
Sagrario Martín-Aragón ◽  
Alfonso José Cruz-Jentoft ◽  
Ana Merello de Miguel ◽  
María-Nieves Vaquero-Pinto ◽  
...  
Keyword(s):  
Hip Fracture ◽  
Muscle Mass ◽  
Older Patients ◽  
Primary Outcome Measure ◽  
First Year ◽  
Increased Risk ◽  
European Working ◽  
Cutoff Points ◽  
Poor Outcomes ◽  
Definition Of

Abstract Background Sarcopenic patients may have an increased risk of poor outcomes after a hip fracture. The objective of this study was to determine whether sarcopenia and a set of biomarkers were potential predictors of 1-year-mortality in older patients after a hip fracture. Methods About 150 patients at least 80 years old were hospitalized for the surgical treatment of a hip fracture. The primary outcome measure was the death in the first year after the hip fracture. Sarcopenia was defined at baseline by having both low muscle mass (bioimpedance analysis) and handgrip and using the updated European Working Group on Sarcopenia in Older People (EWGSOP2) definition of probable sarcopenia. Janssen’s (J) and Masanés (M) cutoff points were used to define low muscle mass. Results Mortality 1 year after the hip fracture was 11.5%. In univariate analyses, baseline sarcopenia was not associated with mortality, using neither of the muscle mass cutoff points: 5.9% in sarcopenic (J) versus 12.4% in non-sarcopenic participants (p = .694) and 16% in sarcopenic (M) versus 9.6% in non-sarcopenic participants (p = .285). Probable sarcopenia (EWGSOP2) was not associated with mortality. Peripheral levels of IL-6 at baseline were significantly higher in the group of participants who died in the year after the hip fracture (17.14 ± 16.74 vs 11.42 ± 7.99 pg/mL, p = .026). TNF-α peripheral levels had a nonsignificant trend to be higher in participants who died. No other biomarker was associated with mortality. Conclusions Sarcopenia at baseline was not a predictor of 1-year mortality in older patients after a hip fracture. IL-6 was associated with a higher risk of mortality in these patients, regardless of sarcopenia status.

Chiropractic (DRAFT)

2018 ◽  
Author(s):  
Susan R. Eisen
Keyword(s):  
Clinical Trials ◽  
Alternative Medicine ◽  
Complementary And Alternative Medicine ◽  
Case Studies ◽  
National Institutes Of Health ◽  
Low Back ◽  
Chiropractic Treatment ◽  
Medical Journals ◽  
Full Discussion ◽  
Definition Of

This chapter focuses on mechanical disorders of the lumbar and pelvic spine associated with sexuality, with a detailed overview of neuromusculoskeletal anatomy. A full discussion is also included regarding the definition of chiropractic as recognized by the National Institutes of Health, as well as its place in complementary and alternative medicine. An explanation of sensory and motor functions of associated nerves is provided. Individual in-office case studies are offered along with reported clinical trials regarding the use of chiropractic in low back conditions and outcomes as reported in prestigious medical journals. Lastly, specific types of chiropractic treatment utilized in the author’s office are discussed.

Pediatric Psychopharmacology: Commonly Used Medications in Children

2018 ◽  
Author(s):  
Lawrence Scahill ◽  
Jaimie Rojas
Keyword(s):  
Clinical Trials ◽  
Psychotropic Drugs ◽  
Serotonin Reuptake ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Atypical Antipsychotics ◽  
National Institutes Of Health ◽  
Pharmaceutical Companies ◽  
Federal Policies ◽  
Risks And Benefits ◽  
Drug Classes

Pediatric psychopharmacology is a relatively young field. Through the decade of the 1990s and into the early 2000s, there was an unprecedented increase in the number of new psychotropic drugs and new formulations of older drugs. During this period, there was also a series of well-intended federal policies that provided pressure and incentives for pharmaceutical companies to conduct studies of new medications in children. The National Institutes of Health also provided funding for investigator-initiated clinical trials. Although still less than optimal, we now have a body of data on stimulants, selective serotonin reuptake inhibitors, and atypical antipsychotics. These three psychotropic drug classes are the most commonly used in children and adolescents. This chapter charts the rise in use of these drug classes and presents their risks and benefits.

scholarly journals CLINICALLY MEANINGFUL CHANGE FOR PHYSICAL PERFORMANCE: PERSPECTIVES OF THE ICFSR TASK FORCE

2019 ◽  
pp. 1-5
Author(s):  
J. Guralnik ◽  
K. Bandeen-Roche ◽  
S.a.r. Bhasin ◽  
S. Eremenco ◽  
F. Landi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Physical Performance ◽  
Performance Measures ◽  
Patient Reported Outcomes ◽  
Task Force ◽  
Meaningful Change ◽  
Patient Reported ◽  
Research Task ◽  
Definition Of ◽  
Clinical Meaningfulness

For clinical studies of sarcopenia and frailty, clinically meaningful outcome measures are needed to monitor disease progression, evaluate efficacy of interventions, and plan clinical trials. Physical performance measures including measures of gait speed and other aspects of mobility and strength have been used in many studies, although a definition of clinically meaningful change in performance has remained unclear. The International Conference on Frailty and Sarcopenia Research Task Force (ICFSR-TF), a group of academic and industry scientists investigating frailty and sarcopenia, met in Miami Beach, Florida, USA in February 2019 to explore approaches for establishing clinical meaningfulness in a manner aligned with regulatory authorities. They concluded that clinical meaningful change is contextually dependent, and that both anchor- based and distribution-based methods of quantifying physical function are informative and should be evaluated relative to patient-reported outcomes. In addition, they identified additional research needed to enable setting criteria for clinical meaningful change in trials.

scholarly journals Sugar-sweetened beverage intake and overweight in children from a Mediterranean country

2010 ◽  
Vol 14 (1) ◽  
pp. 127-132 ◽  
Author(s):  
Hugo Valente ◽  
Vitor Teixeira ◽  
Patricia Padrão ◽  
Mariana Bessa ◽  
Tânia Cordeiro ◽  
...  
Keyword(s):  
Task Force ◽  
Overweight And Obesity ◽  
International Standards ◽  
Mediterranean Country ◽  
Overweight Children ◽  
Sugar Sweetened Beverage ◽  
Sweetened Beverage ◽  
Final Sample ◽  
Increased Risk ◽  
Definition Of

AbstractObjectiveTo assess the association between sugar-sweetened beverage (SSB) consumption and overweight in children from a Mediterranean country.DesignThe children’s dietary intake was measured using a semi-quantitative FFQ completed by the parents. Overall, 2512 questionnaires were returned and 837 children were removed, leaving a final sample of 1675 children, aged between 5 and 10 years. Height and weight were measured according to international standards, and BMI was calculated. The definition of overweight and obesity was based on average centiles according to the International Obesity Task Force cut-offs. To determine the magnitude of the association between SSB consumption and overweight, OR estimates, including CI, were computed using unconditional logistic regression, adjusting for confounders.SettingElementary schools throughout the city of Porto, Portugal.SubjectsWe invited 5867 children, randomly selected, and their parents to participate in the study. Of those schools that agreed to take part, 3391 parents signed and returned the fully filled out consent form.ResultsThe prevalence of overweight (including obesity) was 36·6 % for girls and 38·8 % for boys. With regard to SSB consumption (serving/d), no differences between with overweight and non-overweight children were found even after adjustment for confounders (1–2 servings/d: OR = 1·67, 95 % CI 0·76, 3·66, in girls; OR = 1·63, 95 % CI 0·76, 3·47, in boys; and >2 servings/d: OR = 0·63, 95 % CI 0·33, 1·22, in girls; OR = 0·64, 95 % CI 0·33, 1·52, in boys).ConclusionsThe intake of SSB was not associated with increased risk of overweight in Portuguese schoolchildren.

COMMENTARY: COMBINATION THERAPY FOR ALZHEIMER’S DISEASE: PERSPECTIVES OF THE EU/US CTAD TASK FORCE

2019 ◽  
pp. 1-2
Author(s):  
E. Siemers
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
European Union ◽  
Clinical Trials ◽  
Task Force ◽  
Pharmaceutical Companies ◽  
The European Union ◽  
Combination Therapies ◽  
Regulatory Pathways ◽  
The Eu

In October 2018, the European Union-North American Clinical Trials in Alzheimer’s Disease Task Force (EU/US CTAD Task Force) met to discuss an increasingly important topic, the scientific, regulatory, and logistical challenges to the development of combination therapies for AD. Challenges related to ever-changing scientific knowledge, challenges related to complex regulatory pathways and challenges related to the necessity for pharmaceutical companies to collaborate must all be addressed. These challenges must be met since task Force members unanimously agreed that successful treatment of AD will likely require combination therapies targeting multiple mechanisms and pathways.

scholarly journals BIOMARKERS OF SARCOPENIA IN CLINICAL TRIALS RECOMMENDATIONS FROM THE INTERNATIONAL WORKING GROUP ON SARCOPENIA

2012 ◽  
pp. 1-9
Author(s):  
M. CESARI ◽  
R.A. FIELDING ◽  
M. PAHOR ◽  
B. GOODPASTER ◽  
M. HELLERSTEIN ◽  
...  
Keyword(s):  
Skeletal Muscle ◽  
Clinical Trials ◽  
Working Group ◽  
Task Force ◽  
Scientific Progress ◽  
Health Priorities ◽  
International Working Group ◽  
Age Related ◽  
The Subject ◽  
Preliminary Phase

Sarcopenia, the age-related skeletal muscle decline, is associated with relevant clinical and socioeconomic negative outcomes in older persons. The study of this phenomenon and the development of preventive/therapeutic strategies represent public health priorities. The present document reports the results of a recent meeting of the International Working Group on Sarcopenia (a task force consisting of geriatricians and scientists from academia and industry) held on June 7-8, 2011 in Toulouse (France). The meeting was specifically focused at gaining knowledge on the currently available biomarkers (functional, biological, or imaging-related) that could be utilized in clinical trials of sarcopenia and considered the most reliable and promising to evaluate age-related modifications of skeletal muscle. Specific recommendations about the assessment of aging skeletal muscle in older people and the optimal methodological design of studies on sarcopenia were also discussed and finalized. Although the study of skeletal muscle decline is still in a very preliminary phase, the potential great benefits derived from a better understanding and treatment of this condition should encourage research on sarcopenia. However, the reasonable uncertainties (derived from exploring a novel field and the exponential acceleration of scientific progress) require the adoption of a cautious and comprehensive approach to the subject.

Why are certain age bands used for children in paediatric studies of medicines?

2021 ◽  
pp. archdischild-2020-319019
Author(s):  
Kalle Hoppu ◽  
Helena Fonseca
Keyword(s):  
Clinical Trials ◽  
Clinical Investigation ◽  
Age Groups ◽  
Paediatric Population ◽  
Pharmaceutical Companies ◽  
Regulatory Guidelines ◽  
Paediatric Age ◽  
Paediatric Drug Development ◽  
Definition Of

Rational prescribing of medicines requires evidence from clinical trials on efficacy, safety and the dose to be prescribed, based on clinical trials. Regulatory authorities assess these data and information is included in the approved summary of product characteristics. Regulatory guidelines on clinical investigation of medicinal products in the paediatric population generally propose that studies are done in defined age groups but advise that any classification of the paediatric population into age categories is to some extent arbitrary or that the age groups are intended only as a guide. The pharmaceutical companies tend to plan their studies using age groups the regulatory guidelines suggest, to avoid problems when applying for marketing authorisation. These age bands end up in the paediatric label, and consequently into national paediatric formularies. The age bands of the most commonly used age-subsets: neonates, infant/toddlers, children and adolescents, are more historical than based on physiology or normal development of children. Particularly problematic are the age bands for neonates and adolescents. The age of 12 years separating children from adolescents, and the upper limit of the adolescents set by the definition of paediatric age in healthcare, which varies according to the region, are particularly questionable. Modern pharmacometric methods (modelling and simulation) are being increasingly used in paediatric drug development and may allow assessment of growth and/or development as continuous covariables. Maybe time has come to reconsider the rational of the currently used age bands.

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