Not exact matches
In fact, one of Marathon's
clinical trials that the FDA
used as part of its decision - making process was conducted more than 20 years ago, saving the firm plenty of study costs.
(Culver City, CA August 27, 2013)-- After Oryzatein ® was recognized
as the first plant - based rice protein to equal animal - based whey protein for muscle building and repair
in a
clinical trial published last month, an «Oryzatein ® Inside» endicia is being provided to manufacturers who
use the ingredient
in their food products.
Throughout 2017, ongoing
clinical trials in regenerative medicine
using cord blood have offered hope to families facing life - changing medical conditions, such
as cerebral palsy and autism.1 For some of these families, banking their baby's cord blood with ViaCord gave them the opportunity to participate
in this groundbreaking research.
In addition, there was no effect on breastfeeding duration when the pacifier was introduced at 1 month of age.280 A more recent systematic review found that the highest level of evidence (ie, from clinical trials) does not support an adverse relationship between pacifier use and breastfeeding duration or exclusivity.281 The association between shortened duration of breastfeeding and pacifier use in observational studies likely reflects a number of complex factors such as breastfeeding difficulties or intent to wean.281 A large multicenter, randomized controlled trial of 1021 mothers who were highly motivated to breastfeed were assigned to 2 groups: mothers advised to offer a pacifier after 15 days and mothers advised not to offer a pacifie
In addition, there was no effect on breastfeeding duration when the pacifier was introduced at 1 month of age.280 A more recent systematic review found that the highest level of evidence (ie, from
clinical trials) does not support an adverse relationship between pacifier
use and breastfeeding duration or exclusivity.281 The association between shortened duration of breastfeeding and pacifier
use in observational studies likely reflects a number of complex factors such as breastfeeding difficulties or intent to wean.281 A large multicenter, randomized controlled trial of 1021 mothers who were highly motivated to breastfeed were assigned to 2 groups: mothers advised to offer a pacifier after 15 days and mothers advised not to offer a pacifie
in observational studies likely reflects a number of complex factors such
as breastfeeding difficulties or intent to wean.281 A large multicenter, randomized controlled
trial of 1021 mothers who were highly motivated to breastfeed were assigned to 2 groups: mothers advised to offer a pacifier after 15 days and mothers advised not to offer a pacifier.
The safety of the vaccine has been established
in large
clinical trials and will be continually monitored
as it comes into wider
use,» Ed Yong, health information manager at the charity told politics.co.uk
«Thus, we hope that its potential
as a powerful therapeutic agent for the treatment of autoimmune diseases will facilitate its
use in future
clinical trials.»
«If you don't
use as close to the total physiological system that you can, you're likely to run into troubles,» like being surprised by side effects later on
in clinical trials, says William Haseltine, founder and former chairman and CEO of Rockville, Md. — based Human Genome Sciences.
The results, published online
in the journal Brain, Behavior and Immunity, strengthen the case that transgenic Huntington's disease monkeys could be
used to evaluate emerging treatments (such
as this) before launching human
clinical trials.
Two of the drugs are investigational and approved by the Food and Drug Administration (FDA) for
use in people
as part of
clinical trials; the third drug is FDA - approved to treat rheumatoid arthritis.
«If we find that lymphoscintigrams
using tilmanocept are at least
as good
as the conventional radiocolloid tracer
in identification and visualization of sentinel nodes, we would like to see a randomised
clinical trial involving large numbers of patients,» says Prof de Bree.
As Scientific American reported earlier this year, more than half of the current cancer
clinical trials do incorporate some form of immunotherapy but still oncologists are often only
in the early stages of understanding how to
use such treatment on a larger scale.
People working
in biomanufacturing need to be prepared for inspections by the US Food and Drug Administration and the European Medical Evaluation Agency designed to ensure that mass - produced proteins are of the same quality
as those
used in clinical trials.
The researchers reprogrammed the cells to create induced pluripotent stem cells
in an FDA - compliant facility at the Broad Stem Cell Research Center; the
use of this facility is an important step
in the process
as preclinical research moves toward human
clinical trials.
Although most of the shortages affect old, generic drugs,
clinical trials often
use these staples, either
as controls or
in combination with experimental medicines, including the genetically targeted drugs that many hope will revolutionize cancer care.
The 207 patients enrolled
in the
clinical trial, known
as POSITRON, either did not respond to interferon, could not tolerate it or were unwilling to
use it, despite the fact that there were no other treatment options available to them.
The researchers tested two anti-CK2 drugs for their ability to stimulate the production of new brown fat
in mice: a new small - molecule CK2 - blocker called silmitasertib (CX - 4945), which is already
in clinical trials as a cancer therapeutic; and a more precise next - generation antisense oligonucleotide (ASO) drug developed
in collaboration with Isis Pharmaceuticals, which eliminates CK2 by blocking the RNA instructions cells
use to produce it.
Osaka University scientists found that some potential γ — secretase inhibitors such
as semagacestat, which have been
used in large
clinical trials that ended
in failure, do not function
as true inhibitors
as originally expected, but rather cause accumulation of toxic intraneuronal Aβ.
In the findings, the researchers point to the use of intensive behavioral counseling in combination with pharmaceutical aids as a factor that may have contributed to an increase in smoking cessation rates during clinical trial
In the findings, the researchers point to the
use of intensive behavioral counseling
in combination with pharmaceutical aids as a factor that may have contributed to an increase in smoking cessation rates during clinical trial
in combination with pharmaceutical aids
as a factor that may have contributed to an increase
in smoking cessation rates during clinical trial
in smoking cessation rates during
clinical trials.
In a particularly dramatic demonstration at the Stanford site of the pilot
clinical trial, a woman identified
as «T6,» who is diagnosed with amyotrophic lateral sclerosis, was able to
use BrainGate for six sessions of a few hours each over the course of 42 days without any interruptions for explicit recalibration after the decoder was initialized on the first day.
And up to half of participants enrolled
in clinical trials to treat PTSD fail to respond to therapies including serotonin - reuptake inhibitors — a class of drugs often
used as antidepressants — and cognitive behavioural therapy.
The study, published
in the July issue of the journal Epidemiology, offers benefits over typically
used randomized
clinical trials,
as such studies are often too small to identify rare side effects or may be performed
in a group of patients who do not take other types of medications or have other conditions that could skew the drug's effect
in a broader group following approval.
«Given the continued high prevalence of multivitamin
use in the US, it remains critical for us to understand its role on nutritional status and other long - term health outcomes through
clinical trials such
as PHS II and other new research initiatives.»
The U.K. government also noted that «affected African countries will have the primary role of authorising or allowing
use of investigational vaccines» and said «buy
in» from those communities about the
clinical trials must be obtained
as soon
as possible.
The careful choice of the pig model
as well
as use of readily available microbubbles and ultrasound was instrumental
in studies moving to
clinical trials.
«
As a basic scientist, it is exciting to be able to translate a laboratory discovery into drugs that are now being
used in a
clinical trial.»
«Many
clinical trials in pulmonary hypertension also
use the catheter test
as an outcome measure, but it could provide a significant advantage to be able to replace it with a less invasive MRI scan,
as our model also provides more detailed information on physical changes to the heart itself.»
«RNAi therapies are a unique approach to cancer treatment
as they have the potential to «turn off» the genes» coding for proteins involved
in cancer cell division,» said Ramesh K. Ramanathan, M.D., medical director of the Virginia G. Piper Cancer Center
Clinical Trials Program at Scottsdale Healthcare and deputy director of the
Clinical Translational Research Division of the Translational Genomics Research Institute (TGen)
in Phoenix, Ariz. «
Using a lipid nanoparticle, the RNAi drug can be delivered to a cancer cell to block the expression of specific proteins involved
in tumor growth.»
Among the 60 compounds, they found one that previously had been
used as an antibiotic and is now
in clinical trials for Alzheimer's disease.
Using the large patient group
in the ProTECT III
trial, the researchers hope to validate promising TBI biomarkers
as predictors of
clinical outcome and also evaluate the relationship between progesterone treatment, biomarker levels and outcome.
These results could pave the way for the
use of progesterone against glioblastoma
in a human
clinical trial, perhaps
in combination with standard - of - care therapeutic agents such
as temozolomide.
«Lithium, long
used in mental health
as a highly effective mood stabiliser, has been on the radar
as a potential disease modifying treatment for Alzheimer's disease with positive evidence from preclinical studies and a number of small
clinical trials.
The GDC will support
clinical trials that focus on single patients, known
as «n of 1»
clinical trials, and will become an important component
in how precision medicine is
used to treat individual patients.
This paper provides direct evidence for the role of TNF
in chronic intestinal inflammation
using TNBS colitis
in Tg197 mice
as a model and encourages further
clinical trials with anti-TNF therapeutics for the treatment of Crohn's disease.
As we'll see later on, this has already contributed to their receiving FDA - approval for
use in a
clinical trial.
The SICI - ICF / SAI measure has been shown to provide the footprints of the specific underlying neurotransmitter deficit, having the potential to be
used as an additional diagnostic instrument
in clinical practice and eventually
in clinical trials.
But, he notes that it will be necessary to perform well - designed
clinical trials that test the safety and efficacy of high - grade NMN
in humans before making the leap to
using NMN (or perhaps its analogs)
as pharmacotherapeutic agents.
In this role, Ms. Roxland re-launched and chaired J&J's Ethics Committee, created an enterprise - wide consultation service for teams and individuals confronting complex research ethics issues, and provided guidance on issues such as post-trial access for former research participants, conducting clinical trials in war - torn regions, testing of a potential Ebola vaccine during a public health crisis, commercialization of stem cell therapies, subject recruitment and withdrawal, and expanded access / compassionate us
In this role, Ms. Roxland re-launched and chaired J&J's Ethics Committee, created an enterprise - wide consultation service for teams and individuals confronting complex research ethics issues, and provided guidance on issues such
as post-trial access for former research participants, conducting
clinical trials in war - torn regions, testing of a potential Ebola vaccine during a public health crisis, commercialization of stem cell therapies, subject recruitment and withdrawal, and expanded access / compassionate us
in war - torn regions, testing of a potential Ebola vaccine during a public health crisis, commercialization of stem cell therapies, subject recruitment and withdrawal, and expanded access / compassionate
use.
Applications involving contracts (such
as used for large, multicenter
clinical trials) were not included
in these analyses.
However, with few exceptions, the stem cell and regenerative medicine industry has remained inadequately capitalized to carry out large - scale
clinical trials independently, and major pharmaceutical firms have tended to show more interest
in the
use of hiPSCs
as a source of large, pure populations of specific somatic cells for
use in drug compound screening and toxicology tests, than they have
in therapeutic
uses of stem cells and their derivatives.
Objective: The primary objective of the present study was to estimate how large a sample size would be needed for future
clinical trials for AD - modifying treatments
in Japan
using atrophy measures of the brain
as a surrogate biomarker.
Conclusion: These results show the potential
use of longitudinal hippocampal atrophy measurement
using automated image analysis
as a progression biomarker and ApoE status
as a
trial enrichment strategy
in a
clinical trial of AD - modifying treatment
in Japanese people.
They examined two inhibitors, one known
as avibactam that is already being
used in clinical trials, and another that is a bicyclic boronate inhibitor.
As Head of Project Leader Unit, Nicolas is
in charge of the pharmaceutical development and subsequent production of vaccines - for
use in clinical trials - directly funded by the European Vaccine Initiative (EVI), and European projects funded from other sources coordinated by EVI.
Finally, analysis of tumors from
clinical trials and cell line models will allow discovery of mechanisms of sensitivity and resistance to AR and PI3K inhibitors,
as well
as biomarkers that can be
used in the development of new treatment regimens and selection of patients for future
trials.
«We are very excited about
using VSV
as researchers have seen promising results
using other similar viruses, such
as the polio virus,
in early
clinical trials.»
However, ADCs that
use derivatives of calicheamicin, which promotes double - stranded DNA breaks, such
as GO and inotuzumab ozogamicin, 40,41 have limited activity
in cells with high multidrug resistance protein activity, a phenotype found
in a significant fraction of AML patients.42 Another ADC, SGN - CD123A, comprising an engineered form of the CD123 - targeting 7G3 antibody conjugated to a synthetic pyrrolobenzodiazepine dimer, which acts via DNA crosslinking, has entered
clinical trials after showing robust activity
in preclinical models of AML, including those with multidrug resistance.33
Peppermint extract or oil,
used commonly
in baking, doubles
as a reliable headache cure — one backed by several small
clinical trials and lots of anecdotal evidence.
Information such
as dosage, serving size and,
in many cases, suggested
use are based on the doses
used in actual
clinical trials.
The typical dosage of NAC given
as an oral supplement
in clinical trials is 600 mg b.i.d., although 200 mg t.i.d. has been shown to provide benefit
in just 8 weeks.27 On the other hand, doses
as high
as 1 gram t.i.d. have been
used in cystic fibrosis patients for 4 - 12 weeks with no adverse effects, and
in AIDs patients, oral NAC doses up to 8 grams / day did not cause clinically significant adverse reactions.42 43 44 45 46 47
Whereas the few randomized controlled
trials and observational
clinical outcomes studies support the existence of a health benefit from fasting, substantial further research
in humans is needed before the
use of fasting
as a health intervention can be recommended.