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Study record managers: refer to the Data Element Definitions if submitting registration or results information.

A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.
An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers.
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. This change may or may not be caused by the intervention/treatment being studied.
A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups:

The age groups are:

A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized.
A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment , or no intervention, according to the trial's protocol .
A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm , active comparator arm , placebo comparator arm , sham comparator arm , and no intervention arm .
Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment).
Indicates that the study sponsor or investigator recalled a submission of study results before quality control (QC) review took place. If the submission was canceled on or after May 8, 2018, the date is shown. After submission of study results, a study record cannot be modified until QC review is completed, unless the submission is canceled.
Information required by the Food and Drug Administration Amendments Act of 2007 . In general, this is a description of any agreement between the sponsor of a clinical study and the principal investigator (PI) that does not allow the PI to discuss the results of the study or publish the study results in a scientific or academic journal after the study is completed.
A sponsor or investigator may submit a certification to delay submission of results information if they are applying for FDA approval of a new drug or device, or new use of an already approved drug or device. A sponsor or investigator who submits a certification can delay results submission up to 2 years after the certification/extension first submitted date, unless certain events occur sooner. See Delay Results Type in the Results Data Element definitions for more information about this certification.
The date on which information about a certification to delay submission of results or an extension request was first available on ClinicalTrials.gov. ClinicalTrials.gov does not indicate whether the submission was a certification or extension request. There is typically a delay between the date the study sponsor or investigator submitted the certification or extension request and the first posted date .
The date on which the study sponsor or investigator first submitted a certification or an extension request to delay submission of results. A sponsor or investigator who submits a certification can delay results submission up to 2 years after this date, unless certain events occur sooner. There is typically a delay between the date the certification or extension request was submitted and the date the information is first available on ClinicalTrials.gov ( certification/extension first posted ).
The date on which the study sponsor or investigator first submitted a certification or an extension request that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a certification or extension request one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria. Meeting QC criteria for an extension request does not mean that the National Institutes of Health (NIH) has determined that the request demonstrates good cause. The process for review and granting of extension requests by the NIH is being developed.
In the search feature, the City field is used to find clinical studies with locations in a specific city. The Distance field is used to find studies with locations within the specified distance from a city in number of miles. For example, if you choose Illinois as the state , identifying "Chicago" as the city and "100 miles" as the distance will find all studies listing a location within 100 miles of Chicago.
A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: interventional studies (also called clinical trials) and observational studies .
Another name for an interventional study .
The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419).
An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
In the search feature, the Country field is used to find clinical studies with locations in a specific country. For example, if you choose the United States, you can then narrow your search by selecting a state and identifying a city and distance .
A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two-by-two cross-over assignment involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A. So during the trial, participants "cross over" to the other drug. All participants receive drug A and drug B at some point during the trial but in a different order, depending on the group to which they are assigned.
A group of independent scientists who monitor the safety and scientific integrity of a clinical trial . The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.
A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).
The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers , has age or age group requirements, or is limited by sex .
The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.
A type of eligibility criteria . These are reasons that a person is not allowed to participate in a clinical study.
A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA) . Also called compassionate use. There are different expanded access types .

For more information, see FDA Expanded Access: Information for Patients .


Thank you so much on this information! I had been extremely worried when my doctors were told me I needed an appointment with my PCP immediately about this.I’m only 19. As a child I was in an out of the hospitals. We had discovered that I have Crohns disease, Rheumatoid Arthritis and Sjogrens Disease an then I had just found out I had this. Not to be a negative Nancy but I thought three diseases were enough but now this. My first visit to my adult rheumotologist was deeply concerned about me being able to sleep an awful amount of hours an still exhausted, also I guess she had noticed that it was very hard for me to come up with words or I would just forget what we were saying. I have recently noticed that I can stare at once spot an just blank out. Has anyone had thisproblem? Personally, being a nursing student an still only a child this is very hard for me to grasp.Also has anyone heard of other methods than shots? I’m taking Humera (the worst injection in the world) and its making me want to never have an injection again! Thanks!


Mary, I am reading a book called, “Could It Be B12?” and it talks about how even Bipolar can be in some cases caused by B12 deficiency. The book is written by a nurse and her husband who is a doctor. Also, B12 does affect nerves. So I would get that book and read it and see if you can find a doc to test you before you start taking a vitamin supplement. Maybe her doc would test you? Good luck Mary. Be your own advocate and be strong in caring for your own health. I wish I had known about B12 when I was 15.


Mary Wright says

Hi my name is Mary I’m only 15, but my mother has suffered from sezures for 20 years hers started when she hit her head on a pole. We don’t know what type of sezures she has yet or what to give her but last November I had a sezure and since I have been having them (when there was 350 lbs. of pressure on my jaw). I’m going to try and keep this as short as possible i don’t want to waste your time, but we just found out that she is low on B 12. We believe that I may be too. Due to the fact that I have been diagnosed as bipolar for many years and ADHD and asthma ect. I have always been very independent so sezures scare me. Do you profesionaly think there could be any connection to her sezures and her deficiancy in B12? We are hopeing that if we find her solution we will find mine. There aren’t too many neurologists that take any intrest in dealing with kids.- thank you for your time

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Hi Lynn, you definitely need vitamin B3 to make NADH, which is an essential element of the Krebb’s cycle as an electron acceptor and then in the electron transport chain to donate electrons. This is apart from its role in MTHFR. If you are deficient in it, not only will you have problems in making 5MTHF, but your energy systems will definitly “go slow”. No need to go beserk with supplementation though. You can make it from Tryptophan. You can check out the RDA at the Linus Pauling web-site Mens Visto Nubuck Chukka Sneakers Bruno Magli uOC5QZ
. As for the methyl group depletion, I don’t know if I am a strong advocate of that theory. It is involved in the conversion of methenyl-THF to methylTHF (5MTHF), so technically it is a methyl generator. It has been used at high doses for lipid depletion and atherosclerosis control. Possibly this is due to its role in the CAC. I would, however use nicotinamide, rather than niacin or nicotinic acid, which are supposed to cause flushing.


Hi Greg,this just seems to be getting more complicated for me.i had my first lot of B12 injections back in june.my DR gives daily injections i understand other doctors give weekly injections until levels are high enough than 3 monthly for life.i have fely very light headed extremely tired .im just getting through the days doing the necessary stuff.this is difficult having a 6,8 and 16 year old who are energetiic.ive had tests recently Intrinsic Factor Antibody (negative )Antiparietal Cell Antibody (negative).my serum B12 is 1476 pmol/L.. when i was first tested for B12 my levels were 175 pmol/L .my thyroid meds have been reduced to 100mg a day as i have hypothyroid.now im confused if i had thyroid problems first or B12 deficiency.even though i have been treated for my hypothyroidism for 16 years ,think alot of B12 deficiency symptoms happening back than also.The b12 injections are hydroxocobalamin.i have also purchased the Transdermiol to try when my levels have dropped.think i will get levels tested first try the oil for abit get tested again to see results..my Dr doesnt seem to explain alot or want to discuss options ,necessary testing etc.wondering if high levels can make you feel lousy and can it take sometime after treatment to feel normal.just want to work out why im deficient what tests to have that may help improve things .


@Colleen – The light-headedness and fatigue can be symptoms of potassium deficiency. You were badly deficient in B12, and that slowed some healing/growth processes in the body. When you replenish your B12 reserve, those processes speed up; which can use up your potassium reserves. Another symptom of potassium deficiency is twitching or cramping muscles. I developed a few facial twitches and leg cramps after I started taking B12. Supplementing potassium and magnesium was very helpful. Potassium and magnesium work together, so it’s a good idea to supplement them together.


Anisotropic spatial distribution of molecular and cellular forces results in tissue stress anisotropy. When an otherwise isotropic material is subject to an anisotropic stress, there is a difference between its refraction indices in the direction of larger versus smaller stress. This difference, called ‘birefringence’, is equal to the stress anisotropy multiplied by the so-called ‘photo-elastic constant’, c , which characterizes the material. In a tissue, an image of polarized light intensity transmitted perpendicularly to the tissue plane reveals the map of stress anisotropy within the tissue ( 24623 Womens Loafers Jana Pd9pwMCkQ
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Fig. 4.

Non-mechanical observation techniques. (A) Internal birefringence. (Aa) A tissue under anisotropic stress in axes 1 and 2 has different refractive indices in the directions of larger and smaller stresses (σ and σ). This can be detected using polarized light. In the set-up shown, a sample of thickness is placed between two sets of combined linear and quarter-wavelength polarizers and illuminated. The light beams polarized along axes 1 and 2 acquire a phase difference (‘retardance’) according to the refractive indices of the sample. Spatial variations of retardance therefore provide information on spatial stress anisotropies, according to the following equation: retardance∼ (σ−σ)/ (where is the photo-elastic constant and is the wavelength of light). (Ab) Phase retardance maps (color bar) of control (left) and vertically stretched (right) wing discs. Compressive stress builds up in the center of wing pouch (white arrowheads). Compression is released by tissue stretching. (B) External birefringence. (Ba) By changing the magnitude of forces applied on a calibrated birefringent disk, different fringe patterns are obtained. (Bb) Measurement of forces during the growth of a chickpea root. Fringe patterns are used to infer radial forces exerted by the root. Yellow asterisks label the root tip. (C) Force inference. (Ca) Input image of epithelial cell shapes, here in pupal wing at 23 h after pupa formation (APF). (Cb) Image analysis yields cell shapes, vertex positions and connectivity; they are expressed in force-balance equations, which encompass the pattern geometry and reflect the balance of the set of cell-cell interface tensions () and differences of cell pressures () to be determined. (Cc) Solving these force-balance equations yields a map of cell-cell interface tensions, shown relative to an unknown constant, which is the average tension. (Cd) The inferred map of cell pressures has another unknown, an additive constant, which is the average pressure. Adapted with permission from: (A) Nienhaus et al. (2009 ), (B) Kolb et al. (2012 ), (C) curled dress Diane Von F uFTaFcNrx

This optical property of tissues can thus act as an indirect stress probe, the sensitivity of which is determined by c . Within a tissue, c can be measured in vitro in an explant if birefringence measurements are combined with a micro-manipulation setup to apply stress.

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