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FOOTWEAR - Espadrilles Ana Lublin dpLbPbGb
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Yow know? While you might have some decent points in your matter-of-fact arguments, your demeanor and closing self-righteous sentence: “…..Thank you for giving me the opportunity to share this information, for our sake, for the animals’ sake, for the planet’s sake….” just makes all your entire spill bullshit.

Upon re-reading the original post by the author of this blog (Chris), I don’t know where you see that he was taking shots at vegetarians/vegans with this article. Rather, he stated true-facts that: YES, if you are a vegetarian or vegan, you are AT RISK of low b12 levels. And the true-fact that YES the ***most direct-efficient ways to maintain healthy b12 levels*** are by not being vegetarian/vegan (and consuming animal products), OR by taking supplemental b12 in your diet. SIMPLE AS THAT. Nowhere it tells you that being vegetarian/vegan is a bad thing, only that you should do it responsibly towards your own health.

While I’m omnivore, I’m someone who has been suffering b12-deficiency for over a decade now due to health/genetical issues, and can tell you by-experience that low b12 really f’s you up if not known and controlled. From depression, chemical imbalances, neurological damage, low energy, spending a week in the freaking hospital trying to figure out what is wrong with you, plus multiple doctors appointments after that, monthly b12 injections, etc…. it IS NOT a fun time to be b12 deficient, and something that I do not wish even to my worst enemy.

After all that happened to me, I’ve shared my experience to my friends/family as a word-of-caution. And yes, I’ve shared my experience specially to my friends/acquaintances who are vegetarian/vegan, knowing that they are at risk, all in the hope that they will not have to go through what I went to.

So, in short, THAT is in-itself the purpose of this article and subsequent comments: B12 deficiency is indeed a silent ailment/epidemic out there affecting many people. And so, take care of your health and your diet -whichever diet you chose to follow. And that YES, if you are vegetarian/vegan, make sure you are informed about b12 deficiency, and that you are at-risk of it -that is all.

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Thank you for sharing Lucia! (and to all who do on this site). Your third paragraph hits close to home for me.

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Not a single credible study listed on that page. I’ve posted several, and just take a moment and search Pubmed and you’ll find that B12 deficiency is very common amongst vegans.

For example, this study showed that 50% of vegans are B12 deficient and would be expected to have a higher risk of developing clinical problems due to B12 deficiency. http://www.ncbi.nlm.nih.gov/pubmed/20648045

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We analyzed the sequencing data as described previously ( 1 , 6 , Othello White Mens plain calf leather trainers in white Bally LugWTiVl
, 13 ). Counts of repeat-masked, GC-normalized, and unique aligned reads (1 mismatch allowed) for each 50-kb bin were used to calculate statistical significance and coverage. Statistical significance was determined by calculating a z score for the fraction of autosomal reads mapping to the region of interest relative to the total number of autosomal reads. z Scores were calculated via a previously described robust method: z Sample = (Fraction Sample − Median Fraction Population )/Median Absolute Deviation Population ( 13 ). Coverage was calculated with the formula: Coverage = L × N / G , where L is read length (36 bp), N is the number of repeat-masked, GC-normalized reads, and G is the size of the repeat-masked haploid genome.

Next-generation sequencing was performed upon ccf DNA isolated from plasma samples of the 16 pregnant women, 2 of whom were confirmed by karyotype analysis after amniocentesis to be carrying a fetus affected by chromosome 22q11.2 deletion syndrome. Plasma samples were collected from the 2 affected women at gestational ages (19 and 20 weeks) similar to those of the control samples (median, 20 weeks) (see Table 1 in the Data Supplement that accompanies the online version of this Brief Communication at http://www.clinchem.org/content/vol58/issue7 ). All samples contained >10% fetal DNA (median contribution, 18%); the 2 samples carrying the fetal microdeletion contained 17% and 18% fetal DNA (see Table 1 in the online Data Supplement).

We sequenced each sample with 2 lanes of an Illumina HiSeq2000 flow cell, for a genomic coverage of 3.1-fold to 4.4-fold (see Table 1 in the online Data Supplement). Reads were binned at a bin size of 50 kb, and bins were visualized across chromosome 22 for the affected samples to confirm the location of the microdeletion. Both samples that carried the 22q11.2 microdeletion exhibited decreased representation in this genomic area (see Fig. 1 in the online Data Supplement). For statistical testing, we used a consensus region of 3 × 10 6 bp located between Chr22:19000000 and Chr22:22000000 (see Fig. 1 and Table 1 in the online Data Supplement). We calculated the fraction and the z score for all autosomal reads that mapped to the target region. The control samples contained 0.075% of the reads mapping to 22q11, whereas the affected samples showed only 0.073% of reads in this region. Both affected samples had z scores lower than −3 (−5.4 and −7.1), whereas all samples from the low-risk control individuals had z scores greater than −3 ( Fig. 1 ). Only one of the low-risk samples had a z score higher than +3. Analogous to methods used for aneuploidy detection, in which z scores less than −3 are not evaluated, the clinical relevance of this finding is unclear. Repeated analysis of the 2 affected samples at increased sequencing depth (15.87-fold to 16.77-fold) confirmed the results (see Fig. 2 in the online Data Supplement).

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Individual Patients Intermediate-size Population Treatment IND/Protocol
An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial.
In certain circumstances, a sponsor or investigator may request an extension to delay the standard results submission deadline (generally one year after the primary completion date ). The request for an extension must demonstrate good cause (for example, the need to preserve the scientific integrity of an ongoing masked trial). All requests must be reviewed and granted by the National Institutes of Health. This process for review and granting of extension requests is being developed. See Delay Results Type in the Results Data Element definitions for more information.
A type of intervention model describing a clinical trial in which groups of participants receive one of several combinations of interventions. For example, two-by-two factorial assignment involves four groups of participants. Each group receives one of the following pairs of interventions: (1) drug A and drug B, (2) drug A and a placebo, (3) a placebo and drug B, or (4) a placebo and a placebo. So during the trial, all possible combinations of the two drugs (A and B) and the placebos are given to different groups of participants.
The date on which the study record was first available on ClinicalTrials.gov. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
The date on which the study sponsor or investigator first submits a study record 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 study record 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.
U.S. Public Law 110-85, which was enacted on September 27, 2007. Section 801 of FDAAA amends Section 402 of the U.S. Public Health Service Act to expand ClinicalTrials.gov and create a clinical study results database . For more information on FDAAA 801, see the History, Policies, and Laws page on this site.
Describes the organization that provides funding or support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting. Organizations listed as sponsors and collaborators for a study are considered the funders of the study. ClinicalTrials.gov refers to four types of funders:
A type of eligibility criteria that indicates whether eligibility to participate in a clinical study is based a person's self-representation of gender identity or gender (yes, no). Gender is distinct from sex .
A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
A group of people who review, approve, and monitor the clinical study's protocol . Their role is to protect the rights and welfare of people participating in a study (referred to as human research subjects), such as reviewing the informed consent form . The group typically includes people with varying backgrounds, including a community member, to make sure that research activities conducted by an organization are completely and adequately reviewed. Also called an institutional review board, or IRB, or an ethics committee.

For more information, see Participating in Studies on this site.

A type of eligibility criteria . These are the reasons that a person is allowed to participate in a clinical study.
A process used by researchers to communicate to potential and enrolled participants the risks and potential benefits of participating in a clinical study.

For more information, see Participating in Studies on this site.

The document used in the informed consent or process.
The general design of the strategy for assigning interventions to participants in a clinical study. Types of intervention models include: single group assignment , parallel assignment , cross-over assignment , and factorial assignment .
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol . Participants may receive diagnostic, therapeutic, or other types of interventions.
A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator .
The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
The most recent date on which the study sponsor or investigator submitted changes to a study record to ClinicalTrials.gov. There is typically a delay of a few days between the last update submitted date and when the date changes are posted on ClinicalTrials.gov (the last update posted date).
The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown .
Countries in which research facilities for a study are located. A country is listed only once, even if there is more than one facility in the country. The list includes all countries as of the last update submitted date; any country for which all facilities were removed from the study record are listed under removed location countries .
In the search feature, the Location terms field is used to narrow a search by location-related terms other than Country, State, and City or distance. For example, you may enter a specific facility name (such as National Institutes of Health Clinical Center) or a part of a facility name (such as Veteran for studies listing Veterans Hospital or Veteran Affairs in the facility name). Note: Not all study records include this level of detail about locations.
A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which interventions. Types of masking include: open label, single blind masking, and double-blind masking.
A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier .
An arm type in which a group of participants does not receive any intervention/treatment during the clinical trial.
A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment .
The general design of the strategy for identifying and following up with participants during an observational study . Types of observational study models include cohort, case-control, case-only, case-cross-over, ecologic or community studies, family-based, and other.
An adverse event that is not a serious adverse event , meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect; it also does not put the participant in danger and does not require medical or surgical intervention to prevent one of the results listed above.
Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
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For clinical trials , a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies , a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure .
A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group, who receive drug B.
A summary of the progress of participants through each stage of a clinical study, by study arm or group/cohort . This includes the number of participants who started, completed, and dropped out of the study.
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA) . The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0) , Phase 1 , Phase 2 , Phase 3 , and Phase 4 . Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.
A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo ) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.
Describes trials without FDA-defined phases , including trials of devices or behavioral interventions.
An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
An arm type in which a group of participants receives a placebo during a clinical trial.
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure . Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.
In a clinical study's protocol , the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment . Most clinical studies have one primary outcome measure, but some have more than one.
The main reason for the clinical trial . The types of primary purpose are: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and other.
The person who is responsible for the scientific and technical direction of the entire clinical study.
The written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.
National Library of Medicine (NLM) staff perform a limited review of submitted study records for apparent errors, deficiencies, or inconsistencies. NLM staff identify potential major and advisory issues and provide comments directly to the study sponsor or investigator. Major issues identified in QC review must be addressed or corrected (see First submitted that met QC criteria and Results first submitted that met QC criteria ). Advisory issues are suggestions to help improve the clarity of the record. NLM staff do not verify the scientific validity or relevance of the submitted information. The study sponsor or investigator is responsible for ensuring that the studies follow all applicable laws and regulations.
A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance.
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