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Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
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.
In the search feature, the Other terms field is used to narrow a search. For example, you may enter the name of a drug or the NCT number of a clinical study to limit the search to study records that contain these words.
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.
Not yet recruiting:

In terms of the attractiveness of the country for corporate investment, the judges may have had parent company liability’s potential adverse effects in the back of their minds. Needless to say, imposing parent company liability in these kinds of cases would render the UK less attractive for companies to establish their headquarters or holding companies. Of course, if companies were to pull out of the UK, this would negatively impact the UK economy. While judges rarely explicitly discuss these kinds of effects, we should not assume that they have no influence on their decisions.

Indicators of potential parent company liability

In the Okpabi judgment, the court, although it does not develop a full framework, gives some useful indicators of potential parent company liability. As the analysis above suggests, there is balancing involved and companies need to walk the line between responsible management of their subsidiaries and taking control of their operations resulting in liability exposure. Based on the court’s dicta, the following indicators would appear to be relevant:

The English court’s judgment thus helps parent companies to identify factors that may reduce or increase their exposure to liability for damages caused by their subsidiaries.

Conclusion

The Okpabi judgment of the England and Wales Court of Appeal is another milestone in the evolution of parent company liability and, thus, supply chain liability . Because the court had a keen eye for the broader implications of its ruling, it stayed clear of finding RDS liable for the environmental damage caused by its Nigerian subsidiary. Incidentally, the court identified factors that are relevant to the design and implementation of centrally-directed corporate programs and policies applicable to subsidiaries. Going forward, actual operational control, rather than formal factors, are likely to dominate the analysis of a parent company’s potential liability.

Unlike the English Court of Appeal, the Dutch courts apply a lighter test to find jurisdiction. The UK Court of Appeal’s judgment, however, will make it harder for the Dutch courts to rule in favour of the plaintiffs on the merits for two reasons. First, if RDS does not owe a duty of care to this class of claimants under English law, Dutch tort law is less likely to impose such a duty. Second, the Dutch government just Womens Plus Black soft tapered trousers River Island db2Ue
to please corporate groups such as Shell and keep them headquartered in The Netherlands. If the courts now impose onerous, group-wide tort liabilities, there will be a huge disincentive to stay in The Netherlands, despite the tax benefit.

In any event, it will be a while before parent company liability will be settled in Western Europe. In Okpabi , the Court of Appeal has given a strong signal that England will not lead the way in opening up new avenues to get into the ‘deep pockets’ of parent companies to address harms around the world.

Hi Lorraine, If your B12 is sooooo low, you really will have trouble getting your levels up over 300 and keeping them there. Data out on MMA and Hcy says that you are going to have problems if you are below 257 pmol/L, so you are way low. Your injections will only give you temporary improvement for reasons that you will see on the discussion. For more you can check out http://www.mentorconsulting.net/VB12Home.htm where I have been trying to put much data on. You will find it hard to get the medicos to understand all this, for some reason they appear VERY uninformed about B12 deficiency. Good luck, You can email me direct if you want info that you can’t find. grj@mentorconsulting.net

Reply

Felicia says

Lorraine, I too was diagnosed with pernicious anemia, and thankfully found a naturopath who could identify it and treat it (B12 injections like you are doing plus diet and supplements). Greg has also been really helpful with information so I can do the best I can with where I am. I never tested my serum B12 before I started injections so have no idea what it was then, but now things are much better overall. I hope you can hang in there and get the help you need — working with a practitioner who understands this is not always easy, but so important. And Greg has some valuable data to support you hopefully so you can find some relief. I started out with daily B12 injections then went to 2x a week and now am on 1x a week and that works great for me. I never went to sublinguals because it was believed I couldn’t absorb them as well. For others, those work great. It took a long time (2 years) to see things really turn around but it has so been worth it. If I can be of help to you at all, please let me know.

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Thank you for the information I will look into the information you have advised. I got my last shot yesterday and no further information I was told to take 100 mg of b12 tablet form yes 100mg the pharmacist thought this was hilarious and gave me the sublingual 1000 apparently you just have to deal with it. It is not funny when you can’t walk in a straight line and everyone thinks you are drunk. The Dr’s don’t seem to want to discover the real picture. Thanks for the advice

Reply

Lorraine Saipe says

Hi, I have just found this post last Friday I was diagnosed with Pernicious Anemia after a test for the antibodies I do not have this. I have had 2 injections of B12 and will get another tomorrow and then he says that I can’t have any more and will have to go onto tablets. My B12 was 130 and folate was 1030 my problem is I am walking around like a drunk and this has got worse today. I am having severe bowel problems and have organised to get this checked out within a month. My concern is that the damage is permanent I already have a permanent back injury and am scared of falling and causing more damage. I initially thought that my bp tablets had knocked out the potassium as my bp was dropping low and I was vague in the head then the tingling in the hands and feet started. Any advise you can give me would be appreciated. Thanks Lorraine

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Lily says

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Research Article
Molecularly defined unfolded protein response subclasses have distinct correlations with fatty liver disease in zebrafish
Ana M. Vacaru , Antonio Fabio Di Narzo , Deanna L. Howarth , Orkhontuya Tsedensodnom , Dru Imrie , Ayca Cinaroglu , Salma Amin , Ke Hao , Kirsten C. Sadler
Disease Models Mechanisms 2014 7: 823-835; doi:10.1242/dmm.014472
Ana M. Vacaru
Department of Medicine/Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA. Department of Developmental and Regenerative Biology, Icahn School of Medicine at Mount Sinai, Box 1020, 1 Gustave L. Levy Place, New York, NY 10029, USA.
Antonio Fabio Di Narzo
Department of Genetics and Genomic Sciences and Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
Deanna L. Howarth
Department of Medicine/Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA. Department of Developmental and Regenerative Biology, Icahn School of Medicine at Mount Sinai, Box 1020, 1 Gustave L. Levy Place, New York, NY 10029, USA.
Orkhontuya Tsedensodnom
Department of Medicine/Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA. Department of Developmental and Regenerative Biology, Icahn School of Medicine at Mount Sinai, Box 1020, 1 Gustave L. Levy Place, New York, NY 10029, USA.
Dru Imrie
Department of Medicine/Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA. Department of Developmental and Regenerative Biology, Icahn School of Medicine at Mount Sinai, Box 1020, 1 Gustave L. Levy Place, New York, NY 10029, USA.
Ayca Cinaroglu
Department of Medicine/Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA. Department of Developmental and Regenerative Biology, Icahn School of Medicine at Mount Sinai, Box 1020, 1 Gustave L. Levy Place, New York, NY 10029, USA.
Salma Amin
Department of Medicine/Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA. Department of Developmental and Regenerative Biology, Icahn School of Medicine at Mount Sinai, Box 1020, 1 Gustave L. Levy Place, New York, NY 10029, USA.
Ke Hao
Department of Genetics and Genomic Sciences and Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
Kirsten C. Sadler
Department of Medicine/Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA. Department of Developmental and Regenerative Biology, Icahn School of Medicine at Mount Sinai, Box 1020, 1 Gustave L. Levy Place, New York, NY 10029, USA. Graduate School of Biomedical Sciences, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
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The unfolded protein response (UPR) is a complex network of sensors and target genes that ensure efficient folding of secretory proteins in the endoplasmic reticulum (ER). UPR activation is mediated by three main sensors, which regulate the expression of hundreds of targets. UPR activation can result in outcomes ranging from enhanced cellular function to cell dysfunction and cell death. How this pathway causes such different outcomes is unknown. Fatty liver disease (steatosis) is associated with markers of UPR activation and robust UPR induction can cause steatosis; however, in other cases, UPR activation can protect against this disease. By assessing the magnitude of activation of UPR sensors and target genes in the liver of zebrafish larvae exposed to three commonly used ER stressors (tunicamycin, thapsigargin and Brefeldin A), we have identified distinct combinations of UPR sensors and targets (i.e. subclasses) activated by each stressor. We found that only the UPR subclass characterized by maximal induction of UPR target genes, which we term a stressed-UPR, induced steatosis. Principal component analysis demonstrated a significant positive association between UPR target gene induction and steatosis. The same principal component analysis showed significant correlation with steatosis in samples from patients with fatty liver disease. We demonstrate that an adaptive UPR induced by a short exposure to thapsigargin prior to challenging with tunicamycin reduced both the induction of a stressed UPR and steatosis incidence. We conclude that a stressed UPR causes steatosis and an adaptive UPR prevents it, demonstrating that this pathway plays dichotomous roles in fatty liver disease.

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