The primary purpose of this Phase II/III study is to demonstrate that Kamada-API, a new API concentrate manufactured by Kamada Ltd., is comparable to a currently marketed API product.
Alpha-1 Antitrypsin Deficiency, also called Alpha-1-Proteinase Inhibitor (API) deficiency, is a genetic disorder characterized by the production of an abnormal amount of AAT protein and reduced circulating levels of this protein. Subjects with AAT deficiency are at increased risk for developing chronic obstructive pulmonary disease (COPD). It is believed that this is the result of the chronic activity of elastase released by cells continually present in the lungs in low numbers.
This study is a randomized, double-blind comparison of Kamada API, an Alpha-1-Proteinase Inhibitor with a currently marketed API product.
"At-risk" alleles associated with serum AAT < 11 μM including null alleles and deficiency alleles. This must be documented in the subject's history or laboratory tests performed at screening.
For actively treated subjects, agreement to not receive any exogenous API product (i.e. washout) for five weeks prior to first study infusion.
Use of an effective means of contraception during the 24 weeks of study drug administration (this is applicable to both sexes).
Subjects on the BAL, bronchial brushing/biopsy group must be on inhaled corticosteroids at a stable dose two weeks prior the first Bronchoscopy and throughout the dosing period up the final bronchoscopy.
Laboratory evidence of severe IgA deficiency (from medical history or by IgA testing at screening of at least 20% of lower range).
Abnormal screening or baseline laboratory measurements that in the opinion of the Investigator would affect subject safety.
History of infection with HCV, HBV and/or HIV 1 or 2, or (at baseline) infection indicated by laboratory measurements obtained at screening.
Acute respiratory tract infection or COPD exacerbation which required antibiotic and/or systemic steroid treatment within the past 6 weeks. Patient can be re-evaluated for enrollment 6 weeks after an exacerbation.
Any other condition which in the judgment of the investigator may interfere with the conduct of the study.
If an adequate home health care agency cannot be established by Centric Health Resources due to a potential subject's geographical location.
Today, in commemoration of the eighth anniversary of the Americans with Disabilities Act (ADA), the President is signing an Executive Memorandum aimed at increasing employment and health care options for people with disabilities. He is also announcing the release of a letter to Medicaid Directors clarifying that the ADA obligates states to offer appropriate community based services. Finally, to build on these actions, the President is also announcing his commitment to work with Senator Jeffords and Senator Kennedy to pass affordable, feasible legislation to help people with disabilities maintain their health care coverage and return to work. Today, the President visits a meeting with his Task Force on Employment of People with Disabilities and advocates of people with disabilities. In this meeting, the President is:
Signing A New Presidential Memorandum to Increase Employment and Health Care Options for People with Disabilities. While the ADA has been critically important to people with disabilities, significant challenges remain. Since 1993, 15 million new jobs have been created. But the unemployment rate among the 30 million working-age adults with disabilities continues to be much higher than that of the general population -- close to 75 percent for people with significant disabilities. The President signed an Executive Memorandum that will direct the relevant agencies to:
Expand Public Education About the Americans with Disabilities Act. Although more and more Americans are becoming aware of the ADA, too many employers and employees do not know their rights and responsibilities under the ADA. Today, the President is directing the Attorney General, the Chair of the Equal Employment Opportunity Commission, and the Administrator of the Small Business Administration to expand public education about the requirements of the Americans with Disabilities Act of 1990 to employers, employees, and others whose rights may be affected, with special attention to small businesses and under-served populations.
Increase Information About New Medicaid Buy-in Option. Many people with disabilities are not able to leave Social Security programs to return to work because they will lose their health care coverage. As part of last year's Balanced Budget Act, the President signed into law a new state option to allow individuals with disabilities who return to work, the ability to purchase critically necessary Medicaid coverage as their earnings increase. Today, the President is directing the Secretary of the Department of Health and Human Services to ensure that Governors, state legislators, and state Medicaid directors work with consumer organizations to take advantage of this important option.
Issuing Letter Clarifying That ADA Obligates States to Offer Appropriate Community Based Services. Recent court cases, including Helen L. vs. DiDario, have ruled that the ADA requires states to provide Medicaid services in the "most integrated setting appropriate" to people with disabilities. Today, the Health Care Financing Administration (HCFA) is sending a letter to all State Medicaid Directors clarifying that under these standards, if an individual living in a facility could live in a community with the right mix of support services, reasonable steps should be taken, provided they do not fundamentally alter the state program.
Announcing Support For Policies to Improve Health Options for Working Adults With Disabilities. The President also announced his strong commitment to work with Senators Jeffords and Kennedy and other Members of Congress to pass affordable, feasible legislation that helps people with disabilities maintain their health care coverage and return to work. The Jeffords-Kennedy proposal would increase Medicaid options and state resources for people with disabilities. It would also allow all Americans receiving Social Security Disability Insurance to retain their Medicare when they return to work, eliminating a provision in current law that often requires people with disabilities to choose between work and health insurance. The President directs the Administration to utilize all of its policy and budgetary expertise at HHS, the Office of Management and Budget, and the White House to work towards the passage of affordable legislation before the Congress adjourns this year, consistent with the Administration's commitment to preserving the budget surplus.
Yesâ€¦ She really has the job of a topless waitress. Well, hadâ€¦ According to News: A topless waitress and her boyfriend have faced court for allegedly importing 11.2L of liquid testosterone and 180 vials of human growth hormones after a two-year stin	
The one social media platform that seems to have a line and limit when it comes to NSFW content. They banned another one this week. Maca Diskrecija posted a topless photo of herself lying in bed to social media, which moderators took exception to after it was