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PDF Editor FAQ

What is the procedure to get a disability certificate?

According to the new guidelines issued by The Ministry of Social Justice and Affairs, Department of the Empowerment of Person with Dissability(PwD), one can fill the registration form on the website of the same ministry to get the Dissability certificate directly. Further instructions are given there. Once you get registered, you will be called for medical test by your nearest recognised government hospital. Based on the consent of the medical authorities the ministry will provide you with a Unique Identity Card, yes you heard it right its called an ID card instead of Dissabilitty Certificate! It is applicable universally unlike the former certificate and has more value than the former one.Cheers

What is the process of kidney transplant in India?

THINGS YOU MUST KNOW ABOUT KIDNEY TRANSPLANT IN INDIAKidney transplants in India first initiated in the 1970’s and since that time, India has been a leading country in this field on the Asian sub-continent.Transplantation of Human Organ Act (THO) was passed in India in 1994 to streamline organ donation and transplantation activities. Broadly, the act accepted brain death as a form of death and made the sale of organs a punishable offence.Provisions of Transplantation of Human Organ Act (THO)Living donationWho can donate – mother, father, brothers, sisters, son, daughter, spouse and grandparentsBrain-death and its declaration –Three certifications are required:One certification from treating doctorsTwo more certifications from the doctors nominated by the appropriate authority of the government with one of the two being an expert in the field of neurology.Regulation of transplant activitiesRole of Authorization Committee (AC) –to regulate the process of authorization to approve or reject transplants between the recipient and donors other than a first relative.to ensure that the donor is not being exploited for monetary consideration to donate their organ.Information about approval or rejection is sent by mail to the concerned hospitalsRole of Appropriate Authority (AA) –to regulate the removal, storage, and transplantation of human organs.inspecting and granting registration to the hospitals for transplant surgery, enforcing the required standards for hospitals, conducting regular inspections of the hospitals to examine the quality of transplantation and follow-up medical care of donors and recipients.Authority for removal of human organAny donor may authorize the removal, before his death, of any human organ of his body for therapeutic purposes as specified in Forms 1(A), 1(B), and 1(C), to be submitted with proof of identity and address, marriage registration certificate, family photographs, etc. with attestation by a Notary PublicPoints to remember –Before removing a human organ from the body of a donor before his death, a medical practitioner should satisfy himself that the donor has given authorization in Form 1(A) if the relative is a close relative i.e., a mother, father, brother, sister, son, or daughterThe donor is in a proper state of health and is fit to donate the organ. The registered medical practitioner should then sign a certificate as specified in Form 2.The donor is a close relative of the recipient as certified in Form 3 and has signed Form 1(A).The donor has submitted an application in Form 10 jointly with the recipient and the proposed donation has been approved by the concerned competent authority.Cost of donor management, retrieval, transportation and preservation to be borne by the recipient, institution, government, NGO or society, and not by the donor family.Things a medical practitioner confirm before removing an organ from a dead body –The donor had, in the presence of two or more witnesses (at least one of whom is a close relative of the recipient), unequivocally authorized as specified in Form 5 before his death,the removal of the human organ of his body after his death for therapeutic purposes and there is no reason to believe that the donor had subsequently revoked the authority.The person lawfully in possession of the dead body has signed a certificate as specified in Form 6A registered medical practitioner shall, before removing a human organ from the body of a person in the event of brain-stem death, confirm the following –A certificate as specified in Form 8 has been signed by all the members of the Board of Medical Experts.In the case of brain-stem death of a person of less than 18 years of age, a certificate specified in Form 8 has been signed by all the members of the Board of Medical Experts and an authority as specified in Form 9 has been signed by either of the parents the person.The proposed transplant is between persons related genetically (close relative, i.e., mother, father, brother, sister, son, or daughter above the age of 18 years old), the following shall be evaluated –Results of tissue typing and other basic testsDocumentary evidence of relationship e.g., relevant birth certificates and marriage certificateDocumentary evidence of identity and residence of the proposed donor e.g., Ration Card or Voters Identity Card, Passport, Driving License, PAN Card, or Bank Account and family photograph depicting the proposed donor and the proposed recipient along with another near relativeIf the relationship is not conclusively established after evaluating the above evidence, direct further medical tests may be given as described follows:Test for Human Leukocyte Antigen (HLA), human leukocyte antigen-B alleles to be performed by the serological and /or polymerase chain reaction (PCR) based Deoxyribonucleic Acid (DNA) methodsTest for human leukocyte antigen-Dr beta genes to be performed using PCR-based DNA methodsWhen the proposed donor and the recipient are not close relatives, the Authorization Committee shall evaluate that there is no commercial transaction between the recipient and the donor and the following shall specifically be assessed:An explanation of the link between them and the circumstances that led to the offer being madeReasons why the donor wishes to donateDocumentary evidence of the link, e.g., proof that they have lived togetherOld photographs showing the donor and recipient togetherThere is no middleman or tout involvedThe financial status of the donor and the recipient.The donor is not a drug addict or known person with criminal recordThe next of kin of the proposed unrelated donor is interviewed regarding awareness about his or her intention to donate an organ, the authenticity of the link between the donor and the recipient and the reasons for donation.Points to remember –The approved proposed donor would be subjected to all medical tests as required at relevant stages to determine his biological capacity and compatibility to donate the organ in question.Psychiatrist’s clearance in such cases is deemed mandatory to certify the donor’s mental condition, awareness, absence of any overt or latent psychiatric disease, and ability to give free consent.All prescribed forms have been completed by all relevant persons involved in the process of the transplantation.All interviews should be video recorded.The various forms outlined in the rules are as follows:Form 1: Near-relative consentForm 2: Spouse consentForm 3: Other than near-relative donor consentForm 4: Psychiatrist evaluation of the donorForm 5: HLA DNA profiling reportForm 7: Self consent for deceased donationForm 8: Consent for organ donation from family (also applicable for minors)Form 9: Consent for organ donation from unclaimed bodiesForm 10: Brain death declaration formForm 11: Joint transplant application by donor / recipientForm 12: Registration of hospital for organ transplantationForm 13: Registration of hospital for organ retrievalForm 16: Grant of registrationForm 17: Renewal of registrationForm 18: Decision by hospital authorization committeeForm 19: Decision by district authorization committeeForm 20: Verification of Domicile for non-near-relativeForm 21: Letter from EmbassyPenalties for removal of organ without authority, making or receiving payment for supplying human organs or contravening any other provisions of the Act have been made very stringent in order to serve as a deterrent for such activities.Request Quote from 20+ Hospitals & Doctors for Kidney Transplant in India.

How much does it cost to do a very small investigational clinical trial of a nonprescription supplement?

In the first scene of Saturday Night Fever, Tony Manero’s walking down the street to the Bee Gees’ Staying Alive, and the lyric goes something like “Well, you can tell by the way I use my walk, I’m a woman’s man, no time to talk.” The walk, by John Travolta, has got a certain style. You need style. You’re on the hunt. You’ve spotted an opportunity. You’re not sure how to proceed.You say you’re thinking about an OTC, and that the application wouldn’t require FDA approval. But FDA does regulate claims relating to OTCs, so maybe you’re thinking about an off-label indication - not an approved claim, but just a new use of a drug that’s approved for something else. If you’re a physician yourself, this might work for your own practice, and for word-of-mouth campaign - if this works out, you could tell your colleagues about it, but chances are you won’t affect medical practice all that much beyond your own little (or large) office.You’re on the right track, Tony. You’re in the pocket, now follow through. What you need is a pilot study. Not a fake pilot study that’s never followed by a full-on clinical, but a real pilot study, which means a feasibility study.A pilot study isn’t designed to produce statistically significant results. Most times it can’t be, because you don’t know the magnitude of the effect your experimental treatment might have. What you do know, though, or if you don’t you must define before you start, is the smallest clinically significant difference on some measure. Say you’re dealing with “resilience” in seniors, and you find that a Six-Minute Walk Test has been generally accepted as a good global measure that. You’d pore over the literature on that test and on resilience to identify a generally accepted smallest measure that means anything to anybody. It might be 12 meters over a 6-minute standardized walk. Below that, it means nothing. That or more, it might mean something to somebody. In real life. Outside statistical analyses.Then you do a gut check whether your old dog’s new trick can live up to that standard. If yes, proceed to a pilot study. If there are any subjective measures involved, a blinded, placebo-controlled design is essential. If there are only biological measures involved, you can start with an open-label study. I’d say 10 or 20 subjects at most would be enough.Review and approval by an IRB is essential, as are contract clinical sites. Fees vary. You might pay $75 per subject for Informed Consent, $75 for Medical and Medication History, $125 for a Physical Exam, $20 for a questionnaire, $40 for a vitamin B6 assay, $14 for a serum chemistry panel, $15 for hematology, CBC, and urine analysis, $10 for a pregnancy test, $150 for a coordinator, $45 for the investigator, $150 for the subject, $20 for parking, and $89 for screen fails; repeat most of that for a single follow-up visit, add a 20% overhead, $3,500 of non-refundable startup fees, $1,000 for recruitment ads, $1,800 for IRB review, $500 for the IRB writing the consent form for you (highly recommended), and you come up to $38,672 for 20 subjects. The same simple study would set you back $105,416 for 60 subjects.Once you’ve done that, it’s a straightforward matter to perform a power analysis to find out how many subjects you would need to show a difference between placebo and active treatment that’s as least as large as the smallest clinically meaningful difference.No control, so-called “pilot studies” (so-called because they’re not followed up with a larger study) can also be useful if on the face of it they provide useful guidance to practice. As a case a point, the small study by Dr. David Matlock (http://www.acep.org/content.aspx?id=45601) of Illinois Colllege of Medicine at Peoria, who found that listening to Staying Alive while being trained in CPR helped doctors and medical students keep a good pace of chest comprehensions when they were retested five weeks later.On the other hand you might not need a clinical trial at all man, relax. It’s a tough business. It’s for the big Pharma boys. Have you heard of the failure rate in clinical trials? It’s scrotum-tighteningly high. Clinical trials aren’t the answer for nutrient studies (http://www.ajcn.org/content/62/6/1517S.full.pdf), nor, I imagine, for many OTCs.But if that’s what you really want - if it’s deep in your heart, and just has to come out - if you hope to be understood and believed in this crazy world, you can do worse that grok the Consort statement. (http://www.consort-statement.org/consort-statement/overview0/) There’s nothing sadder than wasted effort. It happens all the times clinical trials. Just conform, for once in your life, follow the rules, and you’ll do better.If you’re feeling like you’re ready for the Big Time, you might step up to double controls: placebo and active. So many fools try to make their offerings shine by comparing it to - nothing. Compare your stuff to the best that’s out there, come on and strut. Who cares what anything does against placebo, really? It’s how it stacks up compared to the best approved therapy that counts. (http://www.nejm.org/doi/full/10.1056/NEJMp0802107)But I’m a gonna try one last time to talk you down. Do you really need a clinical? Let me tell you a story about the “test everything forever” mentality. That initial, uncontrolled, fun study by Dr. Matlock that suggested Staying Alive can help you perform good CPR was replicated in a more rigorously designed study. (http://emj.bmj.com/content/early/2011/10/19/emermed-2011-200187.short?q=w_emj_ahead_tab) And what did they find? Lo and behold, controlled scientific research showed that people performing CPR with disco songs in mind sort of kept to the right time, but not to the right depth - they didn’t push hard enough. This team actually performed two controlled studies on this topic, and this was the second messy, disappointing result - good beat, wrong depth. Conclusion? “This interesting but unproductive area of resuscitation research should be discontinued”; though the lead author of the study did admit, "Any form of CPR is better than none at all.”So: first, open, uncontrolled study: Staying Alive can help you save a life. Second and third, serious, controlled studies: actually, disco music doesn’t help with compression depth (though it does help with the beat). So give it up. One of those researchers mentioned that there are CPR apps now that can give you a variety of cues to maintain correct compression rhythm and depth. That’s just bonkers.I don’t care if you got the CPR app on the home menu of your iPhone 4S motherfucker, if I drop to the floor with my heart stopped, you gonna call 911 or call yourself if you have to, then push hard to the beat of Staying Alive. You know Mr. Chow from that eye-wateringly funny The Hangover movie? Well Mr. Chow is played by Dr. Ken Jeong, who recently launched a brilliant campaign with the American Heart Association promoting the use of Staying Alive. (http://www.youtube.com/americanheartassoc) What’s the American Heart Associations’s answer to the problem of people not pushing hard enough in those previous studies? Was it, “further research is needed”? Screw that. It’s two women in well filled-out t-shirts rushing into the room. On those t-shirts - staring at your eyeballs - are two clear as a bell instructions: 1. Call 911. 2. Push hard and fast. Cue Dr. Jeong dancing. Push hard and fast, you can do it, it's not complicated! Not “more research”! Not “this interesting but unproductive area of resucitation research should be discontinued.” Whose approach saves more lives? Whose approach serves Life? Ultimately, that’s what you’ve got to decide: who is this for? It has to really help people somehow. That’s the only point of doing clinical trials. For already approved drugs, beware the waste of immense effort and time for minuscule bits of knowledge.Good luck!

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