Domain: clinicaltrials.gov
Stories and comments across the archive that link to clinicaltrials.gov.
Comments · 56
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Re:I'm a therapist, yup- it's real
Yea... we don't share a common vocabulary and text has it's limits.
Read these and then try to read my statement below them in light of them.
https://www.ncbi.nlm.nih.gov/p...
https://www.sciencedirect.com/...
https://www.fasciablaster.com/...
https://clinicaltrials.gov/ct2...
https://www.ncbi.nlm.nih.gov/p...
Note especially:
Massage Treatment
Each subject received a total of eight 30-minute massage therapy sessions during the 4-week treatment period. Two massage therapy sessions were administered each week and were separated by at least 48 hours. Massage therapy treatments were conducted by certified massage therapists, each with a minimum of 1000 hours of training and with 3 to 21 years of professional practice. A standardized, precise 30-minute massage treatment protocol was developed, refined, and practiced by each therapist for 4 weeks before the study began. The treatment protocol consisted of 6 distinct phases within the 30-minute time frame; brief descriptions of each phase follow.
Phase 1â"preparatory tissue warm-up
(3 minutes) included bilateral pressure moving from the lower cervical region to the occiput. This procedure was repeated, with completion of 3 passes bilaterally.
Phase 2â"myofascial release
(5 minutes) included 3 palmar glide passes each over the deltopectoral, deltoid, and posterior deltoid regions bilaterally. Additionally, 3 passes with a soft fist contact were made from the occiput to the lateral shoulder along the upper trapezius bilaterally.
Phase 3â"axial cervical traction
(2 minutes) included application of manual axial traction with 1 hand under the head and neck and the other hand on the forehead. Gentle traction was applied with the head first slightly flexed, then with slight right lateral flexion, and finally with the head in slight left lateral flexion. Traction was held for 15 seconds in each position.
Phase 4â"trigger point therapy procedure
(15 minutes) consisted of scanning palpation of the upper trapezius, sternocleidomastoid, suboccipital, splenius capitis, levator scapulae, and temporalis muscles to locate and manually treat trigger points.16 When located, active trigger points were treated by pincer or flat palpation with just enough pressure to elicit referred pain or autonomic referral phenomena. That pressure was maintained on the trigger point until the client reported that the referral pain had dissipated or for a maximum of 2 minutes. Pressure on the active trigger point was then slowly eased to elicit a vascular flushing. This procedure was repeated 3 to 5 times on each trigger point. Typically, 6 active trigger points were treated in the time allotted.
Results
A decrease in both frequency and duration of chronic headaches.(But also notice a small sample size for this study.
/shrug)https://www.ncbi.nlm.nih.gov/p...
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Okay, so in light of those:
Imagine your entire body is enclosed by a layer beneath your skin of soft leathery material which can become less flexible in certain directions and put tremendous pressure on underlying tissues. Pressure applied in directions different than that of the pressure can soften, lengthen, and extend the soft leathery material, reducing pressure on the underlying tissues.
Especially in the case of chronic headaches and migraines this can reduce the duration and intensity of headaches and migraines ( migraines having nausea, light sensitivity, and visual distortion in addition to pain). In my personal experience, the migraines f
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Re:But what's the long-term prognosis?
Excited to see the dialogue about this! Ventricular tachycardia is a very different beast than atrial fibrillation. Medication and catheter ablation for afib is quite effective in most patients. Afib is not life threatening for most. In contrast, VT is very life threatening, and most patients would die from their VT if they didn't have an implanted defibrillator. Likewise, medications and catheter ablation for VT is less effective. Furthermore, once someone becomes refractory to standard VT therapies, their chances of dying from the VT become substantial. Likewise, options for these sick patients are quite limited - heroic attempts at repeat ablation, heart transplant, or even hospice. We employed a unique combination of non-invasive mapping of the VT using a "vest" of electrodes which can 3-dimensional map the VT (ECGI) and combined it with a known non-invasive ablative therapy (SBRT) which I typically use to treat tumors. SBRT is precise, focused, and has been used in thousands of patients. SBRT to the diseased part of the heart causing the VT is what makes this special. You are appropriately skeptical about the long term benefit of such a treatment. Standard therapies fail more than 50% of the time. We aren't proposing that this would necessarily be superior to standard therapies, but certainly provides an alternative to those with no alternatives. With time, it might even become a viable option for more patients. We are carefully studying this now in a prospective trial after we saw these initially encouraging results. We must be diligent about monitoring for unexpected toxicities and results. Thank you for your comments, and for keeping us honest. https://clinicaltrials.gov/ct2...
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Follow-up looks like it's still be studied for Phi
Philadelphia positive patients (9/22)
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These studies and therapies exist in the USA today
OIT https://www.oit101.org/ (oral immuno therapy) AIMT (Aimmune Theraputics) http://www.aimmune.com/clinica... https://clinicaltrials.gov/ct2... 500 person trial ending i november CODIT oral therapy for PN DBVT (ViaSkin Patches) https://www.dbv-technologies.c... Skin patch therapy for peanuts. Go invest in them FWIW... DS
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Re:Score one for research using monkeys.
I've had a chance to be involved in the technical setup of the clinical trial. It is truly fascinating to see the system at work. It will be 8 patients in total by mid-2018, so we'll have to wait until then to see if it truly works.
Restoring walking is a first step because it is also easiest to begin with because walking is largely based on reflexes. These reflex networks are typically preserved after spinal cord injury, but the person is no longer able to activate them voluntarily, thus losing the ability to walk. With electrical stimulation and an extensive rehabilitation program, the aim is that the person regains some of this voluntary control.
Restoring arms and hands function will be the next step. Tasks involving these limbs however, require fine motor control and are less reliant on reflexes. This means that remnant reflexes cannot be exploited and relearning tasks will be much harder (if not impossible...).
My hope is still that one day we can have a paralyzed patient compete in the cybathlon exoskeleton race but with the implanted electrical stimulator instead of an actual exoskeleton.
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Human Clinical Trial
In case you're interested in the details, or know someone who would be willing to try.
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Re:Vagus Nerve Stimulation going to be big money
VNS Clinical Trials
https://www.clinicaltrials.gov/ct2/results?term=vns&Search=Search -
Re:Not even wrong
I have heard that a popular method of drug research is to do clinical studies of a large number of people, but only report on the people that had positive results. You had 500 people in the trial, 10 got better, you report your 10 person drug test. Doctors should be required by law to report negative drug effects to the FDA from all their patients, even for clinical trials.
The only people who do that are quacks like Burzynski, who published a book describing his "successes" who may not have actually had cancer in the first place, and whom he didn't follow more than 6 months.
You couldn't publish something like that in a major peer-reviewed medical journal today.
What the drug companies did do until recently was commission a lot of studies, and publish only the studies with good results. The journals put an end to that by requiring every investigator to report the start of a study in a public registry, like http://www.clinicaltrials.gov.... If they don't report the study, the journals won't publish it when it's done. And doctors can ask the drug companies about the studies that suddenly disappeared.
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Re:Might Be Snake Oil
There are only two double-blind studies with results in that list, and one of them only had 9 participants, leaving only one result:
https://clinicaltrials.gov/ct2...It's not large scale, though - 331 participants.
And that one is for treating a problem that exists in the brain, not the body. And worse, it has no fewer than 35(!) secondary outcome measures. This is p-hunting at its worst. With that many outcomes, there's a statistical near-certainty that there will be one or more "significant" findings. You could test people for drinking 35 different sodas and find a statistical significant result for one of them versus a disease.
Color me not convinced. This smells of snake oil and bad science. That there are that many studies, most of them for ailments that are especially prone to natural variations, and yet not a single focused one that show positive results says all you need to know.
This is zone therapy and chiropracty for the new millennium. -
Re:I predict nothing will come of this
So far the treatments of tinnitus have been effective, but with a few caveats (as with all medical interventions).
Here is the original animal study regarding tinnitus: http://www.nature.com/nature/j...
And a review paper: http://www.sciencedirect.com/s...
Here is a clinical trial that happened: http://onlinelibrary.wiley.com...
And another clinical case study: http://journals.lww.com/otolog...
And here is a clinical trial currently happening: https://clinicaltrials.gov/ct2...To sum up the clinical trial that has already been published: researchers found that VNS did improve tinnitus, but only in patients that were not on drugs that affected neuromodulators such as acetylcholine and norepinephrine.
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Re:I smell bs
Not enough research? Vagus nerve stimulation has been around since '90s, and is already in use in the clinic for both depression and epilepsy. It is more recently being explored as an option for stroke and brain injury recovery.
A simple search of "vagus nerve stimulation" on Google Scholar returns 140,000 results. If you constrict it to only the year 2015, it returns over 2000 results. That's a lot of research.
There are also plenty of clinical trials happening, as you can see here:
https://clinicaltrials.gov/ct2... -
Re: It's just a tool I guess
The Phase III study "Study 801" of the compound under discussion did have an open-label run-in period, *and* was placebo controlled.
I believe the ct.gov link below is the study under consideration. Regardless, the press release mentions the placebo control.
http://clinicaltrials.gov/ct2/...
http://ir.zogenix.com/phoenix....
From the last link:
Zohydro ER was studied in over 1,100 people living with chronic pain who participated in the pivotal Phase 3 efficacy study or an open-label Phase 3 long-term safety study. The efficacy study that enrolled over 500 subjects with chronic low back pain met the primary endpoint in demonstrating that treatment with Zohydro ER resulted in significantly improved chronic pain relief compared to placebo.
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Get Zapped!
If you want to get shocked for science, there are tons of studies that use this technique for all kinds of stuff. http://clinicaltrials.gov/ct2/...
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Fasting and Chemotherapy for Cancer
Some top Google results for "fasting cancer chemotherapy": http://www.scientificamerican.com/article.cfm?id=fasting-might-boost-chemo
"Fasting appears to protect normal cells from chemotherapy's toxic effects by rerouting energy from growing and reproducing to internal maintenance. But cancer cells do not undergo this switch to self-repair and so continue to be susceptible to drug-induced damage -- making for what the researchers call a differential stress resistance. Fasting, then, the authors wrote, should enhance the power of chemotherapies without having to resort to "the more typical strategy of increasing the toxicity of drugs.""So fasting during chemotherapy works in part precisely because it protects the chemotherapy patient's normal cells from becoming weakened.
Human trials are starting up:
"Clinical Trials: Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer"
http://clinicaltrials.gov/show/NCT01175837Research by Valter Longo, of the University of South California (USC) in Los Angeles on mice:
"Fasting May Boost Chemo By Weakening Cancer Cells"
http://www.medicalnewstoday.com/articles/241454.php
"He and his colleagues found, for example, that repeated cycles of fasting with chemotherapy cured 1 in 5 mice with a highly aggressive form of children's neuroendocrine cancer, and 40% of mice with a less severe form. In either case, no mice survived when treated only with chemo. For their study, in which they used used cancer cells and mice, Longo and colleagues found that for all the cancers they tested, fasting combined with chemotherapy improved survival, slowed tumor growth and/or limited the spread of tumors. They found that fasting without chemotherapy, slowed the growth of breast cancer, melanoma, glioma and human neuroblastoma. In several cases, fasting was as effective as chemotherapy."Cancer patients looking into it:
"48 hr Fasting before Chemo"
http://csn.cancer.org/node/237518Here are two books related to fasting in general.
One is from a century ago by Upton Sinclair:
http://www.healingcancernaturally.com/fasting-cure-for-health.htmlOne from a decade or two ago by Joel Fuhrman:
http://www.diseaseproof.com/archives/healthy-food-dr-fuhrman-on-fasting.html
"Therapeutic fasting accelerates the healing process and allows the body to recover from serious disease in a dramatically short period of time. In my practice I have seen fasting eliminate lupus and arthritis, remove chronic skin conditions such as psoriasis and eczema, health the digestive tract in patients with ulcerative colitis and Crohn's disease, and quickly eliminate cardiovascular diseases such as high blood pressure and angina. In these cases the recoveries were permanent: fasting enabled longtime disease suffers unchain themselves from their multiple toxic dugs and even eliminate the need for surgery, which was recommended to some of them as their only solution."One problem of course in Western Medicine is than an oncologist can't justifying charging, say, $20,000 for telling a potential customer just to stop eating for a bit. Not sure if the source is accurate, but the sentiment probably is:
http://www.doctoryourself.com/longevity.html
"One-quarter of what you eat keeps you alive.
The other three-quarters keeps your doctor alive.
(Hieroglyph found in an ancient Egyptian tomb.) "But ultimately, while fasting can help some people, people need to eat healthier long term. One big problem with people today fasting is that there is so many to
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Re:Another misleading headline...
s/DNA/mRNA/g
FWIW, This is an mRNA technique (bonded with protamine to keep it stable). The claimed advantage of a mRNA techique over a DNA technique is that it doesn't have to get all the way into a cell nucleus (where the molecules that read the DNA exist). Since the actual protein synthesis is all you care about, it's likely more efficient to use mRNA, except that the mRNA breaks down (which is why they bond it with protamine).
I haven't seen the timescale involved in how the protamine stabilizes the mRNA, but it doesn't seem like it is "forever" like DNA (although even for a vaccine which used DNA snippets, they probably won't replicate with the chromasomes, so it seems like even the DNA based vaccines don't seem obviously "forever" either).
A quick google shows that they've been trying this kinda stuff for a while with other proteins, but I haven't heard of any "fucking magic" results yet, so I'm not holding my breath for the hype...
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Re:I had to cringe
Approaches in this vein are being tried on HIV first: http://clinicaltrials.gov/ct2/show/NCT00842634
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Re:Oblig: TED Talk
These slimeballs write down those "free" samples at retail price (not at their incremental cost of production) as a business expense. They probably use nearly-staledated inventory to boot. Of course they are never free (libre) products that they promote, just free (beer) samples of their highest-profit lines. In the process, they rationalize compromising patient, pharmacist and doctor integrity and privacy. Pharmacy chains have been caught selling the compiled prescribing histories of doctors to the drugmakers in order to allow them to more accurately target their sample allocations and other marketing-to-prescribers. Just consider what this means for the privacy of people with rare conditions in remote places. All of this has just one purpose: to pad the apparent "justifiable" cost of a product with in many cases little or no additional value to the patient compared to a generic alternative. Notice how remarkably few drug trials are compared against existing gold-standard treatments and how few actually report their underwhelming results. The vast majority compare only against placebo. http://clinicaltrials.gov/ It's long past time that the profit motive was applied to delivering better care rather than the sale of more pills. The elimination of "evergreening" would go a long way toward this.
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Re:Alternative: donate it
You would be better off buying lottery tickets for your kids with the money that you're spending. At least there is a chance it could be used for something.
Consider that the cost of harvesting cord blood is about $1,500 and storing it per year is about $100. For 18 years you spend $3,300 or 1,100 powerball tickets.
Odds of winning the powerball are 1,100 to 195,249,054 (0.0000056%)
Odds of being afflicted with type 1 diabetes and being a part of a case study: 8 in 100,000 (0.00008%)
So actually, you have better odds of actually needing and using your cord blood. Although, as many have suggested, donating is a noble option too.
You forgot to roll in there the odds of successful cord blood treatment of your type 1 diabetes...
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Re:Alternative: donate it
You would be better off buying lottery tickets for your kids with the money that you're spending. At least there is a chance it could be used for something.
Consider that the cost of harvesting cord blood is about $1,500 and storing it per year is about $100. For 18 years you spend $3,300 or 1,100 powerball tickets.
Odds of winning the powerball are 1,100 to 195,249,054 (0.0000056%)
Odds of being afflicted with type 1 diabetes and being a part of a case study: 8 in 100,000 (0.00008%)
So actually, you have better odds of actually needing and using your cord blood. Although, as many have suggested, donating is a noble option too. -
Re:Documentary on Netflix
Here's the problem, though. You CAN'T call the man a quack without the research otherwise you're being just as non-scientific. Instead, check out the post further down by the Anonymous Coward. He links to clinicaltrials.gov and I'll link to a deeper source: http://www.clinicaltrials.gov/ct2/results?term=burzynski&show_down=Y#down
Also note that you and I, through our taxes, pay for many, MANY experiments most of which provide no benefit aside from the "all results are good in science" aspect.
Sometimes you gotta get all James Randi with this stuff. Throw down the money for the challenge that way the people get destroyed and start harming other people. Ya, I'm willing to throw in for that.
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Re:Diabetes? Bad example
No problem. Here's a clinical trial of the paleo diet for treating type II diabetes:
http://www.ncbi.nlm.nih.gov/pubmed/17583796
http://clinicaltrials.gov/ct2/show/NCT00435240
http://www.ncbi.nlm.nih.gov/pubmed/19604407
Some practical advice (books/blogs) you can follow to get you started:
http://thehealthyskeptic.org/diabesity
http://wholehealthsource.blogspot.com/search/label/diabetes
http://perfecthealthdiet.com/
http://thepaleodiet.com/
http://www.marksdailyapple.com/
I wish your wife luck. Definitely read as much as you can before trying this. The links above will just get you started. -
has been around for a bit
There've been experimental uses of this kind of thing since the 1990s. The AutoLITT system mentioned in this mini-article, and Visualase are two commercial systems. There've been some preliminary clinical trials as well.
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Re:Soooo...
There is nothing wrong with going the experimental route when standard treatments have failed.
But if you are going to go the experimental route, joining one of the roughly 20 clinical trials for the same disease by top researchers in the U.S. is probably a better idea than going with some funky trial in Thailand.
A much better last resort.
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Re:What is needed is 2 levels of FDA
She tried some wild crap in Thailand. Not exactly a place known for it's cutting edge science. There are a number of countries doing a lot of really good biology work. Thailand isn't one of them.
Meanwhile, back in the States, where the NIH spends $28+ Billion a year on research, on clinialtrials.gov you can look up her condition, lupus nephritis, and see that there are *19* different clinical trials recruiting patients right now for that disease.
She died of freedom of choice alright. Just not a very good choice.
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Re:Cure?
Damn right. I've been waiting for a cure for valley fever for years. Been taking expensive meds for years which only halt the progression of the disease. I was very hopeful of this new drug called Nikkomycin Z, which eradicated the disease in mice and has not produced dangerous side effects in phase I human testing. I was rather depressed when I heard that studies were terminated due to lack of funding and recruitment challenges. It's true, nobody will fund research for a cure, even at this point, when probability for success is high.
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Re:More than just those three reasons
It's still far too young to see any real successes. Prior to the past year, there wasn't any realistic way to make use of stem cells in many circumstances because of the paucity of cell lines available. Now there's more coming online. The real breakthrough though, Induced pluripotent Stem (iPS) cell technology, is brand new, and people have spent the last year making it safer by removing cMyc and whatever other oncogenes were necessary in the original formulation. That's basically done now and iPS cells should be less cancerous, so people are starting to move forward.
Remember that clinical trials take a very long time, so don't expect to see results so soon. Clinical trials for stem cell therapy are underway and from what little I've read they seem to be going well. You're right that the cancer problem still needs to be solved, and that it's never a good idea to believe wild predictions, things are looking vastly more positive for stem cell therapy than you make out.
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What IF
Instead of creating a vaccine, Doctors could somehow manipulate the CCR-5 genetic mutation? The University of Pennsylvania is attempting to modify CCR-5 Genetic mutation. I don't know what the proper medical speak would sound like as I am NOT a medical professional. Rather,
I'm and individual trying to understand this from a researcher's perspective. It sounds promising, but who knows if or how it might work. Leave that to those more intelligent than us. The Wall Street
Journal had an article about a bone marrow transplant that functionally cured HIV/AIDS by seeking a donor that had a natural occurence of the CCR5 coreceptor mutation.
The WSJ called this a cure however, with only one known person to have this procedure. The first you instance/mention of this possibility I could find was here.
One has to wonder if this could be a real cure/treatment from HIV/AIDS, but we'll never know until a significant amount of testing/research has been done to prove this. -
Re:Lulz
The next best thing was to give a placebo such that the control group would be confident in their new-found immunity to HIV, at least as much as the experimental group. Otherwise the control would use more condoms because they're not on the experimental vaccine.
This page and this page indicate that the study was double-blind. If it was, then I do not see how your worry is reasonable. If both groups were unaware of whether they received the treatment or not, then I do not see how one group that happened to be the control group would reliably act differently than the experimental group. Am I missing something? Or are you claiming that once people believe they have the vaccine, that they will have more unprotected sex and thus increase their risk of contracting HIV?
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Re:Statistics [Re:Lulz]
Then look at effect sizes if you're worried about gaming statistical significance due to sample size. If you're worried about the file drawer problem, then you're welcome to Google around to see if there are any other trials involving the two drugs used (vCP1521 and AIDSVAX B/E). A search of the US gubment's page on clinical trials reveals none. Also realize, that the big journals require that a study that seeks to be published was registered beforehand, and I cannot imagine that an AIDS vaccine study will be taken seriously if it isn't published in one of the major journals. Though there are issues with this process, it does allow for a systematic review of publication bias rather than a vague reference that is meant to undermine the legitimacy of research.
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Re:Randomized trials in surgery
I call bullshit. Here's one: http://clinicaltrials.gov/show/NCT00042081 Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
This study -- which was actually of a drug used to treat tissue before transplantation, rather than of a surgical technique -- found that "Failure of at least 1 vein graft is quite common within 12 to 18 months after CABG surgery. Edifoligide is no more effective than placebo in preventing these events. Longer-term follow-up and additional research are needed to determine whether edifoligide has delayed beneficial effects, to understand the mechanisms and clinical consequences of vein graft failure, and to improve the durability of CABG surgery."
I was excited that you might have found a surgical technique that meets the placebo-controlled blinded test standard, now I'm disappointed. You really ought to read a study's findings before you cite it.
Try Googling randomized controlled trial surgery
Following your link I find studies where the "control" is drug therapy or another medical intervention. If you have one where surgery is compared versus a sham procedure, please, point it out to me -- perhaps there's one mentioned in a study behind a paywall.
It's no good to have a study find that "surgery X is better than drug Y" -- maybe the benefits were due to a few days of enforced rest, skilled nursing care, and hospital food, not to mention that nebulous "placebo effect", or even a side-effect of general anesthesia, rather than due to the actual cutting and sewing of flesh.
The term surgeons use is not "placebo" but "sham surgery".
Sham surgery is a form of placebo.
It may be OK to thread a catheter into somebody's coronary arteries and squirt saline, but nobody is going to ask a patient to undergo abdominal or chest surgery, with a mortality of 1% or even 0.1%, just to satisfy somebody's idea of a perfect scientific design.
But sham thoracic and cranial surgery has been performed. The first, and most famous, use of a placebo surgical technique as a control was to investigate mammary artery ligation for relief of angina pectoris. And tests of transplantation of human embryonic dopamine neurons and of fetal pig cells into the brains Parkinson's patients, were also compared to sham techniques. In all three of these cases, the "real" operation was no more effective than the placebo.
We can add to that a test of arthroscopic surgery for knee arthritis which failed to show any benefit of a real surgery over a fake cut.
So again, I ask: if anyone has an example of a placebo-controlled trail of a surgical technique where the real technique proved more effective that the placebo, please post it.
1-sentence course in medical ethics: A doctor can't do anything to a patient that wouldn't benefit the patient.
The fact that it's difficult to te
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Randomized trials in surgery
There are zero blinded tests -- let alone double blind tests -- demonstrating the effectiveness of surgery.
I call bullshit. Here's one:
http://clinicaltrials.gov/show/NCT00042081
Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
ClinicalTrials.gov Identifier: NCT00042081Try Googling randomized controlled trial surgery
in every case where a surgical procedure has been tested against a placebo operation, the surgery has been no more effective than the placebo.
The term surgeons use is not "placebo" but "sham surgery".
They use sham surgery when they can, but they can't use sham surgery that would be unreasonably harmful to the patient. It may be OK to thread a catheter into somebody's coronary arteries and squirt saline, but nobody is going to ask a patient to undergo abdominal or chest surgery, with a mortality of 1% or even 0.1%, just to satisfy somebody's idea of a perfect scientific design.
1-sentence course in medical ethics: A doctor can't do anything to a patient that wouldn't benefit the patient.
The days of using prisoners, negroes, Jews, Chinese and Puerto Ricans as experimental subjects are long gone.
There's been a lot of progress towards evidence-based medicine in the last generation of surgeons. Most surgeons put their patients' welfare first, understand science better than most people on Slashdot, and spend a lot of effort figuring out what the scientific evidence is for alternative procedures. I've seen them in some gloves-off debates at surgery conferences. Of course there are surgeons who are out first to make a buck, but that's the price of a free market.
I don't know where you get your facts from. At least go to Wikipedia.
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Re:please sign me up!
You go here: http://clinicaltrials.gov/
And find the trial you are interested in, and see if you meet the requirements.
In the case of this one:
http://clinicaltrials.gov/ct2/show/NCT00773097?term=colorectal+vaccine&rank=2
Inclusion Criteria:
Age 40 - 70 years of age.
History of any of the following conditions (operative notes, endoscopy reports, and/or pathology reports must be reviewed locally to confirm that the candidate meets at least one of the following entry criteria).
1. Colorectal adenoma(s) 1 cm in maximal diameter
2. Colorectal adenoma(s) with villous or tubulovillous histology
3. Colorectal adenoma(s) with high-grade dysplasia
o Willingness to avoid pregnancy or impregnate (see below) for the period of active study (1 year).
o ECOG performance status 0 or 1
o Hemoglobin greater than 95% of the lower limit of institutional normal. Platelets 100,000/L.
o AST (SGOT), ALT (SGPT), alkaline phosphatase, total bilirubin, BUN, creatinine 1.5x upper limit of institutional normal.
o ANA 1:160Exclusion Criteria:
* Receiving any other investigational agents.
* Presence of an active acute or chronic infection
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents.
* History of heritable cancer syndrome (FAP, HNPCC)
* Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis.
* History of malignancy 5 years prior to the Registration/Randomization evaluation, excluding non-melanoma skin cancer.
* Any use of oral corticosteroids 12 weeks prior to Registration/Randomization.
* Current or planned use of immunomodulators including: Remicade, 6-MP (Mercaptopurine), Methotrexate, cyclosporine, or other immunomodulatory drugs.
* Pregnant women, because the teratogenic or abortifacient effects of the study agents remain incompletely defined. Breastfeeding women, because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents. -
Re:please sign me up!
You go here: http://clinicaltrials.gov/
And find the trial you are interested in, and see if you meet the requirements.
In the case of this one:
http://clinicaltrials.gov/ct2/show/NCT00773097?term=colorectal+vaccine&rank=2
Inclusion Criteria:
Age 40 - 70 years of age.
History of any of the following conditions (operative notes, endoscopy reports, and/or pathology reports must be reviewed locally to confirm that the candidate meets at least one of the following entry criteria).
1. Colorectal adenoma(s) 1 cm in maximal diameter
2. Colorectal adenoma(s) with villous or tubulovillous histology
3. Colorectal adenoma(s) with high-grade dysplasia
o Willingness to avoid pregnancy or impregnate (see below) for the period of active study (1 year).
o ECOG performance status 0 or 1
o Hemoglobin greater than 95% of the lower limit of institutional normal. Platelets 100,000/L.
o AST (SGOT), ALT (SGPT), alkaline phosphatase, total bilirubin, BUN, creatinine 1.5x upper limit of institutional normal.
o ANA 1:160Exclusion Criteria:
* Receiving any other investigational agents.
* Presence of an active acute or chronic infection
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents.
* History of heritable cancer syndrome (FAP, HNPCC)
* Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis.
* History of malignancy 5 years prior to the Registration/Randomization evaluation, excluding non-melanoma skin cancer.
* Any use of oral corticosteroids 12 weeks prior to Registration/Randomization.
* Current or planned use of immunomodulators including: Remicade, 6-MP (Mercaptopurine), Methotrexate, cyclosporine, or other immunomodulatory drugs.
* Pregnant women, because the teratogenic or abortifacient effects of the study agents remain incompletely defined. Breastfeeding women, because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents. -
Clinical trials on chocolate
For chocolate lovers who don't fit the demographics, peruse this list of ongoing clinical trials, you might get lucky:
http://clinicaltrials.gov/ct2/results?term=chocolate
I think the article descirbes this one, FLAVO, which compares flavonoid-enhanced chocolate with unenhanced:
http://clinicaltrials.gov/ct2/show/NCT00677599?term=chocolate&rank=18
For study subjects: "Flavonoid compounds from cocoa (including epicatechin) and soy to be consumed for 365days in the experimental intervention (versus placebo consumption). 27g chocolate bar the vehicle for flavonoid enrichment."
For controls: "27g placebo chocolate bar to be consumed for 365 days."
27g is about 1 oz. Typical commercial chocolate bars are maybe 1.5 oz.
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Clinical trials on chocolate
For chocolate lovers who don't fit the demographics, peruse this list of ongoing clinical trials, you might get lucky:
http://clinicaltrials.gov/ct2/results?term=chocolate
I think the article descirbes this one, FLAVO, which compares flavonoid-enhanced chocolate with unenhanced:
http://clinicaltrials.gov/ct2/show/NCT00677599?term=chocolate&rank=18
For study subjects: "Flavonoid compounds from cocoa (including epicatechin) and soy to be consumed for 365days in the experimental intervention (versus placebo consumption). 27g chocolate bar the vehicle for flavonoid enrichment."
For controls: "27g placebo chocolate bar to be consumed for 365 days."
27g is about 1 oz. Typical commercial chocolate bars are maybe 1.5 oz.
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Clinical Trial Link
The "drug" is prostaglandin e2 (PGE2), and the link for the clinical trial (from TFA) is here. This is a Phase I clinical trial, which means it's all about safety. (There are secondary endpoints that are related to efficacy.)
I said "drug" because PGE2 is a fatty acid derivative that naturally occurs in the body. The patient won't be exposed to a meaningful amount of PGE2, as it is used to make the cord blood stem cells divide.
What's interesting and exciting is that while it's not that different from current treatments, it will require fewer source cells per patient allowing for more people to be treated. Furthermore, the stem cells implanted into the patient will not be genetically modified, unlike a lot of the stem cells currently derived from adult tissues. So the patient has no drug exposure and no modified cells. If it works, it'll be pretty cool.
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Re:What's the drug?
The clinical trial page linked off the main page of the submission has a list: http://clinicaltrials.gov/ct2/show/NCT00890500
Right now I guess they do not know which one helped, just that it was one of them did. -
Re:Can't we get this funded more quickly?
A trial for that purpose is currently underway.
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Re:uhhh
I am just wondering if they have a way to stop the process if they need to... Ah well. Good work
There has been recent work to treat autoimmune diseases by "erasing" the immune system's "memory" (e.g., memory B cells) by attacking the marrow with chemotherapy, then reseeding the system with harvested haematopoietic stem cells. Here's an example I find after a fast search. Of course, it leaves the patient with 0 immune system while it regenerates from the stem cells, and I'd imagine you'd have to redo all your vaccinations, etc., but I suppose that could do the trick. -- Paul
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Title is misleading.
Before I start, I'd like to say I'm a junior doctor. Secondly, nothing I write in this post constitutes medical advice. Please consult your doctor for any and all advice. Now that the disclaimer is out of the way...
These aren't general medication exams taking place over telemedicine but neuro consults where acute ischemic stroke is suspected. Generally this involves smaller community hospitals contacting regional stroke centers for advice. The local doctors have done a full exam and present their findings to other doctors. The days of dialing up a doctor from home via webcam are getting closer for simpler things but the ability to physically examine a patient using our tools, labs, and diagnostic imaging are still the centerpiece of medical practice today. One of the more difficult parts of medical practice in the early years is learning to translate patient history and examination into data we can use to give us clues to the underlying condition. I really can't imagine a time when doctors will want to stop in-person examination.
For our weekly grand rounds talk 3 months ago, one of the leading doctors from the one of the stoke centers (I believe it was the Neurovascular Disease and Stroke Center at UCSF Medical Center) spoke on this very subject. He said the technology is very promising and allows patients in areas without stroke centers to get adequate care.
The basic tenants of therapy involve answers to the following three points:
* What are the benefits/risks of giving thrombolytics in patients with AIS? When are thrombolytic agents (which increase the risk of brain hemorrhage) too dangerous?
* Which agent should be given?
* When is it too late to salvage brain tissue?These questions are best handled by the stroke specialists. There is also some question as to the safety and effectiveness of telemedicine in acute stroke which are currently being evaluated via randomized clinical trials. The Lancent article above details one of the studies. The other is located here.
That said, there is a real limit to how effective these measures are in the real world. From what we know right now the medicine works but only if the patient makes it into hospital in time. Many caretakers of elder patients and stroke patients themselves don't realize always recognize the signs of a stroke until they're out of the therapeutic window for giving thrombolytics. In those cases the benefit/risk ratio gets skewed towards tPA treatment being either non-therapeutic or dangerous due to the possibility of hemorrhage through revascularization.
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Re:Remind me again...
Taxes DO pay for medical research. There are some examples ( http://clinicaltrials.gov/ct2/results?cntry1=NA%3AUS&fund=0&fund=1 ). And there are of course the research that goes on in the military and other federal organizations. Although, looking back in history (Manhattan Project) you don't really want covert medical research sponsored by the government on unwilling/unwitting human and non-human subjects for the 'public good'.
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Re:Vaccines Suck
A quick check reveals that there are only 1 or 2 that are specifically for males, and a few more that accept both.
http://clinicaltrials.gov/ct2/results?term=gardasil
Good that research is underway, yes, but still a paltry amount of effort being put towards men's health, as usual. -
Of men and mice...I can't find myself fearing fearless mice. Why? Because there was most likely a very good reason for the mice that they are afraid of cats and large things that can eat them... I just can't seem to worry about these things getting loose and breeding in the wild.
It's sort of like the fear of spiders, snakes, bears, and large cats. There are very valid reasons for humans to be naturally afraid of things that can kill/harm and maybe eat us. It's not the mice I'm afraid of, it's the supersoldier program to which this could be applied.
Of course, I'm not entirely sure they took out the mice's fear as much as their ability to detect the smell... maybe that's in TFA, I'll go see. -
Re:Great, but ...
There is an ongoing study with clinical trials in the US testing the use of Huperzine A (a chinese herb) to treat Alzheimer's disease. It's also believed to treat other forms of dementia.
My family has a long history, on my Father's side, of dementia setting in during the 60's -- so my Father and I both read all the news we can regarding such things.
In fact, my Father was mentioning a University study today of a herb that not only has been shown in controlled trials to treat the effects of AD but to also reverse the effects of the disease. Ironically, I can not recollect the name of the University or the herb he was referring to.
Perhaps it's the same herb, perhaps not - I forget. -
Re:The Bleeding edge of Alzheimer's research
Eli Lily's LY450139, and Wyeth/Elan's Bapineuzamab, are working on trial protocols, and should be starting phase III trials in the next few months. Calling their headquarters may provide information on how to apply for the trials. You may also be able to find information at http://www.clinicaltrials.gov/
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200 kHz and it breaks apart clumps
Taken from the US Clinical Trials Site:
http://clinicaltrials.gov/ct/show/NCT00379470?orde r=2
"Since they change direction very rapidly (200 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating."
->So it appears to be low intensity EM radiation at approximately 200 kHz.
"Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause the building blocks of these cells to move and pile up in such a way that the cells physically explode."
->To me it sounds like a rather localized effect requiring significant tuning to see any effect meaning that you're still safe to use your cell phone and can save the tinfoil for BBQing. -
Crohn's and VSL#3
Noticed you have Crohns. Wife has it too, runs in her family so I can relate to a lot of what you are saying. We also live in Canada, Saskatchewan the home of Canadian Medicare. Our province has good universal hospital coverage and a provincial drug plan, but some years our costs can balloon. On my wife's last attack she was off work for over a year. She was taking the usual prescribed drugs (steroids/anti-rejection) to get it under control with minimal success
... the specialist started talking surgery.
Her GP suggested she try a "food supplement" called VSL#3, a pro-biotic by Seafood pharmaceuticals (888-292-3193). The GP noted that there were some interesting studies showing good short and long term control of crohns in over 75% of the test subjects. First week she took two packages a day then went to 1 package a day. Within 2 weeks she was back to "normal" - or as normal as you can get with crohns. She has not had a major attack for over two years. When she gets "the feeling" something is wrong, she doubles her intake for a few days and blands down her diet.
I normally do not believe in the health food cure all VOODOO stuff. My wife had tried other pro-biotics with no effect, but the VSL#3 is different. I saw the change within days with my own eyes, this stuff is amazing. I have been passing this information along to others, and many of them have seen dramatic improvements. The GP and my wife have worked together to removed her off the drugs and she now take just 1 package of VSL#3 a day. At about $3.00 a day it a small price for good health! The downside is the entire cost is yours, no tax deductions or provincial drug assistance as it is considered a "food supplement".
The majority of studies seem to indicate some benefit. I only have two bookmarks on VSL#3, they are:
http://clinicaltrials.gov/ct/show/NCT00367705 (makes reference to an adult test)
http://www.crohns.net/Miva/education/ddw2002.shtml (general commentary)
If you look around I am sure you will find some additional reference material. -
Re:Long way to go yet...
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link to the paper
If slashdot was a technical crowd that likes highly detailed information, I would recommend that whenever a post is related to a publication in a peer reviewed scientific journal, there should be a link to it and the title should be stated. In this case, the Queen of Lyase recently published a paper called Sphingosine-1-phosphate lyase potentiates apoptosis via p53- and p38-dependent pathways and is down-regulated in colon cancer in the Proceedings of the National Academy of Science, or PNAS for short. It deals with cancer epigenetics, which will be one of the most important emerging areas of oncological research. Scientists once thought that cancer was caused by a critical mass of mutations, but now many of them realize that errant epigentic marks such as histone acetylation and cytosine methylation can be equal contributors to cancer. Epigentic marks do this by turning off tumor suppressor genes or activating oncogenes. Several histone deacetylase inhibitors are currently in human clinical trials. Having some nice primary source material is great for us technical folks.
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Re:Two technologiesI am actually an EMT. I am also a college student studying public policy and Emergency Health Services. I personally do not like doctors all that much, but I realize that our emergency medical system is based around their expert opinions.
The distinction that I am drawing is that PolyHeme is in Phase III clinical trials, whereas the aforementioned drug failed much much earlier. PolyHeme has already been shown to be safe; now they need to know if it is effective.
My point in indicating the difference in country is that FDA regulations have no bearing whatsoever in England. If you notice, that drug never made it across the pond for testing.
Straight from the FDA, here is the difference in the three stages of clinical trials:
Most clinical trials are designated as phase I, II, or III, based on the type of questions that study is seeking to answer:- In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
The alternative to this study would be to run a larger test on the exact same groups they used for the past two trials: healthy consenting adults. The drug would pass the test again and would be utilized by thousands of medics across the country without ever having been tested in real trauma patients in a real trauma enviroment. Instead of 600 people being put at risk, everyone in America would face that same risk that you mention. Historically there have been EMS practices applied without being tested and it sometimes takes years to figure it out.
Here is a great quote from another emergency worker at the EMT City forums about this issue: What are we left with without doing studies this way? Guesswork. Guesswork that brought us high-dose epi, isoproteronol, MAST trousers, and other debunked practices since nobody tested them on the population they were designed to help before cutting them loose on the street. Widespread use of unproven science will result in far more harm to far more people than a study population.