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心臓のある もの言う人形。
いつも笑顔でルンタッタ♪
memo:
*Pink Acid - Dead Little Pooki Doll Head ( DREAM GACHA
***Ambrosia***Off Sholder Dress ( TCF
[REZZ to open] Label Motion - Dreams 5 RARE ( DREAM GACHA
""D!va"" Hair "Zaara"
*Tentacio* Galatea Doll. Body Nude Vamp 5 ( GACHA
This morning, Kentucky announced $42mm in funding for Ibogaine research, as well as public-private partnerships to help push Ibogaine through the FDA approval process. The funds are coming from a large pool of Opioid Settlement Funds and will be allocated over the next 7 years. See the full press conference video here. [alas, a changing of the guard shut this down in Kentucky, and they will be trying in Texas instead]
Graph above: pre-print Ibogaine work with Nolan Williams at Stanford Psychedelic Science Symposium with strong results in an open label trial, with 6-month followup.
One treatment session with ibogaine led to 80-90% remission rates for PTSD, depression, anxiety, AND alcoholism in 30 Navy Seals diagnosed with Traumatic Brain Injury.
More below.
presenting at a psychedelic medicine symposium at Stanford. We had dinner together after this talk... utterly fascinating.
Just when you thought psychedelic medicine could not get any better…
We heard the latest results from a number of Stanford research projects yesterday, but let me start with the most mind-blowing… One treatment session with ibogaine led to 83-90% remission rates for PTSD, depression, anxiety, alcoholism AND opiate use disorder in 30 Navy Seals diagnosed with Traumatic Brain Injury. The benefits persisted through the 1 month follow up. Cognitive function improved across the board, and their self-reported disability… well, it disappeared. See below
These results have not been published yet, but should be.
Important caveat: this was an open label trial with no placebo arm. That work is to come; this study was to explore the reports of “miracle cures” from several hundred U.S. veterans who have gone to Mexico to do a day of treatment for their opiate addiction and PTSD and emerged with reports of life-saving healing. Ibogaine is a long-acting, overwhelmingly strong psychedelic with QT-prolongation cardiac risk requiring medical supervision, making it tricky to study. It is not a “party drug” in any sense. And like all of the plant medicines that appear to be more efficacious than any currently FDA-approved therapies, it is a Schedule 1 illegal drug, a relic from Nixon’s duplicitous “war on drugs.” As a fellow donor summarized so poignantly, when it comes to opiates and psychedelics, what they called drugs were actually medicines, and what they called medicines were addictive drugs.
Full disclosure: we are donors to VETS (the non-profit that organizes the trips to Mexico for treatment) and early venture investors in atai, the public company taking several psychedelic medicines through clinical trails, including ibogaine for opiate use disorder: atai.life/programs/ibogaine/
INGREDIENTS: Popcorn, partially hydrogenated soybean oil, less than 2% of: salt, hydrogenated cottonseed oil, natural flavor, color added, freshness preserved with TBHQ, methyl silicone.
Contains: Milk.
CAUTION: Do not allow young children to prepare unsupervised. Do not pop on glass top ceramic range, or over charcoal grill, open campfire, or other uneven heat. To use a camp stove, follow directions for gas range.
We defied campfire admonitions and cooked it anyway -- popped too slowly until we held it right next to the flame.
Barcelona, Spain.
Day two ... today we got the Big Red Bus and began exploring the city. After doing La Sagrada Familia, we carried on wandering.
Our next stop was at Park Guell.
From Wikipedia -
Ruscus aculeatus is a low evergreen Eurasian shrub, with flat shoots known as cladodes that give the appearance of stiff, spine-tipped leaves. Small greenish flowers appear in spring, and are borne singly in the centre of the cladodes. The female flowers are followed by a red berry, and the seeds are bird-distributed, but the plant also spreads vegetatively by means of rhizomes. Ruscus aculeatus occurs in woodlands and hedgerows, where it is tolerant of deep shade, and also on coastal cliffs. It is also widely planted in gardens, and has spread as a garden escape in many areas outside its native range.
Common names include Butcher's Broom, Kneeholy, Knee Holly, Kneeholm, Jew's Myrtle, Sweet Broom, and Pettigree.
Butcher's broom has been known to enhance blood flow to the brain, legs, and hands. It has been used to relieve constipation and water retention and improve circulation. Since Butcher's broom tightens blood vessels and capillaries, it is used to treat a common condition known as varicose veins.
It is also used for hemorrhoids. In a 1999 open-label (not blinded) clinical trial, the herb was tested as a hemorrhoid treatment and showed statistically significant positive results. It also showed reduction in venous insufficiency in two other studies. It was approved by the German Commission E guidelines for hemorrhoids treatment. It is occasionally prescribed for varicose veins which can be a complication of pregnancy. However, since it is classified as a natural product, there is no evidence or trials to suggest complete safety for the fetus. A qualified healthcare practitioner should be consulted prior to using this compound during pregnancy.
Barcelona, Spain.
Day two ... today we got the Big Red Bus and began exploring the city. After doing La Sagrada Familia, we carried on wandering.
Our next stop was at Park Guell.
From Wikipedia -
Ruscus aculeatus is a low evergreen Eurasian shrub, with flat shoots known as cladodes that give the appearance of stiff, spine-tipped leaves. Small greenish flowers appear in spring, and are borne singly in the centre of the cladodes. The female flowers are followed by a red berry, and the seeds are bird-distributed, but the plant also spreads vegetatively by means of rhizomes. Ruscus aculeatus occurs in woodlands and hedgerows, where it is tolerant of deep shade, and also on coastal cliffs. It is also widely planted in gardens, and has spread as a garden escape in many areas outside its native range.
Common names include Butcher's Broom, Kneeholy, Knee Holly, Kneeholm, Jew's Myrtle, Sweet Broom, and Pettigree.
Butcher's broom has been known to enhance blood flow to the brain, legs, and hands. It has been used to relieve constipation and water retention and improve circulation. Since Butcher's broom tightens blood vessels and capillaries, it is used to treat a common condition known as varicose veins.
It is also used for hemorrhoids. In a 1999 open-label (not blinded) clinical trial, the herb was tested as a hemorrhoid treatment and showed statistically significant positive results. It also showed reduction in venous insufficiency in two other studies. It was approved by the German Commission E guidelines for hemorrhoids treatment. It is occasionally prescribed for varicose veins which can be a complication of pregnancy. However, since it is classified as a natural product, there is no evidence or trials to suggest complete safety for the fetus. A qualified healthcare practitioner should be consulted prior to using this compound during pregnancy.
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... watch videos of the crime scene directed to M6 from the Metropolitan Police in Manhattan, New York, NY, USA.. It seems a most unusual murder has taken place.
All police agencies were alerted some time back about the interest Interpol had in a list of men. The confidential list has been forwarded to each of the major police entities around the world. This was the first response M6 had received from this action.
Now, it seems one of the New World Inc.fat men on the list had been murdered. 007 thought he knew what had happened.
Immediately after sending the new numbers and codes to his computer detail, 007 knew a flurry of new activity had taken place on the New World Inc.data bank. Count Armound had become frantic. He knew something was happening, but he didn't know what. His intelligence division came up with a list of potential suspects, people who had for some reason or other left New World Inc. under negative circumstances. Domingo was not on this list for the count, because his intelligence department had reported him positively killed in an airplane accident over the Caribbean Ocean, but one fat man, name George Henley from Chicago, had disappeared along with a sizable amount of cash. He had been located and the decision made not to take further action, unless it seemed he might stir up trouble for New World Inc. The count knew until his one major project was finished, he must not do anything that might draw attention to the firm.
When 007 and Sarah left the M6 video room, 007 rushed back to this computer center and threw himself headlong into solving the mystery of the password "from chaos x 12 comes tranquility." His team had discovered that when this same password placed into the central data bank, a file named Item 12 opened. It had good information, but not the vital information that would tell the exact method by which New World Inc. would acquire the food supplies of the world.
007, exhausted and having trouble keeping his red, itching eyes open once more typed in the entire password and again Item 12 opened. Almost as a mind doodle, 007 typed in "from chaos x 12" without the suffix, "comes tranquility" and again just as before Item 12 opened.
007 seemed to come awake immediately, typed in "from chaos x 11 comes tranquility" and unbelievably a new file opened labeled Item 11.
Again without the suffix, it opened again, and 007 knew exactly what how the password had been developed with the firm's computers. There were 12 divisions and these twelve divisions had almost the same password.
007 spent another two hours trying different variations to reach the vital inner core of the data bank, finally exhausted, he decided to methodically type in the passwords 1 through 12 in one long sequence. He typed in "from chaos x 1 from chaos x 2, from chaos x 3 on through the number 12. At each number the file would open, but if he continued typing it would bring up the next file. It seemed 12 was more important than 1 and New World Inc. was very much on a "need to know" mode. After typing in the 12 individual passwords, 007 typed into "comes tranquility" and instantly the entire data bank was available to him.
007, fully awake began to read. After thirty minutes of reading, he phoned control and said, "I have enough for warrants."
After that phone call things moved with lightening speed. I had been discovered that the goal of New World Inc. was much more evil than had ever been imagined.
Things began to happen with lightening speed almost immediately.
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Citation: Grachev ID, Doder M, Brooks DJ, Hinz R. An in vivo Positron Emission Tomography Study of Adenosine 2A Receptor Occupancy by Preladenant using 11C-SCH442416 in Healthy Subjects. Journal of Diagnostic Imaging in Therapy 2014; 1(1): 20-48.
dx.doi.org/10.17229/jdit.2014-0712-002
Abstract:
Background: This PET study was conducted to investigate the receptor occupancy of 11C-SCH442416 in the human brain and to determine plasma concentrations and dose of preladenant which result in inhibition of 11C-SCH442416 binding to adenosine 2A receptors. Preladenant is a novel non-dopaminergic, high-affinity, and highly selective A2A receptor antagonist being investigated for the management of Parkinson’s disease.
Methods:
This was an open-label, single-center, and pharmacokinetic-pharmacodynamic study performed in 18 healthy subjects. All subjects received an intravenous injection of the radiotracer 11C-SCH442416. Thirteen subjects received a single dose of preladenant 10, 50 or 200 mg orally at 1, 6 or 12 hrs prior to radiotracer injection.
Results:
A blockade of >80% was reached after 50-200 mg doses of preladenant. The Emax model that predicted plasma concentrations corresponding to 50%, 80%, and 90% receptor occupancy was validated. A 5 mg dose, administered BID, was estimated to provide ≥50% receptor occupancy in approximately 75% of the population for the majority of waking hours (12 hours/day).
Conclusions:
Single doses of preladenant were well-tolerated. The Cmax and AUC values of preladenant increased in a dose-related manner. In this study we demonstrated the importance of PET imaging for establishing PK-PD relationships and utilizing this tool in confirming proof-of-target and dose guidance for Phase 2/3 clinical trials.
Keywords: 11C-SCH442416; adenosine A2A receptor; PET; spectral analysis
More cider to add to my alcohol collection for Project 365! Nothing quite like an ice cold cider, unfortunately this one was not ice cold owing to our local Tesco fridge doors being rubbish/broken and therefore wedged open. Disappointing.
Unlike my last shot, this one actually is a Magners and not a Bulmers!!
Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report
For the first time in 2019, The American Diabetes Association endorses a low-carbohydrate and a very-low carbohydrate approach in nutrition therapy for Diabetes. They also include Prediabetes in the recommendations for the first time, which expands coverage of the recommendations to 50-60 % of the population.
Also noting:
Relaxing of recommendation for extensive salt restriction
Confusing discussion on the health impact of various fats, probably due to the well-known points of view of several of the authors. Other analyses have exonerated saturated fat and/or not shown reduction in mortality from substitution of polyunsaturates for saturated fats. Most studies have shown mortality benefit from replacing carbohydrates with saturated fats
As in previous versions, there are still extensive conflicts of interest disclosed (so called “duality”) on the part of the authors
Evert AB, Dennison M, Gardner CD, Garvey WT, Lau KHK, MacLeod J, et al. Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report. Diabetes Care [Internet]. 2019 Apr 18;dci190014. Available from: care.diabetesjournals.org/lookup/doi/10.2337/dci19-0014
“For people with type 2 diabetes or prediabetes, low-carbohydrate eating plans show potential to improve glycemia and lipid outcomes for up to 1 year”
Studies by Saslow, et al and Hallberg, et al, referenced for the first time
Relaxation of sodium restriction
Relaxation of fat restriction
Significant conflicts of interest still present
Source: American Diabetes Association. 5. Lifestyle management: Standards of Medical Care in Diabetesd2019. Diabetes Care 2019;42(Suppl. 1):S46–S60, Used under license: www.diabetesjournals .org/content/license
References:
62. Saslow LR, Daubenmier JJ, Moskowitz JT, et al. Twelve-month outcomes of a randomized trial of a moderate-carbohydrate versus very low-carbohydrate diet in overweight adults with type 2 diabetes mellitus or prediabetes. Nutr Diabetes 2017;7:304
63. Hallberg SJ, McKenzie AL, Williams PT, Bhanpuri NH, Peters AL, Campbell WW, et al. Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at 1 Year: An Open-Label, Non-Randomized, Controlled Study. Diabetes Ther [Internet]. 2018 Apr [cited 2019 Apr 2];9(2):583–612. Available from: www.ncbi.nlm.nih.gov/pubmed/29417495
Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report
For the first time in 2019, The American Diabetes Association endorses a low-carbohydrate and a very-low carbohydrate approach in nutrition therapy for Diabetes. They also include Prediabetes in the recommendations for the first time, which expands coverage of the recommendations to 50-60 % of the population.
Also noting:
Relaxing of recommendation for extensive salt restriction
Confusing discussion on the health impact of various fats, probably due to the well-known points of view of several of the authors. Other analyses have exonerated saturated fat and/or not shown reduction in mortality from substitution of polyunsaturates for saturated fats. Most studies have shown mortality benefit from replacing carbohydrates with saturated fats
As in previous versions, there are still extensive conflicts of interest disclosed (so called “duality”) on the part of the authors
Evert AB, Dennison M, Gardner CD, Garvey WT, Lau KHK, MacLeod J, et al. Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report. Diabetes Care [Internet]. 2019 Apr 18;dci190014. Available from: care.diabetesjournals.org/lookup/doi/10.2337/dci19-0014
“For people with type 2 diabetes or prediabetes, low-carbohydrate eating plans show potential to improve glycemia and lipid outcomes for up to 1 year”
Studies by Saslow, et al and Hallberg, et al, referenced for the first time
Relaxation of sodium restriction
Relaxation of fat restriction
Significant conflicts of interest still present
Source: American Diabetes Association. 5. Lifestyle management: Standards of Medical Care in Diabetesd2019. Diabetes Care 2019;42(Suppl. 1):S46–S60, Used under license: www.diabetesjournals .org/content/license
References:
62. Saslow LR, Daubenmier JJ, Moskowitz JT, et al. Twelve-month outcomes of a randomized trial of a moderate-carbohydrate versus very low-carbohydrate diet in overweight adults with type 2 diabetes mellitus or prediabetes. Nutr Diabetes 2017;7:304
63. Hallberg SJ, McKenzie AL, Williams PT, Bhanpuri NH, Peters AL, Campbell WW, et al. Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at 1 Year: An Open-Label, Non-Randomized, Controlled Study. Diabetes Ther [Internet]. 2018 Apr [cited 2019 Apr 2];9(2):583–612. Available from: www.ncbi.nlm.nih.gov/pubmed/29417495
The RIC3 provides the best overall value for exceptional fiber management. The RIC3 enclosure offers superior fiber density without sacrificing fiber protection and accessibility. Features include a fully removable tray, improved labeling, standard front and rear door locks, and single-finger door latches. With superior cable management, port identification, fiber accessibility and security, the RIC3 is the best way to protect mission critical fiber connections
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Complete Access — Management tray has a positive stop in both front and rear working positions providing complete access for moving, adding, changing, or cleaning of fiber connections
Rotating Grommets — Patented rotating grommets
facilitate loading and retention of jumpers and fiber
while minimizing microbending stress when using
the sliding tray
Maximum Capacity — The RIC3 enables a maximum amount of fibers to be patched or patched and spliced in a 2, 3, and 4U enclosure without compromising
accessibility. This allows more efficient utilization of rack space
Complete Access — Management tray has a positive stop in both front and rear working positions providing complete access for moving, adding, changing, or cleaning of fiber connections Quick-Release Hinges — Spring loaded quick-release hinges enable easy opening and removal of front and rear doors for complete access to fiber connections
This unique single-sided Calendar Card System allows cups to nest in place. Tearing away a pill cup is even faster and easier in this updated design. Great for caregivers in a congregate setting where Punch-Thru opening is not an option. (6-pill capacity)
One of the six new 2008 series of Mountain Dew collectible Green Label Art bottles. This one's entitled "Open Eyes", and was designed by Billy the Artist.
Standards of Medical Care in Diabetes - 2019 - American Diabetes Association
“For people with type 2 diabetes or prediabetes, low-carbohydrate eating plans show potential to improve glycemia and lipid outcomes for up to 1 year”
Studies by Saslow, et al and Hallberg, et al, referenced for the first time
Relaxation of sodium restriction
Relaxation of fat restriction
Significant conflicts of interest still present
Source: American Diabetes Association. 5. Lifestyle management: Standards of Medical Care in Diabetesd2019. Diabetes Care 2019;42(Suppl. 1):S46–S60, Used under license: www.diabetesjournals .org/content/license
References:
62. Saslow LR, Daubenmier JJ, Moskowitz JT, et al. Twelve-month outcomes of a randomized trial of a moderate-carbohydrate versus very low-carbohydrate diet in overweight adults with type 2 diabetes mellitus or prediabetes. Nutr Diabetes 2017;7:304
63. Hallberg SJ, McKenzie AL, Williams PT, Bhanpuri NH, Peters AL, Campbell WW, et al. Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at 1 Year: An Open-Label, Non-Randomized, Controlled Study. Diabetes Ther [Internet]. 2018 Apr [cited 2019 Apr 2];9(2):583–612. Available from: www.ncbi.nlm.nih.gov/pubmed/29417495
docetaxel (as generic or under the trade name Taxotere) is a clinically well-established anti-mitotic chemotherapy medication (that is, it interferes with cell division). It is used mainly for the treatment of breast, ovarian, prostate, and non-small cell lung cancer. Docetaxel has an FDA approved claim for treatment of patients who have locally advanced, or metastatic breast or non small-cell lung cancer who have undergone anthracycline-based chemotherapy and failed to stop cancer progression or relapsed and a European approval for use in hormone-refractory prostate cancer.
According to a 2005 article in the journal drugs, docetaxel administered as a one-hour infusion every three weeks generally over a ten cycle course, docetaxel is considered as or more effective than doxorubicin, paclitaxel and fluorouracil as a cytotoxic antimicrotubule agent. However the effectiveness of Docetaxel vs. Paclitaxel and other taxenes is still controversial. Several more recent articles have found "no evidence that regimens containing docetaxel yield greater benefits than those including paclitaxel." Additionally, the optimal scheduling of docetaxel and other taxenes remains unconfirmed. A three-week administration schedule used to be and is still considered effective but new studies are indicating a weekly schedule might be better. A 2010 article in Current Clinical Pharmacology states, "weekly administration has emerged as the optimal schedule." Docetaxel is marketed worldwide under the name Taxotere by Sanofi-Aventis. Annual sales in 2010 were Euro 2.122 billion ($US 3.1 billion). The patent expired in 2010.
Formulations and compositions
Docetaxel is a white powder and is the active ingredient available in 20 mg and 80 mg Taxotere single-dose vials of concentrated anhydrous docetaxel in polysorbate 80. The solution is a clear brown-yellow containing 40 mg docetaxel and 1040 mg polysorbate 80 per mL. 20 mg Taxotere is distributed in a blister carton containing one single-dose vial of Taxotere (docetaxel) preparation in 0.5 mL sterile pyrogen-free anhydrous polysorbate 80, and a single dose Taxotere solvent vial containing 1.5 mL 13% ethanol in saline to be combined and diluted in a 250 mL infusion bag containing 0.9% sodium chloride or 5% glucose for administration. 80 mg Taxotere is supplied identically but with 2.0 mL polysorbate 80 and 6.0 mL 13% ethanol in saline. The docetaxel and solvent vials are combined to give a solution of 10 mg/mL and the required dose is drawn from this solution. Vials have an overfill to compensate for liquid loss during preparation, foaming, adhesion to vial walls and the dead volume. 20 mg vials may be stored for 24 months below 25 °C away from light and 80 mg vials for 26 months in the same conditions.
Recently Sanofi has got approval for one-vial formulation. With this one-vial formulation, the preparation of the infusion solution is simplified by eliminating the first dilution step. The two-vial and one-vial formulations contain the same drug substance, docetaxel trihydrate, and the same excipients (ethanol, polysorbate 80 and citric acid). The one-vial formulation is administered as an aqueous intravenous solution that contains the same drug substance in the same concentration as the already approved two-vial formulation. The same grade, quality, and quantity of polysorbate 80 are present in the infusion solution of both formulations. The only difference between these two formulations is the quantity of ethanol.
Therapeutic applications and effects
Therapeutic applications
The main use of docetaxel is the treatment of a variety of cancers after the failure of anthracycline-based chemotherapy. Marketing of docetaxel as Taxotere is mainly towards the treatment of breast, prostate and other non-small cell cancers. Clinical data has shown docetaxel to have cytotoxic activity against breast, colorectal, lung, ovarian, prostate, liver, renal, gastric, head and neck cancers, and melanoma.
Breast cancer
In the treatment of breast cancer, eight phase II studies were carried out in patients with either locally advanced or metastatic breast cancer. A total of 283 previously untreated and treated patients underwent the following dose allocations (dosing based on calculatedbody surface area);
Numbers of patients in each dose regiment and previous treatment state
Dosage
75 mg/m²
100 mg/m²
Total
Previously Untreated
55
117
172
Previously Treated
-
111
111
283
Taxotere was administered over a one-hour infusion every three weeks for these trials. The 75 mg/m² cohort showed an overall response rate of 47% and 9% complete responses. Duration of response and the time to progression (treatment failure) had median values of 34 weeks and 22 weeks, respectively. Patients with two or fewer organs involved had a response rate of 58.6%, whereas patients with three or more organs involved showed 29.4% response.
Previously untreated patients in the 100 mg/m² cohort had an overall response rate of 56% and 9.4% complete responses. The previously treated population had an overall response of 48.6% and 3.6% complete responses. Median duration of response and time to progression was 30 weeks and 21 weeks for the previously untreated population and 28 weeks and 19 weeks for the previously treated patients. The 100 mg/m² cohort showed higher toxicity. Previously untreated patients with three or more organs involved had a 54.3% response rate and previously treated patients had a 55.8% response rate.
Two randomised phase III studies of 326 alkylating agent failure and 392 anthracycline failure metastatic breast cancer patients have been carried out with 100 mg/m² dosages administered over a one-hour infusion every three weeks for seven and ten cycles respectively. While no significant differences in median time to progression or survival were observed between docetaxel and doxorubicin in alkylating agent failure patients, anthracycline failure patients showed increased response rate to docetaxel. Median time to progression and median overall survival were also improved with docetaxel.
The following table is the results of an unpublished, non-peer reviewed, comparative, open-label, randomised phase III study of docetaxel and paclitaxel assigned randomly to 449 patients with advanced breast cancer. Docetaxel was administered as a one-hour infusion of 100 mg/m² Taxotere every three weeks and paclitaxel as a three-hour infusion of 175 mg/m² paclitaxel every three weeks.
Results of an open-label, multicentre, randomised phase III study in 449 advanced breast cancer patients, comparing efficacy of docetaxel and paclitaxel
Endpoint
Docetaxel 100 mg/m² n=225
Paclitaxel 175 mg/m² n=224
p-value
Median survival (months)
15.3
12.7
0.03
Median time to progression (weeks)
24.6
15.6
<0.01
Overall response rate (%)
32.0
25.0
0.10
Overall response rate in evaluable population (%)
37.0
26.0
0.01
Lung cancer
Clinical studies have taken place for the treatment of non-small cell lung cancer. Patients treated for non-small cell lung cancer in phase II studies with 100 mg/m² docetaxel showed an overall response rate of 26.9% for previously untreated patients (n=160) and 17% for previously treated patients (n=88).
Metastatic prostate cancer
The TAX 327 trial was a phase III study that showed significant survival benefit from docetaxel in androgen-independent metastaticprostate cancer. Compared with mitoxantrone treatment, docetaxel treated patients showed a 12% overall response rate and mitoxantrone showed a 7% overall response rate. Another large advantage of docetaxel was increased quality of life. Docetaxel showed a 22% response and mitoxantrone had a 13% response. Used in conjunction with prednisone for pain management, docetaxel had a 35% response and Mitoxantrone had a 22% response. This trial leads docetaxel to be a preferred method of treatment to Mitoxantrone where possible. Subsequently EU approval.
STAMPEDE is a UK-based six-arm, five-stage, open-label randomized controlled trial involving more than 3000 men. Arms C and E of this trial involves administering docetaxel in addition to the normal hormone therapy therapy to men starting long-term hormone therapy for the first time. This could be newly diagnosed metastatic, newly diagnosed non-metastatic or high-risk, previously-treated prostate cancer. The trial tests the value of the drug earlier in the treatment pathway instead of waiting until it has become androgen-independent.
Specific outcomes and benefits of treatment
Treatment with docetaxel has the specific outcome of increasing survival time in patients with certain types of cancer. While some clinical trials show median survival times to be increased by approximately only three months, the range of survival time is large. Many patients survive beyond five years with treatment from docetaxel, however it is difficult to attribute these findings directly to treatment with docetaxel. Improved median survival time and response indicates that docetaxel slows metastatic cancer progression and can lead to disease-free survival. Conjunctive treatment of prednisone with docetaxel has been shown to lead to improved survival rate as well as improved quality of life and reduction of pain compared with treatments with mitoxantrone. Docetaxel has been shown to improve survival as an adjuvant therapy with doxorubicin and cyclophosphamide for the treatment of node-positive breast cancer and so docetaxel has the benefit of aiding other treatments.
As well as inhibiting mitosis, the presence of docetaxel has been found to lead to the phosphorylation of the oncoprotein bcl-2, which leads to apoptosis of cancer cells that had previously blocked the apoptotic inducing mechanism, leading to tumour regression. Enhanced effects of radiation therapy when combined with docetaxel has been observed in mice. Docetaxel has also been found to have greater cellular uptake and is retained longer intracellularly than paclitaxel allowing docetaxel treatment to be effective with a smaller dose, leading to fewer and less severe adverse effects.
Adverse effects
Docetaxel is a chemotherapeutic agent and is a cytotoxic compound and so is effectively a biologically damaging drug. As with all chemotherapy, adverse effects are common and many varying side-effects have been documented. Because docetaxel is a cell cycle specific agent, it is cytotoxic to all dividing cells in the body. This includes tumour cells as well as hair follicles, bone marrow and other germ cells. For this reason, common chemotherapy side effects such as alopecia occur; sometimes this can be permanent. However, the drugs company Sanofi Aventis claim they do not routinely keep this data.North westFranceare conducting a survey to establish exactly how many patients are being disfigured in this way. Independent studies show it could be as high as 6.3% which puts this ASE in the 'common and frequent' classification - See more at:
Oral Tolerability of Cysteine-Rich Protein Isolate (Immunocal) in Autism - A Pilot Study
MONTREAL, Aug. 28 /CNW Telbec/ - Immunotec Inc. (TSX-V: IMM) announced
today the completion of an open-label clinical trial on the use of a
cysteine-rich protein isolate in children with autism. Ten children, 3-15
years of age with a diagnosis of autism or autism spectrum disorder (ASD),
were supplemented with a non-denatured whey protein isolate (Immunocal(R)).
Autism symptoms, behavior, side effects, and treatment adherence were
examined, as well as bowel flora. This preliminary study showed the majority
of autistic children were able to consume non-denatured whey protein isolate
(Immunocal(R)) without adverse effects. Changes in all behavioural parameters
showed positive trends but did not reach statistical significance because of
the small numbers of patients in this pilot study. The results will provide
the basis for a larger placebo controlled double blind study to test the
benefits of using whey protein isolate in the treatment of autism. (Kern JK,
Grannemann BD, Gutman J, Trivedi MH, Oral Tolerability of Cysteine-Rich Whey
Protein Isolate in Autism - A Pilot Study, Journal of the American
Nutraceutical Association (JANA), Vol. 11, No. 1, 36-41, 2008.)
Recent evidence suggests that many children with autism have low levels
of glutathione in their cells. Non-denatured whey protein can improve
glutathione levels in a variety of diseases and disorders; however, there are
anecdotal reports that children with autism may have a worsening of behavior,
gastrointestinal (GI) disturbance or related problems after the ingestion of
sulfur-rich compounds.
Principle investigator Dr. Janet Kern stated, "We're very optimistic
about these pilot results, it makes us very comfortable to pursue larger and
longer-term studies using this strategy."
Immunotec President and CEO Jim Northrop is pleased with these initial
results. "Completion of this pilot study will encourage researchers to move on
to the next step of studying the role and benefits of our cysteine-rich
protein (Immunocal) in children with autistic spectrum disorder. I am proud of
Immunotec's commitment to ongoing research and development that continues to
validate the confidence and quality in our products."
About Immunocal
Immunocal is a cysteine-rich protein isolate derived from non-denatured
whey protein. Immunocal(R)/HMS 90(R), is a dietary natural health supplement,
developed and marketed worldwide by Immunotec since 1996. Immunocal(R)/HMS
90(R) is a precursor of the major cellular antioxidant glutathione, an element
important in maintaining a strong immune system.
About Immunotec Inc.
Immunotec is engaged primarily in the development and marketing of
natural health products, dietary supplements, vitamins and personal care
products, many of which are manufactured on its behalf by third parties.
Immunotec's products are distributed and sold in the United States and Canada
through a network marketing system and in other countries through exclusive
distributorship agreements. Immunotec's investment in this study is another
manifestation of its ongoing commitment to research and development.
For further information: Media: John H. Molson, Vice-President, Research
& Development, Immunotec Inc., (450) 510-4450, Fax: (450) 424-9993,
jmolson@immunotec.com; Clare Malbon, R&D Dept., (450) 424-9992 Ext 2377
Immunotec and Nova Southeastern University (NSU) Collaborate on New Autism Study using Immunocal®
MONTREAL, July 26, 2011 /CNW Telbec/ - Immunotec Inc. (TSXV: IMM) (www.immunotec.com/IRL/ Public/en/USA/products_overview.wcp?) announces that Nova Southeastern University (NSU) in Florida is conducting a study to determine the effects of Immunocal on the behaviours of children with autism spectrum disorder (ASD). Immunocal, a whey protein isolate, is Immunotec's flagship product.
The primary focus of the two-year study is to determine if children diagnosed with autism would exhibit improved behaviours after consuming the cysteine-rich whey proteins in Immunocal during the course of the 90-day observation period. The outcome could be a better quality of life, both for the children and their families.
The principal investigator of the NSU-Immunotec study is Ana Maria Castejon, Ph.D., an associate professor at the College of Pharmacy. She and her research team are very enthusiastic about the potential outcomes. "Parents and caregivers are trying different approaches that have gained significant popularity, but have not been proven to be effective," Castejon said. Dr. Gary S. Margules, Vice President of Research and Technology Transfer at NSU, echoes Dr. Castejon's optimism, calling the study an "outstanding example of the multidisciplinary approach to clinical research".
Immunotec President, Stuart MacMillan welcomes the announcement of the study. "Immunotec has a long history of collaboration with leading researchers and scientists. Dr. Castejon and her co-investigators at NSU's Mailman Segal Center of Human Development have vast experience in children with developmental disorders, specifically in the area of autism behaviours and we are proud to be working with them on this study."
Both the Centers for Disease Control (CDC) and Health Canada note that as many as 1 in 150 children worldwide are affected and the numbers are rising. Treatment for autism is usually centered on special schooling and behavioral therapy, and other conventional medical treatments.
"This joint collaborative clinical research initiative marks an important milestone for Immunotec in the field of autism; we are proud to partner with NSU in this study," said John Molson, Immunotec Vice-President, Research and Development.
About Immunotec Inc.
Immunotec is engaged primarily in the development and marketing of natural health products, dietary supplements, vitamins and personal care products which are distributed throughout Canada, the United States and Mexico through a sophisticated, seamless network marketing channel and around the globe through exclusive distributorship agreements.
The TSX Venture does not accept responsibility for the adequacy or accuracy of this release.
For further information:
John H. Molson
Vice-President, Research & Development
Immunotec Inc.
Tel: 450-510-4450
jmolson@immunotec.com
Autism Testimony
artist: Between
title: And the Waters Opened
label: Wergo
country: Germany
date: recording 1973, this reissue 1981
My favorite dessert (well, 2nd fav after creme brulee) ... The Hotel Sacher in Vienna and Salzburg claim to have invented it as do the Demel Cafe in both - we tried all 4 in an open label crossover comparison study ... all in the name of science! en.wikipedia.org/wiki/Sachertorte
Dear Partner,
The pouch is completed and has a little stowaway. I previously planned to put in some hand stitching. However, I'm loving the look of the linen as is, so I will be shipping it today.
Finish 8 in 2013
blogged: www.squawkthat.com/2013/01/pretty-little-bicycles-complet...
Nizam Institute of Medical Sciences (NIMS) has released a notification to fill Study Coordinator posts for the project entitled as ‘Trail No = 1160.186: A Prospective randomized, open label, blinded endpoint (PROBE) study to evaluate DUAL antithrombotic therapy with dabigatran etexilate (110 mg and 150 mg b.i.d) plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin (INR 2.0 – 3.0) plus clopidogrel or ticagrelor and aspirin in patients with nonvalvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting (RE-DUAL PCI)’ on contract basis. Other details are given below…
This month's Ohio Foothills challenge is coming up and I'm still not sure what type of "A" photos I will be entering.
The subject is "A is for ..." and I have been trying to think of many "A" things I could photograph. At any rate, this is a photo of the Aconite from last year since it has already come and gone for this year with the unseasonably warm weather.
Thankfully the care takers of the wildflower garden have labeled the plants, or I would have never known this was aconite. I also wouldn't have known about the little garden if it hadn't been for some of my Flickr friends.
Here's a Wikipedia link about winter aconite ...