First FDA de novo 510(k) Clearance for Marketing of a Product That Used Target Health’s Web-based, eSource-Enabled EDC System

 

We want to congratulate our friends and colleagues at Dignitana for FDA Clearance for Marketing of DIGNICAP®, the first time ever scalp cooling system that can reduce or eliminate chemotherapy-induced hair loss (alopecia) in women with breast cancer. This most important device will improve the quality of life of women undergoing cancer chemotherapy. The clearance has hit the main press including CBS News, ABC News, the Washington Post and US News and World Report.

 

Not only did Target Health manage the entire program including all FDA interactions, the clinical program used for its pivotal trial, the Target e*Clinical Trial Ecosystem™, which includes our patented web-based eSource-enabled EDC system where direct data entry of patient data occurs at the time of the clinic visit with no need for paper records. With one log-in by the clinical site into our EDC system, Target e*CTR® (eClinical Trial Record System) creates a .pdf and .XML file of the eCRF data prior to the data entering any EDC database, thus the creation of a contemporaneous independent investigator original record, under exclusive control of the clinical site. Target Health and 3 major medical centers were inspected with no FDA findings related to Target Health’s approach to the paperless clinical trial.

 

An NDA with 7 studies using the same paperless approach was submitted in November, and a study integrating EDC with the electronic medical record will begin in Q2 2016. Two pivotal trials in neurology are underway as well as phase 2 studies.

 

It is time for the industry to leave the paper world and adopt 21st Century paperless solutions. Please contact us to do a study. Once you do it, you won’t want to turn back as the rewards are so great.

 

ON TARGET is the newsletter of Target Health Inc., a NYC – based, full – service, contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services to the pharmaceutical and device industries, including the paperless clinical trial.

 

For more information about Target Health contact Warren Pearlson (212 – 681 – 2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

QUIZ

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Alopecia

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Alopecia, Wikipedia

 

Alopecia areata (AA), also known as spot baldness, is an autoimmune disease in which hair is lost from some or all areas of the body, usually from the 1) __ due to the body’s failure to recognize its own body cells and destroys its own tissue as if it were an invader. Often it causes bald spots on the scalp, especially in the first stages. In 1-2% of cases, the condition can spread to the entire scalp (alopecia totalis) or to the entire epidermis (alopecia universalis). Conditions resembling AA, and having a similar cause, occur also in other species.

 

Traditional chemotherapeutic agents are cytotoxic, that is to say they act by killing 2) ___ that divide rapidly, one of the main properties of most cancer cells. This means that chemotherapy also harms cells that divide rapidly under normal circumstances: cells in the bone marrow, digestive tract, and hair follicles. This results in the most common side-effects of 3) ___: myelosuppression (decreased production of blood cells, hence also immunosuppression), mucositis (inflammation of the lining of the digestive tract), and alopecia (hair loss). Hair usually starts to regrow a few weeks after the last treatment, and can sometimes change color, texture, thickness and style. Sometimes hair has a tendency to curl after regrowth, resulting in “chemo curls.“ Severe hair loss occurs most often with drugs such as doxorubicin, daunorubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide and etoposide. Permanent thinning or hair loss can result from some standard chemotherapy regimens.

 

Chemotherapy induced hair loss occurs by a non-androgenic mechanism, and can manifest as alopecia totalis, telogen effluvium, or less often alopecia areata. It is usually associated with systemic treatment due to the high mitotic rate of hair follicles, and more reversible than androgenic hair loss,although permanent cases can occur. Chemotherapy induces hair loss in women more often than 4) ___.

 

Scalp cooling offers a means of preventing both permanent and temporary hair loss. Fortunately, FDA has cleared for marketing the DIGNICAP®, the first time ever scalp cooling system that can reduce or eliminate chemotherapy-induced hair loss in women with breast cancer. This most important device will improve the quality of life of women undergoing cancer chemotherapy.

 

 

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DigniCap Cooling and Control Unit

 

Commonly, alopecia areata involves hair loss in one or more round spots on the scalp.

 

Hair may also be lost more diffusely over the whole scalp, in which case the condition is called diffuse alopecia areata.

Alopecia areata monolocularis describes baldness in only one spot. It may occur anywhere on the head.

Alopecia areata multilocularis refers to multiple areas of hair loss.

Ophiasis refers to hair loss in the shape of a wave at the circumference of the head.

The disease may be limited only to the beard, in which case it is called alopecia areata barbae.

If the patient loses all the hair on the scalp, the disease is then called alopecia totalis.

If all body hair, including pubic hair, is lost, the diagnosis then becomes alopecia universalis.

 

Alopecia areata totalis and universalis are rare.

 

 

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Alopecia areata, Wikipedia

 

Typical first symptoms of AA are small bald patches. The underlying skin is unscarred and looks superficially normal. These patches can take many shapes, but are most usually round or oval. AA most often affects the scalp and beard, but may occur on any hair-bearing part of the body. Different skin areas can exhibit hair 5) ___ and regrowth at the same time. The disease may also go into remission for a time, or may be permanent. It is common in children. In alopecia:

 

The area of hair loss may tingle or be painful.

The hair tends to fall out over a short period of time, with the loss commonly occurring more on one side of the scalp than the other.

Exclamation point hairs, narrower along the length of the strand closer to the base, producing a characteristic “exclamation point“ appearance, are often present.

 

When healthy 6) ___ is pulled out, at most a few should come out, and ripped hair should not be distributed evenly across the tugged portion of the scalp. In cases of AA, hair will tend to pull out more easily along the edge of the patch where the follicles are already being attacked by the body’s immune system than away from the patch where they are still healthy. In alopecia, nails may also have pitting or trachyonychia.

 

AA is usually diagnosed based on clinical features. Trichoscopy may aid differential diagnosis. In AA, trichoscopy shows regularly distributed “yellow dots“ (hyperkeratotic plugs), small exclamation-mark hairs, and “black dots“ (destroyed hairs in the hair follicle opening). A biopsy is rarely needed in AA. Histologic findings include peribulbar lymphocytic infiltrate (“swarm of bees“). Occasionally, in inactive AA, no inflammatory infiltrates are found. Other helpful findings include pigment incontinence in the hair bulb and follicular stelae, and a shift in the anagen-to-telogen ratio towards telogen. AA is not contagious. It occurs more frequently in people who have affected family members, suggesting 7) ___ may be a factor. Strong evidence of genetic association with increased risk for AA was found by studying families with two or more affected members. This study identified at least four regions in the genome that are likely to contain these genes. In addition, it is slightly more likely to occur in people who have relatives with autoimmune diseases.

 

AA is thought to be a systemic autoimmune disorder in which the body attacks its own anagen hair follicles and suppresses or stops hair 8) ___. For example, T cell lymphocytes cluster around affected follicles, causing inflammation and subsequent hair loss. A few cases of babies being born with congenital AA have been reported, but these are not cases of autoimmune disease, because an infant is born without a definitely developed immune system.

 

Endogenous retinoids metabolic defect is a key part of the pathogenesis of the AA. In 2010, a genome-wide association study was completed that identified 129 SNPs (single nucleotide polymorphisms) that were associated with AA. The genes that were identified include regulatory T cells, cytotoxic T lymphocyte-associated antigen 4, interleukin-2, interleukin-2 receptor A, Eos, cytomegalovirus UL16-binding protein, and the human leukocyte antigen region. The study also identified two genes, PRDX5 and STX17, that are expressed in the hair follicle. Iron may play a role in some cases of hair loss.

 

In cases of severe hair loss, limited success has been shown from treating AA with the corticosteroids clobetasol or fluocinonide, corticosteroid injections, or cream. The cream however is not as effective and it takes longer in order to see results. Steroid injections are commonly used in sites where the areas of hair loss on the head are small or especially where eyebrow hair has been lost. Whether they are effective is uncertain. Some other medications used are minoxidil, Elocon (mometasone) ointment (steroid cream), irritants (anthralin or topical coal tar), and topical immunotherapy cyclosporin, sometimes in different combinations. Topical corticosteroids frequently fail to enter the skin deeply enough to affect the hair bulbs, which are the treatment target, and small lesions typically also regrow spontaneously. Oral corticosteroids decrease the hair loss, but only for the period during which they are taken, and these drugs have serious adverse side effects.

 

Effects of AA are mainly 9) ___ (loss of self-image due to hair loss). Loss of hair also means the scalp burns more easily in the sun. Patients may also have aberrant nail formation because keratin forms both hair and nails. Hair may grow back and then fall out again later. This may not indicate a recurrence of the condition, however, but rather a natural cycle of growth-and-shedding from a relatively synchronized start; such a pattern will fade over time. Episodes of AA before puberty predispose one to chronic recurrence of the condition. Alopecia can certainly be the cause of psychological stress. Because hair loss can lead to significant appearance changes, individuals may experience social phobia, anxiety, and depression.

 

AA affects 0.1%-0.2% of humans, occurring in both males and females and occurs in people who are apparently healthy and have no skin disorder. Initial presentation most commonly occurs in the late teenage years, early childhood, or young adulthood, but can happen with people of all ages. Patients also tend to have a slightly higher incidence of conditions related to the 10) ___ system: asthma, allergies, atopic dermal ailments, and hypothyroidism.

 

A number of medications are under trial. Abatacept (Orencia), which is FDA-approved for the treatment of rheumatoid arthritis and triamcinolone acetonide, which although already used for the treatment of alopecia areata, has never been rigorously tested. These studies will also test the immunological changes associated with the drug.

 

ANSWERS: 1) scalp; 2) cells; 3) chemotherapy; 4) men; 5) loss; 6) hair; 7) heredity; 8) growth; 9) psychological; 10) immune

 

Sidney Farber MD, Father of Chemotherapy (1903-1973)

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Sidney Farber MD (1903-1973), the father of modern chemotherapy.

 

Chemotherapy (often abbreviated to chemo and sometimes CTX or CTx) is a category of cancer treatment that uses chemical substances, especially one or more anti-cancer drugs (chemotherapeutic agents) that are given as part of a standardized chemotherapy regimen. Chemotherapy may be given with a curative intent, or it may aim to prolong life or to reduce symptoms (palliative chemotherapy). Along with hormonal therapy and targeted therapy, it is one of the major categories of medical oncology (pharmacotherapy for cancer). These modalities are often used in conjunction with other cancer treatments, such as radiation therapy, surgery, and/or hyperthermia therapy. Chemotherapy is also used to treat other conditions, including AL amyloidosis, ankylosing spondylitis, multiple sclerosis, Crohn’s disease, psoriasis, psoriatic arthritis, systemic lupus erythematosus, rheumatoid arthritis, and scleroderma.

 

Traditional chemotherapeutic agents are cytotoxic, that is to say they act by killing cells that divide rapidly, one of the main properties of most cancer cells. This means that chemotherapy also harms cells that divide rapidly under normal circumstances: cells in the bone marrow, digestive tract, and hair follicles. This results in the most common side-effects of chemotherapy: myelosuppression (decreased production of blood cells, hence also immunosuppression), mucositis (inflammation of the lining of the digestive tract), and alopecia (hair loss).

 

Some newer anticancer drugs (for example, various monoclonal antibodies) are not indiscriminately cytotoxic, but rather target proteins that are abnormally expressed in cancer cells and that are essential for their growth. Such treatments are often referred to as targeted therapy (as distinct from classic chemotherapy) and are often used alongside traditional chemotherapeutic agents in antineoplastic treatment regimens. Chemotherapy may use one drug at a time (single-agent chemotherapy) or several drugs at once (combination chemotherapy or poly-chemotherapy). The combination of chemotherapy and radiotherapy is chemo-radiotherapy. Chemotherapy using drugs that convert to cytotoxic activity only upon light exposure is called photo-chemotherapy or photodynamic therapy.

 

Sidney Farber was an American pediatric pathologist. He is regarded as the father of modern chemotherapy, after whom the Dana-Farber Cancer Institute is named. Farber was born to Jewish parents in Buffalo, New York, the third oldest of 14 siblings. He was a graduate of SUNY Buffalo in 1923. In the mid-1920s, Jewish students were often refused admission to US medical schools, prompting him to go to Europe. As Farber was fluent in German, he undertook his first year of medical school at the Universities of Heidelberg and Freiburg in Germany. Having excelled in Germany, Farber entered Harvard Medical School as a second-year student and graduated in 1927. He was married to Norma C. Farber (formerly Holzman), a children’s author. He was the brother of the noted philosopher and SUNY Buffalo professor, Marvin Farber (1901-1980). As a teenager growing up in Buffalo, Sidney Farber witnessed firsthand the power and mystery of a cruel disease. When he was 15, the 1918 flu epidemic hit the city with force, and – despite precautions that included the closing of almost all public spaces – Buffalo eventually lost more than 2,500 citizens to influenza. As an adult, Farber would go on to dedicate the bulk of his career to battling perhaps the cruelest malady of all: cancer.

 

Shortly after graduating from Harvard Medical School, Farber started his pathology work at Children’s Hospital in Boston, regularly examining diseased tissue under a microscope. He was so troubled by the number of autopsies he was performing on young leukemia victims that after World War II he set his sights on finding a way to successfully treat pediatric leukemia patients. At the time, the most effective cancer treatment was surgery or radiation therapy, options which didn’t work for blood cancers like leukemia and lymphoma – so virtually all leukemia patients were dying of the disease, most within a few weeks of diagnosis. After graduate training in pathology at Peter Bent Brigham Hospital (the predecessor of Brigham and Women’s Hospital) in Boston, Massachusetts, where he was mentored by Kenneth Blackfan, Farber was appointed to a resident pathologist post at Children’s Hospital. He became an assistant in pathology at Harvard Medical School in 1928. In 1929, he became the first full-time pathologist to be based at Children’s Hospital. While working at Harvard Medical School on a research project funded by a grant from the American Cancer Society, he carried out both the preclinical and clinical evaluation of aminopterin (synthesized by Yellapragada Subbarow), a folate antagonist in childhood acute lymphoblastic leukemia. He showed for the first time that induction of clinical and hematological remission in this disease was achievable. These findings promoted Farber as the “father“ of the modern era of chemotherapy for neoplastic disease, having already been recognized for a decade as the “father“ of modern pediatric pathology.

 

It was well understood that leukemia was caused by immature white blood cells called blasts that arise in the bone marrow and crowd out healthy white blood cells, leaving patients unable to fight disease. Farber knew that folic acid, an essential vitamin, stimulated the growth and maturation of bone marrow; if he could somehow block folic acid and keep blasts from invading, he believed he could stop leukemia from becoming fatal. A new drug called aminopterin then being tested had this folic-acid blocking ability. In November 1947, Farber and colleague Louis Diamond, MD, gave aminopterin to 16 children seriously ill with leukemia. Ten of them went into temporary remission, the first time that a drug tested as an anticancer agent had proved effective against the disease. The results, reported in The New England Journal of Medicine in May 1948, were initially met with skepticism by many in the medical community. Over time, however, as Farber continued seeing positive results, more and more patient families began traveling to his Children’s Cancer Research Foundation clinic (today Dana-Farber Cancer Institute) for treatment.

 

Throughout the 1950s and ’60s, Farber continued to make advances in cancer research, notably the 1955 discovery that the antibiotic actinomycin D and radiation therapy could produce remission in Wilms’ tumor, a pediatric cancer of the kidneys. And it was during this period that he took his persuasive powers to a national stage. In 1952 Farber described a lipid storage disease that was named subsequently Farber disease. Farber began raising funds for cancer research with the Variety Club of New England in 1947. Together they created The Jimmy Fund, which was one of the first nationwide fundraising efforts to take full advantage of modern media, such as a broadcast of the radio show Truth or Consequences on 22 May 1948. The success of the Jimmy Fund led Farber to realize the importance of marketing in the scientific advancement of knowledge about diseases. According to Siddhartha Mukherjee, this realization set off a seismic transformation in Farber’s career that would far outstrip his transformation from a pathologist to a leukemia doctor. This second transformation – from a clinician into an advocate for cancer research – reflected the transformation of cancer itself. The emergence of cancer from its basement into the glaring light of publicity would change the trajectory of the story of cancer research in the 20th century. Beginning in the early 1950s, and continuing until his death in 1973, Farber became a star presenter at Congressional hearings on appropriations for cancer research. A compelling speaker, he was very successful in his efforts. With Mary Woodard Lasker, a longtime advocate of biomedical research, famed surgeon Michael E. DeBakey, Senator J. Lister Hill of Alabama and Congressman John E. Fogarty of Rhode Island, Farber led the drive for a massive expansion in federal spending for cancer research. Between 1957 and 1967, the annual budget of the National Cancer Institute, the government’s primary funder of cancer research, jumped from $48 million to $176 million.

 

The Dana-Farber Cancer Institute was originally named the Sidney Farber Cancer Center in honor of its founder in 1974. The long-term support of the Charles A. Dana Foundation was acknowledged by incorporating the Institute under its present name of the Dana-Farber Cancer Institute in 1983. Farber Hall, built in 1953 on the South Campus of the University at Buffalo, The State University of New York is named for him. By the time Farber spoke at the New York Academy of Medicine dais on January 12, 1951 (later broadcast as a WNYC Lecture to the Laity), cancer care had entered the era of chemotherapy thanks in large part to his work. Rather than focus on his own success, however, Farber spent his talk recounting the work of other physician-scientists that have lead up to this point – from the 19th century cellular work of Louis Pasteur and Sydney Ringer to the fortuitous discovery during World War II that a chemical related to mustard gas used in warfare (nitrogen mustard) could help thwart cancer. “Our discussion tonight is based upon research – most of it no older than 10 years, and as recent as this moment,“ he tells the crowd. “But it is only the breakthrough which has come in these last few years. What has been accomplished is based clearly upon contributions, made through the centuries and from a variety of disciplines, by individuals and institutions scattered over the world.“ Listening to the recording of Farber’s lecture, one is reminded how far cancer treatment has come since 1951. At the time, chemotherapy could temporarily slow or stop disease, but Farber notes how the vast majority of patients were still dying. “All anti-cancer effects produced by chemical compounds are temporary in man,“ he says, “with effects lasting from weeks to months – and only occasionally for periods as long as six years.“ Farber does offer hope, however, that with patience and hard work these results will continue to improve. “There will be no one V-Day when the cure of cancer will be achieved,“ he says. “Progress will be achieved in spurts, with great unevenness and irregularity. Anti-cancer compounds are being used in daily practice now, producing effects which would have aroused intense excitement a scant five or seven years ago.

 

“On March 30, 1973, at the age of 70, Sidney Farber passed away from cardiac arrest while working in his office. Today the progress continues, as do the achievements. Survivorship for many cancers is now often measured in decades rather than months, and Farber’s vision has become reality.

 

OBESITY

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Target Identified For Reducing Obesity-Related Inflammation

 

Obesity remains a substantial health problem for the nation, affecting more than a third of adults and 17% of children, according to the Centers for Disease Control and Prevention. Efforts to manage weight, however, can be hindered by the effects of obesity-related diseases. For example, an increase in obesity incidence has been associated with an increase in asthma incidence, but asthma makes it difficult for some to be physically active enough to lose weight.

 

According to an article published The Journal of Clinical Investigation (3 November 2015), a protein called SIRT3 has been identified that provides resistance to this inflammatory response and could potentially prevent or reverse obesity-associated diseases of inflammation. The study involved 19 healthy volunteers who fasted for a 24-hour period. By comparing results from cultured cells from these 19 subjects with a group of eight volunteers who did not fast, the study found evidence suggesting that SIRT3 can be activated not only through fasting, but also through the use of nicotinamide riboside, a vitamin B derivative. According to the authors, taken together, these early results point to a potential mechanism for addressing obesity-related inflammation, and thus diseases linked to this type of inflammation, such as asthma, Type 2 diabetes, rheumatoid arthritis, and atherosclerosis — conditions associated with a reduced quality of life and/or premature death.

 

The authors are conducting a follow-up study at the NIH Clinical Center to determine whether the vitamin B derivative nicotinamide riboside can specifically reduce bronchial inflammation in individuals with asthma. If the results of the study are promising, the authors will aim to conduct larger clinical trials to validate the findings and potentially inform treatment of obesity-related inflammation in asthma.

 

OBESITY

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Brain Stimulation Limits Calories Consumed in Adults with Obesity

 

According to an article published in Obesity (4 November 2015), it was found that non-invasive brain stimulation decreased calorie consumption and increased weight loss in adults who are obese. The findings suggest a possible intervention for obesity, when combined with healthy eating and exercise. The study evaluated a total of nine men and women with obesity who resided in a metabolic ward on two separate visits, each for eight days. On each visit, the participants ate a weight-maintaining diet for five days. Then for three days, they unknowingly received either active or sham (fake) transcranial direct current stimulation, or tDCS. Participants then ate and drank as much as they wanted from computerized vending machines.  Applied to the scalp, the active tDCS targeted the brain region controlling behavior and reward.

 

Results showed that the four people who got the sham stimulation during both visits consumed the same number of calories from the vending machines on each visit and did not lose weight. But the five people who got inactive stimulation on the first visit, and active tDCS at the brain target on the second visit, consumed an average of 700 fewer calories and lost an average of 0.8 pounds on the second visit.

 

Going forward, the authors will compare a group getting only active tDCS with a separate group getting only sham stimulation. According to the More study is needed to confirm the safety and effectiveness of tDCS for weight loss.

 

FDA Clears for Marketing of Cooling Cap to Reduce Hair Loss During Chemotherapy

 

Congratulation to our friends and colleagues at Dignitana. Target Health is very proud to be an integral part of this development program.

 

Hair loss is a common side effect of certain types of chemotherapy, commonly associated with the treatment of breast cancer. Hair may fall out entirely, gradually, in sections, or may become thin. Hair loss due to cancer treatment is usually temporary, but minimizing or relieving these kinds of side effects are considered important to overall treatment.

 

The FDA has cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy. The Dignitana DigniCap Cooling System is indicated to reduce the frequency and severity of alopecia during chemotherapy in breast cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used. It is a computer-controlled system that circulates cooled liquid to a head-worn cooling cap during chemotherapy treatment. The cooling cap is covered by a second cap made from neoprene, which holds the cooling cap in place and acts as an insulation cover to prevent loss of cooling.

 

The cooling action is intended to constrict blood vessels in the scalp, which, in theory, reduces the amount of chemotherapy that reaches cells in the hair follicles (hair roots). The cold also decreases the activity of the hair follicles, which slows down cell division and makes them less affected by chemotherapy. The combined actions are thought to reduce the effect chemotherapy has on the cells, which may reduce hair loss. DigniCap may not work with some chemotherapy regimens. Interested patients should talk with their doctors.

 

The efficacy of the cooling system was studied in 122 Stage I and Stage II women with breast cancer who were undergoing chemotherapy, using recognized chemotherapy regimens that have been associated with hair loss. The data from this study may also be applied to some Stage III and IV breast cancer patients because they may have a benefit-risk profile comparable to the patients enrolled in this study. The primary endpoint was a self-assessment of hair loss by the women using standardized photographs at one month (three-six weeks) after the last chemotherapy cycle. More than 66% of patients treated with the DigniCap reported losing less than half their hair.

 

Prevention of hair loss in these patients may be a significant benefit to their quality of life, and the risk of the chemotherapy drug missing an isolated grouping of the breast cancer cells in the scalp because of the cold cap is extremely rare. The most common side effects of the cooling system include cold-induced headaches and neck and shoulder discomfort, chills, and pain associated with wearing the cooling cap for an extended period of time.

 

The FDA reviewed data for DigniCap cooling system through the de novo classification process, a regulatory pathway for some low- to moderate-risk devices that are novel and not substantially equivalent to any legally marketed device.

 

The DigniCap Cooling System is manufactured by Dignitana Inc., in Lund, Sweden.

 

Red Cabbage Salad with Goat Cheese, Cilantro, Dates & Black Sesame Seeds

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This is a holiday salad to die for!  ©Joyce Hays, Target Health Inc.

 

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Up close and colorful.  ©Joyce Hays, Target Health Inc.

 

 

Ingredients

 

1.5 pounds (more or less) red cabbage, sliced very thin on a mandolin

2 heaping teaspoons fresh cilantro, very well chopped

3 Tablespoons your best extra virgin olive oil

2 Tablespoons, fresh lime juice

1 Pinch Salt, pinch black pepper and 1 pinch chili flakes

1 cup pitted dates, coarsely chopped or sliced

8 ounces goat cheese, crumbled

2 fresh garlic cloves, mashed into the dressing

4 teaspoons well-toasted black sesame seeds

 

 

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Just a few fresh ingredients yield something wonderful! ©Joyce Hays, Target Health Inc.

 

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Thinly slice the red cabbage on a mandolin.  As you know, extremely sharp, so be careful and don’t let your kids use it.  ©Joyce Hays, Target Health Inc.

 

Directions

 

In the salad bowl you’ll use for serving, add the olive oil, lime juice, pinch salt & black pepper, and with a fork, mash the two fresh garlic cloves.  Also, add the chili flakes and with the fork, stir the dressing together.

 

Next, add all the cabbage and toss it so that every single piece of cabbage is covered with the dressing.  Do this before you add anything else. It’s extremely important to do this now and not later.  If you don’t cover each piece of cabbage now with the oil, the drier pieces will clump together and won’t toss well later.

 

 

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Toasting all the black sesame seeds in my smallest pan. ©Joyce Hays, Target Health Inc. ©Joyce Hays, Target Health Inc.

 

 

Next, add half of the chopped dates, half of the crumbled cheese, half of the cilantro, half of the black sesame seeds and toss the dressed cabbage, slowly.

 

 

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Chopping the dates.  ©Joyce Hays, Target Health Inc.

 

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Chopping the cilantro.  ©Joyce Hays, Target Health Inc.

 

 

Finally, sprinkle the salad with the remaining dates, cheese, cilantro and sesame seeds and serve.

 

If you want this salad to be less crunchy, let it sit for a while and the cabbage will soften up a bit.

At Ralph Lauren’s new restaurant in midtown Manhattan, (East 50s, so, great for pre-theater dinner), after ordering another salad, I learned that if you add some baked and very hard bread crumbs, pulverized in a food processor, to toasted black sesame seeds, you will get a pleasing crunch along with the flavor, that’s very satisfying.  Might want to try that with this salad recipe.

 

If you bought a mandolin, but it’s turned into a dust gatherer, now you have an excellent reason to use it.  There are certain tools that you cannot do without in a 21st Century kitchen, a mandolin is one of them and a food processor is another; a small kitchen scale also comes to mind.

 

In this colorful salad, every one of the ingredients adds to the final extremely delicious flavor.  I’ve experimented a lot with this recipe and you cannot omit any of these ingredients.  I would even go so far as to say, don’t even substitute.  Wait until you’re able to include all of them.  If you don’t have black sesame seeds, don’t use white, order the black online.  I get mine from Whole Foods, Amazon and FreshDirect.  All the other ingredients are readily available in an urban location.

 

Considering, the extremely positive outcome, this is an easy recipe.  Just a matter of following a few clear steps.

 

 

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The colorful presentation adds to the flavor, as if the flavor needed help. ©Joyce Hays, Target Health Inc.

 

 

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For dessert, we had apple circles cooked in dark brown sugar and brandy. Still working on this; will share when ready.  ©Joyce Hays, Target Health Inc.

 

We had a fabulous weekend: Friday was our annual Holiday Party which we plan a year in advance, attended by our largest crowd ever. Performances by Adam Harris, (professional tenor) and Vadim Tantsyura (professional pianist) playing Chopin.  Both of these talented people are permanent employees of Target Health Inc.  Our company has always attracted extremely creative people and we will continue to include in our Holiday Party more employee and client performances.

 

On Saturday we went to one of our favorite MetOperas, Rigoletto. We have seen this new production before and love it. The MetOpera went out on a limb, allowing the new production to locate Rigoletto in 21st Century Las Vegas. Gross as this may sound to classical opera goers, it works beautifully. As for me, this is as close to a Las Vegas visit as I will ever have.  This opera has a very dark plot, and includes seedy locations for kidnapping, nudity and murder; in my opinion the idea for the Las Vegas venue was a stroke of artistic genius. The music in this opera is non-stop gorgeous; also non-stop is the action on stage as well as your own fast heartbeat.

 

I’m including my favorite Rigoletto piece from Act 3, the Quartet, in a hot link below. You will be treated to the most beautiful tenor voice that ever passed through this veil of tears, Luciano Pavarotti and another wonderful singer, no longer with us, coloratura soprano, Joan Sutherland. We left this gorgeous opera high on music and floating on a cloud.

 

We met new, highly talented friends (one a professional guitar player, who might perform at our next Holiday Party) for dinner and had a wonderful evening at Giovanni Venticinque on East 83rd Street. Time flew by because we were having such a good time.

 

(Verdi) Rigoletto, Act 3 Quartet, Bella Figlia Dell’Amore – Sutherland and Pavarotti

 

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We’re trying out a pricy Italian red, 2012 Tignanello, from Antinori Vineyards.  This Tuscan red packs a wallop that tingles your palate and satisfies with a long warm finish.  We’ll definitely buy more of this. ©Joyce Hays, Target Health Inc.

 

 

From Our Table to Yours!

 

Bon Appetit!