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August 12, 2019What's New
ON TARGET, the online publication of Target Health Inc., is taking August off, as usual, and resuming publication after Labor Day.
It has been a good year sharing the History of Medicine, Weekly Quiz, Medical Topics of Interest and especially, the universally popular, Target Healthy Eating. Our Fax version of the newsletter began in 1995 by Joyce Hays.
Now it's August, and time for well deserved, rest and relaxation. Enjoy Your Vacations to our 6,000 + loyal readers from all over the world. We'll resume after Labor Day.
For more information about Target Health, contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Also visit the Target Health Eating Website to see all of the fantastic recipes since 2012.
Joyce Hays, Founder and Editor in Chief of On Target
Dr. Jules T. Mitchel, Editor
July 22, 2019Target Healthy Eating
2 large ripe (not hard) beefsteak or heirloom tomatoes, sliced about 1/4 inch thick
2 Tablespoons extra virgin olive oil, for cooking
1/2 cup chickpea flour
1 cup Panko flakes mixed well with
1/2 cup Parmesan cheese, grated at home
2 large eggs beaten with a fork or whisk
1 pinch salt
1 pinch black pepper
1 pinch chili flakes
1 container (or cup) cr?me fraiche
1/2 cup Kraft mayo
3 fresh garlic cloves squeezed with garlic press
Zest of 1 lemon (no juice)
2 Tablespoons almond milk, if needed to thin sauce
1. Wash, pat dry your tomatoes. Then cut, with a sharp knife, 1/4 inch slices.
2. Grate your own parmesan cheese.
3. Arrange 3 medium bowls as follows: chickpea flour in first bowl. Egg mixture in 2nd bowl. Panko/parmesan mixture in 3rd bowl. You will take each tomato slice and cover with flour. Then dip on both sides in the egg mixture. Finally, cover both sides in the third bowl with Panko mixture.
4. Pour 2 Tablespoons extra virgin olive oil into skillet, and when tomato slices have been dipped and covered well with contents of the 3 bowls, turn up medium heat and start to fry your tomatoes. First one side, then flip to the other side. You want them to become a lovely golden color.
5. When done, let drain on paper towels
6. Make your sauce, if you haven't, before cooking the tomatoes.
Jules gives my recipe a 5+. Hope you will too. ©Joyce Hays, Target Health Inc.
From Our Table to Yours
Have a Great Week Everyone!
July 22, 2019Regulatory
The FA has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). Recarbrio is a three-drug combination injection containing imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor.
The determination of efficacy of Recarbrio was supported in part by the findings of the efficacy and safety of imipenem-cilastatin for the treatment of cUTI and cIAI. The contribution of relebactam to Recarbrio was assessed based on data from in vitro studies and animal models of infection. The safety of Recarbrio, administered via injection, was studied in two trials, one each for cUTI and cIAI. The cUTI trial included 298 adult patients with 99 treated with the proposed dose of Recarbrio. The cIAI trial included 347 patients with 117 treated with the proposed dose of Recarbrio.
The most common adverse reactions observed in patients treated with Recarbrio included nausea, diarrhea, headache, fever and increased liver enzymes. Recarbrio should not be used in patients taking ganciclovir unless the benefits outweigh the risks as generalized seizures have been reported. Patients should also avoid using Recarbrio when taking valproic acid or divalproex sodium, drugs used to manage seizures, as a reduction in valproic acid level may lead to seizures.
Recarbrio received FDA's Qualified Infectious Disease Product (QIDP) designation. The QIDP designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of QIDP designation, Recarbrio was granted Priority Review under which the FDA's goal is to take action on an application within an expedited time frame.
The FDA granted the approval of Recarbrio for the treatment to Merck & Co., Inc.
July 22, 2019Neurology
According to an article published in Nature Neuroscience (10 June 2019), results of study involving primates suggest that speech and music may have shaped the human brain's hearing circuits. In the eternal search for understanding what makes us human, the authors found that our brains are more sensitive to pitch, the harmonic sounds we hear when listening to music, than our evolutionary relative the macaque monkey. The study highlights the promise of Sound Health, a joint project between the NIH and the John F. Kennedy Center for the Performing Arts that aims to understand the role of music in health.
The study started with a friendly bet between Dr. Conway and Sam Norman-Haignere, Ph.D., a post-doctoral fellow at Columbia University's Zuckerman Institute for Mind, Brain, and Behavior and the first author of the paper. At the time, both were working at the Massachusetts Institute of Technology (MIT). Dr. Conway's team had been searching for differences between how human and monkey brains control vision only to discover that there are very few. Their brain mapping studies suggested that humans and monkeys see the world in very similar ways. But then, Dr. Conway heard about some studies on hearing being done by Dr. Norman-Haignere, who, at the time, was a post-doctoral fellow in the laboratory of Josh H. McDermott, Ph.D., associate professor at MIT.
That is when they got the idea to compare humans with monkeys. Based on his studies, Dr. Conway bet that they would see no differences. To test this, the authors played a series of harmonic sounds, or tones, to healthy volunteers and monkeys. Meanwhile, functional magnetic resonance imaging (fMRI) was used to monitor brain activity in response to the sounds. The authors also monitored brain activity in response to sounds of toneless noises that were designed to match the frequency levels of each tone played. Initially, the scans looked similar and confirmed previous studies. Maps of the auditory cortex of human and monkey brains had similar hot spots of activity regardless of whether the sounds contained tones. However, when the authors looked more closely at the data, they found evidence suggesting the human brain was highly sensitive to tones. The human auditory cortex was much more responsive than the monkey cortex when they looked at the relative activity between tones and equivalent noisy sounds. Results showed that human and monkey brains had very similar responses to sounds in any given frequency range, and that when tonal structure was added to the sounds, that some of these same regions of the human brain became more responsive. The authors added that these results suggest the macaque monkey may experience music and other sounds differently, and that the macaque's experience of the visual world is probably very similar to humans. Further experiments supported these results. Slightly raising the volume of the tonal sounds had little effect on the tone sensitivity observed in the brains of two monkeys.
Finally, the authors saw similar results when they used sounds that contained more natural harmonies for monkeys by playing recordings of macaque calls. Brain scans showed that the human auditory cortex was much more responsive than the monkey cortex when they compared relative activity between the calls and toneless, noisy versions of the calls.
July 22, 2019Neonatology
Previous studies have linked elevated levels of certain kinds of air pollutants to higher risks for gestational diabetes and preeclampsia, a blood pressure disorder of pregnancy. Earlier research also has shown that infants born to women exposed to high levels of air pollutants are at risk for preterm birth, of being small for their gestational age at birth and of growing more slowly than normal in the uterus. As a result, given these associations, a study was performed to determine whether prenatal exposure to air pollution might increase the chance for NICU admission.
According to an article published in Annals of Epidemiology (19 July 2019), infants born to women exposed to high levels of air pollution in the week before delivery are more likely to be admitted to a newborn intensive care unit (NICU). Results showed that depending on the type of pollution, chances for NICU admission increased from about 4% to as much as 147%, compared to infants whose mothers did not encounter high levels of air pollution during the week before delivery.
Researchers analyzed data from the Consortium on Safe Labor, which compiled information on more than 223,000 births at 12 clinical sites in the United States from 2002 to 2008. They linked records from more than 27,000 NICU admissions to data modified from the Community Multiscale Air Quality Modeling System, which estimates environmental pollution concentrations in the United States. Researchers matched air quality data in the area where each birth occurred to the week before delivery, the day before delivery and the day of delivery. They then compared these time intervals to air quality data two weeks before delivery and two weeks after delivery to identify risk of NICU admission associated with pollution levels.
The authors also examined the odds of NICU admission associated with high concentrations of particulate matter (pollution particles) less than 2.5 microns in diameter (PM2.5). These types of particles originate from various sources, among them diesel and gasoline engines, power plants, landfills, sewage facilities and industrial processes. Exposure to high concentrations of organic compounds in the air was associated with a 147% increase in risk of NICU admission. Elemental carbon and ammonium ions presented similar increases in risk (38% and 39%, respectively), while exposure to nitrate compounds was associated with a 16% higher risk of NICU admission. Chances of NICU admission also increased significantly with exposures to traffic-related pollutants on the day before and the day of delivery, compared to the week before delivery: 4% and 3%, respectively, for an approximately 300 parts per million (ppm) increase in carbon monoxide; 13% and 9% for an approximately 26 ppm increase in nitrogen dioxide; and 6% and 3% an approximately 3 ppm increase in sulfur dioxide.
The authors do not know why exposure to air pollution might increase the chances for NICU admission. They theorize, however, that pollutants increase inflammation, leading to impaired blood vessel growth, particularly in the placenta, which supplies oxygen and nutrients to the developing fetus. The authors also noted that rising NICU admission rates present financial challenges for families and society, as average daily NICU costs may reach or exceed $3,000. If their results are confirmed by other studies, limiting pregnant women's exposure to high levels of air pollutants may provide a way to reduce NICU admissions.
July 22, 2019History of Medicine
Metrodora, who was a Greek physician sometime around 200-400 CE, was the author of the oldest medical book known to be written by a woman, On the Diseases and Cures of Women. The book was referenced frequently by other medical writers during the ancient Greek and Roman times, and was used in Medieval Europe as well. Metrodora is known to be the first female medical writer and was influenced by the works of Hippocrates, a major Greek physician (460-370 BC).Her medical treatise covers many areas of medicine, including gynecology, but not obstetrics. It was widely referenced by other medical writers in ancient Greece and Rome, and was also translated and published in Medieval Europe. Nothing is known of Metrodora's identity beyond her name. However, several women physicians are known to have existed in the ancient Greco-Roman world, and she is generally regarded as the first female medical writer.
Metrodora's book, On the Diseases and Cures of Women survives in two volumes, containing 63 chapters. Metrodora's approach was heavily influenced by the work of Hippocrates and the Hippocratic Corpus, as were most physicians of her era, for example, she shared Hippocrates' theories concerning hysteria. Metrodora was decisive about controversial topics involving symptomology and etiology; inflammation of the uterus is one example. She made her own unique contributions to advancing medical understanding of theory and etiology. Although female physicians were active in gynecology and obstetrics in ancient Greece and Rome, it was rare that women physicians practiced in other areas of medicine. Childbirth and obstetrics in antiquity were viewed as acceptable areas of medical practice for women who were able to gain medical training as physicians, in large part because of the ancient tradition of midwifery and its association with women trained by other women. Metrodora writes on many areas of medicine in On the Diseases and Cures of Women, including all aspects of gynecology, but obstetrics is not dealt with in the volumes that are extant. Surgery was not typically practiced in ancient Greece or Rome, and is also not covered in her treatise. This is in contrast with the writing of another female physician, Aspasia the Physician, who covered gynecologic surgery including abortion. Aspasia's work was also often referenced by other physician writers, including Aetius and Soranus. Metrodora did not deal with obstetrics, the traditional domain of midwifery, instead focusing on pathology, the same approach being used by male physicians influenced by Hippocrates. She differed from many other male medical writers of her era in analyzing and referring to the writings of Hippocrates directly, rather than using the proliferation of secondary sources in the intervening centuries as the substance of her work.
The first Latin translations of On the Diseases and Cures of Women appeared between the 3rd and 5th centuries. The oldest known manuscript of Metrodora's work is located in Florence, Italy. Metrodora's work was referenced by other physician writers, and also republished in extracts. The scholarly texts of ancient Greece and Rome were part of the foundation of Western research during the Middle Ages in Europe. Metrodora's work was circulated during this period as well. Her bibliographic references include a Berenice called Cleopatra or mono marciglia, which caused some Medieval publishers to incorrectly attribute her work to the famous Cleopatra VII of Egypt, and it was under the name of Cleopatra that On the Diseases and Cures of Women was published by Caspar Wolf in 1566, and then by Israel Spach in 1597. Metrodora was evidently greatly experienced with clinical practice. Her works reference examinations done both digitally (that is, by hand alone) and using a speculum, and show a detailed familiarity with physiology. She made contributions by formulating classifications of vaginal discharges, and proposed theories on etiology such as the possibility of rectal parasitic infections causing vaginal discharges. Her contributions in these areas appear to have been her original research and theory. There are also many medicine compounds provided in her treatise that have not been found elsewhere. Her work also appears to include the first known alphabetized medical encyclopedia, using alphabetic headings for ease of reference, although it exists in an incomplete manuscript that ends with epsilon.
In ancient Egypt, midwifery was a recognized female occupation, as attested by the Ebers Papyrus which dates from 1900 to 1550 BCE. Five columns of this papyrus deal with obstetrics and gynecology, especially concerning the acceleration of parturition (the action or process of giving birth to offspring) and the birth prognosis of the newborn. The Westcar papyrus, dated to 1700 BCE, includes instructions for calculating the expected date of confinement and describes different styles of birth chairs. Bas reliefs in the royal birth rooms at Luxor and other temples also attest to the heavy presence of midwifery in this culture.
Midwifery in Greco-Roman antiquity covered a wide range of women, including old women who continued folk medical traditions in the villages of the Roman Empire, trained midwives who garnered their knowledge from a variety of sources, and highly trained women who were considered physicians. However, there were certain characteristics desired in a good midwife, as described by the physician Soranus of Ephesus in the 2nd century. He states in his work, Gynecology, that a suitable person will be literate, with her wits about her, possessed of a good memory, loving work, respectable and generally not unduly handicapped as regards her senses [i.e., sight, smell, hearing], sound of limb, robust, and, according to some people, endowed with long slim fingers and short nails at her fingertips. Soranus also recommends that the midwife be of sympathetic disposition (although she need not have borne a child herself) and that she keep her hands soft for the comfort of both mother and child. Pliny, another physician from this time, valued nobility and a quiet and inconspicuous disposition in a midwife. There appears to have been three grades of midwives present: The first was technically proficient; the second may have read some of the texts on obstetrics and gynecology; but the third was highly trained and reasonably considered a medical specialist with a concentration in midwifery.
Midwives were known by many different titles in antiquity, ranging from iatrine (Gr. nurse), maia (Gr., midwife), obstetrix (Lat., obstetrician), and medica (Lat., doctor). It appears as though midwifery was treated differently in the Eastern end of the Mediterranean basin as opposed to the West. In the East, some women advanced beyond the profession of midwife (maia) to that of gynecologist (iatros gynaikeios, translated as women's doctor), for which formal training was required. Also, there were some gynecological tracts circulating in the medical and educated circles of the East that were written by women with Greek names, although these women were few in number. Based on these facts, it would appear that midwifery in the East was a respectable profession in which respectable women could earn their livelihoods and enough esteem to publish works read and cited by male physicians. In fact, a number of Roman legal provisions strongly suggest that midwives enjoyed status and remuneration comparable to that of male doctors. One example of such a midwife is Salpe of Lemnos, who wrote on women's diseases and was mentioned several times in the works of Pliny. However, in the Roman West, information about practicing midwives comes mainly from funerary epitaphs. Two hypotheses are suggested by looking at a small sample of these epitaphs. The first is the midwifery was not a profession to which freeborn women of families that had enjoyed free status of several generations were attracted; therefore, it seems that most midwives were of servile origin. Second, since most of these funeral epitaphs describe the women as freed, it can be proposed that midwives were generally valued enough, and earned enough income, to be able to gain their freedom. It is not known from these epitaphs how certain slave women were selected for training as midwives. Slave girls may have been apprenticed, and it is most likely that mothers taught their daughters.
The actual duties of the midwife in antiquity consisted mainly of assisting in the birthing process, although they may also have helped with other medical problems relating to women when needed. Often, the midwife would call for the assistance of a physician when a more difficult birth was anticipated. In many cases the midwife brought along two or three assistants. In antiquity, it was believed by both midwives and physicians that a normal delivery was made easier when a woman sat upright. Therefore, during parturition, midwives brought a stool to the home where the delivery was to take place. In the seat of the birthstool was a crescent-shaped hole through which the baby would be delivered. The birthstool or chair often had armrests for the mother to grasp during the delivery. Most birthstools or chairs had backs which the patient could press against, but Soranus suggests that in some cases the chairs were backless and an assistant would stand behind the mother to support her. The midwife sat facing the mother, encouraging and supporting her through the birth, perhaps offering instruction on breathing and pushing, sometimes massaging her vaginal opening, and supporting her perineum during the delivery of the baby. The assistants may have helped by pushing downwards on the top of the mother's abdomen.
Finally, the midwife received the infant, placed it in pieces of cloth, cut the umbilical cord, and cleansed the baby. The child was sprinkled with fine and powdery salt, or natron or aphronitre to soak up the birth residue, rinsed, and then powdered and rinsed again. Next, the midwives cleared away any and all mucus present from the nose, mouth, ears, or anus. Midwives were encouraged by Soranus to put olive oil in the baby's eyes to cleanse away any birth residue, and to place a piece of wool soaked in olive oil over the umbilical cord. After the delivery, the midwife made the initial call on whether or not an infant was healthy and fit to rear. She inspected the newborn for congenital deformities and testing its cry to hear whether or not it was robust and hearty. Ultimately, midwives made a determination about the chances for an infant's survival and likely recommended that a newborn with any severe deformities be exposed.
The services of a midwife were not inexpensive; this fact that suggests poorer women who could not afford the services of a professional midwife often had to make do with female relatives. Many wealthier families had their own midwives. However, the vast majority of women in the Greco-Roman world very likely received their maternity care from hired midwives. They may have been highly trained or possessed only a rudimentary knowledge of obstetrics. Also, many families had a choice of whether or not they wanted to employ a midwife who practiced the traditional folk medicine or the newer methods of professional parturition. Like a lot of other factors in antiquity, quality gynecological care often depended heavily on the socioeconomic status of the patient. From the 18th century on, a conflict between surgeons and midwives arose, as medical men began to assert that their modern scientific techniques were better for mothers and infants than the folk medicine practiced by midwives. As doctors and medical associations pushed for a legal monopoly on obstetrical care, midwifery became outlawed or heavily regulated throughout the United States and Canada. In Northern Europe and Russia, the situation was a little easier - in Imperial Russia at the Duchy of Estonia, Professor Christian Friedrich Deutsch established a midwifery school for women at the University of Dorpat in 1811, which existed until World War I. It was the predecessor for the Tartu Health Care College. Training lasted for 7 months and in the end a certificate for practice was issued to the female students. Despite accusations that midwives were incompetent and ignorant, some argued that poorly trained surgeons were far more of a danger to pregnant women. The argument that surgeons were more dangerous than midwives lasted until the study of bacteriology became popular in the early 1900s. Women began to feel safer in the setting of the hospitals with the amount of aid and the ease of birth that they experienced with doctors. Physicians trained in the new century found a great contrast between their hospital and obstetrics practice in women's homes where they could not maintain sterile conditions or have trained help. German social scientists Gunnar Heinsohn and Otto Steiger theorize that midwifery became a target of persecution and repression by public authorities because midwives possessed highly specialized knowledge and skills regarding not only assisting birth, but also contraception and abortion.
By the late 20th century, midwives were recognized as highly trained and specialized professionals in obstetrics. However, at the beginning of the 21st century, the medical perception of pregnancy and childbirth as potentially pathological and dangerous still dominates Western culture. Midwives who work in hospital settings also have been influenced by this view, although by and large they are trained to view birth as a normal and healthy process. While midwives play a much larger role in the care of pregnant mothers in Europe than in America, the medicalized model of birth still has influence in those countries, even though the World Health Organization recommends a natural, normal and humanized birth. The midwifery model of pregnancy and childbirth as a normal and healthy process plays a much larger role in Sweden and the Netherlands than the rest of Europe, however. Swedish midwives stand out, since they administer 80 percent of prenatal care and more than 80 percent of family planning services in Sweden. Midwives in Sweden attend all normal births in public hospitals and Swedish women tend to have fewer interventions in hospitals than American women. The Dutch infant mortality rate in 1992 was the tenth-lowest rate in the world, at 6.3 deaths per thousand births, while the United States ranked twenty-second. Midwives in the Netherlands and Sweden owe a great deal of their success to supportive government policies. Source: Wikipedia
July 22, 2019Quiz
Midwifery is the health science and health profession that deals with pregnancy, childbirth, and the postpartum period (including care of the newborn), in addition to the sexual and reproductive health of 1) ___ throughout their lives. In many countries, midwifery is a medical profession (special for its independent and direct specialized education; should not be confused with the medical specialty, which depends on a previous general training). A professional in midwifery is known as a midwife.
Educational Requirements for Midwives
Certified Nurse Midwife (CNM)
A certified nurse midwife (CNM) has obtained advanced educational credentials in both midwifery and nursing. In addition, midwives have successfully completed the certification program required by the American Midwifery Certification Board (AMCB). Each state sets its specific requirements to which a midwife must adhere to become certified, including the training that qualifies as an acceptable post-secondary degree. A certified nurse midwife is a registered nurse (RN) who has completed coursework approved by the Accreditation Commission for Midwifery Education (ACME). Before working as a certified nurse midwife, RNs must pass a national board exam administered by the ACMB, which also requires licensed midwives to complete and pass a recertification exam once every five years.
Certified Midwife (CM)
The certified midwife credential indicates that the individual graduated from college with a non-nursing degree. However, he or she must meet the requirements established by the AMCB in addition to state-of-residency requirements. The certified midwife also must complete a degree program accredited by the ACME and pass the nationwide AMCB board exam. Typically, a certified midwife holds a bachelor's degree in a health-related field, but he or she is not a registered nurse. Individuals with either the certified midwife or certified nurse midwife title have the same basic responsibilities, although some patients may prefer to work with a certified nurse midwife because of the RN credential.
Midwifery Licensure Requirements
A benefit of earning the certified nurse midwife credential is that these professionals not only can offer a wider range of services, but they are also capable of performing more complex treatments. Additionally, they may be more qualified from a legal standpoint. Since it's in the patient's best interest to work with a highly educated and certified nurse midwife, many states now require midwives to have a graduate degree in nursing to become eligible for licensure. In 2012, the ACME required every program it certifies to offer either a Master of Science in a general health care field, a Master of Science in Nursing, or a Doctor of Nursing Practice degree. A certified nurse midwife can practice in all 50 states as well as in the District of Columbia. The role of a nurse midwife is legally recognized in Delaware, Missouri, New Jersey, and New York. Missouri is one of the few states that does not require licensure for certified midwives. Since state laws and guidelines vary greatly, students must understand and fulfill their state requirements when obtaining licensure and establishing a practice.
A 2013 Cochrane review (English speaking countries) concluded that most women should be offered midwifery-led continuity models of care and women should be encouraged to ask for this option although caution should be exercised in applying this advice to women with substantial medical or obstetric complications. Midwifery is best used by 2) ___ women giving birth. The review found that midwifery-led care was associated with a reduction in the use of epidurals, with fewer episiotomies or instrumental births, and a decreased risk of losing the baby before 24 weeks' gestation. However, midwifery-led care was also associated with a longer mean length of labor as measured in hours.
Trimester means three months. A normal pregnancy lasts about nine months and has 3) ___ trimesters. First trimester screening varies by country. Women are typically offered a Pap smear and urine analysis (UA), and blood tests including a complete blood count (CBC), blood typing (including Rh screen), syphilis, hepatitis, HIV, and rubella testing. Additionally, women may have chlamydia testing via a urine sample, and women considered at high risk are screened for Sickle Cell disease and Thalassemia. Women must consent to all tests before they are carried out. The woman's blood pressure, height and weight are measured. Her past pregnancies and family, social, and medical history are discussed. Women may have an ultrasound scan during the first trimester which may be used to help find the estimated due date. Some women may have genetic testing, such as screening for Down 4) ___. Diet, exercise, and discomforts such as morning sickness are discussed.
The mother visits the midwife monthly or more often during the second trimester. The mother's partner and/or the labor coach may accompany her. The midwife will discuss pregnancy issues such as fatigue, heartburn, varicose veins, and other common problems such as back pain. Blood pressure and weight are monitored and the midwife measures the mother's abdomen to see if the baby is growing as expected. Lab tests such as a UA, CBC, and glucose tolerance test are done if the midwife feels they are necessary.
In the third trimester the midwife will see the mother every two weeks until week 36 and every week after that. Weight, blood pressure, and abdominal measurements will continue to be done. Lab tests such as a CDC and UA may be done with additional testing done for at-risk pregnancies. The midwife palpates the woman's abdomen to establish the presentation and position of the 5) ___ and later, the engagement. A pelvic exam may be done to see if the mother's cervix is dilating. The midwife and the mother discuss birthing options and write a birth care plan. Midwives are qualified to assist with a normal vaginal delivery while more complicated deliveries are handled by a health care provider who has had further training. Childbirth is divided into four stages.
First stage of labor: The first stage of labor involves the opening of the cervix. In the early parts of this stage the cervix will become soft and thin thus preparing for the delivery of the baby. The first stage of labor is complete when the 6) ___ has dilated the full 10cm. During the first stage of labor the mother begins to feel strong and regular contractions that come every 5 to 20 minutes and last 30 to 60 seconds. Contractions gradually become stronger, more frequent, and longer lasting.
Second stage of labor: During the second stage the baby begins to move down the birth canal. As the baby moves to the opening of the vagina it crowns, meaning the top of the head can be seen at the vaginal entrance. At one time an episiotomy, (an incision in the tissue at the opening of the vagina) was done routinely because it was believed that it prevented excessive tearing and healed more readily than a natural tear. However, more recent research shows that a surgical incision may be more extensive than a natural tear, and is more likely to contribute to later incontinence and pain during sex than a natural tear would have. The midwife assists the baby as needed and when fully emerged, cuts the umbilical cord. If desired, the baby's father may cut the cord. In the past the cord was cut shortly after birth, but there is growing evidence that delayed 7) ___-cutting may benefit the infant.
Third stage of labor: The third stage of labor is where the mother must deliver the placenta. In order for the mother to do this, she may need to push. Just like the contractions in the first stage of labor, there may be one or two of these. The midwife may assist the mother in delivering the placenta by gently pulling on the umbilical cord.
Fourth stage of labor: The fourth stage of labor is the period beginning immediately after the birth and extending for about six weeks. The World Health Organization describes this period as the most critical and yet the most neglected phase in the lives of mothers and babies. Until recently babies were routinely removed from their mothers following birth, however beginning around 2000, some authorities began to suggest that early skin-to-skin contact (placing the naked baby on the mother's chest) is of benefit to both mother and infant. As of 2014, early skin-to-skin contact is endorsed by all major organizations that are responsible for the well-being of 8) ___. Thus, to help establish bonding and successful breastfeeding, the midwife carries out immediate mother and infant assessments as the infant lies on the mother's chest. Then she removes the infant for further observations only after the first breastfeed.
Following the birth: if the mother had an episiotomy or a tearing of the perineum, it is stitched. The midwife does regular assessments for uterine contraction, fundal height, and vaginal bleeding. Throughout labor and delivery the mother's vital signs (temperature, blood pressure, and pulse) are closely monitored and her fluid intake and output are measured. The midwife also monitors the baby's pulse rate, palpates the mother's abdomen to monitor the baby's position, and does vaginal checks as needed. If the birth deviates from the norm at any stage, the midwife requests assist from a more highly trained health care provider.
Until the last century most women have used both the upright position and alternative positions to give birth. The lithotomy position was not used until the advent of forceps in the seventeenth century and since then childbirth has progressively moved from a woman supported experience in the home to a medical intervention within the hospital. There are significant advantages to assuming an upright position in labor and birth, such as stronger and more efficient uterine contractions aiding cervical dilatation, increased pelvic inlet and outlet diameters and improved uterine contractility. Upright positions in the second stage include sitting, squatting, kneeling, and being on hands and knees.
For women who have a hospital birth, the minimum hospital stay is six hours. Women who leave before this do so against medical advice. Women may choose when to leave the hospital. Full postnatal assessments are conducted daily in the hospital or more frequently if needed. A postnatal assessment may include: the midwife's observations, general well-being, breasts (either a discussion and assistance with breastfeeding or a discussion about lactation suppression), abdominal palpation (if she has not had a caesarean section) to check for involution of the uterus, or a check of her caesarean wound (the dressing doesn't need to be removed for this), a check of her perineum, particularly if she tore or had stitches, reviewing her lochia, ensuring she has passed urine and had her bowels open and checking for signs and symptoms of a DVT. The baby is also checked for jaundice, signs of adequate feeding, or other concerns. The baby has a nursery exam between six and seventy two hours of birth to check for conditions such as heart defects, hip problems, or eye problems. In the community, the community midwife sees the woman at least until day ten. This does not mean she sees the woman and baby daily, but she cannot discharge them from her care until day ten at the earliest. Postnatal checks include neonatal screening test (NST, or heel prick test) around day five. The baby is weighed and the midwife plans visits according to the health and needs of mother and baby. They are discharged to the care of the health visitor.
At birth, the baby receives an Apgar score at, at the least, one minute and five minutes of age. This is a score out of 10 that assesses the baby on five different areas - each worth between 0 and 2 points. These areas are: color, respiratory effort, tone, heart rate, and response to stimuli. The midwife checks the baby for any obvious problems, weighs the baby, and measure head circumference. The midwife ensures the cord has been clamped securely and the baby has the appropriate name tags on (if in hospital). Babies lengths are not routinely measured. The midwife performs these checks as close to the mother as possible and returns the baby to the mother quickly. 9) ___-to-skin is encouraged, as this regulates the baby's heart rate, breathing, oxygen saturation, and temperature?and promotes bonding and breastfeeding. In some countries, such as Chile, the midwife is the professional who can direct neonatal intensive care units. This is an advantage for these professionals, because they can use the knowledge in perinatology to bring a high quality care of the newborn, with medical or surgical conditions. Midwifery-led continuity of care is where one or more midwives have the primary responsibility for the continuity of care for childbearing women, with a multidisciplinary network of consultation and referral with other health care providers. This is different from medical-led care where an obstetrician or family physician is primarily responsible. In shared-care models, responsibility may be shared between a midwife, an obstetrician and/or a family physician. The midwife is part of very intimate situations with the mother. For this reason, many women as well as physicians, say that the most important thing to look for in a midwife is a level of comfort and trust, since the woman and even her husband, will go to them with personal questions and/or problems.
Licensed midwifery-led care has effects including the following:
At Mount Sinai Hospital in New York City's upper east side, (Manhattan), certified nurse-midwives and certified midwives provide expectant mothers with sensitive care before, during, and after the birthing process. They are typically by your side from the moment you enter the 10) ___ and provide prenatal care, manage labor and delivery, and offer a wide range of well-woman gynecologic services, including routine physical exams and all methods of family planning. Midwives work with consulting physicians to offer integrated care that meets all of the patient's medical needs. After birth, midwives offer physical assessment and advice and provide support on breastfeeding, baby care, contraception, and other issues. In addition, midwives will continue to see new mothers throughout a six-week postpartum period. Mount Sinai Health System has a number of midwives on faculty at Mount Sinai West and has connections to several excellent, well-established groups of independent midwives. Most of these highly trained, certified midwives work in collaboration with a physician. Source: Wikipedia
ANSWERS: 1) women; 2) healthy; 3) three; 4) syndrome; 5) fetus; 6) cervix; 7) cord; 8) infants; 9) Skin; 10) hospital
July 22, 2019What's New
Target Health Inc., established in 1993, has been inspected twice by FDA as part of pre-approval inspections. The first inspection was for a drug and the second inspection for a De Novo 501(k) device. In both cases An FDA 483, Inspectional Observations, was not issued to management during these inspections.
In one of the inspections FDA completed a 4 day, unannounced inspection of Target Health for an NDA under review. For this program Target Health performed all of the clinical and regulatory strategic planning, toxicology, regulatory, study designs, monitoring of the clinical trials (Phase 1, 2 and 3), data management (using Target e*CRF EDC system), statistics, medical writing and preparation of the NDA. There were 2 pivotal trials and a rescue protocol for treatment failures. The FDA audit also included a detailed review of Target e*CRF and data management. The outcome of the inspection is summarized below:
From our evaluation of the establishment inspection report and the documents submitted with that report, we conclude that you adhered to the applicable statutory requirements and FDA regulations governing the monitoring practices of clinical investigations and the protection of human subjects.
For more information about Target Health, contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Also visit the Target Health Eating Website to see all of the fantastic recipes since 2012.
Joyce Hays, Founder and Editor in Chief of On Target
Dr. Jules T. Mitchel, Editor
July 15, 2019Target Healthy Eating
Ingredients for Eggplant Balls
2 Tablespoons extra-virgin olive oil, divided
1 large or 2 medium eggplants, peeled and cubed
1 shallot, finely minced
1 cup fresh mozzarella shredded
1 cup baby spinach, cut in ribbons
1/2 cup jicama, chopped (you can buy it chopped)
3 fresh garlic cloves, minced
Pinch black pepper
Pinch chili flakes
1 Tablespoon fresh parsley, chopped
1 cup Panko flakes or crumbs + 1/4 cup more for rolling
Marinara Sauce Ingredients or Buy it
2 teaspoons extra virgin olive oil or canola oil
2 shallots, minced
3 garlic cloves, minced
1-28 oz. can of Cento crushed tomatoes
1-28 oz. can of Cento whole or diced tomatoes
Pinch black pepper
Pinch chili flakes
1 teaspoon fresh basil, chopped
1 teaspoon fresh oregano, chopped
1 teaspoon fresh parsley, chopped
Make the marinara sauce first and the pasta (any pasta you wish) and set aside
1. In a large-saucepan, heat the oil over medium-high heat. Add the shallots and saute them for 3 minutes. Add the garlic and saute for about 1 minute. Next, add the crushed tomatoes to the saucepan. Then add the whole or diced tomatoes. If you are using whole tomatoes, gently crush them with a potato masher.
2. Add the salt, pepper, basil, oregano and parsley to the sauce. Stir and let cook. When the sauce starts to bubble, lower the heat to medium-low and cover the pan. Let cook for at least 20 minutes. Taste and adjust for seasonings. Set aside.
Make the Eggplant Balls
3. In a large skillet, heat 1 Tablespoon of the oil over medium-high heat. Add the eggplant cubes and saute until they are browned and very soft (8 minutes); then add the kale sprouts or spinach to the eggplant cubes and cook for another 10-12 minutes. Make sure they are super-soft because they need to be mashed. You could also roast the eggplant to make it soft, but in the summer, the oven makes the room so hot, even with the a/c on. When you take the eggplant out of the pan, don't wash the pan. Save any liquid in the pan for later.
4. Transfer the eggplant to the food processor bowl. Pulse the eggplant, until there are no whole pieces left and add the spinach and pulse it along with the eggplant. If you don't have a food processor, use a potato masher. If using a food processor, once the eggplant is all completely mashed into mush, add the shallot, cheese, garlic, salt, pepper and parsley, right into the food processor. Pulse a few times. Be sure all these ingredients are mixed well, into the eggplant.
5. If you are using a food processor, transfer the eggplant mixture to a bowl; use a spatula to get all the eggplant out.
6. Before adding the Panko, add the egg (whisked ahead of time) and the jicama to the eggplant and stir it in so it's well distributed in this mixture.
7. Next add the Panko to the eggplant mixture. Don't add them all at once; you want to feel the mix and see whether you need a whole cup. First add 1/2 cup of Panko and mix it.
8. The best way to mix it, is wet one hand and use it (keep the other hand clean & dry) to gently mix the crumbs into the eggplant. You will probably need more crumbs so add another 1/4 cup and mix it again. You want the consistency to feel firm, so it will hold up as a veggie ball. If it feels too moist, add the last 1/4 cup of Panko. If you end up using all the crumbs, that's fine.
9. Put the eggplant mixture into the fridge for about 30 minutes. Don't skip the refrigerator step. Take the bowl out of the fridge and using a spoon, scoop up some of the eggplant mixture and roll it into a ball with your hands. It should be the size of a golf ball. Roll it until it feels sturdy.
10. Now, push your thumb into the middle of the eggplant ball, stuff some grated mozzarella into that hole; then push the eggplant over the cheese, so the cheese will not ooze out during cooking. Roll it again in the Panko.
11. Place all balls with cheese in the center, on a plate and continue making veggie balls until you use up all the eggplant mix. Spread the remaining 1/4 cup Panko onto a plate and roll each veggie ball in the crumbs.
12. Heat the remaining oil in a large skillet over medium-high heat. Add the eggplant balls to the skillet and fry them. Depending on the size of your skillet, you may need to fry them in batches. Make sure the veggie balls brown on all sides. The way to do this is to pull the pan back and forth by the handle, which makes the veggie balls roll around. By doing this, it covers all the sides better than trying to turn them with a utensil. When you use a spatula, there's a tendency to flatten the veggie balls. When they are browned, transfer the eggplant balls to a paper towel-lined plate and keep covered and warm. If you have a warming drawer, keep your marinara sauce and pasta there, covered until ready to serve.
13. If you're ready to serve, and need to warm up the marinara sauce and pasta, turn a low flame on under the marinara sauce and your pasta. Get out a nice serving dish and arrange the eggplant balls and everything else on it and serve, with some extra freshly grated parmesan. You could consider starting with a salad, which is what we did, along with a lovely chilled New Zealand white wine, Cloudy Bay.
14. Everything on this serving dish can be enough for a meal; however, if you crave more, all of the above will go well with fish, poultry and meat. We would suggest a white wine with the fish and poultry; however, if you want a good red, for all foods, Hall cabernet sauvignon from Napa, is that wine.
The eggplant balls is a recipe I have experimented a lot with. First, with no greens added, another time with different amounts of garlic, another time with scallions and not shallots. The final experiment is the recipe in this newsletter. We think it's absolutely delicious. Its fun and a real challenge to get meatless dishes to taste as good, if not better than those with meat type protein.
For dessert we had strawberry cake, a new recipe that needs to be worked on more, before sharing in the newsletter.
Have a rewarding week, everyone and stay cool.
From Our Table to Yours!
July 15, 2019Regulatory
Multiple myeloma is cancer that begins in plasma cells (white blood cells that produce antibodies) and may also be referred to as plasma cell myeloma. Abnormal plasma cells build up in the bone marrow, forming tumors in many bones of the body. As more antibodies are made, it can cause blood to thicken and keep the bone marrow from making enough healthy blood cells. The exact causes of multiple myeloma are unknown, but it is more common in older people and African Americans.
The FDA has granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
For approval, efficacy was evaluated in 83 patients with RRMM who were treated with Xpovio in combination with dexamethasone. At the end of the study, the overall response rate was measured at 25.3%. The median time to first response was four weeks, with a range of one to ten weeks. The median duration of response was 3.8 months. The efficacy evaluation was supported by additional information from an ongoing, randomized trial in patients with multiple myeloma.
Common side effects of patients taking Xpovio in combination with dexamethasone include a low white blood cell count (leukopenia), a low count of neutrophils, a type of white blood cell (neutropenia), low count of platelets (thrombocytopenia) and low amount of red blood cells (anemia). Patients also reported vomiting, nausea, fatigue, diarrhea, fever, decreased appetite and weight, constipation, upper respiratory tract infections and low blood sodium levels (hyponatremia).
Health care professionals are advised to monitor patients for low blood counts, platelets and sodium levels. Patients should avoid taking Xpovio with other medications that may cause dizziness or confusion and avoid situations where dizziness may be a problem. Health care professionals are advised to optimize the patient's hydration status, blood counts and other medications to avoid dizziness or confusion. The FDA advises health care professionals to tell females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment with Xpovio. Women who are pregnant or breastfeeding should not take Xpovio because it may cause harm to a developing fetus or newborn baby. Xpovio must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks.
Xpovio in combination with dexamethasone was granted accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on an endpoint that is reasonably likely to predict a clinical benefit to patients. Further clinical trials are required to verify and describe Xpovio's clinical benefit.
The FDA granted this application Fast Track designation. Xpovio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted the approval of Xpovio to Karyopharm Therapeutics.