nvestigational biologic administered to the first two subjects in a phase ii clinical trial was not appropriately screened for two viral contaminants, hiv and hepatitis b, due to human error in the screening process. follow-up testing indicated that the subjects an

Answers

Answer 1

The human error in the screening process is an unanticipated problem requiring notification to the IRB and FDA

A clinical trial is a carefully monitored experiment conducted on human volunteers to evaluate the efficacy and safety of interventions or therapies for any illnesses or other health issues. Finding out how new treatments will affect pharmacologically, pharmacokinetically, and pharmacodynamically includes researching negative effects. In addition to the requirement for a suitable and regulated setting, this experiment also necessitates the use of medical equipment.

In hospitals or medical clinics, clinical trials are typically conducted. Clinical trials are tests or studies conducted for medical research. These experiments help researchers formulate theories. Clinical trials are a type of human participant-based, prospective biomedical or behavioral research study that aims to provide answers to particular questions concerning biomedical or behavioral interventions, including novel therapies.

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The complete question is -

An investigational biologic administered to the first two subjects in a Phase II clinical trial was not appropriately screened for two viral contaminants, HIV and Hepatitis B, due to human error in the screening process. Follow-up testing indicated that the subjects and their partners were not infected. The subjects and others were notified of the increased risk.


Related Questions

Suppose a patient receives a drug and then presents with an adverse reaction. it is not clear whether the drug or some other condition caused the adverse reaction. the best practice is to ________.

Answers

When the patient receives a drug and then presents with an adverse reaction, the best practice would be to assume that the reaction is a result of the drug.

What are adverse reactions?

An adverse drug reaction is described as "an interference related to the consumption of a medicinal product that results in a noticeably harmful or unpleasant reaction; adverse effects usually predict risk from prospective administration and justify preventative measures, or treatment available, or modification of the prescribed medication, or withdrawal of the product."

Since 2012, the phrase has included reactions occurring from error, misuse, or abuse along with anticipated reactions to medications that are not authorized or not being used as recommended. It also includes authorized usage of pharmaceuticals at the usual levels. The way we handle ADRs in clinical practise shouldn't be affected by this shift, despite the possibility that it will affect how medication producers and regulators track and control their products.

Therefore, in case of an allergic reaction, the best practice would be to assume that the reaction is a result of the drug.

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How does the healthcare facility utilize the United States Postal Service (USPS) and
other delivery companies?

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Healthcare uses these companies to deliver medication, medical supplies, and personal protective equipment.

a patient calls the clinic to report exposure to poison ivy and an itchy rash that is not helped with over-the-counter antihistamines. what response by the nurse is most appropriate?

Answers

Don’t scratch as it will cause it to spread

Ravon is deaf. He was born without the ability to hear, and has never experienced an auditory stimulus. When people write using "sound" type words like "loud," "soft," and "quiet," he sometimes has difficulty understanding what they are trying to convey. Ravon has ________ deafness.

Answers

Ravon is deaf. He was born without the ability to hear and has never experienced an auditory stimulus. When people write using "sound" type words like "loud," "soft," and "quiet," he sometimes has difficulty understanding what they are trying to convey. Ravon has congenital deafness.

In the field of medicine, congenital deafness is a kind of deafness in which the person has the inability to hear since birth. Such kind of deafness may occur due to genetic causes or non-genetic causes such as infection or premature babies. People with congenital deafness are unable to convert sound energy into the electrical energy of nerve impulses.

In the case above, Ravon is deaf since birth hence he has difficulty perceiving what people are trying to express when they write about a sound. As he has never sensed an auditory stimulus, he does not understand what loud, soft, or quiet noise is.

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A sterile urine specimen for culture and sensitivity has been prescribed for a client who has an indwelling urinary catheter. how should the nurse obtain this specimen?

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A sterile urine specimen for culture and sensitivity has been prescribed for a client who has an indwelling urinary catheter. The nurse  should  withdraw several milliliters of urine from the port on the collection tubing, using a syringe and needle.

What is the purpose of a urinary catheter?

Urine is collected in a drainage bag after the bladder is drained using a flexible tube known as a urinary catheter. A urinary catheter is often implanted by a physician or nurse.

Justification: When a urine sample from a patient with an indwelling catheter is required, it should always be obtained through the catheter's special specimen port. The drainage bag's urine sample could not be brand-new, which could result in a flawed study. It wouldn't be necessary to remove a client's catheter in order to take a urine sample.

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Question:

A sterile urine specimen for culture and sensitivity has been ordered for a client who has an indwelling urinary catheter. How should the nurse obtain this specimen?

- Discontinue the indwelling catheter and insert an intermittent catheter to obtain the sterile specimen

- Withdraw several milliliters of urine from the port on the collection tubing, using a syringe and needle

- Collect a urine specimen from the collection bag first thing in the morning, or a few hours after the client receives a diuretic

- Empty the collection bag, wait 30 minutes, and then collect the contents of the collection bag

the laboring client who is at 3 cm dilation (dilatation) and 25% effaced is asking for a narcotic for pain relief. the nurse explains this usually is not administered prior to the establishment of the active phase. what is the appropriate rationale for this practice?

Answers

Pain med wears off too soon

the nurse is caring for a client at 8 weeks' gestation who states, "i did not plan for this right now and i am not happy or excited about this pregnancy. i am not sure what to do." which response by the nurse is best?

Answers

“During the first trimester, many women experience this.” Option B would be the best response by the nurse during this situation to handle the client about pregnancy.

Fetus during the First trimester

The fetus grows out from a fertilized ovum to about 6 cm long at 12 weeks during the first trimester. Your baby’s heart begins to beat around the end of the first trimester, and the brain, stomach, and intestines are growing as well.

What is a pregnancy’s first trimester?

These trimesters are used to categories the type of pregnancies the first trimester lasts from week one to week twelve.

The second trimester has been already set to be comprised from week 13 through the end of week 26. After this Week 27 takes upto the pregnancy by the end of the third trimester.

The eventual very essential period of growth of any unborn child happens during this first trimester itself and hence this phase is very important.

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Complete Question

The nurse is caring for a client at 8 weeks' gestation who states, "I did not plan for this right now and I am not happy or excited about this pregnancy. I am not sure what to do." Which response by the nurse is best?

A. "We can refer you to a clinic for potential termination if you desire."

B. "Many women feel this way during the first trimester."

C. "You will become excited and happy when you feel the baby move."

D. "Do not worry. Once you hold this baby, everything will be fine."

the nurse finds a client unresponsive in the hospital room and calls a cardiac arrest. which health care professionals will be responsible for an insertion of the endotracheal tube during the cardiac arrest? select all that apply.

Answers

Endotracheal intubation is commonly used by emergency medical services paramedics

Why do they intubate you after cardiac arrest?

Intubation is necessary when your airway is blocked or damaged or you can't breathe spontaneously. Some common conditions that can lead to intubation include: Airway obstruction (something caught in the airway, blocking the flow of air). Cardiac arrest (sudden loss of heart function).

Emergency medical services paramedics in the advanced airway management of OHCA but numerous studies question its safety and effectiveness.

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a nurse is asked to auscultate the fetal heart sounds in a pregnant client. which equipment is most appropriate when auscultating fetal heart sounds at the 12th week?

Answers

Doppler most likely

Which common causes would the nurse identify for accumulation of fluid in the alveoli and interstitial spaces of the lungs? select all that apply.

Answers

Heart failure in a syndrome that occurs when a pulmonary vein occurs, as a precondition of cardiac health functioning conditions, hypercoagulability, patient immobility and older age.

Heart failure

What is Pulmonary edema?

Pulmonary edema is an emergency situation when fluid builds up inside the lungs. This situation of intensity of the dive, verified breathing difficulties and drowning sensation. The condition of acute edema is also called or simply “water on weight”

What happens when a person has a pulmonary embolism?

Pulmonary embolism is a disease caused by the clogging of one or more arteries in the lung. The problem is caused by a clot blocking the flow of blood through the artery. This clot usually forms in other parts of the body and ends up in the lung.

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Which common causes would the nurse identify for accumulation of fluid in the alveoli and interstitial spaces of the lungs? Select all that apply.

Heart failure

Oxygen toxicity

Opioid overuse

the nurse is preparing a sterile field for a procedure in the client’s presence. which is the most appropriate instruction to give the client in this situation?

Answers

Sterile fields must always be kept in sight to be considered sterile.

Which five aseptic technique principles are there?

The following are some of these guidelines: Use only sterile objects in a sterile environment; sterile persons are gowned and gloved; sterile personnel work in a sterile environment (sterile personnel only touch sterile objects or areas; unsterile personnel only contact unsterile objects or areas).

Sterile field must always be kept in sight throughout entire sterile procedure. Never return your back on the sterile field as sterility cannot guaranteed.

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the nurse is discussing a high fiber diet with a client. upon return demonstration, which menu planned by the client follows the high-fiber diet guidelines?

Answers

The nurse is discussing a high fiber diet with a client and upon return demonstration, Option B) cramping menu is planned.

What foods contain the most fiber?

The Top 10 Fiber-Rich Foods

Any such type of bean related food such as Beans, Broccoli, lentils, and other beans are simple ways to get fiber into your diet through soups, stews, and salads.

These vegetables can also be labelled as the “fiber vegetable” along with berries, avocados, popcorn, whole grains, apples, and dried fruits.

What is a diet high in fiber?

Instead of juicing, you should go for raw produce and consume their skins. Try eating the whole of buckwheat, whole wheat couscous or some items like quinoa, bulgur, wheat germ, chia seeds, hemp seeds, lentil pasta, and edamame pasta as provided alternatives to traditional sources of fiber.

Whole grains include popcorn. As a kind of low-fat alternative to butter, serve it as a snack.

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the coach of a client in labor is holding the client's hand and appears to be intentionally applying pressure to the space between the first finger and thumb on the back of the hand. the nurse recognizes this as which form of therapy?

Answers

The coach of a client in labor is holding the client's hand and appears to be intentionally applying pressure to the space between the first finger and thumb on the back of the hand. The nurse recognizes this form of therapy as acupressure.

Acupressure therapy: what is it?

Acupressure practitioners apply pressure to acupoints on the body's meridians using their fingers, palms, elbows, or feet, as well as other objects or specific gadgets. Stretching or acupressure massage are occasionally used in conjunction with acupressure as well as other techniques.

Which conditions can acupressure treat?

Du's research indicates that acupuncture is most helpful in treating conditions that affect the neurological system, gastrointestinal tract, genitourinary system, muscles, bones, and skin, such as stroke, diarrhea, enteritis, dementia, and skin rashes.

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when a nurse is planning for a home care plan for a patient with visual and hearing deficits, is the highest priority that the nurse needs to consider.

Answers

Setting priorities deals with selecting a preferential sequence for managing nursing diagnoses and interventions. In this step, the nurse and the customer begin planning which nursing diagnosis needs attention first.

What is an applicable nursing intervention for a patient who has a visual impairment?

Arrange her personal and self-care items within space, as she directs you, or introduce her to their placement. Recognize and explain unfamiliar sounds, such as monitor alarms. When you help her stride, ask which side she prefers you on. Offer her your component or elbow for her to grasp.

What is a priority check?

Priority Assessment means an evaluation of the possible risk for a food-borne illness to appear in a food assistance facility using a given set of parameters as specified by the Department in Regulation.

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the first scientist that invented
vaccine​

Answers

Answer:

Edward Jenner i believe

Edward Jenner I’m sure

protano, c.; vitali, m. the new danger of thirdhand smoke: why passive smoking does not stop at secondhand smoke. environ. health perspect. 2011, 119, a422.

Answers

Secondhand smoke is described as "the combination of smoke exhaled by the smoker and smoke emitted from the burning end of a cigarette or other tobacco products" (World Health Organization 2007). So, unintentional inhalation of smoke that occurs close to smokers or in enclosed spaces where tobacco has recently been used constitutes secondhand smoke exposure.

Thirdhand smoke is a complicated phenomenon brought on by lingering tobacco smoke particles that stick to smokers' clothes and hair as well as to surfaces, furniture, and dust in enclosed spaces.These toxins continue to exist long after the odor of secondhand smoke has subsided. They either reemit into the gas phase or combine with oxidants or other substances in the environment to create secondary pollutants, some of which are hazardous to human health or carcinogenic (Matt et al. 2011). Thirdhand smoke exposure is thus defined as the inadvertent intake of tobacco smoke and other related substances that takes place in the absence of concurrent smoking and happens mostly by breathing, but also through ingestion and cutaneous routes. Through close contact with smokers and in settings where tobacco is frequently smoked indoors, exposure can occur even years after a person stops smoking.For studies analyzing passive smoking exposure in indoor settings, particularly in home settings, this terminology issue is of particular relevance. Since many nations have banned smoking in enclosed public spaces, residential settings have changed from being the primary sources of passive smoking exposure (World Health Organization 2007). When determining the extent of pollutant intake as a result of passive smoking exposure, we think researchers should take into account the separate contributions of secondhand and thirdhand smoke.

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if a fetus were not receiving enough oxygen during labor because of uteroplacental insufficiency, which pattern would the nurse anticipate seeing on the monitor?

Answers

Seeing on the monitor the nurse would anticipate fetal heart rate declining late with contractions and remaining depressed.

What is uteroplacental insufficiency?

A rare but significant pregnancy condition is placental insufficiency, also known as placental malfunction or uteroplacental vascular insufficiency. It happens when the placenta is injured or does not mature properly. A decrease in the mother's blood supply is a defining feature of this blood flow disease.

The fetal heart rate does not recover right away after a contraction because of inadequate placental filling, which limits blood flow to the fetus.

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which activity would the nurse recommend for a 6-year-old child who is hospitalized with nephrotic syndrome? select all that apply. one, some, or all responses may be correct.

Answers

A  high proteinprotein diet should be offered, active play periods are permitted during remission.                

Which is included in the diet of a child with minimal change nephrotic syndrome?

The diet for a child with nephrotic syndrome may include limiting salt and fluids.

The following nursing interventions are used with children who have nephrotic syndrome: Monitoring fluid intake and output. Maintain accurate records of intake and output, weigh the child every day at the same time on the same scale while wearing the same clothes, and take a daily abdominal measurement at the umbilicus level.

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The transactional theory of stress includes both a primary appraisal of a stressor to determine if a demand is stressful, and a secondary appraisal to determine how to cope with the stressor. True or false?.

Answers

It is true to say that the transactional theory of stress calls for both a primary assessment of a stressor to identify whether a demand is stressful and a later assessment to decide how to deal with the stressor.

Lazarus and Folkman (1984) created the most influential theory of stress and coping, which described stress as the outcome of an imbalance between perceived internal or external demands and the perceived personal and societal resources to deal with them.

The amount of stress is reliant on cognitive assessment and is seen as a potentially stressful occurrence that involves a transaction between the person and their surroundings.

Primary appraisal, secondary evaluation, and emotional forecasting are the first two phases of cognitive appraisal.

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7. health care operations are defined as activities considered in support of treatment and payment and for which protected health information (phi) could be used or disclosed without individual authorization.

Answers

This statement is definitely true about support of treatment and payment under health care operations.

Without the person's consent, a covered entity may use or divulge protected health information for its own operations, including payment and treatment. For instance:

In order to treat a patient and to confer with other medical professionals regarding the patient's care, a hospital may use protected health information about the patient.As part of a reimbursement claim to a health plan, a healthcare professional may divulge protected health information about a patient.Protected health information may be used by a health plan to offer its members customer support.

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Question correction:

Health care operations are defined as activities considered in support of treatment and payment and for which protected health information (phi) could be used or disclosed without individual authorization. Is this true or false?

a nurse is conducting a seminar on basic nutrition and is teaching about the different groups of carbohydrates. which should the nurse identify as recommended sources of carbohydrates for managing diabetes?

Answers

Here are the recommended sources of carbohydrates for managing diabetes:

whole grainslegumeslow-fat milk

The fact that milk such as low-fat milk and other dairy products carry sugar in the form of lactose may confuse you. But because these foods include calcium and protein, they should be a part of a healthy diabetes diet.

In fact, a June 2018 BMJ report indicated that a diet high in fruits, vegetables, whole grains, legumes, nuts, and dairy are all essential components of a healthy diet in the management of diabetes. What do all of them share? Every one of these is a source of carbs.

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When interviewing a client with internal hemorrhoids, what would the nurse expect the client to report?

Answers

When interviewing a client with internal hemorrhoids, the nurse should expect the client to report that Internal hemorrhoids cause bleeding but are less likely to cause pain, unless they protrude through the anus.

what is Hemorrhoid?

This refers to a medical condition which is characterized by the swelling of the vein in the rectal part of the rectal and anus of the affected individual as a result of different types of factors.

Hemorrhoids consists of two types which are Internal and external hemorrhoids. The former cause bleeding but are less likely to cause pain, unless they protrude through the anus.

On the other hand external hemorrhoids causes few symptoms which include producing pain, itching, and soreness of the anus area and is therefore what the nurse expects the client to report about this condition.

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A nurse is preparing to administer medications. which patient would the nurse consider to have the greatest predisposition to an adverse reaction?

Answers

A thirty year old male with kidney disease would have the greatest predisposition to an adverse effect.

Because of potential excretion issues, the person with poor renal function will be at risk of having this medicine accumulate to a hazardous level. Cystitis is a bladder infection, not typically the source of excretion issues that could result in a negative drug reaction. A patient wouldn't be more likely to experience a negative drug reaction if they had a respiratory tract illness. Because medicines are neither metabolized or excreted through the lungs, having a respiratory tract infection would not put a patient at risk for experiencing an adverse reaction. Due to his age, a 9-year-old youngster would not have the "Greatest" tendency to an unfavorable reaction, nor would an ear infection increase his risk.

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Selection of assessment tools is largely determined by the patient’s symptoms, age, and medical status. One other factor may be the.

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Selection of assessment tools is largely determined by the patient’s symptoms, age, and medical status. One other factor may be the therapist's theoretical perspective.

Therapist's theoretical perspective- In counseling, theoretical orientation fundamentally refers to the ideas or viewpoints a mental health practitioner employs to evaluate, comprehend, and treat clients. Theoretical orientation refers to any theory that what a mental health professional utilizes to direct their practice.

Symptoms- A doctor can't see a patient's symptoms, which are their subjective perceptions of a potential health problem. Examples include pains in the stomach after consuming undercooked meat, a pounding headache caused by stress, or an excruciating sense of exhaustion.

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a client has been prescribed baclofen and will be taking the drug on an outpatient basis. the client asks the nurse if it is still okay to drink wine with meals or end the day with a ""nightcap."" what is the nurse’s best response?

Answers

The client asks the nurse if it is still okay to drink wine with meals or end the day with a ""nightcap."" Report the findings to the primary health care provider immediately  is the nurse’s best response.

Primary health care provider

Primary healthcare refers to a wide range of community-based healthcare professionals. A primary healthcare provider is any healthcare professional who is the health system's first point of contact. When they have a non-emergency health problem, most people visit their GP (sometimes known as the 'local doctor'). The primary healthcare system also includes allied health practitioners such as dentists and physiotherapists.

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a low-risk client is in the active phase of labor. the nurse evaluates the fetal monitor strip at 10:00 a.m. and notes the following: moderate variability, fhr in the 130s, occasional accelerations, and no decelerations. at what time should the nurse reevaluate the fhr?

Answers

The nurse examines the fetal monitor strip and observes the following: moderate fluctuation, fhr in the 130s, infrequent accelerations, and no decelerations. The nurse should review the fhr at 10:30 a.m.

Fetal monitor strips

Standard (external) fetal monitor strips (also known as fetal monitoring strips) are little devices that are attached to the mother's stomach/'baby bump' to monitor the child's heartbeat. The fetal monitor strips accomplish this by capturing and tracking the baby's heart activity using Doppler ultrasound. Some fetal monitor strips will also keep a baseline for comparison, providing medical practitioners with extra information about the child's status. Internal monitor strips can also be used, but they must be properly dilated and attached to the child's head.

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the nurse is caring for a client who has been on bed rest. the primary care provider has just written a new prescription for the client to sit in the chair three times a day. which action will be most effective to transfer the client safely into the chair?

Answers

Gait belt maybe or wheelchair depends are they still ambulatory if so gait belt

identify the systolic blood pressure threshold for withholding fibrinolytic therapy to otherwise eligible patients with acute ischemic stroke within what time frame

Answers

The cutoff for withholding fibrinolytic treatment from otherwise qualified individuals with acute ischemic stroke is 185 mm Hg for systolic blood pressure.

What is blood pressure?The force of moving blood exerted on blood vessel walls is known as blood pressure (BP).The heart pumps blood via the circulatory system, which causes the majority of this pressure.The pressure in the major arteries is referred to as "blood pressure" when used without further qualifier.In the cardiac cycle, blood pressure is often stated as the ratio of the systolic pressure (the maximum pressure during one pulse) to the diastolic pressure (the minimum pressure between two heartbeats).It is expressed as an increase in air pressure in millimetres of mercury (mmHg).

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a nurse is conducting an in-service program for staff nurses working in the labor and birth unit. the nurse is discussing ways to promote a positive birth outcome for the woman in labor. the nurse determines that additional teaching is necessary when the group identifies which measure?

Answers

The nurse determines additional teaching is necessary when the group itendies to allowing the woman time to be alone measure.

What can be the positive support for labour and birth unit?

An enjoyable birthing experience is encouraged by supportive relationships and not feeling alone. When a woman is alone, her level of worry and anxiety rise, making it harder for her to handle situations. The woman is better able to handle the difficulties of labor if she feels in control since control fosters self-confidence and self-esteem. Knowing what to expect from the process fosters teamwork, eases fear of the unknown, and boosts the woman's self-assurance in her ability to manage labor.

Due to their ability to reduce uterine blood flow and placental perfusion, catecholamines are released in reaction to worry and panic. Utilizing relaxation techniques can help a woman cope better with labor by lowering her worry and fear, which in turn helps to minimize catecholamine secretion.

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a patient with muscle ache would like to use an over-the-counter nonsteroidal anti-inflammatory drug (nsaid). the patient informs a nurse that he is taking antihypertensive drugs for blood pressure control. why should the nurse caution the patient against the use of an nsaid while on antihypertensive drug therapy?

Answers

Could cause hypotension (low blood pressure)
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