Respond to each students posts regarding the following question. Please put the names of the person to who you are responding too.

QUESTION:
 
 
Mikayla Anoje 
Atherosclerosis
COLLAPSE
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1. Description
   1. Atherosclerosis is a condition where fats and cholesterol plaques collect on the arterial walls. People diagnosed with atherosclerosis are at risk for developing coronary artery disease which blocks blood flow to the heart and carotid artery disease which blocks blood flow to the neck and brain. These conditions can cause blood clots, heart attacks and strokes. Treatments for atherosclerosis include healthy lifestyle habits, medications and or medical procedures or surgery. Some medications commonly used to control the cholesterol levels are atorvastatin, niacin and colesevelam. In this study the use of MRI will be used to evaluate whether the medications on their own or in combinations can decrease the fat content of atherosclerotic plaques within the artery walls.
   2. Participants will be randomly assigned to one of the following 40-month treatment groups:
      1. Group 1 participants will receive atorvastatin, placebo niacin, and placebo colesevelam each day.
      2. Group 2 participants will receive atorvastatin, niacin, and placebo colesevelam each day.

• Group 3 participants will receive atorvastatin, niacin, and colesevelam each day.

36. At a baseline study visit, participants will undergo a blood collection and will receive dietary counseling that will focus on lowering cholesterol levels. They will also undergo an MRI scan of their carotid arteries. For the next 4 months, participants will attend monthly study visits for repeat blood collection and dietary counseling; for the subsequent 36 months, participants will attend study visits every other month. Repeat carotid artery MRI scans will occur at Months 12, 24, and 36. At three different times during the study, researchers will ask participants to record their food consumption for 3 consecutive days.

2. Inclusion Criteria:
   1. Clinically established coronary artery disease or carotid artery disease with greater than 15% stenosis by ultrasound
   2. Family history of cardiovascular disease
   3. Apolipoprotein B level greater than or equal to 120 mg/dL (LDL level should be between 100 and 190 mg/dL without medication)
   4. Has been undergoing lipid therapy for no more than 12 months before study entry
   5. Medically stable
   6. Medically able to undergo MRI procedure
3. Exclusion Criteria:
   1. Uses pacemaker or has metallic implants
   2. Has immediate plans for carotid endarterectomy
   3. History of alcohol or drug abuse
   4. Active liver disease or liver dysfunction, defined by elevations in alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal
   5. Serum creatine kinase (CK) level greater than 3 times the upper limit of normal before study entry
   6. Serum creatinine level greater than 2.5 times the upper limit of normal
   7. Diabetes, with a fasting glucose level greater than 150 mg/dL or hemoglobin A1c (HbA1c) level greater than 8% before study entry
   8. Uncontrolled high blood pressure, defined as average resting systolic blood pressure greater than 200 mm Hg or average resting diastolic blood pressure greater than 95 mm Hg
4. What phase is the trial in
   2019. The trial is still in an active phase (40 months)  but not accepting more participants. The study started June 2001 with a primary completion date of March 2019 and study completion date of April 2019.
5. Single or double blind
   1. Single blind, the participants don’t know what medications they are receiving and of which are placebos or not. Although the providers are unaware as well the persons administering the trial are aware as to who has what medications.
6. What methods does it use (Random Clinical Trial, Community Intervention, Pre/post method or single group design)
   1. Random clinical trial is used in this study. 217 participants who suffer from coronary artery disease or carotid artery disease and were randomly assigned to one of three groups.
7. Based on what you have read in the textbook, what do you think are the limitations of this trial based on what is written in the clinical trials summary of the methods.
   1. One of the main things that stuck out to me was the ability of the study to ensure the participants are practicing healthy lifestyles along with taking their medications. Each group has a different placebo but whether or not the participant is choosing a healthy lifestyle might contribute to the effectiveness of the drugs and reducing plaques.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Alexis Clate 
Monkeypox
COLLAPSE
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Monkeypox
The clinical trial that I chose is designed to evaluate the immunogenicity and safety of IMVAMUNE vaccine. The study is being conducted in a region that has predictable rates of natural Orthopoxvirus transmission. The study targets healthcare and frontline workers in the Congo Basin forest in Central Africa due to the high-risk of Orthopoxvirus transmission which may compromise healthcare delivery or result in death. Participants receive 2 doses of attenuated live virus smallpox vaccine (IMVAMUNE) on day 0 and day 28 through an injection into the deltoid muscle. The study will primarily evaluate how many participants develop suspected or confirmed monkeypox virus infection up to 2 years following the administration of the vaccine and those who become exposed to monkeypox virus for up to 2 years post-vaccination. The study is currently in phase 3 and is expected to conclude August of 2022. This trial is neither single nor double blind (open label) and is a single group design because the participants are knowingly receiving the vaccine and then re-evaluated over the course of 2 years following the administration. Inclusion criteria include:

• Males and non-pregnant females ages 18 and up
• Healthcare workers at risk of monkeypox infection working in the Tshuapa Province of DRC
• Willing to adhere to infection control recommendations
• Willing to complete the informed consent process and study procedures
• Available for all study visits

Exclusion criteria include:

• History of allergy or anaphylaxis to vaccines, eggs, or aminoglycosides
• Current pregnancy
• Acute illness with fever at the time of vaccination
• Experimental research agent or vaccine within 28 days
• Any reason data collected from this participant would be incomplete or of poor quality
• Any reason the participant may be subject to unacceptable risk of injury

The major limitations of clinical trials are that they can be very costly, they may span too great of length of time which may lead to loss to follow-up which may lead to biased measurements, and participant failure to adhere to the protocols of participation.
 
Petersen, B., & Wemakoy, E. O. (2020). IMVAMUNE® Smallpox Vaccine in Adult Healthcare Personnel at Risk for Monkeypox in the Democratic Republic of the Congo – Full Text View. Retrieved December 02, 2020, from https://clinicaltrials.gov/ct2/show/NCT02977715?recrs=d
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