Showing posts with label Research. Show all posts
Showing posts with label Research. Show all posts

Saturday, December 12, 2020

COVID-19 and the increased risk of Parkinson's disease

Hi!

Currently posted in psychiatry, I was reading articles on Parkinson's disease and came through this important finding in context with the coronavirus disease.

Saturday, April 4, 2020

How to cite articles

Hi everyone,

I wanted to write a quick post on how to cite references for Medicowesome Student Guest Authors (MSGAites!). Medicowesome is not a peer-reviewed journal, we are just a website where we post mnemonics, study material, and cool facts. Recently, we've been writing about COVID-19. Because there has been so much fake news and miscommunication about the characteristics of this disease, we decided that all posts related to COVID-19 would have journal articles in literature as references.

There are many styles in which you can format references. You can read more about it in this paper by Kambhampati & Maini, 2019. [1] It is preferred that you use a particular formatting style for all the references in your article. Simply adding links is not preferred because websites change their links all the time. The best way to ensure that your reader finds the article you're referencing is by using a proper reference format. A DOI is guaranteed never to change, so you can use it as a permanent link to any electronic article.

Wednesday, April 1, 2020

COVID-19: Vaccines under development

COVID-19 pandemic has led researchers around the world to work on developing a safe and effective vaccine. At present, there are 5 agents which are being extensively tested as potential vaccines. Here is some information about them.
1. mRNA- 1273 

Trial: Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection
   
- novel lipid nanoparticle encapsulated mRNA based vaccine that encodes for spike protein of SARS-CoV-2
- an open-label phase I dose-ranging clinical trial in the United States
- Study Population: 45 healthy people, males and non-pregnant women aged 18-55
    - enrolled in one of three cohorts - 25mcg, 100mcg, 250mcg
    - IM injection of the vaccine on Day 1 and 29 in deltoid
    - Follow up: 1,2,4 weeks post each vaccination, 3,6,12 months post second vaccine

- Objective
    - To evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 3 dosages in healthy adults 
    - To evaluate the immunogenicity as measured by Immunoglobulin G (IgG) enzyme-linked immunosorbent assay ELISA to the SARS-CoV-2 S (spike) protein following a 2-dose vaccination schedule of mRNA-1273 at Day 57

2. BCG Vaccine

BCG vaccine — developed for Tuberculosis. It has favorable in vitro or in vivo effect against RSV, Yellow fever, HSV, HPV. The hypothesis is that it may induce partial protection against the susceptibility to and/or severity of SARS-CoV-2 infection

Trial 1: BCG-CORONA reducing health care workers absenteeism in SARS-CoV-2 pandemic through Bacillus Calmette-Guérin vaccination, a randomized controlled trial (BCG-CORONA)

- RCT in the Netherlands 

- Study population: 1000 Health care workers with direct COVID-infected patient      
  contact
- Study duration: 6 months
- Objective: 
    - To reduce absenteeism among HCW with direct patient contacts during the epidemic phase of COVID19
    - To reduce hospital admission, ICU admission or death in HCW with direct patient contacts during the epidemic phase of COVID19

Trial 2: BRACE - BCG Vaccination to Reduce the Impact of COVID-19 in Australian Healthcare Workers Following Coronavirus Exposure (BRACE) Trial

- Open-label two group phase III RCT in Australia

- Study population: 4170 Healthcare workers
- Study duration: 12 months
- Objective:
    - COVID 19 disease incidence over 6 months, by 12 months
    - severe COVID 19 disease incidence over 6 months, by 12 months


3. Synthetic Minigene Vaccine

Artificial antigen-presenting cell Vaccine - a synthetic minigene that has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease. The vaccine will be produced using a vector system to express viral proteins and immune modulators genes to modify artificial antigen-presenting cells (APC) and to activate T cells


Trial 1: Safety and Immunity of COVID-19 aAPC Vaccine

- Open-label phase I study in China

- Study population: 100 participants aged 6months to 80 years
- Objective: 
    - Injection of COVID-19/aAPC vaccine to volunteers to evaluate the safety
- To evaluate the anti- COVID-19 reactivity of the COVID-19/aAPC vaccine

Trial 2: Phase I/II Multicenter Trial of Lentiviral Minigene Vaccine (LV-SMENP) of COVID-19 Coronavirus

- Open-label Phase I/II study in China

-Study population: 100 participants aged 6months to 80 years
- Objective:
    - Injection and infusion of LV-SMENP DC and antigen-specific cytotoxic T cell vaccines to  
healthy volunteers and COVID-19 infected patients to evaluate the safety
- To evaluate the anti- COVID-19 efficacy of the LV-SMENP DC and antigen-specific  
cytotoxic T cell vaccines

4. ChAdOx1 nCoV-19 Vaccine

Trial: A Phase I/II Study to Determine Efficacy, Safety, and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers

- Single-blinded, Randomized Phase I/II study in UK
-Study population: 510 participants aged 18 to 55 years
- Objective: 
    - To assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19
    - To assess safety of the candidate ChAdOx1 nCoV


5. Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Trial: A Single-center,Open-label,Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old

- Open label, dose-escalating Phase I study in China
-Study population: 108 participants aged 18 to 60 years
- Objective:
    - To evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Written by Devi Bavishi
Reference: clincialtrials.gov

COVID-19: App based clinical trials

Let’s see how scientists are using app technology to generate data for research on COVID-19.

Sunday, March 29, 2020

COVID19 and research: What can I do?

With the COVID19 pandemic hitting us, it is imperative to know where to get our trusted info from. Multiple research papers are emerging these days with one main big goal: Understanding this disease and how to stop it!

In addition to reading and following these research papers, you, yes you, can be a researcher yourself. You can help in fighting this disease and aid humanity.

The studies mentioned below are international studies aiming at understanding COVID19 and its implications:

1- Covidsurg:

Covidsurg is an international cohort study, aiming to assess the outcomes of surgery in patients diagnosed in COVID-19.

It is for patients who undergo surgery with either suspected or confirmed COVID-19 infection (either before or after surgery). Cases can be entered either prospectively or retrospectively.

There is no evidence to inform the management of surgical patients with COVID-19 infection. Capturing real-world data and sharing international experience will support the management of this complex group of patients, improving their clinical care.

To start, register at: http://tiny.cc/covidsurg

==================

2- CovidSurg-Cancer: 

CovidSurg-Cancer is an international cohort study assessing the safety of surgery for all types of cancer during the COVID-19 pandemic and the impact of the pandemic in cancer delay and treatment pathways.

For more info : https://globalsurg.org/cancercovidsurg/

=================

-You can start these studies at your hospital anywhere now! Get the required IRB approval and collect data.

-All publications will be Pub-Med indexed. A corporate authorship model will be used under CovidSurg Collaborative group.


Stay safe

Murad

Friday, January 3, 2020

Olanzapine dose in CINV

Hi!

Olanzapine, an anti-psychotic, has been used in the patients of cancer for its beneficial effects on chemotherapy-induced nausea and vomiting (CINV) at a dose of 10 mg due to its anti-emetic action (neurotransmitter blockade at serotonin and dopamine receptors).

But due to its major adverse impact of daytime sedation, recent studies and randomized controlled trials have concluded its revised dose to be 5 mg for CINV.

To be noted here that the anti-emetic use of olanzapine is still off label, an unlicensed drug used for this purpose.


That's all
- Jaskunwar Singh

Monday, May 6, 2019

PARTNER 3 trial journal club

Hey everyone!

A few months ago, I did a journal club on the PARTNER 3 trial.

I have been meaning to create an audio file and upload the whole journal club as a video on YouTube but unfortunately, I don't seem to have the time.

This is why, I decided to go ahead and release my slides instead so it helps anyone who is doing a journal club on the same :)

Thursday, April 11, 2019

Hierarchy Of Evidence

Evidence-based medicine is the conscientious and judicious use of current, best research evidence to optimise management plans.
Here’s the order of importance.


[Please click on the image to enhance it]



That’d be all.


- Ashish Singh


Reference(s):
1. Evidence based medicine: what it is and what it isn't by Sackett et al, 1996.








Wednesday, March 20, 2019

Places to Target for Research

Places to target first for a Research Position (Big Guns) :
Mayo Clinic, Rochester
Mayo Clinic, Florida
Cleveland clinic, Ohio
Cleveland clinic, Florida

Email Format for Research

Email Format  for a Research Position

Hello Dr. XYZ,

I am ABC, a medical student, currently doing clinical elective rotations.

I'm highly interested in cardiology. Your /Case Western Reserve University's research work ( refer to either the person's or the University's work) , particularly in general cardiology and electrophysiology is exemplary.

I believe you accept volunteer Research Scholars. It would be an honor to work in this institute as a Research Scholar.

I would be willing to work for a year, and would also consider an unpaid position.

I am attaching my CV with this email.

Hoping to hear back from you.

Wish you a happy new year.

Thanks.

Hope this helps :)

Bhopalwala. H

How to Land a Research Spot in USA

Hey guys, how's it going?
So this post is going to be about how to land a research position in USA.
First of all I would like to briefly speak about  why it is important to have some research experience in USA. Common idea is it helps people to build a strong CV to cover up low scores or any red flags in the CV. What I have realized is that it is not the only benefit, to get into a competitive specialty for residency and also for future fellowships it's very important to have some research background in the field of your interest.

Now let's talk about the steps to go through before you land a research spot.

Friday, March 9, 2018

Understanding randomization in clinical trials


Hi, 
I am writing this to clear basics about randomization. It is a very important concept for understanding the clinical trial design and can come handy while critically analyzing any trial or designing your own study. 
This is not very important for any med school exam. I believe this is really important because of more extensive use of evidence-based medicine (EBM) in clinical practice and many clinicians lack the ability to skillfully evaluate a scientific manuscript.

I am planning to write more blogs related to evidence-based medicine, which might help our readers across the world to become expert in EBM.

  • RANDOMIZATION - randomly allocating participants into different treatment arms, purely on the basis of chance.  

  • Randomization is the cornerstone of clinical trial design. It's a very tricky concept and gets trickier when you start evaluating scientific literature critically or start designing a robust clinical trial.

  • It is pivotal in distributing confounders (eg. sex, age, history) equally in every treatment arm. Except for chance variation among the randomized group at baseline


Two most important  features of successful randomization:

1. Procedure truly allocates treatments randomly (based on chance)
2. Assignments are tamper proof

Randomization techniques:

1. Simple randomization:
By coin flipping (one side for treatment 1 and another side for treatment 2), shuffled deck of cards (even numbers for treatment 1 and odd numbers for treatment 2), throwing dice (numbers <3 for treatment 1 and numbers >3 for treatment 2). More better methods are random table method in stats books and computer software like excel.

Uses: in large sample size (>100 it should be preferred over block randomization)
Drawback: problematic in small sample size because it can create  unequal numbers in groups.

2. Block randomization: Ensure that participants are equally distributed among each group. Randomization is done in blocks, eg block size of six.
For example, a scientist enrolls only 6 patients per visit for a trial of total 60 patients. On each visit, he divides 3 patients each to treatment group A and B. At the end he will have 30 patient in both groups. See the figure 1 below.

 
 Figure 1. Block randomization of 60 patients in 6 patient blocks.

Drawbacks: Not suitable for randomization in non blinded trials, because randomization in small blocks makes a prediction of sequence easy.


3. Stratified Block randomization: It ensure that important predictor of outcome is more evenly distributed among study groups.
For example, if the age is a major determining factor in effectiveness or toxicity of the treatment then its imperative to have a similar distribution of ages in both treatment groups. Hence patients will be the first stratified into age groups and then they will be equally randomized in each arm. Like we did for Block randomization.

Drawback: only small number of baseline variables (2-3) can be managed by this technique.

4. Adaptive randomization: used for balancing more than 2-3 baseline variables.
5. Minimization: more complex adaptive randomization


I will continue more in next blog on randomization or other important concepts. Kindly post comments or question, which might help me, you, or other readers.

Thanks,
Dr. Gee


References:

Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB. Designing clinical research. Lippincott Williams & Wilkins; 2013 May 8.

Suresh, K. (2011). An overview of randomization techniques: An unbiased assessment of outcome in clinical research. Journal of Human Reproductive Sciences, 4(1), 8–11. http://doi.org/10.4103/0974-1208.82352

Monday, July 17, 2017

Brain to gut: Lets talk

Hey Awesomites

The brain and gut chat and share neurohumoral and immunologic messages with each other most of the times. That is why our emotions affect our stomach and intestines and vice versa. This healthy communication is disturbed when we are stressed out, anxious, or depressed.



Stress (more of psychological type) influences the type of bacteria inhabiting the gut, making a loss of our bowel flora diversification and increasing the concentration of harmful pathogens in the gut, thus leading to certain inflammatory and infectious processes.

Chronic flare - ups of inflammatory bowel disease result in deviation of the mood towards negative side by upto 60 percent by a process of rewiring the neuronal circuitary, called neuroplasticity. This inturn worsens the condition of gut on long-term basis.
Recent studies suggest that talk therapy - particularly cognitive behavioral therapy, and anti- depressants may be supportive in such cases to reduce the flaring up of inflammatory bowel syndrome.

In case of irritable bowel syndrome, that is a functional disorder ( without any actual organic cause ), the CBT and use of anti- depressants improve the symptoms in upto 60 percent patients. But which patients are likely to benefit still needs further research. Till then, we know that a referral for talk therapy in the patients of IBS is a must.


Thats all
- Jaskunwar Singh

Sunday, July 16, 2017

Favorites of brain cells: The game of genetics

Hey Awesomites

Many cells in the brain express two copies of a gene - maternal and paternal. But some express only one. If the single copy that is expressed carries a genetic mutation, it may result in cellular dysfunction and thus there are consequences.

Research on newborn mouse suggests that in about 85 percent of genes in the dorsal raphe nucleus, known for secreting serotonin, differentially activate their maternal and paternal gene copies. Ten days later in the juvenile brain, both copies are activated equally for all but 10 percent of genes.

The disparity also occurs in humans and in other systems like liver and muscles.

Like for example, in humans, a gene called DEAF1 that is implicated in autism and intellectual disability, shows a preferential expression of one copy of genes in multiple areas of brain. This is true for genes in other mental and neurologic disorders like Huntington's disease, schizophrenia, ADHD, and bipolar disorder.
Source )


Thats all
- Jaskunwar Singh

Fact of the day: Liquid biopsy for cancer detection

Hey Awesomites

We have known since long that surgical biopsies done routinely in cancer patients to diagnose and detect progression of the disease may increase the risk of carcinogenic changes in the cells in future, due to the changes that had prompted the biopsies.

A non - invasive and painless diagnostic tool that replaces the cutting is "liquid biopsy" that finds the hidden cancer cells anywhere in the body. The liquid biopsy is taken from a simple blood test to look for microscopic pieces of DNA circulating in the blood that contains genetic mutations causing tumors to spread, among billions of other DNA that were in the blood.
A year ago, a circulating tumor DNA test was approved by FDA that spots these mutations.


Thats all
- Jaskunwar Singh

Friday, July 7, 2017

New drug launched for Sickle Cell Disease


Heyy guys, I have taken this post from Medscape. Nonetheless, awareness about this new drug should be spread.
The US Food and Drug Administration (FDA) has approved L-glutamine oral powder (Endari, Emmaus Medical Inc) to reduce severe complications of sickle cell disease in patients aged 5 years and older with the disorder. This is the first approval for the rare disorder in almost 20 years.
"Endari is the first treatment approved for patients with sickle cell disease in almost 20 years," Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Excellence, said in an FDA news release. "Until now, only one other drug was approved for patients living with this serious, debilitating condition."
The decision follows consideration of data from a randomized trial of patients aged 5 to 58 years who had suffered two or more sickle cell pain crises within the 12 months before enrollment in the trial. The researchers randomly assigned patients to receive L-glutamine or placebo. Treatment was evaluated during a 48-week period.
Those who received L-glutamine experienced fewer hospital visits for pain crises that resulted in treatment with parenteral narcotics or ketorolac, on average, compared with those who received placebo (median three vs median four), fewer sickle cell pain hospitalizations (median two vs median three), and fewer hospitalized days (median 6.5 days vs median 11 days).
Those who were given L-glutamine also experienced fewer episodes of acute chest syndrome — a life-threatening sickle cell disease complication — compared with those who were given placebo (8.6% vs 23.1%).
Frequent adverse events include constipation, nausea, headache, abdominal pain, cough, extremity pain, back pain, and chest pain.
L-glutamine received orphan drug designation for sickle cell disease. The FDA's Office of Orphan Products Development (OOPD) is intended to incentivize the development of drugs for rare diseases. Development of this drug was supported in part by the OOPD Grants Program, which provides grants to conduct clinical studies on safety and effectiveness of treatments for rare diseases or conditions.
Approximately 100,000 people in the United States have sickle cell disease, according to the National Institutes of Health. The disease primarily affects African Americans, Latinos, and other minority groups. The average life expectancy for those with sickle cell disease in the United States is 40 to 60 years.
-VM

Parkinson's disease associated with melanoma: Research update

Hey Awesomites

Patients with movement disorder such as the Parkinson's are at four-fold higher risk for malignant melanoma, and vice versa. This is likely due to mutual genetic, environmental and pathogenic ( immune system ) abnormalities and factors that they both share, as suggested by a research study at Mayo clinic.
Source )

- Jaskunwar Singh

Friday, June 23, 2017

My Elective experience

Hey guys,

I was off blogging for a while for obvious reasons and I apologise for that. But, hey! Let me share the reason behind it :D
I was off to the States for my Clinical Electives at Mayo Clinic and Cleveland Clinic, so I'm going to briefly write about Electives in this post.

Overview of US Clinical Experience:

A) HANDS-ON Clinical Experience:
- One to one patient contact, can elicit history, perform physical examinations, write notes, suggest plan of care, have full access to patient records
- Considered better as what can be better than hands-on!
- Can be done only before a Medical Student graduates. ( Therefore, you can't do electives if you're already a Doctor -_-)

1. Sub-Internship equivalent to a 4th year US Medical Student
2. Clinical electives are equivalent to a 3rd year US Medical Student
3. Clerkship (This typically is for US Medical students; not applicable to IMGs)
4. Externships

B) NOT HANDS-ON Clinical Experience:
- You only get to observe (hence, Limited role in patient care)
- Can be done while you're a Medical Student or even after you graduate
- Controversial if it can be considered as USCE?

C) RESEARCH ELECTIVE:
- Usually, longer the elective, the better it is! (Increases yield of getting a fruitful publication out of it.
- No outlined criteria, eligibility varies from place to place.

Now,
I typically like to classify Clinical Electives into: (Although, others may classify them based on different criteria, I believe, classifying this way is logical in terms of expenses majorly)
1. USMLE Step 1 required
2. USMLE Step 1 NOT required
[I shall soon write a separate blog on this, pre requisites for elective application and rough expenses soon, so stay tuned as always :D]

About my elective experience:

I had given my USMLE Step 1 while I was in Third year. So, when I got into Fourth year I applied to Universities that had USMLE Step 1 criteria.
As now a days, getting electives is becoming more and more competitive, along with my friends, I applied to IMG friendly elective places well in advance  (about 10 months prior for a few places). This also meant that we had to wait for a long time to get our acceptances as they don't send out acceptances until 3-1 month prior to your elective start date.

Fortunately, I got accepted at Mayo Clinic, Rochester for Infectious Diseases elective and at Cleveland Clinic, Ohio for Endocrinology elective! Yippie!! (Big thank you to Ikan for guiding me with the application process)

Both, Mayo Clinic and Cleveland Clinic are amazing places to work at! (And if you don't already know, Mayo Clinic has been ranked no.1 and Cleveland Clinic has been ranked no.2 on U.S. News and World Report's Honor Roll :D)

What to do while you're there?

- Be professional, dress professionally, follow code and conduct of your Hospital or Clinic.
- Take histories, perform physical examinations as required, write patient notes, suggest plan of action and so on...
- Volunteer for case presentations/ talks
- If you find an interesting case while you're rotating there, discuss with your residents/ fellows/ attendings if you can submit it to a journal or present it at any conference.
- If you're interested in research, talk to your attending and try to get involved in one.
- Most importantly, As an IMG, it is crucial for us to get A Strong Letter of Recommendation. If you've been working hard, I am sure, most attendings would agree to write you a Strong LoR! Hurray!

Also, once you are done with your elective, in the following week or so, it is good to write your attendings a courtesy/ Thank you email, so that they know you really learnt during your elective!

Stay awesome!
-Rippie


Thursday, June 22, 2017

Immunotherapy for Prostate cancer

Hey Awesomites

Immunotherapy is now an emerging and much promising intervention in the treatment of prostate cancer, apart from the traditional cancer treatments - chemotherapy, radiation and surgery.