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In hospitalized COVID-19 patients, the viral load was significantly reduced by ronapreve drug: clinical trial phase III results of Roche Diagnostics

 

Roche is a leading biopharmaceutical company that has spearheaded the fight against COVID-19 pandemic. Its phase II/III clinical trial showed positive results when the combination of casirivimab and imdevimab drugs were administered to hospitalized patients of COVID-19. Ronapreve is the combined medication of casirivimab and imdevimab drugs.

The testing of this medication was successful as it significantly decreased the viral load of COVID-19 patients who consumed it for seven days. These patients were seronegative, that is, they did not exhibit any antibody response. Moreover, they were treated with low-flow supplemental oxygen.

The pandemic of COVID-19 has been devastating, accounting for more than 4.7 million deaths across the world. Most hospitalized patients succumbed to COVID-19 disease. Although vaccines are quite effective in preventing hospitalization of patients, a significant number of patients still are not vaccinated and their infection escalates, requiring hospitalization. The growing burden of healthcare systems has been eased out on the knowing the results of the latest clinical trial: ronapreve is quite effective in reducing the viral load of hospitalized COVID-19 patients.

In the phase III clinical trial, it was found that Ronapreve medication is safe and effective on COVID-19 patients who were hospitalized and non-hospitalized. Moreover, it is also effective as a preventive medication. The clinical trial of Ronapreve was double-blinded and randomized. The effect of placebo was also measured in this clinical trial.

Among the 1197 patients included in the trial, 530 patients did not receive supplemental oxygen whereas the remaining 667 patients received oxygen at a low-flow rate. Besides ronapreve medication, all the confirmed cases of COVID-19 received standard care in the form of corticosteroids (75%) and remdesivir (55%).

The companies Roche and Regeneron have jointly synthesized and tested the drug ronapreve, which is a combined form of two monoclonal antibodies, namely, casirivimab and imdevimab. The drug design of ronapreve is such that it blocks SARS-CoV-2, that is, the pathogenic virus that leads to the development of COVID-19.

 

 

 

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Healthcare workers do not develop COVID-19 symptoms after receiving mRNA vaccine

 

In clinical practice, healthcare workers may develop symptomatic COVID-19, so they are advised to take mRNA COVID vaccines as a recent study of researchers have found them to be very effective in preventing COVID-19. The study was published in the prestigious New England Journal of Medicine.  In this study, the chances of developing symptoms of COVID-19 decreased as much as 89% in healthcare workers who received two doses of Pfizer-BioNTech vaccine. The Moderna vaccine was even more effective as it reduced the risk of developing COVID-19 by as much as 96%.

The researchers found that the vaccines were effective even in people above 50 years of age. Moreover, certain ethnic groups or racial groups who were more prone to developing COVID-19 were the ones who benefitted the most from vaccination drives. Healthcare workers who were exposed to COVID-19 patients also got immunity with vaccine. Finally, patients with underlying medical conditions benefitted from vaccines but the efficacy of the vaccine was lower in patients with compromised immunity.

The study was conducted by researchers working at the Carver College of Medicine, which is affiliated to the University of Iowa in the US. In this study, 5000 healthcare workers were evaluated: 1482 healthcare workers were found to be COVID-19 positive because they were having symptomatic illness. Moreover, 3449 healthcare workers had symptoms of COVID-19 but they were tested as negative. As many as 33 academic medical centers from the US participated in this study. The participants had to complete a survey questionnaire and provide information about their demographics, type of job, risk factors, severe disease associated with COVID-19, and the status of their vaccination.

Although all the subjects received two doses of mRNA vaccines, the risk of developing COVID-19 was reduced by 95% in Afro American subjects. On the other hand, the risk of COVID-19 declined by about 89% in Asian and Hispanic subjects and by about 94% in American Indian people. In subjects whose immunity was compromised with underlying disease, the risk of developing COVID-19 decreased by only 39%, regardless of whether they received a single dose or two doses of  mRNA vaccine. Among pregnant women who received mRNA vaccine, the risk of developing COVID-19 decreased by about 77%. Even a single dose of the vaccine was quite effective in reducing the risk of COVID-19 as compared to those unvaccinated people. The study was conducted from December 2020 to May 2021.

 

 

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The RTS,S/AS01e (RTS,S) malaria vaccine of GSK received WHO recommendation

 

The World Health Organization (WHO) has recommended GlaxoSmithKline (GSK) company’s RTS, S malaria vaccine for children who are prone to developing this disease, especially those living in sub-Sahara, African countries. It is in these countries that malaria has moderate to high high rate of transmission among children. The RTS, S is the first clinically proven vaccine that has significantly reduced the incidence of malaria in children. It took more than 30 years of intense research to develop this vaccine. The team of researchers worked at GSK and PATH companies.

GSK is working with PATH and other leading NGOs in Kenya, Malawi, and Ghana, regions with moderate to high rate of malaria transmission. In these African countries, the company is developing programs to provide easy access to RTS,S vaccine on a long term basis. For the pilot project, GSK would be donating as much as 10 million RTS,S doses and has planned to provide upto 15 million doses each year, following its widespread recommendation among the masses. Moreover, GSK is going to do technology transfer to Bharat Biotech company in India. This company would also be producing antigens on a long-term basis.

The recommendation by WHO is now considered an important milestone in the success of the vaccine RTS,S. In the August issue of New England Journal of Medicine, a key finding about the vaccine was published. The finding was based on a study conducted on 6,000 children in London, UK. The study was conducted by London School of Hygiene and Tropical Medicine. In this study, the control group received seasonal doses of antimalarial drugs under the Season Malaria Chemoprevention (SMC) program. The experimental group received SMC and RTS,S vaccine. The study was carried out for three years. The incidence of malaria and hospitalization due to malaria were reduced by as much as 70% in the experimental group.

The pilot program of Malaria vaccine was launched in the year 2019. In the three African countries of Kenya, Malawi, and Ghana, the antimalarial vaccination program was introduced successfully. These countries have moderate to high rates of transmission of malaria. More than 800,00 children were vaccinated with at least one dose. Presently, GSK team of researchers have dispersed more than 2.3 million doses of the vaccine. They have even emphasized on delivering the vaccine through the conventional immunization program for children.

 

 

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Metastatic cancer can now be prevented and treated with plant virus

 

In Advanced Science journal, an important research study was published recently. Researchers at the University of California in San Diego made use of a plant virus to prevent metastatic cancer of lungs. This virus was found in plants of black-eyed peas. The growth of tumors was suppressed by treating the lungs with mice, who were suffering from metastatic cancer in breast tissue. Moreover, the plant virus also prevented the spread of this cancer to the lungs of mice afflicted with disease. Lung cancer is not just the most common metastatic cancer, it is also very dangerous and difficult to cure.

At the University of California in San Diego, researchers performed a successful experiment to control the metastatic form of lung cancer. Cowpea mosaic virus is a plant virus that they developed into the form of a body injection. Although the virus does not cause any harm to humans and animals, it is still considered as a foreign body that invades the host. Consequently, it triggers an effective immune response to fight cancer in the body of the patient.

The patient’s immune system is boosted by the plant virus as it tries to identify and destroy cancer cells, which are attacking the lungs. The virus does not cause any infection in the patient’s body. At the same time, the immune cells are alarmed and they go to search and attack the incoming pathogen. To elicit such an immune response from lung tumors, researchers synthesized nanoparticles from cowpea mosaic virus. These nanoparticles effectively attacked proteins in the lungs.

The infection in the lungs was fought back by immune cells, which secreted and expressed the protein S100A9. Researchers decided to target this protein because the growth and spread of tumors was triggered by an overexpression of the protein S100A9. They used nanoparticles to target the metastasis in the lung, thereby making their novel immunotherapy successful. The nanoparticles bind with immune cells that attack tumor cells in the lungs.

The microenvironment of tumor cells in the lungs is changed by localized nanoparticles, which effectively destroy not just well defined tumors but also prevent the growth of future tumors. Researchers synthesized nanoparticles by infecting black-eyed pea plants with cowpea mosaic virus in the lab. The harvested virus appeared in the form of spherical shaped nanoparticles. The target protein molecules S100A9 were then attached to the surface of nanoparticles. The study was successful in both the prevention and treatment of metastatic lung cancer.

 

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Researchers discover the mechanism of drug targets for COVID-19

 

In the latest issue of the journal Molecular Cell, a team of researchers from McGill University have uncovered the underlying mechanism through which drug targets control the progression of several inflammatory diseases, such as cancer, rheumatoid arthritis, and COVID1-9. These researchers have deciphered how cell receptors function within a patient’s body.

Whenever pathogens such as viruses attack human body, the body elicits defense mechanism. The complement system of cell receptors plays a pivotal role in eliciting a defensive response towards antagonistic pathogens. The pathogens that enter our body can either be bacteria or viruses. In the presence of a virulent attack, the complement system activates two membrane receptors, namely, C5aR1 and C5aR2. These were the findings of the international team of researchers.

Although the complement system should be activated in the presence of pathogens, there can be instances where the activation is excessive and uncontrolled. This is a dangerous situation as it can cause inflammation and even life-threatening complications in patients with COVID-19. Latest genetic technologies such as CRISPR are cutting-edge tools to unravel the exact functioning of C5Ar2 membrane receptor of cells, which were also observed through cryogenic electronic microscope. With this information, researchers identified therapeutic drug targets of COVID-19.

According to a noted medical professor, COVID-19 cases can be treated by blocking the activated expression of C5aR1 membrane receptor of cells. Moreover, Avdoralimab is a clinically tested drug that showed high efficacy in tackling severe pneumonia of COVID-19 patients. On the other hand, our current team of researchers were focused on targeting the expression of C5Ar2. For this purpose, they designed novel drug molecules that effectively clung to the receptor C5Ar2, blocking its activated expression and suppressing the related inflammation.

In molecular biology, it is a well-known fact that receptors surround human body cells. These receptors serve as drug targets, that is, the active ingredient of the drug exerts its pharmacological action on receptors, which also function as messengers. In other words, signals are transmitted and received by receptors of cells, which govern various physiological mechanisms in the human body. With the help of latest genetic technologies, our researchers could uncover important information pertaining to novel drug discovery and cell signaling processes.

 

 

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According to Cleveland Clinic, severe COVID-19 disease can be effectively controlled by steroid nasal sprays

 

Recently, a study conducted by Cleveland Clinic was published in the Journal of Allergy and Clinical Immunology. According to this study, severe COVID-19 infection was less likely to develop in subjects who used steroidal nasal sprays on a regular basis. These sprays were so effective that they reduced the chances of hospitalization and mortality by as much as 25%. Researchers at the Cleveland Clinic investigated 72,147 cases of COVID-19: all the patients were 18 years and above in terms of age. This is a very recent study that was conducted between April 1, 2020 and March 31, 2021.

The study cohort of patients included 12,608 hospitalized cases. Among them, as much as 2,935 cases were admitted to intensive care unit (ICU). Finally, the number of patients who died in hospital included 1,880. Interestingly, as much as 10, 187 patients were regularly using steroidal nasal sprays, which are nothing but corticosteroids administered through intranasal route. These patients used nasal sprays even before getting infected with COVID-19. Therefore, the chances of hospitalization declined by as much as 22% in these patients. Moreover, the need for ICU admission decreased by about 23% in these patients. Finally, the chances of dying in the hospital decreased by about 24%, as compared to patients who did not use steroidal nasal sprays.

These findings are quite encouraging to patients who regularly used intranasal corticosteroids. However, it does not mean that these corticosteroids are quite effective in treating and preventing COVID-19 disease. Yes, this seems contradictory but true. But several reports have endorsed the fact that in vitro use of intranasal corticosteroid would effective reduce the expression of ACE2, a protein receptor associated with SARS-CoV-2 virus. Thus, the virus would enter the cells and cause the spread of COVID-19. Nasal sprays contain corticosteroids, which belong to steroidal family of drugs. These nasal sprays are usually inhaled to control several nasal infections, such as stuffy nose, allergies, severe cold, etc.

Intranasal corticosteroids are either sold over the counter or with the help of prescription. However, researchers still do not know the exact mechanism through which these nasal sprays control COVID-19 infection. The findings of this study were coupled with the fact that the expression of ACE2 was highest in the mucosal lining of the nose. Based on this, researchers developed the following hypothesis: the viral load and the expression of ACE2 receptor can be suppressed in the nose with the use of intranasal corticosteroids, making them quite effective against severe COVID-19 infection. However, future studies must be conducted to validate the hypothesis.

 

 

 

 

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A nasal vaccine effectively prevents the transmission of COVID-19

 

The pandemic of COVID-19 has caught the world on fire! Not in the literal sense of the term, but it’s just plain breathing of SARS-CoV-2 virus that leads to the development of this deadly disease in the human body. Currently, most people across the world are aware of vaccines that fight COVID-19. These vaccines are injected through intramuscular route and not through the nose, although the virus simply enters the body through the nose. Most notable companies manufacturing COVID-19 vaccines are Pfizer and Johnson & Johnson.

Scientists believe that nasal vaccine would be more effective in battling COVID-19. This is because the mucosal lining of the nose will develop immunity against the virus, preventing it from entering the body and attacking the lungs. Recently, iScience journal has reported about how biomedical researchers of the University of Houston have developed a subunit of an intranasal vaccine. This vaccine is quite effective in boosting the immunity of the nose against pathogens inhaled by breathing.

These researchers believe that nasal vaccines are non-invasive, boosting both systemic immunity and the immunity of the mucosal lining of the nose. A large population of subjects can be immunized by nasal vaccines. However, they also highlighted a major drawback of nasal vaccines. Antigens cannot be efficiently delivered by mucosal route of vaccination. Moreover, these vaccines need to include suitable adjuvants that boost the immune system effectively without causing any toxic reaction in the subject’s body.

To solve the drawbacks of nasal vaccines, these researchers worked together with nanoparticle experts at the pharmaceutical college affiliated with the University of Houston, Texas. The team of pharmacists successfully captured the agonist that stimulated interferon genes (STING), which were present within liposomes of cells. Thus, they produced the adjuvant and christened it as NanoSTING. The immune response of the human body was stimulated by the adjuvant. The size of a NanoSTING particle is very small at about 100 nm. Nevertheless, it possesses properties that are completely different from that of a normal adjuvant.

 

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SARS-CoV-2 infection can now be controlled by a combination of new drugs

 

Although developed countries have now relaxed the rules of lockdown, the pandemic of COVID-19 is now complicated with an even more severe infection of SARS-CoV-2. This infection would have impeded the bounce back to normal life had there been no effective drugs to control the situation. However, this significant threat is now averted by some breakthroughs in recent research studies. Scientists have developed a combination of drugs named Nafamostat and Pegasys to control the pandemic. They are easy to use, effective, and fulfill the criteria of availability.

Laboratory synthesis of combination drugs

The combination of drugs named Nafamostat and Pegasys were quite effective in suppressing the life-threatening infection of SARS-CoV-2. These drugs were tested at the Department of Clinical and Molecular Medicine, Norweigan University of Science and Technology. A special cell culture was prepared to perform this experiment. The results indicated that the combination of drugs were quite effective, indicating that it is fit for human consumption.

Currently, COVID-19 infection is being controlled by administering monotherapy of Nafamostat. The efficacy of this drug is being extensively tested in laboratories of Japan and other Asian countries. Erstwhile, Pegasys was used to treat patients with hepatitis C. A combination of these two drugs seemed to have a positive impact on patients suffering from SARS-CoV-2 infection.

There is a factor named TMPRSS2 in our cells. It causes the replication of SARS-CoV-2 virus in cells. The combination drugs of Nafamostat and Pegasys effectively attacks this factor in cells, according to a leading professor of molecular biology at the laboratory.  This observation has become a major good news for researchers who are determining how effective is Nafamostat drug against COVID-19 infection.

A low dosage of combination drugs is needed against SARS-CoV-2 infection

The combination of Nafamostat and Pegasys drug is needed to low doses to tackle the serious infection of SARS-CoV-2. Not only has the clinical outcome of patients been positive, the side-effects of this combination therapy been minimum. These clinical advantages have been highlighted by a leading researcher at the laboratory. Although the combination of drugs is not cheap, it is indeed quite inexpensive. Thus, these life-saving drugs can be rendered to patients infected with SARS-CoV-2 all across the world. The only limitation is the fact that Pegasys drug is quite costly.

Scientists all across the world are working hard in the fight against COVID-19 pandemic, which has caused 4.55 million deaths all across the world. Moreover, there are many remote areas in this world where the cause of death is not known accurately, leading to a growing number of deaths unreported. Although an international team of researchers worked at the laboratory, the cohort of patients was only from Norway.

 

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The International Knowledge Civilization and Nanotechnology Conference (IKNC)

Harrisco is organizing the International Knowledge Civilization and Nanotechnology Conference on 19-21st August, 2021 in Seoul, South Korea. This interdisciplinary conference is inviting papers on public health, arts and humanities, religion, etc. The conference is specially focused on vaccines developed for the pandemic of COVID-19.

All overseas researchers can attend the event through online webinar. The conference papers will be reviewed by a strict panel of professors who have published papers in high impact international SCI journals. High quality selected papers will be published completed in a special issue of following SCI journals: The Journal of Dharma (Arts and Humanities), Iranian journal of public health (biomedical papers), and Ethiopian Journal of Health Development (Biomedical papers).

The last date for submission of Abstracts is 31st July, 2021. The last date for abstract acceptance is 3rd August, 2021. The due date for early registration is 6th August, 2021. All abstracts and papers will be checked for plagiarism by CopyKiller software. Complete papers can be submitted by 25th September, 2021. The conference is held in partnership with BIT Congress, an academic conference company in Beijing, China.

The 3rd IKNC conference invites interdisciplinary researchers and experts from both industry and academia. These people will present their work at a global platform and disseminate their knowledge pertaining to innovations. Novice researchers should use this platform for networking with the peer review team of eminent scientists who will also hold talks and presentations at the event.

How to submit the papers? This is the most frequently asked question by interested researchers. We have given all information on conference website www.iknc.org. The official language for abstract is English and researchers have to submit contact details of corresponding authors. The affiliation of authors should also be presented in the abstract. The wordcount limit for all abstracts is 150 words. In case of engineering papers, it should never exceed 250 words. All accepted abstracts need to receive Harrisco editing certificate by 5th August, 2021.

Authors whose abstracts have been accepted are requested to submit their full papers for the conference. A selected list of high quality papers will be published in full in the conference proceeding. All submissions have to be made in the Word template. Authors have to follow the guidelines of the journals that have collaborated with Harrisco for the conference. The guidelines will be provided to the authors with the letter of acceptance.

The online submission system will be accepting full papers till 25th September, 2021. The review process is rigid as the collaborated journals are high impact journals indexed by SCI, SSCI, A&HCI. After adhering to stringent review process, the selected high quality papers will be published after the author pay the additional publication fees.

It is mandatory to send all accepted papers to Harrisco for editing, and the company would be providing Harrisco editing certificate to these papers. Please refer to the company website en.harrisco.net. Both oral and video presentations would be for 20 minutes each. The authors would be given 5 minutes for Question and Answer session.

 

 

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In clinical drug trials of heart disease, women and older patients are under-represented


Doctors have to refer to randomized clinical trials to determine the best ways of treating patients. Furthermore, doctors refer to this information to also determine the most suitable drug that can be prescribed to these patients. Heart illness is the most common disease that afflicts the common man.

In recent years, it has been proven that the number of women having heart ailments would be greater than the number of men having the same ailment. Compared to younger people, older people have a greater tendency of developing heart condition. Does the data presented in clinical trials actually exhibit reality?

In most cases, the data does not actually represent the true picture. A new study was recently published in the journal Circulation: Cardiovascular Quality and Outcomes. Professor Quoc Dinh Nguyen works at Université de Montreal’s Faculty of Medicine.

He supervised a team of researchers who tested new heart drugs on mostly men (71 per cent); however, the majority of people afflicted with heart disease were mostly women. Moreover, the average age of male patients with heart disease was 63; however, the average age of patients who suffered the two most common heart diseases was in the range of 68–69 years.

In the past 20 years, the gender and age gap between subjects participating in drug trials has hardly diminished; however, the population seems to be aging rapidly. Professor Quoc Dinh Nguyen is a geriatrician who works at the Centre Hospitalier de l’Université de Montréal (University of Montreal Hospital Center).

In most drug clinical trials, both women and older patients are under-represented; therefore, both these groups of patients would receive comparatively lesser care. Unlike a young patient, an older patient does not really respond much to several treatments and medications.

Many-a-times, it is very difficult for patients to receive an exact dosage or intervention; moreover, each medication has a set of severe side-effects. However, we do not know the specific course of medication until and unless a large number of older patients are included in clinical trials. Most studies also do not include women in their clinical trials.

In the present scenario, the findings are obtained from a clinical trials conducted predominantly on male and younger subjects. These results do not really patient outcome of women and older subjects generally. Nguyen examined the issue closely while working as a geriatric resident.

They discussed with colleagues to realize that heart disease is a grey area to receive effective treatment. Resident physicians of other departments (anaesthesiology, psychiatry, emergency medicine, and cardiology) also collaborated in their efforts of improving the results.

A brief history

Nearly 20 years ago, researchers were concerned about how under-represented were several sections of the society, especially women. The results of clinical trials were quite often problematic in nature. With a team of researchers headed by Nguyen, we set off to find out if these practices had improved significantly.

The 25 most frequently cited clinical trials were examined closely every year. The examination period was of twenty years, ranging from 1996 to 2015. The data was published in the U.S National Health and Nutrition Examination Survey 2015-2016; this data compared how prevalent was cardiovascular disease in America . The data was classified in terms of following parameters: age and gender.

The research team examined data of following medical conditions: coronary artery disease, hypertension, heart failure, atrial fibrillation. This team also examined several risk factors contributing to cardiovascular diseases. This research team closely examined the correlation between diabetes and heart disease. Previous studies have reported that diabetic patients were more likely to suffer from coronary heart disease.

Bad results

Currently, a greater number of women and older patients are included in clinical trials; therefore, there has been a slight improvement in the representational bias of clinical trials. Eric Peters works as an anesthesiologist at the CHU Saint-Justine children’s hospital; he is the second author of this study.

Depending on our calculations, it would take another 90 years to understand whether clinical trial studies could present data correctly without bias. We need to correctly understand the factors contributing to coronary heart disease. The factors leading to aging population must also be considered in this situation.

After analyzing 500 clinical trials, we arrived at the following conclusion: only 29 percent of participants were women in this clinical trial. Moreover, the average age of participants was just 63 years. According to Nquyen, the reality is quite different in the hospital emergency rooms and departments; these departments are of internal medicine, cardiology, and geriatric medicine.

Women and older patients were hardly represented in clinical trials that were focused on determining the factors associated with CAD and heart failure. Women represent more than 54.6 percent of CAD patients. In clinical trials, more than 27.4 percent of participants for CAD were women.

Is heart disease really a man thing?

It is a general perception that men are afflicted with heart disease; however, most medical research studies have reported about results that are completely obsolete. Heart disease is the leading cause of women’s death in Canada. Fewer men die of heart disease in Canada. In general, heart disease would affect women at a later stage in life.

Nearly after 10 years, women would die of coronary artery disease and heart failure. There has been steady decline in the death caused by heart disease in women; moreover, death caused due to heart disease would be greater in men. One of the most common hypothesis is the fact that men receive timely medical treatment unlike women.

Why are women excluded from clinical trial?

In general, most women were excluded from clinical trials because it was advisable to give them medication during pregnancy; however, this principle should not have been applicable to drugs used for treating heart condition. This is because most patients with heart conditions are usually more than 60 years of age.

To select a woman to participate in clinical trial, we also need to consider the age of the woman. To ensure the adequate participation of women in clinical trials, older patients should be recruited. This is because women are afflicted with cardiovascular disease at a comparatively later stage of treatment, unlike men.

In general, it is difficult to conduct clinical trial of older patients. This is because most older subjects would find it difficult to move around; moreover, it is usually tougher for them to undergo a battery of clinical tests. Older the patients, higher would be their difficulty in moving around. In general, older patients do require several medications as they are afflicted with several ailments.