This document provides an introduction to clinical research and good clinical practice (GCP). It discusses the types of scientific and clinical research, including observational and experimental study designs. The document outlines the phases of clinical trials from I to IV. It emphasizes the importance of ethics in research and describes GCP as international ethical and quality standards for clinical research. GCP aims to protect research participants and ensure valid, reliable results. The document lists the parties involved in clinical research, including investigators, sponsors, and ethics committees, and their roles and responsibilities.
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
Clinical Trial Registration
International Clinical Trials Registry Platform (ICTRP)
What is the Primary Register?
Clinical Trial Registry - India (CTRI)
Goal and Objectives of the Registry
How to Register?
How to prepare and handle a FDA Inspection. When the FDA conducts an audit of your company, you need to be prepared. This presentation shows you what to do when your are faced with a FDA Inspection. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-inspection/
changes and yet everything is completely different."
Clinical Research has evolved a long way since its inception, whether documented or not. It traverses a long and amazing journey. The recorded history of clinical trials dates back to the biblical descriptions of 500 BC. The journey encompasses from dietary therapy - legumes and lemons - to drugs.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of PG thesis are also expected to be registered in the CTRI. The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own, provided ethics approval (in English) is available and the study has not begun enrolling. The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://icmr-nims.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication1, 2.
Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.
Siro Clinical Research Institute
Post Graduate Diploma in Clinical Research
www.siroinstitute.com
www.siroclinpharm.com
In this presentation from Validation Week Europe, Karen Ginsbury discusses the rigors, preparations, strategies, and the do's and the don't of the FDA Inspection process.
In clinical trials and other scientific studies, an interim analysis is an analysis of data that is conducted before data collection has been completed. If a treatment is particularly beneficial or harmful compared to the concurrent placebo group while the study is on-going, the investigators are ethically obliged to assess that difference using the data at hand and to make a deliberate consideration of terminating the study earlier than planned.
In interim analysis, whenever a new drug shows adverse effect on human being while testing the effectiveness of several drugs, we immediately stop the trial by taking into account the fact that maximum number of patients receive most effective treatment at the earliest stage. Interim analysis is also used to possibly reduce the expected number of patients and to shorten the follow-up time needed to make a conclusion. One wouldn't have to spend extra money if he/she already have enough evidence about the outcome. In this presentation, the total sample size is divided into four equal parts to perform the analysis and decision is made based on each individual step.
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
.
.
.
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
An Introductory Presentation to Clinical Research. A go through from this presentation will give you a brief and clear introduction about Clinical Research.
the ppt describes in detail the translational research and path of the drug from lab to bed side, CONSORT guidelines, DCGI guidelines, CTR-I, the GCP principles, medical ethics, sample size estimation for RCT, RCT designs including cross over design and factorial design, Randomized permuted blocks, blinding and matching.
When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.
This presentation will provide a basic overview of clinical research process.
Clinical Trial Registration
International Clinical Trials Registry Platform (ICTRP)
What is the Primary Register?
Clinical Trial Registry - India (CTRI)
Goal and Objectives of the Registry
How to Register?
How to prepare and handle a FDA Inspection. When the FDA conducts an audit of your company, you need to be prepared. This presentation shows you what to do when your are faced with a FDA Inspection. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-inspection/
changes and yet everything is completely different."
Clinical Research has evolved a long way since its inception, whether documented or not. It traverses a long and amazing journey. The recorded history of clinical trials dates back to the biblical descriptions of 500 BC. The journey encompasses from dietary therapy - legumes and lemons - to drugs.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of PG thesis are also expected to be registered in the CTRI. The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own, provided ethics approval (in English) is available and the study has not begun enrolling. The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://icmr-nims.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication1, 2.
Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.
Siro Clinical Research Institute
Post Graduate Diploma in Clinical Research
www.siroinstitute.com
www.siroclinpharm.com
In this presentation from Validation Week Europe, Karen Ginsbury discusses the rigors, preparations, strategies, and the do's and the don't of the FDA Inspection process.
In clinical trials and other scientific studies, an interim analysis is an analysis of data that is conducted before data collection has been completed. If a treatment is particularly beneficial or harmful compared to the concurrent placebo group while the study is on-going, the investigators are ethically obliged to assess that difference using the data at hand and to make a deliberate consideration of terminating the study earlier than planned.
In interim analysis, whenever a new drug shows adverse effect on human being while testing the effectiveness of several drugs, we immediately stop the trial by taking into account the fact that maximum number of patients receive most effective treatment at the earliest stage. Interim analysis is also used to possibly reduce the expected number of patients and to shorten the follow-up time needed to make a conclusion. One wouldn't have to spend extra money if he/she already have enough evidence about the outcome. In this presentation, the total sample size is divided into four equal parts to perform the analysis and decision is made based on each individual step.
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
.
.
.
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
An Introductory Presentation to Clinical Research. A go through from this presentation will give you a brief and clear introduction about Clinical Research.
the ppt describes in detail the translational research and path of the drug from lab to bed side, CONSORT guidelines, DCGI guidelines, CTR-I, the GCP principles, medical ethics, sample size estimation for RCT, RCT designs including cross over design and factorial design, Randomized permuted blocks, blinding and matching.
When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.
This presentation will provide a basic overview of clinical research process.
Research for Medical Students: Luxury or Necessity?Sohail Bajammal
An invited keynote speech, delivered on April 22, 2014 at the 4th Medical Students Research Symposium, Faculty of Medicine ay King Fahd Medical City, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
It argues the necessity of research methodology teaching in medical schools.
The physician shall comply with observing the implementation of all moral criteria and guidelines as well as the social and religious values laid down by the competent authority for conducting medical research on human beings
Clinical trials: quo vadis in the age of covid?Stephen Senn
A discussion of the role of clinical trials in the age of COVID. My contribution to the phastar 2020 life sciences summit https://phastar.com/phastar-life-science-summit
This presentation covers the guidelines for follow up of patients with Hodgkin's lymphoma after they achieve complete remission and complete their therapy.
This is an overview of the adjuvant Tx of pancreatic CA. A Lecture that was given in the annual conference of NCI Egypt: 45 years against cancer in Egypt. Cairo, April, 2013
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
Follow us on: Pinterest
Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
4. Clinical Research
• Observations
• Relations
• Question? Is there a
relation between the time
of car-oil change and •
temperature?
• Hypothesis? Increasing
temperature decreases the
time of car-oil change and
temperature?
5. • Define measurement scales:
– Temp: degrees centigrade
– Time in minutes
• Collect data
• Test hypothesis 70
60
Temperature (oC)
50
• Conclusion: 40
-increasing temp form 0-25 30
oC decreases time 20
10
-while increase above 25 oC 0
increases the time 0 10 20 30
Time (min)
40 50
6. Scientific research
• Systematic investigation of hypothetical
propositions about the presumed relations
among observed phenomena.
8. Clinical research
• Is there a relationship
between Eczema and
number of car-oil change
in workers?
• Number of car-oil change
in workers
– Limits: 16/day
• Eczema
– Limits: non-invasive
(inspection and not biopsy)
– Eczema score: area in CM x
severity (0, 1, 2 3)
13. Why subjects engage in research?
– To help their diseases
– To help other patients
– Other benefits:
• e.g. payment
Ahmed Zeeneldin 13
14. Is research beneficial to patients?
• WE DO NOT KNOW:
– It could be beneficial
(Hopefully)
– It could prove harmful
– It could prove of no
benefit
Ahmed Zeeneldin 14
15. Research vs. routine practice
• Practice:
– Standard
– approved
– benefit
• Research: may not always benefit:
– Non-standard
– Non-approved
– Benefit?
• May receive highest care
• May directly benefit
• May be harmed
• Research gives Knowledge for better health
• Individual: respect, safety and dignity
Ahmed Zeeneldin 15
16. Study designs in health research
• Observational:
– No intervention
• Experimental:
– Intervention and outcome
• Semi-experimental
• True-Experimental
Ahmed Zeeneldin 16
17. Study designs in Clinical Research
• Observational:
– Research
– Not clinical trials
• Experimental:
– Research
– As well as clinical trials
Ahmed Zeeneldin 17
19. Cross-sectional studies
• Example:
– Obesity and Skin cancer
•.
Total SKIN cancer
Obese 350 (70%)
Non-Obese 150 (30%)
Total 500 (100%)
Ahmed Zeeneldin 19
20. Case-control studies
• Example:
– Lung cancer and smoking in Gharbia
Lung cancer No-lung cancer
Smoking 450 (90%) 150 (30%)
No-smoking 50 (10%) 350 (70%)
Total 500 500
Ahmed Zeeneldin 20
21. Cohort studies ﺟﻤﺎﻋﺔ
• Example:
– Skin cancer following chest wall irradiation for
Breast cancer
Breast CA+RT Breast CA- RT
Skin cancer 10 (10%) 4 (1.3%)
No-SKIN cancer 90 (90%) 296 (98.7%)
Total 100 300
Ahmed Zeeneldin 21
22. Experimental Research
Interventional Research
• Phase I
• Phase II
• Phase III:
– Randomized controlled trial (RCT)
• Phase IV
Ahmed Zeeneldin 22
23. Experimental Research
Interventional Research
• Phase I • Semi experimental
• Phase II • Semi experimental
• Phase III: • True experimental
– Randomized controlled
trial (RCT)
• Phase IV
Ahmed Zeeneldin 23
24. Example of clinical trials
• Use of Nigella Sativa oil in treatment of
metastatic malignant melanoma
• اﺳﺗﺧدام زﯾت ﺣﺑﺔ اﻟﺑرﻛﺔ ﻓﻲ ﻋﻼج ﺳرطﺎن اﻟﺟﻠد اﻟﺻﺑﻐﻲ اﻟﻣﻧﺗﺷر
26. Steps
• Preclinical R
– Lab: manufacturing and
purification, solubility and preservation
– Cell lines
• Effective or not
– Animals
• Safe or not?
– Dose and frequency and duration AND Route
• Efficacious or not?
• Clinical R
– Safe or not? à phase I
– Efficacious or not? à phase II
– More effective than current
chemotherapy? à phase III
• What is next?
28. Why we use trials?
• Animal and human trials
• Predictability of safety and efficacy
• Animals:
– Safety prediction
– Diseases are different in animals: X efficacy
• Humans:
– Safety and efficacy prediction
• Prediction is never perfect
Ahmed Zeeneldin 28
32. Pre-clinical animal research
• How long will guinea pig
live in atmospheric
temperature below 0°?
• How long will a guinea
pig live without food or
water?
• Carcinogenicity of car-
oil on guinea pig skin?
33. Clinical research
• How long will a human live in
atmospheric temperature
below 0°?
• How long will a human live
under a collapsed house
without food or water?
• This will decide the time
rescuers will spend on
searching?
• Carcinogenicity of car-oil on
human skin?
34. Clinical research
• Are these trials
acceptable?
• Is this clinical research
practice bad or good ?
• BCRP
• GCRP= GCP
35. Good Clinical Practice (GCP)
• By GCP we mean:
– Set of standards for clinical research
– From design àconduct à monitoring/auditing
à recording à analysis à reporting
• Aspects of GCP
– Science
– Ethics
– Quality
36. GCP
1 Value (science), ،اﻟﻘﯾﻣﺔ
2 Validity (quality), ﺻﻼﺣﯾﺔ
3 Fairness (justice), اﻟﻌداﻟﺔ
4 Risk– benefit ratio ﻧﺳﺑﺔ اﻟﻣﺧﺎطر واﻟﻣﻧﺎﻓﻊ
(beneficence), ()اﻟﻣﻧﻔﻌﺔ
5 Protocol and its اﻟﺑروﺗوﻛول
Independent review, اﻟﻣراﺟﻌﺔ اﻟﻣﺳﺗﻘﻠﺔ
6 Consent, اﻟﻣواﻓﻘﺔ اﻟﻣﺳﺗﻧﯾرة
7 Respect اﻻﺣﺗرام
(Emanuel et al. 2000)
Belmont report, 1979.
37. GCP rules
• Social and scientific Value:
– respond to health needs and
– provide a sound question whose answers will advance
knowledge for the good of science and society.
• Validity (Quality):
– data generated from CR should be valid and interpretable
through proper design, endpoints and methodology.
• Fair subject selection:
– being non-biased and based of scientific grounds.
• Favorable risk– benefit ratio:
– through minimization of vulnerability and risk as well as
maximization of benefits.
38. • Independent review:
– to ensure adherence to the ethical guidelines in design, conduct
and analysis.
• Informed consent:
– the process that provides adequate information allows only
voluntary participation.
– Consent withdrawal should be allowed anytime in the research.
– Consent does not deprive subjects from any of their rights nor
does it alleviate researchers from their responsibilities in
protecting safety, rights and welfare of subjects.
• Respect for the enrolled subject’s:
– autonomy, right and welfare both during and after research.
– Individual’s rights and welfare should precede that of science
and society
39. BCP (Bad Clinical Practice)
• Does skin exposure to car-
oil leads to skin cancer?
• Orphan house
• Deal with manager
• Paint their skin with car-oil
daily for 8 hours then wash
• Do regular punch biopsied
of the skin each month
• Follow them without
treatment for the rest of
their lives
40. Good or bad
Point Fulfill Bad Good
ment
Value √ Skin cancer following Skin cancer following
exposure to car-oil exposure to car-oil
Validity (design) X Artificial exposure Spontaneous natural
exposure
Fair X Orphan house Oil station workers
risk– benefit ratio X No Tx allowed Tx allowed
Independent review X No Yes
Consent X No Yes
Kids Adults
Respect X Withdrawal not allowed Withdrawal allowed
41. Historical background of GCP
460 BC Oath of Hippocrates
1930's U.S. Food, Drugs and Cosmetic Act
1947 Nuremberg Code (following Nazi experiments in WWII)
1948 Declaration of Human Rights
1964 Declaration of Helsinki
1979 The Belmont Report
1982 International Guidelines for Biomedical
Research Involving Human Subjects
1996 ICH-GCP guidelines issued
1997 ICH-GCP guidelines becomes law in some countries
42. Goals of GCP
• To protect the rights, safety and welfare of
humans participating in research
• To assure the quality, reliability and integrity
of data collected
• To provide standards and guidelines for the
conduct of clinical research
43. The 13 principles of ICH-GCP
• Ethics:
1. Ethical conduct of clinical trials
2. Benefits justify risks
3. Rights, safety, and well-being of subjects prevail
• Protocol and science:
4. Nonclinical and clinical information supports the
trial
5. Compliance with a scientifically sound, detailed
protocol
44. The 13 principles of ICH-GCP
• Responsibilities:
6. IRB/IEC approval prior to initiation
7. Medical care/decisions by qualified physician
8. Each individual is qualified (education, training,
experience) to perform his/her tasks
• Informed Consent:
9. Freely given from every subject prior to
participation
45. The 13 principles of ICH-GCP
• Data quality and integrity:
10. Accurate reporting, interpretation, and
verification
11. Protects confidentiality of records
12. Investigational Products Conform to GMP’s and
used per protocol
• Quality Control/Quality Assurance
13. Systems with procedures to ensure quality of
every aspect of the trial
47. Parties involved in research
• Investigator
• Subject
• Sponsor
• CRO
• Ethics
committee
• Regulatory
authorities
48. Summary
• Scientific research
• Clinical research
• Clinical trials
– Phase I, II, III and IV
• Ethics in research
• GCP: standards or guidelines to ensure research is
scientific, ethical and of good quality
• Parties involved in research and their role and
responsibilities
49. Thank You
Ahmed A Zeeneldin
Director of Research Center (RCENCI)
Tel: 01111 000 943
Email: azeeneldin@gmail.com
Ahmed Zeeneldin 49