This study evaluated the effects of atorvastatin for treating asthma patients through a double-blind randomized clinical trial. 62 patients with mild to moderate persistent asthma were alternately allocated to receive either atorvastatin or a placebo for 8 weeks. Asthma control was assessed before and after treatment using the Asthma Control Test questionnaire. The study found no significant differences in asthma control between the atorvastatin and placebo groups, indicating that atorvastatin was not effective for treating mild to moderate asthma over the study period based on the measures used. The summary discusses some limitations of the study related to sensitivity of outcome measures and potential bias from the alternating allocation method used.
Adverse Events and Serious Adverse Events - Katalyst HLSKatalyst HLS
Introduction to Adverse Events & Serious Adverse Events in Pharmacovigilance and Drug Safety in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Hello members...this powerpoint deals with A journal presentation, that aims at highlighting the "Efficacy & safety of Lacosamide in painful diabetic neuropathy patients".
This also elucidates a model of "Journal club presentation" for interested students.
Happy reading!!
:)
What you need to know about the Pharmacovigilance guidelines for companies marketing drugs in India. A concise overview of the six modules in the Guidance Document and the responsibilities of the Marketing Authorization Holders.
Adverse Events and Serious Adverse Events - Katalyst HLSKatalyst HLS
Introduction to Adverse Events & Serious Adverse Events in Pharmacovigilance and Drug Safety in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Hello members...this powerpoint deals with A journal presentation, that aims at highlighting the "Efficacy & safety of Lacosamide in painful diabetic neuropathy patients".
This also elucidates a model of "Journal club presentation" for interested students.
Happy reading!!
:)
What you need to know about the Pharmacovigilance guidelines for companies marketing drugs in India. A concise overview of the six modules in the Guidance Document and the responsibilities of the Marketing Authorization Holders.
Introductory lecture on some epidemiological models in causal inference, including the sufficient component cause model and the potential outcomes model.
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Ticagrelor in acute myocardial infarctionVasif Mayan
Potential benefits of dual antiplatelet therapy beyond 1 year after an MI has not been studied
Patients with MI are at increased risk of RECURRENT ISCHAEMIC EVENTS
Intensive secondary prevention is theoretically beneficial
Finding an ideal drug with best risk-benefit ratio is a challenge
TICAGRELOR
--- Direct acting
Not a pro-drug; does not require metabolic activation
Rapid onset of inhibitory effect on the P2Y12 receptor
Greater inhibition of platelet aggregation than clopidogrel
--- Reversibly bound
Degree of inhibition reflects plasma concentration
Faster offset of effect than clopidogrel
Functional recovery of circulating platelets within ~48 hours
PLATO trial
PEGASUS TIMI trial
Biostatistics Roles and Responsibilities in Clinical Research | PubricaPubrica
This Presentation explains the Roles and Responsibilities of Biostatistics in clinical research
Biostatistics helps to find answer for research question in Biology, Medicine and Public health
- How a new drug works
- What causes cancer
- what is the reason for many diseases
- How long could a person survive with a particular disease?
Learn More: http://pubrica.com/services/research-services/biostatistics-and-statistical-programming-services/
Contact:
Web: www.pubrica.com
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United kingdom : +44-1143520021
Slides from the presentation on extrapolation from progression free survival to overall survival in oncology given at the 2017 HTAi Annual Meeting in Rome
journal club is one of the important academic activity during MD/MS courses. Present PPT is a journal club presented on an article that compare two antihypertensives and the presentation also includes critical analysis of the article.
A brief description about Pharmacovigilance, aims and scope, need of pharmacovigilance, programs by WHO for international drug safety monitoring, UMC, VIGIBASE, WHO causality assessment scale and specific regulatory bodies of various countries
Cardiovascular safety of anti-diabetic drugs.Cardiovascular Outcome Trials ...magdy elmasry
Cardiologists and diabetes.Target organs and action mechanism of antidiabetic drugs.Cardiovascular Outcome Trials
( CVOTs ) in Diabetes.Completed and ongoing CVOTs in type 2 diabetes.Diabetes Medications
and
Cardiovascular Impact.Recommendations for management of diabetes
Cardiovascular safety of anti-diabetic drugs.
Let's Talk Research Annual Conference - 24th-25th September 2014 (Joy Gana-In...NHSNWRD
"The Impact of Self-Management Education on Outcomes for Patients with COPD Attending Pulmonary Rehabilitation": Joy Gana-Inatimi's presentation from the conference.
Introductory lecture on some epidemiological models in causal inference, including the sufficient component cause model and the potential outcomes model.
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Ticagrelor in acute myocardial infarctionVasif Mayan
Potential benefits of dual antiplatelet therapy beyond 1 year after an MI has not been studied
Patients with MI are at increased risk of RECURRENT ISCHAEMIC EVENTS
Intensive secondary prevention is theoretically beneficial
Finding an ideal drug with best risk-benefit ratio is a challenge
TICAGRELOR
--- Direct acting
Not a pro-drug; does not require metabolic activation
Rapid onset of inhibitory effect on the P2Y12 receptor
Greater inhibition of platelet aggregation than clopidogrel
--- Reversibly bound
Degree of inhibition reflects plasma concentration
Faster offset of effect than clopidogrel
Functional recovery of circulating platelets within ~48 hours
PLATO trial
PEGASUS TIMI trial
Biostatistics Roles and Responsibilities in Clinical Research | PubricaPubrica
This Presentation explains the Roles and Responsibilities of Biostatistics in clinical research
Biostatistics helps to find answer for research question in Biology, Medicine and Public health
- How a new drug works
- What causes cancer
- what is the reason for many diseases
- How long could a person survive with a particular disease?
Learn More: http://pubrica.com/services/research-services/biostatistics-and-statistical-programming-services/
Contact:
Web: www.pubrica.com
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United kingdom : +44-1143520021
Slides from the presentation on extrapolation from progression free survival to overall survival in oncology given at the 2017 HTAi Annual Meeting in Rome
journal club is one of the important academic activity during MD/MS courses. Present PPT is a journal club presented on an article that compare two antihypertensives and the presentation also includes critical analysis of the article.
A brief description about Pharmacovigilance, aims and scope, need of pharmacovigilance, programs by WHO for international drug safety monitoring, UMC, VIGIBASE, WHO causality assessment scale and specific regulatory bodies of various countries
Cardiovascular safety of anti-diabetic drugs.Cardiovascular Outcome Trials ...magdy elmasry
Cardiologists and diabetes.Target organs and action mechanism of antidiabetic drugs.Cardiovascular Outcome Trials
( CVOTs ) in Diabetes.Completed and ongoing CVOTs in type 2 diabetes.Diabetes Medications
and
Cardiovascular Impact.Recommendations for management of diabetes
Cardiovascular safety of anti-diabetic drugs.
Let's Talk Research Annual Conference - 24th-25th September 2014 (Joy Gana-In...NHSNWRD
"The Impact of Self-Management Education on Outcomes for Patients with COPD Attending Pulmonary Rehabilitation": Joy Gana-Inatimi's presentation from the conference.
Poster Presentation Title: A Phase 1 clinical trial of a therapeutic prostate cancer vaccine containing PSA/IL-2/GM-CSF in PSA defined biochemical recurrent prostate cancer patients
Meeting: CRI-CIMT-EATI-AACR: Inaugural International Cancer Immunotherapy Conference: Translating Science Into Survival
Immunotherapy for cancer has had two main approaches that have lead to clinical applications. The first is stimulating immune responses to tumor cells with cytokines or cellular immunotherapy and the second is blocking tumor immune evasion and the associated inhibition of T-cell activation with antibodies to the CTLA-4 receptor, PD-1 receptor or PD-L1. At OncBioMune, we have taken a different approach and have developed therapeutic cancer vaccines that are a combination of tumor antigens (whole cells or proteins) with biological adjuvants (the cytokines IL-2 and GM-CSF). This study is a Phase 1a/1b clinical trial of a PSA/IL-2/GM-CSF vaccine in recurrent prostate cancer in hormone-naïve and hormone-independent patients. Major inclusion criteria include adenocarcinoma of the prostate, rising serum PSA and no measurable disease. Phase 1a examines the rate of dose limiting adverse events (DLAEs) in an initial course of 6 vaccinations (“induction vaccination”). The Phase 1b examines the rate of DLAEs with a continued coarse of an additional 6 vaccinations (“maintenance vaccine”). All patients will receive intradermal injections of the PSA/IL-2/GM-CSF vaccine at weeks 1, 2, 3, 7, 11, and 15. In an additional 28 patients the six maintenance vaccines will alternate IL-2 and the complete vaccine (PSA/IL-2/GM-CSF) at weeks 23, 27, 31, 35, 39 and 43. To date, twelve of twenty patients in the Phase 1a portion of the trial have received at least one vaccine injection and ten patients have received all 6 vaccines. Seven of the ten patients that have received 3 vaccines had increased responses to PSA in a lymphocyte blastogenesis assay and five of the nine patients had an increase in their response after 6 vaccines. None of the patients vaccinated in the Phase 1a portion have had a DLAE and enrollment continues in the Phase 1a.
These lecture notes were prepared by Dr. Hamdi Turkey- Pulmonologist- Department of internal medicine - Taiz university
Do Not Forget To Visit Our Pages On Facebook on the following Links:
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RANDOMIZED CONTROL trials
an assessment method
questions validity and applicability of many preventive and therapeutic procedures
reference Park's Preventive and social medicine
Randomized control trial is so called because the patients who constitute the unit of study are allocated into ‘study group’ and ‘control group’ at random depending upon whether they receive or do not receive the intervention.
Freshers in clinical research and regulatory affairs must go through this presentation. It will help you to understand the basis of clinical trial design as per European guidelines, which is the most preferred reference guideline. Initially, I also faced many problems to understand this concept. A student who is studying a clinical research diploma can also use this presentation for their basic understanding.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
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
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
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
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.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
2. Evaluation of Atorvastatin for the Treatment of
Patients With Asthma: A Double-Blind Randomized
Clinical Trial
Abdollatif Moini, Ghasem Azimi, Abdolhay Farivar
Impact Factor 1.913
3. Outline of presentation
1.Summary of article (1-18)
–introduction
– objectives
– Methodology
– Results
– Discussion
2.Epidemiology and biostatics concepts related to
article (19-22)
3.Critical appraisal (23-30)
4. Introduction
• Asthma is a global health problem. Despite the
availability of effective treatment, some
patients develop a type of asthma that is
insensitive to corticosteroid
• The anti-inflammatory and immunomodulatory
effects of satins are well-documented
5. Objective
• the potential therapeutic effects of
atorvastatin were investigated in asthmatic
patients
6. METHODLOGY
Study Setting Hospital -based
Study site asthma clinics of Arak University of
Medical Sciences , Rahahan, Arak,
Iran
Type of Study Randomised clinical trial
Sample Size 62
Study Subjects 18-70 years(grade2/grade3)
asthmatic patients
Scales used Asthma Control Test Questionnaire
(For primary out-come) 6
8. • Inclusion criteria –mild persistent/moderate
persistent asthmatic (grade 2/grade 3) aged in
between 18 to 70 years
• Exclusion criteria
1. taking satins at the time of study
2. h/o of sensitive to satins
3. severe asthma leading to hospitalization within a month
prior to study
4. Smoking
5. hepatitis or active liver disease, myopathy or myositis,
6. pregnancy
9. Methodology
mild persistent to moderate persistent asthma (grades 2 and 3 of severity criteria
for asthma) aged 18 to 70 years who presented at asthma clinics of Arak
University of Medical Sciences from 24 October 2010 to 10 April 2011
73 agreed to participate
Volunteer patients were alternately allocated to the intervention
and control group based on timing of entering study
11. ASTHMA CONTROL TEST
• The ACT is a 5-item patient-administered survey for
assessing asthma control
• Each of the 5 questions is given a score from 1 to 5.
• Responses from the ACT are summed to yield a score
that ranges from 5 (poor control) to 25 (complete
control).
• A cut-off score of 19 or less identifies patients with
poorly controlled asthma.
12. Ethical clearance
• The research protocol was approved by the
Scientific Ethics Committee of Arak University
of Medical Sciences, and written informed
consent was obtained from the volunteers
13. STATISTICAL ANALYSIS
• Statistical analysis carried out with software SPSS 16.0
• Chi-squared test and student t-test were used to compare
the treatment and control group
• independent and dependent t-test were used for the
comparison of groups and subgroups
13
17. DISCUSSION
One probable reason for the lack of a significant clinical
response to satins in this study, as well as in other
human studies, is that the therapeutic effects observed
in vitro and in mice do not necessarily occur in humans
Favourable clinical response requires a higher drug
dosage or a longer period of treatment, or that the
variables selected in this study were insufficiently
sensitive to show improved asthma control
atorvastatin is not effective for the treatment of mild to
moderate asthma 17
18. Limitations
• Did not have access to more sensitive
quantitative methods for evaluating airway
hyper-responsiveness and inflammation.
eg: using a peak flow meter, methacholine
challenge test, CRP assay, number of saliva
eosinophils, the fraction of exhaled nitric oxide,
or alveolar nitric oxide.
18
19. Randomization
Randomization gives each participant a known (usually equal)
chance of being assigned to any of the groups. Successful
randomization requires that group assignment cannot be
predicted in advance.
Basic Benefits of Randomization
• Eliminates assignment basis
• Tends to produce comparable groups
• Produces valid statistical tests (valid false positive error
rates)
20. Why Randomize?
• If, at the end of a clinical trial, a difference in outcomes
occurs between two treatment groups (say, intervention
and control) possible explanations for this difference
would include:
• the intervention exhibits a real effect;
• the outcome difference is solely due to chance
• there is a systematic difference (or bias) between the
groups due to factors other than the intervention.
Randomization aims to obviate the third possibility.
21. Forms of Randomization
• Simple Randomization
• Permuted Block Randomization
• Stratified Block Randomization
• Dynamic (adaptive) random allocation
22. Alternative allocation vs.
Randomisation
• Some investigators incorrectly believe that an
alternating assignment of participants to the
intervention and the control groups (eg-ABABAB…..)
is a randomization
• No random components exits in this type of
allocation except the first participant
• A single-blind or unblinded study, the investigators
know the next assignment that lead to bias
• In double-blind study, if the the blind is broken at
one participant then entire sequence of assignment
is known
24. CRITICAL APPRAISAL-1
• Title and abstract are clear with study design,
balanced summary of what was found
• Background explains the scientific rationale for the
study
• In objectives they mention that the study, the
potential therapeutic effects of atorvastatin were
investigated in asthmatic patients ,but they have
only considered grade-2/3 asthmatic patients in the
study
24
25. CRITICAL APPRAISAL-2
• Inclusion and exclusion criteria for participants are clear
• Settings and locations where the data were collected are
mentioned
• The interventions for each group with sufficient details to
allow replication, including how and when they were actually
administered
• Completely defined pre-specified primary and secondary
outcome measures, including how and when they were
assessed
How sample size was determined is explained
26. CRITICAL APPRAISAL-3
• Detail description of randomisation is not given
• Alternately allocation doesn't survey the purpose of
randomisation
• Statistical methods used to compare groups for
primary and secondary outcomes are mentioned
• A table showing baseline demographic and clinical
characteristics for each group
• Participant flow diagram is given but steps of
randomisation and voluntary data missing is not
clear
27. CRITICAL APPRAISAL-4
• Silent about possible bias
• Internal validity is questionable d/o selection
bais
• Generalisability of this result is not possible to
all asthmatic patient as it uses grade-2/3
asthma in sampling
• Silent about funding
27
The idea of randomisation, first introduced in the design of agricultural experiments by R.A.Fisher, ensured that true treatment effect could be separated from other effects arising from differences in experimental conditions or differences in the subjects studied. Randomisation did not feature in clinical trials until Bradford Hill introduced it formally in a trial of streptomycin for tuberculosis in 1948. Today randomisation is regarded as an essential feature of a well conducted clinical trial.