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Clinical Research - Science topic

Explore the latest questions and answers in Clinical Research, and find Clinical Research experts.
Questions related to Clinical Research
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Hi everyone
I'm looking for a good research subject for my Phd thesis in the hematology field.
Does anyone have a research subject in this field? I can submmit your name in the article as our team member.
Thanks
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Dear Masoumeh
Haematology is a big subject with several sub-specialities. If you are planning to do a PhD in a Haematology subject, you need to be a bit more specific. First, you decide whether you want to do a purely basic scientific research (eg haematopoiesis, cell/molecular biology of blood cancers, various inherited anaemias, bleeding diseases etc) OR applied or clinical research. The second step is to narrow down the field. You must choose a sub-speciality- malignant haematology, non-malignant haematology (general) bleeding/thrombosis, blood transfusion... The next step is to further dissect the selected field. For example, if you choose malignant haematology, then you must decide on the type of malignant disease (acute/chronic leukaemia, lymphoma, myeloma, MDS....). In other words, it should be a methodical process based on your interests. Another option is to go down the diagnostics and develop a new test platform (eg. biosensor). Hope you find this helpful.
Best wishes
Siva
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I am doing an clinical research in homoeopathy "Efficacy of Osteo Arthritis nosode in the treatment of osteoarthritis of knee joint" For the same I need guide lines.
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Research should begin with an educated idea arising from a clinical practice issue. A research topic rooted in a clinical problem provides the motivation for the completion of the research and relevancy for affecting medical practice changes and improvements. The research idea is further informed through a systematic literature review, clarified into a conceptual framework, and defined into an answerable research question. Engagement with clinical experts, experienced researchers, relevant stakeholders of the research topic, and even patients can enhance the research question's relevance, feasibility, and efficiency.
Planning and Conducting Clinical Research: The Whole Process - PubMed (nih.gov)
Consort - Welcome to the CONSORT Website (consort-statement.org)
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Hello,
I am looking thesis topic in clinical research management. I am planning start an internship at CRO company. Areas of interest- Comparative study or retrospective study; GCP , Adverse events reporting or clinical data management etc. Any suggestions will be helpful
Thank you
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thanks for the information. I am right now digging into a few areas, need to narrow it down to one or two. I am too curious and have an interest in adverse events reporting. I will definitely look more into it. Danial Hassan
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What order of authorship holds more weight after first author and senior author? Second author? Or second to senior (second to last)? Are there circumstances when one would be more valued over the other? (Clinical trial v standard clinical research)
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I think that defining the order of authors is one of the most difficult tasks when writing a paper, and there are no strict rules. There may be conflicts about this or even scientific misconduct. Sometimes the authors are indicated in alphabetic order (especially when there are many authors) because it would be not possible to estimate the amount of their contributions. Another method is to put the author who wrote down the results and managed the publication to the first place and list all other authors in alphabetic order. I know a case when two authors who wrote many papers together changed the order of their names from paper to paper. See also these previous discussions:
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After establishing the appropriate dose, clinicians wish to assess the efficacy and safety of a new intravenous agent in patients with recurrent, platinum-resistant ovarian cancer. The primary endpoint was Response Evaluation Criteria in Solid Tumour (RECIST) overall response rate (ORR). The researchers wish to exclude the uninteresting rate of 10%, with a more desirable response rate of 20%. They decide to use a significance level of 10%.
a) The investigators have asked you to calculate a sample size for this study. Write out an appropriate formula.
b) Using a 10% significance level, how many subjects would be required to exclude a response rate worse than 10%?
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Hi James
Thanks for your help. This is not a live exam question.
kind regards
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Is there any specific reason of reporting adverse events during clinical trial phase three in CIOMS format other than as specified by ICH?
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med watch forms in usa pvpi formsissued by cdsc and in clinical trial cioms form
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I am conducting a systematic review about a newly developed psychological intervention for children, but all studies available are of exploratory/feasibility nature and I am not sure how to evaluate/analyse their results.
I am wondering if anyone is aware of guidelines or articles regarding the decision process of going from a pilot/feasibility stage to full RCT?
I am sure this is a relevant question in many departments, deciding if the results from exploratory studies justify going further with expensive RCTs.
I have been looking in to Cochrane Library etc. to see how they evaluate evidence, but what I can find is mostly regarding making clinical guidelines based on evidence availible (RCTs and other sources of evidence).
If anyone knows anything about this process, guidelines for going from exploratory to RCTs, I would be immensely grateful since I feel a bit stuck on this question (how to analyse the results from feasibility/exploratory intervention studies, what criteria can be used for deciding to go ahead or not with RCTs etc..)
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Unfortunately, there is (as is so often the case in scientific research) no pre-determined answer for your question. You will have to consider, decide and substantiate the criteria for inclusion in your study. You might find this specific part of the Cochrane handbook you already consulted specifically helpful in the process:
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Radiology is a victim of its own success. Marked improvement in coverage and turn-around time, principally achieved through technology, has been met with ever increasing pressure for even improved metrics.  Academic departments are sacrificing their defining qualities to improve TAT and faculty surveys, hiring radiologists to work 24/7 in reading rooms that once allowed solo residents to transition to independent practice.  At what point does academic medicine stand up for what it believes in? At what point does there cease to be a significant difference between academics and private practice?
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I was even more surprised after the comment by Deborah Jean Verran that no answers/comments have been made in the five years after that!
Dr Darel E Heitkamp raises a very interesting point. In my community, a lot of academic departments have followed the trends of radiology practices/facilities in the private sector and have lost the "ethos" that was highlighted. The consultant/attending staff are pushed to report more and more. Nobody stands up, they just leave and take the "if you can't beat them, join them" approach. Those of us left behind get even more disillusioned.
Another value-add activity I have found is multi-disciplinary conferences.
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How to participate in clinical research after graduation. clinical practice experience is very important in addition to, research skills ... However, after finishing university it is very hard to find a place in research team or be a part of a clinical research. how can I participate in researching teams or international studies.. Especially if I am away from my University?
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Dear Dana Sultan, you can contact researches and demonstrate your related experiences and skills. Also, it is important to be participative and to have a CV. Also, you can continue your clinical practice and to participate from clinical researchers at the post-graduation programs.
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I am preparing to conduct a study to investigate the association between periodontal status and Kidney health in Saudi patients.
Is it logic to examine randomly selected patients in dental clinics (with unknown systemic diseases) to check periodontal health (1st variable), and then send the patients to nephrology unit to check kidney health (second variable)?
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Hello Dr Hassan H Kaabi.
we have done an extensive study on the relation between periodontal disease and many systemic diseases and we found that periodontal disease affects kidneys
Periodontitis had a significant direct effect, an indirect effect through diabetes, on the incidence of Chronic Kidney disease. Awareness about systemic morbidities from periodontitis should be realized
The American Academy of Periodontology (AAP)
has published a statement on kidney disease and tooth loss (periodontal disease)
Researchers Caution that Tooth Loss May Increase Risk of Chronic Kidney Disease in U.S. Adults
as for your questions about the selection of patients
dr Grubb Vanessa Grubbs, MD, an assistant professor and neprology specialist in the UC San Francisco's School of Medicine who is determined to advance this research as part of her commitment to preventing the chronic health problems associated with kidney disease.
you might want to contact he she can tell you how she selected patients
Dr Grubbsince 2013 has published that paper and i have attached it, it really shows you how she selected her patients and you might want to look at it even copy the method
the title of the paper is The association of periodontal disease with kidney
function decline: a longitudinal retrospective analysis
of the MrOS dental studyin Nephrol dial transplant 2016 31;466-472
i also attached a 2021 paper on the topic, good luck in your study that is a very important topic
sincerely
Dr.K.A.Galil.Professor of Medicine and Professor of Dentistry DDS.,D.Oral & Maxillofacial Surgery ,PH.D,FAGD.,FADI.,Cert.Periodontist(Uof Michigan) (Royal College Dent Surg.Ont) Departments of Periodontics,Orthodontics and Clinical Anatomy Schulich School Of Medicine and Dentistry. University of Western Ontario, London,Ontario.
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I am looking for a funding/ research grant database where you can easily search for upcomming grants based on your interest. Preferably where you can have a personalized account that stores your searches and sends you e-mail alerts.
There are quite a few USA based ones but I think they might be less relevant when living in the Netherlands. My interest is in health/ clinical research (hospital based).
Researchprofessional.com seems promissing. Could anyone recommend other databases?
Thank you.
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Thank you Ajit
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We are currently investigating an integrated treatment module for patients with PTSD and a comorbid eating disorder. Due to the novelty of the treatment, we wish to asses treatment acceptability (TA).
Sekhon et al., (2017) describe TA as ‘a multifaceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention’. TA appears to change over time, as various authors state that prospective TA, concurrent TA and restrospective TA may differ. Furthermore, clinicians and patients may differ in their perspectives on TA.
Serveral instruments have been developed, such as Treatment Acceptability/Adherence Scale (TAAS) by Milosevic et al., (2015), which measures prospective TA, or the Distress/Endorsement Validation Scale (DEVS, Devilly, 2004). Previous research has also utilized visual analogue scales or costumer satisfaction reports.
For patient TA, i'm thinking about administering the TAAS or DEVS at different time points (before, during or after therapy) to see how TA changes during the course of treatment. An alternitive idea would be to use a randomisation strategy, where each participant would either receive the questionnaire before, during or after treatment. It would be interesting to also assess therapist TA and to see whether or not these match.
Does this seem like a logical set up? Are there any methodological considerations to take into account? All feedback/suggestions are welcome, thanks in advance.
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Hi I am a new Clinical Researcher and need suggestion about citation manager. I am doing a systematic review and need a citation manager which has the maximum flexibility. I know little about Endnote but no idea about Zotero. Need help to make a decision.
I know Zotero is free but that's not a big issue . I need to know which one is the most potential in terms of wide range of managing and writing options.
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You can try Mendeley. It is very handy. Freely available.
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I work in a clinical research area where we give study drugs, usually intravenously, then draw PK's and other drug levels at specific time points following the administration. We have some investigators that say all post-administration blood draws must be done peripherally. While others say that after flushing a CVAD well and discarding some "waste" blood, the CVAD can be used for blood draws. of our patients have very limited peripheral access, so a peripheral blood draw may be impossible. Does any know if using a CVAD can skew any results or not? And if so, how long or how much fluid must go through the CVAD before it is considered alright to use? Thanks for your input.
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In general, the difference between IV and CVAD must be confirmed in animal before human kinetics. In addition, the difference is influenced by the kind of drug.
We must consider it based on scientific data only.
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Wondering if anyone here has done this Certification course before and can give a review. Is NIH Introduction to Principles & Practice of Clinical Research course worth doing?
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Although the content is good at explaining theoretical aspects of clinical research, I am not sure if the certification could be a plus in the CV. I took my chances and will see if it can be used as a hint in further PhD opportunities
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clinical research coordinator workload assessment tool
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Assessing clinical trial–associated workload in community-based research programs using the ASCO clinical trial workload assessment tool
Marjorie J Good, Patricia Hurley, Kaitlin M Woo, Connie Szczepanek, Teresa Stewart, Nicholas Robert, Alan Lyss, Mithat Gönen, Rogerio Lilenbaum
Journal of oncology practice 12 (5), e536-e547, 2016
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Fertility Center - IECH, Monterrey, Mx.
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Yes , I would be collaborate in reproductive research especially in the field of Male infertility and we can share our data for planed study project in this field
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This discussion section is about to Explore the issues that medical providers - doctors - nurses face during their battle, share your experience on covid unit,
In addition which factors facilitated in supporting you(mentaly and physically)?
How good does the developed protocols and plans of preparedness work on your facility?
Thank you for your time!
I am looking forward to your replies
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@Aldo P. Thank you. I think Health care workers around the world should be saluted and appreciated in many ways for the selfless acts of humanity we have all illustrated during these unspeakable times. Thank you for your service.
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I'm about halfway through a clinical trial for a behavioral health intervention (software). Our attrition rate is approximately 33%, i.e. 33% of participants do not make it from baseline to 30days. I am calculating effect sizes for each time interval in our preliminary data analysis.
Should I include the dropped participants in the Cohen's d calculation?
More specifically, d = M2-M1/SD, should I include dropped participants in M1?
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Hey Lawson, it depends on what principles you would use for the data analysis.
If you adopt the ‘per-protocol analysis’ that means only the data of subjects who have completed two time-points measurements will be used for the effects evaluation. Then you need to exclude the dropouts when calculating the effect sizes.
But if you use ‘intention-to-treat’ principles, you need to include all subjects (both completers and dropouts) in the data analysis.
Hope it would be helpfu.
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A number of clinical researches are going on. At the same time, outcomes of the completed clinical researches are published. they are at different stages of accomplishment. every research leads a future prospect. it seems research is a continuing process.
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When a book is being written, the author cites suitable research work related to the topic of the textbook. If the research has significant findings pertinent to the subject being written in the textbook, it will get cited. If many researchers are working on the same subject and consenses builds up or the experts in the field discuss the findings of the research and concur, it gets accepted by the scientific community and becomes standard of care and gets included in textbooks.
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What is your recommended analysis for the following problem:
I have 3 (treatment) groups and a non-randomized pre-post design. I want analyze the effects of the groups on the follow-up measure, controlled for the baseline measure.
If the pre-post measures were continuous, I would go with ANCOVA, using the follow-up measure as the dependend variable, the group variable as the factor and the baseline measure as a covariate. But what is your recommended analysis for binary pre- and post- measures?
* 3 treatment groups
* binary outcome (follow up)
* controlled for a binary covariate (baseline)
Thank you in advance for your help .
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Hi Christian,
In this situation, conducting a mixed-effects logistic regression including 'Group' (3 levels), and 'Time' with two levels (i.e., time1, time2) is the only approach I can think of. It will be important to give 'Subject' a random intercept in the model as well since the same individuals are being measured twice (1|Subject).
If you're familiar with R software, you can conduct such an analysis using the lmer() function. Something along these lines:
model <- lmer(DV ~ Group + Time + (1|Subject), data = data)
-Blaine
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We measured the number of epileptic crisis every 2 weeks for 42 days in patients using a placebo-controlled design. At different times of the experiment, some patients leave the clinical research protocol.
At the time of statistical analysis we did not find normality in neither Active group measurement, nor Sham ones, but we found homocedasticity.
We used Skillings-Mack test for intra-group analysis in Active group... We need a method to compare between groups.
Is there any non-parametric test like two-way repeated measures ANOVA for this case?
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Very interesting question, worth following.
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Hi
I am doing a clinical research on how the oseotomy direction (angles) affects the amount of the displacement of the bone,
the problem is, I meaured all the angles, and want to put them into three groups, like anterior cutting, neural cutting, and posterior cutting.
But as theres is no refernece for this paper (it is a genuine thing), i don't know hot to divide these patients and put into specific groups.
Would it by using mean and stadard deviation, so that putting anterior cutting and posterior groups who are out of 2 standar debvation?
I think if i do so, there would be too much with neurtral patiens, and little of anterior or posterior.
How do you usually put the patients of your measurements into the group definition?
thanks
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I think a good approach would be to bin the data. You can bin the data into three groups (or into however you want) that will have almost equal proportions. You can then describe the three bins according to their relative angle (e.g. anterior, posterior, etc).
Thanks
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Hi,
I am looking for some guidance on the appropriate statistical analysis for part of my study. I am looking at outcomes related to infection among 7 different groups based on source of the infection. I want to compare significance between all groups. For example:
Source 1: 2 Dead, 15 alive
Source 2: 9 Dead, 12 alive
Source 3: 9 dead, 5 alive and so on for 7 different groups.
What would be my best test to run? Thank you.
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The Appropriate test for comparison between each two groups is Chi square test. For the comparison among all groups kruksal walas test can be used to give a result that there is a significant difference among the groups.
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How often do you currently use AI in your research studies? Do plan to use AI more or less in the future?
Have you experienced problems introducing AI into your research?
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I had a research in applied AI and develop several AI models for clinical applications. Also, I plan to use AI in the future to support physicians in the clinical decision making.
The problems I observed so far are mainly related to two areas:
a) the lack of correctly annotated data (initial data to use for training of AI models)
b) the black-box nature of AI models demands for human input in the clinical decisions
The good thing is that the modern approaches like active learning and explainable AI answer (partially) the above mentioned problems.
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Recently GCP training is mandated for all researchers proposing to do clinical research? Who could impart GCP training? is there any official document specifying the qualifications of the trainer and the topics to be covered in training?
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I cannot direct you to a document specific to India, but I located an organization in India that provides GCP training. See the link below.
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I am analyzing a dataset. There I have 4 variables that are used to diagnose a disease. Among them, 3 were "Lab test report findings" e.g. Test A, Test B, Test C and 1 "clinical findings" i.e. "Test D (which is obtained by the clinical examination of the patient and is not established for the confirmatory diagnosis of the disease).
To confirm the diagnosis of the disease e.g. "Dengue", Each of the 3 lab tests i.e. A, B, C can independently be used for the confirmatory diagnose of Dengue. In my research, patients had done at least one of the 3 tests to confirm the disease. Some might have done all the 3 tests.
Also, among the patients, a great proportion had shown the positive result of the "Test D".
I want to establish that, the "Test D" could be one of the confirmatory tests along with the other 3 tests i.e. A, B, C. On top of that, "Test D" could be more accurate and reliable to confirm the Dengue compared to other lab tests i.e. A, B, C.
So, what statistical test should I be used to prove and compare the effectiveness of this clinical examination findings? Also, suggest me some graphs, that can visualize with this case)
N.B. All 4 tests had a dichotomous answer. The findings of these tests can either be positive or negative.
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I think you can show an association of the clinical variable with your disease state using linear/logistic regression and calculate Odd Ratio (OR). In addition, you may carry on same for other test, and compare their ORs. It does not need to test sensitivity, precision, and accuracy as like diagnostic tool (i.e., ROC-AUC). It would be supportive for follow-up experiments.
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According to my sample size estimation, the sample size comes to be 14. Would results from a trial with such a little number of subjects be valid? On the other hand I cannot increase the sample size beyond my calculated sample size except for adjustment for loss to follow up. Please suggest me.
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Hi Sir....As discussed above, you can always revisit the effect size (Cohen's d) taken for the sample size calculation. Taking a very large effect size may yield a very low sample size. using G power software will help you to calculate precise effect size and sample size for the your study.
Thanks
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A clinical trial was designed to have one interim analysis, hoping for early termination. Sample size was calculated using the O'Brien and Fleming spending function. Due to overrun of randomizing patients, early termination became unlikely, therefore it was decided to skip the interim analysis. How this decision will affect the study design - sample size, power, etc.? How the changes have to be communicated to regulatory authorities?
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From your description of the trial it looks to me like you made the decision to continue based on reasonable criteria and hence that should be approximately equivalent to any other reason to continue so I would not expect any changes to your final analysis plan. I am not an expert on these trials so I would defer to someone who is. Best wishes, David Booth PS since I do not know what the trial is about I assume that you have considered any relevant safety issues to the participants. If not, then I think you should.
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If an idea or concept from an ongoing study is used to perform a different study in a separate institution, how should the originator of the idea be acknowledged? Should the person be simply mentioned in the acknowledgements section or should author contribution be given?
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Actually, must be one of the authors , or at least will be get attention in the article like acknowledgment to emphasis about the role of idea generator , but my opinion , must be one of the authors
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Hello,
These Questionnaires are extensively used in both clinical and research settings. Berlin questionnaire has more questions and assists the patient snoring. But one disadvantage is that it only categorise patients to high or low risk. While STOP-bang questionnaire is shorter but it categorise patients to high , medium and low risk.
We are conducting a cross sectional study to find the prevalence of possible obstructive sleep apnea among dental patients based on sleep apnea questionnaire and oral findings (airway, tongue size...).
My question is: Which one of these questionnaires is recommended for such study?
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STOP-BANG Questionnaire is more reliably and easier to use
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I'm investigating the benefits or pitfalls of including lay or plain-language summaries with clinical studies. There are a lot of arguments for it (see research piece:
Would you consider this good, bad, necessary ....? What should a lay summary include as a minimum to ensure the paper is correctly represented? Is a different skill set required to write a lay summary - should the author write it or should it be written by an objective reviewer?
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It might need an endorsement from the author(s). Using international validated tools as the guidelines on http://www.equator-network.org is a good way to create the check-list of the plain-language summaries. Hopefully one day the guidelines incorporate this on their checklist
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We are clinicians, passing maximum time of our lives with many indoor patients. Quite often we observe some clear better outcomes or deterioration by certain regimen or management. We want to share this instantly in scientific way to other fellows but complexity of research methodology suppresses our eagerness many a time. Methods take lot of time and ultimately the intention disappears. Do you also feel it sometimes?
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Absolutely not
Statistics is indisputable for any clinical research.
Any clinical intervention should be based on rational scientific evidence to verify its benefit and to avoid harm. Empirical evidences from the accumulation of personal experiences are not acceptable, since the probability of recurrence of the outcome could not be quantified. Statistical methods are essential to quantify probabilities of events and to avoid (as much as possible) our inherent biases.
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Clinical research
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good question
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A subject in a trial had a significant reduction in both WBC and absolute neutrophil count. The decrease of white blood cells seems to be linked with the reduction of neutrophils. I was wondering to know if the two events need to be report separately.Thanks!
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If ony neutrophil count is below the lower limit of normal while each of the other WBC are in the normal range you need to report only low neutrophil count as adverse event.
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Double blind RCT
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Hima - 'authenticity' is not just reliant on levels and degrees of blinding. More blinding does not necessarily equate to more rigour. Other factors - such as levels of control, randomisation are key. A well conducted single-blinded trial is better than a poorer double-blinded. If both a single and double-blinded study are of equal quality - I would argue no one is better than the other - as long as the context for the level of blindness is well rationalised and justified in each case.
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Patients' loss to follow up during clinical trials is real frustrating issue, how to avoid and overcome?
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Check out this resource- its the Short guide on how to maintain successful involvement in EU funded research-
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Estamos en búsqueda de Centros de Investigación y oftalmólogos interesados en Investigación clínica en México.
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Si!!! Hola! Soy oftalmóloga con maestría en investigación clínica. A sus órdenes
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Do compromised "experts" play too large a role in marketing products for the large multi-national Pharmaceutical drug companies?
And what do we do about it?
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Dear Fazleh Mahomed
Its good question and delicate problem. I think some papers around this problem and available e-book may describe current situation:
Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns.
Conflict of Interest in Medical Research, Education, and Practice.
The European Medicines Agency is still too close to industry. https://www.ncbi.nlm.nih.gov/pubmed/?term=10.1136%2Fbmj.i2412
Best regards,
Tomasz
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I am looking for a platform for an efficient implementation of a Electronic Medical Records or Electronic Health Records
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Hi Fadoua Khennou and Mohammad Mosa Daradkah thank you for answers.
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Dear all,
Do you know some papers already published about nontechnical skills (training) for principal investigators in clinical research ?? or related to this....
Thank you
GD
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Thank you very much !!
Have a good 2019
GD
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Hi there,
We are doing research on one drug which has powerful sedative effect. But recent clinical researches indicated that this drug had analgesic effect. We are planning to test this analgesic effect in mice or rat. But we don't know how to exclude the sedative effect on its analgesic effect. Could you give us some suggestions?
Thank you in advance!
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Thank you so much for your response.@ Andrew Sutton
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How to decide total duration of treatment ( Ex: 12, 24 hours drug administration) and dosing schedule/ interval for NCE's in clinical research?
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The duration and interval in drug treatment according .
1. Pharmaco kinetics of drug including t half protein binding,metabolism and excretion. Narrow therapeutic index or not.
2.Therapeutic condition is acute or chronic, age ,underlying disease, renal and hepatic function and does of drug is calculated accordingly.
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Is there a threshold by which 24-hr Blood Pressure needs to be reduced by to be clinically relevant?
or is it possible to use the clinic-based blood pressure thresholds?
any papers would be appreciated.
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I'm a cardiovasculer surgeon.Therefore I cant answer this guestion
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Dear Colleagues,
My team is currently running several clinical research projects and we are in need of dedicated researchers who are able to contribute to our projects at different levels.
Collaborations may include literature review, data extraction from research papers, statistical analysis, and drafting a paper. The collaborator will be listed as a coauthor in the published paper and his/her place in the author list will be determined upon the level of contribution.
If interested or know of anyone seeking collaborative medical research, please contact me at the following email address:
We will be more than happy to work with you!
Regards
Saeed Shoar
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Cardiovascular; Obesity; Metabolic and Bariatric Surgery
But, we are open to launch new projects based on your suggestions.
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I wonder if there is another databases that I can find current clinical trials on certain topic, other than ( ClinicalTrials.gov )
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You can visit the following site which gives the list of international Clinical Trial Registries
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Dear Community,
I am currently planning an RCT. We originally planned a research design with an intervention group and a waiting-list control group and two measurement points (t0 at baseline and t1 as a 3-month follow-up).
We planned the control group as a waiting-list primarilly as an incentive to enhance participation in the trial for the control group participants and so we originally did not intend to use (or even measure) post- treatment data from that group in the statistical analysis. For this design we planned to analyze the data using an ANCOVA with time (t0, t1) as a covariate. The calculated sample size is N=128 (f=0.25, two groups, one covariate, alpha=0.05, power=0.8).
Now we we are required to include post- treatment data from all patients that received the intervention. What are your statistical recommendations for using post- treatment data of the waiting-list group?
I considered to use 3 groups in the ANCOVA (A: intervention group with its t0 and t1 measures, B: waiting-list group prior to the intervention with t0 and t1 and C: waiting-list group with their pre- intervention t1 and post- intervention t2). This would not affect the power calculation as only the number of groups would change from 2 to 3. But I do not consider such an approach as suitable because the two groups from the waiting list would not be independent. Additionally, this approach would use an unequal randomization ratio of 1:2.
I think, a mixed linear effects model also would not be suitable as the intervention group has data from two points of measurement and the waiting- list group is measured three times.
Any suggestions?
Best regards,
Chris.
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Have three timepoints for everyone, t0 at baseline, t1 when the control group switches to treatment, and t2 after about double that time. At t1 you have a between subject treatment comparison of treatment versus control adjusted for the t0 baseline covariate. You also have a within subject comparison within the control-treatment group. The right linear mixed model can combine those estimates under certain assumptions. And stronger assumptions can be made of course if blinding occurs and neither group knows who is on control or treatment to time t1.
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If anybody has attended Clinical Research Workshop, please let me know what are the modules and topics of these sort of workshops?
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Many thanks for the response. My area of interest mainly focuses on the modules to work out when doing with study design to conduct a trial. what can be the topics for study design in conducting a trial?
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Hi
I have a question.We did a clinical research for measuring a specific CD marker in special patients. But we forgot to measure it in normal people. Can we use the measurements of this marker as a controller from other researches in our article?
Do journals publish such work?
Thank you
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Thank You Emmanuel & agoOnengiyeofori .
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Many herbs and plants are said to have healing and health-giving properties. How effective and safe are these herbs? Is most of the evidence anecdotal or based on scientific, clinical research?
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Many scientific studies have been conducted on herbs. Traditionally, herbs are the oldest forms of medicine. They have been used for millennia--and very successfully. There are, of course, some herbs that are harmful, but these are known and catalogued. I used herbs clinically without any harmful effects for 46 years (since 1972). There are many good sources and resources to learn about the beneficial effects of herbs, among them www.greenmedinfo.com and www.naturalnews.com.
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Hi there,
I'm writing a research about "clinical research status in middle eastern country". I need to publish but don't have grant to pay fees. Can you help me in this? considering this is my second experience in writing.
Thanks,
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A good number of Taylor & Francis, Sage and Elsevier journals do not require article processing charge , unless you prefer to publish your work in their open access platforms. Check the website of the journal you wish to publish your work in. You sould be able to find information relating to the requirements for article submission. Alternatively, you may want to consider publishing your work in some credible open access journals. Check the following Directory of Open Access Journals: https://doaj.org/, and search for the journals that are relevant to your research area.
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A discussion about whether to start clinical research by writing review articles or original papers.
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original items would be better. Review articles take time, and they repeat/summarize what was done previously. In my opinion, you'd be better off investing your time toward an original item that contributes new knowledge to the field.
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Drug companies and medical devices industries provide financial support to clinical researchers, to medical meetings and also provide direct and personal support to physicians paying their travell expenses. How do you criticize those financial relations among health care industries and doctors? Are they ethical ? Should they be cancelled? Drug Advertising or Marketing of drugs should be forbidden? Do they influence clinical decisions and research results?
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Pharmaceutical promotional activities take many forms, including provision of samples, face‐to‐face meetings between industry representatives and prescribers, advertising in print and electronic media, and support for meetings and travel. There are a number of studies which report that the amount spent by pharmaceutical companies on promotional activities exceeds the amount spent on research and development of new drugs.
See, for example, a free-access paper by Komesaroff PA: “Ethical issues associated with gifts provided to physicians by the pharmaceutical industry” (available at doi:10.1111/j.1445-5994.2010.02215.x) published in the Internal Medicine Journal in 2010. It is a useful source of information on the influence that pharmaceutical companies have on clinicians. The author argues that “The concern is not merely that the evidence shows that all promotional activities influence prescribing behaviour (contrary to the protestations of many physicians) .… What is [also] of concern is the possible impact of this influence on both the form and content of healthcare delivery.” The paper also has many useful references.
One of these references, a pay-to-view paper by Wazana A: “Physicians and the pharmaceutical industry: Is a gift ever just a gift?” published in JAMA in 2000 (available at doi:10.1001/jama.283.3.373), the author notes that: “Meetings with pharmaceutical representatives were associated with requests by physicians for adding the drugs to the hospital formulary and changes in prescribing practice. Drug company–sponsored continuing medical education (CME) preferentially highlighted the sponsor's drug(s) compared with other CME programs. Attending sponsored CME events and accepting funding for travel or lodging for educational symposia were associated with increased prescription rates of the sponsor's medication. Attending presentations given by pharmaceutical representative speakers was also associated with nonrational prescribing.”
A pay-to-view paper by Greenway T & Ross JR published in The BMJ in 2017, titled “US drug marketing: how does promotion correspond with health value” (available at doi.org/10.1136/bmj.j1855) assesses the effectiveness, usefulness, and affordability of the drugs that get the heaviest promotion. This article also has useful references.
A free-access article by De Ferrari A, Gentille C et al., published in PLoS in 2014, titled “Attitudes and Relationship between Physicians and the Pharmaceutical Industry in a Public General Hospital in Lima, Peru” (available at doi: 10.1371/journal.pone.0100114) presents a study described as being in a undertaken in a resource-poor setting, “where a close relationship between physicians and industry still exists”.
This De Ferrari et al. paper also summarises a number of earlier studies as follows: The interaction between physicians and the pharmaceutical representatives adversely influences doctors’ behaviour and knowledge. There is a tendency for non-rational prescribing, more favourable attitudes towards industry representatives, preference for newer, more expensive drugs and an inability to identify incorrect claims about medications. Moreover, this effect on doctors’ behaviour and knowledge is dose-dependent: frequent contacts and acceptance of gifts (independent of the gift's value) imposes a need to reciprocate that affects medical judgment.
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As a newbie and low-budget neuroscience researcher, i'm looking for webcam based eye tracking softwares, which can measure ''duration of initial fixation'', ''total fixation duration'' and ''area of interest'' accurate and precisely.
I found gazerecorder, and somekind of out of date project;
is anyone recommend me, or used webcam tracers in their clinical research?
thank you for your answers,
Dr. Mirac
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Dear Mirac,
using webcam-based eye-tracking you obviously have to make a tradeoff compared to lab-based recordings in terms of accuracy. However, the fact that most laptops nowadays have an integrated webcam, can make this type of data recording cheap and easy to achieve
Since completing my PhD in Cognitive Science last year, I am working on the Labvanced platform (https://www.labvanced.com). Recently, we integrated the webgazer.js library (https://webgazer.cs.brown.edu/ into our event system. Using this, you get an eyeposition every few milliseconds, and hence can calcualte ''total fixation duration'' and ''area of interest'' etc. in a post hoc analysis. We also extend the functionality of webgazer in a way that with the Labvanced Event System you can use fixations on any object (i.e. fixation cross) as a trigger to control the experiment (e.g. go to the next frame). Find an example webcam-based eye-tracking study here: https://www.labvanced.com/player.html?id=2909
Last but not least I can say from our experience it is important to have a good webcam, good lightning conditions, make only few head movements, as well as make calibrations between trials.
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Dear Researchers,
I have questions, which reviewers usually raise the questions in a clinical research.
Suppose,
1. I do a clinical research; let’s say clinical outcomes of a surgical procedure. I have total number of operated patients are 50 in a particular time (let’s say -2014-2016) and I want to measure the postoperative outcome of that patients. How can I calculate a required sample size?
2. In a comparative study, I want to compare the postoperative outcome of a surgical procedure in two different groups of patients who underwent that particular surgical procedure in a particular time period (Let’s say between 2014-2016), Group A has total cases 50 and B also has 50. Now I want to compare the clinical outcomes of improvement of 2 groups of patients. How can I calculate a required sample size?
I am asking these questions because I have limited cases in that particular time period and there is no way that I can increase the sample size. So, how can I justify that I have adequate sample size?
Thank you and expecting your favorable response.
Regards,
Dr. Saroj
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Hi Saroj,
Essentially, there are two main ways of getting a sample size for any study.
1. Based on prior similar or closely related studies
2. Based on known, specific and relevant parameters in the population under study.
For the former you need to review your literature, for the latter, a combination of literature review and online tools such as epi calculators may be helpful.
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Is there any clinical research group working on the benefits of etanercept for aphasia?
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Are you talking about Primary Progressive Aphasia? I work with post-stroke and post-TBI aphasia, so I'm not that familiar with PPA. There is a center at Northwestern that might be able to give you more help. http://www.brain.northwestern.edu/dementia/ppa/index.html
Also, have you tried searching on clinicaltrials.gov?
A lot of research is being done using transcranial direct current and magnetic stimulation (tDCS and rTMS, respectively) as an adjuvant to speech therapy, so you might want to look for those too.
Best wishes,
Rosalind
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I am a student brand-new to clinical research. I read 10 chapters of Andy Field's Discovering Statistics Using SPSS to prepare myself to perform the statistical analysis on my research paper, and followed his steps closely. Do you have any suggestions on how I might best check my work? Is consulting a professional or faculty necessary, or are there rigorous methods to assure that I've correctly calculated everything?
Thank you!
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Jerry Miller's advice is spot-on! And thanks Jerry for the Gopal Kanji book recommendation. But I must disagree (in part) with Mohammed Yousif Abbas Mohammed - rather use an experienced researcher in your own field than a professional statistician, unless they are familiar with your field. Too often, pure statisticians will take a purist line that ties the beginner in knots. You need someone who knows what will be accepted in the field in question, and what will be publishable.
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I am trying to assess the capacity of clinical research sites and organizations in West Africa to conduct vaccine trials. I have designed a questionnaire, but i need to get a listing of these organizations with contact details. Online clinical trial registries have provided some details but they are very scanty. Also, it excludes those sites that have not been actively conducting or registering clinical trials online, but which, with a little push can be fully functional centers.
Can anybody PLEASE offer suggestions?
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To the best of my knowledge there are not too many of such in West Africa.
Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine is one of the most active. We have been at this for the last 70 years. Check out www.mrc.gm
You can also call +2204495442 and ask to speak to the Head of research governance, Dr Jonas Lexow.
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I'm planning to do a research based on questionnaire/ survey and population are clinical researchers from the whole country. The count of researchers in the country in unknown (I don't know how to get this info). My aim is to publish the results.
1- How to calculate the sample size?
2- Should IRB approve the research?
3- What is the least number of questions they should answer to be included in the stats? or percentage
4- Can I cite the same article(s) in more than on research? The information found in these articles are relevant and I can use for literature.
Thanks in advance.
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You need to identify the hypotheses, power, or beta (usually 0.80), p-value threshold, or alpha (usually 0.05), the statistical method you want to use and hopefully find an approximate effect you want to find (smaller effect needs larger sample). G*power is great and free. Power analysis assumes perfect distributions, so, you can consider increasing the sample size by perhaps 10-20%, to compensate for skewness and outliers in a continuous variable.
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Best EDC tool for Academic clinical research
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You may see the article titled: "Comparison of Electronic Data Capture (EDC) with the Standard Data Capture Method for Clinical Trial Data", that is available at: http://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0025348&type=printable
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It is recommended in some references to avoid the combination of metronidazole & mebendazole as the risk of steven johnson's syndrome is increased.
1-are there any statistics reg the prevalence of this interaction?
2-is it common in specific populations rather than others?
3-is it strictly contraindicated or just cautious?
4-are there any recommendation for spacing intervals if both needed?
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There is an interaction between Mebendazole and Metronidazole. Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. So all the resources ( Product information leaflet, FDA website, Stockley’s interaction) says to avoid concomitant use of mebendazole and metronidazole.
A case control study was conducted in an attempt to identify risk factors associated with an outbreak of Stevens-Johnson syndrome/toxic epidermal necrolysis that occurred amongst Filipino workers in Taiwan. The risk of developing this serious condition was significantly higher in workers who had taken both metronidazole and mebendazole sometime in the preceding 6 weeks (odds ratio of 9.5). In addition, there was an increase in risk with higher doses of metronidazole.However, Stevens-Johnson syndrome/toxic epidermal necrolysis is a serious condition, and therefore, the manufacturer of mebendazole states that the concurrent use of mebendazole and metronidazole should be avoided .
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In clinical research, some of the fundamental ethical issues that arise are the issues of exploitation, induced consent and an exposure of a research participant to an unjustifiable risk. If a pharma company deploys researchers from America to Nigeria with the aim of testing a trial drug that would be used to cure cancer, can this be an act of exploitation? What of if the participants were given some incentives before they were involved in the research protocols, could this be interpreted as a kind of inducement? How can these questions be addressed with the principle of equal moral consideration and human rights?
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I have to find a topic for my master study (Biotechnological Qualitymanagement). The planned direction would be Good Clinical Practice / Clinical Trials.
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Any comparative analysis of Adverse Events registered within clinical trials and in routine practice. Such studies are extremely important but still practically absent.
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I have started an MSc in Physiotherapy and am interested in the abovementioned area of (neuro-)rehabilitation.
Also I am interested in HIIT in the elderly, the frail and chronic stroke patients.
Any information is welcome! I am ready for information overkill!
Thanks.
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Patients will benefit more from doing regular gentle exercise for a good length of time, than exercising very vigorously for a short length of time or infrequently, as was recommended by stroke association.
I recommend very careful monitoring of blood pressure and other signs of exercise intolerance during exercising your patients. Unless blood pressure is carefully monitored, high blood pressure can cause brain blood vessels to rupture.
In addition, it was reported that high intensity exercises can cause detachment of atheromatous plaque from the wall of an atherosclerotic coronary artery, which would obstruct the lumen of the artery leading to myocardial infarction during exercise.
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Are there specific educational courses or a formal degree required in YOUR country to become a clinical researcher?
OR does YOUR country allow for on the job training alone?
What are the government's requirements to practice as a clinical researcher?
 
I am seeking what is required in specific countries, not the general WHO requirement.
Thank you for your input inadvance
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Get a degree in a science subject. Love a specific area and have a passion to investigate further. With a high GPA, you can kick of your career. A well experienced clinical researcher should endeavor to accomplish a PhD degree.
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Dear Researchers,
I would like to know,  how the sample size will be calculated for clinical research. In Ph.D seminar presentation. some of the panelists suggested taking 100 patient in each group (3 groups). But I am trying to choose only 50 per group as my condition of study is rare - unilateral neglect in stroke. please suggest.
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Dear RG colleague,
Determining the sample sizes involve resource and statistical issues. Usually, researchers regard 100 participants as the minimum sample size when the population is large. However, In most studies the sample size is determined effectively by two factors: (1) the nature of data analysis proposed and (2) estimated response rate.
For example, if you plan to use a linear regression a sample size of 50+ 8K is required, where K is the number of predictors. Some researchers believes it is desirable to have at least 10 respondents for each item being tested in a factor analysis, Further, up to 300 responses is not unusual for Likert scale development according to other researchers.
Another method of calculating the required sample size is using the Power and Sample size program (www.power-analysis.com).
Regards,
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The government in low-income countries give less priorities for research. As a consequences, It is difficult for researcher to generate fund for research which play a crucial role for sustainability of researcher. Please suggest international funding agencies who promote clinical research activities in low-income countries. Your suggestions are appreciable.
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Major Research Grants
The Private Enterprise Development in Low-Income Countries (PEDL) programme pursues a research agenda that aims to better understand what determines the strength of market forces driving efficiency in Low-Income Countries (LICs). Existing research suggests that the private sector in LICs faces a multitude of constraints that act upon each other. What is needed is research that allows us to understand how these constraints interact.
PEDL will support approaches that promise to produce credible research results that will be relevant for policy-making. It will promote research related to private enterprises of all sizes. PEDL will initially focus on four research themes, and research proposals should focus on one or more of these themes:
Market frictions, management and organizations
Trade and macro models - agglomeration and spatial location of firms
High growth entrepreneurship
Social compliance and the environment
Major Research Grants have an average grant size of £300,000. Note however that whilst there is a lower limit of £100,000 for each Major Grant, there is no upper limit. Cost effectiveness and value for money will also be important evaluation criteria.
These grants will fund research assistance, data collection and new surveys in low-income countries, and teaching buyouts for the principal investigator.
The deadline for the 5th round of MRG proposals was 2 October 2017.
** Please note that an important criteria for funding of proposals is the relevance to policy in Low-Income Countries and other elegible countries as defined by the PEDL Programme. See the list of the low-income countries here, DFID bilateral programme countries here and additional information available on our FAQ page.
For more information on the submission requirement and procedure, please see the How to Apply for a Major Grant.
For details on how to access the Major Grant application form and successfully submit an application, please refer to the Major Grant step-by-step guide
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According to the Mayo clinic research, is laparoscopy the gold standard for colon/rectal cancer surgery? what is your approach regarding colonic neoplasia, right of left side or rectal cancer, there is any place for laparoscopy in your practice?
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However ALaCaRT, COLOR II, ACOSOG Z0651 ,and COREAN trails have failed to show non inferiority of laparoscopic surgery. Even if you look at subgroup analyzes in COLOR II upper rectal cancer with open approach lead to better results while lower rectal cancer with lap approach reach signifficantly bettter results. So nothing is so clear to put it into gold standard list.
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Hi,
I wonder whether there are some known and widely discussed cases of human disorders caused by SNP (or set of SNPs) in one case and by large-scale genomic rearrangements in other.
How these complex cases are treated in medical practice? Are there any tests available covering different sources of such disorders?
I theorise that such cases might arise from interruption of TAD boundary in chromatin (either CTCF binding site mutation or some deletion/sophisticated rearrangement of TAD boundary).
But I'm rather interested in particular cases known for medical practice. Any ideas?
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Dear Aleksandra,
Here is the paper, summarizing data on several lactic acidosis patients, possessing mutations in PDHA1 and PDHX genes.
Most mutations there include single-nucleotide changes or short deletions, however some are deletions of several Mbp affecting several genes.
Hope, the paper will complement your previous findings.
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Two types of forgiveness, conditional or unconditional, can be distinguished. The first establishes conditions to grant forgiveness and tries to avoid the repetition of the offense. The second considers that forgiveness is a gift that depends entirely on the offended person and not on the behavior of the offender. However, several authors say that this unconditional forgiveness is impossible to achieve. I would love to know if you have known experiences of authentic unconditional forgiveness in your clinical or research work.
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It is said that, human being is a statue of error, that means it is common factor in human life, no exception to any one; hence forgiveness is an essential for giving fair chances for correcting mistakes- errors. The forgiveness is a divine quality for improvement boosting moral.
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I have secured several "informed consent" to terminate life-support after more than twenty years in medical practice, but the number of cases does not make the subsequent cases easier for me. I find every case ethically and legally taxing. One of the most common and challenging issue I have to face is an immediate family member asking me "[W]ho will switch off the device?" In our country, there is no law yet governing end-of-life decisions.
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Generally, turning off life support leads to death which most legal system consider a crime and unethical especially where there is no advance directive or it is done without the consent of the patient, same could be done safely with a court order though
as in the case of Nancy Cruzan and Quin Ann.
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In a clinical research setting, is it better to use QUICKI or HOMA%S as an indicator of insulin sensitivity?
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HOMA
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monoclonal antibodies may be better than polyclonal antibodies is certain clinical and research applications.  But when used as the primary antibody in Western blotting or immunohistology procedures. 
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Monoclonal antibodies bind a single epitope on your antigen, so only one molecule of antibody can bind to each antigen molecule, unless the epitope is repetitive.
On the other hand, polyclonal antibodies bind multiple epitopes on the same antigen, so several antibody molecules can in principle bind to each antigen molecule. That makes the signals usually higher when using polyclonal antibodies. If you have a good polyclonal antibody (highly specific for your antigen), sensitivity of antigen detection should be very high.
There is a second advantage of polyclonal antibodies in some conditions. A monoclonal antibody can work or not in western blot or immunohistochemistry depending on its epitope. For instance, if the antibody recognizes a conformational epitope, probably it will not detect denatured antigen in WB. On the other hand, if the epitope is affected by tissue processing procedures, then the antibody will not work in IHC. As polyclonal antibodies are  mixtures of antibodies recognizing different epitopes, frequently (not always) they are useful for many techniques, because at least a fraction of the epitopes recognized is kept in a given experimental condition.
Additionally, If the antigen is polymorphic having different variants in nature, perhaps a monoclonal antibody is not able to recognize all of them because the epitope is not uniformly present. Polyclonal antibodies, recognizing multiple epitopes, tend to be less affected by such variations.   
Despite the previous comments, in many cases a good monoclonal antibody is ideally suited for a given application. Its only necessary to find the right antibody for your purposes.
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Someone can help me? I have listened informally, but I can not find really formal and conclusive answers on the following questions: 1- Are there well-established and consolidated scientifical data about the efficacy of the use of rolipram, thalidomide, pentoxifylline or rupatadine, alone or combined, in the treatment of rheumatoid arthritis? 2- Are the existing data obtained in studies with experimental models of rheumatoid arthritis sufficient to point out conclusively and clearly the possible beneficial or deleterious effects arising from the use of each one of these drugs in this disease? 3- Would such eventual data be sufficient to justify clinical trials of each one of these drugs in patients with rheumatoid arthritis whose conventional therapeutic drugs are withdrawn?
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I understand. Thanks for your contribution.
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As example: Drug A (Km=2uM), drug B (Km=45 uM). If we do inhibition or DDI study with known inhibitor and found IC50 for drug A is higher than drug B. what will be the explanation of the result (IC50 or Ki) for two drugs (A and B)?
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I was just having a peruse through some DMPK related questions and looked at this out of interest......I know it's a while since the question was posted but just in case it helps.......I'm no expert on enzyme kenetics but I'm not so sure you actually have an issue here, if the Km for drug A is lower than drug B would you not expect the IC of the inhibitor to be higher?  The binding of drug A occurs with higher afinity than B and therefore (without knowledge of 'K off' assuming an equal rate of transport for A and B)  would require an increased level of inhibitor to reduce transport by half in comparison to B.
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Is it necessary to keep subject under monochromatic light or sodium vapour lamp if administered with mesalamine? what will be impact on sabject safety or study data if blood sample collection is done under normal light?
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Sorry I could not find any paper or published article on it.
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