Questions tagged [clinical-study]

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How to find FDA's and EMA's review reports and related minutes

Lately, I've been thinking about how we can't make various decisions without going back to what data and the logic behind the drug's approval. I'd like to ask a question about how to search such ...
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Relationship between FDA Agencies and the Advisory Committee

This article has the following descriptions; "Perhaps what is most surprising is that in mid-August, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9 to 1 to recommend the drug for ...
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The process of drug approval; The flow from R&D, planning a clinical trial to drug approval, or other additional process

I'd like to know the process of drug approval; the flow from R&D, planning a clinical trial to drug approval, or other additional process. As far as I am aware, some documents provide too much detail ...
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Would neurons regenerate even in adults? [closed]

I want to know whether or not the nerves regenerate in human adults. My Question Please give me evidences for this issue. What experiments and logic do they use to prove that the nerves are/are not ...
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What does “pause” mean in Covid19 Vaccine Clinical Trials?

Johnson and Johnson as well as Astra Zeneca recently announced that they were going to "pause" in their respective clinical trials for a Covid19 vaccine. What exactly are they "pausing&...
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What study design is used in this research?

https://www.sciencedirect.com/science/article/abs/pii/S1939865415001113 I've learned about many types of study design including experimental (randomised control trials etc.) and observational study ...
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Is the efficacy of N95 respirators or surgical masks reduced when wet (COVID-19)?

If my face mask gets wet, is its efficacy in preventing the spread of coronavirus diminished? If so, how much? It's monsoon season here in India, and my method of transportation (safer than crowded ...
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Studies On The Affect Of Immunotherapy On Larynx Surgeries

I've been searching online for a study regarding the affect of immunotherapy on the necessity for an affected individual diagnosed with laryngeal cancer to require larynx surgery, to no avail. Could ...
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If placebo controls work even when the patient is aware that the treatment is a placebo. Why are deceptive placebo controls used?

Placebos are “fake” treatments prescribed for the psychological benefit to the patient rather than for any physiological effect. Placebos are used for conditions defined by “self-observation” symptoms ...
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Is there solid data whether abandoning information technology in healthcare increases adverse events or errors made?

Hello fellow scientists, I work in a hospital where a lot of processes are digitalized (e.g., electronic health records, QR-code assisted workflow for prescribing medication etc.). I am looking for ...
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The placebo effect [closed]

Is it possible to eliminate the groups of placebos in all those clinical trials that have a precision medicine nature? Since if it is precision medicine, it is supposed to cure 100% of those affected ...
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Progress of the FDA's review of RMAT products

The U.S. FDA appears to have five shortcut regulatory approval ways, as follows; (1) Accelerated Approval (2) Priority Review (3) Fast Track (4) Breakthrough Therapy (5) RMAT:Regenerative Medicine ...
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Is the MSC-based regenerative medicine promising for Ischemic stroke stroke patients? ; two points difference in the 47-point test

Many papers says, regenerative medicine using MSCs are promising for Ischemic stroke stroke patients. But in my layman's sense, various data don't seem promising. So, I want to hear the opinions of ...
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Meaning of “patients were self-selected to undergo treatment or remain untreated”

From Treatment of Folate Metabolism Abnormalities in Autism Spectrum Disorder: In an open-label therapeutic trial of patients with nonsyndromic infantile ASD, patients were self-selected to undergo a ...
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When would a placebo/control group *not* be used in medical research?

Related: Why use a placebo in some potential COVID-19 vaccine trials? What is the point of a placebo in studies where the subject can determine their group? The answers to the questions above give ...
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Meaning of “I” in a table in a study poster

From a poster to a study: I don't understand the meaning of "I" used in several fields of this table. What could it mean? I've read the abstract of the study but still cannot get it. The ...
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Meaning of “(ref)” in a table describing the characteristics of patients taking part in a cancer study

From a poster describing a study in cancer patients. This is from a table in the poster, which describes the characteristics of the patients (Age groups, Sex ect.) You can see what percentage of the ...
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Meaning of “D1 q3w” in a poster to a clinical trial

From a poster to a clinical trial: I can understand that q3w means "once every 3 weeks", but what is the meaning of D1? I think the first DI must be a typo and it stands for D1 too.
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Efficiency of favipiravir to treat covid 19

I have seen in news that Russia approved the drug Avifavir (favipiravir) for covid treatment.As this drug has significantly reduced the duration of infection.Some scientists Claimed that it is a good ...
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Meaning of “correlates” in “.. clinical therapeutic studies of LAC in depression and TRD and its correlates .. ”

From "Myriad of implications of acetyl-l-carnitine deficits in depression": Nasca et al. (1) were appropriately conservative in interpreting their findings and pointing out multiple directions for ...
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what is the difference between clinical trial study and clinical study?

Can every study that is focused on evaluating the effect of a drug in humans be regarded as a clinical trial study? For example: A study is conducted to find the effect of "Azadirachta indica" on ...
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What would it be like to participate in a (coronavirus) challenge trial, in the US?

I am strongly considering volunteering for any COVID human challenge trial that becomes available near me (midwestern United States). I am willing to undergo long-term isolation. However, I am not ...
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Have any regulatory agencies announced they would allow live Covid-19 human challenges (for vaccine testing purposes)?

It's been mentioned to me in the discussion on another question that the following proposal has been advanced (in a medical journal): Controlled human challenge trials of SARS-CoV-2 vaccine ...
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Can COVID-19 be damaging lung without showing fever? [closed]

Given that a man of 39 years without underlying health condition, is having chest discomfort and tightness, which is more discomfort during evening and night before fall asleep. He don't have cold and ...
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How can I set up alerts to notify me of COVID-19 clinical trial participation opportunities for healthy US volunteers outside of infection “hotspots”?

I live in a mid-size US city not hit too hard by the coronavirus. Is there a good way to set up email alerts (or similar) to alert me to COVID-19 clinical trials in my area that I can volunteer for? I ...
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Among COVID-19 patients who have died - what is the estimated distrubution of the time from symptom onset to death?

In the https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf I found: Among patients who have died, the time from symptom onset to outcome ...
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Effects of placebo on viral load in tests for effectiveness of a drug combination for COVID-19

I have very little background in Medicine, pardon me for that. I came across this reference recently. Loosely speaking, this study aims at testing the effect of azithromycin and hydroxychloroquin for ...
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Influenza vaccine status, non-influenza acute respiratory infections, and COVID-19

Disclaimer This is in no way an "anti-vax" post - it is intended as a serious open discussion as to possible interplay between Influenza vaccine status and non-influenza upper respiratory ...
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What happens when a candidate drug becomes an ATMP? What's the list of ATMPs?

According to The Alliance for Regenerative Medicine, the following six Tissue-Engineered Products are available in Europe. Spherox Novocart 3D ReNovaCell ReGenerCel Vergenix FG Vergenix-STR I ...
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What is the meaning of “group-by-region interaction effects” (PET scan study of brains affected by schizophrenia)?

I was reading a recent study on schizophrenia and came across this sentence: We found significant group and group-by-region interaction effects on volume of distribution (VT). What is the ...
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How to evaluate the results of diagnostic studies: how to prove that new method is better than gold standard?

I understand how to evaluate therapeutic studies: basically you compare the results of two groups that were chosen randomly. One group gets the new drug, the other group gets the placebo (or the drug ...
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What is Spanish equivalent of webpage clinicaltrials.gov?

Can you recommend any Spanish database of medical studies/clinical records, equivalent to English clinicaltrials.gov ? Medical texts should be in Spanish, not webpage necessarily.
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How has the research of the effects/benefits of yoga progressed since 2015?

Four years ago, in 2015, Vox published this piece: I read more than 50 scientific studies about yoga. Here's what I learned. I'm assuming (correct me if I'm wrong) that it's a reasonable survey for ...
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A question about clinical trials for different formulations

Suppose a new antibiotic in an iv formulation exists and has been approved When you want to test the oral formulation and phase 3 comes you should test it against what? A placebo or the iv formulation ...
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In contraceptive effectiveness ratings, are “typical use,” and “perfect use” self-reported?

The effectiveness of contraception methods is typically reported as two percentages: typical use and perfect use. Typical use is the measure of how the average couple is likely to use the method, and ...
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Are there websites with clinical trial reports freely available for download?

I'm a translator, and I'm currently translating clinical trial reports, Russian to English. I wonder if there are depositories of freely available clinical trial reports, with all appendixes and all ...
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Are there any studies that prove the effectiveness of saw palmetto for restoring hair in the bald places and stop hair fall?

I'm looking for studies apart from the ones in the third link in my question, that prove the efficacy of saw palmetto in 1) stop hair fall, and 2) growing back hair in the places of the scalp where ...
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Meaning of “central registration system” in Japanese clinical trials

Quote from a Japanese clinical trial report: METHOD: An observational study was conducted on patients who relapsed after primary systemic therapy with TZM using the central registration system. The ...
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Meaning of “platinum sensitivity and primary PFI being repowered as prognostic factors”

Quote from a clinical trial report: Recurrence eventually affects 70–80% of patients with advanced epithelial ovar-ian cancer [2, 22], with platinum sensitivity and primary PFI being repowered as ...
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Are “data cut off” and “data lock” the same thing in a clinical trial?

Quotes from a clinical trial report (JGOG3022 trial): Follow-up was terminated in February 2017 and data were locked in October 2017. Of the 346 patients enrolled, ineligible patients and patients ...
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What is the purpose of the “observation cohort” in a clinical trial?

Quote from a clinical trial report (JGOG3022 trial): Patients who were scheduled to receive bevacizumab concomitantly with platinum-based combination chemotherapy after PDS or IDS were included in ...
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What is the difference between “clinician” and “therapist”?

I am reading the book Mindfulness and Psychotherapy, and at first I thought clinician and therapist are used interchangeably, but it seems not. So is there any difference between the two? If yes, is ...
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Does vaccination weaken the immune system ? Studies?

A friend recognizes value in vaccinating in general - against major diseases - but with a caveat that they are opposed to the flu vaccine specifically. They claim that vaccines weaken the immune ...
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Definition of “prospective birth cohort study”

From a news article: “Prospective birth cohort studies suggest that childhood infections are associated with increased risk of schizophrenia in adulthood and with abnormal neurodevelopment in ...
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Meaning of “shared familial confounding” in a study

From a news report: Using population-based, longitudinal cohort study data from Sweden, researchers examined the relationship of infection during childhood with IQ and adult nonaffective psychosis....
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How are participants in a clinical study of a new medication selected and monitored?

I don't have any background in medicine, but I'm interested. How are participants in a clinical study of a new medication selected and monitored? Do they make an announcement calling for volunteers? ...
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Do side effects spoil blind studies?

One group is given a newly developed medication X, and the other group placebo. If X has noticeable side effects, like extra sleepiness, change in appetite, tremors, etc, wouldn't the participates in ...
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What clinical studies demonstrated that CelGro improves tissue in-growth and repair for the rotator cuff tendon injuries?

I read on https://stockhead.com.au/health/orthocell-wins-patent-for-tech-that-can-grow-you-a-new-body/ (mirror) CelGro has been shown to improve tissue in-growth and repair in clinical studies using ...
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Long term side effects of Xolair

I get 300mg of Xolair injected twice a month (every 2 weeks). I was wondering if there are any studies showing long term side effects of this medicine that are not published by the manufacturers of ...
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What does “Primary Purpose: Treatment” mean in a clinical study?

At clinicaltrials.gov you can look up studies to learn more about them. On one such study, I saw this block of text: Study Type: Interventional Study Design: Allocation: Randomized ...