Research conducted on gestating women globally during trials

2022 ◽  
Vol 8 (4) ◽  
pp. 301-304
Author(s):  
Sunil Chaudhry ◽  
Vishwas Sovani
Keyword(s):  
Clinical Trials ◽  
Human Physiology ◽  
Clinical Research ◽  
Pregnant Women ◽  
Term Therapy ◽  
Exclusion Criteria ◽  
Regulatory Aspects ◽  
Long Term Therapy ◽  
Physiological And Biochemical

The aim of clinical research is to impart knowledge that will improve human health or improve understanding of human physiology. Although, till the end of 20 century pregnancy was always under exclusion criteria, now pervasive exclusion of pregnant women in clinical trials is currently not justified. Pregnancy brings in an array of anatomical, physiological and biochemical changes that can impact the pharmacokinetics of important medications. Pregnancy is often accompanied by chronic diseases like diabetes, hypertension, tuberculosis, HIV, depression which can require long term therapy. This indicates a need for studies being conducted exclusively in pregnant women. Current communication narrates ethical and regulatory aspects of inclusion of pregnant women in clinical trials.

Antithrombotic Therapy for DVT/PE

1997 ◽  
Vol 17 (03) ◽  
pp. 161-162
Author(s):  
Thomas Hyers
Keyword(s):  
Molecular Weight ◽  
Low Molecular Weight Heparin ◽  
Oral Anticoagulants ◽  
Cost Effective ◽  
Therapeutic Agents ◽  
Great Promise ◽  
Term Therapy ◽  
Low Molecular Weight ◽  
Long Term Therapy

SummaryProblems with unfractionated heparin as an antithrombotic have led to the development of new therapeutic agents. Of these, low molecular weight heparin shows great promise and has led to out-patient therapy of DVT/PE in selected patients. Oral anticoagulants remain the choice for long-term therapy. More cost-effective ways to give oral anticoagulants are needed.

Office-based post-marketing surveillance study on the influence of long term therapy with aripiprazole in patients with schizophrenia

2007 ◽  
Vol 40 (05) ◽  
Author(s):  
M Kungel ◽  
A Engelhardt ◽  
T Spevakné-Göröcs ◽  
M Ebrecht ◽  
C Werner ◽  
...  
Keyword(s):  
Surveillance Study ◽  
Term Therapy ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Long Term Therapy

scholarly journals Amiodarone-induced thyroid dysfunction in children: insights from the THYRAMIO study

2021 ◽  
Vol 12 ◽  
pp. 204201882110011
Author(s):  
Sarah Montenez ◽  
Stéphane Moniotte ◽  
Annie Robert ◽  
Lieven Desmet ◽  
Philippe A. Lysy
Keyword(s):  
Predictive Value ◽  
Thyroid Dysfunction ◽  
Term Therapy ◽  
Older Children ◽  
Thyroid Status ◽  
Clinical Series ◽  
Amiodarone Treatment ◽  
Long Term Therapy ◽  
Treatment Dosage

Background: Amiodarone treatment is effective against various types of arrhythmias but is associated with adverse effects affecting, among other organs, thyroid function. Amiodarone-induced thyroid dysfunction was not thoroughly evaluated in children as it was in adults, yet this affection may lead to irreversible neurodevelopmental complications. Our study aimed to define the incidence and risk factors of amiodarone-induced thyroid dysfunction in children. Methods: The study was designed as an observational study with a retrospective clinical series of 152 children treated by amiodarone in the Pediatric Cardiology Unit of our center from 1990 to 2019. All patients were divided into three groups according to their thyroid status: euthyroid, AIH (amiodarone-induced hypothyroidism) or AIT (amiodarone-induced thyrotoxicosis). Patients from these three groups were compared in terms of key clinical and therapeutic features. Results: Amiodarone-induced thyroid dysfunction was present in 23% of patients. AIT (5.3%) was three times less common than AIH (17.7%), and its occurrence increased with older age ( p < 0.05), treatment dosage ( p < 0.05), treatment duration ( p < 0.05) and the number of loading doses administered ( p < 0.05). There were no distinctive clinical features between euthyroid and AIH groups. A multivariable prediction model of AIT was built, with a yield of 66.7% as positive predictive value and 96.7% as negative predictive value. Conclusion: We observed that one in five children developed amiodarone-induced thyroid dysfunction. Special attention is required for older children with a high dosage and long-term therapy and who received a large number of loading doses, since these children are at risk to develop AIT, which is more delicate to manage than AIH.

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