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Fenugreek Based Products in USA, Australia, Canada, and India
Published in Dilip Ghosh, Prasad Thakurdesai, Fenugreek, 2022
Savita Nimse, Sanjeevani Deshkar
The TGA also provides access to information on the list of indications that are permissible to be used in the listed medicines. The TGA Business Services website has a searchable database for permissible indications known as “the Indications for Listed Medicines Table”. This table provides a list of indications that can be used in listed medicine applications. These preapproved indications can be used in the listed medicine application.
Thoracic Trauma
Published in Ian Greaves, Keith Porter, Jeff Garner, Trauma Care Manual, 2021
Ian Greaves, Keith Porter, Jeff Garner
In some respects, the contraindications are more important than the indications. Perhaps, more important than the indications are the contraindications! There is very limited value in performing emergency thoracotomy in moribund patients with blunt trauma. However, contrary to earlier canonical teaching there is increasing evidence to support the use of pre-hospital thoracotomy which in selected patients is associated with good outcomes,46–48 and patients may occasionally arrive in the emergency department with an opened chest.
Hydatid Cyst of the Liver
Published in Savio George Barreto, Shailesh V. Shrikhande, Dilemmas in Abdominal Surgery, 2020
Rajeev M. Joshi, Murtaza Dadla, Sandeep Sangale
Indications for medical treatment include: Small (less than 4 cm) uncomplicated cysts (CE1 and CE3a)Deep-seated cystDensely calcific cystExtrahepatic manifestations of the diseaseAlveolar form caused by Echinococcus multilocularisPostoperative in case of spillage, partial cyst removal or biliary ruptureWidely disseminated diseaseMoribund patients who are poor surgical candidates
Esketamine nasal spray for major depressive disorder with acute suicidal ideation or behavior: description of treatment access, utilization, and claims-based outcomes in the United States
Published in Journal of Medical Economics, 2023
Maryia Zhdanava, Amanda Teeple, Dominic Pilon, Aditi Shah, Gabrielle Caron-Lapointe, Kruti Joshi
Antidepressants, as monotherapy or combination therapy, have demonstrated efficacy in treating depressive episodes, which supports their use for individuals with MDSI4. For patients with MDD at high risk of suicide, electroconvulsive therapy may be considered3. Esketamine nasal spray is a novel therapy approved by the US Food and Drug Administration (FDA) for treatment-resistant depression (TRD) on 03/05/201915,16 and for MDSI on 08/05/202017. The esketamine MDSI trials were among the first antidepressant global registration studies to enroll patients with MDD at imminent risk of suicide, in which esketamine has demonstrated rapid and significant reduction in depressive symptoms amongst patients with MDSI, when taken in combination with an oral antidepressant18,19. Since suicidal ideation or behavior symptoms may manifest in both MDD and TRD4, patients with MDSI could have been initiated on esketamine after its approval for either indication. Consequently, variations in patient profiles related to drug indication approvals may exist in clinical practice.
Beware of confounding by indication in pharmacoepidemiological studies
Published in Nordic Journal of Psychiatry, 2023
Due to the lack of randomization, the study of drug effects based on observational/register-based data is inherently difficult. Most prominently perhaps, so-called confounding by indication complicates this matter a great deal. As succinctly phrased by Psaty et al. ‘In studies of pharmacologic therapies, confounding by indication may arise when a drug treatment serves as a marker for a clinical characteristic or medical condition that triggers the use of the treatment and that, at the same time, increases the risk of the outcome under study’ [1]. If confounding by indication is not addressed sufficiently by design (via adjustment, matching or stratification etc.) and/or carefully taken into account when interpretating the results of a study, one may reach conclusions that are wrong [2].
Machine learning-based prediction of drug approvals using molecular, physicochemical, clinical trial, and patent-related features
Published in Expert Opinion on Drug Discovery, 2022
A drug-indication pair may have multiple disease group tags, owing to the membership of the corresponding disease/indication to more than one group in the ClinicalTrials.gov database. For instance, a disease may exist both in ‘Cancers & Other Neoplasms’ and ‘Immune System Diseases.’ This is due to the shared characteristics between different disease groups, which is mainly stemming from the heterogeneous nature of diseases. Moreover, one disease group may contain a particular drug multiple times as the drug can be used for multiple indications belonging to the same disease category. If a drug has both approved and unapproved status for different indications under the same disease group, we removed it from our unapproved drugs dataset. On the other hand, a drug labeled as ‘unapproved’ in one disease group may be categorized as an approved drug for another group. We allowed these cases as this does not cause any contradictions. As shown in Table 1, the overall dataset consists of 1,995 unique approved small molecule drugs, 1,127 unique unapproved small molecule drugs, 18,427 unique approved drug-indication pairs and 2,480 unique unapproved drug-indication pairs. The group ‘Rare Diseases’ makes up the largest category. For the majority of these groups, approved drugs data outnumber the ones in the unapproved category.