AI Article Synopsis

Article Abstract

The purpose of a therapeutic clinical trial is to determine the value of a treatment. The main objectives of phase I trials have been to determine a dose that is appropriate for use in phase II and III trials and to determine information about the pharmacokinetics of distribution of the drug. Phase II trials have been performed to determine whether a particular regimen or drug is worthy of phase III evaluation. Phase III trials attempt to prove the usefulness of treatment and determine the new treatment strategy.

Download full-text PDF

Source

Publication Analysis

Top Keywords

phase iii
12
determine treatment
8
phase trials
8
trials determine
8
iii trials
8
determine
5
phase
5
[design analysis
4
analysis clinical
4
clinical trials]
4

Similar Publications

Pharmacology of Intestinal Inflammation and Repair.

Annu Rev Pharmacol Toxicol

January 2025

Institute of Digestive Health Research (IRSD), Toulouse University, INSERM 1022, INRAe, ENVT, University of Toulouse III Paul Sabatier, Toulouse, France;

Chronic inflammation is a common trait in the pathogenesis of several diseases of the gut, including inflammatory bowel disease and celiac disease. Control of the inflammatory response is crucial in these pathologies to avoid tissue destruction and loss of intestinal function. Over the last 50 years, the identification of the mechanisms and mediators involved in the acute phase of the inflammatory response, which is characterized by massive leukocyte recruitment, has led to a number of therapeutic options.

View Article and Find Full Text PDF

Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer: The TaLaR Randomized Clinical Trial.

JAMA

January 2025

Department of General Surgery (Colorectal Surgery), Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.

Importance: Previous studies have demonstrated the advantages of short-term histopathological outcomes and complications associated with transanal total mesorectal excision (TME) compared with laparoscopic TME. However, the long-term oncological outcomes of transanal TME remain ambiguous. This study aims to compare 3-year disease-free survival of transanal TME with laparoscopic TME.

View Article and Find Full Text PDF

Esophageal squamous cell carcinoma (ESCC) is a prevalent and highly lethal malignancy in Asia. Recent advancements in immune checkpoint inhibitors (ICIs) have markedly transformed the systemic therapy landscape for ESCC. Anti-PD-1-based combination with chemotherapy or with ipilimumab, an anti-CTLA-4 antibody, have been established as the new standard first-line treatments for patients with advanced ESCC.

View Article and Find Full Text PDF

Bempedoic Acid: A Review in Cardiovascular Risk Reduction in Statin-Intolerant Patients.

Am J Cardiovasc Drugs

January 2025

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

Oral bempedoic acid (NEXLETOL in the USA; Nilemdo in the EU) and the fixed dose combination (FDC) of bempedoic acid/ezetimibe (NEXLIZET in the USA; Nustendi in the EU) are approved to reduce cardiovascular (CV) risk in statin-intolerant patients who are at high risk for, or have, CV disease. A first-in-class therapy, bempedoic acid inhibits the adenosine triphosphate-citrate lyase enzyme in the cholesterol biosynthesis pathway. In the multinational phase III CLEAR Outcomes trial in statin-intolerant patients, once-daily bempedoic acid 180 mg significantly reduced the risk of the primary endpoint (a four-component major adverse CV event composite of CV death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization) compared with placebo.

View Article and Find Full Text PDF

Background/objectives: In an 18- to 24-month Treatment Phase with once-daily efinaconazole 10% solution, subjects with onychomycosis showed an increased rate of cure at Month 24 versus the phase III trials. In order to further improve efficacy, we initiated an extended intermittent efinaconazole Maintenance Phase with use 2-3 times weekly for an additional 24 months from Month 24 to Month 48. These are the first data presented for a 48-month efinaconazole use period.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!