The clinical research industry is changing, and the number of protocols requiring specialty populations for early-phase clinical studies is increasing. In particular, the demand for studies on renal specialty populations has grown, given the prominent role of the renal system in excreting drugs from the body. Understanding the challenges associated with the use of specialty populations is critical to ensure that the study design will allow for the timely and successful completion of the project, while minimizing costs and safety risks.
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http://dx.doi.org/10.1177/2168479017706512 | DOI Listing |
Dig Dis Sci
January 2025
Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02115, USA.
Background: Chronic constipation, diarrhea, and fecal incontinence (FI) are prevalent with significant impact on quality of life and healthcare utilization. Thyroid dysfunction was recognized as a potential contributor to bowel disturbances in selected populations, but the strength/consistency of this association remain unclear.
Aims: To investigate the relationship between thyroid function and bowel health measures (constipation, diarrhea, and FI) in a nationally representative sample of the U.
Mol Biol Rep
January 2025
Department of Clinical Science, Science and Research Branch, Islamic Azad University, Tehran, Iran.
Background: Infertility is a significant issue in spinal cord injury (SCI) patients. Men with SCI often experience erectile and ejaculatory dysfunctions, and low sperm quality leading to impaired fertility. In this study, we investigated the effectiveness of Erythropoietin (EPO)alginate/chitosan (CH-AL) hydrogel on SCI-induced male rat infertility.
View Article and Find Full Text PDFMol Biol Rep
January 2025
Pediatric Rheumatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
Background: Interleukin-1 receptor-associated kinase1 (IRAK1) plays a considerable role in the inflammatory signaling pathway. The current study aimed to identify any association between (rs1059703) single nucleotide polymorphism (SNP) and vulnerability to rheumatological diseases in the pediatric and adult Egyptian population.
Patients And Methods: The current study included four patient groups: adult Systemic lupus erythematosus (SLE), Rheumatoid arthritis (RA), juvenile systemic lupus erythematosus (JSLE), and juvenile idiopathic arthritis (JIA).
Clin Exp Nephrol
January 2025
Department of Nephrology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Background: Previous studies have suggested a potential role of estrogen in the pathophysiology of chronic kidney disease (CKD); however, the association and causality between estrogen and kidney function remain unclear.
Methods: The cross-sectional correlation between serum estradiol concentration and estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (ACR) was analyzed using data from the National Health and Nutrition Examination Survey 2013-2016. Causality was tested using mutual bidirectional Mendelian randomization (MR) approaches based on six large-scale GWAS studies.
J Cancer Surviv
January 2025
Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.
Purpose: Radiotherapy (RT) for oropharyngeal cancer (OPC) can lead to late toxicity. Fatigue is a known debilitating issue for many cancer survivors, yet prevalence and severity of long-term fatigue in patients treated for OPC is unknown.
Method: As part of a mixed-methods study, fatigue in OPC patients ≥ 2 years post RT + / - chemotherapy was evaluated.
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