Unsupervised cluster analysis reveals distinct subtypes of ME/CFS patients based on peak oxygen consumption and SF-36 scores
This study therefore aims to demonstrate that oxygen consumption is a biomarker of ME/CFS provides a method to classify patients diagnosed with ME/CFS based on their responses to the Short Form-36 (SF-36) questionnaire, which can predict oxygen consumption using cardiopulmonary exercise testing (CPET).METHODS: Two datasets were used in the study. The first contained SF-36 responses from 2,347 validated records of ME/CFS diagnosed participants, and an unsupervised machine learning model was developed to cluster the data. The second dataset was used as a validation set and included the cardiopulmonary exercise test (CPET) re...
Source: Clinical Therapeutics - October 6, 2023 Category: Drugs & Pharmacology Authors: Marcos Lacasa Patricia Launois Ferran Prados Jos é Alegre Jordi Casas-Roma Source Type: research
Can Weight of Evidence, Quantitative Bias, and Bounding Methods Evaluate Robustness of Real-World Evidence for Regulator and Health Technology Assessment Decisions on Medical Interventions?
Clin Ther. 2023 Oct 3:S0149-2918(23)00355-7. doi: 10.1016/j.clinthera.2023.09.010. Online ahead of print.ABSTRACTPURPOSE: High-quality evidence is crucial for health care intervention decision-making. These decisions frequently use nonrandomized data, which can be more vulnerable to biases than randomized trials. Accordingly, methods to quantify biases and weigh available evidence could elucidate the robustness of findings, giving regulators more confidence in making approval and reimbursement decisions.METHODS: We conducted an integrative literature review to identify methods for determining probability of causation, eval...
Source: Clinical Therapeutics - October 5, 2023 Category: Drugs & Pharmacology Authors: Emma M Rosen Mary E Ritchey Cynthia J Girman Source Type: research
Complexities of Deprescribing the Elderly: No Easy Cure
Clin Ther. 2023 Oct 3:S0149-2918(23)00353-3. doi: 10.1016/j.clinthera.2023.09.008. Online ahead of print.NO ABSTRACTPMID:37798220 | DOI:10.1016/j.clinthera.2023.09.008 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - October 5, 2023 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research
Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program
Clin Ther. 2023 Sep 30:S0149-2918(23)00342-9. doi: 10.1016/j.clinthera.2023.08.022. Online ahead of print.ABSTRACTThe Research to Accelerate Cures and Equity (RACE) for Children Act mandates that newly developed targeted oncology drugs be tested in children when molecular targets are relevant to pediatric cancers. In its first year, the RACE for Children Act was effective in creating novel drug development opportunities for children with cancer; however, significant barriers to clinical trial enrollment persist. Pediatric cancer clinical trials are impacted by challenges surrounding logistics, complexity, and access. As su...
Source: Clinical Therapeutics - October 2, 2023 Category: Drugs & Pharmacology Authors: Zachary Rivers Ben Hyde Karyn Ronski Duncan Stearns Stephanie Toll Kevin Ritt Matthew Cooney Halla Nimeiri Noah Federman Kristiyana Kaneva Source Type: research
Use of Silica Nanoparticles for Drug Delivery in Cardiovascular Disease
This article reviews recent progress and advancement in targeted delivery for drugs and diagnostic and theranostic agents using silica nanoparticles to achieve therapeutic efficacy and improved detection of CVD in clinical and preclinical settings.METHODS: A search of PubMed, Scopus, and Google Scholar databases from 1990 to 2023 was conducted. Current clinical trials on silica nanoparticles were identified through ClinicalTrials.gov. Search terms include silica nanoparticles, cardiovascular diseases, drug delivery, and therapy.FINDINGS: Silica nanoparticles exhibit biocompatibility in biological systems, and their shape, ...
Source: Clinical Therapeutics - October 2, 2023 Category: Drugs & Pharmacology Authors: Haritha Kirla David J Henry Shirley Jansen Peter L Thompson Juliana Hamzah Source Type: research
Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program
Clin Ther. 2023 Sep 30:S0149-2918(23)00342-9. doi: 10.1016/j.clinthera.2023.08.022. Online ahead of print.ABSTRACTThe Research to Accelerate Cures and Equity (RACE) for Children Act mandates that newly developed targeted oncology drugs be tested in children when molecular targets are relevant to pediatric cancers. In its first year, the RACE for Children Act was effective in creating novel drug development opportunities for children with cancer; however, significant barriers to clinical trial enrollment persist. Pediatric cancer clinical trials are impacted by challenges surrounding logistics, complexity, and access. As su...
Source: Clinical Therapeutics - October 2, 2023 Category: Drugs & Pharmacology Authors: Zachary Rivers Ben Hyde Karyn Ronski Duncan Stearns Stephanie Toll Kevin Ritt Matthew Cooney Halla Nimeiri Noah Federman Kristiyana Kaneva Source Type: research
Use of Silica Nanoparticles for Drug Delivery in Cardiovascular Disease
This article reviews recent progress and advancement in targeted delivery for drugs and diagnostic and theranostic agents using silica nanoparticles to achieve therapeutic efficacy and improved detection of CVD in clinical and preclinical settings.METHODS: A search of PubMed, Scopus, and Google Scholar databases from 1990 to 2023 was conducted. Current clinical trials on silica nanoparticles were identified through ClinicalTrials.gov. Search terms include silica nanoparticles, cardiovascular diseases, drug delivery, and therapy.FINDINGS: Silica nanoparticles exhibit biocompatibility in biological systems, and their shape, ...
Source: Clinical Therapeutics - October 2, 2023 Category: Drugs & Pharmacology Authors: Haritha Kirla David J Henry Shirley Jansen Peter L Thompson Juliana Hamzah Source Type: research
Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program
Clin Ther. 2023 Sep 30:S0149-2918(23)00342-9. doi: 10.1016/j.clinthera.2023.08.022. Online ahead of print.ABSTRACTThe Research to Accelerate Cures and Equity (RACE) for Children Act mandates that newly developed targeted oncology drugs be tested in children when molecular targets are relevant to pediatric cancers. In its first year, the RACE for Children Act was effective in creating novel drug development opportunities for children with cancer; however, significant barriers to clinical trial enrollment persist. Pediatric cancer clinical trials are impacted by challenges surrounding logistics, complexity, and access. As su...
Source: Clinical Therapeutics - October 2, 2023 Category: Drugs & Pharmacology Authors: Zachary Rivers Ben Hyde Karyn Ronski Duncan Stearns Stephanie Toll Kevin Ritt Matthew Cooney Halla Nimeiri Noah Federman Kristiyana Kaneva Source Type: research
Use of Silica Nanoparticles for Drug Delivery in Cardiovascular Disease
This article reviews recent progress and advancement in targeted delivery for drugs and diagnostic and theranostic agents using silica nanoparticles to achieve therapeutic efficacy and improved detection of CVD in clinical and preclinical settings.METHODS: A search of PubMed, Scopus, and Google Scholar databases from 1990 to 2023 was conducted. Current clinical trials on silica nanoparticles were identified through ClinicalTrials.gov. Search terms include silica nanoparticles, cardiovascular diseases, drug delivery, and therapy.FINDINGS: Silica nanoparticles exhibit biocompatibility in biological systems, and their shape, ...
Source: Clinical Therapeutics - October 2, 2023 Category: Drugs & Pharmacology Authors: Haritha Kirla David J Henry Shirley Jansen Peter L Thompson Juliana Hamzah Source Type: research
Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program
Clin Ther. 2023 Sep 30:S0149-2918(23)00342-9. doi: 10.1016/j.clinthera.2023.08.022. Online ahead of print.ABSTRACTThe Research to Accelerate Cures and Equity (RACE) for Children Act mandates that newly developed targeted oncology drugs be tested in children when molecular targets are relevant to pediatric cancers. In its first year, the RACE for Children Act was effective in creating novel drug development opportunities for children with cancer; however, significant barriers to clinical trial enrollment persist. Pediatric cancer clinical trials are impacted by challenges surrounding logistics, complexity, and access. As su...
Source: Clinical Therapeutics - October 2, 2023 Category: Drugs & Pharmacology Authors: Zachary Rivers Ben Hyde Karyn Ronski Duncan Stearns Stephanie Toll Kevin Ritt Matthew Cooney Halla Nimeiri Noah Federman Kristiyana Kaneva Source Type: research
Use of Silica Nanoparticles for Drug Delivery in Cardiovascular Disease
This article reviews recent progress and advancement in targeted delivery for drugs and diagnostic and theranostic agents using silica nanoparticles to achieve therapeutic efficacy and improved detection of CVD in clinical and preclinical settings.METHODS: A search of PubMed, Scopus, and Google Scholar databases from 1990 to 2023 was conducted. Current clinical trials on silica nanoparticles were identified through ClinicalTrials.gov. Search terms include silica nanoparticles, cardiovascular diseases, drug delivery, and therapy.FINDINGS: Silica nanoparticles exhibit biocompatibility in biological systems, and their shape, ...
Source: Clinical Therapeutics - October 2, 2023 Category: Drugs & Pharmacology Authors: Haritha Kirla David J Henry Shirley Jansen Peter L Thompson Juliana Hamzah Source Type: research
Pituitary Apoplexy-Associated Cerebral Salt Wasting Syndrome: A Case Report and Literature Review
Clin Ther. 2023 Sep 29:S0149-2918(23)00357-0. doi: 10.1016/j.clinthera.2023.09.012. Online ahead of print.ABSTRACTPURPOSE: This is a case report of a patient experiencing hyponatremia who was ultimately diagnosed with pituitary apoplexy-associated cerebral salt wasting syndrome (CSWS).METHODS: Laboratory tests, clinical evaluations, and magnetic resonance imaging were performed by specialists.FINDINGS: The patient presented with severe headache, thirst, and polyuria. Results of laboratory tests indicated hyponatremia, decreased plasma osmolality, and elevated urine osmolality. Fluid restriction worsened the situation, and ...
Source: Clinical Therapeutics - October 1, 2023 Category: Drugs & Pharmacology Authors: Jialu Wu Zhe Yan Bo Li Xijie Yu Hui Huang Source Type: research
Dorzagliatin for Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Phase II/III Trials
This study included a meta-analysis on the efficacy and safety of dorzagliatin in the treatment of T2DM.METHODS: The Cochrane Central Registry of Controlled Trials, PubMed, and Embase were searched from inception to July 25, 2022. A total of 3 studies including 1333 patients were identified in this meta-analysis.FINDINGS: Overall, the meta-analysis showed that dorzagliatin remarkably reduced glycated hemoglobin levels versus placebo by 0.66%. The results of the meta-analysis showed a significant reduction in fasting plasma glucose of 6.77 mg/dL between dorzagliatin and placebo. In addition, dorzagliatin reduced 2-hour post...
Source: Clinical Therapeutics - September 30, 2023 Category: Drugs & Pharmacology Authors: Fei Lin Rong He Baodong Ling Lin Wang Ting Jiang Bin Yu Source Type: research
Compatibility of Omadacycline With Select Parenteral Products in Simulated Y-Site Administration
The objective of this work was to determine the intravenous compatibility of omadacycline with commonly used intravenous fluids and medications using simulated Y-site administration.METHODS: Omadacycline was prepared at concentrations consistent with a maintenance dose (1 mg/mL) and a loading dose (2 mg/mL) with 0.9% sodium chloride according to the prescribing information. Compatibility via simulated Y-site administration was assessed with selected crystalloids (lactated Ringer's solution, magnesium sulfate, and normal saline with potassium chloride) and intravenous medications (bumetanide, furosemide, heparin, and insuli...
Source: Clinical Therapeutics - September 30, 2023 Category: Drugs & Pharmacology Authors: David A Butler Kelly Moolick Donavon McCray Maxwell Gifford Source Type: research
Dorzagliatin for Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Phase II/III Trials
This study included a meta-analysis on the efficacy and safety of dorzagliatin in the treatment of T2DM.METHODS: The Cochrane Central Registry of Controlled Trials, PubMed, and Embase were searched from inception to July 25, 2022. A total of 3 studies including 1333 patients were identified in this meta-analysis.FINDINGS: Overall, the meta-analysis showed that dorzagliatin remarkably reduced glycated hemoglobin levels versus placebo by 0.66%. The results of the meta-analysis showed a significant reduction in fasting plasma glucose of 6.77 mg/dL between dorzagliatin and placebo. In addition, dorzagliatin reduced 2-hour post...
Source: Clinical Therapeutics - September 30, 2023 Category: Drugs & Pharmacology Authors: Fei Lin Rong He Baodong Ling Lin Wang Ting Jiang Bin Yu Source Type: research
