Article
Orthopedics
Eui Ho Park, Jinwon Seo, Yunsin Lee, Kiwon Park, Kyung-Ran Kim, Sujeong Kim, Ali Mobasheri, Heonsik Choi
Summary: The aim of the study was to investigate the analgesic mechanism of TissueGene-C (TG-C) in a pre-clinical animal model with monoiodoacetate (MIA)-induced pain. The results demonstrated that TG-C exerted potent analgesic effects by inhibiting the upregulation of pain mediators and modulating neuronal sensitization.
OSTEOARTHRITIS AND CARTILAGE
(2023)
Review
Biochemistry & Molecular Biology
Luigino Calzetta, Marina Aiello, Annalisa Frizzelli, Elena Pistocchini, Beatrice Ludovica Ritondo, Paola Rogliani, Alfredo Chetta
Summary: Inhaled corticosteroids (ICS) are the main treatment for asthma, but there is a need for innovative medications that selectively target components of inflammation. A review of recent randomized controlled trials identified 16 classes of novel therapeutic options, with lung function being the main assessed outcome. Promising disease-modifying agents, particularly biologics, are being studied, but further research is needed to confirm positive results from Phase I and II trials.
Article
Orthopedics
Jin Kyun Park, Se Han Ahn, Kichul Shin, Yun Jong Lee, Yeong Wook Song, Eun Bong Lee
Summary: High levels of baseline pain are predictive of a clinically meaningful placebo response in patients with hand OA. Further studies are needed to optimize and utilize the benefit of placebo responses in patients with hand OA.
BMC MUSCULOSKELETAL DISORDERS
(2021)
Review
Oncology
G. Griguolo, M. F. Zorzi, M. C. Pirosa, G. Treglia, F. Bertoni, J. Kuruvilla, E. Zucca, A. Stathis
Summary: This study performed a systematic review of phase I trials specifically designed for lymphoma patients and found that these trials were generally safe and reported a high overall response rate.
CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
(2022)
Article
Oncology
Pawel Sobczuk, Huber Batruk, Paulina Wojcik, Krzysztof Iwaniak, Katarzyna Kozak, Piotr Rutkowski
Summary: The current landscape of phase II studies in soft tissue sarcomas (STS) is analyzed in this study, and the impact of statistical design on the results is evaluated. The study finds high heterogeneity in the design of STS phase II trials, mainly in terms of primary endpoints and hypotheses used for sample size calculation. There is a need for standardization that takes into account factors associated with the rarity of the disease, outcomes detected in previous trials and real-life studies, and specific characteristics of new therapeutic agents.
JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY
(2023)
Review
Oncology
F. Martorana, I. Colombo, G. Treglia, S. Gillessen, A. Stathis
Summary: Phase II trials evaluating the combinations of PD-1/PD-L1 inhibitors with other anti-cancer therapies are diverse, with PD-1 inhibitors being the most frequently studied. Only a minority of indications have received regulatory approval from authorities.
CANCER TREATMENT REVIEWS
(2021)
Review
Medicine, General & Internal
Dionysios Palermos, Theodoros N. Sergentanis, Maria Gavriatopoulou, Panagiotis Malandrakis, Theodora Psaltopoulou, Evangelos Terpos, Ioannis Ntanasis-Stathopoulos
Summary: Current lung cancer clinical research focuses on biomarkers and personalized treatment strategies. Adaptive clinical trial designs, such as the seamless phase II/III design, have been used to reduce the total sample size and drug development time. A systematic review identified 28 eligible trials using this design, with the majority being open-label, involving non-small cell lung cancer patients, evaluating targeted therapies and/or immunotherapies, and recruiting patients with advanced disease.
JOURNAL OF CLINICAL MEDICINE
(2022)
Article
Oncology
Faruque Azam, Alexei Vazquez
Summary: Targeted therapies show higher response rates when used in combination with previous non-targeted cancer drugs, indicating that drug combinations should continue to be the standard of care for cancer therapy. Despite the increasing number of cancer drugs, recent targeted agents have not significantly increased response rates, suggesting that further research is needed to improve cancer therapy outcomes.
Editorial Material
Medicine, General & Internal
Christina Abdel Shaheed, Fiona Blyth, Ann-Mason Furmage, Fiona Stanaway
Summary: It is necessary to record and report co-interventions that may impact the outcomes.
BMJ-BRITISH MEDICAL JOURNAL
(2021)
Review
Orthopedics
Lauren K. King, Nicolas S. Bodmer, Pakeezah Saadat, Pavlos Bobos, Gillian A. Hawker, Bruno R. da Costa
Summary: This study reviewed 20 cluster randomized controlled trials (RCTs) in osteoarthritis (OA) and found that only 25% of trials reported the observed intracluster correlation coefficient (ICC), with one trial being underpowered due to a larger ICC value than used for sample size calculation. This highlights the need for more attention and reporting on the importance of ICCs in cluster RCTs.
OSTEOARTHRITIS AND CARTILAGE
(2023)
Article
Biochemistry & Molecular Biology
Helena Port, Anne-Christine Bay-Jensen, Yi He, Morten A. A. Karsdal, Thorbjorn Gantzel, Christian S. S. Thudium, Signe Holm Nielsen
Summary: The development of a competitive chemiluminescence enzyme-linked immunosorbent assay, CALC2, targeting the type II collagen C-terminal pro-peptide as a marker of cartilage formation was evaluated. The CALC2 level was measured after in vitro cleavage of recombinant type II collagen and treatment of human osteoarthritis cartilage explant model with insulin-like growth factor-1. Serum CALC2 levels were found to be decreased in patients with rheumatoid arthritis and ankylosing spondylitis compared to controls. These results suggest that CALC2 may be a novel biomarker of type II collagen formation, but further studies are needed to confirm these findings.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2023)
Article
Neurosciences
Alina Lee, Di Shan, David Castle, Tarek K. Rajji, Clement Ma
Summary: This study evaluated the design characteristics and temporal trends of phase II trials in Alzheimer's disease (AD) and found that the use of adaptive trial designs was limited. Non-randomized parallel group and open-label single arm designs were becoming more common. Industry-sponsored trials were more likely to use a randomized parallel-group design and have a larger sample size.
JOURNAL OF ALZHEIMERS DISEASE
(2023)
Article
Biochemistry & Molecular Biology
Peter Javor, Attila Macsai, Edina Butt, Balint Barath, David Kurszan Jasz, Tamara Horvath, Bence Barath, Akos Csonka, Laszlo Torok, Endre Varga, Petra Hartmann
Summary: This study found that mitochondrial dysfunction is present in both osteoarthritis (OA) and rheumatoid arthritis (RA), but to different extents. Rheumatoid arthritis patients exhibited decreased complex I-linked respiration and mitochondrial uncoupling, while both arthritis groups showed reduced OxPhos activity compared to the control group. It is recommended to focus on respiratory complex I in rheumatoid arthritis research.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2022)
Article
Biochemistry & Molecular Biology
Tal Levinson, Eugene Feigin, Shlomo Berliner, Shani Shenhar-Tsarfaty, Itzhak Shapira, Ori Rogowski, David Zeltzer, Ilana Goldiner, Moshe Shtark, Malka Katz Shalhav, Asaf Wasserman
Summary: This study found that ferritin levels do not rise as expected in acute bacterial infections, indicating a deficiency in ferritin response to the bacterial inflammatory process. Comparison of C-reactive protein (CRP) and ferritin levels showed that ferritin levels were relatively low. This suggests that CRP and ferritin may utilize different pathways in acute phase response, resulting in a failure to increase ferritin concentrations in a state of hyperinflammation. This new entity of normoferremic inflammation serves as a new inflammatory stamp for acute bacterial infections.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2023)
Article
Oncology
Srivandana Akshintala, Nicole C. Mallory, Yao Lu, Karla Ballman, Scott M. Schuetze, Rashmi Chugh, Robert G. Maki, Denise K. Reinke, Brigitte C. Widemann, Ae Rang Kim
Summary: This study analyzes the outcomes of patients with malignant peripheral nerve sheath tumors enrolled on phase II trials conducted by SARC and evaluates the effect of enrollment characteristics on progression-free survival. The results provide a historical baseline for future clinical trials in patients with MPNST.
