Prospective randomized study on the efficacy of three-dimensional reconstructions of bronchovascular structures on preoperative chest CT scan in patients who are candidates for pulmonary segmentectomy surgery: the PATCHES (Prospective rAndomized sTudy efficaCy of tHree-dimensional rEconstructions Segmentecomy) study protocol
AbstractIntroductionPulmonary segmentectomy, when combined with hilar and mediastinal lymphadenectomy, is currently considered the gold standard treatment for early-stage lung tumors (NSCLC) smaller than 2 cm in diameter. The preoperative planning for segmentectomies usually includes a contrast-enhanced CT with 2D reconstructions (axial, coronary, and sagittal). Recent technological advances allow 3D (volume rendering) reconstructions of preoperative CT scans, intended to improve the surgeon ’s understanding of the segmental anatomy.The study aims to investigate the added value of 3D reconstruction in enhancing the surge...
Source: Trials - September 16, 2023 Category: Research Source Type: clinical trials

Q-HAM: a multicenter upfront randomized phase II trial of quizartinib and high-dose Ara-C plus mitoxantrone in relapsed/refractory AML with FLT3-ITD
ConclusionCurrently, there is no commonly accepted standard for salvage chemotherapy treatment. The objective of the salvage therapy is to reduce leukemic burden, achieve the best possible remission, and perform a hemopoietic stem-cell transplantation. Thus, in patients withFLT3-ITD mutation, the comparison of quizartinib with intensive salvage therapy versus chemotherapy alone appears as a logical consequence in terms of efficacy and safety.Ethics and disseminationEthical approval and approvals from the local and federal competent authorities were granted. Trial results will be reported via peer-reviewed journals and pres...
Source: Trials - September 15, 2023 Category: Research Source Type: clinical trials

Spatial and Temporal Characterization of Gliomas Using Radiomic Analysis
Condition:   Glioma Intervention:   Diagnostic Test: Radiomic analysis of imaging - MRI, PET, CT Sponsors:   Tata Memorial Centre;   Indian Statistical Institute, Kolkata Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 13, 2023 Category: Research Source Type: clinical trials

ACELYRIN, INC. Announces Top-Line Results from Placebo-Controlled Clinical Trial of Izokibep for Moderate-to-Severe Hidradenitis Suppurativa
The primary endpoint of HiSCR75 at week 16 did not meet statistical significance in the Non-Responder Imputation (NRI) primary analysis. HiSCR75 did meet statistical significance at week 16 in a Last Observation Carried Forward sensitivity... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 11, 2023 Category: Pharmaceuticals Source Type: clinical trials

The unblinding of statisticians in clinical trials: commentary on Iflaifel et al., Trials 2023
AbstractRecently, the Blinding of Trial Statisticians research team, Iflaifel and colleagues, have produced detailed guidance regarding the blinding or unblinding of statisticians in clinical trials, based on substantial mixed-methods work. I wish to comment on the research findings. In particular, I argue that open-label trials, non-drug trials, or non-inferiority trials should not be treated any differently from blinded superiority trials with regards to the risk of bias assessment. Prevention of bias should be the priority for definitive randomised controlled trials, regardless of the precise study design. (Source: Trials)
Source: Trials - September 11, 2023 Category: Research Source Type: clinical trials