A5101696052- Health Systems, Economic Evaluations, Quality of Life
- Statistical Methods in Clinical Trials
- Advanced Causal Inference Techniques
- Glioma Diagnosis and Treatment
- Hedgehog Signaling Pathway Studies
- Gene Regulatory Network Analysis
- Biomedical Ethics and Regulation
- Medical Imaging Techniques and Applications
- Prostate Cancer Treatment and Research
- Cancer-related Molecular Pathways
- Breast Lesions and Carcinomas
- Breast Cancer Treatment Studies
- Cancer and Skin Lesions
- Neurofibromatosis and Schwannoma Cases
- Chronic Kidney Disease and Diabetes
- Oxidative Organic Chemistry Reactions
- Lung Cancer Diagnosis and Treatment
- Polyomavirus and related diseases
- Nanoplatforms for cancer theranostics
- Pigment Synthesis and Properties
- Radiomics and Machine Learning in Medical Imaging
- Advanced Breast Cancer Therapies
- Peptidase Inhibition and Analysis
- Click Chemistry and Applications
- Neuroblastoma Research and Treatments
Central University of Rajasthan
2022-2024
AbbVie (United States)
2018-2022
Regeneron (United States)
2022
Indian Association for the Cultivation of Science
2022
Jawaharlal Nehru Centre for Advanced Scientific Research
2021
Material (Belgium)
2021
Bangalore University
2021
Erasmus MC
2019
Wayne State University
2001-2005
The Barbara Ann Karmanos Cancer Institute
2005
Abstract Background Depatuxizumab mafodotin (Depatux-M) is a tumor-specific antibody–drug conjugate consisting of an antibody (ABT-806) directed against activated epidermal growth factor receptor (EGFR) and the toxin monomethylauristatin-F. We investigated Depatux-M in combination with temozolomide or as single agent randomized controlled phase II trial recurrent EGFR amplified glioblastoma. Methods Eligible were patients centrally confirmed glioblastoma at first recurrence after...
–The COVID-19 pandemic has had and continues to have major impacts on planned ongoing clinical trials. Its effects trial data create multiple potential statistical issues. The scale of impact is unprecedented, but when viewed individually, many the issues are well defined feasible address. A number strategies recommendations put forward assess address related estimands, missing data, validity modifications analysis methods, need for additional analyses, ability meet objectives overall...
For unifocal invasive breast carcinoma, increasing tumor diameter predictably correlates with a greater frequency of lymph node involvement, thereby facilitating treatment decisions. In tumors presenting multiple nodules, however, it is unclear whether size dissemination in similar manner.The authors analyzed series 101 carcinomas macroscopically apparent lesions (2 foci: n = 77; 3: 20; 4: 4). Two different assessments the (diameter largest focus and combined all foci) were then correlated...
Aims Individuals with diabetes and chronic kidney disease (CKD) are at high risk for renal events. Recent trials of novel treatments have been negative, possibly because variability in response to treatment the target factor. Atrasentan is a selective endothelin A receptor antagonist that reduces urinary albumin‐to‐creatinine ratio (UACR), large between patients. We assessing its effect on outcomes Study Of diabetic Nephropathy AtRasentan (SONAR; NCT01858532) an enrichment design (>30%...
A DTE based photochromic organic cage was used for stabilization of ultra-small Au nanoparticles and the resulting hybrid nanocomposite showed irradiated light regulated photocatalytic CO<sub>2</sub> reduction to CO.
Abstract BACKGROUND Maspin, a novel serine protease inhibitor, has been shown to inhibit prostate tumor cell motility and invasion in vitro growth metastasis vivo. Maspin expression high‐grade carcinoma (PC) is reduced compared with that low‐grade PC. Interestingly, however, PC, benign secretory epithelial cells express significantly less maspin. This observation appears paradoxical putative suppressive role of maspin carcinogenesis, this finding issue needs be clarified. METHODS We examined...
2500 Background: LDE225 is a potent and selective inhibitor of Smo, key signaling protein in the hedgehog (Hh) pathway. Activation Hh pathway implicated pathogenesis wide range malignancies. This first-in-human study aims to determine maximum tolerated dose LDE225, with additional assessments its pharmacokinetics (PK), pharmacodynamics (PD), potential efficacy. Methods: Patients (pts) age ≥18 advanced solid tumors are treated orally once daily on continuous 28-day dosing schedule. A...
9519 Background: Hedgehog (Hh) signaling is crucial in the development and homeostasis of many human organs tissues. Aberrant Hh involved tumorigenesis through promotion cell proliferation, survival, differentiation wide range cancers, including approximately 30% MBs. LDE225 a potent selective inhibitor Smo, key positive regulator signaling. The phase I exploring safety pharmacokinetics pediatric patients with advanced solid tumors that are potentially dependent on Preliminary data from...
An addendum of the ICH E9 guideline on Statistical Principles for Clinical Trials was released in November 2019 introducing estimand framework. This new framework aims to align trial objectives and statistical analyses by requiring a precise definition inferential quantity interest, that is, estimand. explicitly accounts intercurrent events, such as switching anticancer therapies analysis overall survival (OS), gold standard oncology. Traditionally, OS confirmatory studies is analyzed using...
The authors examined the impact of number CAG repeats in exon 1 androgen receptor on disease progression among men with prostate carcinoma after prostatectomy. This polymorphism has been associated alterations activity vitro systems and risk clinically diagnosed some epidemiologic studies. An earlier series found that, at low progressive disease, a small predicted high recurrence, varied different risks disease.
3062 Background: LDE225 is a potent and selective inhibitor of Smo, key regulatory protein in the Hedgehog (Hh) signaling pathway, which linked to pathogenesis many human cancers. This open-label, dose-escalation study aims evaluate tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD), preliminary efficacy LDE225. Methods: Patients (pts) with advanced cancer (n=76) received oral doses LDE225, ranging from 100 3,000 mg QD 400 750 BID, on continuous 28-day dosing schedule, single...
2023 Background: Depatux-M is a tumor-specific antibody-drug-conjugate consisting of an antibody (ABT-806) bound to the toxin monomethylauristatin-F. In primary analysis on EORTC 1410 we reported trend (p = 0.06) towards improved overall survival (OS) in patients with EGFR-amplified (amp) recurrent glioblastoma treated combination TMZ. Methods: Eligible were centrally confirmed EGFRamp at 1st recurrence after TMZ chemo-irradiation, occurring ≥3 months radiotherapy. Patients randomized either...
Background In randomized clinical trials with censored time-to-event outcomes, the logrank test is known to have substantial statistical power under proportional hazards assumption and widely adopted as a tool compare two survival distributions. However, impossible validate in practice until data are unblinded. analysis plan of trial particular its primary method must be pre-specified before any unblinded information may reviewed. Purpose The purpose this article guide applied...
Abstract Two new zinc(II) complexes, [2,6‐ bis (methylphenyliminomethyl)pyridine]ZnBr 2 ( a ) and (triflouromethylphenyliminomethyl)pyridine]ZnBr b were synthesized by the reactions of corresponding 2,6‐ (imino)pyridine based [NNN]‐pincer ligand anhydrous ZnBr in acetonitrile as solvent. The catalytic properties complexes examined azide‐alkyne cycloaddition water. characterized UV‐Vis, 1 H NMR, IR, elemental analysis mass spectroscopy. zinc complex was X‐ray crystallography. efficiently...
The FDA's Accelerated Approval program (AA) is a regulatory to expedite availability of products treat serious or life-threatening illnesses that lack effective treatment alternatives. Ideally, all the many stakeholders such as patients, physicians, regulators, and health technology assessment [HTA] agencies are affected by AA should benefit from it. In practice, however, there intense debate over whether evidence supporting sufficient meet needs who collectively bring an approved product...
Abstract Two new manganese(II) complexes bearing bis (imino)pyridine pincer ligands have been synthesized. These were characterized by UV, IR, elemental analysis studies, and X‐ray crystallography. The crystal data of manganese revealed distorted trigonalbipyramidal geometries around the ion neutral tridentate N^N^N coordination mode for (BIP) ligand. catalytic properties explored oxidation benzylic C−H bonds using TBHP as an oxidant. corresponding carbonyl compounds produced in moderate to...
Depatux-M is an antibody-drug-conjugate consisting of antibody (ABT-806) specific to the activated conformation EGFR bound toxin monomethylauristatin-F. In primary analysis on EORTC 1410 we reported a trend (p = 0.06) towards improved overall survival (OS) in patients with EGFR-amplified (amp) recurrent glioblastoma treated combination temozolomide. Eligible were centrally confirmed EGFRamp at 1st recurrence after temozolomide chemo-irradiation. Patients randomized either a) 1.0 mg/kg every...
Ordinal data are often found in clinical studies. Sometimes the analysis of this is done using binary logistic regression after collapsing categories ordinal responses. However, these analyses may not be appropriate practice because either assumptions violated or information lost. Cumulative shown to a better alternative approach. The efficiency cumulative demonstrated simulation A novel sequential testing approach suggested context cancer data. In addition, absence proper knowledge data, an...
This article provides a novel approach to assess the importance of specific treatment phases within regimen through tipping point analyses (TPA) time-to-event endpoint using rank-preserving-structural-failure-time (RPSFT) modeling. In oncology clinical research, an experimental is often added standard care therapy in multiple improve patient outcomes. When resulting new meaningful benefit over care, gaining insights into contribution each phase becomes important properly guide practice. New...