Publications by authors named "Christina Habermehl"

Unlabelled: Methionine aminopeptidase 2 (MetAP2) is essential to endothelial cell growth and proliferation during tumor angiogenesis. M8891 is a novel orally bioavailable, potent, selective, reversible MetAP2 inhibitor with antiangiogenic and antitumor activity in preclinical studies. The safety, tolerability, pharmacokinetics, and pharmacodynamics of M8891 monotherapy were assessed in a phase I, first-in-human, multicenter, open-label, single-arm, dose-escalation study (NCT03138538).

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The addendum of the ICH E9 guideline on the statistical principles for clinical trials introduced the estimand framework. The framework is designed to strengthen the dialog between different stakeholders, to introduce greater clarity in the clinical trial objectives and to provide alignment between the estimand and statistical analysis. Estimand framework related publications thus far have mainly focused on randomized clinical trials.

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  • Scientists are trying to find the best dose of new cancer treatments that people can handle without too many side effects, known as the maximum tolerated dose (MTD).
  • They are using a smart method called Bayesian adaptive model-based designs to help make better decisions about doses based on how the body absorbs the medicine.
  • By testing different doses in computer simulations, researchers found that these new methods are usually safer and more accurate than older ones, but they also need to closely control how much the medicine is processed in different people's bodies to get the best results.
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  • M4112 is a new medication that blocks certain enzymes related to cancer and is being tested on people with advanced tumors to see if it's safe and effective.
  • In animal tests, M4112 showed it could lower certain harmful substances related to tumors, and during human trials, different doses were given to see how the body reacted.
  • The results showed that M4112 was generally well tolerated by patients, but there weren't strong signs that it significantly helped reduce tumors, with most patients showing no change in their condition.
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The role of salvage high-dose chemotherapy and autologous stem cell transplantation (sHDCT/ASCT) for relapsed and/or refractory multiple myeloma (RRMM) in the era of continuous novel agent treatment has not been defined. This randomized, open-label, phase III, multicenter trial randomized patients with 1st-3rd relapse of multiple myeloma (MM) to a transplant arm (n = 139) consisting of 3 Rd (lenalidomide 25 mg, day 1-21; dexamethasone 40 mg, day 1, 8, 15, and 22; 4-week cycles) reinduction cycles, sHDCT (melphalan 200 mg/m), ASCT, and lenalidomide maintenance (10 mg/day) or to a control arm (n = 138) of continuous Rd. Median PFS was 20.

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Objectives: The German-speaking Myeloma Multicenter Group (GMMG) conducted this trial to investigate efficacy and safety of the three-drug combination bendamustine/prednisone/bortezomib (BPV) as first-line therapy for elderly patients with multiple myeloma (MM).

Methods: Elderly MM patients requiring first-line therapy and not eligible for intensive treatment were enrolled in this phase IIb multicenter study. Patients were treated with BPV regimen for a maximum of nine cycles.

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  • In cancer studies, different patients have different health backgrounds, which can change how they respond to treatments.
  • This can mess up the accuracy of traditional clinical trials, leading to more mistakes than expected.
  • The paper explains two new ways to improve trials by grouping patients or using past data to better predict how well the treatments work.
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In recent years, numerous approaches for biomarker-based clinical trials have been developed. One of these developments are multiple-biomarker trials, which aim to investigate multiple biomarkers simultaneously in independent subtrials. For low-prevalence biomarkers, small sample sizes within the subtrials have to be expected, as well as many biomarker-negative patients at the screening stage.

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  • Functional near-infrared spectroscopy (fNIRS) and diffuse optical tomography (DOT) are noninvasive techniques for monitoring brain activity by measuring changes in near-infrared light absorption and producing three-dimensional images with better resolution.
  • The challenge in reconstructing brain activity images using DOT arises from the need to solve an underdetermined inverse problem, making the choice of regularization methods crucial for accurate results.
  • This study introduces a cross-validation approach to independently select regularization parameters and evaluates seven different image reconstruction methods, highlighting their varying impacts on the quality of cerebral functional DOT reconstructions.
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Dynamic near-infrared fluorescence (DNIF) whole-body imaging of small animals has become a popular tool in experimental biomedical research. In humans, however, the field of view has been limited to body parts, such as rheumatoid hands, diabetic feet or sentinel lymph nodes. Here we present a new whole-body DNIF-system suitable for adult subjects.

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Functional near infrared spectroscopy (fNIRS) is a versatile neuroimaging tool with an increasing acceptance in the neuroimaging community. While often lauded for its portability, most of the fNIRS setups employed in neuroscientific research still impose usage in a laboratory environment. We present a wearable, multi-channel fNIRS imaging system for functional brain imaging in unrestrained settings.

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Topographic non-invasive near infrared spectroscopy (NIRS) has become a well-established tool for functional brain imaging. Applying up to 100 optodes over the head of a subject, allows achieving a spatial resolution in the centimeter range. This resolution is poor compared to other functional imaging tools.

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Non-invasive diffuse optical tomography (DOT) of the adult brain has recently been shown to improve the spatial resolution for functional brain imaging applications. Here we show that high-resolution (HR) DOT is also advantageous for clinical perfusion imaging using an optical contrast agent. We present the first HR-DOT results with a continuous wave near infrared spectroscopy setup using a dense grid of optical fibers and indocyanine green (ICG) as an exogenic contrast agent.

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Non-invasive optical imaging of brain function has been promoted in a number of fields in which functional magnetic resonance imaging (fMRI) is limited due to constraints induced by the scanning environment. Beyond physiological and psychological research, bedside monitoring and neurorehabilitation may be relevant clinical applications that are yet little explored. A major obstacle to advocate the tool in clinical research is insufficient spatial resolution.

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