To establish efficacy and safety of HDM sublingual Immunotherapy (HDM-SLIT) by comparing Odactra and placebo, when given sublingually for 3 years to high risk infants aged between 6 to 12 months at enrollment in preventing the development of asthma, assessed 1.5 years after discontinuation of treatment.

Start Date01 Feb 2027

Sponsor / Collaborator

The Children's Hospital Corp.

[+6]

NCT04948489

/ Not yet recruitingPhase 2IIT

Efficacy of the Levonorgestrel Intrauterine Device With Norethindrone Acetate for Treatment of Endometriosis in Adolescents and Young Adults

Endometriosis is the most common reproductive disease afflicting young women, often leading to debilitating chronic pelvic pain and impaired quality of life. Safe, effective, and convenient long-term treatments are lacking for adolescents and young adults. The levonorgestrel-containing IUD (LNG-IUD) represents an attractive long-term drug delivery system for the treatment of endometriosis during adolescence and young adulthood. However, while the LNG-IUD has an acceptable safety profile, it is not associated with a favorable bleeding profile and may not fully suppress endometriosis pain when used as monotherapy. Investigators hypothesize that the addition of NETA will improve bleeding patterns, maximize pain control, and improve continuation rates of the IUD when the two medications are used in combination. This proposed prospective trial provides the ideal context in which to investigate these clinical questions and advance research on the best treatments for endometriosis.

Start Date01 Jan 2026

Sponsor / Collaborator

The Children's Hospital Corp.

NCT06706336

/ Not yet recruitingNot ApplicableIIT

Radon Asthma Intervention Trial

To determine if radon mitigation can improve asthma

Start Date01 Dec 2025

Sponsor / Collaborator

The Children's Hospital Corp.

100 Clinical Results associated with The Children's Hospital Corp.

0 Patents (Medical) associated with The Children's Hospital Corp.

154,970

Literatures (Medical) associated with The Children's Hospital Corp.

01 Apr 2025·Medical Image Analysis

IVIM-Morph: Motion-compensated quantitative Intra-voxel Incoherent Motion (IVIM) analysis for functional fetal lung maturity assessment from diffusion-weighted MRI data

Article

Author: Kertes, Noga ; Zaffrani-Reznikov, Yael ; Freiman, Moti ; Afacan, Onur ; Warfield, Simon K ; Kurugol, Sila

Quantitative analysis of pseudo-diffusion in diffusion-weighted magnetic resonance imaging (DWI) data shows potential for assessing fetal lung maturation and generating valuable imaging biomarkers. Yet, the clinical utility of DWI data is hindered by unavoidable fetal motion during acquisition. We present IVIM-morph, a self-supervised deep neural network model for motion-corrected quantitative analysis of DWI data using the Intra-voxel Incoherent Motion (IVIM) model. IVIM-morph combines two sub-networks, a registration sub-network, and an IVIM model fitting sub-network, enabling simultaneous estimation of IVIM model parameters and motion. To promote physically plausible image registration, we introduce a biophysically informed loss function that effectively balances registration and model-fitting quality. We validated the efficacy of IVIM-morph by establishing a correlation between the predicted IVIM model parameters of the lung and gestational age (GA) using fetal DWI data of 39 subjects. Our approach was compared against six baseline methods: 1) no motion compensation, 2) affine registration of all DWI images to the initial image, 3) deformable registration of all DWI images to the initial image, 4) deformable registration of each DWI image to its preceding image in the sequence, 5) iterative deformable motion compensation combined with IVIM model parameter estimation, and 6) self-supervised deep-learning-based deformable registration. IVIM-morph exhibited a notably improved correlation with gestational age (GA) when performing in-vivo quantitative analysis of fetal lung DWI data during the canalicular phase. Specifically, over 2 test groups of cases, it achieved an __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__ R f 2 of 0.44 and 0.52, outperforming the values of 0.27 and 0.25, 0.25 and 0.00, 0.00 and 0.00, 0.38 and 0.00, and 0.07 and 0.14 obtained by other methods. IVIM-morph shows potential in developing valuable biomarkers for non-invasive assessment of fetal lung maturity with DWI data. Moreover, its adaptability opens the door to potential applications in other clinical contexts where motion compensation is essential for quantitative DWI analysis. The IVIM-morph code is readily available at:https://github.com/TechnionComputationalMRILab/qDWI-Morph.

01 Feb 2025·Journal of NeuroInterventional Surgery

Infantile dural arteriovenous fistula: a reconsideration

Article

Author: Oushy, Soliman ; Orbach, Darren B

BackgroundInfantile-type dural arteriovenous shunts (IDAVS) are rare and heterogeneous vascular lesions, complicating their classification and management. The current tripartite classification of pediatric dural arteriovenous shunts (DAVS) into dural sinus malformation, infantile-type, and adult-type, does not stand up to scrutiny, given the variable presentations of the latter two types in children. We estimate the prevalence of IDAVS and evaluate the long term outcomes after endovascular treatment (EVT).MethodsA retrospective review of a pediatric cerebrovascular database between 2006 and 2023 was conducted. Clinical and radiographic data were analyzed to evaluate the presentation and long term outcomes of IDAVS.ResultsIDAVS were identified in 8 (0.5%) of 1463 patients, with mean age at diagnosis of 34.7 months; male infants comprised 62.5%. The most common clinical presentations included macrocephaly (37.5%), seizures (25%), and dilated scalp veins (25%). EVT was performed in 87.5% of cases, averaging 5.8 procedures per patient. Radiographic obliteration was observed in 28.6%. Good clinical outcomes (modified Rankin Scale score of ≤2) were achieved in 85.7%. Our findings showcased discrepancies and limitations in the current classification of pediatric DAVS, prompting a re-evaluation.ConclusionIDAVS accounted for a small proportion of pediatric cerebrovascular pathologies, with markedly heterogeneous presentations. Stepwise selective embolization was associated with favorable outcomes, and is recommended over an aggressive approach with the goal of complete angiographic obliteration. Our proposed revised classification system bifurcates pediatric DAVS into dural sinus malformations and all other DAVS that are manifest in children, thereby enhancing diagnostic clarity and therapeutic approaches.

01 Jan 2025·American Journal of Obstetrics and Gynecology

Intrapartum electronic fetal heart rate monitoring to predict acidemia at birth with the use of deep learning

Article

Author: Levine, Lisa D ; Chivers, Corey ; La Cava, William G ; McCoy, Jennifer A ; Teel, Joseph ; Wan, Guangya

BACKGROUNDElectronic fetal monitoring is used in most US hospital births but has significant limitations in achieving its intended goal of preventing intrapartum hypoxic-ischemic injury. Novel deep learning techniques can improve complex data processing and pattern recognition in medicine.OBJECTIVEThis study aimed to apply deep learning approaches to develop and validate a model to predict fetal acidemia from electronic fetal monitoring data.STUDY DESIGNThe database was created using intrapartum electronic fetal monitoring data from 2006 to 2020 from a large, multisite academic health system. Data were divided into training and testing sets with equal distribution of acidemic cases. Several different deep learning architectures were explored. The primary outcome was umbilical artery acidemia, which was investigated at 4 clinically meaningful thresholds: 7.20, 7.15, 7.10, and 7.05, along with base excess. The receiver operating characteristic curves were generated with the area under the receiver operating characteristic assessed to determine the performance of the models. External validation was performed using a publicly available Czech database of electronic fetal monitoring data.RESULTSA total of 124,777 electronic fetal monitoring files were available, of which 77,132 had <30% missingness in the last 60 minutes of the electronic fetal monitoring tracing. Of these, 21,041 were matched to a corresponding umbilical cord gas result, of which 10,182 were time-stamped within 30 minutes of the last electronic fetal monitoring reading and composed the final dataset. The prevalence rates of the outcomes in the data were 20.9% with a pH of <7.2, 9.1% with a pH of <7.15, 3.3% with a pH of <7.10, and 1.3% with a pH of <7.05. The best performing model achieved an area under the receiver operating characteristic of 0.85 at a pH threshold of <7.05. When predicting the joint outcome of both pH of <7.05 and base excess of less than -10 meq/L, an area under the receiver operating characteristic of 0.89 was achieved. When predicting both pH of <7.20 and base excess of less than -10 meq/L, an area under the receiver operating characteristic of 0.87 was achieved. At a pH of <7.15 and a positive predictive value of 30%, the model achieved a sensitivity of 90% and a specificity of 48%.CONCLUSIONThe application of deep learning methods to intrapartum electronic fetal monitoring analysis achieves promising performance in predicting fetal acidemia. This technology could help improve the accuracy and consistency of electronic fetal monitoring interpretation.

397

News (Medical) associated with The Children's Hospital Corp.

07 Jan 2025

·www.businesswire.com

AI Proteins Appoints Founder Dr. Chris Bahl as Chief Executive Officer; Company to Present at Biotech Showcase 2025 during J.P. Morgan Healthcare Week

BOSTON--( BUSINESS WIRE )--AI Proteins, Inc., a pioneering company utilizing artificial intelligence to design novel protein therapeutics, announces the appointment of its founder, President and Chief Scientific Officer, Dr. Chris Bahl, as Chief Executive Officer. Dr. Bahl will lead the company into its next phase, advancing its innovative platform and pipeline of groundbreaking therapies. Dr. Bahl will succeed Noah Beerman, who left the company in December. Dr. Bahl is a renowned leader in the field of protein design. Prior to founding AI Proteins, he was a founding faculty member at the Institute for Protein Innovation in Boston and held appointments at Boston Children's Hospital and Harvard Medical School. His pioneering work in de novo protein design has laid the foundation for AI Proteins' unique approach to drug discovery. "Chris' vision and expertise have been instrumental in establishing AI Proteins as a leader in AI-driven protein design," said Drew Dennison, Managing Director of Lightchain Capital and lead Director of the AI Proteins board. "His deep understanding of the science, combined with his passion for innovation, makes him the ideal leader to guide the company forward." "I am honored and excited to take on the role of CEO at this pivotal time for AI Proteins," said Dr. Bahl. "We have built a remarkable platform with the potential to unlock a new era of protein-based medicines. I look forward to working with our talented team to accelerate our research and bring transformative therapies to patients in need. I’d like to thank Noah for his leadership and important contributions to the company." Dr. Bahl, along with Chief Business Officer Wendy Dwyer and Chief Strategy Officer Michael Krepps, will present at the investor and networking event Biotech Showcase 2025, which takes place annually in conjunction with the JP Morgan Healthcare Conference. “We look forward to presenting at Biotech Showcase, one of the biotech industry’s most prominent events for investment and partnerships. This opportunity allows us to showcase our recent milestones as well as to share our long-term strategy to create breakthrough therapies by leveraging the strength of our miniprotein platform in partnership with industry pioneers and world-renowned academic institutions.” About AI Proteins Boston-based AI Proteins is a biotech company on a mission to re-imagine protein therapeutics with a novel approach for designing entirely new proteins. Using AI-based design and a high-throughput drug discovery platform, AI Proteins creates de novo proteins optimized for a variety of therapeutic applications. Partnered with leading global biopharmaceutical companies, the company continues to pursue collaborations in inflammation, metabolic diseases, oncology, and other therapeutic areas, in addition to advancing its internal pipeline. The company’s technology enables the development of inexpensive, durable, highly specific proteins with differentiated and enhanced therapeutic properties and with the potential for multiple routes of delivery. Additionally, the AI Proteins platform can dramatically accelerate the development of lead therapeutic candidates ready for IND-enabling studies. For more information please visit aiproteins.com .

Executive Change

23 Dec 2024

·www.drugs.com

2023 Saw Decline in BMI, Obesity Prevalence in the United States

MONDAY, Dec. 23, 2024 -- Body mass index (BMI) and obesity prevalence declined in the United States in 2023, according to a research letter published online Dec. 13 in JAMA Health Forum . Benjamin Rader, Ph.D., M.P.H., from Boston Children's Hospital, and colleagues examined national trends in BMI and obesity among U.S. adults between Jan. 1, 2013, and Dec. 31, 2023. The mean population BMI and percentage of adults with obesity were calculated annually. Overall, 16,743,822 unique adults contributed 47,939,382 BMI measurements. The researchers observed an increase in mean population BMI annually from 2013 to 2021, followed by a plateauing in 2022, and a slight decrease in 2023 (29.65 to 30.23, 30.24, and 30.21, respectively). The percent changes of adults with obesity followed the same pattern. Obesity prevalence decreased in the South, among individuals aged 66 to 75 years, and among women. In a sensitivity analysis using unweighted data, the 2023 decline in prevalence of obesity was also seen. Glucagon-like peptide 1 receptor agonist (GLP-1 RA) dispensing differed by region in a subset of individuals with available 2023 insurance claims (South, 6.0 percent; Midwest, 5.1 percent; Northeast, 4.4 percent; West, 3.4 percent). "These findings suggest that BMI and obesity prevalence in the U.S. decreased in 2023 for the first time in more than a decade," the authors write. "The most notable decrease was in the South, which had the highest observed per capita GLP-1RA dispensing rate." One author disclosed ties to Optum. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

17 Dec 2024

·www.businesswire.com

ALKemist Bio Appoints Adi Hoess to Board of Directors

TURIN, Italy--( BUSINESS WIRE )-- ALKemist Bio , a biotechnology company dedicated to transforming the treatment of ALK-positive cancers, today announced the appointment of Dr. Adi Hoess to the company’s Board as an independent director. Dr. Hoess brings over three decades of leadership experience from across the biopharmaceutical industry and a significant commitment to the development of immuno-oncology therapeutics. As the former CEO of Affimed N.V., he played a pivotal role in advancing groundbreaking therapies that harness the immune system to combat cancer, aligning with ALKemist Bio’s mission to effectively target Anaplastic Lymphoma Kinase (ALK). ALK is a driver oncogene associated with several cancer types that often develop as an aggressive and recurrent disease after failure of ALK inhibition therapy. The addition of an experienced Board member strengthens the company’s ongoing preclinical evaluation and upcoming clinical development of its T cell-based therapies for ALK-positive tumors. “ Adi’s deep expertise in cellular therapies and impressive track record of driving biotech innovation and corporate development will be instrumental as ALKemist Bio enters its next phase of growth,” said Pietro Puglisi, Executive Chairman of ALKemist Bio. " With his guidance, we are well-positioned to achieve important progress in our pipeline and prepare for clinical evaluation, with the overall objective of bringing transformative therapies to patients with ALK-positive cancers.” “ The team at ALKemist Bio is developing groundbreaking ALK-specific cell therapies, which in preclinical testing eliminated ALK-positive cancer cells,” Dr. Hoess commented. “ ALK-positive tumors are aggressive and often relapse despite the availability of innovative kinase inhibitors, while T cell-based approaches offer the potential for more durable responses. I look forward to contributing to ALKemist’s growth and supporting its mission to improve outcomes for patients.” Dr. Adi Hoess has had a broad-ranging career in leading biotechnology companies through important value-building transitions, including advancing innovative drug candidates into clinical development and executing corporate and collaborative transactions. After leaving Nasdaq-listed Affimed, where he served as CEO for 13 years, Dr. Hoess joined ViaNautis Bio, a company pioneering targeted delivery solutions for genetic medicines, as CEO in October 2024. He was also Chief Commercial Officer of Jerini, which was acquired by Shire. He started his career at MorphoSys, attaining the title of Vice President Licensing and Business Development, where he oversaw multiple in- and out-licensing deals. Dr. Hoess holds a medical degree from the Technical University of Munich and a PhD in Chemistry and Biochemistry from Munich University. ALKemist Bio has achieved several key milestones over the past year. In December 2023, the company secured €6.9 million in funding through an investment round led by Claris Ventures, enabling the advancement of its first-in-class T Cell Receptor (TCR) cell therapy. Additionally, in July 2024, ALKemist Bio signed an exclusive license agreement with Boston Children’s Hospital, granting the company rights to develop and commercialize ALK-specific TCR therapies. These achievements underscore ALKemist Bio’s dedication to delivering innovative and life-changing solutions for patients with ALK-positive cancers. About ALKemist Bio ALKemist Bio’s mission is to change the treatment and prognosis of aggressive ALK-positive cancers by developing T cell-based immunotherapies that can eradicate ALK-positive cancer cells, overcome resistance and extend remissions for these patients. Leveraging deep collaborations with leading hospitals and research institutions, our objective is to prove the effectiveness of T cell-based therapies to radically extend the gains of ALK inhibition. By closing in on ALK, we aim to bring a sea change to cancer treatment that will mean hope for all patients with ALK-positive tumors.

Executive ChangeLicense out/inImmunotherapyCell Therapy

100 Deals associated with The Children's Hospital Corp.

100 Translational Medicine associated with The Children's Hospital Corp.

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Pipeline Snapshot as of 11 Feb 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Xylitol	Otitis Media More	Phase 3
Fluorothymidine F-18	Brain Cancer More	Phase 2
BCH_BBLCR-shRNA(bluebird bio, Inc.) ( BCL11A x Hemoglobins )	Anemia, Sickle Cell More	Phase 1
OBD9 ( TNIK )	Colorectal Cancer More	Preclinical
ICAM1-DM1 ADC (Boston Children's Hospital) ( ICAM-1 x Tubulin )	Pancreatic Cancer More	Preclinical

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