Effectiveness and Safety of the 4-Step Versus 6-Step Milk Ladder in Children with IgE-Mediated Cow's Milk Protein Allergy: Protocol for an Open-Label Randomised Controlled Trial

Cow's milk protein allergy (CMPA) is one of the most common food allergies in early childhood. The first-line treatment of CMPA is the elimination of cow's milk proteins (CMPs) from the child's or maternal diet.
Available data from the literature indicate that most children with CMPA acquire tolerance to CMPs with age. An assessment of tolerance acquisition to CMPs is commonly performed using milk ladder. However, scientific evidence regarding the effectiveness and safety of the milk ladder in children with CMPA is limited. Currently, there is no standardised milk ladder protocol, and different versions of the ladder and recommend by scientific societies in various countries.
This study aims to assess the effectiveness and safety of the 4-step milk ladder (4-ML) compared to the 6-step milk ladder (6-ML) in children with IgE-mediated CMPA. This is an open-label, randomised superiority trial with two parallel arms and a 1:1 allocation ratio.

开始日期2025-01-01

申办/合作机构

Warszawski Uniwersytet Medyczny

NCT06652698 / Not yet recruitingN/AIIT

Early Supplementation for Cow's Milk Allergy Prevention in Breastfed Infants in Poland (ESCAPE-PL): a Protocol for Randomised Controlled Trial

Cow's milk allergy (CMA) is a common food allergy in infants and young children that can have a significant impact on the individual and their family due to dietary restrictions, risk of nutritional deficiencies, social limitations, and decreased quality of life. It also represents a financial burden for families and healthcare resources.
There is an ongoing debate about the significance of early exposure to cow's milk proteins within hours or days after birth and its relationship to the risk of developing CMA later in life. Current recommendations for early introduction of cow's milk proteins in infants who cannot be breastfed vary and are inconsistent due to a lack of clear evidence. This knowledge gap underscores the need for further research to provide a definitive understanding of the relationship between early exposure to cow's milk proteins and the development of CMA, which will ultimately inform evidence-based prevention strategies to improve the health and well-being of affected individuals and their families.
This trial aims to investigate whether early supplementation with various nutritional interventions (cow's milk formula [CMF], amino acids formula [AAF], donor human milk [DHM], or high-pressure processed "pascalized" donor human milk [DHM-P]) could serve as an effective strategy for the primary prevention of CMA in breastfed neonates.
This study is an open-label randomized, controlled, head-to-head trial with four parallel arms and allocation 1:1:1:1.

开始日期2025-01-01

申办/合作机构

Warszawski Uniwersytet Medyczny

[+1]

NCT06661317 / Not yet recruitingN/AIIT

Presence of HIV-1 DRMs As a Risk Factor of Failure of Two Drugs Based ART Regimens, Including LAI ART, in Cohorts of Primary and Secondary DRMs.

The presence of drug resistance mutations (DRMs) in HIV plays an important role in ART effectiveness. Despite very good results of ART, there is constant concern about the emergence of HIV strains with DRMs, what may lead to virological suppression failure. The concerns grow especially among patients treated with two drugs based regimens, including long acting therapies in injections (LAI ART) or regimens used in preexposure prophylaxis (PreP).

开始日期2024-11-01

申办/合作机构

Warszawski Uniwersytet Medyczny

100 项与 Warszawski Uniwersytet Medyczny 相关的临床结果

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16,167

项与 Warszawski Uniwersytet Medyczny 相关的文献（医药）

2025-01-01·JOURNAL OF AFFECTIVE DISORDERS

Probiotic Lactobacillus plantarum 299v supplementation in patients with major depression in a double-blind, randomized, placebo-controlled trial: A metabolomics study

Article

作者: Barbas-Bernardos, Cecilia ; Pawlak, Dariusz ; Bernardos, Cecilia Barbas ; Waszkiewicz, Napoleon ; Ciborowski, Michal ; Lopez-Gonzalvez, Angeles ; Ostrowska, Lucyna ; Szulc, Agata ; Kalaska, Bartlomiej ; Kretowski, Adam ; García, Antonia ; Rudzki, Leszek ; Swieton, Justyna ; Barbas, Coral ; Godzien, Joanna

BACKGROUND:

Understanding the multifactorial nature of major depressive disorder (MDD) is crucial for tailoring treatments. However, the complex interplay of various factors underlying the development and progression of MDD poses significant challenges. Our previous study demonstrated improvements in cognitive functions in MDD patients undergoing treatment with selective serotonin reuptake inhibitors (SSRIs) supplemented with Lactobacillus plantarum 299v (LP299v).

METHODS:

To elucidate the biochemical mechanisms underlying cognitive functions improvements, we explored underlying metabolic changes. We employed multi-platform metabolomics, including LC-QTOF-MS and CE-TOF-MS profiling, alongside chiral LC-QqQ-MS analysis for amino acids.

RESULTS:

Supplementation of SSRI treatment with LP299v intensified the reduction of long-chain acylcarnitines, potentially indicating improved mitochondrial function. LP299v supplementation reduced N-acyl taurines more than four times compared to the placebo, suggesting a substantial impact on restoring biochemical balance. The LP299v-supplemented group showed increased levels of oxidized glycerophosphocholine (oxPC). Additionally, LP299v supplementation led to higher levels of sphingomyelins, L-histidine, D-valine, and p-cresol.

LIMITATIONS:

This exploratory study suggests potential metabolic pathways influenced by LP299v supplementation. However, the need for further research hinders the ability to draw definitive conclusions.

CONCLUSIONS:

Observed metabolic changes were linked to mitochondrial dysfunction, inflammation, oxidative stress, and gut microbiota disruption. Despite the subtle nature of this alterations, our research successfully detected these differences and connected them to the metabolic disruptions associated with MDD. Our findings emphasise the intricate relationship between metabolism, gut microbiota, and mental health prompting further research into the mechanisms of action of probiotics in MDD treatment.

2025-01-01·MEDICAL IMAGE ANALYSIS

Real-time placental vessel segmentation in fetoscopic laser surgery for Twin-to-Twin Transfusion Syndrome

Article

作者: Sánchez, Clara I. ; Szczepański, Tomasz ; Korzeniowski, Przemysław ; Sánchez, Clara I ; Calvo, Jesús Rodriguez ; Khalil, Asma ; Szenejko, Paula ; Sitek, Arkadiusz ; Shamshirsaz, Alireza ; Płotka, Szymon ; Išgum, Ivana ; Brawura-Biskupski-Samaha, Robert

Twin-to-Twin Transfusion Syndrome (TTTS) is a rare condition that affects about 15% of monochorionic pregnancies, in which identical twins share a single placenta. Fetoscopic laser photocoagulation (FLP) is the standard treatment for TTTS, which significantly improves the survival of fetuses. The aim of FLP is to identify abnormal connections between blood vessels and to laser ablate them in order to equalize blood supply to both fetuses. However, performing fetoscopic surgery is challenging due to limited visibility, a narrow field of view, and significant variability among patients and domains. In order to enhance the visualization of placental vessels during surgery, we propose TTTSNet, a network architecture designed for real-time and accurate placental vessel segmentation. Our network architecture incorporates a novel channel attention module and multi-scale feature fusion module to precisely segment tiny placental vessels. To address the challenges posed by FLP-specific fiberscope and amniotic sac-based artifacts, we employed novel data augmentation techniques. These techniques simulate various artifacts, including laser pointer, amniotic sac particles, and structural and optical fiber artifacts. By incorporating these simulated artifacts during training, our network architecture demonstrated robust generalizability. We trained TTTSNet on a publicly available dataset of 2060 video frames from 18 independent fetoscopic procedures and evaluated it on a multi-center external dataset of 24 in-vivo procedures with a total of 2348 video frames. Our method achieved significant performance improvements compared to state-of-the-art methods, with a mean Intersection over Union of 78.26% for all placental vessels and 73.35% for a subset of tiny placental vessels. Moreover, our method achieved 172 and 152 frames per second on an A100 GPU, and Clara AGX, respectively. This potentially opens the door to real-time application during surgical procedures. The code is publicly available at https://github.com/SanoScience/TTTSNet.

2025-01-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Physicochemical and structural analysis of N-phenylacetyl-L-prolylglycine ethyl ester (Noopept) – An active pharmaceutical ingredient with nootropic activity

Article

作者: Pisklak, Dariusz Maciej ; Szeleszczuk, Łukasz ; Bethanis, Kostas ; Araj, Szymon Kamil ; Zielińska-Pisklak, Monika ; Christoforides, Elias ; Gubica, Tomasz ; Dudek, Marta Katarzyna

N-Phenylacetyl-L-prolylglycine ethyl ester (Noopept, GVS-111, omberacetam) is an orally available active pharmaceutical ingredient (API), with neuroprotective properties and ability to enhance cognitive function. It belongs to nootropic family of drugs and is included in the group of racetams, although its chemical structure is quite different than the other compounds from this group, including the most popular one - piracetam. The mechanism of action of this API is multifaced and is considered to be involving modulation of various neurotransmitter systems within the brain. Despite the significant amount of works devoted to the pharmacodynamics of Noopept, very little is known about its structural and physicochemical properties. Therefore, the aim of current study was to investigate this API in a very thorough way. In this work, the detailed physicochemical analysis of Noopept has been done using TGA/DSC, ¹H and ¹³C liquid state NMR, ¹³C CP/MAS NMR, SEM, SCXRD, and PXRD. Additionally, quantum chemical DFT computations under periodic boundary conditions, using CASTEP, were conducted to facilitate the analysis of experimental results. Besides, we've performed a polymorphism screening of this molecule.

项与 Warszawski Uniwersytet Medyczny 相关的新闻（医药）

2024-08-06

·drugs

Vestibular Neurectomy Effective for Severe Meniere Disease

TUESDAY, Aug. 6, 2024 -- Vestibular neurectomy is an effective vertigo treatment in patients with severe Meniere disease, according to a study published online June 7 in the Journal of Clinical Medicine . Agnieszka Jasińska-Nowacka, M.D., Ph.D., from the Medical University of Warsaw in Poland, and colleagues evaluated functional outcomes and balance compensation in patients with severe Meniere disease after vestibular neurectomy. The analysis included data from 20 patients with unilateral Meniere disease before and two years after vestibular neurectomy. The researchers found that all patients reported a complete resolution of vertigo attacks after the vestibular neurectomy, while 95 percent of patients reported functional-level improvement according to a scale proposed by the American Academy of Otolaryngology-Head and Neck Surgery. All patients showed clinical improvement in the Dizziness Handicap Inventory, with the average result decreasing from 81.7 to 16.4. There were no statistically significant differences between the sensory organization test results before and after vestibular neurectomy. There were significant correlations between a patient’s age and postoperative results of the Dizziness Handicap Inventory and posturography. "Vestibular neurectomy is an effective vertigo treatment in patients with severe Meniere disease with no clinical improvement despite conservative treatment," the authors write. "It results in subjective physical, functional, and emotional improvement, enabling patients to return to daily activities and work." Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果

2024-08-05

·drugs

Vestibular Neurectomy Effective for Meniere Disease

MONDAY, Aug. 5, 2024 -- For patients with Meniere disease (MD), vestibular neurectomy is effective, resolving vertigo episodes and resulting in hydrops regression, according to a study published online July 30 in Acta Neurologica Belgica . Agnieszka Jasińska-Nowacka, M.D., Ph.D., from the Medical University of Warsaw in Poland, and colleagues assessed endolymphatic hydrops in patients with severe MD before and after vestibular neurectomy. Magnetic resonance imaging was performed before and after vestibular neurectomy in 20 patients with unilateral definite MD. The researchers found that in all patients, endolymphatic hydrops were visualized in the preoperative scans. All patients presented a complete resolution of vertigo episodes after the vestibular neurectomy. Analyzing the cochlea and vestibule, regression of the endolymphatic hydrops was observed in 35 and 15 percent of cases, respectively. Withdrawal of the hernia was visualized in 71.43 percent of patients with utricular herniation into the lateral semicircular canal. In 17.64 percent of cases, asymmetrical contrast enhancement in the cochlea regressed. Analyzing all parameters collectively, partial regression of at least one of the radiological signs was confirmed in the follow-up examination in 60 percent of patients. After the surgery, no progression of the endolymphatic hydrops was visualized in either the cochlea or the vestibule. "Although it is known to be an effective symptomatic treatment of vertigo attacks, vestibular neurectomy may also effectively halt the progression of the endolymphatic space dilatation and result in hydrops regression," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果临床研究

2023-04-04

·PRNewswire

Cantargia to host R&D Day on new clinical results of nadunolimab in pancreatic cancer on April 24, 2023

LUND, Sweden, April 4, 2023 /PRNewswire/ -- Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today announced it will host an R&D Day focusing on new clinical results and biomarker data for its lead asset, the IL1RAP-binding antibody nadunolimab (CAN04), in pancreatic cancer (PDAC) patients, following presentation of these results at the AACR Annual Meeting 2023 (AACR 2023). The R&D Day will be hosted by Cantargia management and Prof. Eric Van Cutsem, principal investigator in the CANFOUR trial. Cantargia recently announced new results from the phase I/IIa clinical trial CANFOUR, evaluating nadunolimab in combination with chemotherapy for treatment of PDAC, to be presented at AACR 2023 on April 17, 2023. A key finding is that patients with high tumor levels of IL1RAP, the target of nadunolimab, benefit most from the treatment. During the R&D Day, Prof. Van Cutsem, Division Head of Digestive Oncology at University of Leuven and University Hospitals Gasthuisberg in Leuven, Belgium, and renowned expert in PDAC, will discuss the current treatment landscape in PDAC and the relevance of the new nadunolimab data. He will be joined by Dr. Dominique Tersago and Dr. David Liberg from Cantargia's management team. Event details and registration information Date and time: April 24, 2023 2:00-3:30 PM CET (8:00-9:30 AM EST). Venue: Redeye, Mäster Samuelsgatan 42, 10 tr, Stockholm The event will be conducted in English and a simultaneous live webcast will be available for those unable to attend in person at the following link. The webcast will also be accessible on-demand, shortly after the event, at Cantargia's website . A live question and answer session will follow the formal presentations. Participation in the event on-site requires registration at the following link. Program Welcome and introduction to Cantargia – Göran Forsberg, CEO Nadunolimab mechanism of action – David Liberg, VP Research Clinical results including new biomarker data of nadunolimab – Dominique Tersago, CMO Pancreatic cancer and relevance of nadunolimab results – Prof. Eric Van Cutsem Cantargia's ongoing clinical trials – Dominique Tersago Upcoming milestones and concluding remarks – Göran Forsberg For further information, please contact Göran Forsberg, CEO Telephone: +46 (0)46-275 62 60 E-mail: [email protected] The information was submitted for publication, through the agency of the contact person set out above, at 12.30 CET on 4 April 2023. About Cantargia Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. The main program, the antibody nadunolimab (CAN04), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on systemic sclerosis and myocarditis. Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at . About nadunolimab (CAN04) The antibody nadunolimab binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1α and IL-1β signaling. Nadunolimab can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. Nadunolimab is investigated in multiple clinical trials; the phase I/IIa trial CANFOUR evaluates nadunolimab in combination with standard chemotherapies in patients with PDAC (gemcitabine/nab-paclitaxel) or NSCLC (cisplatin/gemcitabine) (NCT03267316). Positive interim data show durable responses for the combination therapy in 73 PDAC patients, resulting in median iPFS of 7.2 months and median survival of 12.7 months. Strong efficacy was also observed in 30 NSCLC patients with median PFS of 6.8 months and a response rate of 53%; even higher responses were observed in non-squamous NSCLC patients previously treated with pembrolizumab. Early efficacy data from the phase Ib/II trial TRIFOUR (NCT05181462) also shows signs of promising efficacy in TNBC with a 50% response rate for nadunolimab combined with carboplatin/gemcitabine. Nadunolimab is also investigated with chemotherapy in the clinical trials CAPAFOUR (NCT04990037) and CESTAFOUR (NCT05116891), and with the checkpoint inhibitor pembrolizumab in the CIRIFOUR trial (NCT04452214). About Prof. Eric Van Cutsem, MD, PhD Eric Van Cutsem, MD, PhD, is full professor and Division Head of Digestive Oncology at University of Leuven (KUL) and University Hospitals Gasthuisberg, Leuven, Belgium. In 2018, he became doctor honoris causa of the Medical University of Warsaw, Poland. Prof Van Cutsem's research focuses on the development of new treatment strategies for gastrointestinal cancers, including drug development and identification of molecular markers and diagnostic tools. He is Member of the Belgian Royal Academy of Medicine and President of the Belgian Foundation against Cancer. The following files are available for download: SOURCE Cantargia AB

临床结果AACR会议

100 项与 Warszawski Uniwersytet Medyczny 相关的药物交易

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100 项与 Warszawski Uniwersytet Medyczny 相关的转化医学

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