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1,688 results for “Advanced therapies”
ValRun: GMP-grade Manufacturing and Quality Control of a Non-Virally engineered Advanced Therapy Medicinal Product for Personalized Treatment of Age-Related Macular Degeneration
<p><strong>VaLRun: </strong></p> <p><strong>Raw data of "GMP-grade Manufacturing and Quality Control of a Non-Virally engineered Advanced Therapy Medicinal Product for Personalized Treatment of Age-Related Macular Degeneration"</strong></p> <p>(Excel-, pdf-, GraphPad-files, mp4 videos and a READ-ME text file)</p> <p>The introduction of new therapeutics requires validation of Good Manufacturing Practice (GMP)-grade manufacturing including suitable quality controls. This is challenging for Advanced Therapy Medicinal Products (ATMP) with personalized batches. We have developed a person-alized, cell-based gene therapy to treat age-related macular degeneration and established a vali-dation strategy of the GMP-grade manufacture for the ATMP; manufacturing and quality control were challenging due to a low cell number, batch-to-batch variability and short production duration. Instead of patient iris pigment epithelial cells, human donor tissue was used to produce the transfected cell product (“tIPE”). We implemented an extended validation of 104 tIPE productions. Procedure, operators and devices have been validated and qualified by determining cell number, viability, extracellular DNA, sterility, duration, temperature and volume. Transfected autologous cells were transplanted to rabbits verifying feasibility of the treatment. A container has been engineered to insure a safe transport from the production to the surgery site. Criteria for successful validation and qualification were based on tIPE’s Critical Quality Attributes and Process Parameters, its manufacture and release criteria. The validated process and qualified operators are essential to bring the ATMP into clinic and offer a general strategy for the transfer to other manufacture centers and personalized ATMPs.</p>
Raw data corresponding to the scientific paper: "A modular telerehabilitation architecture for upper limb robotic therapy" (Advances in Mechanical Engineering 2017, Vol. 9(1) 1-13)
<p>Acquired raw data necessary to implement the adaptive control strategy grounded on multimodal information.<br> In addition, raw data for the computation of the communication parameters needed for the assessment of the implemented telerehabilitation architecture are provided.</p> <p>a) End-effector positions and velocities (x, y, vx, vy) in three conditions: healthy (Fig 9) and constraint simulated stroke behaviour (Fig 10) without robotic assistance and simulated stroke behavior with robotic assistance (Fig 11)</p> <p>b) Performance indicators and control parameters for all the recruited subjects in both conditions healthy behaviour and simulated stroke behaviour (Fig 12a and Fig 12b)</p> <p>c) Computational values for evaluating telerehabilitation performance (Table 1)</p> <p> </p> <p> </p>
Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Brea
ClinicalTrials.gov study NCT03839823. IPD Sharing: YES. Countries: 13. Publications: 1.
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
ClinicalTrials.gov study NCT04478266. IPD Sharing: YES. Countries: 30. Publications: 2.
Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients
ClinicalTrials.gov study NCT03623243. IPD Sharing: YES. Countries: 2. Publications: 1.
A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
ClinicalTrials.gov study NCT01712490. IPD Sharing: YES. Countries: 21. Publications: 9.
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progres
ClinicalTrials.gov study NCT03056755. IPD Sharing: YES. Countries: 19. Publications: 4.
Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
ClinicalTrials.gov study NCT03284957. IPD Sharing: YES. Countries: 10. Publications: 1.
High CD8 + / FOXP3+ Ratio is Significantly Associated with Primary Endocrine Therapy Resistance Occurrence in Locally Advanced Luminal B Her-2 Negative Breast Cancer Patients
<p>High CD8 + / FOXP3+ Ratio is Significantly Associated with Primary Endocrine Therapy Resistance Occurrence in Locally Advanced Luminal B Her-2 Negative Breast Cancer Patients</p>
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
ClinicalTrials.gov study NCT02576509. IPD Sharing: Not stated. Countries: 22. Publications: 4.
Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)
ClinicalTrials.gov study NCT03783078. IPD Sharing: YES. Countries: 8. Publications: 1.
The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE Trial
ClinicalTrials.gov study NCT01166347. IPD Sharing: Not stated. Countries: 1. Publications: 3.
BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers
ClinicalTrials.gov study NCT04021043. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Neoadjuvant Therapy for Locally Advanced Colon Cancer
ClinicalTrials.gov study NCT04625803. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
ClinicalTrials.gov study NCT02466971. IPD Sharing: Not stated. Countries: 3. Publications: 2.
Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer
ClinicalTrials.gov study NCT02240238. IPD Sharing: Not stated. Countries: 5. Publications: 1.
Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer
ClinicalTrials.gov study NCT02254278. IPD Sharing: Not stated. Countries: 4. Publications: 1.
Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma
ClinicalTrials.gov study NCT03117309. IPD Sharing: Not stated. Countries: 1. Publications: 2.
Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
ClinicalTrials.gov study NCT00791778. IPD Sharing: Not stated. Countries: 14. Publications: 2.
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
ClinicalTrials.gov study NCT00147290. IPD Sharing: Not stated. Countries: 1. Publications: 4.
ScienceDex guides
Understand access before you commit
These curated guides explain access requirements, typical timelines, costs, and reuse considerations for widely used research datasets.
Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.