Patient-reported outcome

MMRF Research Programs Expand Understanding of the Biology of Multiple Myeloma and Patient-Reported Outcomes in New Data Featured at the 20th IMS Annual Meeting

Retrieved on: 
Wednesday, September 27, 2023
Biotechnology, Health, Philanthropy, General Health, Pharmaceutical, Oncology, Other Science, Research, Genetics, Foundation, Science, Abstract, Patient-reported outcome, Multiple myeloma, PRO, Multiple Myeloma Research Foundation, Publication, Data, Patient, IMS, Biology, Disease, MMRF, Pharmaceutical industry

The Multiple Myeloma Research Foundation (MMRF) today announced that findings from three studies based on analyses of its CoMMpass℠ and CureCloud℠datasets will be featured in an oral abstract and poster presentations at the 20th International Myeloma Society (IMS) Annual Meeting in Athens, Greece, September 27-30, 2023.

Key Points: 
  • The Multiple Myeloma Research Foundation (MMRF) today announced that findings from three studies based on analyses of its CoMMpass℠ and CureCloud℠datasets will be featured in an oral abstract and poster presentations at the 20th International Myeloma Society (IMS) Annual Meeting in Athens, Greece, September 27-30, 2023.
  • Topics include:
    A real-world longitudinal investigation of patient treatments and outcomes, including Patient Reported Outcome (PRO) surveys from the MMRF CureCloud Research Initiative
    Additionally, data from the CoMMpass Study are cited in 24 posters and four education sessions, demonstrating its enduring value in driving new advancements across multiple myeloma research.
  • To develop a more comprehensive picture of myeloma disease biology, the MMRF is expanding the CoMMpass dataset with immune data from its Immune Atlas research program.
  • The MMRF makes the datasets from CoMMpass, Immune Atlas, and CureCloud available to researchers, facilitating the development of optimal treatments for all myeloma patients.

Zhongchao Inc. Introduces PRO-Based Disease Management Model for Lung Cancer Patients

Retrieved on: 
Monday, September 25, 2023
Rapid response system, Depression, Duration, Anxiety, PRO, Cancer, Lung cancer, Appetite, App Store (iOS/iPadOS), American Journal of Clinical Oncology, WeChat, Patient, Nausea, Patient-reported outcome, Health, Fatigue, Medical imaging, Wu Zhongchao

This model is geared toward aiding the recovery of lung cancer patients and enhancing their life quality.

Key Points: 
  • This model is geared toward aiding the recovery of lung cancer patients and enhancing their life quality.
  • Zhongchao's existing patient management services already features a comprehensive range of offerings for lung cancer patients.
  • Weiguang Yang, Chairman and Chief Executive Officer of Zhongchao, commented, "We believe that PRO-based symptom management method provides an invaluable way to detect lung cancer patients' underlying health issues accurately and comprehensively, assist clinical decisions and improve the quality of care for our lung cancer patients.
  • At Zhongchao, we are continually refining our approaches to patient management services, aiming to achieve meaningful and lasting impacts on the lives of cancer patients."

BioMarin to Present ROCTAVIAN™ (valoctocogene roxaparvovec) Data from Longest and Largest Hemophilia Gene Therapy Clinical Trial Program at the International Society on Thrombosis and Haemostasis (ISTH) 2023 Congress

Retrieved on: 
Thursday, June 22, 2023
Transfer, Additive effect, Impact, Life, DSM-IV codes, BioMarin Pharmaceutical, Factor VIII, Requirement, Quality of life, Haemophilia, Patient, European Commission, Patient-reported outcome, Congress, SAN, International Society, PDUFA, Thrombosis, Health, FDA, Haemophilia A, EC, Exercise, BLA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, Medical device, Vaccine, ISTH, New Data Seal

SAN RAFAEL, Calif., June 22, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced it will present new data from the ROCTAVIAN™ (valoctocogene roxaparvovec) gene therapy clinical trial program. These data will be shared this week in four oral presentations and two posters at the 31st Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Montreal, Canada.

Key Points: 
  • These data will be shared this week in four oral presentations and two posters at the 31st Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Montreal, Canada.
  • The U.S. Food and Drug Administration (FDA) has set a PDUFA Target Action Date of June 30, 2023, for the Company's Biologics License Application (BLA) for valoctocogene roxaparvovec gene therapy.
  • The European Commission (EC) granted conditional marketing authorization under the brand name ROCTAVIAN on August 24, 2022.
  • "These data presented at ISTH will highlight the clinical impact of ROCTAVIAN for people living with severe hemophilia A more than three years post-infusion."

Citius Pharmaceuticals Announces Positive Results from the Phase 2b Study of Halo-Lido (CITI-002) for the Treatment of Hemorrhoids

Retrieved on: 
Tuesday, June 20, 2023
CMH, Pros, Ulobetasol, Patient-reported outcome, Quality of Life Index for Atopic Dermatitis, Lidocaine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PRO, Hemorrhoid, Clinical trial, 21st Century Cures Act, Patient, Trial of the century, Pain, Patent, Semantics, MCT, FDA, Safety, COA, Disease, Pharmaceutical industry, Medical device, Citius, Altius, Fortius

CRANFORD, N.J., June 20, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR) today announced results from the Company's Phase 2b clinical study of Halo-Lido (CITI-002), a topical formulation for the relief of hemorrhoid symptoms.  This trial was designed to assess the efficacy of the combination product, select the appropriate dose and endpoints for a Phase 3 trial and to validate the PRO.  The high dose formulation of CITI-002, a lidocaine and halobetasol propionate combination formulation, provided a meaningful reduction in symptom severity, as reported by patients, when compared to individual components alone. Moreover, there were no reported significant adverse events and CITI-002 was well tolerated by patients in the study.  Citius intends to schedule an end of Phase 2 meeting with the U.S Food and Drug Administration (FDA) to begin planning the next steps in the regulatory and clinical development program for CITI-002.

Key Points: 
  • Moreover, there were no reported significant adverse events and CITI-002 was well tolerated by patients in the study.
  • Approximately 300 adults with a clinical diagnosis of symptomatic hemorrhoids were enrolled in the Halo-Lido Phase 2b study ( NCT05348200 ), a multi-center, randomized, dose-ranging, double-blind, parallel group comparison clinical trial.
  • Moreover, the current results reinforce our confidence in the safety and tolerability of CITI-002 and strongly support further evaluation of CITI-002 in a Phase 3 study.
  • We are looking forward to sharing the Phase 2b data with the FDA and seeking guidance for further development of this drug."

Stallergenes Greer Showcases Clinical Relevance and Persisting Benefits of Its Allergen Immunotherapy Treatments at 2023 EAACI Congress

Retrieved on: 
Friday, June 9, 2023
Biotechnology, General Health, Other Health, Health, Cardiology, Real, European Academy of Allergy and Clinical Immunology, Abstract, International, AIT, RCT, EAACI, Patient, Congress, Allergy, Allergen, Medicine, Patient-reported outcome, Real world evidence, Pharmaceutical industry

Stallergenes Greer, a leading global healthcare company specialising in allergen immunotherapy (AIT), will be hosting a company-sponsored symposium entitled “Patient’s perspective: A must have for the future of Allergen Immunotherapy” at the 2023 European Academy of Allergy and Clinical Immunology (EAACI) Congress taking place June 9-11 in Hamburg (Germany).

Key Points: 
  • Stallergenes Greer, a leading global healthcare company specialising in allergen immunotherapy (AIT), will be hosting a company-sponsored symposium entitled “Patient’s perspective: A must have for the future of Allergen Immunotherapy” at the 2023 European Academy of Allergy and Clinical Immunology (EAACI) Congress taking place June 9-11 in Hamburg (Germany).
  • During the symposium, four of the world’s leading experts in respiratory allergy will showcase advancements regarding the clinical relevance of its AIT treatments, which contribute to furthering precision medicine and enhance patient benefits.
  • “Stallergenes Greer is committed to therapeutic progress to meet the needs of patients and the medical community.
  • During the congress, Stallergenes Greer will also present 13 abstracts on precision medicine in AIT and patient benefits and announce new data from clinical trials (EfficAPSI, Practis, and long-term data generated in Japan).

Remission Medical enters know-how agreement with Mayo Clinic to transform rheumatology care delivery

Retrieved on: 
Thursday, June 1, 2023
Medicine, ER, Mayo Clinic, Education, Urgent care center, EMR, PRO, Research, Multimedia, Patient, TTI, Patient-reported outcome, Triage, Practitioner, Algorithm, Rheumatoid arthritis, Rheumatology, Diagnosis, Health, Osteoarthritis, Gout, Lupus, Conditional sentence, Pharmaceutical industry, Nursing, Osteoporosis

RICHMOND, Va., June 1, 2023 /PRNewswire/ -- REMISSION MEDICAL today announced it has entered into a know-how agreement with Mayo Clinic to further develop Time to Treatment Initiation (TTI) in rheumatology and increase predictive patient care.

Key Points: 
  • RICHMOND, Va., June 1, 2023 /PRNewswire/ -- REMISSION MEDICAL today announced it has entered into a know-how agreement with Mayo Clinic to further develop Time to Treatment Initiation (TTI) in rheumatology and increase predictive patient care.
  • Mayo Clinic and Remission Medical announce collaboration in rheumatology.
  • Remission Medical is a virtual rheumatology clinic addressing the full range of rheumatological conditions including Rheumatoid Arthritis, Osteoporosis, Osteoarthritis, Lupus, and Gout, among others.
  • "Remission Medical's mission is to both improve access to care and improve the care overall for rheumatology patients across the spectrum from onset to – as our name implies – remission," said Blake Wehman, founder and CEO of Remission Medical.

MeiraGTx Announces Positive Clinical Data from the AQUAx Phase 1 Clinical Study of AAV2-hAQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia

Retrieved on: 
Tuesday, December 13, 2022
Eye, Annual report, Collection, Head, Quality of life, Clinical trial, Systematic review, Meta-analysis, Saliva, Head and neck cancer, Parotid duct, Prevalence, Failure, Nature, Security (finance), Public opinion, FDA, Safety, Xerostomia, 8-K, Stensen, Loss, Supportive Care in Cancer, Patient-reported outcome, Treatment, Gene expression, Central nervous system, Neurodegeneration, Form 10-K, DLT, Toxicity, Șaeș, Retina, Disease, COVID-19, RIX, Pilocarpine, Pharmaceutical industry, Medical imaging, Patient, Webcast

ET

Key Points: 
  • ET
    LONDON and NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced positive clinical data from the ongoing Phase 1 AQUAx study of AAV2-hAQP1 for the treatment of grade 2/3 radiation-induced xerostomia (RIX).
  • The study is being conducted at 4 centers, 3 in the US and 1 in Canada.
  • All participants are to be followed for 1-year post-treatment and will then enter a long-term follow-up study for an additional 4 years.
  • Secondary endpoints include change from baseline in patient reported measures of xerostomia symptoms as well as whole salivary flow rates.

Treace Announces First Patient Treated in MTA3D™ Adductoplasty® Clinical Study

Retrieved on: 
Monday, November 21, 2022
DPM, Patient, Recurrence, Toe, Shoe, MS, Correction, Bunion, Pain, Dayton, Ohio, Foot, Deformity, MD, Weight-bearing, Surgeon, Patient-reported outcome, DRS, Quality of life, Consultant, Trial of the century, Dentistry, Medical imaging, TREAC

With the first patient now treated, we look forward to advancing the MTA3D Clinical Study and reporting on outcomes following the procedures.

Key Points: 
  • With the first patient now treated, we look forward to advancing the MTA3D Clinical Study and reporting on outcomes following the procedures.
  • Our MTA3D Clinical Study reinforces our focused leadership in the surgical correction of bunions, as well as our commitment to building upon our differentiated clinical body of evidence.
  • The MTA3D Clinical Study is a prospective, multicenter, post-market study designed to evaluate outcomes of the combined Adductoplasty and Lapiplasty Procedures for patients in need of metatarsus adductus and hallux valgus corrective surgery.
  • The study will evaluate for consistent, maintained radiographic correction and patient reported outcome scores following combined Adductoplasty and Lapiplasty procedures.

uMotif Announces First New Validated Innovation in eCOA/ePRO Since Paper Instruments Were Deployed on Smartphones

Retrieved on: 
Friday, November 18, 2022
Real World, Health, Patient, Android, Physician, Real, Clinical data management, Research, DNA, Motif, RWE, Patient-reported outcome, ICC, Dublin City University, Clinical trial, IOS, Smartphone, Language, VRS, Medical imaging, Medical device

BOSTON, Nov. 18, 2022 /PRNewswire-PRWeb/ -- uMotif, one of the clinical trial technology market's fastest growing companies, continues its transformation of the eCOA/DCT market with the announcement that its proprietary Motif data capture interface offers a validated alternative to text-based instruments for clinical, post-marketing and real-world research.

Key Points: 
  • Fifty-five participants completed testing in two randomized groups using the Motif interface and a traditional 5-point Verbal Response Scale (VRS-5).
  • Equivalence testing was based on the most commonly used PROM the EQ-5D-5L which was provided for the study with support from Euroqol.
  • "The results from this study are exciting, as the Motif is the first new data capture interface since paper instruments were put onto a smartphone.
  • uMotif's configurable, modular and customizable eClinical cloud native platform powers site-based to fully decentralized clinical, real world, and post marketing research.

Brainlab Enters Cooperation with the German Society for Orthopedics and Orthopedic Surgery (DGOOC)

Retrieved on: 
Monday, October 24, 2022
Security, Other Health, Radiology, Research, Software, Networks, Medical Devices, Hospitals, Data Management, Science, Online Privacy, Practice Management, Technology, Clinical Trials, General Health, Surgery, Health, University, Education, Physician, LinkedIn, Orthopedic surgery, Patient-reported outcome, Science, Society, Organization, Patient, General officer, Executive Committee of the National Economic Council, Privacy, Hospital, Twitter, Research, Instagram, Executive Committee, Multimedia, Collection, Facebook, Partnership, Technology, Education, CEO, Health, The German, RSG, Rehabilitation, Culture, EPRO, Ageing, Solution, Medicine, Medical device, Medical imaging, Brainlab, COVID-19

In order to realize the cooperation with Brainlab, the registry technology -- in particular the data trust center -- was outsourced to RSG. Together, Mint Medical and RSG intend to further advance the data trust center software to record and evaluate additional important clinical parameters, such as patient images. Both organizations also aim to simplify the collection of relevant data from orthopedic interventions.

Key Points: 
  • Brainlab , a digital medical technology company, and the German Society for Orthopedics and Orthopedic Surgery (DGOOC ) will work together in the field of data privacy-compliant registry solutions.
  • In order to realize the cooperation with Brainlab, the registry technology -- in particular the data trust center -- was outsourced to RSG.
  • The cooperation with Brainlab adds another layer of expertise to the collection and analysis of patient data.
  • The Germany Society for Orthopedics and Orthopedic Surgery (DGOOC) is a medical-scientific professional society and a non-profit organization founded in 1901 as the German Society for Orthopedic Surgery.