Real World Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention (MONITOR Study)

The goal of this observational study is to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization in patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, and inflammatory bowel disease type undetermined) initiating therapy with vedolizumab (Entvyio). The main questions it aims to answer are:
1. Assess and compare adherence to intravenous (IV) and subcutaneous vedolizumab maintenance therapy in patients with IBD using a novel remote monitoring system.
2. Assess symptom response to vedolizumab post induction (week 6-8) and during maintenance therapy (week 22) using a novel remote monitoring system.
3. Assess time to response to vedolizumab during induction (weeks 0-6) using a novel remote monitoring system.
Researchers will compare medication adherence between participants using IV and subcutaneous vedolizumab maintenance therapy to see if adherence is lower with self-administration.
Participants will be asked to register adherence to medication using the novel remote monitoring system each time they take a dose of vedolizumab and to respond to two questions about bowel symptoms weekly for the first 6 weeks after starting vedolizumab then monthly thereafter for 6 months. Additionally, participants will be asked to enter information regarding demographics and social determinants of health at baseline and other variables listed below at baseline and at weeks 2, 6, 14, and 22 post baseline unless otherwise denoted:
* MARS-5
* Healthcare utilization (22 weeks only)
* Harvey Bradshaw Index (Crohn's disease only)
* Simple clinical colitis activity index (Ulcerative colitis only)
* PROMIS Global Health Scale
* PROMIS Anxiety
* PROMIS Depression
* PROMIS Sleep Disturbance
* PROMIS Pain Interference
* PROMIS Physical Function
* IBD Self-Efficacy
* Attitudinal Survey (22 weeks only)

开始日期2025-05-05

申办/合作机构

Mercy Medical Center Redding

[+1]

NCT03976973

/ Unknown status临床2期

A Phase 2, Multi-centre Study of BromAc for Recurrent Peritoneal Mucinous Tumour or Pseudomyxoma Peritonei

Pseudomyxoma peritonei (PMP) is an orphan disease, characterized by the progressive accumulation of jelly-like material within the abdomen, which occurs in approximately 2-3 people per million per year. Advanced disease is often the result of tumour perforation and seeding of tumour cells within the peritoneal cavity. Complete cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CCRS HIPEC) is the current standard of care for PMP.
An Australian pharmaceutical company is developing BromAc for diseases involving mucin. This drug is composed of Bromelain and Acetylcysteine. During pre-clinical development, the sponsor found that BromAc rapidly dissolved and removed tumour mucin, making it a potent mucolytic. BromAc in combination have the ability, as shown in pre-clinical studies, to remove the mucin protective framework expressed by cancer including mucin (MUC) 1, MUC2, MUC4, MUC5AC and MUC16. The sponsor has shown the mechanism of action of BromAc - to break peptide and glycosidic linkages and disulphide bonds in tumour produced and respiratory mucin. BromAc has been safe in preclinical development with a manageable adverse event profile and preliminary efficacy in a phase 1 study.
This current study will examine the efficacy and safety of applying BromAc directly into recurrent mucinous tumour deposits in patients that are found to be unsuitable for repeat curative intent intervention by CCRS HIPEC.

开始日期2022-05-01

申办/合作机构

Mucpharm Pty Ltd.

[+4]

NCT04588077

/ Recruiting临床4期IIT

Comparison the Seroconversion Rate Between Two-dose and Three-dose Regimens of Heplisav B Among Patients With Cirrhosis, a Randomized-control Prospective Study.

Investigators want to compare the seroconversion rates between two-dose and three-dose regimens of the hepatitis B vaccine (Heplisav B) among patients with cirrhosis, a randomized prospective study.

开始日期2020-09-14

申办/合作机构

Mercy Medical Center Redding

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2024-02-01·Critical care medicine

Society of Critical Care Medicine Guidelines on Recognizing and Responding to Clinical Deterioration Outside the ICU: 2023

Review

作者: Rowley, Daniel D. ; DeVita, Michael ; Wax, Randy S. ; Downar, James ; Jones, Daryl ; Fujitani, Shigeki ; Wax, Sophie P. ; Hecht, Jonathan D. ; Honarmand, Kimia ; Cheatham, Michael L. ; Welch, John ; Inada-Kim, Matthew ; Fuller, Raeann M. ; Kellett, John ; Fox-Robichaud, Alison ; Edelson, Dana ; Davis, Daniel P. ; Rochwerg, Bram ; Knowles, Heidi ; Lighthall, Geoffery ; Kolb, Philipp ; Penoyer, Daleen ; Kumar, Anand ; Haskell, Helen ; Sebat, Frank ; Shipley, Jonathan K. ; Baldisseri, Marie R. ; Olsen, Keith M. ; Danesh, Valerie

RATIONALE::

Clinical deterioration of patients hospitalized outside the ICU is a source of potentially reversible morbidity and mortality. To address this, some acute care hospitals have implemented systems aimed at detecting and responding to such patients.

OBJECTIVES::

To provide evidence-based recommendations for hospital clinicians and administrators to optimize recognition and response to clinical deterioration in non-ICU patients.

PANEL DESIGN::

The 25-member panel included representatives from medicine, nursing, respiratory therapy, pharmacy, patient/family partners, and clinician-methodologists with expertise in developing evidence-based Clinical Practice Guidelines.

METHODS::

We generated actionable questions using the Population, Intervention, Control, and Outcomes (PICO) format and performed a systematic review of the literature to identify and synthesize the best available evidence. We used the Grading of Recommendations Assessment, Development, and Evaluation Approach to determine certainty in the evidence and to formulate recommendations and good practice statements (GPSs).

RESULTS::

The panel issued 10 statements on recognizing and responding to non-ICU patients with critical illness. Healthcare personnel and institutions should ensure that all vital sign acquisition is timely and accurate (GPS). We make no recommendation on the use of continuous vital sign monitoring among unselected patients. We suggest focused education for bedside clinicians in signs of clinical deterioration, and we also suggest that patient/family/care partners’ concerns be included in decisions to obtain additional opinions and help (both conditional recommendations). We recommend hospital-wide deployment of a rapid response team or medical emergency team (RRT/MET) with explicit activation criteria (strong recommendation). We make no recommendation about RRT/MET professional composition or inclusion of palliative care members on the responding team but suggest that the skill set of responders should include eliciting patients’ goals of care (conditional recommendation). Finally, quality improvement processes should be part of a rapid response system.

CONCLUSIONS::

The panel provided guidance to inform clinicians and administrators on effective processes to improve the care of patients at-risk for developing critical illness outside the ICU.

2023-10-01·Plastic and reconstructive surgery

Reply: The Superficial Vein–Only DIEP Flap

Article

作者: Chang, Bernard ; Park, Jungwon ; Nigro, Lauren C.

We would like to thank you for the critical analysis of our recent article “The Superficial Vein−Only DIEP Flap.”1 The purpose of this article was to share our experience with a variation of the deep inferior epigastric artery perforator (DIEP) flap in which the superficial inferior epigastric vein (SIEV) can safely provide the only source of venous outflow. The viability of the superficial vein−only (SVO) DIEP flap has been suggested by anatomical studies, and this correlates clinically with our results.2 Since the article was written, an additional 43 SVO-DIEP flaps have been completed by the senior author, with only one flap failure to date (1.3% flap failure rate). Notably, the flaps in our study were not completed as salvage procedures (ie, the deep inferior epigastric vessels were not inadvertently damaged or ligated). However, our study may provide some reassurance to the surgeon who has inadvertently damaged the deep inferior epigastric venous outflow and the SIEV is the only remaining option. Perforator selection is a subjective, albeit critical, component of DIEP flap dissection. Our use of Acland clamps to systematically assess the flap’s viability with various permutations of perforators and/or the SIEV vessels has been very successful, and this technique is described in the article. When perforating vessels are in a row and more than one is needed for venous outflow, this is readily noted. However, we prefer not to use multiple perforators when possible to avoid the morbidity to the abdominal wall musculature and innervation. Our preference is to use the deep inferior epigastric vein (DIEV) for venous outflow whenever possible and save the SVO-DIEP for scenarios when the flap becomes congested without SIEV outflow, despite DIEV patency. The critical factor in these flaps is that the flap is significantly dependent on the SIEV for venous outflow and would not survive without its use. The argument for adding a DIEV and SIEV in parallel highlights the crux of this article: do you need to couple two veins or is the SIEV sufficient? We have shown that coupling a DIEV is not always necessary, but we are not discouraging the use of two veins; this decision should be made by the surgeon. We agree that flap size is an important consideration. In our experience, we have found the majority of larger flaps have corresponding large perforator vessels. Our average body mass index is approximately 30 kg/m2 and therefore we are typically raising larger flaps without the need to cross midline for our unilateral flaps. When we do cross midline, we do not include zone IV. If a unilateral breast reconstruction needs additional volume beyond what a unilateral flap can provide, we recommend considering stacking flaps, addition of an implant, or use of staged fat grafting. Our preference for the thoracodorsal artery and vein as the recipient vessels for the SVO-DIEP is based on senior author preference; however, we do not discourage the use of the internal mammary vessels or, as di Pompeo et al. prefer, the circumflex scapular vessels. Our backup flap options include gluteal artery perforator flaps and medial thigh–based flaps, and we therefore do not rely on preservation of the thoracodorsal vessels. We recommend that surgeons consider the DIEA and SIEV vessel length and flap orientation when selecting their recipient vessels. We thank the authors for their interest in our article and appreciate their contribution to this discussion. DISCLOSURE The authors have no financial interests to report.

2022-06-01·Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses4区 · 医学

Nurse, Parent, and Nurse Leader Perspective on Adoption of iPads for Pediatric Preoperative Anxiety Reduction

4区 · 医学

Article

作者: Woodworth, Jennie ; Patmon, Frances ; Holder, Danyell ; Anderson, Matthew ; Gee, Perry M ; Rylee, Tina L

PURPOSE:

The purpose of this study was to examine the use of an iPad to facilitate distraction and reduce anxiety with preoperative pediatric patients.

DESIGN:

The authors conducted a descriptive case study in a Pre-Anesthesia Surgical Suite.

METHODS:

Nurses were trained on the use of the iPad, which came preloaded with games. The research staff took detailed notes during training and implementation. Research staff conducted interviews with nurses, leaders, and patient guardians for the study.

FINDINGS:

The authors discovered different perspectives among the clinical nurse, parent, and nursing leadership. The clinical nurse felt the iPad afforded them more focused time with the parents before surgery, though there was some hesitation at the beginning due to ownership of the devices. The parents felt the iPads were helpful to distract their child but worried there were not enough games appropriate for various age ranges. Nursing leadership found the iPads helpful in building a connection with the patient and their parents. Still, they felt many obstacles made integrating the use of the iPads in the nurses' workflow very difficult. There were technological issues that also delayed and discouraged the use of iPads. Once these preliminary issues were resolved, the iPad appeared to reduce anxiety in both patients and their parents.

CONCLUSIONS:

The iPad is an evidence-based intervention used for preoperative anxiety reduction. This study identifies essential facilitators and barriers associated with adopting the technology from the perspective of key stakeholders (nurses, parents, and nursing leadership). Overall, the iPad was considered a valuable tool to help parents feel less stressed with their child, allowing them to interact more effectively with the clinician. However, additional work is indicated to address the limitations regarding sample size and actual measures of anxiety.

项与 Mercy Medical Center Redding 相关的新闻（医药）

2026-03-03

·Business Wire

RecovryAI Announces FDA Breakthrough Device Designation for Patient-Facing Clinical AI

SAN FRANCISCO--(BUSINESS WIRE)--RecovryAI today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Virtual Care Assistants (VCAs), physician-prescribed, patient-facing clinical AI designed to support patients during post-operative recovery. The designation, reserved for medical devices that address serious conditions and demonstrate the potential to meaningfully improve existing standards of care, enables earlier and more frequent engagement with the FDA while maintaining the full requirements for demonstrating safety and reliability. The milestone coincides with RecovryAI’s emergence from stealth following more than two years of product development and clinical evaluation. Post-surgical care in the United States has fundamentally shifted outside the hospital. More than 80 percent of procedures are now performed on a same-day basis, leaving patients to recover at home during their longest and least-supervised phase of care, including the first 72 hours, where the majority of complications occur. Early signs of complications can go unnoticed, discharge instructions cannot cover every question or situation, and providers lack continuous visibility into patient recovery between discharge and follow-up visits, increasing the risk of avoidable emergency department visits, readmissions, and delayed intervention. At the same time, care teams are burdened with high volumes of routine patient questions and recovery updates, limiting their capacity to focus on higher-acuity cases. RecovryAI's Virtual Care Assistants are designed to extend continuity of care from hospital discharge into recovery at home. VCAs are physician-prescribed AI that deliver recovery guidance based on established clinical protocols and escalate deviations from expected recovery patterns to the prescribing care team with full clinical context. RecovryAI's initial VCA focuses on total joint arthroplasty, with the architecture designed to expand across procedural domains, subject to regulatory authorization. RecovryAI is pursuing FDA authorization under a novel Class II pathway for patient-facing Software as a Medical Device (SaMD). The company has engaged the FDA through the pre-submission process since 2024 to align on clinical evidence requirements, with full submission expected later this year. If authorized, this decision would establish a new device classification and the special controls governing future devices in this category. “Healthcare innovation will not scale without trust,” said Scott Walchek, CEO and co-founder of RecovryAI. “Most healthcare AI today lives in two lanes: clinician-facing tools like decision support and ambient documentation, and consumer health and wellness applications. Patient-facing AI inside the care pathway is different. It guides behavior and carries clinical responsibility. In this lane, trust is underwritten by FDA authorization. Without it, there’s no durable basis for safety, accountability, reimbursement, or real scale. From day one, we built within a regulatory framework and embraced the rigor clinical deployment requires.” RecovryAI is currently conducting its pivotal clinical study evaluating the safety and system behavior of its Virtual Care Assistants in total joint arthroplasty recovery. The multi-site study includes OrthoArizona, one of the nation’s largest orthopedic practices, and Mercy Medical Center in Baltimore, MD, among other participating sites. Data from the company’s limited pilot phase showed that VCA system behavior generally aligned with physician judgment, supporting advancement into the pivotal study. “Deploying generative AI in a regulated clinical environment requires a structured medical reasoning framework,” said Dr. Richard Watson, co-founder and Chief Science Officer of RecovryAI. “We designed our platform to continuously evaluate patient-reported information against expected recovery trajectories, deliver procedure-specific guidance when recovery is progressing appropriately, and escalate deviations to the prescribing physician’s care team with the complete patient interaction history and relevant clinical context. That architecture allows the AI to manage routine, low-acuity concerns while ensuring that clinicians retain oversight and exercise final medical judgment.” RecovryAI is led by a team with deep clinical, regulatory, and technology expertise. Chief Science Officer Dr. Richard Watson holds more than 100 medical device patents and has led three prior FDA submissions. He and Chief Medical Officer co-founder Dr. Martin Sellberg, a 30-year emergency medicine veteran, previously founded and successfully exited a medical device company. CEO Scott Walchek brings four decades of experience building and exiting venture-backed technology companies across multiple industries, and Chief Product Officer Jesse Thomas adds more than a decade of healthcare technology product leadership. About RecovryAI RecovryAI develops physician-prescribed Virtual Care Assistants that support patients during post-procedure recovery. Starting with total joint arthroplasty and expanding across procedural domains subject to regulatory authorization, RecovryAI is building toward a future in which every patient is prescribed a Virtual Care Assistant upon discharge — infinitely scalable patient-facing clinical AI for a healthcare system whose demand is outpacing its workforce. The company is headquartered in the San Francisco Bay Area. www.recovry.ai

临床2期突破性疗法

2025-01-15

·Business Wire

CareView Communications Announces New Business Agreement With Mercy Medical Center in Cedar Rapids, IA

LEWISVILLE, Texas--( BUSINESS WIRE )--CareView Communications, a leading provider of integrated virtual care solutions for the healthcare industry (“CareView” or the “Company”) (OTCQB: CRVW), today announced a new business agreement with Mercy Medical Center in Cedar Rapids, Iowa. Mercy Medical Center is an integrated healthcare system that serves as a major medical provider across Eastern Iowa. Founded 125 years ago, Mercy Medical Center continues to provide exceptional healthcare, with an emphasis on personalized and compassionate care for its patients. The system employs nearly 3,000 individuals across its more than two dozen locations. “Mercy Medical Center has a rich tradition of serving its communities with a commitment to high quality healthcare services and compassionate care,” said Sandra McRee, Chief Operating Officer of CareView Communications. “For over 100 years, their commitment has been first and foremost to their patients, a commitment CareView shares, and we are excited to partner with their team to continue to enhance patient safety and experience.” CareView’s Patient Safety System is designed to optimize virtual sitting outcomes. Leveraging AI and patented predictive technology, including Virtual Bed Rails® and Virtual Chair Rails®, it ensures continuous monitoring of multiple patients from a centralized location. Utilizing these innovative tools enhances patient safety while reducing sitter costs. CareView’s solutions will focus on reducing patient falls and increasing patient safety. Focusing on quality and patient safety is a key initiative for the Mercy Medical team. Mercy Medical Center has a group purchasing organization (GPO) contract with Vizient, Inc. CareView maintains strong relationships with Vizient and serves multiple healthcare systems with Vizient contracts, adding to the synergies and alignments the two organizations bring to this agreement. About CareView Communications Inc. CareView has been dedicated to supporting hospital care teams for over a decade with its innovative virtual care solutions. The Company has established successful partnerships with over 200 hospitals nationwide, implementing effective inpatient virtual care strategies that greatly enhance patient safety and overcome critical staffing challenges. The CareView platform, fueled by industry-leading predictive technology and supported by its purpose-built hardware, specifically addresses the unique requirements of virtual nursing and virtual sitting use cases. The CareView team works closely with their hospital partners to understand their evolving needs and deliver tailored virtual care strategies that align with their objectives. By providing healthcare professionals with the tools they need to deliver exceptional care, CareView contributes to improved patient outcomes and a more sustainable healthcare ecosystem. Learn more at care-view.com or follow CareView on LinkedIn .

2024-09-10

·PRNewswire

Lumendi's Double Balloon Interventional Platform, DiLumen® EZ-Glide, Continues to Demonstrate Significant Time and Cost Savings in Colorectal ESD

DiLumen Reduced Total Procedure Time by 36.5%, Leading to an Average Cost Savings of $610.16 Per Patient and Improved En Bloc Resection Rate to 97.2%, Compared to 87% With Traditional Methods WESTPORT, Conn., Sept. 10, 2024 /PRNewswire/ -- Lumendi, LLC, a leader in minimally invasive endoscopic devices, today announced that new data showcasing the substantial benefits of its Double Balloon Interventional Platform (DBIP), DiLumen® EZ-Glide, which continues to demonstrate significant time and cost savings in colorectal endoscopic submucosal dissection (ESD), has been published in the peer reviewed journal, Gastrointestinal Endoscopy. Lead authored by Dr. Sergey V. Kantsevoy, Professor of Medicine, Director of Therapeutic Endoscopy at Mercy Medical Center, the paper is entitled, "Prospective, Randomized Controlled Study Evaluating Double Balloon Interventional Endoscopic Platform For Colorectal ESD," and can be accessed through the following link: (24)03338-8/abstract. "DiLumen has revolutionized our approach to colorectal ESD, significantly reducing procedure times and improving patient outcomes," stated Dr. Kantsevoy. "This study adds to the growing body of evidence supporting DiLumen's efficacy and cost-effectiveness." The prospective, randomized controlled study found that DiLumen reduced total procedure time by 36.5%, leading to an average cost savings of $610.16 per patient. Additionally, DiLumen improved the en bloc resection rate to 97.2%, compared to 87.0% with traditional methods, with no reported adverse events in the study group. Studies conducted outside of the United States have also demonstrated similar time and cost savings. As a result, the economic benefits of the DBIP extend beyond immediate procedural costs, reducing long-term treatment costs through lower recurrence rates and improved curative outcomes. "Dr. Kantsevoy's study further corroborates the significant time savings we have observed with DiLumen in our own retrospective propensity matched comparison presented at Digestive Disease Week (DDW) in 2021," said Dr. Stavros Stavropoulos, Director of Endoscopy at Mount Sinai South Nassau Center for Digestive Health. "The enhanced efficiency and safety of DiLumen make it an invaluable tool for the advanced endoscopist especially in patients with redundant colons and complex polyps," added Dr. Stuart Gordon, Director of GI Endoscopy at Dartmouth Hitchcock Medical Center. DiLumen's conduit feature facilitates suturing with the Overstitch device during ESD procedures, enhancing procedural efficiency and patient safety. This feature increases the likelihood of same-day discharge, adding to cost savings and providing peace of mind for treating gastroenterologists. This groundbreaking study positions DiLumen as a cost-effective and efficient tool for colorectal ESD, promising to enhance patient care and streamline endoscopic procedures. About Lumendi Lumendi Ltd, Maidenhead UK is dedicated to improving patient outcomes and reducing healthcare costs through innovative endoscopic devices. Lumendi LLC, Westport CT, is a 100% subsidiary of Lumendi Ltd. For more information, visit or . Contact Paula Schwartz Managing Director Rx Communications Group, LLC 917-633-7790 [email protected] SOURCE Lumendi Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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