A 26-week Single Site, Randomized, Double-blind, Active-controlled, Parallel Group, Human PoC Study to Evaluate Superiority of RK-01, Valsartan Plus Celecoxib Addon to Metformin Versus Metformin Alone in Type 2 Diabetes Patients

Evaluation of safety, tolerability and superiority of RK-01, a valsartan plus celecoxib dual add-on to metformin-HCL XR over metformin in newly diagnosed and obese adult type 2 diabetes patients with high blood pressure, arthritis and inadequate glycemic control with metformin monotherapy, diet and exercise over 26 weeks of treatment.
Objective: To assess effect of RK-01 on HbA1c levels, beta cell function and insulin resistance with co-administration of valsartan, celecoxib and metformin-HCl XR relative to metformin monotherapy.
Hypothesis: After 26 weeks of treatment with valsartan, celecoxib and metformin-HCl XR provides greater improvements in glycemic, inflammatory and atherogenic parameters compared to metformin monotherapy.

开始日期2025-10-10

申办/合作机构

Arkay Therapeutics LLC初创企业

[+1]

NCT06517901 / Not yet recruitingN/AIIT

MRI-targeted Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

The MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques:
1. Software-based fusion of MRI and ultrasound images (software fusion) or
2. Visually estimated MRI-informed (cognitive fusion) technique
To date, there is a lack of adequately powered RCTs directly comparing the cognitive vs fusion targeted biopsy. This randomized study will directly compare the detection rates of clinically significant prostate cancer following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on multi-parametric MRI (mp-MRI) of prostate.

开始日期2024-11-01

申办/合作机构

Albany Medical College

NCT06668766 / Not yet recruitingN/AIIT

Superior Ultrasound-Guided Venous Access: Single-Lumen Midline Catheters Vs Long Peripheral IVs for Difficult IV Access in the Emergency Department, a Randomized Controlled Trial

Many patients in the emergency department have veins that are difficult to get an intrevenous (IV) catheter into (called "difficult IV access"). These patients may require other methods to obtain access to a vein for administration of the necessary medications. The 2-inch long IV is most commonly used in emergency departments for people with difficulty IV access. Typically, a healthcare worker will use an ultrasound to help to see the veins underneath the skin while inserting the IV into the vein. That is, the ultrasound helps the healthcare worker visualize veins that are deeper in the arm and may not be felt through the skin. Another device that can be used is a 4-inch midline catheter. This device is less commonly used as many emergency departments do not have participants available, but it serves the same purpose as the 2-inch long IVs (that is, to give medicine into the vein and sometimes to take blood). A 4-inch midline catheter is similar to a 2-inch long IV, but has a few differences. First, the 4-inch midline catheter is even longer than the 2-inch long IV. The 4-inch midline catheter is 10-cm (about 4-inches or the size of 4 quarters side-by-side), while the 2-inch long IV is 4.78-cm (nearly 2-inches or two quarters side-by-side). Second, the 4-inch midline catheter is inserted into using a guidewire to help move the catheter in the vein (similar in concept to a train moving along a track), while the 2-inch long IV does not have this guidewire. The guidewire does not hurt and most do not know it is being used. It is just an additional step to help guide the catheter in the vein. The investigators are conducting this research study to determine which catheter is better for patients with difficult IV access: the 4-inch midline catheter or the 2-inch long IV.

开始日期2024-10-21

申办/合作机构

Albany Medical College

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10,843

项与 Albany Medical College 相关的文献（医药）

2024-12-01·PEC innovation

Examining technology use and mental health among parents with newborns in the intensive care unit during the COVID-19 pandemic: A cross-sectional study

Article

作者: Ross, Juliet L ; Cagino, Sarah G ; Denefrio, Cassandra L

Objectives:

To investigate the relationship between pandemic-related stressors, mental health, and technology use among parents of hospitalized infants during the COVID-19 pandemic.

Methods:

A cross-sectional study of 47 participants who had an infant in the Neonatal Intensive Care Unit (NICU) during the pandemic was completed. Participants ranked several statements on a Likert scale to assess mental health, technology use, and COVID-19-related stress during their infant's stay in the NICU.

Results:

Mental health wellness scores were negatively associated with COVID-19-related stress (r_s - 0.40, p = .015). The most prevalent stressor was hospital visitation restriction. Higher COVID-19-related stress was associated with greater use of text and video chat [(r_s0.35, p = 0.016) and (r_s0.33, p = .025)]. Enjoyment of technology use and access to technology were positively associated with higher mental health wellness scores [(r_s0.42, p = .003) and (r_s0.38, p = .009)].

Conclusions:

Social uses of technology were valuable in a cohort of parents with infants hospitalized during the COVID-19 pandemic.

Innovation:

Technology is a tool that can help parents cope with the stress of having a hospitalized infant. Digital literacy and technology access should be promoted in the post-pandemic landscape to help parents of infants in the NICU attain more benefit from these resources.

2024-11-01·Journal of Surgical Education

Impact of Holistic Application Scoring on Interview Offers

Article

作者: Ullmann, Timothy M. ; DiBrito, Sandra ; King, KMarie ; Ullmann, Timothy M ; Zaman, Jessica ; Desai, Pooja

OBJECTIVE:

We aimed to develop a holistic screening tool for surgical residency application processing to capture the diverse skills and attributes of the applicant, based on characteristics most commonly associated with success in our residency program.

DESIGN:

We developed an application-scoring rubric with 4 domains based on ACGME Holistic reviewing criteria: academic potential, experiences, personal attributes, and clinical competency. We scored academic potential based on a composite of Step 2 score, MSPE tier rank, surgery clerkship grade, college honors, publications, and presentations. An additional score accounted for personal adversity overcome or "distance travelled". This included previous homelessness, first-generation college student or immigrant status, noted socioeconomic hardship, disability overcome, or other stated personal experience of discrimination including underrepresented in medicine status. We sorted the list of top 200 candidates by adversity score, Step 2 score, academic potential score, and total overall score to compare the groups in terms of interview offers.

SETTING:

We are an academic surgical residency program housed within a private medical college in the Northeast region.

PARTICIPANTS:

All categorical applicants to our program were managed with our holistic screening approach.

RESULTS:

There were 29 students with the highest adversity score (AS) of 4 and 26 (90%) were selected to interview based on holistic overall score and reviewer comments. Fourteen students had an AS of 3, and 12 (86%) were selected to interview. Twenty-five students had an AS of 2, and 23 (92%) were selected to interview. If Step 2 score alone had been used to determine which applicants should be interviewed, only 11 students (38%) with an AS of 4 would have been interviewed. If the academic potential alone was used for screening, only 10 (35%) of students with an AS of 4 would have been interviewed. Taking all students with any adversity score into account (n = 70), when screened with only Step 2 scores, just 31(44%) would have been interviewed. When ranked by academic potential score, 35 (50%) would have been interviewed. When applying our holistic overall score alone, 56 (80%) would have been interviewed.

CONCLUSIONS:

Performing a holistic application review and ranking students not only by standardized exam scores, but also considering other history of academic achievement, personal attributes, experiences in leadership or service, and clinical competency can allow for mitigation of implicit bias. Allowance for an adversity score can help programs recognize students who have significantly longer "distance traveled" to make it through medical education and who have the potential to be fantastic residents.

2024-11-01·Journal of Surgical Education

Bias Perpetuates Bias: ChatGPT Learns Gender Inequities in Academic Surgery Promotions

Article

作者: DiBrito, Sandra R ; Wang, Hao ; Ullmann, Timothy M. ; Ullmann, Timothy M ; Desai, Pooja ; DiBrito, Sandra R. ; Davis, Lindy

OBJECTIVE:

Gender inequities persist in academic surgery with implicit bias impacting hiring and promotion at all levels. We hypothesized that creating letters of recommendation for both female and male candidates for academic promotion in surgery using an AI platform, ChatGPT, would elucidate the entrained gender biases already present in the promotion process.

DESIGN:

Using ChatGPT, we generated 6 letters of recommendation for "a phenomenal surgeon applying for job promotion to associate professor position", specifying "female" or "male" before surgeon in the prompt. We compared 3 "female" letters to 3 "male" letters for differences in length, language, and tone.

RESULTS:

The letters written for females averaged 298 words compared to 314 for males. Female letters more frequently referred to "compassion", "empathy", and "inclusivity"; whereas male letters referred to "respect", "reputation", and "skill".

CONCLUSIONS:

These findings highlight the gender bias present in promotion letters generated by ChatGPT, reiterating existing literature regarding real letters of recommendation in academic surgery. Our study suggests that surgeons should use AI tools, such as ChatGPT, with caution when writing LORs for academic surgery faculty promotion.

项与 Albany Medical College 相关的新闻（医药）

2024-07-30

·Business Wire

Tris Pharma to Present New Safety Data for First-In-Class Investigational Pain Therapy and Host Symposium at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain

MONMOUTH JUNCTION, N.J.--( BUSINESS WIRE )--Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced that the company will present data from its first-in-class, late-stage investigational pain therapy with a novel mechanism of action, cebranopadol, at the upcoming International Association for the Study of Pain (IASP) 2024 World Congress on Pain, taking place August 5-9, 2024, in Amsterdam. “I am inspired to see the rise in interest, funding and research into the development of novel treatment options for the millions of people who suffer daily from debilitating pain that impacts their quality of life,” said Ketan Mehta, founder and CEO at Tris Pharma. “Our team has been working with urgency to advance cebranopadol, a first-in-class investigational pain therapy with a novel mechanism of action, through clinical studies with the goal of offering physicians an effective treatment option that they can confidently prescribe and patients feel is safe. We look forward to collaborating with the pain community at IASP 2024 and sharing our latest findings.” Cebranopadol is the first and only dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist in development to treat moderate-to-severe pain. Dual-NMR agonist compounds have the potential to deliver gold-standard pain relief with a strong safety profile because they mimic the body’s natural pain-modulation processes by synergizing the analgesic and safety characteristics of the NOP receptor with the analgesic advantages of the MOP receptor. Tris Pharma plans to share important news regarding its Phase 3 clinical trials in the near future. Symposium Highlighting Novel Pain Mechanism Tris Pharma will host a symposium featuring a series of presentations focused on dual-NMR agonists, a promising new mechanism of action in treating pain, and its potential to overcome the shortfalls of opioids for moderate-to-severe pain. The symposium will be presented as part of the congress by leading scientists with extensive experience in the research and development of novel pain therapies. Details of the symposium are as follows: Symposium: Break the Mold in Pain Biology: The Promise of a New Mechanism that May Overcome the Shortfalls of Current Moderate to Severe Pain Medications Presenters: Charles E. Argoff, MD, Albany Medical College; Roberto Ciccocioppo, PhD, University of Camerino; Jeffrey Gudin, MD, University of Miami Miller School of Medicine Location: RAI Amsterdam Convention Centre, Elicium I Date and Time: August 6, 12:45 – 1:45 p.m. CEST At IASP 2024 Tris Pharma will be present at Booth #316 where company executives will be available to provide additional information and data presented at the congress. About Cebranopadol (TRN-228) Cebranopadol is the first and only investigational dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist for the treatment of moderate-to-severe pain, as well as opioid use disorder (OUD). Cebranopadol offers a first of its kind and novel mechanism of action that takes advantage of the inherent properties of the NOP receptor, which has demonstrated both the potential to lessen the risk of misuse while still providing effective pain relief, and the potential to block drugs of abuse from producing drug-seeking behaviors. The FDA has granted Fast Track Designation to cebranopadol for chronic low back pain. Cebranopadol’s profile has been well-characterized in pain management studies, and if approved, it could become the first and only pain-relief therapy with the demonstrated ability to provide efficacy equivalent to opioids with significantly less risk for misuse or risk of physical dependence, addiction or overdose. About Tris Pharma Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @ TrisPharma .

快速通道

2024-07-25

·PRNewswire

The Inner Circle acknowledges, Nicole R. Smizer, MD, FACOG as a Pinnacle Lifetime Member

LAKE SUCCESS, N.Y., July 25, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Nicole R. Smizer, MD, FACOG is acknowledged as a Pinnacle Lifetime Member for her contributions to Delivering Excellence in Women's Health. Dr. Nicole R. Smizer is dedicated to providing comprehensive obstetric and gynecologic care with a focus on patient education and empowerment. As the leading practitioner at Women for Women OBGYN, she offers a wide range of services, including major and laparoscopic surgeries, ensuring that her patients receive personalized and compassionate care. Continue Reading Nicole R Smizer, MD Dr. Smizer's expertise in obstetrics and gynecology is complemented by her commitment to staying at the forefront of medical advancements, particularly in minimally invasive procedures. Her journey in medicine began with a Bachelor of Science Degree in Biology from Siena College in 2005, followed by the completion of her Medical Degree from Albany Medical College in May 2010. She then underwent residency training in obstetrics and gynecology at Northwell Long Island Jewish Medical Center, further honing her skills and expertise. As a Diplomate of the American Board of Obstetrics and Gynecology and a Fellow of the American College of Obstetrics and Gynecology, Dr. Smizer maintains the highest standards of professional excellence. She is committed to providing her patients with the highest quality of care, ensuring their well-being and satisfaction. Beyond her clinical practice, Dr. Smizer is actively involved in giving back to the community. She is a regular contributor to the Bridget Alliance and the Women's Prison Association, leveraging her expertise to support and uplift women in need. Throughout her career, Dr. Smizer has been recognized for her outstanding achievements and contributions to the field of obstetrics and gynecology. She received The Society of Laparoendoscopic Surgeons Resident Achievement Award in 2014 and served as Administrative Chief Resident in the Department of OBGYN at Hofstra Northwell Health LIJ Medical Center from 2013 to 2014. Additionally, she was honored with the Resident Teaching Award in 2014, highlighting her commitment to education and mentorship. Dr. Nicole R. Smizer's dedication to excellence, compassion, and patient-centered care makes her a trusted and respected figure in women's health in the Lake Success community and beyond. Contact: Katherine Green, 516-825-5634, [email protected] SOURCE The Inner Circle

高管变更临床研究

2024-06-10

·Science Daily

Discovery unveils key to heart development in womb, unravels cause of spongy heart disease

Having explored how the heart is formed in utero, a researcher is reporting how cells and molecules act during that early formation and what might cause the heart disease called left ventricular non-compaction or spongy heart, for which patients often require heart transplants. Having explored how the heart is formed in utero, a University of Houston pharmacology researcher is reporting how cells and molecules act during that early formation and what might cause the heart disease called left ventricular non-compaction. LVNC is a type of heart muscle disease (or cardiomyopathy) also known as a spongy heart, for which patients often require heart transplants. "We found the absence of a certain gene, called Itgb1, may cause inability in the developing heart to maintain its shape and develop normally, causing left ventricular non-compaction," reports Mingfu Wu, associate professor at the UH College of Pharmacy, in Cardiovascular Research. "Itgb1 deletion at an early stage causes distinct defects." Wu's findings involve examination of the trabeculae, which are sheet-like structures in developing hearts that protrude from the heart wall. These structures are crucial in early heart development -- before the coronary system develops -- to supply blood, as they increase the inner surface area of the heart wall and enhance the exchange of oxygen and nutrients between blood and the heart wall. "Without trabeculae, the heart wall would suffer from insufficient oxygen and nutrients, potentially leading to death. Conversely, an excess of trabeculae can result in an overly porous heart wall, leading to left ventricular non-compaction cardiomyopathy, commonly known as spongy heart," said Wu. While certain signals controlling trabeculae formation are known, the precise mechanisms by which individual cells that make up the cardiac muscle (cardiomyocytes) are organized to form these structures remain unclear. "This study reveals that deleting a gene called Itgb1 in heart wall cardiomyocytes prevents trabeculae formation. We found that the protein β1 integrin encoded by Itgb1 and its ligands, the extracellular matrix, create a molecular network that acts as a scaffold for cardiomyocytes in the heart wall. When Itgb1 is deleted, cardiomyocytes disengage from this scaffold, losing their ability to maintain shape, divide properly, migrate, and form trabeculae," said Wu. The study suggests that the molecular network may be a common organizational mechanism in organ formation. "We believe these insights will greatly interest researchers in organ development and regeneration, potentially reshaping our understanding of tissue organization and development," said Wu. Wu's collaborators from the University of Houston include Lianjie Miao, Yangyang Lu, Anika Nusrat, Luqi Zhao Micah Castillo, Yongqi Xiao, Hongyang Guo, Yu Liu, Preethi Gunaratne, Robert, J Schwartz, Alan R Burns, Ashok Kumar and C. Michael DiPersio, Albany Medical College.

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