Clinical trials: sponsored by Montefiore Medical Center
Apathy, Loneliness
A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults
Reminiscence therapy is a non-invasive, non-pharmacological intervention that has been shown to improve cognition, mood, functional status, quality of life, and apathy in older adults.
- Conditions
- Apathy, Loneliness, Reminiscence Therapy
- Trial name
- LSC Feasible (NCT06919094)
- Testing
- Life Story Club
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Montefiore Medical Center
Pelvic Pain
Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain
The investigator team proposes a randomized, double-blind, double-dummy comparative effectiveness trial conducted in two urban emergency departments (EDs) in the Bronx, New York.
- Trial name
- PIVOTAL (NCT07595302)
- Testing
- Acetaminophen 1000mg PO, IV Acetaminophen 1000mg
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Montefiore Medical Center
Anxiety Depression, Aneurysm Cerebral
Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)
The impact of cerebrovascular procedures on patients experiencing anxiety and depression is not well studied despite the high prevalence of these mental health disorders.
- Conditions
- Anxiety Depression, Aneurysm Cerebral, Mental Health Wellness 1
- Trial name
- POUIA (NCT06123325)
- Testing
- Clipping, Endovascular embolization, Surveillance imaging
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Montefiore Medical Center
Chronic Subdural Hematoma
Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)
This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.
- Trial name
- MESH (NCT06181994)
- Where
- 22 sites in United States, Australia and 1 more
- Volunteers
- 5,000 people
- Sponsor
- Montefiore Medical Center
Intracranial Aneurysm
International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)
This multicenter retrospective cohort study aims to evaluate and compare the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors.
- Trial name
- IRF (NCT06174727)
- Where
- 13 sites in United States, Canada
- Volunteers
- 5,000 people
- Sponsor
- Montefiore Medical Center
Parenting Stress, Parent Child Relationship
A Male Caregiver Adaptation Study of the Connecting and Reflecting Experience Parenting Program
Male caregivers play a critical role in children's emotional development, yet they are often underrepresented in parenting interventions and may experience unique barriers to emotional engagement and support.
- Conditions
- Parenting Stress, Parent Child Relationship, Father-Child Relations, Emotional Regulation
- Trial name
- Male-CARE (NCT07419308)
- Testing
- Connecting and Reflecting Experience (CARE) Program
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Tricuspid Regurgitation
Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the…
- Trial name
- TRIPLACE (NCT06033274)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 31 sites in United States, Canada and 6 more
- Volunteers
- 800 people
- Sponsor
- Montefiore Medical Center
Pelvic Floor Disorders, Stress Urinary Incontinence
The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence
FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM…
- Trial name
- SUI (NCT03194789)
- Testing
- Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy, Traditional Pelvic Floor Therapy
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Montefiore Medical Center
Crohn's Disease, Ulcerative Colitis
Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease
The bidirectional effects between psychological distress and inflammatory bowel disease (IBD) activity mean that not only does increased IBD activity trigger psychological distress, but psychological distress triggers increased…
- Conditions
- Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- Trial name
- DMBI (NCT06510296)
- Testing
- Digital Mind Body Intervention mobile application
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Chronic Rhinosinusitis With Nasal Polyps
Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis
The central hypothesis of this study is that the addition of dupilumab treatment onto standard-of-care intranasal corticosteroids will improve patient-reported measures of disease activity and sense of smell in a cohort of mostly…
- Trial name
- CRSwNP (NCT05246267)
- Testing
- Dupilumab
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Montefiore Medical Center
Nutrition Aspect of Cancer, Cancer
Enhancing Cancer Care: RestoreMe App for Personalized Nutrition and Activity in Cancer Patients
This is a single institution feasibility study of the updated RestoreMe app. The investigators plan to recruit 150 participants to this study with participants being recruited either prior to the initiation of their curative…
- Conditions
- Nutrition Aspect of Cancer, Cancer, Dietary Recommendations, Mobile Applications
- Trial name
- RestoreMe (NCT07575685)
- Testing
- RestoreMe
- Volunteers
- 150 people
- Sponsor
- Montefiore Medical Center
Asthma
ASTHMAXcel Voice Study
The objective of this study is to conduct a randomized controlled trial (RCT) to compare the adapted and refined ASTHMAXcel Voice platform to usual care (UC).
- Trial name
- NCT06935084
- Testing
- ASTHMAXcel Voice platform
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Montefiore Medical Center
Childhood Obesity, Epigenetics
Early Childhood Obesity Programming by Intrauterine Growth Restriction
The molecular mechanisms underlying developmental programming of childhood obesity remain poorly understood. Here, the investigators address major questions about early childhood obesity programming by studying CD3+ T-cells from…
- Trial name
- NCT03402139
- Where
- United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Acute Uncomplicated Diverticulitis
Non-antibiotic Management in Acute Uncomplicated Diverticulitis
Diverticulitis is a common condition that causes swelling and pain in part of the colon (the large intestine). Doctors classify it as "mild" when there are no serious complications.
- Trial name
- NAMAD (NCT07625267)
- Testing
- Symptomatic treatment (ibuprofen and acetaminophen), Amoxicillin-clavulanate, Ciprofloxacin plus metronidazole
- Sponsor
- Montefiore Medical Center
Keloid
Radiotherapy for Keloids
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.
- Trial name
- NCT04722263
- Testing
- Radiotherapy
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Montefiore Medical Center
Breast Cancer, Peripheral Neuropathy
Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer
This is a double-blinded randomized controlled clinical trial that aims to study if desloratadine can reduce rates of peripheral neuropathy development in patients with breast cancer receiving taxane chemotherapy.
- Trial name
- DETOXp (NCT07109817)
- Testing
- Desloratodine
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Montefiore Medical Center
Liver Cancer, Hepatocellular Carcinoma
HepQuant: Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer
This is a pilot and feasibility study assessing the role of quantitative multiparametric MRI and blood-based biomarkers for the measurement of liver function in patients receiving radiation therapy for liver cancer, including…
- Conditions
- Liver Cancer, Hepatocellular Carcinoma, Hepatocellular Cancer, Cholangiocarcinoma
- Trial name
- HepQuant (NCT06899152)
- Testing
- HepQuant DuO, Multiparametric MRI Scans
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Montefiore Medical Center
Large Language Models
Physician Response Evaluation With Contextual Insights vs. Standard Engines - Artificial Intelligence RAG vs LLM Clinical Decision Support
Clinical decision support tools powered by artificial intelligence (AI) are being rapidly integrated into medical practice. Two leading systems currently available to clinicians are OpenEvidence, which uses retrieval-augmented…
- Trial name
- PRECISE (NCT07037940)
- Testing
- OpenEvidence, GPT-4
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Chronic Pain
Virtual Intelligence for Transformative Lifestyle Solutions in Pain
This pilot study aims to evaluate the feasibility and acceptability of a VR-based chronic pain management intervention with a virtual AI coach for patients with Opioid misuse and opioid use disorder (OM/OUD).
- Trial name
- VITALS-Pain (NCT07124598)
- Testing
- VR Headset Device - Meta Quest 3
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Montefiore Medical Center
Chronic Kidney Disease
Multicultural Healthy Diet in Chronic Kidney Disease
This is a pilot intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention in participants with chronic kidney disease.
- Trial name
- NCT05504850
- Testing
- Multicultural Health Diet
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Montefiore Medical Center