Clinical trials: sponsored by Montefiore Medical Center
Surgical Site Infection
The Mepilex Cesarean Delivery Trial / MEPIDEL
The goal of this clinical trial is to learn whether a silver-containing foam dressing (Mepilex Border Post-Op Ag) works as well as the standard dressing in preventing surgical site infection after cesarean delivery.
- Trial name
- MEPIDEL (NCT07914569)
- Testing
- Mepilex Border Post-Op Ag, Standard Postoperative Dressing
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Erectile Dysfunction
The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men.
The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function.
- Trial name
- ERECTION 2 (NCT06273592)
- Testing
- Animal-based meal, Plant-based meat meal
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
AML/MDS, Acute Myeloid Leukemia
Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML
This is a Phase 1 study investigating the safety and efficacy of Danvatirsen as a monotherapy followed by combination with Venetoclax in patients with relapsed/refractory myelodysplastic syndromes (MDS) or acute myeloid leukemia…
- Conditions
- AML/MDS, Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Trial name
- NCT05986240
- Testing
- Danvatirsen, Danvatirsen + Venetoclax
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Spine Surgery Complications, Infection
Surgical Recovery Support Pillow for Spine Surgeries
The present study investigates the feasibility of a support pillow for use after spinal surgical procedures, and more particularly, to protect the midline region of the back following spinal surgery.
- Trial name
- NCT07720856
- Testing
- Surgical Recovery Support Pillow
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Opioid Use Disorder, Opioid Use Disorder, Severe
Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses
This study is testing whether offering buprenorphine treatment directly at syringe service programs (SSPs) helps more people start and stay in treatment for opioid use disorder (OUD) than referring them to community buprenorphine…
- Conditions
- Opioid Use Disorder, Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate
- Trial name
- BISTRO (NCT07631598)
- Testing
- Standard of Care Referral, Low Threshold Buprenorphine
- Where
- 8 sites in United States
- Volunteers
- 512 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Scarring Alopecia, Androgenetic Alopecia
1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and scarring alopecia.
- Trial name
- NCT05460611
- Testing
- Sciton HALO 1470nm Non-ablative laser
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.
- Conditions
- Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation, Laser-Induced Hyperpigmentation
- Trial name
- NCT05362929
- Testing
- Sciton Halo
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Erectile Dysfunction
The Impact of Dietary Pattern on Erectile Function
The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.
- Trial name
- ERECTION (NCT04349059)
- Testing
- Animal based diet, Plant based diet
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- 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
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
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
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
Inflammatory Bowel Diseases
Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease
Optimizing health related-quality of life (HRQoL) for patients with inflammatory bowel disease (IBD), who often experience a relapsing disease course, is an essential component of care.
- Trial name
- NCT06266663
- Testing
- Survey
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Cervical Preparation
Mifepristone vs Misoprostol
The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care, the proportion of…
- Trial name
- NCT06502158
- Testing
- Mifepristone, Misoprostol
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Surgical Site Infection Following Cesarean Delivery
The Mepilex Cesarean Delivery Trial
The goal of this clinical trial is to learn whether using a silver-containing antimicrobial foam dressing (Mepilex Ag) can help prevent surgical site infections in patients undergoing cesarean delivery.
- Trial name
- MEPIDEL (NCT07066254)
- Testing
- Mepilex Ag Dressing, Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Gestational Diabetes
Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes Management: A Randomized Controlled Trial (AIM-GDM)
The purpose of this study is to assess whether an AI based counseling service can be beneficial for patients to assist in management of gestational diabetes.
- Trial name
- AIM-GDM (NCT06582719)
- Testing
- GPT-based counseling, Nutritional Counseling
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Vaginal Laceration During Delivery
The PAIN (Pelvic Area Injection for Numbness) Study
Postpartum pain can interfere with patient's ability to care for themselves, and their newborn, and untreated pain is associated with risk of greater opioid use, postpartum depression, and development of persistent pain.
- Trial name
- PAIN (NCT05972681)
- Testing
- Bupivacaine, Epinephrine
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Diabetic Foot Ulcer
Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
The investigator team will study the adherence of the participant cohort to a non significant risk device over a six month period.
- Trial name
- DFUMAT (NCT05968924)
- Testing
- Podimetrics SmartMat
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Eyelid Diseases, Eyelid Droop
Spacer Graft Study
To determine which of three types of spacer grafts (hard palate vs autologous ear cartilage vs Enduragen) are the most effective in lower eyelid retraction repair outcomes as measured by MRD2 (margin to reflex distance 2)
- Trial name
- NCT04140734
- Testing
- Spacer Graft
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Hiv, Tobacco Use
Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes
Cigarette smoking is now the leading killer of people with HIV (PWH) in the US, and most cessation strategies tried to date have failed to increase long-term quit rates.
- Trial name
- NCT05642715
- Testing
- EX+, Varenicline, HR
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center