Clinical trials: open to volunteers, sponsored by Icahn School of Medicine at Mount Sinai
Anorexia Nervosa
Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
This project includes a 4-week randomized trial comparing pre-meal vagal nerve stimulation (taVNS) to pre-meal sham stimulation.
- Trial name
- NCT05554172
- Testing
- taVNS
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Eating Disorder
Development and Testing of a Peer-Coaching Model for the Treatment of Eating Disorders
This project includes developing and testing a coaching approach during the treatment of eating disorders. It is expected that with the addition of support outside of regular treatment, caregivers will experience improvements in…
- Trial name
- NCT05562258
- Testing
- Parent Coaching and Patient Education, Parent Education and Patient Coaching
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Alopecia Areata
Dupilumab in the Treatment of Pediatric Alopecia Areata
This is a prospective, randomized, double-blind, placebo-controlled clinical trial. The study will take place at four sites. This trial will enroll a total of 76 children and adolescents with moderate to severe AA (affecting at…
- Trial name
- PEDAL (NCT05866562)
- Testing
- Dupilumab
- Where
- 5 sites in United States
- Volunteers
- 76 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Keloid
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
Keloids are common, benign cutaneous overgrowths that manifest clinically as raised, hypertrophic, often hyperpigmented lesions which are formed in response to dermal injury or idiopathic stimuli.
- Trial name
- NCT06373458
- Testing
- Ritlecitinib
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Hypertension, Diabetes
Group-Care for Hypertension and Diabetes Management in Nepal
Hypertension and diabetes represent significant and growing public health challenges in Nepal, particularly in underserved communities.
- Trial name
- GCHD- Nepal (NCT07439380)
- Testing
- Low Intensity Community-Based Group NCD Care, High Intensity Community-Based Group NCD Care
- Where
- Nepal
- Volunteers
- 1,110 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Procedural Pain
Virtual Reality for Pain Control in US-Guided Obstetric Needle Procedures
This is a single-site randomized controlled pilot study at Mount Sinai Hospital evaluating the effect of virtual reality on procedural pain and anxiety in obstetric patients undergoing ultrasound-guided needle procedures.
- Trial name
- NCT07094451
- Testing
- Virtual Reality, Ultrasound
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Acute Spinal Cord Injury, Blood Pressure
TSCS for Acute SCI
This project will focus on a novel approach to stabilizing blood pressure (BP) during inpatient rehabilitation after acute SCI. After SCI, people have unstable blood pressure, ranging from too low (orthostatic hypotension) to too…
- Conditions
- Acute Spinal Cord Injury, Blood Pressure, Hypotension
- Trial name
- NCT05305118
- Testing
- TSCS Mapping, Transcutaneous spinal cord stimulation
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Atrial Fibrillation, Arrhythmias, Cardiac
Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
Atrial fibrillation (AF) affects 1 in 4 individuals during their lifetime and continues to increase in frequency and impact. Exercise intervention has established benefits to improve AF symptoms and burden in clinical studies.
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases
- Trial name
- EASE-AF (NCT06938412)
- Testing
- Physical Activity Intervention Using FitBit Wearable Device
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Liver Transplant, Post Transplant Diabetes
Liver Transplant CGM
This investigator initiated study aims to describe continuous glucose monitoring (CGM) based glycemic metrics after discharge from liver transplant and assess relationship with glycemic metrics and liver transplant outcomes.
- Conditions
- Liver Transplant, Post Transplant Diabetes, Type 2 Diabetes
- Trial name
- NCT07216508
- Testing
- Libre 3+
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Crohn's Disease, Perianal Fistula
MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease
This Phase 4, single-arm, open-label study will evaluate the effectiveness and safety of mirikizumab combined with surgical curettage and closure in adults with active perianal fistulizing Crohn's disease.
- Trial name
- MIRICURE (NCT07782021)
- Testing
- Mirikizumab, Fistula Tract Curettage and Closure
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Colorectal Cancer Screening
Evaluating the Efficacy of the eNav Toolkit to Improve Colorectal Cancer Screening
The purpose of this research study is to evaluate the efficacy of a digital navigation tool, called the eNav to improve colorectal cancer screening uptake among patients treated at federally qualified health centers (FQHC)s.
- Trial name
- NCT06184594
- Testing
- eNav, Standard of Care
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Kidney Stones
CaOx Stone Prevention
This single-center randomized controlled trial at Mount Sinai West will enroll 80 patients undergoing percutaneous nephrolithotomy for calcium oxalate stones.
- Trial name
- NCT07225764
- Testing
- Chlorthalidone, Low oxalate diet
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Prematurity
The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control.
- Trial name
- NCT05223192
- Testing
- Music Therapy Entrainment with Ocean Disc Intervention
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Ovarian Cancer, Malignant Neoplasm of Uterus
Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer
This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer.
- Trial name
- NCT06040970
- Testing
- Sacituzumab, Cisplatin
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Gestational Diabetes Mellitus (GDM)
Validating CGM for GDM
This is a prospective pilot study to assess the validity of using a continuous glucose monitor (CGM) in diagnosing gestational diabetes mellitus (GDM).
- Trial name
- VALID (NCT06858787)
- Testing
- Continuous glucose monitor
- Where
- 3 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Crohn's Disease
Behavioral Therapy for Crohn's Disease
People living with Crohn's disease (CD) experience psychological and emotional symptoms, in addition to known chronic and disabling physical symptoms, which prevent them from living their life to the fullest (flourishing).
- Trial name
- NCT06512597
- Testing
- Primary Intervention for Combination Therapy - IBD Coping Strategies Program, Time and Attention Control - IBD Support Program
- Where
- 2 sites in United States
- Volunteers
- 170 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Liver Fibrosis
Isocaloric Navy-Bean Substitution in Adults With MASLD
This study is a 24-week randomized crossover feasibility trial evaluating an isocaloric navy-bean dietary substitution in 40 adults with metabolic dysfunction-associated steatotic liver disease (MASLD) and intermediate-stage…
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Liver Fibrosis, Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Trial name
- BEAN-MASLD (NCT07730853)
- Testing
- Dietary Supplement/Behavioral: Navy Bean-Rich Diet, Habitual Diet (Control)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Type 2 Diabetes, Steroid-induced Diabetes
CGM After Discharge From Hospital
This is an investigator initiated prospective, randomized controlled trial which aims to compare two groups of patients with either type 2 or steroid-induced diabetes who are discharged with insulin.
- Trial name
- NCT07510386
- Testing
- Libre 3 Plus continuous glucose monitoring (CGM) system, Blinded Continuous Glucose Monitoring, Finger stick
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Multiple Myeloma
Delayed Toxicities Post-CAR-T
This is an observational umbrella protocol evaluating toxicities after CAR-T therapy with ciltacabtagene autoleucel (cilta-cel) for RRMM, with a goal to identify key inflammatory features contributing to toxicities, define…
- Trial name
- NCT07665307
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Melanocortin Obesity Syndrome, MCOS
Atomoxetine in Melanocortin Obesity Syndrome
This is a phase 2 randomized placebo-controlled crossover trial to determine the safety and efficacy of atomoxetine for treating obesity caused by loss-of-function variants in the melanocortin-4 receptor (MC4R), the most common…
- Trial name
- MCOS (NCT06899178)
- Testing
- Atomoxetine
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Icahn School of Medicine at Mount Sinai