Clinical trials: sponsored by 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
Long COVID, Chronic Fatigue Syndrome
tVNS in Long COVID-19
A prior open label study has shown that transcutaneous vagus nerve stimulation [tVNS] can improve the health of some patients with postacute sequelae of SARS-CoV-2 infection (PASC), severely affected enough to also fulfill…
- Trial name
- NCT06585254
- Testing
- Transcutaneous vagus nerve stimulator
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Cardiac Disease, Postoperative Pain
Rectus Sheath Block in Cardiac Surgery
This is a prospective, randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of a type of peripheral nerve block, Rectus Sheath Block. 1.
- Trial name
- NCT05833048
- Testing
- Rectus sheath block
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Alzheimer's Disease
Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia
To test the effect of a tailored lighting intervention controlled by the Readings At Desk (RAD) controller on sleep and mood in Alzheimer's disease participants.
- Trial name
- NCT05519137
- Testing
- Active lighting intervention, Control lighting intervention
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Breast Neoplasms, Breast Diseases
Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast
This is a multicenter, phase I/II trial of anastrozole, palbociclib, trastuzumab, and pertuzumab is proposed as first-line therapy in metastatic hormone receptor-positive, HER2-positive breast cancer patients.
- Trial name
- NCT03304080
- Testing
- Anastrozole, Palbociclib, Trastuzumab
- Where
- 5 sites in United States
- Volunteers
- 44 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Suicide Crisis Syndrome, Psychological Distress
Psychopharmacological Treatment of Emotional Distress
This is an inpatient four-arm randomized control trial comparing single drug clonazepam (S arm), a two-drug combination clonazepam/olanzapine (D arm), and a three-drug combination clonazepam/olanzapine/buprenorphine (T arm) with…
- Trial name
- NCT06133114
- Testing
- Clonazepam, Olanzapine, Buprenorphine
- Where
- United States
- Sponsor
- Icahn School of Medicine at Mount Sinai
Hepatocellular Carcinoma
Atezolizumab and Bevacizumab in Combination With Y^90 Radioembolization in HCC for Liver Transplant
A single institution, single arm, two-cohort feasibility trial to evaluate the combination of locoregional Y^90 therapy with systemic atezolizumab and bevacizumab, in participants presenting with hepatocellular carcinoma (HCC) 1)…
- Trial name
- NCT07059494
- Testing
- Atezolizumab, Bevacizumab, Y^90 Radioembolization
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Chronic Subdural Hematoma
The CHALLENGER Registry
The study is a multi-center prospective, single-arm, post-market study evaluating the efficacy and radiologic and functional outcomes associated use of the Numen SILK coils for Middle Meningeal Artery (MMA) embolization following…
- Trial name
- CHALLENGER (NCT07197840)
- Testing
- Numen SILK coil embolization system
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Sleep Disturbances, Depression
Methodology Issues in a Tailored Light Treatment for Persons With Dementia
Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia
- Trial name
- NCT01816152
- Testing
- High Active intervention, Inactive intervention, Mid Level Active Intervention
- Where
- 2 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Musculoskeletal Pain, Neuropathic Pain
Virtual Reality (VR) Self-Hypnosis Software
This single-site study of self-hypnosis software using an off-the-shelf virtual reality (VR) device (OculusGo™) to determine the software's safety, usability, and preliminary efficacy in pain relief for HIV-associated chronic…
- Conditions
- Musculoskeletal Pain, Neuropathic Pain, Neuralgia
- Trial name
- NCT06398847
- Testing
- Virtual Reality headset
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Opiate Use Disorder
Mindfulness-Oriented Recovery Enhancement (MORE) in Heroin Addiction
In this study, neuroimaging of reward processing, drug cue reactivity and inhibitory control is used before and immediately after 8 weeks of two types of group therapy in individuals with opioid addiction; clinical outcomes will…
- Trial name
- MORE (NCT04112186)
- Testing
- Behavioral group therapy #1, Behavioral group therapy #2
- Where
- United States
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Stroke and Aphasia
The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers
The study will focus on the impact of communal singing on patients with stroke and their personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the first group of 20 stroke survivors and their…
- Trial name
- NCT02328573
- Testing
- Communal singing
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
NAS
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.
- Trial name
- NCT03533985
- Testing
- Song of Kin, Gato box, Ocean disc
- Where
- 6 sites in United States
- Volunteers
- 200 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
HPV-positive Oropharyngeal Squamous Cell Carcinoma
The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)
The purpose of this study is to determine whether treatment of HPV-related oropharyngeal squamous cell carcinoma in patients with undetectable postoperative HPV circulating tumor DNA (cfHPVDNA) with transoral robotic surgery…
- Trial name
- NCT05419089
- Testing
- Robotic surgery
- Where
- 2 sites in United States
- Volunteers
- 83 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Congenital Disorders of Glycosylation
Clinical and Basic Investigations Into Congenital Disorders of Glycosylation
The purpose of this research is to study the natural history of congenital disorders of glycosylation and its causes and treatments.
- Trial name
- NCT04199000
- Where
- 12 sites in United States
- Volunteers
- 500 people
- Sponsor
- Icahn School of Medicine at Mount Sinai