Clinical trials: sponsored by Northwell Health
Electrical Status Epilepticus of Slow-Wave Sleep
Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).
This study aims to assess the efficacy of Epidiolex in patients with ESES. ESES is characterized by sleep potentiated spikes with a spike index greater than 85% (conventional definition) and 50% (new definition)1.
- Trial name
- NCT04721691
- Testing
- Epidiolex 100 mg/mL Oral Solution
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Northwell Health
Hemostasis, Blood Biomarkers
Ultrasound of the Spleen Utilizing Low-energy (Diagnostic Level) Insonification.
This is a three-cohort, randomized, double-blinded , sham-controlled, single-center, early feasibility research trial to determine whether organ-specific biologic effects on platelet activity and coagulation are achievable…
- Conditions
- Hemostasis, Blood Biomarkers, Ultrasound
- Trial name
- NCT06934096
- Testing
- Ultrasound Pulsed Doppler Imaging System
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Northwell Health
Type 2 Diabetes
Feasibility of a Diabetes Self-Management Program With Continuous Glucose Monitoring for Adults With Type 2 Diabetes
The purpose of this study is to determine if combining a virtual diabetes self-management program (DECIDE®) with continuous glucose monitoring (CGM) is practical and well-received by adults with type 2 diabetes.
- Trial name
- NCT07743307
- Testing
- The DECIDE Self-Management Program, Continuous Glucose Monitoring (CGM)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Northwell Health
Post-Concussion Syndrome, Headache
Assessment of the Efficacy of Medrol Dose Pack for Acute Post-Concussive Headaches
This novel pilot project will assess the effectiveness of corticosteroids in treatment of acute post-concussion headache. The investigators hypothesize that the use of corticosteroids will cause significant headache reduction in…
- Trial name
- NCT04685772
- Testing
- Methylprednisolone
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Northwell Health
Neuroblastoma, Pheochromocytoma
A Compassionate Use/Expanded Access Protocol Using 131I-MIBG Therapy for Patients With Refractory Neuroblastoma and Metastatic Pheochromocytoma
This is an expanded access protocol/compassionate use single institution study designed to determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive neuroblastoma and metastatic pheochromocytoma who…
- Trial name
- NCT03015844
- Testing
- 131-I-meta-iodobenzylguanidine
- Where
- United States
- Sponsor
- Northwell Health
Schizophenia Disorder
Biomarkers to Enhance Early Schizophrenia Treatment
This study is recruiting participants who are experiencing a first episode of psychosis and who have certain genetic factors that may make them respond better to certain medications that are used to treat people with psychosis.
- Trial name
- BEEST (NCT06969755)
- Testing
- aripiprazole, risperidone, clozapine
- Where
- 5 sites in United States, Canada
- Volunteers
- 180 people
- Sponsor
- Northwell Health
Child Obesity, Breast Feeding
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Intervention Development Trial
The goal of this intervention development study is to optimize the Starting Early to Prevent Obesity Using Telehealth (StEP OUT) intervention for feasibility and acceptability, using human-centered design and community-engaged…
- Conditions
- Child Obesity, Breast Feeding, Feeding Behavior, Nutrition, Healthy
- Trial name
- NCT06486922
- Testing
- StEP OUT
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Northwell Health
Schizophrenia Disorder, Schizophreniform Disorder
MicroRNAs as Biomarkers in First Episode Schizophrenia
This study investigates whether tiny molecules called microRNAs (miRNAs), found in special brain-derived "packages" (neural-derived extracellular vesicles, or NDEs) that travel from the brain into the blood, can serve as helpful…
- Conditions
- Schizophrenia Disorder, Schizophreniform Disorder, Schizoaffective Disorder, Psychosis Not Otherwise Specified (NOS)
- Trial name
- MIRFEST (NCT07703670)
- Testing
- Plasma NDE miRNA Sequencing, Whole Genome Sequencing
- Where
- United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Northwell Health
Caregiver Burden, Alzheimer's Disease
WeCareToFeedDysphagia to Reduce Care-partner Burden Full-scale RCT
The goal of this clinical trial is to learn if a newly-created website tool, called WeCareToFeedDysphagia, helps to reduce feelings of burden in care partners of patients with Alzheimer's disease and related dementias (AD/ADRD)…
- Conditions
- Caregiver Burden, Alzheimer's Disease, Dementia, Oropharyngeal Dysphagia
- Trial name
- NCT07250113
- Testing
- WeCareToFeedDysphagia web tool
- Where
- United States
- Volunteers
- 802 people
- Sponsor
- Northwell Health
Lupus Erythematosus, Systemic, Musculoskeletal Pain
Using the Cholinergic Anti-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune, inflammatory disease and musculoskeletal pain is one of the most common symptoms.
- Trial name
- NCT02822989
- Testing
- Vagus nerve stimulation
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Northwell Health
Colon Cancer Metastatic
NIMBLE-CRC: NeoImmunoModulation Before Leveraging Excision in Colorectal Rectal Cancer
This is a Phase II, single-arm, open-label trial evaluating the feasibility, safety, and preliminary activity of neoadjuvant Zanzalintinib (a VEGFR-targeting TKI) and Retifanlimab (an anti-PD-1 antibody) in patients with…
- Trial name
- NIMBLE (NCT07677579)
- Testing
- Retifanlimab, Zanzalintinib
- Volunteers
- 26 people
- Sponsor
- Northwell Health
GVHD - Graft-Versus-Host Disease
Phase I-II PTCy, Bortezomib and Sitagliptin for Prevention of GvHD Following Allogeneic HSCT
Phase I-II studying post transplant cyclophosphamide, bortezomib and sitagliptin for GvHD prevention in allogeneic HSCT. Adults with hematologic malignancies undergoing an RIC allogeneic PBSC transplant from a 5/6 or 6/6 sibling…
- Trial name
- NCT07675174
- Testing
- Post transplant cyclophosphamide, bortezomib and sitagliptin in 3+3 design to MTD
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Northwell Health
Insufficient Physical Activity
A BCT Intervention for Physical Activity Among Individuals on Statins
The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change intervention required to increase levels of physical activity (PA) among participants on primary prevention statin…
- Trial name
- NCT05273723
- Testing
- 5 Behavioral Change Techniques
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Northwell Health
Metastatic Pancreatic Cancer
Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy
This is a study that aims to understand whether a blood test measuring tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA) shows a similar response as observed by a follow-up CT scan.
- Trial name
- NCT07122466
- Testing
- Tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Northwell Health
Colorectal Cancer Metastatic
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
Microdevices have been used to ascertain in vivo drug response, which can lead to improved cancer treatment delivery; however, they have not been evaluated for liver tumors.
- Trial name
- NCT07193862
- Testing
- Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Northwell Health
Pediatric Acute Respiratory Distress Syndrome (PARDS), Pediatric Respiratory Diseases
IPV and Lung Compliance in Invasively Ventilated Children
The goal of this observational study is to determine if Intrapulmonary Percussive Ventilation (IPV) improves lung compliance in children receiving conventional invasive mechanical ventilation.
- Conditions
- Pediatric Acute Respiratory Distress Syndrome (PARDS), Pediatric Respiratory Diseases, Lung Compliance
- Trial name
- NCT06836050
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Northwell Health
Covid-19
Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19
The overall objective of this study is to evaluate the clinical efficacy of oral famotidine in symptomatic non-hospitalized patients with confirmed COVID-19.
- Trial name
- NCT04724720
- Testing
- Famotidine
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Northwell Health
Sepsis
Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department
The FloPatch device will be applied to 150 septic patients in the emergency department before they receive fluid resuscitation. This study will assess whether initial FloPatch measured volume-responsiveness and volume of fluids…
- Trial name
- POCUS Sepsis (NCT05544903)
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- Northwell Health
Spinal Metastases
Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study
Kypho-IORT is a novel approach to combine kyphoplasty, a minimally invasive procedure, with a single dose of intraoperative radiotherapy (IORT) for the treatment of unstable or potentially unstable spinal cord metastases.
- Trial name
- Kypho-IORT (NCT02987153)
- Testing
- Kypho-IORT
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Northwell Health
Gastric Outlet Obstruction
Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach.
- Trial name
- EAT-GO (NCT05561907)
- Testing
- Surgical gastrojejunostomy (SGJ), Endoscopic gastrojejunostomy (EGJ)
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Northwell Health