Clinical trials: completed, sponsored by Columbia University
Triple Negative Breast Cancer
Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer
Assess response to pembrolizumab in both primary tumor, normal breast stroma, circulating lymphocytes and serum exosomes in treatment naive triple negative breast cancer (TNBC) patients.
- Trial name
- Pembro/IORT (NCT02977468)
- Testing
- Merck 3475 Pembrolizumab, Intraoperative radiation therapy (IORT)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Columbia University
Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast
Comparison of the Breast Tumor Microenvironment
The goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation…
- Trial name
- NCT03165487
- Testing
- Breast tissue collection, Blood sample collection
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Columbia University
Alzheimer Disease
Information About Alzheimer's Disease for Latinos in New York City
This study will assess the psychosocial and behavioral impacts of receiving Alzheimer's disease genetic risk assessment incorporating APOE genotypes among Latinos in northern Manhattan.
- Trial name
- IDEAL (NCT04471779)
- Testing
- Disclosure of APOE genotype
- Where
- United States
- Volunteers
- 374 people
- Sponsor
- Columbia University
Insulin Resistance, Hyperinsulinemia
Graded Insulin Suppression Test P&F
The goal of this study is to learn about how the hormone insulin controls blood sugar in a variety of people. The main question it aims to answer is about how much insulin the body actually needs to maintain a normal blood sugar…
- Conditions
- Insulin Resistance, Hyperinsulinemia, Obesity, Healthy
- Trial name
- GIST (NCT06592261)
- Testing
- Insulin regular, 2.0-3.2 mU/m2/min (euinsulinemia), Insulin regular, 32 mU/m2/min (hyperinsulinemia), Octreotide Acetate, 6-45 ng/kg/min
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Columbia University
Atrial Fibrillation, Patient Engagement
Data-driven SDM to Reduce Symptom Burden in AF
This study is a single-group feasibility study evaluating decision aid visualizations which display common post-ablation symptom patterns as a tool for shared decision-making.
- Trial name
- NCT04993807
- Testing
- Shared decision-making tool
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- Columbia University
Schizophrenia, Schizo Affective Disorder
Young Adults With Violent Behavior During Early Psychosis (Aim 2)
This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.
- Conditions
- Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders, Delusional Disorder
- Trial name
- NCT05756855
- Testing
- adapted behavioral intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Columbia University
Syncope, Presyncope
Practical Approaches to Care in Emergency Syncope
Syncope, or transient loss of consciousness, is a common reason for visit to the Emergency Department and often leads to extensive testing and hospitalization.
- Trial name
- PACES (NCT04533425)
- Where
- 5 sites in United States
- Volunteers
- 1,297 people
- Sponsor
- Columbia University
Hyperinsulinemia, Insulin Resistance
Glycemic Effect of Diazoxide in NAFLD
The goal of this clinical trial is to compare a two-week course of diazoxide (at two different doses) and placebo in people with overweight/obesity and insulin resistance (IR) with, or at high risk for, non-alcoholic fatty liver…
- Conditions
- Hyperinsulinemia, Insulin Resistance, Non-Alcoholic Fatty Liver Disease, Prediabetic State
- Trial name
- NCT05729282
- Testing
- Diazoxide oral suspension, 1 mg per kg per dose, Diazoxide oral suspension, 2 mg per kg per dose, FreeStyle Libre Pro
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Columbia University
Prematurity, Very Preterm Maturity of Infant
Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are: 1.
- Trial name
- NCT05711927
- Testing
- SNOO Smart Sleeper, Traditional bassinet
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Columbia University
Asthma
CAMP Air: Efficacy and Cost-effectiveness in Urban Adolescents
This study will test the efficacy and cost-effectiveness of Controlling Asthma Program for Adolescents (CAMP Air), an e-health intervention, among urban predominately Black and Hispanic adolescents with uncontrolled asthma.
- Trial name
- NCT05091034
- Testing
- Controlling Asthma Program for Adolescents (CAMP Air), Attention Control Asthma Education Intervention
- Where
- United States
- Volunteers
- 374 people
- Sponsor
- Columbia University
Diet, Healthy, HbA1c
Medically Tailored Meals for Cardiovascular Health
This randomized clinical trial (RCT) will investigate novel approaches to enhance effectiveness, engagement, reach, and cost-effectiveness of medically tailored meals (MTM) programs for promoting cardiovascular health, focusing…
- Conditions
- Diet, Healthy, HbA1c, Blood Pressure
- Trial name
- MTM4CVH (NCT06550297)
- Testing
- Medically Tailored Meals and Nutritional Counseling, Cardiovascular Health Promotion Educational Program
- Where
- United States
- Volunteers
- 176 people
- Sponsor
- Columbia University
Cancer in Adolescence
Needs Navigation for Caregivers of AYAs
The overall aim of the study is to address unmet health-related social needs and reduce outcome disparities among AYA (adolescent and young adult) cancer survivors.
- Trial name
- Cope-CAYAC (NCT06296641)
- Testing
- Needs navigation intervention
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV, Trauma Exposure
A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories.
- Trial name
- ImpACT+ (NCT04793217)
- Testing
- Improving AIDS Care After Trauma +, Adapted Problem-Solving Therapy
- Where
- South Africa
- Volunteers
- 350 people
- Sponsor
- Columbia University
Alcohol and Substance-Related Mental Disorders
Effectiveness of an Evidence-based Stepped Care System for Alcohol and Other Drug Use Problems Among Congolese Refugees in Zambia
This is a randomized controlled trial (RCT) evaluating the effectiveness of a screening, brief intervention, and referral to treatment (SBIRT) stepped-care system in reducing unhealthy AOD use among Congolese refugees and the…
- Trial name
- NCT05471921
- Testing
- SBIRT, Treatment as usual
- Where
- 2 sites in United States, Zambia
- Volunteers
- 400 people
- Sponsor
- Columbia University
Internal Carotid Artery Stenosis, Cognitive Impairment
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)
We aim to determine whether cognitive impairment attributable to cerebral hemodynamic impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible with restoration of flow.
- Trial name
- CREST-H (NCT03121209)
- Testing
- Revascularization, Intensive Medical Management (IMM) alone
- Where
- 58 sites in United States, Canada
- Volunteers
- 392 people
- Sponsor
- Columbia University
Depression
Depression Screening in Black Churches
The overall aim of this study is to employ Community Health Workers (CHWs) to screen for depression in 30 Black churches and compare the effectiveness of Screening, Brief Intervention, and Referral to Treatment (SBIRT)…
- Trial name
- NCT04524767
- Testing
- SBIRT, Referral as Usual
- Where
- 2 sites in United States
- Volunteers
- 505 people, healthy volunteers welcome
- Sponsor
- Columbia University
Postoperative Insomnia, Postoperative Delirium
Efficacy of Suvorexant on Post-operative Sleep Disturbance
The study is a parallel group, double blind, randomized trial. Subjects will be recruited from individuals undergoing elective surgery for orthopedic, abdominal, urologic, gynecologic or spine reasons.
- Trial name
- NCT05823844
- Testing
- Suvorexant
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Columbia University
Maternal Death, Maternal Complication of Pregnancy
Assessing the Maternal Outcome Monitoring Systems
Pregnancy-related death is a growing public health issues, which are of particular concern to minority groups, including African-Americans and Spanish-speaking Latinas.
- Trial name
- MOMS (NCT06415942)
- Testing
- Maternal Outcome Monitoring and Support system
- Where
- 2 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV, Infant Morbidity
Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides
Primary Objective: To evaluate the effects of synbiotics on infectious morbidity and growth while it is in place from 4 to 24 weeks of age.
- Conditions
- HIV, Infant Morbidity, Breast Feeding
- Trial name
- MIGH-T MO (NCT05282485)
- Testing
- Synbiotic, Maltodextrin
- Where
- South Africa
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Columbia University
Brain Neoplasms, Primary Malignant
Topotecan by Intracerebral Clysis for Recurrent Primary Malignant Brain Tumors
This study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it is given directly into brain tumors by a delivery technique called convection-enhanced delivery.
- Trial name
- NCT00308165
- Testing
- Convection-Enhanced Delivery, Topotecan
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Columbia University