Actively Recruiting Studies

Obstetrics

HOPE (Heart Outcomes in Pregnancy Expectations) (Co-PI: Cecila Avila)


Where:
Recruiting outpatient pregnant women with heart conditions

Inclusion criteria:
1. 18 years or older
2. Any pregnant person at any point in gestation (with singleton or multiple gestation) prior to delivery.
3. English and/or Spanish speaking
4. Attends at least one cardio obstetrics clinic visit
5. Must have one or more of the conditions within the following 6 categories
  a.  Congenital or structural heart disease
  b.  Aortopathies
  c.  Arrhythmia
  d.  Cardiomyopathies and heart failure
  e.  Coronary disease
  f.  Other

Exclusion criteria:
1.  Previously enrolled in HOPE (current study).
2.  Unable to participate in follow-up
  a.  Incarcerated or current prisoner
  b.  Current diagnosis of dementia
  c.  Subjects without a way to contact for follow-up
3.   Refused participation in the study
4.   Unable to consent for self
5.   Traumatic aortic disease
6.   Perpartum cardiomyopathy diagnosed in the current pregnancy (new diagnosis)
Contact: alessa.ramosvargas@stonybrookmedicine.edu

IMPAACT 2041 (PI: Sharon Nachman)


Where:
Recruiting pregnant patient with hepatitis C virus (HCV) to describe pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB).

Inclusion criteria: 
Age: 16-45 years of age (inclusive)
GA: 14-32 weeks gestation, SINGLETON (no known anomalies, no growth restriction)
HCV status: At screening, detectable HCV RNA test result based on testing of a specimen collected within 30 days prior to enrollment.

Other labs within 30 days prior to enrollment:
•    Hepatitis B surface antigen negative
•    AST/ALT (<10.0 x ULN)
•    Hemoglobin (≥8.5 g/dL)
•    Creatinine (≤1.8 x ULN)
•    INR (<1.5 x ULN)
•    Platelet count (≥100,000 cells/mm3)
•    Total bilirubin (<1.6 x ULN)
•    HIV status
 
Exclusion criteria:

  1. Previous treatment for hepatitis C with a DAA regimen
  2. History of spontaneous preterm delivery at less than 34 weeks
  3. Shortened cervix less than 20 mm if noted on ultrasound
  4. Clinical diagnosis of acute hepatitis not otherwise attributable to hepatitis C with AST or ALT ≥2.5 x ULN, evidence of decompensated cirrhosis including history of or present variceal hemorrhage, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatocellular carcinoma, hepatorenal syndrome, or hepatopulmonary syndrome
  5. Any medical condition that the site investigator that participation in the study would be unsafe
  6. Receipt of any prohibited medication within 14 days prior to entry:
    •    ARVs and pharmacoenhancers: (Atazanavir, Cobicistat, Darunavir, Efavirenz, Etravirine, Lopinavir, Ritonavir)
    •    HMG-CoA reductase inhibitors: (Atorvastatin, Lovastatin, Simvastatin)
    •    Other
    •    Carbamazepine
    •    Medications containing more than 20 mcg ethinyl estradiol (e.g., combined oral contraceptives)
    •    Proton pump inhibitors
    •    Rifampin, rifapentine, rifabutin
    •    Nirmatrelvir/ritonavir
    •    St. John’s wort (hypericum perforatum)
     
    Contact: David.Garry@stonybrookmedicine.edu & sharon.nachman@stonybrookmedicine.edu

Effect of Metformin on Vitamin B12 Levels in Pregnancy (PI: Jennifer Choi)
Recruiting pregnant patient who failed GTT in outpatient clinics.

Contact: samantha.gobioff@stonybrookmedicine.edu

ERCT on Single (oxytocin) vs Double (oxytocin + misoprostol) Uterotonic Agents to Prevent PPH (PI: James Bernasko)
Recruiting patients prior to delivery on L&D.

Contact: obgyn.sbresearch@stonybrookmedicine.edu

Perceived Agency in Decision Making for Cesarean Section (PI: Joseph Chappelle) 
Recruiting post cesarean patients in the postpartum unit.

Contact: angelina.mozier@stonybrookmedicine.edu

Circulating mRNAs from placental exosomes in pregnant women with substance use exposure (PI: David Garry)
Recruiting patients in the third trimester that are on medications for OUD and a healthy control group.

Contact: Rachel.lee@stonybrookmrdicine.edu

Brain Imaging of Mothers (BIOM) (PI: James Swain) 
Pregnant or up to five year postpartum including those with OUD, mental health illness, or healthy controls. 

Contact: elle.eggers@stonybrookmedicine.edu.

 

 

Gynecology

Educational video to reduce anxiety before colposcopy (PI: Dorota Kowalska) 
Recruiting outpatient clinics patient with abnormal PAP prior to colposcopy

Contact: Dorota.kowalska@stonybrookmedicine.edu

ERAS Educational Video to Reduce Anxiety and ED Visits (PI: Sara Kim) 
Recruiting patients undergoing hysterectomy and myomectomy.

Contact: sara.kim@stonybrookmedicine.edu & megan.wood@stonybrookmedicine.edu

Gynecologic Oncology

Ovarian Cancer Organoid Study (PI: William Burke & Medhi Damaghi) 
Recruiting gynecological oncology patients prior to biopsy or surgery.

Contact: mehdi.damaghi@stonybrookmedicine.edu & elayna.kirsch@stonybrookmedicine.edu

Salpingectomy vs. Salpingo-oophorectomy to reduce ovarian cancer risk in BRCA1 carriers (PI: William Burke) 
Recruiting patients with BRCA1 that did not  have ovarian cancer risk reduction surgery.

Contact: Catherine.Izzo@stonybrookmedicine.edu

Randomized phase 3 trial on use of immunochemotherapy (Olvi-Vec) for ovarian cancer treatment (PI: William Burke) 
Patients with platinum-resistant/ refractory ovarian cancer.

Contact: Catherine.Izzo@stonybrookmedicine.edu