Clinical trials: Newborn Complication
Klinefelter Syndrome
Androgen Effect on Klinefelter Syndrome Motor Outcome
The purpose of this study is to evaluate the effects of low-dose androgen on the motor and cognitive development of boys with Klinefelter syndrome.
- Trial name
- NCT00348946
- Testing
- androgen oxandrolone
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- Thomas Jefferson University
Sleep, Pregnancy
Halifax PrenaBelt Trial
Back and right-sided sleeping position in pregnant women has recently emerged as a potential risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature.
- Conditions
- Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight
- Trial name
- NCT02377817
- Testing
- PrenaBelt
- Where
- Canada
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Allan Kember
Gastroesophageal Reflux, Bronchopulmonary Dysplasia
GER Poses a Potential Risk for Late Complications of BPD
Bronchopulmonary dysplasia (BPD) is a common condition in the low birth weight infants. Although most of the BPD symptoms improved after a regular treatment in infancy, there are still a few late complications left such as the…
- Trial name
- NCT03014453
- Where
- China
- Volunteers
- 187 people
- Sponsor
- Shengjing Hospital
Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Infant Development
Maternal Adversity, Vulnerability and Neurodevelopment
Maternal Adversity Vulnerability and Neurodevelopment (MAVAN) project is a prospective community-based, pregnancy and birth cohort of Canadian mother-child dyads.
- Conditions
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Infant Development, Infant Behavior
- Trial name
- MAVAN (NCT03434457)
- Where
- Canada
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- Douglas Mental Health University Institute
Klinefelter Syndrome
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about body composition (muscle and fat) and male hormones and look at the effect of testosterone shots on body composition.
- Trial name
- NCT02408445
- Testing
- testosterone cypionate 200mg/ml
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
Preterm Birth, Extreme Prematurity
Sustained Aeration of Infant Lungs Trial
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants.
- Trial name
- SAIL (NCT02139800)
- Testing
- Sustained Inflation, Standard of Care
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 460 people
- Sponsor
- University of Pennsylvania
Urologic Diseases, Hypospadias
Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel
This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.
- Conditions
- Urologic Diseases, Hypospadias, Undescended Testes, Chordee
- Trial name
- Baby ORIOLES (NCT04826484)
- Testing
- Exparel 133 miligrams per 10 milliliter injection, Bupivacaine Hydrochloride
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- Johns Hopkins University
Autosomal Dominant Polycystic Kidney Disease
Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease
This study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.
- Trial name
- SIDIA (NCT06435858)
- Testing
- Empagliflozin
- Where
- 2 sites in Switzerland
- Volunteers
- 16 people
- Sponsor
- Cantonal Hospital Graubuenden
Electronic Fetal Monitoring, Fetal Hypoxia
Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings
Maternal oxygen administration for concerning fetal heart rate tracing (FHT) patterns is common practice on Labor and Delivery units in the United States.
- Conditions
- Electronic Fetal Monitoring, Fetal Hypoxia, Fetal-Placental Circulation
- Trial name
- O2C2 (NCT02741284)
- Testing
- Room air, 10L Oxygen by nonrebreather mask
- Where
- United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Obesity, Induction of Labor Affected Fetus / Newborn
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term
Obesity increases the risk of pregnancy complications, including among others puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI).
- Trial name
- APPOINT (NCT03801252)
- Testing
- Cefazolin, Azithromycin
- Where
- United States
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Seizures, Disorder of Fetus or Newborn
Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures
The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.
- Trial name
- Keppra (NCT00884052)
- Testing
- Low dose levetiracetam, High dose levetiracetam
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Richard H. Haas
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeNEW (NCT02649946)
- Testing
- Covera Vascular Covered Stent following PTA, Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
- Where
- 24 sites in United States, Australia and 6 more
- Volunteers
- 280 people
- Sponsor
- C. R. Bard
Neurogenic Detrusor Overactivity
A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity
This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 2-15 years, with neurogenic detrusor overactivity.
- Trial name
- NCT00712322
- Testing
- Darifenacin
- Where
- 12 sites in United States, Colombia
- Volunteers
- 35 people
- Sponsor
- Warner Chilcott
Glioblastoma
A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy
This is an event driven, adaptive design, a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 3 study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent…
- Trial name
- NCT03149003
- Testing
- DSP-7888 Dosing Emulsion, Bevacizumab
- Where
- 61 sites in United States, Canada and 3 more
- Volunteers
- 221 people
- Sponsor
- Sumitomo Pharma America, Inc.
Healthy Volunteers
A Study of RGLS8429 in Healthy Volunteers
Primary Objective To assess the safety and tolerability of single ascending doses of RGLS8429 Secondary Objectives To identify dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of a single SC dose of…
- Trial name
- NCT05429073
- Testing
- RGLS8429
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Regulus Therapeutics Inc.
Polycystic Kidney Disease, Adult, ADPKD
Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
This is a Phase 3, open-label, repeat-dose study designed to assess liver safety, non-liver safety, and efficacy of lixivaptan in participants who previously experienced liver chemistry test abnormalities while treated with…
- Trial name
- ALERT (NCT04152837)
- Testing
- Lixivaptan
- Where
- 6 sites in United States
- Volunteers
- 7 people
- Sponsor
- Palladio Biosciences
Adrenal Insufficiency, Excess Androgen
Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia
Background: Congenital adrenal hyperplasia (CAH) is a genetic disorder of the adrenal gland. The adrenal gland is located in the abdomen and produces small amounts of hormones such as cortisol, aldosterone, and androgen.
- Conditions
- Adrenal Insufficiency, Excess Androgen, Congenital Adrenal Hyperplasia (CAH)
- Trial name
- NCT01859312
- Testing
- Hydrocortisone (Solucortef), Insulin pump (Medtronic)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Congenital Adrenal Hyperplasia
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due…
- Trial name
- NCT04806451
- Testing
- Crinecerfont
- Where
- 46 sites in United States, Belgium and 8 more
- Volunteers
- 103 people
- Sponsor
- Neurocrine Biosciences
End Stage Renal Disease, AV Fistula
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.
- Conditions
- End Stage Renal Disease, AV Fistula, Kidney Failure
- Trial name
- SAVE (NCT01471041)
- Testing
- Venous Window Needle Guide
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Vital Access Corp.
Total Parenteral Nutrition-induced Cholestasis, Cholestasis
Compassionate Use of Omegaven in Children
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
- Conditions
- Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis
- Trial name
- NCT02370251
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Oklahoma