Clinical trials: Delivery
Contraception
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
- Trial name
- NCT01181479
- Testing
- AG200-15 (cycles 1-13), Lessina crossover to AG200-15
- Where
- 80 sites in United States
- Volunteers
- 1,504 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
Cystinosis, Nephropathic Cystinosis
Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™
In order to meet FDA standards of safety and efficacy reporting for most new drugs, food-effect bioavailability (the impact that the presence of food in the digestive tract has on the rate and extent at which a drug is absorbed…
- Trial name
- NCT01432561
- Testing
- Cysteamine bitartrate
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Pain, Postoperative
Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery
This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery.
- Trial name
- NCT02487303
- Testing
- Acetaminophen Intravenous, Acetaminophen Oral
- Where
- United States
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Infections, Rotavirus
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after…
- Trial name
- NCT01198769
- Testing
- Rotarix TM
- Where
- Taiwan
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
RSV Infection
Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children
The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine (RSV 6120/∆NS2/1030s) in RSV-seropositive children…
- Trial name
- NCT03387137
- Testing
- RSV 6120/∆NS2/1030s
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Erectile Dysfunction
Caverject User Study
The purpose of this study is to demonstrate the usability of the system.
- Trial name
- NCT01008605
- Testing
- delivery system
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Pfizer
Preterm Birth, Injuries
Nurse-Family Partnership Impact Evaluation in South Carolina
This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial.
- Conditions
- Preterm Birth, Injuries, Maternal Behavior
- Trial name
- NFP (NCT03360539)
- Testing
- Nurse-Family Partnership
- Where
- 9 sites in United States
- Volunteers
- 5,670 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
C. Diff. Infections
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.
- Trial name
- NCT04893239
- Testing
- LMN-201 Anti-toxin B VHH-1, LMN-201 Anti-toxin B VHH-2, LMN-201 Anti-toxin B VHH-3
- Where
- 3 sites in Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lumen Bioscience, Inc.
Respiratory Syncytial Virus
A Prospective, Epidemiological Study to Assess the Disease Burden of Respiratory Syncytial Virus Associated, Suspected Lower Respiratory Tract Infections in Newborns, From 0 to 2 Years of Age and Risk of Development of Wheeze and Asthma From 0 to 6 Years of Age
The purpose of this study is to assess the incidence and associated healthcare utilization of RSV-associated, suspected LRTI in a general population of infants from birth up to 2 years of age, and also to assess the accuracy of a…
- Trial name
- NCT01995175
- Testing
- Nasal swab sampling, Blood sampling, Diary cards
- Where
- 23 sites in United States, Argentina and 6 more
- Volunteers
- 2,409 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Subjects
Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers
Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.
- Trial name
- NCT01199965
- Testing
- MAP0004, IV DHE
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Allergan
Premature Infants, Stool Bacterial Composition
Effects of Probiotic and Prebiotic Combinations on Premature Infants
The purpose of this study is to see how oral preparations containing both probiotics and prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain fatty acid content in premature infants.
- Conditions
- Premature Infants, Stool Bacterial Composition, Growth
- Trial name
- NCT00282113
- Testing
- ProBioPlus, Culturelle
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Adolescents, 18 and Under When Child Was Born for Mothers
Young Parents Program, Project Connect
1. Specific Aims 1. To evaluate the effects of life skills/parenting groups that are embedded within a comprehensive multidisciplinary clinic for adolescent parents (the Young Parents Program), using a randomized control design.
- Conditions
- Adolescents, 18 and Under When Child Was Born for Mothers, 25 and Under When Child Was Born for Fathers
- Trial name
- YPPProCon (NCT01379924)
- Testing
- Parenting/Life Skills Intervention, Teen-tot medical home
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Premature Birth of Newborn, Enterocolitis, Necrotizing
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.
- Trial name
- NCT02477423
- Testing
- Ampicillin, Gentamicins
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Spinal Cord Injury
Biomechanical Validation of the Transfer Assessment Instrument (TAI)
The purpose of this research study is to further develop and refine the Transfer Assessment Instrument (TAI). The TAI is a clinical tool to be used by therapists to evaluate transfer techniques and performance.
- Trial name
- NCT01183546
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Pain, Postoperative, Depression, Postpartum
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)
The purpose of this study is to identify a tolerable dose for postpartum ketamine infusion using a maximum tolerated dose (MTD) 3+3 design.
- Trial name
- NCT05907213
- Testing
- Ketamine (Ketalar) Dose Level 1, Ketamine (Ketalar) Dose Level 2, Ketamine (Ketalar) Dose Level 3
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Grace Lim, MD, MS
Opioid-use Disorder, Pain, Postoperative
BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control
This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD).
- Trial name
- NCT04365465
- Testing
- NSS-2 Bridge, Inactive NSS-2 Bridge, Active control
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Grace Lim, MD, MS
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Respiratory Syncytial Virus Infections
Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants 6 to 24 Months of Age
The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single intranasal dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24…
- Trial name
- LID (NCT02890381)
- Testing
- RSV LID cp ΔM2-2 Vaccine
- Where
- 5 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infection
Timing of Antibiotic Prophylaxis for Cesarean Deliveries
The current standard of care to prevent post partum infectious morbidities is to administer antibiotic prophylaxis to all women undergoing a cesarean delivery.
- Trial name
- NCT00805545
- Testing
- Antibiotic
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of Florida
Surgical Site Infection
Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis
Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean related surgical site infection.
- Trial name
- CAPICA (NCT02202577)
- Testing
- Chlorhexidine - Isopropyl alcohol, Povidone-Iodine Scrub and Paint
- Where
- United States
- Volunteers
- 932 people, healthy volunteers welcome
- Sponsor
- Case Western Reserve University