Clinical trials: Parturition
Pelvic Floor, Perineal Rupture
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
The mechanical demands placed on the pelvic floor structures during vaginal delivery often exceed physiological tissue limits, resulting in maternal childbirth trauma, considerable postpartum morbidity, and increased risk of…
- Conditions
- Pelvic Floor, Perineal Rupture, Obstetric Trauma
- Trial name
- NCT03883867
- Where
- 3 sites in United States, Czechia
- Volunteers
- 20 people
- Sponsor
- Advanced Tactile Imaging, Inc.
Pregnancy
Study to Determine if Monitoring of Labor Shortens the Time to Delivery
The purpose of this study is to test the hypothesis that using the BirthTrack for management of labor shortens the time to delivery and thus improves both maternal and perinatal outcomes.
- Trial name
- BirthTrack (NCT01005667)
- Testing
- BirthTrack
- Where
- Canada
- Volunteers
- 600 people
- Sponsor
- Barnev, Inc.
Plasma Cell Myeloma Refractory
A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult…
- Trial name
- SubQSA (NCT06356571)
- Testing
- Isatuximab SC-OBDS, Montelukast, Dexamethasone
- Where
- 34 sites in United States
- Volunteers
- 64 people
- Sponsor
- Sanofi
Peripheral Vascular Disease
The Complete® Self-Expanding Stent and Stent Delivery System Registry
The purpose of this study is to show if a new delivery system with a modified stent is safe in treating occluded iliac arteries in patients with peripheral vascular disease.
- Trial name
- NCT00730730
- Testing
- Complete SE Iliac Stent
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Endovascular
Macular Edema
A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina
The Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator is used to deliver an implant with medicine to the eye. AbbVie is updating the DEX PS DDS Applicator.
- Trial name
- NCT04976777
- Testing
- Updated DEX PS DDS Applicator, Approved DEX PS DDS Applicator, Dexamethasone
- Where
- 7 sites in United States
- Volunteers
- 54 people
- Sponsor
- AbbVie
Low Birth Weight Infants
The Influence by Dietary Human Milk Oligosaccharide in Low Birth Weight Infants
This study aims to investigate the concentration of various growth factors and cytokines in blood, and to examine the gut microbiota of low birth weight infants fed with formulas with or without Human Milk Oligosaccharide (HMO)…
- Trial name
- NCT05203900
- Testing
- Infant formula with Human Milk Oligosaccharide, Infant formula without Human Milk Oligosaccharide
- Where
- Thailand
- Volunteers
- 60 people
- Sponsor
- Meiji Co., Ltd.
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
Preterm Birth
A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor
Prospective multicenter observational study to further develop and validate a preterm birth risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks gestation.
- Trial name
- TREETOP (NCT02787213)
- Where
- 18 sites in United States
- Volunteers
- 5,011 people
- Sponsor
- Sera Prognostics, Inc.
Diabetes, Diabetes Mellitus, Type 2
A Study of the Treatment of Type 2 Diabetes With an Insulin Infusion Pump
This trial is conducted in the United States of America (USA). This is an in-patient trial investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week out-patient maintenance period.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Delivery Systems
- Trial name
- NCT00115973
- Testing
- pump, insulin aspart
- Where
- 6 sites in United States
- Volunteers
- 71 people
- Sponsor
- Novo Nordisk A/S
Bronchopulmonary Dysplasia
Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia
PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended to treat premature infants with bronchopulmonary dysplasia. This study is to assess the safety and the efficacy of this study drug.
- Trial name
- NCT01297205
- Testing
- Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- Medipost Co Ltd.
HIV Infections
Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Vaginal Ring
The proposed study is a single center, double-blind placebo-controlled trial to assess the safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted for 28 days in 16 healthy, HIV-negative women.
- Trial name
- NCT02920827
- Testing
- Dapivirine Vaginal Ring
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Healthy Adult
Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects
The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose…
- Trial name
- NCT07540494
- Testing
- 5 Methoxy N,N Dimethyltryptamine, GH001 Aerosol Delivery System
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- GH Research Ireland Limited
Infant Developmental Assessment
A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or…
- Trial name
- NCT01362660
- Testing
- Unintentional exposure in utero
- Where
- 8 sites in United States
- Volunteers
- 7 people
- Sponsor
- Pfizer
Acute Heart Failure
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (AHF)
- Trial name
- RELAX-PEDS-PK (NCT02151383)
- Testing
- Serelaxin
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B Infection, Congenital Malformation
Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission
Immunoprophylaxis with two hepatitis B vaccinations following the hepatitis B immune globulin (HBIg) and hepatitis B vaccine at birth is largely effective in protecting infants from hepatitis B virus (HBV) infection.
- Conditions
- Hepatitis B Infection, Congenital Malformation, Birth Defect, Viremia
- Trial name
- NCT03476083
- Testing
- Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.
- Where
- 7 sites in China
- Volunteers
- 280 people
- Sponsor
- New Discovery LLC
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Infant, Small for Gestational Age
A Pharmaco-epidemiological Study of Short Patients Born Small for Gestational Age (SGA), Treated With Saizen® (Recombinant Somatropin)
This one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians in private, mixed private and hospital…
- Trial name
- SEPAGE (NCT01082354)
- Testing
- recombinant somatropin
- Where
- 40 sites in France
- Volunteers
- 150 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Obesity
A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range
Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide.
- Trial name
- NCT05671653
- Testing
- PF-07081532, Semaglutide
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer
Post Partum Haemorrhage, Maternal Care Patterns
Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage
Oli is a predictive, non-invasive device, intended to be placed on the participant's maternal abdomen during the intrapartum period, which can alert healthcare professionals of an impending cumulative blood loss of ≥500 ml…
- Conditions
- Post Partum Haemorrhage, Maternal Care Patterns, High Risk Pregnancy
- Trial name
- NCT06655207
- Testing
- Oli is a non-invasive, wearable device, designed to provide clinicians with an early indication if the participant is at a higher risk of developing abnormal postpartum uterine bleeding
- Where
- 7 sites in United States, Australia
- Volunteers
- 1,000 people
- Sponsor
- Baymatob Operations Pty Ltd
Influenza (Pandemic)
Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body that…
- Trial name
- NCT00347529
- Testing
- pPML7789 with and without pPJV2012 administered by PMED
- Where
- United Kingdom
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- PowderMed
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