Clinical trials: Delivery; Trauma
Hypoxic-Ischemic Encephalopathy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant…
- Trial name
- STAR (NCT05778188)
- Testing
- RLS-0071
- Where
- 15 sites in United States
- Volunteers
- 70 people
- Sponsor
- ReAlta Life Sciences, Inc.
Childbirth
A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth
This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device.
- Trial name
- NCT06698185
- Testing
- Materna Prep Device
- Where
- United States
- Sponsor
- Materna Medical
Bone Fracture, Fresh Fracture
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period.
- Trial name
- NCT05883241
- Testing
- Sustained Acoustic Device with 2.5% Diclofenac Patch, 2.5% Diclofenac Patches
- Where
- 2 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- ZetrOZ, Inc.
Aging
Health in Motion Pragmatic Clinical Trial - WRAPAROUND
Falls among older adults are a serious public health concern, and injuries resulting from falls can cause significant loss of independence, premature death, and higher caregiver burden.
- Trial name
- NCT06619496
- Testing
- Human-led fall prevention program, Avatar-led fall prevention program
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Blue Marble Rehab Inc
Diabetic Foot Ulcers
Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers
This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12 weeks duration to evaluate the safety and effectiveness of EPIFLO for the treatment of Diabetic Foot Ulcer.
- Trial name
- NCT01291160
- Testing
- Epiflo, Moist Wound Therapy
- Where
- 14 sites in United States
- Volunteers
- 130 people
- Sponsor
- Neogenix, LLC dba Ogenix
Vaginal Delivery, Pelvic Organ Prolapse
EASE: The Materna Prep Pivotal Study
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
- Trial name
- NCT03973281
- Testing
- Materna Prep Device, Standard of Care (SOC)
- Where
- 22 sites in United States
- Volunteers
- 420 people
- Sponsor
- Materna Medical
Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic
A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury
The DOSED clinical study evaluates the safety and utility of a novel delivery device to deliver LCTOPC1, a cell therapy, to the spinal cord of patients with a spinal cord injury (SCI).
- Conditions
- Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic, Spinal Cord Injury, Acute, Spinal Cord Injury
- Trial name
- DOSED (NCT06841770)
- Testing
- OPC1
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Lineage Cell Therapeutics, Inc.
Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Non-healing Wound
Phase 2 Randomized Study to Compare Ultrasonic Drug Delivery to Standard of Care for the Treatment of Infections in Non-Healing Wounds
This is a randomized study to compare the safety and efficacy of a single dose of up to 2 grams of cefazolin administered using a new drug delivery method called Ultrasonic Drug Delivery (UDD), combined with standard of care…
- Trial name
- NCT03732365
- Testing
- Ultrasonic Drug Delivery, Standard of Care Antibiotic Treatment
- Volunteers
- 30 people
- Sponsor
- Sonescence, Inc.
Wound of Skin, Ulcers
TrueLok Elevate PMCF Study
The TrueLok Elevate Transverse Bone Transport System is a modular external fixation device designed for transverse bone transport.
- Conditions
- Wound of Skin, Ulcers, Soft Tissue Defect
- Trial name
- NCT07079774
- Testing
- Transverse Bone Transport System
- Where
- 14 sites in Germany, Italy and 4 more
- Volunteers
- 153 people
- Sponsor
- Orthofix s.r.l.
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics
Cerebral Palsy, Multiple Sclerosis
Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery
The purpose of this study is to record signatures from the fluid surrounding the spinal cord from people who have an implanted drug infusion system.
- Conditions
- Cerebral Palsy, Multiple Sclerosis, Traumatic Brain Injury, Spinal Cord Injury
- Trial name
- NCT01117090
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- MedtronicNeuro
Infant, Premature, Neonatal Respiratory Distress
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
Oxygen treatment is common in management of preterm babies requiring intensive care. Delivery of too much or too little oxygen increase the risk of damage to eyes and lungs, and contributes to death and disability.
- Conditions
- Infant, Premature, Neonatal Respiratory Distress, Oxygen Saturation, Bronchopulmonary Dysplasia
- Trial name
- MODERATION Neo (NCT05030012)
- Testing
- Automated Control, Manual Control
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Vapotherm, Inc.
Neurogenic Detrusor Overactivity
Safety and Tolerability of TAR-302-5018 in Subjects With Neurogenic Detrusor Overactivity Resulting From Spinal Cord Injury
The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with neurogenic detrusor overactivity (NDO) resulting from spinal cord injury (SCI).
- Trial name
- NCT03168828
- Testing
- Trospium-Releasing Intravesical System (TAR-302-5018)
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- Taris Biomedical LLC
Obstetric Anal Sphincter Injury, Delivery, Obstetric
Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries
The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in detection of anal sphincter injuries in women in the early postpartum period. The study is prospective.
- Trial name
- NCT03769792
- Testing
- Blood and faeces tests, Impedance spectroscopy test, Full gynecological and proctological examination
- Where
- Poland
- Volunteers
- 20 people
- Sponsor
- OASIS Diagnostics S.A.
Cardio-Respiratory Failure, Extracorporeal Membrane Oxygenation Complication
Safety and Performance of the Novalung Ultimate Kit and Xenios 2.0 During Stationary Use in Hospital and Ground-based Transport of Patients on Extracorporeal Life Support (ECLS)
This prospective observational study will evaluate the safety and performance of the Novalung ultimate kit in combination with the Xenios 2.0 and the MultiSupport Ground during stationary use in hospital and ground-based…
- Conditions
- Cardio-Respiratory Failure, Extracorporeal Membrane Oxygenation Complication, Acute Lung Injury
- Trial name
- Transport+ (NCT07156669)
- Testing
- Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)
- Where
- 3 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Xenios AG
Bronchopulmonary Dysplasia
Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study
PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular therapy product for prevention of Bronchopulmonary…
- Trial name
- NCT02381366
- Testing
- Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Medipost, Inc.
Sepsis, Acute Kidney Injury
A Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis)
Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI.
- Conditions
- Sepsis, Acute Kidney Injury, Septic Shock
- Trial name
- LAPIS (NCT04434209)
- Testing
- Subject management guided by NephroCheck® test, Standard of Care
- Where
- 12 sites in United States, Belgium and 2 more
- Volunteers
- 19 people
- Sponsor
- BioMérieux
Acute Kidney Injury, Acute Renal Failure
Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)
This is a prospective, observational, multi-center study with consecutive enrollment. Up to 500 patients will be enrolled. All (consecutive) adult patients in whom one or more components of the Benephit Infusion System are…
- Conditions
- Acute Kidney Injury, Acute Renal Failure, Renal Failure Chronic Contrast Induced, Chronic Kidney Disease
- Trial name
- PROVIDE (NCT01064895)
- Testing
- Benephit catheter for Targeted Renal Therapy
- Where
- 15 sites in United States
- Sponsor
- Angiodynamics, Inc.
Postmenopausal Osteoporosis
Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).
- Trial name
- NCT04064411
- Testing
- abaloparatide, abaloparatide solid microstructured transdermal system
- Where
- 97 sites in United States, Denmark and 3 more
- Volunteers
- 511 people
- Sponsor
- Radius Health, Inc.
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott