Clinical trials: Delivery Systems
Anemia of Prematurity, Necrotizing Enterocolitis
Transfusion-related Inflammatory Cytokine and Neutrophil Extracellular Trap Quantification in Neonates
Despite many advances in neonatal care, necrotizing enterocolitis (NEC) remains a leading cause of morbidity and mortality among premature infants.
- Trial name
- NCT01735552
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- University of Utah
Fetal Macrosomia, Intrauterine Growth Disorders (IUGR and Macrosomia)
Estimation of Fetal Weight by Measuring Abdominal Circumference, Abdominal Subcutaneous Soft Tissue Thickness, Femur Length and Mid-thigh Soft Tissue Thickness
Traditional methods for estimating fetal weight (EFW) often miss the mark because they focus on bone and circumference while ignoring fetal fat. This study proposes a more inclusive formula to fix that.
- Conditions
- Fetal Macrosomia, Intrauterine Growth Disorders (IUGR and Macrosomia), Intrauterine Growth Restriction (IUGR)
- Trial name
- NCT07575152
- Testing
- 3rd trimester ultrasound examination within 48-72 hours of delivery
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Assiut University
Autism Spectrum Disorder, Sleep Disturbance
Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD
This trial investigates the behavioural effects of Internet-based Cognitive behaviour therapy for insomnia (CBT-I) in adolescents with autism spectrum disorder with sleep problems. This is a randomised controlled trial.
- Conditions
- Autism Spectrum Disorder, Sleep Disturbance, Insomnia
- Trial name
- NCT03624400
- Testing
- Internet-based CBT-I, Internet-based psychoeducation
- Where
- Sweden
- Volunteers
- 240 people
- Sponsor
- Stockholm University
Chronic Pain, Multiple Sclerosis
Telephone Intervention for Pain Study (TIPS)
Treatments teaching people how to manage pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these treatments delivered over the telephone can benefit persons with multiple…
- Conditions
- Chronic Pain, Multiple Sclerosis, Amputation, Spinal Cord Injury
- Trial name
- TIPS (NCT00663663)
- Testing
- Telephone-Delivered Intervention 1, Telephone-Delivered Intervention 2
- Where
- United States
- Volunteers
- 207 people
- Sponsor
- University of Washington
Functional Gastrointestinal Disorders (FGIDs), Weight Loss
Effects of Multi-strain Bacillus Spore Probiotics on Growth, Digestive Function, and Gut Microbiota in Cesarean-Delivered Neonates
Infants born by cesarean section commonly show early weight loss and slower recovery of birth weight, together with characteristic patterns of gut microbiota dysbiosis marked by reduced Bifidobacterium and Bacteroides and…
- Trial name
- NCT07320287
- Testing
- RO water, LiveSpo PREG-MOM, LiveSpo CONSY
- Where
- Vietnam
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Anabio R&D
Hypophosphatemia, X-linked Hypophosphatemia
FGF23 and Angiotensin-(1-7) in Hypophosphatemia (GAP)
Hereditary hypophosphatemia encompasses rare genetic conditions characterized by renal phosphate wasting. Increased circulating levels of fibroblast growth factor 23 (FGF23), a key regulator of phosphorus metabolism, are critical…
- Conditions
- Hypophosphatemia, X-linked Hypophosphatemia, Renin-angiotensin System, Left Ventricular Hypertrophy
- Trial name
- GAP (NCT03489993)
- Testing
- Ang II and Ang-(1-7), FGF23 and klotho
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Wake Forest University Health Sciences
Asthma
An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma
This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate…
- Trial name
- NCT01706198
- Testing
- fluticasone furoate + vilanterol, inhaled corticosteroid with or without a long acting beta2-agonist
- Where
- 180 sites in United Kingdom
- Volunteers
- 4,233 people
- Sponsor
- GlaxoSmithKline
Well-Being, Psychological
Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
There is no widely used, statistically validated assessment for physical and mental health for the short- to medium-term in a postpartum population.
- Trial name
- NCT06002763
- Testing
- PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System), WHOQoLBREF (World Health Organization Quality of Life Brief Version), EQ-5D-3L1 (not an acronym)
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Asthma
Launching an Asthma Initiative Designed to Improve Asthma Management and Outcomes
Following on from a 10 year study conducted in Finland this study is designed to test the validity and sustainability of an enhanced asthma management model for the UK.
- Trial name
- NCT02140671
- Volunteers
- 33,370 people
- Sponsor
- Research in Real-Life Ltd
Type 1 Diabetes
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
The study is a two centre, open-label, uncontrolled single group phase 1A study of C19-A3 GNP peptide (10 μg peptide equivalent content) administered via Nanopass microneedles every 28 days for 8 weeks (3 doses), with follow-up…
- Trial name
- EE-ASI-1 (NCT02837094)
- Testing
- C19-A3 GNP
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Cardiff University
Healthy
Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System
Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.
- Trial name
- NCT02158572
- Testing
- AG200-15
- Volunteers
- 2,032 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
HIV Infections, Drug Use
INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit
The purpose of this study is to determine the efficacy of using a mobile health delivery unit ("mobile unit") to deliver "one stop" integrated health services - particularly medication for opioid use disorder (MOUD) and…
- Conditions
- HIV Infections, Drug Use, Opioid Use, Opioid-use Disorder
- Trial name
- INTEGRA (NCT04804072)
- Testing
- Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD), HIV testing, HIV treatment for participants living with HIV not already in care
- Where
- 5 sites in United States
- Volunteers
- 447 people
- Sponsor
- HIV Prevention Trials Network
Hiv
Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform
The investigators will conduct a cluster RCT in Kisumu, Kenya to determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery…
- Trial name
- NCT05467306
- Testing
- Nurse-Navigator Enhanced PrEP Support
- Where
- Kenya
- Volunteers
- 1,900 people, healthy volunteers welcome
- Sponsor
- University of Washington
Postpartum Period
Evaluation of Blood Loss After Cesarean Delivery Via US Compared to Standard Care
Postpartum hemorrhage and anemia are considered a major health concern due to their impact on maternal morbidity and mortality, quality of life, and maternal cognitive and emotional functioning after delivery, which are…
- Trial name
- NCT06963047
- Testing
- Ultrasound, Standard care
- Where
- Israel
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Holy Family Hospital, Nazareth, Israel
Multiple Myeloma
A Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate the tolerability and safety of subcutaneous (SC) delivery of co-formulated daratumumab and rHuPH20 preparation (DARA SC) in Japanese participants with relapsed or refractory multiple…
- Trial name
- NCT03242889
- Testing
- DARA SC
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Janssen Pharmaceutical K.K.
Pregnancy Related, Immune-mediated Diseases
Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development
What is this project about? This project aims to better understand how the immune system develops in babies whose mothers received immunomodulatory treatments during pregnancy.
- Trial name
- NEWbornIMMPACT (NCT07033663)
- Testing
- Monoclonal antibody
- Where
- 3 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Fundació Sant Joan de Déu
Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma
Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer
This phase I/II trial studies the effect of sonoporation in addition to standard of care chemotherapy in treating patients with pancreatic cancer.
- Conditions
- Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8, Stage IIA Pancreatic Cancer AJCC v8
- Trial name
- NCT04821284
- Testing
- Gemcitabine Hydrochloride, Nab-paclitaxel, Fluorouracil
- Where
- 2 sites in United States, Norway
- Volunteers
- 120 people
- Sponsor
- Flemming Forsberg
Diabetes Mellitus, Type 1
Insulin Delivery Using the DBLG1 Closed-loop on Glycemic Control and PROMs in Adults Living With Type 1 Diabetes
To evaluate the impact of the DBLG1 hybrid closed-loop system on glycemic control and patient-reported outcomes in adults living with type 1 diabetes under real-life conditions.
- Trial name
- INLOOP (NCT06154135)
- Where
- 12 sites in Belgium
- Volunteers
- 165 people
- Sponsor
- Erasme University Hospital
Implantable Cardioverter Defibrillator(ICD)
To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
To compare Treatment Group (settings of Early Multiple ATP) and Control Group (settings of extended detection time for the conventional ATP) in Japanese patients, and confirm their safety and efficacy
- Trial name
- BIO|ATP (NCT05426785)
- Testing
- 1:1 ratio for Treatment Group and Control Group
- Where
- Japan
- Volunteers
- 398 people
- Sponsor
- Biotronik SE & Co. KG
Pain Management, Postoperative Pain
PCDD Generation 1 Oral Liquid Acetaminophen Delivery Evaluation
This prospective randomized pilot study evaluates the feasibility, acceptability, and preliminary efficacy of the Patient-Controlled Dispenser and Deactivator (PCDD) Generation 1 system for patient-controlled oral liquid…
- Trial name
- NCT07765238
- Testing
- PCDD Generation 1 system
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Yale University
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