Clinical trials: Birth, First, open to volunteers
Mesial Temporal Lobe Epilepsy
AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
The main goals of this clinical study are to learn if AMT-260 is safe and tolerable and works to reduce the frequency of seizures in adults with unilateral mesial temporal lobe epilepsy (MTLE).
- Trial name
- GenTLE (NCT06063850)
- Testing
- AAV9-hSyn1-miGRIK2
- Where
- 18 sites in United States
- Volunteers
- 12 people
- Sponsor
- UniQure Biopharma B.V.
Premature Birth, Psychological Stress
Parental Stress and Attachment in Preterm Infants
Introduction: Advances in neonatology mean a significant reduction in mortality in premature infants as well as an increase in the risk of morbidity in the medium, short and long term.
- Conditions
- Premature Birth, Psychological Stress, Physiological Stress
- Trial name
- NCT06813560
- Testing
- hair cortisol, salivary cortisol, salivary Oxytocin
- Where
- Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Cardenal Herrera University
Perineal Laceration, Tear, or Rupture During Delivery
Study on Fewer Tears (SOFT) - The Effect of Local Anesthesia on the Incidence of Perineal Tears in the First Vaginal Birth
The SOFT study investigates whether local anaesthesia during the second stage of labor decreases the incidence of perineal tears, including sphincter injuries, in women with their first vaginal birth (non-instrumental).
- Trial name
- SOFT (NCT07499752)
- Testing
- Perineal protection techniques
- Where
- Sweden
- Volunteers
- 1,350 people
- Sponsor
- Karolinska Institutet
Aboriginal Health, Cultural Safety
The Communicate Study Partnership
The vision of the Communicate Study Partnership is to ensure more Aboriginal patients receive culturally safe healthcare in their first language.
- Conditions
- Aboriginal Health, Cultural Safety, Access to Interpreters, Healthcare Provider Training
- Trial name
- NCT05629416
- Testing
- Interventions to transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoples
- Where
- 4 sites in Australia
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- Menzies School of Health Research
Liver Cancer, Antibody
Checkpoint Inhibitor Combinations Therapy as First Line for HCC Via IT
This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or/and bevacizumab through…
- Trial name
- NCT06482801
- Testing
- ipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Second Affiliated Hospital of Guangzhou Medical University
Wheezing, LRTI
Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration.
- Conditions
- Wheezing, LRTI, Premature
- Trial name
- PROTEA (NCT05063149)
- Testing
- Broncho-Vaxom
- Where
- Netherlands
- Volunteers
- 500 people
- Sponsor
- Franciscus Gasthuis
Bronchopulmonary Dysplasia
Early Prediction of Bronchopulmonary Dysplasia in Preterm Infants Using Clinical Data
Early Prediction of Bronchopulmonary Dysplasia in Preterm Infants Using Clinical Data from the First Three Postnatal Weeks with Large Language Models: A Retrospective Study This retrospective, observational study aims to evaluate…
- Trial name
- NCT07525167
- Testing
- Artificial Intelligence-Based Risk Prediction
- Where
- Turkey (Türkiye)
- Volunteers
- 108 people
- Sponsor
- Konya City Hospital
Preterm, Father-Child Relations
The SUPPORTED Study - First-time Fathers of Preterm Infants.
The purpose is to support first-time fathers of premature infants in early parenthood by promoting early paternal-infant relationships.
- Trial name
- NCT06116747
- Testing
- Intervention
- Where
- Denmark
- Volunteers
- 915 people, healthy volunteers welcome
- Sponsor
- Hvidovre University Hospital
Mother Who Has Given Birth to a Singleton Newborn, Mother-newborn Dyad
Olfactory Communication in the First Days of Life: From Chemical Mechanisms to Improved Breastfeeding
For a newborn, locating and latching onto the mother's breast is the foundational social interaction. This pivotal moment not only influences the newborn's survival but also determines the mother's physiological (lactation) and…
- Conditions
- Mother Who Has Given Birth to a Singleton Newborn, Mother-newborn Dyad, Singleton Newborn
- Trial name
- OD-ALL (NCT07616076)
- Testing
- Chemical description of the scent of the breast or a newborn, Breast secretion samples, The newborn and its role in colostrum secretion
- Where
- France
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon
Cardiac Abnormalities, Nutrient Intake
Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Preterm infants are babies born before 37 completed weeks of pregnancy. Early nutrition is important for their growth and development, and it may also be associated with how their heart develops and functions during infancy.
- Trial name
- NCT07892209
- Testing
- echocardiography
- Volunteers
- 117 people
- Sponsor
- Assiut University
Type 1 Diabetes Mellitus
VV-14300 for the Treatment of Type 1 Diabetes
This study is testing VV-14300 in adults with long-standing type 1 diabetes (T1D) whose blood sugar is not well controlled despite using an automated insulin delivery (AID) system.
- Trial name
- RELIEVE (NCT07831798)
- Testing
- VV-14300
- Where
- 2 sites in Canada, New Zealand
- Volunteers
- 29 people
- Sponsor
- Kriya Therapeutics, Inc.
Pelvic Floor Dysfunction, Perineal Laceration
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to determine whether using a soft perineal protection device (BabySlide®) in addition to standard manual perineal support during vaginal delivery can reduce the risk of perineal trauma in…
- Conditions
- Pelvic Floor Dysfunction, Perineal Laceration, Wound Dehiscence, Anal Incontinence
- Trial name
- PeriPROTECT (NCT07862660)
- Testing
- Perineal protection device, BabySlide, Standard manual perineal support
- Where
- Sweden
- Volunteers
- 4,226 people
- Sponsor
- Region Skane
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
Neonatal Disease
New Procedure to Reduce Mother-newborn Separation
The goal of this single-centre interventional study without medication neither device (for procedure) is to limit the separation between mother and newborn by implementing a new procedure for the management of the newborn with…
- Trial name
- NCT06594458
- Testing
- Observation of newborn with respiratory distress in the delivery room
- Where
- Italy
- Volunteers
- 142 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Meditation
Meditation in Early Labor: Impact on Self-Efficacy and Childbirth Fear in First-Time Mothers
Aim-Introduction: The feeling of uncertainty about what will happen during labor, and the mother's perception of inadequacy regarding childbirth, can lead to anxiety and stress in some pregnant women, resulting in fear of…
- Trial name
- NCT07201220
- Testing
- meditation
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Seyhan District Health Directorate, Adana
Hearing Loss
WhatsApp AI Support vs Paper Support for First-Time Hearing Aid Users
The purpose of this study is to advance hearing care in low- and middle-income countries (LMICs) through the rigorous evaluation and optimization of innovative interventions and technologies.
- Trial name
- NCT07690670
- Testing
- Go Ultra Hearing Aids, WhatsApp-delivered AI-enabled support, Paper-Based Support Programme
- Where
- 2 sites in South Africa
- Volunteers
- 66 people
- Sponsor
- University of Pretoria
Malnutrition Pregnancy, Malnutrition in Children
Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories
Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to also develop it.
- Conditions
- Malnutrition Pregnancy, Malnutrition in Children, Malnutrition (Calorie), Environmental Enteric Dysfunction
- Trial name
- UZBCS-2 (NCT07195006)
- Testing
- Malnutrition in pregnancy as exposure, Poor WASH living conditions as exposure
- Where
- Zimbabwe
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- University of Zimbabwe
Cerebral Palsy (CP), Intraventricular Hemorrhage Neonatal
Intelligent Physiological Monitoring to Predict Preterm Brain Injury
Cerebral palsy (CP) remains prevalent among very (28-31 weeks) and extremely (<28 weeks) preterm infants. Prematurity-related brain injuries (high-grade intraventricular haemorrhage, IVH or periventricular leukomalacia, PVL)…
- Conditions
- Cerebral Palsy (CP), Intraventricular Hemorrhage Neonatal, Periventricular Leukomalacia, Neurodevelopmental Delay
- Trial name
- AI4NICU (NCT07880431)
- Testing
- EEG, NIRS
- Where
- Ireland
- Volunteers
- 413 people
- Sponsor
- University College Cork
Extreme Prematurity, Enteral Nutrition
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung…
- Conditions
- Extreme Prematurity, Enteral Nutrition, Bronchopulmonary Dysplasia
- Trial name
- MEND-BPD (NCT07307612)
- Testing
- High-energy group, Standard-energy group
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Preterm Birth
Initial Oxygen Concentration at Birth in Late-Preterm Infants
This study is aims to examine the best amount of oxygen to give preterm babies (born between 32 and 35 weeks) right after birth.
- Trial name
- OXY-PREEM (NCT07315594)
- Testing
- 60% Oxygen Group - Infants will start in 60% oxygen, 30% Oxygen Group - Infants will start in 30% oxygen
- Where
- Canada
- Volunteers
- 1,520 people
- Sponsor
- University of Alberta