Clinical trials: Birth, First
Heart Failure With Reduced Ejection Fraction
First in Humans to Evaluate Collagen Patches With Stem Cells in Patients With Ischemic Left Ventricular Dysfunction
It´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that…
- Trial name
- CARDIOMESH (NCT03746938)
- Testing
- VB-C01
- Where
- 2 sites in Spain
- Volunteers
- 10 people
- Sponsor
- Viscofan
Contraception
LCS16 vs. COC User Satisfaction and Tolerability Study
To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age [inclusive]), using LCS16 compared to a COC over a period of 12 months.
- Trial name
- NCT03074045
- Testing
- Levonorgestrel (Kyleena, BAY86-5028), Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)
- Where
- 9 sites in Russia
- Volunteers
- 145 people
- Sponsor
- Bayer
Aortic Aneurysm, Abdominal
Aorfix Intelliflex First in Human Study
The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with…
- Trial name
- FIH-NZ (NCT02907762)
- Testing
- Endovascular aneurysm repair EVAR
- Volunteers
- 10 people
- Sponsor
- Lombard Medical
Bronchopulmonary Dysplasia
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants.
- Trial name
- NCT01897987
- Testing
- Pneumostem®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 62 people
- Sponsor
- Medipost Co Ltd.
Tick Born Encephalitis
Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults
evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster
- Trial name
- NCT00387634
- Testing
- TBE vaccine for adults
- Where
- Czechia
- Volunteers
- 323 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Contraception
LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study
The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months.
- Trial name
- NCT01254292
- Testing
- Levonorgestrel IUD (LCS, BAY86-5028), Yasmin (EE30/DRSP, BAY86-5131)
- Where
- 94 sites in United States, Austria and 3 more
- Volunteers
- 567 people
- Sponsor
- Bayer
Pain
A Dose Proportionality and Bioavailability Assessment of Buprenorphine Transdermal Delivery System Second Generation Patches
The purpose of this study is to obtain pharmacokinetic data for a dose proportionality and relative bioavailability assessment of 2nd generation BTDS patches compared to 1st generation BTDS patches.
- Trial name
- NCT02160067
- Testing
- Second generation BTDS patch, First generation BuTrans patch
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mundipharma Research Limited
Luteal Phase Insuffiency, Progesterone Delivery
First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
The aim of this clinical trial is to assess safety of a new vaginal 400mg progesterone drug-device combination product in a first in human trial.
- Trial name
- FREEDOM (NCT07136922)
- Testing
- 400mg progesterone Callavid - 2hr wear, Cyclogest 400 mg, 400mg progesterone Callavid - 3hr wear
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Calla Lily Clinical Care Ltd
Mitral Valve Insufficiency, Mitral Valve Disease
The Conveyor Study
To demonstrate that the Conveyor System can safely provide left ventricular access to deliver the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients who have been diagnosed with prior mitral…
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
- Trial name
- NCT03893578
- Testing
- Mitral valve-in-valve
- Volunteers
- 10 people
- Sponsor
- Synecor, LLC
Infections, Streptococcal
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis…
- Trial name
- NCT00390910
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Infanrix hexa
- Where
- 8 sites in Greece, Spain
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Locally Advanced Soft Tissue Sarcoma, Recurrent Soft Tissue Sarcoma
First-in-man Clinical Trial of CEB-01 PLGA Membrane in Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma
This is an open label, first-in-man clinical trial to assess safety and tolerability of CEB-01 PLGA membrane in patients with recurrent or locally advanced retroperitoneal soft tissue sarcoma after surgery.
- Trial name
- NCT04619056
- Testing
- CEB-01 membrane loaded with SN-38
- Where
- 5 sites in Spain
- Volunteers
- 21 people
- Sponsor
- CEBIOTEX
Glioblastoma Multiforme
The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme
The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL® Wafer following…
- Trial name
- NCT00076986
- Testing
- IL13-PE38QQR, surgery and catheter placement (2 procedures), prolifespan 20 with carmustine implant (GLIADEL® Wafer)
- Where
- 60 sites in United States, Canada and 4 more
- Volunteers
- 300 people
- Sponsor
- INSYS Therapeutics Inc
Obstetric Labour, Premature, Premature Ejaculation
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.
- Trial name
- NCT00549211
- Testing
- GSK557296
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Locally Resectable Pediatrics Tumors
CEB-01 in Pediatrics With Locally Resectable Abdominal Tumors
The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent.
- Trial name
- NCT06986811
- Testing
- Standard surgery, CEB-01
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- CEBIOTEX
Depressive Disorder
Bupropion & Cardio Birth Defect (Slone)
Bupropion is a unique drug that is used both to treat depression and as an aid in smoking cessation. In 2008, the final report from the Bupropion pregnancy registry described 24 congenital malformations among the 675 women…
- Trial name
- NCT01597661
- Testing
- Exposure to any bupropion during the first trimester, Exposure to bupropion alone during the first trimester, Referent group: no exposure to any anti-depressant or anti-smoking drug during pregnancy
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Pancreatic Adenocarcinoma Non-resectable
A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
This study is being done to find out if delivering gemcitabine using the ACT-IOP-003 device directly to the area where the tumor is in the pancreas is safe and tolerable.
- Trial name
- NCT07481383
- Testing
- ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Continuity Biosciences, LLC
Overactive Bladder
Vibe First In Human Study for the Assessment of Safety and Initial Performance of the Vibe Delivery System in Subjects With Idiopathic Overactive Bladder
This First In Human study is aimed to evaluate the safety and initial efficacy of the Vibe delivery system in delivering Botox (TM) to the bladder wall in patients diagnosed with overactive bladder.
- Trial name
- NCT03874780
- Testing
- Vibe Delivery system
- Where
- 2 sites in Czechia, Portugal
- Volunteers
- 10 people
- Sponsor
- Vensica Therapeutics Ltd.
Non-valvular Atrial Fibrillation (NVAF)
FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients
To evaluate the preliminary safety and feasibility of the LAmbreTM II Left Atrial Appendage Occluder and the Occluder Delivery System in patients with non-valvular atrial fibrillation who are at increased risk for stroke and…
- Trial name
- NCT07385599
- Testing
- LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Healthy Volunteers
A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform
The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers
- Trial name
- RaniPill (NCT03798912)
- Testing
- RaniPill capsule containing octreotide
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- RANI Therapeutics