Clinical trials: Pulmonary Insufficiency
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
Dyspnea, Hypercapnia
Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence
This study will evaluate the ability of a new High Velocity Nasal Insufflation [HVNI] device design to effect ventilation and related physiological responses relative to the current HVNI device design.
- Conditions
- Dyspnea, Hypercapnia, Respiratory Insufficiency
- Trial name
- NCT04590014
- Testing
- Conventional Precision Flow, HVNI HVT2.0 Device
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Vapotherm, Inc.
Multiple Myeloma
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg
1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form…
- Trial name
- NCT02921828
- Where
- 2 sites in United States, Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Nasal Obstruction
Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction
Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction
- Trial name
- AERWAY (NCT04277507)
- Testing
- Vivaer Stylus
- Where
- 10 sites in United States
- Volunteers
- 122 people
- Sponsor
- Aerin Medical
Exocrine Pancreatic Insufficiency, Steatorrhea
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic…
- Conditions
- Exocrine Pancreatic Insufficiency, Steatorrhea, Malabsorption Syndromes, Cystic Fibrosis
- Trial name
- NCT00662675
- Testing
- Pancrease MT 10.5, or MT 21
- Where
- 11 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Dry Nose, Nose Irritation
Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated Nose
As the medical device is CE marked, the objective of this study is to provide performance and safety data on SULFEX 13081.22 nasal spray as close as possible to the routine care.
- Trial name
- NCT05499078
- Testing
- SULFEX 13081.22
- Where
- 2 sites in France
- Volunteers
- 40 people
- Sponsor
- Church & Dwight Company, Inc.
Nasal Obstruction
The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)
Post-market study to access the clinical use of the Vivaer Arc Stylus to treat Septal Swell Bodies (SSB).
- Trial name
- SWELL (NCT05099263)
- Testing
- Vivaer Arc Stylus
- Where
- 9 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Aerin Medical
Non-small Cell Lung Cancer
Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency
The purpose of this study is to determine whether Icotinib is efficient and safe in treating advanced non-small cell lung cancer (NSCLC) patients with hepatic insufficiency.
- Trial name
- NCT02062515
- Testing
- icotinib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Nasal Airway Obstruction
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority.
- Trial name
- CompAer (NCT06922955)
- Where
- 35 sites in United States
- Volunteers
- 400 people
- Sponsor
- Aerin Medical
Chronic Respiratory Failure, Acute Respiratory Failure
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
This study evaluates EMILY.AI, an investigational (non-CE-marked) smart oxygen valve that automatically adjusts the oxygen flow delivered to a patient, second by second, according to oxygen saturation (SpO2), heart rate and…
- Conditions
- Chronic Respiratory Failure, Acute Respiratory Failure, Hypoxemic Respiratory Failure, Hypercapnic Respiratory Failure
- Trial name
- NCT06952816
- Testing
- Emily.AI, Manual oxygen titration
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Aether Tech S.L.
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and…
- Trial name
- NCT00297167
- Testing
- EUR-1008 (APT-1008)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Forest Laboratories
Chronic Obstructive Pulmonary Disease
PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers
The purpose of the study is to obtain pharmacokinetics, safety and tolerability data after single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment as well as healthy volunteers under the same…
- Trial name
- NCT05431426
- Testing
- CH6001
- Where
- Bulgaria
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Congenital Heart Disease, Tetrology of Fallot
Harmony TPV Post-Approval Study
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT05077774
- Testing
- Harmony TPV System
- Where
- 20 sites in United States, Canada
- Volunteers
- 174 people
- Sponsor
- Medtronic Cardiovascular
Kidney Transplantation, Transplantation
Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
The purpose of this study is to evaluate two groups of kidney transplant recipients, to determine the proportion of patients that achieve therapeutic blood concentrations of tacrolimus by Day 3 after transplantation.
- Trial name
- NCT00297310
- Testing
- tacrolimus
- Volunteers
- 89 people
- Sponsor
- Janssen-Cilag Pty Ltd
Heart Failure, Cardiomyopathies
Multimodal Physiologic State Intelligence Study
The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state…
- Conditions
- Heart Failure, Cardiomyopathies, Pulmonary Hypertension, Myocarditis; Acute or Subacute
- Trial name
- OMNIPHYS (NCT07814118)
- Testing
- OMNIPHYS Multimodal Ultrasound Imaging System
- Where
- United States
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
Airway Obstruction, Sedation Complication
Evaluation of Medical Device for Airway Patency During Sedation (SW01-2022)
The goal of this four-part preclinical [I-II] and clinical [III-IV] trial is to compare, with randomised crossover study design [I-IV], a new medical airway device with standard procedure (biteblock or no device) for upper airway…
- Conditions
- Airway Obstruction, Sedation Complication, Safety Issues, Patient Satisfaction
- Trial name
- NCT05708651
- Testing
- Investigational device [I-IV], Comparator [I-IV]
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Stairway Medical AB