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NCT ID: NCT03464175 Completed - Clinical trials for Brain Injuries, Traumatic

Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation

Aerovent-
Start date: January 22, 2018
Phase: N/A
Study type: Interventional

The intention is to enroll a specific sample of intubated patients. To compare the effect of respiratory gas conditioning on lung deposition and considering the well-known influences of lung pathology on lung deposition, intubated patients with healthy lungs will be included. Postoperative neurosurgery ventilated patients respond perfectly to this criteria. A previous study including 17 postoperative neurosurgery patients was performed in 2013 with a perfect collaboration between the ICU and the Department of Neurosurgery and Anesthesiology.

NCT ID: NCT03464136 Completed - Crohn Disease Clinical Trials

Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

SEAVUE
Start date: March 29, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

NCT ID: NCT03464019 Completed - Clinical trials for Paroxysmal Supraventricular Tachycardia

Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxymal Supraventricular Tachycardia (PSVT). NODE 301 [Part 1 and Part 2 (RAPID Study)]

Start date: June 18, 2018
Phase: Phase 3
Study type: Interventional

This is a two-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by patients who experience an episode of paroxysmal ventricular tachycardia (PSVT) in an at-home setting. Part 1 comprised the conduct of the NODE-301 study up to the date of the adjudication of 150th positively adjudicated PSVT episode and Part 2 comprises the conduct of the NODE-301 study after the completion of Part 1. The RAPID Study (NODE-301 - Part 2) will enroll patients enrolled during Part 1 who had not dosed with the double-blind study drug, or had not discontinued the study before the adjudication of the 150th positively adjudicated PSVT episode in Part 1, and patients enrolled into the study following the completion of Part 1. The study will continue for approximately 6 months after the date of the adjudication of the 180th positively adjudicated PSVT episode (the data on which the primary efficacy analysis of RAPID will be conducted). The study will include the following visits: A Screening Visit, A Test Dose Randomization Visit, Monthly Follow-up Visits, A Randomized Treatment Period, A Randomized Treatment Period Follow-Up Visit, An Open-Label Treatment Period, and A Final Study Visit.

NCT ID: NCT03463369 Completed - Clinical trials for Hepatitis B, Chronic

A First-In-Human Study to Evaluate Safety, Tolerability, Reactogenicity, and Immunogenicity of JNJ-64300535, a DNA Vaccine, Administered by Electroporation-Mediated Intramuscular Injection, in Participants With Chronic Hepatitis B Who Are on Stable Nucleos(t)Ide Therapy and Virologically Suppressed

Start date: April 18, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and reactogenicity of escalating doses of JNJ-64300535 delivered via electroporation-mediated intramuscular injection in nucleos(t)ide analogs (NA)-treated chronic hepatitis B (CHB) participants.

NCT ID: NCT03462550 Completed - Clinical trials for Airway Complication of Anesthesia

A Study Comparing the Laryngeal Mask Airway Supreme With the Laryngeal Mask Airway Protector In the Ambulatory Surgery Unit

Start date: July 26, 2017
Phase: N/A
Study type: Interventional

The Laryngeal Mask Airway is a supraglottic airway device that has been used in anesthesia for decades. Now the third generation (LMA Supreme) is commonly used. Recently the LMA Protector is manufactured. The primary hypothesis of this study is: the oropharyngeal leak pressure of the LMA Protector is 5 cmH2O higher than the oropharyngeal leak pressure of the LMA Supreme. Secondary outcome measures are: ease of insertion, fibreoptic position, ease of gastric tube placement. Differences between LMA Supreme and LMA Protector are: the LMA protector has a dual gastric drainage channel, LMA supreme one. For LMA protector, airway tube and cuff are 100% silicone, in LMA supreme the cuff is polivinylchloride. Silicone cuffs have shown to reduce risk of sore throat and achieve higher seal pressures. There are no aperture bars in the LMA protector (2 in LMA supreme). The tube of LMA protector is more flexible. An integrated cuff pressure indicator for single use airway management devices that enables continuous cuff pressure monitoring only in the LMA protector.

NCT ID: NCT03461289 Completed - SMA Clinical Trials

Single-Dose Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1

STRIVE-EU
Start date: August 16, 2018
Phase: Phase 3
Study type: Interventional

Phase 3, open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi (gene replacement therapy) in patients with spinal muscular atrophy (SMA) Type 1 who meet enrollment criteria and are genetically defined by a biallelic pathogenic mutation of the survival motor neuron 1 gene (SMN1) with one or two copies of survival motor neuron 2 gene (SMN2). Up to 30 patients < 6 months (< 180 days) of age at the time of gene replacement therapy (Day 1) will be enrolled.

NCT ID: NCT03460418 Completed - Humeral Fractures Clinical Trials

Treatment of Humerus Fractures by a Multiloc Nail, Through a Minimally Invasive Procedure.

Start date: April 1, 2018
Phase:
Study type: Observational

Proximal humerus fractures are more common in older people. They can be caused by a minor trauma on an osteoporotic bone. Non- or little-displaced proximal humerus fractures are treated orthopedically. When the displacement is more important, the choice of the treatment is crucial and the algorithm of treatment is in permanent evolution. The technology and design of the implants and the operative techniques of osteosynthesis and arthroplasty have evolved. Patients live longer, they lead a more active life and their expectations have changed. The goals of the treatment should be an increase in shoulder function and a decrease in treatment failure. This study analyzes the results of the treatment by intramedullary osteosynthesis using a Multiloc nail from Synthes between 2012 and June 2017. The study will compare the functional results obtained after fixation by a Multiloc nail, a Philos plate or arthroplasty.The functionality of the shoulder and the quality of life will be evaluated according to the type of treatment.

NCT ID: NCT03459196 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.

QDOT-FAST
Start date: April 2, 2018
Phase: N/A
Study type: Interventional

The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.

NCT ID: NCT03459014 Completed - Healthy Clinical Trials

Immersive Virtual Reality During Robot-assisted Walking.

Start date: September 12, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of manipulating the optic flow (OF) speed in 2 different virtual environments (VE) on active participation in healthy participants during virtual reality (VR) - enhanced robot-assisted gait(RAG). The second aim is to investigate the effect of two different VEs on active participation during RAG.

NCT ID: NCT03457363 Completed - Hypoxia Clinical Trials

Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia

Start date: June 20, 2018
Phase: N/A
Study type: Interventional

The objective of the study is to determine whether adjunctive mask of our design (Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed with severe hypoxia.