Clinical Trials Logo

Filter by:
NCT ID: NCT03138811 Completed - Asthma Clinical Trials

A Bronchoprovocation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CSJ117 in Adult Subjects With Mild Atopic Asthma

Start date: December 18, 2017
Phase: Phase 1
Study type: Interventional

This is a non-confirmatory, randomized, subject and investigator blinded, placebo-controlled, parallel-design, multi-center bronchoprovocation study. Approximately 55 subjects with mild stable atopic asthma who exhibit an EAR and LAR to a common inhaled allergen will receive multiple once daily doses of inhaled CSJ117 or placebo over 12 weeks. Two sequential dose cohorts are planned for this study, Cohort 1 and Cohort 2. Cohort 2 will be split into two parts, Cohort 2a and 2b

NCT ID: NCT03138772 Completed - Observational Clinical Trials

Tracking CF Lung Disease Through the Early Years: Utility of the LCI

LCITRACK
Start date: October 5, 2017
Phase:
Study type: Observational

This is a prospective observational study to follow a cohort of patients with Cystic Fibrosis and healthy controls for a period of two years. This study will include monitoring the subjects lung clearance index (by performing a breathing test called the multiple breath washout), as well as spirometry and their respiratory symptoms every three months as well as during a pulmonary exacerbation and after their recovery.

NCT ID: NCT03138655 Completed - Ulcerative Colitis Clinical Trials

Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Start date: November 8, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.

NCT ID: NCT03138512 Completed - Clinical trials for Carcinoma, Renal Cell

A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney

CheckMate 914
Start date: July 7, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

NCT ID: NCT03138291 Completed - Pregnancy Related Clinical Trials

Efficacy of Oral Appliances on Obstructive Sleep Apnea During Pregnancy

OSApod
Start date: June 2016
Phase: N/A
Study type: Interventional

Issue: The prevalence and severity of sleep-disordered breathing increases during pregnancy due to weight gain, physiological and hormonal changes. These sleep breathing disorders have a negative impact on perinatal health for both the mother and the child.The optimal treatment of obstructive sleep apnea in pregnancy is unknown. Although CPAP therapy is often the treatment of choice, the mandibular advancement appliance would be an interesting alternative to solve the matter. Objectives: The main objective of this pilot study is to evaluate the feasibility of mandibular advancement device to treat sleep apnea during the 2nd and 3rd trimesters of pregnancy. Secondary objectives will be tools to plan a future randomized controlled trial to determine the efficacy of this treatment.

NCT ID: NCT03138148 Completed - Clinical trials for Mechanical Ventilation

Evaluation of the Patient-ventilator Asynchrony During Mechanical Ventilation for Pediatric Acute Respiratory Failure

Asynchrony
Start date: May 26, 2010
Phase: N/A
Study type: Observational

The synchronization between the patient and the ventilator is an essential objective during mechanical ventilation (MV). Maintaining the patient's respiratory activity during MV reduces ventilation pressures, improves oxygenation, and decreases sedation. In order to do this, the inspiratory or expiratory effort of the patient must be detected by the respirator' sensor systems, so that the assistance delivered by the respirator is coordinated with the patient's respiratory cycles. The usual systems do not actually detect the beginning of the effort but its result: variation in flow rate or pressure at the respirator circuit, which depends on the patient's respiratory mechanics and sensitivity of the sensor. This detection is currently imperfect, which generates asynchrony between the patient's needs and the assistance of the respirator. The asynchrony comprises the periods of delay between the beginning of the inspiration (or expiration) and the response of the respirator, but also of the unsuitable cycles: inspiratory efforts of the patient not detected by the respirator, or inversely triggering assistance in the absence of inspiration by the patient (self-initiation), or delivery of 2 cycles of assistance for a single inspiration (double triggering). Asynchrony is a risk factor for prolonged mechanical ventilation in adults. Adult studies have shown that patient-ventilator asynchrony is common during MV, and is associated with prolonged MV duration. An association with length of stay in intensive care and in hospital was also observed. In children, patient-ventilator synchronization is more difficult to achieve than in adults due to a higher respiratory rate and smaller current volumes. The impact of patient-ventilator asynchrony on evolution has not been studied in pediatrics. Patient-ventilator synchronization could be improved by the development of new ventilatory modes. The new NAVA (neurally adjusted ventilatory assist) ventilation mode detects the patient's breathing efforts earlier by monitoring the electrical activity of the diaphragm through the esophagus. This new mode seems to improve synchronization in children. NAVA ventilation may therefore be a step forward, but its clinical benefits remain to be seen. The objective of this study is to evaluate the impact of patient-ventilator asynchrony on the duration of mechanical ventilation in children with acute respiratory failure.

NCT ID: NCT03137602 Completed - Clinical trials for Pediatric Multiple Sclerosis

ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study

Start date: March 7, 2018
Phase: N/A
Study type: Interventional

Taking part in recommended levels of physical activity in youth with MS may have an important and positive impact on disease symptoms, long-term disability and health outcomes. Unfortunately, youth with MS are highly inactive. In order to address this issue, the investigators have developed an MS-specific mobile application for teens called Active Teens with Multiple Sclerosis (ATOMIC). In this research the investigators will evaluate the feasibility of using the ATOMIC program in youth with MS. The results of this pilot study will provide the data necessary to ensure the ATOMIC program aligns with the needs of youth with MS.

NCT ID: NCT03137264 Completed - Clinical trials for Non-small Cell Lung Cancer

Resistance & Activating Mutations Diagnosed Among NSCLC Community Dwelling EGFR Mutation Positive Patients

RADIANCE
Start date: October 24, 2017
Phase:
Study type: Observational

The study is being done to determine if non-invasive testing (urine and plasma testing) is as effective as tissue testing in identifying epidermal growth factor receptor (EGFR) T790M mutation status. EGFR is a type of protein found on the surface of cells in the body. When this protein is mutated and becomes too active, it can lead to cancer growth. T790M is a mutation that develops in response to treatment of the EGFR mutation. Participating patients will have tumor tissue (via cobas test), as well as 2 plasma samples (via cobas and Guardant360 tests) and 1 urine sample (via Trovera test), tested for EGFR T790M mutation status. If the results of the cobas tissue and/or plasma test show that a patient is T790M positive, they will be treated according to standard of care, which may include treatment with osimertinib. Osimertinib is approved for use in the United States for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC).

NCT ID: NCT03137069 Completed - Urticaria Clinical Trials

A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).

Start date: May 26, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of GDC-0853 compared with placebo in participants with Refractory Chronic Spontaneous Urticaria (CSU) already treated with anti-histamines. Participants have the option to enter the Open-Label Extension (OLE) study after completing the 8-week treatment period.

NCT ID: NCT03136848 Completed - Clinical trials for Kidney Transplantation

The Feasibility and Safety of Normothermic ex Vivo Kidney Perfusion

NEVKP
Start date: December 19, 2016
Phase: N/A
Study type: Interventional

Kidney transplantation is the treatment of choice for end-stage kidney failure, but access to transplantation is limited by a severe shortage of donor organs. Although the use of kidneys from higher risk deceased donors has increased the availability of organs, these grafts are associated with a greater risk of delayed function, inferior performance, and shorter survival than standard criteria donor kidneys. The current standard of care for kidney graft preservation prior to transplantation is static cold storage. Preliminary results from large animal kidney transplantation studies and a human clinical trial suggest that normothermic machine perfusion of kidneys prior to transplantation may ameliorate the injury sustained by kidney grafts during cold static preservation, allow assessment of organ viability prior to transplantation, and reduce the risk of delayed graft function or non-function. Such a strategy may not only improve the performance of kidneys that are currently considered acceptable for transplantation, but may also facilitate the assessment and utilization of kidneys that are currently not considered for transplantation. This study will examine the feasibility and safety of normothermic ex vivo perfusion of human kidneys prior to transplantation. The study will evaluate kidney function after transplantation using standard clinical parameters. Study participants will be followed for 3 months following transplantation and their outcomes recorded. Feasibility will be measured using the ratio of actual:eligible kidney grafts preserved by normothermic ex vivo perfusion and will also take into account logistical issues with respect to implementation and ease of use of the ex vivo perfusion device. Safety will be assessed by rates of device failure resulting in organ discard, primary graft non-function, delayed graft function, graft failure, and recipient mortality.