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NCT ID: NCT03361371 Completed - Bronchiolitis Clinical Trials

Suctioning of NOse Therapy in Bronchiolitis

SNOT
Start date: March 6, 2020
Phase: N/A
Study type: Interventional

Research Questions: Primary: In otherwise healthy infants 4 weeks to 12 months of age discharged home from the ED with acute bronchiolitis,1 is there a difference in the probability of "treatment failure" by 72 hours post discharge from the index ED visit in those receiving nasal suctioning via Zo-Li device prior to feeds compared to infants who receive nasal suctioning via bulb? Treatment failure is defined as 1) any bronchiolitis-related healthcare visit, except visits that have occurred only due to ED-recommendation at time of ED discharge or 2) the use of additional (non-study assigned) suctioning devices (see Outcome Measures section) within approximately 72 hours post discharge at the index ED visit. Hypothesis: We hypothesize that the infants who undergo scheduled nasal suctioning via ZoLi device will experience a lower treatment failure probability by approximately 72 hours post discharge from index ED visit compared to those managed by suction via a bulb. Secondary: 1. In these infants, is there a difference in the mean number of medical visits for bronchiolitis (defined as #1 under primary outcome above) within 72 hours of ED discharge? 2. In these infants, is there a difference in the mean number of unscheduled medical visits for bronchiolitis within 72 hours of ED discharge? 3. In these infants, is there a difference in the mean number of ED visits for bronchiolitis within 72 hours of ED discharge? 4. In these infants, is there a difference in the probability of a parent reporting normal/near normal feeds on approximately 72 hours discharge? 5. In these infants, is there a difference in the probability of a parent reporting normal/near normal sleeping on approximately 72 hours post ED discharge? 6. For the parent, is there a difference in the probability of a parent reporting their own normal/near normal sleeping on approximately 72 hours post ED discharge? 7. In these infants, is there a difference in the probability of parents reporting at 72 hours post ED discharge as being "very satisfied" or "satisfied" with their ability to care for their child during the study period? The sample size calculation is based on the assessment of the between-group difference in probability of treatment failure. The estimated total re-visit probability in bronchiolitis based on a recently published study was approximately 35% within 72 hours of ED discharge.49 In our pilot we have found the same rate of treatment failure. This is a superiority study in which the adoption of nasal suctioning will be recommended for future practice if the observed proportion of the primary outcome in this group is significantly lower than in the controls. With 162 patients per arm (324 in total) a two-sided test with a type I error of 0.05 will have 80% power to achieve statistical significance if suctioning reduces the probability of treatment failure from 40% to 25% (i.e. absolute reduction of 15%). This estimate is based on clinically relevant differences agreed upon by study investigators and it also represents an NNT of 7. In the Cochrane review of asthma therapies an NNT of a comparable magnitude led to a change in national practice recommendations.51 Since bronchiolitis and related medical visits are highly prevalent,20 this target difference would also have an important economic impact. Based on our previous bronchiolitis trials, the anticipated refusal rate may be 20%. Given the study design and our past experience, the study non-completion rate and loss to follow-up can safely be assumed to be no higher than 5% each. Therefore, to have complete data on 324 patients we plan to randomize 360 (i.e. 324/ (1 - 0.05) *(1 - 0.05) and to approach 450 (i.e. 360/ (1 - 0.20).

NCT ID: NCT03361150 Completed - Colorectal Cancer Clinical Trials

High-Intensity Interval vs. Moderate Continuous Training in Surgical Prehabilitation.

Start date: January 2016
Phase: N/A
Study type: Interventional

Surgery is a stressful procedure associate with perioperative physical impairment. In a previous study, the investigators showed that physical fitness could be optimize in surgical patients using prehabilitation, a preoperative conditioning intervention in form of exercise, nutrition and relaxation technique. The best modality of exercise has yet to be known.The purpose of this study is to compare high interval (HIT) vs. moderate continuous intensity (MC) training, integrated in a prehabilitation intervention in colorectal surgical patients.

NCT ID: NCT03360747 Completed - Clinical trials for Familial Chylomicronemia Syndrome

Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)

Start date: December 21, 2017
Phase: Phase 2
Study type: Interventional

This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRx for reduction of triglyceride (TG) levels in participants with FCS.

NCT ID: NCT03360669 Completed - Hypertension Clinical Trials

Comparison of Blood Pressure Measurement With an Omron HEM-907 Device in a Clinical Setting and a Research Setting

OMRONHEM-907
Start date: November 27, 2017
Phase: N/A
Study type: Interventional

Automated office blood pressure (AOBP) devices are recommended for high blood pressure diagnosis. One of those devices is the Omron HEM-907 (Omron Healthcare). It is currently not known if blood pressure measurements performed with this device in a clinical setting are equivalent to those made in a research setting. Therefore, this randomized-controlled trial was designed. It aims to compare the blood pressure measurements performed in a clinical and a research setting. Seventy patients will be included and randomized to a clinical/research or research/clinical sequence.

NCT ID: NCT03359551 Completed - Choroideremia Clinical Trials

Natural History of the Progression of Choroideremia Study

NIGHT
Start date: June 30, 2015
Phase:
Study type: Observational

The objective of this natural history study is to gain a better understanding of the progression of choroideremia (CHM) and add to the knowledge base for this rare disease.

NCT ID: NCT03358771 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

COPD Discharge Bundle Delivered Alone or Enhanced Through a Care Coordinator

PRIHS
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is a common, chronic progressive lung disease that is characterized by shortness of breath, activity limitation, and a predisposition to flare-ups resulting in frequent emergency department (ED) visits and hospitalizations. COPD flare-ups increase risks of disease progression and mortality and account for the greatest proportion of preventable hospitalizations among major chronic diseases. Evidence show that timely integrated disease management can prevent future COPD flare-ups and readmissions, but recent data indicate that appropriate follow-up after a COPD hospitalization is limited. To reduce this care gap, the investigators developed a discharge care bundle to help a patient that are being discharged from hospital or ED after COPD flare-up transition to community care. The aim of this study is to assess how effective and cost-effective is such bundle delivered alone or supported by the dedicated care manager. The investigators will be assessing reduction of ED and hospital readmission.

NCT ID: NCT03357627 Completed - Clinical trials for Lymphoma, Non-Hodgkin

A Study of TAK-659 in Combination With Venetoclax for Adult Participants With Previously Treated Non-Hodgkin Lymphoma

Start date: February 16, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TAK-659 and venetoclax when administered in combination in participants with non-Hodgkin lymphoma (NHL) relapsed and/or refractory after at least 1 prior line of therapy and to evaluate safety and tolerability of TAK-659 and venetoclax when administered in combination.

NCT ID: NCT03357458 Completed - Preterm Birth Clinical Trials

Parent-child Interactions, Child Developmental Health, and Health System Costs at 6 Months Corrected Age

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

The aim of this novel health services research proposal is to assess the longer-term outcomes, to 6 months corrected age, of an adapted Family Integrated Care (FICare) model of care for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU). This follow-up study will enroll infants at 6 months CA (± 1 month) recruited to the original FICare randomized controlled trial (clinicaltrials.gov ID: NCT02879799) from four level II NICU sites; two intervention and two control.

NCT ID: NCT03356977 Completed - Atopic Dermatitis Clinical Trials

A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis

Start date: January 16, 2018
Phase: Phase 4
Study type: Interventional

This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.

NCT ID: NCT03356756 Completed - Sarcoidosis Clinical Trials

PET MRI Study in Patients With Cardiac Sarcoidosis

Start date: June 27, 2016
Phase:
Study type: Observational

Myocarditis or inflammatory cardiomyopathy refers to inflammation of the heart muscle (the myocardium). Sarcoidosis is a multisystem granulomatous disorder that may involve the heart, causing inflammation, and potentially resulting in complications including arrhythmia and sudden death. The objective of this study is to evaluate the diagnostic and prognostic significance of simultaneous combined 18F-FDG PET and cardiac MRI imaging in the evaluation of inflammatory cardiomyopathies including cardiac sarcoidosis. Combined PET/MRI imaging may allow for detection and quantification of active myocardial inflammation as well as chronic fibrosis and scarring. Results of this study may allow for earlier detection of cardiac inflammation when compared with methods in current clinical use, and may lead to better understanding of the disease processes contributing to adverse outcomes. Elucidation of imaging findings associated with future adverse event risk may impact patient management such as providing an indication for pacemaker or defibrillator implantation, or escalation of medical therapy.