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NCT ID: NCT04249011 Completed - Clinical trials for Sleep Disorder; Breathing-Related

WatchPAT Compared to PSG at 8500'

Start date: May 2, 2018
Phase:
Study type: Observational

Subjects who consent to participate in the research will undergo a simultaneous recording of inlab PSG and WatchPAT200 for comparing the WatchPAT data to PSG at an altitude of 8500'.

NCT ID: NCT04248933 Completed - Clinical trials for Substance Use Disorders

Peer-Delivered Behavioral Activation for Methadone Adherence - Pilot Phase

HEAL Together
Start date: October 9, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) among low-income, minoritized individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this pilot trial, the investigators will evaluate the feasibility, acceptability, and fidelity of this approach (implementation outcomes) and preliminary effectiveness on methadone treatment retention at three months.

NCT ID: NCT04248777 Completed - Clinical trials for Left Main Coronary Artery Stenosis

Optical Coherence Tomography - Guided Protocol for Left Main Percutaneous Coronary Intervention

LEMON
Start date: May 18, 2018
Phase: N/A
Study type: Interventional

LEMON aim is to evaluate the feasibility, efficiency and security of a standardized Optical Coherence Tomography (OCT) - guided protocol for completion and optimization of Left Main (LM) Percutaneous Coronary Intervention (PCI).

NCT ID: NCT04248062 Completed - Phenylketonurias Clinical Trials

Patient and Observer Reported Outcome Measurements in Inborn Errors of Metabolism

MetaPROM
Start date: August 1, 2019
Phase:
Study type: Observational

lnborn errors of metabolism (IEM) are a heterogeneous group of rare, sometimes debilitating or even fatal diseases . In IEM, both definition and assessment of meaningful outcome parameters is often extremely difficult resulting in a limited body of evidence. Limited evidence results in weak recommendations which are perceived as unbinding and thus sustains heterogeneous study designs, choice of outcomes and interventions again producing non-uniform data. The goal of the current study is to identify and select reliable instruments, that measure patients' and their parents' perception about relevant (social, emotional, cognitive and physical) aspects in their lives. This set of instruments will secure the comparability of future research findings. Furthermore this instruments will improve the screening of paediatric IEM patients regarding their need for additional (psychosocial or consultative) support in daily hospital routine.

NCT ID: NCT04247477 Completed - Acute Lung Injury Clinical Trials

Comparison of Different PEEP Titration Strategies Using Electrical Impedance Tomography in Patients With ARDS

DELTA
Start date: September 22, 2020
Phase: N/A
Study type: Interventional

The aim of the this study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit. Two of those strategies are based on electrical impedance tomography (EIT) monitoring.

NCT ID: NCT04246996 Completed - Clinical trials for Pelvic Organ Prolapse

Gentamicin Intravesical Efficacy for Infection of Urinary Tract

GIVEIT
Start date: January 29, 2020
Phase: Phase 2
Study type: Interventional

Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. This prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in 50 mL of saline versus usual care on the proportion of women treated for UTI within 6 weeks following surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

NCT ID: NCT04246983 Completed - HIV/AIDS Clinical Trials

Point-of Care Ultrasound for Patients With HIV

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Rationale: Point-of-care ultrasound (POCUS) is increasingly used by various specialists in the Netherlands, but its role in managing patients with HIV is unclear. In settings endemic for tuberculosis, Fast Assessment with Sonography for HIV/Tuberculosis (FASH) has proven its value to detect extrapulmonary tuberculosis in patients with HIV. However, there is no data to support POCUS for patients with HIV in resource affluent settings. Objective: The investigators aim to determine the feasibility and diagnostic value of POCUS in detecting opportunistic disease in HIV patients with advanced disease stages in the Netherlands. Study design: The investigators will perform a prospective observational pilot study. Study population: The investigators will include new adult patients with HIV presenting with a cluster of differentiation 4 (CD4) T-cell count below 350 cells/mm3, and all adult HIV patients requiring admission to hospital. Intervention (if applicable): The investigators will perform a focused ultrasound examination including FASH, and ultrasound of the lung, liver and kidneys. In case of positive findings additional examinations will be undertaken to determine the underlying pathology and/or treatment started as indicated. In case of negative findings, patients will be followed for 12 months to observe for (possibly missed) opportunistic infections. Main study parameters/endpoints: Our primary outcomes include acceptability of POCUS by patients, interobserver variation in interpretation of POCUS images, and number of diagnosed AIDS and non-AIDS related problems. Secondary outcomes include sensitivity and specificity, negative predictive value and positive predictive value of our POCUS protocol. In addition, incidence rates of opportunistic infections will be compared to a historical matched control group. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The ultrasound examination is painless and without risk to the participants. It will take approximately 30 minutes and will be combined with routine visits to the hospital. Benefits include potential earlier detection of opportunistic disease, while adverse effects may arise from false positive findings requiring further examinations which may cause stress or anxiety. The rate of false positive findings in POCUS has not been formally investigated, but appears low. The effect of POCUS in advanced HIV/AIDS can only be studied in HIV patients.

NCT ID: NCT04246866 Completed - Clinical trials for Macular Degeneration

First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration

Start date: December 19, 2019
Phase: Phase 1
Study type: Interventional

The study is designed to identify the maximum tolerated dose (MTD) for intravitreal (IVT) administration of GEM103 in subjects with geographic atrophy (GA) secondary to dry AMD. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of dose-limiting toxicities (DLTs). Each subject will be followed for safety, pharmacokinetic (PK), clinical, and biomarker evaluations. Three escalating dose cohorts are planned.

NCT ID: NCT04246736 Completed - Insomnia Clinical Trials

A Proactive Intervention Promoting Strategies for Sleep and Recovery in Nurses

Start date: January 30, 2017
Phase: N/A
Study type: Interventional

Considering the known challenges facing newly graduated nurses, there are possibilities to implement preventive actions. The aim of the current study was to evaluate the effects of a preventive intervention among newly graduated nurses, supporting proactive strategies for sleep and recuperation in relation to work related stress and shift work.

NCT ID: NCT04246320 Completed - Clinical trials for Obstructive Sleep Apnea

Taking Brain Monitoring to the Next Level

HDBRAIN
Start date: January 30, 2020
Phase: N/A
Study type: Interventional

This one arm clinical study will assess the impact of a goal directed therapy intervention, aiming at optimizing depth of anesthesia and intraoperative blood pressure on the incidence of postoperative cognitive dysfunction and delirium relative to a standardized anesthetic plan. We will enroll 60 patients and will measure the neurocognitive status (MoCA test) of patients before and after surgery (at discharge, within 2 weeks after surgery and 6 months after surgery) to determine the relative impact of anesthetic care on the development of postoperative delirium and cognitive decline. All patients will have a brain scan (fMRI) before and after surgical intervention. Patients will also be asked to participate in an optional blood draw which will take place during their brain imaging visit and post operatively (within 2 days after surgery).