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NCT ID: NCT03635918 Recruiting - Sleep Apnea Clinical Trials

Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test

Start date: August 15, 2018
Phase: N/A
Study type: Interventional

Extensive Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to traditional PSG and HSAT monitors.

NCT ID: NCT03635359 Enrolling by invitation - Clinical trials for Trisomy 21 and Other Fetal Aneuploidy

Automated Screen for Fetal Aneuploidy

Start date: July 15, 2017
Study type: Observational

The purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening of fetal aneuploidy.

NCT ID: NCT03634475 Recruiting - Clinical trials for Non-infectious Uveitis

A Safety Study of Intravitreal PP-001 in Patients With Chronic, Non-Infectious Uveitis

Start date: January 2017
Phase: Phase 1/Phase 2
Study type: Interventional

In this study, PP-001 is assessed for safety and efficacy in patients diagnosed with non-infectious chronic uveitis. PP-001 is a novel small molecule that inhibits a specific enzyme (Dihydroorotate Dehydrogenase) and has shown pre-clinical efficacy in treatment of non-infectious uveitis. PP-001 will be administered to participants as a single intravitreal injection in ascending doses.

NCT ID: NCT03634345 Not yet recruiting - Dermatitis, Atopic Clinical Trials

Drug Drug Interaction Study Evaluating the Effect of Fluvoxamine or Fluconazole on PK and Safety of PF-04965842.

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

A Phase 1, Open Label, Parallel-Cohort, Randomized, Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between PF-04965842 and Fkuvoxamine (cohort 1) or Fluconazole (Cohort 2) in healthy subjects.

NCT ID: NCT03632148 Enrolling by invitation - Clinical trials for Decompensated Cirrhosis

Effect of Liver MSCs in Blood of Patients With Liver Disease.

Start date: December 20, 2017
Study type: Observational

Liver MSCs or Adult Derived Human Liver Stem/progenitor Cells (ADHLSCs) infusions are currently being developed as a therapeutic medicinal product for the treatment of different liver defects. Nevertheless, a main concern for clinicians and health authorities is the risk of therapy-induced thrombosis, which has been reported in several patients after intravenous infusion. Previous studies showed in fact that most MSCs express a procoagulant activity. ADHLSCs could be used to treat acute de-compensated cirrhotic patients due to their immunomodulatory and anti-fibrotic effects. However in these patients, disturbances of coagulation and haemostasis are common and result in profound haemostatic alterations that can lead to thrombosis as well as to bleeding complications. The aim of this study is to evaluate the effect of ADHLSCs in cirrhotic blood compared to control blood.

NCT ID: NCT03628482 Active, not recruiting - Pain Syndrome Clinical Trials

Pulsed Radiofrequency to Relieve Knee Pain

Start date: March 15, 2017
Phase: N/A
Study type: Interventional

Knee osteoarthritis is a leading cause of chronic pain, disability, and decreased quality of life. Lesioning of genicular nerves by continuous radiofrequency treatment proved to be effective in relieving pain and disability caused by osteoarthritis of the knee. In contrast to continuous radiofrequency lesioning, pulsed radiofrequency treatment offers pain control with no or only minimal histological lesions. As a non-destructive alternative to continuous radiofrequency ablation, pulsed radiofrequency treatment may have inherent appeal because it may mitigate concerns regarding complications associated with the ablation of nerves. However, studies comparing the ability of the continuous and the pulsed modalities of radiofrequency treatment to relieve pain and incapacity due to osteoarthritis of the knee are lacking. Therefore, it was the aim of the investigators of current study to compare efficacy of continuous and pulsed radiofrequency treatments of genicular nerves to alleviate pain and disability in patients with advanced osteoarthritis of the knee.

NCT ID: NCT03627273 Completed - Healthy Clinical Trials

6MWT With and Without Walker

Start date: July 2014
Phase: N/A
Study type: Interventional

Elderly subjects repeated 6MWT with or without walker

NCT ID: NCT03626428 Completed - Clinical trials for Failed Back Surgery Syndrome

Effective Connectivity in Patients Receiving Spinal Cord Stimulation: an fMRI and EEG Dynamic Causal Modeling Study

Start date: March 2016
Study type: Observational

In this study, a retrospective analysis will be performed on collected data of 14 patients with Failed Back Surgery Syndrome, treated with Spinal cord stimulation. In separate studies, fMRI and EEG recordings were made in resting state conditions on two time points. The fMRI assessments and EEG recordings were performed before the SCS implantation (baseline) and repeated around 3 months after the definitive SCS implantation. During both assessments, patients were asked to fill in a VAS diary for their leg and back pain (scores from 0 to 10). The aim of the current retrospective study is to correlate the clinical data obtained from the VAS scores, with estimates of effective connectivity (obtained from fMRI and EEG). Effective connectivity will be calculated by using dynamic causal modeling (DCM) on the baseline data and the data obtained 3 months after SCS. The aim is to evaluate whether DCM data of EEG is equally/worse/better correlating with the clinical data as DCM data of fMRI.

NCT ID: NCT03623828 Recruiting - Clinical trials for Disorder of Consciousness

Treating Severe Brain-injured Patients With Apomorphine

Start date: September 15, 2018
Phase: Phase 2
Study type: Interventional

Background: Patients who survive severe brain injury may develop chronic disorders of consciousness. Treating these patients to improve recovery is extremely challenging because of scarce and inefficient therapeutical options. Among pharmacological treatments, apomorphine, a potent direct dopamine agonist, has exhibited promising behavioral effects, but its true efficacy and its mechanism remains unknown. This pilot study aims to verify the effects of apomorphine subcutaneous infusion in patients with disorders of consciousness, investigate the neural networks targeted by this treatment and evaluate the feasibility of a larger double-blind randomized placebo-controlled trial. Methods/design: This study is a prospective open-label pilot clinical trial. Six patients diagnosed with disorders of consciousness will be included to receive a 4-weeks regimen of daily subcutaneous infusions of apomorphine hydrochloride. Patients will be monitored for four weeks before the initiation of the therapy, closely during treatment and they will undergo a 4-weeks inpatient follow-up after washout, as well as a two-year long-term remote follow-up. Shortly before and after the treatment regimen, the subjects will receive a multimodal assessment battery including neuroimaging exams. Primary outcome will be determined as behavioral response to treatment as measured by changes of diagnosis using the Coma Recovery Scale - Revised (CRS-R), while secondary outcome measures will include the Nociception Coma Scale - Revised (NCS-R, circadian rhythm modifications using actimetry, core body temperature recording and night electroencephalography (EEG), positron emission tomography (PET), resting-state high-density EEG and functional magnetic resonance imaging (fMRI). The Glasgow Outcome Scale - Extended (GOS-E) and a phone-adapted version of the CRS-R will be used for long-term follow-up. Statistical analyses will focus on the detection of changes induced by apomorphine treatment at the individual level (comparing data before and after treatment) and at the group level (comparing responders with non-responders). Response to treatment will be measured at four different levels: 1. behavioral response (CRS-R, NCS-E, GOS-E), 2. brain metabolism (PET), 3. network connectivity (resting-state fMRI and high-density EEG) and 4. Circadian rhythm changes (actimetry, body temperature, night EEG). Discussion: Apomorphine is a promising and safe candidate for the treatment of disorders of consciousness but its efficacy, the profile of the responding population and its underlying mechanism remain to be determined. This pilot study will provide unprecedented data that will allow to investigate the response to apomorphine using multimodal methods and shed new light on the brain networks targeted by this drug in terms of metabolism, functional connectivity and behavioral response. The investigators aim to better define the phenotype of potential responders to identify them more easily and develop personalized patient management. This preliminary study will lay ground for a subsequent larger-scale placebo-controlled double-blind trial which will provide quantitative data on effect size controlled for spontaneous recovery.

NCT ID: NCT03623529 Recruiting - Septic Shock Clinical Trials

A Study of LJPC-501 in Paediatric Patients With Hypotension Associated With Distributive or Vasodilatory Shock

Start date: August 2018
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) as assessed by standard of care vasopressor dose reduction in pediatric patients with catecholamine-resistant hypotension (CRH). In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, evaluate changes in catecholamine and other vasopressor doses over time, evaluate the change in MAP over time, and the change in Pediatric Logistic Organ Dysfunction-2 (PELOD-2) scores.