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NCT ID: NCT04625101 Completed - Clinical trials for Epileptic Encephalopathy

Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

Start date: April 26, 2021
Phase: Phase 2
Study type: Interventional

This is a phase 2, double-blind study to assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-827104 when administered once daily for 13 weeks in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS).

NCT ID: NCT04624009 Completed - Clinical trials for Impaired Oxygen Delivery

Non-Invasive Measurement of SjvO2 Using Near Infrared Spectroscopy in Critically Ill Patients

NIRS-SCJVO2
Start date: January 1, 2022
Phase:
Study type: Observational

ScvO2 is an important parameter in the management of critically ill patient. The only way to measure it is to have an internal jugular or subclavian central venous catheter. With this trial, the investigators want to show a positive relationship between invasive ScvO2 measurement and noninvasive SjvO2 measurement with VO 100 medical device from Mespere LifeSciences, allowing the use of SjvO2 as a noninvasive surrogate of ScvO2 in critically ill patients.

NCT ID: NCT04621253 Completed - Clinical trials for Drug-drug Interaction

Inhibition Metamizole 2020

Start date: April 29, 2020
Phase: Phase 1
Study type: Interventional

This clinical phase I trial had 3 arms: inhibition by fluconazole, inhibition by ciprofloxacin and placebo. Subjects were treated for 3 days prior to the study day. The intervention was a single dose of 1 gram metamizole. We took blood samples at set time points and analysed the concentration of the main metabolites of metamizole at each time point in plasma.

NCT ID: NCT04620733 Completed - Clinical trials for Primary Biliary Cholangitis

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: April 21, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo

NCT ID: NCT04618302 Completed - Healthy Clinical Trials

Lung Diffusing Capacity for Nitric Oxide During Cycling Exercise

Start date: October 19, 2020
Phase:
Study type: Observational

This study investigates the test-retest reliability of the lung diffusing capacity for nitric oxide in healthy individuals during exercise.

NCT ID: NCT04618276 Completed - Clinical trials for Surgical Site Infection

Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-II)

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

The overarching aim of this research project is to prevent orthopedic implant-associated infections. This study aims to investigate if PDT has an effect on bacterial skin colonization in order to improve skin antisepsis strategies for the prevention of surgical site infections.

NCT ID: NCT04617444 Completed - Smoking Cessation Clinical Trials

The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function

ESTxENDS
Start date: September 7, 2020
Phase: N/A
Study type: Interventional

--> This is a substudy of the main ESTxENDS trial (NCT03589989). Olfactory function outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989. Up to one in five people have suffered loss or impairment of their sense of smell, limiting their available information about the environment, including possible hazards (e.g. gas or smoke). An impaired sense of smell is strongly associated with smoking, but its prevalence in smokers has yet to be established. Since only a few prospective cohort studies among smokers have compared change in olfactory function in smokers, it is not known how much or how fast smoking may impair olfactory function. Some studies describe improvement in olfactory function among quitters, supporting anecdotal evidence from ex-smokers who say they regained their sense of smell over time. As far as the investigators know, no randomized controlled trial has tested the effects of a smoking cessation intervention on olfactory function. A reliable and validated olfactory function test is the Burghart Sniffin' Sticks 16-item Identification-test, which is quick and easy to administer. 16 familiar odours will be presented to the participants, each for 3-4 seconds. After each odour the participant is asked to select the correct answer from 4 possible answers. With increasing popularity of e-cigarettes, their effect on the olfactory function also needs to be assessed. It is known, that e-cigarettes produce toxic compounds such as carbonyl and aldehydes, what could impair the sense of smell - especially if the liquid-level is too low or the temperature on the coil is too hot. This is the source of a phenomenon called "dry-hit", which is said to leave a burnt taste or smell to be recognized by users. However, it is unclear if e-cigarettes users with an olfactory dysfunction can adequately recognize a "dry-hit". Therefore, the goal is to investigate the effects of smoking cessation and use of ENDS on olfactory function and the recognition of a "dry-hit" from a test e-cigarette. For the main ESTxENDS trial (NCT03589989), cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 24-month period. The primary objective is to assess changes in olfactory function from baseline to 6 months post target quit date (TQD) in cigarette smokers randomized to the intervention group compared to the control group.

NCT ID: NCT04614831 Completed - Clinical trials for Plaque Psoriasis, Psoriatic Arthritis

A Worldwide Survey on the Understanding of Psoriatic Disease Among Patients With Psoriasis and Psoriatic Arthritis

Start date: November 12, 2020
Phase:
Study type: Observational

The study is a Worldwide Survey on the Understanding of Psoriatic Disease among Patients with Psoriasis and Psoriatic Arthritis.

NCT ID: NCT04614116 Completed - Metabolism Disorder Clinical Trials

Cold Induced Futile Cycles In White Adipose Tissue

Metabol
Start date: June 15, 2021
Phase: N/A
Study type: Interventional

Investigation of futile cycles in white adipose tissue under cold conditions for thermogenesis using two substitutes for glucose metabolism (18F-FDG and 13C-Glucose).

NCT ID: NCT04610450 Completed - Clinical trials for Sensorineural Hearing Loss

The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation

Start date: April 26, 2021
Phase: N/A
Study type: Interventional

The cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of portions of the mastoid bone through a mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation. To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place. This study primarily aims to explore the performance of robotic cochlear implantation surgery.