Clinical Trials Logo

Filter by:
NCT ID: NCT05287009 Completed - Clinical trials for Epiretinal Membrane of Both Eyes

Optical Coherence Tomography Angiography (OCTA) Changes in Patients With Epiretinal Membranes (ERM) With and Without Peeling of the Internal Limiting Membrane (ILM)

Start date: June 25, 2020
Phase: N/A
Study type: Interventional

Main objective The objective is to compare two surgical options in vitrectomies for epiretinal membranes using parameters of optical coherence tomography angiography. Background State of the art treatment for epiretinal membranes consists of pars plana vitrectomy, staining of the epiretinal membrane with a blue colouring dye and epiretinal membrane peeling. The vitrectomized space is filled with fluid (balanced salt solution) during the procedure and the fluid can optionally be replaced with air as a final step. After ERM peeling (but before the selection of the tamponade), the internal limiting membrane (the innermost layer of the retina) is either peeled as well or left untouched and the question which method should be preferred has been a hot topic in recent years. The investigators want to investigate possible effects of the used method (peeling vs. nonpeeling) on retinal perfusion parameters represented by OCTA. Two epiretinal membrane patient groups will therefore be formed: The first group's (group 1) ILM will be peeled, the second group's (group 2) ILM will not be peeled. After recruitement, patients will therefore be electronically randomized to one of the two groups. The groups will then be compared by the means of OCTA. Study design - Since there are no previous data on our research question, this investigation is defined as a pilot study. - 40 patients with epiretinal membranes will be included. This appears to be a reasonable number given the incidence of epiretinal membranes. Previous studies that compared peeling versus nonpeeling in ERM used similar sample sizes. The detectable effect size was calculated at d = 0.91. We intend to complete this pilot study within 9 months. - Randomization will be performed using electronic randomization. 20 patients each will be randomized to either group 1 or group 2. - Both eyes in each patient will be imaged. - No treatment decisions will be made based on OCTA findings. Treatment decisions will be made according to the clinic's standard of care. - Three follow-up visits specific to the study are needed. These visits will be scheduled one week, one month and three months after surgery. All other preoperative and follow-up visits will be decided by the treating physician and follow the clinic standard of care. Examinations - Distance visual acuity using ETDRS (Early Treatment Diabetic Retinopathy Study) standard at 4 meters as per clinic standard of care. - Tonometry as per clinic standard of care. - Slit-lamp evaluation as per clinic standard of care. - Arterial blood pressure. - Axial eye length. - Heidelberg Spectralis conventional OCT. - The following 2 AngioVue scans will be taken: A. One 3mm x 3mm, 304 x 304 A-scan OCTA of the macula B. One 6mm x 6mm, 304 x 304 A-scan OCTA of the macula Hypothesis The null hypothesis of our investigation indicates that there are no statistically significant differences in OCTA perfusion parameters based on the used option. The alternative hypothesis states that there are statistically significant differences in OCTA perfusion parameters based on the used option. Primary Objective To demonstrate possible differences in OCTA perfusion parameters based on the used option. Secondary Objectives To assess the feasibility of the AngioVue optical coherence tomography angiography system in evaluating subtle changes in the retinal perfusion of patients with epiretinal membranes.

NCT ID: NCT05286424 Completed - Clinical trials for The Impact of Adipose Tissue Quality on Fat Graft Retention

Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery

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

The primary aim of this project is to standardize the method for lipofilling by identifying the best technique. In this context, the study will investigate the impact of adipose tissue composition and ideal quantity of the injected fat particularly in view of resorption rate. Correlations between adipose tissue composition, amount of transferred fat, already existing subcutaneous fat layer at the grafting site and resorption rate will be made. The punch biopsy and the non-invasive Lipometer measurements to determine the subcutaneous fat layer thickness in the harvesting and grafting region will be performed in 10 female subjects that undergo elective lipofilling. The study was registered on Clinicaltrials.gov after start of recruitment.

NCT ID: NCT05275751 Completed - Pain Clinical Trials

Mechanisms of Human Heat Perception - Involvement of TRPA1, TRPV1 and TRPM3

Start date: June 13, 2022
Phase: Early Phase 1
Study type: Interventional

Animal studies suggest that the ion channels TRPV1, TRPA1 and TRPM3 are the relevant heat sensors. This study aims to validate these findings in humans.

NCT ID: NCT05274269 Completed - Cystic Fibrosis Clinical Trials

Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation

Start date: May 9, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, pharmacodynamics (PD) and safety of ELX/TEZ/IVA in participants 6 years of age and older with a non-F508del ELX/TEZ/IVA-responsive cystic fibrosis transmembrane conductance regulator gene (CFTR) mutation.

NCT ID: NCT05269498 Completed - Cranial Aneurysm Clinical Trials

Navigation Support With Mixed Reality With CORTEXPLORER MED

CXmed
Start date: June 8, 2022
Phase: N/A
Study type: Interventional

During the last 15 years, neuronavigation has become an essential neurosurgical tool for pursuing minimal invasiveness and safety. One drawback of such devices is the fact, that the neurosurgeon has to look away from the surgical field onto a dedicated workstation screen. Additionally, the operator is required to transfer this information from the "virtual" environment of the navigation system to the real surgical field - whereas the real patient may be fixated and positioned differently compared to the visualization on the screen. Mixed-reality may have the potential to support this, by merging data from the real environment with virtual information and vice-versa. In the context of surgical navigation, the main goal of mixed reality systems is to provide a real-time updated 3D virtual model of anatomical details, overlaid on the real surgical field. In this sense, the mixed reality is the process of enrichment of reality with additional virtual contents. This clinical investigation aims at the collecting of clinical data about the mixed-reality supported planning, the registration accuracy and overall precision of the navigation system and the clinical outcome.

NCT ID: NCT05267249 Completed - Endodontic Disease Clinical Trials

Revascularisation of Autotransplanted Teeth

Start date: August 6, 2021
Phase: N/A
Study type: Interventional

Retrospective Analysis of a Study cohort that experienced autotransplantation of mature teeth with simultaneous root end resection Note: The study was registered on Clinicaltrials.gov after termination of study.

NCT ID: NCT05263388 Completed - Infertility Clinical Trials

A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation

ADAPT-1
Start date: July 10, 2022
Phase: Phase 3
Study type: Interventional

Hormone preparations like REKOVELLE and GONAL-F are used to make the body produce multiple egg sacs, allowing more eggs to be collected from women undergoing infertility treatment. The main purpose of this trial is to see how many eggs are produced with a starting dose of 15 µg REKOVELLE compared to a starting dose of 225 IU GONAL-F. This research is intended to provide more knowledge about REKOVELLE, including the doses given in the trial.

NCT ID: NCT05262595 Completed - Clinical trials for Diabetes Mellitus, Type 1

A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin Pump

Start date: March 3, 2022
Phase: Phase 1
Study type: Interventional

This study is looking at the effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump. The study will test how 3 different formulations of insulin NNC0471-0119 are tolerated by the body, how they are transported in participants bloodstream, how long they stay there and how the blood sugar is lowered. The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant insulin basal rate and compared to Faster Aspart (Fiasp®). Participants will get 3 formulations of insulin NNC0471-0119 and Faster Aspart (Fiasp®) Insulin NNC0471-0119 is a new rapid-acting insulin designed to be used in an insulin pump. Faster Aspart (Fiasp®) is a globally used medication for the treatment of diabetes. Participants will have each study medicine administered once via pump at separate study visits. This mean that participants will have a total of 4 dosing visits where participants will get a study medicine. Which study medicine participants get at what visit will be decided by chance. The study will last 1-4 months. Participants will have 7 visits at the clinic, 4 of them will require an in-house stay of 3 consecutive days each. During the in-house visits 2 intravenous (into the vein) cannulas will be inserted for blood sampling and infusions. Women: Women cannot take part if they are of childbearing potential.

NCT ID: NCT05259722 Completed - Chronic Hand Eczema Clinical Trials

A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

Start date: June 15, 2022
Phase: Phase 3
Study type: Interventional

This is a 24-week study in adult participants with severe chronic hand eczema (CHE) and with a documented inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable. Eligible participants will be randomised to receive topical administration of delgocitinib cream 20 mg/g, twice-daily, or oral administration of alitretinoin capsules 30 mg (with an option to reduce to 10 mg during trial conduct), once-daily. The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life. The purpose of this trial is to compare the efficacy, health-related quality of life, and safety of delgocitinib cream and alitretinoin capsules.

NCT ID: NCT05257655 Completed - Clinical trials for Glossopharyngeal Neuralgia

Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

GLOA-MRT
Start date: January 9, 2023
Phase: N/A
Study type: Interventional

The blockade of the superior cervical ganglion (GCS) of the sympathetic trunk is a very special form of therapy. The transoral blocking technique, also known as GLOA (ganglionic local opioid analgesia), is very suitable for achieving GCS. A total of 5 μg of sufentanil in 2 ml of sodium chlorid are applied. Since no imaging evidence of the injected substances has been published for a GLOA in a living person, it is planned to carry out an MRI examination immediately after the ganglionic local opioid analgesia in order to show the spread and distribution pattern of the injected substance. It is also planed to show a correlation of the spread of the injected substance with the efficacy of the intervention. To determine the interrater reliability, the GLOA is carried out alternately by 2 different examiners and the existing MRI images of the GLOA are assessed by an radiologist and anatomist in a blinded manner. In a follow-up after 1 and 3 months, the questionnaires and pain scores are evaluated again.