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NCT ID: NCT05935280 Completed - Pain Clinical Trials

Mechanism of Human Cold Pain Perception - Involvement of TRPA1, TRPM8, Nav1.7 and Nav1.8

Start date: July 7, 2023
Phase: Early Phase 1
Study type: Interventional

Animal studies suggest that the transient receptor potential ion channels TRPM8 and TRPA1 are cold sensors and that sodium channels Nav1.8 and Nav1.7 are essential for detecting pain induced by cold temperatures. This study aims to validate these findings in humans.

NCT ID: NCT05915429 Completed - Cataract Clinical Trials

Predicting Lens Tilt Using Optical Coherence Tomography and Partial Least Squares Regression Modelling

Tilt
Start date: April 12, 2022
Phase:
Study type: Observational

Misalignment of IOLs can cause severe loss of visual quality. Different types of misalignment are known. Tilt is one type of misalignment that is thought to play a negative role for the optical performance in eyes with IOL designs, especially, if they have aspheric, toric or multifocal optics. Due to the fact that tilt has an influence on visual quality, the prediction of the post-operative tilt could improve IOL power calculaton significantly especially for toric IOLs. the Aim of this study is to measure tilt with two modern OCT based devices and one Scheimpflug camera and to predict the post-operative tilt using partial least squares regression.

NCT ID: NCT05910996 Completed - Clinical trials for ARDS Due to Disease Caused by SARS Co-V-2

Prediction of Conversion From Vv-ECMO to Va-ECMO in COVID-19 Patients

ECMOPred-vvva
Start date: September 30, 2023
Phase:
Study type: Observational

In December 2019, cases of a novel lung disease, later referred to as COVID-19, were first reported in China. The virus SARS-CoV-2 was identified as the causative agent. Due to the sharp increase in the number of cases worldwide, a pandemic outbreak was declared by WHO in March 2020. The infection presents with a broad clinical spectrum. Frequently, there is respiratory infection with fever (80%), dry cough (56%), fatigue (22%), and muscle pain (7%), but completely asymptomatic infection is also possible. Severe courses may be associated with pneumonia resulting in acute respiratory distress syndrome (ARDS) requiring intensive care. In the context of intensive care therapy, it is sometimes necessary to use extracorporeal organ replacement procedures due to increasing lung failure. In this context, extracorporeal membrane oxygenation (ECMO) was used during the pandemic. With this procedure it is possible to replace on the one hand the oxygenation and ventilation function of the lung and on the other hand additionally the pumping function of the heart, if configured appropriately. The switch from venovenous (vv) configuration, with which only lung function is replaced, to venoarterial (va) configuration (lung function and heart function are replaced) is made in cases of intensive care necessity, e.g., increasing decompensation of heart failure. Heart failure manifests itself, among other things, through insufficient pumping function of the heart muscle. This results in an undersupply of peripheral tissues with arterial blood, leading to increased anaerobic glycolysis. Lactate and B-type natriuretic peptide (BNP) are used as surrogate parameters of this undersupply. Increased oxygen depletion from oxygen available in arterial blood is detected by the surrogate parameter central venous oxygen saturation (ScvO2). In addition to ECMO, drug interventions are also used to improve cardiorespiratory performance at various doses. As described by Suwalski et al, there may be a relationship between this drug therapy and conversion from vv to va ECMO. Currently, few studies exist on conversion from vv-ECMO to va-ECMO. In this regard, Suwalski et al. describe a population that experienced any ECMO therapy for a maximum period of 16.5 ± 10.0 days, with the group with conversion receiving 17.8 ± 10.5 days of therapy and the group without conversion receiving 16.4 ± 9.4 days. The need for conversion to va-ECMO requires additional expertise that is not readily available despite acute intensive care transport readiness. It is likely that by predicting the need for conversion, early logistical planning for transfer to an appropriate center with experience and equipment can occur, or if transfer is not necessary, staffing and equipment preparation can occur earlier and more safely. As described by Falk et al, planned and prepared conversion can also be expected to have an impact on patient* survival. The aim of this retrospective, exploratory data analysis is to predict conversion before placement of vv-ECMO within 30 days from ICU care from vv-ECMO to va-ECMO in COVID-19 patients.

NCT ID: NCT05900258 Completed - Actinic Keratosis Clinical Trials

Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

SunDamage
Start date: May 11, 2023
Phase: Phase 4
Study type: Interventional

Interventional, monocentric, national, single-arm, uncontrolled, open, prospective phase IV study. Since this study is not powered for confirmative testing, analysis is done by descriptive statistics Eligible AK patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC. Diagnosis and monitoring of treatment effects are supported by UV imaging using Canfield VISIA®. Safety and efficacy are assessed at end of treatment visit (EoT, approximately 3 days after the last dose, i.e, day 8 ± 2) and at a follow-up visit (FuV) 57 ± 7 d after the start of the treatment. UV images (Canfield VISIA®) will be taken at baseline, EoT and FuV, accompanied by conventional dermatological assessment according to clinical routine.

NCT ID: NCT05897671 Completed - Clinical trials for Full Thickness Macular Hole

Foveal Sparing ILM Peeling With ILM Flap Transposition

Start date: June 1, 2023
Phase:
Study type: Observational

Foveal sparing internal limiting membrane (ILM) peeling with ILM flap transposition over the macular hole combines the benefits of foveal sparing ILM peeling with ILM flap techniques. Aim of this study is to retrospectively examine the rate of postsurgical macular hole closure, development of central atrophy in the foveal area, and improvement of best corrected distant visual acuity in a group of patients having undergone foveal sparing ILM peeling with ILM flap transposition for macular hole repair.

NCT ID: NCT05892367 Completed - Clinical trials for Complication of Treatment

Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease

TBA
Start date: July 10, 2018
Phase: N/A
Study type: Interventional

The aim of the present study is an evaluation, whether an immobilization of the upper extremity by means of a positioning splint can help to reduce the incidence of local complications after transbrachial puncture for peripheral arterial interventions, or not.

NCT ID: NCT05871320 Completed - Clinical trials for Neuroendocrine Tumors

Novel 99mTc-labeled Somatostatin Antaginosts in the Diagnostic Algotithm of Neuroendocrine Neoplasms

TECANT
Start date: December 23, 2022
Phase: Early Phase 1
Study type: Interventional

The main goal of the study is to expand cancer preclinical research results on the usefulness of SSTR2-Antagonist [99mTc]Tc-TECANT1 in clinical practice. Detection of NEN and monitoring of response to therapy is still challenging due to their cellular heterogeneity. Initial preclinical studies suggest that NEN imaging with the use of SSTR2-Antagonist may be advantageous in comparison to the widely used SSTR2-Agonists. Recently, novel radiopharmaceuticals, based on SSTR2-Antagonists, were shown to provide superior SSTR2 visualisation than currently used agonists. The need for molecular imaging of NEN is expected to grow significantly in the near future due to their increasing incidence and prevalence. Although a persistent trend to shift the molecular imaging of NEN from conventional SPECT/CT gamma cameras to PET/CT has been observed in the last decade, labelling the compound with Tc-99m offers significant advantages by its extremely wide availability, low cost and low radiation exposure to patients. Effective and accessible molecular imaging methods as an integral part of personalised patient management are needed to optimise selection and follow-up of available therapeutic modalities. The Tc-99m-labeled SSTR2-Antagonist [99mTc]Tc-TECANT1 is expected to be an effective, widely available compound for quantitative assessment of SSTR2 NEN status, allowing a personalised therapeutic approach.

NCT ID: NCT05853315 Completed - Clinical trials for Basal Cell Carcinoma

BCC Excision Revisited

Start date: November 12, 2019
Phase:
Study type: Observational

To readdress basal cell carcinoma (BCC) in the periocular region to prove histologically controlled surgical treatment efficacy and to identify high-risk characteristics.

NCT ID: NCT05811182 Completed - Clinical trials for Cystoid Macular Edema Following Cataract Surgery

Vitreous Hyper Reflective Dots in Association With Pseudophakic Cystoid Macular Edema

Start date: July 1, 2018
Phase:
Study type: Observational

The aim of this study is to assess the association between vitreous hyper-reflective dots (VHD) and the macular thickness changes following uneventful phacoemulsification. In this prospective study the investigators performed optical coherence tomography (OCT) imaging in patients undergoing cataract surgery preoperatively and postoperatively after 1 week, 1 month and 3 months and analyzed the OCTs for VHDs. The investigators then measured the macular thickness in patients with VHDs and without VHDs and correlated the macular thickness with the number of VHDs.

NCT ID: NCT05779306 Completed - Clinical trials for Cataract Complicated

Performance of Two Sclera Fixated Intraocular Lens Concepts

Carlevale
Start date: January 19, 2023
Phase:
Study type: Observational

To evaluate and compare the post-operative outcome of two different sceral fixated IOL concepts, the Yamane method (ZA9003, J&J, USA) and the Carlevale IOL (FIL-SSF, Soleko, Italy).