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NCT ID: NCT03438669 Completed - Clinical trials for Macular Degeneration

Correlation Between Visual Acuity Measurements, Quality of Life and Morphological Parameters in Wet AMD Patients

COSP
Start date: February 24, 2017
Phase: N/A
Study type: Observational

Patient-reported vision-related quality of life (QOL) outcomes are increasingly incorporated into clinical trials of new treatments for age-related macular degeneration (AMD). In patients with central visual field defects they often do not correlate with distance visual acuity changes as evaluated according to the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Therefore there is the need for better correlated visual acuity (VA) outcome measures for these patients. In a current big trial for treatment of dry AMD (geographic atrophy) reading speed and low luminance visual acuity are used as outcome measures for the first time. However, limited information is available regarding the associations between distance ETDRS visual acuity, reading speed, low luminance visual acuity, contrast sensitivity, morphological parameters and the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) subscales judged relevant to these measures. Evaluating these correlations could provide the basis for objective study outcome parameters which are better correlated to patient-reported outcomes. Further it increases the understanding of the impact of visual impairment on activities and functioning in patients with eye diseases. There is an immediate benefit to the study patients, as they might gain information regarding their individual results regarding objective VA measures, contrast sensitivity (and their impact on reading ability). Furthermore, the results of the study could be beneficial for future patients due to, e.g., a better understanding of the disease, especially regarding factors which have an impact on their near vision ability and therefore their quality of life. The study could provide a basis to find and include outcome measures which are correlated better with quality of life than ETDRS distance VA for further AMD trials.

NCT ID: NCT03438526 Recruiting - Hypoactive Delirium Clinical Trials

The Basel BOMP-AID Randomized Trial

BOMP-AID
Start date: January 3, 2022
Phase: Phase 4
Study type: Interventional

Delirium is a neurobehavioural syndrome that frequently develops in the postoperative and/or ICU setting. The incidence of elderly patients who develop delirium during hospital stay ranges from 11-82%. Delirium was first described more than half a century ago in the cardiac surgery population, where it was already discovered as a state that might be accompanied by serious complications such as prolonged ICU and hospital stay, reduced quality of life and increased mortality. Furthermore, the duration of delirium is associated with worse long-term cognitive function in the general ICU population. This long-term experience with delirium suggests a high socioeconomic liability and has been a focus of many studies. The aforementioned consequences of delirium are observed in all of three subtypes: hypoactive, hyperactive, and mixed. Pharmacological treatment options for hypoactive delirium are lacking. Since patients in hypoactive delirium suffer from disturbed circadian rhythm, the investigators suggest that the administration of melatonin as a promising possibility in these patients to shorten delirium duration and to lower its severity. Previous investigations confirmed loss of melatonin rhythm in patients that had developed delirium thus reasoning the study hypothesis. In this randomized study, the investigators aim to test the hypothesis that the reinstitution of a normal circadian rhythm by the administration of melatonin compared to placebo after diagnosis of hypoactive delirium, decreases the duration of delirium and reduces the transmission to a form of agitated delirium. The administration might have to be repeated several times to achieve resolution of delirium.

NCT ID: NCT03437551 Completed - Clinical trials for Insulin-Dependent Diabetes Mellitus 1

Prevalence of DRP and DME Among Type 1 Diabetics Treated With Long-term Intensified Insulin Therapy

Start date: September 2012
Phase: N/A
Study type: Observational

This study is designed to evaluate the prevalence of different stages of diabetic retinopathy and diabetic macular edema among patients suffering from type 1 diabetes (DM1) for 5 to 25 years and have been treated with intensified insulin therapy aiming near-normal blood glucose levels for the whole duration of disease. Prevalence of different stages of diabetic retinopathy and diabetic macular edema is assessed using the modified Airlie House classification and the Early Treatment Diabetic Retinopathy Study (ETDRS) retinopathy severity scheme. Results of this study will provide the basis for designing further studies as well as staging and screening guidelines for diabetic retinopathy/diabetic macular edema.

NCT ID: NCT03437356 Completed - Atrial Fibrillation Clinical Trials

Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation

POWDER-AF2
Start date: February 26, 2018
Phase: N/A
Study type: Interventional

In the POWDER 1 study, paroxysmal atrial fibrillation (AF) patients undergoing conventional contact force (CF)-guided PVI were investigated. Patients were randomized between continuing previously ineffective antiarrhythmic drug therapy (ADT) or stopping ADT at the end of the blanking period. This trial, showed an added value of ADT after ablation (in support of 'hybrid rhythm control' as an alternative treatment strategy for AF in some patients). In the POWDER 2 trial, an analogue study in persistent AF patients will be performed. All patients will undergo ablation index (AI)- and IL distance (ILD)-guided PVI (just like in VISTAX trial) and continue previously ineffective ADT during the blanking period. 'PVI only' was chosen as the ablation strategy according to the STAR AF trial findings.

NCT ID: NCT03436602 Active, not recruiting - Follicular Lymphoma Clinical Trials

Personalized Risk Stratification Model of Follicular Lymphoma Patients

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

The study aims at developping and validating an integrated clinico-molecular model for an accurate identification of FL patients who are progression free and progressed, respectively, at 24 months after treatment.

NCT ID: NCT03435796 Recruiting - Neoplasms Clinical Trials

Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

Start date: June 19, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

NCT ID: NCT03435094 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes

Start date: February 25, 2018
Phase:
Study type: Observational

Compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance and on treatment adherence (including compliance and persistence).

NCT ID: NCT03434314 Active, not recruiting - Clinical trials for Aortic Aneurysm, Thoracoabdominal

Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging

PAPAartis
Start date: November 8, 2018
Phase: N/A
Study type: Interventional

Aortic aneurysms represent the most common and dangerous aortic diseases. Although conventional aortic repair techniques cure the disease, there is a high risk of paraplegia particularly in extensive thoracoabdominal aneurysms due to impaired blood supply to the spinal cord. The PAPA-ARTiS trial will assess the clinical safety and efficacy of the MISACE (Minimally-Invasive Segmental Artery Coil-Embolization) procedure, a novel therapeutic concept to reduce the risk of paraplegia due to aneurysm repair. The study investigates the MISACE procedure as a potential pre-treatment prior to open or endovascular aneurysm repair in patients with thoracoabdominal aortic aneurysms. Patients will be randomized to one of the two treatment strategies: a) aneurysm repair without MISACE pre-treatment, or b) aneurysm repair with MISACE pre-treatment.

NCT ID: NCT03432351 Completed - General Anesthesia Clinical Trials

Multi-center Isoelectric EEG Study in Children Under General Anesthesia

Start date: June 21, 2018
Phase:
Study type: Observational

Multi-center, prospective, observational study investigating the incidence of isoelectric electroencephalography (EEG) events and the associated peri-operative factors in infants 0-3yo undergoing general anesthesia.

NCT ID: NCT03431740 Terminated - Radiotherapy Clinical Trials

FENO, Extended NO Analysis and NO/CO Diffusing Capacity in Thoracic Radiation Therapy

Start date: February 15, 2018
Phase:
Study type: Observational

The investigators aim to investigate the impact of thoracic radiation therapy on diffusion capacity of the lung (primary endpoint: diffusion capacity for nitric oxide, DLNO) and on exhaled nitric oxide.