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NCT ID: NCT04019730 Completed - Clinical trials for Upper Respiratory Tract Infections

The Effect of a Ketogenic Diet on the Exercise Induced Immune Response

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

comparing the exercise induced immune response after two weeks on a low carbohydrate (ketogenic) diet with the response after two weeks on a high carbohydrate diet.

NCT ID: NCT04019483 Terminated - Ischemic Stroke Clinical Trials

Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke

ENCLOSE
Start date: January 23, 2018
Phase:
Study type: Observational

Rationale: Over 20.000 people suffer an ischemic stroke in the Netherlands each year. Large artery occlusions are easy to identify and can be treated with endovascular clot removal. 70% of patient will however suffer from a more distal occlusion resulting in small volume stroke or a transient ischemic attack (TIA). Small ischemic lesions are hard to detect with current acute stroke protocols. TIA and small volume stroke patients, are at an increased risk for recurrent stroke, making immediate diagnosis critical. Because thrombo-embolic sources often cause these strokes, identifying and treating the underlying aetiology has the potential to radically lower the risk of recurrence and improve the outcome of these patients. Objectives: 1) To identify clinical and imaging predictors of recurrent stroke; 2) To improve early detection of small volume stroke with admission computed tomography perfusion (CTP) in patients with suspected acute ischemic stroke with small volume stroke or no ischemia on admission imaging. Study design: Prospective, multicenter cohort study. Study population: All patients who visited the University Medical Center (UMC) Utrecht, the Amsterdam University Medical Centers (Amsterdam UMC), location Academic Medical Center (AMC) or the St. Antonius Hospital and who underwent a CT-scan of the brain within 9 hours after onset of stroke symptoms with an age ≥18 years. Within 36 months, 720 patients will be enrolled in the study. Of these patients, 300 patients will be included for the follow-up magnetic resonance imaging (MRI). Main study parameters/endpoints: The main study endpoints are: 1) Stroke recurrence rate at 2 years; 2) Presence and volume of acute ischemic lesions on follow-up diffusion weighted imaging MRI.

NCT ID: NCT04017455 Recruiting - Rectal Cancer Clinical Trials

Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)

TARZAN
Start date: October 22, 2019
Phase: Phase 2
Study type: Interventional

In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab

NCT ID: NCT04017325 Completed - Clinical trials for Cancer of the Prostate

European Randomised Study of TOOKAD® Soluble for Prostate Cancer vs Active Surveillance. Post Study Follow-up

Start date: March 17, 2016
Phase:
Study type: Observational

This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). Additional 60-month follow-up study

NCT ID: NCT04017195 Completed - Healthy Clinical Trials

A Study of New Transdermal Contraceptive Patch at End of Shelf Life and Currently Marketed EVRA at the Beginning of Shelf Life in Healthy Women

Start date: July 12, 2019
Phase: Phase 1
Study type: Interventional

The main objectives of this study are to determine the bioequivalence of the hormones (example, norelgestromin [NGMN] and ethinyl estradiol [EE]) from the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component, evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component and show non-inferior adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component.

NCT ID: NCT04016324 Completed - Overactive Bladder Clinical Trials

InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study

BASIC
Start date: November 28, 2019
Phase: N/A
Study type: Interventional

Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation.

NCT ID: NCT04015518 Completed - Clinical trials for Palmoplantar Pustulosis (PPP)

A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis

Start date: July 31, 2019
Phase: Phase 2
Study type: Interventional

The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety. Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.

NCT ID: NCT04015466 Completed - Gastric Cancer Clinical Trials

Advanced GC Multi-omic Characterization in EU and CELAC Populations

LEGACY-2
Start date: June 12, 2019
Phase:
Study type: Observational

Observational study (cohort type) of advanced GC patients that will be recruited prospectively to study biological factors associated with the disease and relevant clinical outcomes.

NCT ID: NCT04015193 Recruiting - Raynaud Phenomenon Clinical Trials

Follow-up of SPTS in Patients With Raynaud's Phenomenon

Start date: March 28, 2019
Phase:
Study type: Observational

Background: Raynaud's phenomenon is a vasospasm of the extremities, leading to extensive discomfort in daily life and potentially severe ischemia. Some patients are resistant to conventional vasodilatory drug treatment. In the University Medical Center Groningen, single-port thoracoscopic sympathicotomy (SPTS) was developed. This is a new minimally invasive endoscopic technique, extensively limiting surgical burden. In many hospitals in the Netherlands, this operation is sometimes performed on patients with Raynaud's phenomenon. However, the techniques used are more invasive than the SPTS technique. Furthermore, studies on sympathectomy and sympathicotomy in Raynaud's are limited and encompass obsolete more invasive techniques. Also, it is unclear which patients would benefit the most and for how long and in which percentage of patients treatment effects persist over time. In a recent study on the new SPTS technique, it was found that one month after the procedure, the Raynaud's attacks were substantially reduced and the hand perfusion increased on the operated side. Based on these short term effects and previously reported broad experience with this technique for other indications, it is possible to offer this option to a broader range of patients with Raynaud's as a reasonable and safe treatment option. However, whether the effects persist on the long-term needs to be established. Main research question: The aim of the study is to assess the 5 year efficacy and outcome in patients with primary and secondary Raynaud's phenomenon in whom SPTS has been performed. Design (including population, confounders/outcomes): Patients with Raynaud's, who will undergo SPTS in patient care setting, will be included. Data from the patient file will be collected, including vascular measurements to assess hand perfusion, a Raynaud diary (Raynaud condition score, duration and frequency of the attacks), quality of life questionnaires, and adverse events.

NCT ID: NCT04015180 Active, not recruiting - Clinical trials for Retinopathy of Prematurity (ROP)

Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090

FIREFLEYE next
Start date: March 18, 2020
Phase: Phase 3
Study type: Interventional

This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.