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NCT ID: NCT04232553 Recruiting - Crohn's Disease Clinical Trials

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

VIVID-2
Start date: June 22, 2020
Phase: Phase 3
Study type: Interventional

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

NCT ID: NCT04231006 Recruiting - Prostate Cancer Clinical Trials

Salvage HDR for Locally Recurrent Prostate Cancer

PROSALBRA
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy

NCT ID: NCT04230421 Recruiting - Bipolar Disorder Clinical Trials

Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The Smart Bipolar RCT is a pragmatic RCT aiming to investigate effects of smartphone-based add on treatment in large scale clinical practice (N= 200 patients).

NCT ID: NCT04229875 Recruiting - Bipolar Disorder Clinical Trials

The CAG Bipolar the CAG Bipolar RCT

Start date: January 13, 2020
Phase: N/A
Study type: Interventional

The CAG Bipolar study is a large-scale pragmatic randomized controlled trial aiming to investigate whether specialized and more centralized treatment (into a clinical academic group (CAG)) improves lives and outcomes for patients with bipolar disorder (N= 1000 patients).

NCT ID: NCT04229056 Recruiting - Stroke Clinical Trials

COMPuter-assisted Self-training to Improve EXecutive Function

COMPEX
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared generally cognitively stimulating activities on a computer

NCT ID: NCT04226547 Recruiting - Stroke Clinical Trials

Amplatzer Amulet LAAO vs. NOAC

CATALYST
Start date: July 7, 2020
Phase: N/A
Study type: Interventional

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

NCT ID: NCT04223999 Recruiting - Clinical trials for Recurrent Glioblastoma

Improving Tumor Treating Fields Treatment for Brain Cancer Patients With Skullremodeling Surgery (Neurosurgery)

OptimalTTF-2
Start date: October 1, 2020
Phase: Phase 2
Study type: Interventional

The aim of this trial is to test a new potential treatment, skullremodeling surgery (SR-surgery) combined with tumor treating fields (TTFields), for patients with first recurrence of malignant brain tumor (first recurrence of glioblastoma). Glioblastoma is one of the most malignant cancers. TTFields is a new treatment for brain cancer (glioblastoma), which is used in additional to surgery (removal of the tumor), chemotherapy and radiation. TTFields work by sending alternating current to the tumor. The current disrupts cell division and thus prevents cancer growths. Electrodes are placed on the scalp and the current is delivered via a small portable battery (1kg). Treatment duration is 18 hours during the day, where the patient can do normal daily activities. The average life expectancy of a newly diagnosed brain cancer patient (glioblastoma) is increased from 15 months to 21 months by adding TTFields. SR-surgery is a minor and safe procedure, that involves creating small burrholes in the skull over the tumor location. The burrholes are approximately 15 mm in diameter. The burrholes increase the electric current in the tumor by funneling the electricity trough the path of least resistance, since bone hinders the electricity. The theory is that combining TTFields with SR-surgery we can increase the effect of TTFields and in return increase overall survival for brain cancer patients. The investigators have recently finished a phase 1 clinical trial, with 15 trial participants, testing the safety and efficacy of our combined treatment. The investigators concluded that TTFields and SR-surgery combined is safe and showed promising results by increasing overall survival with the trial participants. Therefor we wish to proceed with a phase 2 trial. Method The investigators aim to include 70 patients with first recurrence of glioblastoma (brain cancer). Each patient will be randomized to one of two treatment arms. Both treatment arms will receive the best current brain tumor treatment. In addition, one arm receives TTF and the other arm TTFields and SR-surgery. All patients are expected to receive better treatment than current best practice, since TTFields is not standard treatment in Denmark. The primary aim of the trial is to assess the 12-month overall survival in both groups. The theory is that more trial participants will be alive after 12 months in the group that receives both TTF and SR-surgery. The trial duration is 36 months with an average expected follow-up of 18 months.

NCT ID: NCT04223856 Recruiting - Urothelial Cancer Clinical Trials

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

EV-302
Start date: March 30, 2020
Phase: Phase 3
Study type: Interventional

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

NCT ID: NCT04223050 Recruiting - COPD Exacerbation Clinical Trials

Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation

O2flow-COPD
Start date: February 3, 2020
Phase: Phase 4
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is a common disorder that affects approximately 400,000 Danish citizens. About 3,000-3,500 Danes die yearly because of the disorder, and the costs associated with hospital admissions are estimated to be 535 million Danish kroner (DKK). Patients with COPD risk a worsening of their disorder, and in most cases, this will require hospitalization. One of the used treatments is providing oxygen to the patients via e.g. masks. The recommendations on oxygen treatment are currently based on a study from 2010 where 37% of the participants in this study did not receive the intended treatment, which may have had massive effects on the results. It is worrying that no other studies have shown which oxygen treatment is safest for the patients. As such, we deem it important to study how best to treat the patients. Our study is of high clinical relevance as hospitals receive patients with worsening of COPD daily. We need more, better data regarding the oxygen treatment of our patients, in order to provide our patients with the best possible care. The purpose of our study is thus to determine which oxygen treatment is best for patients with acute worsening of COPD symptoms. We will use a prospective, randomized controlled open-label trial. We will use two treatments: Treatment 1 is giving oxygen to the patient to reach a peripheral oxygen saturation of above 94%. Treatment 2 is giving oxygen to reach a peripheral oxygen saturation of between 88% and 92%. Our primary outcome is 30-day all-cause mortality, with secondary outcomes being 7-day all-cause mortality, need for non-invasive ventilation, intubation or intensive care admission, over-all length of hospital stay and respiratory acidosis. We believe that a lower oxygen saturation percentage may be superior as one study (Austin et al., 2010) showed a lower mortality rate in the group of patients that had a lower peripheral oxygen saturation. Additionally, the risk of respiratory acidosis and hypercapnia were lower. We wish to perform our study in the hospital sector as this study was performed in the prehospital sector and thus their results cannot be translated directly.

NCT ID: NCT04221035 Recruiting - Clinical trials for High-Risk Neuroblastoma

High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

HR-NBL2
Start date: November 5, 2019
Phase: Phase 3
Study type: Interventional

This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma.