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NCT ID: NCT02769351 Terminated - Acute Heart Failure Clinical Trials

Global rEgistry on decongestioN Therapy Using Less invasivE UltraFiltration

GENTLE-UF
Start date: December 3, 2015
Phase:
Study type: Observational [Patient Registry]

In patients with advanced volume overload, minimally invasive ultrafiltration treatment in the acute phase can have a positive effect on clinical outcome. The aim is to collect treatment data in the context of a prospective registry of the safety and performance of minimally invasive ultrafiltration. The data will be recorded via an electronic case report form (eCRF); the eCRF runs on a server located in Germany and complies with current data protection regulations. It is intended to include about 300-500 patients with advanced volume overload at a minimum of 10 sites. In addition, data on a disease management programme (in-body measurement and home monitoring) will be recorded in up to 40 of these patients. The treatment data from each patient will be recorded over 12 months. An interim analysis will be performed after 150 patients have been observed for 6 months. The knowledge about ultrafiltration in volume overload obtained from the registry, in some cases in combination with a disease management programme, is intended to improve the body of evidence. In addition, the data will be used for hypothesis generation.

NCT ID: NCT02760602 Terminated - Alzheimer's Disease Clinical Trials

A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease

ExpeditionPRO
Start date: June 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).

NCT ID: NCT02744651 Terminated - Clinical trials for Gastrointestinal Neoplasms

EUS-Endodrill vs. EUS-FNA for Diagnosis of Submucosal Tumors in the Upper GI Tract

Start date: February 17, 2017
Phase: N/A
Study type: Interventional

Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this study is as follows: - Compare EUS-guided Endodrill biopsies with endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in terms of ability to establish the correct diagnosis of submucosal tumors in the upper GI tract.

NCT ID: NCT02731118 Terminated - Glaucoma Clinical Trials

Antisecretory Factor (AF) Effects on Intraocular-pressure

Start date: April 2016
Phase: Phase 3
Study type: Interventional

Glaucoma is a complex and chronic eye disease which damages the optic nerve. One of the main risk factors for the progression of glaucoma is IOP. The aim of the study is to examine if Salovum, an anti-secretory factor (AF), can reduce the level of the intraocular pressure (IOP) in the eye of patients affected by glaucoma. Anti-secretory factor (AF) is an endogenous protein which controls the transport of water and ions across the cell membrane. AF plays an important part in the immune system and has an anti-secretory and anti-inflammatory effect. The investigators' hypothesis is that Salovum can restore a normal salt-water balance in the eye, which in turn would lower the IOP. This would eliminate or reduce the risk of subsequent visual impairments/neurological damage.

NCT ID: NCT02720757 Terminated - Clinical trials for Pulmonary Disease, Chronic Obstructive

Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)

Start date: August 26, 2016
Phase:
Study type: Observational

The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks. A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to Visit 2 (final visit at the end of the study, approx. 6 weeks after Visit 1), as well as patient satisfaction with Spiolto® Respimat® at Visit 2.

NCT ID: NCT02704403 Terminated - Clinical trials for Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

RESOLVE-IT
Start date: March 2016
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

NCT ID: NCT02703272 Terminated - Clinical trials for Lymphoma, Non-Hodgkin

A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma

Start date: July 1, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone (part 2).

NCT ID: NCT02682095 Terminated - Hypertension Clinical Trials

To Achieve Blood Pressure Control With Retained Quality of Life

Start date: April 2016
Phase:
Study type: Observational

The purpose of the study is to get an understanding about what problems patients with hypertension are facing, how they manage these challenges, how they feel and what requirements they believe are important to have in their treatment. These factors will later act as a foundation and incentive for designing an intervention that may result in more patients achieving blood pressure control with maintained quality of life.

NCT ID: NCT02670083 Terminated - Alzheimer's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).

CREAD
Start date: March 22, 2016
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.

NCT ID: NCT02650492 Terminated - Melanoma Clinical Trials

Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma

Start date: October 2015
Phase: N/A
Study type: Interventional

Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherpy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size. The immunologic response has previously been characterized in breast cancer patients after receiving imILT treatment , and presumed abscopal effects induced by imILT have also been described in a malignant melanoma patient. The purpose of this trial is to investigate the functionality and safety of the imILT treatment method in patients diagnosed with malignant melanoma. The inflammatory process, following on the treatment, will also be described in order to provide a more in depth knowledge of the treatment for this indication. The purpose is also to evaluate efficiency when it comes to local tumor destruction as well as understanding of the subsequent immunological effects. Since immunologically based treatment of malignant melanoma is under intense review with so called "immune checkpoint inhibitors" this trial will also provide valuable information on how imILT, in the future, could be combined with these new and, for some patients, very effective treatment regimens. The treatment method has successfully been used for treatment of patients with breast cancer and malignant melanoma . Treatment of breast cancer patients caused an increase of cytotoxic T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border. Regulatory T lymphocytes decreased in the regional lymph nodes. This trial is explorative, prospective, open and non-randomized. Five malignant melanoma patients stage III - IV will be treated in this trial, which is estimated to be carried out during a time period of 12 months.