Clinical Trials Logo

Filter by:
NCT ID: NCT03965000 Recruiting - Clinical trials for Cardiovascular Diseases

Human Solute Carrier Family 5 Member 2 (SLC5A2) Deficiency and the Glucagon-Incretin Axis

Start date: January 24, 2019
Phase:
Study type: Observational

Sodium-glucose-cotransporter 2 (SGLT2) are a new type of oral antidiabetic drugs. SGLT2 inhibitors increase the urinary glucose excretion and thereby decrease blood glucose levels. Beside their glucose lowering effects SGLT2 inhibitors showed beneficial effects on the cardiovascular health. But several studies in cell culture and mice showed that the physiological inhibition of glucagon after meal consumption is impaired when using SGLT2 inhibitors. The patients carry a rare genetical disease called Familial renal glucosuria (FRG), a human model of life long SGLT2 inhibition. To elucidate the effects of partial and complete SGLT2 inhibition in humans the investigators perform a mixed-meal tolerance test (MMTT), the gold standard for elucidation of insulin and glucagon dynamics.

NCT ID: NCT03963037 Recruiting - Low-LDL-syndrome Clinical Trials

Characterization of Two Novel Mutations in the Apob Gene

Start date: January 24, 2019
Phase:
Study type: Observational

The pilot study has the target to evaluate the outcomes of two novel mutations in the gene of Apolipoprotein B (ApoB). ApoB is the main part of the low-density lipoprotein (LDL). LDL is the main transporter of cholesterol from the liver to the periphery. The two novel mutations lead to a heavily truncated Apolipoprotein B. Therefore the patients show severely decreased ApoB and LDL-Cholesterol levels. The acquired disease is known as "Familial Hypobetalipoproteinemia". Beside the protection from cardiovascular disease due to decreased LDL-Cholesterol, patients tend to show elevated serum aminotransferases, fatty liver and occasional cases of cirrhosis and carcinoma. To elucidate the differences in lipoprotein assembly the investigators aim to characterize the changes due to the mutations in the patients. Family members not carrying the mutations are the control group. The assessment includes lipoprotein fractionation, MRI scans of the liver and a thorough assessment of medical history of all patients to look for potential side effects of the mutation. The only intervention needed for the study is to draw blood samples of every participant. The necessary positive vote from the ethics committee of the Medical University of Innsbruck is given.

NCT ID: NCT03960840 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, ALL and 1L HR LBCL

Start date: June 26, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (3L+ DLBCL), adult acute lymphoblastic leukemia (ALL) and 1st Line High Risk Large B-Cell Lymphoma (1L HR LBCL).

NCT ID: NCT03954574 Recruiting - Clinical trials for Pulmonary Circulation Diseases

Pulmonary Hemodynamics During Exercise - Research Network

PEX-NET
Start date: December 1, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data.

NCT ID: NCT03950232 Recruiting - Ulcerative Colitis Clinical Trials

An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

ELEVATE UC OLE
Start date: September 5, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

NCT ID: NCT03950076 Recruiting - Atrial Fibrillation Clinical Trials

EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)

ENRICH-AF
Start date: September 20, 2019
Phase: Phase 4
Study type: Interventional

To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage.

NCT ID: NCT03946644 Recruiting - Clinical trials for Endovenous Laser Ablation

Safety Distance for Endovenous Laser Ablation of the Great Saphenous Vein

SDEVLA
Start date: September 26, 2018
Phase: N/A
Study type: Interventional

Chronic venous disease is one of the most common diseases in the western world and worldwide with a prevalence of 83,6%. It is a chronic progressive disease, which causes a significant burden on health systems, treatment and care of these patients. Recurrence of varicose veins after successful treatment remains a problem and has been reported in up to 30% of patients after endovenous laser ablation (EVLA), which is the recommended treatment of choice for incompetence of the truncal veins. The aim of this project is to investigate a variation of the EVLA, which has the potential to reduce the recurrence rate in the long-term. If this assumption is true, the investigators expect reduction of costs in the health system and improved quality of life for individual patients.The primary objective of the project is the evaluation of long-term anatomical effectiveness of EVLA treatment with and without keeping a distance to sapheno-femoral junction (SFJ), defined as complete obliteration of the great saphenous vein (GSV) or absence of an open saphenous stump at the SFJ after 3 years. Secondary objectives are: 1. . Evaluation of the effectiveness of EVLA treatment with and without keeping a distance to SFJ, measured as duplex sonographic reflux (≥ 0,5 sec) in the GSV or any other axial vein at the SFJ after 1 year and 3 years. 2. . Evaluation of the anatomical effectiveness of EVLA treatment with and without keeping a distance to SFJ, measured as the length of the open saphenous stump (in centimeters) after 1 year and 3 years. 3. . Assessment of quality of life 3 months, 1 year and 3 years after EVLA. 4. . Evaluation of the clinical efficacy and tolerability measured as a clinical score at 3 months, 1 year and 3 years after EVLA. 5. . Safety assessment measured as the number of thromboembolic events 1 week and 3 months after EVLA.This project is planned as a prospective randomized parallel group double-blind study. For the assessment of efficacy and safety parameters, clinical examinations and duplex sonographic examinations will be performed 3 months, 1 year and 3 years after the intervention. For the assessment of tolerability endpoints, clinical scores and quality of life score will be performed 3 months, 1 year and 3 years after EVLA. Clinical scores include Clinical, Etiologic, Anatomical, and Pathophysiological Classification (CEAP) and Venous Clinical Severity Scoring (VCSS) and for evaluation of quality of life Aberdeen Varicose Veins Questionnaire (AVVQ) will be used.

NCT ID: NCT03944798 Recruiting - Soft Tissue Sarcoma Clinical Trials

Surveillance AFter Extremity Tumor surgerY

SAFETY
Start date: November 19, 2019
Phase: N/A
Study type: Interventional

Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Therefore, careful post-operative surveillance is an integral element of patient care. However, the detection of metastases does not necessarily affect long-term survival and may negatively impact quality of life. Surveillance strategies have not been well researched and have been identified as the top research priority in the extremity sarcoma field. Using a 2X2 factorial design to maximize efficiency and reduce overall trial costs, the SAFETY trial will randomize 830 extremity soft-tissue sarcoma (STS) patients to determine the effect of surveillance strategy on overall patient survival after surgery for a STS of the extremity by comparing the effectiveness of both surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs).

NCT ID: NCT03944525 Recruiting - Clinical trials for Hypercapnic Respiratory Failure

High-flow Air Via Nasal Cannula vs Non-invasive Continuous Positive Airway Pressure for Hypercapnic Respiratory Failure

HIGHforHyper
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The study will be performed as a randomized controlled non-inferiority trial. HFA has been increasingly used in the last years to treat hypoxic respiratory failure (i.e. type I failure), and numerous studies have shown its efficiency in this indication. Despite this good evidence for HFA in hypoxic respiratory failure, it has only reluctantly been used for hypercapnic respiratory failure. HFA has been shown to generate PEEP, despite not being a closed system, and to improve CO2 clearance by flushing anatomical dead space. It might also help to reduce inspiratory resistance and facilitate secretion clearance from humidified gas. A study on COPD patients showed an increase in breathing pressure amplitude and mean pressure, as well as tidal volume, with a trend towards reduction of carbon dioxide partial pressure. Intervention consists of HFA using standard equipment at the department. A gas flow of 60 litres per minute and a FiO2 as clinically feasible will be used. Therapy will be continued until a pCO2-level of 50 mmHg or less is reached, or therapy has to be aborted because of lack of tolerance by the patient or indication for intubation. Control consists of non-invasive continuous positive airway pressure ventilation support using a tight mask and standard respirator equipment of the Department of Emergency Medicine. A positive airway pressure of 3,67 mmHg and a FiO2 as clinically feasible will be used. Therapy will be continued until a pCO2-level of 50 mmHg or less is reached, or therapy has to be aborted because of lack of tolerance by the patient or indication for intubation.

NCT ID: NCT03937154 Recruiting - Clinical trials for Chemotherapy-induced Thrombocytopenia

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer

Start date: February 26, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer measured by the ability to administer on-time, full-dose chemotherapy