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NCT ID: NCT02607878 Completed - Cardiac Arrest Clinical Trials

Automated Pupillometry for Coma Prognostication After Cardiac Arrest

Start date: January 2015
Phase:
Study type: Observational

Background: Sedation and therapeutic hypothermia (TH) delay neurological responses and might reduce the accuracy of clinical examination to predict outcome after cardiac arrest (CA). Electroencephalography (EEG) and somato-sensory evoked potentials (SSEP) might significantly improve prognostication of post-CA coma, however, EEG and SSEP are not always available and require specific expertise for their interpretation. Automated video pupillometry is a novel electronic device that contains an infrared light camera which enables to measure quantitatively the percentage of pupillary reaction to a calibrated light stimulation. In a recent study of a cohort of comatose CA survivors (n=50 patients) it was found that quantitative PLR was more accurate than standard PLR (manual pen light) in predicting 3-month outcome, irrespective of temperature and sedation, and had comparable prognostic accuracy than electrophysiological exams, including electroencephalography (EEG) and somato-sensory evoked potentials (SSEP). Aim of the study: In light of these promising results, the investigators would like to confirm the prognostic value of quantitative PLR in a large multicenter cohort of comatose post-CA patients. Design of the study: Prospective, multicenter, observational outcome trial.

NCT ID: NCT02606461 Completed - Clinical trials for Dedifferentiated Liposarcoma

Selinexor in Advanced Liposarcoma

SEAL
Start date: January 4, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 342 total patients will be randomized to study treatment (selinexor or placebo).

NCT ID: NCT02605538 Withdrawn - Cystic Fibrosis Clinical Trials

Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

Start date: September 1, 2015
Phase: N/A
Study type: Interventional

CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients according to European consensus. The aim of the study is to vaccinate as many patients as possible and to follow up whether immunization has been complete.

NCT ID: NCT02605447 Completed - Clinical trials for Coronary Artery Disease

EVOLVE Short DAPT Study

Start date: February 16, 2016
Phase: Phase 4
Study type: Interventional

The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a SYNERGY Stent System.

NCT ID: NCT02605148 Active, not recruiting - Type 1 Diabetes Clinical Trials

TEFA Family Prevention: Glutenfree Diet to Preserve Beta-cell Function

TEFA
Start date: December 2015
Phase: N/A
Study type: Interventional

To evaluate the effect of Gluten Free Diet (GFD) on beta-cell function and glucose metabolism in subjects with one or several islet autoantibodies without and with dysglycemia at baseline. Additionally, all subjects will be given treatment with Vitamin D, omega fatty acids and probiotics. Subjects will be randomized to GFD or normal diet during 18 months. Beta cell function will be evaluated at baseline, and during follow-up by glucose tolerance tests.

NCT ID: NCT02604706 Completed - Anxiety Clinical Trials

Auricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use.

Start date: October 2010
Phase: Phase 2
Study type: Interventional

Background. A common alternative treatment for substance abuse is ear acupuncture. The aim of the study was to evaluate the short and long-term effect of auricular acupuncture on anxiety, sleep, drug use and addiction treatment utilization in adults with substance abuse. Method. Adults with substance abuse and psychiatric comorbidity were randomly assigned to either of two variants of auricular acupuncture - The National Acupuncture Detoxification Association protocol (NADA) or a local protocol (LP) - or relaxation training (controls). Primary outcomes were measured using the Beck Anxiety Inventory (BAI) and Insomnia Severity Index (ISI) with assessment before treatment and follow-ups after five weeks and three months. Secondary outcomes were drug use and addiction service utilization.

NCT ID: NCT02603679 Active, not recruiting - Clinical trials for Estrogen Receptor Positive Tumor

Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases

PREDIX LumB
Start date: February 2015
Phase: Phase 2
Study type: Interventional

The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of chemotherapy using weekly paclitaxel (arm A) versus the combination of the cdk 4/6 inhibitor palbociclib and standard endocrine treatment (arm B). After 12 weeks treatment is switched crossover. During the 24-weekly treatment period, clinical and radiological evaluations are performed repeatedly. Switch between the treatment arms A and B is allowed in case of lack of response or due to toxicity. A translational subprotocol is a mandatory part of the study protocol, except for use of PET-CT evaluations. Postoperatively, patients receive three 3-weekly courses of chemotherapy with a combination of epirubicin and cyclophosphamide.

NCT ID: NCT02603432 Completed - Urothelial Cancer Clinical Trials

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

Start date: April 25, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

NCT ID: NCT02601989 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effects on Insulin Resistance With Tadalafil in Type 2 Diabetes - a Double-blind, Placebo-controlled Crossover Study

MAKROTAD
Start date: November 2015
Phase: Phase 2
Study type: Interventional

The aim is to continue our program on PDE5 inhibition by evaluating effects on insulin resistance, including glucose metabolism and subclinical inflammation, after a 6-week administration of tadalafil in T2D patients. The primary objective is to study the effect of tadalafil compared with placebo on insulin sensitivity during a euglycemic hyperinsulinemic clamp. This is a double-blind, placebo-controlled crossover study with one study site. Twenty-five T2D patients will be recruited and randomized to per oral intake of tadalafil 20 mg o.d. for six weeks and after a wash-out period of eight weeks intake of placebo for another six weeks, or vice versa. At the end of each 6 week treatment period a glucose clamp, subcutaneous needle biopsies as well as muscle and subcutaneous microdialysis will be performed. Endothelial function tests and arginin stimulation of insulin secretion tests will be performed after 3 weeks in each treatment arm.

NCT ID: NCT02601131 Completed - Multiple Sclerosis Clinical Trials

Post-transfusion Platelet Count

Start date: February 2016
Phase: N/A
Study type: Observational

The purpose of this study is to identify how the platelet count, complement system and endothelial markers are affected over time, after platelet transfusion in 4 different hematological patient groups.