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NCT ID: NCT03210298 Recruiting - Colorectal Cancer Clinical Trials

International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)

PIPACRegis
Start date: January 2016
Phase:
Study type: Observational [Patient Registry]

Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.

NCT ID: NCT03210012 Recruiting - Clinical trials for Endothelial Dysfunction

Bubbles, Stress, Diastole

Start date: June 11, 2017
Phase: N/A
Study type: Observational

This is a monocentric pilot study to assess the safety profile of a 30-meter deep underwater diving using 3 different type of gas mixtures: AIR (21% O2 and 79% N2), NITROX 32 (32% O2 And 68% N2) and TRIMIX (21% O2, 44% N2 and 35% He).

NCT ID: NCT03207867 Terminated - Pancreatic Cancer Clinical Trials

A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma

Start date: August 28, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.

NCT ID: NCT03207373 Terminated - Clinical trials for Sudden Cardiac Death

Stress ECG Test for the Evaluation of the Risk of Sudden Cardiac Death in a Paediatric Cohort With WPW Pattern

Start date: April 13, 2017
Phase: N/A
Study type: Interventional

Patients with preexcitation are at risk for sudden cardiac death. The pathogenesis is a rapid antegrade conduction of atrial fibrillation over the accessory pathway to the ventricle resulting in ventricular fibrillation. Today it is possible to eliminate the conduction over the accessory pathway by catheter intervention (radiofrequency ablation) with a low rate of complications and a high rate of success. In clinical practice it is therefore important to estimate the risk for sudden cardiac death in an individual patient to give an advice to the patient and the parents about the further evaluation and therapeutic strategy. The velocity of the conduction over the accessory pathway can be estimated by analysing the ECG during sinus tachycardia. If the preexcitation disappears at a relatively low heart rate, the risk for sudden death is less than in patients with persisting preexcitation at the maximal heart rate. Compared to the gold standard i.e. measurement of the refractory period of the accessory pathway during invasive electrophysiological study (EPS), the measurements at the stress ECG have been reported to be a relatively poor indicator for an elevated risk which may be explained by a high intraindividual variability of this test. This study is designed to define the clinical relevance of the stress ECG in paediatric patients with preexcitation (compared to the invasive electrophysiological study). First Hypothesis: The results of the 3 stress ECG-tests are reproducible in an individual patient. Null hypothesis: there is no difference between the three measurements of cycle length during stress ECG. Alternate hypothesis: the difference between the three measurements of cycle length is > 10%. Second Hypothesis: There is a close correlation between the results at stress ECG and the results at the invasive electrophysiological Intervention.

NCT ID: NCT03206671 Recruiting - Clinical trials for Mature B-cell Non-Hodgkin Lymphoma

Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents

B-NHL 2013
Start date: August 3, 2017
Phase: Phase 3
Study type: Interventional

The trial B-NHL 2013 is a collaborative prospective, multi-national, multi-center, randomized trial with participating centers of the NHL-BFM group (Austria, Switzerland, Czech Republic, Germany) and the Scandinavian NOPHO group (Denmark, Finland, Norway, Sweden). The aim of the trial is to evaluate the role of rituximab in the treatment of mature aggressive B-cell Non-Hodgkin lymphoma and leukemia (B-NHL and B-AL) in children and adolescents. The following primary study questions are going to be analyzed: - the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 and R2 stage I and II) of substituting anthracyclines by the rituximab window without compromising survival rates. - the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 stage III) randomly assigned to receive the rituximab window plus standard chemotherapy or standard chemotherapy without the rituximab window. - the effectiveness (event-free survival) and the immune reconstitution (recovery of CD19+ B-cells, IR) in pediatric patients with advanced mature B-NHL/B-AL (R3 and R4 incl. R4 CNS+) treated with BFM-type chemotherapy and randomly assigned schedules of one versus seven doses rituximab. Secondary study questions will address - additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates - kinetics of immune reconstitution after treatment - adverse event and severe adverse event profile - inter-individual variability of rituximab response - role of different mechanisms of action of rituximab in advanced B-NHL/B-AL

NCT ID: NCT03204669 Completed - Critical Illness Clinical Trials

Trace Element Repletion Following Severe Burn Injury

Start date: June 1, 1999
Phase: N/A
Study type: Observational

Major burn patients are characterized by large exudative losses of Cu, Se and Zn. Trace element (TE) repletion has been shown to improve clinical outcome. The study aimed to check if our repletion protocols were achieving normalization of TE plasma concentrations of major burn patients and if the necessity for continuous renal replacement therapy (CRRT) might increase the needs.

NCT ID: NCT03204578 Completed - Clinical trials for Cytochrome P450 CYP3A Enzyme Deficiency

Physiological Study of the Human CYP3A Activity (PiSA)

PiSA
Start date: August 18, 2017
Phase: Phase 4
Study type: Interventional

Investigator-initiated physiological study to characterize the function of a major drug metabolizing enzyme using a microdosed phenotyping probe to avoid unwanted, concentration-dependent effects.

NCT ID: NCT03204396 Completed - Smoking Cessation Clinical Trials

Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues

SKIP
Start date: June 26, 2017
Phase: Phase 2
Study type: Interventional

Cigarette smoking is the leading preventable cause of premature death worldwide. However smoking is a very difficult addiction to break whereby main reasons for not quitting or relapsing after cessation are the nicotine withdrawal syndrome and post-cessational weight gain. GLP-1 analogues are well known to stimulate insulin secretion and to reduce energy intake and therefore body weight. Recent findings from animal and human studies suggest a role of GLP-1 in the pathophysiology of addiction. The putative role of GLP-1 analogues in nicotine reward regulation combined with its weight reducing effects might be of major interest in view of novel pharmacotherapeutic options for smoking cessation. - Substudy "fMRI": This substudy is to evaluate effects of Dulaglutide treatment on functional neuronal changes in smokers who want to quit smoking. - Substudy "Energy": This substudy is to investigate the effect of Dulaglutide (Trulicity®) on REE and further parameters associated with energy metabolism (bodycomposition, haemodynamic parameters and catecholamine action) in a subset of patients recruited for the main trial.

NCT ID: NCT03203850 Terminated - Clinical trials for Hereditary Hemochromatosis

Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis (HH)

Start date: January 11, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of deferasirox film coated tablet (FCT) versus phlebotomy for the management of iron overload in adults with Hereditary Hemochromatosis (HH) at risk of iron-related morbidity. This evaluation provided information on the two treatment options in terms of the rate of response of proportion of patients reaching the study target SF ≤ 100 μg/L and their associated safety profiles. In addition to exploring the safety and efficacy of deferasirox FCT in hereditary hemochromatosis (HH), this study is being conducted to fulfill an FDA post-marketing requirement [PMC 750-10 (Exjade) /PMR 2888-8 (Jadenu)] to provide additional randomized data to confirm the ocular safety profile of deferasirox through detailed ocular assessments in patients treated with deferasirox FCT for 2 years.

NCT ID: NCT03202667 Completed - Hyponatremia Clinical Trials

Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study

SANDx
Start date: December 15, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water retention and secondary natriuresis and is a common cause for hyponatremia. Especially chronic (>72h) SIADH is difficult to treat as standard therapeutic options (water restriction, urea, salt tablets) often do not succeed in correction of hyponatremia, making additional therapy necessary. Empagliflozin is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a well-tolerated treatment option for type 2 diabetes mellitus. The inhibition of SGLT2 in the proximal tubule leads to renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with chronic SIADH, as it resembles the aquaretic effect of urea. The aim of this study is to evaluate whether empagliflozin has an effect on the serum sodium levels of patients with chronic SIADH.