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NCT ID: NCT03439150 Terminated - Clinical trials for Acute Myocardial Infarction

Resistance STEMI Study

Start date: October 15, 2018
Phase: N/A
Study type: Interventional

In acute myocardial infarction, early restoration of blood flow to the jeopardized myocardium is of paramount importance to limit infarct size and to improve long term outcome. Primary percutaneous coronary intervention (PPCI) is the treatment of choice in these patients. Despite achievement of adequate epicardial coronary artery reperfusion in many patients, transient or persistent myocardial microvascular dysfunction is often present, also referred to as the no-reflow phenomenon. This microvascular dysfunction and the time course during which it recovers, is most likely also related to long term outcome. If microvascular reperfusion is still limited immediately after myocardial infarction but recovers quickly in the days thereafter, this might be beneficial for long term prognosis. Several treatments have been suggested to limit microvascular injury and to improve microvascular reperfusion in the acute phase of myocardial infarction (such as intra-aortic balloon pumping, glycoprotein IIB/IIIA inhibitors, adenosine, verapamil, nitroglycerine, cyclosporine, or gap-junction-inhibitors), but it has been difficult to assess the effect of such treatment due to the simple fact that no methodology has been available for quantitative assessment of the microcirculation of the heart. Assessment of microvascular perfusion and function has been very difficult so far and has been hampered by a number of methodological and technical shortcomings. Measurement of absolute blood flow in the infarcted area and true quantitative calculation of absolute resistance in acute myocardial infarction, has been introduced in the last years using a technique with thermodilution and continuous infusion of small amounts of saline. This technique offers the possibility to study the course of microvascular (dys)function after acute myocardial infarction with potentially important implications for treatment at follow-up. Technical performance of such measurements was difficult so far because of a complex instrumentation and the necessity of additional administration of intravenous adenosine. In the last 2 years, this technique has been largely simplified by the introduction of a new multipurpose monorail infusion catheter (RayFlow ®, Hexacath, Paris) and the observation that saline infusion of 15-20 ml/min in itself already ensures maximum coronary hyperemia. Finally, easy to handle software has been developed for online interpretation of such measurements. Consequently, measurement of absolute blood flow and myocardial resistance has become easy to perform now and the complete measurements only take a few minutes in addition to a regular PPCI or Fractional Flow Reserve (FFR) measurement. The measurements are absolutely safe, reproducible, only a small amount of saline (100 ml at room temperature) is needed, no additional medication is necessary, the patient doesn't experience any discomfort of the measurement and the measurements can be repeated multiple times within minutes. Therefore, a window is opened for further examination and quantitative assessment of the microcirculation of the heart. The purpose of the present study is to evaluate changes in myocardial resistance over time in ST-Elevation Myocardial Infarction (STEMI) patients, both in the early stage and the subacute phase. Furthermore, the course of such changes and recovery of the microcirculation will be correlated to long-term outcome as assessed by Magnetic Resonance Imaging (MRI) measurements and final infarct size. It is hypothesized that patients can be divided into 3 groups: A. Patients with an (almost) normal resistance and flow immediately after PPCI B. Patients with still elevated resistance and decreased flow immediately after PPCI, but (partial) recovery in the next days C. Patients with elevated resistance and decreased flow immediately after PPCI which do not recover at all. The investigators would like to evaluate changes in microvascular resistance of the infarcted area in the first hour after ST-elevation myocardial infarction and during the recovery period (<5 days). Classify patients according to recovery of microvascular resistance and relate the (recovery of) microvascular resistance to outcome and preservation of left ventricular function (with MRI, echo and clinical follow-up at 1 year).

NCT ID: NCT03435575 Terminated - Physical Activity Clinical Trials

BOOSTH: Serious Gaming in Combination With Physical Activity Promotion

Start date: November 9, 2017
Phase: N/A
Study type: Interventional

Physical inactivity is considered to be one of the ten principal risk factors for death worldwide. Children need to perform one hour of daily moderate-to-vigorous intensity physical activity whereof at least twice a week these activities are of vigorous intensity. In 2010, the percentage of 4-11 year-old normoactive Dutch children was approximately 20%. In addition, there is a dose-response relationship between BMI by sex and physical activity levels. Previous interventions that aimed to increase childhood physical activity produced small to negligible effects. One possible explanation is that individuals were not intrinsically motivated towards PA during the intervention period. Children spend a substantial amount of their time behind a game consule. There are a number of applications that motivate increase in PA in a fun way through engaging individuals in games that mix real and computing worlds. These games became known as serious games. In this study we want to investigate if the incorporation of a serious game BOOSTH in combination with an activity tracker to stimulate physical activity behaviour in overweight/ obese children.

NCT ID: NCT03419403 Terminated - Clinical trials for Glioblastoma Multiforme

UNITE Study: Understanding New Interventions With GBM ThErapy

Start date: July 30, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study was to evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated with depatuxizumab mafodotin (ABT-414).

NCT ID: NCT03399435 Terminated - Anesthesia Clinical Trials

A Study in Healthy Male Volunteers to Investigate the Safety and Tolerability of a Single Dose of Neosaxitoxin Alone and in Combination With Bupivacaine (With and Without Epinephrine) for Brachial Plexus Blockade

Start date: January 30, 2018
Phase: Phase 1
Study type: Interventional

Neosaxitoxin is a new compound that is in clinical development as local anesthetic for surgical anesthesia and postoperative analgesia. The primary objective of this study is to evaluate the systemic and local safety and tolerability of ascending doses of neosaxitoxin alone and in combination with fixed doses of bupivacaine (with and without epinephrine), following brachial plexus blockade in healthy male subjects. Secondary objectives: - Evaluate the pharmacodynamics (PD) of ascending doses of neosaxitoxin, alone and in combination with fixed doses of bupivacaine (with and without epinephrine), following brachial plexus blockade. - Characterize the pharmacokinetics (PK) of neosaxitoxin and bupivacaine after brachial plexus blockade with neosaxitoxin alone or different drug combinations: neosaxitoxin and epinephrine, neosaxitoxin and bupivacaine, or neosaxitoxin and bupivacaine and epinephrine.

NCT ID: NCT03398837 Terminated - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

RESOLVE-1
Start date: December 18, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.

NCT ID: NCT03394716 Terminated - Brain Tumor Clinical Trials

Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors

Start date: January 12, 2018
Phase:
Study type: Observational [Patient Registry]

This study aims to evaluate anatomical and functional changes during RT for patients receiving fractionated RT for brain tumors. Anatomical changes during RT will be registered and analyzed and if needed the radiotherapy plan will be modified for the individual patient. This means that the "to be irradiated volume" will be modified according to the shape changes of the tumor. The functional MRI sequences will be used to evaluate what parameters, and at which time point, are important for radiotherapy outcome.

NCT ID: NCT03393806 Terminated - Asthma Clinical Trials

Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)

Start date: April 18, 2018
Phase: Phase 2
Study type: Interventional

This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.

NCT ID: NCT03381196 Terminated - Influenza A Clinical Trials

A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications

Start date: January 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.

NCT ID: NCT03379233 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence

ADVICE
Start date: July 11, 2018
Phase: Phase 3
Study type: Interventional

This study was evaluating the effect of reminder notifications and motivational/adaptive messages on treatment adherence behavior in subjects with COPD. The effect will be measured over 24 weeks on the subject's on time treatment adherence and total treatment adherence. The delivery of the medication and tracking of inhaler use is done by the Concept2 inhaler. The reminder notification, feedback on inhaler use and motivational messages are provided by the patient application, who is receiving the inhaler use information from the Concept2 inhaler.

NCT ID: NCT03376321 Terminated - Influenza A Clinical Trials

A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection

Start date: January 3, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.