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NCT ID: NCT03586076 Recruiting - Healthy Subjects Clinical Trials

A Comparative Safety and Pharmacokinetic Study of JHL1922 and Pulmozyme® in Healthy Subjects

Start date: January 26, 2018
Phase: Phase 1
Study type: Interventional

This is a double-blind, randomised, 2 single-doses and then repeated-dose (5 days), 2-arm, 2-period crossover phase 1 study in 24 healthy male or female subjects. Subjects will be randomised to one of two treatment sequences in 2 treatment periods: JHL1922 (test treatment) first and then Pulmozyme (reference treatment) or Pulmozyme (reference treatment) first and then JHL1922 (test treatment).

NCT ID: NCT03582514 Not yet recruiting - Clinical trials for Glioblastoma Multiforme

Dose and Volume Escalation of Preoperative Brain Irradiation in GBM Patients -the POBIG Trial -

POBIG
Start date: July 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The pre-operative brain irradiation in GBM (POBIG) is a phase I-II study assessing the feasibility, safety and efficacy to irradiate (partially) the tumor in patients with a high suspicion of glioblastoma (GBM). After the single fraction of radiotherapy, patients will receive the standard treatment. The standard treatment consists of resection of the tumor followed by (chemo)radiation (i.e. radiotherapy +/- daily temozolomide (75mg/m2) for 6 weeks (60Gy/30fr) or for 3 weeks (40Gy/15fr)) and (if indicated) adjuvant temozolomide (150-200mg/m2, 5/28 days, 6 cycles).

NCT ID: NCT03582293 Recruiting - Clinical trials for Hematoma, Subdural, Chronic

Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma

TORCH
Start date: June 19, 2018
Phase: Phase 3
Study type: Interventional

Rationale: Chronic subdural hematoma (cSDH) is a relatively frequently occurring neurological disease, occurring mainly in the elderly. Surgical evacuation of the hematoma is an effective treatment, but is also associated with life-threatening risks. In these old, often frail, patients with multi-comorbidity, surgery also comes with significant risks for future cognitive functioning and, therefore, loss of independency. In five small retrospective series, tranexamic acid (TXA), an antifibrinolytic drug, showed a beneficial effect on the spontaneous resolution of the hematoma and, with that, the necessity for surgery. This randomised, placebo-controlled clinical trial aims to prove the efficacy of TXA. Objectives: Primarily to evaluate the efficacy of TXA to prevent surgery for cSDH. Secondarily to evaluate the efficacy of TXA to reduce cSDH volume, to reduce neurological impairment (mNIHSS), to reduce the incidence of falling incidents, to improve cognitive functioning (MOCA), to improve performance in activities of daily living (Barthel and Lawton-Brody), to improve functional outcome (mRS), to improve the level of quality of life, to reduce the mortality rate and to reduce the use of care and health-related costs (iMCQ and iPCQ). Study design: Double-blind, placebo-controlled, multicentre, randomized clinical trial. Study population: All patients, age 50 and above, diagnosed with cSDH for which a conservative treatment is selected as primary treatment strategy. Intervention: During four weeks, the intervention group will receive oral TXA 500mg twice daily, the control group will receive a placebo twice daily. The TXA or placebo treatment is additional to standard care. Main study endpoint: The number of patients requiring surgery within 12 weeks after start of treatment. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will use the study medication twice daily for four weeks. Follow-up is at four, eight and 12 weeks with a standard CT-scan of the head, outpatient clinic visits and four patient-reported questionnaires (at baseline and at 12 weeks). These outpatient clinic visits are standard care; the third CT-scan, the questionnaires and extra clinical tests during the visits are extra for this study. Each patient may benefit from the study if the study medication proves effective in preventing surgery for cSDH, whereas the risk of potential side effects of the medication is slight (e.g. the risk of thromboembolic events is only 0.01-0.1%). Surgery remains a possibility for those patients in whom study medication is not effective.

NCT ID: NCT03580122 Active, not recruiting - Clinical trials for Classic Galactosemia

The Effect of Arginine on Classic Galactosemia

ARGALT
Start date: December 5, 2017
Phase: Phase 2
Study type: Interventional

Rationale: Classic galactosemia is a rare inherited metabolic disease that presents in neonatal patients with a life-threatening multi-organ toxic syndrome. Although the current standard of care - a galactose-restricted diet - quickly relieves the severe neonatal clinical picture, it fails to prevent brain and gonadal sequelae. There is a need for new therapeutic strategies. As arginine is an amino acid that is therapeutically widely used with no side effects described, we propose to use it in a pilot-clinical study. We aim to evaluate the effects of arginine in classic galactosemia patients, in order to determine its potential therapeutic role in this disease. Objective: To evaluate the possible effect of arginine on the whole body galactose oxidative capacity in classic galactosemia patients. Study design: Interventional pilot-clinical study with pre-post single arm design. Study population: We aim to include 5 classic galactosemia adult patients homozygous for the p.Q188R mutation. Intervention: All participants will receive arginine in the form of Asparten ® (arginine aspartate) during 1 month, by oral administration. The main study parameter is whole body galactose galactose oxidative capacity.

NCT ID: NCT03579719 Recruiting - Healthy Volunteers Clinical Trials

A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers

Start date: July 10, 2018
Phase: Phase 1
Study type: Interventional

This study will be a non-randomized, open-label, one-sequence, two-period within-subject study to investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female volunteers using itraconazole as a CYP3A inhibitor. The study will be conducted at 1 site in the Netherlands.

NCT ID: NCT03578809 Recruiting - Clinical trials for ST Elevation Myocardial Infarction

A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

REAL-TIMI 63B
Start date: June 5, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult subjects presenting with acute STEMI (ST segment elevation myocardial infarction). The study will enrol subjects presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all subjects, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of subjects will also undergo an index and an end of study CTA.

NCT ID: NCT03578510 Completed - Clinical trials for Patients With End Stage Renal Disease on Hemodialysis

Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

Start date: September 17, 2012
Phase: N/A
Study type: Interventional

Intradialytic hypotension (IDH) is a frequent and serious complication that may occur during hemodialysis treatment. The investigators and others have shown that the Hemocontrol biofeedback system is associated with improved hemodynamic stability. Hemocontrol is a technique that guides the patients' blood volume along a pre-set trajectory by continuously adjusting the ultrafiltration rate and dialysate conductivity. In a recent pilotstudy, the investigators found significantly higher plasma vasopressin levels during the first hour of dialysis with Hemocontrol in comparison with standard hemodialysis. Increased vasopressin levels may contribute to intradialytic hemodynamic stability during hemodialysis by enhanced vasoconstriction. These results, however, did not prove directly that the improved hemodynamic stability with Hemocontrol is indeed caused by higher initial plasma vasopressin levels. Alternative explanations might be that 1) the higher initial plasma sodium levels with Hemocontrol dialysis enhance activity of the sympathetic nervous system directly, causing vasoconstriction and thereby improved hemodynamic stability and/or 2) that the higher initial plasma levels of sodium in Hemocontrol inhibit the release of nitric oxide by the vascular endothelium. Another goal of this study is to investigate whether vasopressin is removed with hemodialysis.

NCT ID: NCT03577405 Recruiting - Critical Illness Clinical Trials

Simple Intensive Care Studies II

SICS-II
Start date: May 14, 2018
Phase:
Study type: Observational [Patient Registry]

Critically ill patients admitted to the intensive care unit (ICU) frequently suffer from circulatory shock or respiratory distress, with high morbidity and mortality up to 40%. After initial fluid resuscitation other complications associated with either treatment or disease may arise. A consequence of treatment might be fluid overload or overfilling. Multiple studies have shown the possible negative effects of - too much - fluid administration, such as venous congestion. Venous congestion entails venous fluid overload, manifested by for example an increased central venous pressure (CVP) or peripheral oedema. This venous congestion may contribute to the occurrence of short-term organ failure by causing a high ''afterload'' in the venous tracts of organs. There is no consensus on how to measure venous congestion. It is important to identify variables that reflect the development of venous congestion in order to investigate whether venous congestion is associated with short-term organ failure. Variables that indicate venous congestion may be obtained with clinical examination and biochemical analyses, supplemented by hemodynamic variables derived from critical care ultrasonography (CCUS) with information about organ perfusion, and both arterial and venous function. The development of short-term organ failure can be assessed by collecting clinical, biochemical and hemodynamic variables at multiple moments. Using repeated measurements is likely to add dynamic information about the diagnostic and prognostic value of these variables. The dynamics of variables, in any direction, over time might improve the diagnostic accuracy and prognostic value of clinical, biochemical and hemodynamic variables that can be collected at the beside of the critically ill patient. Aim and hypotheses This study aims to investigate the association between dynamic variables that reflect venous congestion and the development of short-term organ failure and mortality in the critically ill. The primary objective of this study is to identify the combination of variables at different time points that indicate venous congestion and predict patient outcome. Secondary objectives are to identify a combination of CCUS variables that precede serum creatine rises in patients who develop acute kidney injury (AKI) after an acute ICU admission {diagnostic}; to identify a combination of variables per organ system or subset of populations to predict short-term organ deterioration and 7-day mortality {prognostic}; to identify a combination of variables over 48 hours of ICU admission that predict long-term (90 day) morbidity and mortality {prognostic} and; to validate multiple prognostic risk scores developed for critically ill ICU patients.

NCT ID: NCT03577262 Not yet recruiting - Healthy Clinical Trials

A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density

Start date: June 25, 2018
Phase: Early Phase 1
Study type: Interventional

Up to 20 subjects will receive an injection with [11C]-UCB-J followed by a PET scan on Days 1 and 28

NCT ID: NCT03577197 Recruiting - Clinical trials for Metastatic Breast Cancer

Southeast Netherlands Advanced Metastatic Breast Cancer Registry

SONABRE
Start date: January 1, 2007
Phase:
Study type: Observational [Patient Registry]

The Southeast Netherlands Advanced Breast Cancer (SONABRE) Registry is a real life multi-center study. The registry aims to include all patients diagnosed with advanced breast cancer as of 2007 in 14 hospitals in the Netherlands. Data on patient, tumor and treatment characteristics are collected retrospectively from electronic medical files by trained registry clerks.