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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: 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: 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: 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: 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.

NCT ID: NCT03577015 Recruiting - Clinical trials for Disseminated Intravascular Coagulation

International Prospective Registry of Disseminated Intravascular Coagulation

Start date: November 1, 2017
Phase:
Study type: Observational [Patient Registry]

Objectives: to evaluate the current diagnostic and therapeutic approaches for sepis-associated disseminated intravascular coagulation (DIC) in a large prospective registry. Design: prospective, multicenter, international registry. Study population: patients 18 years or older with severe infection to be potentially associated with DIC will be eligible for the study. The clinical visits and monitoring of the patients will follow local routine practices. No specific imaging tests or laboratory evaluations will be required and patients will be evaluated and treated according to local policy. All the involved centers will be asked to update information on included patients at 2, 4, 6, 8, 10 and 28 days after severe infection diagnosis. Study outcomes: The primary outcome of the study is the development of DIC. Secondary outcomes are thrombotic (arterial and venous) and bleeding events, overall mortality at 28 days. Study sample, feasibility, and analysis plan: We plan to enroll a minimum of 1000 patients.

NCT ID: NCT03573596 Recruiting - CML, Relapsed Clinical Trials

Persistence of MR3 in Chronic Myeloid Leukemia (CML) After a 2nd Stop of TKI Treatment

DASTOP2
Start date: February 1, 2018
Phase: Phase 2
Study type: Interventional

This study will enroll CML patients who have failed a first TKI stopping attempt. After failure and at least a year of TKI treatment, patients will proceed to dasatinib treatment for another 2 years. If MR4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. After verification of MR4, TKI treatment will be stopped and patients followed in the same manner as after first stop. If MMR is lost (BCR-ABL >0.1% (IS)), TKI treatment will once again be restarted.

NCT ID: NCT03571789 Recruiting - Atrial Fibrillation Clinical Trials

Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients

CAPTURE
Start date: September 12, 2017
Phase: N/A
Study type: Interventional

Vine™ is a permanent carotid filter designed to provide protection against embolic stroke in people with atrial fibrillation. It is implanted bilaterally in the common carotid arteries from a thin needle under ultrasound guidance. The procedure is performed without general anesthesia and takes minutes. The safety, feasibility and tolerability of Vine™ will be evaluated. Patients who are eligible will receive Vine™ and will be followed-up for a year after device implantation.

NCT ID: NCT03571373 Recruiting - Ulcerative Colitis Clinical Trials

PIBD-SETQuality; the PIBD-NET Inception Cohort and Safety Registry

Start date: January 3, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors.