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NCT ID: NCT03609008 Completed - Headache Clinical Trials

The Effect of Levcromakalim Infusion on the Cranial Arteries Over Several Hours Using a High Resolution MRA Technique in a Randomized, Double-blind Placebo-controlled Design in Healthy Volunteers.

Start date: June 26, 2018
Phase: N/A
Study type: Interventional

Healthy participants vill randomly be allocated in a 2:1 order to receive 1 mg levcromakalim or placebo (isotonic saline) for 20 min. The investigator here examine the effect of levcromakalim infusion on the MMA and the MCA circumference over several hours using a high resolution MRA technique in a randomized, double-blind placebo-controlled design in healthy volunteers. The investigator hypothesized that levcromakalim induces dilatation of cranial arteries.

NCT ID: NCT03608748 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Early Detection of Advanced Fatty Liver Disease

Start date: November 1, 2018
Phase:
Study type: Observational

Non-alcoholic fatty liver disease is the most common cause of chronic liver disease in the western world, affecting one in every three subjects. The investigators hypothesize that a patient population without known liver disease has a certain percentage of patients with liver fibrosis who are undiagnosed and not monitored.

NCT ID: NCT03608735 Completed - Clinical trials for Functional Gastrointestinal Disorders

Prevalence of Functional Gastrointestinal Disorders (FGIDs), Related Signs and Symptoms in Infants/Toddlers in Thailand

GI_Planet
Start date: November 7, 2018
Phase:
Study type: Observational

Prevalence and impact of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand

NCT ID: NCT03608696 Completed - Clinical trials for Neonatal Abstinence Syndrome

Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure

B-PHORE
Start date: August 29, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen.

NCT ID: NCT03608683 Completed - Clinical trials for Proximal Abdominal Aortic Aneurysms

Evaluation of the Treatment of Abdominal Aortic Pathology With Hostile Necks, Para-/Juxra-renal and Sovrarenal Pathology at Short, Mid and Long Term

p-AAA
Start date: July 4, 2018
Phase:
Study type: Observational

Although open repair (OR) is currently reported as the gold standard of treatment, fenestrated endovascular repair (FEVAR) is being increasingly applied for the treatment of proximal abdominal aortic aneurysms (p-AAA) such as hostile-necked, juxta-, para- and supra-renal aortic aneurysms.1 Nevertheless, advantages of FEVAR in terms of lowering postoperative complications, should be balanced with the need of both complex device configurations and operators with large endovascular expertise. The aim of this study is to report the experience of Data from patients treated will be prospectively collected. All post-operative results will be recorded. Major adverse event (MAE) are defined as the presence of one of the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, respiratory failure, stroke and renal insufficiency. Furthermore, the pre-operative contrast-enhanced computed tomography scans (CTA) of all patients, stored in the hospital PACS, will be analyzed on the dedicated workstation with OsiriX software (Pixmeo sarl, Bernex, Switzerland) currently employed in our Unit for imaging assessment. Patients will undergo standard control with the execution of a Doppler ultrasound and creatinine serum levels at 1, 6, 12, 24, 36, 48 and 60 months. A CTA will also be performed at 12 months as per standard clinical practice. of p-AAA treatment.

NCT ID: NCT03608475 Completed - Clinical trials for Developmental Dysplasia of the Hip

Assessing a Limited Ultrasound Protocol in DDH

Start date: July 27, 2018
Phase: N/A
Study type: Interventional

Developmental Dysplasia of the Hip (DDH) is a common diagnosis in children that if untreated may lead to degeneration and arthritis of the hip joint at a young age. Ultrasound imaging is used to monitor progress of the developing hip joint during treatment. Initial data from our practice suggests that interim ultrasounds do not alter the course or outcome of treatment. Additionally, these ultrasounds add significant time to clinic visits and carry a substantial cost to the health care system. The goal of this study is to determine if limiting the number of ultrasounds during treatment results in the same outcomes while also evaluating the amount of time and money saved by omitting the ultrasounds.

NCT ID: NCT03608423 Completed - Clinical trials for Intracerebral Hemorrhage

Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study

DIST pilot
Start date: December 3, 2018
Phase: N/A
Study type: Interventional

Background: Intracerebral hemorrhage (ICH) accounts for 15-20% of all strokes in Western Europe, and contributes profoundly to mortality and disability. Thirty day case fatality is 40% and of those surviving, only few gain independence. Except for stroke unit care and early blood pressure lowering there is currently no treatment of proven benefit. Important predictors of poor outcome are increasing age, decreasing Glasgow Coma Scale score, increasing ICH volume, presence of intraventricular hemorrhage and deep or infratentorial location. In addition, secondary injury due to development of edema and inflammatory response, contribute to disability and death. Surgical treatment, mostly comprising craniotomy, has so far not been proven effective. In the largest trials STICH and STICH II, the median time to treatment was more than 24 hours, which may be an important explanation for the lack of treatment effect. The investigators hypothesize that early, minimally-invasive, endoscopy-guided surgery improves outcome in patients with spontaneous supratentorial ICH. Objective: to study safety, feasibility and technical effectiveness of minimally-invasive endoscopy guided surgery for treatment of spontaneous supratentorial ICH and to estimate the potential effect on outcome. Study design: a multicenter, prospective intervention study (phase II) with a telephonic follow up interview at 90 and 180 days.The pilot study serves as a prelude to a randomized phase III trial in which the investigators aim to assess whether this intervention improves functional outcome at 90 and 180 days. Study population: patients with spontaneous supratentorial ICH of 18 years and older. Forty patients in three participating centers (Radboudumc, Erasmus MC and AMC) will undergo minimally-invasive endoscopy-guided surgery. Three-hundred-and-sixty patients undergoing standard medical treatment in one of 7 other participating centers, will be included as a control group. Intervention: minimally-invasive endoscopy-guided surgery within 8 hours of symptom onset, in addition to standard medical management. Primary study outcomes: safety (death within 24 hours, 7-day procedure related complications, 7-day mortality, 30-day mortality) and technical effectiveness (proportional volume reduction, proportion of participants with volume reduction > 60 and >80%, and proportion with remaining clot volume <15mL). Secondary outcomes: modified Rankin Scale score at 90 and 180 days after ICH (functional outcome).

NCT ID: NCT03608332 Completed - Clinical trials for Diaphragmatic Ultrasound in Weaning

Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation

Start date: April 30, 2018
Phase: N/A
Study type: Interventional

To assess value of adding ultrasound derived variables to the usual parameters on success rate of weaning from mechanical ventilation in critically ill patients and to validate sensitivity and specificity of ultrasound derived variables (thickening fraction /diaphragmatic excursion)

NCT ID: NCT03608254 Completed - Clinical trials for Vascular Health of Postmenopausal Women

Acute Effects of Watermelon on Vascular Function and Serum Lycopene

Start date: November 5, 2015
Phase:
Study type: Observational

This study aimed to examine the effects of a one-time dose of 100% watermelon juice on circulating lycopene levels and measures of vascular health among a cohort of postmenopausal women.

NCT ID: NCT03608228 Completed - Clinical trials for Parkinson's Disease Patients Undergoing Deep Brain Stimulation (DBS) Surgery

Invasive Approach to Model Human Cortex-Basal Ganglia Action-Regulating Networks

Start date: December 6, 2016
Phase:
Study type: Observational

The brain networks controlling movement are complex, involving multiple areas of the brain. Some neurological diseases, like Parkinson's disease, cause abnormalities in the brain networks. Deep brain stimulation is a treatment that is used to treat these types of neurological diseases. Through this research, the investigators will take advantage of the unique opportunity provided by awake deep brain stimulation surgery to learn more about how the brain functions in a diseased state and how deep brain stimulation changes these networks. This study aims to enroll up to 75 subjects over a period of 2.5 years. Those who participate in the study will spend up to 40 minutes during their deep brain stimulation surgery during which researchers will record signals from deep structures within the brain as well as the surface of the brain using electrodes that are temporarily placed for research purposes. During the study, researchers will record signals while subjects perform three different tasks, in some cases while the brain is stimulated. Study participation is limited to the intraoperative environment with no additional study visits required.