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NCT ID: NCT03832998 Recruiting - Migraine Clinical Trials

Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine

OASIS(CM)
Start date: September 5, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine. The study hypothesis is that in pediatric participants with chronic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).

NCT ID: NCT03831126 Recruiting - Pregnancy Clinical Trials

Stress and Fetal Brain Development

Start date: February 1, 2019
Phase:
Study type: Observational

The current proposal aims to investigate the impact of acute stress on the fetal autonomic nervous system.

NCT ID: NCT03827798 Recruiting - Clinical trials for Hidradenitis Suppurativa

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa

Start date: February 27, 2019
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006, MAS825 , LOU064 and VAY736 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.

NCT ID: NCT03827226 Recruiting - Breech Presentation Clinical Trials

Breech External Cephalic Version Intervention Trial

BREXIT
Start date: February 5, 2019
Phase:
Study type: Observational

A prospective study assessing the use of external cephalic version for the management of breech presentation in pregnancy.

NCT ID: NCT03825900 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Transcranial Direct Current Stimulation and the Interaction Between Chronic Pain and the Intestinal Epithelial Barrier in Patients With Chronic Inflammatory Bowel Diseases (IBD)

Start date: June 1, 2018
Phase: Phase 3
Study type: Interventional

In the study the investigators aim to test whether transcranial direct current stimulation (tDCS) induced pain reduction is in association with functional changes in the brain measured with magnetic resonance imaging (MRI) and also with a change in permeability of the intestinal epithelial barrier in patients with chronic inflammatory bowel diseases (IBD) Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases, which is in association with changes in the brain measured via MRI. Additionally, transcranial direct current stimulation and the induced pain reduction influence the permeability of the intestinal epithelial barrier

NCT ID: NCT03821428 Recruiting - Clinical trials for Gagging During Transesophageal Echocardiography

Acupuncture for Relief of Gag Reflex

AcuGag
Start date: January 13, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to test whether stimulation of acupuncture points CV24 and P6 is better than placebo acupuncture in treatment of gagging in patients undergoing elective transesophageal echocardiography (TEE)

NCT ID: NCT03821142 Recruiting - Clinical trials for Pelvic Organ Prolapse

Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair

CASPO
Start date: March 10, 2021
Phase: N/A
Study type: Interventional

Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal pelvic organ prolapse repair in women with anterior POP with or without apical vaginal involvement

NCT ID: NCT03820765 Recruiting - Clinical trials for Complication of Renal Dialysis

Cessation of Dialysis Treatment in Reinbek and Geesthacht

CoDiRaG
Start date: January 1, 2016
Phase:
Study type: Observational [Patient Registry]

Currently, approximately 80.000 patients with end stage renal disease (ESRD) in Germany undergo chronic renal replacement therapy, either as hemodialysis or peritonealdialysis. Since the nationwide registry for chronic dialysis patients (QuasiNiere) was terminated in 2006, no data exist from that time on regarding alterations in morbidity and mortality of patients with end stage renal disease in Germany. With this study we start a single center prospective registry of all patients undergoing hemodialysis or peritonealdialysis therapy in our two nephrology departments Reinbek and Geesthacht. In these centers we perform approximately 34.000 hemodialysis sessions and supervise about 10.000 peritoneal treatment days of about 300 ESRD patients annually. The aim of the study is to analyze all patients who stopped dialysis treatment in our centers due to death, kidney transplantation, recovery of renal function or other causes. Patients characteristics such as underlying renal diseases, duration of dialysis, co-morbidities as well as laboratory parameters will be recorded. The data is collected with an Microsoft Access Database and analyzed by a statistician of the University of Luebeck (Germany). Power calculations revealed, that at least 200 patients were necessary to detect differences in particular interesting variables such as vascular access or the need of palliative care. During the last years at least 50 patients stopped chronic renal replacement therapy at out centers annually. Thus, the first interims evaluation is expected after 4 years. The results of our study are important to estimate the development of patient age and renal diseases responsible for dialysis therapy in our centers. Moreover, the results may add important information to our internal quality assurance.

NCT ID: NCT03820492 Recruiting - Coronary Stenosis Clinical Trials

Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

OPTICO-LM
Start date: May 28, 2019
Phase: N/A
Study type: Interventional

Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate judgement of the prognostic significance of LM stenosis is essential to improve patients' prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries a Class Ia recommendation to assess functional significance of intermediate coronary stenosis in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area (MLA) represents an accurate measure to determine LM significance as shown in multiple studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging method with a greater spatial resolution (15μm vs. 100μm), faster image acquisition and facilitated image interpretation, OCT derived-MLA has never been validated against FFR and accordingly, it is not mentioned in the current guidelines for myocardial revascularization. Coronary computed tomography angiography (CTA) has emerged as a noninvasive alternative of coronary angiography with its excellent negative predictive value, while the positive predictive value of CTA is limited. Computational fluid dynamics is an emerging method that enables prediction of blood flow in coronary arteries and calculation of FFR from computed tomography (FFRCT) noninvasively. Noninvasive and accurate assessment of functional significance would bring a great benefit for patients with LM stenosis, however, there are no data to evaluate the diagnostic accuracy of FFRCT for LM stenosis in comparison with FFR and minimal lumen area derived by OCT. This study will investigate the optimal OCT-derived MLA cut-off point and the diagnostic performance of FFRCT for intermediate LM stenosis compared with FFR ≤0.8 as a reference standard.

NCT ID: NCT03820375 Recruiting - Clinical trials for Embolic Stroke of Undetermined Source

Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke

Catch-up-ESUS
Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

Up to know, there is no clear diagnostic and therapeutic pathway for patients with embolic stroke of undetermined source (ESUS). This prospective registry study, which follows up adult ESUS patients for 36 months, is intended to provide important data for the detection of an individual approach in ESUS patients based on a structured diagnostic and therapeutic pathway.