Clinical Trials Logo

Filter by:
NCT ID: NCT04396899 Recruiting - Heart Failure Clinical Trials

Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure

BioVAT-HF
Start date: February 3, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The BioVAT-HF trial will test the hypothesis that cardiomyocyte implantation via engineered heart muscle (EHM), the proposed investigational medicinal product (IMP; designated "Biological Ventricular Assist Tissue" or BioVAT), results in sustainable remuscularization and biological enhancement of myocardial performance in the failing heart. EHM are constructed from defined mixtures of induced pluripotent stem cell (iPSC)-derived cardiomyocytes and stromal cells in a bovine collagen type I hydrogel. Comprehensive preclinical testing confirmed the rationale for the clinical translation of the myocardial remuscularization strategy by EHM implantation. The patient target population for EHM therapy is patients suffering from advanced heart failure with reduced ejection fraction (HFrEF; EF: ≤35%) and no realistic option for heart transplantation.

NCT ID: NCT04396574 Recruiting - Migraine Clinical Trials

A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

PIONEER-PEDS2
Start date: June 30, 2020
Phase: Phase 3
Study type: Interventional

The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

NCT ID: NCT04396236 Recruiting - Migraine Clinical Trials

A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

PIONEER-PEDS1
Start date: June 15, 2020
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.

NCT ID: NCT04393519 Recruiting - Portal Hypertension Clinical Trials

Non-invasive Evaluation Program for TIPS and Follow Up Network 2 (NEPTUN2)

NEPTUN2
Start date: May 12, 2020
Phase:
Study type: Observational

Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.

NCT ID: NCT04393389 Recruiting - Clinical trials for Peripheral Artery Disease

Acotec DCB Post Market Clinical Follow-up

FLOWER
Start date: June 4, 2020
Phase:
Study type: Observational

All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical Category (RCC) 4-6

NCT ID: NCT04392947 Recruiting - Clinical trials for Major Depressive Disorder

Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation

TBS-D
Start date: September 29, 2020
Phase: N/A
Study type: Interventional

This is a randomized, double-blind, sham-controlled multicenter clinical trial. The aim is to provide evidence for efficacy of TBS in the treatment of patients with major depression. There will be a direct comparison between combined cTBS/iTBS with sham TBS. Overall, 236 patients with major depression will be randomized either to active TBS or sham TBS in a 1:1 ratio. The planned stimulation paradigms will be applied as add-on therapy to standard therapy (antidepressive medication and / or psychotherapy). Patients will receive 30 stimulation sessions in a 6-week treatment period (one session daily from Monday to Friday). Follow up assessments are scheduled 1 and 3 months after end of treatment period.

NCT ID: NCT04392258 Recruiting - Clinical trials for Ventricular Tachycardia

Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Cardiopulmonary Resuscitation

Thyro-CPR
Start date: May 1, 2021
Phase:
Study type: Observational

Time-limited adaptive responses of thyroid function are common in the critically ill. About 70% of all patients treated on intensive care units develop a so-called non-thyroidal illness syndrome (NTIS) or TACITUS (thyroid allostasis in critical illness, tumours, uraemia and starvation), which is marked by low serum concentrations of the thyroid hormone T3 and other adaptive reactions of thyroid homeostasis. Occasionally, temporarily elevated concentrations of thyrotropin (TSH) and peripheral thyroid hormones are to be observed, especially after cardiopulmonary resuscitation (CPR). However, the available evidence is limited, although abnormal concentrations of thyroid hormones after CPR have occasionally been reported. Aim of the planned study is to investigate the thyrotropic (i.e. thyroid-controlling) partial function of the anterior pituitary lobe immediately after CPR. It is intended to evaluate statistical measures of TSH concentration and peripheral thyroid hormones in de-identified datasets (protocol A). Additionally, a prospective sub-study (protocol B) aims at a more precise description of pituitary and thyroid responses by means of serial investigations in routine serum samples, both immediately after CPR and during the course of ongoing treatment. This includes the evaluation of additional possible predictors, too. Primary endpoint of the study is changed TSH concentration immediately after CPR compared to the TSH value 24 hours later. Secondary endpoint is the relation between thyroid-controlling pituitary function and mortality. A high proportion of patients undergoing CPR will eventually receive iodinated radiocontrast media (e.g. for computed tomography or coronary angiography). This is one of the reasons why early identifying subjects at high risk for possible iodine-induced thyrotoxicosis is important. Increased oxygen consumption of the heart in hyperthyroidism is one of the reasons for high mortality in thyrotoxicosis. Therefore, accurate diagnosis of alterations in the hypothalamus-pituitary-thyroid (HPT) axis is of paramount importance.

NCT ID: NCT04387357 Recruiting - Dementia Clinical Trials

Multimodal Imaging in the Study of Disorientation in the Hospital

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

The purpose of this study is to investigate whether markers of brain structure and function from MRI are associated with different levels of spatial orientation and gait parameters in people with mild cognitive impairment or dementia due to Alzheimer's disease when walking through a real world environment.

NCT ID: NCT04387331 Recruiting - Clinical trials for Pseudophakic Bullous Keratopathy

The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK

Start date: May 11, 2020
Phase:
Study type: Observational

This study aims to investigate the influence of postoperative head position on clinical outcomes after DMEK via a wearable sensor.

NCT ID: NCT04385290 Recruiting - Clinical trials for Acute Myeloid Leukemia

Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)

MOSAIC
Start date: September 4, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II clinical trial evaluates the safety and efficacy of the combined administration of midostaurin and gemtuzumab ozogamicin in the frame of first-line standard chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients displaying a cytogenetic aberration or fusion transcript in the core-binding factor (CBF) genes or FMS-like tyrosine Kinase 3 (FLT3) mutation.