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NCT ID: NCT03739840 Terminated - Clinical trials for Drug-Resistant Epilepsy

A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy

DUET
Start date: March 6, 2019
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.

NCT ID: NCT03720080 Terminated - Type1diabetes Clinical Trials

The OpenAPS_ShadowMode Study

Start date: May 16, 2019
Phase:
Study type: Observational

The "Open Artificial Pancreas System (OpenAPS)" was designed to quickly spread technology and knowledge about the construction of artificial pancreas systems to patients with diabetes without awaiting clinical regulatory approval. OpenAPS is based on a privately shared software programs and available insulin pumps and glucose sensors. OpenAPS includes a "decision making" algorithm, which issues adaptions of basal rates to insulin pumps, which represents all fundamental aspects of closed loop artificial pancreas systems. The present study aims to compare the accuracy and performance of a self-constructed OpenAPS system with the approved hybrid closed loop system Medtronic Minimed 670G. While wearing the Medtronic Minimed 670G in automode, study participants will wear an OpenAPS system in parallel, which does calculate basal rate adaptions based on continuous glucose monitoring data and its respective algorithm. The investigators aim to recruit 15 participants in an open label, single-center, single-arm, observational study. Insulin injection will only be provided by the Medtronic 670G HCL system (Basal rate insulin). The OpenAPS system will be worn contemporaneously, calculate recommended basal rate insulin adjustments but will not inject insulin. The maximum treatment period will be 2 weeks per patient.

NCT ID: NCT03699410 Terminated - Clinical trials for Locally Advanced Rectal Cancer

Observational Study on Rectal Cancer to Verify if Response After Chemo-radiotherapy Can be Predicted With a Particular Blood Test.

LiBReCa
Start date: August 28, 2018
Phase:
Study type: Observational

Research project for patients with locally advanced rectal cancer in which biological material and health-related personal data are collected. The aim is to investigate if an additional method (liquid biopsies) can predict the response after chemo-radiotherapy and before surgery.

NCT ID: NCT03689244 Terminated - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment

SELECT
Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in participants with inoperable or persistent/recurrent CTEPH.

NCT ID: NCT03687125 Terminated - Clinical trials for Multiple Myeloma in Relapse

Tinostamustine Conditioning and Autologous Stem Cell

TITANIUM1
Start date: October 15, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1 The primary objectives of Phase 1 of this study are to: - Establish the safety, toxicity, and maximum tolerated dose (MTD) of the tinostamustine conditioning regimen. - Identify the recommended Phase 2 dose (RP2D) of tinostamustine for use in the Phase 2 portion of the study. The secondary objective of Phase 1 of this study is to: - Investigate the pharmacokinetics (PK) of tinostamustine.

NCT ID: NCT03680066 Terminated - Food Allergy Clinical Trials

Study to Assess Tolerance of Traces in Peanut/Tree Nut Allergic Children.

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

This protocol will help better define whether patients with peanut and/or tree nut food allergy can tolerate traces in products with precautionary allergen labelling.

NCT ID: NCT03651245 Terminated - Deafness Clinical Trials

European Alpha-Mannosidosis Participant

EUMAP
Start date: August 20, 2018
Phase:
Study type: Observational

International, multicenter, observational, longitudinal monitoring study to investigate the prevalence of Alpha-Mannosidosis in participants at risk for Alpha-Mannosidosis.

NCT ID: NCT03649672 Terminated - Clinical trials for Neuromuscular Blockade

The Validity and Tolerability of Awake Calibration of the TOF Watch SX Monitor

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

Neuromuscular blocking agents (NMBAs) are frequently used in anesthesia and quantitative monitoring of neuromuscular block is standard care. Normally the calibration of the neuromuscular monitor is done after anesthesia induction to avoid patient discomfort. Under certain circumstances there is no time for the calibration process. In the so-called rapid sequence induction (RSI) the neuromuscular blocking agent has to be injected immediately after the induction agent. As the neuromuscular monitor cannot be calibrated, precise neuromuscular monitoring is not possible, and this is of particular disadvantage, when high doses of non-depolarizing neuromuscular blockers are injected to fasten the onset of neuromuscular block. The primary objective is to validate the measurements of the TOF Watch SX® monitor calibrated in awake patients by comparing them with the measurements obtained with the TOF Watch SX® monitor calibrated after anesthesia induction (Gold standard). The secondary objective is to evaluate the tolerability of the awake calibration process of the TOF Watch SX® monitor.

NCT ID: NCT03648619 Terminated - Oncology Clinical Trials

Automatized "Semi-Whole-Body"-MRI Protocol for Cancer Staging

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

The aims of this study are - to evaluate the image quality and robustness of a whole-body MRI protocol by using an innovative partially automatic algorithm (DOT engine), that automatically optimizes protocol parameters depending on body region (e.g. thorax versus abdomen) - to compare lesion detectability between wb-MRI and the gold standard positron emission tomography (PET)/CT - to compare patient comfort between PET/CT and wb-MRI using a dedicated questionnaire - to compare duration of image acquisition with regards to cost-effectiveness

NCT ID: NCT03637231 Terminated - Clinical trials for Coronary Artery Disease

Ultra-low-dose CACS in a Large Population

ULDCACSLARGE
Start date: July 5, 2018
Phase: N/A
Study type: Interventional

Radiation exposure to patients from CT for CAC scoring has steadily decreased in recent years. This is mainly achieved through lowering tube currents alongside with the introduction of iterative reconstruction algorithms which allow compensating for increased image noise. However, the greatest radiation dose reduction can be obtained by reducing peak tube voltage. Yet lowering peak tube voltage remains challenging because tissue attenuation is closely related to photon energy, thus rendering the established thresholds for calculating CAC scores (i.e. Agatston scores) incomparable if peak tube voltages other than the standard 120 kilovolt peak (kVp) are applied. The investigators have developed novel tube-adapted thresholds for CAC scoring by CT at 80 kVp and 70-kVp tube voltage and have shown that these novel thresholds are valid, yielding results closely comparable to the standard 120-kVp protocol. The present study aims to optimize application of such low-dose scans in a general population through assessment of the impact of physiological patient parameters on image parameters such as image noise which per se may impact the accuracy and feasibility of ultra-low-dose CAC scoring with reduced tube voltage. Furthermore, the prognostic performance of such low-dose CAC scoring will be elucidated.