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NCT ID: NCT04056611 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)

FREESIA
Start date: December 26, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.

NCT ID: NCT04051853 Terminated - Clinical trials for CP-B Liver Cirrhosis

Sorafenib PK in Patients With Advanced HCC and Child-Pugh B

SORBE
Start date: May 2014
Phase: Phase 2
Study type: Interventional

Sorafenib has proven efficacy in advanced hepatocellular carcinoma (HCC). Most patients with HCC have impaired liver function due to underlying liver cirrhosis. The severity of liver cirrhosis might have implications on sorafenib metabolism. To date, no data showing unequivocal activity and tolerability of sorafenib in patients with moderate cirrhosis (Child-Pugh (CP)-B) have been published. To specifically address this issue, this study aims to explore population pharmacokinetics of sorafenib and to explore the relationship between sorafenib exposure and its efficacy and toxicity in CP-B patients with irresectable HCC.

NCT ID: NCT04039919 Terminated - Clinical trials for Healthy Participants

A Study to Test the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol

Start date: July 17, 2019
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the pharmacodynamic (PD) interaction between steady-steady treatment with padsevonil (PSL) and Ethanol and the pharmacokinetic (PK) interaction between stead-state treatment with PSL and cannabidiol (CBD).

NCT ID: NCT04036279 Terminated - Clinical trials for Primary Osteoarthritis

NANOS Neck Preserving Hip Stem

NANOS
Start date: January 21, 2010
Phase:
Study type: Observational

The objective of this study is to determine the long-term safety and effectiveness of the NANOS neck preserving stem in terms of radiographic and clinical performance as well as short-, mid- and long-term survivorship

NCT ID: NCT04033159 Terminated - Clinical trials for Centronuclear Myopathy

Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies

Unite-CNM
Start date: January 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)/preliminary efficacy of a new medicine called DYN101 in patients ≥ 16 years of age with CNM caused by mutations in Dynamin2 (DNM2) or Myotubularin1 (MTM1). The trial will consist of a consent, a screening period, a run-in period (if applicable), a Single dose treatment part (SAD) with 4 weeks of follow-up after the drug administration and a washout period of at least 12 weeks (followed by follow-up phone calls), a Multiple dose treatment part (MAD) of 12 weeks of weekly dosing, and a Multiple dose extension part of 12 weeks. All subjects will participate in the SAD, MAD, and MAD extension parts, unless they withdraw. During this time, multiple test will be performed in order to better understand how the drug is distributed and then later removed from the body and whether there any signs of an effect. As this trial is investigational, there is no defined, expected benefit for subjects who participate in this trial except a better knowledge of their disease.

NCT ID: NCT04025632 Terminated - Clinical trials for Immune Mediated Necrotizing Myopathy

Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy

Start date: November 7, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.

NCT ID: NCT04019483 Terminated - Ischemic Stroke Clinical Trials

Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke

ENCLOSE
Start date: January 23, 2018
Phase:
Study type: Observational

Rationale: Over 20.000 people suffer an ischemic stroke in the Netherlands each year. Large artery occlusions are easy to identify and can be treated with endovascular clot removal. 70% of patient will however suffer from a more distal occlusion resulting in small volume stroke or a transient ischemic attack (TIA). Small ischemic lesions are hard to detect with current acute stroke protocols. TIA and small volume stroke patients, are at an increased risk for recurrent stroke, making immediate diagnosis critical. Because thrombo-embolic sources often cause these strokes, identifying and treating the underlying aetiology has the potential to radically lower the risk of recurrence and improve the outcome of these patients. Objectives: 1) To identify clinical and imaging predictors of recurrent stroke; 2) To improve early detection of small volume stroke with admission computed tomography perfusion (CTP) in patients with suspected acute ischemic stroke with small volume stroke or no ischemia on admission imaging. Study design: Prospective, multicenter cohort study. Study population: All patients who visited the University Medical Center (UMC) Utrecht, the Amsterdam University Medical Centers (Amsterdam UMC), location Academic Medical Center (AMC) or the St. Antonius Hospital and who underwent a CT-scan of the brain within 9 hours after onset of stroke symptoms with an age ≥18 years. Within 36 months, 720 patients will be enrolled in the study. Of these patients, 300 patients will be included for the follow-up magnetic resonance imaging (MRI). Main study parameters/endpoints: The main study endpoints are: 1) Stroke recurrence rate at 2 years; 2) Presence and volume of acute ischemic lesions on follow-up diffusion weighted imaging MRI.

NCT ID: NCT04009720 Terminated - Clinical trials for Aortic Valve Stenosis

RESPOND EDGE Post Market Study

RESPOND EDGE
Start date: October 11, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Edge Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

NCT ID: NCT03996473 Terminated - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study to Test the Safety and How Radium-223 Dichloride an Alpha Particle-emitting Radioactive Agent Works in Combination With Pembrolizumab an Immune Checkpoint Inhibitor in Patients With Stage IV Non-small Cell Lung Cancer With Bone Metastases

Start date: March 6, 2020
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the safety and test the efficacy of the combination of radium-223 dichloride and pembrolizumab in patients with stage IV non-small cell lung cancer (NSCLC) with bone metastases who either have not received any systemic therapy for their advanced disease or have progressed on prior immunologic checkpoint blockade with antibodies against the programmed cell death protein-(ligand) 1 (PD-1/PD-L1). In this study researchers want to measure tumor shrinkage in response to treatment and how long that shrinkage lasts and gather information on safety. Pembrolizumab is an immunologic checkpoint blocker that promotes an immune response against the tumor. Radium-223 dichloride is an alpha particle-emitting radioactive agent which kills cancer cells.

NCT ID: NCT03993613 Terminated - Clinical trials for ß-thalassemia Intermedia

Apotransferrin in Patients With β-thalassemia

Start date: March 21, 2019
Phase: Phase 2
Study type: Interventional

The aim of the trial is to study the effect of apotransferrin administration in patients suffering from β-thalassemia intermedia in order to restore the erythropoiesis as reflected by enhanced haemoglobin levels or reduced transfusion dependency.