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NCT ID: NCT03572933 Completed - Clinical trials for CDKL5 Deficiency Disorder

Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder

Marigold
Start date: June 30, 2018
Phase: Phase 3
Study type: Interventional

A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.

NCT ID: NCT03571256 Completed - Tourette Syndrome Clinical Trials

A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)

ARTISTS2
Start date: May 31, 2018
Phase: Phase 3
Study type: Interventional

Standard placebo-controlled, double-blind study design (TEV-50717 [low dose and high dose] vs. placebo in a 1:1:1 ratio) was chosen to determine whether study drug treatment results in a statistically significant effect on the tics in participants with TS.

NCT ID: NCT03570697 Completed - Clinical trials for Coronary Artery Disease (CAD)

Imaging of Coronary Plaques in Participants Treated With Evolocumab

Start date: November 19, 2018
Phase: Phase 3
Study type: Interventional

To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in participants with non-ST-elevation acute coronary syndrome (NSTE-ACS) who are taking maximally tolerated statin therapy.

NCT ID: NCT03569072 Completed - Clinical trials for Non Small Cell Lung Cancer Stage III

High Intensity Functional Image Guided Vmat Lung Evasion

HI-FIVE
Start date: July 1, 2018
Phase: N/A
Study type: Interventional

This study is being performed to assess the feasibility of adapting radiotherapy plans based on functional lung information and increasing the dose to the primary tumour. This is a single arm interventional pilot study involving 20 patients. Aims Primary: to assess the feasibility of using ventilation and perfusion positron emission computed tomography (V/Q PET/CT) scans to adapt radiotherapy plans using Volumetric Modulated Arc Therapy (VMAT) to avoid regions of functional lung and deliver a higher dose to the primary tumour Secondary: to assess the incidence of acute and late radiotherapy toxicities, to quantify regional ventilation loss and regional perfusion loss on post treatment V/Q PET/CT, to assess associations of V/Q PET/CT with other functional lung imaging techniques, to assess overall survival, progression free survival and quality of life outcomes. Participants: 20 patients stage IIIa-c non-small cell lung cancer for curative intent radiotherapy. Methods: All patients will receive functional lung adapted 60 Gray (Gy) in 30 fractions to the primary and nodal planning target volume with a simultaneous integrated boost to the primary tumour to a total dose 69Gy in 30 fractions. Expected outcomes: That functionally adapted lung radiotherapy using V/Q PET/CT imaging and VMAT planning is technically feasible.

NCT ID: NCT03566238 Completed - PFIC2 Clinical Trials

This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2

PEDFIC 1
Start date: May 16, 2018
Phase: Phase 3
Study type: Interventional

Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC) types 1 and 2.

NCT ID: NCT03565900 Completed - Clinical trials for Pneumococcal Infections

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)

Start date: September 12, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to 1) evaluate the safety and tolerability, and immunogenicity of blinded V114 and Prevnar 13™ within each vaccination group, and 2) evaluate the safety and tolerability, and immunogenicity of PNEUMOVAX™23 (administered as open label, 12 months after allogeneic hematopoietic stem cell transplant [allo-HSCT] in participants who do not develop chronic graft-versus-host disease [GVHD]).

NCT ID: NCT03563183 Completed - Herpes Zoster Clinical Trials

A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022

Start date: June 5, 2018
Phase:
Study type: Observational

As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study participants completed quality of life (QoL) questionnaires. The only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study. The purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.

NCT ID: NCT03559166 Completed - Fibrosis Clinical Trials

First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis

Start date: July 11, 2018
Phase: Phase 1
Study type: Interventional

First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.

NCT ID: NCT03559062 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis

Start date: May 17, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).

NCT ID: NCT03551769 Completed - Alzheimer Disease Clinical Trials

Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production

Start date: August 5, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.