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NCT ID: NCT04640584 Recruiting - Lower Extremity Clinical Trials

C-Brace Prospective Registry

Start date: April 2015
Phase:
Study type: Observational [Patient Registry]

To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.

NCT ID: NCT04639310 Terminated - Epilepsy Clinical Trials

XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy

EPIK
Start date: March 29, 2021
Phase: Phase 3
Study type: Interventional

To investigate the potential antiseizure effects of adjunctive XEN496 (ezogabine) compared with placebo in children with KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE).

NCT ID: NCT04639258 Terminated - Clinical trials for Aortic Valve Stenosis

Medtronic Evolutâ„¢ EXPAND TAVR I Feasibility Study

Start date: May 28, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolutâ„¢ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.

NCT ID: NCT04639141 Completed - Anxiety Clinical Trials

Combined Gut-brain Therapy for Children With Autism

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

CLINICAL ISSUE: Children with Autism Spectrum Disorder (ASD) are four times more likely to suffer with functional gastrointestinal disorders (FGIDs) than their neurotypical peers. The presence of FGIDs are linked to increased undesirable behaviour and ASD severity. Current behavioural approaches for ASD therapy do not alleviate the high comorbidity of FGIDs within this population. BACKGROUND: Dysfunction of the microbiome-gut-brain (MGB) axis has been implicated in pathogenesis of both ASD and FGIDs. Probiotics and prebiotics can modulate the gut microbiome and research has shown efficacy at improving gastrointestinal (GI) symptoms in children with ASD and neurotypical (NT) children with FGIDs. Gut-directed hypnotherapy (GDH) has shown utility in treating FGIDs in NT children and adults but has not yet been trialed in children with ASD. Targeting therapies to address the dysfunction of the bidirectional MGB axis will likely be more effective than either brain/behavioural or gut-based therapy alone. HYPOTHESIS: A synbiotic (prebiotic + probiotic mixture) with combined GDH will be more effective than a synbiotic alone at reducing GI symptoms in children with ASD aged 5.00 to 10.99 years over a 12-week period.

NCT ID: NCT04639050 Recruiting - Alzheimers Disease Clinical Trials

Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease

Start date: March 15, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to moderate Alzheimer's disease (AD), who are amyloid positive based on amyloid positron emission tomography (PET) scan.

NCT ID: NCT04638634 Terminated - Clinical trials for Coronavirus Disease 2019 (COVID-19)

Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects

Start date: February 2, 2021
Phase: Phase 1
Study type: Interventional

CSL760 is a human hyperimmune product of the purified gamma immunoglobulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). CSL is evaluating CSL760 as a passive immunotherapy for COVID-19 (Coronavirus Disease 2019).

NCT ID: NCT04638543 Completed - Gout Clinical Trials

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia

Start date: November 27, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics study of 6 different dose regimens of ABP-671 compared with placebo. The study will consist of three sequential groups with escalating total daily ABP-671 doses. Each group is further divided into two dose cohorts with either QD or BID dosing. Each dose group will have 3 stages following screening: Run-in, Dose Evaluation, and Follow-up.

NCT ID: NCT04638517 Recruiting - Pulmonary Fibrosis Clinical Trials

The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically Improve Health Outcomes for Adults and Children With Pulmonary Fibrosis

Start date: September 7, 2021
Phase: Phase 2
Study type: Interventional

TELO-SCOPE is a national, multi-centre, double-blind, placebo-controlled, randomised (2:1) trial which will test the hypothesis that, compared to placebo, the addition of danazol to standard of care in pulmonary fibrosis associated with short telomeres is safe and will result in reduced telomere attrition.

NCT ID: NCT04638153 Terminated - Achondroplasia Clinical Trials

A Study Of Safety, Tolerability And Effectiveness Of Recifercept In Children With Achondroplasia

Start date: December 2, 2020
Phase: Phase 2
Study type: Interventional

Approximately 63 participants will be randomized to one of three doses to receive Recifercept either - Low Dose - Medium Dose - High Dose Participants will will attend the clinic at baseline and at Day 1, 4, 8, 15, 29 & then Month 2, 3 6, 9 & 12. Assessments include safety, blood sampling, physical examination, vital signs, anthropometric body measurements & patient/caregiver quality of life questionnaires Participants will received treatment with Recifercept for 12 months. All participants who complete the study and in the opinion of the investigator, continue to have a positive risk:benefit profile, will be offered to enroll into an open-label extension (OLE) study. A PK cohort will include 12 participants who will randomly receive a single dose of 3 mg/kg of Phase 2 study (process 1c) formulation and a single dose of 3 mg/kg of the proposed Phase 3 (process 2) study formulation in a cross over study. Dose of the cohort could be changed due to emerging safety and efficacy data in the study.

NCT ID: NCT04637763 Recruiting - Lymphoma Clinical Trials

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

Start date: May 26, 2021
Phase: Phase 1
Study type: Interventional

CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.