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NCT ID: NCT03741062 Terminated - Pain Measurement Clinical Trials

Effects of Laser Stimulation on Wound Healing of Human Palatal Tissue

Start date: January 24, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effects of photobiomodulation (PBM) with an Er:YAG laser on the palatal donor site following subepithelial connective tissue graft (SECTG) surgery. Patient-centred outcomes and wound healing will be compared between a control group, who receives no laser treatment, and the test group receiving PBM therapy. It is hypothesized that laser stimulation will have a beneficial effect on the patient's post-operative experience as well as the healing of the tissues.

NCT ID: NCT03738800 Terminated - Lamellar Ichthyosis Clinical Trials

A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis

Start date: May 1, 2019
Phase: Phase 2
Study type: Interventional

This is a phase 2 randomized, multi-center, double-blind, vehicle controlled, 90 day, safety, efficacy, and systemic exposure study followed by a 90 day open-label extension of trifarotene cream in adults and adolescents with autosomal recessive ichthyosis with lamellar scale.

NCT ID: NCT03738423 Terminated - Atopic Dermatitis Clinical Trials

Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Start date: November 13, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess the efficacy of REGN3500 monotherapy in Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD. Secondary objectives are to: - Assess the safety and tolerability of subcutaneous (SC) doses of REGN3500 monotherapy in adult patients with moderate-to-severe AD - Assess the Pharmacokinetics (PK) of REGN3500 in adult patients with moderate-to-severe AD - Assess the immunogenicity of REGN3500 in adult patients with moderate-to-severe AD

NCT ID: NCT03733444 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care

ISABELA2
Start date: November 5, 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study was to see how GLPG1690 works together with the current standard treatment on your lung function and IPF disease in general. The study also investigated how well GLPG1690 is tolerated (for example if you get any side effects while on study drug).

NCT ID: NCT03731728 Terminated - Clinical trials for Major Depressive Disorder

Group CBT and Exercise in Management of Depression

Start date: April 15, 2019
Phase: N/A
Study type: Interventional

INTRODUCTION: There is strong evidence indicating the effectiveness of Cognitive-Behavior Therapy (CBT) in the management of Major Depressive Disorder (MDD) and some clinical trials indicating physical exercise (PE) as an effective treatment for the disorder. However, few studies have evaluated the effect of group CBT or PE compared to wait-listing to receive treatment as usual (TAU) in the management of MDD. This study will evaluate and compare the effectiveness of: 1) group CBT plus wait-listing for TAU; versus 2) group PE plus wait-listing for TAU; versus 3) only wait-listing for TAU in management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or PE (plus wait-listed for TAU) arms of the study will achieve superior outcomes compared to participants only wait-listed for TAU. METHODS AND ANALYSIS: This is a prospective rater-blinded randomized controlled trial assessing the benefits for participants with MDD. 120 patients with MDD referred to Addiction and Mental Health (AMH) clinics in Edmonton Zone who are informed about the study and consent to participate will be randomly assigned to one of the 3 arms of the study: 1) 40 participants wait-listed for TAU will receive weekly sessions of group CBT for 14 weeks; 2) 40 participants wait-listed for TAU will receive PE 3 times a week for 14 weeks; and 3) 40 participants will only be wait-listed for TAU. Participants will be assessed at enrollment, 3 and 6 months post enrolment, mid-treatment, and at treatment completion . Their assessments will cover primary outcomes including functional variables (relationships, well-being, physical activity) and symptom variables (changes in depressive symptoms scores). Secondary client outcomes will be service variables (e.g. patient compliance, retention in treatment, patient satisfaction). In addition, participants in the intervention groups will be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point. ETHICS AND DISSEMINATION: The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong Amendment) and Good Clinical Practice (Canadian Guidelines). Written informed consent will be obtained from each subject. The study has received ethical clearance from Health Ethics Research Board of the University of Alberta (Ref. # Pro 00080975) and operational approval from the provincial health authority (AHS # 43638). The results will be disseminated at several levels, including patients, practitioners, academics/researchers, and healthcare organizations.

NCT ID: NCT03713320 Terminated - Clinical trials for Cutaneous T-Cell Lymphoma/Mycosis Fungoides

SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides

SOLAR
Start date: April 2, 2019
Phase: Phase 2
Study type: Interventional

The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype. Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries. Participants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects. Participants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.

NCT ID: NCT03712787 Terminated - Alzheimer's Disease Clinical Trials

An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)

Start date: March 22, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in participants with early AD.

NCT ID: NCT03712345 Terminated - Clinical trials for Microscopic Polyangiitis (MPA)

Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA

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

The purpose of this study is to investigate the safety and tolerability of two dose regimens of IFX-1 as add-on to standard of care (SOC) in subjects with GPA and MPA compared with placebo.

NCT ID: NCT03712046 Terminated - Clinical trials for Diabetic Foot Infection

Comparison of FDG PET and Bone Scintigraphy/Labelled Leukocyte/Gallium Scintigraphy in Diabetic Foot Osteomyelitis

Start date: January 15, 2019
Phase: N/A
Study type: Interventional

Diabetic foot osteomyelitis is a common and serious complication of diabetes. While the diagnosis of soft tissue infection can be made with simple physical examination in most cases, bone involvement can be harder to diagnose, often requiring medical imaging. In addition to conventional radiological examinations (x-ray and MRI) nuclear medicine procedures can also provide important physiological information in these patients. These procedures include triple phase bone scan combined with Gallium scintigraphy or a combination of labelled leukocyte scintigraphy and bone marrow scintigraphy using sulfur colloid. These procedure, while they provide useful physiological information, are time consuming, generally requiring at least 2 separate image acquisition on separate days, and can be costly. 18F-FDG is a glucose analog that can be used for PET imaging. In addition to its application in oncology, the literature has shown that FDG can be used to investigate a wide variety of inflammatory and infectious conditions, including diabetic foot infections. The aim of this study is to compare the usefulness of FDG PET imaging versus "conventional" nuclear medicine (either bone scan and Gallium scintigraphy or labelled leukocytes and sulfur colloid scintigraphy) in patient with suspected diabetic foot osteomyelitis.

NCT ID: NCT03710291 Terminated - Clinical trials for Chronic Kidney Disease

Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis

VALOR-CKD
Start date: November 20, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.