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NCT ID: NCT03705429 Completed - Breast Neoplasms Clinical Trials

A Study Comparing Two Standard of Care Adjuvant Chemotherapy Regimens for Lower Risk HER-2 Positive Breast Cancer

Start date: May 1, 2019
Phase: Phase 3
Study type: Interventional

Multi-center, open-label, randomized trial of patients with low-risk, HER2+ disease, who will receive adjuvant taxane-based chemotherapy (i.e. docetaxel and cyclophosphamide with trastuzumab [TC-H] or weekly paclitaxel with trastuzumab [P-H]) at the standard approved doses, aiming to gather more information regarding cost-effectiveness, toxicity, quality of life (QoL), patient reported outcomes and clinical benefits of the two treatment strategies.

NCT ID: NCT03704870 Completed - Lung Cancer Clinical Trials

Outcomes Following Omission of Daily Routine Chest Radiographs Following Pulmonary Resection

Start date: January 26, 2018
Phase: Phase 2
Study type: Interventional

Currently, it is the standard of care practice to perform daily routine CXR when a chest tube is in situ following pulmonary resection. However, previous research as well as experience of thoracic surgeons suggested this kind of management has poor diagnostic and therapeutic value. Eliminating daily routine CXR for adult patients having undergone pulmonary surgery might decrease the frequency of radiation exposure and hospitalization costs per patient without increasing reintervention rates, length of hospital stays, readmission rates or any adverse events.

NCT ID: NCT03704649 Completed - Malnutrition Clinical Trials

Evaluating a Participatory Nutrition Education Model on Nutrition Literacy of Adolescent Girls in Rural Ghana.

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

Adolescent girls in the Upper Manya Krobo (UMK) district, Ghana are disproportionately burdened by ill-health in relation to their male counterparts. Research also shows that this demographic lacks access to nutrition education and health services. This research aims to assess the feasibility and influence of an intervention that utilizes a participatory video education model on adolescent girls' nutrition knowledge, dietary habits and health behaviour. To address our research objectives, we will conduct a school-based cluster randomized control pilot trial with adolescent girls, 12-16 years of age, who are part of existing girls' clubs in 20 schools of the Upper Manya Krobo district. The intervention group (10 schools) will use a participatory video education model and the control group consists of standard-of-care education received in regular girls' club gatherings. The intervention groups develop a storyboard and produce a short 5-7 minute film on a nutritional issue. These videos can be used by teachers as a means of sharing nutrition information with students and in stimulating discussion around the nutrition topic. Baseline and end line surveys will be conducted to assess nutrition literacy indicators and nutrition behaviour. We will use surveys to assess nutritional knowledge and attitude; food frequency questionnaire to record dietary intakes; and in-depth interviews with participants and school staff to assess challenges and strengths of the nutrition education model being delivered.

NCT ID: NCT03703882 Completed - Clinical trials for Muscular Dystrophy, Duchenne

Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy

PolarisDMD
Start date: October 2, 2018
Phase: Phase 3
Study type: Interventional

The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from 4-7 years of age (up to 8th birthday) will be enrolled. Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is the key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.

NCT ID: NCT03703310 Completed - Clinical trials for Basal Cell Nevus Syndrome

Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome)

Start date: February 19, 2019
Phase: Phase 3
Study type: Interventional

This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome. Participants will be required to apply the investigational product for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new BCCs that develop over the 12 month period.

NCT ID: NCT03703102 Completed - Atopic Dermatitis Clinical Trials

Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis

Start date: October 22, 2018
Phase: Phase 2
Study type: Interventional

A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.

NCT ID: NCT03702647 Completed - Achalasia Clinical Trials

Ropivacaine For Post-POEM Pain Control

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

POEM (Peroral Endoscopic Myotomy) is an endoscopic procedure most commonly used to treat achalasia. Achalasia is a disorder resulting from the inability of esophageal muscles to relax.The POEM procedure, performed under general anesthesia, involves inserting an endoscope into the esophagus where a specialized knife is able to cut a new pathway through the esophageal tissue. The knife is then used to incise, and therefore loosen, tight muscles within the esophagus, lower esophageal sphincter, and the upper region of the stomach that are responsible for the symptoms.This study seeks to improve patient's post-operative pain levels by placing ropivacaine (a local anesthetic) into the newly cut pathway that is created in the POEM procedure. It is hypothesized that the topical irrigation of the POEM tunnel with ropivacaine will result in decreased pain scores and a decreased need for additional pain medications.

NCT ID: NCT03701620 Completed - Clinical trials for Traumatic Brain Injury

Heart Rate Variability in Children With Traumatic Brain Injury

HRV-TBI
Start date: January 1, 2018
Phase:
Study type: Observational

Using a prospective cohort of children admitted to the PICU, the investigators will determine HRV monitoring is feasible, if a decreased HRV in the 7 days following moderate or severe TBI in children is associated with a worse outcome 6 months post-TBI and investigate HRV as a tool that can predict adverse events (neurological crisis) within 2 days following TBI.

NCT ID: NCT03698760 Completed - Alzheimer Disease Clinical Trials

Computerized Olfactory Test - Alzheimer Disease Mild Stage

Start date: June 25, 2019
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of the smell tests that are used in early diagnosis of mild dementia.

NCT ID: NCT03698279 Completed - Influenza Clinical Trials

Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age

QHD04
Start date: October 9, 2018
Phase: Phase 2
Study type: Interventional

The objectives of this study were: - To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including adverse events of special interest throughout the study). - To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by hemagglutination inhibition (HAI) measurement method. - To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement method. - To describe the antibody response induced by the highest acceptable dosage of QIV-HD compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN measurement methods.