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NCT ID: NCT03567291 Terminated - Tourette Syndrome Clinical Trials

Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents

ARTISTS
Start date: May 25, 2018
Phase: Phase 3
Study type: Interventional

This is an otherwise open-label, single-arm study that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period followed by a 3 week blinded maintenance or re-titration, and then a maintenance period. This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies.

NCT ID: NCT03566823 Terminated - Crohn's Disease Clinical Trials

Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)

CARMEN CD 306
Start date: July 17, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

NCT ID: NCT03566732 Completed - Quality of Life Clinical Trials

ERANet-LAC CODE: International Care Of the Dying Evaluation

Start date: August 15, 2017
Phase:
Study type: Observational

Providing high quality care for dying patients and their families is very important. One way one can assess the care provided is to ask bereaved relatives to complete a questionnaire after their family member has died. The questionnaire can ask about their experiences and their thoughts about the care provided to their family member. One such questionnaire is the 'Care Of the Dying Evaluation' (or CODE). CODE has been developed with the help and support of bereaved relatives and has been used extensively within the United Kingdom. In this project the investigators want to use the CODE questionnaire to look at bereaved relatives' views about care provided in seven different countries within Europe and Latin America. In the first part of the project CODE was translated into the main language of each country. Volunteers and bereaved relatives in each country were asked to give feedback about whether CODE was easy to understand, sensitive, and easy to complete. Based on the feedback a common version of CODE that is suitable for use across all the countries was developed. In the next phase of the project, relatives who have recently experienced a bereavement where one of their family members has died from cancer in a hospital, will be invited to complete the CODE questionnaire about two months after the patient's death. The relatives may complete CODE on paper, using a computer, or by interview. The aim is to have 100 completed CODE questionnaires from each of the seven countries. The data from the questionnaires will be used to make a report on the current quality of care for dying cancer patients in hospitals across the seven countries. It will also be possible to compare the care between the countries and identify areas needing improvement. In the next phase of the project, health care professionals, researchers and bereaved relatives together will use their knowledge and experience to find effective ways to improve the weak areas identified, and assess the results of putting these changes into practice.

NCT ID: NCT03564184 Completed - Preterm Birth Clinical Trials

Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers

LongSTEP
Start date: August 25, 2018
Phase: N/A
Study type: Interventional

Background: Preterm birth has major medical, psychological and socio-economic consequences worldwide. A recent systematic review suggests positive effects of music therapy (MT) on physiological measures of preterm infants and maternal anxiety, but methodologically rigorous studies including long-term follow-up of infant and parental outcomes are missing. Drawing upon caregivers' inherent resources, this study emphasizes caregiver involvement in MT to promote attuned, developmentally-appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalization and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development. Methods: Design: International multi-center, assessor-blind, 2x2 factorial, pragmatic randomized controlled trial. A feasibility study has been completed; ethical approval for the main trial is pending. Participants: 250 preterm infants and their parents. Intervention: MT focusing on singing specifically tailored to infant responses, will be delivered during NICU and/or during a post-discharge 6-month period. Primary outcome: Changes in mother-infant bonding until 6 months corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: Mother-infant bonding at discharge and over 12 months CA; child development over 24 months; and parental depression, anxiety, and stress, and infant re-hospitalization, all over 12 months. Discussion: This study fills a gap by measuring the long-term impact of MT for preterm infants/caregivers, and of MT beyond the hospital context. Outcomes related to highly involving parents in MT will directly inform the development of clinical practice in Scandinavia and other contexts with similar social welfare practices. By incorporating family-centered care, continuity of care, user involvement, and cultural relevance, this study can potentially contribute to improved quality of care for premature infants and their parents worldwide.

NCT ID: NCT03560466 Active, not recruiting - Asthma Clinical Trials

Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)

Start date: June 21, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: - To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate the efficacy of dupilumab in children of 6 to <12 years of age with uncontrolled persistent asthma in the Japan sub-study. Secondary Objectives: - To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: - Systemic exposure. - Anti-drug antibodies (ADAs). - Biomarkers. - To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study - To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to: - Systemic exposure, - Anti-drug antibodies (ADAs), - Biomarkers

NCT ID: NCT03557307 Completed - Asthma Clinical Trials

Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma

PONENTE
Start date: August 1, 2018
Phase: Phase 3
Study type: Interventional

This is a study designed to evaluate efficacy and safety of Benralizumab in reducing the Oral Corticosteroid (OCS) use in adult patients with severe asthma who are receiving OCS with or without additional asthma controller medications.

NCT ID: NCT03556202 Terminated - Psoriasis Clinical Trials

A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)

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

The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.

NCT ID: NCT03552757 Completed - Obesity Clinical Trials

Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity

STEP 2
Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years

NCT ID: NCT03552276 Completed - Psoriatic Arthritis Clinical Trials

Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.

Start date: July 11, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

A long term study to demonstrate the safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab

NCT ID: NCT03551626 Completed - Malignant Melanoma Clinical Trials

Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

COMBI-APlus
Start date: August 29, 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.