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NCT ID: NCT05153382 Recruiting - Bipolar Disorder Clinical Trials

Dialectical Behavior Therapy for Youth With and/or at Familial Risk for Bipolar Disorder

DB1
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Dialectical behavior therapy (DBT) will be conducted over 1 year in youth with and/or at familial risk for bipolar disorder (BD). DBT will be divided into two modalities: 1) DBT skills training; and 2) DBT individual therapy sessions. Skills training sessions will incorporate the 5 standard adolescent DBT modules: mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills and an additional module on psychoeducation about DBT and BD. This study seeks to build upon the knowledge base in this area by offering DBT to youth with and/or at familial risk for BD with an emphasis on predictors and mediators of treatment outcomes.

NCT ID: NCT05153369 Recruiting - Bipolar Disorder Clinical Trials

Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder (DB3)

DB3
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

This study seeks to bridge the knowledge-to-action gap regarding psychosocial treatment "dosing" for youth with and/or at familial risk for bipolar disorder (BD). In psychiatry, pragmatic collaborative decisions between patient and care provider about pharmacological titrations and tapers are common. Less frequently are there considerations made regarding the pragmatic dosing of psychosocial interventions. Whereas some youth clearly require full/"high-dose" treatment, others may benefit from "lower-dose" interventions, alongside re-evaluation of dosing needs over time. Furthermore, there is a subset of youth who do not require or do not want the intensity and frequency of treatment that current interventions provide. This research presents a unique opportunity to better understand different levels of care within a subspecialized outpatient mental health clinic serving youth with and/or at familial risk for BD who vary greatly in terms of risk indicators, type and severity of symptoms, associated distress, and compounding functional impairment.

NCT ID: NCT05153317 Active, not recruiting - Cystic Fibrosis Clinical Trials

Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older

Start date: January 17, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long term safety, tolerability, efficacy and pharmacodynamics of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in CF participants 2 years of age and older.

NCT ID: NCT05153239 Recruiting - Clinical trials for Relapsed Small Cell Lung Cancer

Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)

Start date: July 22, 2022
Phase: Phase 3
Study type: Interventional

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.

NCT ID: NCT05152758 Recruiting - Clinical trials for Anterior Cruciate Ligament Reconstruction

STABILITY: Physical Activity Intervention at 7 Years Post-Anterior Cruciate Ligament Reconstruction

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

Anterior cruciate ligament (ACL) ruptures are very common knee injuries amongst youth involved in sports and are often treated through ACL reconstruction surgeries. Unfortunately, up to 50% of individuals who undergo ACL reconstruction develop post-traumatic osteoarthritis (PTOA) in their injured knee by 20 years post-reconstruction causing pain, decreasing mobility, and impacting quality of life in young active individuals. Much remains unknown regarding the secondary prevention of PTOA, and more investigation is necessary to better understand its disease progression post-ACL reconstruction and types of conservative interventions that can prevent or delay its onset. Physical activity has improved patient-reported outcomes across many different chronic diseases including knee osteoarthritis (OA), and physical activity prescription has been shown to be an effective way to increase patients' levels of physical activity. It has not yet been heavily investigated in the context of post-ACL reconstruction, and individuals often exhibit decreased physical activity after ACL reconstruction which causes suboptimal cartilage health. Thus, physical activity prescription may improve habitual joint loading, leading to improved cartilage health and patient-reported health outcomes.

NCT ID: NCT05152719 Not yet recruiting - Cognitive Function Clinical Trials

Effect of Sprint Interval Training and Intermittent Fasting on Cognitive Function

Start date: December 2, 2021
Phase: N/A
Study type: Interventional

Several lifestyle modifications, such as manipulating diet and exercise, have been shown to enhance cognitive function. This study aims to determine if a combination of Sprint Interval Training (SIT) and Time Restricted Eating (TRE) elicits greater enhancements in cognitive function than either of these interventions alone. SIT and TRE have both been proven to have high adherence rates and require minimal lifestyle changes, therefore the implementation of these may allow for a feasible method of improving cognition in healthy populations. A group of young adults will be randomized into either a SIT group, TRE group, or a SIT+TRE group. To assess the changes in cognitive function, cognitive tests will be performed at baseline and biweekly. Secondly, we will be monitoring the differences in the three groups in terms of body composition, which will be measured using a BodPod. It is hypothesized that the SIT+TRE group will display the greatest improvements in cognitive function and body composition versus the TRE only group and the SIT only group.

NCT ID: NCT05152147 Recruiting - Clinical trials for Esophageal Adenocarcinoma

A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

HERIZON-GEA-01
Start date: December 2, 2021
Phase: Phase 3
Study type: Interventional

This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).

NCT ID: NCT05151965 Recruiting - Clinical trials for Anterior Shoulder Dislocation

Return to Sport and Functional Performance Following Surgical Intervention for Anterior Glenohumeral Instability

Start date: September 1, 2022
Phase:
Study type: Observational

The purpose of this prospective cohort study is to compare patient-reported, clinical, and functional outcomes in patients who have elected to have either the Bankart with Remplissage or Latarjet procedure for the treatment of anterior glenohumeral instability (AGHI) up to 24-months postoperative.

NCT ID: NCT05151900 Recruiting - Eating Disorders Clinical Trials

Implementing Virtual Parent Support Groups for Eating Disorders Across Canada

vPLPSG
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

During the COVID-19 pandemic, Canada has experienced a surge in new pediatric eating disorder cases and hospitalizations and long treatment waitlists, with parents experiencing anxiety due to a lack of support. As it has not been rigorously studied, there is an urgent need to understand and mitigate the impact of the COVID-19 pandemic on children, youth, and families living with eating disorders across Canada. The investigator's proposed research has two goals. First, the investigators plan to understand the impact of the COVID-19 pandemic faced by this population throughout the country, as well as describe stakeholder views on virtual parent-led peer support groups. Given the increased burden faced by parents of children with eating disorders during the COVID-19 pandemic, the second goal is to study whether the national implementation of virtual parent-led peer support groups helps to mitigate the impact of the pandemic among affected parents. The investigators will use qualitative semi-structured interviews to gather an understanding of the impact of the pandemic on relevant stakeholders across the country. At the same time, the investigators will evaluate the feasibility and acceptability of the implementation of virtual parent-led peer support groups in several regions of Canada by examining parent and parent peer support provider experiences.

NCT ID: NCT05151744 Active, not recruiting - Clinical trials for Diabetic Macular Edema

A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema

Start date: December 17, 2021
Phase: Phase 2
Study type: Interventional

Study BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 76 weeks.