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NCT ID: NCT04155138 Not yet recruiting - Cochlear Implant Clinical Trials

Recipients With Limited Bimodal Benefit: HA or CROS

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

The rationale is to determine (in individuals with limited perceived bimodal benefit) whether the CROS device may be a better solution for obtaining two-sided input. If yes, this study would be practice-changing.

NCT ID: NCT04155034 Recruiting - Clinical trials for Extensive Stage Lung Small Cell Carcinoma

S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer

Start date: May 4, 2020
Phase: Phase 3
Study type: Interventional

This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.

NCT ID: NCT04154956 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients

CARMEN-LC03
Start date: February 6, 2020
Phase: Phase 3
Study type: Interventional

Primary Objectives: - Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS]) - Study success is defined either on PFS or OS - The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) - The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: - To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel - To compare the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel - To evaluate the safety of tusamitamab ravtansine compared to docetaxel - To assess the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel

NCT ID: NCT04154917 Recruiting - Frail Older Adults Clinical Trials

Effectiveness of a Comprehensive Patient-centered Hospital Discharge Planning Intervention for Frail Older Adults

HOME
Start date: November 7, 2019
Phase: N/A
Study type: Interventional

A large number of frail older adults have difficulty performing activities of daily living and resuming former roles in the months following hospital discharge. This increases the risk of unplanned hospital readmissions and emergency visits after they return home. Comprehensive, patient-centered discharge planning has been reported to improve older adults' ability to perform activities of daily living and to reduce readmission rates after hospital discharge. However, to our knowledge, no evidence-based discharge protocol is routinely used in Canada with the frail population. An innovative discharge planning intervention called "HOME" was recently developed in Australia, which includes: 1) hospital based partnership with patient and family to establish goal setting and problem solving; 2) pre-discharge home assessment to address safety issues and problems with patient and family; 3) post-discharge home assessment and in-home training to address unmet needs; and 4) follow-up telephone calls to provide ongoing support to patient and family. A Canadian version of HOME has been developed. This will be followed by a large trial to investigate if this intervention increases functioning in daily life activities and decreases hospital and emergency readmissions for frail patients who are discharged home. Our proposed study is a preliminary and necessary step to identify problems that may arise during this large trial and address them proactively. If proven beneficial, the Canadian version of HOME would be an appropriate, applicable and acceptable intervention to improve patients' experiences and outcomes as well as change health practice surroundings discharge planning with frail older adults.

NCT ID: NCT04154189 Completed - Osteosarcoma Clinical Trials

A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma

Start date: March 23, 2020
Phase: Phase 2
Study type: Interventional

This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents, and Young Adults with Relapsed or Refractory Osteosarcoma.

NCT ID: NCT04154085 Completed - Clinical trials for Obsessive-Compulsive Disorder

Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder

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

This is a prospective exploratory study using narrative therapy in group format, over 20 sessions, 2 hours per session, weekly, to determine whether this modality can provide any benefit to OCD symptoms, mood, sense of social connectedness, sense of identity, and/or quality of life in individuals living with treatment-resistant OCD. NOTE: an amendment is now in place so that the group can occur virtually given the COVID pandemic; Zoom will be used as our platform.

NCT ID: NCT04154072 Active, not recruiting - Parkinson Disease Clinical Trials

A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease

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

This is a phase 2 study designed to assess the safety, tolerability and efficacy of NLY01 in subjects with early untreated Parkinson's disease (PD). Evidence suggests NLY01, a pegylated form of exenatide, may be beneficial in PD and is being developed as a potential treatment for neurodegenerative disorders.

NCT ID: NCT04153929 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.

Start date: April 30, 2020
Phase: Phase 2
Study type: Interventional

This study is open to adults with type 2 diabetes who take metformin but still have too high blood sugar. The purpose of the study is to find the best dose of BI 456906 that reduces blood sugar. The study also looks at whether BI 456906 helps the participants lose weight. Participants are in the study for about 23 weeks. During this time, most participants visit the study site about 13 times. Some participants visit the study site about 20 times. At the start of the study, the participants are put into 7 groups. The participants in groups 1 to 6 get injections under the skin once or twice every week. Some participants get different doses of BI 456906 and other participants get placebo. Placebo injections look like the BI 456906 injections, but contain no medicine. Participants in group 7 get semaglutide injections every week. Semaglutide is another medicine for adults with type 2 diabetes. During the study, the doctors regularly take blood samples from the participants and measure their body weight. The changes in blood sugar levels and body weight are compared between the groups. The doctors also check the general health of the participants.

NCT ID: NCT04153864 Active, not recruiting - Clinical trials for Perinatal Depression

Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT)

SUMMIT
Start date: January 6, 2020
Phase: N/A
Study type: Interventional

SUMMIT's (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal depression and anxiety (N=1226). Specifically, and through a multi-site, randomized, pragmatic trial, the trial examines whether a brief, behavioral activation (BA) treatment delivered via telemedicine is as effective as the same treatment delivered in person; and whether BA delivered by non-mental health providers (e.g., nurses), with appropriate training is as effective as when delivered by specialist providers (psychiatrists, psychologists and social workers) in reducing perinatal depressive and anxiety symptoms. The study will be conducted in Toronto, NorthShore University HealthSystem in Evanston and surrounding areas including Chicago, and North Carolina. The trial will also identify relevant underlying implementation processes and determine whether, and to what extent, these strategies work differentially for certain women over others.

NCT ID: NCT04153760 Completed - Clinical trials for Venous Thromboembolism

Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

PARTUM
Start date: October 7, 2020
Phase: Early Phase 1
Study type: Interventional

The pilot PARTUM trial is a randomized, multicenter, placebo-controlled trial. Women who are at modest risk of VTE (as defined by the inclusion criteria) will be identified during pregnancy, labor and delivery and up to 48 hours postpartum. Eligible and consenting participants will be randomly assigned to one of two study arms: aspirin 81 mg daily or placebo daily for 6 weeks.