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NCT ID: NCT04626518 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B)

Start date: December 17, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

NCT ID: NCT04626479 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

Start date: December 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

NCT ID: NCT04625270 Active, not recruiting - Ovarian Cancer Clinical Trials

A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation

RAMP 201
Start date: December 21, 2020
Phase: Phase 2
Study type: Interventional

This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy and in combination with defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

NCT ID: NCT04622319 Active, not recruiting - Clinical trials for Residual Invasive Breast Cancer

A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)

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

Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.

NCT ID: NCT04620499 Active, not recruiting - Depression Clinical Trials

PEER Interactive to Inform the Prescription of Medications

Start date: February 2016
Phase: Phase 4
Study type: Interventional

Improving the prescription accuracy of psychotropic medications for military personnel diagnosed with neuropsychiatric disorders is imperative to promote accelerated treatment response and recovery. This study will determine whether PEER (Psychiatric EEG Evaluation Registry) Interactive (a comparison of a quantitative electroencephalogram (QEEG) to an existing database of subject outcomes) provides an objective adjunctive tool that is more effective in guiding treatment than the current standard of practice in the treatment of military personnel suffering from non-psychotic mental illness. For this prospective, multicenter, randomized, single-blinded, controlled study, 100 participants with a primary diagnosis of a DSM-V depressive disorder, with comorbidity of non-psychotic behavioral disorders to include mild Traumatic Brain Injury (mTBI) and Post Traumatic Stress Disorder (PTSD), will be enrolled. Participants will be randomized into a control or experimental group, and all will undergo a quantitative electroencephalogram (QEEG). For the experimental group, research staff will receive an Outcome Report from PEER Interactive and will follow the guidance of the Report to inform treatment. For the control group, research staff will not receive a participant Outcome Report from PEER Interactive and these participants will be treated based on current standards. For the control group, Outcome Reports will be sequestered for post-hoc analysis. Research staff in collaboration with CNS Response (the Sponsor) will evaluate and validate if the guidance provided by PEER Interactive correlates with the predicted participant outcome. Research staff in collaboration with the Sponsor will also evaluate if the treatment guidance provided by PEER Interactive results in improved mental health and/or a reduction of risk as measured by a reduction in severe adverse events, including suicidality.

NCT ID: NCT04619797 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

SKYSCRAPER-06
Start date: December 14, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase: - Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin - Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).

NCT ID: NCT04619615 Active, not recruiting - Education, Medical Clinical Trials

Increasing Access to Evidence-based Treatments for Depression

Start date: July 27, 2020
Phase: N/A
Study type: Interventional

The goal of this single-blind, randomized controlled pilot study is to evaluate the acceptability and feasibility of an Interpersonal Psychotherapy (IPT) asynchronous self-directed digital training platform for psychiatry residents, as compared to synchronous large group online workshop teaching. This study has the potential to improve access to competency-based training and dissemination of IPT, impacting healthcare delivery with increasing access to this evidence-based psychological depression treatment.

NCT ID: NCT04619420 Active, not recruiting - Alzheimer Disease Clinical Trials

A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease

Autonomy
Start date: January 6, 2021
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function.

NCT ID: NCT04619069 Active, not recruiting - Prostate Cancer Clinical Trials

Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer

Start date: October 27, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study is evaluating whether adding stereotactic radiotherapy (a new, more focused type of radiotherapy) to treat all the tumours that are present will improve outcomes or not compared to drugs alone for patients who are negative on conventional imaging and positive on PSMA PET scan

NCT ID: NCT04617132 Active, not recruiting - Clinical trials for Postpartum Depression

Online MBI for Families Affected by PPDA

Start date: October 20, 2020
Phase:
Study type: Observational

The aim of this study is to explore the feasibility of delivering clinical mindfulness groups for families affected with postpartum depression and anxiety (PPDA). Families with PPDA are a vulnerable population who already face challenges during the postpartum period, but now the Covid-19 era has brought extra challenges - lower availability of family members or support systems to help in person, older children at home as childcare facilities are closed, etc. Clinical mindfulness groups are now being run online to support this population, with the current barriers of having to stay at home. Through this study, we want to capture the challenges that both clinicians and participants might face using virtual platforms (e.g. technical difficulties), to see whether online delivery of clinical mindfulness groups is feasible.