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NCT ID: NCT04398407 Active, not recruiting - Mental Health Clinical Trials

Testing the Effectiveness of Mainstream Management Tools to Increase Organizational Commitment and Job Satisfaction and Decrease Turnover Among Peer Providers

Start date: May 28, 2021
Phase: N/A
Study type: Interventional

The role of peer support specialists (PSS) has burgeoned in the mental health field. Peer support specialists are individuals with a psychiatric condition who are in recovery and who are employed to provide various kinds of tangible and other supports to individuals with psychiatric conditions, generally in public mental health programs. Partially because of the newness of this role, PSS experience confusion about their role and tasks as well as conflict with other mental health providers who are uncertain about how to utilize PSS effectively in services. This project was designed to bring a coaching service to PSS to assist them to address challenges in their job. The investigators will conduct a randomized control trial to evaluate a novel coaching, Coaching and Advancement for Peer Providers (CAPP). Our hypotheses are that individuals participating in the CAPP intervention will experience a reduction in burnout, role confusion, and intention to leave their job or the field. Participants in CAPP will also experience an increase in job satisfaction, role clarity and organizational commitment.

NCT ID: NCT04397796 Active, not recruiting - COVID Clinical Trials

Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation

Start date: August 3, 2020
Phase: Phase 1
Study type: Interventional

This is a phase 1b randomized, double-blind, placebo-controlled study in adult subjects with Coronavirus Disease 2019 (COVID-19). This clinical trial will evaluate the preliminary safety and efficacy of BM-Allo.MSC vs placebo in treating subjects with severe disease requiring ventilator support during COVID 19 infection.

NCT ID: NCT04397679 Active, not recruiting - Glioblastoma Clinical Trials

Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma

Start date: August 12, 2021
Phase: Phase 1
Study type: Interventional

This trial studies the side effects of partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy for the treatment of newly diagnosed glioblastoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chloroquine is normally used to treat strains of malaria and prior preclinical and clinical data suggests that it may increase the efficacy of both radiation and tumor treating fields therapy. Tumor treating fields therapy uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cells to die. The purpose of this study is to determine the safety of partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy in patients with gliobastoma

NCT ID: NCT04396860 Active, not recruiting - Gliosarcoma Clinical Trials

Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma

Start date: September 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This phase II/III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy in combination with immunotherapy with ipilimumab and nivolumab in treating patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses high energy photons to kill tumor and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temozolomide, may not work as well for the treatment of tumors that have the unmethylated MGMT. Immunotherapy with monoclonal antibodies called immune checkpoint inhibitors, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is possible that immune checkpoint inhibitors may work better at time of first diagnosis as opposed to when tumor comes back. Giving radiation therapy with ipilimumab and nivolumab may lengthen the time without brain tumor returning or growing and may extend patients' life compared to usual treatment with radiation therapy and temozolomide.

NCT ID: NCT04395222 Active, not recruiting - Clinical trials for Hematologic Malignancy

Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation

Start date: October 7, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety of reducing and ultimately eliminating anti-thymocyte globulin (ATG) from the haplo-cord transplant conditioning regimen and replacing it with tocilizumab, an IL-6 receptor monoclonal antibody, to improve immune reconstitution and reduce relapse while preserving low rates of graft failure and graft versus host disease (GVHD).

NCT ID: NCT04395079 Active, not recruiting - Clinical trials for Recurrent Malignant Female Reproductive System Neoplasm

Brachytherapy With Durvalumab or Tremelimumab for the Treatment of Patients With Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies

Start date: August 7, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and how well brachytherapy with durvalumab or tremelimumab work for the treatment of gynecological malignancies that is resistant to platinum therapy (platinum-resistant), does not respond to treatment (refractory), has come back (recurrent), or has spread to other places in body (metastatic). Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see whether brachytherapy with durvalumab or tremelimumab works better in treating patients with gynecological malignancies.

NCT ID: NCT04395001 Active, not recruiting - Chronic Pain Clinical Trials

Pain Response Evaluation of a Combined Intervention to Cope Effectively

PRECICE
Start date: February 24, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this research is is to determine if the combination of non-opioid medication (duloxetine) and web-based pain-coping skills training (PCST) is beneficial for individuals with chronic musculoskeletal pain (CMP).

NCT ID: NCT04394650 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma

Start date: August 18, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in participants with relapsed and/or refractory multiple myeloma. The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-98633 to establish a recommended Phase 2 dose RP2D(s); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-98633 at the RP2D(s).

NCT ID: NCT04394624 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04)

CARMEN-LC04
Start date: August 31, 2020
Phase: Phase 2
Study type: Interventional

Primary Objectives: Doublet Cohort Part 1 (safety run-in): To assess the tolerability and to confirm the recommended dose of tusamitamab ravtansine in combination with ramucirumab in the NSQ NSCLC population. Part 2: To assess the antitumor activity of tusamitamab ravtansine in combination with ramucirumab in the NSQ NSCLC population. Triplet cohort To assess the tolerability and to confirm the recommended dose of tusamitamab ravtansine in combination with ramucirumab and pembrolizumab in the NSQ NSCLC population. Secondary Objectives: Doublet Cohort To assess the safety and tolerability of tusamitamab ravtansine in combination with ramucirumab. To assess the durability of the response to treatment with tusamitamab ravtansine in combination with ramucirumab. To assess anti-tumor activity of tusamitamab ravtansine in combination with ramucirumab on progression free survival (PFS) and disease control rate (DCR). To assess the pharmacokinetic (PK) profiles of tusamitamab ravtansine (SAR408701) and ramucirumab when given in combination. To assess the immunogenicity of tusamitamab ravtansine (SAR408701) when given in combination with ramucirumab. Triplet cohort To assess the safety and tolerability of tusamitamab ravtansine in combination with ramucirumab and pembrolizumab To assess the antitumor activity of tusamitamab ravtansine in combination with ramucirumab and pembrolizumab in the NSQ NSCLC population. To assess the immunogenicity of tusamitamab ravtansine when given in combination with ramucirumab and pembrolizumab

NCT ID: NCT04394559 Active, not recruiting - Opioid Use Clinical Trials

Prevention of Opioid Use Disorder After Surgery

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

The objective of this study is to design, implement, and pilot test a multi-faceted intervention to support safer opioid prescribing, self-administration, and monitoring and reduce persistent opioid use and opioid use disorder for patients transitioning to the community setting after major orthopedic surgery. The multi-faceted intervention includes: 1) communication with outpatient providers and counseling of patients and caregivers at hospital discharge; 2) standardized opioid prescribing discharge order sets for each type of surgery; 3) an outpatient pain management follow-up visit embedded within routine post-operative care for managing pain and opioid use, and 4) a mobile patient-reported outcomes application for assessing pain, function, and possible development of opioid use disorder (OUD). The primary outcome will be persistent opioid use (in the 6 months after surgery) based on state-wide prescription data. Secondary outcomes will include the total morphine-equivalent dose of opioids prescribed at discharge; total post-operative opioids dispensed in the 6 months after surgery; and self-reported opioid misuse, pain and function 90 and 180 days after surgery.