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NCT ID: NCT04924101 Active, not recruiting - Clinical trials for Small Cell Lung Cancer

Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99)

Start date: July 15, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study.

NCT ID: NCT04923880 Active, not recruiting - Quality of Life Clinical Trials

Pragmatic Implementation Trial of a CF Primary Palliative Care Intervention

Start date: June 25, 2021
Phase: N/A
Study type: Interventional

Five Cystic Fibrosis (CF) centers, key stakeholders, and a palliative care institute have collaborated to create a novel primary palliative care intervention for patients with CF, "Improving Life with CF: A Primary Palliative Care Partnership," and established the infrastructure and support necessary for a follow-on implementation study. This intervention provides a framework for a nationally generalizable model to improve best practices in generalist-level palliative care in CF. Objectives: Aim 1: Implement a primary palliative care intervention comprising screening-and-triage workflows, best practice treatment guides for high frequency problems, patient/family and provider education, and a quality improvement (QI) toolkit. Aim 2: Evaluate feasibility, uptake, and preliminary outcomes during a multisite pragmatic, implementation trial of the intervention at 5 diverse Cystic Fibrosis (CF) Centers. Subaim 2.1: Evaluate feasibility and uptake as measured by rates of screening and treatment delivery. Hypothesis 1: Related to feasibility and uptake of the intervention: 1. > 80% of individuals with CF of all ages will receive an annual palliative care screening. 2. > 25% of individuals with CF will receive a palliative care screening prompted by hospitalization, new diagnosis of CF-Related Diabetes, need for transplantation, or another disease- or treatment-specific trigger. Hypothesis 2: Related to provider education: a) > 80% will access >1 training(s) (on-demand webinars or in-service by trained site educators). Subaim 2.2: Evaluate data on preliminary outcomes for individuals with CF by comparing ratings on patient- and caregiver-reported outcome measures (e.g., Integrated Palliative Care Outcome Scale, Cystic Fibrosis Questionnaire-Revised, Memorial Symptom Assessment Scale-Cystic Fibrosis, and Brief Assessment Scale for Caregivers) during the trial to baseline ratings and exploring covariates of change (age, race/ethnicity, gender, disease severity, CFTR modifier treatment, psychological distress, and varied indicators reflecting intervention implementation).

NCT ID: NCT04923867 Active, not recruiting - Clinical trials for Cerebrospinal Fluid Leak

Suturable DuraGen™ PMCF Study

Start date: April 28, 2021
Phase:
Study type: Observational

The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.

NCT ID: NCT04922554 Active, not recruiting - Clinical trials for Mycobacterium Infections, Nontuberculous

Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)

Start date: October 15, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc)

NCT ID: NCT04922307 Active, not recruiting - Kidney Cancer Clinical Trials

Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer

RESTRICT
Start date: July 23, 2021
Phase: N/A
Study type: Interventional

The Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer Trial (RESTRICT). The primary objective is to reduce the number of units of allogenic blood transfusion in locally advanced kidney cancer (≥ cT2). Secondary objectives include reduction in perioperative complications, assessment of recurrence free-survival and improving overall survival.

NCT ID: NCT04922216 Active, not recruiting - Obesity Clinical Trials

Adaptive Goals and Interventions for Lifestyle Enhancement

AGILE
Start date: April 28, 2022
Phase: N/A
Study type: Interventional

Mobile obesity interventions have the potential to reach a diverse population in need; however, while effective, have not resulted in weight losses obtained in in-person interventions. Newer digital approaches called Just-in-Time Adaptive Interventions (JITAI) that offer adaptive, personalized feedback 'when needed' and in 'real time' offer an opportunity to use digital health tools "just in time". This study seeks to identify the optimal components of a comprehensive weight loss JITAI that results in weight losses that meet or exceed those in existing remotely delivered interventions.

NCT ID: NCT04922190 Active, not recruiting - Parkinson Disease Clinical Trials

Promoting Physical Activity Engagement for People With Early-mid Stage Parkinson's Disease (Engage-PD)

Engage-PD
Start date: March 15, 2020
Phase: Phase 1
Study type: Interventional

Engage-PD is a single cohort evaluation of implementation of a telehealth-delivered physical activity coaching program for people with early-mid stage Parkinson's disease. The program utilizes a physical or occupational therapist to provide one-on-one coaching for individuals with early-mid stage Parkinson's disease to provide individualized structured support to facilitate and optimize exercise uptake as part of an effective self-management program. The structure of the coaching program is based on previous research in neurodegenerative disease including Parkinson's disease and Huntington's disease.

NCT ID: NCT04921800 Active, not recruiting - Clinical trials for Cervical Spine Fusion

Measuring Dysphagia After ACDF Surgery Through A Novel Wearable Sensor

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the function and reliability of a noninvasive, skin-like electronic sensor. The investigators hypothesize that this skin sensor will address an unmet need to wirelessly and noninvasively monitor and characterize the recovery process in post-operative patients who have undergone anterior cervical discectomy and fusion (ACDF). Specifically, the investigators will validate the use of the sensor in this patient population through monitoring of key physiological signals in the recovery process, including heart rate, respiratory rate, swallow count, talking time, energy expenditure, neck specific motion, and body orientation.

NCT ID: NCT04920344 Active, not recruiting - Clinical trials for Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Swallowing Outcomes and Circulating Tumor DNA in Patients With HPV Related Oropharyngeal Cancer Treated With Transoral Surgery and Reduced Intensity Adjuvant Therapy

Start date: July 19, 2021
Phase: Phase 2
Study type: Interventional

This is a non-randomized, open-label phase II clinical trial that studies the effect of reduced dose radiation therapy and chemotherapy after surgery in treating patients with human papillomavirus (HPV) caused throat cancer. Giving reduced dose radiation therapy and chemotherapy after surgery may improve quality of life compared with standard of care primary chemoradiation approach without compromising survival.

NCT ID: NCT04920188 Active, not recruiting - Clinical trials for Leukemia, Myeloid, Acute

Development and Application of a Novel Digital Array PCR for Acute Myeloid Leukemia (AML)

Start date: May 28, 2021
Phase:
Study type: Observational

Purpose: The purpose of this trial is to investigate whether a digital array assay can detect trace amounts of residual leukemia and predict relapse in acute myeloid leukemia (AML) patients in remission who have undergone allogeneic stem cell transplantation (SCT) at the North Carolina Cancer Hospital (NCCH). Participants: Adult patients (18 years of age or older) with diagnosed AML who are going to undergo stem cell transplant (SCT). Procedures (methods): A total of 10 eligible subjects will be treated per standard of care with SCT. Peripheral blood and bone marrow aspirate (10 mL each) for digital array assay analysis will be collected along with routine lab draws and bone marrow biopsy procedures prior to SCT. Beginning 1 month after SCT peripheral blood (10 ml) will be collected to assess MRD by digital array assay analysis on a monthly basis for up to 6 months. In addition, bone marrow aspirate will be collected at approximately Month 3 and 6 following SCT for assay analysis. Patient medical records will be reviewed 6 and 12 months after completing their last MRD follow up assessment to confirm survival status, remission status, and gather information related to relapse.