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NCT ID: NCT04887272 Not yet recruiting - Covid19 Clinical Trials

Weathering the Storm: Lung, Heart, and Brain Vascular Rehabilitation for COVID-19

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

Background: Respiratory and cardiovascular complications have emerged as dominant threats during and following coronavirus disease (COVID19) infection. Severe COVID19 infection is categorized as acute respiratory dysfunction leading to hospitalization, where as a mild infection is identified as symptoms of dyspnea, muscle pains, migraines, palpitations and/or fatigue persisting for several weeks. Recovery from COVID19 infection is poorly characterized, but symptoms appear to gradually decline over a four to eight-week period. Unfortunately, recovery from severe infection is similar to symptoms experienced with mild infection making it rather difficult to provide a physiological definition of recovery for mild infection sufferers. Considering that 81% of COVID19 infections are found to be mild, approximately 4.5 million Americans may be vulnerable to inadequate cardiovascular recovery that exacerbates reductions in physical capacity and quality of life. Combined respiratory muscle and exercise training enhance cardiorespiratory function, maximize return to activities of daily living, and reduces hospitalization times in heart failure, sepsis and severe acute respiratory syndrome. However, it is unclear if these interventions will also enhance cardiorespiratory and cerebrovascular COVID19 recovery. Therefore, utilizing cardiorespiratory and cerebrovascular rehabilitation techniques we propose these specific research aims and hypotheses to investigate the following: 1. Does individualized cardiac exercise rehabilitation enhance cardiorespiratory & cerebrovascular recovery? Hypotheses: 1. Individualized exercise therapy designed to increase fitness will enhance cardiorespiratory function at rest, as well as during and following exercise in individuals recovering from COVID19. 2. Cerebrovascular function at rest, as well as during and following exercise will be enhanced following individualized exercise therapy in individuals recovering from COVID19 infection. 3. The magnitude of post-training cardiorespiratory enhancements will be associated with cerebrovascular adaptations in individuals recovering from COVID19 infection. 2. Does combining inspiratory muscle and cardiac exercise rehabilitation provide additive cardiorespiratory and cerebrovascular COVID19 recovery benefits? Hypotheses: 1. The addition of inspiratory muscle training to individualized exercise therapy will enhance cardiorespiratory adaptation in individuals recovering from COVID19 infection. 2. Improved cardiorespiratory function associated with inspiratory muscle training and exercise therapy will add further recovery advantage to cerebrovascular function in individuals recovering from COVID19 infection. Study Design Scientific Plan: This project aims to collect pre- and post-intervention cardiorespiratory and cerebrovascular measures in individuals 1- 4 weeks after recovering from COVID19 infection (n=40; 20 ♀ & 20♂). Each participant will be randomized to either Supervised Exercise Training (EXT; n=20) or combined inspiratory muscle and exercise testing (IMET; n=20) interventions. Randomization will match for age and sex, and will attempt balanced matching of any cardiovascular (hypertension, atherosclerosis), respiratory (chronic obstructive pulmonary disease, asthma), and metabolic (diabetes, metabolic syndrome) comorbidities between interventions. Prior to beginning EXT or IMET, participants will complete baseline fitness, respiratory muscle testing, cardiovascular, and cerebrovascular measures to DEXA body composition scan (dual energy X-ray absorptiometry, DEXA) determine the initial intensity and post-intervention effectiveness, respectively. Following baseline testing, participants will complete a 6-week EXT or IMET intervention. EXT: Supervised EXT will include a progressive individualized program that combines aerobic and resistance protocols. Volume progression will begin with 3-days of supervised training sessions/wk and will increase by 1 session/wk to a maximum of 5-days/wk. Each EXT session will include 30 minutes of aerobic training (15 minutes cycling; 15 minutes treadmill walking/running/elliptical) and 30 minutes of resistance training (specifics below). Considering individual fatigue will be a concern, therefore similar to exercise training standards in COPD, the duration of rest periods may be extended (~1-3 min) as needed, however all exercise durations will be completed within a 1.5-hour time slot. IMET: All IMET sessions will be performed similar to EXT, with the exception of having 3-sessions of at home IMT training. On these days, all training will be spread out over a 2-hour session with periods of IMT training occurring at the beginning, middle and end of the session.

NCT ID: NCT04883619 Not yet recruiting - Lupus Nephritis Clinical Trials

A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

Start date: January 15, 2026
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).

NCT ID: NCT04882280 Not yet recruiting - Sleep Clinical Trials

Dose-dependent Impact of Daytime Lighting on Evening Responses to Light

Start date: July 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to systematically examine the impact of different intensities of daytime light and the subsequent impact that such exposure has on non-image forming responses to light in the evening.

NCT ID: NCT04881981 Not yet recruiting - Malignant Neoplasms Clinical Trials

A Phase I Study Evaluating the Safety of Stereotactic Central Ablative Radiation Therapy (SCART) for Bulky Metastatic or Recurrent Cancer

Start date: June 5, 2021
Phase: Phase 1
Study type: Interventional

We aim to evaluate the feasibility and toxicity of testing the tolerance and immunogenic effects of high-dose SCART radiotherapy in patients with bulky metastatic or recurrent cancer in the setting of a single-arm phase I clinical trial. The primary endpoint of the study was to determine dose-limiting toxicities (DLT)s and the Maximum Tolerated Dose (MTD) of SCART to bulky metastatic or recurrent cancers.

NCT ID: NCT04880707 Not yet recruiting - Acute Pain Clinical Trials

Twin Block, Pain Medications and Third Molar Extractions

Start date: March 2024
Phase: Phase 2
Study type: Interventional

Each year, over 3.5 million, mostly, healthy young adults, have their third molar teeth ('wisdom teeth') removed under sedation and are often given opioid prescriptions for managing their pain. Wisdom molar removal is one of the most common reasons for opioid prescriptions to be given to adolescents. There is a national thrust to reduce both the dose and the duration of such opioid prescriptions because even short-term opioid exposures increase risk for narcotic addiction and misuse. Non-opioid options to manage pain will still allow for sufficient pain control without risking addiction, and hence, a fundamental component of our response to combat the current national opioid crisis. The investigators are going to study a promising option- the Twin Block dental anesthetic injection. The Twin block involves injecting the standard dental numbing medication in a way that 'numbs' the 'jaw-clencher' muscles on the side of the face. The investigators found that the Twin block relieved jaw pain stemming from these muscles, in a quick and sustained manner, even in patients whose pain following wisdom tooth removal primarily came from 'taut' and tender jaw-clencher muscles. However, what is not known is- how often do patients who have their wisdom teeth removed under sedation, end up in significant pain from taut and tender jaw-clencher muscles? Will using the twin block effectively reduce pain in such patients? In this pilot study, the investigators will examine wisdom molar extraction patients one day after their procedure. Those with significant pain (pain rated ≥ 5 on a 0-10 scale) in their jaw-clencher muscles, will get either the Twin block injection or a placebo. The investigators will track both 1) pain before and after the injection, and 2) pain medication usage over a 7-day period to see if both pain and opioid dosage come down with the Twin block. This study can support a simple, safe and inexpensive means to reduce pain after a common procedure.

NCT ID: NCT04876755 Not yet recruiting - Clinical trials for Prostate Cancer Recurrent

MBM-02 (Tempol) for the Treatment of Biochemical Recurrent Prostate Cancer

Start date: May 30, 2021
Phase: Phase 2
Study type: Interventional

This is an open label trial to assess the efficacy of MBM-02 (Tempol) as a treatment for patients diagnosed with prostate cancer in biochemical recurrence.

NCT ID: NCT04874506 Not yet recruiting - Glioblastoma Clinical Trials

MBM-02 (Tempol) for the Treatment of Glioblastoma Multiforme (GBM)

Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

MBM-02 (Tempol) is an HIF-1 and HIF-2 inhibitor that is being tested as an addition to standard of care treatment that includes radiotherapy and TMZ. MBM-02's ability to increase progression free survival and decrease side effects of TMZ and radiotherapy treatment will be assessed.

NCT ID: NCT04871477 Not yet recruiting - Clinical trials for Hematopoietic and Lymphoid Cell Neoplasm

Adoption of Audio Recording in the Outpatient Supportive Care Center

Start date: January 30, 2025
Phase:
Study type: Observational

This study evaluates how patients feel about having an audio recording of their visit to help remember information given to them and share that information with family members and/or caregivers not present during a clinic visit. Information from this study may help evaluate the effectiveness of using technology to help improve patient care by recording consultation recommendations.

NCT ID: NCT04869865 Not yet recruiting - Healthy Clinical Trials

The Effects of a Springtime Home Cleanse on Skin, Gut, Metabolic and Mental Health

Start date: April 29, 2021
Phase: N/A
Study type: Interventional

This pilot study will evaluate the effects of a Springtime Home Cleanse on skin, gut, metabolic, and mental health. The study will also assess changes in overall quality of life. The results will be used to design a larger cleanse-based study in the future.

NCT ID: NCT04869709 Not yet recruiting - Prematurity Clinical Trials

Late Preterm Corticosteroids and Neonatal Hypoglycemia

Start date: July 2021
Phase: Phase 4
Study type: Interventional

This is a prospective randomized controlled trial investigating the timing of betamethasone administration in late preterm infants in relation to delivery and impact on neonatal hypoglycemia. Previous data has shown that neonatal hypoglycemia is increased in late preterm infants that were exposed to antenatal corticosteroids. The investigators hypothesize that the timing of steroid administration may impact the development of neonatal hypoglycemia.