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ACTIV-6: COVID-19 Study of Repurposed Medications – Arm F (Montelukast)

Number of Participants With Hospitalization or Death [ Time Frame: Up to 28 days ]
Number of Participants With Mortality [ Time Frame: Up to 28 days ]
Time to mortality [ Time Frame: Up to 28 days ]
Time to mortality was the number of days between drug receipt and death.

Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death [ Time Frame: Up to 28 days ]
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7. [ Time Frame: Day 7 ]
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.

Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14. [ Time Frame: Day 14 ]
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.

Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28. [ Time Frame: Day 28 ]
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.

Quality of Life (QOL) as measured by the PROMIS-29 – Physical Function [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function.

Quality of Life (QOL) as measured by the PROMIS-29 – Fatigue [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue.

Quality of Life (QOL) as measured by the PROMIS-29 – Pain [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain.

Quality of Life (QOL) as measured by the PROMIS-29 – Depression [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domain with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression.

Quality of Life (QOL) as measured by the PROMIS-29 – Anxiety [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.

Quality of Life (QOL) as measured by the PROMIS-29 – Social [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities.

Quality of Life (QOL) as measured by the PROMIS-29 – Sleep [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep.

Time Unwell in Days as Measured by the Symptom and Clinical Event Scale [ Time Frame: Up to 14 days ]
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.

Mean Days Benefit as Measured by the Symptom and Clinical Event Scale [ Time Frame: Up to 14 days ]
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

June 9, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
Gastric Ultrasound Assessment for Preoperative Prandial State of Patients Taking Glucagon-Like Peptide-1 Receptor Agonists

Diagnostic Test: Gastric ultrasound

Patient will be scanned first in the supine position and then in the right lateral decubitus position. The ultrasound probe will be placed in a sagittal plane in the epigastric region at the left subcostal margin and then will be moved past the midline in a fan like manner to the right subcostal region. Qualitative and quantitative assessments will be done.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

June 9, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus

Experimental: Ticagrelor
ticagrelor 60 mg bid monotherapy
Drug: Ticagrelor monotherapy
Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
Other Name: Brilinta

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

June 9, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
Safety and Efficacy of Faricimab in Patients With NPDR

California Retina Consultants

Bakersfield, California, United States, 93309

Contact: Luis Lopez    661-325-4393    luis.lopez@californiaretina.com   

Principal Investigator: Dante Pieramici, MD         

Retinal Consultants Medical Group

Modesto, California, United States, 95356

Contact: Diana Heredia    916-339-2693    herediad@retinalmd.com   

Principal Investigator: Margaret Chang, MD         

Florida Retina Institute

Jacksonville, Florida, United States, 32216

Contact: Karen Yesensky    904-997-9202 ext 22402    kareny@floridaretinainstitute.com   

Principal Investigator: Benjamin Thomas, MD         

Florida Retina Institute

Orlando, Florida, United States, 32806

Contact: Martha Haddox    407-849-9621    marthah@floridaretinainstitute.com   

Principal Investigator: Matthew Cunningham, MD         

Retina Group of Florida

Sarasota, Florida, United States, 34233

Contact: Courtney Smith    941-924-0303    CSmith@retinasarasota.com   

Principal Investigator: Jesse McCann, MD         

Retina Consultants of Minnesota St. Louis Park

Saint Louis Park, Minnesota, United States, 55416

Contact: Mallorie Schieck    952-259-6264    mschieck@retinamn.com   

Principal Investigator: Abdhish Bhavsar, MD         

Mississippi Retina Associates

Jackson, Mississippi, United States, 39202

Contact: Anne Britt    601-948-0761    abritt@msretina.com   

Principal Investigator: Michael Borne, MD         

Long Island Vitreoretinal Consultants

Westbury, New York, United States, 11590

Contact: Kristen D’Amore    516-466-0390    kdamore@vrcny.com   

Principal Investigator: Philip Ferrone, MD         

North Carolina Retina Associates

Wake Forest, North Carolina, United States, 27587

Contact: Amanda Smith    919-435-9382    asmith@ncretina.com   

Principal Investigator: John Thordsen, MD         

Charleston Neuroscience Institute

Ladson, South Carolina, United States, 29456

Contact: Carlos Ortiz    843-763-4466    c.ortiz@retinacharleston.com   

Principal Investigator: Virgil Alfaro, MD         

Palmetto Retina Center

West Columbia, South Carolina, United States, 29169

Contact: Shan Woody    803-931-0077    swoody@palmettoretina.com   

Principal Investigator: Stephen Hypes, MD         

Tennessee Retina, PC

Nashville, Tennessee, United States, 37203

Contact: Lisa Walden    615-345-8912    lwalden@tnretina.com   

Principal Investigator: Carl Awh, MD         

Austin Retina Associates

Austin, Texas, United States, 78705

Contact: Jenae Goode    512-451-0103    jgoode@austinretina.com   

Principal Investigator: Robert Wong, MD         

Retina Consultants of Texas

Beaumont, Texas, United States, 77707

Contact: Jessica Hamiton    800-833-5921    jessica.hamilton@retinaconsultantstexas.com   

Principal Investigator: Will Pearce, MD         

Retina Consultants of Texas

Bellaire, Texas, United States, 77401

Contact: Allison Stroh    800-833-5921    allison.stroh@retinaconsultantstexas.com   

Principal Investigator: David Brown, MD         

Retina Consultants of Texas

Katy, Texas, United States, 77494

Contact: Kourtney Storey    800-833-5921    Kourtney.Storey@retinaconsultantstexas.com   

Principal Investigator: Effie Rahman, MD         

Retina Consultants of Texas

San Antonio, Texas, United States, 78240

Contact: Lydia Adams    800-833-5921    lydia.adams@retinaconsultantstexas.com   

Principal Investigator: Sarah Holy, MD         

Retina Consultants of Texas

The Woodlands, Texas, United States, 77384

Contact: Cassie Cone    800-833-5921    ccone@retinaconsultantsofamerica.com   

Principal Investigator: Charles Wykoff, MD         

Retina Associates of Utah

Salt Lake City, Utah, United States, 84107

Contact: Caity Kwun    801-312-2070    ckwun@retinautah.com   

Principal Investigator: Robert Kwun, MD         

Retina Center NW, PLLC

Silverdale, Washington, United States, 98383

Contact: Anna Nelson    360-307-0300    anna@retinacenternw.com   

Principal Investigator: David Spinak, MD         

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

June 9, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)
Active Comparator: Surgery

Surgery followed by risk-adjusted adjuvant treatment (observation, radiation, or chemoradiation).

Procedure: Surgery

Cohort A will undergo initial surgical resection of the primary and neck dissection with pathologic features directing predetermined adjuvant treatment. Pathology of the primary and nodal specimens will then be reviewed as to determine the next intervention per protocol. Based on operative findings including degree of nodal involvement, extracapsular spread, perineural invasion, and lymphovascular involvement, patients will be designated to adjuvant treatment arms consisting of observation, adjuvant radiation, or adjuvant chemoradiation.

Combination Product: Chemoradiation

Patients will receive an initial plan with a single prescription of 30 Gy in 15 fractions to PTV_High and PTV_Low with RT given once daily, 5 days a week (Monday through Friday). After analysis of mid-treatment PET/CT, the remaining radiation treatment will be delivered as a conedown to the gross disease only. Patients will be planned to receive a total dose of 70 Gy, 54 Gy, or 44 Gy to PTV_High in 2 Gy per fraction.

Other: Observation

Cohort A will undergo initial surgical resection of the primary and neck dissection with pathologic features directing predetermined adjuvant treatment. Pathology of the primary and nodal specimens will then be reviewed as to determine the next intervention per protocol. Based on operative findings including degree of nodal involvement, extracapsular spread, perineural invasion, and lymphovascular involvement, patients will be designated to adjuvant treatment arms consisting of observation, adjuvant radiation, or adjuvant chemoradiation.

Radiation: Post-operative radiation

Patients will receive adjuvant radiation based on pathologic features.Total radiation treatment doses and prescriptions will include 36 Gy in 18 fractions, 50 Gy in 25 fractions and 60 Gy in 30 fractions.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

June 9, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
Watermelon Dose Response Blood Pressure Study

Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05892328

Contacts

Layout table for location contacts

Contact: Indika Edirisinghe, Ph.D.
312-567-5300
iedirisi@iit.edu

Contact: Chelsea Preiss, M.S.
312-567-5300
cpreiss@iit.edu

Locations

Layout table for location information

United States, Illinois

Clinical Nutrition Research Center
**RECRUITING NOW**

Chicago, Illinois, United States, 60616

Contact: Chelsea Preiss, M.S.    312-567-5300    cpreiss@iit.edu   

Contact: Indika Edirisinghe, Ph.D.    3125675300    iedirisi@iit.edu   

Principal Investigator: Amandeep Sandhu, Ph.D.         

Sub-Investigator: Indika Edirisinghe, Ph.D.         

Sub-Investigator: Britt Burton-Freeman, Ph.D.         

Sponsors and Collaborators
Clinical Nutrition Research Center, Illinois Institute of Technology
National Watermelon Promotion Board
Investigators

Layout table for investigator information

Principal Investigator:
Indika Edirisinghe, Ph.D.
Illinois Institute of Technology

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

June 8, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
DiaBetter Together for Young Adults With Type 1 Diabetes

Experimental: DiaBetter Together Intervention
Young Adult participants with type 1 diabetes (ages 17-25) who are approaching transfer from pediatric to adult care will be randomized to either the DiaBetter Together Intervention group or the Usual Care group. After randomization to the intervention group, young adults will be assigned a Peer Mentor. Following an intervention manual, the Peer Mentor will teach behavioral strategies and offer support to the young adult. In both conditions, participation in this study will not impact participants’ ability to contact the pediatric TCH diabetes care team or any other medical services to receive medical care.
Behavioral: DiaBetter Together
Following an intervention manual, the Peer Mentor will teach behavioral strategies and offer support to the young adult, including (a) teaching and modeling strengths-based skills for goal-setting, problem-solving, and stress management; (b) guiding participants in obtaining support from their social support network (e.g., family, friends); (c) developing a plan for accountability around diabetes management and follow-up in adult care; (d) sharing his/her transition experiences and strategies for successfully navigating the adult healthcare system; (e) discussing how to prioritize diabetes self-care; and (f) assisting them in accessing diabetes-related resources (e.g., local diabetes groups, apps, social media). Contact will be in-person, by phone, email, text message, and/or video, approximately weekly for first 3 mos, approximately biweekly for next 3 mos, and approximately monthly for last 6 mos (while COVID-19 safety recommendations are in place, in-person meetings will not occur).

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

June 8, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
The Role of Type 2 Diabetes on Skeletal Muscle Atrophy and Recovery Following Bed Rest in Older Adults

Older adults with type 2 diabetes experience an accelerated rate of sarcopenia, which is the deterioration in muscle mass, strength and physical performance. Periods of disuse caused by illness or hospitalization cause rapid loss of muscle mass and strength, which negatively impact physical function upon re-ambulation. The impact of type 2 diabetes on acute muscle atrophy and recovery from disuse is a critical issue that has not been investigated.
The overall objectives of this study are to employ highly innovative methods in muscle biopsy specimens in order to decipher the temporal sequence by which mitochondrial dysfunction and lipotoxicity in older adults with pre-diabetes and type 2 diabetes impact atrophy and recovery of muscle mass, strength and physical function following bed rest. Older adults with and without pre-diabetes/type 2 diabetes will complete 10 days of strict bed rest followed by 4 weeks of ambulatory recovery. During bed rest muscle biopsies will be collected to determine mitochondrial function and lipid profile. During the recovery period the recovery of muscle mass, strength and physical function will be determined.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

June 8, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes

The purpose of this research study is to test if CGMs are tolerable to youth with pre-diabetes (PD) and their caregivers. We are also evaluating if CGMs add benefit to standard treatment in youth with prediabetes. The CGM in question, Abbott Freestyle Libre 2 is approved by the Food and Drug Administration (FDA) to treat patients aged 4 and up with diabetes. We want to determine if this CGM may benefit people who have PD. People who enter the study will either receive standard medical care for prediabetes or receive standard medical care for prediabetes plus use a CGM for 2 weeks each month to receive real-time biofeedback on their glucose levels during the day.
There will be 3 visits over a 6-month period, baseline, 3-month, and 6-month visits. At each visit fasting labs will be obtained including: complete metabolic panel, lipid panel, pro-insulin, c-peptide, insulin. Anthropomorphics including body mass index, waist circumference, and hip circumference will be monitored.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

June 8, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain
Experimental: Patients already on Tucatinib

Cohort A: This is a non-interventional study patients who will enter while already on Tucatinib . Patients in cohort A who are already on Tucatinib at a dose reduction (i.e., for toxicity) will continue the same dose.

Drug: Tucatinib

Standard dose of 300mg orally twice daily for 4 days prior to surgery (day -4 to 0).

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

June 8, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine