Endocrinology Studies

  • Home
  • Endocrinology Studies
Spatial-Motor Stroke-Rehab Study

Spatial Neglect (SN) is defined as pathological asymmetric spatial behavior causing functional disability and occurs in greater than 50% of individuals with right hemisphere stroke. SN post-stroke is associated with increased fall risk, increased hospital length of stay, poorer rehabilitation outcomes, and severe long-term disability. Prism adaptation therapy (PAT) is an evidence-based treatment for SN after stroke, however, the effects of SN on gait are not well known. Neuromuscular electrical stimulation delivered via surface electrodes is a common therapeutic adjunct in stroke rehabilitation, including for SN and gait training. However, the additive therapeutic effects of combining electrical stimulation and PAT, as well as the effects of motor training on gait deficits associated with SN are poorly understood. Furthermore, although there is limited literature examining the effects of electrical stimulation on corticospinal tract output (CST), there is an inadequate understanding of the neural mechanisms of PAT and the combinatorial effects of PAT with electrical stimulation. To parse out the neural mechanisms of PAT and electrical stimulation on the visuospatial system, researchers will first examine the effects of PAT with or without electrical stimulation in neurologically unimpaired adults, researchers will then compare results to individuals with stroke with spatial neglect.
The primary objective is to study the effects of PAT on visuospatial behavior and motor cortical excitability in able-bodied individuals (young and older), and on spatial neglect, motor cortical neurophysiology, and walking function in individuals post-stroke.
The long-term goal of this project is to develop novel, effective, and personalized rehabilitation protocols targeting SN deficits and gait dysfunction to reduce disability in stroke survivors. The rationale of this project is to explore and generate data regarding future novel combinatorial motor-spatial retraining approaches that will enhance the rehabilitation approach of SN and gait performance in individuals post-stroke.

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.

September 26, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
Left Atrial Appendage Closure With WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding: The GI-FLX Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 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.

ClinicalTrials.gov Identifier: NCT06052358

Recruitment Status : **RECRUITING NOW**
First Posted : September 25, 2023
Last Update Posted : September 25, 2023

Sponsor:
Kansas City Heart Rhythm Research Foundation
Collaborators:
Kansas City Heart Rhythm Institute, Overland Park, Kansas
Texas Cardiac Arrythmia Institute, Austin, Texas
Los Robles Health System, Los Robles, California
Centennial Medical Center, Nashville, Tennessee
Information provided by (Responsible Party):
Kansas City Heart Rhythm Research Foundation

Study Description

Go to 

Brief Summary:
The GI-FLX Registry is intended to create a registry of patients with a history of Atrial Fibrillation (AF) and Gastrointestinal (GI) bleed who will receive Left Atrial Appendage Closure (LAAC) with WATCHMAN FLX device and compare to patients with AF and GI bleed who do not have LAAC. The GI-FLX Registry will be a multi-center, non-randomized registry. Approximately 250 prospective patients will be enrolled at all 4 sites. Historical cohort of 250 patients after propensity score matching with WATCHMAN-FLX arm will be included in the final analysis.

Condition or disease
Intervention/treatment

Atrial Fibrillation GI Bleeding
Device: LAAC with Watchman FLX device

Detailed Description:
A large gap in the literature exists as no prior study has evaluated the outcomes of those with prior GI bleeding undergoing LAAC. Furthermore, patients with prior GI bleed may be on no or minimal antithrombotic therapy prior to LAAC and subsequently require escalation of antithrombotic therapy following LAAC. Long-term outcomes including bleeding events will be most relevant and informative to this potentially high-risk subgroup. Therefore, this is an attempt to create a prospective registry describing outcomes of patients with AF and prior GI bleed undergoing LAAC to provide insight into safety and efficacy and will also compare to a historical cohort of patients with AF and GI bleed without LAAC.

Study Design

Go to 

Layout table for study information

Study Type :
Observational [Patient Registry]

Estimated Enrollment :
500 participants

Observational Model:
Cohort

Time Perspective:
Prospective

Target Follow-Up Duration:
12 Months

Official Title:
Left Atrial Appendage Closure With WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding: The GI-FLX Registry

Actual Study Start Date :
August 23, 2023

Estimated Primary Completion Date :
August 2025

Estimated Study Completion Date :
August 2025

Resource links provided by the National Library of Medicine

Groups and Cohorts

Go to 

Group/Cohort
Intervention/treatment

Patients with a history of AF and GI bleeding who will undergo LAAC
This is group of patients who will undergo LAAC with Watchman FLX device and have a history of AF and GI bleed.

Device: LAAC with Watchman FLX device
LAAC with Watchman FLX device

Patients with a history of AF and GI bleeding without LAAC
This is a historical cohort of patients with AF and recurrent GI bleeding without LAAC.

Outcome Measures

Go to 

Primary Outcome Measures :

To evaluate baseline characteristics [ Time Frame: 12 Months ]
To evaluate baseline characteristics such as Primary systemic thromboembolism (STE)/stroke, Recurrent bleeding after initial period of oral anticoagulant (OAC) requiring blood transfusion or hospitalization and Hemorrhagic stroke

Secondary Outcome Measures :

Complications [ Time Frame: 45 Days, 6 Months and 12 Months ]
Peri-device leaks (PDL)

Complications [ Time Frame: 45 Days, 6 Months and 12 Months ]
Device related thrombosis (DRT) related to WATCHMAN-FLX, Minor bleeding episodes leading to hospital visit but no transfusion, Incidence of hospitalization and Mortality at 12 months

Complications [ Time Frame: 45 Days, 6 Months and 12 Months ]
If hospitalized, Hospital length of stay

Eligibility Criteria

Go to 

Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:  
18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  
All

Accepts Healthy Volunteers:  
No

Sampling Method:  
Non-Probability Sample

Study Population
Approximately 250 patients who will undergo LAAC with Watchman FLX device and have a history of AF and GI bleed will be enrolled. This group will be compared to a historical cohort group of 250 patients with AF and recurrent gastrointestinal bleeding without LAAC.
Criteria

Inclusion Criteria:

All male and female patients who are > 18 years of age
Have Atrial Fibrillation
Have CHADS2VASc > 2
Have history of GI bleeding OR hospital admission that required blood transfusion OR emergency room visit requiring stopping of OAC OR outpatient 2 gm of Hgb drop from baseline, with or without evidence of upper or lower GI bleeding and requiring endoscopic procedure with holding of OAC.
Ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria:

Inability or unwillingness of individual to give written informed consent.
Other indications for OAC like deep vein thrombosis (DVT) or Pulmonary embolism (PE) or mechanical heart valve.
Patient who is pregnant will be excluded (Pregnancy will be excluded by checking urine beta-HCG).
Patient not following up with our practice / clinic after the procedure

Contacts and Locations

Go to 

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): NCT06052358

Contacts

Layout table for location contacts

Contact: Donita Atkins
816-651-1969
Datkins@kchrf.com

Locations

Layout table for location information

United States, Kansas

Kansas City Heart Rhythm Institute – Roe Clinic
**RECRUITING NOW**

Overland Park, Kansas, United States, 66211

Contact: Donita Atkins    816-651-1969    Datkins@kchrf.com   

Principal Investigator: Dhanunjaya Lakkireddy, MD         

Overland Park Regional Medical Center
**RECRUITING NOW**

Overland Park, Kansas, United States, 66215

Contact: Donita Atkins    816-651-1969    Datkins@kchrf.com   

United States, Missouri

Research Medical Center Clinic
**RECRUITING NOW**

Kansas City, Missouri, United States, 64032

Contact: Donita Atkins    816-651-1969    Datkins@kchrf.com   

Research Medical Center
**RECRUITING NOW**

Kansas City, Missouri, United States, 64032

Contact: Donita Atkins    816-651-1969    Datkins@kchrf.com   

Sponsors and Collaborators
Kansas City Heart Rhythm Research Foundation
Kansas City Heart Rhythm Institute, Overland Park, Kansas
Texas Cardiac Arrythmia Institute, Austin, Texas
Los Robles Health System, Los Robles, California
Centennial Medical Center, Nashville, Tennessee
Investigators

Layout table for investigator information

Principal Investigator:
Dhanunjaya Lakkireddy, MD
Kansas City Heart Rhythm Institute

More Information

Go to 

Publications:

Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG- 00445N). Washington, DC: Centers for Medicare & Medicaid Services, 2016. In.

Darden D, Duong T, Du C, Munir MB, Han FT, Reeves R, Saw J, Zeitler EP, Al-Khatib SM, Russo AM, Minges KE, Curtis JP, Freeman JV, Hsu JC. Sex Differences in Procedural Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry. JAMA Cardiol. 2021 Nov 1;6(11):1275-1284. doi: 10.1001/jamacardio.2021.3021. Erratum In: JAMA Cardiol. 2021 Oct 20;:

Layout table for additonal information

Responsible Party:
Kansas City Heart Rhythm Research Foundation

ClinicalTrials.gov Identifier:
NCT06052358    

Other Study ID Numbers:
KCHRRF_GI FLX_0022

First Posted:
September 25, 2023    Key Record Dates

Last Update Posted:
September 25, 2023

Last Verified:
September 2023

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:
No

Studies a U.S. FDA-regulated Device Product:
Yes

Additional relevant MeSH terms:

Layout table for MeSH terms

Gastrointestinal HemorrhageAtrial FibrillationHemorrhageArrhythmias, CardiacHeart Diseases
Cardiovascular DiseasesPathologic ProcessesGastrointestinal DiseasesDigestive System Diseases

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.

September 26, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
Spanish Decision Tool for Ovarian Cancer Maintenance Therapy

Study population: This study will enroll patients and clinical providers.
Inclusion criteria: Patients
• Eligible patients must be: 1) individuals ≥ 18 years with advanced stage high grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are receiving or have completed platinum-based chemotherapy for ovarian cancer and are potentially eligible to receive maintenance therapy; 2) able to understand, speak or read in Spanish.
Exclusion criteria: Patients
1) Inability or unwillingness to sign informed consent
Inclusion criteria: Clinicians
• Eligible clinicians will include: 1) MD Anderson gynecologic oncologists and advanced practice providers who practice at the Houston Area Locations (HALs), MD Anderson Cancer Center, or our county safety net hospital, The Harris Health System (LBJ Hospital).
Exclusion criteria: Clinicians
1) Inability or unwillingness to sign informed consent

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.

September 26, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
Geriatric Assessment Guided Interventions to Accelerate Functional Recovery After CAR-T Therapy for Patients 60 Years and Older With B-cell Non-Hodgkin Lymphoma or Multiple Myeloma, GOCART Study

PRIMARY OBJECTIVE:

I. Evaluate the effects of a GA-informed multi-disciplinary intervention in attenuating physical function decline among older patients receiving CAR-T therapy at day +30 post-CAR-T infusion.

SECONDARY OBJECTIVES:

I. Determine success in coordinating trimodality optimization before lymphodepletion.

II. Compare rates of geriatric syndromes of frailty, cognitive impairment and malnourishment in SOC and GA-intervention cohorts at 30 days post-CAR-T infusion.

III. Evaluate rates and duration of CAR-T related neurotoxicity in SOC and GA-intervention groups.

EXPLORATORY OBJECTIVES:

I. Quantify trimodality optimization intensity throughout treatment course. II. Compare longitudinal trajectory of Short Physical Performance Battery (SPPB), frailty, cognitive impairment and malnourishment between the two arms, at day +100 post-CAR-T infusion.

III. Evaluate quality of life trajectories using the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale at baseline and days +30 and +100 in both cohorts.

IV. Incidence of intensive care unit (ICU) admissions by day 100. V. Overall survival, response rate and progression-free survival through one year.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo GA before lymphodepleting chemotherapy and recommendations based on assessment results communicated to treating physicians. Patients receive physical therapy (PT) and delirium prevention education prior to lymphodepletion, at least once before CAR-T therapy, at least 2 times a week while inpatient, and at least once every other week outpatient up to day 30. Additionally, patients receive personalized nutritional guidance from a registered dietician prior to lymphodepletion, prior to CAR-T therapy and at least once a week up to day 30.

ARM II: Patients undergo GA and receive standard of care throughout study.

After completion of study treatment, patients are followed up at day 100 and then up to 1 year.

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.

September 26, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
The Gut Microbiome and Immunotherapy Response in Solid Cancers

Frontline treatment for solid cancers such as renal cell carcinoma includes immunotherapies such as immune checkpoint inhibitor (ICI) therapy. Despite an increase in overall survival in cancer patients undergoing ICI therapy, many patients’ tumors are unresponsive or eventually progress. Recent studies indicate that the gut microbiome composition is associated with clinical response to ICI treatment. Following the success of preclinical research, two recent studies investigated the efficacy of fecal microbiota transplant (FMT) from cancer patients responsive to programmed cell-death protein 1 (PD-1) blockade, a type of ICI treatment, to patients nonresponsive to treatment. Notably, 30-40% of the FMT recipients in these studies subsequently responded to anti-PD-1 therapy. However, the effectiveness of FMT may vary among donors, there is no clear agreement on the ideal FMT composition, and FMT carries the risk of transmitting infection. An alternative to FMT is identification of specific efficacious commensals for supplementation. While the specific commensals enriched in cancer patients with more favorable outcomes vary from study to study, several are commonly reported, including Akkermansia muciniphila, Bacteroides spp., Bifidobacterium spp., Ruminococcaceae spp., and Faecalibacterium spp.

Cancer-related fatigue is experienced by nearly all patients during treatment, and cancer-related cognitive impairment (CRCI), which is a decrease in neurocognitive functioning that can be caused by cancer or its treatment, is present in up to ¾ of patients during treatment. Fatigue and CRCI have both been linked to the composition of the gut microbiome in cancer patients.

Specific Aims

Specific Aim 1: Characterize the gut microbiome of solid cancer patients that have had disease progression during standard-of-care treatment with PD-1 or programmed cell death ligand 1 (PD-L1) blockade and compare to solid cancer patients that were stable or experienced tumor shrinkage during standard-of-care treatment with PD-1/PD-L1 blockade.

Specific Aim 2: Assess neuropsychological measures of cognition and fatigue in solid cancer patients undergoing standard-of-care treatment with PD-1/PD-L1 blockade and determine associations with composition of the gut microbiome.

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.

September 25, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response
Experimental: MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response

Participants randomized to the MONITOR arm will be provided dietary coaching biweekly to discuss nutrition concerns, anti-inflammatory diet compliance, and set SMART goals based on their most recent Vioscreen food frequency questionnaires.

Behavioral: Quality fo Life Questionnaire (FHSI)

Participants will take a survey at baseline and visit 2 (weeks 6-8), and visit 3 (week 10-14). The Functional Assessment of Cancer Therapy Hepatobiliary Cancer Symptom Index-8 (FHSI) questionnaire uses a 5-point Likert-type scale, 0=not at all and 4=Very much. A lower total score indicates better quality of life.

Behavioral: Vioscreen Food Frequency Questionnaire (FFQ)

Participants will receive a web-based link and information to complete VioScreen, a web-based food frequency questionnaire, which allows participants to choose the average frequency of consumption of food items over a given time frame (1 month, 3 month, 1 year, etc.) on a Likert scale with choices ranging by individual questions. Total energy and nutrient intake is estimated by summing intakes from each food based on the selected portion size, reported frequency of consumption, and nutrient content of each food item. Anti-inflammatory and pro-inflammatory dietary patterns are calculated using the energy-adjusted dietary inflammatory index (DII) score to represent the inflammatory potential of an individual’s overall diet, using data from FFQ responses. Higher DII scores represent more pro-inflammatory diets while lower (i.e., more negative) DII scores represent more anti-inflammatory diet.

Behavioral: NutritionCoaching

Participants will receive bi-weekly nutrition coaching on anti-inflammatory dietary patterns and foods.

Behavioral: Follow-Up Survey

Participants will complete a custom exit/follow up survey regarding relevance, acceptability, intervention length and timing, an barriers/facilitators. This survey contains 38 questions scored from 1 -Strongly agree to 5-Strongly disagree. A lower score indicates patient satisfaction with the program and the skills and knowledge gained in the program.

Behavioral: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire

The FAACT questionnaire uses a 5 point Likert-type scale, 0=Not at all, 4=Very much. A higher score indicates better appetite and quality of life.

Behavioral: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire

Participants will complete the PROMIS-Cog form which measures self-reported cognitive deficits. The questionnaire uses a 5 point Likert-type scale, 1=Very often and 5=Never. A higher score indicates higher cognitive function.

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.

September 24, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
Can Patients With Chronic Stroke Regain Living Independence by Daily Energizing With Biophoton Generators

Investigational product and mode of administration The hotel bed is powered by a standardized set of 14 biophoton generators of 32-Oz size, which was previously tested as safe and effective. The active device is FDA registered over-the-counter (OTC) medical device. The device can be used by anyone who wants to increase blood circulation and reduce bodily pains, according to the label claims. For this study, the active or inactive devices will be labeled with individual codes. The participant, caregiver and the study staff cannot know if the hotel room is equipped with a set of active or inactive devices. When the participant is lying on the hotel bed, she/he may or may not receive biophotons. The study physician, participant or the caregiver will record the ADL and other changes, and answer the standard study questionnaires at the baseline, 2, or 4 weeks after study treatment, respectively.
Study procedure Each of all participants assigned to the Control or Treatment Group will be continually treated with the current standard of care (SOC), if any. The Control group will use the coded placebo devices, and the Treatment Group will use the coded treatment product. All coded products will be packed with the same container with the same size and weight. Each participant will use the Treatment or Control device at least for 8-hours every day for 4-weeks during sleep and any daytime during the day. Each participant and caregiver will be guided by the study physician to use Katz Index of Independence in Activities of Daily Living (ADL) to measure the level of life independence. The study physician will perform neurological examination. Stroke Impact Scale (SIS) for stroke-specific health status measurement, SF-36 questionnaires (SF-36) to measure life quality, Electroencephalography (EEG) test, and Bio-Well energy test, will be conducted respectively at the baseline, 2 or 4 weeks after the study treatment. SIS and SF-36 questionnaires will be recalled 4 weeks before the baseline for each participant.
Comparator and mode of administration The same shape, size, and weight of the device without generating biophoton is to be labelled with individual codes and used as a comparator. The comparator device will be placed in the same way as the Treatment device in the hotel room during the designed study period.
Study duration Estimated date of the first participant enrolled: May 2023. The estimated date of the last patient completed: December 2023. The participants randomized in the Control group will be switched to the Treatment after observing the placebo effects for four weeks. They will be treated with the active device for 4-weeks for self-comparison analysis.
Duration of treatment Participants in the Control and Treatment Groups will actively participate in the study for 4-weeks. Each participant and caregiver will answer the standard study questionnaires at the baseline, 2 or 4 weeks of the study, respectively. The participants randomized in the Control will participate in the study for a total of 6 weeks.

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.

September 23, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
Mezigdomide (CC-92480) Post Idecabtagene Vicleucel in Treating Patients With Relapsed Multiple Myeloma

PRIMARY OBJECTIVE:
I. To evaluate the safety and tolerability of mezigdomide (CC-92480) given post idecabtagene vicleucel when administered as a continued therapy.
SECONDARY OBJECTIVES:
I. To evaluate the anti-tumor activity of mezigdomide (CC-92480) when administered post idecabtagene vicleucel.
II. To determine the persistence of CAR T cells at day 90 (D90), day 180 (D180), and day 365 (D365) after start of mezigdomide (CC-92480) therapy.
EXPLORATORY OBJECTIVES:
I. To assess levels of serum BCMA monthly at day 1 of every cycle. II. To assess the effects of mezigdomide (CC-92480) on non-cancer immune cells in the peripheral blood and bone marrow samples.
OUTLINE: This is a dose-escalation study of mezigdomide.
Starting between 30 and 90 days after infusion of idecabtagene vicleucel, patients receive mezigdomide orally (PO) on days 1-21 or days 1-14 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET)/computed tomography (CT) during screening. Patients also undergo bone marrow aspiration and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days, every 3 months within 1 year of start of treatment, and then every 6 months until progression or for up to 2 years.

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.

September 23, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
ACTIV-6: COVID-19 Study of Repurposed Medications – Arm G (Metformin)

Time to sustained recovery in Days [ Time Frame: Up to 28 days ]
(If not evaluated as primary endpoint for the given study drug appendix) Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time. The overall effect of each study drug versus matching placebo will be quantified using one of these two primary endpoints, which will be defined and documented per study drug appendix prior to the initial IA: clinical events (hospitalization or death) or time to recovery. The other will be evaluated as a secondary endpoint.

Number of Participants With Hospitalization or Death [ Time Frame: Up to 28 days ]
(If not evaluated as primary endpoint for the given study drug appendix)

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, 120, and 180 ]
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, 120, and 180 ]
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, 120, and 180 ]
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, 120, and 180 ]
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, 120, and 180 ]
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, 120, and 180 ]
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, 120, and 180 ]
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.

September 23, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
GLP-1 Receptor Agonist Use and Incidence of Retained Gastric Food on Endoscopy
Patients taking a GLP-1 agonist medication

Participants meeting all inclusion/exclusion criteria who are taking a GLP-1 agonist medication

Other: Esophagogastroduodenoscopy

All patients will undergo an esophagogastroduodenoscopy per standard of care, as scheduled.

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.

September 23, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine