Trial record 1 of 1 for:
NCT04726254
The JULI Registry--Hemp and Cannabis Observational Registry (JULI)
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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: NCT04726254 |
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Recruitment Status :
Recruiting
First Posted : January 27, 2021
Last Update Posted : July 19, 2022
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Sponsor:
Juva Life
Collaborator:
Targeted Medical Education
Information provided by (Responsible Party):
Juva Life
- Study Details
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Brief Summary:
The JuLi Registry seeks to fill some of the gaps associated with the clinical use of CBD (cannabidiol) and other cannabinoid formulations including THC and others. The overarching goal of this Registry is to rapidly advance research and understanding of the use of cannabis and hemp-based formulations, in the clinical community setting, when it is utilized to manage the symptoms of cancer treatment and other underlying health issues. These symptoms include nausea, neuropathy, and sleeplessness and chronic pain.
| Condition or disease |
|---|
| Chronic Pain Appetite Disorders Neuropathy Menopausal Syndrome Anxiety Sleep Disturbance Nausea |
Show detailed description
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 2000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Months |
| Official Title: | The JUvaLIfe Registry |
| Actual Study Start Date : | August 1, 2021 |
| Estimated Primary Completion Date : | February 15, 2024 |
| Estimated Study Completion Date : | February 15, 2025 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Symptom Relief [ Time Frame: 3 months ]Percentage of patients who obtain and report symptom relief, by symptom, condition and cannabis formulation
- Reduction in reliance on Rx medications [ Time Frame: 3 months ]Percentage of patients who report reduction or increase in use of Rx medications
Secondary Outcome Measures :
- Reduction in reliance on OTC medications [ Time Frame: 3 months ]Percentage of patients who report reduction or increase in use of Rx medications
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.
| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All patients greater than or equal to 21 years of age who are seeking to use hemp-based or cannabis-based formulations to relieve symptoms associated with medical interventions or conditions
Criteria
Inclusion Criteria:
- 21 years of age or older
- Have requested from and/or decided with their providers to try CBD (hemp-based) or other cannabis products to relieve one or more symptoms related to a medical diagnosis
- Consent to have their health data included in a Registry and participate in PRO (patient reported outcomes) surveys and data collection via a study app.
Exclusion Criteria:
- Patient pregnant
- Unwilling or unable to provide informed consent
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): NCT04726254
Contacts
| Contact: Mary Kay K Hardwick, MBA | 5106826256 | mkhardwick@tmebcn.com | |
| Contact: Peter Beitsch, MD | 214 350 6672 | pbeitsch@tmebcn.com |
Locations
| United States, California | |
| Precision Cancer Specialists | Recruiting |
| Los Gatos, California, United States, 95032 | |
| Contact: Rakesh Patel, MD 608-347-3405 medrockpatel@gmail.com | |
| Principal Investigator: Rakesh Patel, MD | |
| Justin Lo MD | Recruiting |
| San Jose, California, United States, 95128 | |
| Contact: Justin Lo, MD 408-295-8628 justin@justinlomd.com | |
| United States, Tennessee | |
| Nashville Breast Center | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Pat Whitworth, MD 615-620-5535 pwhitworth@tmebcn.com | |
| Contact: Kristie Appleton 615-620-5535 | |
| United States, Texas | |
| Dallas Surgical Group | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Contact: Peter Beitsch, MD 214-420-8499 pbeitsch@tmebcn.com | |
| Principal Investigator: Peter Beitsch, MD | |
Sponsors and Collaborators
Juva Life
Targeted Medical Education
Publications of Results:
Other Publications:
Other Publications:
| Responsible Party: | Juva Life |
| ClinicalTrials.gov Identifier: | NCT04726254 |
| Other Study ID Numbers: |
JULI1000 |
| First Posted: | January 27, 2021 Key Record Dates |
| Last Update Posted: | July 19, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Dyssomnias Parasomnias Chronic Pain Feeding and Eating Disorders Pain |
Neurologic Manifestations Sleep Wake Disorders Nervous System Diseases Mental Disorders |