Raw Ground Truth
Inclusion Criteria:Participant at the time of screening has a diagnosis of uterine fibroids documented by a pelvic ultrasound [transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)].Participant has HMB associated with uterine fibroids as evidenced by menstrual blood loss (MBL) > 80 mL during 1 menses in screening as measured by the alkaline hematin method.Participant has negative urine and/or serum pregnancy test in Washout (if applicable) and/or Screening and just prior to first dose.Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.Exclusion Criteria:Participant has screening pelvic ultrasound or saline infusion sonohysterography (SIS) or magnetic resonance imaging (MRI; if SIS is unevaluable), results that show a clinically significant gynecological disorder.Participant has history of osteoporosis, osteopenia, or other metabolic bone disease.Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.
Raw Prediction
## Modified Eligibility Criteria for Version 18 of ClinicalTrials.gov
Based on the provided text, here are the modified eligibility criteria for Version 18 of ClinicalTrials.gov, incorporating the evidence and addressing potential inconsistencies:
**Inclusion Criteria:**
* **Age:** 18 to 51 years old at the time of Screening.
* **Diagnosis:** Documented uterine fibroids by pelvic ultrasound (transabdominal ultrasound [TAU], transvaginal ultrasound [TVU]) with a minimum diameter of 2 cm (longest diameter) or a total uterine volume of ≥ 200 cm3 to ≤ 2,500 cm3.
* **Menstrual Blood Loss (MBL):** HMB associated with uterine fibroids as evidenced by MBL > 80 mL during 1 menses in Screening as measured by the alkaline hematin method.
* **Hormonal Status:**
* **Premenopausal:** Not currently pregnant or breastfeeding.
* **Contraception:** Must be using at least 2 forms of non-hormonal contraception (dual contraception) consistently throughout the Washout, Screening, Treatment, and PTFU periods.
* **Medical History:**
* **Exclusionary Medications:** Must meet the criteria outlined in Table 1 for washout periods.
* **Medical Conditions:** No history of:
* Hereditary blood coagulation disorder (e.g., Von Willebrand disease, Factor V Leiden).
* History of surgery-related severe bleeding or severe and prolonged bleeding associated with dental work.
* Two separate events of blood transfusions within 9 months prior to Screening (with exception of transfusions associated with low hemoglobin or low hematocrit due to uterine fibroids) or blood transfusions within 60 days prior to Day 1.
* Active malignancy or history of malignancy (except basal cell carcinoma of the skin) with or without systemic chemotherapy.
* Documented history of a severe, life-threatening, or other significant sensitivity to any drug.
* Newly diagnosed, clinically significant medical condition requiring therapeutic intervention (e.g., new onset hypertension) that has not been stabilized prior to Day 1.
* Clinically significant medical condition anticipated to require intervention during the course of the study participation (e.g., anticipated major elective surgery).
* An unstable medical condition making the subject an unsuitable candidate for the study in the opinion of the investigator.
* Any suicide attempts "ever" or subject answers "yes" to questions 4 or 5 on the suicidal ideation portion (referring to within the last year) of the Columbia-Suicide Severity Rating Scale (C-SSRS) when administered during Screening or prior to dosing on Study Day 1.
* Drug abuse and/or alcohol abuse within 12 months prior to Screening.
* Major depression or post-traumatic stress disorder (PTSD) episode within 2 years prior to Screening.
* Other major psychiatric disorders at any time (e.g., schizophrenia, bipolar disorder).
* Surgical history of:
* Hysterectomy (with or without oophorectomy).
* Bilateral oophorectomy.
* Bariatric surgical procedures of any type within 6 months prior to Screening.
* **Laboratory Values:**
* Hemoglobin ≥ 7 g/dL at Screening.
* Other laboratory values must meet the criteria at Screening (unless otherwise specified).
**Exclusion Criteria:**
* **Pregnancy or Breastfeeding:** Pregnant or breastfeeding at the time of Screening or during the study.
* **Other:** Any other medical condition that would make the subject unsuitable for the study in the opinion of the investigator.
**Important Notes:**
* This is a summary of the modified eligibility criteria based on the provided text.
* The complete and official eligibility criteria should be found in the full protocol document.
* It is crucial to consult the full protocol for the most accurate and up-to-date information.
* This information is for educational purposes only and should not be considered medical advice.
* Always consult with a healthcare professional for any health concerns or before making any decisions related to your health or treatment.
Processed Ground Truth
1. Participant at the time of screening has a diagnosis of uterine fibroids documented by a pelvic ultrasound [transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)].Participant has HMB associated with uterine fibroids as evidenced by menstrual blood loss (MBL) > 80 mL during 1 menses in screening as measured by the alkaline hematin method.Participant has negative urine and/or serum pregnancy test in Washout (if applicable) and/or Screening and just prior to first dose.Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.Exclusion Criteria:Participant has screening pelvic ultrasound or saline infusion sonohysterography (SIS) or magnetic resonance imaging (MRI; if SIS is unevaluable), results that show a clinically significant gynecological disorder.Participant has history of osteoporosis, osteopenia, or other metabolic bone disease.Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.
Processed Prediction
1. Modified Eligibility Criteria for Version 18 of ClinicalTrials.gov
2. Based on the provided text, here are the modified eligibility criteria for Version 18 of ClinicalTrials.gov, incorporating the evidence and addressing potential inconsistencies:
1. Age: 18 to 51 years old at the time of Screening.
2. Diagnosis: Documented uterine fibroids by pelvic ultrasound (transabdominal ultrasound [TAU], transvaginal ultrasound [TVU]) with a minimum diameter of 2 cm (longest diameter) or a total uterine volume of ≥ 200 cm3 to ≤ 2,500 cm3.
3. Menstrual Blood Loss (MBL): HMB associated with uterine fibroids as evidenced by MBL > 80 mL during 1 menses in Screening as measured by the alkaline hematin method.
4. Hormonal Status:
5. Premenopausal: Not currently pregnant or breastfeeding.
6. Contraception: Must be using at least 2 forms of non-hormonal contraception (dual contraception) consistently throughout the Washout, Screening, Treatment, and PTFU periods.
7. Medical History:
8. Exclusionary Medications: Must meet the criteria outlined in Table 1 for washout periods.
9. Medical Conditions: No history of:
10. Hereditary blood coagulation disorder (e.g., Von Willebrand disease, Factor V Leiden).
11. History of surgery-related severe bleeding or severe and prolonged bleeding associated with dental work.
12. Two separate events of blood transfusions within 9 months prior to Screening (with exception of transfusions associated with low hemoglobin or low hematocrit due to uterine fibroids) or blood transfusions within 60 days prior to Day 1.
13. Active malignancy or history of malignancy (except basal cell carcinoma of the skin) with or without systemic chemotherapy.
14. Documented history of a severe, life-threatening, or other significant sensitivity to any drug.
15. Newly diagnosed, clinically significant medical condition requiring therapeutic intervention (e.g., new onset hypertension) that has not been stabilized prior to Day 1.
16. Clinically significant medical condition anticipated to require intervention during the course of the study participation (e.g., anticipated major elective surgery).
17. An unstable medical condition making the subject an unsuitable candidate for the study in the opinion of the investigator.
18. Any suicide attempts "ever" or subject answers "yes" to questions 4 or 5 on the suicidal ideation portion (referring to within the last year) of the Columbia-Suicide Severity Rating Scale (C-SSRS) when administered during Screening or prior to dosing on Study Day 1.
19. Drug abuse and/or alcohol abuse within 12 months prior to Screening.
20. Major depression or post-traumatic stress disorder (PTSD) episode within 2 years prior to Screening.
21. Other major psychiatric disorders at any time (e.g., schizophrenia, bipolar disorder).
22. Surgical history of:
23. Hysterectomy (with or without oophorectomy).
24. Bilateral oophorectomy.
25. Bariatric surgical procedures of any type within 6 months prior to Screening.
26. Laboratory Values:
27. Hemoglobin ≥ 7 g/dL at Screening.
28. Other laboratory values must meet the criteria at Screening (unless otherwise specified).
1. Pregnancy or Breastfeeding: Pregnant or breastfeeding at the time of Screening or during the study.
2. Other: Any other medical condition that would make the subject unsuitable for the study in the opinion of the investigator.
3. Important Notes:
4. This is a summary of the modified eligibility criteria based on the provided text.
5. The complete and official eligibility criteria should be found in the full protocol document.
6. It is crucial to consult the full protocol for the most accurate and up-to-date information.
7. This information is for educational purposes only and should not be considered medical advice.
8. Always consult with a healthcare professional for any health concerns or before making any decisions related to your health or treatment.