bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Condition: Heavy Uterine Bleeding; Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Menorrhagia; Hemorrhage
Intervention: Elagolix placebo; Elagolix; 0.5 mg estradiol / 0.1 mg norethindrone acetate; 1 mg estradiol / 0.5 mg norethindrone acetate; E2/NETA placebo
Intervention description: oral coated tablet; oral coated tablet; oral hard capsule; oral hard capsule; oral hard capsule
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 571.0
Sex: Female
Minimum age: 18 Years
Maximum age: 51 Years
Healthy volunteers: No
Keywords: Uterine Fibroids; Leiomyomata; Elagolix; Menorrhagia; Elagolix sodium; Heavy Uterine Bleeding; ABT-620

Summary:

      This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety
      and efficacy of elagolix alone and in combination with add-back therapy versus placebo on
      heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is pre-menopausal female 18 to 51 years of age at Screening.

          -  Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.

          -  Subject has heavy uterine bleeding associated with uterine fibroids.

        Exclusion Criteria:

          -  Subject has had a myomectomy, uterine artery embolization or high intensity focused
             ultrasound for fibroid destruction within 6 months prior to Screening or endometrial
             ablation within 5 years prior to Screening.

          -  Subject has a history of osteoporosis or other metabolic bone disease.

          -  Subject shows evidence of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including
             depression, schizophrenia, bipolar disorder), or neurologic diseases or any
             uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any
             history of attempted suicide.

          -  Subject has a history of clinically significant condition(s) including but not limited
             to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes * Chronic
             kidney disease * Any cancer (except treated basal cell carcinoma of the skin),
             including breast or ovarian cancer or subject has taken any systemic cancer
             chemotherapy
A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Faricimab; Ranibizumab
Intervention description: Faricimab will be administered by IVT injection in the study eye.; Ranibizumab will be administered by IVT injection in the study eye.
Intervention MeSH terms: Ranibizumab; Faricimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 229.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multiple-center, multiple-dose, randomized, active comparator-controlled,
      double-masked, three parallel group, 36-week study in participants with center-involving
      diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes
      meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA)
      will be defined as the study eye. The study will consist of a treatment period (20 weeks) and
      an observational period (up to 16 weeks). Treatment naive participants will be randomized in
      a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated
      with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in
      a 1:1 ratio to Arms A and C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Macular edema associated with diabetic retinopathy

          -  Decreased visual acuity attributable primarily to DME

          -  Diagnosis of diabetes mellitus

        Exclusion Criteria:

          -  High risk proliferative diabetic retinopathy

          -  Cataract surgery within 3 months of Baseline, or any other previous intraocular
             surgery

          -  Uncontrolled glaucoma

          -  Current or history of ocular disease in the study eye other than DME

          -  Major illness or major surgical procedure within 1 month prior to Day 1

          -  Uncontrolled blood pressure

          -  Glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%) at screening

          -  Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin
             within 4 months prior to Day 1
Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Fluocinonide cream
Intervention description: Fluocinonide cream 0.1% applied twice daily for 5 days.
Intervention MeSH terms: Fluocinonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: eczema; itch; scratching; actigraphy; adherence

Summary:

      The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide
      cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female with mild to severe atopic dermatitis, 12 years of age or older, that
             agree to participate and provide written consent (parent permission and assent if
             applicable).

          -  Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating
             of 2 through 4 in the Investigator Global Assessment).

          -  Visual Analog Scale of Itch score at Baseline must be greater than or equal to 50 on a
             100-point scale.

          -  Percentage of overall body surface area of involvement (BSA) must be ≥2%.

          -  Women of childbearing potential will be allowed to participate in the study, and will
             be required to use at least one form of birth control.

        Exclusion Criteria:

          -  Use within four weeks from Baseline any systemic anti-inflammatory medication, which
             may influence study outcome, such as systemic corticosteroids.

          -  Application or use within two weeks of Baseline topical corticosteroid medications or
             topical anti-inflammatory medication, which may influence study outcome.

          -  Presence of a concurrent medical condition, which is determined by the investigator to
             potentially interfere with study outcomes or patient assessments.

          -  Introduction of any other prescription medication, topical or systemic, for atopic
             dermatitis while participating in the study.

          -  Use of anti-histamines while participating in the study will not be permitted unless
             the subject meets criteria for anti-histamine use on the VAS scale. Additionally, the
             subject must remain on a stable dose of anti-histamine throughout the study period. If
             a patient meets such criteria for anti-histamine use, this will be noted in the
             subject's chart.

          -  Amount of disease involvement that would require >60 gm of cream in a 1 week period.

          -  Subjects with known allergy or sensitivity to topical Vanos® cream or components.

          -  Pregnant women

          -  Women who are breastfeeding
Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Teriflunomide; Placebo (for Teriflunomide); Interferon-β
Intervention description: Film-coated tablet
Oral administration; Film-coated tablet
Oral administration; Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Intervention MeSH terms: Interferons; Interferon-beta; Teriflunomide; Interferon beta-1b
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: MS; interferon-beta; adjunctive therapy; relapses

Summary:

      The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide
      administered once daily for 24 weeks, compared with placebo, in patients with multiple
      sclerosis [MS] with relapses who were on a stable dose of interferon-β [IFN-β].

      Secondary objectives were:

        -  to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in
           combination with a stable dose of IFN-β on Magnetic Resonance Imaging [MRI] parameters,
           relapse rate and patient-reported fatigue;

        -  to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with
           a stable dose of IFN-β.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Definite MS diagnosis according to McDonald's criteria;

          -  Relapsing clinical course, with or without progression;

          -  Expanded Disability Status Scale [EDSS] less or equal to 5.5 (ambulatory);

          -  Stable dose of IFN-β for at least 26 weeks prior to the screening visit;

          -  No onset of MS relapse in the preceding 60 days prior to randomization;

          -  Clinically stable for 4 weeks prior to randomization.

        Exclusion Criteria:

          -  Other chronic disease of the immune system, liver function impairment or chronic
             pancreatic disease;

          -  Pregnant or nursing woman;

          -  Alcohol or drug abuse;

          -  Use of cladribine, mitoxantrone, or other immunosuppressant agents such as
             azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before
             enrollment;

          -  Human immunodeficiency virus [HIV] positive status;

          -  Any known condition or circumstance that would prevent in the investigator's opinion
             compliance or completion of the study.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.
Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: H.pylori eradication
Intervention description: Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Steatohepatitis,; Helicobacter pylori,; Insulin resistance,; Alanine aminotransferase,; Aspartate aminotransferase,

Summary:

      The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat
      content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)
      index, and anthropometric measurements (body mass index and waist circumference)in
      non-diabetic subjects with non-alcoholic fatty liver disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dyspeptic patients with positive antibody to H.pylori and persistent elevated
             aminotransferase levels with the evidence of fatty liver in ultrasonography, who were
             referred to a gastroenterology clinic.

        Exclusion Criteria:

          -  Alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
             diabetes mellitus, heart disease (ischemic or congestive), hepatic disease (viral
             hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion),
             renal disease (serum creatinine concentration of > 1.5 mg/dl), any severe systemic
             co-morbidities, neoplasm, using any medication during the past 3 months, previous
             history of peptic ulcer, previous history of H.pylori eradication, existence of alarm
             signs (weight loss, dysphagia, anemia, vomiting, positive family history of
             gastrointestinal cancers), and pregnant or lactating women.
Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests
Condition: Gastrointestinal Endoscopy; Gastrointestinal Polypectomy
Intervention: Placebo; ICI35,868 (propofol); ICI35,868 (propofol); ICI35,868 (propofol); ICI35,868 (propofol); ICI35,868 (propofol); ICI35,868 (propofol)
Intervention description: Infusion of placebo, same infusion rates as for arm 2; Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute; Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute; Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute; Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute; Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute; Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
Intervention MeSH terms: Propofol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 123.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: propofol endoscopy sedation

Summary:

      Phase IIB study to find the optimal dose rate range of propofol to maintain
      minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal
      polypectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female (females of child bearing potential to confirm not pregnant via test or
             contraception)

          -  Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy,
             including polypectomy that shall be completed within 1 hour

        Exclusion Criteria:

          -  American Society of Anesthesiologists (ASA) grade III, IV V and VI

          -  Baseline oxygen saturation<90% (room air)

          -  Body Mass Index (BMI) >=35
A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis
Condition: Inflammation; Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Inflammation; Ulcer
Intervention: catridecacog; placebo
Intervention description: Catridecacog (recombinant factor XIII, rFXIII) will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week at a dose of 35 IU/kg; Placebo will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe. The aim of the trial is to investigate the effect of
      recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active
      ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ulcerative colitis for at least 3 months from the time of initial
             diagnosis. The diagnosis must have been confirmed by historical endoscopy and
             histology. The severity of disease must have been confirmed by endoscopy at screening

          -  Currently receiving oral aminosalicylates at approved doses of at least 2g/day for at
             least 6 weeks. Doses of oral aminosalicylates should be stable for at least two weeks
             prior to dosing (Visit 2)

        Exclusion Criteria:

          -  Diagnosis of UC limited to the rectum (ulcerative proctitis only, defined as less than
             15 cm from the anal verge)

          -  Requiring hospitalisation for current episode of severe UC

          -  Use of biologic therapies for the treatment of UC within 12 weeks prior to dosing
             (Visit 2)

          -  Treatment failures to anti-tumour necrosis factor-alfa (anti-TNF-a) agents (e.g.
             infliximab, adalimumab)

          -  Use of immunosuppressant agents (e.g. azathioprine) within 4 weeks prior to dosing
             (Visit 2)

          -  Use of corticosteroids (oral, intravenous (i.v.), intramuscular (i.m.), or rectal )
             within 14 days prior to dosing (Visit 2)

          -  Use of enemas (corticosteroid or aminosalicylate) within 14 days prior to screening
             (Visit 1)

          -  Use of cyclosporine, tacrolimus, D-penicillamine, leflunomide, methotrexate,
             mycophenolate mofetil, or thalidomide within 4 weeks prior to dosing (Visit 2)

          -  Currently receiving total parenteral nutrition
Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: Bis-Choline Tetrathiomolybdate
Intervention description: Participants will be initiated at 15 milligrams once daily, then the dose will be increased to 30 milligrams once daily at Week 6.
Intervention MeSH terms: Tetrathiomolybdate; Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: This study is only pathologist-blinded for the assessments of liver histology samples.
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Copper; ALXN1840; Histology; Liver Biopsy

Summary:

      The main objective of the study is to evaluate the change in liver copper (Cu) concentration
      following 48 weeks of treatment with ALXN1840 in adult participants with Wilson Disease (WD)
      who have been previously treated for at least 1 year with standard of care (that is,
      trientine, penicillamine, or zinc). In the Treatment Period, efficacy and safety of ALXN1840
      will be assessed at Week 48.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of WD by Leipzig Criteria ≥ 4 or by historical test results.

          2. Continuous treatment for WD with penicillamine, trientine or zinc for at least 1 year
             prior to screening.

          3. Body mass index < 30 kilograms/meter squared.

          4. Able to cooperate with a percutaneous liver biopsy.

          5. Willing and able to follow protocol-specified contraception requirements.

          6. Capable of giving signed informed consent.

        Exclusion Criteria:

          1. Decompensated cirrhosis or Model for End Stage Liver Disease score > 13.

          2. Modified Nazer score > 7.

          3. Clinically significant gastrointestinal bleed within past 3 months.

          4. Alanine aminotransferase > 2 × upper limit of normal.

          5. History of bleeding abnormality or known coagulopathy, including platelet count <
             100,000, and international normalized ratio for prothrombin time ≥ 1.5.

          6. Participant unwilling to accept blood products, if required.

          7. Marked neurological disease requiring either nasogastric feeding tube or intensive
             inpatient medical care.

          8. Hemoglobin less than lower limit of the reference range for age and sex.

          9. Participants in renal failure, defined as in end-stage renal disease on dialysis
             (chronic kidney disease 5) or creatinine clearance < 30 milliliters/minute.

         10. Lymphoma, leukemia, or any malignancy within the past 5 years.

         11. Current or chronic history of liver disease not associated with WD.