bioihbjkbjnl/mcl2 huggingface dataset:
A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Telapristone Acetate; Placebo
Intervention description: Telapristone acetate, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.; Matching placebo, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: Female
Minimum age: 18 Years
Maximum age: 47 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the safety and efficacy of two oral doses
      of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by
      an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a pre-menopausal female, between 18 and 47 years

          -  Participant has a history of at least 3 regular menstrual cycles in which menorrhagia
             (heavy bleeding) is due to uterine fibroids

          -  Confirmed uterine fibroid(s) at screening

          -  Visit 1 historical pictorial blood loss assessment chart of >120 milliliters (mL) of
             blood loss, to ensure participants have a menstrual blood loss of at least 80 mL by
             Alkaline Hematin Assay (during the baseline assessment period).

          -  A Body Mass Index (BMI) between 18 and 45 inclusive

        Exclusion Criteria:

          -  Participant is pregnant or lactating or is attempting or expecting to become pregnant
             during the entire study period

          -  Received an investigational drug in the 30 days prior to the screening for this study

          -  Has an intrauterine device in place

          -  Observation or history of abnormal endometrial biopsy including the presence of
             endometrial intraepithelial neoplasia

          -  Participants with abnormally high liver enzymes or liver disease
A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: RSLV-132; Placebo
Intervention description: RNase-Fc fusion protein; Saline placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the
      cutaneous manifestations in subjects with systemic lupus erythematosus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CLASI score greater than or equal to 10 at Baseline

          -  Positive for one or more RNA autoantibodies

        Exclusion Criteria:

          1. severe, active central nervous system (CNS) involvement at Screening;

          2. severe renal involvement at Screening (urine protein/creatinine ratio of >200 mg/mmol,
             or an estimated creatinine clearance of <30 mL/min);

          3. use of cyclophosphamide within 3 months of the Baseline visit;

          4. use of rituximab within 6 months of the Baseline visit;

          5. use of belimumab within 3 months of the Baseline visit;

          6. use of background medications within 1 month of Baseline in excess of: i.
             mycophenolate mofetil > 3 g/day; ii. azathioprine > 200 mg/day; iii. methotrexate > 25
             mg/day; iv. hydroxychloroquine > 400 mg/day; v. prednisone (or equivalent) > 15
             mg/day;

          7. use of an intravenous steroid "pulse" within 2 months of Baseline;

          8. use of an intramuscular steroid injection within 1 month of Baseline;

          9. change in SLE medications within 1 month of Baseline;

         10. the presence of a clinically significant infection in the judgement of the
             Investigator within seven days prior to the receipt of the first dose of study drug;

         11. positive viral load test for hepatitis B, C, or HIV at Screening;

         12. participation in another clinical trial with receipt of an investigational product
             within 3 months or 5 half- lives, of last administration (whichever is longer) from
             Baseline;

         13. positive pregnancy test at Screening or at Baseline;

         14. female subjects currently breast feeding at Baseline;

         15. inability or unwillingness to comply with protocol-specified procedures which, in the
             opinion of the Investigator, would make the subject unsuitable for study
             participation.
AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Atorvastatin 20 mg; AEGR-733 5 mg; AEGR-733 10 mg; Placebo; AEGR-733 5 mg + atorvastatin 20 mg; AEGR-733 10 mg + atorvastatin 20 mg
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: cholesterol

Summary:

      The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and
      in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with
      moderately high cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women between the ages of 18 and 70 years.

          2. Elevated LDL cholesterol based on risk factors for cardiovascular disease or presence
             of cardiovascular disease

        Exclusion Criteria:

          1. Women who are pregnant, lactating, planning to become pregnant, or women of
             childbearing potential who have not successfully been using acceptable contraceptive
             methods over the previous 3 months, e.g., intrauterine device (IUD) and barrier method
             plus spermicide.

          2. Uncontrolled hypertension

          3. History of chronic kidney problems

          4. History of liver disease

          5. Positive for Hepatitis B or Hepatitis C.

          6. Any major surgical procedure occurring less than 3 months ago

          7. Cardiac insufficiency

          8. History of a malignant cancer (other than basal cell or squamous cell carcinoma of the
             skin that has been removed) within the previous 5 years.

          9. Regular alcohol use >1 drink per day.

         10. Regular consumers of grapefruit juice, or currently taking the following medications:
             cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin,
             HIV protease inhibitors, and nefazodone.

         11. Use of other cholesterol lowering medications that cannot be stopped.

         12. Heart attack or stroke within the previous 6 months

         13. Diabetes Mellitus

         14. Body mass index (BMI) ≥ 40 kg/m2.

         15. Significant gastrointestinal symptoms, such as irritable bowel syndrome.

         16. Current use of fish oils, niacin, and herbal weight loss products that cannot be
             stopped.
Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: AZD1656; Placebo
Intervention description: Oral tablet administered twice daily during 4 months; administered twice daily during 4 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 224.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; Japanese; phase 2; AZD1656; efficacy; dose regimen; pharmacokinetics

Summary:

      The purpose of this study is to compare the effect on glucose control of 3 different AZD1656
      dosing regimens with placebo in Japanese type 2 diabetes mellitus (T2DM) patients, as
      evaluated by the change in HbA1c from baseline to the end of treatment at 4 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women of non-childbearing potential.

          -  Provision of informed consent prior to any study specific procedures

          -  Naïve T2DM patients with HbA1c ≥ 7.5% but ≤ 10% or T2DM Patients treated with one or
             two oral anti-hyperglycaemic agent(s) with HbA1c ≥ 7.5% but ≤ 9.5% at enrolment visit
             (Visit1)

        Exclusion Criteria:

          -  Clinically relevant medical history or concurrent disease such as cardiovascular
             disease, renal disease, hepatic disease and haematological disease.

          -  The investigator(s) judged that the Subject should not participate in the study
             according to screening test or medical history.

          -  Participation in another clinical trial and/or intake of another investigational drug
             within the last 30 days prior to enrolment visit
The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Norethindrone acetate + estrogens; norethindrone acetate + placebo
Intervention description: Norethindrone acetate 5 mg by mouth daily + Conjugated equine estrogens 0.625 mg by mouth daily; norethindrone acetate 5 mg by mouth daily + Placebo capsule 1 pill by mouth daily
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estrogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: Female
Minimum age: 13 Years
Maximum age: 22 Years
Healthy volunteers: No
Keywords: Endometriosis; Adolescents; Bone density; GnRH Agonist; Add-back therapy

Summary:

      The purpose of this study is to determine whether a regimen of norethindrone acetate +
      placebo or norethindrone acetate + conjugated estrogens is superior in maintaining skeletal
      health and quality of life in adolescents treated with a GnRH agonist for endometriosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 13-22 years, at least two years post-menarche

          -  Body mass index (BMI, kg/m2) between 18 -30 kg/m2

          -  Surgical diagnosis of endometriosis

          -  Clinical decision to treat with a GnRH agonist, leuprolide depot (Lupron Depot®; TAP
             Pharmaceuticals, Inc.) 11.25 mg intra-muscular every 3 months

        Exclusion Criteria:

          -  Concomitant chronic diseases which affect bone health, such as cystic fibrosis,
             inflammatory bowel disease, renal disease, or diabetes mellitus

          -  Markedly impaired liver function or liver failure

          -  Personal history of thromboembolic event (such as deep venous thrombosis)

          -  Medication use known to affect bone metabolism:

               -  Glucocorticoid therapy (including inhaled steroids) or anticonvulsants used in
                  the last 6 months
A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Cyclophosphamide; Bortezomib; Dexamethasone
Intervention description: In Part 1, cyclophosphamide with dose ranging from 900 to 1500 mg will be administered intravenously on Day 1 of each 21 day cycle for 3 cycles to determine optimal dose. In Part 2, optimal dose determined in Part 1 will be administered on Day 1 of each 21 day cycle for 3 cycles.; Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1,4,8, and 11 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).; Participants will receive dexamethasone 40 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 401.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Untreated multiple myeloma; Bortezomib; VELCADE; Cyclophosphamide; Dexamethasone; Chemotherapy; Remission therapy; Induction therapy; Stem Cell Transplantation

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of bortezomib in
      combination with a standard regimen of cyclophosphamide and dexamethasone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologically or histologically diagnosed with multiple myeloma stage II/III

          -  Participants without preceding cytostatic (tending to retard cellular activity and
             multiplication) treatment (pretreatment with radiation or dexamethasone is allowed)

          -  Agree to use one of the contraception methods as defined in the protocol

          -  Karnofsky performance status 60 percent or more

          -  Adequate laboratory test values

        Exclusion Criteria:

          -  Non-secretory multiple myeloma

          -  Estimated life expectancy less than 3 months

          -  History of cancer (except basal cell carcinoma) in the last 5 years

          -  Peripheral neuropathy (disorder of the peripheral nerves) grade 2 or more

          -  Positive human immunodeficiency virus test and active hepatitis B and/or hepatitis C

          -  Pregnant or breast-feeding female participants
Melatonin Supplements for Improving Sleep in Individuals With Hypertension
Condition: Sleep Disorders; Hypertension
MeSH terms: Sleep Wake Disorders; Parasomnias; Hypertension
Intervention: Melatonin; Placebo
Intervention description: 2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks; Placebo
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 35 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Sleep disorders; High blood pressure

Summary:

      This study will evaluate the effectiveness of treatment with melatonin supplements in
      improving sleep in individuals with high blood pressure who are taking beta-blockers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with uncomplicated hypertension

          -  Currently being treated with Atenolol (a beta-blocker)

        Exclusion Criteria:

          -  History of medical illness other than essential hypertension

          -  Personal or family history of psychiatric illness

          -  Current use of any medication other than anti-hypertensive drugs

          -  Any recent travel across time zones

          -  History of working various shifts on an irregular basis
Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: AndroGel; placebo
Intervention description: Androgel 1%, 10g daily; placebo
Intervention MeSH terms: Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate; cancer; testosterone replacement; AndroGel; prostatic cancer; prostatic neoplasms

Summary:

      The purpose of this study is to determine whether prostate cancer growth can be slowed in
      patients who receive Androgel® 1% at 10 gram dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prostate cancer

          -  Patient must have received primary definitive local therapy to the prostate (surgery
             and/or radiotherapy)

          -  Patient was surgically or pharmacologically castrated at least 6 months prior to
             starting the study

          -  Patient must have had a previous trial of anti-androgen therapy

          -  Patient must have a rising PSA

          -  No evidence of distant metastatic disease

          -  ECOG performance status < 2

          -  Age >18 years

          -  Patients must have normal hepatic function

        Exclusion Criteria:

          -  Patients with a history of any previous cytotoxic therapy or radionuclide therapy
             (such as rhenium, strontium, or samarium)

          -  Patients may not be receiving any other investigational agents

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris,
             uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would
             limit compliance with study requirements

          -  Patients receiving renal dialysis

          -  Patients with significant pulmonary disease who have received chronic or pulse steroid
             therapy within the last 3 months prior to randomization will be excluded

          -  Patients who have known hypersensitivity to any of the AndroGel ingredients, including
             testosterone that is chemically synthesized from soy
A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: abicipar pegol; ranibizumab; sham procedure
Intervention description: Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.; Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.; Sham procedure to the study eye at weeks 12 and 16.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of abicipar pegol in patients with neovascular
      age-related macular degeneration to establish comparability between Japanese and
      non-Japanese.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of wet age-related macular degeneration in at least 1 eye

          -  Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better
             in the fellow eye

        Exclusion Criteria:

          -  Hypersensitivity, allergy, or anaphylactic reaction to iodine

          -  Cataract or refractive surgery within the last 3 months

          -  History of vitrectomy
A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: SAGE-217; Levodopa; Antiparkinsonian Agent(s)
Intervention description: Levodopa (including carbidopa-levodopa) administered as antiparkinsonian agent(s).; Antiparkinsonian agent(s) were administered as a clinical practice as standard of care, which includes levodopa (i.e. levodopa/carbidopa) or dopamine agonists or catechol-O-methyltransferase (COMT) inhibitors or monoamine oxidase (BMAO-B) inhibitors.
Intervention MeSH terms: Levodopa; Antiparkinson Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Parkinson's

Summary:

      This study assesses the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in 29
      participants with moderate to severe Parkinson's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has a diagnosis of idiopathic Parkinson's Disease (Hoehn and Yahr Stage 2
             or Stage 3) with a duration of less than 7 years prior to screening [Part A]

          -  Participant has a diagnosis of idiopathic Parkinson's Disease (Hoehn and Yahr Stage
             1-4, assessed during the "on" period) [Part B]

          -  Participant is on a stable dose (at least 1 month prior to baseline visit) of an
             antiparkinsonian agent and is willing to remain on this dose for the duration of the
             study

        Exclusion Criteria:

          -  Participant has early (Hoehn and Yahr Stage 1) or advanced (Hoehn and Yahr Stage 4 or
             Stage 5) Parkinson's Disease [Part A]

          -  Participant has advanced (Hoehn and Yahr Stage 5) Parkinson's Disease [Part B]

          -  Participant with presence of drug-induced parkinsonism, metabolic identified
             neurogenetic disorders, encephalitis, or other atypical Parkinsonian syndromes

          -  Participant with medical history of electroconvulsive therapy or stereotaxic brain
             surgery for Parkinson's Disease

          -  Participant with medical history of suicide attempt within 2 years of screening or
             current suicidal ideation

          -  Participant with medical history of impulse control disorder