bioihbjkbjnl/mcl2 huggingface dataset:
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
Condition: Uterine Leiomyoma; Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: ExAblate Enhanced Sonication
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fibroids; leiomyoma; neoplasm; benign tumors

Summary:

      This is a phase 3 study to determine the safety of the new features to the FDA approved
      ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women age 18 or older, who present with symptomatic fibroids

          2. Women who have given written informed consent

          3. Women who are able and willing to attend all study visits.

          4. Patient is pre or peri-menopausal (within 12 months of last menstrual period).

          5. Able to communicate sensations during the ExAblate procedure.

          6. Uterine fibroids, which are device accessible (i.e., positioned in the uterus such
             that they can be accessed without being shielded by bowel or bone).

          7. Fibroids(s) clearly visible on non-contrast MRI.

        Exclusion Criteria:

          1. Women who are pregnant, as confirmed by serum test at time of screening, or urine
             pregnancy test on the day of treatment

          2. Patient who desire to become pregnant in the future.

          3. Patients who are breast-feeding.

          4. Patients with an active pelvic inflammatory disease (PID)

          5. Active local or systemic infection

          6. Metallic implants that are incompatible with MRI

          7. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)

          8. Severe claustrophobia that would prevent completion of procedure in the MR unit.

          9. Extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in
             the treatment path.

         10. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and
             adenomatous hyperplasia.

         11. Pedunculated fibroids.

         12. Intrauterine device (IUD) anywhere in the treatment path

         13. Undiagnosed vaginal bleeding.
Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: adalimumab; adalimumab
Intervention description: Adalimumab 40 mg Every Other Week dosing; Adalimumab 40 mg Every Week dosing if participant experiences a disease flare or is not responding to treatment. A disease flare is defined as an increase of 3 points or more on the HBI compared to the Baseline score and a total HBI score of 7 or higher. Non-response is defined as a decrease by fewer than 3 points in the HBI compared to Baseline.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 945.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety of adalimumab for treatment of patients
      with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on
      patient general well-being, health-related quality of life (QoL), fistula healing, CD-related
      extra-intestinal manifestations, work performance, and overall activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of moderate to severe Crohn's Disease confirmed by endoscopy or radiologic
             evaluation for greater than 4 months (16 weeks)

          -  Inadequate response to conventional therapy for Crohn's Disease

          -  Subjects >=18 and <=75 years of age and in good health (Investigator discretion) with
             a recent stable medical history

          -  Harvey Bradshaw Index score of 7 or higher

        Exclusion Criteria:

          -  Subject considered by the investigator, for any reason, to be an unsuitable candidate
             for the study

          -  Subject who has had surgical bowel resections within the past 6 months or is planning
             any resection at any time point while enrolled in the study

          -  Female subject who is pregnant or breast-feeding or considering becoming pregnant

          -  Previous treatment with adalimumab or previous participation in an adalimumab clinical
             study

          -  Subject considered by the investigator, for any reason, to be an unsuitable candidate
             for the study

          -  Subjects with any prior exposure to Tysabri® (natalizumab)

          -  Subjects on prednisone >40 mg/day (or equivalent), subjects on budesonide >9 mg/day,
             or subjects who are taking prednisone and budesonide concurrently at Baseline
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8 mg/kg (max. 800 mg) iv every 4 weeks, 6 infusions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra
      (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an
      inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients
      will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks
      for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study.
      Anticipated time on study treatment is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Active moderate to severe rheumatoid arthritis of >/= 6 months duration

          -  >/=1 non-biologic DMARD and/or anti-TNF therapy at stable dose for >/=8 weeks at any
             time prior to study treatment

          -  Inadequate clinical response to non-biologic DMARD or anti-TNF therapy

          -  Oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to
             first dose of study drug

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or major
             surgery planned within 6 months of enrolment

          -  Rheumatic autoimmune disease other than RA

          -  Functional class IV (ACR classification)

          -  Prior history of or current joint disease other than RA

          -  Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline

          -  Previous treatment with RoActemra/Actemra

          -  Known active current or history of recurrent infection

          -  History of or currently active primary or secondary immunodeficiency

          -  Active tuberculosis requiring treatment within the previous 3 years

          -  Positive for HIV
Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
Condition: Insomnia; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders
Intervention: rozerem; Placebo
Intervention description: Ramelteon (rozerem) 8mg oral before bedtime; placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      The objective of the study is to determine if treatment with Ramelteon will help to improve
      insomnia in older adults with co-existent insomnia and sleep apnea. The primary study
      objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will
      be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study
      objective is to determine if subject compliance with CPAP treatment of their sleep apnea is
      improved in subjects taking Ramelteon (their compliance may be improved because they would
      have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that
      compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo
      arm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obstructive sleep apnea

          -  Insomnia

          -  Age>60

        Exclusion Criteria:

          -  Cognitive impairment

          -  Active alcohol or substance abuse

          -  Active use of other sedative-hypnotic agents

          -  Active use of fluvoxamine (drug interaction with Ramelteon

          -  Evidence of hepatic dysfunction (Ramelteon contraindicated) on liver function panel

          -  Presence of Periodic Limb Movement Disorder or Restless Legs Syndrome

          -  Severe Chronic Obstructive Pulmonary Disease
A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: Mycophenolate Mofetil; Corticosteroids; Azathioprine; Cyclophosphamide
Intervention description: 0.5 g PO BID from Day 0 to the end of Week 1, followed by 1.0 g PO BID from Weeks 2 through 24, and 0.75 g PO BID from Weeks 32 to 48; 0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reaches 10 mg/day up to Week 48; 100 mg PO daily for participants with a body weight of 50 to 70 kg,150 mg PO daily for subjects with a body weight of more than 70 kg up to Week 48; 0.75 g/m^2 IV every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2 to maintain a minimum WBC count of ≥ 2500 per mm^3 from Weeks 5 through 24
Intervention MeSH terms: Mycophenolic Acid; Prednisolone; Cyclophosphamide; Azathioprine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids,
      versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine
      in the maintenance phase, in maintaining remission and renal function in patients with lupus
      nephritis. Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for
      24 weeks, followed by CellCept 0.75g bid po plus corticosteroids for the following 24 weeks,
      or cyclophosphamide 0.5-1.0g/m2 monthly plus corticosteroids for 24 weeks, followed by
      azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks. Response rate
      will be assessed at the end of the induction phase, and at the end of study. The anticipated
      time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-75 years of age;

          -  systemic lupus erythematosus;

          -  histological diagnosis of lupus nephritis.

        Exclusion Criteria:

          -  not in need of immunosuppressive treatment (in addition to corticosteroids);

          -  continuous dialysis starting >2 weeks before randomization, with an anticipated
             duration of >8 weeks;

          -  previous or planned kidney transplant.
Study of Transitioning From Alendronate to Denosumab
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: alendronate; Denosumab (AMG 162)
Intervention description: 70 mg oral QW; 60 mg SC q 6 mos
Intervention MeSH terms: Denosumab; Alendronate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 504.0
Sex: Female
Minimum age: 55 Years
Healthy volunteers: No
Keywords: RANKL; RANK; denosumab; AMG 162; osteoporosis; bone turnover; bone mineral density; clinical trial; postmenopausal osteoporosis; alendronate; total hip bone mineral density

Summary:

      The study will evaluate the efficacy and safety of transitioning postmenopausal women on
      current alendronate therapy to denosumab. Endpoints studied will include bone mineral
      density, bone turnover markers and bone histology in a subset of subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal females 55 yrs or older

          -  Received alendronate therapy for osteoporosis for at least 6 months prior to entry
             into study

          -  Lumbar spine or total hip Bone Mineral Density (BMD) corresponding to T-score ≤ -2 and
             ≥ -4

        Exclusion Criteria:

          -  Vitamin D deficiency

          -  Administration of intravenous bisphosphonate, or

          -  fluoride (except for dental treatment) or

          -  strontium ranelate

          -  Administration of Parathyroid Hormone (PTH) or Parathyroid Hormone (PTH) derivatives
             (eg; teriparatide) within the last year

          -  Administration of any bisphosphonate other than alendronate (ALN) within 1 year of
             screening
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Intervention: AZLI; Placebo
Intervention description: AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily; Placebo to match AZLI administered via nebulizer three times daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The AIR-BX1 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and
      gram-negative airway infection. Participants received two 28-day courses of either Aztreonam
      for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a
      28-day off-drug period. Following the two blinded courses, all participants received a 28-day
      course of open-label AZLI then were followed for an additional 56 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/Female 18 years or older with non-CF bronchiectasis

          -  Chronic sputum production on most days

          -  Positive sputum culture for gram-negative organisms

          -  Must have met lung function requirements

        Exclusion Criteria:

          -  History of CF

          -  Hospitalized within 14 days prior to joining the study

          -  Previous exposure to AZLI

          -  Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study

          -  Must have met liver and kidney function requirements

          -  Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with
             activity and at night was allowed)

          -  Treatment for nontuberculous mycobacteria infection or active mycobacterium
             tuberculosis infection within 1 year of enrollment

          -  Other serious medical conditions.
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Evolocumab
Intervention description: Administered by subcutaneous injection once a month
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 770.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to characterize the safety and tolerability of long-term
      administration of evolocumab in adults with known coronary artery disease and
      hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed week 80 of study 20120153 (NCT01813422).

        Exclusion Criteria:

          -  Did not complete investigational product in the 20120153 parent study

          -  Have an unstable medical condition, in the judgment of the investigator

          -  Known sensitivity to any of the products to be administered during dosing

          -  Currently enrolled in another investigational device or drug study (excluding
             evolocumab (AMG 145) parent study), or less than 30 days since ending another
             investigational device or drug study(s),or receiving other investigational agent(s)
Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia
Condition: Chronic Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lurasidone HC1; Quetiapine XR
Intervention description: Lurasidone 40-160 mg/day flexibly dosed.; Quetiapine XR 200-800 mg/day flexibly dosed.
Intervention MeSH terms: Quetiapine Fumarate; Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Schizophrenia; SM-13496; Latuda; Lurasidone

Summary:

      Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This
      clinical study is designed to test the hypothesis that lurasidone is effective, tolerable,
      and safe as compared with quetiapine XR long term among schizophrenic outpatients with
      chronic schizophrenia.
    

Eligibility criteria:

        Entry Criteria:

          -  Screening for the present study will take place after subjects' participation in Study
             D1050233 has been completed, and after providing informed consent.

        Inclusion Criteria:

          -  Completed all required assessments on the final study visit in Study D1050233.

          -  Suitable for treatment in an outpatient setting.

        Exclusion Criteria:

          -  Any chronic organic disease of the CNS (other than schizophrenia).

          -  Considered by the investigator to be at imminent risk of suicide or injury to self,
             others, or property.
Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel; Androgen Hormonal Suppression and Radiation; Androgen Suppression Therapy and Radiation Therapy
Intervention description: 60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.; Total Androgen Ablation and external beam radiation therapy; Total Androgen Ablation and External Beam Radiation Therapy
Intervention MeSH terms: Ascorbic Acid; Docetaxel; Methyltestosterone; Androgens; Estrogens, Conjugated (USP)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 350.0
Sex: Male
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Hormone Refractory; Metastatic; Localized; Locally Advanced; Prostate Cancer - High Risk Localized or Locally Advanced

Summary:

      This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to
      one of the standard treatments (radiation and hormones) for men with high-risk prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven prostate cancer

          -  Clinical Tumor Category T1b, T1c, T2a and PSA greater than (>) 10 or Gleason score
             equal or greater than 4+3=7 or PSA velocity > 2.0 ng/ml per year and also eligible
             patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any
             minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal
             Vesicle Invasion); Gleason = or > 3+4=7 with 50% or more cores positive

          -  Negative bone scan

          -  Lymph node assessment by CT or MR

          -  Adequate hematologic function (Blood Counts)

          -  Adequate liver functions (blood tests)

          -  ECOG performance Status 0 or 1

          -  Peripheral neuropathy must be =< grade 1

          -  PSA obtained within 3 months of entry

        Exclusion Criteria:

          -  Prior history of malignancy that are < 5 years except for cancers found to be
             "in-situ" and would not likely impact a patient's life expectancy with appropriate
             medical management.

          -  Prior pelvic radiation therapy

          -  Prior hormonal therapy (up to 4 weeks prior to enrollment allowed)

          -  Individuals unable to tolerate lying still 5 - 10 minutes

          -  Patients with a history of severe hypersensitivity reaction to docetaxel or other
             drugs formulated with polysorbate 90.