bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant
Intervention description: intramuscular injection
Intervention MeSH terms: Fulvestrant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 736.0
Sex: Female
Minimum age: 45 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Advanced Breast Cancer; Metastatic Breast Cancer

Summary:

      The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant
      with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive
      advanced breast cancer who have failed on a previous endocrine treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Breast Cancer has continued to grow after having received treatment with an
             anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor

          -  Requiring hormonal treatment

          -  Postmenopausal women defined as a woman who has stopped having menstrual periods

          -  Evidence of positive estrogen receptor hormone sensitivity

          -  Written informed consent to participate in the trial

        Exclusion Criteria:

          -  Treatment with an investigational or non-approved drug within one month

          -  An existing serious disease, illness, or condition that will prevent participation or
             compliance with study procedures

          -  A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor
             oil)

          -  Treatment with more than one regimen of chemotherapy for advanced breast cancer

          -  Treatment with more than one regimen of hormonal treatment for advanced breast cancer
A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab; Placebo to tocilizumab; Methotrexate; Placebo to methotrexate
Intervention description: Tocilizumab was supplied in vials.; Placebo to tocilizumab was supplied in vials.; Initially, patients received methotrexate 7.5 mg (3, 2.5 mg tablets) orally once a week. If a patient had swollen or tender joints, the dose was increased to 15 mg and 20 mg weekly, at the Week 4 and Week 8 visits, respectively.; Patients received placebo to methotrexate orally once a week.
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, double-blind, parallel group study will assess the safety, disease
      remission, and prevention of structural joint damage in patients with early moderate to
      severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with
      methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A)
      tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4
      weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks)
      plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po
      weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can
      receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients ≥ 18 years of age.

          -  Rheumatoid arthritis of ≤ 2 years duration.

          -  Disease Activity Score 28 (DAS28) > 3.2.

          -  Swollen joint count (SJC) ≥ 4 of 66 joints, tender joint count (TJC) ≥ 6 of 68 joints.

          -  Rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) positive
             (if RF and anti-CCP negative > 1 erosion required at screening).

          -  Erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ 10 mg/L
             at screening.

        Exclusion Criteria:

          -  Previous treatment with tocilizumab.

          -  Previous treatment with methotrexate or biologic agent.

          -  Rheumatic autoimmune disease other than rheumatoid arthritis (RA).

          -  History of or current inflammatory joint disease other than RA.

          -  Functional class IV as defined by the American College of Rheumatology (ACR)
             Classification of Functional Status in RA.
SVT-15652 Otic Solution for the Treatment of Otomycosis
Condition: Otomycosis
MeSH terms: Otomycosis
Intervention: SVT-15652; Placebo
Intervention description: 1 vial twice daily; 1 vial twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in
      patients suffering from Otomycosis. This study will compare the efficacy and safety of
      SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14
      days.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  At least 18 years of age

          -  Clinical diagnosis of otomycosis in one or both ears, where topical treatment is
             indicated.

          -  Signs/symptoms of pruritus, otalgia and ear fullness.

          -  Debris or drainage clinically consistent with fungal infection.

        Main Exclusion Criteria:

          -  Known bacterial otitis externa or malignant otitis externa.

          -  Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.

          -  Structural ear anomalies which may difficult the evaluation of the therapeutic
             response.

          -  Uncontrolled diabetes mellitus.

          -  Any infection requiring systemic antimicrobial or systemic antifungal therapy.

          -  Concomitant medicines that may interfere with the study evaluations.
A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness; Paresis
Intervention: ARGX-113
Intervention description: Intravenous administration of ARGX-113
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the
      ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG.
      Patients who have completed at least 1 cycle of treatment and at least 1 year of trial
      ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial
      ARGX-113-2002 to receive efgartigimod by SC administration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with the ability to understand the requirements of the trial, provide written
             informed consent, and comply with the trial protocol procedures.

          2. Patients who participated in trial ARGX-113-1704 and are eligible for roll over, as
             specified in the protocol.

        Other more specific inclusion criteria are further defined in the protocol.

        Exclusion Criteria:

          1. Patients who discontinued early from trial ARGX-113-1704 or patients who discontinued
             early from randomized treatment for pregnancy or rescue reasons or an (S)AE that might
             jeopardize the safety of the patient in that trial.

          2. Pregnant and lactating women, and those intending to become pregnant during the trial
             or within 90 days after the last dosing. Women or childbearing potential should have a
             negative urine pregnancy test at SEB.

          3. Male patients who are sexually active and do not intend to use effective methods of
             contraception during the trial or within 90 days after the last dosing or male
             patients who plan to donate sperm during the trial or within 90 days after the last
             dosing.

          4. Patients with known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human
             Immunodeficiency Virus (HIV) seropositivity.

        Other, more specific exclusion criteria are further defined in the protocol.
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: PEP005 (ingenol mebutate) Gel; Vehicle gel
Intervention description: two day treatment; two day treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peplin; Actinic keratosis; PEP005

Summary:

      The purpose of this study is to determine whether topical application of PEP005 is effective
      for the treatment of actinic keratoses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be male or female and at least 18 years of age.

          -  Female patients must be of:

          -  Non-childbearing potential;

          -  Childbearing potential, provided negative serum and urine pregnancy test and using
             effective contraception.

          -  4 to 8 AK lesions on non-head locations.

        Exclusion Criteria:

          -  Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected
             treatment area.

          -  Treatment with immunomodulators, or interferon/ interferon inducers or systemic
             medications that suppress the immune system within 4 weeks.

          -  Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and
             2 cm of treatment area
Preoperative Alignment of Total Knee Replacement
Condition: Knee Arthritis
MeSH terms: Arthritis
Intervention: trumatch group; control group
Intervention description: these patient will have CT based customized knee instruments used for surgery; these patients will have standard instrumentation used for for knee replacement
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: alignment

Summary:

      The hypothesis of this study is that total knee alignment will be improved by preoperative
      planning from CT scans and the production of custom instruments compared to the use of
      standard instruments.
    

Eligibility criteria:

        Inclusion Criteria:patients undergoing primary total knee replacement -

        Exclusion Criteria:patients who have hardware involving the hip, knee or ankle

        -
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Condition: Venous Leg Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Intervention: Dermagraft(R); Profore
Intervention description: Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.; Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 537.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Venous leg ulcer; randomized trial; clinical trial; Dermagraft; compression therapy; surgical debridement; venous stasis; chronic ulcer; chronic wound; fibroblasts

Summary:

      This study randomly assigns patients with venous leg ulcers to receive standard therapy
      (compression) alone or compression plus Dermagraft(R). Dermagraft is a device containing live
      human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they
      heal or the 16-week treatment period is complete. Follow-up visits are conducted monthly for
      three months in order to assess patients for longer term safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years of age

          -  ABI > 0.80

          -  Three or fewer venous leg ulcers, if multiple must be separated by 2 cm

          -  Ultrasound demonstrates venous reflux >0.5 seconds

          -  Study wound present for 1-24 months

          -  Study wound 2-15 sq cm surface area

          -  Clean, granulating wound

          -  Patient able and willing to sign informed consent and comply with study procedures.

          -  Women of childbearing potential must use birth control pills, barriers or abstinence
             and have a negative pregnancy test.

        Exclusion Criteria:

          -  Wound etiology uncertain or not from venous hypertension.

          -  BMI>40

          -  Acute or chronic infectious skin disease

          -  Allergy or intolerance to Profore(R)

          -  Wound infection, cellulitis, osteomyelitis

          -  >2 weeks' treatment with immunosuppressive agents in recent past

          -  Investigational drug use within 30 days

          -  Severe malnutrition, drug and/or alcohol abuse

          -  Malignant disease unless in remission for 5 years

          -  History of radiation at the study site

          -  Other conditions that could impede wound healing

          -  Known history of HIV or AIDS

          -  Prior participation in any Dermagraft study

          -  Treatment with other bioengineered tissue products within 30 days

          -  Unable to understand the aims and objectives of the trial

          -  Inability to comply with study protocol

          -  NYHA Class III or IV CHF

          -  Uncontrolled diabetes mellitus

          -  Dorsal foot ulcer
STEP: Social Support To Empower Parents
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: STEP
Intervention description: Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This RCT intervention provides parental social support (informational, affirmational, and
      emotional) using parent mentors (experienced in the management of the chronic illness) for
      mothers and fathers of young children newly diagnosed with type 1 diabetes. The parent
      mentors provide both home visits and phone call support over the course of the first year
      after diagnosis. The hypothesis is that newly diagnosed parents who receive the intervention
      will perceive less parental concern and worry, less negative impact on the family, more
      perceived confidence and social support compared to those mothers and fathers not receiving
      the intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mothers and fathers of children 12 years and younger with type 1 diabetes
A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)
Condition: HIV
Intervention: Comparator: Raltegravir 400 mg b.i.d.; Experimental: Raltegravir 800 mg q.d.; TRUVADA™
Intervention description: Raltegravir 400 mg tablet by mouth (PO) twice daily (b.i.d.) + two raltegravir placebo tablets + one tablet of TRUVADA™ once daily (q.d.); Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d.; One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
Intervention MeSH terms: Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 775.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV Infections; Treatment Naïve

Summary:

      A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared
      to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-naïve
      human immunodeficiency virus (HIV)-infected patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female 18 years of age or older

          -  Patient is HIV positive

          -  Patient is naïve to antiretroviral therapy (ART) or has received less than 7 days
             total of any ART

        Extension Study:

          -  The planned extension study did not take place as the study was terminated after the
             Week 48 analysis.

        Exclusion Criteria:

          -  Patient is a user of recreational or illicit drugs or has had a recent history (within
             the last year) of drug or alcohol abuse or dependence

          -  Patient has documented resistance to tenofovir or emtricitabine

          -  Patient is currently participating or has participated in a study with an
             investigational compound or device within 45 days of signing informed consent

          -  Patient is pregnant or breastfeeding, or expecting to conceive
Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation
Condition: Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Atrial Flutter
Intervention: warfarin; apixaban
Intervention description: Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0); Oral tablets, 5.0 mg or 2.5 mg, twice daily
Intervention MeSH terms: Warfarin; Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20976.0
Sex: All
Healthy volunteers: No

Summary:

      The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is
      as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in
      subjects with atrial fibrillation and risk factors for stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females ≥ 18 yrs with atrial fibrillation (AF) and one or more of the
             following risk factors for stroke:

          -  Age ≥ 75, previous stroke

          -  transient ischemic attack (TIA) or Systemic Embolism (SE)

          -  Symptomatic congestive heart failure or left ventricular dysfunction with left
             ventricular ejection fraction (LVEF) ≤ 40%

          -  Diabetes mellitus or hypertension requiring pharmacological treatment
An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
Condition: Spinal Cord Diseases; Spinal Cord Injuries; Neuralgia; Pain
MeSH terms: Spinal Cord Injuries; Neuralgia; Spinal Cord Diseases
Intervention: pregabalin
Intervention description: Pregabalin capsules taken twice a daily (150-600mg/day)
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Central Nervous System Diseases; Therapeutic Uses; Wounds and Injuries; Trauma; Nervous System; pregabalin

Summary:

      The purpose of this study is to assess the safety of the long-term use of pregabalin at doses
      up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain,
      post stroke pain, and multiple sclerosis pain).
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion criteria for subjects to be shifted from Study A0081107

          -  Subjects who completed the 18-week study period in Study A0081107 conducted for
             chronic neuropathic pain after spinal cord injury;

          -  Subjects who completed assessments of all efficacy endpoints until the end of the
             treatment phase of the preceding Study A0081107 (V7);

        Inclusion criteria for subjects to be new participants in this study

          -  Subjects with central neuropathic pain after stroke or multiple sclerosis;

          -  At least 6 months have passed after the onset of central neuropathic pain;

          -  Pain VAS at least 40mm in Visit 1 and Visit 2;

        Exclusion Criteria:

          -  Creatinine clearance < 60 mL/min;

          -  Platelet count < 100 × 103/mm3 ; White blood cell (WBC) count < 2500 / mm3; Neutrophil
             count < 1500/ mm3;

          -  Subjects who are expected to require surgery during the trial;