bioihbjkbjnl/mcl2 huggingface dataset:
A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: PEP005 Gel; Vehicle gel
Intervention description: 0.015%, three day treatment; Vehicle gel, three day treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peplin; Actinic keratosis; PEP005

Summary:

      This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when
      applied to an area of skin containing 4-8 AK lesions on the face or scalp.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female and at least 18 years of age

          -  Female patients must be of either:

               -  Non-childbearing potential, post-menopausal

               -  Childbearing potential, provided there are negative serum and urine pregnancy
                  test results prior to study treatment, to rule out pregnancy

        Exclusion Criteria:

          -  Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 the selected treatment area
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8mg/kg iv (60 minute infusion)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1681.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single arm study will investigate the safety, tolerability and efficacy of
      tocilizumab monotherapy, or combination therapy with non-biologic disease modifying
      antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive
      tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The
      anticipated time on study treatment is 3-12 months, and the target sample size is >500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male and non-pregnant or nursing female patients >=18 years of age;

          -  body weight <=150kg;

          -  moderate to severe active RA (DAS28 >=3.2) of >=6 months duration;

          -  on >=1 non-biologic DMARDs at a stable dose for a period of >= 8 weeks prior to start
             of treatment;

          -  inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF
             therapy;

          -  if receiving oral corticosteroids, the dose must have been stable for at least 25 of
             28 days prior to start of treatment.

        Exclusion Criteria:

          -  major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months following enrollment;

          -  rheumatic autoimmune disease other than RA;

          -  prior history of, or current inflammatory joint disease other than RA;

          -  functional class IV as defined by the ACR Classification of Functional Status in RA.
Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing.
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BFF; Symbicort Turbuhaler
Intervention description: Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler); Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler)
Intervention MeSH terms: Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      Study comparing the same drugs as a dual combination product (budesonide and formoterol)
      given via two different inhalers. To see which one results in the best effect on breathing.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Subject must be 40 to 80 years of age inclusive, at the time of signing the ICF.

          2. Individuals who have a physician diagnosis of COPD as defined by the American Thoracic
             Society (ATS)/European Respiratory Society (ERS)

          3. Require COPD maintenance therapy: all subjects must be receiving 2 or more inhaled
             maintenance therapies, including at least 1 long-acting bronchodilator, for the
             management of their COPD for at least 4 weeks prior to Visit 1.

          4. A post-bronchodilator FEV1/FVC of <0.70 and post-bronchodilator FEV1 of <50% predicted
             normal value at Visit 2.

          5. A pre-bronchodilator PIF of <50 L/min using the InCheck Inspiratory Flow Measurement
             Device set to Turbuhaler S resistance at Visit 2.

          6. Current or former smokers with history of at least 10 pack-years of cigarette smoking.

        Key Exclusion Criteria:

          1. Current diagnosis of asthma, in the opinion of the Investigator.

          2. Other respiratory disorders including known active tuberculosis, lung cancer, cystic
             fibrosis, significant bronchiectasis (high resolution CT evidence of bronchiectasis
             that causes repeated acute exacerbations), immune deficiency disorders, severe
             neurological disorders affecting control of the upper airway, sarcoidosis, idiopathic
             interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary
             thromboembolic disease.

          3. A moderate or severe exacerbation of COPD ending within 6 weeks prior to randomization
             (Visit 3).

          4. Need for mechanical ventilation within 3 months prior to Visit 1.
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab; Placebo
Intervention description: Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Extension study, psoriatic arthritis, pre-filled syringe

Summary:

      This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It
      aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for
      subjects who completed the core study CAIN457F2306, to obtain further long term efficacy,
      safety and tolerability information in subjects with active psoriatic arthritis receiving
      secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed
      the assessments associated with the core study visit and subsequently continued in this
      extension study on the same dose that they were receiving during the core study. The regular
      assessments of disease activity ensure that subjects who are experienced worsening of disease
      in any of the treatment groups could exit the study upon their own wish or based on the
      advice of the investigator at any time.
    

Eligibility criteria:

        Inclusion criteria

          -  Subjects must be able to understand and communicate with the investigator and comply
             with the requirements of the study and must give a written, signed and dated informed
             consent before any study assessment is performed

          -  Subjects must have participated in core study CAIN457F2306, and must have completed
             the entire treatment period

          -  Subjects must be deemed by the investigator to benefit from continued secukinumab
             therapy

        Exclusion criteria

          -  Any subject taking other concomitant biologic immunomodulating agent(s) except
             secukinumab

          -  Any subject who is deemed not to be benefiting from the study treatment based upon
             lack of improvement or worsening of their symptoms

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential, unless they are using effective methods of
             contraception during the entire study or longer if required by locally approved
             prescribing information (e.g., 20 weeks in EU)

        Other protocol-defined inclusion/exclusion criteria may apply
A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Mirabegron; Placebo
Intervention description: Mirabegron tablets; Matching mirabegron placebo tablets.
Intervention MeSH terms: Mirabegron
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2030.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urgency; YM178; Urinary incontinence; Mirabegron; Micturition; Frequency; Urinary urgency incontinence; Overactive Bladder

Summary:

      The study is intended to test efficacy, safety and tolerability of two doses of once daily
      (qd) Mirabegron against placebo to treat patients with symptoms of overactive bladder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is willing and able to complete the micturition diary and questionnaires
             correctly

          -  Patient has symptoms of overactive bladder (OAB) for ≥ 3 months

          -  Patient must experience frequency of micturition on average ≥ 8 times per 24-hour
             period during the 3-day micturition diary period

          -  Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without
             incontinence during the 3-day micturition diary period

        Exclusion Criteria:

          -  Patient is breastfeeding, pregnant, intends to become pregnant during the study, or of
             childbearing potential, sexually active and not practicing a highly reliable method of
             birth control

          -  Patient has significant stress incontinence or mixed stress/urge incontinence where
             stress is the predominant factor

          -  Patient is using medications intended to treat OAB

          -  Patient has an indwelling catheter or practices intermittent self-catheterization

          -  Patient has diabetic neuropathy

          -  Patient has evidence of urinary tract infection, chronic inflammation such as
             interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous
             or current malignant disease of the pelvic organs

          -  Patient receives non-drug treatment including electro-stimulation therapy

          -  Patient has severe hypertension

          -  Patient has participated in a clinical study within 30 days, or had participated in
             any previous study with mirabegron

          -  Patient had an average total daily urine volume > 3000 mL as recorded in the 3-day
             micturition diary period

          -  Patient has serum creatinine of >150 μmol/L, or aspartate aminotransferase (AST) or
             alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or
             gamma-glutamyl transpeptidase (γ-GT) > 3x ULN

          -  Patient has a clinically significant abnormal electrocardiogram (ECG)
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: IDP-123 Lotion; IDP-123 Vehicle Lotion
Intervention description: Tazarotene 0.045% Lotion; Vehicle Lotion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 813.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed
      to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123
      Vehicle Lotion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 9 years of age and older;

          2. Written and verbal informed consent must be obtained. Subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit);

          3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global
             Severity assessment at the baseline visit;

          4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count
             no less than 20 but no more than 50;

          5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no
             less than 25 but no more than 100;

          6. Subjects with two or fewer nodules

        Exclusion Criteria:

          1. Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study;

          2. Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis,
             eczema;

          3. Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive;

          4. Subjects with a facial beard or mustache that could interfere with the study
             assessments;

          5. Subjects with more than two (2) facial nodules;

          6. Evidence or history of cosmetic-related acne
A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Daclatasvir; Sofosbuvir
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 238.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the
      treatment of hepatitis C virus and HIV coinfection.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Key Inclusion Criteria:

          -  Patients must be able to understand and agree to/comply with the prescribed dosing
             regimens and procedures, report for regularly scheduled study visits, and reliably
             communicate with study personnel about adverse events and concomitant medications

          -  Patients chronically infected with hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or
             6, as documented by positive HCV RNA at screening

          -  Patients who are HCV treatment-naive

          -  Patients who are HCV treatment-experienced and who have had prior anti-HCV therapies
             discontinued or completed at least 12 weeks prior to screening

          -  Patients with HCV RNA ≥10,000 IU/mL at screening

          -  Patients with HIV-1 infection

        Key Exclusion Criteria:

          -  Presence of AIDs-defining opportunistic infections, as defined by the Centers of
             Disease Control and Prevention, within 12 weeks prior to study entry

          -  Patients infected with HIV-2

          -  Liver or any other organ transplant (including hematopoietic stem cell transplants)
             other than cornea and hair

          -  Current or known history of cancer (except in situ carcinoma of the cervix or
             adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
             to screening

          -  Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained
             imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this
             was performed

          -  Evidence of decompensated liver disease, including radiologic criteria, a history or
             presence of ascites, bleeding varices, or hepatic encephalopathy
Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Continuous glucose monitor; Home blood glucose monitor
Intervention description: Daily use of a continuous glucose monitor; Home monitoring 3 or more times a day
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 4 Years
Maximum age: 9 Years
Healthy volunteers: No
Keywords: Continuous Glucose Monitor

Summary:

      The purpose of this study is to determine the efficacy, tolerability, safety, and effect on
      quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least
             twelve months

          2. Age >4.0 to <10.0 years

          3. HbA1c >= 7.0%

          4. Current insulin regimen involves either use of an insulin pump or multiple daily
             injections of insulin (at least 3 shots per day) for the last three months, with no
             plans to switch the modality of insulin administration during the next 6 months (e.g.,
             injection user switching to a pump, pump user switching to injections, or the addition
             of Lantus (Glargine) insulin)

        Exclusion Criteria:

          1. Diabetes diagnosed <6 months of age

          2. Use of a medication such as oral/inhaled glucocorticoids that in the judgment of the
             investigator will affect the wearing of the sensors or the completion of any aspect of
             the protocol.

          3. The presence of any of the following diseases or another disease that the investigator
             believes to be a contraindication to participation in the protocol:

               -  Asthma if treated with systemic or daily inhaled corticosteroids in the last 6
                  months (Intermittent treatment with inhaled corticosteroids does not exclude
                  subjects from enrollment)

               -  Cystic fibrosis (Celiac disease and adequately treated thyroid disease do not
                  exclude subjects from enrollment)

          4. Home use of CGM in past 6 months.

          5. Participation in an intervention study (including psychological studies) in past 6
             weeks.

          6. Another member of the same household is participating in this study.
Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
Condition: Dupuytren's Contracture
MeSH terms: Dupuytren Contracture; Contracture
Intervention: Xiapex
Intervention description: Xiapex 0.58 mg in diluent, 0.25 ml for MP joints and 0.20 ml for PIP joints, injection to cord over joint using either 26 or 27 gauge needle, maximum 3 injections with 30 days interval between injections to any single site, maximum 5 injections in this protocol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Dupuytren's; treatment; injection; recovery; health care resources

Summary:

      This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the
      affected fingers and the patient and physician reported treatment satisfaction and disease
      severity and their relation to ROM. Recovery to normal activities, recovery time (How long
      overall, time to use hand, time to return to work or daily activities, amount of work or
      daily activity time missed or reduced and affects on productivity and daily activities) will
      be assessed via patient diary. Use of concomitant analgesic medications will be recorded and
      total healthcare resource utilization (HCRU).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presenting with a Dupuytren's contracture of at least 20 degrees caused by a palpable
             cord in at least one finger other than the thumb.

          -  Positive "table top test" defined as the inability to simultaneously place the
             affected finger(s) and palm flat against a table top.

        Exclusion Criteria:

          -  Received a treatment on the selected joint, within 90 days of enrollment in the study,
             for Dupuytren's contracture including needle aponeurotomy or any surgical procedure

          -  On anticoagulant medication or has received anticoagulant medication (except aspirin
             less than 150 mg daily) within 7 days before the first injection

          -  Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands