bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: IDP-122 Lotion; IDP-122 Vehicle Lotion
Intervention description: Medicated topical lotion; Vehicle topical lotion with no active ingredient
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the safety and efficacy of a topical lotion when applied once daily
      to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's
      Global Assessment [IGA] score of 3 or 4).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, of any race, at least 18 years of age (inclusive).

          -  Freely provides both verbal and written informed consent.

          -  Has an area of plaque psoriasis appropriate for topical treatment that covers a body
             surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms,
             soles, axillae, and intertriginous areas are to be excluded in this calculation.

          -  Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
             radiation (natural and artificial) for the duration of the study.

          -  Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or
             4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded
             in this assessment).

        Exclusion Criteria:

          -  Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
             psoriasis, as determined by the Investigator.

          -  Presents with psoriasis that was treated with prescription medication and failed to
             respond to treatment, even partially or temporarily, as determined by the
             Investigator.

          -  Presents with any concurrent skin condition that could interfere with the evaluation
             of the treatment areas, as determined by the Investigator.

          -  Is pregnant, nursing an infant, or planning a pregnancy during the study period.

          -  Has received treatment with any investigational drug or device within 60 days or 5
             drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently
             participating in another clinical study with an investigational drug or device.
An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Condition: Keratoconjunctivitis Sicca
MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes
Intervention: OTX-101 0.09%
Intervention description: 0.09% cyclosporine nanomicellar solution
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a safety extension enrolling subjects participating in Study OTX-101-2016-001
      (NCT02688556)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of Study OTX-101-2016-001

        Exclusion Criteria:

        -
Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; placebo; liraglutide; liraglutide; glimepiride; metformin; placebo
Intervention description: 0.6 mg/day, s.c. (under the skin) injection; Glimepiride placebo, capsules; 1.2 mg/day, s.c. (under the skin) injection; 1.8 mg/day, s.c. (under the skin) injection; Capsules, 4.0 mg/day; Tablets, 1.5-2.0 g/day; Liraglutide placebo, s.c. (under the skin) injection
Intervention MeSH terms: Metformin; Liraglutide; Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 929.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic
      control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic
             drugs (OADs) for the last 3 months

          -  HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone

          -  HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy

          -  BMI less than 45.0 kg/m^2

        Exclusion Criteria:

          -  Treatment with insulin within the last 3 months prior to the trial

          -  Impaired liver or/and renal function

          -  Significant cardiovascular disease over the last 6 months

          -  Known retinopathy or maculopathy

          -  Recurrent major hypoglycaemia or hypoglycaemic unawareness
Study of Fampridine-SR Tablets in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fampridine-SR; Placebo
Intervention description: Tablets, 10 mg, twice daily, 9 weeks; placebo (sugar pill)
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: multiple sclerosis; MS; walking; leg strength; demyelination

Summary:

      The purpose of the study is to show that individuals treated with Fampridine-SR tablets are
      significantly more likely to have consistent improvements in their walking than those treated
      with placebo tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with clinically defined multiple sclerosis

          -  All patients must be able to complete two trials of a timed 25 foot walk

        Exclusion Criteria:

          -  Female patients who are either pregnant or breastfeeding.
A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome
Condition: Dravet Syndrome
MeSH terms: Seizures; Epilepsies, Myoclonic; Syndrome
Intervention: ZX008 (Fenfluramine Hydrochloride)
Intervention description: ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will be titrated to an effective dose beginning with 0.2 mg/kg/day (maximum: 30 mg/day).
Intervention MeSH terms: Fenfluramine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: ZX008-1503 Fenfluramine, open-label
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 2 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: seizure; tonic clonic; epilepsy; myoclonic; encephalopathy

Summary:

      This is an exploratory sub-study to ZX008-1503 [NCT02823145]. Subjects will be fitted with an
      Embrace seizure detection watch and seizures detected by the watch will be compared to those
      entered into an electronic seizure diary.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meeting all of the main study ZX008-1503 [NCT02823145] inclusion criteria

          -  Subject is willing to wear the Embrace watch on the wrist (alternatively ankle, if
             needed for younger children). Subjects are asked to wear the watch for as many hours
             of the day as possible and for the entire night, if possible, for the duration of the
             sub-study.

          -  Subject's parent/caregiver is willing to use the Alert App.

          -  Subject/subject's caregiver is willing to ensure that the Embrace watch remains within
             close proximity of the paired iPod Touch running the Empatica Alert app.

        Exclusion Criteria:

          -  Subject has a known hypersensitivity to any of the Embrace device materials.

          -  Subject has a clinically significant condition, or has had clinically relevant
             symptoms or a clinically significant illness in the 4 weeks prior to Visit 1, other
             than epilepsy, that would negatively impact study participation, collection of study
             data, or pose a risk to the subject.
A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg
Condition: Asthma
MeSH terms: Asthma
Intervention: Symbicort pMDI; Symbicort pMDI; Budesonide pMDI
Intervention description: Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily; Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily; Budesonide pMDI 80µg, 2 acuations twice daily
Intervention MeSH terms: Budesonide; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 882.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: asthma, children, budesonide pMDI

Summary:

      The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and
      Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in
      Children Ages 6 to <12 Years with Asthma during 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months
             prior to Visit 2

          -  Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last
             dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to
             100% of predicted normal

          -  Demonstrated reversibility of clinic FEV1 of ≥12% from pre -albuterol/salbutamol level
             within 15 to 30 minutes after administration of a standard dose of
             albuterol/salbutamol.

        Exclusion Criteria:

          -  Have been hospitalized at least once or required emergency treatment more than once
             for an asthma-related condition during the 6 months prior to Visit 1

          -  Have required treatment with systemic corticosteroids (eg, oral, parenteral, or
             rectal) for any reason within the 6 weeks prior to Visit 1
Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Sponsor is also masked.
Enrollment: 986.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of the study drug known
      as galcanezumab in participants with episodic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of migraine as defined by International Headache Society (IHS)
             International Classification of Headache Disorders (ICHD)-3 beta version (1.1 or 1.2)
             (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to
             screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 MHD.

        Exclusion Criteria:

          -  Are currently enrolled in or have participated within the last 30 days or within 5
             half-lives (whichever is longer) in a clinical trial involving an investigational
             product.

          -  Current use or prior exposure to galcanezumab or another Calcitonin Gene-Related
             Peptide (CGRP) antibody.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins, or to galcanezumab.

          -  History of persistent daily headache, cluster headache or migraine subtypes including
             hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
             with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 394.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spondyloarthritis; Spondylarthropathy

Summary:

      The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab
      compared to placebo in participants with active psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6
             months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria

          -  Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints

          -  Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)

          -  Men must agree to use a reliable method of birth control or remain abstinent during
             the study

          -  Women must agree to use reliable birth control or remain abstinent during the study
             and for at least 12 weeks after stopping treatment

          -  Have been treated with 1 or more conventional disease-modifying antirheumatic drugs
             (cDMARDs)

        Exclusion Criteria:

          -  Current or prior use of biologic agents for treatment of Ps or PsA

          -  Inadequate response to greater than or equal to 4 conventional disease-modifying
             antirheumatic drugs (DMARDS)

          -  Current use of more than one cDMARDs

          -  Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other
             than PsA

          -  Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal
             antibody (MAb) therapy

          -  Serious disorder or illness other than psoriatic arthritis

          -  Serious infection within the last 3 months

          -  Breastfeeding or nursing (lactating) women
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: raltegravir potassium; Comparator: placebo
Intervention description: Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.; Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 351.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Treatment Experienced

Summary:

      This study will investigate the safety and efficacy of raltegravir as a therapy for Human
      Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral
      resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be HIV positive with HIV RNA values that are within ranges required by
             the study

          -  Patient must have documented failure of certain antiretroviral therapy

          -  Patient must be on the same antiretroviral therapy for at least the past two months

        Exclusion Criteria:

          -  Patient less than 16 years old

          -  Additional study criteria will be discussed and identified by the study doctor
Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: TA-7284 Low; TA-7284 High; Placebo
Intervention description: The patients will receive TA-7284-Low orally for 24 weeks.; The patients will receive TA-7284-High orally for 24 weeks.; The patients will receive Placebo orally for 24 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 272.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: TA-7284; JNJ-28431754; Canagliflozin; Sodium Glucose Co-transporter (SGLT2 inhibitor)

Summary:

      The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in
      patients with type 2 Diabetes for 24 weeks administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women age ≥20 years old

          -  Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period

          -  HbA1c of ≥7.0% and ≤10.0%

        Exclusion Criteria:

          -  Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder,
             secondary diabetes mellitus

          -  Past or current history of severe diabetic complications

          -  Fasting plasma glucose > 270 mg/dL before treatment start

          -  History of hereditary glucose-galactose malabsorption or primary renal glucosuria

          -  Patients requiring insulin therapy
Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Atrovent Respimat (20 mcg); COMBIVENT MDI (36/206 mcg); Combivent Respimat (20 mcg/100 mcg); Placebo via corresponding inhaler for blinding purposes
Intervention MeSH terms: Ipratropium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1480.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to compare the effect of ipratropium
      bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20
      mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20
      mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of
      12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to
      COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent
      Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent
      Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed.
      In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of
      therapy will be characterized in a subgroup of patients.
    

Eligibility criteria:

        Inclusion Criteria:

        Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted
        normal and FEV1/FVC 70%).

        Exclusion Criteria:

        Patients with significant diseases other than COPD that may either put the patient at risk
        because of participation in the study or a disease which may influence the results of the
        study or the patient's ability to participate in the study, with a history of asthma or
        allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day
        and in the investigator's opinion will be unable to abstain from the use of oxygen therapy
        or using oral corticosteroid me dication at unstable doses (i.e., less than 6 weeks on a
        stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20
        mg every other day will be excluded.
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferumoxytol; Iron Sucrose
Intervention description: IV Ferumoxytol; IV Iron Sucrose
Intervention MeSH terms: Ferrosoferric Oxide; Ferric Oxide, Saccharated
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 605.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron deficiency anemia; Feraheme; ferumoxytol; iron sucrose; Venofer; IDA

Summary:

      The purpose of the study is to evaluate the efficacy and safety of intravenous (IV)
      ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).
    

Eligibility criteria:

        Key Inclusion Criteria include:

          1. Males and females ≥18 years of age

          2. Participants with IDA defined as having:

               1. Hemoglobin <10.0 g/deciliter (dL)

               2. Transferrin saturation (TSAT) <20%

          3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral
             iron cannot be used

          4. Female participants of childbearing potential who are sexually active must be on an
             effective method of birth control for at least 1 month prior to screening and agree to
             remain on birth control until completion of participation in the study

        Key Exclusion Criteria include:

          1. History of allergy to IV iron

          2. Allergy to two or more classes of drugs

          3. Participants on dialysis or with an estimated glomerular filtration rate <30
             mL/minute(min)/1.73 square meter (m^2)

          4. Female participants who are pregnant, intend to become pregnant, are breastfeeding,
             within 2 weeks postpartum, or have a positive serum/urine pregnancy test

          5. Hemoglobin ≤7.0 g/dL

          6. Serum ferritin >600 nanogram/mL