bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo MDPI; Albuterol MDPI
Intervention description: Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.; Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; dry powder inhaler; short-acting beta2-agonist; SABA; bronchoconstriction; bronchodilation; bronchodilator; metered dose inhaler; Albuterol Spiromax®

Summary:

      The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus
      placebo in subjects with persistent asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent/assent

          -  At least 12 years of age at screening

          -  General good health

          -  Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility

          -  Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone
             propionate/day) for at least 4 weeks prior to the Screening Visit.

          -  Ability to perform spirometry in an acceptable manner as per protocol guidelines

          -  Other inclusion criteria apply

        Exclusion Criteria:

          -  A known hypersensitivity to albuterol or any of the excipients in the formulations.

          -  History of a respiratory infection or disorder that has not resolved within 1 week
             preceding the Screening Visit (SV).

          -  History of life-threatening asthma that is defined for this protocol as an asthma
             episode that required intubation.

          -  Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A
             subject must not have had any hospitalization for asthma within 6 months prior to the
             SV.

          -  Hospitalization due to asthma exacerbation 2 or more times in the past year

          -  Initiation of immunotherapy or dose escalation during the study period

          -  Other exclusion criteria apply.
3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Placebo; Ziprasidone; Ziprasidone
Intervention description: Placebo with mood stabilizer (either lithium or divalproex); Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex); Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 680.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex
      in acutely manic subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode
             manic (296.4x), or mixed (296.6x) as defined in Diagnostic and Statistical Manual of
             Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International
             Neuropsychiatric Interview (MINI).

          -  At screening and at baseline (within 12 hours prior to the first dose of double-blind
             medication) subjects must have a Young Mania Rating Scale score of 18 or higher.

          -  Subjects must be actively receiving lithium or divalproex for their bipolar disorder
             in order to be considered for this study.

        Exclusion Criteria:

          -  Subjects with a Diagnostic and Statistical Manual of Mental Disorders IV- Text
             Revision (DSM-IV TR) diagnosis of schizophrenia (295.XX), schizoaffective disorder
             (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or
             psychotic disorder not otherwise specified (NOS) (298.9).

          -  Subjects with other DSM-IV-TR Axis I or Axis II disorders (in addition to Bipolar I
             disorder) are ineligible if the comorbid condition is clinically unstable, requires
             treatment, or has been a primary focus of treatment within the 6-month period prior to
             screening.
Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China
Condition: Diabetic Neuropathies
MeSH terms: Neuralgia; Diabetic Neuropathies
Intervention: Duloxetine Hydrochloride; Placebo
Intervention description: 60 mg every day (QD) (morning or evening), by mouth (PO); Placebo every day (QD), by mouth (PO)
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 215.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic
      Neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes
             with the pain beginning in the feet and present for at least 6 months.

          -  May not be pregnant and agree to utilize medically acceptable and reliable means of
             birth control during participation in the study.

          -  Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

        Exclusion Criteria:

          -  Glycosylated hemoglobin (A1C) > 12%

          -  Severe hepatic disease

          -  History of substance abuse or dependence within the past year, excluding nicotine and
             caffeine.

          -  Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or
             severe cirrhosis), kidney, respiratory, blood disorder, seizure disorder, problems
             with peripheral vascular disease, or other medical conditions or psychiatric
             conditions that would hinder your participation or likely to lead to hospitalization
             during the course of the study.

          -  Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the
             potential need to take during or within 5 days after discontinuation from the study.

          -  Treatment of fluoxetine within 30 days of starting the study.

          -  Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Lithium carbonate; Valproate; Risperidone
Intervention description: Titrated until blood level is 1.1 to 1.3 mEq/L; Titrated until blood level is 111 to 125 ug/mL; Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID
Intervention MeSH terms: Valproic Acid; Risperidone; Lithium Carbonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 379.0
Sex: All
Minimum age: 6 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Mania

Summary:

      This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate
      (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar
      disorder or symptoms of mania.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV criteria for bipolar I (manic or mixed) or mania for at least 4 weeks

          -  CGAS less than or equal to 60

          -  Good physical health

        Exclusion Criteria:

          -  Schizophrenia or any pervasive developmental disorder

          -  Major medical or neurological disease

          -  History of addiction to illicit substances or alcohol or drug abuse within the last 4
             weeks

          -  IQ less than 70

          -  Pregnancy or breast-feeding

          -  Unacceptable methods of contraception

          -  In-patient care at baseline
Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2
Condition: Diabetes Mellitus; Local Anesthesia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: L+C maxillary anesthesia; L+C mandibular anesthesia; L+E maxillary anesthesia; L+E mandibular anesthesia
Intervention description: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml); Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml); Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000); Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Intervention MeSH terms: Anesthetics
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether 2% lidocaine (L) + clonidine (C) (15
      mcg/ml) as a vasoconstrictor achieves efficient (equal or better parameters of intraoral
      local anesthesia in comparison to 2% lidocaine + epinephrine (E) (1:80 000)) and safe (stable
      cardiovascular parameters - systolic, diastolic, mean blood pressure and heart rate)
      intraoral local anesthesia in patients with Diabetes mellitus type 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants: ASA I

          -  Diabetic type 2 participants: ASA III (HbA1c level < 9%)

          -  Required a single-root teeth indicated for non-complicated extraction

          -  Dental diagnosis of periodontal disease, tooth fracture, chronic periapical lesion and
             root infection

          -  Subjects give informed written consent

        Exclusion Criteria:

          -  Pregnancy and lactation

          -  Allergy to used drugs and food

          -  Hepatic and/or renal failure

          -  ASA IV patients

          -  Tobacco smokers

          -  History of alcoholism and/or drug abuse and addiction
Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)
Condition: Shingles
MeSH terms: Herpes Zoster
Intervention: Zoster Vaccine, Live (Zostavax™); Comparator: Placebo
Intervention description: A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1.; A single dose of 0.65 ml Placebo (A vaccine stabilizer of Zostavax™ with no live virus) was administered by subcutaneous injection on Day 1.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22439.0
Sex: All
Minimum age: 50 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will look at how well Zostavax™ works in preventing shingles in participants ages
      50-59 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be between 50 - 59 years of age

          -  No fever on day of vaccination

          -  Females of reproductive potential must be willing to use acceptable form of birth
             control

        Exclusion Criteria:

          -  Have received chicken pox or shingles vaccine

          -  Have already had shingles

          -  Have recently had another vaccination

          -  Pregnant or breast feeding. Have participated in another research study in the last 30
             days

          -  You are taking certain antiviral drugs

          -  History of allergic reaction to any vaccine component, including gelatin or neomycin
Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Sorafenib (Nexavar, BAY43-9006); Placebo
Intervention description: Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib; Placebo: matching placebo
Intervention MeSH terms: Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 458.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCC; Cancer; Liver Cancer; TACE

Summary:

      Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Aged of 18 and over

          -  Advanced hepatocellular carcinoma

        Exclusion Criteria:

          -  History of prior systemic chemotherapy

          -  Failure in vital organ
Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: LCZ696; Amlodipine; Placebo
Intervention description: LCZ696 will use tablets available at a strength of 200mg. Patients will be instructed to take the prescribed medication once a day.; Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day.; Matching placebo to LCZ696
Intervention MeSH terms: Amlodipine; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Essential hypertension; High blood pressure

Summary:

      This study will assess whether LCZ696 when used in combination with amlodipine will provide
      greater BP lowering benefit compared to amlodipine alone in Asian hypertensive patients not
      adequately responsive to amlodipine therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients must give written informed consent and have a diagnosis of hypertension:

        Untreated patients must have an msSBP ≥ 150 mmHg and < 180 mmHg at both Visit 1 and Visit
        101. Pre-treated patients must have an msSBP ≥ 145 mmHg and < 180 mmHg after wash out at
        Visit 101. All patients must have an office msSBP ≥ 145 mmHg and < 180 mmHg at the
        completion of the 4-week run-in epoch (at the randomization visit (Visit 201).

        Patients must successfully complete ABPM and pass technical requirements at Visit 201.

        Exclusion Criteria:

        Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or
        msSBP ≥ 180 mmHg).

        History of angioedema, drug-related or otherwise. History or evidence of a secondary form
        of hypertension. Transient ischemic cerebral attack (TIA) during the 12 months prior to
        Visit 1 or any history of stroke.

        History of myocardial infarction, coronary bypass surgery or PCI during the 12 months prior
        to Visit 1

        Other protocol-defined inclusion/exclusion criteria may apply
A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Placebo; Ustekinumab 45 mg; Ustekinumab 90 mg
Intervention description: SC injections; SC injections; SC injections
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 615.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arthritis, Psoriatic; Ustekinumab; CNTO 1275; Stelara; Psoriasis

Summary:

      The purpose of this study is to evaluate the effectiveness (improvement of signs and
      symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had a documented diagnosis of psoriatic arthritis (PsA) at least 6 months

          -  Have a diagnosis of active PsA at the time of entry into the study

          -  If the participant is using methotrexate they should have started treatment at a dose
             not to exceed 25 milligram per week at least 3 months prior to the beginning of the
             study and should have no serious toxic side effects attributable to methotrexate.
             Methotrexate route of administration and doses should be stable for at least 4 weeks
             prior to the first administration of study agent. If currently not using methotrexate,
             must have not received methotrexate for at least 4 weeks prior to the first
             administration of the study agent

        Exclusion Criteria:

          -  Have other inflammatory diseases, including but not limited to rheumatoid arthritis,
             ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease

          -  Have used any therapeutic agent targeted at reducing interleukin (IL)-12 or IL-23,
             including but not limited to ustekinumab and briakinumab (ABT-874)

          -  Have used any biologic agents that are targeted for reducing tumor necrosis
             factor-alpha, including but not limited to infliximab, etanercept, adalimumab, and
             golimumab

          -  Have a medical history of latent or active granulomatous infection

          -  Have any known malignancy or have a history of malignancy (with the exception of basal
             cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in
             situ that has been treated with no evidence of recurrence, or squamous cell carcinoma
             of the skin that has been treated with no evidence of recurrence within 5 years of the
             beginning of the study
Comparative Performance of PureVision Lens Designs
Condition: Myopia
MeSH terms: Myopia
Intervention: Currently Marketed PureVision Contact Lens.; Alternate Design of the PureVision Contact Lens.
Intervention description: Contact lens for continuous wear; Contact lens for continuous wear
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the performance of the PureVision Lens designs
      when worn on a 30-day continuous wear basis
    

Eligibility criteria:

        Inclusion Criteria:

          -  subject is myopic

          -  VA correctable to 0.3 logMAR or better (driving vision)

          -  Clear central cornea

        Exclusion Criteria:

          -  Systemic disease affecting ocular health

          -  using systemic or topical medications

          -  wear monovision, multifocal or toric contact lenses

          -  Any grade 2 or greater slit lamp findings
Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
Condition: GVHD; Adult Acute Myeloid Leukemia; Adult Acute Lymphoid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Syndrome
Intervention: US-ATG-F; Placebo
Intervention description: 20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation; 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Intervention MeSH terms: Immunoglobulins; Antilymphocyte Serum
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: adult acute myeloid leukemia; adult acute lymphoid leukemia; adult myelodysplastic syndrome; allogenic stem cell transplantation; unrelated donor; GVHD; US-ATG-F (Anti-human-T-lymphocyte Immune Globulin, Rabbit)

Summary:

      The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to
      standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe
      chronic GVHD-free survival.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients designated to undergo allogeneic peripheral blood or bone marrow stem cell
             transplantation following the diagnosis of one of the primary diseases in early or
             intermediate disease status (i.e., acute myeloid leukemia, acute lymphoid leukemia,
             and myelodysplastic syndrome)

          -  Patients with an unrelated HLA-A,-B, -C and -DRBI matched donor

          -  Patients with a Karnofsky Performance Score ≥ 70%

        Key Exclusion Criteria:

          -  Clinically significant concomitant diseases (i.e., cardiac, pulmonary, renal and CNS)

          -  Bacterial, viral, or fungal infections

          -  Known positive for Hepatitis B surfaces antigen, or Hepatitis C antibody, or who have
             been tested positive for HIV

          -  Patients with any concurrent malignancy. Cancer treated with curative intent < 5 years
             previously will not be allowed except for patients with resected basal cell carcinoma
             or treated cervical carcinoma in situ

          -  Known contraindications to the administration of rabbit immunoglobulin antibodies

          -  Hypersensitivity to methylprednisolone, tacrolimus, methotrexate or any excipients
             contains in these products