bioihbjkbjnl/mcl2 huggingface dataset:
A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an ACEI or ARB and an Additional Antihypertensive Medication
Condition: Type 2 Diabetes
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo matching Dapagliflozin
Intervention description: Tablets, Oral, 10 mg, once daily, Up to 12 weeks; Tablets, Oral, 0 mg, once daily, Up to 12 weeks
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2245.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Angiotensin Receptor Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Cardiovascular Agents; Pharmacological Actions

Summary:

      The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can
      improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled
      hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin
      Receptor Blocker (ARB).The safety of this treatment will also be studied
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic
             control HbA1c between 7-10.5% and uncontrolled hypertension Systolic Blood Pressure
             (SBP) 140-165 and Diastolic Blood Pressure (DBP) 85-105

          -  Subjects must have a mean 24 hr blood pressure ≥ 130/80 determined by Ambulatory Blood
             Pressure Monitoring (ABPM) within 1 week prior to Day 1 visit

          -  Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks [12 wks for
             Thiazolidinedione (TZD)] or a stable daily dose of insulin, as a monotherapy or in
             combination with another OAD, for 8 weeks, and a stable dose of ACEI or ARB and 1
             additional antihypertensive medication for at least 4 weeks

          -  C-peptide ≥ 0.8 ng/mL

          -  Body Mass Index ≤ 45.0 kg/m2

          -  Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

        Exclusion Criteria:

          -  Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0*upper
             limit of normal (ULN)

          -  Serum total bilirubin ≥ 1.5*ULN

          -  Creatinine kinase > 3*ULN

          -  Symptoms of severely uncontrolled diabetes

          -  History of malignant or accelerated hypertension

          -  Currently unstable or serious cardiovascular, renal, hepatic, hematological,
             oncological, endocrine, psychiatric, or rheumatic diseases
Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Bepreve (bepotastine besilate ophthalmic solution) 1.5%; placebo comparator; Bepotastine Besilate Ophthalmic Solution 1.0%
Intervention description: sterile ophthalmic solution; sterile ophthalmic solution; sterile ophthalmic solution
Intervention MeSH terms: Bepotastine besilate; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic
      conjunctivitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be at least 10 years of age

        Exclusion Criteria:

          -  No active ocular disease
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 (Ingenol Mebutate) gel, 0.015%; Vehicle Gel
Intervention description: once daily for 3 consecutive days; once daily for 3 consecutive days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 278.0
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
Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Vitamin D and fish oil; Fish oil (EPA/DHA) alone; Vitamin D alone; Placebo
Intervention description: 2000 IU vitamin D and 1g/d fish oil; 1 g/d fish oil; 2000 IU vitamin D; Vitamin D placebo and fish oil placebo
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25871.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study will examine whether an intervention with vitamin D or fish oil supplements can
      reduce the risk of heart failure among adult men and women during a follow up period of up to
      five years (starting from the time of randomization into the parent VITAL trial). The
      investigators hypotheses are that both vitamin D and fish oil supplements will each reduce
      the risk of heart failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men aged 50 or older or women aged 55 or older

          -  Be consuming no more than 800 IU of vitamin D from all supplemental sources combined
             (individual vitamin D supplements, calcium+vitamin D supplements, medications with
             vitamin D [e.g., Fosamax Plus D], and multivitamins), or, if taking, willing to
             decrease or forego such use during the trial;

          -  Be consuming no more than 1200 mg/d of calcium from all supplemental sources combined,
             or, if taking, willing to decrease or forego such use during the trial;

          -  Not be taking fish oil supplements, or, if taking, willing to forego their use during
             the trial

        Exclusion Criteria:

          -  prevalent heart failure

          -  History of cancer (except non-melanoma skin cancer), heart attack, stroke, transient
             ischemic attack, angina pectoris, CABG, or PCI

          -  History of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism,
             severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such
             as active chronic tuberculosis or Wegener's granulomatosis;

          -  Allergy to fish or soy
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium bromide 200 μg bid; Aclidinium bromide 400 μg bid; Placebo
Intervention description: Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks; Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks; Placebo twice-daily by inhalation for 24 weeks
Intervention MeSH terms: Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 828.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; antimuscarinic; COPD

Summary:

      The main purpose of this study is to assess the long term bronchodilator efficacy, safety and
      tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD
      patients and the benefits of the product in disease-related health status, COPD symptoms and
      COPD exacerbations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD
             guidelines).

          -  Post-salbutamol (FEV1) < 80% and ≥30% of predicted normal value and Post-salbutamol
             FEV1/FVC < 70%.

          -  Current or ex-smokers of ≥10 pack-years.

        Exclusion Criteria:

          -  Patients with no history or current diagnosis of asthma.

          -  No evidence of an exacerbation within 6 weeks prior to the screening visit.

          -  No evidence of clinically significant respiratory and/or cardiovascular conditions or
             laboratory abnormalities.

          -  No contraindication to use of anticholinergic drugs such as known symptomatic
             prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection
Condition: Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Ibuprofen; Placebo
Intervention description: Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen); Single dose of a placebo
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fever; antipyretic; uncomplicated acute viral infection; uncomplicated acute bacterial infections

Summary:

      This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared
      to placebo in patients with a fever due to an uncomplicated acute infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed with a fever secondary to an uncomplicated acute viral or bacterial
             infection.

          -  Oral temperature measurement from 100 to 104 degrees Fahrenheit.

          -  Onset of fever 3 days or less.

          -  Otherwise good health.

        Exclusion Criteria:

          -  Fever secondary to a chronic underlying medical condition or serious infection.

          -  Currently taking antibiotics or antivirals.

          -  Currently taking any medication which may interfere with the assessment of fever.

          -  Pregnancy or breast-feeding.

          -  Any serious medical or psychiatric disorder.
Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Valsartan/amlodipine 160/5 mg; Valsartan 160 mg; Placebo
Intervention description: Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.; Valsartan 160 mg capsule taken orally once daily.; 1 capsule or tablet taken orally once daily
Intervention MeSH terms: Amlodipine; Valsartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 932.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Blood pressure; hypertension; Exforge; valsartan/amlodipine

Summary:

      This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill
      combination in patients with uncomplicated essential hypertension not adequately controlled
      (MSDBP ≥90 mmHg and <110 mmHg) on valsartan 160 mg alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must give written informed consent

          -  Male or female ages 18 or older and less than 86 years

          -  Diagnosed as having essential diastolic hypertension, as follows:

               -  Visit 2/Single-blind run-in entry, all participants MUST have a MSDBP ≥ 95 mmHg
                  and < 100 mmHg

               -  At Visit 3/Core double-blind treatment period entry, all patients MUST have a
                  MSDBP >=90 mmHg and <110 mmHg

        Exclusion Criteria:

          -  Severe hypertension

          -  Evidence of secondary form of hypertension (coarctation of the aorta,
             hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease,
             pheochromocytoma or polycystic kidney disease )

          -  Malignant hypertension

          -  Administration of any agent indicated for the treatment of hypertension after Visit 1

          -  Known moderate or malignant retinopathy.

          -  Known or suspected contraindications, including history of allergy or hypersensitivity
             to Angiotensin II Receptor Blockers (ARBs), Calcium Channel Blockers (CCBs), or to
             drugs with similar chemical structures

          -  History of hypertensive encephalopathy, cerebrovascular accident, or transient
             ischemic attack, myocardial infarction or all types of revascularization, angina
             pectoris of any type, including unstable angina

          -  History of heart failure Grade II-IV according to New York Heart Association (NYHA)
             classification

          -  Second of third degree heart block regardless of the use of a pacemaker, concomitant
             potentially life-threatening arrhythmia or symptomatic arrhythmia

        Other protocol-defined inclusion/exclusion criteria may apply
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Condition: Uterine Fibroids; Heavy Menstrual Bleeding
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Intervention: Estradiol/Norethindrone Acetate; Elagolix
Intervention description: capsules; film-coated tablets
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 433.0
Sex: Female
Minimum age: 18 Years
Maximum age: 51 Years
Healthy volunteers: No
Keywords: Uterine Fibroids; Elagolix; Heavy Menstrual Bleeding; Elagolix Sodium; Elagolix plus Norethindrone Acetate

Summary:

      This is an extension study for women who have already received six months of treatment in the
      phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate
      the long-term efficacy and safety of elagolix administered alone and in combination with
      estradiol/norethindrone acetate for an additional six months in the treatment of heavy
      menstrual bleeding associated with uterine fibroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has completed the 6-Month Treatment Period of their respective Pivotal
             Study (either Study M12-815 or Study M12-817).

          -  Participant did not meet removal criteria in bone mineral density (BMD) decrease in
             the spine, total hip and femoral neck at Month 6 of the Treatment Period of their
             respective Pivotal Study

          -  Participant has negative urine and/or serum pregnancy test(s) results were
             consistently negative during the Treatment Period of their respective Pivotal Study
             and prior to first dose in this study.

          -  Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal
             Study shows no clinically significant endometrial pathology.

        Exclusion Criteria:

          -  Participant met criteria for removal from therapy in her respective Pivotal Study.

          -  Participant is planning a pregnancy within the next 18 months.

          -  Participant has current suicidal markers as noted at the Month 6 visit of her
             respective pivotal study.

          -  Participant has any new medical conditions that may be unsuitable for participation.

          -  Participant is using any systemic corticosteroids for over 14 days or is likely to
             require treatment with systemic corticosteroids during the course of the study.
             Over-the-counter and prescription topical, inhaled, intranasal or injectable (for
             occasional use) corticosteroids are allowed.
A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Fostamatinib disodium; Placebo
Intervention description: Fostamatinib (100 mg PO bid or 150 mg PO bid); Placebo tablet PO bid (morning and evening) over the course of 24 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Persistent Immune Thrombocytopenic Purpura; Chronic Immune Thrombocytopenic Purpura

Summary:

      The purpose of this study is to determine whether fostamatinib is safe and effective in the
      treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of persistent/chronic ITP for at least 3 months.

          -  Average platelet count < 30,000/µL (and none > 35,000 unless as a result of rescue
             therapy) from at least 3 qualifying counts

        Exclusion Criteria:

          -  Clinical diagnosis of autoimmune hemolytic anemia

          -  Uncontrolled or poorly controlled hypertension

          -  History of coagulopathy including prothrombotic conditions
Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography
Condition: Heart Disease
MeSH terms: Heart Diseases
Intervention: sulphur hexafluoride lipid-type A microspheres
Intervention description: Ultrasound imaging contrast agent
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 9 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV
      EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the
      study in pediatric subjects represented those utilized in routine clinical practice in
      adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide Written informed consent from parent(s) or legal guardian

          -  Provide assent when required according to local regulations

          -  Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for
             congenital heart disease

          -  Undergone a previous transthoracic echocardiogram within one month prior to enrollment
             resulting in suboptimal left ventricular endocardial border defined as ≥ 2 contiguous
             segments in any given view that cannot be visualized.

        Exclusion Criteria:

          -  Children < 9 years of age

          -  Previously enrolled in the study

          -  Administered any other contrast agent either intravascularly or orally within 48 hours
             of Lumason administration

          -  Known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated
             saline study performed before administration of Lumason)

          -  Known hypersensitivity to one or more of the ingredients of the investigational
             product

          -  Received an investigational compound within 30 days before enrolling into this study

          -  Pregnant or lactating female

          -  Determined by investigator to be unsuitable for the study