bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren; Valsartan; Hydrochlorothiazide (HCTZ)
Intervention description: Aliskiren 300 mg; Valsartan 320 mg; Hydrochlorothiazide (HCTZ) 12.5-25 mg
Intervention MeSH terms: Valsartan; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 601.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension, aliskiren, valsartan, HCTZ, blood pressure

Summary:

      Assessment of the long-term safety and tolerability of the combination of aliskiren and
      valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of
      long-term safety and tolerability of the combination of
      aliskiren/valsartan/Hydrochlorothiazide(HCTZ).
    

Eligibility criteria:

        Inclusion Criteria: -

          -  Male and female outpatients 18 years of age and older.

          -  For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥
             90 and < 110 mmHg at Visit 1 and Visit 4

          -  For previously treated patients with essential hypertension defined as msDBP ≥ 90 and
             < 110 mmHg after 2 to 4 weeks of washout (Visit 4)

          -  Patients who were eligible and able to participate in the study and who consented to
             do so after the purpose and nature of the investigation had been clearly explained to
             them (written informed consent).

        Exclusion Criteria:

          -  Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg)

          -  Women of child-bearing potential, unless they met definition of post-menopausal or
             were using acceptable methods of contraception.

          -  History or evidence of a secondary form of hypertension.

          -  History of hypertensive encephalopathy or cerebrovascular accident.

        Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
Condition: Cryopyrin-associated Periodic Syndromes; Familial Cold Autoinflammatory Syndrome; Muckle-Wells Syndrome; Neonatal Onset Multisystem Inflammatory Disease
MeSH terms: Cellulitis; Eosinophilia; Cryopyrin-Associated Periodic Syndromes; Syndrome
Intervention: ACZ885
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Enrollment: 17.0
Sex: All
Minimum age: 1 Year
Maximum age: 4 Years
Healthy volunteers: No
Keywords: Cryopyrin-associated periodic syndromes (CAPS); Familial Cold Autoinflammatory Syndrome (FCAS); Muckle-Wells Syndrome (MWS); Neonatal Onset Multisystem Inflammatory Disease (NOMID); children, systemic autoinflammatory disease; CIAS-1 gene; NALP-3; NLRP3; ACZ885; canakinumab; human monoclonal anti-human interleukin-1 antibody; autosomal dominant; familial autoinflammatory syndrome; childhood immunizations vaccinations

Summary:

      This trial will provide long-term safety, efficacy and tolerability of ACZ885 in CAPS
      patients that completed the CACZ885D2307 study
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients who completed the core CACZ885D2307 study (a patient is defined as having
             completed the core study if they completed the study up to and including the EOS visit
             with no major protocol deviations in the core).

          2. Male and female patients that are ≥ 1 year of age at the time of the roll-over visit.

          3. Parent or legal guardian written informed consent must be obtained before any
             assessment in the extension CACZ885D2307E1 study is performed.

        Exclusion criteria:

          1. Patients for who continued treatment in the CACZ885D2307E1 extension study is not
             considered appropriate by the treating physician.

          2. Patients who discontinued from the core CACZ885D2307 study

        Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
Condition: Moderate to Severe Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: AIN457 150mg; AIN457 300mg
Intervention description: (1 injection per dose) and placebo to secukinumab 150 mg; secukinumab 150 mg (2 injections per dose)
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 967.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; plaque; inflammatory skin disease; scaly patches; AIN457; secukinumab; Moderate to Severe Plaque-type Psoriasis

Summary:

      This study will assess the safety and efficacy of two different doses and two different dose
      regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic,
      plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.

        Severity of disease meeting all of the following three criteria:

          -  PASI score of 12 or greater,

          -  Investigator's Global Assessment (IGA) score of 3 or greater

          -  Total body surface area (BSA) affected of 10% or greater.

          -  Inadequate control by prior use of topical treatment, phototherapy and/or systemic
             therapy.

        Exclusion criteria:

          -  Current forms of psoriasis other than chronic plaque-type psoriasis (for example,
             pustular, erythrodermic, guttate).

          -  Current drug-induced psoriasis.

          -  Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.

          -  Significant medical problems such as uncontrolled hypertension, congestive heart
             failure or a condition that significantly immunocompromises the subject.

          -  Hematological abnormalities.

          -  History of an ongoing, chronic or recurrent infectious disease, or evidence of
             untreated tuberculosis.

          -  History of lymphoproliferative disease or history of malignancy of any organ system
             within the past 5 years.

          -  Pregnant or nursing (lactating) women.

          -  Other protocol-defined inclusion/exclusion criteria may apply.
Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Intervention: valganciclovir; Placebo
Intervention description: valgan 900mg QD x 9 months post lung transplant
Intervention MeSH terms: Valganciclovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute rejection; Non-CMV infections; Resistance

Summary:

      The study evaluated the efficacy and safety of a prolonged, continuous course of
      Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the
      standard of care upon initiation of the study, to 12 months of Valganciclovir.
    

Eligibility criteria:

        Inclusion Criteria for Phase I:

          -  Adult lung transplant recipients age 18 or older

          -  At risk for CMV (donor or recipient serology must be positive for CMV)

          -  Adequate hematological and renal function,

          -  On intravenous (IV) ganciclovir within 24 hours of surgery

          -  Agreement to use effective methods of contraception

          -  Negative pregnancy

          -  Tolerate oral medications within 2 weeks of transplant

          -  Negative baseline CMV PCR

          -  Able to understand and sign the informed consent

        Exclusion Criteria for Phase 1:

          -  Repeat transplantation

          -  Mechanical ventilation at study entry

          -  Oral or intravenous ganciclovir treatment outside the study protocol

          -  Invasive fungal infection

          -  Participation in another investigational study

          -  Acute CMV infection or disease

          -  Anti-CMV therapy within 30 days before enrollment

          -  Uncontrolled diarrhea or malabsorption

          -  Allergic reaction to study drug

          -  Required use of prohibited medications

          -  Lactating women

          -  Pregnancy

          -  Renal failure

        Inclusion Criteria for Phase II:

          -  Negative serial post transplant PCRs at day 75

          -  Negative bronchial cultures for CMV

          -  Adequate hematological and renal function at day 75

          -  IV ganciclovir for up to 2 weeks post operation and open label up to day 90

          -  Effective contraceptives

          -  Negative pregnancy

        Exclusion Criteria Phase II:

          -  Renal failure

          -  Serious adverse events (SAE) related to study drug

          -  CMV disease (study endpoint)

          -  Withdraw consent for Phase II
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: Botulinum Toxin Type A; Placebo (saline)
Intervention description: Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.; Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 679.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a 60 week study including a double-blind phase followed by an open-label extension
      phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Frequent migraine (>=15 headache days per month)

          -  >=4 distinct headache episodes lasting >=4 hours

          -  >=50% of baseline headache days migraine/probable migraine days

        Exclusion Criteria:

          -  Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin
             serotype

          -  Any medical condition that puts the patient at increased risk with exposure to BOTOX

          -  Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache,
             hemicrania continua, new daily persistent headache

          -  Use of prophylactic headache medication within 28 days prior to week -4

          -  Unremitting headache lasting continuously throughout the 4-week baseline period

          -  Known or suspected Temporomandibular Disorders (TMD)

          -  Diagnosis of fibromyalgia

          -  Beck depression inventory score >24 at week-4

          -  Psychiatric problems that may have interfered with study participation
An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Placebo; Teriflunomide
Intervention description: Film-coated tablet
Oral administration; Film-coated tablet
Oral administration
Intervention MeSH terms: Teriflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1169.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: relapsing multiple sclerosis

Summary:

      The primary objective of the study was to assess the effect of two doses of teriflunomide, in
      comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants
      with relapsing MS.

      Key secondary objective was to assess the effect of the two doses of teriflunomide, in
      comparison to placebo, on disability progression.

      Other secondary objectives were:

        -  To assess the effect of the two doses of teriflunomide in comparison to placebo on:

             -  Fatigue;

             -  Health-related quality of life, a measure of the impact of the participant's health
                on his or her overall well being.

        -  To evaluate the safety and tolerability of teriflunomide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsing multiple sclerosis,

          -  Two relapses in prior 2 years or one relapse in prior year.

        Exclusion Criteria:

          -  Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major
             systemic disease,

          -  Significantly impaired bone marrow function or, significant anemia, leukopenia or
             thrombocytopenia,

          -  Pregnant or nursing woman,

          -  Alcohol or drug abuse,

          -  Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant
             agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or
             mycophenolate,

          -  Human immunodeficiency virus (HIV) positive,

          -  Any known condition or circumstance that would prevent, in the investigator's opinion,
             compliance or completion of the study.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
National Lung Screening Trial (NLST) Screening
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: low-dose helical computed tomography; chest radiography
Intervention description: A LDCT is a computerized tomography image with low-dose technique without contrast. The scan is done from the neck to the diaphragm in one breath-hold.; The chest x-ray in this study was a single posterior-anterior film done with the participant upright.
Phase: Phase 3
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53454.0
Sex: All
Minimum age: 55 Years
Maximum age: 74 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: small cell lung cancer; non-small cell lung cancer

Summary:

      RATIONALE: Effective screening tests should help doctors detect lung cancer early and plan
      curative treatment. It is not yet known whether low-dose helical computed tomography (LDCT)
      screening is more effective than chest radiography (CXR) screening in reducing death from
      lung cancer.

      PURPOSE: Randomized clinical trial to compare the effectiveness of LDCT scan with that of CXR
      in screening individuals who are at high risk for developing lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 55-74 years (pack-years = packs per day * years smoked)

          -  30 or more pack-years of cigarette smoking history

          -  Former smokers: quit smoking within the previous 15 years

          -  Ability to lie on the back with arms raised over the head

          -  Signed informed consent form

        Exclusion Criteria:

          -  Metallic implants or devices in the chest or back, such as pacemakers or Harrington
             fixation rods

          -  Treatment for, or evidence of, any cancer other than nonmelanoma skin cancer or
             carcinoma in situ (with the exception of transitional cell carcinoma in situ or
             bladder carcinoma in situ) in the 5 years prior to eligibility assessment

          -  History of lung cancer

          -  History of removal of any portion of the lung, excluding needle biopsy

          -  Requirement for home oxygen supplementation

          -  Participation in another cancer screening trial

          -  Participation in a cancer prevention study, other than a smoking cessation study

          -  Unexplained weight loss of more than 15 pounds in the 12 months prior to eligibility
             assessment

          -  Recent hemoptysis

          -  Pneumonia or acute respiratory infection treated with antibiotics in the 12 weeks
             prior to eligibility assessment

          -  Chest CT examination in the 18 months prior to eligibility assessment
Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Saxagliptin; Saxagliptin; Placebo matching Saxagliptin; Metformin; Placebo matching Metformin; Saxagliptin; Metformin
Intervention description: Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT]); Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 500 mg, daily (42 months LT); Tablets, Oral, 0 mg, daily (42 months LT); Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label; Tablets, Oral, 500-2000 mg (as needed for rescue)
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1035.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is
      more effective than placebo as a treatment for type 2 diabetic subjects who are not
      sufficiently controlled with diet and exercise
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

          -  Drug naive

          -  Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)

          -  Fasting C-peptide >= 1 ng/mL

          -  Body mass index <= 40 kg/m2

        Exclusion Criteria:

          -  Symptomatic poorly controlled diabetes

          -  Recent cardiac or cerebrovascular event

          -  Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for Women of Child Bearing
             Potential
Myocardial Ischemia and Transfusion Pilot
Condition: Myocardial Infarction; Unstable Angina; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Angina, Unstable; Infarction; Ischemia
Intervention: Red blood cell transfusion
Intervention description: Liberal versus restrictive transfusion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: blood transfusion; red blood cell transfusion; myocardial infarction; acute coronary syndrome; anemia

Summary:

      The purpose of this study is to evaluate two approaches to red blood cell transfusion in
      anemic patients with acute coronary syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 or older;

          -  STEMI (ST segment elevated myocardial infarction)

          -  NSTEMI (Non ST segment elevation myocardial infarction)

          -  unstable angina

          -  stable coronary artery disease (undergoing cardiac catheterization during the index
             hospitalization);

          -  written informed consent has been obtained

          -  hemoglobin concentration less than 10 g/dL at the time of random allocation.

        Exclusion Criteria:

          -  bleeding cannot be controlled at the cardiac catheterization puncture site and/or
             require surgery to repair vessel

          -  retroperitoneal bleeding requiring surgery

          -  clinically important hemodynamic instability based on the judgment of the treating
             physician

          -  terminal malignancy or life expectancy less than 6 months

          -  scheduled for cardiac surgery within the next 30 days

          -  symptomatic at the time of randomization

          -  declines blood transfusion

          -  history of a clinically significant transfusion reaction

          -  inability to provide informed consent;

          -  enrolled in a competing study

          -  previous participation in the MINT trial

          -  any patient who in the judgment of the research team should not be enrolled in the
             trial. This would include, but not be limited to, factors such alcohol or drug
             dependence, or psychiatric illness.
Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
Condition: Hormone-Refractory Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: sipuleucel-T; APC-Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: asymptomatic metastatic hormone-refractory prostate cancer

Summary:

      This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous
      antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic,
      hormone-refractory prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented adenocarcinoma of the prostate

          -  Metastatic disease as evidenced by soft tissue and/or bony metastases

          -  Prostate-specific antigen value of at least 5 ng/mL

          -  Tumor progression while on hormonal therapy

          -  Castration levels of testosterone (defined as less than 50 ng/dL)

          -  Life expectancy of at least 16 weeks

          -  Adequate hematologic, renal, and liver function

        Exclusion Criteria:

          -  Visceral organ metastases

          -  Metastatic disease expected to be in need of radiation therapy within 4 months.

          -  Concurrent therapy with experimental agents