bioihbjkbjnl/mcl2 huggingface dataset:
Belimumab in Remission of VASculitis
Condition: Vasculitis
MeSH terms: Microscopic Polyangiitis; Vasculitis
Intervention: Placebo; Belimumab 10 mg/kg; Azathioprine
Intervention description: Placebo; Belimumab 10 mg/kg; Azathioprine
Intervention MeSH terms: Azathioprine; Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Wegener's Granulomatosis; anti-MPO; WG; Belimumab; GPA; anti-proteinase 3; anti-neutrophil cytoplasmic antibody; anti-myeloperoxidase; Granulomatosis with polyangiitis; Vasculitis; Autoimmune Diseases; Microscopic Polyangiitis; anti-PR3; ANCA; MPA; Systemic Vasculitis

Summary:

      The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination
      with azathioprine, for the maintenance of remission following a standard induction regimen in
      patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in
      this study is "1 to 1" which means that participants have an equal chance of receiving
      belimumab or placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill
             criteria.

          -  Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids
             and 1 of the following medications: rituximab, oral cyclophosphamide OR IV
             cyclophosphamide.

          -  Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO)
             antibodies at any time prior to enrollment.

          -  Achieve remission no more than 26 weeks after first dose of induction treatment.
             Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and
             receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive
             visits 21 to 35 days apart.

          -  Maintenance therapy on this study must start no more than 2 weeks after confirmation
             of remission.

        Key Exclusion Criteria:

          -  Pregnant or nursing.

          -  Receipt of a B cell targeted therapy (other than rituximab) at anytime

          -  Receipt of an investigational biological agent within the past 60 days.

          -  Required management of acute or chronic infections within the past 60 days.

          -  Current drug or alcohol abuse or dependence.

          -  Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or
             hepatitis C.

          -  History of severe allergic reaction to contrast agents or biological medicines.
Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: MK0974 50 mg; MK0974 150 mg; MK0974 300 mg; Comparator: Placebo
Intervention description: MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1703.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a
      placebo for acute migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has at least 1 year history of migraine (with or without aura)

          -  Females of childbearing years must use acceptable contraception throughout trial

        Exclusion Criteria:

          -  Patient is pregnant/breast-feeding (or is a female expecting to conceive during the
             study period)

          -  Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency
             Virus (HIV) disease. Patient has uncontrolled cardiovascular disease

          -  Patient has major depression, other pain syndromes that might interfere with study
             assessments, psychiatric conditions, dementia, or significant neurological disorders
             (other than migraine)

          -  Patient has a history of gastric or small intestinal surgery or has a disease that
             causes malabsorption

          -  Patient has a history of cancer within the last 5 years
Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Daclatasvir; Telaprevir; Peginterferon alfa-2a; Ribavirin
Intervention description: Film-coated tablet, oral, 60 mg, once daily, 24 weeks; Film-coated tablet, oral, 750 mg, 3 times daily; Solution for injection, subcutaneous injection, 180 μg, weekly; Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
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: Hepatitis C Virus

Summary:

      The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and
      Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b
      patients
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants chronically infected with hepatitis C virus (HCV) genotype 1a or 1b

          -  HCV RNA viral load ≥10,000 IU/mL

          -  No prior treatment including but not limited to interferon, ribavirin, and
             direct-acting antivirals

          -  No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year

          -  Body mass index of 18 to 35 kg/m^2

          -  Negative for HIV and hepatitis B virus

        Key Exclusion Criteria:

          -  Evidence of decompensated liver disease

          -  Evidence of medical condition other than HCV contributing to chronic liver disease
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
Condition: Nosocomial Pneumonia (NP); Ventilator-associated Pneumonia (VAP)
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia
Intervention: ceftazidim-avibactam (CAZ-AVI, experimental product); meropenem (active comparator)
Intervention description: 2000mg ceftazidime plus 500mg avibactam; 1000mg of Meropenem
Intervention MeSH terms: Meropenem; Ceftazidime; Avibactam; Avibactam, ceftazidime 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: 969.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Ceftazidime,; Meropenem,; Anti-Bacterial Agents,; Anti-Infective Agents,; Therapeutic Uses,; Pharmacologic Actions,; Physiological Effects of Drugs

Summary:

      The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to
      Meropenem for treating hospitalized adults with nosocomial pneumonia including
      ventilator-associated pneumonia
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 90 years of age inclusive

          -  Females can participate if surgically sterile or completed menopause; if able to have
             children, must have negative serum pregnancy test, agree not to attempt pregnancy and
             use acceptable contraception while receiving study therapy and for 1 week after

          -  Onset of symptoms ≥ 48 hours after admission or <7 days after discharge from an
             inpatient acute or chronic care facility

          -  New or worsening infiltrate on chest X-ray obtained within 48 hours prior to
             randomization

          -  At least 1 of the following systemic signs:Fever (temperature >38 C) or hypothermia
             (rectal/core temperature <35 C); White blood cell count >10,000 cells/mm3, or White
             blood cell count <4500 cells/mm3, or >15% band forms.

        Exclusion Criteria:

          -  Pulmonary disease that, in the investigator's judgment, would preclude evaluation of
             therapeutic response (e.g. lung cancer, active tuberculosis, cystic fibrosis,
             granulomatous disease, fungal pulmonary infection or recent pulmonary embolism).

          -  Patients with lung abscess, pleural empyema or post obstructive pneumonia.

          -  Patients with an estimated creatinine clearance <16ml/min by Cockcroft Gault formula
             or patients expected to require haemodialysis or other renal support while on study
             therapy.

          -  Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute
             decompensation of chronic hepatic failure.

          -  Patients receiving hemodialysis or peritoneal dialysis.
A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease
Condition: Iron Deficiency Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferumoxytol
Intervention description: IV Ferumoxytol
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Iron deficiency anemia; Feraheme; ferumoxytol; chronic kidney disease; CKD; pediatric; dialysis-dependent; nondialysis-dependent

Summary:

      Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375)
      and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic
      treatment of iron deficiency anemia (IDA) with ferumoxytol.
    

Eligibility criteria:

        Key Inclusion Criteria include:

          1. Participants who had completed participation in the combined AMAG-FER-CKD-251 and
             AMAG-FER-CKD-252 studies within 4 weeks of screening

          2. Female participants of childbearing potential who are sexually active must be on an
             effective method of birth control and agree to remain on birth control until
             completion of participation in the study

          3. Participant and/or legal guardian is capable of understanding and complying with the
             protocol requirements and is available for the duration of the study

        Key Exclusion Criteria include:

          1. Experienced a serious adverse event related to IV iron therapy in the combined
             AMAG-FER-CKD-251 and AMAG-FER- CKD-252 studies

          2. Hemoglobin level ≤7 g/dL
Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene lotion 0.1%; Adapalene Lotion Vehicle
Intervention description: Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks; Vehicle will be applied topically to the face, once a day, for 12 weeks
Intervention MeSH terms: Adapalene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1067.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acne Vulgaris; Adapalene

Summary:

      The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in
      the treatment of Acne Vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with Moderate or Severe Acne Vulgaris,

          -  20-50 papules and pustules in total on the face excluding the nose

          -  30-100 non-inflammatory lesions on the face excluding the nose.

          -  Negative urine pregnancy test for all females.

        Exclusion Criteria:

          -  Subjects with more than one acne nodule.

          -  Subjects with any acne cyst on the face.

          -  Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced
             acne, etc.), or severe acne requiring systemic treatment.

          -  Subjects with underlying diseases or other dermatologic conditions that require the
             use of interfering topical or systemic therapy, such as, but not limited to, atopic
             dermatitis, perioral dermatitis or rosacea.

          -  Subjects who are pregnant, nursing, or planning a pregnancy.
The Efficacy of a Toothpaste to Reduce Sensitivity
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: Triclosan, Silicon dioxide, fluoride; Triclosan, fluoride
Intervention description: Brush twice daily; Brush twice daily
Intervention MeSH terms: Silicon; Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 626.0
Sex: All
Minimum age: 12 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Hypersensitivity
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects, ages: 12 years or older.

          -  Availability for the eight-week duration of the study.

          -  Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical
             erosion/abrasion or gingival recession.

          -  Qualifying response to Tactile stimuli (Yeaple Probe) as defined by a score between
             10-50 grams of force.

          -  Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the
             Schiff Cold Air Sensitivity Scale.

          -  Subjects need to satisfy the qualifying response to stimuli for both parameters
             assessed (Tactile or Air Blast) on at least two teeth to be entered into the study.

          -  Good general health with no known allergies to products being tested.

          -  Use of a non-desensitizing dentifrice for one month prior to entry into the study.

          -  Signed Informed Consent Form.

        Exclusion Criteria:

          -  Gross oral pathology, chronic disease, or history of allergy to test products.

          -  Advanced periodontal disease or treatment for periodontal disease (including surgery)
             within the past twelve months.

          -  Sensitive teeth with a mobility greater than one.

          -  Teeth with extensive/defective restorations (including prosthetic crowns), suspected
             pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.

          -  Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers,
             anti-inflammatory drugs, or analgesics.

          -  Participation in a desensitizing dentifrice study or regular use of a desensitizing
             dentifrice within the past one month.

          -  Current participation in any other clinical study.

          -  Allergies to triclosan, or oral care products, personal care consumer products, or
             their ingredients.

          -  Medical condition which prohibits not eating/drinking for 4 hours.
Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inflexal V; Inflexal V
Intervention description: vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart; Inflexal V 0.5 mL administrated once only
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 205.0
Sex: All
Minimum age: 6 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Virus; Vaccination; Immunisation

Summary:

      The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL
      2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline
      for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as
      reference.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female children

          -  Aged ≥6 to <36 months on Day 1

          -  Born at a gestational age ≥37 weeks

          -  Written informed consent

          -  No previous influenza vaccination

        Exclusion Criteria:

          -  Acute respiratory infection or other acute disease

          -  Acute febrile illness (≥38.0 °C)

          -  Past vaccination with an influenza vaccine, including vaccination against the
             influenza strain A/California/7/2009 (H1N1)-like virus

          -  Laboratory-confirmed infection with any influenza strain, including the pandemic
             influenza strain H1N1 (A/California/7/2009 (H1N1)-like virus)

          -  Known hypersensitivity to any vaccine component

          -  Known history of egg protein allergy or severe atopy

          -  Known blood coagulation disorder

          -  Chronic (longer than 14 days) administration of immunosuppressants or other
             immune-modifying drugs within 6 months before the first dose of the study vaccine,
             incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent for
             ≥14 days (inhaled or topical steroids are allowed)

          -  Known immunodeficiency (including leukemia, cancer, HIV seropositivity)

          -  Investigational medicinal product received in the past 3 months (90 days)

          -  Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months
             (90 days)

          -  Vaccination with the MMR vaccine in the past 4 weeks, or planned within the study
             period

          -  Participation in another clinical trial

          -  Child or legal charge of the investigator or an employee at the study site, or living
             in the same household as the investigator/employee and/or dependent on the
             investigator/employee

          -  Suspected non-compliance
PMP-300E (Smart Watch): Portable Monitoring Device Study
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: PMP-300E; In-lab PSG
Intervention description: Data collected from Level 3 device; Data collected from Type I In-Lab Polysomnography
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep
      Apnea.
    

Eligibility criteria:

        Inclusion Criteria:Inclusion Criteria:

          -  Age 18 and over.

          -  Require a sleep diagnostic study by physician's order.

          -  Able and willing to provide written informed consent.

          -  Able to speak and read English.

        Exclusion Criteria:Exclusion Criteria:

          -  Participation in another interventional research study within the last 30 days.

          -  Unstable medical or psychiatric conditions that would interfere with the demands of
             the study or the ability to commit to follow-up assessment. Examples include unstable
             congestive heart failure, neuromuscular disease, cancer, and renal failure.

          -  Chronic respiratory failure or insufficiency with suspected or known neuromuscular
             disease, moderate or severe COPD or other pulmonary disorders, or any condition with
             an elevation of arterial carbon dioxide levels (> 45 mmHg) while awake or participants
             qualifying for oxygen therapy (arterial saturation 88% for more than five minutes).

          -  Consumption of ethanol more than 4 nights per week. (CAGE criteria)

          -  Use of recreational drug within the past 12 months.

          -  Women who are pregnant or currently lactating.
Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers
Condition: Psoriasis
MeSH terms: Psoriasis; Pruritus
Intervention: Secukinumab; Placebo
Intervention description: 150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe); Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and
      lesional biomarkers.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic moderate to severe plaque type psoriasis as diagnosed by a qualified physician
             at least 6 months prior to baseline and with a PASI score > 10 at baseline.

          -  Psoriasis patients with pruritus intensity of ≥ 30 on a 100-point VAS, with a recall
             period of 24h as part of the PGA-CP, both, at screening and at baseline.

        Key Exclusion Criteria:

          -  Underlying conditions other than psoriasis which in the opinion of the investigator
             currently cause or influence pruritus of the skin (e.g. drug induced pruritus, renal
             insufficiency, diabetes).

          -  Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and
             guttate) at screening or study start.

          -  Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have
             to be adhered to. If the use of any of the prohibited treatments is required, then the
             subject may not be included into the study.

          -  Pregnancy, breast feeding or inadequate contraception (if necessary)
Safety Study of Olopatadine Nasal Spray
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Olopatadine 0.6% nasal spray; Placebo Nasal Spray
Intervention description: 2 sprays each nostril twice daily; 2 sprays each nostril twice daily
Intervention MeSH terms: Olopatadine 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: 890.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: rhinitis; perennial allergic rhinitis; allergic rhinitis

Summary:

      The purpose of this study is to determine whether olopatadine nasal spray is safe and
      effective when used for up to one year by patients with perennial allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and
             older

        Exclusion Criteria:

          -  Age 11 years and younger