bioihbjkbjnl/mcl2 huggingface dataset:
Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)
Condition: Gastric Ulcer; Duodenal Ulcer
MeSH terms: Peptic Ulcer; Stomach Ulcer; Duodenal Ulcer; Ulcer
Intervention: Esomeprazole 40 mg; Esomeprazole 20 mg; Placebo
Intervention description: Esomeprazole 40 mg once daily; Esomeprazole 20 mg once daily; Placebo once daily
Intervention MeSH terms: Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2426.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peptic ulcer; low-dose ASA

Summary:

      The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily
      versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous
      low-dose acetylsalicylic acid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the
             following (a-e):

          -  Aged ≥65 years.

          -  Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s).

          -  Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior
             to randomization).

          -  Aged ≥60 years and with stable coronary artery disease.

          -  Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as
             judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the
             finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.

        Exclusion Criteria:

          -  Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).

          -  Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline

          -  History of peptic ulcer complications such as clinically significant bleeding and/or
             perforation.
Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis
Condition: Adult Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Intervention: minocycline HCl 2.1%; Scaling and root planing
Intervention description: Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.; scaling and root planing
Intervention MeSH terms: Minocycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 602.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of
      the root surfaces of the teeth. This is also called scaling and root planing. Placing a
      topical antibiotic into the periodontal pocket at the time of scaling and root planing may
      help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl)
      2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now
      being tested in the US.
    

Eligibility criteria:

        Inclusion Criteria:

          -  moderate to severe periodontitis

        Exclusion Criteria:

          -  recent periodontal therapy

          -  certain medical or dental conditions

          -  pregnancy

          -  allergy to active drug or related drugs
Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Vilanterol; Salmeterol Inhalation Powder; Placebo Inhalation Powder NDPI; Placebo Inhalation Powder Diskus
Intervention description: Vilanterol inhalation powder inhaled orally once daily for 12 weeks; Salmeterol inhalation powder inhaled orally twice daily for 12 weeks; Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler; Placebo inhalation powder inhaled orally twice daily for 12 weeks
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 348.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: asthma

Summary:

      The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation
      powder administered once daily in the evening in adolescent and adult subjects 12 years of
      age and older with persistent asthma over a 12-week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient at least 12 years of age

          -  Both genders; females of childbearing potential must be willing to use birth control
             method

          -  Clinical diagnosis of asthma for ≥12 weeks

          -  Best pre-bronchodilator FEV1 of 40%-90% predicted

          -  Reversibility of FEV1 of at least 12% and 200mls

          -  Current asthma therapy that include an inhaled corticosteroid for at least 12 weeks
             prior to 1st visit

          -  Ability to use replace current short-acting rescue treatment with albuterol and
             ability to withhold albuterol use for at least 6 hours prior to study visits

        Exclusion Criteria:

          -  History of life-threatening asthma

          -  Respiratory infection within last 4 weeks leading to change in asthma management

          -  Asthma exacerbation within last 3 months

          -  Concurrent respiratory disease or other disease that would confound study
             participation or affect subject safety

          -  Allergies to study drugs, study drugs' excipients, or medications related to study
             drugs

          -  Taking another investigational medication or medication prohibited for use during the
             study.

          -  Previous participation in a vilanterol (GW642444) study
Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
Condition: Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction
MeSH terms: Stomach Neoplasms
Intervention: S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm); Fluorouracil/cisplatin (control arm)
Intervention description: 25 mg/m² body surface area (BSA) orally 2 times daily from Days 1 through 21 followed by a 7 day rest period, plus cisplatin 75 mg/m2 BSA on Day 1 each 28 day cycle Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles.; 5-FU: 800 mg/m2 BSA/24 hours by continuous intravenous infusion (CIV) from Days 1 through 5 plus cisplatin 80 mg/m2 BSA on Day 1 each 21 day cycle.
Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles.
Intervention MeSH terms: Cisplatin; Fluorouracil; Tegafur
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 361.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastric Cancer , S-1, Phase 3

Summary:

      The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin
      compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and
      gastro-esophageal junction cancer previously untreated with chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has given written Informed Consent.

          -  Histologically confirmed, unresectable, metastatic diffuse gastric cancer including
             carcinoma of the gastro-esophageal junction.

          -  No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant
             chemotherapy more than 12 months ago.

          -  Life expectancy of at least 3 months.

          -  Able to take medications orally.

          -  Eastern Cooperative Oncology Group performance status 0 to 1.

          -  Adequate organ function (bone marrow, kidney and liver).

        Exclusion Criteria:

          -  Certain type(s) of non-measurable lesion(s), if the only one(s).

          -  Certain serious illness or medical condition(s).

          -  Lost greater than or equal to 10% of body weight in the 3 months proceeding signing
             the Informed Consent Form.

          -  Treatment with drugs interacting with S-1, 5-FU, or cisplatin.

          -  Pregnant or lactating female.

          -  Known hypersensitivity to fluoropyrimidines or cisplatin.

        Other protocol-defined inclusion/exclusion criteria may apply.
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
Condition: Chronic Sinusitis
MeSH terms: Sinusitis
Intervention: Sinuplasty
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sinusitis; rhinitis; sinus surgery; maxillary; ethmoid; sphenoid; frontal; FESS; sinuplasty

Summary:

      A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal
      sinuses.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years and greater

          2. Both male and female patients eligible

          3. Diagnosis of chronic sinusitis that is not responsive to medical management

          4. Planned endoscopic sinus surgery (recommended by PI, consented to by patient)

        Exclusion Criteria:

          1. Extensive sinonasal polyps

          2. Extensive previous sinonasal surgery

          3. Extensive sinonasal osteoneogenesis

          4. Cystic fibrosis

          5. Sampter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)

          6. Sinonasal tumors or obstructive lesions

          7. History of facial trauma that distorts sinus anatomy and precludes access to the sinus
             ostium

          8. Ciliary dysfunction

          9. Pregnant females
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: tocilizumab [RoActemra/Actemra]; Placebo; Non-steroidal anti-inflammatory drugs (NSAIDs); methotrexate; corticosteroids
Intervention description: 8mg/kg (patients>=30kg) or 12mg/kg (patients <30kg) iv every 2 weeks. In Part III, administration frequency may be reduced to every 3 and every 4 weeks, respectively, according to an optional alternative dosing schedule.; iv every 2 weeks for 12 weeks; as prescribed; as prescribed; orally, as prescribed
Intervention MeSH terms: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in
      patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate
      clinical response to NSAIDs and corticosteroids. In Part I of the study patients will be
      randomized 2:1 to receive iv infusions of RoActemra/Actemra (8mg/kg iv for patients >=30kg,
      or 12mg/kg for patients <30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will
      be continued throughout. After 12 weeks of double-blind treatment, all patients will have the
      option to enter Part II of the study to receive open-label treatment with RoActemra/Actemra
      for a further 92 weeks, followed by a 3-year continuation of the study in Part III in which,
      for patients who meet specific criteria, an optional alternative dosing schedule decreasing
      the study drug administration frequency will be introduced. Anticipated time on study
      treatment is up to 5 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 2-17 years of age

          -  Systemic juvenile idiopathic arthritis with >= 6 months persistent activity

          -  Presence of active disease (>=5 active joints, or >=2 active joints + fever +
             steroids)

          -  Inadequate clinical response to nonsteroidal anti-inflammatory drugs (NSAIDs) and
             corticosteroids due to toxicity or lack of efficacy

        Exclusion Criteria:

          -  Wheelchair-bound or bed-ridden

          -  Any other autoimmune, rheumatic disease or overlap syndrome other than systemic
             juvenile idiopathic arthritis

          -  Intravenous long-acting corticosteroids or intra-articular corticosteroids within 4
             weeks of baseline, or throughout study

          -  Disease-modifying antirheumatic drugs (DMARDs), other than methotrexate

          -  Previous treatment with tocilizumab
A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Condition: Recurrent Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Recurrence
Intervention: Oteseconazole (VT-1161); Placebo
Intervention description: Oteseconazole (VT-1161) 150mg capsule; matching placebo capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 438.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is
      defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of
      oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for
      RVVC than other oral anti-fungal medicines.

      This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the
      treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for
      the treatment of the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd
      part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg
      or a placebo (according to a random assignment), and then a 36-week follow-up period.

      In addition, at participating sites, an amendment to the study allows US patients who
      complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a
      48-week observational extension period designed to evaluate the continued effectiveness of
      oteseconazole (VT-1161).

      This study is identical to VMT-VT-1161-CL-012 (NCT03561701).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  3 or more episodes of acute VVC in the past 12 months

          -  Positive KOH or Gram stain

          -  Total vulvovaginal signs and symptoms score of ≥3 at screening visit

          -  Total vulvovaginal signs and symptoms score of <3 at baseline visit

          -  Must be able to swallow pills

        Key Exclusion Criteria:

          -  Presence or a history of another vaginal or vulvar condition(s)

          -  Evidence of major organ system disease

          -  History of cervical cancer

          -  Poorly controlled diabetes mellitus

          -  Pregnant

          -  Recent use of topical or systemic antifungal or antibacterial drugs

          -  Recent use of immunosuppressive or systemic corticosteroid therapies
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
Condition: Peripheral Nerve Discontinuities
Intervention: Processed Nerve Allograft (human); Collagen Nerve Cuff
Intervention description: Bovine collagen based nerve cuff
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and
      functional outcomes for the repair of nerve injuries in the hand.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Peripheral Nerve Injury

        Exclusion Criteria:

          -  Peripheral Neuropathy

          -  Allergic to Bovine products such as Bovine Collagen Nerve Cuff
Long-Term Safety Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: interferon γ-1b
Intervention description: ACTIMMUNE® will be administered three times per week by subcutaneous injection. The initial dose will be individualized for each participant and will be determined by the investigator, provided that the initial dose does not exceed the maximum tolerated dose in HZNP-ACT-302 (NCT02593773). The investigator may subsequently adjust the dose for any participant if deemed clinically appropriate, provided that the dose does not exceed 100 μg/m².
Intervention MeSH terms: Interferons; Interferon-gamma
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 11 Years
Maximum age: 27 Years
Healthy volunteers: No
Keywords: ACTIMMUNE; interferon y-1b

Summary:

      The purpose of this long term extension study is to evaluate the long-term safety of
      ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia (FA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and child assent, if applicable.

          -  Completed 26 weeks of treatment and the Week 28 Follow-Up visit in Study HZNP-ACT-302
             (NCT02593773).

          -  If female, the subject is not pregnant or lactating or intending to become pregnant
             during the study, or within 30 days after the last dose of study drug. Female subjects
             of child-bearing potential must have a negative urine pregnancy test result at Week 26
             of Study HZNP-ACT-302 (NCT02593773) and agree to use a reliable method of
             contraception throughout the study and for 30 days after the last dose of study drug.

        Exclusion Criteria:

          -  If in the opinion of the Investigator, patients have a concomitant disease or
             condition that could interfere with the conduct of the study or potentially put the
             subject at unacceptable risk, the subject will be excluded from the study.
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Capecitabine; Oxaliplatin; Leucovorin (LV); 5-Fluorouracil (5-FU)
Intervention description: 1000 milligrams per square metre of body surface area (mg/m^2) orally twice daily on days 1-15 of each 3-week cycle.; 130 mg/m^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.; Administered by one of two regimens, as specified in the arm description.; Administered by one of two regimens, as specified in the arm description.
Intervention MeSH terms: Leucovorin; Capecitabine; Fluorouracil; Oxaliplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1886.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus
      Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery
      for colon cancer and no previous chemotherapy. Patients will be randomized to receive either
      1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or
      2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment
      is until disease progression and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed colon carcinoma, AJCC/UICC Stage III (Dukes stage C)

          -  Complete tumor resection; Patients operated with curative intent and with no
             macroscopic or microscopic evidence for remaining tumor who can be randomized to
             either treatment arm within 8 weeks after surgery. As this is an adjuvant trial
             patients should never have had any evidence of metastatic disease (including presence
             of tumor cells in the ascites).

          -  Have a life expectancy of at least 5 years

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Sexually active males and females (of childbearing potential) unwilling to practice
             contraception during the study

          -  Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently
             treated colon cancer

          -  Patients who have not completely recovered from surgery
A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)
Condition: Asthma
MeSH terms: Asthma
Intervention: Zero-dose; 90 mcg of PROAIR® HFA; 180 mcg of 90 mcg of PROAIR® HFA; 90 mcg of albuterol sulfate inhalation aerosol
Intervention description: Treatment A; Treatment B; Treatment C; Treatment D
Intervention MeSH terms: Albuterol; Procaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90
      mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate)
      Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild
      Asthma
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or non-pregnant women 18 to 65 years of age.

          2. Signed informed consent form that meets all criteria of current Food and Drug
             Administration (FDA) regulations.

          3. Females of childbearing potential must not be pregnant or lactating (as confirmed by a
             negative urine pregnancy test

          4. Ability to use inhalation aerosol correctly.

        Exclusion Criteria:

          1. Any clinically significant finding on physical exam in the opinion of the
             Investigator, would compromise subject's safety or data integrity.

          2. Employees of the Investigator or research center or their immediate family members.

          3. Previous participation in this study.

          4. Inability to understand the requirements of the study and the relative information and
             are unable or not willing to comply with the study protocol.