bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Recurrence of Diverticulitis
Condition: Diverticulitis
MeSH terms: Diverticulitis; Recurrence
Intervention: SPD476 (1.2g); SPD476 (2.4 g); SPD476 (4.8 g); Placebo
Intervention description: 1.2g SPD476 once daily (QD) orally; 2.4g SPD476 QD orally; 4.8g SPD476 QD orally; QD orally
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 590.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether SPD476 is effective in reducing recurrence
      of diverticulitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females =>18yrs of age.

          2. If female of childbearing potential (FOCP), has demonstrated a negative beta HCG
             (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any
             applicable contraceptive requirements of the protocol.

          3. An episode of acute diverticulitis that resolved without colonic resection.

          4. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at
             least three diverticula noted.

        Exclusion Criteria:

          1. Previous colorectal surgery, including surgical intervention for diverticular disease
             (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)

          2. Active peptic ulcer disease

          3. History of or current presence of inflammatory bowel disease (IBD)

          4. Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication

          5. Allergy or hypersensitivity to aspirin or related compounds

          6. Allergy to radiologic contrast agents

          7. Use of another Investigational product within 30 days of Baseline

          8. Use of antibiotic therapy within 4 weeks of Baseline

          9. Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well
             as drugs active at the 5HT-receptor or anti-spasmodic agents

         10. Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal
             steroids is acceptable

         11. Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except
             for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis

         12. History of alcohol or other substance abuse within the previous year

         13. Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to
             Baseline

         14. Females who are lactating
Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Intervention: Mycophenolate Mofetil (MMF); MMF Placebo; ACEi; FOS
Intervention description: Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID.; Placebo only, oral administration; Administer same as pre-treatment regimen.; Administer same as pre-treatment regimen
Intervention MeSH terms: Mycophenolic Acid; Enzyme Inhibitors; Angiotensin-Converting Enzyme Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 184.0
Sex: All
Minimum age: 7 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Proteinuria; Immunoglobulin A

Summary:

      IgA nephropathy (IgAN) is the most common type of glomerulonephritis worldwide. 15-40% of
      individuals diagnosed with IgAN, including children, will eventually progress to chronic
      renal insufficiency (CRI) and end stage renal disease (ESRD). The study is to evaluate the
      safety and benefits of MMF in patients with IgAN who have been pre-treated (and continue to
      be treated) with angiotensin converting enzyme inhibitors (ACEi) and fish oil supplements
      (FOS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ages 7-70 years old

          -  Renal biopsy, diagnostic for IgA nephropathy

          -  Must be able to take oral medication

        Exclusion Criteria:

          -  Clinical and histologic evidence of systemic lupus erythematosus

          -  Well-documented history of Henoch-Schonlein purpura.

          -  Clinical evidence of cirrhosis or chronic liver disease

          -  Abnormal laboratory values at the time of study entry

          -  Estimated GFR outside of protocol defined limits

          -  History of significant gastrointestinal disorder

          -  Active systemic infection or history of serious infection within one month of entry or
             known infection with HIV, hepatitis B, or hepatitis C.

          -  Other major organ system disease or malignancy

          -  Current or prior treatment with MMF or azathioprine
TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Condition: Skin and Subcutaneous Tissue Bacterial Infections
MeSH terms: Infections; Bacterial Infections
Intervention: TR-701 FA; Linezolid
Intervention description: TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion
TR-701 FA Tablets, 200 mg, orally once daily; Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion
Linezolid Tablets, 600 mg, orally every 12 hours
Intervention MeSH terms: Linezolid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 666.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ABSSSI; Tedizolid Phosphate; TR-701; Acute Bacterial Skin and Skin Structure Infections

Summary:

      This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to
      oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every
      12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start treatment
      with at least 2 IV doses and may receive IV therapy for the entire treatment duration.

      Approximately 100 to 140 sites globally will participate in this study. Patients with an
      ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be
      randomized 1:1 to study treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients requiring IV antibiotic therapy and with systemic signs of infection
             diagnosed with ABSSSI.

          -  Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

        Exclusion Criteria:

          -  Uncomplicated skin infections

          -  Severe sepsis or septic shock

          -  ABSSSI solely due to gram-negative pathogens
Acetaminophen Before Vaccines for Infants Study (AVIS)
Condition: Fever
MeSH terms: Fever
Intervention: Acetaminophen; placebo
Intervention description: Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.; Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
Intervention MeSH terms: Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 374.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 9 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acetaminophen; Vaccination; Immunization

Summary:

      The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol)
      for routine infant vaccinations is helpful in preventing fever or other symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Child is a current Group Health enrollee.

          2. Child will be seen at a Group Health clinic for a Well Child visit that is expected to
             include 2 or more vaccines after 6 wks and before 10 months of age.

        Exclusion Criteria:

          1. If child was born at less than 36 weeks of gestation, the child is not eligible until
             4 months of age or older.

          2. If the child's birth weight was less than 5.5 pounds (2500 grams), the child is not
             eligible until 4 months of age or older.
A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Gantenerumab
Intervention description: Gantenerumab was administered as SC injection Q4W.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Healthy volunteers: No

Summary:

      The main purpose of the study was to evaluate the safety and tolerability of long-term
      administration of gantenerumab in participants with AD. All participants who have completed
      the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of
      this study. Of these, participants who completed Week 104 visit in Part 1. Participants
      received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the
      same dose as administered in the parent studies (part 1)/ Week 104 visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203
             or WN28745 will be eligible to participate in Part 1 of the study

          -  Part 2: All participants who have completed Week 104 visit in Part 1 will be eligible
             for Part 2 of the study

          -  For Part 1 and Part 2:

          -  For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use contraceptive methods that result in a failure rate
             of <1% per year during the treatment period and for at least 16 weeks after the last
             dose of study drug

          -  Agreement to not donate blood or blood products for transfusion for the duration of
             the study and for 1 year after final dose of study drug

          -  Availability of a person ('caregiver') who in the investigator's judgement, has
             frequent and sufficient contact with the participant

        Exclusion Criteria:

          -  Prematurely discontinued from the OLEs of studies WN25203 or WN28745 or from study
             drug for any reason

          -  Any medical condition that may jeopardize the participant's safety if he or she
             continues to receive study treatment

          -  If the participant is unlikely to benefit from gantenerumab therapy, based on disease
             progression or other factors, or if study participation is otherwise not in the
             participant's best interest

          -  Any investigational treatment other than gantenerumab during or since completion of
             the OLEs of studies WN25203 or WN28745

          -  Pregnancy

          -  Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal
             leptomeningeal hemosiderosis)

          -  Evidence of intracerebral macrohemorrhage

          -  Part 2: Participants who have been discontinued from Part 1 of the study
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)
Condition: Aortic Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Intervention: ezetimibe (+) simvastatin; Comparator: Placebo
Intervention description: Duration of Treatment: 4 years; matching Placebo
Intervention MeSH terms: Simvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1873.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate whether treatment with an investigational drug as
      compared to placebo will reduce the risk of major cardiovascular events in patients with
      aortic stenosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 45 to 85 with mild abnormalities of the aortic valve as confirmed by an
             echocardiogram.

        Exclusion Criteria:

          -  Patients previously in a trial using the study drug, or currently taking any
             medications that are not allowed in this study.
Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).
Condition: Smoking Cessation
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: placebo; Varenicline Tartarate
Intervention description: 1mg (placebo) by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days); 1 mg by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 504.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: smoking cessation; smoking cessation in COPD

Summary:

      This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette
      smokers with the intent of demonstrating differences in smoking cessation between varenicline
      and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be current cigarette smokers who have smoked an average of at least 10
             cigarettes per day during the past year and during the month prior to the screening
             visit.

          -  mild to moderate COPD confirmed by spirometry

          -  Subjects must have a clinical diagnosis of COPD.

        Exclusion Criteria:

          -  Subjects who have made a serious attempt to quit smoking in the past 3 months.

          -  Subjects who have been previously randomized in a study that has included varenicline.
A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.
Condition: Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Methoxy Polyethylene Glycol-epoetin Beta
Intervention description: Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of subcutaneous Mircera for
      correction of anemia in participants with chronic kidney disease who are not on dialysis and
      are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will
      receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting
      dose of 1.2 micrograms/kilogram [mcg/kg]). The anticipated time on study treatment is 3-12
      months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  chronic kidney disease, stage 3 or 4;

          -  anemia (baseline hemoglobin between 9 and 11 grams per deciliter [g/dL]).

        Exclusion Criteria:

          -  previous therapy with ESA within 12 weeks prior to screening;

          -  significant acute or chronic bleeding such as overt gastrointestinal bleeding;

          -  red blood cell transfusions within 8 weeks before screening;

          -  active malignant disease (except non-melanoma skin cancer).
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe
Condition: Neovascular Age-related Macular Degeneration (nAMD)
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: SOK583A1 (40 mg/mL); Prefilled Syringe (PFS)
Intervention description: SOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration; Prefilled Syringe (PFS)
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Open label study,; intravitreal injection,; biosimilar,; aflibercept,; PFS

Summary:

      This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet)
      nAMD, eligible for IVT aflibercept treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥ 50 years of age at baseline

          -  Subjects diagnosed with nAMD (uni- or bilateral)

          -  Subjects already under IVT Eylea treatment (last injection of the induction period or
             maintenance phase)

        Exclusion Criteria:

          -  Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in
             the study eye at baseline, which is of clinical significance according to the
             investigator's judgment, such as active infections of the anterior segment; this
             includes conjunctivitis (except mild blepharitis), keratitis, scleritis, idiopathic or
             autoimmune associated uveitis or endophthalmitis

          -  Any uncontrolled ocular hypertension or glaucoma in the study eye (defined as
             intraocular pressure (IOP) ≥ 26 mmHg, despite treatment with anti-glaucomatous
             medication)

          -  History of a medical, ocular or non-ocular condition, that in the judgment of the
             investigator, would preclude a safe administration of investigational product

          -  Visual Acuity Score (VAS) worse than 20/200 on a Snellen chart, the generally accepted
             level of legal blindness

          -  Receipt of any systemic anti-VEGF within the last 6 months prior to enrollment

          -  Uncontrolled hypertension (defined as a systolic value ≥ 160 mmHg or diastolic value ≥
             100 mmHg at Screening)

          -  Subjects who do not comply with the local COVID-19 regulations of the study site
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: vedolizumab; Placebo
Intervention description: Vedolizumab for intravenous infusion; Placebo intravenous infusion
Intervention MeSH terms: Vedolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 895.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study was to determine the effect of vedolizumab induction
      treatment on clinical response at 6 weeks and to determine the effect of vedolizumab
      maintenance treatment on clinical remission at 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient must meet all of the following inclusion criteria to be enrolled in the study:

          1. Diagnosis of moderately to severely active ulcerative colitis

          2. Demonstrated, over the previous 5 year period, an inadequate response to, loss of
             response to, or intolerance at least 1 of the following agents:

               1. Immunomodulators

               2. Tumor necrosis factor-alpha (TNFα) antagonists

               3. Corticosteroids

          3. May be receiving a therapeutic dose of conventional therapies for inflammatory bowel
             disease (IBD) as defined by the protocol

        Exclusion Criteria:

          1. Evidence of abdominal abscess at the initial screening visit

          2. Extensive colonic resection, subtotal or total colectomy

          3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine

          4. Have received non permitted IBD therapies within either 30 or 60 days, depending on
             the medication, as stated in the protocol

          5. Chronic hepatitis B or C infection

          6. Active or latent tuberculosis
Actual Use Trial of Naproxen Sodium
Condition: Pain
Intervention: Naproxen Sodium ER (BAYH6689)
Intervention description: BAYH6689; oral tablet used as needed upon incidence of pain
Intervention MeSH terms: Naproxen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 778.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Actual Use Trial

Summary:

      An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of
      Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the
      frequency at which consumers exceed the label-defined daily dose, thus putting themselves at
      clinical risk, and 2) the reasons for exceeding the labeled daily dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 12 years of age

          -  Report taking OTC analgesics for pain on at least 5 days in the last month

          -  Report having had pain at least once in the last 3 months lasting longer than 12 hours
             or that they believe would have lasted longer than 12 hours if they had not treated it

          -  Able to read and understand English

          -  Provide written informed consent (subjects 12-17 years of age provide written assent
             and/or parent or legal guardian provide written consent)

          -  Provide contact information

          -  Purchase the investigational product

        Exclusion Criteria:

          -  Have participated in a trial involving OTC analgesics in the last 6 months

          -  They or someone else in the household work for a market research company, an
             advertising agency, a public relations firm, a pharmaceutical company, as a healthcare
             professional, or as part of a health care practice (eliminated for reasons of
             confidentiality or increased awareness of drugs and their labels)

          -  Have a history of known allergies to NSAIDs (i.e., naproxen, ibuprofen, aspirin, etc.)

          -  Have a history of heart surgery in the last 60 days or plans for heart surgery in the
             next 60 days

          -  (Female subjects) are pregnant or breastfeeding