bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis
Condition: Primary Disease
MeSH terms: Conjunctivitis
Intervention: 300 IR; Placebo
Intervention description: 300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season; Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 381.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: allergic rhinoconjunctivitis

Summary:

      The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of
      grass pollen allergen extract when initiated 2 months before the grass pollen season compared
      with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.
    

Eligibility criteria:

        Inclusion criteria:

          1. Male or female outpatients aged 12 to 65 years (inclusive).

          2. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last
             two grass pollen seasons.

          3. Positive SPT

          4. RRTSS during the previous pollen season of greater than or equal to 12 out of a
             possible 18.

        Exclusion Criteria:

          1. Positive SPT to any other seasonal allergens present during the grass pollen season

          2. Patients with clinically significant confounding symptoms of allergy to other
             allergens

          3. Significant symptomatic perennial allergy due to an allergen to which the patient is
             regularly exposed.

          4. Patients with moderate or severe persistent asthma (Global Initiative for Asthma
             [GINA] 3 or 4).
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: pantoprazole sodium enteric-coated spheroid
Intervention description: pediatric spheroids taken daily x 8 weeks
Intervention MeSH terms: Pantoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 1 Year
Maximum age: 5 Years
Healthy volunteers: No
Keywords: GERD; Children; Child; Child, Preschool

Summary:

      To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5
      years of age with endoscopically proven symptomatic GERD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to undergo endoscopy with required biopsy

          -  Ages 1 through 5 years

          -  Endoscopically confirmed GERD by positive endoscopic evidence of reflux related
             esophagitis or positive histologic evidence of esophagitis consistent with GERD Other
             inclusions apply.

        Exclusion Criteria:

          -  History or presence of upper gastrointestinal anatomic or motor disorders

          -  Known current or active cow's milk allergy

          -  Malignancy

          -  Other exclusions apply.
Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Intervention: NAFT-600 (naftin 2 % gel); Placebo
Intervention description: Topical; applied once daily for two weeks; Topical; applied once daily for two weeks.
Intervention MeSH terms: Naftifine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 860.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: fungal infection; athlete foot

Summary:

      This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group
      Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the
      treatment of tinea pedis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of
             child-bearing potential must have a negative urine pregnancy test.

          -  For minors (less than 18 years), the parent/legal guardian must complete the informed
             consent process AND the subject must complete the assent process and sign the
             appropriate form (if age appropriate).

          -  Presence of interdigital only or both interdigital and moccasin types of tinea pedis
             on one or both feet characterized by clinical evidence of a tinea infection (at least
             moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in
             the affected area(s).

        Exclusion Criteria:

          -  Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer,
             unstable angina or myocardial infarction) within the last 6 months.

          -  Subjects with abnormal findings - physical or laboratory - that are considered by the
             investigator to be clinically important and indicative of conditions that might
             complicate interpretation of study results.

          -  Subjects with a known hypersensitivity to study drugs or their components.

          -  Subjects who have a recent history or who are currently known to abuse alcohol or
             drugs.

          -  Uncontrolled diabetes mellitus.

          -  Hemodialysis or chronic ambulatory peritoneal dialysis therapy.

          -  Current diagnosis of immunocompromising conditions.

          -  Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact
             dermatitis.

          -  Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous
             candidiasis or bacterial skin infection.

          -  Extremely severe tinea pedis (incapacitating).

          -  Female subject who is pregnant or lactating, who is not using or does not agree to use
             an acceptable form of contraception during the study, or who intends to become
             pregnant during the study.
Prostate Cancer Intervention Versus Observation Trial (PIVOT)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Radical prostatectomy
Intervention description: Surgical removal of the prostate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 731.0
Sex: Male
Maximum age: 75 Years
Healthy volunteers: No
Keywords: cancer of the prostate (CAP); cancer treatment; chronic diseases; expectant management; genitourinary; prostate; prostate specific cancer mortality; radical prostatectomy

Summary:

      Radical prostatectomy provides potentially curative removal of the cancer. However, it
      subjects patients to the morbidity and mortality of the surgery and may be neither necessary
      nor effective. Expectant management does not offer potential cure. However, it provides
      palliative therapy for symptomatic or metastatic disease progression, avoids potentially
      excessive and morbid interventions in asymptomatic patients, and emphasizes management
      approaches for focus on relieving symptoms while minimizing therapeutic complications.

      The primary objective of this study is to determine which of two strategies is superior for
      the management of clinically localized CAP: 1) radical prostatectomy with early aggressive
      intervention for disease persistence or recurrence, 2) expectant management with reservation
      of therapy for palliative treatment of symptomatic or metastatic disease progression.
      Outcomes include total mortality, CAP mortality, disease free and progression free survival,
      morbidity, quality of life, and cost effectiveness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with clinically localized CAP

          -  Diagnosis of Prostate Cancer within previous 6 months

          -  Age 75 years or younger

        Exclusion Criteria:

        PSA > 50 ng/ml Bone scan consistent with metastatic disease Other evidence that cancer of
        the prostate is not clinically localized Diagnosis of prostate cancer greater than 12
        months ago Life expectancy less than 10 years Serum creatinine greater than 3 mg/dl
        Myocardial infarction within last 6 months Unstable angina New York Heart Association Class
        III or IV congestive heart failure Severe pulmonary disease Lifer failure Severe dementia
        Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5
        years
Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images
Condition: Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: [18F]Flutemetamol
Intervention description: No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.
Intervention MeSH terms: Flutemetamol
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alzheimer's Disease; Mild Cognitive Impairment; Positron Emission Tomography (PET); PET Images

Summary:

      To Evaluate the Effectiveness of an Electronic Training Program for Orienting and
      Interpreting [18F]flutemetamol Positron Emission Tomography (PET) Images.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185
             MBq to approximately 370 MBq.

          -  The subject was classified as one of the following:

               1. End-of-life subject who expired and underwent brain autopsy, with histochemical
                  (HC) confirmation of brain amyloid status.

               2. Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent
                  brain biopsy, with HC confirmation of brain amyloid status.

               3. Elderly healthy volunteer (age ≥55).

               4. Young healthy volunteer (age ≤40).

               5. Subject with probable Alzheimer Disease (pAD).

               6. Subject with amnestic Mild Cognitive Impairment (aMCI).

        Exclusion Criteria:

          -  Not Applicable
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
Condition: Otitis Media With Effusion in Children; Otitis Media Recurrent
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Intervention: EXE844 Sterile Otic Suspension, 0.3%; Tympanostomy Tube Insertion
Intervention description: Surgical procedure for treating pediatric cases of recurrent or chronic otitis media
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 404.0
Sex: All
Minimum age: 6 Months
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to
      tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and
             eligible for bilateral myringotomy and tympanostomy tube insertion.

          -  Suspected bacterial infection at time of surgery in at least 1 ear.

          -  Willing to refrain from water immersion of the ears following surgery without the use
             of adequate ear protection during swimming, bathing, showering and other water-related
             activities.

          -  Legally Authorized Representative (LAR) must read and sign the informed consent.

          -  Parent or caregiver must agree to comply with the requirements of the study and
             administer study medication as directed, complete required study visits, and comply
             with the protocol.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Previous otologic or otologic-related surgery within the past 30 days or ongoing
             complications.

          -  Middle ear pathology in either ear other than otitis media.

          -  Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions
             which could interfere with evaluation of the study drug.

          -  Any systemic disease or disorder, complicating factor or structural abnormality that
             would negatively affect the conduct or outcome of the study based upon assessment by
             the Investigator.

          -  Known or suspected allergy or hypersensitivity to quinolones or other active or
             inactive ingredients present in the medications to be used in the study.

          -  Other protocol-specified exclusion criteria may apply.
Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)
Condition: Central Abdominal Bulging
Intervention: LIPO-202; Placebo
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 793.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the
      safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to
      subcutaneous fat in non-obese subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or non-pregnant female subjects

          -  Capable of providing written consent.

          -  BMI < 30 kg/m2

          -  Stable diet and exercise routine

          -  Central abdominal bulging that is evaluated by the clinician at least slight bulge,
             not flat

        Exclusion Criteria:

          -  Have had any treatment of the fat around your abdomen, including surgical procedures
             (tummy tuck, liposuction), injections for fat loss or treatments with devices to
             reduce fat in your abdomen.

          -  Plan on starting a weight loss or exercise program during the study.

          -  Known hypersensitivity to study drugs
A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: PF-06410293; adalimumab
Intervention description: SC injection; SC injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 455.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after
      switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in
      combination with methotrexate in subjects with moderately to severely active rheumatoid
      arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration.

          -  Moderately to severely active RA based on local standard of care.

        Exclusion Criteria:

        -Evidence of untreated or inadequately treated latent or active TB.
Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Pancrelipase Delayed Release; Placebo Comparator
Intervention description: 24000 unit Capsule; Placebo
Intervention MeSH terms: Pancrelipase; Pancreatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Pancreatic exocrine insufficiency; Cystic Fibrosis

Summary:

      This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat
      and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis

          -  Confirmed PEI by historical CFA < 70% without supplementation or current or historical
             fecal elastase < 50µg/g stool (within the last 12 months)

          -  Subjects of 12 years or older

          -  Currently receiving treatment with a commercially available pancreatic enzyme product
             on a stable dose for more than 3 months

          -  Clinically stable condition without evidence of acute respiratory disease or any other
             acute condition

          -  Females of child-bearing potential must agree to continue using a medically acceptable
             method of birth control

        Exclusion Criteria:

          -  Ileus or acute abdomen

          -  History of fibrosing colonopathy

          -  History of distal ileal obstruction syndrome within 6 months of enrollment

          -  Use of an immunosuppressive drug

          -  Any type of malignancy involving the digestive tract in the last 5 years

          -  Known infection with HIV
TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: Combination Product (sumatriptan succinate / naproxen sodium); RELPAX(eletriptan) 40mg Tablet
Intervention description: sumatriptan/naproxen sodium; eletriptan tablets
Intervention MeSH terms: Naproxen; Sumatriptan; Eletriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Combination product, sumatriptan succinate, naproxen sodium, absorption, pharmacokinetics, disintegration, gastric transit, gastric scintigraphy

Summary:

      An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and
      naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consented males and nonpregnant females using adequate contraception, between 18 and
             55 years of age, with at least 1-6 migraines per month for past 6 months. Subjects
             will be excluded for confirmed or suspected ischemic heart disease, uncontrolled
             hypertension at screening; a history of epilepsy or structural brain lesions which
             lowered the convulsive threshold; confirmed or suspected cardiovascular,
             cerebrovascular, peripheral vascular, congenital heart disease, or ischemic bowel
             disease; impaired hepatic or renal function; basilar or hemiplegic migraine. Other
             exclusion criteria included use of a monoamine oxidase inhibitor within 2 weeks before
             screening; ergot prophylactics in past 3 months; anticoagulants; smoking more than 10
             cigarettes/day, evidence of alcohol or substance abuse; GI bleeding disorders,
             inflammatory bowel disease; or any concurrent medical or psychiatric condition that in
             the investigator's opinion could affect interpretation of efficacy or safety
             information or which otherwise contraindicated participation in the study.
A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Amlodipine; Amlodipine
Intervention description: Amlodipine 5mg/ day; Amlodipine 10mg/ day
Intervention MeSH terms: Amlodipine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 305.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The changes in the trough systolic blood pressure from the baseline were assessed after 8
      weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg
    

Eligibility criteria:

        Inclusion Criteria:

          -  Untreated Hypertensive Patients: An systolic blood pressure of >=160 mmHg or diastolic
             blood pressure >=100mmHg.

          -  Treated Hypertensive Patients: An systolic blood pressure of >=140 mmHg or diastolic
             blood pressure of >= 90 mmHg.

          -  Patients with insufficient response to 5 mg of amlodipine in the screening period:Two
             successive systolic blood pressure measurements at Visit 4 (Week -2) and Visit 5 (Week
             0 = baseline) >=140 mmHg

          -  Patients with a screening treatment compliance rate >= 80%

        Exclusion Criteria:

          -  Subjects with secondary hypertension (renal disease, pheochromocytoma, and Cushing's
             syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmHg or higher,
             or diastolic blood pressure of 110 mmHg or higher), and malignant hypertension