bioihbjkbjnl/mcl2 huggingface dataset:
Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Rabeprazole ER; Ranitidine
Intervention description: 50 mg capsule, taken orally, once daily for 26 weeks.; 150 mg capsule, taken orally, twice daily for 26 weeks.
Intervention MeSH terms: Rabeprazole; Ranitidine; Ranitidine bismuth citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Gastroesophageal; Reflux; Disease; GERD

Summary:

      The purpose of this study is to compare the efficacy of rabeprazole extended release 50 mg
      (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in
      subjects with healed erosive gastroesophageal reflux disease (eGERD).
    

Eligibility criteria:

        KEY INCLUSION CRITERIA:

        1. Prior completion of Study E3810-G000-302 or -303. Subjects will need to have healed
        erosive esophagitis (absence of esophageal mucosal breaks or erosions) confirmed by EGD and
        sustained resolution of heartburn at Visit 4 or 5 of Study E3810-G000-302 or -303.

        KEY EXCLUSION CRITERIA:

          1. Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm).

          2. Barrett's esophagus or esophageal stricture.

          3. Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine
             receptor antagonists (H2RA), antacids, sucralfate, misoprostol, prokinetics or drugs
             with significant anticholinergic effects throughout the study.

          4. Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs),
             oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day).

          5. Significant hepatic, renal, respiratory, endocrine, hematologic, neurologic,
             psychiatric, or cardiovascular system abnormalities that would be likely to interfere
             with the conduct of the study, the interpretation of study results, or the health of
             the subject during the study.

          6. Any condition that would make the subject, in the opinion of the Investigator or
             Sponsor, unsuitable for the study.
Study of Lupron Depot In The Treatment of Central Precocious Puberty
Condition: Puberty, Precocious
MeSH terms: Puberty, Precocious
Intervention: Lupron (leuprolide acetate)
Intervention description: Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Maximum age: 10 Years
Healthy volunteers: No
Keywords: CPP; central precocious puberty; pediatrics; suppression of LH; Lupron; leuprolide acetate; depot formulation; GnRHa; GnRH agonist; GNRH analog; LH; Tanner staging

Summary:

      The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and
      effective in treating children with Central Precocious Puberty (CPP), and to assess long term
      effects of leuprolide acetate treatment after therapy is discontinued.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of isosexual central precocious puberty with onset of Tanner scores
             of Stage II for breast or pubic hair earlier than age 8.0 years in girls or Stage II
             for pubic hair or genitalia earlier than 9.0 years in boys.

          -  Confirmation of diagnosis by a pubertal response to a gonadotropin-releasing hormone
             (GnRH) stimulation test (LH > 10 U/L at baseline).

          -  Chronological age less than 9.0 years in girls or less than 10.0 years in boys at time
             of first dosing.

          -  Bone age advanced at least 1 year beyond the chronological age at entry into the
             study.

          -  The condition may be idiopathic or secondary to another lesion. If secondary, therapy
             of the primary condition will have been undertaken and stabilized.

          -  No evidence of abnormal pituitary, adrenal, thyroid and gonadal function except for
             premature secretion of gonadotropins.

        Exclusion Criteria:

          -  Irradiation to the central nervous system.

          -  Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including
             prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).
Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
Condition: Ventilator-Associated Pneumonia (VAP)
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated
Intervention: Ceftolozane/Tazobactam; Piperacillin/Tazobactam
Intervention MeSH terms: Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination; Ceftolozane; Ceftolozane, tazobactam drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the
      safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV
      piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult
      participants .
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant has received mechanical ventilation for > 48 hours

          -  Acute Physiology and Chronic Health Evaluation (APACHE) II score of 11-35

          -  Presence of a new or progressive infiltrate on chest x-ray

          -  Presence of clinical criteria consistent with VAP

        Key Exclusion Criteria:

          -  History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics

          -  Known end stage renal disease or requirement for dialysis
Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
Condition: Nonproliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: Intravitreal aflibercept injection [IAI]; Sham
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to assess the efficacy of intravitreal (IVT)
      aflibercept compared to sham treatment in the improvement of moderately severe to severe
      nonproliferative diabetic retinopathy (NPDR).

      The secondary objectives of the study are:

        -  To characterize the safety of IVT aflibercept in patients with moderately severe to
           severe NPDR

        -  To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and
           reduce the incidence of DME

        -  To determine the anatomic effects of IVT aflibercept in patients with moderately severe
           to severe NPDR
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Men or women ≥18 years of age with type 1 or 2 diabetes mellitus who have moderately
             severe to severe nonproliferative diabetic retinopathy (NPDR) [(diabetic retinopathy
             severity scale (DRSS) levels 47 or 53)], confirmed by the central reading center, in
             whom panretinal photocoagulation (PRP) can be safely deferred for at least 6 months
             per the investigator

          2. Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS)
             letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40
             or better)

        Key Exclusion Criteria:

          1. Presence of diabetic macular edema (DME) threatening the center of the macula in the
             study eye

          2. Evidence of retinal neovascularization on clinical examination or Fluorescein
             Angiography (FA)

          3. Any prior focal or grid laser photocoagulation or any prior PRP in the study eye

          4. Any prior systemic anti-vascular endothelial growth factor (VEGF) treatment or
             intravitreal (IVT) anti-VEGF treatment in the study eye

          5. Any prior intraocular steroid injection in the study eye

          6. Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional
             retinal detachment visible at the screening assessments in the study eye

        Note: Other inclusion/ exclusion criteria apply
A Study of Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (FRDA) Patients
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: idebenone; Placebo
Intervention description: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.; 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
Intervention MeSH terms: Idebenone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 232.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No
Keywords: FRDA; idebenone; FRDA disease

Summary:

      The purpose of this trial is to study the efficacy, safety and tolerability of idebenone in
      12 months of treatment in children and adults with Friedreich's Ataxia. This is a randomised
      placebo-controlled double-blind trial conducted in Europe. Efficacy outcomes include measures
      of neurological impairment and function, and measures of the heart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of FRDA with confirmed FRDA mutations

          -  Patients 8 years of age or older at baseline

          -  Patients with body weight ≥ 25kg

          -  Patients who in the opinion of the investigator are able to comply with the
             requirements of the study, including swallowing the medication

          -  Negative urine pregnancy test at screening and at baseline (women of childbearing
             potential)

        Exclusion Criteria:

          -  Treatment with idebenone or Coenzyme Q10 within the past 1 month

          -  Pregnancy and/or breast-feeding

          -  Clinically significant abnormalities of clinical haematology or biochemistry
             including, but not limited to, elevations greater than 1.5 times the upper limit of
             normal of SGOT, SGPT, or creatinine

          -  Past or present history of abuse of drugs or alcohol
A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Palbociclib; Letrozole; Placebo; Letrozole
Intervention description: Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment; Letrozole, 2.5mg, orally once daily (continuously); Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment; Letrozole, 2.5mg, orally once daily (continuously)
Intervention MeSH terms: Letrozole; Palbociclib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 340.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: breast cancer; postmenopausal women; estrogen-receptor positive; HER2 negative; locoregionally recurrent; metastatic

Summary:

      The study is designed to compare the clinical benefit following treatment with letrozole in
      combination with Palbociclib versus letrozole in combination with placebo in Asian
      postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior
      systemic anti cancer therapies for their advanced/metastatic disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult Asian women with locoregionally recurrent or metastatic disease not amenable to
             curative therapy

          -  Confirmed diagnosis of ER positive breast cancer

          -  No prior systemic anti-cancer therapy for advanced ER+ disease

          -  Postmenopausal women

          -  Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or
             bone-only disease

          -  Eastern Cooperative Oncology Group [ECOG] 0-1

          -  Adequate organ and marrow function

          -  Patient must agree to provide tumor tissue

        Exclusion Criteria:

          -  Confirmed diagnosis of HER2 positive disease

          -  Patients with advanced, symptomatic, visceral spread that are at risk of life
             threatening complication in the short term

          -  Known uncontrolled or symptomatic CNS metastases

          -  Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie,
             anastrozole or letrozole) with disease recurrence while on or within 12 months of
             completing treatment

          -  Prior treatment with any CDK 4/6 inhibitor
Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
Condition: Acute Migraine
MeSH terms: Migraine Disorders
Intervention: Acetaminophen 250 mg and Aspirin 250 mg; Placebo
Intervention description: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg; 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Intervention MeSH terms: Aspirin; Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 900.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Migraine; acetaminophen; aspirin

Summary:

      The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin
      versus placebo in the acute treatment of migraine
    

Eligibility criteria:

        Inclusion criteria:

          1. Male or female aged 18 years and over.

          2. International Headache Society (IHS) diagnosis of migraine without aura or typical
             aura with migraine headache.

          3. History of experiencing at least 1, but not more than 8, acute migraine attacks
             monthly during the previous year.

          4. History of at least moderate migraine pain intensity, if left untreated.

          5. History of frequently or always experiencing nausea with the migraine attack.

        Exclusion criteria:

        Subjects eligible for inclusion in this study must not fulfill any of the following
        criteria:

          1. Headache symptoms which may be due to or aggravated by:

               -  Recent (within 6 months) head or neck trauma (e.g., whiplash)

               -  Head or neck pain secondary to an orthopedic abnormality

               -  Cluster headache

               -  Specific migraine variants (e.g., basilar-type artery migraine, opthalmoplegic
                  migraine, hemiplegic migraine, migraine aura without headache)

               -  Other serious, non-migraine causes of headache (e.g., increased intracranial
                  pressure, intracranial bleeding, meningitis, malignancy)

               -  Non-serious, non-migraine causes of headache (e.g., cold, flu, hangover)

          2. History of vomiting during more than 20% of migraine attacks.

        Other protocol-defined inclusion/exclusion criteria may apply
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Condition: Rosacea
MeSH terms: Rosacea
Intervention: CLS001 (Omiganan); Vehicle
Intervention description: Topical gel; Vehicle gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel
      compared to vehicle gel in subjects with severe papulopustular rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy, male and non-pregnant female subjects, 18 years of age or older.

          2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at
             Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.

          3. Subjects with the presence of telangiectasia at Baseline.

          4. Subjects with an erythema score of at least 2 on the Investigator Assessment of
             Erythema scale at Baseline.

          5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.

        Exclusion Criteria:

          1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).

          2. Subjects with nodular rosacea.

          3. Standard exclusion criteria.
Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Radiation therapy; Observation
Intervention description: PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 356.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet
      known if giving radiation therapy to the head is effective in preventing CNS metastases in
      patients who have stage III non-small cell lung cancer.

      PURPOSE: This randomized phase III trial is studying how well radiation therapy to the head
      works in preventing CNS metastases in patients who have been previously treated for stage III
      non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of stage IIIA or IIIB non-small cell lung cancer

               -  Complete response, partial response, or stable disease after definitive
                  locoregional therapy (with surgery and/or radiation therapy, with or without
                  chemotherapy (chemotherapy alone does not constitute definitive therapy))

                    -  No more than 16 weeks since prior therapy

          -  No progressive disease

          -  No extracranial distant metastatic disease

          -  No suspicion of CNS metastases by MRI or CT scan

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Not specified

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Other

          -  No other malignancy within the past 3 years except nonmelanoma skin cancer

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent anticancer biologic therapy

        Chemotherapy

          -  See Disease Characteristics

          -  No concurrent anticancer cytotoxic chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  No prior cranial irradiation

        Surgery

          -  See Disease Characteristics

        Other

          -  Recovered from all prior therapies

          -  No concurrent enrollment on any other phase III study that has progression-free,
             disease-free, or overall survival as an endpoint
Liposomal Bupivacaine With Bupivacaine in Ankle Fracture Open Reduction Internal Fixation (ORIF)
Condition: Ankle Fracture
MeSH terms: Ankle Fractures
Intervention: Liposomal Bupivacaine with Bupivacaine
Intervention description: Pain medications injected locally during surgery around affected ankle.
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a randomized controlled trial assessing pain control in ankle fractures
      repaired with open reduction and internal fixation. Patients are consented and enrolled
      pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine
      administered intra-operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients at least 18 years old.

          2. Male or Female

          3. All racial and ethnic groups

          4. Fractures and fracture/dislocations of the ankle

          5. Patients who opt for surgical treatment of their fractures.

          6. Patients who consent to be randomized.

          7. Patients who are willing to follow-up for a minimum of 52 weeks.

        Exclusion Criteria:

          1. Patients younger than 18 years old

          2. Patients who are on chronic opioids

          3. Patients who abuse opioids

          4. Patients who are unwilling to follow-up for a minimum of 52 weeks

          5. Neurologic condition that could interfere with pain sensation