bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
Condition: Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferric Carboxymaltose; Standard Medical Care (SMC)
Intervention description: 15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.; Per product label
Intervention MeSH terms: Ferric gluconate; Iron-Dextran Complex
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 735.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety of FCM in patients with anemia who are
      not dialysis dependent
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥18 years of age and able to give informed consent

          -  Iron deficiency is the primary etiology of anemia

          -  Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL

          -  Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when
             TSAT was ≤30%

        Exclusion Criteria:

          -  Previous participation in a FCM trial

          -  Known hypersensitivity reaction to FCM

          -  Requires dialysis for treatment of chronic kidney disease

          -  Current anemia not attributed to iron deficiency

          -  Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the
             screening phase

          -  Anticipated need for surgery requiring general anesthesia 30 days prior to screening
             or during the study period

          -  AST of ALT greater than 1.5 times the upper limit of normal

          -  Received an investigational drug within 30 days of screening

          -  Pregnant or sexually-active females who are not able to use an effective form of birth
             control
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer
Condition: Bone Metastases
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
Intervention: zoledronic acid; denosumab
Intervention description: Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC; Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes
Intervention MeSH terms: Zoledronic Acid; Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1904.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bone metastases; Hormone-refractory prostate cancer; Skeletal; Fractures; Compressions; Bisphosphonates

Summary:

      The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid
      (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men >/= 18 years of age with histologically confirmed prostate cancer

          -  Radiographic evidence of at least one bone metastasis

          -  Failure of at least one hormonal therapy as evidenced by a rising PSA

          -  Serum testosterone level of <50 ng/dL

          -  ECOG PS 0, 1, or 2

          -  Adequate organ function

        Exclusion Criteria:

          -  Current or prior IV bisphosphonate administration

          -  Current or prior oral bisphosphonates for bone mets

          -  Life expectancy of less than 6 months
An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Intervention: Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®); Comparator: Placebo
Intervention description: Human Papillomavirus (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6; aluminum-contained, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 600.0
Sex: All
Minimum age: 9 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV infections

Summary:

      This is a China registration study. A randomized, double-blind, placebo-controlled
      immunogenicity and safety study in Chinese female participants aged 9 to 45 years and male
      participants aged 9 to 15 years. Approximately 600 participants will be randomized in a 1:1
      ratio to receive either vaccine or aluminum-containing placebo. Each participant received one
      injection at each visit at Day 1, Month 2, and Month 6. Vaccine or placebo was given as a
      0.5-mL intramuscular injection. Serum will be collected from all participants to evaluate
      immune response against anti-Human Papillomavirus (HPV) 6/11/16/18 with Luminex Assay. At
      Month 2, Month 6, Month 7, subjects will be evaluated for any new medical condition or health
      concerns and Serious Adverse Experiences throughout the study. The primary objective is to
      evaluate the vaccine-induced serum anti-HPV 6, 11, 16 and 18 antibody titers following 3-dose
      regimen of Gardasil® compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female participants aged 9-45 years old and male participants aged 9-15 years
             old

          -  Participants agrees to provide study personnel with a primary telephone number as well
             as an alternate telephone number for follow-up purposes

          -  Not pregnant now (as demonstrated by a negative urine beta-Human Chorionic
             Gonadotropin (beta-HCG) test) for post-pubertal female participants
Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Vdrive Lasso navigation; Manual Lasso navigation
Intervention description: Remote robotic Lasso navigation; Manually maneuver a Lasso catheter
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: magnetic navigation; robotic control; RMT ThermoCool catheter

Summary:

      This study will evaluate the use of a robotic device that is remotely controlled to maneuver
      a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation
      procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Left atrial AF ablation procedure requiring the use of a Lasso mapping catheter

          -  Subject must be at least 18 years of age

          -  Subject must be male, female of no childbearing potential, or a female that has a
             negative pregnancy test prior to randomization

        Exclusion Criteria:

          -  Unable to safely expose subject to a magnetic field

          -  Prior AF ablation procedure

          -  Patients with fewer than 4 PVs are excluded

          -  Patients with persistent AF in whom early recurrence of AF following cardioversion
             would preclude completion of the pacing maneuvers described in the protocol or
             patients with other conditions that would similarly preclude completion of the pacing
             maneuvers

          -  Contraindication to procedure or unable to return for follow-up

          -  History of clotting disorder, bleeding abnormalities or contraindication to
             anticoagulation

          -  Actively participating in other cardiac device trial(s)

          -  Currently pregnant

          -  Under 18 years of age

          -  Prosthetic valves

          -  Atrial abnormalities (thrombus, myxoma or baffle)

          -  Other exclusions per the investigator
A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Intervention: Sci-B-Vac-Lot B; Sci-B-Vac-Lot A; Engerix-B
Intervention description: Sci-B-Vac Lot B -10 μg of HBsAg, intramuscular injection of 10 μg/ml; Sci-B-Vac Lot A - 10 μg of HBsAg, intramuscular injection of 10 μg/ml; Engerix-B (hepatitis B vaccine (recombinant)) is indicated for active immunization against hepatitis B virus infection
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind, three-arm, two-stage, randomized study
Masking: Single (Participant)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sci-B-Vac; Prophylactic vaccine; Hepatitis B vaccines; Phase 3; pre-S1; pre-S2; Surface antigen; 3-antigen

Summary:

      This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one
      site in Vietnam whose primary objective was to demonstrate clinical equivalence of the two
      production lots of Sci-B-Vac vaccine produced at two different facilities (OLD facility (Lot
      A) and NEW facility (Lot B) with respect to anti-hepatitis B-Surface (HBs) response.
      Secondary efficacy analysis was performed to demonstrate non-inferiority of seroprotection of
      each lot of Sci-B-Vac vaccine when compared to Engerix-B vaccine
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy adults 18 to 45 years of age who were seronegative for HBsAg, anti-HBs,
        anti-Hepatitis B core antigen, HIV, and Hepatitis C Virus (HCV)

        Exclusion Criteria:

          -  Evidence of alcoholism or drug abuse, history of HIV, or HCV

          -  Blood transfusions within the three months prior to inclusion in the study

          -  Uncontrolled hypertension and other cardiovascular diseases

          -  Chronic/concurrent administration (>14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose. Inhaled and
             topical steroids were permitted

          -  History of anaphylaxis (including shock) or any significant allergy or atopy
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Condition: Uncontrolled Asthma
MeSH terms: Asthma
Intervention: Experimental: Tralokinumab; Placebo
Intervention description: Tralokinumab subcutaneous injection; Placebo subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 856.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3
      Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with
      Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 12 -75

          2. Documented physician-diagnosed asthma.

          3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg
             fluticasone propionate dry powder formulation equivalents) and a LABA

          4. Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of
             age) of their PNV.

          5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1

          6. ACQ-6 score ≥1.5

        Exclusion Criteria:

          1. Pulmonary disease other than asthma

          2. History of anaphylaxis following any biologic therapy

          3. Hepatitis B, C or HIV

          4. Pregnant or breastfeeding

          5. History of cancer

          6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years

          7. Previous receipt of tralokinumab
Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autism Spectrum Disorder; Developmental Disabilities; Child Development Disorders, Pervasive
Intervention: Placebo; Mirtazapine
Intervention description: Subjects randomized to placebo will receive placebo for duration of the study; Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg per week for subjects weighing less than 50 kg and up to 15 mg per week for subjects weighing more than 50 kg depending on efficacy and tolerability.
Intervention MeSH terms: Mirtazapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Autistic Disorder; Asperger's Disorder; Pervasive Developmental Disorder

Summary:

      This study will determine the effectiveness of mirtazapine in reducing anxiety in children
      with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 5-17 years

          -  Diagnosis of autistic disorder, Asperger's disorder or Pervasive Developmental
             Disorder Not Otherwise Specified (PDD NOS)

          -  Clinically significant anxiety as evidenced by a Pediatric Anxiety Rating Scale (PARS)
             score of 10 or greater

          -  Abbreviated intelligence quotient (IQ) greater than 50 on the Stanford Binet 5th Ed.

        Exclusion Criteria:

          -  Diagnosis of Rett's disorder or childhood integrative disorder

          -  Diagnosis of obsessive-compulsive disorder (OCD), post-traumatic stress disorder,
             major mood disorder, psychotic disorder, or substance use disorder

          -  Presence of any past or present medical conditions that would make treatment with
             mirtazapine unsafe

          -  Use of other antidepressants or benzodiazepines

          -  Use of other psychotropic medications which are ineffective, poorly tolerated, or
             sub-optimal in terms of dose

          -  Previous adequate trial of mirtazapine
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: IDP-122 Lotion; IDP-122 Vehicle Lotion
Intervention description: Topical lotion; Topical lotion. No active ingredient.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the safety and efficacy of a topical lotion when applied once daily
      to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's
      Global Assessment [IGA] score of 3 or 4).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female, of any race, at least 18 years of age (inclusive).

          -  Freely provides both verbal and written informed consent.

          -  Has an area of plaque psoriasis appropriate for topical treatment that covers a body
             surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms,
             soles, axillae, and intertriginous areas are to be excluded in this calculation.

          -  Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
             radiation (natural and artificial) for the duration of the study.

          -  Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or
             4 (the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded
             from this calculation, if psoriasis is present).

        Key Exclusion Criteria:

          -  Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
             psoriasis, as determined by the Investigator.

          -  Presents with psoriasis that was treated with prescription medication and failed to
             respond to treatment, even partially or temporarily, as determined by the
             Investigator.

          -  Presents with any concurrent skin condition that could interfere with the evaluation
             of the treatment areas, as determined by the Investigator.

          -  Is pregnant, nursing an infant, or planning a pregnancy during the study period.

          -  Has received treatment with any investigational drug or device within 60 days or 5
             drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently
             participating in another clinical study with an investigational drug or device.
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Rabeprazole sodium; Esomeprazole
Intervention description: Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks.; Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.
Intervention MeSH terms: Esomeprazole; Rabeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1061.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: GERD; erosive GERD; erosive esophagitis

Summary:

      The purpose of this study is to determine the safety and efficacy of Rabeprazole extended
      release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among
      subjects with erosive gastroesophageal reflux disease (GERD).
    

Eligibility criteria:

        KEY INCLUSION CRITERIA:

          1. Male or female, ages 18 to 75 years.

          2. History of GERD symptoms for at least 3 months immediately before screening.

          3. Heartburn for at least 2 days a week for at least 1 month before screening.

          4. Esophageal erosions of Los Angeles (LA) grades C or D based on EGD taken within 14
             days prior to enrollment.

          5. Subjects who are H. pylori negative based on a screening test.

          6. Females should be either of non-childbearing potential or of childbearing potential.
             Females of childbearing potential must have negative pregnancy tests prior to
             randomization. Female subjects of childbearing potential must agree to use medically
             acceptable methods of contraception.

          7. Subjects must be able to read, write, and understand the language of the symptom
             diary.

        KEY EXCLUSION CRITERIA:

          1. Current or a history of esophageal motility disorders.

          2. Current or a history of Barrett's esophagus. Current esophageal strictures or
             esophagitis (known or suspected to be due to etiology other than GERD such as
             infection or medications).

          3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory
             conditions, or current gastric or duodenal ulcer.

          4. Current or a history of cancer, with the exception of fully excised skin basal cell
             carcinoma.

          5. Inflammatory bowel disease.

          6. Unstable diabetes mellitus.

          7. History of esophageal, gastric and duodenal surgery except simple suturing of an
             ulcer.

          8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral
             steroids (->;= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day).
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent; Coronary Artery Bypass Surgery
Intervention description: Drug Eluting Stent; Coronary Artery Bypass Surgery
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1800.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Three-vessel coronary artery disease; Left main coronary artery disease

Summary:

      The SYNTAX trial is designed to determine the best treatment for patients with complex
      coronary disease (blocked or narrowed arteries in both the right and left sides of the heart)
      by randomizing patients to receive either percutaneous coronary intervention (PCI) with
      polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Three-vessel disease, left main disease or LM equivalent with or without 1, 2 or 3VD
             (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA]
             territory)

          -  De novo lesions with at least 50% stenosis

          -  Myocardial ischemia (stable, unstable, silent)

        Exclusion Criteria:

          -  Prior PCI or CABG

          -  Acute myocardial infarction (with creatinine kinase >2x upper limit of normal)

          -  Concomitant cardiac valve disease requiring surgical therapy (reconstruction or
             replacement)

          -  Participation or planned participation in another cardiovascular clinical study before
             1 year follow-up is completed

          -  Inability to give informed consent due to mental condition, mental retardation, or
             language barrier