bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Methotrexate; ocrelizumab; Placebo
Intervention description: Methotrexate tablet was administered orally at a dose 7.5-25 mg; Ocrelizumab was administered via IV infusion at a dose specified in arm description; Matching placebo to ocrelizumab was administered via IV infusion
Intervention MeSH terms: Methotrexate; Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1015.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anti-CD20; stage; CD20; RA

Summary:

      This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in
      combination with methotrexate in patients with active rheumatoid arthritis who have had an
      inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of
      intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of
      i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg -
      25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment
      is 1-2 years. Target sample size is 1000.
    

Eligibility criteria:

        Inclusion criteria:

          -  Adult patients, ≥18 years of age

          -  Rheumatoid arthritis for ≥ 3 months

          -  Inadequate clinical response to methotrexate at a dose of 7.5-25mg/week for ≥ 12 weeks

        Exclusion criteria:

          -  Rheumatic autoimmune disease or inflammatory joint disease, other than RA

          -  Prior receipt of any biologic therapy for RA

          -  Concurrent treatment with any DMARD (other than methotrexate)
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BGF MDI 320/14.4/9.6 μg; GFF MDI 14.4/9.6 μg; BFF MDI 320/9.6 μg
Intervention description: Budesonide, Glycopyrronium, and Formoterol Fumarate; Glycopyrronium and Formoterol Fumarate; Budesonide and Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-Blind
Enrollment: 627.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with
      Moderate to Very Severe Chronic Obstructive Pulmonary Disease
    

Eligibility criteria:

        Inclusion Criteria:

        Given their signed written informed consent to participate. Must have agreed to participate
        in and complete the lead-in Study PT010006.(NCT02497001)

        Exclusion Criteria:

        Severe osteoporosis Unable to achieve an acceptable DEXA scan Inability to achieve pupil
        dilation to at least 6 mm Subjects with an implanted artificial intraocular lens or are
        scheduled to undergo cataract surgery
40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: asenapine; Olanzapine
Intervention description: Asenapine, 40 weeks; Olanzapine, 40 weeks
Intervention MeSH terms: Olanzapine; Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Bipolar disorder is characterized by mood swings that range from from high (manic) to low
      (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed
      episodes). Asenapine is an investigational medication for the treatment of manic or mixed
      episodes of bipolar disorder. Patients who completed study A7501006 (a 9 week extension
      study) could continue with the same treatment that they had been receiving: asenapine or
      olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40
      -week continuation study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed asenapine 3-week and 9 -week studies for the treatment of an acute
             manic or mixed episode and not had any major protocol violations..

        Exclusion Criteria:

          -  Patients with unstable medical conditions or clinically significant laboratory

        abnormalities.
A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo MDPI; Albuterol MDPI
Intervention description: Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.; Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; dry powder inhaler; short-acting beta2-agonist; SABA; bronchoconstriction; bronchodilation; bronchodilator; metered dose inhaler

Summary:

      The study will measure the change in lung function in subjects with asthma after inhaling
      from either of two inhalers: Albuterol Spiromax® or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent/assent

          -  General good health

          -  Persistent asthma, with an FEV1 50-80% predicted.

          -  Ability to perform spirometry in an acceptable manner as per protocol guidelines.

          -  Ability to perform PEFR with a handheld peak flow meter.

          -  Demonstration of reversible bronchoconstriction as verified by a 15% or greater
             increase from baseline FEV1.

          -  Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the
             Screening Visit.

          -  Non-smokers.

          -  Capable of understanding the requirements, risks, and benefits of study participation.

          -  Other inclusion criteria apply.

        Exclusion Criteria:

          -  Participation in any investigational drug trial within the 30 days preceding the
             Screening Visit (SV).

          -  A known hypersensitivity to albuterol or any of the excipients in the formulations.

          -  History of severe milk protein allergy.

          -  History of a respiratory infection or disorder that has not resolved within the 2
             weeks preceding the Screening Visit (SV).

          -  Currently requires treatment with β2-adrenergic receptor antagonists or non-selective
             β-receptor blocking agents.

          -  History of life-threatening asthma that is defined for this protocol as an asthma
             episode that required intubation.

          -  Any asthma exacerbation requiring oral corticosteroids within 3 months of the
             Screening Visit (SV). A subject must not have had any hospitalization for asthma
             within 6 months prior to the Screening Visit (SV).

          -  Historical or current evidence of any clinically significant non-asthmatic acute or
             chronic condition including.

          -  Other exclusion criteria apply.
Improving Pregnancy Outcomes With Progesterone
Condition: Pre-term Birth; HIV-1-infection
MeSH terms: Premature Birth
Intervention: 17P; Placebo
Intervention description: Synthetic progestin; Non-active placebo comparator
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase III, double-masked, placebo-controlled, randomized controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 800.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PreTerm Birth; HIV-1-infection; Antiretroviral Treatment

Summary:

      This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking
      place in Zambia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  less than 24 0/7 weeks of gestation

          -  viable intrauterine singleton pregnancy confirmed by ultrasound

          -  antibody-confirmed HIV-1 infection

          -  currently receiving antiretroviral l therapy (ART) or intending to commence ART in
             pregnancy

          -  ability and willingness to provide written informed consent

          -  intent to remain in current geographical area of residence for the duration of study

          -  willing to adhere to weekly study visit schedule

        Exclusion Criteria:

          -  confirmed prior spontaneous preterm birth

          -  multiple gestation

          -  known uterine anomaly

          -  planned or in situ cervical cerclage

          -  major fetal anomaly detected on screening ultrasound

          -  indication for planned delivery prior to 37 weeks (e.g., prior classical cesarean)

          -  threatened abortion, preterm labor, or ruptured membranes at time of enrollment

          -  known allergy or medical comorbidity listed as a contraindication to 17P in the
             prescribing information

          -  prior participation in the trial

          -  any other condition (social or medical) which, in the opinion of the study staff,
             would make trial participation unsafe or complicate data interpretation.
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Intervention: AR101; Placebo
Intervention description: AR101 powder provided in capsules; Placebo powder provided in capsules
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2:1 randomization to AR101 or placebo
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 506.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Peanut-Allergic Children; Desensitization; ARC007; Characterized Oral Desensitization Immunotherapy (CODIT™)

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101
      using the characterized oral desensitization immunotherapy (CODIT™) regimen in
      peanut-allergic children.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ages 4 to 17 years, inclusive

          -  History of physician-diagnosed peanut allergy that includes allergic signs and
             symptoms within two hours of known oral exposure to peanut

          -  Mean peanut wheal diameter on SPT of at least 8mm and elevated psIgE of at least 14
             kUA/L at screening

          -  Written informed consent from the subject's parent/guardian

          -  Written assent from the subject as appropriate (per local regulatory requirements)

          -  Use of effective birth control by sexually active female subjects of childbearing
             potential

        Key Exclusion Criteria:

          -  Subjects in whom the clinical diagnosis of peanut allergy is uncertain

          -  Severe or uncontrolled asthma

          -  History of cardiovascular disease, including uncontrolled or inadequately controlled
             hypertension

          -  History of severe or life-threatening episode of anaphylaxis or anaphylactic shock
             within 60 days of screening

          -  History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal
             disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD),
             symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology

          -  History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic
             idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold
             urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema

          -  Any other condition that, in the opinion of the Investigator, precludes participation
             for reasons of safety
Zalutumumab in Patients With Non-curable Head and Neck Cancer
Condition: Head and Neck Cancer; Squamous Cell Cancer
MeSH terms: Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell
Intervention: Zalutumumab; Control
Intervention description: Individual dose titration weekly i.v doses; Best Supportive Care
Intervention MeSH terms: Zalutumumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 286.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate if zalutumumab in combination with Best
      Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and Females age ≥ 18 years

          2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral
             cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy

          3. Failure to at least one course of standard platinum-based chemotherapy

        Exclusion Criteria:

          1. Three or more chemotherapy regimens other than platinum-based chemotherapy

          2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors

          3. Past or current malignancy other than SCCHN, except for certain other cancer diseases
Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Fuji IX EXTRA; ACTIVA KIDS bioactive restorative material
Intervention description: High-viscosity glass ionomer (Fuji IX EXTRA); Modified composite (ACTIVA KIDS)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 4 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioactive Restorative Material , ART

Summary:

      The study will be two parallel group, triple blinded randomized controlled clinical trial
      that based on CONSORT (consolidated standards of reporting trials) guideline .The selected
      participants according to inclusion and exclusion criteria will be randomly allocated in two
      groups using (Research Randomizer Program) .
    

Eligibility criteria:

        Inclusion Criteria:

          1. Children aged from 4 to 8 years old, in good general health

          2. Children classified as class 3 or 4 based on Frankel et al. classification. (26)

          3. The children have at least one primary molar with class I carious lesion.

          4. Asymptomatic teeth (without spontaneous pain)

        Exclusion Criteria:

          1. Medically compromised patient

          2. Presence of pulp exposure, pain, mobility

          3. Presence of swelling, abscess or fistula near the tooth

          4. Not accessible carious lesion to hand instruments
Immediate Versus Delayed Insertion of Implanon in Postpartum Adolescents
Condition: Contraceptive Usage
Intervention: Etonogestrel contraceptive implant
Intervention description: Etonogestrel contraceptive implant
Intervention MeSH terms: Contraceptive Agents; Etonogestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: participants were randomized to receive a contraceptive implant before hospital discharge or at their six week postpartum visit
Masking: None (Open Label)
Enrollment: 81.0
Sex: Female
Minimum age: 15 Years
Maximum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Implanon; Bleeding Acceptability; Contraceptive Implant; Adolescent Pregnancy Prevention; Post Partum Insertion of Implanon

Summary:

      The specific aim of this study is to evaluate whether insertion of a long-acting
      contraceptive implant in postpartum adolescents prior to hospital discharge increases use of
      this highly effective contraception during the first twelve months postpartum among
      adolescents who elect Implanon® as their preferred method of contraception. Additionally,
      this study aims to compare the acceptability of bleeding in postpartum adolescents who have
      an etonogestrel contraceptive implant prior to discharge versus those with insertion at the
      six week postpartum visit. The investigators will evaluate the acceptability of bleeding
      rather than collect prospective diaries because the investigators feel subjective perceptions
      of bleeding impact contraceptive continuation more than quantitative differences in bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 15-21

          -  women

          -  english or spanish speaking

          -  less than 120 hours post partum

        Exclusion Criteria:

          -  women who are breastfeeding

          -  contraindications to Implanon® insertion including current or prior thrombo-embolic
             disease, liver disease, hypersensitivity to components of Implanon®, or are using
             medications such as rifampin, phenytoin, or carbamazepine that increase metabolism of
             steroid hormones.

          -  indicate unwillingness to continue follow-up for one year.
Glutamate for Metabolic Intervention in Coronary Surgery
Condition: Coronary Artery Bypass; Myocardial Ischemia; Myocardial Infarction; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Infarction; Ischemia
Intervention: Intravenous infusion of saline; Intravenous glutamate infusion
Intervention description: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.; Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 865.0
Sex: All
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Coronary Artery Bypass; Myocardial Protection; Angina, Unstable; Myocardial Ischemia; Myocardial Infarction; Unstable Coronary Artery Disease; Glutamate

Summary:

      The main purpose of this study is to determine whether intravenous glutamate infusion given
      in association with surgery for unstable coronary artery disease can protect the heart from
      myocardial injury, postoperative heart failure and death.
    

Eligibility criteria:

        Inclusion Criteria:

          -  surgery for unstable coronary artery disease (unstable angina, non-STEMI)

          -  accepted for surgery < 2 weeks after STEMI

          -  coronary surgery for indications above performed with or without cardiopulmonary
             bypass

          -  coronary surgery for indications above with or without simultaneous valve procedure

        Exclusion Criteria:

          -  informed consent not possible because of critical condition or other reason

          -  preoperative use of inotropes or mechanical circulatory assist

          -  preoperative dialysis

          -  redo-procedure

          -  unexpected intraoperative finding / event that increased the dignity of the procedure
             to overshadow the originally planned operation

          -  body weight > 125 kg

          -  food allergy known to have caused flush, rash or asthma
Investigation of Dental Plaque and Gingival Index
Condition: Dental Plaque
MeSH terms: Dental Plaque
Intervention: Sodium Monofluorophosphate; Triclosan/Fluoride/Copolymer
Intervention description: Brush teeth and evaluate plaque score after one use of the study toothpaste; Brush teeth and evaluate plaque score after one use of the study toothpaste
Intervention MeSH terms: Listerine; Triclosan; Fluorides; Sodium Fluoride; Fluorophosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via
      modified gingival margin plaque index method.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be aged 18 to 65 years inclusive

          -  Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present

          -  Give written informed consent

          -  Be in good general health

          -  Must discontinue oral hygiene for 24-hrs.after initial appointment.

          -  No known history of allergy to personal care/consumer products or their ingredients,
             relevant to any ingredients in the test products as determined by the dental/medical
             professional monitoring the study

        Exclusion Criteria:

          -  Medical condition which requires pre-medication prior to dental visits/procedures

          -  Advanced periodontal disease

          -  5 or more decayed, untreated dental sites

          -  Diseases of the soft or hard oral tissues

          -  Orthodontic appliances

          -  Abnormal salivary function

          -  Use of drugs that can currently affect salivary flow

          -  Use of antibiotics one (1) month prior to or during this study

          -  Use of any over the counter medications other than analgesics (i.e. aspirin,
             ibuprofen, acetaminophen, naproxyn)

          -  Pregnant or breastfeeding.

          -  Participation in another clinical study in the month preceding this study

          -  Allergic to common dentifrice ingredients.

          -  Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)