bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study to Compare Dental Plaque Control
Condition: Dental Plaque
MeSH terms: Dental Plaque
Intervention: Fluoride; Triclosan/Fluoride; Triclosan/Fluoride; Triclosan/Fluoride
Intervention description: Brush two times a day for 4 days.; Brush two times daily for 4 days; Brush twice daily for 4 days; Brush twice daily for 4 days
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: Double (Participant, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 53 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This clinical study was to evaluate the control of dental plaque formation after
      toothbrushing for 4 days with each of the 4 study toothpastes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers at least 18 - 53 years of age

          -  Good general health

          -  Must sign informed consent form

          -  Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.

          -  No history of allergy to personal care consumer products, or their ingredients,
             relevant to any ingredient in the test products as determined by the dental/medical
             professional monitoring the study.

        Exclusion Criteria:

          -  Subjects unable or unwilling to sign the informed consent form.

          -  Medical condition which requires pre-medication prior to dental visits/procedures

          -  Moderate or advanced periodontal disease or heavy dental tartar (calculus).

          -  2 or more decayed untreated dental sites at screening.

          -  Other disease of the hard or soft oral tissues.

          -  Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

          -  Use of medications that are currently affecting salivary function

          -  Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

          -  Pregnant or nursing women.

          -  Participation in any other clinical study within 1 week prior to enrollment into this
             study.

          -  Use of tobacco products

          -  Subjects who must receive dental treatment during the study dates.

          -  Current use of Antibiotics for any purpose.

          -  Presence of an orthodontic appliance which interferes with plaque scoring.

          -  History of allergy to common dentifrice ingredients.

          -  History of allergy to arginine (amino acid)

          -  History of allergy to bicarbonate

          -  Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle
Intervention: G2-TR intraocular implant containing travoprost; Sham surgery + active-comparator eye drops
Intervention description: Provided in Arm/Group descriptions.; Sham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%).
Intervention MeSH terms: Travoprost; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 590.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase III study to compare the safety and efficacy of intraocular implants containing
      travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5%
      (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma
      (OAG) or ocular hypertension (OHT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with open-angle glaucoma or ocular hypertension.

          -  C/D ratio ≤ 0.8

          -  Zero to three preoperative ocular hypotensive medications

        Exclusion Criteria:

          -  Active corneal inflammation or edema.

          -  Retinal disorders not associated with glaucoma.
A Study to Assess the Safety of Adacel® Vaccine
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
Intervention description: 0.5 mL, Intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; Adacel®

Summary:

      The objective of this study is to describe the safety of Adacel® vaccination in adults
      subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in
      support to Adacel® registration.

      Primary objective:

      To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after
      immunization.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Male or female (not pregnant) from 18-45 years of age.

          -  Healthy, with no current illnesses.

          -  Have not been immunized against diphtheria, pertussis and tetanus in the past 5 years.

          -  Women of childbearing age will agree to use birth control during the study.

          -  In good health, as verified by the following criteria: Heart rate, blood pressure,
             temperature and health history.

          -  Able to understand and comply with requirements of the study.

          -  A voluntary consent form is required before participating in the study.

        Exclusion Criteria :

          -  History of allergy to any ingredient in the vaccine.

          -  A positive pregnancy test (for women of childbearing age) or women who are
             breastfeeding.

          -  Compromised immune system due to treatment of a progressive disease.

          -  Currently on oral or injected steroids, inhaled high-dosage steroids or other
             immunodeficiency or toxic drugs.

          -  History of taking Immunoglobulin or other products during the 3 months prior to
             participating in the study.

          -  Received other vaccines during the 4 months prior to participating in the study.

          -  Has an acute or chronic condition that affects safety (including but not limited to:
             chronic liver disease, some kidney pathologies, progressive or unstabilized nerve
             disorders, diabetes and organ transplants).

          -  Experienced a severe adverse event after receiving ADACEL® vaccine.

          -  History of acute illness with temperatures over 37.5ºC during the week before
             receiving the vaccine.

          -  Human immunodeficiency virus (HIV) infection.

          -  History of alcohol or drug addiction during the past 5 years.

          -  Plans to travel outside of the study area between shots and visits.

          -  History of Guillain-Barré syndrome.
Propofol in Obese Children
Condition: Pharmacodynamics; Obesity
MeSH terms: Obesity
Intervention: Propofol; Propofol
Intervention description: Each Obese child/subject in this group will receive a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design); This arm of patients(non-obese)will act as the control group for the obese children. Each non-obese child/subject will receive a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)
Intervention MeSH terms: Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 80.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Propofol; Childhood obesity; Pharmacodynamics

Summary:

      Obesity in children,as in adults,has rapidly become a public health concern. Studies in
      adults have shown that obesity, now considered to be a disease state, is a modifier of the
      effect of drugs on the body as well as how the body handles the drug.The anesthetic
      management of obese children poses a variety of significant challenges which include
      determination of the appropriate dose of anesthetic intravenous agents. Dosing of most drugs
      is calculated based on the effective dose in 50% of patients but the more practical and
      required information is the effective dose in 95%(ED95%)of patients. The aim of this study is
      to determine the effective dose in 95% of patients(children). The hypothesis is the ED95 of
      propofol in obese children will be higher than that of non-obese children.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Children between the ages of 3 and 17 years who fall into the categories of
             non-obese(BMI percentile between 25-84th percentile) or obese(>95th percentile)

          2. American Society of Anesthesiology(ASA) classification 1 or 2-

        Exclusion Criteria:

          1. Patients classified as ASA (American Society of Anesthesiology) Class 3 or greater.

          2. Patients with documented kidney or liver disease or those presenting for open surgery
             on the liver or kidney.

          3. Patients who will NOT be receiving propofol for induction as part of their anesthetic
             regimen.

          4. Patients who are currently on anti-convulsant medication or receiving drugs with
             sedative effects.

          5. Patients currently being treated for attention deficit disorder.

          6. Patients who are diagnosed with failure to thrive or those with a BMI less than 25th
             percentile.

          7. Patients who are hemodynamically unstable.

          8. Patients with egg allergy.

          9. Patients with low levels of albumin -
Pain Reduction With Intranasal Medications for Extremity Injuries
Condition: Pain; Traumatic Limb Injury
MeSH terms: Wounds and Injuries
Intervention: Ketamine; Fentanyl
Intervention MeSH terms: Fentanyl; Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study compares the analgesic effect of intranasal sub-dissociative dosing of ketamine
      and intranasal fentanyl in children presenting to the Emergency Department with acute
      extremity injuries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  8 years to 17 years (up to the 18th birthday)

          -  Presenting to emergency department with one or more extremity injuries

          -  Visual analog scale score 35 mm or greater

          -  Parent or legal guardian present and willing to provide written consent

        Exclusion Criteria:

          -  Received narcotic pain medication prior to arrival

          -  Evidence of significant head, chest, abdomen, or spine injury

          -  Glasgow coma score less than 15 or unable to self report pain score

          -  Nasal trauma or aberrant nasal/airway anatomy

          -  Active epistaxis

          -  Allergy to ketamine, fentanyl or meperidine

          -  Non-English speaking parent and/or child

          -  History of psychosis

          -  Postmenarchal female without a urine or serum assay documenting the absence of
             pregnancy

          -  Brought in my juvenile detention center or in police custody

          -  Pregnancy
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: Amoxicillin-Clavulanate potassium
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 6 Months
Maximum age: 23 Months
Healthy volunteers: No
Keywords: ear infections; antibiotics; antibiotic resistance; pediatrics; infants; children; amoxicillin-clavulanate

Summary:

      To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced
      concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered
      at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided
      doses for 10 days. Investigators will focus on the proportion of subjects who develop
      protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the
      prescription of antifungal medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age range: 6 to 23 months

          -  Evidence of AOM

          -  Recent (within 48 hours) onset of signs and symptoms.

          -  Middle ear effusion evidenced by the presence of at least 2 of the following:
             decreased or absent mobility of the tympanic membrane (TM), yellow of white
             discoloration of the TM, and/or opacification of the TM

          -  Acute inflammation evidenced by one of the following: 1+ bulging of the TM with either
             intense erythema or otalgia or 2+ or 3+ bulging of the TM

        Exclusion Criteria:

          -  Toxic appearance (capillary refill >3 seconds, systolic blood pressure <60 mm Hg)

          -  Inpatient hospitalization

          -  Clinical or anatomical characteristics that might obscure response to treatment (e.g.,
             tympanostomy tubes in place, cleft palate, Down syndrome)

          -  Sensorineural hearing loss (unilateral or bilateral)

          -  Allergy to amoxicillin or amoxicillin clavulanate

          -  Recent treatment of AOM within the last 14 days
XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: XP13512 (GEn)
Intervention description: 1200 mg XP13512, orally, once daily for 52 weeks
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 581.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to assess the long-term safety and efficacy of XP13512
      (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless
      Legs Syndrome (RLS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have successfully completed one of the following studies: XP052 (110963
             [NCT00298623]), XP053 (111460 [NCT00365352]), XP081 (111462 [NCT01332305]), and XP083
             (111463 [NCT01332318]).

        Exclusion Criteria:

          -  Subjects who, in the opinion of the Investigator, would be non-compliant with the
             study visit schedule, procedures, or medication administration.
A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CP-690,550; CP-690,550; Placebo/CP-690,550; Placebo/CP-690,550
Intervention description: 10 mg oral BID, Continuous treatment for 52 Weeks; 5 mg oral BID, Continuous treatment for 52 Weeks; 0 mg oral BID, Continuous Treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo); 0 mg oral BID, Continuous Treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 960.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Xeljanz; tofacitinib; Jak-inhibitor; oral treatment; chronic; severe; moderate; Pruritus; Itch; DLQI; treatment; safety; efficacy; CP-690,550; Plaque Psoriasis; Psoriasis Vulgaris

Summary:

      The main objective of this study is to compare the effects of CP-690,550 with the effects of
      placebo in patients being treated for moderate to severe chronic plaque psoriasis. This
      one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older with diagnosis for at least 12 months of moderate to severe plaque
             psoriasis covering at least 10% of body surface area

          -  A Psoriasis Area and Severity Index (PASI) score of 12 or greater

          -  Are considered to be candidates for systemic or light therapy

          -  Have no evidence of active or latent tuberculosis

        Exclusion Criteria:

          -  Non-plaque or drug-induced forms of psoriasis

          -  Cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot
             discontinue phototherapy (PUVA or UVB)

          -  Any uncontrolled significant medical condition
Etanercept (Enbrel®) in Psoriasis - Pediatrics
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Etanercept; Placebo
Intervention description: Etanercept 0.8 mg/kg (up to an intended dose of 50 mg) by subcutaneous injection once a week; Placebo matching to etanercept administered by subcutaneous injection once a week
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 211.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric Psoriasis

Summary:

      This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with
      Psoriasis.
    

Eligibility criteria:

        -  Patients with plaque psoriasis

          -  Patient may not receive certain psoriasis medications during the study
Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Ziprasidone oral capsules
Intervention description: Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid.
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 221.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Adolescent Subjects

Summary:

      The purpose of this study is to assess the safety and tolerability of ziprasidone during
      long-term open-label administration in adolescents (ages 13-17) with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation in double-blind treatment study A1281134, meeting specific criteria of
             duration and safety

        Exclusion Criteria:

          -  Imminent risk of suicide or homicide, as judged by the site investigator

          -  Serious adverse event related to study medication in study A1281134

          -  Significant prolongation of QT interval in study A1281134
Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone propionate; Fluticasone furoate; Placebo
Intervention description: Fluticasone propionate inhalation powder, 250 µg; Fluticasone furoate inhalation powder, 100 µg; Placebo inhalation powder
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 350.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: fluticasone propionate; Fluticasone furoate

Summary:

      A randomised, double-blind, double-dummy, placebo controlled (with rescue medication),
      multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation
      powder in the treatment of persistent asthma in adults and adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Outpatient at least 12 years of age

          -  Both genders; females of child bearing potential must be willing to use approved birth
             control method

          -  Pre-bronchodilator FEV1 of 40-90% predicted

          -  Reversibility FEV1 of at least 12% and 200mLs

          -  Current asthma therapy that includes an inhaled corticosteroid for at least 4 weeks
             prior to first visit

        Exclusion Criteria:

          -  History of life threatening asthma

          -  Respiratory infection or candidiasis

          -  Asthma exacerbation within 6 months prior to first visit

          -  Concurrent respiratory disease or other disease that would confound study
             participation or affect subject safety

          -  Allergies to study drugs, study drug excipients, medications related to study drugs

          -  Taking another investigational medication or medication prohibited for use during this
             study