bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Chronic Low Back Pain Study
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: hydrocodone/acetaminophen extended release; Placebo
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study was to evaluate the analgesic effect and safety of
      hydrocodone/acetaminophen extended release compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration

        Exclusion Criteria:

        Subjects with a history of surgical or invasive intervention
Translational Neuroscience Optimization of GlyT1 Inhibitor
Condition: Cognitive Impairments Associated With Schizophrenia
MeSH terms: Schizophrenia
Intervention: PF-03463275; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase II, randomized, double-blind, placebo-controlled, cross-over POC study of
      stable patients with Schizophrenia or Schizoaffective disorder. The primary objective of this
      study is to test the efficacy of treatment with one of two does of a glycine transporter
      inhibitor (GlyT1I) combined with cognitive remediation to enhavce cognitive function.
      Subjects will be randomized to one of two doses of the glycine transporter inhibitor (GlyT1I)
      and placebo twice daily in addition to their antipsychotic medication for 2 treatment
      periods, each lasting a minimum of 5 weeks. Treatment periods will be separated by a washout
      period lasting approximately 3 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1) Males or females 21 to 65 years of age (inclusive).

          -  2) Diagnosis of Schizophrenia or Schizoaffective Disorder

          -  3) Able to provide written informed consent.

          -  4) Only CYP2D6 extensive metabolizers.

        Exclusion Criteria:

          -  1) No ongoing acute medical issues

          -  2) Clinically significant ECG abnormality

          -  3) Blood donation within eight weeks of the start of the study

          -  4) Current treatment with Clozapine
A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine
Condition: Pain
MeSH terms: Toothache
Intervention: JNJ-10450232 / Not yet marketed; JNJ-10450232 / Not yet marketed; JNJ-10450232 / Not yet marketed; acetaminophen / Tylenol
Intervention description: Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.; Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.; Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.; Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
Intervention MeSH terms: Acetaminophen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 269.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: dental pain; post-surgical dental pain

Summary:

      To assess the safety and effectiveness one dose of a new pain reliever medicine (JNJ-10450232
      at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen
      1000 mg after surgical removal of third molars. The primary endpoint will evaluate pain
      relief effectiveness up to 6 hours after administration of the study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 18-45 years

          -  At least moderate dental pain assessed by a categorical scale pain intensity scale and
             a score of at least 5 on the 11-point (0-10) pain intensity numerical rating scale
             (PI-NRS) following surgical removal of three third-molars

        Exclusion Criteria:

          -  Subjects who are not otherwise healthy

          -  Test positive for the urine drug screen

          -  Taking prohibited medications will not be allowed to participate in this study
Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
Condition: Malaria
MeSH terms: Malaria; Malaria, Vivax
Intervention: KAF156
Intervention description: KAF156 was supplied as tablets for oral use.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: acute malaria, KAF156

Summary:

      This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria
      patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400
      mg/day (Part 1) and single dosing with KAF156 at 800mg (Part 2)
    

Eligibility criteria:

        Inclusion Criteria:

        -Male and female patients aged 20 to 60 years;Presence of mono-infection of P. falciparum
        or P. vivax; Weight between 40 kg to 90 kg.

        Exclusion Criteria:

          -  Patients with signs and symptoms of severe/complicated malaria

          -  Infection with more than one parasite species

          -  Women of child-bearing potential; pregnant or nursing women

          -  Those who have taken any anti-malarial treatment in the preceding 14 days or other
             investigational drugs within 30 days or 5 half-lives
Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
Condition: Burns; Sedation
MeSH terms: Burns
Intervention: Dexmedetomidine
Intervention description: Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: pediatric; burn; sedation

Summary:

      Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care
      units. We are studying whether this drug is cardiovascularly safe in pediatric patients who
      have recently been burned.
    

Eligibility criteria:

        Inclusion Criteria:

          -  pediatric patient

          -  >25% total body surface area (tbsa) burn and < 90% tbsa

          -  opioid requirements > 0.1 mg/kg/hour of morphine (or equivalent)

          -  midazolam requirement > 0.1 mg/kg/hour

          -  treatment team determined that patient should be started on dexmedetomidine

        Exclusion Criteria:

          -  hemodynamically unstable patients (epinephrine > 1.0 ug/kg/min, levophed > 0.75
             ug/kg/min, dopamine > 10 ug/kg/min)

          -  pregnant patients

          -  patients with history of heart block

          -  patients with congenital heart disease

          -  patients with significant hepatic dysfunction

          -  patients with urine output < 0.5 ml/kg/hour [averaged] over past 24 hours
Premature Ventricular Contractions (PVCs) and Blood Pressure Control
Condition: Ventricular Premature Complexes; Blood Pressure
MeSH terms: Premature Birth; Ventricular Premature Complexes
Intervention: PVC Suppression using Flecainide; No PVC Suppression using Placebo
Intervention description: Flecainide will be administered to result in a reduction in PVC burden.; Placebo (sugar pills) will be given to result in no alteration in PVC burden.
Intervention MeSH terms: Flecainide
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if reduction in premature ventricular contraction
      (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma
      catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC
      suppression in a randomized, double-blinded, crossover fashion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Frequent symptomatic premature ventricular contractions (PVCs) (>10% of total QRSs on
             a 24-hour Holter)

          -  Willingness to participate in research

        Exclusion Criteria:

          -  Age > 65 years old

          -  Pacemaker implantation

          -  Implantable cardioverter defibrillator implantation requiring pacing

          -  Sick sinus syndrome

          -  Atrio-ventricular (AV) block

          -  Left ventricular dysfunction defined as left ventricular ejection fraction < 50%

          -  History of myocardial infarction or coronary artery disease

          -  Severe left ventricular hypertrophy (wall thickness > 1.5 cm by echocardiography
             performed within 3 months from enrollment)

          -  Severe liver dysfunction

          -  Creatinine clearance of 35 mL/min/1.73 square meters or less

          -  Pregnancy

          -  Known hypersensitivity to the drug

          -  QRS duration > 120 ms

          -  Recent change in blood pressure medication within 30 days of enrollment
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Lenabasum 20 mg; Lenabasum 5 mg; Placebo
Intervention description: Subjects will receive lenabasum 20 mg twice daily.; Subjects will receive lenabasum 5 mg twice daily.; Subjects will receive placebo twice daily.
Intervention MeSH terms: Dronabinol; Lenabasum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, double-blind, randomized, placebo-controlled, parallel group study.
Masking: Double (Participant, Investigator)
Enrollment: 447.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Pulmonary exacerbation, lenabasum, JBT-101

Summary:

      This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing
      the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12
      years of age or older. Approximately 415 subjects will be enrolled in this study at about 100
      sites in North America, and Europe. The planned duration of treatment with study drug is 28
      weeks.

      Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ≥ 12 years of age at the time Informed Consent/ Assent is signed.

          2. Weight ≥ 40 kg.

          3. FEV1 ≥ 40% predicted and < 100% predicted in the last 12 months.

          4. Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months
             for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the
             last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more
             times in the past 12 months for a new PEX.

        Exclusion Criteria:

          1. Severe or unstable CF at screening or Visit 1.

          2. Any of the following values for laboratory tests at screening:

               1. A positive pregnancy test.

               2. Hemoglobin < 10 g/dL in males and < 9 g/dL in females.

               3. Neutrophils < 1.0 x 10^9 /L.

               4. Platelets < 75 x 10^9/L.

               5. Creatinine clearance < 50 mL/min according to Modification of Diet in Renal
                  Disease (MDRD) Study equation.

               6. Serum transaminases > 2.5 x upper limit of normal.

          3. Any medical condition or concurrent medical therapies at screening or Visit 1 that may
             put the subject at greater safety risk, influence response to study drug or interfere
             with study assessments.
Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Plovamer acetate 0.5 milligram (mg); Copaxone 20 mg; Plovamer acetate 3 mg; Plovamer acetate 10 mg; Plovamer acetate 20 mg
Intervention description: Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.; Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.; Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.; Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.; Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
Intervention MeSH terms: Glatiramer Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Relapsing Remitting; Plovamer acetate; Copaxone

Summary:

      This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4
      doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing
      Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for
      minimum treatment duration of 40 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, between the ages of 18 and 60 years

          -  Subject is able to learn and self-administer subcutaneous injections (a care-giver may
             be trained to inject the subject)

          -  Subjects must have a current diagnosis of Relapsing Remitting Multiple Sclerosis
             (RRMS) (according to the 2010 McDonald MS diagnostic criteria)

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Any multiple sclerosis categorized as primary progressive, secondary progressive or
             progressive relapsing

          -  Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for
             MRI

          -  Any requirement for continuous systemic glucocorticoid administration during the trial
             period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will
             be allowed until the baseline visit, as no wash-out period is needed)

          -  Contraindication to Copaxone use

          -  Other protocol defined exclusion criteria could apply
Acamprosate in Youth With Fragile X Syndrome
Condition: Fragile X Syndrome; Autism Spectrum Disorders
MeSH terms: Fragile X Syndrome; Syndrome; Autism Spectrum Disorder
Intervention: Acamprosate
Intervention MeSH terms: Acamprosate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Fragile X Syndrome; Acamprosate

Summary:

      Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS
      is inherited from the carrier parent, most often the mothers. FXS is associated with severe
      interfering behavioral symptoms which include anxiety related symptoms, attention deficit
      hyperactivity, and aggressive behaviors. Approximately 25-33% of individuals with FXS also
      meet criteria for autistic disorder. The hypothesis of this study is that treatment with
      acamprosate will reduce inattention/hyperactivity, language impairment, irritability, social
      deficits, and cognitive delay in youth with FXS. The purpose of this study is to investigate
      the effectiveness and tolerability of acamprosate in youth with Fragile X Syndrome and to
      assess the potential psychophysiological differences between FXS and autism spectrum
      disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients between the ages of 5 and 17 years.

          -  Confirmed diagnosis of Fragile X Syndrome based upon genetic testing.

          -  Stable dosing of all psychotropic medications for at least 2 weeks prior to baseline.

          -  Subjects with a stable seizure disorder or history of only childhood febrile seizures
             will be included.

          -  Clinical Global Impression-Severity Score of 4 (Moderately Ill) or greater.

          -  Must be in good physical health.

          -  Subjects of child bearing age of both genders will be required to utilize birth
             control as applicable.

        Exclusion Criteria:

          -  Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder or alcohol or
             other substance abuse based on Diagnostic and Statistical Manual Fourth Edition-Text
             Revised (DSM-IV-TR).

          -  A significant medical condition such as heart, liver, renal or pulmonary disease or
             unstable seizure disorder.

          -  Females with a positive urine pregnancy test

          -  Creatinine clearance of less than 30.

          -  Concomitant use of another glutamatergic agent (memantine,riluzole, d-cycloserine,
             amantadine topiramate, gabapentin, among others.

          -  Evidence of hypersensitivity to acamprosate or potentially serious adverse effect.

          -  Subjects who, in the opinion of the investigator, are unsuitable in any other way to
             participate in this study including being unable to comply with the requirements of
             the study for any reason.
Dexamethasone Solution and Dexamethasone in Mucolox™
Condition: Oral Lichen Planus; Mucous Membrane Pemphigoid; Pemphigus Vulgaris; Chronic Graft-versus-host-disease
MeSH terms: Lichen Planus, Oral; Bronchiolitis Obliterans Syndrome; Pemphigoid, Benign Mucous Membrane; Lichen Planus; Pemphigoid, Bullous; Pemphigus; Graft vs Host Disease
Intervention: dexamethasone 0.5mg/5ml solution; dexamethasone 0.5mg/5ml solution in Mucolox™
Intervention description: Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution three times a day for 4 weeks and expectorate; Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution in Mucolox™ three times a day for 4 weeks and expectorate
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Pharmaceutical Solutions; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Topical steroid therapy is considered the first line of treatment for Oral Inflammatory
      Ulcerative Diseases with current treatment regimens requiring multiple application or rinses
      daily. Using Mucolox™ as a vehicle to deliver topical dexamethasone to the oral mucosa has
      the potential to effectively prolong contact time between the medication. The primary
      objective of this study is to determine the clinical efficacy and tolerability of compound
      dexamethasone at 0.5 mg/5 mL in Mucolox™ for the treatment of Oral Inflammatory Ulcerative
      Diseases as measured by a reduction in oral symptoms between patients treated with compounded
      dexamethasone 0.5mg/5ml solution in Mucolox™ (group A) and patients treated with topical
      commercial dexamethasone 0.5mg/5ml solution only (group B). and mucosa, leading to improved
      clinical outcomes due to the need for less frequent application.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and older.

          -  Patients with symptomatic biopsy proven Oral Inflammatory Ulcerative Diseases (worst
             VAS sensitivity score ≥ 7 over the last week).

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Patients already on topical or systemic steroids.

          -  Inability to comply with study instructions.

          -  Uncontrolled intercurrent illness or psychiatric illness/social situations that would
             limit compliance with study requirements.

          -  VAS sensitivity score < 7.

          -  Pregnant women. A urine pregnancy test will be performed for women of child bearing
             potential.

          -  Allergy to fluconazole.