bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: Placebo; 100mg SPN-812; 200mg SPN-812; 300mg SPN-812; 400mg SPN-812
Intervention description: Placebo was administered once daily; 100mg SPN-812 was administered once daily and compared to placebo; 200mg SPN-812 was administered once daily and compared to placebo; 300mg SPN-812 was administered once daily and compared to placebo; 400mg SPN-812 was administered once daily and compared to placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 222.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group,
      dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release
      Capsule) in children 6-12 years of age with ADHD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of
             ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM
             IV), confirmed with the Mini International Neuropsychiatric Interview for Children and
             Adolescents (MINI-KID).

          2. ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.

          3. CGI-S score of at least 4

          4. Weight of at least 20 kg.

          5. Free of medication for the treatment of ADHD or any psychosis for at least one week
             prior to enrollment.

        Exclusion Criteria:

          1. Current or lifetime diagnosis of major depressive disorder, bipolar disorder,
             personality disorder, Tourette's disorder, or psychosis not otherwise specified.

          2. Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive
             compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as
             primary diagnosis.

          3. Significant systemic disease.

          4. Evidence of suicidality within the six months before Screening or at Screening.

          5. BMI greater than 95th percentile for the appropriate age and gender.

          6. Pregnancy or refusal to practice abstinence during the study for female subjects of
             childbearing potential (FOCP).

          7. Substance or alcohol use during the last three months.

          8. Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
Condition: Skin and Subcutaneous Tissue Bacterial Infections; Gram-Positive Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Gram-Positive Bacterial Infections
Intervention: TNP-2092; Vancomycin
Intervention description: TNP-2092 100mg/vial; Vancomycin 1g/vial
Intervention MeSH terms: Vancomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TNP-2092; ABSSSI; Safety; Efficacy

Summary:

      The purpose of this study is to evaluate safety, tolerability, pharmacokinetic
      characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be
      caused by gram-positive pathogens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects may be included in the study if they meet all of the following inclusion
             criteria:

               -  Males or females, 18 years of age or older;

               -  ABSSSI suspected or confirmed to be caused by gram-positive pathogens, including:

               -  Cellulitis/erysipelas;

               -  Wound infection;

               -  Major cutaneous abscess;

               -  Lesion with a minimum surface area of 75 cm2;

               -  Capable of giving signed informed consent.

        Exclusion Criteria:

          -  Subjects will be excluded from the study if any of the following exclusion criteria
             apply prior to randomization:

               -  History or hypersensitivity or intolerability to any fluoroquinolone, rifamycin
                  or glycopeptide classes;

               -  ABSSSI suspected or confirmed to be caused by pathogens that are resistant to the
                  glycopeptide class;

               -  Prior administration of systemic antibacterial therapy within 96 hours before
                  randomization;

               -  ABSSSI with suspected or confirmed infection caused by gram-negative or anaerobic
                  organisms;

               -  ABSSSI with suspected or confirmed infection caused by fungal, mycobacterial,
                  parasitic, or viral pathogens;

               -  Evidence of significant hepatic, hematologic, or immunologic disease;

               -  History or evidence of severe renal disease.
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
Condition: Palmoplantar Pustulosis
MeSH terms: Psoriasis
Intervention: Imsidolimab; Placebo
Intervention description: Administered by subcutaneous injection once a month; Administered by subcutaneous injection once a month
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: PPP

Summary:

      A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple
      doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically confirmed diagnosis of PPP

          -  Disease duration of at least 6 months prior to screening

          -  Present with active pustules on palms or/and soles at screening

        Exclusion Criteria:

          -  Any other ongoing inflammatory disease that interfere with the investigator's ability
             to evaluate the subject's response to therapy

          -  History of recurrent or active/serious infection

          -  Ongoing use of psoriasis prohibited medication

        Other protocol-defined inclusion/exclusion criteria may apply
Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole ointment 2% BID; Placebo ointment (vehicle)
Intervention description: Crisaborole ointment 2% BID for 15 days (double blind); additional 28 days (open label); Placebo ointment (vehicle) BID for 15 days (double blind)
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atopic dermatitis; atopic eczema; eczema; topical treatment; skin diseases; phosphodiesterase-4 inhibitor; PDE-4 inhibitor; crisaborole

Summary:

      This study is being conducted to characterize the mechanism of action of crisaborole ointment
      2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD)
      lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate
      AD. Two identified AD skin lesions for each subject will be treated for the first 15 days,
      one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for
      biomarker analysis will be performed on the lesions. Following completion of the blinded
      treatment period, subjects will start the 28 day open label period during which all AD
      affected skin lesions will be treated with crisaborole ointment 2% twice daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history
             prior to Screening and that has been clinically stable for 1 month.

          -  Investigator's Static Global Assessment (ISGA) of 2 (mild) or 3 (moderate) at
             Baseline.

          -  Body surface area (BSA) covered with AD of at least 0.5% and no more than 10% at
             Baseline, calculation excluding face, scalp, axilla, genitals, groin area, palms, back
             of the hands, and soles.

          -  Two lesions of AD at least 3 cm x 3 cm in size and at least 5 cm apart, with identical
             Lesion ISGA score of greater than/equal to 3.

        Exclusion Criteria:

          -  Clinically infected AD or requires high potency topical corticosteroids or systemic
             (oral/injectable) corticosteroids to manage AD.

          -  History of angioedema or anaphylaxis to topical products or known sensitivity to
             components of crisaborole ointment 2%.

          -  History of cancer (except squamous or basal cell carcinoma or carcinoma in situ of the
             skin).

          -  Previous treatment with any topical or systemic PDE4 inhibitor unless stopped for the
             reason of lack of efficacy.
A New Oral Treatment For Type II Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; DEN 2.5 mg; DEN 7.5 mg; DEN 15 mg; DEN 30 mg; DEN 45 mg
Intervention description: Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 375.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: NIDDM

Summary:

      This is a 24-week study investigating the safety and efficacy of several dosages of a
      potential new oral medicine for Type II diabetes mellitus.
    

Eligibility criteria:

        Inclusion criteria:

          -  Women must not be pregnant and must not be breastfeeding.

          -  Have Type II diabetes.

          -  Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

        Exclusion criteria:

          -  Have any underlying or significant active disease that would prevent the subject from
             safely participating in the trial by the judgement of the study doctor.
A Study to Evaluate the Effects of LCI699 on Cortisol in Participants With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: LCI699-matching placebo; LCI699
Intervention description: LCI699-matching placebo oral capsules; LCI699 oral capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Blood Pressure; Hypertension; Cortisol

Summary:

      This study determined the maximum dose of LCI6999 with respect to effect on the
      ACTH-stimulated cortisol response in participants with hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of hypertension with blood pressure ≥ 140/90 millimeters of mercury (mmHg)
             and < 180/110 mmHg on current antihypertensive treatment

          -  Male and female participants 18-75 years of age

          -  Participants must weigh at least 50 kilograms (kg)

        Exclusion Criteria:

          -  Recent history of myocardial infarction, heart failure, unstable angina, coronary
             artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy,
             cerebral accident or transient ischemic attack

          -  Clinically significant electrocardiography (ECG) findings related to cardiac
             conduction defects

          -  Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c [HbA1c] > 9%)

          -  Malignancies within the last 5 years (excluding basal cell skin cancer)

          -  Liver disease

        Other protocol-defined inclusion/exclusion criteria may apply.
Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: granisetron
Intervention description: Application granisetron transdermal patch preoperatively
Intervention MeSH terms: Granisetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: PONV; anesthesia; granisetron

Summary:

      The objective of the study is to evaluate the efficacy and safety of adding transdermal
      preparation of granisetron (Sancuso ®) to the current postoperative nausea and vomiting
      (PONV) standard prophylaxis regimen with dexamethasone and ondansetron in patients with the
      previous history of severe, particularly delayed and/or post-discharge, PONV and undergoing
      surgical procedure under general anesthesia.

      The specific aims of the study include:

        1. efficacy of the investigated therapy in prevention of PONV up to 120 hours after surgery

        2. incidence and seriousness of the observed side effects

        3. ability of patients to self-administer preoperatively and maintain the investigated
           patch during the perioperative period

        4. level of satisfaction with the preoperative PONV prophylaxis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients that are between the ages of 18 and 89

          -  Scheduled to undergo surgical procedures with general anesthesia

          -  Seen in the anesthesia clinic at least 24 hours before surgery

          -  History of severe PONV after previous general anesthesia

          -  Surgical procedures with anticipated duration > 1 hour and no more than 5 hours

          -  American Society of Anesthesiologists (ASA) physical status I to III

        Exclusion Criteria:

          -  Allergy to granisetron or other 5HT3RA drugs

          -  Previous allergic reactions to any drug skin patches

          -  Recent (less than 1 month) or current chemo- or radiotherapy

          -  Any nausea, vomiting, or retching within 24 hours prior to anesthesia

          -  Any type of eye surgeries

          -  History or diagnosis of gastrointestinal obstruction or ileus

          -  History of serotonin syndrome

          -  Unable to sign consent
A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: BMS-919373; Placebo (Matching with BMS-919373)
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation (AF)
      through its effect on AF burden (AFB), or the percent of time in AF, in subjects with
      paroxysmal AF (pAF) when administered orally at a range of doses (2 mg once daily (QD), 5 mg
      QD, 12 mg QD following a 1-week period of loading doses of 3 mg QD, 8 mg QD and 20 mg QD,
      respectively) for a total of 4 weeks. It is hypothesized that treatment with BMS-919373 will
      reduce AF burden as compared to baseline relative to placebo.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Signed informed consent

          -  Paroxysmal Atrial Fibrillation (pAF) with available documentation of AF and reporting
             symptoms within 6 months prior to screening

          -  Able to tolerate withdrawal of antiarrhythmic therapy (rhythm control)

          -  Echocardiographically measured left ventricular ejection fraction (LVEF) ≥40%,measured
             within 12 months of enrollment

          -  Echocardiographically measured left atrial (LA) diameter ≤ 5.0 cm, measured within 12
             months of enrollment

        Exclusion Criteria:

          -  Women of childbearing potential

          -  AFB < 3% or > 70%, during both screening periods independently

          -  Permanent or persistent Atrial Fibrillation

          -  Cardioversion within 3 months of study drug administration

          -  Stroke within 12 months of study drug administration

          -  TIA within 12 months of study drug administration

          -  Heart failure of NYHA class III or greater (symptoms of heart failure at rest or with
             minimal exertion)

          -  Heart failure of NYHA class II (symptoms of heart failure with routine levels of
             exertion)with ejection fraction <40% as measured by echocardiography at any time
             within 12 months of study enrollment (i.e. additional ejection fraction measurements ≥
             40% over this period will not counter this exclusion)

          -  Valvular heart disease (including any valvular insufficiency or stenosis greater
             than"mild")

          -  Ablation within 3 months of study enrollment
A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: AMG 827; Placebo
Intervention description: SC injection.; SC injection.
Intervention MeSH terms: Brodalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Amgen; chronic inflammatory disease; wheezing

Summary:

      The purpose of this study is to determine if AMG 827 is effective compared to placebo as
      measured by change in Asthma Control Questionnaire (ACQ) composite scores.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women 18 to 65 years of age

          -  Percent of predicted FEV1 ≥ 50% and ≤ 80%

          -  At least 12% reversibility over pre-bronchodilator FEV1

          -  Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent

          -  Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points

        Exclusion Criteria:

          -  Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit

          -  History of chronic obstructive pulmonary disease or other chronic pulmonary condition
             other than asthma

          -  Any uncontrolled or clinically significant systemic disease (eg, uncontrolled
             diabetes, liver disease)
Safety and Efficacy of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders
Condition: Corneal Epithelial Disorders
Intervention: High Dose SJP-0035 Ophthalmic Solution; Low Dose SJP-0035 Ophthalmic Solution; Vehicle of SJP-0035 Ophthalmic solution
Intervention description: 0.001% SJP-0035 Ophthalmic Solution; 0.0002% SJP-0035 Ophthalmic Solution; 0% SJP-0035 Ophthalmic Solution
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether SJP-0035 ophthalmic solution is effective
      in promoting corneal epithelial wound healing in conditions associated with corneal
      epithelial disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is capable of understanding the written informed consent form (ICF), provides signed
             and witnessed written ICF, and agrees to comply with protocol requirements, including
             all required study visits

          -  Is a male or female 18 years of age or older

          -  Has a moderate to severe corneal epithelial disorder in both eyes

          -  Has blurred vision caused by corneal epithelial disorders in both eyes at Screening
             and Randomization

          -  Is a female of childbearing potential with a negative pregnancy test result at
             Screening and Randomization and agrees to use effective contraception throughout the
             study, or is a postmenopausal woman with a negative pregnancy test result at Screening
             and Randomization

        Exclusion Criteria:

          -  Has any corneal stromal or endothelial abnormalities including an active bacterial or
             viral ocular infection, bullous keratopathy, chemical burns, or any trauma to the
             cornea in either eye at Screening and Randomization

          -  Has any active or chronic allergic, bacterial, or viral infection of ocular adnexa and
             eye structures in either eye at Screening and Randomization

          -  Has had intraocular surgery (including cataract or vitreous) in either eye within the
             last 30 days prior to the first dose of study drug

          -  Has had refractive surgery (including ocular surface laser surgery) in either eye
             within the last 6 months prior to the first dose of study drug

          -  Has used any ocular medication (except mydriatics, stain, and topical anesthesia used
             for study assessments) in either eye within 14 days prior to the first dose of study
             drug, or is anticipated to require such medications during the study.

          -  Is a contact lens wearer and cannot discontinue use in both eyes from Screening
             through EOS