bioihbjkbjnl/mcl2 huggingface dataset:
Desensitization and Cross-Desensitization During Oral Grass or Ragweed Pollen Immunotherapy
Condition: Immunologic Desensitization
Intervention: allergen extract tablet; Placebo tablet
Intervention description: 1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet; 1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Allergic rhinitis; Immunotherapy, Allergen; Sublingual Immunotherapy

Summary:

      The purpose of this study is to determine if sublingual allergen immunotherapy tablets work
      by inducing a state of desensitization in mast cells and basophils.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Verified allergic sensitivity to either Timothy Grass or Short Ragweed pollen (primary
             allergen)

          -  Verified allergic sensitivity to at least one allergen in addition to the primary
             allergen

        Exclusion Criteria:

          -  Negative skin testing to Timothy Grass or Short Ragweed pollen and at least one other
             environmental allergen

          -  Dermatographism

          -  Severe dermatologic condition that may interfere with skin testing

          -  Pregnancy

          -  H1 receptor antihistamine taken within 7 days of testing

          -  Systemic steroids

          -  Omalizumab taken at any time in the past

          -  Receiving or received allergen immunotherapy

          -  Desensitized to any drug within 6 months

          -  Current uncontrolled or severe asthma

          -  Eosinophilic esophagitis

          -  Significant pulmonary, cardiovascular, renal, hepatobiliary, or neurological diseases,
             or another disease process felt to put a subject at increased risk for adverse events

          -  Hypersensitivity to any of the inactive ingredients in the allergen extract tablets

          -  History of mental illness or drug or alcohol abuse that could interfere with the
             ability to comply with study requirements

          -  Inability or unwillingness to give written informed consent
A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
Condition: Narcolepsy With Cataplexy
MeSH terms: Narcolepsy; Cataplexy
Intervention: JZP-258; Placebo
Intervention description: JZP-258 oral solution 0.5 g/mL, which is equivalent to 0.413 g/mL of oxybate; Matching placebo solution (aqueous solution containing sodium citrate, malic acid, and sucralose; all ingredients were compendial [United States Pharmacopeia/ National Formulary])
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the
      efficacy and safety of JZP-258.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects between 18 and 70 years of age, inclusive.

          2. Have a primary diagnosis of narcolepsy with cataplexy that meets ICSD-3 criteria or
             DSM-5 criteria, and currently untreated or treated with or without anticataplectics.

          3. If applicable, treated with a stimulant or alerting agent at unchanged doses for at
             least 2 months prior to dosing or not treated with a stimulant or alerting agent.

          4. Willing and able to comply with the study design schedule and other requirements.

          5. Willing and able to provide written informed consent.

        Exclusion Criteria:

          1. Narcolepsy secondary to another medical condition (e.g., CNS injury or lesion)

          2. History or presence of any unstable or clinically significant medical condition,
             behavioral or psychiatric disorder (including active suicidal ideation), or history or
             presence of another neurological disorder or surgical history that might affect the
             subject's safety and/or interfere with the conduct of the study in the opinion of the
             Investigator.

          3. Treatment with any central nervous system sedating agents, including but not limited
             to benzodiazepines, nonbenzodiazepine anxiolytics/ hypnotics/sedatives, neuroleptics,
             opioids, barbiturates, phenytoin, ethosuximide, or MCT inhibitors, e.g. diclofenac,
             valproate, ibuprofen, within 2 weeks prior to enrollment (discontinuation for the
             purpose of study enrollment is permitted only if considered safe by the Investigator
             and approved by the Medical Monitor).

          4. Treatment with an antidepressant for cataplexy, if the withdrawal of the
             antidepressant during cross-titration with JZP-258 might be unsafe due to prior
             history of depression.

          5. Unsafe for the subject to receive placebo treatment for 2 weeks, in the opinion of the
             Investigator.
PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: ADHD
Intervention: PRC-063 oral capsules; Placebo oral capsules
Intervention description: Daily dose; Daily dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase
      3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in adults
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females 18 to 60 years of age

          2. Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or
             predominately inattentive type) by a psychiatrist, psychologist, or licensed allied
             healthcare professional

          3. Subject is willing and able to comply with all the protocol requirements.

        Exclusion Criteria:

          1. Primary and/or comorbid psychiatric diagnosis other than ADHD

          2. Has a current or recent history of hypertension, symptomatic cardiovascular disease,
             advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious
             heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems
             that may place them at increased vulnerability to the sympathomimetic effects of a
             stimulant drug;

          3. Has used any investigational drug within 30 days of the screening visit;
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Dapagliflozin; Placebo for dapagliflozin
Intervention description: Tablets; Tablets
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 815.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Dapagliflozin; Efficacy; Safety; Add on to insulin; Oral Antidiabetic; Type 1 diabetes

Summary:

      The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and
      effective therapy to improve glycemic control in patients with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 1 Diabetes mellitus (T1DM)

          -  Central laboratory C-peptide < 0.7 ng/ml (0.23 nmol/L)

          -  Insulin use for at least 12 months per patient reported or medical records

          -  Method of insulin administration (MDI or CSII) must have been unchanged for at least 3
             months prior to screening

          -  Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior
             to screening

          -  If on MDI insulin administration, subject must be on ≥ 3x injections per day

          -  Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%

          -  Body mass index (BMI) ≥ 18.5 kg/m2

        Exclusion Criteria:

          -  History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young
             (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased
             beta cell capacity

          -  Taking any non-insulin antihyperglicemic agent within 1 month prior to screening

          -  Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly
             administration and within 1 month prior to screening for once or twice daily
             administration

          -  Taking metformin and/or thiazolidinediones within 2 months prior to screening

          -  History of diabetes ketoacidosis requiring medical intervention within 1 month prior
             to screening

          -  History of hospital admission for glycemic control (either hyperglycemia or
             hypoglycemia) within 1 month prior to screening

          -  Frequent episodes of severe hypoglycemia (more than one episode requiring medical
             assistance, emergency care), and/or glucagon therapy administered by a third-party
             individual within 1 month prior to screening

          -  History of Addison's disease
A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: TVP-1012 1mg
Intervention description: TVP-1012 1mg Tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 30 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in
      Japanese participants with early Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has completed the preceding study.

          -  The participant has shown no safety issues during the study treatment in the preceding
             study, in the opinion of the investigator or subinvestigator.

        Exclusion Criteria:

          -  The participant has undergone blood collection of >= 400 mL within 90 days prior to
             the start of treatment in this study.

          -  The participant is required to take any of the excluded medications or treatments.

          -  The participant is required surgery or hospitalization for surgery during the study
             period.
An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BMS-986165
Intervention description: Oral tablet administration
Intervention MeSH terms: Deucravacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate BMS-986165 given to Japanese participants with
      moderate-to-severe psoriasis.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

        a. For participants with plaque psoriasis: i. Stable plaque psoriasis for at least 6 months
        ii. Moderate to severe disease iii. Candidate for phototherapy or systemic therapy b.
        Additional protocol-specified inclusion criteria apply for subjects with psoriatic
        arthritis, erythrodermic psoriasis, or generalized pustular psoriasis

        Exclusion Criteria:

          1. Guttate, inverse, or drug-induced psoriasis at Screening or Baseline

          2. History of recent infection

          3. Prior exposure to BMS-986165

        Other protocol defined inclusion/exclusion criteria could apply
Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma
Condition: Hemangioma
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Intervention: Propranolol; Atenolol
Intervention description: Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24.; Initiated at a dosage of 0.5 mg/kg per day in a single dose for 1 week, and then increased to 1 mg/kg per day in a single dose from weeks 2 to 24.
Intervention MeSH terms: Propranolol; Atenolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 377.0
Sex: All
Maximum age: 24 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infantile hemangioma; Propranolol; Atenolol; Efficacy; Safety

Summary:

      The purpose of this study is to compare the efficacy of orally administered propranolol
      versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients younger than 24 weeks.

          -  Presenting a hemangioma with the following characteristics:

          -  Subcutaneous and/or cutaneous

          -  Minimum diameter of 1.5 cm on face, 3 cm outside face and 1.5 cm if it is ulcerated.

          -  Consent of both parents (or the person having parental authority in families)

        Exclusion Criteria:

          -  Infant presenting contraindications for the administration of propranolol or atenolol.

          -  Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only
             other treatments.

          -  Patients with an inability to participate or to follow the study treatment and
             assessment plan.
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: MED3000 (Male); Tadalafil 5mg (Male); MED3000 (Female); Tadalafil 5mg (Female)
Intervention description: Gel formulation; Tablets; Gel formulation; Tablets
Intervention MeSH terms: Tadalafil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets after a 4 -6 week screening period
Masking: None (Open Label)
Enrollment: 116.0
Sex: Male
Minimum age: 22 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of
      erectile dysfunction in patients from 22 to 70 years of age. Each patients will be expected
      to participate for up to 30 weeks. Eligible patients will be randomised to receive either
      MED3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male heterosexual patients aged 22-70 years.

          -  Confirmed clinical diagnosis of mild, moderate or severe ED for more than 3 months.

          -  Involved in a continuous heterosexual relationship with their partner for at least 6
             months.

        Exclusion Criteria:

          -  Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal,
             haematological, endocrinological, metabolic, neurological or psychiatric disease.

          -  History of unstable medical or psychiatric condition or using any medication that, in
             the opinion of the Principal Investigator, is likely to affect the patient's ability
             to complete the investigation or precludes the patient's participation in the
             investigation.
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: Botulinum Toxins, Type A; Placebos
Intervention description: Intramuscular injection; Intramuscular injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: glabellar lines, frown lines

Summary:

      This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to
      severe frown lines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent including authorization to release health information

          -  Moderate (2) or severe (3) glabellar lines during maximum frown based on the
             Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale

          -  Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient
             Frown Wrinkle Severity (PFWS) scale

          -  Willing and able to follow all trial procedures, attend all scheduled visits, and
             successfully complete the trial

        Exclusion Criteria:

          -  Any neurological condition that may place the subject at increased risk with exposure
             to botulinum toxin type A, including peripheral motor neuropathic diseases such as
             amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional
             disorders such as Lambert-Eaton syndrome and myasthenia gravis

          -  Active skin disease, infections or inflammation at the injection sites

          -  Plan to receive botulinum toxin type A anywhere in the face through the duration of
             the study

          -  History of allergy or sensitivity to any botulinum toxin preparations or to any
             component of the test article

          -  Current enrollment in an investigational drug or device trial or participation in such
             a trial within the last 30 days prior to screening through end of trial
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis
Condition: Genital Psoriasis; Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: genital

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of the study drug
      ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at
             least 6 months before baseline.

          -  Have moderate-to-severe psoriasis in the genital area at screening and baseline.

          -  Have plaque psoriasis in a nongenital area at screening and baseline.

          -  Have failed to respond to, or are intolerant of, at least 1 topical therapy used for
             treatment of psoriasis affecting the genital area.

          -  Must agree to use reliable method of birth control, which could include abstinence,
             during the study and for at least 12 weeks following the last dose of study drug.

        Exclusion Criteria:

          -  Pustular, erythrodermic, and/or guttate forms of psoriasis.

          -  History of drug-induced psoriasis.

          -  Have recently received certain treatments for psoriasis (in particular, within the
             past 4 weeks but the restriction can go up to 12 months for some treatments).

          -  Have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug
             with a similar mode of action.

          -  Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
             prior to baseline and during the study.

          -  Are currently enrolled in any other clinical trial involving an investigational
             product.

          -  Serious disorder or illness other than plaque psoriasis.

          -  Active or history of malignant disease within 5 years prior to baseline.

          -  Serious infection within the last 3 months.

          -  Have received a live vaccine within 3 months of baseline or plan to do so during the
             study.

          -  Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year.

          -  Pregnant or breastfeeding (lactating) women.