bioihbjkbjnl/mcl2 huggingface dataset:
Anti-vasculaR Endothelial Growth Factor plUs Anti-angiopoietin 2 in Fixed comBination therapY: Evaluation for the Treatment of Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: REGN910-3; Intravitreal Aflibercept Injection (IAI)
Intervention description: Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to compare the efficacy of intravitreal
      (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in
      improving best corrected visual acuity (BCVA) in participants with diabetic macular edema
      (DME).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus who have
             clinically significant DME with central involvement in the study eye

          2. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the
             study eye

          3. Willing and able to comply with clinic visits and study-related procedures

          4. Provide signed informed consent

        Key Exclusion Criteria:

          1. Evidence of macular edema due to any cause other than diabetes mellitus in either eye

          2. IVT anti-VEGF in the study eye within 12 weeks of the screening visit

          3. Panretinal laser photocoagulation or macular laser photocoagulation in the study eye
             within 3 months of screening

        Note: Other inclusion/ exclusion criteria apply
A Research Study for Patients With Overactive Bladder
Condition: Overactive Bladder; Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive
Intervention: botulinum toxin Type A; Placebo
Intervention description: botulinum toxin Type A injected into detrusor on Day 1; Placebo (normal saline) injected into detrusor on Day 1
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate whether injections of botulinum toxin Type A into
      the bladder are safe and effective in treating overactive bladder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be between 18-85 years old

          -  Must have been diagnosed by his/her doctor with overactive bladder at least 6 months
             ago

          -  Must weigh at least 50 kg (110 lbs)

          -  Must be willing and able to record information regarding bladder function into a diary
             (provided)

          -  Must be willing and able to complete the entire course of the study

        Exclusion Criteria:

          -  Cannot currently be catheterizing as a way to control incontinence

          -  Must not have used botulinum toxin type A or any other botulinum toxin previously for
             any condition
Dose-ranging Study in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Placebo; Sotagliflozin
Intervention description: Placebo, once daily, before the first meal of the day; Sotagliflozin,once daily, before the first meal of the day
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to define the dose leading to desirable efficacy, as
      measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant had given written informed consent to participate in the study in
             accordance with local regulations.

          -  Adult participants 18 years and older with a diagnosis of type 1 diabetes mellitus
             (T1D) made at least 1 year prior to informed consent.

          -  Participants were being treated with insulin or insulin analog delivered via
             continuous subcutaneous insulin infusion (CSII) or multiple daily injection (MDI).

          -  At the Screening Visit, A1C had to be between 7.0% and 10.0%.

          -  Females of childbearing potential had to use an adequate method of contraception and
             have a negative pregnancy test.

        Exclusion Criteria:

          -  Use of antidiabetic agent other than insulin or insulin analog at the time of
             screening.

          -  Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to
             screening.

          -  Chronic systemic corticosteroid use.

          -  Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the
             Investigator.
Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Levetiracetam
Intervention description: Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).
For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily).
Intervention MeSH terms: Levetiracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 1 Month
Maximum age: 4 Years
Healthy volunteers: No
Keywords: Epilepsy; Child; Levetiracetam; Keppra®; Infusion; Intravenous

Summary:

      Keppra injection is approved in the US as adjunctive therapy in the treatment of partial
      onset seizures in adults with epilepsy. The objective of the current study is to assess the
      safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4
      years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between 1 month and 4 years of age, inclusive

          -  The subject suffers from epilepsy (except status epilepticus)

          -  The subject is requiring levetiracetam IV treatment in place of oral therapy for a
             short period of time

        Exclusion Criteria:

          -  The subject has difficult venous accessibility

          -  History of status epilepticus during the 3 months prior to Screening

          -  The subject is on felbamate with less than 18 months continuous exposure before
             Screening.

          -  The subject presents with current depressive symptoms, current suicidal ideation
             and/or behavior.
Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
Condition: Healthy Volunteers
MeSH terms: Dengue
Intervention: TDV
Intervention description: TDV SC injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 4 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the cellular immune responses following 2 doses given
      3 months apart of tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy
      participants.
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Is aged 4 to 16 years, inclusive (Latin America) or 4 to 8 years, inclusive (Asia).

          2. Are in good health at the time of entry into the study as determined by medical
             history, physical examination (including vital signs), and clinical judgment of the
             investigator.

        Main Exclusion Criteria:

          1. Febrile illness (body temperature ≥38°C) or moderate or severe acute illness or
             infection at the time of enrolment.

          2. History or any illness that, in the opinion of the investigator, might interfere with
             the results of the study or pose an additional risk to the participant due to
             participation in the study.

          3. Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days
             (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccines
             within 28 days after Day 1 (Month 0).

          4. Previous participation in any clinical study of a dengue candidate vaccine, or
             previous receipt of any dengue vaccines (investigational or licensed).
Efficacy and Safety of CD5024 1% in Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: CD5024 1% cream; CD5024 cream placebo; CD0271/CD1579 gel; CD0271/CD1579 gel placebo
Intervention description: 500 µL on half-face, five days a week during 6 weeks; 500 µL on half-face, five days a week during 6 weeks; 500 µL on half-face, five days a week during 6 weeks; 500 µL on half-face, five days a week during 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using
      intra-individual comparison involving subjects with acne vulgaris on face to evaluate the
      efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject is a male or a female aged from 18 to 35 years old at screening visit.

          2. The subject has a medical diagnosis of acne vulgaris :

             2.1 at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred)
             non-inflammatory lesions (nose is excluded for the lesion count) at Baseline

             2.2 symmetry of the lesions: No more than twice as many acne lesions on one side as
             compared to the other side at Baseline

          3. If the subject is a female of childbearing potential, she must agree to use an
             effective contraceptive method for the duration of the study

        Exclusion Criteria:

          1. The subject has an underlying known disease surgical or medical condition, in the
             opinion of the investigator might interfere with interpretation of the study results
             or put the subject at risk (e.g., other dermatological diseases affecting the
             treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or
             serious diseases which would normally prevent participation in any clinical study,
             such as a cancer, leukemia or severe hepatic impairment), (Screening).

          2. The subject has acne conglobata, acne fulminans, secondary acne (chloracne,
             drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.

          3. The subject has a known or suspected allergies or sensitivities to any components of
             any of the study drugs (see Investigator's Brochure/Product label).

          4. The subject is a male with beard or facial hair, which would interfere with clinical
             evaluation or clinical procedure (Screening and Baseline).
Vitamin D to Prevent Autism in Newborn Siblings
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Intervention: Vitamin D3
Intervention description: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 20 Years
Maximum age: 44 Years
Healthy volunteers: No
Keywords: Autism; Pregnancy; Newborn siblings

Summary:

      The purpose of this study is to determine whether by administering vitamin D to mothers who
      already have at least one child with autism and who are pregnant, that the vitamin D will
      prevent the recurrence of autism in the newborn sibling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant mothers who have had at least one child with autism spectrum disorder

        Exclusion Criteria:

          -  Child with autism must not be from a syndrome such as Fragile X syndrome, Retts
             Syndrome

          -  Mother must be before the third trimester
Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Intervention: Escitalopram
Intervention description: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Intervention MeSH terms: Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Selective Serotonin Reuptake Inhibitor; Escitalopram; Borderline Personality Disorder; Major Depressive Disorder; Self-harm

Summary:

      The goal of this study is to examine the effectiveness the selective serotonin reuptake
      inhibitor (SSRI) escitalopram (also known by the trade name "Lexapro") in reducing desire to
      self-harm and actual self-harming among young adults with borderline personality disorder who
      are also currently depressed. Subjects will receive either escitalopram or placebo for eight
      weeks. During this time subjects will be make weekly visits to see the psychiatrist and
      record their thoughts and feelings several times each day using an electronic diary.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Borderline Personality Disorder

          -  Current Major Depression

        Exclusion Criteria:

          -  Past 2 months SSRI use

          -  Past 6 months non-SSRI antidepressant use

          -  Past 2 months initiation of psychotherapy

          -  Lifetime bipolar disorder, organic disorder, psychotic disorder

          -  Current alcohol or drug dependence

          -  Current severe suicidal / homicidal ideation necessitating immediate medical
             intervention

          -  Currently pregnancy or nursing

          -  Unable or unwilling to cooperate with study protocol
Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy
MeSH terms: Myotonic Dystrophy
Intervention: Mexiletine; Placebo
Intervention description: 150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months; 150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
Intervention MeSH terms: Mexiletine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Myotonic Dystrophy; Myotonic Dystrophy Type 1 (DM1); Muscular Dystrophy; Mexiletine

Summary:

      The purpose of this study is to investigate the effects of mexiletine treatment for 6 months
      on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning,
      cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of DM1, confirmed by DM1 genetic mutation

          -  Ability to walk 30 feet (assistance with cane and/or leg bracing permitted)

          -  Presence of grip myotonia

        Exclusion Criteria:

          -  Congenital DM1

          -  Treatment with Mexiletine within past 8 weeks

          -  Second or third degree heart block, atrial flutter, atrial fibrillation, ventricular
             arrhythmias, or is receiving medication for treatment of a cardiac arrhythmia

          -  Receiving another antimyotonia drug

          -  Liver or kidney disease requiring ongoing treatment

          -  Has a seizure disorder

          -  Is pregnant or lactating

          -  Had severe depression within 3 months or a history of suicide ideation

          -  Has any one of the following medical conditions: uncontrolled diabetes mellitus,
             congestive heart failure, symptomatic cardiomyopathy, symptomatic coronary artery
             disease, cancer (other than skin cancer) less than five years previously, multiple
             sclerosis, or other serious medical illness.

          -  Drug or alcohol abuse within 3 months

          -  Coexistence of another neuromuscular disease

          -  Is unable to give informed consent

          -  Severe arthritis or other medical condition (besides DM1) that would significantly
             impact ambulation
PTG-300 in Subjects With Hereditary Hemochromatosis
Condition: Hereditary Hemochromatosis
MeSH terms: Hemochromatosis; Hemosiderosis
Intervention: PTG-300
Intervention description: Active treatment with PTG-300 injected subcutaneously.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single Arm Study
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will be conducted at multiple sites and every patient will get treated with
      PTG-300. The objective of the study is to assess the effect of PTG-300 in treating adult
      hereditary hemochromatosis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged 18 and older

          -  Confirmed diagnosis of HFE-related hereditary hemochromatosis with prior genotype
             testing

          -  Documented stable phlebotomy for ≥ 6 months

          -  Screening hemoglobin >11.5 g/dL

          -  Documented evidence of prior serum ferritin ≥500 ng/mL

          -  Serum ferritin >50 ng/mL and <300 ng/mL at screening

        Exclusion Criteria:

          -  Clinically meaningful laboratory abnormality

          -  Receiving iron chelation therapy

          -  Receiving erythrocytapheresis

          -  Pregnant or lactating females

          -  Infection requiring hospitalization or intravenous antimicrobial therapy, or
             opportunistic infection within 3 months of dosing; any infections requiring
             antimicrobial therapy within 4 weeks of dosing.

          -  Serious or unstable medical or psychiatric condition that would prevent subject
             providing informed consent

          -  Organ damage from iron overload

          -  Primary or secondary immunodeficiency

          -  Positive hepatitis B or hepatitis C or known human immunodeficiency virus infection

          -  Known history of autoimmune/inflammatory diseases

          -  Any surgical procedures requiring general anesthesia within 1 month prior to screening
             or planned surgery during study

          -  History of invasive malignancies within last 2 years, except non-malignant skin cancer
             and local cured prostate cancer, cervical cancer, or ductal carcinoma in situ

          -  Receipt of an investigational agent within 30 days of screening