bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
Condition: Amatoxin Poisoning; Amanita Poisoning; Mushroom Poisoning; Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; Poisoning; Mushroom Poisoning
Intervention: Silibinin
Intervention description: 20 mg/kg continuous IV is over 24 hours
Intervention MeSH terms: Silybin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Healthy volunteers: No
Keywords: amatoxin; amanita; mushroom poisoning; hepatic failure; milk thistle; Silibinin; Legalon

Summary:

      Legalon® SIL will be administered to patients with amatoxin poisoning diagnosed by history,
      gastrointestinal symptoms, elevated liver enzymes, and/or diagnostic assay (should one become
      available). Patients may or may not also demonstrate abnormalities in bilirubin and/or
      creatinine. Treatment consists of a 5 mg/kg loading dose followed by 20 mg/kg/day via
      continuous infusion. The treating physician is expected to administer supportive therapy of
      his/her choosing but consistent with best practices. Legalon® SIL will be stopped when
      coagulopathy is no longer present, and when liver function tests have returned significantly
      towards the normal range. Patients will be followed 7-14 days after the end of Legalon® SIL
      therapy with follow up lab studies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed Informed Consent(s) for clinical trial participation (due to the potential
             critical status of the subject upon presentation, consent may need to be obtained from
             Legally Authorized Representative (LAR) per sites consenting policy and ICH/GCP
             guidance) Signed Informed Consent for Clinical Trial participation

          2. History of eating foraged mushrooms

          3. Gastrointestinal symptoms suggestive of amatoxin poisoning (cramping abdominal pain,
             nausea, vomiting, and / or watery diarrhea) usually 24-48 hours after of mushroom
             ingestion

          4. Liver function tests suggestive of amatoxin poisoning: AST or ALT above the
             institutions upper limit of normal after mushroom ingestion

        Exclusion criteria:

        1. Evidence of significant medical illness or any other abnormal laboratory finding that,
        in the Investigator's judgment, will substantially increase the risk associated with the
        subject's participation in, and completion of the study or could preclude the evaluation of
        the subject's response.
Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
Condition: Acute Anterior Uveitis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis
Intervention: LME636 60 mg/mL ophthalmic solution; Dexamethasone 0.1% ophthalmic solution; LME636 Vehicle
Intervention description: Inactive ingredients used for masking purposes
Intervention MeSH terms: Dexamethasone; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute anterior uveitis; LME636

Summary:

      The purpose of the study is to determine whether topical ocular administration of LME636 60
      mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC)
      associated with acute anterior uveitis (AAU).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent.

          -  Diagnosis of non-infectious AAU in at least 1 eye.

          -  Anterior chamber cell score of 2+ or 3+ as per Standardization of Uveitis Nomenclature
             (SUN) in at least one eye.

          -  Able to communicate well with the Investigator, to understand and comply with the
             requirements of the study.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of child-bearing potential unwilling to use effective contraception methods as
             defined in the protocol.

          -  AC cell score of 4+ (SUN) or hypopyon.

          -  Onset of anterior uveitis more than 2 weeks prior to enrollment in the study.

          -  Presence of intermediate-, posterior-, or panuveitis in either eye.

          -  Administration of stable doses >10 mg daily systemic prednisone or corticosteroids as
             described in the protocol.

          -  Recurrent corneal abrasion or ulceration in either eye (past or present).

          -  Tuberculosis (past or present).

          -  Other protocol-specified exclusion criteria may apply.
A Study in Adults and Adolescents With Angelman Syndrome (STARS)
Condition: Angelman Syndrome
MeSH terms: Angelman Syndrome; Syndrome
Intervention: OV101 Regimen 1; OV101 regimen 2; Placebo
Intervention MeSH terms: Gaboxadol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 13 Years
Maximum age: 49 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol)
      in adult and adolescent subjects with Angelman syndrome. In addition, several exploratory
      efficacy outcome measures will be investigated.
    

Eligibility criteria:

        Inclusion Criteria

          1. Age 13- 49 years

          2. Diagnosis of Angelman syndrome

          3. Receiving a stable regimen of concomitant medications for at least 4 weeks prior to
             Baseline, and able to maintain these throughout the duration of the study

          4. Has a caregiver capable of providing informed consent on behalf of the subject and
             able to attend scheduled study visits

          5. Able to ingest study medication

          6. Caregivers must agree not to post any subject or study information on social media

        Exclusion Criteria

          1. Unable to perform the study related safety and exploratory efficacy assessments, such
             as motor function

          2. Poorly controlled seizure activity

          3. Concomitant cardiovascular, respiratory, liver, renal, or hematologic diseases of a
             degree that would limit participation in the study

          4. Pregnancy or women of child-bearing potential who are not using and acceptable method
             of contraception

          5. Concomitant use of minocycline, levodopa, zolpidem, zaleplon, eszopiclone, ramelteon,
             and cannabinoid derivatives, or any other use of any investigational agent, device,
             and/or investigational procedure 4 weeks prior to Baseline and during the study

          6. Allergy to OV101 or any excipients

          7. At increased risk of harming self and/or others based on investigator assessment

          8. Any condition or reason that in the opinion of the investigator makes the subject
             unsuitable for enrollment

          9. Inability of subject or caregiver to comply with study requirements

        Other protocol-defined inclusion/exclusion criteria may apply.
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: elezanumab; placebo
Intervention description: solution for infusion; solution for infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Relapsing multiple sclerosis; Multiple sclerosis; Elezanumab; ABT-555

Summary:

      The purpose of this study is to evaluate the safety and efficacy of elezanumab in
      participants with relapsing Multiple Sclerosis (RMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has diagnosis of relapsing remitting multiple sclerosis (RRMS) or
             secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24
             months.

          -  Participant has cranial magnetic resonance imaging (MRI) demonstrating lesion(s)
             consistent with multiple sclerosis (MS).

          -  Participant has evidence of physical disability according to Expanded Disability
             Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.

        Exclusion Criteria:

        - Participants must not have experienced or be recovering from a clinical MS relapse within
        6 months of Screening.
Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Ganaxolone
Intervention description: oral suspension or capsules
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: PCDH19; ganaxolone; neurosteroid; CDKL5; LGS; CSWS

Summary:

      To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled
      seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an
      open-label proof-of-concept study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Have parent or legal guardian available and willing to give written informed consent.

          2. Male and female outpatients between 2 and 18 years of age years of age at time of
             consent.

          3. Have any of the following epilepsy syndromes: PCDH19; CDKL5; Dravet Syndrome; Lennox
             Gastaut Syndrome (LGS); Continuous Spikes and Waves during Sleep (CSWS)

          4. Have uncontrolled cluster seizures and/or non-clustered seizures.

          5. Subjects should be on a stable regimen of anti-epileptic medication, and generally in
             good health.

          6. Parent or guardian is able and willing to maintain an accurate and complete daily
             written seizure calendar.

          7. Able and willing to take study medication with food, two or three times daily.

        Key Exclusion Criteria

          1. Have had previous exposure to ganaxolone.

          2. Known sensitivity or allergy to any component in the study drug, progesterone, or
             other related steroid compounds.

          3. Exposure to any investigational drug or device < 90 days prior to screening, or plans
             to participate in another drug or device trial at any time during the study.

          4. Concurrent use of vigabatrin, tiagabine, or ezogabine is not permitted.

          5. Have any medical condition that, in the investigator's judgment, is considered to be
             clinically significant and could potentially affect subject safety or study outcome,
             including but not limited to: clinically significant cardiac, renal, pulmonary,
             gastrointestinal, hematologic or hepatic conditions; or a condition that affects the
             absorption, distribution, metabolism or excretion of drugs.

          6. Have active suicidal plan/intent, or have had active suicidal thoughts in the past 6
             months or a suicide attempt in the past 3 years.

          7. Have Alanine transferase (ALT; SGPT) or Aspartate transferase (AST; SGOT) levels > 3
             times upper limits of normal (ULN), or total bilirubin >1.5 time ULN at the screening
             and baseline visits.
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
Condition: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)
MeSH terms: Sinusitis; Chronic Disease
Intervention: LYR-210; Sham comparator
Intervention description: A single administration of LYR-210 depot; Sham comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to
      Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic
      Sinusitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of CS.

          -  Two trials of medical treatments for CS in the past.

          -  Minimum CS symptom score.

          -  Ability to tolerate topical anesthesia.

          -  Has been informed of the nature of the study and has provided written informed consent
             as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the
             respective clinical site.

          -  Agrees to comply with all study requirements.

        Exclusion Criteria:

          -  Have undergone previous sinus surgery.

          -  Pregnant or breast feeding.

          -  Known history of hypersensitivity or intolerance to corticosteroids.

          -  History or clinical evidence or suspicion of invasive fungal sinusitis, allergic
             fungal rhinosinusitis, or atrophic rhinitis.

          -  Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning
             serum cortisol level at screening outside of the normal range.

          -  Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening
             visit.

          -  Past or present functional vision in only one eye.

          -  Has cataracts

          -  Past, present, or planned organ transplant or chemotherapy with immunosuppression.

          -  Currently participating in an investigational drug or device study
Evaluation 2% Chlorhexidine Gluconate
Condition: Skin Coverage
Intervention: 2% CHG
Intervention description: Chlorhexidine Gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Medline 2% CHG cloth (Active) - A single cloth from the pack was used per treatment area. The
      investigational test article was applied topically by vigorously scrubbing the skin in a back
      and forth motion for three minutes (and halfway through the 3-minute application time, the
      cloth was turned over) over the treatment area (7" x 10" of the subject's back), and the skin
      was allowed to air dry.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy males of at least 18 years of age having skin within 6 inches of the test regions
        that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders,
        with no history of sensitivity to CHG and were able to lie prone for up to 30 minutes.
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).
Treatment of Hemoglobin SC Disease With Hydroxyurea
Condition: Hemoglobin SC Disease
MeSH terms: Hemoglobin SC Disease
Intervention: hydroxyurea
Intervention description: Treat symptomatic HbSC patients to MTD on hydroxyurea, and assess for clinical improvement using the PedsQL™ Sickle Cell Disease Module version 3.0 after 6 months at MTD, compared to entrance scores
Intervention MeSH terms: Hydroxyurea
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 5 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Hemoglobin SC disease; hydroxyurea; quality of life; viscosity; red cell density

Summary:

      Sickle cell disease (SCD), specifically hemoglobin SC disease (HbSC), is a subtype of sickle
      cell disease with typically higher hemoglobin and milder or later disease complications.
      Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped. This
      can result in painful episodes, serious infections, and damage to body organs. One medication
      used to treat sickle cell disease is hydroxyurea.

      Hydroxyurea therapy offers significant benefits for infants, children, and adolescents with
      sickle cell anemia. These include a reduction in the frequency of pain crises and acute chest
      syndrome (inflammation of the lungs). Hydroxyurea has been given to many HbSC patients but
      HbSC patients were not included in the large clinical trials used to test hydroxyurea in SCD,
      so less is known about how HbSC patients respond to hydroxyurea.

      The purpose of this research study is to see if hydroxyurea, a medication given to many
      children with the most common type of sickle cell, those who are homozygous for the sickle
      mutation (HbSS), helps children who have HbSC. The investigators will see if it helps by
      giving a questionaire when the medication is started, and then every two months at a clinic
      visit. The questionaire, called the Pediatric Quality of Life Inventory (PedsQL™) Sickle Cell
      Disease Module version 3.0, measures quality of life. The investigators will also see how
      hydroxyurea changes laboratory test numbers, and blood thickness.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of HbSC disease

          2. Score equal or lower than 80 on the PedsQL™ Sickle Cell Disease Module version 3.0

          3. Have experienced a sickle cell disease related complication

        Exclusion Criteria:

          1. Failure to meet inclusion criteria.

          2. Hydroxyurea usage in the last 3 months.

          3. Chronic RBC transfusion therapy.

          4. Packed red blood cell transfusion in the last 3 months (temporary exclusion).

          5. Pregnancy, or refusal to use medically effective birth control if female and sexually
             active.
Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution
Condition: Ocular Hypertension; Open Angle Glaucoma
MeSH terms: Glaucoma, Open-Angle; Ocular Hypertension
Intervention: Netarsudil ophthalmic solution 0.02%; Netarsudil Ophthalmic Solution Vehicle
Intervention description: Once daily in both eyes (OU) in the evening (PM) for 7 days; Once daily in both eyes (OU) in the evening (PM) for 7 days
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: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal
      Intraocular Pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older.

          2. Ocular hypertension or open-angle glaucoma in both eyes.

          3. Unmedicated intraocular pressure > 17 mmHg in one or both eyes and < 30 mmHg in both
             eyes.

          4. Corrected visual acuity in each eye equivalent to 20/200 or better.

          5. Able and willing to give signed informed consent and follow study instructions.

        Exclusion Criteria:

          1. Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle
             closure, narrow angles.

          2. Intraocular pressure ≥ 30 mmHg.

          3. Use of ocular medications within 30 days.

          4. Known hypersensitivity to any component of the test formulations or to medications
             used routinely during a clinical eye examination.

          5. Previous eye surgery (other than cataract).

          6. Ocular trauma within 6 months.

          7. Clinically significant ocular disease that might interfere with the study.

          8. Central corneal thickness greater than 620 µm.