bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Fosmetpantotenate (RE-024) in PKAN Participants
Condition: Pantothenate Kinase-Associated Neurodegeneration
MeSH terms: Pantothenate Kinase-Associated Neurodegeneration; Nerve Degeneration
Intervention: Fosmetpantotenate; Placebo
Intervention description: Daily dosing; Daily dosing
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 6 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: PKAN

Summary:

      This study investigated whether fosmetpantotenate (RE-024), a phosphopantothenate replacement
      therapy, was safe and effective in treating participants with PKAN.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant had a diagnosis of PKAN as indicated by confirmed mutations in the
             pantothenate kinase 2 gene.

          2. The participant was male or female aged 6 to 65 years, inclusive.

          3. The participant had a score of ≥ 6 on the PKAN-specific activities of daily living
             measure.

        Exclusion Criteria:

          1. The participant had required regular or intermittent invasive ventilatory support to
             maintain vital signs within 24 weeks prior to randomization.

          2. The participant had a deep brain stimulation device implanted within 6 months prior to
             screening.

          3. The participant had taken deferiprone within 30 days prior to screening.

          4. The participant was unable to maintain stable doses of allowed concomitant medications
             for the first 24 weeks of the study.
An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
Condition: Tuberous Sclerosis Complex; Seizures
MeSH terms: Tuberous Sclerosis; Seizures; Sclerosis
Intervention: GWP42003-P
Intervention description: Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Minimum age: 1 Year
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The
      open-label extension phase only will be described in this record. All participants will
      receive the same dose of GWP42003-P. However, investigators may subsequently decrease or
      increase the participant's dose until the optimal dose is found.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completion of the GWEP1521 Blinded Phase
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
Condition: Keratitis; Corneal Ulcer
MeSH terms: Corneal Ulcer; Keratitis; Ulcer
Intervention: T4020; Vehicle
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients diagnosed with one chronic keratitis/corneal ulcer

          -  Patients who signed and dated informed consent

        Exclusion Criteria:

          -  Patient under 18 years

          -  Patient with a perforated corneal ulcer OR any risk of immediate perforation of
             corneal ulcer.
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Condition: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267; ABT-333; Ribavirin (RBV)
Intervention description: Tablet for oral use; Tablet for oral use; Ribavirin was provided as 200 mg tablets, and dosed based on weight, 1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 615.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Hepatitis C Genotype 1; Compensated Cirrhosis; Cirrhosis; Naïve; Hepatitis C; Hepatitis C Virus; Treatment-Experienced; Relapser; Null responder; Non responder

Summary:

      The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated
      with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without
      ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Females must be post-menopausal for more than 2 years or surgically sterile or
             practicing specific forms of birth control

          2. Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at
             screening)

          3. HCV genotype 1 infection per screening laboratory result

        Exclusion Criteria:

          1. Use of contraindicated medications within 2 weeks of dosing

          2. Abnormal laboratory tests

          3. Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody

          4. History of solid organ transplant, clinical evidence of Child-Pugh B or C
             classification or clinical history of liver decompensation

          5. Presence of hepatocellular carcinoma at screening
Metoclopramide for Post Traumatic Headache
Condition: Post-Traumatic Headache
MeSH terms: Post-Traumatic Headache; Headache
Intervention: Metoclopramide; Diphenhydramine; Normal saline
Intervention description: Metoclopramide 20mg; Diphenhydramine 25mg; 100ml normal saline
Intervention MeSH terms: Diphenhydramine; Promethazine; Metoclopramide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Nearly 1.5 million patients present to US emergency departments annually following head
      trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study
      is to see if an intravenous medication called metoclopramide can improve the symptoms of
      patients with acute post-traumatic headache.
    

Eligibility criteria:

        Inclusion Criteria:

        Included patients will be adults who meet International Classification of Headache
        Disorders criteria for acute post-traumatic headache. These are as follows:

          -  Traumatic injury to the head has occurred

          -  Headache has developed within 7 days of injury to the head

          -  Headache is not better accounted for by another diagnosis (eg, previous history of
             migraine or tension-type headache)

        The headache must be rated as moderate or severe in intensity at the time of initial
        evaluation.

        Exclusion Criteria:

        Patients will be excluded if more than ten days have elapsed since the head trauma, if the
        headache has already been treated with an anti-dopaminergic medication, or for medication
        contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use
        of MAO inhibitors, and use of anti-rejection transplant medications.
A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Dexamethasone, 0.4mg; Placebo plug with no drug
Intervention description: Ophthalmic Insert; Ophthalmic Insert
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to evaluate the efficacy and safety of OTX-DP as a
      dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the
      treatment of the signs and symptoms of allergic conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a positive history of ocular allergies and a positive skin test reaction to a
             perennial allergen and a seasonal allergen

          -  Has a positive bilateral CAC reaction to a perennial allergen within minutes of
             instillation

        Exclusion Criteria:

          -  History of refractive surgery (including LASIK procedures) within the past 2 years

          -  History of retinal detachment, diabetic retinopathy, or active retinal disease

          -  Presence of an active ocular infection or positive history of an ocular herpetic
             infection at any visit

          -  History of IOP increase as a result of steroid treatment

          -  A female who is currently pregnant, planning a pregnancy, or lactating
A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY900014; Insulin Glargine
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being done to evaluate glycemic control in participants with type 2 diabetes
      who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine.
      Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system)
      during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed (clinically) with type 2 diabetes mellitus (T2D) for at least 1
             year prior to screening.

          -  Have been treated with basal-bolus multiple daily injection (MDI) therapy for at least
             90 days prior to screening including:

               -  Basal insulin glargine U-100, in combination with bolus insulin analog (insulin
                  lispro, insulin aspart, or insulin glulisine) with meals.

               -  Participant must have been treated with the same type of allowed bolus insulin
                  analog for at least 30 days prior to screening.

          -  Participants may be treated with up to 3 of the following oral antihyperglycemic
             medications (OAMs) for T2D in accordance with local regulations:

               1. Metformin

               2. Dipeptidyl peptidase-4 (DPP-4) inhibitor

               3. sodium glucose cotransporter 2 (SGLT2) inhibitor

               4. oral glucagon-like peptide 1 (GLP-1) agonist

          -  Doses of OAMs are required to have been stable for at least 90 days prior to
             screening.

          -  Participants may be treated with injectable GLP-1 receptor agonist for T2D in
             accordance with local regulations. The GLP-1 receptor agonist dose is required to have
             been stable for at least 90 days prior to screening.

          -  Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening.

        Exclusion Criteria:

          -  Have been diagnosed at any time with type 1 diabetes mellitus or latent autoimmune
             diabetes in adults.

          -  Have had any episode of severe hypoglycemia (defined as requiring assistance due to
             neurologically disabling hypoglycemia) within 6 months prior to screening.

          -  Have had any episode of hyperglycemic hyperosmolar state or diabetic ketoacidosis
             within 6 months prior to screening.

          -  Have hypoglycemia unawareness as judged by the investigator.
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Condition: Bilateral Middle Ear Effusion
MeSH terms: Otitis Media with Effusion
Intervention: OTO-201
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with
      bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will
      receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the
      middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The
      study is designed to characterize safety and any procedural issues associated with TTT drug
      administration of OTO-201.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject is a male or female aged 6 months to 17 years, inclusive

          -  Subject has a clinical diagnosis of bilateral middle ear effusion requiring
             tympanostomy tube placement

          -  Subject's caregiver is willing to comply with the protocol an attend all study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has a history of prior ear or mastoid surgery, not including myringotomy or
             myringotomy with tympanostomy tube placement

          -  Subject has a history of sensorineural hearing loss

          -  Subject has been designated for any other surgical procedure that would occur
             concurrently with TT placement, such as, but not limited to adenoidectomy or
             tonsillectomy
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
Condition: Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Evolocumab; Placebo
Intervention description: Dose of subcutaneous evolocumab every 4 weeks; Dose of subcutaneous placebo treatment every 4 weeks
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 158.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Hypercholesterolemia; Elevated Cholesterol; High Cholesterol; Heterozygous Familial Hypercholesterolemia; PCSK9 mutations; Paediatric; pediatric; Childhood Familial Hypercholesterolemia

Summary:

      A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged
      10-17 years diagnosed with heterozygous familial hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 10 to ≤ 17 years of age (before 18th birthday)

          -  Diagnosis of heterozygous familial hypercholesterolemia

          -  On an approved statin with stable optimized dose for ≥ 4 weeks

          -  Other lipid-lowering therapy stable for ≥ 4 weeks (fibrates must be stable for ≥ 6
             weeks)

          -  Fasting LDL-C ≥ 130 mg/dL (3.4 mmol/L)

          -  Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

        Exclusion Criteria:

          -  Type 1 diabetes, or type 2 diabetes that is or poorly controlled

          -  Uncontrolled hyperthyroidism or hypothyroidism

          -  Cholesterylester transfer protein (CETP) inhibitor in the last 12 months, or
             mipomersen or lomitapide in the last 5 months

          -  Previously received evolocumab or any other investigational therapy to inhibit
             proprotein convertase subtilisin/kexin type 9 (PCSK9).

          -  Lipid apheresis within the last 12 weeks prior to screening.

          -  Homozygous familial hypercholesterolemia
Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq
Condition: Turner Syndrome; Renal Insufficiency, Chronic; Pituitary Diseases; Dwarfism
MeSH terms: Dwarfism; Pituitary Diseases; Renal Insufficiency; Turner Syndrome; Gonadal Dysgenesis; Renal Insufficiency, Chronic
Intervention: Somatropin (rDNA origin)
Intervention description: Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: growth; child development; growth hormone; inadequate growth hormone secretion; growth failure

Summary:

      The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq
      treated children, using newly developed capillary blood spot IGF-1 measurement technology.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children under 18 with growth failure associated with inadequate growth hormone
             secretion, or Turner syndrome or chronic renal insufficiency.

        Exclusion Criteria:

          -  Children with closed epiphyses

          -  Children with active neoplasm

          -  Children with acute critical illness
JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo; PF-04965842; PF04965842
Intervention description: Placebo; 100 mg QD; 200 mg QD
Intervention MeSH terms: Abrocitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 287.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis, JAK1 inhibitor

Summary:

      This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to
      evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to <18 years of
      age with moderate to severe AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged between 12 and to 17 with a minimum body weight of 40 kg

          -  Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate
             to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS
             severity 4)

        Exclusion Criteria:

          -  Acute or chronic medical or laboratory abnormality that may increase the risk
             associated with study participation

          -  Unwilling to discontinue current AD medications prior to the study or require
             treatment with prohibited medications during the study

          -  Prior treatment with JAK inhibitors

          -  Other active non-AD inflammatory skin diseases or conditions affecting skin

          -  Medical history including thrombocytopenia, coagulopathy or platelet dysfunction,
             malignancies, current or history of certain infections, lymphoproliferative disorders
             and other medical conditions at the discretion of the investigator

          -  Pregnant or breastfeeding women, or women of childbearing potential who are unwilling
             to use contraception
Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion
Condition: Other Abnormal Granulation Tissue Nos
Intervention: Silver Nitrate; Kenalog (Triamcinolone); Washcloth Abrasion
Intervention description: Silver nitrate to be applied 3 times weekly for a period of 3 weeks.; Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.; Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.
Intervention MeSH terms: Silver Nitrate; Triamcinolone; Triamcinolone Acetonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Granulation tissue, or excess tissue, forms around gastrostomy tube sites and is a common
      problem seen in the pediatric surgery population. There is no standard treatment that has
      been identified in clinical practice to treat granulation tissue effectively. Clinicians
      prescribe treatments of varying nature to help treat this condition. By conducting this
      study, the investigators hope to identify if there is any difference in the treatment groups
      and if there is any superiority for one treatment over the other. The three arms in the study
      are Silver Nitrate treatment, treatment with Kenalog, and Washcloth abrasion. Treatments will
      continue over a period of three weeks, and the progress will be followed using surveys and
      photographs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient falling within age group with granulation tissue around G tube site

        Exclusion Criteria:

          -  Patients falling outside of age group range