bioihbjkbjnl/mcl2 huggingface dataset:
Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder
Condition: CDKL5 Deficiency Disorder
Intervention: ganaxolone; Placebo
Intervention description: active drug; inactive
Intervention MeSH terms: Pregnanolone; Ganaxolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The double-blind phase will randomize subjects to adjunctive ganaxolone or placebo at a 1:1 ratio to standard of care
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 2 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: refractory seizures; genetic pediatric encephalopathies; epilepsy in children; seizure disorder

Summary:

      A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone
      therapy compared to placebo for the treatment of seizures in children and young adults with
      genetically confirmed CDKL5 gene mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genetically confirmed CDKL5 gene mutation, seizure onset by 1 year of age and lack of
             independent ambulation by 2 years of age

          -  Failure to control seizures despite 2 or more anti-seizure medications

          -  At least 16 seizures per 28 days of primary seizure types

          -  On a stable regimen of 0-4 anti-seizure medications (Vagus nerve stimulator, ketogenic
             diet, and modified Atkins diet do not count towards this limit)

          -  Additional Inclusion Criteria apply and can be discussed with study team

        Exclusion Criteria:

          -  Previous exposure to ganaxolone

          -  West Syndrome with hypsarrhythmia pattern on EEG or seizures predominantly of
             Infantile Spasms type

          -  Use of adrenocorticotropic hormone (ACTH), prednisone or other glucocorticoid or use
             of moderate or strong inducers or inhibitors of CYP3A4/5/7 are prohibited

          -  Use of tetrahydrocannabinol (THC) or cannabidiol (CBD) is prohibited during the
             double-blind phase, unless patient has a prescription of Epidiolex®

          -  Exposure to any other investigational drug within 30 days or fewer than 5 half-lives
             prior to screening

          -  Plasma allopregnanolone-sulfate (Allo-S) levels greater than or equal to 6.0 ng/ml at
             screening visit

          -  Additional Exclusion Criteria apply and can be discussed with study team
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: DCV/ASV/BMS-791325
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Healthy volunteers: No

Summary:

      To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed
      dose combination in Genotype 1 Chronic Hepatitis C subjects.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subject chronically infected with HCV genotype 1 (GT-1)

          -  Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)

          -  HCV RNA ≥ 10,000 IU/mL at screening

          -  Treatment-naïve subject with no previous exposure to an interferon formulation (ie,
             IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)

          -  Interferon (IFN) experienced subject who have received previous treatment with IFNα,
             with or without RBV

        Exclusion Criteria:

          -  Liver or any other transplant (including hematopoietic stem cell transplants) other
             than cornea and hair;

          -  Current or known history of cancer (except in situ carcinoma of the cervix or
             adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
             to screening;

          -  Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously
             obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy
             if this was performed);

          -  Evidence of decompensated liver disease including, but not limited to, radiologic
             criteria, a history or presence of ascites, bleeding varices, or hepatic
             encephalopathy
SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
Condition: Exocrine Pancreatic Insufficiency; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: Liprotamase Powder for Oral Solution
Intervention description: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 28 Days
Healthy volunteers: No
Keywords: Exocrine Pancreatic Insufficiency; Cystic Fibrosis; Liprotamase; Pancreatic Enzyme Replacement Therapy (PERT)

Summary:

      Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and
      amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be
      formulated without enteric coating for administration either as a capsule or as a dosing
      solution dissolved in water or juice. The purpose of the present study is to provide efficacy
      and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral
      Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  For Part A: males or females ≥7 years of age

          -  For Part B: males or females 28 days to <7 years

          -  Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride

          -  Low fecal elastase

          -  Fair-to-good nutritional status

        Exclusion Criteria:

          -  History or diagnosis of fibrosing colonopathy

          -  Distal intestinal obstruction syndrome in 6 months prior to screening

          -  Receiving enteral tube feedings

          -  Chronic diarrheal illness unrelated to pancreatic insufficiency

          -  Liver abnormalities, or liver or lung transplant, or significant bowel resection
Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
Condition: Juvenile Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile
Intervention: Etanercept; Placebo
Intervention description: Administered by subcutaneous injection twice a week; Administered by subcutaneous injection twice a week
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Systemic Onset Juvenile Rheumatoid Arthritis; SOJRA; Fever; Rash; Joint Pain

Summary:

      The primary objective of this study was to determine the efficacy of etanercept in pediatric
      patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  2 - 18 years of age

          -  SOJRA for at least 3 months, with stable systemic features

          -  If taking methotrexate, hydroxychloroquine, or NSAIDs, dose must be stable

          -  Must take prednisone at a stable dose

        EXCLUSION CRITERIA:

          -  Need for other DMARDs or prestudy requirements for oral or parenteral pulse steroids
             or intra-articular steroids

          -  Pregnant or nursing female

          -  Clinically significant abnormal laboratory test results for blood cells, liver or
             kidney function, or serology

          -  Previous receipt of any tumor necrosis factor (TNF) inhibitor

          -  Live virus vaccine within 12 weeks of study entry

          -  Participation in another study requiring informed consent within 12 weeks of entry

          -  Diabetes that requires insulin treatment

          -  Infection, chronic, recurrent, or currently active

          -  Any serious medical or psychiatric condition or history of alcohol or drug abuse
Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT
Condition: Cetuximab-induced Papulopustular (Acneiform) Rash Who Have; Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma
MeSH terms: Squamous Cell Carcinoma of Head and Neck
Intervention: Topical Dapsone 5% Gel; Moisturizer; oral antibiotics
Intervention description: The moisturizer for the study will be Vanicream™ Lite Lotion.
Intervention MeSH terms: Anti-Bacterial Agents; Dapsone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Topical Dapsone 5% Gel; Moisturizer; rash; 13-012

Summary:

      The purpose of this study is to see if the investigators can prevent or reduce the severity
      of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin.
      One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an
      FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin
      moisturizers are recommended to patients who receive Cetuximab treatment. In addition to
      these topical agents they will be given a pill to take once a day. This pill has already been
      shown to help fight rashes from Cetuximab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years or older with underlying diagnosis of metastatic colorectal cancer
             or head and neck squamous cell carcinoma including newly diagnosed patient

          -  Patients must provide written informed consent to participate in the study

          -  Anticipated initiation of cetuximab treatment with or without additional chemotherapy.

          -  Able to self-administer topical interventions or provide for another person to apply
             the topical interventions

        Exclusion Criteria:

          -  Females of childbearing potential who are pregnant or nursing

          -  Patients with allergy, hypersensitivity or other contraindication to dapsone, sulfa
             antibiotics, or excipients of the dapsone gel product

          -  Patients with pre-existing dermatologic condition affecting the face and chest that
             would impair assessment of papulopustular rash including dense and/or long facial hair
             (per investigator discretion)

          -  Patients currently using prescription and/or over-the-counter topical medications to
             the face and/or chest who are unwilling to discontinue use during the trial
             intervention period (day 0 ± 2 days through day 28 ± 2 days)

          -  Previous or concurrent radiation therapy to head, neck, and chest (i.e. application
             sites only)

          -  Previous therapy with cetuximab within 6 months of consent
Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Investigational Medical Product (IMP) administered in parent study
Intervention description: IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A4091064 is a multicenter, long-term observational study of subjects from tanezumab
      interventional studies (regardless of treatment group) who undergo a total knee, hip or
      shoulder replacement during participation in the study. The study is designed with a total
      duration of subject follow-up of 24 weeks after the total joint replacement surgery. There
      will be two methods of data collection utilized in this study: interview by site staff via
      the telephone and interactive web-response system (or paper if the subject has no access to
      the internet).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Personally signed and dated informed consent document.

          -  Randomized and treated with subcutaneous investigational product in a tanezumab study
             and has completed the study or been withdrawn from the study.

          -  Actual or planned total knee, hip or shoulder replacement surgery during the tanezumab
             study.

          -  Willing and able to comply with scheduled visits and other study procedures.

        Exclusion Criteria:

        - None.
QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: indacaterol and glycopyrronium (QVA149); Placebo to fluticasone/salmeterol; fluticasone/salmeterol; Placebo to indacaterol and glycopyrronium (QVA149)
Intervention description: QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.; Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.; Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.; Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily
Intervention MeSH terms: Fluticasone; Xhance; Glycopyrrolate; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 523.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: QVA149; indacaterol; NVA237; COPD; fluticasone/salmeterol

Summary:

      The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol
      and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a
      26-week period in patients with moderate to severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoking history of at least 10 pack years

          -  Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as
             classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD]
             Guidelines, 2009)

          -  Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >40% and < 80% of the
             predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <70%

        Exclusion Criteria:

          -  Patients who have had a COPD exacerbation that required treatment with antibiotics,
             systemic steroids (oral or intravenous) or hospitalization in the last year.

          -  Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.

          -  Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Any patient with lung cancer or a history of lung cancer (within last 5 years)

          -  Patients with a history of certain cardiovascular co-morbid conditions
17OHP-C Dosing Among Obese Pregnant Women
Condition: Premature Birth; Absorption; Chemicals
MeSH terms: Premature Birth
Intervention: 17-Hydroxyprogesterone Capronate
Intervention description: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is
      associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher
      doses of 17OHP-C may help to prevent spontaneous PTB among obese women. The study aims to
      compare the pharmacokinetics of 17 OHP-C in obese compared with non-obese women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  - Pregnant women, with a singleton gestation

          -  Ages 18 - 55

          -  Able to read and write in English and / or Spanish

          -  History of spontaneous PTB

          -  Obesity (≥ 30 kg / m2 ) vs non-obese groups (18 - 29.9 kg / m2 ) defined by first
             documented body mass index at an office visit

          -  Gestational age between 12 weeks, 0 days and 24 weeks, 6 days of gestation

          -  An ultrasound before 24 + 6 weeks gestation to confirm dating and to rule out major
             fetal anomalies

          -  Willing to have weekly injections at the physician's office

          -  The newborn will be enrolled on the mothers consent for chart review only

        https://register.clinicaltrials.gov/prs/html/definitions.html?popup=true#Eligibility

        Exclusion Criteria:

          -  - Multifetal gestation

          -  Known fetal anomaly

          -  Current progesterone treatment

          -  Known or suspected breast cancer, other hormone-sensitive cancer, or history of these
             conditions

          -  Current or history of thrombosis or thromboembolic disorder

          -  Current anticoagulation

          -  Undiagnosed abnormal vaginal bleeding unrelated to pregnancy

          -  Cholestatic jaundice of pregnancy

          -  Liver tumors, benign or malignant, or active liver disease

          -  uncontrolled hypertension (controlled hypertension is eligible)

          -  A seizure disorder

          -  Current or planned cervical cerclage

          -  Plan to deliver elsewhere
Long Term Open Label Continuation Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Adalimumab
Intervention description: Subcutaneous injection of 40 mg adalimumab every other week (eow) or monthly for up to 520 weeks (10 years)
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 846.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The purpose of the study was to assess the long-term safety and clinical efficacy following
      repeated administration of adalimumab in patients with rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria

          -  Participant was in a prior D2E7 (adalimumab) study

          -  Participant was age 18 or older and in good health (Investigator discretion) with a
             recent stable medical history.

        Exclusion Criteria

          -  Participant was considered by the investigator, for any reason, to be an unsuitable
             candidate for the study

          -  Participant was a female subject who is pregnant or breast-feeding or considering
             becoming pregnant

          -  Participant had any ongoing chronic or active infection
Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in the Pediatric Emergency Department
Condition: Migraine
MeSH terms: Migraine Disorders; Emergencies; Recurrence
Intervention: Dexamethasone; Placebo
Intervention description: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose; Matched oral solution
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: 12.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Migraine recurrence is common amongst pediatric patients being discharged from the emergency
      department after treatment for migraine. Despite the commonality of migraine recurrence
      within the week following discharge, no known effective therapies are available in the
      pediatric population, though dexamethasone has been established as efficacious in the adult
      migraine population. The proposed study will randomly assign children and adolescents
      visiting the emergency department (ED) for migraine to receive either one dose of oral
      dexamethasone or oral placebo. Twenty patients will be recruited to this randomized,
      double-blind, pilot trial over a 6 month period, and the aim of the study will be to
      determine the feasibility and acceptability of the protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Between the ages of 8 and 18 years (ie. > 8.0 years and < 18.0 years)

          2. Diagnosed with migraine according to a modified version of International
             Classification of Headache Disorders 3rd edition (ICHD-3, beta version) where
             criterion A (ie. minimum of 5 prior episodes meeting criteria B-D) has been removed to
             increase sensitivity of diagnosis in the emergency department setting

        Exclusion Criteria:

          1. Received a dose of a steroid medication in the past 7 days

          2. Known allergy to dexamethasone

          3. Immunosuppressed

          4. Cushing's syndrome

          5. Known diabetes mellitus

          6. Known peptic or duodenal ulcer or other major gastrointestinal illness (ex. ulcerative
             colitis)

          7. Known myasthenia gravis

          8. Glaucoma

          9. Febrile at triage

         10. History of head trauma in the past 7 days

         11. Presence of any known active infection (eg. on antibiotics or antivirals, diagnosed
             with active infection in the ED, etc)

         12. Current secondary headache (as per the treating physician's clinical impression)