bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal ACWY conjugate vaccine (MenACWY-CRM); Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap); saline placebo
Intervention description: 4.5 mg sodium chloride per 0.5 ml dose
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1072.0
Sex: All
Minimum age: 11 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; healthy subject; vaccine

Summary:

      Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and
      Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female 11-25 years old healthy subjects;

          -  who had received the primary immunization with a vaccine containing DT or Tdap
             antigens and a T, Td, or Tdap booster injection at least 5 years prior to study entry

        Exclusion Criteria:

          -  previous ascertained or suspected disease caused by N. meningitidis

          -  previously been immunized with a meningococcal vaccine or vaccine containing
             meningococcal antigen(s)

          -  serious acute, chronic or progressive disease

          -  history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine
             component

          -  known or suspected impairment/alteration of immune function, either congenital or
             acquired
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
Condition: Narcolepsy; Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Narcolepsy; Sleepiness
Intervention: JZP-110
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 645.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110
      in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or
      ADX-N05 202.
    

Eligibility criteria:

        Major Inclusion Criteria:

          1. Subject meets one of the following:

               1. Completed Study 14-002 or 14-003 (Group A)

               2. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)

          2. Body mass index from 18 to <45 kg/m2

          3. Consent to use a medically acceptable method of contraception

          4. Willing and able to provide written informed consent

        Major Exclusion Criteria:

          1. Female subjects who are pregnant, nursing, or lactating

          2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
             narcolepsy or OSA that is associated with excessive sleepiness

          3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
             schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5
             criteria

          4. Presence of any acutely unstable medical condition, behavioral or psychiatric disorder
             (including active suicidal ideation), or surgical history that could affect the safety
             of the subject or interfere with study efficacy or safety assessments, or the ability
             of the subject to complete the trial per the judgment of the Investigator

          5. History of bariatric surgery within the past year or a history of roux-en-y procedure

          6. Presence or history of significant cardiovascular disease

          7. Use of any over the counter (OTC) or prescription medications that could affect the
             evaluation of excessive sleepiness

          8. Received an investigational drug other than JZP-110 in the past 30 days or five
             half-lives (whichever is longer)

          9. History of phenylketonuria (PKU) or history of hypersensitivity to
             phenylalanine-derived products
Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Imatinib; Placebo
Intervention description: Participants, who received imatinib 200 mg in the core study, CQTI571A2301 (NCT00902174), and completed the core study, received imatinib 200 mg every day (qd) in the extension. Participants, who were randomized to receive imatinib 400 mg in the core study and completed the core study, received imatinib 400 mg qd in the extension. Participants, who terminated early from the core study or who were randomized to placebo and completed the core study, started the extension with imatinib 200 mg qd. After 2 weeks, the dose was increased to 400 mg qd if tolerated.; To preserve the blind of the core study until the core study, CQTI571A2301 (NCT00902174), was completed, participants received a blinded study drug package containing a 70-tablet bottle of imatinib and a 70-tablet bottle of matching placebo.
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary arterial hypertension, imatinib, 6MWD, pulmonary hypertension

Summary:

      This is a multinational, multi center extension study. This study will provide data on the
      long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary
      arterial hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who participated in CQTI571A2301 clinical trial and completed the week 24
             visit of the study protocol, including all Study Completion assessments

          -  Patients who withdrew from the CQTI571A2301 study prematurely for reasons not related
             to study drug or not related to a safety issue but performed all Study Completion
             assessments

        Exclusion Criteria:

          -  Patients with a pulmonary capillary wedge pressure > 15 mmHg at time of Study
             Completion assessments in core protocol CQTI571A2301. If pulmonary capillary wedge
             pressure is not attainable, then a left atrial pressure measurement may be used in its
             place.

          -  LVEF < 45%

          -  Patients with thrombocytopenia, platelet count < 50E9/L (50E3/µL)

          -  Patients with uncontrolled systemic arterial hypertension, systolic > 160 mmHg or
             diastolic > 90 mmHg

          -  Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of
             right branch bundle block (based on Visit 1 ECG if required to be performed)

        Other protocol-defined inclusion/exclusion criteria may apply
Corneal Collagen Cross-linking for Progressive Keratoconus
Condition: Progressive Keratoconus
MeSH terms: Keratoconus
Intervention: riboflavin ophthalmic solution; UVA Irradiation
Intervention description: riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL); UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Intervention MeSH terms: Riboflavin; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 14 Years
Healthy volunteers: No
Keywords: keratoconus; cross-linking; riboflavin; UVA light; cornea

Summary:

      Prospective, randomized multicenter study to determine the safety and effectiveness of
      performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with
      progressive keratoconus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of keratoconus

          -  Documented progression over previous 24 months

          -  Decreased BSCVA

          -  Must complete all study visits

        Exclusion Criteria:

          -  Prior corneal surgery or Intacs

          -  History of delayed wound healing
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: TC-5214; Placebo
Intervention description: Tablet, oral, twice daily for 8 weeks; Tablet, oral, twice daily for 8 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Depression; Safety; add-on therapy

Summary:

      The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like
      medicine tablet or capsule, but contains no active medicine) is safe and effective when taken
      together with another antidepressant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated informed consent before initiation of any study-related
             procedures.

          -  The patient must have a clinical diagnosis of major depressive disorder (MDD) with
             inadequate response to no more than one antidepressant.

          -  Out-patient status at enrollment and randomization.

        Exclusion Criteria:

          -  Patients with a lifetime history of bipolar disorder, psychotic disorder or
             post-traumatic stress disorder.

          -  Patients with a history of suicide attempts in the past year and/or seen by the
             investigator as having a significant history of risk of suicide or homicide.

          -  History of renal insufficiency or impairment or conditions that could affect
             absorption or metabolism of the investigational product in this patient population
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Oxymorphone ER
Intervention description: Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period.
Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications
Intervention MeSH terms: Oxymorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Opioid tolerant; Pediatric; Male 6-17 years of age; Female 6-17 years of age; Pain; Non malignant; Malignant

Summary:

      Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the
      Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every
      12 hours. Dosing adjustments will be based on the review of the subject's pain scores.
      Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain
      medication (as needed). Titration Period will end when the fixed dose of study medication is
      tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the
      open-label 3-month maintenance period on the fixed dose of study medication established
      during the Titration Period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a
             strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45
             mg/daily (qd) oral morphine equivalent)

          -  Weigh at least 50 kg

          -  Expected to continue to require a strong opioid for pain relief for at least 4 weeks
             and up to 4 months.

        Exclusion Criteria:

          -  Have a life expectancy <4 weeks

          -  Plan to undergo a surgical procedure within 3 days of study entry or during the
             Titration Period

          -  Have dysphagia or difficulty swallowing whole tablets

          -  Have a previous exposure to oxymorphone

          -  Have an ileostomy
Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Intervention: Paclitaxel; GW572016 (Lapatinib)
Intervention description: Active Comparator; Oral GW572016 Lapatinib
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Lapatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 580.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic breast cancer; ErbB1; kinase inhibitor; ErbB2; EGFR; lapatinib; Her2-neu

Summary:

      The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine
      kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in
      first line advanced or metastatic breast cancer.
    

Eligibility criteria:

        Inclusion criteria:

          -  Signed Informed Consent

          -  Able to swallow an oral medication

          -  Cardiac ejection fraction within the institutional range of normal as measured by
             echocardiogram

          -  Adequate kidney and liver function

          -  Adequate bone marrow function

          -  Tumor tissue available for testing

          -  Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or
             anthracenedione-containing regimen however, subjects must have had cumulative doses of
             less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of
             mitoxantrone

          -  No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has
             never been tested

        Exclusion criteria:

          -  Prior treatment regimens for advanced or metastatic breast cancer.

          -  Pregnant or lactating

          -  Conditions that would effect the absorption of an oral drug

          -  Active infection

          -  Brain metastases

          -  Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.

          -  Known hypersensitivity to Taxol or excipients of Taxol

          -  Peripheral neuropathy of Grade 2 or greater is not permitted

          -  Severe Cardiovascular disease or cardiac disease requiring a device.

          -  Serious medical or psychiatric disorder that would interfere with the patient's safety
             or informed consent.
Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System
Condition: Healthy
Intervention: AG200-15
Intervention description: Transdermal contraceptive delivery system
Intervention MeSH terms: Contraceptive Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2032.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: prevention of pregnancy

Summary:

      Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, sexually active woman at risk for pregnancy seeking to use hormonal
             contraception for at least 1 year

          -  Ability to demonstrate willingness to participate and adhere to study protocol

        Exclusion Criteria:

          -  Known or suspected pregnancy

          -  Lactating women

          -  Anticipates use of condoms or any other form of back-up contraception during the study

          -  History of dermal sensitivity to medicated patches (nicotine) or to bandages, surgical
             tape, etc.

          -  Has a contraindication to combined estrogen-progestin contraceptive use

          -  Any disease that may worsen under hormonal treatment (cardiovascular, liver,
             metabolic)

          -  Smoker who is 35 years old or over
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
Condition: Epilepsy, Benign Neonatal
MeSH terms: Seizures; Epilepsy, Benign Neonatal
Intervention: Phenobarbital Sodium Injection
Intervention description: The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose.
Intervention MeSH terms: Phenobarbital
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 34 Weeks
Maximum age: 44 Weeks
Healthy volunteers: No
Keywords: Neonatal Seizures; Phenobarbital; Anticonvulsants

Summary:

      This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of
      the administration of phenobarbital sodium injection in neonates who have suffered from
      electrographic or electroclinical seizure. As neonatal seizures can have long-term adverse
      effects, including death, placebo-controlled studies are not appropriate for this population.
      This study is designed to show intravenous phenobarbital is effective at preventing
      subsequent seizures by demonstrating greater efficacy at a higher dose compared to a lower
      dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female neonates with a gestational age of ≥ 34 - ≤44 weeks admitted into the
             NICU with a high probability of developing seizures (e.g., HIE, stroke, intracerebral
             hemorrhage, central nervous system infection)

          -  Parental informed consent (in-person or remote consent)

          -  Undergoing continuous video electroencephalogram (cvEEG) monitoring

          -  Has evidence of electrographic seizure burden of at least 30 seconds/h

        Exclusion Criteria:

          -  Received anticonvulsant treatment, including phenobarbital, prior to randomization
             (with exception of lorazepam administered for sedation > 24 hours before enrollment)

          -  Strong suspicion or confirmed diagnosis of brain malformation, inborn error of
             metabolism genetic syndrome, or major congenial malformation prior to randomization

          -  Seizures responding to correction of hypoglycemia, hypocalcemia or any other metabolic
             disorder

          -  Death appears to be imminent as assessed by the NICU attending physician

          -  Is currently enrolled in another study assessing the same and/or similar
             primary/secondary endpoints with/without drug treatment.
Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer
Condition: Lymphedema; Stage 0 Cervical Cancer; Stage 0 Uterine Corpus Cancer; Stage 0 Vulvar Cancer; Stage I Uterine Corpus Cancer; Stage I Vulvar Cancer; Stage IA Cervical Cancer; Stage IB Cervical Cancer; Stage II Uterine Corpus Cancer; Stage II Vulvar Cancer; Stage IIA Cervical Cancer; Stage IIB Cervical Cancer; Stage III Cervical Cancer; Stage III Uterine Corpus Cancer; Stage III Vulvar Cancer; Stage IV Uterine Corpus Cancer; Stage IVA Cervical Cancer; Stage IVB Cervical Cancer; Stage IVB Vulvar Cancer
MeSH terms: Uterine Cervical Neoplasms; Vulvar Neoplasms; Lymphedema
Intervention: Management of Therapy Complications; Management of Therapy Complications; Quality-of-Life Assessment
Intervention description: Receive standard home maintenance therapy and perform self-manual lymphatic drainage; Receive Flexitouch home maintenance therapy; Ancillary studies
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial is studying Flexitouch® home maintenance therapy to see how
      well it works compared with standard home maintenance therapy in treating patients with
      lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or
      endometrial cancer. Flexitouch® home maintenance therapy may lessen lower-extremity
      lymphedema caused by treatment for gynecologic cancer. It is not yet known whether the
      Flexitouch® system is more effective than standard home maintenance therapy in treating
      lymphedema.
    

Eligibility criteria:

        Criteria:

          -  Has lower-extremity lymphedema on one side of the body caused by surgery,
             chemotherapy, and/or radiation therapy.

          -  At least 6 months since clinic therapy for lower-extremity lymphedema

          -  Is within 3 years from finishing cancer treatment

          -  No active or recurrent cancer

          -  More than 3 months since cancer treatment
The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Participants Who Have Already Been Treated With ALN-TTR02 (Patisiran)
Condition: Amyloidosis
MeSH terms: Amyloidosis
Intervention: Patisiran
Intervention description: Patisiran was administered IV.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All the participants received only patisiran but divided into 3 arm groups based on administration in the parent study (placebo or patisiran in 003 [NCT01961921] or 004 [NCT01960348] studies).
Masking: None (Open Label)
Enrollment: 211.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: RNAi therapeutic; FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis

Summary:

      The purpose of this study is to evaluate the safety and efficacy of long-term dosing with
      ALN-TTR02 (patisiran) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed a patisiran study (i.e., completed the last efficacy visit in the
             parent study) and, in the opinion of the investigator, tolerated study drug

          -  Be willing and able to comply with the protocol-required visit schedule and visit
             requirements and provide written informed consent

        Exclusion Criteria:

          -  Any new or uncontrolled condition that could make the participant unsuitable for
             participation