bioihbjkbjnl/mcl2 huggingface dataset:
A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: GED-0301; Placebo
Intervention description: Mongersen; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 310.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Crohn's Disease; GED 0301; Mongersen; Safety; Irritable Bowel Disease

Summary:

      The purpose of this study is to assess long-term safety data of GED-0301 for a period of up
      to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3
      GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of
      age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will
      receive active treatment, this study is double-blinded for the entire 208 weeks for the
      purpose of preserving the blind of the subject's treatment allocation in the initial, core
      Phase 3 GED-0301 study.

      The GED-0301-CD-003 trial was not initiated; see detailed description.
    

Eligibility criteria:

        Inclusion Criteria for Adult Subjects:

        Subjects must satisfy the following criteria to be screened and enrolled in the study:

          -  Male or female ≥ 18 years of age.

          -  Subject must have participated in the GED-0301-CD-002 or GED 0301 CD 003 study.

          -  Subject must use protocol approved contraception.

        Inclusion Criteria for Adolescent Subjects:

        Adolescent subjects must satisfy the following criteria to be screened and enrolled in the
        study

          -  Male or female 12 to 17 years of age.

          -  Subject must have participated in the GED 0301 CD 003 study.

          -  Subject is able to swallow the IP tablets.

          -  Subject must use protocol approved contraception.

        Exclusion Criteria for Adult and Adolescent Subjects:

        The presence of any of the following will exclude a subject from screening and enrollment:

          -  Subject had experienced a serious adverse event (SAE) related to the investigational
             product while participating in the previous Phase 3 GED-0301 study.

          -  Subject has initiated biologic agents, such as TNF-α blockers or integrin antagonists.

          -  Subject is pregnant or breastfeeding.

          -  Subject has developed a known hypersensitivity to oligonucleotides, GED 0301 or any
             ingredient in the investigational product.
Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
Condition: Osteoarthritis; Cancer Pain; Recurrent Low Back Pain
MeSH terms: Low Back Pain; Cancer Pain
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, diclofenac, administered in parent study
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 0 Years
Maximum age: 2 Months
Healthy volunteers: No
Keywords: Exposure in utero in tanezumab program

Summary:

      A4091065 is a multicenter, prospective, cohort study with enhance physical an
      neurodevelopmental surveillance to characterize the outcomes related to the development of
      infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or
      comparator via maternal exposure or in utero in any tanezumb study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is an infant born to a mother who was exposed to study drug on a tanezumab
             clinical study.

          -  The infant's mother (who was the tanezumab clinical study participant) must review,
             agree and sign an informed consent document explaining the details of the perinatal
             and post natal follow up. Where local regulations mandate, the male parent would also
             review and sign the informed consent.

          -  Parents or legal guardian must be willing and able to comply with scheduled visits and
             study procedures.

        Exclusion Criteria:

          -  There are no exclusion criteria for participating in this study.
Bupivacaine With Epidural Volume Extension
Condition: Spinal Anesthesia; Epidural; Anesthesia
Intervention: 10 mg Bupivacaine; 5 mg Bupivacaine
Intervention description: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space; 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Neuraxial epidural techniques; Combined spinal epidural; Epidural volume extension; Transient Neurologic Symptoms (TNS)

Summary:

      In this study the investigator will address the efficacy of using low dose bupivacaine spinal
      anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing
      short obstetric procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing short obstetric procedure in the operating room requiring
             neuraxial anesthesia.

        Exclusion Criteria:

          -  coagulopathy

          -  platelets <80,000

          -  allergy to local anesthetic or fentanyl

          -  previous spinal surgery

          -  spinal or intracranial mass

          -  history of lower extremity weakness
Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea
Condition: Erythema; Rosacea
MeSH terms: Rosacea; Erythema
Intervention: Oxymetazoline HCL Cream 1.0%; Vehicle to Oxymetazoline HCL Cream
Intervention description: Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days.; Vehicle to Oxymetazoline HCL Cream (AGN-199201) applied to the face once daily for 29 days.
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 445.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of oxymetazoline hydrochloride (HCl) cream
      1.0% (AGN-199201) once daily compared to vehicle for the treatment of persistent moderate to
      severe facial erythema associated with rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

        -Moderate to severe persistent facial erythema associated with rosacea.

        Exclusion Criteria:

          -  Greater than 3 inflammatory lesions on the face

          -  Current treatment with monoamine oxidase (MAO) inhibitors

          -  Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or
             Sjogren's syndrome.
Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CDP870; Placebo of CDP870
Intervention description: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC); Placebo given every 2 weeks until Week22 (SC)
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 230.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Certolizumab Pegol; Cimzia

Summary:

      The objectives of this study are to verify the superiority in efficacy (American College of
      Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus
      placebo without coadministration of MTX in active RA patients in whom MTX cannot be
      administrated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a diagnosis of adult-onset RA of at least 6 months but not longer
             than 15 years in duration as defined by the 1987 American College of Rheumatology
             classification criteria.

          -  Subjects must have active RA disease as defined by:

               -  At least 6 tender joints and 6 swollen joints

               -  ESR of 28 mm/hour or CRP of 2.0 mg/dL

          -  Subjects who have failed to respond or have been resistant to at least one DMARD
             (including MTX)

          -  Subjects in whom MTX cannot be administered for any of the reasons(incomplete
             response/safety concerns)

        Exclusion Criteria:

          -  Patients who have a diagnosis of any other inflammatory arthritis

          -  Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis,
             fibromyalgia)

          -  Patients who currently have, or who have a history of, a demyelinating or convulsive
             disease of the central nervous system (eg, multiple sclerosis, epilepsy)

          -  Patients who have NYHA (New York Heart Association) Class III or IV congestive heart
             failure

          -  Patients who currently have, or who have a history of, tuberculosis

          -  Patients who have a high risk of infection (with a current infectious disease, a
             chronic infectious disease, a history of serious infectious disease)

          -  Patients who currently have, or who have a history of, malignancy

          -  Female patients who are breastfeeding or pregnant, who are of childbearing potential

          -  Patients who previously received treatment with 2 or more anti-TNFα drugs or who
             previously failed to respond to treatment with 1 or more aint-TNFα drugs.
Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: dimethyl fumarate
Intervention description: administered orally
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatrics

Summary:

      The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects
      who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate
      the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS)
      outcomes in subjects who completed Study 109MS202 (NCT02410200).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ability of parents, legal guardians, and/or subjects to understand the purpose and
             risks of the study and provide signed and dated informed consent and authorization to
             use confidential health information in accordance with national and local subject
             privacy regulations. Subjects will provide assent in addition to the parental or
             guardian consent, as appropriate, per local regulations.

          -  Subjects who completed, as per protocol, the previous BG00012 clinical study 109MS202
             (NCT02410200) and remain on BG00012 treatment.

        Key Exclusion Criteria:

          -  Unwillingness or inability to comply with study requirements, including the presence
             of any condition (physical, mental, or social) that is likely to affect the subject's
             ability to comply with the protocol.

          -  Any significant changes in medical history occurring after enrollment in the parent
             Study 109MS202 (NCT02410200), including laboratory test abnormalities or current
             clinically significant conditions that in the opinion of the Investigator would have
             excluded the subject's participation from the parent study. The Investigator must
             re-review the subject's medical fitness for participation and consider any factors
             that would preclude treatment.

          -  Subjects from Study 109MS202 (NCT02410200) who could not tolerate study treatment.

        NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Levetiracetam
Intervention description: 500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: NEWLY DIAGNOSED EPILEPSY; LEVETIRACETAM; KEPPRA; N01175 (NCT00175903)

Summary:

      For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from
      newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175
      (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the
      treatment, to receive treatment with levetiracetam until the monotherapy indication for
      levetiracetam is granted in Europe.

      To continue to assess safety of levetiracetam as per adverse event reporting and observation
      of weight changes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/female adult subjects (≥ 16 or 18 years)

          -  Diagnosis of epilepsy (all types of seizures may be included)

          -  Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam
             monotherapy

        Other inclusion criteria may apply

        Exclusion Criteria:

          -  Subjects withdrawn from N01175 (NCT00175903) trial for any reason

          -  Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial

          -  Subject requiring add-on antiepileptic treatment

          -  Subjects from countries where levetiracetam is authorized for use as monotherapy in
             epilepsy treatment

          -  Sexually active woman with childbearing potential who is not using a medically
             accepted birth control method
Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20vPnC
Intervention description: 20-valent pneumococcal conjugate vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 839.0
Sex: All
Minimum age: 15 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy
      children 15 months through 17 years of age
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female children ≥15 months to <18 years of age at the time of consent.

          -  Healthy children determined by clinical assessment, including medical history and
             clinical judgment, to be eligible for the study.

          -  For children <5 years of age, written documentation of receipt of at least 3 doses of
             13vPnC. The last dose of 13vPnC must have been administered >2 months before enrolment
             into the study

        Exclusion Criteria:

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis)

          -  Major known congenital malformation or serious chronic disorder

          -  Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results

          -  Previous vaccination with any investigational pneumococcal vaccine or with PPSV23, or
             planned receipt through study participation

          -  Cohorts 3 and 4: Pregnant or breastfeeding female participants
A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C
Condition: Constipation Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Tenapanor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 312.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects
      with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III
      criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks)
      studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total
      based on previous protocol and this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302

          -  Subject demonstrated adequate compliance with the study procedures during either the
             TEN-01-301 or TEN-01-302 studies

          -  Females must be of non-childbearing potential; If of child-bearing potential, must
             have negative pregnancy test and confirm the use of one of the appropriate means of
             contraception

          -  Males must agree to use appropriate methods of barrier contraception or have
             documented surgical sterilization

        Exclusion Criteria:

          -  Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or
             TEN-01-302

          -  The subject reports using any prohibited medication and is not willing to abide by the
             restrictions for intake

          -  Pregnant or lactating women
Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer
Condition: Anxiety Disorder; Breast Cancer; Depression; Fatigue; Pain; Sleep Disorders
MeSH terms: Breast Neoplasms; Sleep Wake Disorders; Parasomnias; Fatigue; Depression; Anxiety Disorders
Intervention: energy-based therapy; sham intervention
Intervention description: Given once a day for 18 weeks; Given once a day for 18 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 161.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: depression; anxiety disorder; fatigue; pain; sleep disorders; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer

Summary:

      RATIONALE: Cranial microcurrent electrical stimulation (CES) is mild electrical current
      received through electrodes placed on the earlobes. CES may lessen symptoms in women with
      breast cancer receiving chemotherapy. It is not yet known whether CES is more effective than
      sham therapy in reducing symptoms caused by chemotherapy in women with breast cancer.

      PURPOSE: This randomized phase III trial is studying mild electrical stimulation to see how
      well it works compared with sham therapy in reducing symptoms caused by chemotherapy in women
      with stage I, stage II, or stage IIIA breast cancer receiving chemotherapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of stage I-IIIA breast cancer

          -  Scheduled to receive adjuvant chemotherapy

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Pre, peri, or post-menopausal

          -  ECOG performance status 0-1

          -  No dementia

          -  No active psychosis

          -  No history of seizure disorder

          -  No implanted electrical device

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior chemotherapy

          -  No initiation of a medication regimen for depression or other psychiatric condition
             within the past 30 days