bioihbjkbjnl/mcl2 huggingface dataset:
A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Sarecycline
Intervention description: Administered based on participant's body weight.
Intervention MeSH terms: Sarecycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 490.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral
      sarecycline in the long-term treatment of participants with moderate to severe facial acne
      vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successfully completed participation in Phase 3 study of sarecycline (SC1401 or
             SC1402)

          -  Signed informed consent or assent form

          -  Body weight between 33 kg and 136 kg, inclusive

          -  Negative urine pregnancy test for females of childbearing potential

          -  Agrees to use effective method of contraception throughout study, if applicable.

          -  Able to fulfill protocol requirements, indicated willingness to participate in study
             and agrees to all study procedures by providing written informed consent/assent and
             authorization to disclose (personal health information)

        Exclusion Criteria:

          -  Currently participating in another clinical study, unless it is a pharmacokinetic
             sarecycline study and participation approved by medical monitor; has received
             investigational medication (except sarecycline) within 30 days of enrollment.

          -  Discontinued participation in a Phase 3 study with sarecycline for any reason

          -  Had poor compliance wtih study requirements/study drug dosing in a Phase 3 study with
             sarecycline

          -  Is receiving/planning to receive any systemic acne medication, systemic retinoids,
             systemic corticosteroids or any androgen/anti-androgenic therapy (eg, testosterone,
             spironolactone)

          -  Is pregnant, lactating or planning a pregnancy during the study period

          -  Has a significant intercurrent illness (including clinically significant abnormality
             in clinical laboratory tests), psychiatric disorder, or other factors that, in the
             opinion of the Investigator or Medical Monitor, precludes participation in the study

          -  Is judged by the Investigator to be unsuitable for any reason
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
Condition: Opioid-induced Bowel Dysfunction
MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Opioid-Induced Constipation
Intervention: Lubiprostone; Placebo
Intervention description: 24 mcg administered orally twice daily (BID); Matching placebo, 0 mcg administered orally twice daily (BID)
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Care provider and outcomes assessor were also blinded for this double-blind trial.
Enrollment: 439.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone
      administration in subjects with Opioid-induced Bowel Dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

        A patient can be considered for eligibility to participate if he/she:

          -  Has been consistently treated for chronic, noncancer-related pain with any oral,
             transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to
             screening

          -  Is diagnosed with OBD

          -  Is capable of utilizing an electronic diary to report daily spontaneous bowel
             movements (SBMs)

          -  Is willing to continue opioid therapy and discontinue the use of laxatives, stool
             softeners, and other concomitant medications affecting gastrointestinal motility
             throughout the study

        Exclusion Criteria:

        A patient cannot be considered for eligibility to participate if he/she:

          -  Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical
             bowel obstructions, bowel disorders, and constipation not arising from opioid use, but
             instead attributable to dietary, neurologic, congenital, or endocrine disorders,
             scleroderma, and/or for the management of drug addiction
Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.
Intervention description: Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis; secukinumab; AIN457H; SpondyloArthritis

Summary:

      The purpose of this study was to assess the clinical efficacy, safety and tolerability of
      secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS
      despite current or previous non-steroidal anti-inflammatory drugs (NSAIDs) and/or anti-tumor
      necrosis factor (TNF) α therapy. Efficacy and safety data were used to support the
      registration of secukinumab in Japan for the treatment of active AS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or
             radiologist's report) fulfilling the Modified New York criteria for AS with active AS
             assessed by BASDAI ≥ 4 (0-10) and spinal pain as measured by VAS≥ 4 cm (BASDAI
             question #2) at Baseline

          -  Patients should have been on NSAIDs at the highest recommended dose for at least 3
             months prior to baseline with an inadequate response or failure to respond, or less
             than 3 months if therapy had to be withdrawn due to intolerance, toxicity or
             contraindications

          -  Patients who have been on a TNFα inhibitor (not more than one) must have experienced
             an inadequate response to previous or current treatment given at an approved dose for
             at least 3 months prior to baseline or have been intolerant to at least one
             administration of an anti-TNFα agent

        Exclusion Criteria:

          -  Patients with total ankylosis of the spine

          -  Patients previously treated with any biological immunomodulating agents except for
             those targeting TNFα

          -  Active ongoing inflammatory diseases other than AS that might confound the evaluation
             of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis

          -  Known infection with HIV, hepatitis B or hepatitis C at screening or baseline
Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Condition: Grade B Acute Graft Versus Host Disease; Grade C Acute Graft Versus Host Disease; Grade D Acute Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Intervention: Remestemcel-L
Intervention description: No intervention was given in Study MSB-GVHD002 (NCT02652130). It was a safety follow-up trial of remestemcel-L-treated participants from Study MSB-GVHD001.
Intervention MeSH terms: Remestemcel-l
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 2 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: GVHD

Summary:

      Ongoing safety assessment follow-up to Protocol MSB-GVHD001 (NCT02336230) of remestemcel-L
      treatment in pediatric participants with acute graft versus host disease (aGVHD), following
      allogeneic hematopoietic stem cell transplant (HSCT), that have failed to respond to
      treatment with systemic corticosteroid therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have participated in MSB-GVHD001 and have received at least one
             infusion of remestemcel-L.

          -  Participant or participant's authorized representative must be capable of providing
             written informed consent. Assent, if applicable, must also be collected when required
             by the Institutional Review Board (IRB)/Ethics Committee (EC).

          -  Female participants of childbearing potential (≥ 10 years of age) must use a medically
             accepted method of contraception and must agree to continue use of this method for the
             duration of the study and for the follow-up time period. Acceptable methods of
             contraception include abstinence, barrier method with spermicide, intrauterine device
             (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in
             conjunction with a barrier method.

          -  The participant must be willing and able to comply with study procedures, remain at
             the clinic as required during the study period, and return to the clinic for the
             follow-up evaluation as specified in this protocol.

        Exclusion Criteria:

          -  The investigator believes it to be in the best interest of the participant not to
             participate in the safety follow-up study.

          -  Participant has participated or is currently participating in any autologous or
             allogeneic stem cell or gene therapy study for the treatment of aGVHD. Participants
             participating in investigative protocols aimed at modification of the transplant graft
             (such as T cell depletion) or aimed at modification of the conditioning regimen will
             be allowed in the study.
A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Romosozumab; Placebo
Intervention description: Administered by subcutaneous injection once a month (QM); Administered by subcutaneous injections once a month
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 67.0
Sex: Female
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Osteoporosis.; Osteoporosis-Postmenopausal.; Bone Diseases-Metabolic.; Bone Diseases.; Musculoskeletal Diseases.

Summary:

      The primary objective is to evaluate the effect of treatment with romosozumab for 6 months
      compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as
      assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment.

          -  Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more
             consecutive months prior to screening.

          -  BMD T-score </= -2.50 at the lumbar spine, total hip or femoral neck.

          -  At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by
             DXA.

          -  Other inclusion criteria may apply.

        Exclusion Criteria:

          -  Subjects with a BMD T-score </= -4.0 at the lumbar spine, total hip, or femoral neck.

          -  History of hip fracture.

          -  Bone disease other than osteoporosis/ or evidence of any other clinically significant
             disorder, condition/ or disease or significant laboratory abnormalities.

          -  Known sensitivity or intolerance calcium and vitamin D products.

          -  Other exclusion criteria may apply.
Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Condition: Submental Fat; Healthy
Intervention: ATX-101; Placebo
Intervention description: Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction
      of submental fat.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Any participant who completed follow-up visits at 12 and 24 weeks after the last dose
             in one of the two predecessor studies

          2. Willingness to comply with the schedule and procedures of this study.

          3. Signed informed consent form (ICF).

        Exclusion Criteria:

        1. Participants who have had any treatment or condition (e.g., pregnancy or metabolic
        disease, which may lead to unstable weight) that may affect assessment of safety or
        efficacy since enrollment in the predecessor study.
An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor
Intervention description: Subjects will be treated with ivacaftor for 6 months and followed for 7 months and will undergo assessments along the way to measure sweat chloride and sputum amounts.
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This postmarketing N of 2 study is designed to evaluate the efficacy and safety of open-label
      ivacaftor treatment in two sisters with cystic fibrosis and pancreatic sufficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects are >18 years of age and able to provide informed consent.

          -  Subjects reside in the US and are willing to be treated with ivacaftor.

          -  Subjects have the splicing mutation of interest.

          -  Subjects are willing and able to perform requirements of the study.

        Exclusion Criteria:

          -  There are no relevant exclusion criteria for this n-of-2 study.
A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions
Condition: Emergency Contraception
MeSH terms: Emergencies
Intervention: Use Phase (Ulipristal Acetate, 30 mg)
Intervention description: All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take 30 mg of ulipristal acetate.
Subjects are to use the investigational product based on their understanding of the directions on the outer packaging including Drug Facts Label and inside the product packaging (in the Consumer Information Leaflet).
Intervention MeSH terms: Ulipristal acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1270.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Emergency contraception

Summary:

      This study is designed to assess whether consumers select and use ella® (ulipristal acetate
      30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in
      an OTC-like setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who are self-pay or who are willing to be self-pay for the purposes of the study
             and who present for emergency contraception only for their own use

        Exclusion Criteria:

          -  Cannot read, speak and understand English

          -  Cannot see well enough to read information on the label
Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: USL261; Placebo
Intervention MeSH terms: Midazolam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 292.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Epilepsy; seizure clusters; acute repetitive seizures; rescue treatment; ARTEMIS

Summary:

      The purpose of this study is to examine the safety and effectiveness of USL261 for the
      outpatient treatment of seizure clusters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a competent, adult caregiver who can recognize and observe the subject's seizure
             cluster episodes

          -  Has an established diagnosis of partial or generalized epilepsy that includes the
             following:

               -  A documented history of seizure clusters lasting a minimum of 10 minutes

               -  Seizure cluster pattern is observable, stereotyped, and recognizably different
                  from the subject's other non-cluster seizure activity (if any)

               -  A second seizure in the seizure cluster typically occurring within 6 hours from
                  the time of cluster recognition

               -  A seizure cluster pattern composed of multiple (≥ 2) partial or generalized
                  seizures

               -  A seizure cluster pattern established > 3 months before Visit 1

               -  A frequency of ≥ 3 seizure clusters during the year before Visit 1

               -  At least 1 seizure cluster occurring ≤ 4 months before Visit 1

               -  Seizure cluster pattern is confirmed by a central reviewer

          -  Currently on a stable regimen of anti-epileptic drugs (AEDs) with no changes in type
             of AEDs since Visit 1 and for ≥ 7 days before Visit 2, with or without intermittent
             use of benzodiazepines at a constant dose

          -  Weight is 40 kg to 125 kg, inclusive

        Exclusion Criteria:

          -  Has a neurological disorder that is likely to progress in the next year

          -  Has severe chronic cardio-respiratory disease

          -  Has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1

          -  Has a history of their stereotypical seizure cluster progressing to status epilepticus
             within the 2 years before Visit 1

          -  Has a history of acute narrow-angle glaucoma.

          -  Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before
             Visit 1 or a suicide attempt in the past 5 years

          -  Currently using a vagal nerve stimulator (VNS) unless the device has been implanted
             for at least 6 months and the setting stable for 4 weeks before Visit 1
Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Idelalisib; Rituximab; Bendamustine; Placebo to match idelalisib
Intervention description: Idelalisib 150 mg administered orally twice daily; Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions; Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions; Placebo to match idelalisib administered orally twice daily
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride; Idelalisib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 416.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Zydelig; CLL; CAL-101; GS 1101; GS-1101; PI3K; Rituxan; Rituximab; Bendamustine; Leukemia; idelalisib

Summary:

      The primary objective of this study is to evaluate the effect of the addition of idelalisib
      (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in
      participants with previously treated chronic lymphocytic leukemia (CLL)
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Previously treated recurrent CLL

          -  Measurable lymphadenopathy

          -  Requires therapy for CLL

          -  Has experienced CLL progression < 36 months since the completion of the last prior
             therapy

        Key Exclusion Criteria:

          -  Recent history of a major non-CLL malignancy

          -  Evidence of an ongoing infection

          -  CLL refractory to bendamustine

          -  Concurrent participation in another therapeutic clinical trial

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.