bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Pimecrolimus Cream, 1%; Placebo Cream; Pimecrolimus Cream, 1%
Intervention MeSH terms: Pimecrolimus; Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 654.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No

Summary:

      To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of
      reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate
      Atopic Dermatitis.

      To establish superiority of each active treatment over the placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-immuno compromised male or female aged 8 years and older

          -  Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)

          -  Failed to respond adequately to other topical prescription treatments for AD, or for
             whom those treatments are not advisable.

          -  A diagnosis of AD for at least 3 months

          -  An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at
             baseline (score of 2 or 3)

          -  Affected area of AD involvement at least 5% body surface area (BSA)

          -  Treated with a bland emollient for at least 7 days

        Exclusion Criteria:

          -  Females who are pregnant, breast feeding, or who wish to become pregnant during the
             study period

          -  Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g.,
             clinically infected atopic dermatitis, impetigo).

          -  Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline,
             which would interfere with evaluations

          -  History or presence of confounding skin conditions, e.g., psoriasis, rosacea,
             erythroderma, ichthyosis, or scabies.

          -  History or presence of Netherton's Syndrome, immunological deficiencies or diseases,
             HIV, diabetes, malignancy, serious active or recurrent infection, clinically
             significant severe renal insufficiency or severe hepatic disorders

          -  Concurrent disease or treatment likely to interfere with the study treatment or
             evaluations

          -  Known allergy or hypersensitivity to pimecrolimus or any other component of the drug
             products

          -  Not willing to minimize or avoid natural and artificial sunlight exposure during
             treatment
Extension in AS: Sustainability of Benefits, Safety and Tolerability
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab; Placebo (Pbo)
Intervention description: Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W; Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, PFS, pre-filled syringe, secukinumab, self-injection

Summary:

      This 3-year extension study aims at making available the treatment with secukinumab in
      prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III
      study CAIN457F2305, defined as "core study", as well as to generate additional data on the
      sustainability of clinical benefits, safety and tolerability during long-term administration
      of secukinumab.
    

Eligibility criteria:

        Inclusion Criteria: patients having completed the "core study" CAIN457F2305, indication for
        treatment extension. -- Exclusion Criteria: history of hypersensitivity to secukinumab or
        to any drug of similar chemical classes, use of any investigational drug other than
        secukinumab during the "core study" CAIN457F2305.
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
Condition: Chemotherapy Associated Neutropenia; Breast Cancer
MeSH terms: Breast Neoplasms; Neutropenia
Intervention: EP2006; Filgrastim
Intervention description: Eligible patients will be teated with EP2006; Eligible patients will be teated with Filgrastim
Intervention MeSH terms: Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 218.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Filgrastim; G-CSF, neutropenia; supportive care; breast cancer

Summary:

      The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean
      duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast
      cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histologically proven breast cancer, eligible for neoadjuvant or
             adjuvant myelosuppressive chemotherapy

          2. Women ≥ 18 years of age

          3. Estimated life expectancy of more than six months

        Exclusion Criteria:

          1. Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in
             situ carcinoma of the cervix, or other solid tumor treated curatively, and without
             evidence of recurrence for at least ten years prior to study entry

          2. Any serious illness or medical condition that may interfere with safety, compliance,
             response to the products under investigation and their evaluation, e.g.:

        Other protocol-defined inclusion/exclusion criteria may apply.
A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
Condition: Schizophrenia
MeSH terms: Psychomotor Agitation; Schizophrenia
Intervention: Intramuscular ziprasidone mesylate; Intramuscular haloperidol
Intervention description: The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days.; The haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days.
Intervention MeSH terms: Haloperidol; Haloperidol decanoate; Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Intramuscular ziprasidone, agitation, efficacy and safety

Summary:

      This local registration study is to confirm the hypothesis of the efficacy, tolerability and
      safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in
      schizophrenia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Chinese subjects aged 18-65 years (including 65) at screening.

          -  Subjects meeting the ICD-10 (Classification of Mental and Behavioral Disorders)
             criteria for schizophrenia (F20.X).

          -  Subjects who are in acute phase of schizophrenia and are appropriate to receive
             intramuscular medication for at least 3 days

        Exclusion Criteria:

          -  History of clinically significant physical illness especially myocardial infarction,
             non compensatory heart failure etc.

          -  Subjects receiving an investigational agent in the previous 3 months prior to
             screening.

          -  Use of antipsychotic agents within 12 hours or parenteral benzodiazepines within 4
             hours prior to randomization and during the study.
A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: albiglutide; insulin glargine
Intervention description: albiglutide weekly injection; insulin glargine
Intervention MeSH terms: Insulin Glargine; rGLP-1 protein
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 779.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes

Summary:

      A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes

          -  BMI 20-45kg/m2 inclusive

        Exclusion Criteria:

          -  females who are pregnant, lactating or within <6 weeks post-partum

          -  current symptomatic heart failure (NYHA Class III-IV)
Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Edoxaban-based Regimen; VKA-based Regimen
Intervention description: 15 mg, 30 mg and 60 mg film coated tablet for oral use (with anti-platelet therapy pre-declared at randomization if prescribed); Dosed at International Normalized Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in the country location (with anti-platelet therapy pre-declared at randomization if prescribed).
Intervention MeSH terms: Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1426.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Transcatheter Aortic Valve Implantation -- TAVI; Anticoagulation; Atrial Fibrillation; ENVISAGE-TAVI-AF

Summary:

      When the upper chambers of a person's heart receive or generate irregular electrical signals,
      it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation.

      Atrial fibrillation goes along with blood clots that may cause mainly strokes and less often
      other diseases, such as a heart attack. Some patients with atrial fibrillation have other
      heart disease, such as heart valves that may need to be replaced using catheters.

      Often doctors give patients drugs that reduce those blood clots. These are either vitamin K
      antagonist (VKA) or direct anticoagulants, such as edoxaban. In these patients, it is unclear
      which of the drugs is better for reducing stroke without increasing severe bleedings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets protocol-specified criteria for qualification and contraception

          -  Is willing and able to comply with any restrictions related food, drink and
             medications

          -  Voluntarily consents to participate and provides written informed consent prior to any
             protocol-specific procedures

        Exclusion Criteria:

          -  Has history or current use of over-the-counter medications, dietary supplements, or
             drugs (including nicotine and alcohol) outside protocol-specified parameters

          -  Has signs, symptoms or history of any condition that, per protocol or in the opinion
             of the investigator, might compromise:

               1. the safety or well-being of the participant or study staff

               2. the safety or well-being of the participant's offspring (such as through
                  pregnancy or breast-feeding)

               3. the analysis of results
Efficacy and Safety of BIIB111 for the Treatment of Choroideremia
Condition: Choroideremia
MeSH terms: Choroideremia
Intervention: BIIB111
Intervention description: Administered as specified in the treatment arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 169.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NightstaRx; NSR-REP1; Gene Therapy; AAV; REP1; Timrepigene Emparvovec

Summary:

      The objective of the study is to evaluate the efficacy and safety of a single sub-retinal
      injection of BIIB111 in participants with choroideremia (CHM).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Are willing and able to give informed consent for participation in the study.

          -  Have a documented genetically-confirmed diagnosis of CHM.

          -  Have active disease clinically visible within the macular region in the study eye.

          -  Have a BCVA of 34-73 ETDRS letters (equivalent to worse than or equal to 6/12 or 20/40
             Snellen acuity, but better than or equal to 6/60 or 20/200 Snellen acuity) in the
             study eye.

        Key Exclusion Criteria:

          -  Have a history of amblyopia in the eligible eye.

          -  Have had previous intraocular surgery performed in the study eye within 3 months of
             Visit 1.

          -  Have any other significant ocular or non-ocular disease/disorder which, in the opinion
             of the investigator, may either put the participants at risk because of participation
             in the study, or may influence the results of the study, or the participant's ability
             to participate in the study.

          -  Have participated in another research study involving an investigational product in
             the past 12 weeks or received a gene/cell-based therapy at any time previously.

          -  Are unwilling to use barrier contraception methods, or abstain from sexual
             intercourse, for a period of 3 months, if treated with AAV2-REP1.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)
Condition: Primary Immunodeficiency Disease
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: NewGam
Intervention description: The initial dose and dosing interval for each participant was the dose and dosing interval the participant received at the end of the NGAM-01 study. The dose of NewGam, solvent/detergent treated human normal immunoglobulin 10%, remained the same throughout the study, as long as the minimum trough level of serum immunoglobulin G (IgG) was above 5 g/L. If the serum IgG trough level dropped to 5 g/L or less, the dose was to be adjusted at the investigator's discretion. NewGam was supplied as a solution for infusion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 2 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Primary Immunodeficiency Disease; PID

Summary:

      This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III
      study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks,
      continuing the patient's infusion interval in the main study NCT01012323 [NGAM-01]) for 3
      months. The primary objective of the study was to assess the safety and tolerability of high
      infusion rates of NewGam.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of the main study NGAM-01.

          -  At each of the last 3 infusions in the main study NGAM-01, administration of NewGam at
             the maximum infusion rate of 0.08 mL/kg/min and without the need for premedication.

        Exclusion Criteria:

          -  Any condition or circumstance that would have led to the exclusion of the subject from
             the NGAM-01 study.

          -  Administration of any immunoglobulin infusion other than NewGam between conclusion of
             the NGAM-01 study and the beginning of the present study.

          -  A deviation of the subject's treatment interval of more than 7 days between the last
             infusion of NewGam in the NGAM-01 study and the first infusion of NewGam in the
             present study.
A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Bevacizumab; Capecitabine
Intervention description: Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Bevacizumab was supplied in single-use vials.; Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.
Intervention MeSH terms: Bevacizumab; Capecitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 280.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination
      with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with
      metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5
      mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000
      mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m^2
      orally twice a day on Days 1-14 of each 3-week cycle) alone.

      No notable trends or interactions in laboratory values, electrocardiogram, or vital signs
      suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or
      capecitabine monotherapy were observed during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 70 years of age.

          -  Cancer of the colon or rectum.

          -  Metastatic disease diagnosed ≤ 6 months before enrollment.

          -  ≥ 1 measurable metastatic lesion.

        Exclusion Criteria:

          -  Adjuvant anti-vascular endothelial growth factor (VEGF) treatment.

          -  Prior chemotherapeutic treatment for metastatic colorectal cancer.

          -  Past or current history of other malignancies (with the exception of basal and
             squamous cell cancer of the skin, or in situ cancer of the cervix).

          -  Clinically significant cardiovascular disease.

          -  Current or recent daily use of aspirin (> 325 mg/day) or other non-steroidal
             anti-inflammatory drug (NSAID), or full dose anticoagulants.
Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: pregabalin 600 mg/day; pregabalin 150 mg/day
Intervention description: pregabalin 600 mg/day (300mg BID), duration is 20 weeks.; pregabalin 150 mg/day (75mg BID), duration is 20 weeks.
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epilepsy; partial seizures; pregabalin monotherapy; double-blind and randomized trial

Summary:

      This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by
      itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment
      of partial seizures. The duration of the trial is about 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of epilepsy with partial seizures.

          -  Males or females, age 18 years or older.

          -  Documented history of at least 4 partial seizures in the 8 weeks prior to the
             screening visit.

          -  Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the
             screening visit.

        Exclusion Criteria:

          -  Current diagnosis of febrile seizures or seizures related to an ongoing acute medical
             event.

          -  Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or
             infectious origin.

          -  Primary generalized epilepsy or status epilepticus within the previous year.