bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia
Condition: Primary Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Intervention: NewGam
Intervention description: NewGam is a solution of human normal immunoglobulin 10% treated with solvent/detergent and nanofiltered for intravenous administration.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: ITP; Primary immune thrombocytopenia

Summary:

      NewGam is a newly developed human normal immunoglobulin solution for intravenous
      administration (IGIV). This study will evaluate the safety and efficacy of NewGam 10% in
      patients with primary immune thrombocytopenia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age of ≥ 18 and ≤ 65 years.

          2. Confirmed diagnosis of chronic primary immune thrombocytopenia (ITP) (diagnosed with a
             threshold platelet count < 100x10^9/L) of at least 12 months duration.

          3. Platelet count of no more than 20x10^9/L with or without bleeding manifestations.

          4. Freely given written informed consent from patient.

          5. Women of childbearing potential must have a negative result on a pregnancy test (human
             chorionic gonadotropin [HCG]-based assay) and need to practice contraception using a
             method of proven reliability for the duration of the study.

        Exclusion Criteria:

          1. Thrombocytopenia secondary to other diseases (such as acquired immunodeficiency
             syndrome [AIDS] or systemic lupus erythematosus [SLE]), or drug-related
             thrombocytopenia.

          2. Administration of intravenous immunoglobulin (IGIV), anti-D immunoglobulin or
             thrombopoietin receptor agonists, or other platelet enhancing drugs (including
             immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrollment,
             except for:

               -  Long-term corticosteroid therapy when the dose has been stable during the
                  preceding 3 weeks and no dosage change is planned until study Day 22.

               -  Long-term azathioprine, cyclophosphamide, or attenuated androgen therapy when the
                  dose has been stable during the preceding 3 months and no dosage change is
                  planned until study Day 22.

          3. Unresponsive to previous treatment with IGIV or anti-D immunoglobulin.
Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Elagolix
Intervention description: Elagolix tablets administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 496.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Endometriosis-associated pain; Elagolix; Gonadotropin-releasing Hormone Antagonist; Dysmenorrhea (DYS); Non-menstrual Pelvic Pain (NMPP); Dyspareunia

Summary:

      A randomized study evaluating the continued safety and efficacy of elagolix in the management
      of moderate to severe endometriosis associated pain in adult pre-menopausal women who
      completed 6 months treatment in pivotal Study M12-671 (NCT01931670).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed the 6-Month Treatment Period in pivotal study M12-671.

          -  Agrees to use required birth control methods during the study through Month 6 of the
             Post-treatment Follow-up period

        Exclusion Criteria:

          -  Clinically significant gynecological condition

          -  Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine,
             femoral neck or total hip

          -  Plans to become pregnant in the next 18 months
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Ketotifen/naphazoline; Naphazoline; Ketotifen; Vehicle
Intervention description: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.; One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.; One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.; One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Intervention MeSH terms: Ketotifen; Naphazoline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 141.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline
      ophthalmic solution compared to vehicle and its individual components in alleviating the
      signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive history of ocular allergies and positive skin test reaction to cat hair, cat
             dander, grasses, ragweed, and/or trees within the past 24 months.

          -  Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as
             measured using the ETDRS chart.

          -  Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of
             instillation of the last titration of allergen at visit 1.

          -  Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.

        Exclusion Criteria:

          -  Known contraindications or sensitivities to the study medication or its components.

          -  Any ocular condition that, in the opinion of the investigator, could affect the
             subjects safety or trial parameters.

          -  Use of disallowed medications during the period indicated prior to study enrollment or
             during the study.
Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: QIVc; TIV1c; TIV2c
Intervention description: Novartis Investigational Quadrivalent Vaccine; Licensed Influenza Vaccine; Novartis Investigational Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2333.0
Sex: All
Minimum age: 4 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza vaccine; Novartis; children

Summary:

      Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than
      4 years old to less than 18 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged 4 years to less than 18 years of age.

          2. Individual who had a parent or guardian who could give written informed consent after
             understanding the nature of the study and comply with study procedures and were
             available for follow-up.

          3. If the individual was of an age where, according to local regulations, informed assent
             is required, that individual had provided assent to participate in the study.

        Exclusion Criteria:

          1. Individuals recently vaccinated against influenza

          2. Subjects with contraindications to receive influenza vaccine
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Ingenol Mebutate; Vehicle
Intervention description: Vehicle gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 729.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for
      actinic keratosis applied to large treatment areas once daily for three consecutive days on
      face, scalp or chest.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs)
        non-hyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged
        skin on either:

          -  The full face

          -  The full balding scalp

          -  A contiguous area of approximately 250 cm2 on the chest

        Exclusion Criteria:

          -  Location of the treatment area (full face, full balding scalp or chest) within 5 cm of
             an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC)
             or squamous cell carcinoma (SCC).

          -  Previously assigned treatment in this clinical trial or previously participated in a
             clinical trial in the LEO clinical programme on ingenol mebutate gel for larger
             treatment areas.

          -  Treatment with ingenol mebutate gel in the selected treatment area within the last 12
             months.

          -  Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous
             horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two
             previous occasions).
A Study of Abatacept in Patients With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: abatacept; placebo; abatacept
Intervention description: Dextrose 5% in water, intravenous (IV).
Placebo on days Induction Period (IP)-1, IP-15,IP-29, IP-57;
3 mg/kg on days IP-1, IP-15,IP-29, IP-57;
~10 mg/kg on days IP-1, IP-15,IP-29, IP-57,
or 30 mg/kg on days IP-1,IP-15 and ~10 mg/kg on days IP-29, IP-57.
Induction Period 3 months
Maintenance Period 12 months; Normal saline, IV, 0 mg/kg, every 28 days.
Induction Period 3 months
Maintenance Period 12 months; ~10 mg/kg, every 28 days.
Open- Label Extension Period until the drug is marketed for Crohn's Disease (CD)or the CD development program for abatacept is discontinued
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 451.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if abatacept can improve signs and
      symptoms of active Crohn's Disease in patients who have not had an adequate response to other
      therapies. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  have had Crohn's Disease for at least 3 months

          -  moderate to severely active Crohn's Disease

          -  have had an inadequate response or intolerance to other Crohn's Disease treatments
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Octreotide capsules
Intervention MeSH terms: Octreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Octreotide Capsules; Acromegaly; somatostatin receptor ligands (SRLs); Mpowered; OOC-ACM-302

Summary:

      Octreotide capsule is a novel, orally-administered formulation of the commercially-available
      injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide
      capsules demonstrated sustained biochemical response up to 13 months in patients with
      acromegaly previously managed with somatostatin analog injections (ref).

      The objective of this study was to compare the efficacy, safety, and patient reported
      outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands
      (SRLs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of acromegaly

          -  Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least
             6 months

          -  Biochemical control (IGF -1 < 1.3 x ULN and GH < 2.5ng/mL)

        Exclusion Criteria:

          -  Injections of long-acting somatostatin analogs, at a dosing interval > 8 weeks.

          -  Pituitary radiotherapy within 5 years

          -  Pituitary surgery within six months

          -  Patients who previously participated in CH-ACM-01 study

          -  Any clinically significant uncontrolled concomitant disease

          -  Symptomatic cholelithiasis

          -  Previous treatment with:

          -  Pegvisomant, within 12 weeks

          -  Dopamine agonists, within 6 weeks

          -  Pasireotide, within 12 weeks
Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: ecallantide; Phosphate Buffer Saline (PBS),
Intervention description: dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.; given as three 1mL subcutaneous injections.
Intervention MeSH terms: Ecallantide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an
      investigational product) is safe and relieves symptoms of HAE in patients suffering from
      moderate to severe acute attacks of HAE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 10 and older

          -  Documented diagnosis of HAE, Type I or II

          -  Executed informed consent

          -  Presentation for treatment within 8 hours of patient recognition of moderate to severe
             HAE attack

        Exclusion Criteria:

          -  Receipt of investigational drug or device, other than DX-88, within 30 days of
             treatment

          -  Receipt of non-investigational C1-INH (C1 esterase inhibitor) within 7 days of
             treatment

          -  Diagnostic of acquired angioedema, estrogen-dependent angioedema or drug induced
             angioedema

          -  Pregnancy or breastfeeding

          -  Patients who have received DX-88 within 7 days of presentation for dosing in the
             Double-blind Phase
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Intervention: nonacog beta pegol
Intervention description: A single dose of 40 U/kg will be administered intravenously, i.v. (into the vein) once weekly.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Minimum age: 0 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and North America. The aim of the trial is to
      evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body)
      of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with
      Haemophilia B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients with moderately severe or severe congenital haemophilia B with a Factor
             IX activity level below or equal to 2% according to medical records

          -  Age below or equal to 12 years (until patient turns 13 years, at time of inclusion)

          -  Body weight above or equal to 10 kg

          -  History of at least 50 exposure days (EDs) to other FIX products

          -  The patient and/or parent(s)/caregiver are capable of assessing a bleeding episode,
             keeping an electronic diary (eDiary), capable of conducting home treatment and
             otherwise able to follow trial procedures

        Exclusion Criteria:

          -  Known history of FIX inhibitors

          -  Current FIX inhibitors above or equal to 0.6 Bethesda Units (BU)

          -  Congenital or acquired coagulation disorder other than haemophilia B

          -  Platelet count below 50,000/mcL at screening

          -  Alanine aminotransferase (ALT) above 3 times the upper limit of normal reference
             ranges at screening

          -  Creatinine level above or equal to 1.5 times above the upper normal limit of normal
             reference ranges at screening

          -  Human immunodeficiency virus (HIV) positive, defined by medical records, and with a
             CD4+ lymphocyte count below or equal to 200/mcL

          -  Immune modulating or chemotherapeutic medication (except single pulse treatment,
             inhaled and topical steroids)

          -  Previous arterial thrombotic events (myocardial infarction and intracranial
             thrombosis, as defined by medical records)
Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes
Condition: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Intervention: CP-464,005; CP-464,005; CP-464,005
Intervention description: Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose: adjusted based on the results of self-monitoring of blood glucose before each meal.; Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose: adjusted based on the results of self-monitoring of blood glucose before each meal.; Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose:adjusted based on the results of self-monitoring of blood glucose before each meal.
Intervention MeSH terms: Insulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus

Summary:

      Assess the safety and toleration of CP-464,005 and Inhaler following 1-year (52 week)
      administration to Type 1 and Type 2 diabetes patients (non-smokers)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have been diagnosed with Type 1 or Type 2 diabetes for at least 1 year,
             based on the diagnostic criteria for diabetes.

        Exclusion Criteria:

          -  Patients who have smoked during the 6 months prior to screening (smoking shall be
             prohibited during the term of this study, as well)

          -  Patients exhibiting pulmonary function test (spirometry) abnormalities (FVC or FEV1 <
             70% of predicted) ) at Week -4.
Addressing Involuntary Movements in Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Intervention: SD-809; Placebo
Intervention description: SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food.; Placebo tablets taken twice daily for 12 weeks. Tablets were swallowed whole with water and taken with food.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms

Summary:

      The purpose of this study is to determine whether fixed-doses of an investigational drug,
      SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of
      tardive dyskinesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of using a dopamine receptor antagonist for at least 3 months

          -  Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months
             prior to screening

          -  Subjects with underlying psychiatric diagnosis are stable and have no change in
             psychoactive medications

          -  Have a mental health provider and does not anticipate any changes to treatment regimen
             in the next 3 months

          -  History of being compliant with prescribed medications

          -  Able to swallow study drug whole

          -  Be in good general health and is expected to attend all study visits and complete
             study assessments

          -  Female subjects must not be pregnant and must agree to an acceptable method of
             contraception throughout the study

        Exclusion Criteria:

          -  Currently receiving medication for the treatment of tardive dyskinesia

          -  Have a neurological condition other than tardive dyskinesia that may interfere with
             assessing the severity of dyskinesias

          -  Have a serious untreated or undertreated psychiatric illness

          -  Have recent history or presence of violent behavior

          -  Have unstable or serious medical illness

          -  Have evidence of hepatic impairment

          -  Have evidence of renal impairment

          -  Have known allergy to any component of SD-809 or tetrabenazine

          -  Has participated in an investigational drug or device trial and received study drug or
             device within 30 days

          -  Have acknowledged use of illicit drugs

          -  Have a history of alcohol or substance abuse in the previous 12 months