bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: recombinant Factor VIII
Intervention description: intravenous infusion of factor FVIII every other day.
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will determine the efficacy of human-cl rhFVIII in previously treated patients
      with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in
      surgical prophylaxis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe hemophilia A ((FVIII:C <= 1%)

          -  Male subjects >= 12 years of age

          -  Previously treated with FVIII concentrate, at least 50 EDs

          -  Immunocompetent (CD4+ count > 200/ul)

          -  Negative for anti- HIV; if positive, viral load < 200 particles/u; or <400,000
             copies/mL

        Exclusion Criteria:

          -  Other coagulation disorder than hemophilia A

          -  Present of past FVIII inhibitor activity (.= 0.6 BU)

          -  Severe liver and kidney disease

          -  Receiving of scheduled to receive immuno-modulating drugs
Anidulafungin In Treatment Of Candidemia In Asian Subjects
Condition: Candidemia
MeSH terms: Candidemia
Intervention: Anidulafungin
Intervention description: Eligible subjects will be initiated on a single loading dose of 200 mg IV anidulafungin, followed by 100 mg IV anidulafungin once daily for a minimum of 5 days but not more than 42 days.
Intervention MeSH terms: Anidulafungin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether or not the Investigational Study Drug
      anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in
      Asian subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with at least one positive blood test for Candida pathogen from a blood
             sample taken within 96 hours prior to start of study treatment.

          -  Subjects with clinical evidence of candida infection within 48 hours prior to
             enrollment.

          -  Acute Physiology and Chronic Health Enquiry (APACHE) score less than or equal to 20.

        Exclusion Criteria:

          -  Prior exposure to systemic antifungals for more than 48 hours.

          -  Subjects who had, at any time, previously received anidulafungin.

          -  Subjects with poor venous (vein) access that would inhibit the administration of the
             intravenous study drug or withdrawing of multiple blood samples.

          -  Life expectancy < 72 hours.
Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer
Condition: Carcinoma, Squamous Cell of Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab; Cisplatin/Carboplatin; 5-fluorouracil
Intervention description: Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m^2) on Day 1 and a subsequent dose of 250 mg/m^2 on Day 8 and Day 15 of each 21-day treatment cycle.; Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle.; Participants received 5-fluorouracil (FU) at a dose of 750 mg/m^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle.
Intervention MeSH terms: Carboplatin; Fluorouracil; Cetuximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial aimed to assess efficacy and safety of cetuximab when given in combination with
      chemotherapy compared with chemotherapy alone in Chinese participants with recurrent and/or
      metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of SCCHN

          -  Recurrent and/or metastatic SCCHN, not suitable for local-regional treatment

          -  Presence of at least 1 measurable lesion according to RECIST Version 1.1

          -  Signed written informed consent before any trial-related activities are carried out

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Other protocol-defined inclusion criteria could apply

        Exclusion Criteria:

          -  Prior systemic chemotherapy, except if given as part of multimodal treatment for
             locally advanced disease, that was completed within 6 months before randomization

          -  Surgery (excluding prior biopsy for diagnosis) or irradiation within 4 weeks before
             trial entry

          -  Previous treatment with monoclonal antibody or signal transduction inhibitors
             targeting epidermal growth factor receptor

          -  Nasopharyngeal carcinoma

          -  Known central nervous system metastasis and/or leptomeningeal disease

          -  Medical or psychological condition that would not permit the participant to complete
             the trial or sign informed consent

          -  Legal incapacity or limited legal capacity

          -  Other protocol-defined exclusion criteria could apply
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
Condition: Plasma Cell Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: isatuximab SAR650984; carfilzomib; dexamethasone
Intervention description: Pharmaceutical form: solution for infusion
Route of administration: intravenous; Pharmaceutical form: solution for infusion
Route of administration: intravenous; Pharmaceutical form: tablets or solution for infusion
Route of administration: oral or intravenous
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anti-CD38 monoclonal antibody

Summary:

      The purpose of this study it to compare the efficacity of isatuximab when combined to
      carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple
      myeloma already treated with 1 to 3 prior lines of therapy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with MM previously treated with prior 1 to 3 lines and with measurable
             serum M-protein (>= 0.5 gram/deciliter) and/or urine M-protein (>= 200 milligram/24
             hours).

        Exclusion criteria:

          -  Participants previously pretreated with carfilzomib, who never achieved at least one
             minor response during previous therapies and/or last previous therapy completed within
             14 last days.

          -  Participants with serum free light chain (FLC) measurable disease only.

          -  Participants less than 18 years old, participants with Eastern Cooperative Oncology
             Group performance status more than 2.

          -  Participants with inadequate biological tests.

          -  Participants with myocardial infarction, severe/unstable angina pectoris,
             coronary/peripheral artery bypass graft, New York Heart Association class III or IV
             congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or
             transient ischemic attack within last 6 months, and/or left ventricular ejection
             fraction lower than 40%.

          -  Participants with previous cancer unless disease free for more than 5 years or in situ
             cancer curatively treated.

          -  Participants with known acquired immunodeficiency syndrome related illness or human
             immunodeficiency virus requiring antiretroviral treatment, or hepatitis A, B, or C
             active infection.

          -  Women of childbearing potential or male participant with women of childbearing
             potential who do not agree to use highly effective method of birth control.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Intervention: Standard fluid management; Goal directed fluid therapy with the Edwards EV1000 system
Intervention description: The patient will receive standard fluid management; This arm will have fluid therapy guided by the Edwards EV1000 system.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Perioperative Fluid Management; liver resection; 12-056

Summary:

      The purpose of this study is to help us learn what is the best amount of fluid to administer
      to patients during liver surgery. Patients will receive either an amount for this surgery
      based on weight, blood pressure, heart rate and urine output or an amount guided by a
      computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The
      FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on
      real time information like blood pressure, pulse and the ability of the heart and blood
      vessels to maintain normal vital signs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (18 years old or greater) who are able to provide informed consent.

          -  Patients who undergo an open, elective liver resection. Including those initially
             approached laparoscopically but converted to an open resection and those undergoing
             additional procedures.

        Exclusion Criteria:

          -  Active coronary disease.

          -  Patients with a history of coronary disease will be eligible if they have had a
             cardiac stress study showing no reversible ischemia and normal LV function within 3
             months of operation.

          -  Active symptomatic cerebrovascular disease.

          -  Active congestive heart failure and ejection fraction <35%.

          -  Active severe restrictive or obstructive pulmonary disease and resting SpO2 <90%.

          -  Active renal dysfunction (Cr >1.8)

          -  Abnormal coagulation parameters (INR > 1.8 not on Coumadin, or platelet count <
             100,000 per mcL)

          -  Presence of active infection including HIV

          -  Patients with active atrial fibrillation or flutter.

          -  Preoperative hypoalbuminemia (Albumin < 2g/dl).

          -  Female patients who are pregnant (female patients of child-bearing potential must have
             a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to
             surgery with a negative urine pregnancy test the morning of surgery).

          -  Presence of ascites.

          -  BMI > 45 or <17
Maintenance Effect of Clobex Shampoo on Participants With Moderate to Severe Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: Clobex® Shampoo; Clobex® Vehicle Shampoo; Clobex® Shampoo
Intervention description: Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks.; Clobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months.; Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months.
Intervention MeSH terms: Clobetasol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: maintenance; scalp psoriasis; Galderma

Summary:

      The objective of the study was to assess the maintenance effect on scalp psoriasis of Clobex®
      Shampoo 0.05% when used twice weekly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 18 years or older.

          -  Subjects with moderate to severe scalp psoriasis

        Exclusion Criteria:

          -  Subjects who needed systemic treatment for their body psoriasis

          -  Subjects with a washout period for topical treatment(s) on the scalp less than:

               -  Corticosteroids 2 weeks

               -  All other anti-psoriasis medications 2 weeks

          -  Subjects with a washout period for systemic treatment(s) less than:

               -  PUVA therapy 4 weeks

               -  Biological therapies 12 weeks

               -  Treatments other than biologicals with a possible efficacy on psoriasis 4 weeks

               -  Treatment known to worsen psoriasis 2 weeks
Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate 20 mg long-acting capsules
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD; methylphenidate; children; food effect; Attention-Deficit Hyperactivity Disorder (ADHD) in children

Summary:

      This study evaluated the safety and clinical effect of treatment with methylphenidate under
      different breakfast conditions (minimal breakfast versus standard continental breakfast) in
      children with Attention-Deficit Hyperactivity Disorder (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 6-12

          -  Diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD)

          -  Current medication with either 20 mg or 40 mg immediate release methylphenidate

        Exclusion Criteria:

          -  Concomitant psychiatric disorders requiring pharmacological treatment

          -  Concomitant severe somatic disorders

          -  Eating disorders

          -  Addiction disorders

          -  Very high or low body weight according to age

          -  Known hypersensitivity to methylphenidate

          -  Contraindications for methylphenidate

        Other protocol-defined inclusion/exclusion criteria applied to the study.
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
Condition: Contraception
Intervention: AG200-15 (cycles 1-13); Lessina crossover to AG200-15
Intervention description: AG200-15 containing ethinyl estradiol and levonorgestrel; Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1504.0
Sex: Female
Minimum age: 17 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraceptive

Summary:

      The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal
      contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy females

          -  17(in states where the legal age of consent to receive contraceptives is 17)-40 years

          -  Regular, consistent menstrual cycles between 25 and 35 days

          -  Sexually active women requesting birth control

          -  In good general health, confirmed by medical history, physical (including gynecologic)
             examination and screening laboratory values

        Exclusion Criteria:

          -  Known or suspected pregnancy;

          -  Lactating women

          -  Significant skin reaction to transdermal preparations or sensitivity to surgical /
             medical tape

          -  Any disease that may worsen under hormonal treatment (cardiovascular, liver,
             metabolic)

          -  Use of other contraceptive methods than study medication
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: HBVAXPRO™
Intervention description: Single 0.5 mL intramuscular dose
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 207.0
Sex: All
Minimum age: 8 Years
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to demonstrate the durability of protection against hepatitis B
      virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an
      estimation study, and no formal hypothesis testing was performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is healthy (based on a review of medical history and targeted physical examination)
             based on the clinical judgment of the investigator.

          -  Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or
             participated in Protocol V419-008 and received a 2 + 1 Vaxelis® schedule.

          -  The participant (or legally acceptable representative if applicable) provides written
             informed consent/assent for the study.

        Exclusion Criteria:

          -  Has a history of diagnosis (clinical, serological, or microbiological) of HBV
             infection.

          -  Has a known or suspected impairment of immunological function (e.g., human
             immunodeficiency virus (HIV), splenectomy).

          -  Has a known hypersensitivity to any component of the study vaccine.

          -  Has a known or suspected blood dyscrasias, leukemia, lymphomas of any type or other
             malignant neoplasms affecting the haematopoietic and lymphatic system.

          -  Has a bleeding disorder contraindicating intramuscular vaccinations.

          -  Has received any hepatitis B vaccine after participation in Protocol V419-007 or
             V419-008.

          -  Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or
             child) who is investigational site or Sponsor staff directly involved with this study.
Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
Condition: Smoking Cessation
MeSH terms: Cardiovascular Diseases
Intervention: placebo; Varenicline
Intervention description: 1 mg placebo twice daily by mouth for 12 weeks; 1 mg twice daily by mouth for 12 weeks
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 714.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to determine whether or not varenicline will help people
      with cardiovascular disease quit smoking and to confirm it is safe in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have stable, documented cardiovascular disease (including at least
             one of the following diagnosed > 2 months prior to the Screening visit - angina,
             myocardial infarction (MI), revascularization, transient ischemic attack (TIA), and
             peripheral vascular disease (PVD).

          -  Participants that smoke > 10 cigarettes / day.

        Exclusion Criteria:

          -  Participants with unstable cardiovascular disease

          -  Cardiovascular events in the past 2 months

          -  Moderate or severe chronic obstructive pulmonary disease (COPD)
Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Intervention: Budesonide; Pulmicort Turbuhaler
Intervention description: Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks; Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Asthma; Pulmicort Respules

Summary:

      The primary objective of the study is to show similarity of efficacy on Pulmicort Respules
      1.0 mg/day or 2.0 mg/day for 6 weeks in the treatment period and the corresponding doses of
      Pulmicort Turbuhaler 400 μg/day or 800 μg/day for 4 weeks in the observation period in
      Japanese adult asthmatic patients with age of 16 years or older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures.

          -  A minimum of 6 months documented history of asthma according to the JGL 2006
             definition

          -  Asthma patients under prescribed treatment with ICS at least 3 months before Visit 2.

        Exclusion Criteria:

          -  Current or previous tobacco smokers with a history of >= 10 pack-years

          -  Use of β-blockers including eye drops

          -  Clinically significant respiratory infection affecting the asthma, as judged by the
             investigator(s) within 4 weeks prior to visit 2

          -  Intake of oral, rectal or parenteral GCS within 4 weeks prior to Visit 2