bioihbjkbjnl/mcl2 huggingface dataset:
A Study of E7080 in Subjects With Advanced Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: E7080 capsule
Intervention description: E7080 is administered as continuous once daily dosing in an uncontrolled manner
Intervention MeSH terms: Lenvatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Thyroid cancer

Summary:

      This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally
      administered once daily (QD) in subjects with advanced thyroid cancer.
    

Eligibility criteria:

        Inclusion criteria

          1. Histologically or clinically diagnosed with thyroid cancer

          2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2

          3. Adequate laboratory values/organ function tests

        Exclusion criteria

        Participants with following complication or disease history

          1. Brain metastasis

          2. Systemic severe infection

          3. Significant cardiovascular impairment

          4. QTc greater than 480 milliseconds

          5. Active hemoptysis

          6. Bleeding or thrombotic disorders

          7. Having greater than 1+ proteinuria on urine dipstick testing will undergo 24 hour
             urine collection for quantitative assessment of proteinuria

          8. Gastrointestinal malabsorption or any other condition in the opinion of the
             investigator that might affect the absorption of E7080

          9. Major surgery within 3 weeks before enrollment

         10. With co-existing effusion requiring drainage
An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: FB825, FB825-15D11, Anti-CemX
Intervention description: Pharmaceutical form: 20mg/ml solution Route of administration: IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with
      Atopic Dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects between 20 and 65 years of age, inclusive.

          2. The subject has a physician-confirmed diagnosis of chronic atopic dermatitis based on
             3 years history of symptoms defined by the Eichenfield revised criteria of Hannifin
             and Rajka and supported by positive allergen-specific IgE at the screening visit.

          3. Eczema Area and Severity Index (EASI) score ≧14 at the screening and baseline visits.

          4. Investigator's Global Assessment (IGA) score ≧ 3 (5-point scale) at the screening and
             baseline visits.

          5. ≧10 % body surface area (BSA) of AD involvement at the screening and baseline visits.

        Exclusion Criteria:

          1. Female subjects who are pregnant or lactating.

          2. The subject is on diet or with poor intake.

          3. The subject has a history of heart arrhythmias (any clinically relevant).

          4. The subject has a positive test result for hepatitis B surface antigen, hepatitis C
             virus antibody, or human immunodeficiency virus types 1 and 2 antibodies at screening.

          5. The subject has a history of alcohol or drug abuse that would impair or risk the
             patients' full participation in the study, in the opinion of the investigator.
The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment
Condition: Infertility
MeSH terms: Infertility
Intervention: Kisspeptin 1.6nmol/kg; Kisspeptin 3.2nmol/kg; Kisspeptin 6.4nmol/kg; Kisspeptin 9.6nmol/kg; Kisspeptin 12.8nmol/kg; Kisspeptin 9.6 nmol/kg double; Kisspeptin 9.6 nmol/kg + saline
Intervention description: single kisspeptin dose 1.6 nmol/kg subcutaneously; single kisspeptin dose 3.2 nmol/kg subcutaneously; single kisspeptin dose 6.4 nmol/kg subcutaneously; single kisspeptin dose 9.6 nmol/kg subcutaneously; single kisspeptin dose 12.8 nmol/kg subcutaneously; kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously; kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Different dose for each volunteer
Masking: Double (Participant, Care Provider)
Masking description: participants and IVF physicians were blinded.
Enrollment: 175.0
Sex: Female
Minimum age: 18 Years
Maximum age: 34 Years
Healthy volunteers: No
Keywords: kisspeptin; infertility; in vitro fertilisation

Summary:

      We want to find out if kisspeptin is successful in stimulating oocyte maturation when it is
      used as a 'trigger' injection during IVF therapy for infertility.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 - 34 years

          -  Body mass index between 18 and 29 kg/m2

          -  Stable body weight for at least 3 months

          -  Normal early menstrual cycle follicular phase serum FSH concentration

          -  Serum anti-Mullerian hormone (AMH) > 40pmol/L

          -  No more than one previous IVF treatment cycle

          -  Both ovaries intact

        Exclusion Criteria:

        History of any medical, psychological or other condition, or use of any medications,
        including over-the-counter products, which, in the opinion of the investigators, would
        either interfere with the study or potentially cause harm to the volunteer

          -  Without access at home to a telephone, or other factor likely to interfere with
             ability to participate reliably in the study

          -  Treatment with an investigational drug within the preceding 2 months

          -  Donated blood during the preceding 3 months or intention to do so before the end of
             the study

          -  Previous poor response to IVF treatment
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
Condition: Retinopathy of Prematurity (ROP)
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: rhIGF-1/rhIGFBP-3
Intervention description: Participants who received "rhIGF-1/rhIGFBP-3" in study ROPP-2008-01 (NCT01096784) will be enrolled to this study. No investigational product will be administered in this study.
Intervention MeSH terms: Mecasermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 40 Weeks
Maximum age: 108 Weeks
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the long-term efficacy and safety outcomes
      following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study
      ROPP-2008-01 (NCT01096784).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant was randomized in Study ROPP-2008-01 Section D (NCT01096784).

          -  Participants parent or legally authorized representative(s) must provide written
             informed consent prior to performing any study-related activities. Study-related
             activities are any procedures that would not have been performed during normal
             management of the participant.

        Exclusion Criteria:

          -  Any other condition or therapy that, in the Investigator's opinion, may pose a risk to
             the Participant or interfere with the participants ability to be compliant with this
             protocol or interfere with the interpretation of results.

          -  The participant or participants parent or legally authorized representative(s) is
             unable to comply with the protocol as determined by the Investigator.
A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Tezacaftor/Ivacaftor; Ivacaftor; Placebo; Placebo
Intervention description: TEZ 100 mg/IVA 150 mg fixed-dose combination tablet.; IVA 150 mg tablet.; Placebo matched to TEZ/IVA fixed-dose combination tablet.; Placebo matched to IVA tablet.
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination
      with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT)
      at Week 72, and to evaluate the safety of TEZ/IVA through Week 72.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Homozygous for the F508del CFTR mutation

          -  Confirmed diagnosis of CF

          -  Percent predicted forced expiratory volume (ppFEV1) ≥70% of predicted normal for age,
             sex, and height during screening.

          -  Stable CF disease as judged by the investigator

        Exclusion Criteria:

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             subject.

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 28 days before Day 1
             (first dose of study drug)

          -  Pregnant or nursing females.

          -  Sexually active subjects of reproductive potential who are not willing to follow the
             contraception requirements.

          -  Any contraindication to undergoing chest imaging, as per the site's institutional
             guidelines
Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: OPK-88003; Placebo
Intervention description: OPK-88003 subcutaneous injection; Placebo subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC)
      OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects
      with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or
      treated with a stable dose of metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged 18 to 80 years with T2DM treated with diet and exercise alone or on
             a stable dose of metformin (≥ 1000 mg/day),

          -  BMI ≥27 and ≤45 kg/m2

          -  HbA1c ≥7.0% and ≤10.5% at screening

        Exclusion Criteria:

          -  Type 1 diabetes mellitus

          -  Previous treatment with incretin mimetic drugs

          -  Have used insulin for diabetic control for more than 6 consecutive days within the
             prior year

          -  Have had two or more emergency room visits or hospitalizations due to poor glucose
             control within the prior 6 months

          -  Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase
             (>2 x ULN).
Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients
Condition: Portal Hypertension; Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension
Intervention: Ifetroban; Placebo
Intervention description: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule; matched placebo delivered as infusion and oral capsule
Intervention MeSH terms: Ifetroban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This placebo-controlled study will assess the safety and efficacy of a 90-day course of
      treatment with ifetroban for portal hypertension in cirrhotic patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  liver cirrhosis

          -  baseline hepatic venous pressure gradient (HVPG) >= 8 mmHg and <= 18 mmHg

          -  stable liver function enzymes

        Exclusion Criteria:

          -  portal or splenic vein thrombosis

          -  Transjugular intrahepatic portosystemic shunt (TIPS) or portocaval shunt

          -  variceal bleed in last 2 months

          -  hemodialysis

          -  Child-Pugh Score >= 12

          -  Model for End-stage Liver Disease- Sodium score (MELD-Na) >= 20

          -  Acute kidney injury, Chronic kidney disease and/or Serum Creatinine >= 2.0 mg/dL

          -  current alcohol consumption > 2 drinks per day

          -  Platelet count (PLT) < 60 x 10^3/microliter (uL)

          -  A change in statin therapy in the last 3 months

          -  Current Hepatitis Virus B or C (HBV or HCV) therapy; or planned initiation of therapy
             during the treatment period

          -  Myocardial infarction within 30 days

          -  History of bleeding diathesis or current (within previous 14 days) or planned use of
             anticoagulant or antiplatelet drugs including aspirin
PF-06741086 Long-term Treatment in Severe Hemophilia
Condition: Hemophilia A or B
MeSH terms: Hemophilia A
Intervention: PF-06741086
Intervention description: PF-06741086 subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 12 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: hemophilia

Summary:

      This study is designed to evaluate the safety, tolerability and efficacy of long-term
      treatment with PF-06741086 in subjects with severe hemophilia who participated in the 3-month
      Phase 1b/2 B7841002 study. Additionally, de novo subjects will be recruited into this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe hemophilia A or B (Factor VIII or Factor IX activity ≤ 1%)

          -  Subjects enrolled as Factor VIII or Factor IX inhibitor patients must have a positive
             inhibitor test result (above the upper limit of normal) at the local laboratory and
             must receive a bypass agent as primary treatment for bleeding episodes.

          -  Episodic (on-demand) treatment regimen prior to screening

          -  At least 6 acute bleeding episodes during the 6-month period prior to screening

        Exclusion Criteria:

          -  Known coronary artery, thrombotic, or ischemic disease

          -  Concomitant treatment with activated prothrombin complex concentrate
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Kidney Failure, Chronic
Intervention: SOF/VEL
Intervention description: 400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate safety, efficacy, and tolerability of
      treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end
      stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic HCV infected, male and non-pregnant/non-lactating females aged 18 years or
             older who are on dialysis for ESRD, including adults with HIV co-infection if they are
             suppressed on a stable, protocol-approved antiretroviral (ARV) regimen for ≥8 weeks
             prior to screening.

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Vilazodone for Corticosteroid-Induced Memory Impairment
Condition: Memory Impairment
MeSH terms: Memory Disorders
Intervention: Vilazodone; Placebo; Hydrocortisone
Intervention description: Participants will be randomized to either vilazodone or placebo titrated as follows: 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days.; Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment
Intervention MeSH terms: Hydrocortisone; Vilazodone Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to examine whether vilazodone attenuates the memory and mood
      effects of corticosteroids on the human hippocampus in 24 healthy controls.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men and women age 18-50 years

          -  Education of ≥ 12 years and baseline RAVLT total words recalled score ≥ 35 (normal
             baseline memory)

          -  BMI between 18.5-30 (not underweight or obese)

        Exclusion Criteria:

          -  History of major psychiatric illness defined as major depressive disorder, bipolar
             disorder, posttraumatic stress disorder, panic disorder, schizoaffective disorder,
             schizophrenia, eating disorders, or drug/alcohol abuse/dependence or current tobacco
             use

          -  History of neurological disorders including seizures, brain surgery, multiple
             sclerosis, Parkinson's disease

          -  Taking CNS-acting medications within 30 days of study

          -  History of allergic reaction or medical contraindication to vilazodone or
             hydrocortisone

          -  Significant medical conditions (e.g., myocardial infarction, cancer, diabetes)

          -  Vulnerable population including pregnant or nursing women, the incarcerated, and
             severe cognitive disorders

          -  Baseline HRSD (Hamilton Rating Scale for Depression) > 7 or current suicidal ideation
             or history of suicide attempt

          -  History of systemic Corticosteroid (CS) use or recent (past 6 months) inhaled CS use
Open-Label Extension and Safety Study of Talazoparib
Condition: Cancer
Intervention: Talazoparib
Intervention description: Maximum starting dose: 1mg/day or last tolerated dose in the originating protocol
Intervention MeSH terms: Talazoparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a single-arm, open-label, extended treatment, safety study in patients treated with
      talazoparib in qualifying studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

          -  Female patients of childbearing potential must have a negative pregnancy test before
             the first dose of talazoparib and must agree to use a highly effective birth control
             method from the time of the first dose of talazoparib through 45 days after the last
             dose.

          -  Male patients must use a condom when having sex with a pregnant woman or with a woman
             of childbearing potential from the time of the first dose of talazoparib through 105
             days after the last dose. Contraception should be considered for a nonpregnant female
             partner of childbearing potential.

          -  Female patients may not be breastfeeding at the first dose of talazoparib and must not
             breastfeed during study participation through 45 days after the last dose of
             talazoparib.

        Exclusion Criteria:

          -  Permanently discontinued from any Medivation sponsored study with talazoparib alone or
             in combination with another agent.

          -  Received an antineoplastic therapy or investigational agent after treatment with
             talazoparib in the originating protocol.

          -  Has a clinically significant cardiovascular, dermatologic, endocrine,
             gastrointestinal, hematologic, infectious, metabolic, neurologic, psychologic, or
             pulmonary disorder or any other condition, including excessive alcohol or drug abuse,
             or secondary malignancy, that may interfere with study participation in the opinion of
             the investigator.

          -  Diagnosis of myelodysplastic syndrome (MDS).
Pharmacokinetics of Advantage Anti-Caries Varnish
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Anti-caries varnish
Intervention description: topical tooth varnish
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label exposure--response study
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adults; povidone iodine; sodium fluoride

Summary:

      The study aim is to characterize the kinetics of iodine and fluoride following topical
      application of a combined PVP-I and NaF anti-dental caries varnish in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18 y and older, at least 20 teeth, not taking prescription or OTC
             medications.

        Exclusion Criteria:

          -  Pregnant, weighed less than 110 pounds, had oral mucositis, ulcerative lesions,
             sensitivity to shellfish or iodine or fluoride varnish, or had known hypothyroidism,
             hyperthyroidism, dermatitis herpetiformis, hypocomplementemic vasculitis, nodular
             thread with heart disease, multi nodular goiter, Graves disease, or autoimmune
             thyroiditis