bioihbjkbjnl/mcl2 huggingface dataset:
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery
Condition: Tympanomastoid Surgery; Cochlear Implant; Mastoidectomy; Cholesteatoma
MeSH terms: Cholesteatoma
Intervention: 0.25% Bupivacaine + Clonidine
Intervention description: Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
Intervention MeSH terms: Clonidine; Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Tympanomastoid Surgery; Cochlear Implant; Mastoidectomy; Cholesteatoma; Pediatrics; Clonidine; Bupivacaine; Greater Auricular Nerve Block; Regional Anesthesia

Summary:

      The investigators goal is to determine the efficacy and duration of analgesia with the
      addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of
      the great auricular nerve in children undergoing tympanomastoid surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 1-18 years

          -  tympanomastoid surgery (cochlear implant, mastoidectomy, cholesteatoma surgery)

          -  ASA I, II

          -  informed consent and assent obtained

        Exclusion Criteria:

          -  allergic to local anesthestic

          -  taking chronic aspirin or Ibuprofen therapy

          -  ASA IV

          -  history of clinically important renal, hepatic, respiratory, cardiac, or neurological
             conditions

          -  Patients who have cardiovascular surgery other than an atrial septal defect or a
             ventricular septal defect, or who have undergone complete corrective intracardiac
             repair of congenital heart disease.

          -  Informed consent not obtained

          -  Patients expected to receive dexamethasone or ondansetron intra-operative
Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: lurbinectedin (PM01183)
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the
      duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the
      PM01183 plasma concentration/QTc relationship, and to explore related ECG parameters in
      patients with selected solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily signed and dated informed consent

          -  Normal cardiac conduction and function (centrally read)

          -  Blood pressure between 90 and 150 mmHg systolic, inclusive, and not higher than 90
             mmHg diastolic.

          -  Specific serum electrolyte levels

        Exclusion Criteria:

          -  Age > 65 years

          -  Performance status = 2 [Eastern Cooperative Oncology Group (ECOG)]

          -  Heart rhythm disturbances

          -  Significant ischemic coronary disease, heart failure, myocardial infarction, or
             unstable angina within the last six months.

          -  Prior exposure to anthracyclines at a cumulative dose of doxorubicin (or equivalent) >
             450 mg/m²
Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis
Condition: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Non-Radiographical Axial Spondyloarthritis
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
Intervention: Filgotinib; Placebo; Standard of Care
Intervention description: 200-mg tablet administered orally once daily; Placebo to match filgotinib tablet administered orally once daily; Locally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: Male
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the effect of filgotinib on semen
      parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing
      spondylitis, or non-radiographic axial spondyloarthritis.

      Results of this study may be pooled with the results of a separate study being conducted in
      participants with inflammatory bowel disease (Protocol GS-US-418-4279; NCT03201445) with the
      same objective.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
             or, non-radiographic axial spondyloarthritis for at least 12 weeks prior to screening,
             meeting the corresponding specific disease classification criteria as specified in the
             protocol

        Key Exclusion Criteria:

          -  Previously documented problems with male reproductive health

          -  Prior diagnosis of male infertility

          -  Use of any prohibited concomitant medication as outlined by protocol

        Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
Condition: Acute Heart Failure
MeSH terms: Heart Failure
Intervention: Serelaxin
Intervention description: Serelaxin was administered intravenously for up to 48 hours.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Acute heart failure; RELAX-AHF-PEDIATRIC PK; AHF

Summary:

      The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an
      intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients
      with acute heart failure (AHF)
    

Eligibility criteria:

        Key Inclusion criteria:

          -  Body weight ≥2.5 kg to ≤120 kg

          -  Hospitalized in an intensive care unit or step-down unit with the following:

          -  - Signs and symptoms of acute heart failure of any etiology

          -  - Stable dose of vasoactive and/or inotropic drugs

          -  - For non-surgical patients echocardiographic evidence of reduced ventricular function
             (ejection fraction <50% or fractional shortening <28%)

          -  Systolic blood pressure (SBP) ≥25th percentile SBP for age and gender.

        Key Exclusion criteria:

          -  Moderate to severe left ventricular outflow tract, mitral stenosis, or aortic arch
             obstruction

          -  Single ventricle physiology

          -  Fixed pulmonary hypertension

          -  Blood lactate levels >5 mmol/L at screening

          -  Birth < 36 weeks post-conceptual age (for patients <1year old)

          -  Confirmed or clinically suspected systemic infection or severe localized infection

          -  Dyspnea or acute lung injury primarily due to non-cardiac causes

          -  Patients with severe renal impairment, those known to have significant renal disease
             and those having renal replacement therapy

          -  High use of inotropic and/or vasoactive agents at screening

          -  Electrocardiographic abnormalities

          -  Solid organ transplant recipient within 1 year of transplantation or one who presents
             with severe organ rejection
Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: BN83495
Intervention description: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the protocol is to determine the effect of BN83495 on the progression of
      endometrial cancer with estrogen receptor in post menopausal women who had previously
      received chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent prior to any study related procedures.

          -  postmenopausal or ovariectomised female patient over 18 years of age.

          -  histologically confirmed diagnosis of ER positive endometrial carcinoma in the primary
             tumour or metastatic disease

          -  patient has received one line of chemotherapy prior to enrolment in the adjuvant or in
             the metastatic setting (including chemoradiotherapy) and progressed after this line of
             chemotherapy

          -  patient has at least one measurable disease site (RECIST criteria version 1.1)

        Exclusion Criteria:

          -  patient has received hormone therapy for endometrial cancer in the adjuvant or
             metastatic setting

          -  patient has received more than one line of chemotherapy in the adjuvant or metastatic
             setting

          -  patient was treated with any other investigational agent within the 3 weeks before
             study entry.

          -  patient has ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade
             (NCI CTCAE) or QTcF interval >460 msec.
Safety and Efficacy of AIN457 in Noninfectious Uveitis
Condition: Non-infectious Uveitis
MeSH terms: Uveitis
Intervention: AIN457; AIN 457; AIN457
Intervention description: AIN457 subcutaneous dose; AIN457 low dose (i.v); AIN457 high dose (i.v)
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Uveitis; eye; IL-17; IL-17A; IL17; AIN457; Vogt-Koyanagi-Harada; Behcet's; Behcet; Sympathetic ophthalmia; Multifocal choroiditis; Birdshot; HLA-B27; Birdshot retinochoroiditis; Retinal vasculitis; Sarcoidosis; Intermediate uveitis; Panuveitis; Posterior uveitis

Summary:

      This study was performed to evaluate the efficacy and safety of AIN457 for patients with
      active uveitis that requires systemic immunosuppression.
    

Eligibility criteria:

        Inclusion criteria:

          -  Active uveitis (i.e., uveitis that is not in remission).

          -  Intermediate uveitis, posterior uveitis, or panuveitis must be sufficiently severe
             that systemic immunosuppression is indicated.

        Exclusion criteria:

          -  Active infection.

          -  Weight must not be greater that 120kg.

        Other protocol-defined inclusion/exclusion criteria may apply
Fish Oil (Omega 3), Immune Function, and Mood
Condition: Inflammation
MeSH terms: Inflammation
Intervention: Omega 3 (Fish Oil) Supplementation; Placebo
Intervention description: 1.25 g or 2.496 g daily for 4 months; matching placebo capsule daily for 4 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 40 Years
Maximum age: 88 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: affect; inflammation

Summary:

      This study is designed to examine the effects of fish oil on immune function and mood.
    

Eligibility criteria:

        Recruiting men and women ages 40-88 from the Greater Columbus Ohio area. Participation
        involves taking capsules for 4 months and completing 6 appointments (for a total of 19.5
        hours) at Ohio State.

        Inclusion Criteria:

          -  Healthy men and women

          -  NOT currently taking any sort of fish oil or omega 3 supplement

        Exclusion Criteria:

          -  Use of blood pressure medicines, cholesterol-lowering drugs, steroids, or
             antidepressants

          -  Certain lifestyle habits such as smoking or exercising vigorously for 2 or more hours
             a week may also exclude applicants from participating
Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's Disease
Condition: Apathy; Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Transcranial direct current stimulation
Intervention description: tDCS 2 mA, dorsolateral pre-frontal cortex
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Apathy; Alzheimer's Disease; Dementia

Summary:

      This is a phase 2 double-blind, randomized, sham-controlled study to investigate the effects
      of repeated transcranial direct current stimulation for the treatment of apathy in moderate
      Alzheimer's Disease in patients selected from an outpatient clinics in São Paulo, Brazil.
    

Eligibility criteria:

        Inclusion criteria:

          1. Dementia defined by DSM-IV (Diagnostic and Statistical Manual version IV)

          2. Possible Alzheimer's Disease defined by NINCDS-ADRDA (National Institute for
             Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and
             Related Disorders Association)

          3. Mini Mental State Examination scores from 10 to 20

          4. Apathy defined by a score equal or higher to 14 in Apathy Scale

        Exclusion criteria:

          1. Clinical instability

          2. Epilepsy

          3. Metallic clip in the head

          4. Use of alcohol and psychotropic drugs
A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Ticagrelor Tablets; Clopidogrel (over encapsulated) capsule; Aspirin Tablets
Intervention description: Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily (BD); Oral 75 mg; 600 mg loading dose followed by 75 mg once daily (ODD); Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study.
Intervention MeSH terms: Aspirin; Clopidogrel; Ticagrelor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronary artery disease; CAD; heart attack; stable angina; Stable coronary artery disease

Summary:

      The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet
      medication, affects platelets. Anti-platelet agents are medications that block the formation
      of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding,
      but when they form inside the arteries their formation is linked to a risk of medical
      problems such as heart attack and stroke. This study investigated how long it takes for
      Ticagrelor to begin working and how long it takes for it to stop working after the last dose
      of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment
      for preventing blood clots, and placebo plus Aspirin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented stable Coronary Artery Disease (stable angina, previous MI history,
             previous history of revascularization);

          -  Females of child bearing potential must have a negative pregnancy test prior to
             receiving study drug and be willing to use a hormonal contraceptive in addition to
             double barrier contraception

        Exclusion Criteria:

          -  History of Acute Coronary Syndromes within 12 months of screening or need for
             revascularization (angioplasty or Coronary Artery Bypass Graft (CABG))

          -  History of liver or kidney disease

          -  Have increased bleeding risk, eg, recent gastrointestinal bleed, uncontrolled high
             blood pressure, low platelet count, recent major trauma

          -  History of intolerance or allergy to Aspirin or clopidogrel
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)
Condition: Anemia; Non-dialysis Dependent Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Vadadustat; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Anemia; kidney; non-dialysis dependent chronic kidney disease; CKD; NDD-CKD; renal; vadadustat; AKB-6548; hypoxia-inducible factor; hypoxia-inducible factor (HIF); HIF; prolyl-hydroxylase inhibitor (PHI); PHI; Japan; Japanese; Akebia (AKB)

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess
      the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally
      administered vadadustat in Japanese participants with anemia secondary to Non-dialysis
      Dependent Chronic Kidney Disease (NDD-CKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female Japanese participants ≥20 years of age

          -  Diagnosis of chronic kidney disease (CKD) based on an estimated glomerular filtration
             rate ≤60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m^2)

          -  Hemoglobin (Hb) ≤10.5 grams per deciliter (g/dL)

          -  Not currently being treated with dialysis and not expected to start dialysis within 3
             months of screening

        Exclusion Criteria:

          -  Anemia due to a cause other than CKD or presence of active bleeding or recent blood
             loss

          -  Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic
             malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia

          -  Red blood cell transfusion within 4 weeks prior to or during screening

          -  Intravenous iron within 4 weeks prior to or during screening

          -  Any use of erythropoiesis-stimulating agents within 6 weeks prior to or during
             screening
Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
Condition: Congenital Fibrinogen Deficiency; Afibrinogenemia
MeSH terms: Afibrinogenemia
Intervention: Octafibrin; Haemocomplettan® P or RiaSTAPTM
Intervention description: Octafibrin was supplied as a powder for reconstitution with water for injection.; Commercially available Haemocomplettan® P or RiaSTAPTM (same product with different names in different markets) were supplied as powders for reconstitution with water for injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy
      and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital
      fibrinogen deficiency
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 12 years.

          -  Documented congenital fibrinogen deficiency (afibrinogenemia).

        Exclusion Criteria:

          -  Life expectancy > 6 month.

          -  Bleeding disorder other than congenital fibrinogen deficiency.

          -  Presence or history of hypersensitivity to study medication.

          -  Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior
             to enrollment.

          -  Presence or history of arterial thrombosis with 1 year prior to enrollment.

          -  Hypersensitivity to human plasma products.

          -  Acute bleeding.

          -  Pregnant or currently breast-feeding women.

          -  Suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery
             (if available).

          -  Blood or plasma donation in the 3 months prior to enrollment.

          -  Human immunodeficiency virus (HIV) positive with a viral load > 200 particles/µl or >
             400000 copies/mL.

          -  End-stage liver disease.

          -  History of oesophageal varicose bleeding.