bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Moroctocog alfa ( AF-CC); Laboratory tests
Intervention description: Dosing is at the discretion of the Investigator; Factor VIII PK samples, Hematology, Chemistry and Coagulation testing, FactorVIII Inhibitor and Anti Factor VIII antibody
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: Male
Maximum age: 11 Years
Healthy volunteers: No
Keywords: hemophilia A

Summary:

      The study will be investigating pharmacokinetics, safety and efficacy in patients less than
      12 years of age with severe hemophilia A that have been previously treated with Factor VIII
      products ( including blood products).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects less than 12 years of age with a documented history of severe hemophilia
             A (FVIII:C less than 1%).

          -  Subjects who are less than 6 years of age must have had at least 50 Exposure Days
             (EDs) to prior FVIII products (including blood products).

          -  Subjects who are equal to or greater than 6 years of age must have had greater than
             150 EDs to prior FVIII products (including blood products).

        Exclusion Criteria:

          -  For laboratory assessments, any measured Bethesda inhibitor titer equal to or greater
             than 0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor
             titer greater than ULN for the testing laboratory at the time of screening.

          -  Any other bleeding disorder in addition to hemophilia A.

          -  Treatment with any investigational drug or device within 30 days before the time of
             signing the parental informed consent/assent form.

          -  Major surgery planned to occur during the course of the study.

          -  Regular (e.g., daily; every other day) use of agents or medications known to influence
             platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs
             (NSAIDS).

          -  Regular, concomitant therapy with immunomodulating drugs (e.g., intravenous
             immunoglobulin [IVIG], routine systemic corticosteroids), or currently receiving
             immune tolerance induction (ITI) for inhibitor treatment.

          -  The subject is receiving treatment for HIV or hepatitis infection (unless the subject
             is on a stable antiviral regimen [i.e., consistent treatment regimen for at least 3
             months before the parental informed consent/assent form is signed]).

          -  Platelet count less than 100,000/µL.

          -  Prothrombin time (PT) equal to or greater than 1.25 x ULN, or international normalized
             ratio (INR) equal to or greater than 1.5.

          -  Known hypersensitivity to hamster protein.
Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose
Condition: Magnetic Resonance Imaging
Intervention: Gadoterate (Dotarem/Clariscan); Gadobutrol (Gadavist/Gadovist, BAY86-4875)
Intervention description: Patients received a single dose of 0.5 molar gadoterate (0.1 mmol per kg body weight) intravenously.; Patients received a single dose of 1.0 molar BAY86-4875 (0.075 mmol per kg body weight) intravenously.
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gadolinium; Contrast enhancement; Central nervous system lesion

Summary:

      The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used
      for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system
      (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions.
      Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is
      applied to improve the analysability of MRI-images.

      The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the
      gadolinium-based contrast agent gadobutrol delivers images of similar quality to those
      obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Known or highly suspected central nervous system (CNS) pathology referred for
             contrast-enhanced MRI of the CNS.

          -  Glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m2 derived from a serum
             creatinine result within four weeks prior to the first study MRI.

          -  Women with negative urine pregnancy test within 1 hour prior to the administration of
             gadoterate (the first MRI).

        Exclusion Criteria:

          -  No enhancing lesion visible on the gadoterate-enhanced MRI scan.

          -  Pregnancy or breastfeeding.

          -  Severe cardiovascular disease
Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
Condition: Hepatitis A; Measles; Mumps; Rubella; Chickenpox
MeSH terms: Hepatitis A; Measles; Rubella; Chickenpox; Hepatitis
Intervention: VAQTA®; ProQuad
Intervention description: 0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.; 0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1800.0
Sex: All
Minimum age: 12 Months
Maximum age: 17 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella
      [Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data
      will be collected following each vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Negative clinical history of hepatitis A, measles, mumps, rubella, varicella
             (chickenpox), and/or zoster

          -  No other vaccinations scheduled to be administered at the time of the first or second
             doses of VAQTA(TM) and ProQuad(TM)

        Exclusion Criteria:

          -  Previously vaccinated with any hepatitis A vaccine, measles, mumps, rubella, and/or
             varicella vaccine either alone or in any combination

          -  History of allergy to any vaccine component

          -  History of seizure disorder

          -  Immunosuppressed including congenial and acquired conditions and immunosuppressive
             therapy

          -  Known severe thrombocytopenia or any other coagulation disorder that would
             contraindicate intramuscular injections

          -  Recent (<72 hours) febrile illness (>100.3 degrees F [>37.9 degrees C] oral
             equivalent) prior to study vaccination.
Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia
Condition: Hyperlipoproteinemia; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias
Intervention: Niacin/ Laropiprant
Intervention description: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Intervention MeSH terms: Niacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 19 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial
      lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and
      postprandial biomarkers of endothelial dysfunction and inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects or postmenopausal female subjects aged between 19-70 years

          -  High risk patients (PROCAM risk ≥20%) on a stable statin-therapy, but at least
             simvastatin 20 mg/d

          -  HDL-cholesterol ≤50 mg/dl and /or triglycerides 150-400 mg/dl and/or LDL-cholesterol
             70 - 150 mg/dl

          -  Lipoprotein (a) < 30 mg/dl

          -  Patients may have normal glucose metabolism (normal HOMA), be insulin resistant
             (abnormal HOMA), have impaired fasting glucose or impaired glucose tolerance but not
             diabetes mellitus.

          -  Without niacin therapy for at least 6 months

          -  Dosage of any concomitant medication has been stable for at least 3 weeks

          -  If female, postmenopausal (absence of menstruation for at least 12 months or absence
             of menstruation > 6 months with FSH > 40 ng/ml respectively oestrogen < 20 pg/ml)

        Exclusion Criteria:

          -  Subjects with additional causes for hyperlipoproteinemia

          -  Diabetes mellitus or antidiabetic medication

          -  Subject has history of cardiovascular ischemia in previous 3 months or acute
             myocardial infarction or unstable angina

          -  History of psychiatric disorder or cognitive impairment that would interfere with
             participation in the study

          -  History of alcoholism

          -  Contraindication against niacin and/or laropiprant

          -  Subject has participated in an investigational study within 30 days prior to study
             initiation

          -  Fasting triglycerides >400 mg/dl

          -  Life-threatening disease (e.g. cancer)

          -  Renal insufficiency (GFR ≤ 30 ml/min )

          -  Major hepatic impairment

          -  Known allergic reaction/intolerance against niacin and/or laropiprant

          -  Active peptic ulcer disease
Randomized Controlled Trial for Exparel Hip Fracture
Condition: Hip Fractures
MeSH terms: Fractures, Bone; Hip Fractures
Intervention: Exparel; Sodium Chloride
Intervention description: Subcutaneous injection at conclusion of surgical fixation of hip fracture; Saline Injection
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      This is a prospective, randomized study looking at the effect that a long-acting local
      anesthetic has on pain control in patients having surgery for hip fractures. The
      investigators are conducting the study to see if that reduces the amount of pain medicine
      needed after surgery, and if it reduces other medical complications after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 55 or older

          -  Sustaining either an OTA/AO type 31A or 31B fracture undergoing ORIF or
             hemiarthroplasty

          -  Able to consent

          -  Isolated injury

        Exclusion Criteria:

          -  OTA/AO 31B1 (Impacted/slightly displaced)

          -  Baseline dementia or cognitive deficit

          -  Inability to consent

          -  Chronic Opioid use

          -  End stage liver disease with Model for End-Stage Liver Disease (MELD) greater than 20.

          -  End stage renal disease as defined by patients requiring hemodialysis at least twice
             weekly

          -  Polytrauma, defined as: concurrent upper or lower extremity fracture, pelvis fracture,
             spine fracture, rib fractures, or facial fractures, Blunt chest or abdominal trauma
             resulting in diagnosed organ injury, Head trauma resulting in intracranial bleed or
             diagnosed concussion

          -  Allergy to amide-type local anesthetics

          -  Prisoners (unlikely to be accessible for follow-up)
Folate Supplementation in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Folate; Placebo
Intervention description: Folic acid taken as 2, 1mg capsule daily for 12 weeks; Placebo taken as 2, 1mg capsule daily for 12 weeks
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No
Keywords: Schizophrenia; Negative Symptoms; Folate

Summary:

      This study aims to examine factors potentially contributing to differences in blood folate,
      homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low
      folate is associated with negative symptoms, and to examine the efficacy of folate
      supplementation for reducing negative symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Schizophrenia, any subtype

          2. Ages 18-68

          3. Male or female

          4. A score at least a 3 (moderate or greater severity) on at least one of the SANS global
             assessment subscales, with the exception of the attention global assessment subscale

          5. Stable antipsychotic dose for > 6 weeks

          6. Capable of providing informed consent

        Exclusion Criteria:

          1. Unstable medical illness

          2. Substance abuse

          3. Megaloblastic anemia

          4. Non-english speaking
Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Docetaxel-Carboplatin
Intervention description: Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin AUC 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
Intervention MeSH terms: Carboplatin; Docetaxel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung cancer; Adjuvant therapy

Summary:

      The purpose of this study is to determine whether it is safe to treat lung cancer patients
      who have undergone an attempt at curative resection with the combination of docetaxel and
      carboplatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-small cell lung cancer stage IB - IIIA, complete resection with mediastinal lymph
             node dissection

          -  ECOG status 0-1

          -  >14 and <56 days since resection

        Exclusion Criteria:

          -  Prior chemotherapy and/or radiation therapy for lung cancer

          -  Peripheral neuropathy > grade 1

          -  Concurrent other malignancies, other than basal cell or squamous cell carcinoma of the
             skin or carcinoma in situ of the cervix

          -  Medical condition that will not permit treatment or follow up according to the
             protocol

          -  Prior treatment with docetaxel or carboplatin

          -  Hypersensitivity to polysorbate 80, platinum-containing compounds or mannitol

          -  Treatment with other investigational anti-cancer drugs within 30 days of registration

          -  Pregnant or nursing women

          -  HIV-positive patients
Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers
Condition: Bacterial Infections; Eye Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Eye Infections
Intervention: Azithromycin; Moxifloxacin
Intervention description: azithromycin topical solution 1% given as a single drop in a single eye; Moxifloxacin topical solution given as a single drop in a single eye
Intervention MeSH terms: Moxifloxacin; Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to
      Vigamox at various time points in conjunctiva tissue of healthy volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured
             using Early Treatment of Diabetic Retinopathy Study chart

        Exclusion Criteria:

          -  Have a known allergy and/or sensitivity to the test article(s) or its components or
             any therapies associated with the trial

          -  Have active signs or symptoms of any clinically significant ocular disorder (other
             than refractive disorders)

          -  Have a known bleeding disorder or history of bleeding complications after surgical or
             dental procedures

          -  Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin)
             including prescription, over the counter, or homeopathic therapies

          -  Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or
             anticipate having ocular surgery during the study
The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Intervention: Fluvastatin XL®
Intervention description: Fluvastatin extended release 80 mg
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 614.0
Sex: All
Minimum age: 20 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Metabolic syndrome,dyslipidemia,fluvastatin extended release

Summary:

      This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release
      (80 mg once daily) in patients with metabolic syndrome
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 3 criteria for metabolic syndrome National Cholesterol Education Program Adult
             Treatment Panel III (NCEP ATP III criteria)

          -  Triglyceride (TG) < 400 mg/dl and Low Density Lipoprotein-Cholesterol (LDL-C) 100
             mg/dl to 190 mg/dl

          -  Written informed consent for participating in the study

        Exclusion Criteria:

          -  Severe renal disease or renal dysfunction

          -  Chronic liver disease or liver function impairment

          -  Inflammatory muscle dysfunction or findings of muscle problems

          -  Severe cardiac failure

        Other protocol defined inclusion exclusion criteria may apply
Performance of Junctional Tourniquets in Normal Human Volunteers
Condition: Hemorrhage
MeSH terms: Hemorrhage
Intervention: CRoC; AAJT; JETT; SJT
Intervention description: Use of Combat Ready Clamp (CRoC); Use of Abdominal Aortic and Junctional Tourniquet (AAJT); Use of Junctional Emergency Treatment Tool (JETT); Use of SAM Junctional Tourniquet (SJT)
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Normal human adult volunteers wereused to investigate the performance of medical devices
      intended to stop junctional bleeding on the battlefield.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult human volunteers who are recruited, screened, and consent to participate

          -  Ages at least 18 years old to no more than 60 years old (<61) on the date of consent

          -  Male or female

          -  A worker for the US Military or US Government (active duty military, civilian
             employees, contractors)

        Exclusion Criteria:

          -  Active-duty military subjects without their supervisor's permission to participate

          -  Detainees or prisoners

          -  Evidence of major disease of an artery (e.g., artery or vein surgery, atherosclerotic
             disease diagnosis, stroke, peripheral vascular disease or dysfunction such as
             Reynaud's phenomenon, migraine headaches, or cardiovascular disease [uncontrolled
             hypertension, heart attack, or arrhythmias]), active abdominal, inguinal, gluteal, or
             thigh disease, major deformity, or hernias

          -  Pregnancy

          -  Contracted employees to the US Military or US Government without contractual
             permission to participate in the research
Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency
Condition: Neuromuscular Blockade
Intervention: sugammadex; Neostigmine; Glycopyrrolate
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective Randomized Double Blinded
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Participants, Care Providers, Investigators, and Outcome Assessors are blinded from the type of NMBA reversal agent used prior to completion of data collection
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep
      neuromuscular blockaded (induced by rocuronium)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for open ventral hernia repair or open colectomy

          -  ASA class I-III

          -  18 years and older

          -  Subjects with a body mass index (BMI) of <45kg/m2 and weight less than 150kg

          -  Subjects who have given written informed consent

        Exclusion Criteria:

          -  Subjects with medical conditions and/or undergoing surgical procedures that are not
             compatible with the use of the TOF-Watch® SX (e.g., injuries to the thumbs/distal
             forearms, bilateral ulnar nerve damage or subjects with cardiac pacemaker

          -  Subjects known or suspected to have neuromuscular disorders impairing neuromuscular
             blockade (e.g., subjects with myasthenia gravis)

          -  Subjects known or suspected to have significant renal dysfunction (e.g. creatinine
             clearance < 30 mL.min-1

          -  Subjects known or suspected to have a (family)history of malignant hyperthermia; have
             significant hepatic dysfunction

          -  Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or
             other medications used during general anesthesia;

          -  Subjects known or suspected to be hypersensitive to Sugammadex or other cyclodextrins
             or Rocuronium or any of its excipients

          -  Subjects who have a contraindication to, Rocuronium or Sugammadex

          -  Female subjects who are pregnant

          -  Morbidly obese subjects with a BMI > 45 kg/m2 or weight more than 150 kg