bioihbjkbjnl/mcl2 huggingface dataset:
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: Evolocumab; Ezetimibe; Placebo to Evolocumab
Intervention description: Administered by subcutaneous injection; Administered orally once a day; Administered by subcutaneous injection
Intervention MeSH terms: Ezetimibe; Evolocumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 411.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: High cholesterol; Proprotein convertase subtilisin/kexin type 9 (PCSK9); Treatment for high cholesterol; Lowering cholesterol; Lowering high cholesterol; Hypercholesterolemia

Summary:

      The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG
      145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change
      from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 to ≤ 75 years of age

          -  Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and < 190 mg/dL

          -  Framingham risk score of 10% or less

          -  Fasting triglycerides < 400 mg/dL

        Exclusion Criteria:

          -  History of coronary heart disease

          -  New York Heart Association (NYHA) II - IV heart failure

          -  Uncontrolled cardiac arrhythmia

          -  Uncontrolled hypertension
A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell; Basal Cell Nevus Syndrome
Intervention: Vismodegib; Placebo
Intervention description: Vismodegib 150 mg hard gelatin capsule orally once daily; Vismodegib placebo orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 229.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess
      the efficacy and safety of two different vismodegib regimens in participants with multiple
      basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in
      an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24
      weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks
      vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, >/= 18 years of age

          -  Participants with multiple basal cell carcinomas, including participants with Gorlin
             syndrome, with at least 6 clinically evident basal cell carcinomas at the time of
             randomization, of which 3 measure 5 mm or more in diameter and are considered target
             lesions. All other lesions are considered to be non-target lesions

          -  Histopathologic confirmation that at least one of the three target lesions is basal
             cell carcinoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

          -  Adequate renal and hepatic function and hematopoietic capacity

          -  Women of childbearing potential must agree to use contraception as defined by protocol
             during treatment and for at least 9 months after completion of study treatment

          -  Male participants with female partners of childbearing potential must agree to use
             contraception as defined by protocol during treatment and for 2 months after
             completion of study treatment

        Exclusion Criteria:

          -  Inability or unwillingness to swallow capsules

          -  Pregnant or breastfeeding women

          -  Any metastatic basal cell carcinoma

          -  Locally advanced basal cell carcinoma lesion that is considered to be inoperable or to
             have medical contraindications to surgery

          -  Recent (i.e., within the past 28 days prior to randomization) or current participation
             in another experimental drug study

          -  Known or suspected alcohol abuse

          -  One of the following known rare hereditary conditions: galactose intolerance, primary
             hypolactasia or glucose-galactose malabsorption
Study of Vitamin D and Effect on Heart Disease and Insulin Resistance
Condition: Human Immunodeficiency Virus (HIV); Vitamin D Deficiency; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Insulin Resistance; Vitamin D Deficiency; Immunologic Deficiency Syndromes
Intervention: Vitamin D; Placebo
Intervention description: Vitamin D 4000 IU will be administered to enrollees on the active comparator arm; Placebo pills will be administered to enrollees in this arm
Intervention MeSH terms: Vitamin D
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin D; Human Immunodeficiency Virus (HIV); Complementary Therapies

Summary:

      The purpose of this study is to evaluate how Vitamin D affects endothelial function,
      inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infected

          -  HIV-RNA < 400 copies/ml at study entry and for 12 wks. prior

          -  25-hydroxyvitamin D level <20

          -  On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry

        Exclusion Criteria:

          -  Pregnancy or Breast Feeding

          -  Diabetes

          -  Creatinine Clearance <50

          -  Any active infectious or inflammatory condition

          -  aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 within 6
             months prior to study entry
A Clinical Study to Evaluate the Effect of Naturlose (Tagatose)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: D-Tagatose
Intervention description: powder to be dissolved in water prior to dosage.
Intervention MeSH terms: Tagatose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is a six-month, prospective, randomized, multicenter, single- blind, controlled
      clinical study to evaluate the effect of three low-doses of Naturlose (Tagatose) on glycemic
      control and safety in subjects with Type 2 diabetes under diet control and exercise. The
      subjects were randomized in one of the 3 arms receiving 2.5, 5 or 7.5 gm of Tagatose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetics in accordance with WHO.

          -  Male and female patients, between 18 and 75 years of age.

          -  Diabetic patients who are not on medication for the disease. Patients may be treated
             with diet and exercise.

          -  Normal blood creatine clearance and normal liver function test results.

          -  BMI less than or equal to 45 kg/m2

        Exclusion Criteria:

          -  Treatment with sulfonylurea (e.g., Glyburide, Glipizide, Glimepiride, Chlorpropamide,
             Tolazamide, Acetohexamide, or Tolbutamide), TZDs, metformin, acarbose, Byetta,
             insulin, and any antidiabetic medications within the prior 3 months.

          -  Therapy with beta-blockers or thiazide diuretics within the prior 3 months

          -  Pregnancy, breastfeeding, or intention of becoming pregnant or judged to be using
             inadequate contraceptive measure.

          -  Documented gastrointestinal disease, or taking of medications likely to alter gut
             motility or absorption.

          -  Receiving any investigational drug within 30 days of the baseline visit.
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: PXL065; Placebo oral tablet
Intervention description: PXL065 oral tablet; Placebo oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess the effect of 3 doses of PXL065 versus placebo on liver fat content in
      NASH patients after 36 weeks of treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients have given written informed consent

          -  Body mass index (BMI) ≤ 50 kg/m²

          -  For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or
             under stable oral glucose lowering drug

          -  Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73m²

          -  Liver fat content ≥ 8% on MRI-PDFF

          -  Qualifying liver biopsy (NAS) ≥ 4 and fibrosis score F1, F2 or F3

          -  Effective contraception for women of child bearing potential

        Exclusion Criteria:

          -  Evidence of another form of liver disease

          -  Evidence of liver cirrhosis

          -  Evidence of hepatic impairment

          -  Positive serologic evidence of current infectious liver disease

          -  History of excessive alcohol intake

          -  Acute cardiovascular disease within 6 months prior to Randomization

          -  Any disease which in the Investigator's opinion which in the Investigator's opinion
             would exclude the patient from the study

          -  Use of non-permitted concomitant medication

          -  Pregnancy or lactation
Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)
Condition: Allergic Skin Reaction
Intervention: Hyaluronidase; Histamine; Saline
Intervention description: Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms.; Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms.; Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm.
Intervention MeSH terms: Histamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 253.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hyaluronidase; enzymes with tissue spreading activity; allergic reaction; intradermal skin testing

Summary:

      This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers
      using an intradermal skin test.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy volunteers of either gender; Those without clinically significant cardiovascular
        gastrointestinal, hepatic, neurological, psychiatric, endocrine, or other major systemic
        disease that would unduly risk the subject's safety or interfere with the interpretation of
        results, assessed according to the judgment of the Principal Investigator. A non-inclusive
        list which would not be exclusionary and define healthy individual for the purposes of this
        study are:

          -  hypothyroidism,

          -  stable hypertension except those subjects on beta blockers including ocular
             preparations,

          -  seasonal/perennial allergic rhinitis if able to wash out of antihistamines,

          -  stable, mild intermittent asthma (subjects using beta agonists as a monotherapy on an
             as-needed basis, excluding daily usage),

          -  migraine if not taking excluded medications,

          -  mild anxiety/depression if not taking excluded medications, and

          -  mild arthritic conditions if not taking excluded medications.

               -  Willingness and ability to sign an informed consent document;

               -  18 - 80 years of age;

               -  Intact skin at the forearm ;

               -  Female participants are currently practicing effective birth control methods or
                  abstinence.

        Exclusion Criteria:

          -  Known allergy, hypersensitivity or contraindications to hyaluronidase, thimerosal,
             edetate disodium (EDTA);

          -  Use of medications within a duration considered to interfere with skin testing.

          -  Known dermographism which may interfere with skin testing.

          -  Pregnant or lactating women.
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide
Intervention description: Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100 mg /day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/ day per week up to a maximum of 800 mg/ day. Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase was followed by a 5-week End-of-Study Phase, during which subjects had to be tapered off Lacosamide at a recommended decrease rate of 200 mg/ day per week.
Intervention MeSH terms: Lacosamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Primary Generalized Tonic-Clonic (PGTC) Seizures; Absence Seizures; Myoclonic Seizures; Idiopathic Generalized Epilepsy (IGE)

Summary:

      The purpose is to obtain data on the safety and seizure frequency associated with long-term
      oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects
      with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed
      SP0961 (NCT01118949) to continue to receive Lacosamide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject completed the SP0961 (NCT01118949) study

          -  Subject is expected to benefit from participation in an open-label extension study
             with Lacosamide, in the opinion of the investigator

        Exclusion Criteria:

          -  Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an
             ongoing Serious Adverse Event (SAE)
Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Ventricular Dysfunction; Ventricular Dysfunction, Left; Infarction
Intervention: Ramipril; Firibastat
Intervention description: 1 or 2 capsules administered orally, twice daily; 1 or 2 capsules administered orally, twice daily
Intervention MeSH terms: Ramipril; Firibastat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2
      study to evaluate the safety and efficacy of firibastat administered orally BID (2 daily
      doses) versus ramipril administered orally BID over 12 weeks after acute anterior MI.

      Subjects will be followed for 12 weeks (over 4 study visits). A total of 294 male and female
      subjects with a diagnosis of first acute anterior MI will be randomized. The subjects will
      need to have a primary percutaneous coronary intervention (PCI) of the index MI related
      artery within 24 hours after MI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of first acute anterior MI (ST-elevation myocardial infarction) defined as
             chest pain >30 minutes and ST elevation ≥0.2 mV in at least 2 consecutive
             electrocardiogram (ECG) leads in the anterior area (DI, aVL, V1 V6).

          -  Primary PCI of the index-MI-related artery within 24 hours after the MI.

        Exclusion Criteria:

          -  Body mass index >45 kg/m².

          -  Subject is hemodynamically unstable or has cardiogenic shock.

          -  Subjects with clinical signs of HF (Kilipp III and IV).

          -  Systolic blood pressure <100 mmHg at inclusion visit

          -  Early primary PCI of the index-MI-related artery performed within 3 hours after MI.

          -  Subjects treated with angiotensin-converting-enzyme inhibitor (ACE I), angiotensin
             receptor blocker (ARB) or sacubitril/valsartan prior to the index magnetic resonance
             imaging. Note: if treatment was for HTN, ACE I/ARB should be stopped, and, if
             necessary, another therapeutic class can be prescribed for HTN. If the ACE I/ARB was
             prescribed for congestive HF, the subject is not considered eligible; if the ACE I/ARB
             prescribed for another reason cannot be stopped, the subject is not eligible for study
             inclusion.

          -  Subjects scheduled for implantable cardioverter defibrillator (ICD), cardiac
             resynchronization therapy, or pacemaker within the next 3 months. If an ICD is
             indicated for ventricular arrhythmia during the course of the study, a life vest, when
             possible, should be prescribed and the ICD scheduled after study completion.
Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration
Condition: Subfoveal Choroidal Neovascularization; Age-Related Maculopathy
MeSH terms: Choroidal Neovascularization; Macular Degeneration; Neovascularization, Pathologic
Intervention: 700 ug dexamethasone; ranibizumab; sham
Intervention description: Intravitreal injection of 700 ug dexamethasone into study eye; Intravitreal injection of ranibizumab into study eye; Sham needle-less injection administered in the study eye
Intervention MeSH terms: Dexamethasone; Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive
      therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of
      patients with choroidal neovascularization secondary to age-related macular degeneration
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received at least 2 and no more than 3 monthly Lucentis or Avastin injections

          -  Last Lucentis or Avastin was injected approximately 4 weeks prior to screening

          -  Visual acuity between 20/320 and 20/40

        Exclusion Criteria:

          -  Active ocular infection

          -  Contraindication to pupil dilation in either eye

          -  Eye surgery including cataract surgery and/or laser of any type within 3 months
New Medication Treatment for Stimulant Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Ondansetron; Placebo
Intervention description: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy; twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Intervention MeSH terms: Ondansetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cocaine dependence; cocaine abuse; cocaine; crack

Summary:

      This study will evaluate the efficacy of ondansetron compared with placebo in the treatment
      of cocaine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females who have given written informed consent.

          -  Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg.

          -  Good physical health as determined by a complete physical examination, an EKG within
             normal limits, and laboratory screening tests within acceptable parameters.

          -  Current DSM-IV diagnosis of cocaine dependence.

          -  At least one positive urine drug screen for cocaine at screen or baseline prior to
             randomization.

          -  The pregnancy test for females at intake must be negative.

          -  Literacy in English and ability to read, understand, and complete the ratings scales
             and questionnaires accurately, follow instructions, and make use of the behavioral
             treatments.

          -  Answered an advertisement in the newspaper/radio/television, and expressing a wish to
             stop using cocaine.

          -  Willing to participate in behavioral treatments for cocaine dependence.

        Exclusion Criteria:

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