bioihbjkbjnl/mcl2 huggingface dataset:
Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects
Condition: Healthy
Intervention: Carvedilol 25 mg tablets; COREG® 25 mg tablets
Intervention description: 1 x 25 mg; 1 x 25 mg
Intervention MeSH terms: Carvedilol
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this randomized, single-dose, two-way crossover evaluation is to compare the
      relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and
      equivalent oral dose of the commercially available carvedilol (COREG®, SmithKline Beecham
      Pharmaceuticals) in a test population of 36 adult individuals under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sex: Male of Female; similar proportions of each preferred.

          -  Age: At least 18 years.

          -  Weight: Minimum of 120 pounds and a BMI (body mass index) of less than 30.

        Exclusion Criteria:

          -  Subjects not complying with the above inclusion criteria must be excluded from the
             study.

          -  In addition, any one of the conditions listed below will exclude a subject from the
             study.

          -  History of treatment for alcoholism, substance abuse, or drug abuse within the past 24
             months

          -  History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other
             serious illness.

          -  History of treatment for any gastrointestinal disorder within the past five (5) years.

          -  History of, or presence of, asthma

          -  History of peripheral vascular disease

          -  History of heart failure

          -  History of pre-existing cardiac arrythmias associated with tachycardia

          -  History of severe sensitivity to allergens, requiring urgent medical treatment.

          -  Females who are pregnant or lactating

          -  History of hypersensitivity to carvedilol, or any beta adrenergic blocking drug.

          -  Conditions upon screening which might contraindicate or require that caution be used
             in the administration of carvedilol, including:

          -  sitting systolic blood pressure below 100 mmHg, or diastolic pressure below 60 mmHg.

          -  Heart rate less than 60 beats per minute after a 5-minute rest in a seated position.

          -  Inability to read and/or sign the consent form.

          -  Treatment with any other investigational drug during the four (4) weeks prior to the
             initial dosing for this study.

          -  Subjects who smoke or use tobacco products or are currently using nicotine products
             (patches, gums,etc.) Ninety (90) days abstinence is required.

          -  subjects who have donated blood within four (4) weeks prior to the initial dosing for
             this study.
The Renin-Aldosterone Axis in Postural Tachycardia Syndrome
Condition: Postural Orthostatic Tachycardia Syndrome (POTS)
MeSH terms: Postural Orthostatic Tachycardia Syndrome; Tachycardia; Syndrome
Intervention: Angiotensin II
Intervention description: Angiotensin II infusion for 1 hour
Intervention MeSH terms: Angiotensin II; Giapreza; Angiotensinogen
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: POTS; Orthostatic intolerance

Summary:

      The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in
      the pathophysiology of postural tachycardia syndrome, and to provide an insight about the
      disease process in this disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction
             Center criteria

          -  Age between 18-64 years

          -  Male or females are eligible

          -  Able and willing to provide informed consent

          -  Healthy control subjects with no major medical problem (including postural tachycardia
             syndrome), free of medications during the study

        Exclusion Criteria:

          -  Overt cause of postural tachycardia e.g., dehydration

          -  Inability to give or withdraw informed consent

          -  Pregnancy

          -  Hypertension (BP > 140/90)

          -  Significant co-morbid condition

          -  Other factors which in the investigator's opinion would prevent the subject from
             completing the protocol
Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: MK-1075
Intervention description: MK-1075 supplied as 10 mg or 100 mg tablets for oral administration.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: In each panel (A, B, C, and D), participants will receive a single dose of MK-1075 (100, 200, 400, and 800 mg, respectively) in a fasted state. Safety and viral load (VL) data from the previous panel will be assessed before dosing the subsequent panel.
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to
      determine the ability of MK-1075 to reduce HCV viral load, following administration of a
      single dose in HCV-infected participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of non-child bearing potential

          -  In good health other than HCV genotype (GT) 1 infection

        Exclusion Criteria:

          -  Is mentally incapacitated or legally institutionalized

          -  Has a history of clinically significant and not stably controlled endocrine,
             gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection),
             immunological, renal, respiratory, genitourinary or major neurological (including
             stroke and chronic seizures) abnormalities or diseases

          -  Has a history of cancer

          -  Is positive for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus
             (HIV)

          -  Has participated in another investigational trial within 4 weeks (or 5 half-lives)
             prior to Screening

          -  Consumes >2 alcoholic beverages a day or uses illegal drugs

          -  Has evidence or history of chronic hepatitis not caused by HCV including but not
             limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced
             hepatitis, or autoimmune hepatitis

          -  Has clinical or laboratory evidence of advanced or decompensated liver disease,
             evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior
             liver biopsy
Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: vorinostat; Gemcitabine; Platinum-based agent
Intervention description: Dose escalation study: vorinostat 300-500 mg capsules once daily for 7-14 days in continuous cycles of 21 days; Dose escalation study: Gemcitabine 1000-1250 mg/m2 will be given for 2 days in each 21 day cycle; Cisplatin IV 75 mg/m2 will be given for 1 day in each 21 day cycle or carboplatin dosed according to renal function.
Intervention MeSH terms: Gemcitabine; Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Stage IIIB/IV Non-Small Cell Lung Cancer

Summary:

      This is a clinical trial to determine the safety and tolerability of MK0683 in combination
      with gemcitabine and cisplatin and/or carboplatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have a histologically-confirmed metastatic or locally advanced non-small
             cell lung cancer that has not been previously treated with systemic chemotherapy or
             has received non-platinum and non-gemcitabine based neoadjuvant or adjuvant
             chemotherapy if the last dose was at least 6 months prior to study enrollment

        Exclusion Criteria:

          -  Patient who has had chemotherapy, radiotherapy, or biological therapy prior to
             entering the study, except for adjuvant or neoadjuvant chemotherapy, as allowed for
             treatment of a tumor
Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.
Condition: Healthy
Intervention: Nitisinone 20 mg; Nitisinone 10 mg
Intervention description: Nitisinone 20 mg capsules; Nitisinone 10 mg capsules
Intervention MeSH terms: Nitisinone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Orfadin; Nitisinone; Bioequivalence

Summary:

      The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg
      capsules in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female volunteers between 18-55 years of age, inclusive.

          -  BMI between 18,5-30,0 kg/m2, inclusive.

        Exclusion Criteria:

          -  Subjects with current keratopathy, or other abnormalities found by slit-lamp
             examination.

          -  Subjects who are heavy smokers or consume more than 5 cups of coffee per day.

          -  Subjects with history of drug and/or alcohol abuse or a positive drug screen or
             alcohol breath test.

          -  Subjects with positive screens for hepatitis B surface antigen, hepatitis C antibodies
             and human immunodeficiency virus (HIV) 1-2 antibodies.

          -  Subjects who were enrolled in another concurrent clinical study or intake of an
             investigational medicinal product within three months prior to inclusion in this
             study.

          -  Subjects who donate more than 50 mL of blood within 60 days prior to drug
             administration or donate more than 1,5 liters of blood in the 10 months prior to first
             drug administration.

          -  Female subjects that are pregnant or breastfeeding.

          -  Female subjects of childbearing potential and all male subjects must be willing to use
             effective forms of contraception.
A Study of Evacetrapib in Healthy Japanese Participants
Condition: Healthy Volunteers
Intervention: Evacetrapib
Intervention description: Administered orally
Intervention MeSH terms: Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine if two different dosing strategies for evacetrapib
      will have essentially the same effect on the body. The study will also explore the effect of
      a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks,
      not including screening. Screening is required within 28 days prior to the date of first
      dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy Japanese, as determined by medical history and physical examination

          -  Have a body mass index (BMI) of 18.0 to 29.9 kg/m^2

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures

        Exclusion Criteria:

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  Have an abnormal supine blood pressure as determined by the investigator

          -  Have a history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs; of
             constituting a risk when taking the study medication; or of interfering with the
             interpretation of data

          -  Are women who are pregnant or lactating

          -  Have used or intend to use over-the-counter, prescription medications, or herbal
             medicine 14 days prior to enrollment and during the study

          -  Have donated blood of more than 400 mL in the last 12 weeks (males) or in the last 16
             weeks (females), or any blood donation (including apheresis) within the last 4 weeks

          -  Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14
             units per week (females), or are unwilling to abide by alcohol restrictions

          -  Are participants who currently smoke more than 10 cigarettes per day or are unwilling
             to abide by smoking restrictions
Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: MM-121; Carboplatin; Pemetrexed; Cabazitaxel; Gemcitabine
Intervention description: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV; administered at AUC 6; administered IV at 500 mg/m2; administered IV at 20 mg/m2 or 25 mg/m2; administered IV at 1000 mg/m2 or 1250 mg/m2
Intervention MeSH terms: Carboplatin; Gemcitabine; Pemetrexed
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced-stage; Solid Tumors; MM-121; Carboplatin; Pemetrexed; Gemcitabine; Cabazitaxel; ErbB3; Phase I; Cancer

Summary:

      To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer
      therapies
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced-stage solid tumors

          -  ≥ 18 years of age

          -  Adequate liver and kidney function

        Exclusion Criteria:

          -  Any other active malignancy

          -  No known HIV, Hepatitis C or B
A Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route
Condition: Pain; Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Intervention: CL-108; M366; Placebo
Intervention description: 7.5 mg/325 mg/12.5 mg tablet; 7.5 mg/325 mg tablet
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain; Nausea; Vomiting

Summary:

      The purpose of this study is to assess the abuse potential of CL-108 tablets, including the
      abuse deterrent effects of promethazine, following oral administration, relative to
      hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid
      users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)

          -  Healthy, as determined by no clinically significant medical history, physical
             examination findings, 12-lead ECG findings, vital signs measurements, and laboratory
             results at screening, as judged by the investigator

          -  Current opioid users who had used oral opioids for recreational (non-therapeutic)
             purposes, at least 10 times in the past year

        Exclusion Criteria:

          -  Drug or alcohol dependence within the last 12 months (except nicotine)

          -  Subjects who had ever been in treatment for substance use disorders (except smoking
             cessation

          -  History of presence of any clinically significant cardiac, neurologic, pulmonary,
             psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic,
             dermatologic, renal, or other major disease at screening, which in the opinion of the
             investigator, would have jeopardized the safety of the subject or the validity of the
             study results

          -  History or presence of hypotension, judged to be clinically significant based on
             investigator judgement
Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy
Condition: Nonarteritic Anterior Ischemic Optic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Optic Nerve Diseases; Optic Neuropathy, Ischemic; Ischemia
Intervention: ranibizumab
Intervention description: All patients (n=15) will be treated with open label 0.5mg ranibizumab given intravitreally monthly as needed for 6 months.
Intervention MeSH terms: Ranibizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: non-arteritic ischemic optic neuropathy; ranibizumab; naion

Summary:

      The purpose of this study is to explore the safety and efficacy of ranibizumab to treat
      non-arteritic ischemic optic neuropathy based on clinical and anatomical findings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  provide written informed consent

          -  21 years of age or older

          -  new onset, within 14 days, of ischemia and vision loss

          -  Best Corrected Visual Acuity (BCVA) 20/40 or worse

        Exclusion Criteria:

          -  pregnancy or lactation

          -  proliferative diabetic retinopathy,

          -  diabetic macular edema,

          -  uveitis,

          -  history of ocular trauma,

          -  severe glaucoma,

          -  age-related macular degeneration.

          -  prior or concomitant treatment of oral steroids within 30 days,

          -  participation in any studies of investigational drugs within 30 days,

          -  participation in a ranibizumab clinical trial or,

          -  prior treatment intravitreally or intravenously of Avastin or steroids.
Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF)
Condition: Ischemic Cardiomyopathy
MeSH terms: Cardiomyopathies
Intervention: Intramyocardial Injection of stem cells via NOGA Mapping; Control, then Stem Cell Therapy
Intervention description: Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping to deliver cells in the active arm of the protocol.; Subject is randomized to receive a NOGA mapping and no injections (sham treatment)at time of active enrollment and treatment then offered stem cell therapy at 6 months.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Autologous; Cardiac; Stem Cell; Transplant

Summary:

      This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear
      stem cells in ischemic cardiomyopathy patients. The patients must have a Left Ventricular
      Ejection Fraction (LVEF) of less than or equal to 45%. Once the patient meets all inclusion
      criteria, and no exclusion criteria are found, the subject is consented for the study, and
      extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline
      testing criteria is met, the patient has their own bone marrow harvested and later that day
      the subject is taken to a cardiac catheterization lab where left ventricular
      electromechanical mapping using NOGA software (NOGA mapping) is performed and the processed
      stem cells are injected under electromechanical guidance into the affected areas of the left
      ventricle. The patient is usually discharged home the next day and returns for follow up
      visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4,
      5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits,
      including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell
      injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  LVEF less than 45%

          -  Functional class III or IV angina

          -  At least 7% reversibility by Single Photon Emission Computed Tomography (SPECT)
             nuclear study

          -  there are additional inc. criteria

        Exclusion Criteria:

          -  AGe <18 or >70 years of age

          -  Constant atrial fibrillation

          -  Left ventricular (LV) thrombus

          -  History of malignancy in the last 5 years

          -  LV wall thickness of < 8 mm at the target site

          -  there are additional exclusion criteria
Phase I Combination w/ Epirubicin
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Ixabepilone; Epirubicin
Intervention description: Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study.; Infusion, intravenous (IV): 75 mg/m^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².
Intervention MeSH terms: Epirubicin; Epothilones
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Tumor response information was obtained for all participants who received at least 2 cycles
      of study drug, underwent requisite baseline and on-treatment disease assessments and had at
      least one post-treatment assessment. Tumor response assessment in evaluable participants was
      done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ≥18 years

          -  Histologically or cytologically confirmed diagnosis of metastatic breast cancer

          -  Measurable or nonmeasurable disease defined by Response Evaluation Criteria In Solid
             Tumors (RECIST)

        Exclusion Criteria:

          -  Number of prior chemotherapy lines of treatment in the metastatic setting ≥2