bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Two Doses of 18F-AV-45 in Alzheimer's Disease and Healthy Volunteers
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: florbetapir F 18
Intervention description: single dose IV injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Amyloid imaging; Positron Emission Tomography; 18F-AV-45; florbetapir F 18; Diagnostic imaging

Summary:

      This study will test two different doses of florbetapir F 18 to determine which dose is best
      to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron
      emission tomography (PET) scanner.
    

Eligibility criteria:

        Inclusion Criteria (AD group):

          -  Greater than 50 years of age

          -  Probable AD according to the National Institute of Neurological and Communication
             Disorders and Stroke-Alzheimer's Disease and Related Disorders Association
             (NINCDS-ADRDA) criteria

          -  Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score
             ranging from 10 to 24, boundaries included, at screening

          -  History of cognitive decline gradual in onset and progressive over a period of at
             least 6 months

        Inclusion Criteria (healthy volunteer group):

          -  35 to 55 years of age, inclusive

          -  MMSE of 29 or greater

        Exclusion Criteria (both groups):

          -  Neurodegenerative disorders other than AD, including, but not limited to Parkinson's
             disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome,
             Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear
             palsy

          -  Diagnosis of other dementing / neurodegenerative disease

          -  Diagnosis of mixed dementia

          -  Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain
             infection, brain cancer, endocrine disease, or mental retardation

          -  Clinically significant infarct or possible multi-infarct dementia as defined by the
             NINCDS criteria

          -  Evidence on screening MRI or other biomarker that suggests alternate etiology for
             cognitive deficit (for healthy controls, evidence suggesting the presence of AD
             pathology)

          -  Clinically significant psychiatric disease

          -  History of epilepsy or convulsions

          -  Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances

          -  Current clinically significant cardiovascular disease

          -  Received investigational medication within the last 30 days
A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: RO5185426; RO5185426; RO5185426
Intervention description: Single oral dose, fasted; Single oral dose, with high fat meal; Continuous administration, orally twice daily
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, open-label, two period crossover study will evaluate the effect of food on
      the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous
      administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients
      will be randomized to receive in a crossover design single oral doses of RO5185426 with or
      without food, with a 10-day washout period between doses. Following the crossover periods,
      patients will receive RO5185426 orally twice daily on a continuous basis until disease
      progression or unacceptable toxicity occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on
             Cancer)

          -  Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test

          -  Previously treated patients must have failed at least one prior treatment regimen; if
             patients have received prior systemic treatments for metastatic melanoma, the time
             elapsed from previous therapy must be >/= 28 days; patients must have recovered fully
             from toxicities of all prior therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Evaluable disease (measurable for disease progression according to RECIST criteria)

          -  Adequate hematological, renal and liver function

        Exclusion Criteria:

          -  Active CNS lesions

          -  History of or known spinal cord compression or carcinomatous meningitis

          -  Anticipated or ongoing administration of anti-cancer therapies other than those
             administered in this study

          -  Previous malignancy within the past 5 years except for basal or squamous cell
             carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix

          -  Previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor

          -  Refractory nausea or vomiting, malabsorption, external biliary shunt, or history of
             any type of gastrointestinal surgery that would preclude adequate absorption of study
             drug
A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Prednisone 15 mg; Placebo Tablets; Prednisone 7.5 mg; Placebo Over-Encapsulated Tablets
Intervention description: Prednisone 15 mg tablets once daily for 15 days.; Prednisone placebo tablets once daily for 15 days.; Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days; Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
Intervention MeSH terms: Prednisone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will compare the effects of prednisone vs placebo on synovial blood flow and
      overall DAS (disease activity score) in patients with rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is willing to limit alcohol intake to 3 or less beverages per day

          -  Patient agrees to use only acetaminophen/paracetamol for breakthrough pain

        Exclusion Criteria:

          -  Patient has other inflammatory arthritis (e.g. lupus). Patient has had major surgery
             or donated or lost 1 unit of blood in the last 4 weeks

          -  Patient has a history of drug or alcohol abuse in the last 2 years

          -  Patient has had a vaccine (with a live or attenuated virus) in the last two weeks
Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Ocular Hypertension
Intervention: OPC-1085EL ophthalmic solution; Carteolol long-acting ophthalmic solution; Latanoprost ophthalmic solution
Intervention MeSH terms: Carteolol; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost
      ophthalmic solution are administered once daily for 7 days and the effect on the blood
      concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating
      the combination drug will be determined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are considered medically healthy per investigator's judgment

        Exclusion Criteria:

          -  Subjects with ocular conditions as defined by the protocol

          -  Subjects with intraocular pressure: <10 or ≥22 mmHg
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
Condition: Adenocarcinoma, Gastric; Neoplasm, Breast
MeSH terms: Adenocarcinoma; Breast Neoplasms
Intervention: DS-8201a
Intervention description: An antibody drug conjugate
Intervention MeSH terms: Trastuzumab deruxtecan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Stomach cancer; Cancer where the esophagus meets the stomach; Human epidermal growth factor 2; HER2; Breast Cancer; Adenocarcinoma, Gastroesophageal Junction (GEJ); Gastric Cancer; Antibody drug conjugate (ADC); Oncology

Summary:

      HER2-positive cancer is a cancer that tests positive for a protein called human epidermal
      growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study
      will test DS-8201a (trastuzumab deruxtecan), a HER2-targeted antibody and topoisomerase I
      inhibitor conjugate.

      The safety and tolerability profile of DS-8201a will be assessed in Chinese patients with
      certain types of stomach and breast cancer that test positive for HER2. It also will test how
      DS-8201a moves within the body (pharmacokinetics).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a pathologically documented unresectable or metastatic gastric or GEJ
             adenocarcinoma, or breast cancer, with HER2 expression [immunohistochemistry (IHC) 3+,
             2+, or 1+ and/or in situ hybridization (ISH) +] that is refractory to or intolerable
             with standard treatment, or for which no standard treatment is available

          -  Has a left ventricular ejection fraction (LVEF) ≥ 50%

          -  Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

        Exclusion Criteria:

          -  Has a medical history of myocardial infarction within 6 months before enrollment

          -  Has a medical history of ventricular arrhythmias, other than rare occasional premature
             ventricular contractions

          -  Has uncontrolled or significant cardiovascular disease

          -  Has any other history or condition that might compromise:

               1. Safety of the participant or offspring

               2. Safety of study staff

               3. Analysis of Results
Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components
Condition: Healthy
Intervention: Linagliptin + Pioglitazone; Linagliptin + Pioglitazone; Linagliptin/Pioglitazone; Linagliptin/Pioglitazone
Intervention description: Medium doses, oral administration; Medium doses, oral administration; Medium dose oral administration; Medium dose oral administration
Intervention MeSH terms: Pioglitazone; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current study is to establish the bioequivalence of linagliptin/
      pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and
      pioglitazone administered together.
    

Eligibility criteria:

        Inclusion criteria:

        Healthy male and female subjects

        Exclusion criteria:

        Any relevant deviation from healthy conditions
MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: MRKAd5 HIV-1 gag vaccine (V520); Comparator: Placebo; Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed; MRKAd5 HIV-1 gag vaccine (V520)
Intervention description: 3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^9 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26; 1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26; 0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only; 3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^10 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      A Study to assess the general safety and tolerability of the administration of a 3-dose
      prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis
      C virus infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject who is of reproductive potential agrees to use a acceptable method of birth
             control through week 52 of the study

        Exclusion Criteria:

          -  Subject weighs less than 110 lbs.

          -  Subject has received treatment for hepatitis C virus infection in the 3 months before
             enrollment in this study or is anticipated to begin treatment with in 1 year after
             enrollment

          -  Subject has any history of anaphylaxis or allergy to vaccine components

          -  Subject has any history of anaphylaxis or allergy to Tetanus and Diphtheria Toxoids
             Adsorbed (Td)

          -  Subject has clinical signs suggestive of cirrhosis

          -  Subject has had a liver biopsy showing bridging fibrosis or cirrhosis

          -  Subject is HBsAg positive

          -  Subject has other known chronic liver disease

          -  Subject has evidence of hepatocellular carcinoma on liver biopsy

          -  Subject has had a liver transplant or is anticipated to have a liver transplant within
             1 year of enrollment

          -  Subject has been vaccinated with a live virus vaccine in the past 30 days

          -  Subject has been vaccinated with an inactive virus vaccine in the past 14 days

          -  Female subject is pregnant or breast-feeding, Male subject is planning to impregnate

          -  Subject has active drug or alcohol abuse

          -  Subject is at high risk for HIV infection
Bioequivalence Study of Colchicine Tablets
Condition: Healthy
Intervention: Colchicine; Colchicine; Colchicine/Probenecid
Intervention description: 0.6mg tablet administered after a fast of at least 10 hours; 0.6mg tablet administered after a standardized high-fat, high-calorie breakfast; 0.5mg/500mg tablet administered after a fast of at least 10 hours
Intervention MeSH terms: Colchicine; Probenecid
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bioequivalence; fasting; fed; healthy

Summary:

      This randomized, single dose, three-way crossover study will evaluate the bioequivalence of
      two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed
      combination product (colchicine 0.5 mg with probenecid 500 mg), administered under fasting
      conditions. It will also determine the bioavailability following a standard high-fat meal and
      evaluate the safety and tolerability of the test product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult volunteers, male and female, 18 to 45 years of age, inclusive, with BMI
             between 18-30 kg/m2, inclusive, and weighing at least 110 pounds.

          -  Female volunteers must be postmenopausal, surgically sterile, or must commit to
             abstain from heterosexual contact or to use two methods of reliable birth control.

        Exclusion Criteria:

          -  Subjects who report receiving any investigational drug within 28 days prior to
             initiation of dosing.

          -  Subjects who report presence or history of significant cardiovascular, respiratory,
             renal, gastrointestinal, immunologic, hematologic, endocrine, neurologic, or
             psychiatric disease.

          -  Subjects with clinical lab results outside accepted reference range, or reactive
             screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.

          -  Subjects who report a history of allergies to colchicine or related drugs, or history
             of other clinically significant allergies including drug allergies.

          -  Subjects who report a clinically significant illness during the 4 weeks prior to
             initiation of dosing.

          -  Subjects who report a history of drug or alcohol addiction or abuse within the past
             year, or who demonstrate a positive drug abuse screen.

          -  Subjects who currently use or have used tobacco products within 6 months prior to dose
             administration.

          -  Subjects who report donating greater than 150 ml of blood within 28 days or donating
             plasma within 14 days prior to initiation of dosing.

          -  Subjects who have a positive pregnancy screen, or are currently pregnant or
             breastfeeding.
PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine
Condition: Neoplasms
Intervention: PF-00477736; gemcitabine
Intervention description: Escalating doses of PF-00477736 will be administered intravenously on Days 2 and 9 and gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).
If a patient is administered Cycle 0 - only PF-0047736 will be administered intravenously on Days 1 and 8 of a 21-day cycle for patients who have a 3-hour infusion and Days 1 and 8 of a 14-day cycle for patients who have a 24-hour infusion.; gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).
Intervention MeSH terms: Gemcitabine; PF 00477736
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced cancer

Summary:

      To determine the overall safety of PF-00477736 when given in combination with gemcitabine, a
      chemotherapy agent, in patients with advanced solid tumors and determine the maximum dose of
      PF-00477736 that can be safely given in combination with gemcitabine. This is the first study
      of PF-00477736 in humans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytopathological diagnosis of solid malignancy that is refractory to
             standard therapy or for which no curative therapy exists.

          -  ECOG performance status 0 or 1.

          -  Adequate blood cell counts, kidney function and liver function.

        Exclusion Criteria:

          -  Prior treatment with gemcitabine.

          -  Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or
             leptomeningeal disease.

          -  NCI CTC Grade 2 or higher ARDS, non-infectious pneumonitis, or pulmonary fibrosis.

          -  NCI CTC Grade 2 or higher cardiovascular toxicities with the exception of NCI CTC
             Grade 3 hypertension that is well controlled.

          -  Known human immunodeficiency virus (HIV) seropositivity.

          -  Concurrent treatment with anticoagulants or known coagulopathy
PPI and Clopidogrel Response
Condition: Drug Interaction
Intervention: omeprazole and pantoprazole
Intervention description: The clopidogrel dose will be a 600mg loading dose followed by a 75mg daily maintenance dose, starting the next day for 7 days. Omeprazole will be used at a daily dose of 40mg and pantoprazole at 80mg.
Intervention MeSH terms: Omeprazole; Pantoprazole
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: proton pump inhibitor; clopidogrel; platelet function

Summary:

      Clopidogrel, in combination with aspirin, is currently the recommended treatment for
      secondary prevention of ischemic events in high-risk patients and for prevention of coronary
      artery stent thrombosis. Patients receiving aspirin and clopidogrel are frequently treated
      with proton pump inhibitors, such as omeprazole or pantoprazole, in order to prevent the risk
      of gastrointestinal bleeding, accorded to guidelines. An interaction between proton pump
      inhibitors and clopidogrel has been suggested, which may lead to a decrease of clopidogrel
      effects. It remains unclear whether this interaction between PPIs and clopidogrel might be a
      class effect or if this may be affected by timing regimen.

      The objectives of this two-phase investigation are:

        1. to compare clopidogrel platelet inhibitory effects when taken at the same time versus
           separated at least 8 hours from omeprazole administration.

        2. to compare clopidogrel-induced inhibitory effects when taken at the same time versus
           staggered at least 8 hours from pantoprazole administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers aged between 18 and 75 years

        Exclusion Criteria:

          1. Known allergies to clopidogrel or omeprazole.

          2. Blood dyscrasia or bleeding diathesis.

          3. Recent antiplatelet treatment (< 30 days) with a glycoprotein IIb/IIIa antagonist,
             thienopyridine (ticlopidine, clopidogrel), cilostazol or dipyridamole.

          4. Treatment with other medications that may interfere with the CYP system (ketoconazole,
             itraconazole, diltiazem, erythromycin, clarithromycin, fluvoxamine, fluoxetine,
             nefazodone, or sertraline).

          5. Platelet count <100x106/microL.

          6. Diabetes mellitus

          7. History of coronary artery disease, gastrointestinal bleed, gastroesophageal reflux
             disease (GERD), cerebrovascular event or any active malignancy.

          8. Active bleeding or hemodynamic instability.

          9. Serum creatinine >2mg/dL.

         10. Baseline ALT >2.5 times the upper limit of normal.

         11. Pregnant females.

         12. Patients taking omeprazole or any H2 antagonist or proton pump inhibitors