bioihbjkbjnl/mcl2 huggingface dataset:
AMP as a Better Delivery System of Adenosine
Condition: Ischemia
MeSH terms: Ischemia
Intervention: Adenosine; Adenosine Mono Phosphate (AMP)
Intervention description: Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each; Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)
Intervention MeSH terms: Adenosine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adenosine; AMP; Microdialysis; Blood Flow

Summary:

      Adenosine and AMP are substances normally present in the body. Adenosine is also given for
      the treatment of some heart rhythm problems and may be used to reduce heart damage during
      heart attacks. The problem in using adenosine is that it is taken up by cells and, therefore,
      very little of the adenosine we give by vein or in the artery actually reaches the tissue. We
      propose to use AMP as a way to improve delivery of adenosine. AMP is inactive by itself, but
      is converted to adenosine in tissue. We hope that by giving AMP we will increase levels of
      adenosine in tissue. To see if this is true, we will give either adenosine or AMP into the
      forearm artery while we measure how much adenosine reaches the forearm tissue.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers

          -  Age 18-65

          -  Non smokers

        Exclusion Criteria:

          -  Smokers

          -  Any chronic disease
Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine
Condition: Healthy
Intervention: Ciprofloxacin XR + MMX Placebo; MMX Mesalazine/mesalamine + Ciprofloxacin XR
Intervention description: MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4; MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
Intervention MeSH terms: Ciprofloxacin; Mesalamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR
      administered alone & in combination with MMX Mesalazine/mesalamine.
    

Eligibility criteria:

        Inclusion Criteria

          1. Age 18-55 years inclusive at the time of consent. The date of signing informed consent
             is defined as the beginning of the Screening Period.

          2. Subject is willing to comply with any applicable contraceptive requirements of the
             protocol and is:

               -  Male, or

               -  Non-pregnant, non-lactating female

               -  Females must be at least 90 days post-partum or nulliparous.

        Exclusion Criteria

          1. A history of current or recurrent disease that could affect the colon. This includes
             gastrointestinal disease, peptic ulceration, gastrointestinal bleeding, celiac
             disease, lactose intolerance, ulcerative colitis, Crohn's disease, or Irritable Bowel
             Syndrome. Subjects who have a history of chronic constipation, which is physician
             diagnosed and treated, will also be excluded from the study (frequency of bowel
             movements >48 hours between samples).

          2. A history of current or relevant serious, severe, or unstable (acute or progressive)
             physical or psychiatric illness.

          3. A history of gastrointestinal surgery performed within the past 12 months prior to the
             first dose of investigational product, with the exception of an appendectomy.

          4. A history of or current clinically relevant moderate or severe renal or hepatic
             impairment.

          5. A history of asthma or bronchospasm associated with the use of 5-ASA or other
             non-steroidal anti-inflammatory drugs.

          6. Known or suspected intolerance or hypersensitivity to the investigational product or
             ciprofloxacin XR, closely related compounds, or any of the stated ingredients
Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets
Condition: Healthy Volunteers
Intervention: Amlodipine - reference; Amlodipine ODT - test; Amlodipine ODT - test
Intervention description: 10 mg tablet, single dose, with water; 10 mg orally disintegrating tablet (ODT), single dose, with water; 10 mg orally disintegrating tablet (ODT), single dose, without water
Intervention MeSH terms: Amlodipine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: biological availability; bioavailability; amlodipine; orally disintegrating tablet; ODT; tablets

Summary:

      This study is being performed to determine the bioavailability, or extent of absorption into
      the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to
      the bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects (Healthy is defined as no clinically relevant
             abnormalities identified by a detailed medical history, full physical examination,
             including blood pressure and pulse rate measurement, 12-lead ECG and clinical
             laboratory tests).

          -  Body Mass Index (BMI) of 18 to 26 kg/m2; and a total body weight >50 kg (110 lbs).

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing).

          -  A positive urine drug screen.
Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg Once A Day (OAD) Formulation Versus Zytram® 200 mg
Condition: Pain
Intervention: Tramadol Contramid OAD; Zytram
Intervention description: 1 Tramadol Contramid OAD 200 mg tablet as a single dose; 1 Zytram 200 mg tablet as a single dose
Intervention MeSH terms: Tramadol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to compare the pharmacokinetic profile to establish the
      better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg,
      Labopharm) and its bioavailability in relation with the commercialised reference (Zytram®
      tablets of 200 mg, Zambon), single dose administered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects of either gender

          -  Age between 18 and 45 years

          -  Body mass index between 19 and 27kg/m2

          -  Normal medical history

          -  Normal or no clinically significant physical examination findings

          -  Normal or no clinically significant findings in analytical tests

          -  Negative hepatitis B, hepatitis C or HIV serology

          -  Negative drugs of abuse in urine

          -  Negative pregnancy test in females

          -  The subject understands and accepts the study procedures and grants in writing his/her
             informed consent

        Exclusion Criteria:

          -  Did not fulfill the inclusion criteria

          -  Organic disorders or underwent major surgery, within 90 days before study screening

          -  Psychiatric history

          -  Alcohol drink intake greater than 30gr/day

          -  Cigarette smoking greater than 10 cigarettes/day

          -  Excessive consumption of food or beverages containing xanthines (more than five units
             of coffee, tea or cola per day)

          -  Medical treatment within 30 days before screening, and/or any medication 7 days before
             starting the study

          -  Participation in other clinical study or donate blood within 90 days before starting
             this study

          -  Antecedents of gastric, hepatic, renal and other kind of disorder that could affect
             ADME (absorption, distribution, metabolism or excretion of the study drug)

          -  Hepatitis B, hepatitis C or HIV positive serology

          -  Pregnant or breastfeeding

          -  Clinically relevant hypersensitivities (in particular to drugs)

          -  Woman taking oral contraceptive drugs

          -  Incapable of communicating and cooperating with investigators
Reinforcing Effects of Cocaine During Phendimetrazine Maintenance
Condition: Cocaine Use Disorder
Intervention: Phendimetrazine; Cocaine; Placebo
Intervention description: Phendimetrazine will be administered in divided doses twice daily.; Intranasal cocaine will be administered during experimental sessions.; Placebo capsules will contain only cornstarch.
Intervention MeSH terms: Cocaine; Phendimetrazine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for
      cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which
      the subjective, physiological and reinforcing effects of cocaine are evaluated during
      maintenance on placebo and phendimetrazine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recent cocaine use

        Exclusion Criteria:

          -  Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians
             deem clinically significant

          -  Current or past histories of substance abuse or dependence that are deemed by the
             study physicians to interfere with study completion

          -  History of serious physical disease, current physical disease, impaired cardiovascular
             functioning, chronic obstructive pulmonary disease, history of seizure or current or
             past histories of serious psychiatric disorder that in the opinion of the study
             physician would interfere with study participation will be excluded from participation

          -  Females not currently using effective birth control

          -  Contraindications to cocaine or phendimetrazine
Avandamet Bioequivalence Study Brazil - Fed Administration
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg; Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
Intervention description: Avandamet reference product; Avandamet test product
Intervention MeSH terms: Metformin; Rosiglitazone; Maleic acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Metformin; Rosiglitazone; Healthy volunteers; Avandamet; Fed conditions; Bioequivalence

Summary:

      The study is prospective, open-label, randomized, crossover, with 02 treatments, 02
      sequences, and 02 periods. The volunteers received, in each period, the reference or the test
      formulation after standardized meals.
    

Eligibility criteria:

        EXCLUSION CRITERIA:

          -  The volunteer has a known hypersensitivity to the study drug or to compounds
             chemically related;

          -  History or presence of hepatic or gastrointestinal illnesses, or other condition that
             interferes over the drug's absorption, distribution, excretion or metabolism;

          -  History of neurological, endocrine, pulmonary, hamatologic, immune, brain, metabolic
             or cardiovascular illness;

          -  Hypo or hypertension of any etiologic that needs pharmacologic treatment;

          -  The results of the laboratory exams are out of the values considered as normal
             according this protocol's rules, unless that they are considered as clinically
             irrelevant by the investigator;

          -  Has history of alcohol or drugs abuse;

          -  History of use drug inducing and/or inhibitors of hepatic metabolism within 30 days
             prior to drug study administration;

          -  Use of MAO inhibitors two weeks before the start of treatment; - Use of inhibitors of
             5-TH reuptake,

          -  Pregnancy or breastfeeding,

          -  Smoking;

          -  Use of regular medication within 4 weeks prior to study iniciation;

          -  Use of experimental drug or participation in any clinical study within 6 months prior
             to study iniciation.

        INCLUSION CRITERIA:

          -  Age between 18 and 50 years;

          -  Body mass index ≥ 18,5 and ≤25,0, can vary up to 15% for the upper limit (18,5 to
             28,75);

          -  Good health conditions;

          -  Obtain the Informed Consent's signed.
Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: Atazanavir + Ritonavir + Combivir
Intervention description: Capsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Lamivudine, zidovudine drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1 infected pregnant women, either treatment naive or on ATV/RTV combined with ZDV/3TC

Summary:

      To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug
      exposure during pregnancy compared to drug exposure in historical data in human
      immunodeficiency virus (HIV) infected participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-infected pregnant women

          -  > 18 years of age

          -  Between week 12 and 32 gestation

          -  CD4 > 200 cells/mm³

          -  Treatment-naive with HIV RNA > 400 c/mL, on HAART with HIV RNA <50 c/mL, or previously
             treated with ATV (< 3 weeks) with HIV RNA>400 c/mL
A Dose Escalation Study of Intravenous L-citrulline in Steady-state Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Intravenous (IV) citrulline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the maximum tolerated dose, safety and
      pharmacokinetics of an investigational drug, intravenous (IV) citrulline, in subjects in
      steady-state sickle cell disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sickle cell disease genotypes (HbSS, HbS/β° thalassemia, HbS/β+thalassemia, HbSC)

        Exclusion Criteria:

          -  Presence of any acute illness defined by fever >100.4° F within the past 48 hours

          -  Presence of sickle cell pain crisis defined by the presence of pain requiring oral or
             parental opioid therapy.

          -  Presence of acute chest syndrome or presence of any other complication related to
             sickle cell disease requiring hospitalization such as splenic sequestration, hepatic
             sequestration, stroke, avascular necrosis of the hip/shoulder, acute priapism, and
             patients with diabetes etc.

          -  Severe anemia (hemoglobin < 5g/dL)

          -  History of red blood cell transfusion within the last 14 days

          -  Systemic steroid therapy within the last 48 hours

          -  Pregnant (as confirmed by a negative urine pregnancy test) or lactating female

          -  Alanine/aspartate transferase >2x upper limit of normal laboratory range for age.

          -  Elevated serum creatinine >1.5mg/dL

          -  Patients with an inability to give consent will be excluded

          -  Medications that are known to be contra-indicated with use of L-citrulline (concurrent
             use of hydroxyurea will be allowed).

          -  History of diabetes due to risk of electrolyte imbalance
Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin
Condition: Healthy
Intervention: Quinine Sulfate Capsules 324 mg; Ciprofloxacin 500 mg; Quinine Sulfate Capsules 324 mg
Intervention description: A single dose of quinine sulfate (2 x 324 mg capsules) administered on the morning of Day 1 after an overnight fast of at least 10 hours.; A single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) in the morning on Day 11 after an overnight fast of at least 10 hours.; A single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) in the morning on Day 11 after an overnight fast of at least 10 hours.
Intervention MeSH terms: Ciprofloxacin; Quinine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: quinine sulfate; ciprofloxacin; drug interactions; cytochrome p450; male; female; adult; pharmacokinetics

Summary:

      Ciprofloxacin is moderate inhibitor of cytochrome P450 1A2 (CYP1A2), one of the enzymes
      responsible for the metabolism of quinine. This study will evaluate the effect of
      ciprofloxacin-related inhibition of CYP1A2 on the pharmacokinetics of quinine sulfate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age

          -  Non-smoking

          -  Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive
             measures)

          -  Body mass index (BMI)between 18 and 32

          -  Medically healthy on the basis of medical history and physical examination

          -  Hemoglobin > or = to 11.5 g/dL

          -  Completion of the screening process within 28 days prior to dosing

          -  Provision of voluntary written informed consent

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or plasma donation

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
             biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, neurologic, or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study

          -  Drug allergies to mefloquine or quinidine
A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants
Condition: Healthy Volunteers
Intervention: Baricitinib; Digoxin
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Digoxin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the effect of baricitinib on the levels of digoxin
      in the blood stream and how long it takes the body to remove digoxin. This study will also
      look at how safe and well-tolerated baricitinib is when given at the same time as digoxin in
      healthy participants. This study will last approximately 3-4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination

          -  Women not of child-bearing potential

          -  Menopausal women

          -  Have a body mass index of 18.0 to 29.0 kilograms per square meter (kg/m^2)

        Exclusion Criteria:

          -  Women who are lactating

          -  Have previously completed or withdrawn from this study or any other study
             investigating baricitinib

          -  Currently enrolled in, have completed or discontinued within the last 90 days from a
             clinical trial involving an investigational product

          -  Have a pulse rate less than 50 beats per minute (bpm) at screening

          -  Have a current or recent history (less than 30 days prior to screening and/or less
             than 45 days prior to Day -1) of a clinically significant bacterial, fungal,
             parasitic, viral (not including rhinopharyngitis), or mycobacterial infection

          -  Have an absolute neutrophil count less than 2000 cells/microliter (2×10^9/liter) at
             screening or Day -1

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  Have been exposed to a live vaccine within 12 weeks prior to the first dose or
             expected to need/receive a live vaccine

          -  Intend to use over-the-counter or prescription medication and/or herbal supplements
             within 14 days prior to dosing and during the study

          -  Have used or intend to use any drugs or substances that are known to be substrates,
             inducers, or inhibitors of P-glycoprotein (P-gp) within 30 days prior to dosing and
             throughout the study

          -  Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to
             the first dose