bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-operative Pain.
Condition: Asymptomatic Necrotic Teeth
MeSH terms: Pain, Postoperative; Necrosis
Intervention: triple antibiotic paste with an anti-inflammatory drug
Intervention description: Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
Intervention MeSH terms: Anti-Bacterial Agents; Anti-Inflammatory Agents
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: post operative pain; triple antibiotic paste; intracanal medication

Summary:

      The purpose of this study is to determine whether the use of triple antibiotic paste as
      intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will
      reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic
      necrotic teeth.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject's age between 18-50 years.

          2. Both male and female subjects.

          3. Medically free and healthy subjects.

          4. Mandibular and maxillary single rooted teeth.

          5. Asymptomatic non vital teeth.

        Exclusion Criteria:

          1. Teeth with acute dentoalveolar abscess.

          2. Subjects having more than one tooth that require root canal treatment.

          3. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the
             10 days prior to the start of treatment.

          4. Pregnant females.

          5. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or
             Psychological disturbance.

          6. Teeth with periodontal disease or pulp calcification.

          7. Subjects taking chronic pain medications.
E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
Condition: Non-small-cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: E7080; E7080; Paclitaxel; Carboplatin
Intervention description: Drug: E7080 will be administered orally starting at a dose of 6 mg twice daily during the 7-day run-in period and for 3 weeks (Cycle 1).; Maximum tolerated dose determined in the Dose-Escalation Cohort will be administered to the Expansion Cohort. After E7080 is taken on Day 1, paclitaxel (200 mg/m2) will be administered intravenously (IV), followed by IV carboplatin (AUC 6.0 min/mg/mL).; Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080.; Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.
Intervention MeSH terms: Paclitaxel; Carboplatin; Lenvatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Cancer; Lung Cancer

Summary:

      The purpose of this study is to determined the maximum tolerated dose (MTD), safety and
      tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered
      continually twice daily in combination with carboplatin and paclitaxel to patients with
      advanced or metastatic non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion criteria:

          1. Subjects with a histologically or cytologically confirmed diagnosis of non-small cell
             lung cancer (NSCLC).

          2. Locally advanced and/or metastatic non-small cell lung cancer (NSCLC) (Stage IIIB/IV).

          3. Subjects with at least one measurable tumor lesion by Response Evaluation Criteria In
             Solid Tumors (RECIST).

          4. Subjects with Performance Status (PS) 0-1.

          5. Subjects with adequate organ function.

        Exclusion criteria:

          1. Subjects who have ever received the following therapy for non-small cell lung cancer
             (NSCLC):

               1. Chemotherapy

               2. Biological or immunotherapies

               3. Surgery for primary focus

               4. The radiation therapy for primary focus

          2. Subjects with the severe complications or disease history.

          3. Subjects with brain metastasis accompanying clinical symptoms or requiring treatment.

          4. Subjects with simultaneous or metachronous cancers.

          5. Subjects who cannot take oral medication.

          6. Subjects who are using drugs that strongly inhibit or induce cytochrome P450 (CYP)
             3A4.
Characteristics of Glargine in Type 2 Diabetics
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Placebo; Insulin Glargine 0.5 u/kg body wt SC; Insulin Glargine 1.0 u/kg body wt SC; Insulin Glargine 1.5 u/kg body wt SC; Insulin Glargine 2.0 u/kg body wt SC
Intervention description: single dose of Placebo injected s/c at 8am and monitor blood glucose over 24 hours; 8 weeks later, a differing dose (0.5, 1.0, 1.5, 2.0 u/kg body wt.) of Insulin Glargine and monitoring over a 24 hour period each separated by 8 weeks (5 separate study visits)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 diabetes; Insulin Glargine; Endogenous Glucose Production

Summary:

      The study is to determine the dose response relationship of insulin glargine in type 2
      diabetes over a 24-hour period and measuring the differences in glucose production among the
      differing doses of glargine.

      Hypothesis: Differing doses of insulin glargine over a 24-hour period in type 2 diabetes will
      show differing effects on endogenous glucose production, glucose disposal and carbohydrate
      and lipid flux.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 adults (males or females) with type 2 diabetes for at least six (6) months. May be
             using oral agents (SUs, metformin, acarbose or glitinides) with or without insulin.

          -  HgbA1c 7 -12%

          -  Age 18-70 years

          -  BMI 27-40 kg/m²

        Exclusion Criteria:

          -  Any past or present clinically relevant abnormality, medical condition, or
             circumstance making the subject unsuitable for participation in the study

          -  Evidence of hepatic, renal or cardiac failure

          -  Abnormal results following screening tests

          -  Pregnant or lactating females or females of childbearing potential who are unwilling
             to abstain from sexual intercourse or use reliable, medically accepted methods of
             contraception

          -  Currently using TZDs

          -  History of alcoholism or drug abuse within 12 months of the study
Drug-drug Interaction of BI 201335 and Microgynon
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: levonorgestrel; Ethinylestradiol; levonorgestrel; BI 201335; Ethinylestradiol
Intervention description: multiple doses; multiple doses; multiple doses; multiple doses; multiple doses
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will investigate possible effect of multiple oral doses of BI 201335 on the steady
      state pharmacokinetics of ethinylestradiol and levonogestrel
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: mesylate imatinib capsule; Glivec
Intervention description: Single and multiple oral mesylate imatinib capsule 400mg qd; Single and multiple oral Glivec 400mg qd
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      1. purpose: To conduct the relative bioavailability study of a single dose and multiple
           doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus
           Glivec (Novartis Pharma Stein AG).

        2. Experimental Design： Two-period crossover design

        3. Test drug: imatinib mesylate capsule Reference drug: Glivec

        4. Sample size：20
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with chronic myeloid leukemia;

          -  Age: 18-65 years,gender:both.

          -  Weight: standard weight ± 20% within, and avoid weight disparity is too large;

          -  No previous radiation therapy, chemotherapy, or surgery within 1 weeks before
             treatment with imatinib;

          -  Performance status 0 to 3 (WHO scale); Life expectancy greater than 3 months;

          -  No other malignancy;

          -  Adequate hepatic, renal, and bone marrow function
             (WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥80×109/L. Serum bilirubin≤1.5×the institutional upper
             limit of normal, ALT、ALP≤2.5×the institutional upper limit of normal,
             creatinine≤1.5×the institutional upper limit of normal);

          -  Ability to understand objectives of the study, the study procedure, the
             pharmacological properties of the drug and possible adverse reactions and the
             willingness to sign a written informed consent.

        Exclusion Criteria:

          -  Suffering from heart, liver, kidney disease or severe acute and chronic
             gastrointestinal diseases;

          -  Pregnant or lactating women and be sensitive to drug;

          -  Subjects are thought unsuitable for the study by investigators;

          -  Inability to comply with protocol or study procedures in the opinion of the
             investigator;

          -  Attending other clinical trials or attended other clinical trials 3 months ago.
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Condition: Healthy Adults
Intervention: Drug:OP0201; Drug: Placebo
Intervention description: Drug: OP0201; Drug: Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
    

Eligibility criteria:

        Inclusion Criteria includes but is not limited to:

          1. Body Mass Index (BMI) 18 to 30 and a minimum body weight of 50 kg at screening.

          2. No history or presence of significant medical condition or a clinically significant
             abnormal finding, as determined by the investigator.

          3. Negative urine pregnancy test at screening and baseline for females of childbearing
             potential

          4. Agree to refrain from water immersion of the ears from the time of signed informed
             consent to the end of trial

          5. Physiologic tympanogram type A (normal) or type C at screening visit

        Exclusion Criteria includes but is not limited to:

          1. Known substance abuse (e.g., alcohol, licit or illicit drugs) within 96 weeks prior to
             screening visit

          2. Positive urine drug screen at screening visit

          3. Upper respiratory tract infection currently or within 6 weeks prior to screening visit

          4. Allergy or sinus conditions (e.g., sinusitis, non-specific nasal inflammation)
             currently or within 6 weeks prior to screening visit

          5. Claustrophobia that is sufficient to prevent them tolerating assessments while in a
             hypobaric/hyperbaric atmospheric pressure chamber

          6. Smoker (e.g ., cigarettes, vapor) within the last 48 weeks prior to screening visit

          7. Clinically significant findings on ear nose and throat exam

          8. Gastroesophageal reflux disease currently or within 6 weeks prior to screening visit

          9. Current diagnosis of sleep apnea

         10. Evidence of craniofacial anomalies (eg, cleft palate, Down's Syndrome) that may
             interfere with ET function

         11. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg,
             cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
ORAL T-8 Oral Testosterone for Male Hormonal Contraception
Condition: Healthy
Intervention: Oral Testosterone; Acyline
Intervention description: Oral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills); 300 ug/kg injection on Day 0
Intervention MeSH terms: Testosterone; Acyline
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Experimental; Acyline plus 27 oral testosterone pills; taken 3x/day

Summary:

      The purpose of this study is to test how the body absorbs a new form of oral testosterone
      (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at
      the University of Washington to monitor blood testosterone levels over a 24-hour period.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  able and willing to

          -  not participate in another drug study or donate blood, not take medications

          -  use contraception, comply with the protocol

        EXCLUSION CRITERIA:

          -  abnormal evaluation, based on physical exam, medical history, blood tests (including
             serum chemistry, hematology, HIV, HCV, hormone levels)

          -  history or current use of alcohol, drug, steroid abuse, >3 alcohol drinks/day

          -  history of testicular disease, severe testicular trauma, major psychiatric disorder,
             bleeding disorders, current use of anti-coagulants or testosterone

          -  participation in hormonal drug study within past month
AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184
Condition: Healthy
Intervention: Radiolabeled SPD602 (FBS0701, SSP-004184)
Intervention description: A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the
      study drug. Further, the study will determine how much of the study drug gets into the
      bloodstream and how long it takes the body to get rid of it when given as a single dose to
      healthy male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult male subjects aged between 18 and 65 years inclusive

        Exclusion Criteria:

        -
Evaluation of Safety and Tolerability of Single Rising Doses of BI 473494 in Healthy Subjects
Condition: Healthy
Intervention: BI 473494; Placebo
Intervention description: Solution for injection; Solution for injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to investigate the safety and tolerability of single
      rising doses of BI 473494 in healthy male subjects.

      The secondary objective is the exploration of PK including dose proportionality, and PD of BI
      473494 after single dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects according to the assessment of the investigator, based on a
             complete medical history including a physical examination, vital signs (Blood Pressure
             [BP], Pulse Rate [PR]), 12-lead Electrocardiogram [ECG], and clinical laboratory tests

          -  Age of 18 to 45 years (incl.)

          -  Body Mass Index [BMI] of 20.0 to 29.9 kg/m2 (incl.)

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice [GCP] and local legislation

        Exclusion Criteria:

          -  Any finding in the medical examination (including Blood Pressure [BP], Pulse Rate [PR]
             or Electrocardiogram [ECG]) is deviating from normal and judged as clinically relevant
             by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
             diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
             range of 50 to 90 bpm

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease judged as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Use of drugs within 30 days prior to administration of trial medication if that might
             reasonably influence the results of the trial (incl. QT/QTc interval prolongation)

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures or stroke), and other relevant neurological or psychiatric disorders

          -  Further exclusion criteria apply
Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
Condition: Healthy
Intervention: linagliptin/metformin(high dose); Linagliptin/metformin(low dose)
Intervention description: patient would take fixed dose combination tablets of linagliptin /metformin (high dose) and single linagliptin and metformin (High dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.; patient would take fixed dose combination tablets of linagliptin /metformin (low dose) and single linagliptin and metformin (Low dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.
Intervention MeSH terms: Metformin; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of the trial is to assess the relative bioavailability of fixed dose combination
      tablets of linagliptin and metformin compared to the administration of two single tablets
      (linagliptin and metformin ) in Chinese subjects. The availability of a fixed dose
      combination tablet is expected to significantly enhance patients' compliance with
      antidiabetic treatment., in particular with concern to the frequent polypharmacy in diabetic
      patients.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male and female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
A Study of Milvexian Using an IV Microtracer With Additional Formulation and Food Effect Comparison in Healthy Participants
Condition: Healthy Volunteers
Intervention: BMS-986177 Oral Solution; [14C]BMS-986177 Solution for Infusion; BMS-986177 Spray-dried Dispersion Capsules
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioavailability; BMS-986177; 14C-Microtracer; Milvexian

Summary:

      The purpose of this study is to evaluate the absolute oral bioavailability (amount of drug
      entering the bloodstream) of spray-dried dispersion (SDD) milvexian capsules in the fed and
      fasted states, and to bridge the exposures seen using only the oral solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, as determined by no clinically significant deviation from normal in medical
             history, physical examination, electrocardiograms (ECGs), and clinical laboratory
             determinations

          -  Body mass index (BMI) of 18.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/ (height
             [m])²

        Exclusion Criteria:

          -  History of gastrointestinal (GI) disease, upper or lower GI bleeding within 6 months,
             intracranial bleeding, tumor, aneurysms

          -  History or evidence of abnormal bleeding or coagulation disorder and/or evidence of
             coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent
             unexplained bruising or thrombus formation, or a history of spontaneous bleeding, such
             as epistaxis, or family history of coagulopathies

          -  Any acute or chronic medical illness considered clinically significant by the
             investigator

          -  History of clinically significant cardiovascular, renal, hepatic, dermatological,
             chronic respiratory, neurological or psychiatric disorder, as judged by the
             investigator

        Other protocol-defined inclusion/exclusion criteria apply