bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacodynamic Study of Cilostazol in Healthy Volunteers
Condition: Healthy
Intervention: Cilostazol; Acetylsalicylic acid; Clopidogrel
Intervention MeSH terms: Aspirin; Cilostazol; Clopidogrel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers

Summary:

      The primary objective of this study is to investigate the effects of Cilostazol,
      Acetylsalycylic acid and Clopidogrel alone as well as combinations of
      Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function (PF)
      testing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Caucasian male subjects

          -  Able to read, to write and to fully understand German language

          -  Provision of written informed consent before screening and baseline

          -  BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg,
             inclusive

          -  Good general health as determined by the investigator by medical history, physical
             examination, vital signs, electrocardiogram, baseline and safety lab

        Exclusion Criteria:

          -  Personal or family history of bleeding disorders, or reasonable suspicion of vascular
             malformations, including aneurysms

          -  Known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6
             month) haemorrhagic stroke, proliferative diabetic retinopathy, poorly controlled
             hypertension)

          -  Use of antibiotics within thirty (30) days prior to screening and until baseline visit

          -  Clinically significant abnormalities in medical history, physical examination, vital
             signs, electrocardiogram, baseline and safety lab

          -  Supine pulse rate > 100 beats/min or <50 beats/min

          -  Systolic blood pressure <100 or >140 mmHg

          -  Diastolic blood pressure <50 or >90 mmHg

          -  Concomitant use of any other medication including over-the-counter preparations
Drug Interaction Study
Condition: Antivirals/HIV
Intervention: Rifabutin; Rifabutin + Atazanavir + Ritonavir
Intervention description: Capsule, Oral, 150 mg, once daily, 11 Days; Capsules, Oral, 18 Days
Rifabutin (150 mg, 2x/wk)
Atazanavir (300 mg, once daily)
Ritonavir (100 mg, once daily)
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Rifabutin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered
      with atazanavir and ritonavir (ATV/RTV)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects between the ages of 18 to 50 years old with a body
             mass index (BMI) of 18 to 32 kg/m²

          -  Prior to enrollment, subjects must have physical and laboratory test findings within
             the normal limits, and women of childbearing potential (WOCBP) must have a negative
             pregnancy test

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Evidence of organ dysfunction or any clinically significant deviation from normal in
             physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory
             determinations

          -  Use of any prescription drugs or over-the-counter acid controllers within 4 weeks
             prior to study drug administration

          -  Use of any other drugs, including over-the-counter medications of herbal preparations
             within 1 week prior to study drug administration
A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to learn more about the safety and side effects of
      tirzepatide in Chinese participants with type 2 diabetes mellitus. The study will also
      measure how much tirzepatide gets into the bloodstream and how long it takes the body to
      remove it. The study will last about six or eight months for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are
             stable on a single oral antihyperglycemic medication (OAM), metformin, acarbose, or
             sulphonylureas only (other types of OAM [dipeptidyl peptidase IV inhibitors,
             sodium-glucose cotransporter-2 inhibitors, and thiazolidinediones] are not allowed in
             this study), for at least 3 months

          -  Have a body mass greater than or equal to (≥)23 kilograms per square meter (kg/m²),
             inclusive

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus

          -  Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6
             months prior to Visit 1

          -  Have a history of heart block or PR interval greater than (>)220 milliseconds (msec)
             or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the
             opinion of the investigator, increases the risks associated with participating in the
             study

          -  Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or a GI
             disease that impacts gastric emptying or could be aggravated by glucagon-like
             peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors

          -  Have known allergies to tirzepatide, GLP-1 analogs, or related compounds or any
             components of the formulation
A Study of Xeloda (Capecitabine) in Combination With Oxaliplatin in Patients With Metastatic Colorectal Cancer.
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Avastin; Oxaliplatin; capecitabine [Xeloda]
Intervention description: 7.5mg/kg iv (cycle 3 only); 130mg/m2 iv (cycles 1, 2 and 3); 1000mg/m2 po bid (cycles 1, 2 and 3)
Intervention MeSH terms: Capecitabine; Oxaliplatin; Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will investigate possible pharmacokinetic interactions between Xeloda
      and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is
      influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic
      analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a
      treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in
      cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study
      treatment is 3-12 months, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  adenocarcinoma of colon or rectum, with metastatic or locally advanced disease.

        Exclusion Criteria:

          -  previous systemic treatment for advanced or metastatic disease;

          -  previous treatment with oxaliplatin or Avastin.
Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept (BMS-188667)
Intervention description: Solution for injection, Intravenous, 750 mg, Single dose, 1 day,
Intervention MeSH terms: Abatacept
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 223.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667)
      drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers
      Squibb are comparable in healthy subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects as determined by no clinically significant deviation from normal in
             medical history, physical examination, electrocardiograms (ECGs), and clinical
             laboratory determinations

          -  Body weight will be between 60 and 100 kg, inclusive

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Any major surgery within 4 weeks of study drug administration

          -  Smoking more than 10 cigarettes per day

          -  Recent (within 6 months of study drug administration) drug or alcohol abuse.

          -  Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human
             Immunodeficiency Virus-1, Human Immunodeficiency Virus-2 antibody

          -  History of any significant drug allergy or asthma

          -  Women who are pregnant or breastfeeding and/or unwilling or unable to use an
             acceptable method to avoid pregnancy for the entire study period
AMG 529 First in Human Study
Condition: Cardiovascular
Intervention: AMG 529; Placebo
Intervention description: Ascending single doses of AMG 529 by subcutaneous (SC) or intravenous (IV) injection; Single doses of matching placebo by SC or IV injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Within each dose cohort participants were randomized in a 3:1 ratio to receive either AMG 529 or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study to assess the safety and tolerability of AMG 529 following single, ascending doses
      administered subcutaneously (SC) or intravenously (IV) in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy men and women ≥ 18 to ≤ 55 years old with no history or evidence of clinically
             relevant medical disorders

          2. Body mass index (BMI) between 18 and 32 kg/m², inclusive, at screening

          3. Women must be of non-reproductive potential as defined in protocol

          4. Other inclusion criteria may apply

        Exclusion Criteria:

          1. Currently receiving treatment in another investigational device or drug study, or less
             than 30 days or 5 half-lives (whichever is longer), since ending treatment on another
             investigational device or drug study(s) prior to receiving the first dose of
             investigational product

          2. Women who are lactating/breastfeeding or who plan to breastfeed while on study through
             90 days after receiving the dose of investigational product

          3. Men with partners who are pregnant or planning to become pregnant while the subject is
             on study through 90 days after receiving the dose of investigational product

          4. Positive pregnancy test at screening or day -1

          5. Other exclusion criteria may apply
Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults
Condition: Healthy Volunteer
Intervention: MEDI4920 3 mg; MEDI4920 10 mg; MEDI4920 30 mg; MEDI4920 100 mg; MEDI4920 300 mg; MEDI4920 1000 mg; MEDI4920 3000 mg; Placebo
Intervention description: Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.; Participants received single IV dose of MEDI4920 10 mg infused on Day 1.; Participants received single IV dose of MEDI4920 30 mg infused on Day 1.; Participants received single IV dose of MEDI4920 100 mg infused on Day 1.; Participants received single IV dose of MEDI4920 300 mg infused on Day 1.; Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.; Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.; Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Male; Healthy Female of non child bearing potential

Summary:

      Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy as determined by a responsible study physician based on medical evaluation

          -  Body weight 40 to 100 kg

          -  Body mass index 19.0 to 30.0 kg/m2

        Exclusion Criteria:

          -  History of allergy or sensitivity to Shellfish or protein based antigens

          -  previous immunization with KLH

          -  previous splenectomy

          -  History of diagnosed or suspected thromboembolic event or coagulation disorder
A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas
Condition: Pancreatic Neoplasm
MeSH terms: Pancreatic Neoplasms
Intervention: monoclonal antibody; chemotherapy
Intervention description: CP-870,893 intravenous administration [IV] on day 3 of 4-week cycles; gemcitabine 1000 mg/m^2 intravenous administration [IV] q week [wk]x3 of 4-week cycles
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pancreas cancer; cancer of the pancreas; gemcitabine; chemotherapy; monoclonal antibody; immunotherapy; CD40

Summary:

      This study aims to seek evidence that activation of certain cells of the immune system will
      be safe and well tolerated in combination with cytotoxic chemotherapy. Preliminary evidence
      of clinical anti-tumor activity will be sought.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1st-line surgically incurable cancer of the pancreas

          -  ECOG(Eastern Cooperative Oncology Group) performance status 0-1

        Exclusion Criteria:

          -  Previous systemic therapy for pancreas cancer

          -  History of cancer-associated blood clots

          -  History of autoimmune disease
Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients
Condition: Pediatric Patients With Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: High-dose trivalent inactivated influenza vaccine; Standard dose trivalent inactivated influenza vaccine
Intervention description: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.; 0.5 mL standard dose trivalent inactivated influenza vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent
      inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with
      Acute Lymphoblastic Leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia.

          -  Must be in 1st complete remission.

          -  Must be 4 weeks into maintenance therapy.

          -  17 years of age, inclusive.

          -  Available for duration of study.

        Exclusion Criteria:

          -  History of hypersensitivity to previous influenza vaccination or hypersensitivity to
             eggs/egg protein.

          -  History of Guillain-Barre syndrome.

          -  Evidence of relapsed disease.

          -  Have any condition that would, in the opinion of the site investigator, place them at
             an unacceptable risk of injury or render them unable to meet the requirements of the
             protocol.

          -  Have any condition that the investigator believes may interfere with successful
             completion of the study.

          -  History of receiving 2010 - 2011 influenza vaccine.

          -  Pregnant female.

          -  History of proven influenza disease after September 1, 2010.
Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
Condition: Healthy
MeSH terms: Dermatitis, Photoallergic
Intervention: Ointment Vehicle; Xenaderm
Intervention description: Subject acts as own control. 20 mg under Finn chambers; 20 mg under Finn chambers
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: wound healing; photoallergenicity; Healthy subjects

Summary:

      The product is being tested to see if exposure to light causes photoallergic reactions on the
      skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects

        Exclusion Criteria:

          -  Less than 18 years
Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours
Condition: Cancer; Advanced Solid Malignancies
MeSH terms: Neoplasms
Intervention: AZD4547; AZD4547; AZD4547
Intervention description: Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily; Patients start at a dose of 80 mg twice daily, with no washout; Single dose is followed by washout 5-10 days before multiple dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 25 Years
Maximum age: 149 Years
Healthy volunteers: No
Keywords: Cancer; Tumour; Advanced Solid Malignancies; FGFR; Squamous NSCLC; Gastric adenocarcinoma

Summary:

      This study is primarily designed to assess the safety and tolerability of AZD4547 at
      increasing doses in patients with advanced solid malignancies and for whom no standard
      medication options are available. It also assesses the blood levels and action of AZD4547 in
      the body over a period of time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Minimum life expectancy of 12 weeks

          -  The presence of a solid, malignant tumour that is resistance to standard therapies or
             for which no standard therapies exist

          -  In the expansion for the study patients must have a tumour at least 1cm in size that
             can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor
             company for testing of FGFR1 and/or 2 amplification

          -  Expansion, 5 groups of advanced cancer

          -  Solid tumours,FGFR1 and/or FGFR2 gene amplified

          -  Squamous NSCLC, FGFR1 gene low & high amplified

          -  Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction,
             FGFR2 gene low & high amplified

          -  Aged at least 25 years

        Exclusion Criteria:

          -  Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3
             weeks before the first dose of study

          -  An inability to be able to take the study medication

          -  A bad reaction to AZD4547 or any drugs similar to it in structure or class.
Mood Effects of Serotonin Agonists Extended
Condition: Healthy
Intervention: Placebo; Serotonin agonist - 13ug; Serotonin agonist - 26ug
Intervention description: Drug will be administered in solution form; 13ug lysergic acid diethylamide; 26ug lysergic acid diethylamide
Intervention MeSH terms: Serotonin; Serotonin Receptor Agonists
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In this study we are examining the effects of repeated very low doses of serotonin agonists
      on mood individuals with negative mood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English fluency

          -  High school level education

          -  BMI between 19 and 30

        Exclusion Criteria:

          -  Diagnosed medical condition

          -  women who are nursing, pregnant, or plan to become pregnant within 3 months

          -  History of psychotic disorder or family history of psychotic disorder