bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
Condition: Non-Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight
Intervention: SHP626; Placebo
Intervention MeSH terms: Volixibat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in
      overweight and obese adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males that comply with any applicable contraceptive requirements or females of
             non-childbearing potential

          -  No history of active or chronic disease other than that allowed by study
             (hypertension, hyperlipidemia and GERD or heartburn)

          -  Has a body mass index of 25-35 kg/m2 with a body weight of greater than 140lbs
             (assessed at screening)

        Exclusion Criteria:

          -  No history of alcohol or substance abuse, including use of tobacco

          -  No substantial changes in eating habits or exercise routine.
A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
Condition: Myelodysplastic Syndrome; Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes
Intervention: PF-04449913 (Glasdegib); Azacitidine
Intervention description: Daily dose of PF-04449913 100mg tablet in a continuous regimen of 28 day cycles; 75mg/m2 on Days 1-7 (+/- 3 days for each dose) of a 28 day cycle
Intervention MeSH terms: Azacitidine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MDS; AML; CMML

Summary:

      This multi center open label Phase 1b study is designed to evaluate the safety, efficacy,
      pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined
      with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome
      (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical
      study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase
      with an AML cohort and an MDS cohort.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients must have previously untreated MDS, AML, or CMML according to the WHO 2016
             classification.

          -  MDS patients must have Intermediate (>3 to 4.5 points), High Risk (>4.5 - 6) or Very
             High Risk (>6 points) disease according to the Revised International Prognostic
             Scoring System 2012 (IPSS-R).

          -  Clinical indication for treatment with azacitidine for MDS or AML.

        Exclusion criteria:

          -  Patients with AML who are candidates for standard induction chemotherapy as first line
             treatment.

          -  Patients with known active CNS leukemia.

          -  Prior treatment with a smoothened inhibitor (SMOi) and/or hypomethylating agent.
Safety and PK Study of MP-424 to Treat Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: MP-424 (Telaprevir)
Intervention description: Three tablets of MP-424 250mg tablet at a time, every 8 hours, 12 weeks administration (dose in a day: 2250 mg)
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Protease Inhibitor

Summary:

      The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C
      virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with
      chronic hepatitis C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with genotype 1b chronic hepatitis C

          -  Patients naive to the concomitant medications with interferon

        Exclusion Criteria:

          -  Patients diagnosed with decompensated cirrhosis

          -  Patients diagnosed with positive HBs(Hepatitis B virus surface) antigen in the test
A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
Condition: Nerve Pain
MeSH terms: Neuralgia
Intervention: Pregabalin (Lyrica); Placebo
Intervention description: Oral, 75mg or 150mg capsules, BID; Oral, matched capsules, BID
Intervention MeSH terms: Pregabalin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess whether a cross-over type study design in
      post-traumatic neuropathic patients can be used to assess the activity of potential analgesic
      agents
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients require a diagnosis of post-traumatic peripheral neuropathic pain (NeP),
             including post-surgical NeP and NeP due to peripheral nerve injury, which has lasted
             at least 3 months following the traumatic event.

          -  Patients during the screening week must have completed ≥ 4 daily pain scores and have
             an average daily pain score ≥ 4.

          -  Female patients of childbearing potential must have a negative urine pregnancy test at
             Screening and be practicing an acceptable form of contraception.

        Exclusion Criteria:

          -  Patients with neuropathic pain (NeP) that is not due to trauma; e.g. patients with
             trigeminal neuralgia, central pain, complex region pain syndrome type I, phantom limb
             pain, radiculopathy, painful diabetic neuropathy or post-herpetic neuralgia or
             patients with any other co-existing pain which cannot be differentiate from NeP of
             peripheral origin.

          -  Patients who have previously failed to respond to pregabalin at a total daily dose of
             equal to or greater than 300 mg or are intolerant to those doses.

          -  Patients who have previously failed to respond to gabapentin at a total daily dose of
             equal to or greater than 1800 mg.

          -  Patients with any type or history of malignancy, except either where there has been no
             ongoing treatment for at least 6 months or all basal cell carcinomas; all patients
             with a history of brain or spinal tumors will be excluded.

          -  Patients who currently have ongoing litigation related to any injury affecting their
             pain symptomatology.
CC100: Safety and Tolerability of Single Doses
Condition: Healthy
Intervention: CC100; Placebo
Intervention description: CC100 reconstituted in diluent; Diluent. Amount to match CC100 dose.
Intervention MeSH terms: Caffeic acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase 1; Healthy Volunteer; Safety; Healthy Volunteer Safety Study

Summary:

      The purpose of this study is to see if CC100, given by mouth, is safe and is tolerated in
      increasing doses. How long the drug remains in the body will also be calculated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men must practice a reliable method of birth control during study and for 2 weeks
             following study. Women must be non-fertile or post-menopausal.

        Exclusion Criteria:

          -  Have serious or unstable illnesses as determined by the investigator.

          -  Have current or a history of asthma, or severe drug allergies or pollen allergy.

          -  Have used medications (except for calcium supplements or externally applied eye drops
             or antibiotics) within 30 days prior to dosing or are expected to use other
             medications during the study.

          -  Have had serious infectious disease affecting the brain within the preceding 5 years;
             or have known or existing evidence of serious infection.

          -  Have laboratory test values that are considered clinically significant as determined
             by the investigator.

          -  Have ECG abnormalities that are clinically significant.

          -  Have donated blood (a pint or more) or received an experimental drug within 30 days
             prior to dosing.

          -  Have a history of chronic alcohol or drug abuse within the past 2 years.
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
Condition: Healthy
Intervention: SB2; EU Remicade; US Remicade
Intervention description: IV infusion; IV infusion; IV infusion
Intervention MeSH terms: Infliximab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics

Summary:

      The purpose of this study is to compare the pharmacokinetics, safety, tolerability and
      immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female subjects of non-childbearing potential and healthy male subjects

          -  Have a body weight between 60.0 and 94.9 kg and a body mass index between 20.0 and
             29.9 kg/m², inclusive.

        Exclusion Criteria:

          -  history and/or current presence of clinical significant atopic allergy,
             hypersensitivity or allergic reactions, also including known or suspected clinically
             relevant drug hypersensitivity to any components of the test and reference IP
             formulation or comparable drugs.

          -  active or latent Tuberculosis or who have a history of Tuberculosis.

          -  history of invasive systemic fungal infections or other opportunistic infections

          -  systemic or local infection, a known risk for developing sepsis and/or known active
             inflammatory process

          -  serious infection associated with hospitalisation and/or which required intravenous
             antibiotics

          -  history of and/or current cardiac disease

          -  have received live vaccine(s) within 30 days prior to Screening or who will require
             live vaccine(s) between Screening and the final study visit.

          -  Intake medication with a half-life > 24 h within 1 month or 10 half-lives of the
             medication prior to the administration of investigational product.
Perfusion Assessment in Laparoscopic Left Anterior Resection
Condition: Rectal Cancer; Colon Cancer; Crohn's Disease; Polyp; Procidentia; Diverticulitis
MeSH terms: Rectal Neoplasms; Colonic Neoplasms; Crohn Disease; Diverticulitis; Prolapse
Intervention: PINPOINT Endoscopic Fluorescence Imaging System
Intervention description: The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Laparoscopic low anterior colon resection; Laparoscopic left colectomy; Colectomy; Rectal cancer; Colon cancer; Crohn's Disease; Polyp; Procidentia; Diverticulitis

Summary:

      The purpose of this study is to demonstrate that NIR fluorescence angiography using the
      PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess
      viability of colon tissue during laparoscopic left colectomy. This information will provide
      the surgeon with clinically relevant information in assessing whether or not the tissue has
      adequate blood supply in the lower section of the colon prior to a colectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is scheduled for laparoscopic left colectomy in the lower region (planned
             anastomosis located 5 - 15 cm from anal verge)

          -  A negative pregnancy test for women of childbearing potential prior to surgery

        Exclusion Criteria:

          -  Subject has a previous history of adverse reaction or known allergy to ICG, iodine or
             iodine dyes

          -  Subject has any medical condition, which in the judgment of the Investigator and/or
             designee makes the subject a poor candidate for the investigational procedure

          -  Subject is a pregnant or lactating female
Safety of Single Rising Doses and Relative Bioavailability of BI 691751
Condition: Healthy
Intervention: BI 691751; BI 691751; Placebo; BI 691751; BI 691751; BI 691751; BI 691751; BI 691751; BI 691751; BI 691751
Intervention description: oral solution BI 691751, dose 6; oral solution; placebo solution; oral solution BI 691751, dose 2; oral solution BI 691751, dose 5; 1 tablet; oral solution BI 691751, dose 3; oral solution BI 69175, dose 4; oral solution BI 691751, dose 7; oral solution BI 69175, dose 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 81.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single
      rising doses of BI 691751 in healthy male subjects (part I).

      To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution
      (part II)
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy male subjects

          2. Subjects must be able to understand and comply with study requirements

          3. Age from 18 to 55 years

          4. BMI range: from 18.5 to 29.9 kg/m2

          5. Known genotype as specified in the study protocol

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
A Phase 1, First Time in Human (FTIH) Study to Evaluate GSK3352589, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Healthy Volunteers
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Intervention: GSK3352589; Matching Placebo
Intervention description: It will be available in the dose of 1, 5, 25 and 100 mg tablet for oral administration.; It will be available across all strengths to match active drug in the form of tablet for oral administration.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: REarranged during Transfection

Summary:

      This FTIH study is designed to assess the safety, tolerability and pharmacokinetic (PK) of
      escalating single and repeat oral doses of GSK3352589 in normal healthy volunteers. This is a
      randomized, double-blind (sponsor unblinded), placebo controlled, dose escalation study that
      will have two parts; Part A and Part B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 18 and 55 years of age inclusive, at the time of signing the informed consent.

          -  Healthy as determined by the investigator based on a medical evaluation including
             medical history, physical examination, laboratory tests and cardiac monitoring. -
             History of regular bowel habits

          -  Male or Female of non-childbearing potential.

          -  Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions.

        Exclusion Criteria:

          -  ALT and bilirubin >1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is
             acceptable if bilirubin is fractionated and direct bilirubin <35%).

          -  Previous Diagnosis of IBS

          -  Estimated Glomerular Filtration Rate <60 millilter per minute per 1.73 square meter
             (mL/min/1.73m^2)

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones)

          -  History of Gastroesophageal reflux disease (GERD), dyspepsia, Gastrointestinal (GI)
             bleeding, diverticulitis, diverticular stricture or other intestinal strictures, GI
             surgery that could affect motility

          -  Unwillingness or inability to follow the procedures outlined in the protocol
Phase 1, TAK-648, Single-Rising Dose Study
Condition: Healthy Volunteers
Intervention: TAK-648; TAK-648 Placebo
Intervention description: TAK-648 Solution; TAK-648 placebo-matching solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to determine the safety, tolerability and pharmacokinetics of
      TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose levels
      in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a healthy adult male or non-pregnant, non-lactating female.

          2. Is aged 18 to 55 years, inclusive.

          3. Weighs at least 55 kg (121 lbs) and has a body mass index (BMI) between 18.0 and 30.0
             kg/m^2, inclusive.

          4. Has a systolic blood pressure >90 and ≤150 mm Hg and a diastolic blood pressure of >60
             and ≤90 mm Hg at Screening and at Check-in (Day -2).

          5. Has a calculated creatinine clearance >60 mL/min at Screening and Check-in (Day -2).

        Exclusion Criteria:

          1. Has a known hypersensitivity to any component of the formulation of TAK-648,
             phosphodiesterase inhibitors or Listerine strips.

          2. Has significant medical histories or currently uncontrolled clinical conditions, which
             may not be safe for participant to participate in the study, may impact the
             participant's ability to participate in the study; may influence absorption of the
             study drug, or may potentially confound the study results.

          3. Has a history of persistent, chronic or intermittent nausea, vomiting, or diarrhea or
             had a current or recent (within 6 months) gastrointestinal disease that would
             influence the absorption of drugs

          4. Has a diagnosis of major depression, bipolar disorder, or anxiety disorders or
             received any medication to treat any psychological disorders within 1 year prior to
             Screening.

          5. Has abnormal laboratory values that suggest a clinically significant underlying
             disease or has the following laboratory abnormalities: alanine aminotransferase (ALT)
             and/or aspartate aminotransferase (AST) >2.5 times the upper limits of normal.

          6. Use of any excluded medications, supplement, or food product outlined in the protocol.

          7. Use of new medications during the course of the study including through the Follow-up
             period.
Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit
Condition: Healthy
Intervention: fesoterodine fumarate; placebo; solifenacin
Intervention description: 8 mg OD for 14 days; OD for 14 days; 10 mg OD for 14 days
Intervention MeSH terms: Solifenacin Succinate; Fesoterodine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Fesoterodine; Solifenacin

Summary:

      To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic
      transit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female subjects

        Exclusion Criteria:

          -  Evidence or history of clinically significant findings at screening