bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3025876 in Participants With Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY3025876; Placebo; Liraglutide
Intervention description: Administered SQ; Administered SQ; Administered SQ
Intervention MeSH terms: Liraglutide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to assess the safety and tolerability of LY3025876 given
      alone (Part A) and in combination with liraglutide (Part B) in participants with type 2
      diabetes mellitus (T2DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 2 diabetes mellitus (T2DM) as determined by the investigator,
             controlled with diet or exercise alone or on a stable dose of metformin for at least
             30 days

          -  Have a body mass index (BMI) greater than or equal to 23 and less than or equal to 45
             kilograms per square meter (kg/m^2) at screening

          -  Have a supine blood pressure reading at screening of between 90-160 millimeter of
             mercury (mmHg) (systolic) and 40-95 mmHg (diastolic)

          -  Women not of child-bearing potential due to surgical sterilization (hysterectomy or
             bilateral oophorectomy or tubal ligation) or menopause

        Exclusion Criteria:

          -  Have taken LY3025876 or investigational drugs like it (for example, other fibroblast
             growth factor-21 [FGF21]-related drugs) or have known allergies to these drugs

          -  History or presence of bone disease (including osteoporosis or unhealed fractures)

          -  Current active treatment of periodontal disease

          -  Have had a significant change in weight, defined as a gain or loss of at least 4
             kilogram (kg) (9 pounds) in the last 3 months

          -  Have had greater than 1 episode of severe hypoglycemia within 6 months of screening
             that required the assistance of another person to actively administer carbohydrate,
             glucagon, or other resuscitative actions or had a seizure or coma

          -  Have known allergies or a history of intolerance to liraglutide, glucagon-like peptide
             1 (GLP-1) analogues, or other related compounds

          -  Have a history of acute or chronic pancreatitis

          -  Have a personal or family history of medullary thyroid carcinoma or have multiple
             endocrine neoplasia syndrome type 2
Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer
Condition: Rectal Neoplasms
MeSH terms: Rectal Neoplasms
Intervention: capecitabine; Capecitabine; Capecitabine; Capecitabine; Capecitabine
Intervention description: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation; oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation; oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation; oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation; oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Intervention MeSH terms: Capecitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 75 Years
Healthy volunteers: No
Keywords: rectal neoplasms; aged; chemoradiotherapy; clinical trials, phase I; capecitabine

Summary:

      This phase I study is designed to determine the maximum tolerant dose of capecitabine when
      used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75
      years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).

          -  KPS status no less than 70; Charlson comorbidity no more than 3.

          -  life expectancy more than 6 months.

          -  hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L,
             platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP
             normal.

          -  do not have allergy history to thymidine phosphorylase.

          -  do not receive surgery ( except palliative colostomy) or chemotherapy or other
             anti-cancer treatment

          -  no previously pelvic irradiation history

          -  informed consent signed

        Exclusion Criteria:

          -  other cancer history, except curable non-melanoma skin cancer or cervix in-situ
             carcinoma

          -  previous pelvic irradiation history

          -  receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer
             treatment

          -  allergy history to thymidine phosphorylase

          -  active infection existed

          -  severe complication, such as acute myocardial infarction in 6 months, uncontrolled
             diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe
             cardiac arrhythmia， etc.

          -  anticipate other clinical trials in four weeks before enrollment
Feasibility of VOICES Elder Abuse Intervention in Primary Care Setting (VOICES-PC Feasibility)
Condition: Elder Abuse
Intervention: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)
Intervention description: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: VOICES Elder Abuse Intervention
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To test an interactive intervention to screen for Elder Abuse and Mistreatment (EM) in the
      Primary Care (PC) setting to promote self-identification and self-disclosure of EM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 60 years or older

          -  Alert and oriented to person and place

          -  Abbreviated Mental Test (AMT-4) score of 4

          -  Able to consent and communicate in English

          -  Agrees and able to use the iPad

        Exclusion Criteria:

          -  subjects who live in nursing homes or other long-term care sitting and do not reside
             in community setting

          -  patients will be excluded if they cannot safely undergo the studies required for
             participation

          -  subjects with clear signs of EM

          -  Patient or clinician refusal to participate

          -  severe hearing and vision impairment

          -  COVID-19 positive
A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects
Condition: Bacterial Enteritis
MeSH terms: Enteritis
Intervention: 14C-OPS-2071
Intervention description: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Male
Minimum age: 35 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males

          -  Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive

          -  Subjects will have given their written informed consent to participate in the study
             and to abide by the study restrictions

        Exclusion Criteria:

          -  Subjects who have a significant history of alcoholism or drug/chemical abuse, as
             determined by the Investigator.

          -  Subjects who smoke, or who have used nicotine within 3 months prior to screening..

          -  Subjects who have a significant history of drug allergy, as determined by the
             Investigator.

          -  Subjects who have any clinically significant abnormal physical examination finding.

          -  Subjects who have any clinically significant medical history, as determined by the
             Investigator.

          -  Subjects who are exposed to radiation as a result of their occupation.

          -  Subjects who have had an X ray or CT scan, or who have participated in any trial
             involving a radiolabelled investigational product or have been exposed to
             radiolabelled substances within 12 months prior to dose administration.
Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers
Condition: Congenital Bleeding Disorder; Healthy
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Intervention: vatreptacog alfa (activated); vatreptacog alfa (activated); vatreptacog alfa (activated); vatreptacog alfa (activated); placebo; placebo; placebo; placebo
Intervention description: One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg; One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg; One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg; One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg; Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg; Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg; Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg; Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Japan. The aim of this trial is to assess the safety and
      tolerability of activated recombinant human coagulation factor VII analogue (NN1731,
      vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the
      pharmacokinetics of NN1731 will be examined
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male subjects, who are considered to be generally healthy based on assessment
             of medical history, physical examination and clinical laboratory data at screening, as
             judged by the Investigator or Sub-investigator

          -  Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (inclusive)

        Exclusion Criteria:

          -  Any clinical laboratory values deviated from the reference range at the laboratory
             (except for cases within physiological change) or any abnormal electrocardiogram (ECG)
             findings at the screening, as judged by the Investigator or Sub-investigator

          -  Presence or history of cancer or any clinically significant cardiac, respiratory,
             metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological,
             venereal, haematological, neurological, or psychiatric diseases or disorders

          -  Evidence of clinically relevant pathology or a potential thromboembolic risk as judged
             by the Investigator or Sub-investigator

          -  Presence or history of atherosclerosis, arteriosclerosis or thromboembolic events

          -  Any past history of migraine

          -  Overt bleeding, including from the gastrointestinal tract
A Study of Baricitinib in Healthy Participants
Condition: Healthy
Intervention: Baricitinib suspension; Baricitinib tablet
Intervention description: Administered orally; Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are to determine:

        -  If there are any differences in the amount of baricitinib in the blood/body when taken
           in two different forms.

        -  How a high-fat, high-calorie meal affects the amount of baricitinib in the blood/body.

        -  The safety and tolerability of baricitinib.

      The study has two parts. Individuals will participate in only one part.

      Participants will be admitted to the clinical research unit (CRU) and will be discharged from
      the CRU following the completion of 3 overnight stays.

      Each part of this study will last from 8-10 days, not including screening. Follow-up will
      occur 7 to 14 days after the last dose of baricitinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination

          -  Women not of child-bearing potential

          -  Have a body mass index (BMI) of 18.5 to 29.9 kilograms per meter squared (kg/m²)
             inclusive, at screening

        Exclusion Criteria:

          -  Have received live vaccine(s) within 3 months of screening, or intend to during the
             study

          -  Have a current or recent history (less than [<] 30 days prior to screening and/or <45
             days prior to Day -1 in Period 1) of a clinically significant bacterial, fungal
             parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants
Condition: Healthy Volunteers
Intervention: TAK-935 Tablets; TAK-935 Oral Solution
Intervention description: Tablets; Oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 9.0
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 assess the relative bioavailability (BA) of 300 milligram
      (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of
      food on the BA of TAK-935 300 mg tablets in healthy adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0
        kilogram per square meter (kg/m^2), inclusive at Screening and Day -2.

        Exclusion Criteria:

          1. Has received TAK-935 in a previous clinical study or as a therapeutic agent.

          2. Has a history of any psychiatric disorder as diagnosed utilizing Diagnostic and
             Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria.

          3. Has any lifetime history of drug abuse (defined as any illicit drug use) or any
             lifetime history of alcohol abuse prior to the screening visit or is unwilling to
             agree to abstain from alcohol and drugs throughout the study. One unit is equivalent
             to a half-pint of beer or a single measure of spirits or 1 small glass of wine.

          4. Has a history of cancer, except basal cell carcinoma which has been in remission for
             at least 5 years prior to Day 1.

          5. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus
             (HCV) antibody, human immunodeficiency virus (HIV) antibody at Screening or a known
             history of human immunodeficiency virus infection.

          6. Has used nicotine-containing products (including but not limited to cigarettes, pipes,
             cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to
             Check-In Day -1. Cotinine test is positive at Screening or Check-In (Day -1).

          7. Has poor peripheral venous access.

          8. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day
             1 of Period 1.
Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer.
Condition: Breast Neoplasms; Stomach Neoplasms
MeSH terms: Neoplasms; Breast Neoplasms; Stomach Neoplasms
Intervention: Herceptin; afatinib; trastuzumab; Herceptin; afatinib; afatinib
Intervention description: 3-weekly; at MTD level; 3-weekly; weekly; at MTD level; escalating dose
Intervention MeSH terms: Trastuzumab; Afatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in
      combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the
      efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2
      overexpressing metastatic breast cancer.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients aged 18 years and older

          2. Patients with cancers overexpressing HER2 by Immunohistochemistry test( IHC) 3+ and/or
             IHC 2+ with positive gene amplification by FISH (confirmation on archived tissue
             needed)

          3. Written informed consent that is consistent with ICH-GCP guidelines.

          4. Patients must be eligible for treatment with trastuzumab.

          5. Patients must have adequate organ function (kidney, liver, bone marrow, cardiac)

          6. Eastern Cooperative Oncology Group (ECOG) = 0 or 1.

          7. Measurable disease according to RECIST 1.1 (Phase Ib).

        Exclusion criteria:

          1. Active brain metastases.

          2. Prior treatment with erbB family targeting therapies within the past four weeks before
             start of therapy or concomitantly with the trial other than trastuzumab and/or
             lapatinib.

          3. Patients having more than 2 lines of chemotherapy for the treatment of metastatic
             breast cancer (Phase Ib).
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
Condition: Clostridium Difficile Infection; Clostridium Difficile Diarrhea
MeSH terms: Clostridium Infections; Diarrhea
Intervention: Vaccine diluent buffer; Clostridium difficile toxoid vaccine (50 μg); Clostridium difficile toxoid vaccine (100 μg)
Intervention description: 0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.; 0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.; 0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clostridium difficile diarrhea; Clostridium difficile toxoid vaccine

Summary:

      This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess
      the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine.
      Population: healthy male and female adults, 18 to 55 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult males or females, 18 - 55 years in good general health

        Exclusion Criteria:

          -  Evidence of current C. difficile infection, as determined by a positive stool C.
             difficile cytotoxin assay at screening

          -  Evidence of any previous antibiotic-associated diarrhea caused by any etiology
             including C. difficile that required medical intervention or medication

          -  Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea
             of any etiology, or inflammatory bowel disease.
4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: BI 207127 middle dose +SOC; BI 207127 high dose+SOC; Placebo + SOC; BI 207127 low dose + SOC
Intervention description: BI 207127 middle dose tid + SOC; BI 207127 high dose tid +SOC; Placebo tid +SOC; BI 207127 low dose tid + SOC
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week
      combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C
      virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected
      patients.
    

Eligibility criteria:

        Inclusion criteria:

          1. HCV genotype 1

          2. HCV viral load >100,000 IU/mL

          3. histology or fibroscan to rule out cirrhosis

          4. Absence of retinopathy

          5. treatment naive patients and treatment experienced patients

          6. Age 18 - 70 years

          7. Male OR female with documented hysterectomy OR postmenopausal

        Exclusion criteria:

          1. Fertile males not willing to use an adequate form of contraception

          2. Pretreatment with any HCV-polymerase inhibitor

          3. Any concurrent disease if clinically significant based on the investigator's medical
             assessment

          4. Current alcohol or drug abuse, or history of the same

          5. Positive test for HIV or HBs

          6. History of malignancy

          7. Planned or concurrent usage of any other pharmacological therapy including any
             antiviral therapy or vaccination

          8. Usage of any investigational drug within thirty (30) days prior to enrolment or 5
             halflives, whichever is longer

          9. Any clinically significant laboratory abnormalities based on the investigator's
             medical assessment at screening

         10. Patients treated with any interferon (approved or investigational) or Peg-IFN and/or
             Ribavirin within 3 months prior to screening

         11. Known hypersensitivity to drugs or excipients; Further exclusion criteria apply