bioihbjkbjnl/mcl2 huggingface dataset:
Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Intervention: capecitabine; oxaliplatin; sunitinib malate; capecitabine; cisplatin; sunitinib malate
Intervention description: Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.; Oxaliplatin is given 110mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.; sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.; Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.; Cisplatin is given 80mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.; sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
Intervention MeSH terms: Capecitabine; Oxaliplatin; Sunitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine the safe and tolerable doses of sunitinib given
      together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients
      who have advanced gastric cancer who have not received prior chemotherapy for their advanced
      cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  confirmed diagnosis of stomach cancer

          -  advanced stomach cancer of stage IV

          -  adequate blood chemistry, blood counts and kidney function

          -  willing to participate to study requirements and sign an informed consent document

        Exclusion Criteria:

          -  prior chemotherapy for the stomach cancer in its advanced stage

          -  excessive toxicities related to prior therapies

          -  pregnant or breastfeeding patients
Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.
Condition: Solid Malignancies
MeSH terms: Neoplasms
Intervention: Ixabepilone
Intervention description: Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the dose limiting toxicities, minimum tolerated
      dose and recommended dose for Phase II studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  confirmed diagnosis of a primary solid tumor

          -  measurable or non-measurable disease

          -  progressive disease

          -  men and women greater or equal to 18 years of age.

        Exclusion Criteria:

          -  women of child bearing potential who are not using birth control

          -  women who are pregnant or breast feeding

          -  women with a positive pregnancy test on enrollment

          -  patients with brain metastasis

          -  prior treatment with Ixabepilone

          -  known history of human immunodeficiency virus (HIV)
First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: AG-013736; AG-013736; AG-013736; AG-013736; AG-013736; AG-013736
Intervention description: Axitinib continuous oral dosing (10 mg once a day, 10 mg twice a day, 20 mg twice a day or 30 mg twice day) in the fed state; Axitinib continuous oral dosing (20 mg twice a day) in the fed state; Axitinib continuous oral dosing (5 mg twice a day) in the fed state; Axitinib continuous oral dosing (15 mg once a day) in the fed state; Axitinib continuous oral dosing (5 mg twice a day) in the fasted state; Axitinib continuous oral dosing (2 mg twice a day on the first day of dosing, followed by 5 mg twice a day) in the fasted state
Intervention MeSH terms: Axitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study was to characterize the safety of investigational agent AG-013736,
      in patients with solid tumors in this First In Human trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with cytologically or histologically confirmed solid tumor(s) and with at
             least one measurable disease site

          -  Patients with adequate bone marrow, liver and kidney function

          -  Patients with life expectancy of at least 12 weeks

        Exclusion Criteria:

          -  Patients who have received chemotherapy, immunotherapy, radiotherapy or any
             investigational agent within 4 weeks of study entry

          -  Patients with have had a major surgical procedure within 4 weeks of study entry
Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
Condition: Breast Cancer; Fatigue
MeSH terms: Breast Neoplasms; Fatigue
Intervention: CoQ10 & Vitamin E; Placebo & Vitamin E
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 236.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: fatigue; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Summary:

      RATIONALE: Coenzyme Q10 is a vitamin that may be effective in relieving fatigue and
      depression in women who are undergoing chemotherapy for breast cancer.

      PURPOSE: This randomized clinical trial is studying how well coenzyme Q10 works in relieving
      treatment-related fatigue in women with breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed consent

          -  Hg > 11g/dl; supportive measures (erythropoietin, transfusion, iron therapy) should be
             utilized to assist with maintaining Hgb levels

          -  Total cholesterol > 160mg/dL.

          -  Female with primary cancer diagnosis (breast)

          -  Planned adjuvant chemotherapy (neoadjuvant chemotherapy is excluded)

          -  KPS > 60

          -  Bilirubin < 1.5 x ULN

          -  SGOT < 2.5 x ULN

          -  SGPT < 2.5 x ULN

        Exclusion Criteria:

          -  Recent involuntary weight loss (> 5% of body weight in the past 3 months)

          -  Statin therapy - current or planned during study. Below is a list of some commonly
             used statin drugs.(Note: This is a helpful guide, not a complete list.)

               -  Atorvastatin (Lipitor)

               -  Cerivastatin

               -  Fluvastatin (Lescol)

               -  Lovastatin (Mevacor, Altocor, Advicor)

               -  Mevastatin

               -  Pravastatin (Pravachol)

               -  Rosuvastatin

               -  Simvastatin (Zocor)

          -  Current or planned use of the following medications for fatigue

               -  Corticosteroids (intermittent use as part of chemotherapy regimen is allowed)

               -  Amphetamines or other stimulants including methylphenidate (Ritalin)or modafinil
                  (Provigil)

          -  Patients diagnosed with uncontrolled hypertension

          -  Breast cancer patients who are male

          -  Pregnant women are excluded from participation in this study. A Serum pregnancy test
             is required within 1 week of registration if the patient is a woman of childbearing
             potential.

          -  Anticoagulant therapy - current or planned during study (except for maintenance of
             catheter patency)

          -  Patients with uncontrolled thyroid dysfunction
Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Intervention: whole liver lobe cTACE doxorubicin; superselective cTACE doxorubicin
Intervention description: Doxorubicin CTACE administered in a whole liver lobe manner.; Doxorubicin CTACE administered in a super-selective (close to the tumor) manner.
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients with primary and secondary liver cancer may participate in this study. The purpose
      is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on
      the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization
      (cTACE). cTACE is a procedure in which chemotherapy drugs are injected, followed by an
      injection of small beads to block the tumor-feeding arteries. Doxorubicin is a
      chemotherapeutic agent used in the cTACE procedure. This study will examine doxorubicin
      pharmacokinetics in patients who: 1) receive whole liver cTACE; and 2) receive
      super-selective CTACE (i.e., delivered in close proximity to the tumor).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years.

          2. Histologically, cytologically, or radiologically confirmed liver dominant or liver
             only malignancy.

          3. Preserved liver function (Child-Pugh A-B class) without significant liver
             decompensation.

          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry.

          5. Measurable or evaluable disease that will be directly treated with intrahepatic
             therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).

          6. Suitable for TACE based on blood parameters such as platelet count, bilirubin, and
             international normalized ratio.

          7. May be enrolled with a history of prior liver directed intra-arterial therapy if
             intra-arterial therapy to the target lesion occured > 1 year prior to enrollment date.
             Intra-arterial therapy to different targets within 1 year prior to enrollment date
             will not exclude subjects.

        Exclusion Criteria:

          1. Serum total bilirubin > 3.0 mg/dL

          2. Creatinine > 2.0 mg/dL

          3. Platelets < 50000/µL

          4. Complete portal vein thrombosis with reversal of flow

          5. Ascites (trace ascites on imaging is acceptable)
Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Bexagliflozin; Metformin; Glimepiride; Sitagliptin
Intervention description: Bexagliflozin tablets, 20 mg; 1000 mg metformin; 4 mg glimepiride; 100 mg sitagliptin
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Glimepiride; Bexagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to examine the drug-drug interaction in your body when given the
      study drug, bexagliflozin, with three commonly used ant-diabetic medications, metformin,
      glimepiride or sitagliptin. The study will also evaluate how safe the study drug is and how
      well the study drug is tolerated when taken with metformin, glimepiride or sitagliptin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2

          2. Subjects who are non-smokers for at least 3 months prior to screening

          3. Subjects who are willing and able to be confined to the clinical research facility as
             required by the protocol

        Exclusion Criteria:

          1. Subjects with a clinically significant history of allergy to drugs or latex.

          2. Subjects with a history of alcohol or drug dependence in the past 12 months.

          3. Subjects who have donated a significant amount of blood in the past 2 months

          4. Female subjects who are pregnant or breastfeeding

          5. Subjects who are not willing to use an adequate form of birth control during the study
             and for 30 days after discharge from clinic

          6. Subjects who have taken an investigational drug in the past 30 days or 7 half-lives of
             the investigational drug, whichever is longer

          7. Subjects who had previously received anti-diabetic medication, including metformin,
             sitagliptin, glimepiride or drugs of the same class (i.e. biguanides, DPP-4 inhibitors
             or sulfonylureas), or SGLT2 inhibitors, in the past 3 months
Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: IMO-2125; Saline placebo
Intervention description: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system; saline placebo given subcutaneously
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hepatitis C; unresponsive to pegylated interferon and ribavirin therapy; hepatitis C virus

Summary:

      First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV-positive

          -  Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with
             standard-dose ribavirin

        Exclusion Criteria:

          -  Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)

          -  Inadequate bone marrow, liver, and renal function

          -  Treatment with any IFN (interferon)-based or other experimental or antiviral therapies
             within 30 days

          -  Other significant medical diseases

          -  Known alcohol or drug abuse within the past 12 months
A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: OCV-501; OCV-501; OCV-501
Intervention description: subcutaneously administered once a week, 4 times at the dose of 0.3 mg; subcutaneously administered once a week, 4 times at the dose of 1 mg; subcutaneously administered once a week, 4 times at the dose of 3 mg
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Acute myeloid leukemia; WT1

Summary:

      The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with
      acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who
      completed a standard consolidation therapy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients with acute myeloid leukemia including patients with secondary leukemia.
             However, the patients with MDS apparently evolved itno AML and patients with AML
             accompanied by t(15;17)(q22;q12),(PML/RARalpha) , should be excluded.

          -  Patients who achieved the first complete remission after the induction regimen and
             finished a standard consolidation therapy.

          -  Age: ≥ 60years of age(at the time of signature of the informed consent form)

          -  Sex: Male and Female

          -  Patients who are capable of giving informed consent

          -  Patient's blasts cells show expression of WT1mRNA, detected by quantitative RT-PCR.

          -  Patients must be one of the following HLA DRB1 types: HLA-DRB1*01:01, *04:05, *15:01,
             *15:02, *08:03 and *09:01.

        Key Exclusion Criteria:

          -  Patients who are scheduled for a bone marrow transplantation

          -  Patients who were administered exceeded acceptable therapeutic dose of
             immunosuppressants and adrenal cortical steroids.

          -  Patients with uncontrollable active infectious diseases

          -  Patients with autoimmune diseases (including Hashimoto's disease, idiopathic
             thrombocytopenic purpura, and autoimmune hepatitis) or with a medical history of
             active autoimmune diseases

          -  Immunocompetent patients

          -  Patients with a complication of interstitial pneumonia or with a medical history of
             interstitial pneumonia
W-SUDs for COVID-19
Condition: Substance Use Disorders; Alcohol Use Disorder
MeSH terms: Substance-Related Disorders; Alcoholism
Intervention: Woebot Substance Use Disorder
Intervention description: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the efficacy of a substance use disorder intervention
      delivered via a mobile application in an adult population during the COVID-19 pandemic.

      This study that will test the comparative efficacy of the mobile-app based substance use
      disorder program to reduce substance use relative to a wait list control condition, and
      explore between group differences on quality of life indices as well as retention and
      engagement during COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All genders aged 18-65 years

          -  Access to a smartphone

          -  Available and committed to engage with app and complete assessments

          -  Be willing to provide email address (as this is how assessment incentives will be
             distributed),

          -  Literate in English (as W-SUDs conversational and video materials will be in English).

        Exclusion Criteria:

          -  Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of
             this population)

          -  History of severe drug/alcohol use

          -  History of opioid misuse without medication-assisted treatment

          -  Suicide attempt within the past year

          -  Opioid overdose within the past year
Entospletinib (ENTO) as Monotherapy and in Combination With Chemotherapy in Japanese Adults
Condition: Hematologic Malignancy; Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neoplasms; Hematologic Neoplasms
Intervention: Entospletinib; Daunorubicin; Cytarabine
Intervention description: 400 mg (2 × 200 mg tablets) orally twice daily; 60 mg/m^2 administered intravenously daily on Days 1 to 3 of each 28-day induction cycle; 100 mg/m^2 intravenous administration twice daily on Days 1 to 7 of each 28-day induction cycle
Hi-DAC: 3 g/m^2 IV administration twice daily on days 1, 3, and 5 (≤ 60 years of age) or 1 g/m^2 IV administration once daily on Days 1 to 5 (> 60 years of age) of each 28-day post-remission cycle
Intervention MeSH terms: Cytarabine; Daunorubicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed or Refractory Hematologic Malignancy; Previously untreated AML

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of
      entospletinib (ENTO) monotherapy and in combination with chemotherapy in Japanese
      participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  ENTO monotherapy (Group A): relapsed or refractory hematologic malignancies by World
             Health Organisation (WHO) criteria and who are not eligible to receive standard of
             care

          -  ENTO + cytarabine + daunorubicin (Group B): previously untreated AML by WHO criteria,
             who are deemed fit for cytarabine and daunorubicin (7+3) induction chemotherapy and
             are able to undergo up to 2 cycles of induction chemotherapy, as determined by the
             treating physician

          -  Must have been born in Japan and must not have lived outside of Japan for a period > 1
             year in the 5 years prior to Day 1 of study treatment

          -  Must be able to confirm the Japanese origin of their maternal and paternal ancestry

        Key Exclusion Criteria:

          -  Known active central nervous system or leptomeningeal leukemic involvement

          -  Ongoing liver injury, or known infection with chronic active hepatitis C virus (HCV)
             or chronic active hepatitis B virus (HBV)

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.