bioihbjkbjnl/mcl2 huggingface dataset:
A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: docetaxel; LY2181308 sodium; Prednisone
Intervention description: Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.; LY2181308 sodium (referred to as LY2181308 throughout this record) administered weekly plus docetaxel 75 mg/m² intravenously administered every 21 days. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.; Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy
Intervention MeSH terms: Prednisone; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hormone Refractory Prostate Cancer

Summary:

      The primary purpose of this study is to determine whether LY2181308 in combination with
      docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate which is
             metastatic and/or unresectable

          -  Hormone refractory prostate cancer defined as progressive based by documented 2
             increase Prostate specific antigen (PSA) values over a previous reference value.

          -  Eastern Cooperative Oncology Group (ECOG) status 0-2

          -  Adequate hematological functions, liver and renal functions

        Exclusion Criteria:

          -  Known hypersensitivity to docetaxel or taxane therapy

          -  Documented central nervous system or leptomeningeal metastasis at time of study entry

          -  Had prior treatment with chemotherapy, bone-seeking radionuclides in past 6 weeks
             prior to enrollment, or radiotherapy involving more than 25% of marrow producing area.

          -  Evidence of painful and/or destructive bone metastases for which radiation therapy,
             bisphosphonates or bone-seeking radionuclides are necessary.

          -  Have received treatment in the last 30 day with a drug which has not received
             regulatory approval for any indication at the time of study entry.
Aripiprazole Augmentation of Antidepressants in PTSD
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Aripiprazole; Placebo
Intervention description: Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks; Same as active drug.
Intervention MeSH terms: Aripiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PTSD; Antidepressant; Aripiprazole; OEF; OIF

Summary:

      The proposed investigation will determine the therapeutic potential of aripiprazole
      augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder
      (PTSD) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans
      with PTSD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient veterans with posttraumatic stress disorder (PTSD)

          -  Receiving treatment with an antidepressant at a stable dose for 4 weeks

          -  Male or female

          -  Ages 18-65 years old
Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: granisetron
Intervention description: Application granisetron transdermal patch preoperatively
Intervention MeSH terms: Granisetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: PONV; anesthesia; granisetron

Summary:

      The objective of the study is to evaluate the efficacy and safety of adding transdermal
      preparation of granisetron (Sancuso ®) to the current postoperative nausea and vomiting
      (PONV) standard prophylaxis regimen with dexamethasone and ondansetron in patients with the
      previous history of severe, particularly delayed and/or post-discharge, PONV and undergoing
      surgical procedure under general anesthesia.

      The specific aims of the study include:

        1. efficacy of the investigated therapy in prevention of PONV up to 120 hours after surgery

        2. incidence and seriousness of the observed side effects

        3. ability of patients to self-administer preoperatively and maintain the investigated
           patch during the perioperative period

        4. level of satisfaction with the preoperative PONV prophylaxis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients that are between the ages of 18 and 89

          -  Scheduled to undergo surgical procedures with general anesthesia

          -  Seen in the anesthesia clinic at least 24 hours before surgery

          -  History of severe PONV after previous general anesthesia

          -  Surgical procedures with anticipated duration > 1 hour and no more than 5 hours

          -  American Society of Anesthesiologists (ASA) physical status I to III

        Exclusion Criteria:

          -  Allergy to granisetron or other 5HT3RA drugs

          -  Previous allergic reactions to any drug skin patches

          -  Recent (less than 1 month) or current chemo- or radiotherapy

          -  Any nausea, vomiting, or retching within 24 hours prior to anesthesia

          -  Any type of eye surgeries

          -  History or diagnosis of gastrointestinal obstruction or ileus

          -  History of serotonin syndrome

          -  Unable to sign consent
Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
Condition: Biliary Cancer; Cholangiocarcinoma
MeSH terms: Adenocarcinoma; Cholangiocarcinoma
Intervention: Gemcitabine, Irinotecan, Panitumumab
Intervention description: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Intervention MeSH terms: Gemcitabine; Irinotecan; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Biliary Cancer; Cholangiocarcinoma; Panitumumab

Summary:

      This study evaluates the combination chemotherapy with gemcitabine, irinotecan and
      panitumumab in patients with advanced biliary cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically or cytologically confirmed local advanced unresectable/metastatic
             adenocarcinoma of biliary tract

          -  measurable disease

          -  available tumor tissue for investigational immunohistochemical evaluations

          -  ECOG PS 0-2

          -  No prior chemotherapy, biologic therapy or radiation therapy

          -  Age Eighteen and older

          -  Lab values per protocol

        Exclusion Criteria:

          -  Life expectancy less than three months

          -  Concurrent use of chemotherapy not indicated in the study protocol or any other
             investigational agents and patients who have received investigational drugs less than
             four weeks prior to enrollment

          -  Prior therapy, which affects or targets the EGF pathway

          -  Treatment for other carcinomas within the last five years, except cured non-melanoma
             skin and treated in-situ cervical cancer

          -  Recovery from major surgery within three weeks of the start of study treatment
Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash
Condition: Mucositis
MeSH terms: Mucositis
Intervention: Ketamine
Intervention description: 20mg/5ml swish and spit four times daily
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ketamine; Mucositis; Oral ketamine rinse

Summary:

      Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect when
      chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about 40% of
      patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy of
      the head and neck, and up to 100% of patients undergoing a bone marrow transplant. Because
      the pain from mucositis can be so bad it can cause the inability to eat or drink, inability
      to talk, gagging and drooling. Many times mucositis can affect cancer treatment because
      patients may have to be given a lower dose of a drug or stop treatment completely. There are
      not many treatments today that can help relieve the severe pain caused from mucositis. This
      research study will help researchers determine if using an oral mouthwash called Ketamine
      will help lessen mucositis pain.

      Ketamine is approved by the Food and Drug Administration (FDA) for use with general
      anesthesia, sedation and for severe pain. WVU Hospital is now using Ketamine mouthwash as a
      standard treatment option for mucositis pain.

      During this study patients will be assessed to determine the level of pain caused by their
      mucositis. This will occur before the first dose, one hour after the first dose, and then
      daily until they are no longer on the study. Patients will use the mouthwash by swishing and
      spitting (20mg/5ml) four times each day, and also every four hours as needed. Patients will
      use the mouthwash on this study until their mucositis gets better or until the mucositis gets
      worse (or if the pain does not get better after three days of treatment).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has oral mucositis pain that is grade 3 or 4 according to the World Health
             Organization (WHO) Oral Mucositis Scale

          -  Patient has received at least one prior chemotherapy or radiation treatment

          -  Patient is at least 18 years old

          -  Patient or their legally authorized representative understands and voluntarily signs
             the written informed consent prior to any study-specific procedures. A copy of the
             signed informed consent form will be retained by the treating institution.
A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: MEDI4736
Intervention description: MEDI4736 (durvalumab) by intravenous infusion every two weeks. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier. Patients who achieve CR, PR or SD through the end of the initial 12-month treatment period can restart treatment with MEDI4736 (durvalumab) when they eventually do progress. This retreatment period can continue for as long as the investigator considers to patient to be receiving clinical benefit.
Intervention MeSH terms: Durvalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 446.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Locally advanced, metastatic, Non-Small Cell Lung Cancer, MEDI4736, Durvalumab, PD-L1

Summary:

      A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or
      Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged at least 18 years.

          -  Documented evidence of NSCLC (stage IIIB/IV disease)

          -  Disease progression or recurrence after both a platinum-based chemotherapy and at
             least 1 additional regimen for treatment of NSCLC

          -  World Health Organisation (WHO) Performance Status of 0 or 1

          -  Estimated life expectancy of more than 12 weeks

          -  Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane
             staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane
             staining (Cohort 3))

        Exclusion Criteria:

          -  Prior exposure to any anti-PD-1 or anti-PD-L1 antibody

          -  Brain metastases or spinal cord compression or unless asymptomatic, treated and stable
             (not requiring steroids).

          -  Active or prior autoimmune disease or history of immunodeficiency

          -  Evidence of severe or uncontrolled systemic diseases, including active bleeding
             diatheses or active infections including hepatitis B, C and HIV.

          -  Evidence of uncontrolled illness such as symptomatic congestive heart failure,
             uncontrolled hypertension or unstable angina pectoris.

          -  Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy.

          -  Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous
             immunotherapy agent, or any unresolved irAE >Grade 1

          -  Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative
             colitis)
A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ARRY-438162, MEK inhibitor; oral; Placebo; oral
Intervention description: multiple dose, single schedule; matching placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the
      effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in
      patients on stable doses of methotrexate, and to further evaluate the safety of the study
      drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and
      Romania will be enrolled in this study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR)
             1987 Revised Criteria, prior to first dose of study drug.

          -  Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose
             of study drug and is willing to continue on this regimen for the duration of the
             study.

          -  Patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue
             on this regimen for the duration of the study.

          -  No prior use of biological agents for the treatment of rheumatoid arthritis.

          -  Additional criteria exist.

        Key Exclusion Criteria:

          -  Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere
             with disease activity assessments or clinically apparent osteoarthritis which would
             affect subsequent efficacy measures.

          -  A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological,
             gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe
             systemic involvement with rheumatoid arthritis.

          -  Additional criteria exist.
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
Condition: Liver Fibrosis; Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fibrosis
Intervention: BMS-986036; Placebo
Intervention description: Specified dose on specified days.; Specified dose on specified days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic
      Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by
      alcohol) and stage 3 liver fibrosis (severe fibrosis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If
             historical biopsy is not available, a liver biopsy will be performed during the
             screening period. Biopsy must be consistent with NASH, with: a) a score of at least 1
             for each NAS component (steatosis, lobular inflammation, and ballooning), as assessed
             by the central reader, and b) stage 3 liver fibrosis according to the NASH CRN
             classification, as assessed by the central reader

          -  Participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must
             have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins)
             prior to and during the screening period

          -  Participants taking vitamin E at doses greater than or equal to (>=) 800 IU/day must
             have been on stable doses for at least 6 months (26 weeks) prior to and during the
             Screening Period. Vitamin E treatment (>=800 IU/day) must not have been initiated
             after the qualifying liver biopsy was performed.

        Exclusion Criteria:

          -  Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus
             infection, chronic hepatitis C virus [HCV] infection, autoimmune hepatitis,
             drug-induced hepatotoxicity, Wilson disease, α-1-antitrypsin deficiency, iron
             overload, and hemochromatosis); participants with HCV sustained viral response
             (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study
             eligibility may be eligible

          -  Current or past history of hepatocellular carcinoma (HCC)

          -  Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding,
             hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver
             transplantation

        Other protocol defined inclusion/exclusion criteria could apply
A Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor (Ruxolitinib; INBC018424) in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Ruxolitinib 25 mg; Dexamethasone 40 mg
Intervention description: Ruxolitinib was supplied as 5 and 25 mg tablets.; Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to determine clinical efficacy and safety of ruxolitinib
      (INCB018424), a small molecule Janus kinase 2 (JAK2)-inhibitor, in patients with refractory
      or relapsed multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of multiple myeloma with evidence of measurable disease.

          -  Relapsed or refractory disease with at least one line of prior therapy.

          -  Adequate bone marrow reserve.

        Exclusion Criteria:

          -  Received anti-cancer medications or investigational therapy in the past 28 days.

          -  Intracranial disease or epidural disease.