bioihbjkbjnl/mcl2 huggingface dataset:
Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma, Renal Cell
Intervention: Sunitinib malate
Intervention description: Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Healthy volunteers: No

Summary:

      A phase II study to allow patients with advanced kidney cancer access to sunitinib malate
      treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a
      continuous daily regimen (once per day) for one year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced kidney cancer

        Exclusion Criteria:

          -  Previous treatment for kidney cancer, except surgical removal of kidney tumor
AZD9773 Dose Escalation Study
Condition: Severe Sepsis
MeSH terms: Sepsis
Intervention: AZD9773 (CytoFab); Placebo
Intervention description: intravenous infusions; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sepsis; septic shock; Systemic Inflammatory Response Syndrome

Summary:

      This is a double-blind, placebo-controlled, multi-center, dose-escalation study to assess the
      safety, tolerability, Pharmacokinetics and Pharmacodynamics of single and multiple ascending
      intravenous infusions of CytoFab (AZD9773) in adult patients with severe sepsis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical evidence of infection requiring treatment with parenteral antibiotics

          -  Patients must meet multiple Systemic Inflammatory Response Syndrome (SIRS) criteria

          -  Patients must meet criteria for cardiovascular and/or respiratory dysfunction

          -  Sepsis (infection plus SIRS criteria) must be present prior to organ dysfunction

        Exclusion Criteria:

          -  Moribund and death is considered imminent, or patient not expected to survive 90 days
             because of underlying medical condition, or classified as Do Not Resuscitate or Do Not
             Treat

          -  Patient cannot attain a MAP >60 mmHg when measured via an arterial line and/or a
             Systolic Blood Pressure (SBP) >80 mmHg in the presence of vasopressors and iv fluids
             for a period of ≥2 hours

          -  Receiving immunosuppressants, or high dose steroids within 2 months of provision of
             informed consent

          -  Any history of hypersensitivity reaction to sheep products, latex, papain or papaya,
             or chymopapain or previously administered antivenom manufactured using ovine serum,
             digoxin immune fab (DigiFab™ , DIGIBIND® ), crotalidae polyvalent immune fab (ovine)
             (CroFab™ ), or other sheep derived product.

          -  Treatment with anti Tumor-Necrosis-Factor (anti-TNF) antibodies within 8 weeks before
             provision of written informed consent.
Reducing Internalized Stigma in People With Serious Mental Illness
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Major Depression With Psychotic Features
MeSH terms: Schizophrenia; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Intervention: Ending Self Stigma (ESS); Health and Wellness Group
Intervention description: Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.; The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 252.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Mental Disorders; Psychotic Disorders; Schizophrenia; Stigmatization; Mood Disorders; Schizophrenia and Disorders with Psychotic Feature

Summary:

      The purpose of this study is to determine if Ending Self-Stigma (ESS), a 9-session group
      intervention designed to assist veterans with serious mental illness to develop skills (SMI)
      to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and
      stereotypes, is more effective in reducing internalized stigma and its associated effects
      than an active comparison group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Schizophrenia

          -  Schizoaffective disorder

          -  Bipolar Disorder

          -  or Major Depression with Psychotic Features

          -  Age 18 to 80

          -  Receiving services at one of VA Medical Center study sites

          -  Ability and willingness to provide consent to participate

          -  Agreement obtained from the treating clinician that the patient is clinically stable
             enough to participate in the study

        Exclusion Criteria:

          -  Severe or profound mental retardation by chart review
Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer
Condition: Breast Cancer; Breast Neoplasms, Male; Carcinoma, Ductal
MeSH terms: Breast Neoplasms; Carcinoma, Ductal; Breast Neoplasms, Male
Intervention: pemetrexed
Intervention description: 600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purposes of this study are to determine whether pemetrexed can help patients with
      metastatic (cancer that has spread to other parts of the body) breast cancer, to determine
      any side effects that may be associated with the drug, to determine how much pemetrexed
      should be given to patients, and to collect DNA for future research regarding metastatic
      breast cancer. The collection of DNA is optional to the patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have been diagnosed with either advanced or metastatic breast cancer.

          -  Chemotherapy has not been given for advanced or metastatic breast cancer.

          -  The diagnosis of advanced or metastatic breast cancer was made at least 12 months
             after chemotherapy was given after breast surgery.

          -  Able to carry out work of a light nature (for example, light housework, office work).

          -  Must be at least 18 years old.

        Exclusion Criteria:

          -  Have received prior bone marrow or peripheral stem cell transplantation.

          -  Have received prior chemotherapy for metastatic breast cancer.

          -  Are currently pregnant or breast-feeding.

          -  Have an active infection that your doctor decides will affect your safety.

          -  Are unable to take folic acid or vitamin B12.
A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
Condition: Down Syndrome
MeSH terms: Dementia; Down Syndrome; Syndrome
Intervention: ELND005; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      This is a prospective, randomized, double-blind, placebo-controlled, parallel-group,
      three-arm, multicenter study of the safety and PK of ELND005 administered orally for 4 weeks.
      This study will enroll Down Syndrome patients 18 to 45 years of age (inclusive) without
      dementia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 - 45 years of age

          -  Has an IQ of > 40 (K-BIT)

          -  Able and willing to have a brain MRI

        Exclusion Criteria:

          -  Symptoms of dementia or worsening cognition over the past year.

          -  Has a history of hepatitis B, hepatitis C, or HIV
A Study Of SU011248 As Therapy 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: carboplatin; paclitaxel; sunitinib
Intervention description: AUC of 6 mg*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices.; 175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices.; 50 mg orally daily for 4 weeks followed by 2 weeks off treatment up to 1 year (after completing 1 year of treatment, pts deriving clinical benefit may continue to receive sunitinib in a separate continuation protocol).
Intervention MeSH terms: Paclitaxel; Carboplatin; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Neoplasms

Summary:

      The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit
      when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and
      also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell
      Lung Cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven NSCLC

          -  Stage IIIB (locally advanced with malignant effusion) or Stage IV disease

          -  No prior therapy for NSCLC

          -  Evidence of unidimensionally measurable disease

        Exclusion Criteria:

          -  Previous treatment with systemic chemotherapy for lung cancer

          -  History of or known brain metastases

          -  NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment

          -  Evidence of hemoptysis within 4 weeks of starting study treatment

          -  Serious acute or chronic illness or recent history of significant cardiac abnormality

          -  Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors
             of EGFR and PDGFR
Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)
Condition: HPV 16 Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Comparator: HPV 16 L1 Vaccine; Comparator: Placebo
Intervention description: A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6; A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2409.0
Sex: Female
Minimum age: 16 Years
Maximum age: 23 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy,
      immunogenicity, and safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, unmarried females age 16 to 23 years with intact uteri

          -  Not pregnant at enrollment

          -  Agreed to use effective contraception through Month 7 of the study

          -  A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least
             one episode of insertive intercourse

        Exclusion Criteria:

          -  No prior history of Human Papillomavirus (HPV) vaccination

          -  No receipt of any other vaccination within 1 month prior to enrollment or plans to
             receive any other vaccination within 1 month prior to or after any dose of study
             vaccine

          -  No prior history of an abnormal Papanicolaou (Pap) test showing Squamous
             intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia
             (CIN)
18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 18F-DCFPyL
Intervention description: 18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an interventional, single group assignment, prospective nonrandomized, open label
      Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate
      cancer with increasing prostate-specific antigen (PSA) levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of prostate cancer

          -  Biochemical recurrence was defined as a PSA of 0.2 or more ng/mL measured more than 6
             weeks after prostatectomy or a PSA of 2 or more ng/mL rise above nadir following
             radiation therapy (ASTRO Phoenix consensus definition)

          -  Age ≥ 18 years of age

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)

          -  Ability to understand and willingness to sign a written informed consent document

          -  Willing to comply with clinical trial instructions and requirements

        Exclusion Criteria:

          -  History of another active malignancy within 3 years, other than basal cell and
             squamous cell carcinoma of the skin

          -  Presence of prostate brachytherapy implants unless approved by the PI

          -  Administration of another radioisotope within five physical half-lives of trial
             enrollment

          -  Radiation or chemotherapy within 2 weeks prior to trial enrollment

          -  Estimated glomerular filtration rate (eGFR) < 15 ml/mmol

          -  Serum total bilirubin > 3 times the upper limit of normal

          -  Aspartate transaminase (AST) or alanine aminotransferase (ALT) > 5 times the upper
             limit of normal

          -  Inadequate venous access

          -  Claustrophobia or any other condition that would preclude PET imaging

          -  Patients must not be receiving ADT except per criteria directly below. Patients who
             received in the past must have a serum testosterone that is recovered to at least 100
             ng/dL.

          -  Patients who have been on ADT +/- novel hormonal agent (NHA) and developed M0 CRPC
Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: Erlotinib; Bevacizumab; Paclitaxel; Carboplatin; 5-FU; Radiation therapy; Surgery
Intervention description: Erlotinib; Bevacizumab; Paclitaxel; Carboplatin; 5-FU; Radiation therapy; Surgery
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin; Fluorouracil; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib)
      further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation
      therapy in patients with operable esophageal cancer.

      Side effects (toxicity) information will also be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically confirmed esophageal or gastroesophageal junction cancer stage I, II or III

          -  No prior treatment for esophageal cancer

          -  Must be surgical candidate based on stage and location of disease

          -  Measurable or evaluable disease

          -  Able to be up and perform self care

          -  Adequate liver, renal function and bone marrow function

          -  Patients will have to have a central venous access device placed

          -  Able to give written informed consent.

          -  Age 18 or older

        Exclusion Criteria:

          -  Stage IV disease

          -  Prior cancer treatment for advanced cancer in the last 5 years

          -  Pregnant or lactating women

          -  History of stroke, transient ischemic attacks, or acute MI within the past 6 months or
             any other serious cardiovascular disease

          -  History of neurological disease

          -  Recent history of blood in the sputum or vomitus

          -  Non-healing wounds, ulcer or long bone fractures

          -  History of bleeding problems or coagulation problems

          -  History of abdominal fistula, gi perforation or intrabdominal abscess within 6 months

          -  History of uncontrolled hypertension

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have. You can then decide if you wish to
        participate.
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
Condition: Cancer; Hepatic Injury
MeSH terms: Wounds and Injuries
Intervention: Omegaven
Intervention description: initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purposes of this study are to make Omegaven® available to cancer patients with liver
      disease and to determine if Omegaven® can improve or prevent further liver disease. The study
      will also look at the effects Omegaven® has on immune function.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female; ages 18 to 80 years old

          2. Receiving treatment at Cancer Treatment Centers of America

          3. Receiving PN (either in the infusion center or at home)

          4. Have existing hepatic dysfunction defined as Elevation of > 3x the normal level of one
             or more of the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST),
             or Alanine Aminotransferase ALT) and/or Bilirubin > 2 mg/dl in the absence of biliary
             obstruction

          5. Able to provide informed written consent

        Exclusion Criteria:

          1. Hypertriglyceridemia (triglycerides [TG] > 400)

          2. Allergy to fish or egg protein

          3. Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin

          4. Hemodynamically unstable

          5. Bilirubin > 5 mg/dL

          6. Documented liver metastases

          7. Unstable diabetes with known diabetic ketoacidosis within 7 days of screening

          8. Recent cardiac infarction (within 6 months) and taking plavix

          9. Severe hemorrhagic disorders

         10. Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism

         11. Active sepsis

         12. Undefined coma status

         13. In patients with abnormal kidney function, renal insufficiency with calculated
             creatinine clearance < 30 mL/min

         14. Pregnancy or lactation
A Study to Assess Efficacy of HL036 in Subjects With Dry Eyes
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: HL036 ophthalmic solution; Placebo vehicle solution
Intervention description: HL036 ophthalmic solution; Placebo vehicle solution
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study was to compare the safety and efficacy of 0.10% and 0.25% HL036
      Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a patient-reported history of dry eye for at least 6 months prior to enrollment

          -  Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
             of Visit 1

          -  Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2

        Exclusion Criteria:

          -  Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
             ocular inflammation at Visit 1

          -  Have used Restasis® or Xiidra® within 60 days of Visit 1

          -  Be currently taking any topical ophthalmic prescription (including medications for
             glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and
             cannot discontinue these medications for the duration of the trial (excluding
             medications allowed for the conduct of the study)

          -  Have an uncontrolled systemic disease

          -  Be a woman who is pregnant, nursing or planning a pregnancy