bioihbjkbjnl/mcl2 huggingface dataset:
Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
Condition: Head and Neck Cancer
MeSH terms: Thyroid Neoplasms
Intervention: irinotecan hydrochloride
Intervention MeSH terms: Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: thyroid gland medullary carcinoma; recurrent thyroid cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with
      metastatic or inoperable thyroid cancer.
    

Eligibility criteria:

        Inclusion

          -  Histologically confirmed medullary thyroid cancer

          -  Metastatic or inoperable locoregional disease

          -  Measurable disease by CT scan

          -  18 years and over

          -  ECOG PS 0-1

        Adequate lab functions including:

          -  Granulocyte count > 1,000/mm^3

          -  Platelet count > 100,000/mm^3

          -  Bilirubin < 1.5 mg/dL

          -  ALT and AST < 2.5 times upper limit of normal

          -  No unstable or uncompensated hepatic disease

          -  Creatinine clearance > 60 mL/min

          -  No unstable or uncompensated renal disease

          -  Negative pregnancy test

          -  More than 3 months since prior biologic therapy

          -  More than 3 months since prior chemotherapy

          -  No prior radiotherapy to > 25% of bone marrow

          -  More than 3 months since prior radiotherapy

          -  Recovered from prior oncologic or other major surgery

          -  More than 30 days since prior non-approved or investigational drugs

        Exclusion:

          -  Patients with elevated calcitonin levels as the only measurement of disease are not
             eligible

          -  Unstable or uncompensated cardiovascular disease

          -  Unstable or uncompensated respiratory disease

          -  Pregnant or nursing

          -  Diarrhea ≥ grade 2 (antidiarrheals allowed)

          -  Other severe or uncontrolled systemic disease

          -  Other malignancy within the past 5 years except squamous cell or basal cell skin
             cancer or cervical cancer

          -  Illness that would preclude study participation

          -  Significant clinical disorder or laboratory finding that would preclude study
             participation
A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Prexasertib
Intervention description: Administered IV
Intervention MeSH terms: Prexasertib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DNA damage repair; replication stress

Summary:

      The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with
      platinum-resistant or refractory recurrent ovarian cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.

          -  Cohorts 1 to 3: Have platinum-resistant disease and have documented test results
             assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.

          -  Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.

          -  Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.

          -  Cohort 3: Are BRCA positive and have previously received a PARP.

          -  Cohort 4: Have primary platinum refractory disease.

          -  Have adequate organ function.

          -  Must be able and willing to undergo mandatory tumor biopsy.

        Exclusion Criteria:

          -  Cohorts 1-3: Have previously received all of the following agents at any time in the
             platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and
             paclitaxel.

          -  Have known central nervous system malignancy or metastasis.

          -  Have previously participated in any study involving a checkpoint kinase 1 inhibitor or
             have hypersensitivity to the study drug or excipients.

          -  Have at least one of the following:

               -  history of abdominal fistula or gastrointestinal perforation

               -  intra-abdominal abscess within last 3 months prior to the first dose of study
                  drug

               -  a radiographically confirmed bowel obstruction within 3 months prior to the first
                  dose of study drug

          -  Have a symptomatic human immunodeficiency virus infection or symptomatic
             activated/reactivated hepatitis A, B, or C (screening is not required).

          -  Have a serious cardiac condition.

          -  Have a history of prior radiotherapy to the whole pelvis.

          -  Have chronic daily treatment with corticosteroids, excluding inhaled or topical
             steroids.

          -  Have known factors that may increase the risk of infection while on study drug
             treatment. These may include, but are not limited to, an indwelling peritoneal
             catheter or open wounds. Catheters for vascular access are permitted.
Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Medication management; Non-pharmacological pain management; Buprenorphine-Naloxone
Intervention description: Individualized management of medications for pain; Individualized management of non-medication pain treatment approaches; Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 820.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Opioid analgesics; Opioid partial agonists; Health care delivery; Back pain; Osteoarthritis; Veterans health

Summary:

      Background and significance: Treatment with opioid pain medications (like hydrocodone and
      morphine) is common for severe pain, but studies show these medications may not always help
      and can cause serious problems. High daily doses of opioids can be especially unsafe. To help
      patients with chronic pain have better quality of life and avoid medication toxicity, health
      care teams need to manage pain while helping patients reduce opioid medication doses to safer
      levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate or high-dose long-term opioid therapy (≥ 20 ME mg daily for at least 3
             months) for chronic pain

          -  Chronic pain of at least moderate severity (defined as pain that is present every or
             nearly every day for ≥ 6 months and with a score on the PEG 3-item pain measure of ≥
             5)

        Exclusion Criteria:

          -  Dementia diagnosis

          -  Unstable or severe untreated psychiatric disorder, including severe untreated
             substance use disorder or active suicidal ideation

          -  Unstable or end-stage medical disease that would interfere with participation,
             including cancer requiring active treatment and life expectancy < 12 months

          -  Documentation of suspected controlled substance diversion

          -  Inability to communicate by telephone
Modulation of Lung Injury Complicating Lung Resection
Condition: Acute Lung Injury
MeSH terms: Lung Injury; Acute Lung Injury; Wounds and Injuries
Intervention: N-acetylcysteine; 0.9% saline
Intervention description: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively; 0.9% saline 1 litre intravenous over 12 hours pre-operatively
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute lung injury; Lung resection

Summary:

      The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day
      pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on
      blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective lung resection for cancer

        Exclusion Criteria:

          -  Age less than 18 years

          -  Women of child-bearing age or potential

          -  Known allergy to N-acetylcysteine

          -  Oral steroid in the preceding 1 month

          -  N-acetylcysteine in the preceding 1 month

          -  Unable to receive standardised anaesthetic approach
A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lurasidone 80mg tablet
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Schizophrenia; Latuda; Lurasidone

Summary:

      A 1-year outpatient study to test the safety and tolerability of a new medication in the
      treatment of schizophrenia
    

Eligibility criteria:

        -  Patients must have participated in study D1050196 (A Study to Test the Effectiveness
             and Safety of a New Medication in the Treatment of Schizophrenia) and either:

          -  Successfully completed

          -  OR

          -  Patients must have been discontinued after a minimum of 2 weeks of treatment due to
             lack of efficacy
Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva
Condition: Stage III Vulvar Cancer; Stage IVB Vulvar Cancer; Vulvar Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Vulvar Neoplasms
Intervention: 3-Dimensional Conformal Radiation Therapy; Cisplatin; Conventional Surgery
Intervention description: Given IV
Intervention MeSH terms: Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Female
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving radiation therapy together with cisplatin
      followed by surgery works in treating patients with locally advanced cancer of the vulva.
      Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from
      dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage
      tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor
      so it can be removed during surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of locally advanced squamous cell carcinoma of the vulva

               -  T3 or T4 (N0-3, M0)

          -  Not amenable to surgical resection by standard radical vulvectomy

          -  Previously untreated disease

          -  No recurrent disease

          -  No vulvar melanoma or sarcoma

          -  Performance status - GOG 0-3

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Bilirubin no greater than 1.5 times normal

          -  Alkaline phosphatase no greater than 3 times normal

          -  SGOT no greater than 3 times normal

          -  Creatinine no greater than 2.0 mg/dL

          -  No gastrointestinal bleeding

          -  No severe gastrointestinal symptoms

          -  Capable of tolerating a radical course of chemoradiotherapy

          -  No septicemia

          -  No severe infection

          -  No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

          -  No circumstance that would preclude study completion or follow-up

          -  No prior cytotoxic chemotherapy

          -  No prior pelvic radiotherapy

          -  No concurrent boost brachytherapy

          -  No prior anticancer therapy that would contraindicate study therapy
Ubiquinol (Reduced COQ10) for Patients With Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Intervention: Ubiquinol; Placebo
Intervention description: Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.; Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study aims to determine if Ubiquinol (reduced form of COQ10) will attenuate
      mitochondrial injury and decrease inflammatory response in patients suffering from sepsis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over 18 years old

          -  Suspected or confirmed infection

          -  Presence of 2 or more systemic inflammatory response syndrome (SIRS) criteria

          -  Admission to the ICU

        Exclusion Criteria:

          -  Under 18 years old

          -  Current CoQ10 supplementation

          -  Unable to receive enteral medications

          -  Would need a nasogastric or orogastric tube solely for the purposes of the study

          -  Pregnancy, incarceration, mentally disability

          -  Patient confirmed Comfort measures only, Do not resuscitate (DNR) and/or Do not
             intubate. Patients with DNR but intubated and being provided full care are eligible
Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV NSCLC
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Sorafenib + Docetaxel/Carboplatin
Intervention description: 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle
Intervention MeSH terms: Carboplatin; Docetaxel; Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stage IIIB/IV

Summary:

      This is an open-label, single institution, phase II study of Sorafenib in combination with
      docetaxel and carboplatin in patients with advanced non-small cell lung cancer. Docetaxel and
      carboplatin will be given on day 1 of every three week cycle. Patients will take Sorafenib
      twice a day on the 1st day of treatment and continue to take the medication every day until
      progression of disease, prohibitive toxicity, or patient withdrawal from the study.
      Chemotherapy courses will repeat every 21 days in the absence of disease progression or
      unacceptable toxicity for a total of four cycles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed NSCLC with clinical or radiological evidence
             of advanced disease (Stage IIIB/IV)

          -  Uni-dimensionally measurable disease

          -  Age => 18 years

          -  ECOG performance status of 0-1

          -  Life expectancy > 3 months

        Exclusion Criteria:

          -  Small-cell or mixed histologies including a small cell component

          -  Prior chemotherapy, biotherapy, radiotherapy to an area of measurable disease

          -  Patients with peripheral neuropathy grade => 2
Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: PRT-2761 0.5%; PRT-2761 1%; Patanol; Pred-forte; PRT-2761 0%
Intervention description: Six drops in each eye over a 17 day period.; Six drops in each eye over a 17 day period.; Six drops in each eye over a 17 day period.; Four drops in each eye over a 3 day period.; Six drops in each eye over a 17 day period.
Intervention MeSH terms: Prednisolone acetate; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic
      solution for the treatment of the signs and symptoms of acute and chronic allergic
      conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  be at least 18 years old

          -  be willing and able to avoid all disallowed medications and contact lenses

          -  must have a pregnancy test if of childbearing potential

          -  must be able to read an eye chart from 10 feet away

        Exclusion Criteria:

          -  must not have any allergies to the study medications

          -  must not have any ocular or non ocular condition that investigator feels will
             interfere with study parameters

          -  must not have used an investigational drug or device in the past 30 days or
             concurrently enrolled in another investigational trial
A Study Designed to Evaluate ODSH in Subjects With Exacerbations of COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Open-Label; Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride; ODSH
Intervention description: ODSH administered open-label; Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride; Randomized, Blinded, ODSH Arm
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 158.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; COPD; Heparin; ODSH; Exacerbations of COPD

Summary:

      The purpose of this study is to determine whether ODSH, when added to conventional treatment,
      is more effective in treating COPD exacerbations than conventional therapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients (40 years of age or older) with an established diagnosis of
             COPD based upon medical history who are being admitted to the hospital to treat an
             exacerbation of COPD;

          2. Normal prothrombin time and activated partial thromboplastin time; Platelet count;
             hemoglobin and hematocrit

        Exclusion Criteria:

          1. Certain diseases such as:

               -  asthma;

               -  left heart failure or pulmonary embolism;

               -  lung cancer;

               -  pneumonia

               -  liver or kidney disease

               -  blood clotting disorder

               -  Positive HIV or hepatitis tests

               -  GI bleeding, physical trauma with bleeding, any disease with bleeding within 60
                  days of study entry

          2. Certain medications such as:

               -  Plavix®

               -  Warfarin

               -  Heparin therapy

               -  Certain antibiotics

          3. Exacerbations that are too severe (requiring intubation and mechanical ventilation)

          4. Women of child-bearing potential, pregnancy or breast-feeding

          5. Unable or unwilling to provide informed consent and follow study procedures.