bioihbjkbjnl/mcl2 huggingface dataset:
Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage
Condition: Abscess; Cellulitis
MeSH terms: Abscess; Cellulitis
Intervention: Type of dressing - Iodoform; Type of dressing - Aquacel
Intervention description: Dressing for packing a cutaneous abscess; Aquacel dressing
Intervention MeSH terms: Carboxymethylcellulose Sodium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Aquacel vs. Iodoform Gauze
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: abscess; MRSA; Aquacel dressing; Iodoform dressing

Summary:

      This study compares Aquacel against routine Iodoform packing for packing abscess cavities
      after incision and drainage. It is hypothesized that Aquacel will produce speedier healing of
      the abscess.
    

Eligibility criteria:

        Inclusion Criteria:

          -  presenting to Maricopa Medical Center ED with cutaneous abscess requiring incision and
             drainage

        Exclusion Criteria:

          -  known sensitivity to Aquacel

          -  pregnant, nursing, or expecting to become pregnant

          -  incarcerated patient

          -  prior treatment of same abscess with incision and drainage

          -  multiple abscesses

          -  immunodeficiency

          -  facial abscess

          -  suspected osteomyelitis or septic arthritis

          -  diabetic foot, decubitis, or ischaemic ulcers

          -  unable to provide informed consent or assent
Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Pemetrexed; Gemcitabine
Intervention description: 500mg/m2 IV over 10 min, Day 1, prior to gemcitabine; 1500mg/m2, 30min IV
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to study the role of an active and well-tolerated non-platinum agent,
      gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced
      NSCLC. This study will serve to define the role of next generation agents in a new
      combination regimen in the treatment of advanced NSCLC. This combination regimen may
      ultimately be important in further expanding treatment options for patients while improving
      survival, quality of life, and symptom control compared with platinum-based combination
      regimens - and with acceptable toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, you must meet the following criteria:

          -  Histologically confirmed non-small cell bronchogenic carcinoma

          -  Newly diagnosed or recurrent unresectable stage III or stage IV disease

          -  No mixed tumors with small cell anaplastic elements

          -  Measurable disease

          -  Must not have received any prior antineoplastic chemotherapy for lung cancer

          -  Age > 18 years

          -  Able to perform activities of daily living with little or no assistance

          -  Adequate bone marrow, liver and kidney

          -  Understand the nature of this study and give written informed consent.

        Exclusion Criteria:

        You cannot participate in this study if any of the following apply to you:

          -  Female patients who are pregnant or are lactating

          -  History of serious cardiovascular disease within the previous six months

          -  Serious active infection at the time of treatment

          -  Other serious underlying medical condition

        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.
Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia
Condition: Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Endocarditis
MeSH terms: Staphylococcal Infections; Bacteremia; Endocarditis
Intervention: CF-301; Placebo
Intervention description: CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion; Placebo, given as a single 2 hour iv infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Staphylococcus aureus; bacteremia; staphylococcal endocarditis

Summary:

      The purpose of this study is to evaluate the safety, tolerability, efficacy and
      pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC)
      antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream
      infections (bacteremia), including endocarditis in adults. Patients will be randomized to
      receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial
      therapy. Patients will be prescribed standard of care antibiotics selected by the
      investigators based on their professional experience, practice guidelines and local
      antibiotic susceptibility information for the treatment of S. aureus bacteremia.

      CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has
      demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone
      and in addition to conventional antibiotics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female, 18 years or older

          -  blood culture positive for S. aureus

          -  at least one sign or symptom attributable to S. aureus bacteremia

          -  known or suspected complicated S. aureus BSI and/or endocarditis by Modified Duke
             Criteria

          -  patient is not pregnant or breastfeeding and is not of reproductive potential or
             agrees to use contraception if of reproductive potential.

        Exclusion Criteria:

          -  patient previously received CF-301.

          -  treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for
             more than 72 hours within 7 days before randomization.

          -  presence of any removable infection source that will not be removed or debrided within
             72 hours after randomization.

          -  brain abscess or meningitis.

          -  community acquired pneumonia or known polymicrobial bacteremia
Belatacept Pharmacokinetic Trial in Renal Transplantation
Condition: Renal Transplantation
Intervention: Belatacept
Intervention description: IV infusion
Intervention MeSH terms: Abatacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the pharmacokinetics and safety of belatacept in de
      novo renal transplant subjects treated with belatacept-based immunosuppressant medication
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient of a living or deceased donor kidney

          -  First or second transplant

          -  Men and women, including women of childbearing potential, 18 years and older

        Exclusion Criteria:

          -  Panel reactive antibodies ≥ 30%

          -  Significant infection
A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure
Condition: Diabetes Mellitus and Heart Failure
MeSH terms: Heart Failure; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LIK066; Placebo; Empagliflozin
Intervention description: LIK066 was supplied in different doses as tablets taken orally.; Placebo was supplied as tablets and capsules taken orally.; Empagliflozin was supplied as capsules taken orally.
Intervention MeSH terms: Empagliflozin; Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes mellitus; LIK066; Obesity; Type 2 diabetes mellitus (T2DM); Heart Failure (HF); Hypertension; Renal dysfunction; Adult-onset diabetes; Noninsulin-dependent diabetes mellitus (NIDDM); High blood sugar

Summary:

      This was a dose-finding study to evaluate the efficacy, safety and tolerability of 3
      different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart
      failure
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  BMI ≥ 22kg/m^2

          -  Type 2 diabetes with HbA1c between 6.5% and 10.0%

          -  Documented symptomatic chronic heart failure (NYHA II-IV)

          -  Plasma NT-proBNP > 300pg/ml

          -  eGFR ≥ 45ml/min/1.73m^2 (calculated by MDRD)

        Key Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or
             secondary forms of diabetes

          -  History of ketoacidosis, lactic acidosis, or hyperosmolar coma

          -  Symptomatic genital infection or UTI within 4 weeks of screening

          -  Myocardial infarction, stroke, surgery for heart disease, percutaneous coronary
             intervention within 3 months of randomization

          -  Unstable angina within 3 months of screening

          -  Isolated right HF due to pulmonary disease

          -  Patients with a mean sitting systolic blood pressure ≤ 100mmHg, at randomization

          -  History of lower limb amputation

          -  Diabetic foot ulcer at screening
Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: SelK2; Enoxaparin
Intervention description: I.V., single-dose; SC, QD for up to 10 ± 2 days
Intervention MeSH terms: Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was an adaptive design study. The first two arms of the study enrolled patients in a 1:1 ratio to receive either SelK2 or an active comparator. The adaptive arm (SelK2 plus active comparator) was initiated at the discretion of the Steering and Safety Committee. The study then enrolled patients in a 2:1 ratio to receive either SelK2 with an active comparator or an active comparator only.
Masking: Single (Outcomes Assessor)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: venous thromboembolism; adhesion molecule; P-selectin glycoprotein ligand 1; P-selectin; venous thrombosis

Summary:

      The main purpose of this study is to determine if an investigational medication called SelK2
      works in preventing a condition called "venous thromboembolism" (VTE) in patients having a
      total knee replacement. SelK2 has been designed to attach to a protein found on blood cells
      and blood vessels. By attaching to this protein, SelK2 is designed to decrease the
      inflammatory process in the blood vessel wall that leads to the formation of blood clots in
      the vessel (called thrombosis). By decreasing the inflammatory process, SelK2 may reduce the
      risk of VTE following joint replacement surgery. In addition, because SelK2 is not a blood
      thinner, it is expected that the risk for bleeding will also be reduced.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or females, 18-80 years of age (inclusive)

          -  Planned to undergo elective, primary total unilateral Total Knee Arthroplasty under
             general anesthesia

        Key Exclusion Criteria:

          -  Previous deep vein thrombosis (DVT) of the leg or pulmonary embolism (PE) within the
             past year

          -  Any underlying condition (e.g., atrial fibrillation, mechanical heart valve, or recent
             pulmonary embolism) that may lead to the required concomitant use of
             anticoagulants/antiplatelet agents (e.g., warfarin, dabigatran, rivaroxaban, apixaban,
             clopidogrel) that may affect study outcome or any other drug influencing coagulation
             (except low dose aspirin (100 mg or less))

          -  Anticipated use of intermittent pneumatic compression devices and/or
             electrical/mechanical muscle stimulators post Total Knee Arthroplasty procedure
Phase IIA Study in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: AZD2624; Olanzapine; Placebo
Intervention description: Oral Suspension; PO BID
Intervention MeSH terms: Olanzapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      This study is designed to assess the effects of AZD 2624 in patients with schizophrenia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of non-childbearing potential

          -  Diagnosis of Schizophrenia

        Exclusion Criteria:

          -  Clinically relevant disease and /or abnormalities.

          -  Alcohol or substance abuse not in remission

          -  Enrollment in another investigational study within 30 days
Normobaric Oxygen (NBO) Therapy in Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Oxygen; Room air
Intervention description: Oxygen is inhaled for 30 minutes during migraine attack; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: migraine; oxygen therapy

Summary:

      This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in
      acute migraine headache.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects with frequent migraine (at least 1 attack per month)

        Exclusion Criteria:

          -  Secondary (non-migraine) headache

          -  Chronic obstructive pulmonary disease

          -  Pregnant
Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma; Osteosarcoma
Intervention: Dacarbazine
Intervention MeSH terms: Dacarbazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the overall best tumor response rate to dacarbazine
      given until disease progression as assessed by RECIST criteria, CT and clinical exams in
      patients with metastatic sarcomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven diagnosis of soft tissue or bone sarcoma

          -  Metastatic or locally recurrent and unresectable sarcoma which progressed after one or
             more prior chemotherapy regimens (excluding adjuvant chemotherapy).

          -  At least one measurable tumor lesion (by CT scan) At least one FDG avid (SUV ≥ 3)
             tumor lesion (by PET/CT) which must have been performed at this institution. At least
             one of these target lesions must be ≥ 1.5 cm in smallest dimension as measured on the
             baseline CT

          -  Age greater than 18 yrs old

          -  ECOG Performance Status of 0-2

          -  Baseline ANC ≥ 1000/uL, Hgb ≥ 8 Gr/dL, platelets ≥ 100,000/ dL.

          -  Baseline serum creatinine </= 2.0 mg/dL

          -  Baseline serum total bilirubin </= 2.0, AST or ALT < 3x ULN

          -  No active infection

          -  Signed Informed Consent by patient or legally authorized representative

        Exclusion Criteria:

          -  Current pregnancy or breast feeding.

          -  A serious uncontrolled medical disorder that in the opinion of the Investigator would
             impair the ability of the subject to receive protocol therapy.

          -  Chemotherapy, radiation therapy, or investigational agents given with the last 21
             days.

          -  Investigational agents given with the last 30 days

          -  Uncontrolled diabetes mellitus. (Subjects with a fasting blood glucose > 200 at time
             of PET scanning may need to reschedule to another day after consulting with
             appropriate physicians.)
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial
Condition: Central Neuropathic Pain; Allodynia; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Neuralgia; Hyperalgesia; Wounds and Injuries
Intervention: Dextromethorphan; Lidocaine; Placebo (Dextromethorphan); Placebo (Lidocaine)
Intervention description: Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); 0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose); 0mg Dextromethorphan; 0mg/kg LBM Lidocaine
Intervention MeSH terms: Lidocaine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: chronic pain; central neuropathic pain; spinal cord injury; dextromethorphan; lidocaine; combination therapy; analgesia

Summary:

      This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a
      larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of
      chronic oral (PO) dextromethorphan and intravenous (IV) lidocaine in central neuropathic pain
      following spinal cord injury.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or female adults, age 18 to 70 with central neuropathic pain for a
             minimum of 3 months following SCI as confirmed by neurologic evaluation, with an
             average pain intensity score of at least moderate over at least 50% of the day for the
             7 days prior to the screening visit and over the 7 days prior to starting study
             medication.

          2. Subjects used no medication or a stabilized medication regimen for chronic and
             well-controlled medical conditions

          3. Serum laboratory examination obtained at study entry:

          4. Normal cognitive function.

          5. Signed informed consent.

        Exclusion Criteria:

          1. Pregnancy or breast-feeding.

          2. Renal or hepatic dysfunction.

          3. Significant cardiac disease (e.g. MI within 1 year).

          4. Signs or symptoms of central neurological disorder, excluding SCI.

          5. Severe psychological disorder requiring treatment.

          6. History of hypersensitivity or intolerance to dextromethorphan or lidocaine.

          7. Participation in a study of an investigational drug or device within 30 days prior to
             screening for this study.
A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib [Tarceva]
Intervention description: 150 mg daily, orally
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 688.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in
      newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer
      (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm
      study to evaluate progression-free survival and quality of life with first-line Tarceva
      (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily.
      Anticipated time on study treatment is until progressive disease or unacceptable toxicity
      occurs. Patients with negative EGFR mutation results will be offered treatment as per the
      centre's standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Locally advanced or metastatic (stage IIIB/IV) non-small cell lung cancer (NSCLC)

          -  ECOG performance status 0-3

          -  Treatment phase: histologically confirmed EGFR exon 19 deletion or exon 21 mutation in
             the diagnostic phase of the study

          -  Adequate haematological, liver and renal function

          -  Female patients must be postmenopausal, surgically sterile, or agree to use a barrier
             method of contraception

          -  Male patients must be surgically sterile or agree to use a barrier method of
             contraception

        Exclusion Criteria:

          -  Previous treatment for NSCLC with chemotherapy or therapy against EGFR, either with
             antibody or small molecule (tyrosine kinase inhibitor)

          -  Symptomatic cerebral metastases

          -  Pregnant or lactating women

          -  Any other concomitant anti-cancer therapy (until disease progression and
             discontinuation of Tarceva therapy)