bioihbjkbjnl/mcl2 huggingface dataset:
The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Prasugrel; Clopidogrel
Intervention description: Prasugrel 10-mg tablet taken orally as a daily maintenance dose for a 14-day treatment period.; Clopidogrel two 75-mg tablets taken orally as a daily maintenance dose for a 14-day treatment period.
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, cross-over study to compare the
      pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg
      maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel,
      following a 900-mg loading dose (LD) of clopidogrel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with acute coronary syndrome (ACS) and have planned treatment with a one-time
             900-mg loading dose of commercially available clopidogrel (administered as a single or
             cumulative dose).

          -  Are between the ages of 18 and 85 years.

          -  Willing and able to sign informed consent.

        Exclusion Criteria:

          -  Have overt ST-segment elevation myocardial infarction (STEMI).

          -  Have cardiogenic shock.

          -  Have refractory ventricular arrhythmias.

          -  Have New York Heart Association (NYHA) Class IV congestive heart failure.

          -  Have severe and uncontrolled hypertension.

          -  Have active internal bleeding or history of bleeding diathesis.

          -  Have an increased risk of bleeding.

          -  Have history of cerebrovascular accidents.

          -  Have certain abnormal blood level values.

          -  Are currently receiving chemotherapy or radiation therapy.
Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy
Condition: NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Intervention: Vandetanib; Placebo
Intervention description: Tablet, oral, daily; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vandetanib, NSCLC, Maintenance, Phase II

Summary:

      This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study
      comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as
      maintenance treatment in patients with locally advanced or metastatic NSCLC, who have
      received and responded to prior platinum-doublet systemic chemotherapy. The primary objective
      of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally
      advanced or metastatic NSCLC patients with or without vandetanib maintenance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (IIIb-IV)
             at the time of original diagnosis.

          -  Completion of 4 cycles of chemotherapy of gemcitabine (1,000 or 1250mg/m^2/day on day
             1 and 8) and cisplatin (70-80mg/m^2/day on day 1) every 3 weeks and have shown
             response, Complete Response(CR), Partial Response (PR) or stable disease (SD) by
             RECIST.

          -  WHO PS 0-1

          -  No prior radiotherapy to chest, immunotherapy or biologic therapy

        Exclusion Criteria:

          -  Mixed small cell and non small-cell lung cancer history.

          -  Prior treatment with EGFR TKIs or VEGFR TKIs (prior treatment with cetuximab [Erbitux]
             or bevacizumab [Avastin] is not permitted.)

          -  Evidence of severe or uncontrolled systemic disease or any concurrent condition which
             in the investigator's opinion makes it undesirable for the patient to participate in
             the study or which would jeopardize compliance with the protocol.

          -  Radiation therapy within 4 weeks before the start of study therapy. Major surgery
             within 4 weeks, or incomplete healed surgical incision before starting study therapy.
Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction
Condition: Posterior Blepharitis; Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction; Blepharitis
Intervention: AXR-270 Low Dose; AXR-270 High Dose; AXR-270 Vehicle
Intervention description: AXR-270 Topical Eyelid Cream; AXR-270 Topical Eyelid Cream; AXR-270 Topical Eyelid Cream Vehicle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Meibomian Gland Dysfunction; Posterior Blepharitis

Summary:

      This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating
      posterior blepharitis associated with Meibomian Gland Disease (MGD)
    

Eligibility criteria:

        Inclusion Criteria:

        Male or female, 18 years or older

        Have a clinical diagnosis of moderate to severe MGD (total MGD score between 5 and 14 on a
        scale with a range between 0 and 15; and clinical severity score of eyelid margin
        vascularity of at least 2 (moderate))

        Have a score of ≥35 on Eye Discomfort using VAS

        Have a tFCS score between 3 and 14 on the NEI scale

        Have a Schirmer score of >7 mm

        Have a OSDI score >30

        If female, then subject should be non-pregnant and non-lactating

        Exclusion Criteria:

        Subjects with iritis, uveitis in either eye

        Subjects with conjunctivitis, keratitis, severe anterior keratitis not related to MGD

        Subjects with lid abnormalities

        Subjects with ocular fungal, viral or bacterial infection

        Subjects unable or unwilling to withhold the use of eyelid scrubs

        Subjects with glaucoma and serious systemic disease
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: bevacizumab [Avastin]; capecitabine [Xeloda]; trastuzumab [Herceptin]
Intervention description: 15mg/kg iv on day 2 of first 3-week cycle,and on day 1 of subsequent cycles; 1000mg/m2 bid po on days 1-14 of each 3-week cycle; 8mg/kg iv loading dose on day 1 of first 3-week cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles
Intervention MeSH terms: Bevacizumab; Trastuzumab; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of Avastin in combination with
      Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent
      or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin
      (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of
      subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and
      Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The
      anticipated time on study treatment is until disease progression, and the target sample size
      is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  breast cancer with measurable locally recurrent or metastatic lesions;

          -  candidate for chemotherapy;

          -  HER2-positive disease;

          -  ECOG PS of <=2.

        Exclusion Criteria:

          -  previous anticancer therapy for metastatic breast cancer;

          -  previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy
             >=6 months before enrollment);

          -  chronic daily treatment with corticosteroids (>=10mg/day), aspirin (>325 mg/day) or
             clopidogrel (>75mg/day);

          -  other primary tumor within last 5 years, except for adequately treated cervical cancer
             in situ, squamous or basal cell skin cancer;

          -  uncontrolled hypertension or significant cardiovascular disease.
Topical Anesthetic Use In Pessary Management
Condition: Pain
Intervention: lidocaine-prilocaine cream; Placebo cream
Intervention description: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point; The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
Intervention MeSH terms: Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pessary; Pain; EMLA; lidocaine; prilocaine

Summary:

      The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce
      pain and discomfort at the time of vaginal pessary removal and insertion. Half of the
      participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will
      receive a placebo cream.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women in the Loyola Urogynecology clinic who use a pessary for management of pelvic
             organ prolapse (POP) or urinary incontinence (UI)

          -  Read and speak the English language

        Exclusion Criteria:

          -  Non-English speaking

          -  Allergy or contraindication to topical anesthetic

          -  Participation/randomization in the study at a previous visit

          -  Currently pregnant or lactating or planning a pregnancy within the next 6 months
Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Brodalumab; Placebo
Intervention description: Administered as as an intravenous (IV) infusion over at least 30 minutes.; Administered as as an intravenous (IV) infusion over at least 30 minutes.
Intervention MeSH terms: Brodalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Ileal Crohn's Disease; Ileo-colonic Crohn's Disease; Colonic Chron's Disease

Summary:

      The study will examine the safety and effectiveness of brodalumab for the treatment of
      moderate to severe Crohn's disease. Participants will randomly assigned to receive either
      brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the
      doctor nor the patient will know what treatment is being given.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6
             months prior to initiating study drug

          -  Moderately to severely active Crohn's disease, as defined by a CDAI score >250 and <
             450 at baseline

          -  Evidence of active inflammation

        Exclusion Criteria:

          -  Short bowel syndrome

          -  Stricture with obstructive symptoms within 3 months

          -  Bowel surgery within 3 months

          -  Ileostomy and/or colostomy

          -  Any gastric or intestinal pouch

          -  Ulcerative colitis

          -  Evidence of an infected abscess

          -  Bowel perforation or evidence of noninflammatory obstruction during the 6 months

          -  Stool positive for C. Difficile toxin at screening

          -  Presence of active infection requiring treatment

          -  Serious infection within 8 weeks

          -  Significant concurrent medical conditions

          -  Pregnant or breast feeding

          -  Significant Laboratory abnormalities

          -  Any anti-tumor necrosis factor (TNF) agent within 2 months

          -  Steroid enemas within 2 weeks

          -  Tysabri (natalizumab) within 1 year

          -  Biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 3
             months

          -  Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus
             within 2 months
Acupuncture for Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Intervention: Acupuncture; Sham acupuncture
Intervention description: Acupuncture twice weekly for 6 weeks.; Twice a week for 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 127.0
Sex: Female
Minimum age: 25 Years
Healthy volunteers: No
Keywords: urinary incontinence

Summary:

      This research study will evaluate the effectiveness of acupuncture in decreasing urinary
      incontinence (involuntary urine loss) in women. The study will involve 12 acupuncture
      sessions over 6 weeks. We will compare the effectiveness of acupuncture and sham (placebo)
      acupuncture (a procedure in which the needle feels like it penetrates the skin, but is not
      actually inserted into the body) on the frequency and volume of involuntary (accidental)
      urine loss after completing the intervention, and again one month later. Individuals
      participating in this study will be randomly assigned to receive either the actual or sham
      acupuncture. Randomization means being assigned by chance, similar to flipping a coin. Study
      participants will not know which group (actual or sham acupuncture) they were assigned to
      until one month after completing the 6-weeks of treatment. The sham acupuncture needles look
      similar to the real acupuncture needles and feel like they penetrate the skin, but do not
      actually do so. If individuals are assigned to the sham acupuncture group, they will be
      eligible to receive the actual acupuncture one month after completing the sham acupuncture if
      they wanted to. All individuals will be followed for 6 months after completing the
      acupuncture treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Urge or stress urinary incontinence at least twice a week on average for at least 3
             months

        Exclusion Criteria:

          -  History of previous acupuncture

          -  History of a neurologic problem such as Parkinson's disease or multiple sclerosis that
             could affect bladder function

          -  Current treatment with overactive bladder medications or medications that relax the
             bladder

          -  Urinary catheter

          -  Pregnancy

          -  Inability to empty the bladder effectively

          -  Inability to toilet independently

          -  Current treatment with steroid

          -  Interstitial cystitis

          -  Chronic pelvic pain

          -  Current treatment with warfarin
A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: MP-376; Placebo
Intervention description: MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles; same frequency as study drug using the same method of delivery
Intervention MeSH terms: Levofloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 322.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Patients

Summary:

      Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent
      acute exacerbations (AECB) which are associated with enormous healthcare expenditures and
      significant morbidity, specifically an increased risk of death, a decline in pulmonary
      function and a significant change in quality of life. Bacteria appear to have an important
      role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in
      COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In
      addition, recent studies indicate that acquisition of a new strain of H. influenzae, M.
      catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations.
      Chronic inflammation and bacterial infection predispose many patients to frequent and
      recurrent acute exacerbations.

      Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will
      decrease the incidence of acute exacerbations by both by lowering the organism burden, and
      resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial
      strains.
    

Eligibility criteria:

        Inclusion Criteria (selected):

          -  > 40 years of age

          -  History of COPD

          -  Forced expiratory volume in 1 second (FEV1) </= 70% of predicted and FEV1/Forced vital
             capacity (FVC) </= 0.7 value at screening

          -  Have at least two acute exacerbation episodes in the proceeding year

          -  Clinically stable with no changes in health status within the last 30 days

          -  Lifetime smoking history of at least 10 pack-years

          -  Willing and able to use a daily electronic diary

        Exclusion Criteria (selected):

          -  Use of any systemic or inhaled antibiotics within 30 days prior to baseline

          -  History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication

          -  Creatinine clearance < 40 mg/ml/min, AST, ALT >/= 5 x upper limit of normal (ULN) or
             total bilirubin >/= 3 x ULN at Screening
Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma, Renal Cell
Intervention: AG-013736
Intervention description: AG-013736 5 mg BID will be administered orally on continuous schedule. Cycle length is 28 days. If the drug is well tolerated at 5 mg BID, the dose of AG-013736 may be titrated to 7 mg BID and then to a maximum of 10 mg BID.
Number of cycles: until progression or unacceptable toxicity develops.
Intervention MeSH terms: Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: AG-013736; RCC; Phase 2

Summary:

      To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients histologically diagnosed as metastatic renal cell cancer with a component of
             clear cell cancer.

          -  Patients who are refractory to cytokine therapy as 1st line.

          -  Patients who experienced nephrectomy.

          -  Patients with at least 1 target lesion, as defined by RECIST.

          -  Patients with no uncontrolled hypertension.

        Exclusion Criteria:

          -  Gastrointestinal abnormalities

          -  Current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2/3A4
             inducers.

          -  Active seizure disorder or evidence of brain metastases.

          -  Patients with hemoptysis.
Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Bort, Dex, and Dox with ALCAR
Intervention description: Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
Intervention MeSH terms: Acetylcarnitine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: previously treated multiple myeloma

Summary:

      Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of
      4 to 8 times (based on response to the treatment). Patients will also receive
      acetyl-L-carnitine (ALCAR) daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with previously treated multiple myeloma with measurable serum or urine
             monoclonal protein.

        Exclusion Criteria:

          -  Patients with previous doxorubicin treatment totaling 220 mg/m2 or more

          -  LVEF less than 45%

          -  Patients with >grade II sensory neuropathy at baseline as assessed by the PI will be
             excluded

          -  No history of seizures as ALCAR may lower the seizure threshold

          -  Known HIV infection

          -  Current pregnancy.