bioihbjkbjnl/mcl2 huggingface dataset:
Acamprosate Safe to Use in Individuals With Liver Disease.
Condition: Alcohol-related Liver Disease
MeSH terms: Liver Diseases
Intervention: Acomprosate
Intervention description: Acamprosate will be administered orally and will be dosed at 333 mg three times a day, if tolerated it will be increased to 666 mg three times a day. Acamprosate will be administered for a total of 3 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      Is acamprosate safe to use in individuals with liver disease.
    

Eligibility criteria:

        Inclusion criteria:

          -  Aged 21 or over

          -  Diagnosis of alcohol-related liver disease and AUD.

               -  The diagnosis of alcohol-related liver disease will be determined by a
                  hepatologist based on history of regular and excessive alcohol consumption in the
                  absence of other causes of liver cirrhosis or acute hepatitis, compatible
                  clinical, imaging and laboratory findings and typical histology on liver biopsy,
                  if performed. Underlying liver disease may include alcoholic hepatitis, advanced
                  (F3-F4) fibrosis, and/or portal hypertension.

               -  The diagnosis of AUD will be determined by a hepatologist and/or addiction
                  psychiatrist based on history obtained that is consistent with DSM-5 diagnostic
                  criteria for AUD (all categories of mild, moderate and severe considered
                  eligible) (American Psychiatric Association, 2013; questions from NIH, 2016).

          -  Abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to
             initiating acamprosate treatment.

          -  At study enrollment, initial MELD-Na score must be less than 20 for the five
             individuals enrolling in the first phase of the pilot safety assessment. The second
             phase of the pilot safety assessment will include individuals with a MELD-Na of 20 or
             more at enrollment.

          -  Have capacity to provide consent themselves

        Exclusion criteria:

          -  Individuals with a glomerular filtration rate (GFR) of less than 30 ml/min

          -  Congestive heart failure (NYHA class II or higher)

          -  Hypotension, requiring the use of vasoconstrictors (i.e. midodrine)

          -  Pregnancy, lactation or refusal to use a reliable method of birth control if a
             sexually active female of childbearing potential. Although no human trial data is
             available, animal studies suggest possible teratogenic effects of acamprosate (Merck,
             2005).
A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Atacicept; Atacicept; Atacicept; Placebo matched to atacicept
Intervention description: Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.; Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.; Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.; Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Relapsing Multiple Sclerosis; Atacicept

Summary:

      To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces
      central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as
      assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study
      medication is administered via subcutaneous (under the skin) injections.
    

Eligibility criteria:

        Inclusion Criteria:

        - Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion
        criteria could apply.

        Exclusion Criteria:

          -  Have primary progressive multiple sclerosis (MS)

          -  Have secondary progressive MS without superimposed relapses

          -  Relevant cardiac, hepatic and renal diseases as specified in the protocol

          -  Pretreatment with immunosuppressants and immunomodulating drugs as specified in the
             protocol

          -  Clinical significant abnormalities in blood cell counts and immunoglobulin levels as
             specified in the protocol

          -  Clinical significant acute or chronic infections as specified in the protocol Other
             protocol-defined exclusion criteria could apply.
Study to Assess the Safety and Effectiveness of the Penumbra System
Condition: Stroke
MeSH terms: Stroke
Intervention: Penumbra System
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Penumbra; Ischemic; Stroke; Intervention; Neurovascular; Thrombus; Embolectomy; Ischemic stroke

Summary:

      This clinical evaluation is a prospective, single-arm, multi-center trial.

      The purpose of this clinical evaluation is to assess the safety and effectiveness of the
      Penumbra System in the revascularization of patients presenting with acute ischemic stroke
      secondary to intracranial, large vessel, occlusive disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical signs consistent with acute ischemic stroke

          -  18 to 79 years of age

          -  Neurological deficit resulting in an NIH Stroke Scale (NIHSS) score > 8

          -  TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System

          -  Signed informed consent

          -  Present within 8 hours of stroke symptom onset; ineligible or refractory to
             intravenous tissue plasminogen activator (t-PA) therapy if presenting within 3 hours
             of symptom onset.

        Exclusion Criteria:

          -  Evidence of rapidly improving neurological signs of stroke at time of enrollment

          -  NIHSS > 30 or coma

          -  Females who are pregnant

          -  Vessel tortuosity too difficult to allow endovascular access

          -  Known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy
             with an International Normalized Ratio (INR) > 3.0

          -  Partial thromboplastin time (PTT) greater than 2 times the lab normal

          -  Admission platelets < 30,000

          -  Pre-existing neurological or psychiatric disease that could confound the study results

          -  Known severe allergy to contrast media

          -  Uncontrolled hypertension

          -  Computed tomography (CT) evidence of significant mass effect with a midline shift

          -  CT reveals evidence of large hypodensity region > 1/3 of the middle cerebral artery
             territory

          -  CT reveals evidence of intracranial hemorrhage

          -  CT reveals significant mass effect with midline shift

          -  Angiographic evidence of an arterial stenosis proximal to the occlusion that could
             prevent thrombus removal

          -  Angiographic evidence of preexisting arterial injury

          -  Life expectancy of less than 90 days

          -  Participation in another clinical investigation that could confound the evaluation of
             the study device.
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
Condition: Cystic Fibrosis (CF)
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: MP-376; Placebo
Intervention description: 3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days; same frequency as study drug using the same nebulizer
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: 151.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory
      tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which
      has been particularly problematic to eradicate and been implicated as the major cause of
      morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung
      increases the local concentrations of antibiotic at the site of infection resulting in
      improved antimicrobial effects compared to systemic administration. Bacterial resistance to
      current aerosol antibiotic treatments indicate a need for improved therapies to treat CF
      patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and
      other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to
      have antimicrobial effects on even the most resistant organisms.
    

Eligibility criteria:

        Inclusion Criteria (selected):

          -  > 16 years of age

          -  Confirmed Diagnosis of Cystic Fibrosis

          -  Positive sputum culture for P. aeruginosa within the past 18 months

          -  Patients are able to elicit a forced expiratory volume in 1 second (FEV1) >/= 25% but
             </= 85% of predicted value at screening

          -  Have received at least 3 courses of inhaled antimicrobials over the preceding 12
             months

          -  Clinically stable with no changes in health status within the last 30 days

          -  Able to reproducibly produce sputum and perform spirometry

        Exclusion Criteria (selected):

          -  Use of any nebulized or systemic antibiotics within 30 days prior to baseline

          -  History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication

          -  Evidence of acute upper within 10 days or lower respiratory infections within 30 days
             prior to dosing

          -  Creatine clearance < 50mg/ml, aspartate transaminase (AST), alanine transaminase (ALT)
             or total bilirubin >/= 3 x upper limit of normal (ULN) at Screening
1% Topical Pimecrolimus Cream for the Treatment of the Rash Associated With ERBITUX
Condition: Rash
MeSH terms: Exanthema
Intervention: Pimecrolimus; Placebo
Intervention description: Pimecrolimus 1% topical cream applied twice daily for four weeks on one side of the face.; Placebo cream applied twice daily for four weeks on opposite side of the face from the Pimecrolimus side.
Intervention MeSH terms: Pimecrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cetuximab rash; Erbitux rash; Rash; Pimecrolimus; 1% Topical pimecrolimus cream

Summary:

      When cancer patients are treated with the drug cetuximab they very often develop a rash.
      Usually it appears on their face and back and other parts of the body. The rash looks like
      acne and is treated with skin creams or antibiotics most of the time. The rash can become
      very painful and cause patients to stop using cetuximab to treat their cancer, even if
      cetuximab was helping fight their cancer.

      Cetuximab is known to be a good drug to help treat cancer. This study will help us learn
      about the rash cetuximab causes so hopefully future patients can finish taking cetuximab for
      their cancer. In this study the investigators will use a cream called pimecrolimus (Elidel)
      to see if it will help prevent the rash or keep the rash from getting worse. The
      investigators also want to see how the rash affects patients and their quality of life.

      Participants will be in this study for about four weeks if their rash does not get worse.
      They will need to apply the study cream and placebo two times daily and answer quality of
      life questionnaires during this study. Participants will also be seen by a dermatologist and
      have pictures taken of their rash.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is starting treatment with cetuximab at the WVU Cancer Center

          -  Patient has advanced (unresectable or metastatic) malignancy

          -  Patient is expected to remain on cetuximab treatment for at least 2 weeks after
             enrollment on study.

          -  Patients should be 18 years or older

          -  Patients should not have a known contraindication to topical pimecrolimus therapy

          -  Patients should have given written informed consent

          -  Sexually active men and women of child bearing potential agree to use an effective
             method of contraception during study participation and for three months afterwards.

          -  Negative pregnancy test for woman of child bearing potential

        Exclusion Criteria:

          -  Known allergy to topical pimecrolimus.

          -  Patients with active or recent (within one month) infection in face

          -  Psoriasis, eczema or others skin conditions not related to cetuximab involving face

          -  Pregnant or nursing women
A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Obstructive Airway Disease; COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases
Intervention: placebo; active comparator; Low Dose PF-03635659; Mid Dose PF-03635659; High Dose PF-03635659
Intervention description: oral inhaled formulation, single dose; oral inhaled formulation, single dose; oral inhaled formulation, single dose, low dose; oral inhaled formulation, single dose, mid dose; oral inhaled formulation, single dose, high dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Safety; Pharmacokinetics; Pharmacodynamics; PF-03635659; COPD

Summary:

      PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease.
      This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659
      in patients with Chronic Obstructive Pulmonary Disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female (women of non-childbearing potential) subjects between the ages of 40
             and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who
             meet the following criteria for GOLD stage II disease

          -  Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88
             lbs).

          -  Current smokers, or ex-smokers who have abstained from smoking for at least 6 months

        Exclusion Criteria:

          -  Subjects having more than 2 exacerbations requiring treatment with oral steroids or
             hospitalization for the treatment of COPD in the previous year.

          -  History of lower respiratory tract infection or significant disease instability during
             the month preceding screening or during the period between screening and
             randomization.
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms; Inflammatory Breast Neoplasms
Intervention: Afatinib once daily (OD); Vinorelbine Weekly
Intervention description: Patient to receive afatinib monotherapy until progression of their disease; Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy
Intervention MeSH terms: Vinorelbine; Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The general aim of this study is to investigate the efficacy and safety of afatinib alone and
      in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy
      within this trial) as treatment in patients with HER2-overexpressing, locally advanced or
      metastatic inflammatory breast cancer. The study will include patients who have and have not
      failed prior trastuzumab treatment.
    

Eligibility criteria:

        Inclusion criteria:

          1. Female patients >=18 years with proven diagnosis of HER2-overexpressing,
             histologically confirmed breast cancer

          2. Locally advanced or metastatic disease

          3. Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation
             Criteria for Solid Tumours version 1.1)

          4. For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment

          5. Investigator-confirmed diagnosis of Inflammatory Breast Cancer

          6. Must have biopsiable disease

        Exclusion criteria:

          1. Prior treatment with HER2-targeted small molecules or antibodies other than
             trastuzumab (which must have been given in the trastuzumab-failure study population)

          2. Must not have received prior vinorelbine treatment
A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis; Calcinosis; Constriction, Pathologic
Intervention: Ataciguat (HMR1766); Placebo Comparator: Matching Placebo
Intervention MeSH terms: 5-chloro-2-(5-chlorothiophene-2-sulfonylamino)-N-(4-(morpholine-4-sulfonyl)phenyl)benzamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Stenosis; Aortic Valve; Aorta; Calcified; Calcific; Calcification

Summary:

      The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows
      progression of valve calcification in patients with moderate calcific aortic valve stenosis.
      Secondary and tertiary objectives are to determine whether Ataciguat slows progression of
      aortic valve function, reduces systemic inflammation, and prevents left ventricular
      dysfunction in patients with moderate calcific aortic valve stenosis.
    

Eligibility criteria:

        Inclusion Criteria

          1. Age > 50 years

          2. Male or female sex

          3. Aortic valve area greater than 1.0 cm2 but less than 2.0 cm2

          4. Aortic valve calcium levels greater than 300 AU from chest CT

          5. Ejection fraction >50%

        Exclusion Criteria

          1. Orthostatic intolerance or symptomatic hypotension prior to study or during study
             visits

          2. Positive pregnancy test during screening visit

          3. Nitrate use or α-antagonist medication use within 24 hours

          4. Systolic blood pressure <110 mm Hg

          5. Mean systemic arterial pressure <75 mm Hg

          6. Severe mitral or aortic regurgitation

          7. Retinal or optic nerve problems

          8. Recent (≤30 days) acute coronary syndrome

          9. Oxygen saturation <90% on room air

         10. Congenital valve disease

         11. Hepatic dysfunction/elevated liver enzymes

         12. Prescription of drugs known to alter NO-sGC-cGMP signaling (sildenafil, nitrates,
             etc.)

         13. Prescription of Warfarin (Coumadin) for chronic anticoagulation

         14. Concomitant participation in other trials at Mayo Clinic or elsewhere

         15. Use of phenytoin or related compounds for any indication

         16. Chronic midazolam treatment for any indication

         17. Use of monoamine oxidase inhibitors for any indication

         18. Use of anti-diabetic drugs in the sulfonylurea family
Prevention of Alcohol Intolerance
Condition: Alcohol Sensitivity
MeSH terms: Hypersensitivity
Intervention: Broccoli Sprout Extract; Placebo
Intervention description: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge; 80% acetone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Broccoli sprouts; alcohol sensitivity; sulforaphane; alcohol metabolism; in the Asian Community

Summary:

      This study is designed to determine whether Asians who are especially sensitive to alcohol
      exposure can be protected by boosting their activities of an alcohol disposing enzyme. This
      will be accomplished by administering broccoli sprouts that are rich in an agent that
      increases protective enzyme activity. The test system involves applying alcohol patches to
      the skin and measuring skin redness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-70 years old,

          -  sensitive to alcohol on the skin, Japanese

        Exclusion Criteria:

          -  recent skin abnormalities /tanning