bioihbjkbjnl/mcl2 huggingface dataset:
Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Intervention: Furosemide Cohort 1; Furosemide Cohort 2; Furosemide Cohort 3; Placebo
Intervention description: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.; furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.; furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.; Sugar water will be administered in a equivalent volume as drug intervention.
Intervention MeSH terms: Furosemide
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 7 Days
Maximum age: 28 Days
Healthy volunteers: No

Summary:

      This study will describe the safety of furosemide in premature infants at risk of
      bronchopulmonary dysplasia and determine the preliminary effectiveness and pharmacokinetics
      (PK) of furosemide. Funding Source - FDA OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          1. Receiving positive airway pressure (nasal continuous airway pressure, nasal
             intermittent positive pressure ventilation, or nasal cannula flow > 1LPM) or
             mechanical ventilation (high frequency or conventional)

          2. < 29 weeks gestational age at birth

          3. 7-28 days postnatal age at time of first study dose

        Exclusion Criteria:

          1. Exposure to any diuretic ≤ 72 hours prior to first study dose

          2. Previous enrollment and dosing in current study, "Safety of Furosemide in Premature
             Infants at Risk of Bronchopulmonary Dysplasia"

          3. Hemodynamically significant patent ductus arteriosus, as determined by the
             investigator

          4. Major congenital anomaly (e.g. congenital diaphragmatic hernia, congenital pulmonary
             adenomatoid malformation)

          5. Meconium aspiration syndrome

          6. Known allergy to any diuretic

          7. Serum creatinine >1.7 mg/dL < 24 hours prior to first study dose

          8. BUN >50 mg/dL < 24 hours prior to first study dose

          9. Na <125 mmol/L < 24 hours prior to first study dose

         10. K ≤2.5 mmol/L < 24 hours prior to first study dose

         11. Ca ≤ 6 mg/dL < 24 hours prior to first study dose

         12. Indirect bilirubin >10 mg/dL < 24 hours prior to first study dose

         13. Any condition which would make the participant, in the opinion of the investigator,
             unsuitable for the study
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
Condition: Liver Fibrosis; Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fibrosis
Intervention: BMS-986036; Placebo
Intervention description: Specified dose on specified days.; Specified dose on specified days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic
      Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by
      alcohol) and stage 3 liver fibrosis (severe fibrosis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If
             historical biopsy is not available, a liver biopsy will be performed during the
             screening period. Biopsy must be consistent with NASH, with: a) a score of at least 1
             for each NAS component (steatosis, lobular inflammation, and ballooning), as assessed
             by the central reader, and b) stage 3 liver fibrosis according to the NASH CRN
             classification, as assessed by the central reader

          -  Participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must
             have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins)
             prior to and during the screening period

          -  Participants taking vitamin E at doses greater than or equal to (>=) 800 IU/day must
             have been on stable doses for at least 6 months (26 weeks) prior to and during the
             Screening Period. Vitamin E treatment (>=800 IU/day) must not have been initiated
             after the qualifying liver biopsy was performed.

        Exclusion Criteria:

          -  Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus
             infection, chronic hepatitis C virus [HCV] infection, autoimmune hepatitis,
             drug-induced hepatotoxicity, Wilson disease, α-1-antitrypsin deficiency, iron
             overload, and hemochromatosis); participants with HCV sustained viral response
             (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study
             eligibility may be eligible

          -  Current or past history of hepatocellular carcinoma (HCC)

          -  Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding,
             hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver
             transplantation

        Other protocol defined inclusion/exclusion criteria could apply
ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: acalabrutinib; Placebo
Intervention MeSH terms: Methotrexate; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Acalabrutinib

Summary:

      This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and
      efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Diagnosis of RA according to the 2010 ACR/EULAR Classification Criteria .

          -  Must be on a stable MTX dose (7.5 to 25 mg/week)

          -  Subjects must be able to read and understand the consent form, complete the
             study-related procedures, and communicate with the study staff.

          -  Are willing and able to adhere to the study visit schedule, and understand and comply
             with other protocol requirements.

        Main Exclusion Criteria:

          -  Prior malignancy, except for adequately treated basal cell or squamous cell skin
             cancer, in situ cervical cancer, or other cancer from which the subject has been
             disease free for ≥ 5 years.

          -  A life-threatening illness, medical condition or organ system dysfunction which, in
             the investigator's opinion, could compromise the subject's safety, interfere with the
             absorption or metabolism of ACP-196, or put the study outcomes at undue risk.

          -  Subjects who have taken any investigational drug within the previous 30 days before
             randomization.

          -  Use of all other synthetic disease-modifying antirheumatic drugs (DMARDS) such as but
             not limited to leflunomide, azathioprine, cyclosporine, penicillamine or gold salts
             within 8 weeks of randomization.

          -  Use of etanercept, anakinra, tofacitinib within 4 weeks of randomization.

          -  Use of abatacept, humira, infliximab, or tocilizumab within 8 weeks of randomization.
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: AL-335; Odalasvir; Simeprevir
Intervention description: AL-335 800 mg (2*400) tablet will be administered once daily.; Odalasvir 25 mg tablet will be administered once daily.; Simeprevir 75 mg capsule will be administered once daily.
Intervention MeSH terms: Simeprevir; Odalasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 365.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; AL-335; Odalasvir; Simeprevir; ODV; SMV; ACH-3102; ACH-0143102; TMC435

Summary:

      The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12),
      safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335,
      odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected
      subjects without cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection

          -  Documented as treatment naive or experienced with a prior regimen consisting of
             Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response

          -  Absence of cirrhosis

          -  Screening laboratory values within defined thresholds

          -  Must use specific contraceptive methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)

          -  Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination
             with pegylated interferon (PegIFN) or IFN-free

          -  Current or prior history of clinical hepatic decompensation

          -  History of clinically significant illness or any other medical disorder including
             cardiovascular conditions that may interfere with individual's treatment, assessment
             or compliance with the protocol

          -  Pregnant or a nursing female
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Placebo; PF-06649751 low dose (1 mg QD); PF-06649751 middle dose 1 (3 mg QD); PF-06649751 middle dose 2 (7 mg QD); PF-06649751 high dose (15 mg QD)
Intervention description: Placebo; PF-06649751 low dose (1 mg QD); PF-06649751 lower middle dose 1 (3 mg QD); PF-06649751higher middle dose 2 (7 mg QD); PF-06649751 high dose (15 mg QD)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson Disease; Motor Fluctuation

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751
      in Parkinson's disease patients who experience motor-fluctuations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of non-childbearing potential and/or male subjects between the ages of 40 and
             85 years, inclusive.

          -  Clinical diagnosis of Parkinson's disease.

          -  Able to refrain from any Parkinson's disease medication not permitted by the protocol.

        Exclusion Criteria:

          -  Female of childbearing potential

          -  History or presence of atypical Parkinsonian syndrome.

          -  History of surgical intervention for Parkinson's disease.

          -  Severe acute or chronic medical or psychiatric condition or laboratory abnormality.

          -  Any condition possibly affecting drug absorption.

          -  Participation in other studies involving investigational drug(s), or treatment with
             any investigational drug within 30 days.
Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: PS-341, doxorubicin
Intervention description: bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle
Intervention MeSH terms: Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary objective is to determine the effectiveness of the combination of bortezomib and
      doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase
      II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with
      doxorubicin IV on days 1 and 8 of a 21-day cycle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologically or histologically confirmed metastatic breast cancer

          -  Measurable or evaluable disease

          -  Age > 18, PS 0,1,2

          -  MUGA > 45%

          -  Received one or fewer chemotherapies or investigational regimens for metastatic
             disease, no limit to the number of prior hormonal therapies. May have had single agent
             Herceptin and/or Herceptin plus single-agent chemotx.

          -  Must meet designated laboratory criteria within 14 days of enrollment

        Exclusion Criteria:

          -  Doxorubicin for metatstatic disease.

          -  Pregnant or lactating.

          -  Active infections, no myocardial infarction within 2 months of enrollment.

          -  Investigational drugs within 14 days of enrollment.

          -  Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4
             weeks of enrollment.

          -  Neuropathy that is > grade 2.

          -  Active brain mets.

          -  Hypersensitivity to bortezomib, boron, or mannitol.
Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)
Condition: Hypophosphatasia
MeSH terms: Hypophosphatasia
Intervention: asfotase alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 24 Weeks
Maximum age: 42 Months
Healthy volunteers: No
Keywords: Hypophosphatasia; HPP; Bone disease; Soft bones; Low alkaline phosphatase; Genetic metabolic disorder; Alkaline phosphatase; Tissue non-specific alkaline phosphatase; Rickets; Osteomalacia

Summary:

      This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and
      young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042).

      Partial funding for this study was provided by the Office of Orphan Product Development
      (OOPD).
    

Eligibility criteria:

        Inclusion Criteria

          -  Patient completed participation in ENB-002-08 (NCT00744042)

          -  Written informed consent by parent or other legal guardian prior to any study
             procedures being performed

          -  Parent or other legal guardian willing to comply with study requirements

        Exclusion Criteria

          -  History of sensitivity to any of the constituents of the study drug

          -  Clinically significant disease that precludes study participation

          -  Enrollment in any study (other than ENB-002-08) involving an investigational drug,
             device, or treatment for HPP (e.g., bone marrow transplantation)
Intranasal Insulin for Weight Management During Smoking Cessation
Condition: Tobacco Abstinence Syndrome
Intervention: Intranasal Insulin; Placebo
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in
      reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  smokers (>10 cig/day) for the past 1 year

          -  normosmic olfactory function

        Exclusion Criteria:

          -  previous/current use of insulin

          -  current Diagnostic and Statistical Manual-IV-Revised (DSM-IV-R) Axis I disorder

          -  current pregnancy (or lactation)

          -  lifetime history of endocrine disease

          -  excessive alcohol use (>25 standard units of alcohol/week)

          -  current use of illicit drugs

          -  current use of a smoking cessation aid (NRT, Chantix or Wellbutrin), or a psychotropic
             agent

          -  local infections, inflammation, structural abnormalities, or other nasal pathology

          -  current use of any medications administered intranasally, including intranasal
             steroids
A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: LY3375880; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: eczema; atopic eczema

Summary:

      The reason for this study is to see if the study drug LY3375880 is safe and effective in
      adults with moderate-to-severe atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have diagnosis of AD >= 12 months according to the American Academy
             of Dermatology criteria.

          -  Participants must have moderate to severe AD at screening and randomization.

          -  Participants must have inadequate response to topical medications within 6 months of
             screening (or history of intolerance).

        Exclusion Criteria:

          -  Participants must not have concurrent treatment with topical or systemic treatments
             for AD.
PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection
Condition: Adult Hepatocellular Carcinoma; Localized Resectable Adult Liver Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Intervention: Computed Tomography; 18F-fluoromethylcholine; Positron Emission Tomography
Intervention description: Undergo FCH PET/CT; Undergo FCH PET/CT; Undergo FCH PET/CT
Intervention MeSH terms: Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This clinical trial studies positron emission tomography (PET)/computed tomography (CT) in
      diagnosing patients with liver cancer undergoing surgical resection. Diagnostic procedures,
      such as fluorine-18 fluoromethylcholine PET/CT, may help find and diagnose liver cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Liver tumor diagnosed histologically as HCC or suspected of being HCC in association
             with serum alpha-fetoprotein level > 200 or tumor mass with characteristics of
             malignancy on diagnostic imaging

          -  Under the care of a surgical attending

          -  Deemed a surgical candidate and has agreed to surgery to remove a portion of the liver
             containing tumor

          -  Child-Pugh A/B

        Exclusion Criteria:

          -  Weight > 350 lbs

          -  Pregnant or lactating female, a serum pregnancy test will be performed within 2 weeks
             or less before the date of the FCH PET/CT scan in all women capable of becoming
             pregnant

          -  Serious underlying medical condition that would impair patient's ability to tolerate
             the imaging procedure

          -  Concurrent treatment with chemotherapy, molecule-selective, biological, or
             radiotherapeutic agent
A Study to Establish the Safety and Tolerability of Zimura® (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
Condition: Idiopathic Polypoidal Choroidal Vasculopathy
MeSH terms: Polypoidal Choroidal Vasculopathy; Vascular Diseases
Intervention: Zimura
Intervention description: Subjects will receive monthly intravitreous injections of Zimura in combination with Lucentis, Avastin or Eylea.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: idiopathic polypoidal choroidal vasculopathy; IPCV; Zimura™; Avastin®; Eylea®; Lucentis®

Summary:

      The objectives of this study are to evaluate the safety and tolerability of Zimura™
      intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF)
      therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years

          -  Diagnosis of IPCV

          -  Treatment-experienced defined as prior treatment with anti-VEGF mono therapy of ≥ 8
             injections in the previous twelve (12) months

        Exclusion Criteria:

          -  Any intraocular surgery or thermal laser within three (3) months of trial entry

          -  Any prior thermal laser in the macular region, regardless of indication

          -  Any ocular or periocular infection in the twelve (12) weeks prior to entry

          -  History of any of the following conditions or procedures in the study eye:
             Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g.
             trabeculectomy), glaucoma drainage device, corneal transplant

          -  Previous therapeutic radiation in the region of the study eye

          -  A diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy
             and/or leakage from retinal vasculature in a subject with diabetes mellitus)