bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer
Condition: Pancreatic Neoplasm
MeSH terms: Pancreatic Neoplasms
Intervention: enzastaurin; gemcitabine
Intervention description: 1200 milligrams (mg) loading dose then 500 mg, orally, daily, six 28-day cycles; 1000 milligrams/square meter (mg/m^2), intravenously on Days 1, 8 and 15 per cycle, six 28-day cycles
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to determine the effects and toxicity of gemcitabine
      alone or gemcitabine plus enzastaurin in participants with pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of adenocarcinoma of the pancreas.

          -  Pretreatment tumor specimen must be available.

          -  No prior chemotherapy immunotherapy, biological therapy, or hormonal therapy for
             pancreatic cancer, including 5-fluorouracil (5-FU) with radiation therapy.

          -  Prior radiation allowed.

          -  Ability to stop some types of anti-seizure medicines within 14 days of enrollment.

        Exclusion Criteria:

          -  Endocrine pancreatic tumor or ampullary cancer.

          -  Central Nervous System (CNS) metastases.

          -  Inability to swallow tablets.

          -  10% or greater weight loss over the 6 weeks before study entry.
The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Roflumilast Cream 0.3%; Roflumilast Cream 0.15%; Vehicle Cream
Intervention description: Applied once daily for 12 weeks; Applied once daily for 12 weeks; Applied once daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel group, double blind, vehicle-controlled study
Masking: Double (Participant, Investigator)
Masking description: Roflumilast drug product will be supplied as a 0.3% and 0.15% cream. The matching vehicle cream will contain only excipients of roflumilast cream.
Enrollment: 331.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a parallel group, double blind, vehicle-controlled study in which roflumilast
      (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD)
      for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body
      surface area.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants legally competent to sign and give informed consent

          -  Males and females ages 18 years and older (inclusive)

          -  Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined
             by the Investigator

          -  Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at
             Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must
             agree to use at least one form of highly effective contraception throughout the trial.

          -  In good health as judged by the Investigator, based on medical history, physical
             examination, serum chemistry labs, hematology values, and urinalysis.

          -  Subjects are considered reliable and capable of adhering to the Protocol and visit
             schedule, according to the judgment of the Investigator.

        Exclusion Criteria:

          -  Planned excessive exposure of treated area(s) to either natural or artificial sunlight
             or tanning bed.

          -  Females who are pregnant, wishing to become pregnant during the study, or are
             breast-feeding.

          -  Previous treatment with roflumilast cream or its active ingredient

          -  Subjects with any serious medical condition or laboratory abnormality that would
             prevent study participation or place the subject at significant risk, as determined by
             the Investigator.

          -  Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation
             of study medication.

          -  Subjects who are unable to communicate, read or understand the local language, or who
             display another condition, which in the Investigator's opinion, makes them unsuitable
             for clinical study participation.
Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
Condition: Diabetic Kidney Disease (DKD)
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: CSL346; Placebo
Intervention description: VEGF-B antagonist monoclonal antibody; Normal saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No

Summary:

      This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy,
      safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with
      diabetic kidney disease (DKD) and albuminuria receiving standard of care treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects ≥ 25 years of age with a diagnosis of type 2 diabetes
             mellitus (T2DM)

          -  Urinary ACR ≥ 150 mg/g

          -  eGFR > 20 mL/min/1.73m2

          -  Glycosylated HbA1c < 12%

        Exclusion Criteria:

          -  Current diagnosis of type 1 diabetes mellitus

          -  History of acute kidney injury or chronic dialysis/renal transplant

          -  Uncontrolled hypertension or class III / IV heart failure

          -  Left ventricular ejection fraction < 50% by echocardiogram

          -  Troponin-I > the upper reference limit

          -  b-type natriuretic peptide > 200 pg/mL

          -  ALT > 2x the upper limit of normal
Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain
Condition: Constipation
MeSH terms: Constipation
Intervention: N-methylnaltrexone bromide (MOA-728); placebo
Intervention description: Oral; placebo
Intervention MeSH terms: Bromides; Methylnaltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the safety and dose-response relationship of
      N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects
      with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel
      dysfunction (OIBD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not
             due to malignant cancer.

          -  Taking oral, transdermal, intravenous, or subcutaneous opioids.

          -  Willingness to discontinue all pre-study laxative therapy and use only study permitted
             rescue laxatives.

        Exclusion Criteria:

          -  History of chronic constipation before the initiation of opioid therapy.

          -  Other GI disorders known to affect bowel transit.

          -  Women who are pregnant, breast-feeding, or plan to become pregnant.
Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: 70 mg SC; 210 mg SC; 140 mg SC; 280 mg SC; Placebo
Intervention description: 70 mg SC; 210 mg SC; 140 mg SC; 280 mg SC; Placebo SC
Intervention MeSH terms: Brodalumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent
      of improvement in PASI score at week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has had stable moderate to severe plaque psoriasis for at least 6 months

          -  Subject has received at least one previous phototherapy or systemic psoriasis therapy
             or has been a candidate to receive phototherapy or systemic psoriasis therapy in the
             opinion of the investigator.

          -  Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.

        Exclusion Criteria:

          -  Subject diagnosed with erythrodermic psoriasis, pustular psoriasis,
             medication-induced, or medication-exacerbated psoriasis.

          -  Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate
             psoriasis) that would interfere with evaluations of the effect of IP on psoriasis.

          -  Subject has any active CTCAE grade 2 or higher infection

          -  Subject has a significant concurrent medical condition or laboratory abnormalities, as
             defined in the study protocol.

          -  Subject has used the following therapies within 14 days of the first dose: UVB therapy
             or topical psoriasis therapies other than Class I or II topical steroids

          -  Subject has used the following therapies within 28 days of the first dose: Class I or
             II topical steroids, UVA therapy (with or without psoralen), or systemic psoriasis
             therapies

          -  Subject has used the following therapies within 3 months of the first dose:
             adalimumab, alefacept, etanercept, infliximab, certolizumab, or live vaccines

          -  Subject has used an anti-IL12/IL23 inhibitor within 6 months of the first dose

          -  Subject has previously used an anti-IL17 biologic therapy, efalizumab, or rituximab
Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
Condition: Liver Transplant; Kidney Transplant
Intervention: PPM-based Computation Assisted Drug Dosing; Tacrolimus
Intervention description: Tacrolimus dosing based on application of PPM.; Dosing of calcineurin inhibitor, tacrolimus
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Phenotypic Precision Medicine (PPM); Tacrolimus; Calcineurin Inhibitors

Summary:

      Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver
      and/or kidney transplant recipients to show improvement in maintaining drug trough levels
      within the target range.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults undergoing liver and/or kidney transplantation

        Exclusion Criteria:

          -  transplant patients with contraindications to tacrolimus
Furosemide for Accelerated Recovery of Blood Pressure Postpartum
Condition: Hypertension, Pregnancy-Induced
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Intervention: Oral furosemide; Placebo Oral Tablet
Intervention description: Furosemide (Lasix), 20 milligram, PO, PO, daily; Placebo, PO, daily
Intervention MeSH terms: Furosemide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind, randomized, placebo control design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Study medication (furosemide) and placebo will be stored at room temperature at the University of Pennsylvania research pharmacy. Pharmacy will be responsible for labeling and randomizing the medications.
Enrollment: 384.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Furosemide; Postpartum; Hypertension

Summary:

      A randomized, double-blind, placebo-controlled single center investigation of furosemide's
      effect on postpartum blood pressure control in pregnancies affected by hypertensive disorders
      of pregnancy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum

          -  Gestational hypertension

          -  Pre-eclampsia with or without severe features

          -  Superimposed pre-eclampsia with or without severe features

          -  New diagnosis of HDP within 24 hours from delivery

          -  Postpartum, delivery ≥ 20 weeks estimated gestational age

          -  Age ≥18 years old

        Exclusion Criteria:

          -  History of allergic reaction to furosemide

          -  High risk comorbidities for which treatment may be indicated or contraindicated: class
             C or higher diabetes mellitus, chronic kidney disease or baseline creatinine >1.2,
             cardiac disorders including cardiomyopathy, congenital heart disease, angina or
             coronary heart disease, rheumatic disease (lupus), sickle cell disease

          -  Baseline labs with K <3

          -  Use of furosemide or other diuretics antepartum or intrapartum

          -  Use of ototoxic agents including aminoglycosides (ie, Gentamicin for >1 dose),
             cephalosporins (ie Ancef >1 dose),

          -  Patient unstable for protocol per investigator's judgement
Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Cognitive Dysfunction; Psychotic Disorders
Intervention: Cannabidiol; Placebo
Intervention description: Active Cannabidiol daily over 6 weeks; Placebo
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is a six-week, randomized, placebo-controlled, fixed dose trial comparing
      cannabidiol Vs. placebo added to a stable dose of antipsychotic medications in patients
      diagnosed with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Schizophrenia or Schizoaffective disorder (DSM-IV SCID-confirmed),

        Exclusion Criteria:

          -  Women who are pregnant, nursing or unwilling to use appropriate birth control measures
             during study participation.
Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma
Condition: Ocular Hypertension; Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Latanoprost ophthalmic solution; AKB-9778 4%; Placebo
Intervention description: Latanoprost opthalmic solution to be dosed once daily; Razuprotafib opthalmic solution; placebo for razuprotafib opthalmic solution
Intervention MeSH terms: Ophthalmic Solutions; Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 194.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 2, double masked, randomized, multi-center, parallel-group, 28-day study
      assessing the safety, tolerability and ocular hypotensive efficacy of AKB-9778 Ophthalmic
      Solution 4.0% administered once (AM) or twice (AM & PM) daily when used as an adjunctive
      therapy to latanoprost ophthalmic solution 0.005% once daily (PM) in subjects with elevated
      IOP due to OAG or OHT.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of OAG or OHT in each eye (OAG in one eye and OHT in the fellow eye is
             acceptable)

          -  Must be receiving treatment with a stable regimen of topical prostaglandin eyedrop for
             a minimum of 2 weeks prior to the Screening Visit; may be taking one additional IOP
             lowering eyedrop

          -  IOP of ≥ 18 mmHg and ≤ 27 mmHg in one eye or both eyes at Screening visit

          -  Following 4 week washout period, IOP ≥ 24 mmHg and < 36 mmHg at 08:00 hour and IOP ≥
             22 mmHg and < 36 mmHg in both eyes at 10:00, 12:00 and 16:00 hours.

        Key Exclusion Criteria:

          -  Clinically significant ocular disease which might interfere with interpretation of the
             study efficacy endpoints or with safety assessments

          -  Pseudoexfoliation or pigment dispersion component glaucoma

          -  History of angle closure glaucoma, or narrow angles or with evidence of peripheral
             anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to
             Screening

          -  Intraocular pressure ≥ 36 mmHg

          -  Cup/disc ratio of > 0.8 in either eye

          -  Severe visual field defect or significant defect (sensitivity of ≤ 10dB) within 10
             degrees of fixation in either eye
Vilazodone Treatment for Marijuana Dependence
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Intervention: Vilazodone; Placebo
Intervention description: up to 40 mg capsule daily; up to 40 mg capsule daily
Intervention MeSH terms: Vilazodone Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Marijuana; Vilazodone; Contingency management; Motivational enhancement therapy

Summary:

      Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated
      pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of
      vilazodone for reducing marijuana use in marijuana-dependent adults. A contingency management
      intervention (CM)and motivational enhancement therapy (MET)will be incorporated to encourage
      study engagement and retention, and genomic DNA will be extracted to characterize subjects
      according to polymorphisms of genes potentially relevant to the activity of vilazodone. It is
      hypothesized that vilazodone combined with MET and CM will reduce the percent of
      marijuana-positive urine drug screen results in marijuana-dependent individuals as compared
      to a placebo treatment combined with MET and CM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must meet DSM-IV criteria for marijuana dependence

          -  Must be between the ages of 18 and 65 years old

          -  If female and of childbearing potential, must agree to use acceptable method of birth
             control for duration of the trial.

          -  Cannabis-positive urine drug screen at screening

          -  Must consent to random assignment

          -  Must be able to read and provide informed consent

        Exclusion Criteria:

          -  Women who are pregnant, nursing, or plan to become pregnant during course of study

          -  Must not have a history of or current psychotic disorder, bipolar disorder, or eating
             disorder

          -  Must not pose a current suicidal or homicidal risk

          -  Must not have evidence or history of serious medical disease

          -  Must not require concomitant therapy with psychotropic medication or CYP3A4 inhibitors

          -  Must not be currently dependent on other substances, with the exception of nicotine;

          -  Patients who, in the investigator's opinion, would be unable to comply with study
             procedures or assessments
A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin; Doxorubicin/Placebo
Intervention description: Multi kinase inhibitor plus Chemotherapy; Chemotherapy plus Placebo
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Liver Cancer; Hepatocellular carcinoma; HCC

Summary:

      The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus
      sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma
      (HCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have a life expectancy of at least 12 weeks

          -  Patients with advanced HCC (unresectable, and/or metastatic) which has been
             histologically or cytologically documented

          -  Patients must have at least one tumor lesion that meets both of the following
             criteria:

               -  can be accurately measured in at least one dimension according to Response
                  Evaluation Criteria in Solid Tumors (RECIST)

               -  has not been previously treated with local therapy

          -  Patients who have received local therapy except chemoembolization, such as surgery,
             radiation therapy, hepatic arterial embolization, radiofrequency ablation,
             percutaneous ethanol injection or cryoablation are eligible, provided that they either
             have a target lesion which has not been subjected to local therapy and/or the target
             lesion(s) within the field of the local therapy has shown an increase of 25% in the
             size. Local therapy must be completed at least 4 weeks prior to the baseline scan

          -  Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of
             0, 1 or 2

        Exclusion Criteria:

          -  Previous or concurrent cancer that is distinct in primary site or histology from HCC,
             EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial
             bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry
             is permitted

          -  History of cardiac disease

          -  Serious myocardial dysfunction

          -  Active, clinically serious infections

          -  Known history of Human Immunodeficiency Virus (HIV) infection

          -  Known Central Nervous System (CNS) tumors including metastatic brain disease

          -  Patients with clinically significant gastrointestinal bleeding within 30 days prior to
             study entry