bioihbjkbjnl/mcl2 huggingface dataset:
Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide; Leuprolide acetate; radiation
Intervention description: 160mg by mouth each day; 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months; External beam radiation will be delivered as per standard radiation therapy protocol
Intervention MeSH terms: Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Male
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: prostate cancer, enzalutamide, radiation, hormone therapy

Summary:

      The study is being done to find out whether combining two FDA approved drugs along with
      radiation therapy for the treatment of high risk localized prostate cancer is safe and well
      tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically proven adenocarcinoma of the prostate within 6 months of screening

          -  Eastern Cooperative Oncology Group(ECOG) score 0-2

          -  adequate organ and and blood marrow function

          -  must be a candidate for long-term androgen deprivation in combination with external
             beam radiation for the treatment of high risk prostate cancer

          -  patient must permit a targeted prostate biopsy at the time of study initiation or at
             the beginning of radiation treatment

          -  men who are sexually active with female partners of child-bearing potential mush agree
             to use adequate contraception

        Exclusion Criteria:

          -  prior treatment with agents known to have endocrine effects on prostate cancer

          -  treatment with corticosteroids within 4 weeks of enrollment

          -  treatment with androgens within 6 months of enrollment

          -  may not be receiving any other investigational agents

          -  Prostate specific antigen greater than 160ng/dL

          -  history of malignancy( other than non-melanoma skin cancer) within 5 years

          -  uncontrolled intercurrent illness

          -  cardiovascular event within 6 months of enrollment

          -  seizure or seizure disorder history

          -  contraindications to MRI- pacemakers, clips, etc
Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: OPK-88003; Placebo
Intervention description: OPK-88003 subcutaneous injection; Placebo subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC)
      OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects
      with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or
      treated with a stable dose of metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged 18 to 80 years with T2DM treated with diet and exercise alone or on
             a stable dose of metformin (≥ 1000 mg/day),

          -  BMI ≥27 and ≤45 kg/m2

          -  HbA1c ≥7.0% and ≤10.5% at screening

        Exclusion Criteria:

          -  Type 1 diabetes mellitus

          -  Previous treatment with incretin mimetic drugs

          -  Have used insulin for diabetic control for more than 6 consecutive days within the
             prior year

          -  Have had two or more emergency room visits or hospitalizations due to poor glucose
             control within the prior 6 months

          -  Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase
             (>2 x ULN).
Safety and Efficacy of a Glaucoma Drug Delivery System
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle
Intervention: High Dose Device; Low Dose Device; Placebo Device
Intervention description: inserted for 14 days; inserted for 14 days; inserted for 14 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug
      delivery system in open-angle glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man or woman 21 years of age or greater

          -  must have open angle glaucoma or ocular hypertension.

          -  Corrected visual acuity in each eye of 20/200 or better.

        Exclusion Criteria:

          -  Previous glaucoma intraocular surgery or refractive surgery.

          -  Planned contact lens use during the study.

          -  Clinically significant ocular or systemic disease that might interfere with the study.

          -  Use of chronic corticosteroids by any route.
Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)
Condition: Sleep Apnea, Obstructive; Hypopnea Syndrome; Excessive Daytime Sleepiness
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence; Syndrome; Sleepiness
Intervention: Comparator: MK0249; Comparator: placebo; Comparator: modafinil
Intervention description: Patients will be assigned to receive MK0249 film coated tablet (FCT). The doses of MK0249 that are included for possible investigation (depending upon an adaptive allocation process) are 3 mg, 5 mg, 8 mg, 10 mg, and 12 mg. Study medication will be taken for 14 days, during each of the 3 treatment periods, by mouth (po) once a day (qd).; Placebo; Patients will be assigned to receive placebo, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.; Patients will be assigned to receive modafinil 200mg oral compressed tablet (OCT), across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and efficacy of MK0249 in treating
      refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep
      Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP)
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female and is at least 18 years old and less than 65 years old

          -  Patient must have a diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome

          -  Patient has been using nCPAP treatment for at least 2 months prior to Visit 1

          -  Patient is willing to stay at a sleep laboratory for 4 full days and nights for
             observation and assessments

          -  Patient is willing to refrain from napping for the duration of the study

        Exclusion Criteria:

          -  Patient is pregnant, breastfeeding, or planning to become pregnant within the next 4
             months

          -  Patient is or has participated in a study with an investigational compound or device
             within 30 days of signing the informed consent

          -  Patient has had asthma-related visit to the emergency room or hospitalization within 6
             months of Visit 1

          -  Patient has donated or received blood products within 8 weeks of signing consent or is
             planning on doing either for the duration of the study
Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Intervention: Banaba; placebo
Intervention description: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.; Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
Intervention MeSH terms: Magnesium Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Metabolic syndrome; central obesity; Banaba; insulin secretion; insulin sensitivity

Summary:

      The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult
      population suffers the disease.

      Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin
      secretion.

      The investigators hypothesis was that the the administration of resveratrol modifies the
      metabolic syndrome, insulin sensitivity and insulin secretion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients both sexes,

          -  Age between 30 and 60 years,

          -  Metabolic Syndrome according to the IDF criteria

          -  Waist circumference

          -  Man ≥90 cm

          -  Woman ≥80 cm

        And two of the following criteria:

          -  High density lipoprotein

          -  Man ≤40 mg/dL

          -  Woman ≤50 mg/dL

          -  Fasting glucose ≥100 mg/dL

          -  Triglycerides ≥150 mg/dL

          -  Blood pressure ≥130/85 mmHg

          -  Informed consent signed

        Exclusion Criteria:

          -  Women with confirmed or suspected pregnancy

          -  Women under lactation and/or puerperium

          -  Hypersensibility to resveratrol

          -  Physical impossibility for taking pills

          -  Known uncontrolled renal, hepatic, heart or thyroid diseased

          -  Previous treatment for the metabolic syndrome components

          -  Body Mass Index ≥39.9 kg/m2

          -  Fasting glucose ≥126 mg/dL

          -  Triglycerides ≥500 mg/dL

          -  Total cholesterol ≥240 mg/dL

          -  Low density lipoprotein (c-LDL) ≥190 mg/dL

          -  Blood Pressure ≥140/90 mmHg
A Study of Flovent in Patients With Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Flovent; Placebo
Intervention description: 1760 mcg daily; Placebo
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 3 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Eosinophilic Esophagitis

Summary:

      The purpose of this study is to test the effects (both good and bad) of high dose swallowed
      fluticasone propionate (Flovent) in subjects with eosinophilic esophagitis (EoE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent for study by subject, or parent/guardian if subject is a
             minor. Assent will be obtained from all minors 11 years of age and older.

          -  Histological findings on esophageal biopsy to include peak eosinophil density ≥ 24 per
             high power field (400x) in the proximal or distal esophagus validated by a pathologist
             at CCHMC.

          -  Allergy evaluation including skin-prick testing with multiple food antigens to ensure
             elimination diet is not indicated.

          -  Have undergone a minimum 3 months of elimination diet as indicated by skin-prick
             testing without detectable resolution by repeat endoscopy with biopsies demonstrating
             persistent EE OR subject/parental refusal to follow elimination diet. If the
             subject/parent refuses the elimination diet, they are eligible for this study.

          -  Treatment with a proton-pump inhibitor for at least two months (rounded to nearest
             month) prior to endoscopy OR failure of histological improvement as defined by < 1
             eosinophil per HPF after 2 month (rounded to nearest month) trial of proton pump
             inhibitor documented by prior endoscopy. The PPI must be used prior to endoscopy to
             rule out the possibility of GERD.

        Exclusion Criteria:

          -  History of poor tolerance to Fluticasone Propionate (FP), as defined as multiple
             episodes of oral candidiasis, hypothalamic-pituitary-adrenal axis suppression as
             evidenced by signs of Cushing syndrome, headaches, or increased respiratory infections
             during exposure to Flovent

          -  Unable to cooperate with use of MDI

          -  Pregnant females

          -  Concurrent or recent (within 3 months) use of systemic corticosteroids.

          -  Unable to swallow medicines (i.e., fed only by gastrostomy tube).

          -  Comorbid eosinophilic disorders.

          -  Previously treated with swallowed glucocorticoid for EE within 3 months of the
             screening visit. Nasal glucocorticoids taken for EE are permitted.
Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
Condition: Reduction of Hypertrophic Skin Scarring
MeSH terms: Hypertrophy; Cicatrix
Intervention: PF-06473871; PF-06473871
Intervention description: Single dose administered by injection four different times; Single dose administered by injection three different times
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Double (Participant, Investigator)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Skin scarring; cicatrix; breast scar; hypertrophic scar

Summary:

      The study will compare how well PF-06473871 works versus placebo in reducing skin scarring
      after scar revision surgery of existing breast scars. The study will also evaluate the safety
      of PF-06473871 in healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have hypertrophic (raised) breast scars from previous surgery

          -  Subjects must be healthy

        Exclusion Criteria:

          -  Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or
             breast-feeding.

          -  Presence of history of breast cancer
Study of Diclofenac Capsules to Treat Dental Pain
Condition: Dental Pain
MeSH terms: Toothache
Intervention: Diclofenac Test (lower dose); Diclofenac Test (upper dose); Celecoxib 400 mg; Placebo
Intervention description: 18-mg Single dose; 35-mg Single dose; Capsules 2 x 200 mg Single-dose; Capsules 2 Single-dose
Intervention MeSH terms: Celecoxib; Diclofenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are
      safe and effective for the treatment of dental pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female between 18 and 50 years of age

          -  For women of child-bearing potential: a woman who is not pregnant and not nursing, and
             who is practicing an acceptable method of birth control

          -  Patient requires extraction of 2 or more third molars

          -  Patient must be willing to stay at the study site overnight

        Exclusion Criteria:

          -  Patient has hypersensitivity, allergy, or clinically significant intolerance to any
             medications to be used in the study, or related drugs

          -  Patient has a current disease or history of a disease that will impact the study or
             the patient's well-being

          -  Patient has used or intends to use any of the medications that are prohibited by the
             protocol

          -  Patient has a history of drug or alcohol abuse or dependence, or patient has a
             positive urine drug screen or alcohol breathalyzer test

          -  Patient has taken another investigational drug within 30 days prior to Screening
Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals
Condition: Cancer Diagnosis; Diagnostic Techniques and Procedures; Diagnostic Imaging
Intervention: F-18 FDG; Ga-68-DOTA-TATE; Positron Emission Tomography / Computed Tomography (PET/CT) Scan; Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan
Intervention description: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging; Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging; Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.; Scan using a NOVEL GE PET/MRI scanner.
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants receive both scans.
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial studies how well positron emission tomography (PET)/computed tomography
      (CT) works compared to PET/magnetic resonance imaging (MRI) in evaluating patients with
      cancer. PET/CT and PET/MRI may determine which scanner is best for the patient's type of
      cancer and other types of cancers.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Cancer diagnosis

          -  Capable of complying with study procedures

          -  Able to remain still for duration of imaging procedure (approximately 90 minutes
             total)

          -  Written informed consent

        EXCLUSION CRITERIA

          -  Pregnant or nursing

          -  Metallic implants

          -  Impaired renal function
Feasibility Study of Metformin Therapy in ADPKD
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Metformin; Placebo
Intervention description: Monitoring of safety and tolerability; Monitoring of safety and tolerability
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Metformin; total kidney volume; glomerular filtration rate

Summary:

      This study is being done to determine if treatment with metformin, a drug widely used for the
      treatment of diabetes type 2, is safe and well tolerated by individuals with Autosomal
      Dominant Polycystic Kidney Disease (ADPKD) who are not diabetic and who have slightly
      decreased kidney function. The study will also evaluate the effects of metformin on kidney
      growth and kidney function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Autosomal Dominant Polycystic Kidney Disease and

          -  An estimated glomerular filtration (GFR) rate of 50-80 ml/min/1.73 m2;

          -  Subject is able to sign an Informed Consent

        Exclusion Criteria:

          -  Diabetes mellitus,

          -  Active infection,

          -  Congestive heart failure,

          -  Liver disease,

          -  Alcohol or substance dependence,

          -  Cigarette smoking within the last 12 months;

          -  Females who are pregnant or breast feeding, or

          -  Are unwilling to use contraception;

          -  Are unable to undergo magnetic resonance imaging, or

          -  Have a contraindication to the use of metformin
PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
Condition: Chronic Kidney Disease Requiring Hemodialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Intervention: PA21; PA21; PA21; PA21; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 183.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Hemodialysis; Hyperphosphatemia

Summary:

      To investigate dose-response efficacy and safety in hemodialysis patients with
      hyperphosphatemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 20 or older, regardless of gender.

          -  Receiving stable maintenance hemodialysis 3 times a week.

          -  Patients not having changed their phosphate binder agent dose, for 4 weeks or more
             before their observation period start.

        Exclusion Criteria:

          -  Patients having history of a pronounced brain / cardiovascular disorder.

          -  Patients having severe gastrointestinal disorders.

          -  Patients having severe hepatic disorders.