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
Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria
Condition: Hyperuricemia; Albuminuria; Type 2 Diabetes
MeSH terms: Albuminuria; Hyperuricemia
Intervention: Verinurad 9 mg+Febuxostat 80 mg; Placebo
Intervention description: Capsule administered orally, once daily for 24 weeks; Capsule administered orally, once daily for 24 weeks
Intervention MeSH terms: Febuxostat; Verinurad
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, double-dummy, placebo-controlled, parallel, independent groups, repeated measures, multi-center study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Verinurad capsules/matching placebo capsules and febuxostat/matching placebo capsules with randomization code printed on each label
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to evaluate signals of potential clinical
      benefit of the combination of Verinurad and Febuxostat in lowering concentrations of
      circulating uric acid and thus improving kidney or cardiovascular status of patients with
      hyperuricemia, albuminuria, and Type 2 diabetes (T2DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Serum Uric Acid ≥6.0 mg/dL

          -  eGFR ≥30 mL/min/1.73 m2

          -  UACR between 30 mg/g and 3500 mg/g inclusive

          -  Diagnosed with T2DM

        Exclusion Criteria:

          -  Treated with any drug for hyperuricemia in the 6 months preceding randomization.Drugs
             for hyperuricemia include all XO inhibitors (allopurinol, febuxostat and topiroxostat)
             and URAT1 inhibitors (lesinurad, verinurad, probenecid, and benzbromarone)

          -  Prior history of gout, unless prophylaxis therapy isn't required

          -  Patients who are pregnant, lactating, or planning to become pregnant

          -  Patients unsuitable or unable to undergo MRI assessment
A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Diclofenac Sodium Active Topical Patch 1; Diclofenac Sodium Active Topical Patch 2; Placebo patch
Intervention description: HP-5000 Active Topical Patch 1 were applied on subjects with Osteoarthritis of the knee(s); HP-5000 Active Topical Patch 2 were applied on subjects with Osteoarthritis of the knee(s); Topical placebo patches were applied on subjects with Osteoarthritis of the knee(s)
Intervention MeSH terms: Diclofenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 289.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate
      the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee
             according to the American College of Rheumatology (ACR) criteria, including:

          -  Symptoms for at least 6 months prior to screening, AND

          -  Knee pain in the target knee for 30 days of the preceding month (periarticular knee
             pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND

          -  The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs
             (NSAIDs) either over the counter (OTC) per recommendation of a physician or
             prescribed.

        Exclusion Criteria:

          -  Body mass index (BMI) > 40

          -  Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue
             medication) during Screening Washout Period.

          -  Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic
             neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Cetuximab; 5-FU; Hydroxyurea; Twice-daily radiation; Cisplatin; Accelerated fraction radiotherapy with concomitant boost
Intervention description: 250mg/m2(day 1, weekly x 10);; 600 mg/m2/day; days 0-5 (120 h total) every other week x 5; 500 mg PO BID, days 0-5 every other week x 5; 150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks); 100 mg/m2, week 1 and 4 on day 1 (or 2); 72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.
Intervention MeSH terms: Cetuximab; Hydroxyurea
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cetuximab; Erbitux; locally; advanced; head; neck; cancer; neoplasms; squamous; carcinoma; lymphoepithelioma

Summary:

      The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®)
      added to two concurrent chemoradiotherapy platforms of different intensity in locally
      advanced head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Stage III and IV head and neck cancer

          -  Patients with squamous cell carcinoma of unknown primary and suspected origin in the
             head and neck area

          -  No prior chemotherapy or radiotherapy

          -  Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures
             only

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

          -  Normal organ and marrow function

        Exclusion Criteria:

          -  Unequivocal demonstration of metastatic disease

          -  Known severe hypersensitivity to drugs used in the study

          -  Treatment with a non-approved or investigational drug within 30 days before Day 1

          -  Incomplete healing from previous surgery

          -  Pregnancy or breast feeding

          -  Uncontrolled intercurrent illness including

          -  Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any
             history of clinically significant CHF

          -  Acute hepatitis or known HIV

          -  Severe baseline neurologic deficits

          -  Prior therapy which specifically and directly targets the EGFR pathway

          -  Prior severe infusion reaction to a monoclonal antibody
Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
Condition: Head Lice Infestation
MeSH terms: Lice Infestations; Parasitic Diseases; Mite Infestations
Intervention: Abametapir Lotion 0.74% w/w; Vehicle Lotion
Intervention description: 200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.; control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No

Summary:

      The purpose of the study was to evaluate ovicidal efficacy of a single application of
      abametapir lotion 0.74% w/w intended for the treatment of head lice.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or female based on medical history

          2. Six months of age or older.

          3. Has an active head lice infestation with a minimum of 3 live head lice and at least 10
             undamaged and unhatched head lice eggs in their hair.

          4. Agrees to an examination for head lice and compliance with the study procedures.

          5. All adult subjects must sign a written voluntary informed consent. For minors, the
             parent/ legal guardian agrees to the subject participating in the study as determined
             by the signing of an assent of informed consent.

        Exclusion Criteria:

          1. Has scalp disease or a history of allergies or prior reactions to any head lice
             products.

          2. Has a condition that, in the opinion of the Investigator, may interfere with the
             study.

          3. Is receiving systemic or topical medication, which in the opinion of the Investigator,
             may compromise the integrity of the safety and/or efficacy assessments.

          4. Had treatment (over-the-counter (OTC) or home remedy medication) for head lice within
             14 days prior to Day 0.

          5. Has received an investigational agent within 30 days prior to Day 0.
Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Oral testosterone undecanoate (TU) (300 mg T equivalents/dose); Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose); Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food); Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)
Intervention description: Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.; Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.; Two capsules each containing 100 mg T as TU, BID for 8 days. 200 mg T equivalents BID 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods.; Two capsules each containing 150 mg T as TU and 150 mg T as TE, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner.
Masking: None (Open Label)
Enrollment: 29.0
Sex: Male
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No
Keywords: testosterone; male hypogonadism; low testosterone

Summary:

      The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester
      formulations can be used effectively to treat men with low testosterone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, ages 18-68

          -  Serum total T less than or equal to 275 ng/dL

        Exclusion Criteria:

          -  Significant intercurrent disease of any type, in particular, liver, kidney or heart
             disease, uncontrolled diabetes mellitus or psychiatric illness.

          -  Abnormal prostate digital rectal examination, elevated prostate-specific antigen
             (PSA), American Urological Association (AUA) symptom score of >15, and/or history of
             prostate cancer.

          -  Hematocrit of <35 or >50%

          -  Body mass index (BMI) >36

          -  Serum transaminases > 2 times upper limit of normal or serum bilirubin > 2.0 mg/dL
Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer
Condition: Prostate Adenocarcinoma; PSA Progression; Recurrent Prostate Carcinoma
MeSH terms: Prostatic Neoplasms; Adenocarcinoma; Disease Progression
Intervention: Gallium Ga 68 DOTA-NeoBOMB1; Gallium Ga 68 PSMA-R2
Intervention description: Administered intravenously (IV); Administered intravenously (IV)
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2
      positron emission tomography (PET)/magnetic resonance imaging (MRI) work in diagnosing
      participants with prostate cancer that has come back. Diagnostic procedures, such as gallium
      Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 PET/MRI, may help find and diagnose prostate
      cancer and find out how far the disease has spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven prostate adenocarcinoma.

          -  Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or
             radiation therapy (external beam or brachytherapy).

             a. Post radical prostatectomy (RP) - American Urological Association (AUA)
             recommendation.

             (i) PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical
             prostatectomy.

        (ii) Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements
        greater than 0.2 ng/mL).

        b. Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology
        (ASTRO)-Phoenix consensus definition.

        (i) A rise of PSA measurement of 2 or more ng/mL over the nadir.

          -  Able to provide written consent.

          -  Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group
             [ECOG]/World Health Organization [WHO] equivalent).

        Exclusion Criteria:

          -  Inability to lie still for the entire imaging time.

          -  Inability to complete the needed investigational and standard-of-care imaging
             examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).

          -  Any additional medical condition, serious intercurrent illness, or other extenuating
             circumstance that, in the opinion of the Investigator, may significantly interfere
             with study compliance.

          -  Known allergy, hypersensitivity, or intolerance to the investigational product or its
             excipients.

          -  Metallic implants (contraindicated for magnetic resonance imaging [MRI]).
Exploratory Subjective Sleep Study of a Prototype Nasal Dilator
Condition: Sleep Disorders; Congestion, Nasal
MeSH terms: Sleep Wake Disorders
Intervention: Prototype Nasal Dilator; Marketed Nasal Strip; Placebo Nasal Strip
Intervention description: Prototype nasal dilator AB2R11; Breathe Right Nasal Strip- Clear small/medium; Placebo strip
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: trouble with sleep; night time nasal congestion

Summary:

      The purpose of this exploratory study is to evaluate the subjective measures of congestion
      and sleep quality in subjects who suffer from chronic nasal congestion and report trouble
      with their sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with leptorrhine noses

          -  Subjects suffering from chronic nocturnal nasal congestion and report trouble with
             sleep
Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
Condition: Morphea
MeSH terms: Scleroderma, Localized
Intervention: Crisaborole
Intervention description: Apply Crisaborole 2% ointment to affected skin twice per day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Morphea, Localized Scleroderma

Summary:

      This is a pilot study to determine the safety and clinical efficacy of crisaborole 2%
      ointment in the treatment of morphea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. >= 18 years of age

          2. Clinical diagnosis of morphea.

          3. <20% Total body surface area involvement.

          4. Does not require systemic immunosuppressive therapy for morphea.

          5. No immunosuppressive systemic therapy 1 month prior to starting the study
             (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide,
             prednisone >=10 mg PO daily).

          6. No immunomodulating topical therapy (topical steroids or topical calcineurin
             inhibitor), and no topical vitamin D analogue, 2 weeks prior to starting study.

          7. No allergy to crisaborole or vehicle.

          8. No known renal disease

          9. Able to give informed consent.

        Exclusion Criteria:Subjects fulfilling any of the following criteria are not eligible for
        inclusion in this study.

          1. Clinical diagnosis of depression or history of suicidal ideation.

          2. Pregnant or breastfeeding women, with pregnant women being defined as the state of a
             female after conception until the termination of gestation, confirmed by a positive
             urine human chorionic gonadotropin (hCG) laboratory test. Women with a positive urine
             hCG at any time during the study will be withdrawn from the study.
Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
Condition: Type 2 Diabetes Mellitus; Insulin Resistance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Inflammation
Intervention: Resveratrol
Intervention description: 1,000mg twice daily for 28 days
Intervention MeSH terms: Resveratrol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Resveratrol; Therapeutic Uses

Summary:

      Resveratrol is a natural polyphenol (a compound containing a phenol functional group) that
      can be found in many plants. The purpose of this research is to study the effects of
      resveratrol on the action of insulin (a hormone produced in the body by the pancreas that
      regulates the amount of sugar in the blood), fat accumulation, and inflammation in the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI: 26-35

          -  Non-smoker

          -  Normal screening labs (CMC, chemistry, LFTs PT/PTT)

          -  No CAD

          -  Good IV access

        Exclusion Criteria:

          -  High cholesterol

          -  <4 week history of participation in another drug trial

          -  Severe hypertension

          -  Heart disease

          -  Liver disease of liver abnormalities

          -  Cerebrovascular disease, i.e. stroke

          -  CVD

          -  Seizures

          -  Bleeding disorders

          -  Muscle disease

          -  Cancer

          -  HIV

          -  Hepatitis (all types)

          -  Mentally disabled persons

          -  Pregnant women

          -  Allergies to Novocaine, Lidocaine, Benzocaine

          -  Subjects on the following medications:

               -  Anticoagulant and antiplatelet drugs

               -  Anti-epileptic drugs

               -  Mexiletene

               -  Quinidine

               -  Cyclosporine

               -  Tacrolimus

               -  HIV protease inhibitors