bioihbjkbjnl/mcl2 huggingface dataset:
YCFM (Youth Correctional Facilities Males)
Condition: Chlamydial Infection
MeSH terms: Infections; Chlamydia Infections
Intervention: Azithromycin
Intervention description: Azithromycin 1 gm PO single dose given as directly observed
Intervention MeSH terms: Azithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: Male
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Azithromycin; Chlamydia; Correctional; Facilities; Symptoms; Urethral; Urogenital; Youth

Summary:

      The proposed study is a single center (with multiple long-term YCFs) treatment trial of the
      CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males. This study is
      designed primarily to determine the frequency of chlamydia treatment failure following
      azithromycin in males who do versus do not have urethral symptoms of urethral discharge
      and/or dysuria. Anticipated enrollment is 446 males, between the age of 12 to 21 years old,
      with subject participation duration of 28 days and study duration of 4 years. The primary
      objective of the study is to assess the microbiological efficacy of azithromycin in
      uncomplicated Chlamydia trachomatis infection in males with versus without urethral symptoms
      in YCFs.
    

Eligibility criteria:

        Inclusion Criteria:

        1.Male between the ages of 12 and 21 years 2.Residing in a long-term gender-segregated (no
        co-ed) YCF 3.Diagnosed with urogenital chlamydia as determined by a screening C.
        trachomatis NAAT 4.Anticipated length of stay at the YCF at the time of enrollment is at
        least 28 days 5.Willingness to provide written consent 6.Willingness to comply with study
        procedures

        Exclusion Criteria:

        1.Diagnosed with gonorrhea as determined by a screening Neisseria gonorrhoeae NAAT
        2.Clinical diagnosis of epididymitis based on review of medical records 3.Known allergy to
        azithromycin, erythromycin, any macrolide or ketolide drug 4.History of liver problems due
        to use of azithromycin 5.Having received antimicrobial therapy with activity against C.
        trachomatis within 21 days of the positive chlamydia screening NAAT or in the interval
        between the positive screening NAAT and study enrollment 6.Any concomitant infection, which
        requires antimicrobial therapy with activity against C. trachomatis 7.Previously enrolled
        in this study 8.Unable to swallow pills 9.Other exclusion criteria, per clinician judgment,
        that prohibits subject from enrolling in study
Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: botulinum toxin Type A; Normal saline
Intervention description: botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.; Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 315.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of intraprostatic administration of
      botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to
      benign prostatic hyperplasia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical enlargement of the prostate gland

          -  Body weight ≥ 50 kg or 110 lbs

        Exclusion Criteria:

          -  History of chronic prostatitis

          -  History of two or more urinary tract infections in the past year or one in the last 6
             months

          -  History of bladder stones

          -  History of previous prostate surgery

          -  History of bladder cancer or prostate cancer

          -  Any previous or current usage of botulinum toxin therapy of any serotype for any
             urological condition

          -  Botulinum toxin therapy of any serotype for any non-urological condition or usage
             (e.g., cosmetic) during the previous 12 weeks prior to study entry
A Study of INCB050465 in Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: Parsaclisib
Intervention description: Parsaclisib administered orally once daily at the protocol-defined dose.
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: 18 Years
Healthy volunteers: No
Keywords: Primary Sjögren's syndrome; PI3Kδ inhibitor

Summary:

      The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of
      Sjögren's syndrome (SS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary SS diagnosed according to the revised American-European Consensus Group (AECG)
             criteria.

          -  Minimum score of 2 on the SGUS score for parotid and submandibular glands.

          -  EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥ 5.

          -  Positive serum titers of anti-SS-A and/or anti-SS-B antibodies.

          -  Symptomatic oral dryness score of at least 5 on patient questionnaire.

          -  Willingness to avoid pregnancy or fathering children based on protocol-defined
             criteria.

        Exclusion Criteria:

          -  Diagnosis of secondary SS according to the revised AECG criteria (eg, the presence of
             a previously diagnosed or a present diagnosis of rheumatoid arthritis, systemic lupus
             erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis,
             dermatomyositis, immunoglobulin G4-related disorder, sarcoidosis, or any other defined
             autoimmune rheumatologic disorder).

          -  Concurrent conditions and history of other diseases per protocol-defined criteria.

          -  Positive test results for tuberculosis (TB) from the QuantiFERON-TB Gold test or
             T-spot.TB test.

          -  Positive serology test results for HIV antibody, hepatitis B surface antigen,
             hepatitis B surface antigen antibody, HBV core antibody, or HCV (HCV antibody with
             positive HCV-RNA).

          -  Severely impaired liver function (Child-Pugh Class C).

          -  Prior or ongoing therapy with protocol-defined drugs.

          -  Receipt of any live vaccine in the 30 days before screening.

          -  No major surgery within 30 days before screening. Inadequate recovery from toxicity
             and/or complications from a major surgery before starting therapy.

          -  Current alcohol or drug use that, in the opinion of the investigator, will interfere
             with the participant's ability to comply with the dose regimen and study evaluations.

          -  Laboratory values at screening outside the protocol-defined ranges.
An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler
Intervention description: Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 229.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous completion of PDC-INS-0008 or MKC-TI-005

          -  Subjects must be able to attend all scheduled visits and, in the opinion of the
             Investigator, be able to complete this safety trial

          -  Subjects must be able to understand English or have access to validated primary
             language trial documents

          -  Written informed consent

        Exclusion Criteria:

          -  Drug or alcohol dependency

          -  Smokers (subjects are expected to remain non-smokers throughout their participation in
             this trial)

          -  Known hypersensitivity to the trial drug or to drugs of similar chemical structures

          -  Anemia (hemoglobin level < 11 g/dL for females or < 12 g/dL for males)

          -  Evidence of moderate or greater ketones in urine

          -  Women of childbearing potential practicing inadequate birth control. (Adequate birth
             control is defined as using oral contraceptives, condoms or diaphragms with
             spermicide, intrauterine devices, Depo-Provera, contraceptive patches or surgical
             sterilization)

          -  Women who are pregnant

          -  Clinically significant adverse events that remain unresolved from the previous trial
             and/or clinically significant abnormal laboratory values which are determined by the
             Investigator or the MKC Medical Monitor to be unsafe or confounding to continued
             participation
Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms
Condition: Aortic Aneurysm, Abdominal
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Intervention: 31 mm GORE EXCLUDER® AAA Endoprosthesis
Intervention description: GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER®
      AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infrarenal AAA > or equal to 4.5 cm in diameter

          -  Proximal infrarenal aortic neck length > or equal 15mm

          -  Anatomy meets 31mm EXCLUDER specification criteria

          -  Access vessel able to receive 20 Fr. introducer sheath

          -  Life expectancy >2 years

          -  Surgical candidate

          -  ASA Class I, II, III, or IV

          -  NYHA Class I, II, III

          -  21 years of age or older

          -  Male or infertile female

          -  Ability to comply with protocol requirements including follow-up

          -  Signed Informed Consent Form

        Exclusion Criteria:

          -  Mycotic or ruptured aneurysm

          -  Participating in another investigational device or drug study within 1 year

          -  Documented history of drug abuse within 6 months

          -  Coexisting thoracic aortic aneurysm (50% larger than proximal aorta)

          -  Myocardial infarction or cerebral vascular accident within 6 weeks

          -  Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate
             due to pulmonary function

          -  Renal insufficiency (Creatinine > 2.5 mg/dL) without dialysis

          -  Iliac anatomy that would require occlusion of both internal iliac arteries

          -  "Planned" occlusion or reimplantation of significant mesenteric or renal arteries

          -  "Planned" concomitant surgical procedure or previous major surgery within 30 days

          -  Previous prosthesis placement in the same position of the aorta or iliac arteries

          -  Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome

          -  Proximal neck angulation > 60 degrees

          -  Presence of significant thrombus at arterial implantation sites
Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension; Brinzolamide ophthalmic suspension, 1%; Brimonidine tartrate ophthalmic solution, 0.2%; Vehicle
Intervention description: Inactive ingredients used as placebo
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions; Brinzolamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-Angle Glaucoma; Ocular Hypertension; Brinzolamide; Brimonidine; Intraocular Pressure

Summary:

      The purpose of this study was to compare the safety and intraocular pressure (IOP)-lowering
      efficacy of a new fixed combination of brinzolamide/brimonidine (Brinz/Brim) to:

        -  its individual components (Brinz and Brim), and

        -  the concomitant administration of Brinz and Brim (Brinz+Brim).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign Informed Consent document.

          -  Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular
             pressure within protocol-specified range at eligibility visit/s.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Females of childbearing potential if pregnant, lactating, or not using highly
             effective birth control measures.

          -  Any form of glaucoma other than open-angle glaucoma.

          -  Severe central vision loss in either eye.

          -  Chronic, recurrent, or severe inflammatory eye disease.

          -  Ocular trauma within the preceding 6 months.

          -  Ocular infection or ocular inflammation within the preceding 3 months.

          -  Clinically significant or progressive retinal disease such as retinal degeneration,
             diabetic retinopathy, or retinal detachment.

          -  Best-corrected visual acuity score worse than 55 letters using the Early Treatment
             Diabetic Retinopathy Study chart.

          -  Other ocular pathology (including severe dry eye) that may, in the opinion of the
             Investigator, preclude the administration of study product.

          -  Ocular surgery within the preceding 6 months.

          -  Ocular laser surgery within the preceding 3 months.

          -  Any abnormality preventing reliable applanation tonometry.

          -  Any other conditions, including severe illness, which could make the patient, in the
             opinion of the Investigator, unsuitable for the study.

          -  Other protocol-specified exclusion criteria may apply.
A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients
Condition: Kidney Transplantation
Intervention: CP-690,550; CP-690,550; tacrolimus
Intervention description: 15 mg twice daily; 30 mg twice daily; dose adjusted according to level
Intervention MeSH terms: Tacrolimus; Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: tofacitinib; CP-690550; kidney transplant

Summary:

      This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of
      CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with
      basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant
      patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had
      completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the
      same treatment groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient of a first-time kidney transplant

          -  Between the ages of 18 and 70 years, inclusive

        Exclusion Criteria:

          -  Recipient of any non-kidney transplant
Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel; Dexamethasone; Estramustine; Zoladex; Casodex; Radical Prostatectomy
Intervention description: Given by an IV infusion over 1 hour on day 2 of a three-week cycle; Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel; Taken orally three times a day for 5 days for the first part of every three week cycle; Given subcutaneously for 4 doses every three months; Taken orally once a day for 6 months; after the chemo and hormonal therapy all patients have a radiacal prostatectomy
Intervention MeSH terms: Dexamethasone; Goserelin; Estramustine; Docetaxel; Bicalutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostatectomy; docetaxel

Summary:

      The purpose of this research study is to determine if the combination of chemotherapy and
      hormone therapy is safe and helpful for patients who plan to have their high-risk prostate
      cancer surgically removed. Some physicians believe that patients with high risk cancer that
      is located in one area, may have an early but small spread of the cancer outside of the
      prostate, and perhaps even to distant organs. Therefore, better treatments for the entire
      body are needed to improve the ability of surgery or other local therapies to cure prostate
      cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced
      prostate cancer patients, it is possible that using chemotherapy combined with hormonal
      therapy earlier in the course of localized but high risk patients might improve the outcomes
      for these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the prostate

          -  Potential candidate for radical prostatectomy

          -  Any of the following: a) clinical stage T3 patients, b) Serum PSA greater than or
             equal to 20 ng/ml, c) Gleason score 8-10, d) Clinical T2 disease and either MRI
             evidence of seminal vesicle involvement or Gleason 4+3 cancer with either 5 or 6
             biopsies positive

          -  ECOG Performance Status 0-1

          -  WBC > 3,000 ul

          -  HCT > 30%

          -  PLT > 100,000/ul

          -  LFTS within normal limits

        Exclusion Criteria:

          -  Prior hormones, radiation or chemotherapy for prostate cancer

          -  Myocardial infarction within 1 year, significant change in anginal pattern within last
             6 months, current congestive heart failure (NYHA Class 2 or higher), or deep venous
             thrombosis within 1 year

          -  Evidence of active infection

          -  Significant peripheral neuropathy
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS topical
Intervention description: topical treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following
      Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non pregnant, non lactating females

        Exclusion Criteria:

          -  Patients under 2 years of age
Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Intervention: DDAVP injection (desmopressin acetate)
Intervention description: 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes
Intervention MeSH terms: Deamino Arginine Vasopressin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: intracerebral hemorrhage; platelets

Summary:

      The investigators intend to show that DDAVP improves platelet activity from baseline to 60
      minutes after treatment start.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Spontaneous intracerebral hemorrhage as documented by head CT scan

          -  Documented regular aspirin use or VerifyNow-ASA result of ≤ 550 aspirin reaction units
             (ARU), indicating anti-platelet medication

        Exclusion Criteria:

          -  International normalized ratio (INR) of ≥ 1.7 from coagulopathy or warfarin use

          -  History of von Willebrand disease

          -  Pregnancy

          -  Known hypersensitivity to DDAVP or desmopressin

          -  Active cardiovascular disease or unstable angina

          -  Hyponatremia or history of hyponatremia

          -  Current or historical deep venous thrombosis or pulmonary embolism
A Study to Evaluate the Pharmacokinetics of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Applied in a Maximal Use Setting to the Dorsal Aspect of the Forearm in Patients With Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: PEP005 (ingenol mebutate) Gel, 0.05%; Vehicle Gel
Intervention description: PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days; Vehicle Gel once daily for 2 consecutive days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peplin; PEP005; Actinic Keratosis

Summary:

      This Phase II study is designed to evaluate the pharmacokinetics of PEP005 (ingenol mebutate)
      Gel, 0.05% when applied in a maximal use setting to the dorsal aspect of the forearm in
      patients with actinic keratoses
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female;

          -  Multiple actinic keratosis (AK) lesions over a 100 cm^2 area of skin located on the
             dorsal aspect of one forearm.

        Exclusion Criteria:

          -  Cosmetic or therapeutic procedures: within 2 weeks and within 2 cm of the selected
             treatment area(s);

          -  Treatment with immunomodulators, or interferon/interferon inducers or systemic
             medications that suppress the immune system: within 4 weeks;

          -  Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks
             and within 2 cm of the selected treatment area(s).