bioihbjkbjnl/mcl2 huggingface dataset:
An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
Condition: Gout
MeSH terms: Inflammation
Intervention: Magnetic Resonance Imaging; Febuxostat; Colchicine
Intervention description: An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).; All subjects in the sub-study will be started on febuxostat 40mg daily at baseline. If their serum urate level is > 6.0 at months 1 or 3, then the febuxostat dose will be increased to 80mg daily.; Colchicine will be dosed at 0.6mg by mouth BID for the first three months then 0.6mg daily from months 3 to 6, and then discontinued at month 6.
Intervention MeSH terms: Colchicine; Febuxostat
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gout; Synovial pannus; Magnetic resonance imaging

Summary:

      The purpose of this study is to show that patients with gout suffer from chronic inflammation
      of their joints, observable by MRI, even in the absence of symptomatic gouty attacks.
      Secondary end-points of this study will include analyzing the effects of uric acid-lowering
      therapy (specifically with the FDA approved medication Febuxostat) in a subgroup of patients,
      checking for the presence of inflammatory markers to see if there is any correlation with the
      proposed chronic inflammation, and evaluating for other characteristic findings of gout on
      MRI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age > or = 18 - Open ended to both males and females.

          2. Have a known history of gout diagnosed by current or previous documentation of
             intracellular MSU crystals in synovial fluid, a tophus proved to contain MSU crystals,
             or at least six of the twelve ACR diagnostic criteria for gout (see appendix with the
             12 diagnostic criteria of gout).

          3. English of Spanish speaking

          4. Able to give informed consent

        Exclusion Criteria:

          1. Age < 18.

          2. Unable to give informed consent.

          3. Do not speak or write in English or Spanish.

          4. History of any other inflammatory arthritis.

          5. History of another crystal induced arthritis.

          6. Serum creatinine >1.8 mg/dL

          7. Patients taking oral corticosteroids (any dose) [or within 4 weeks]

          8. Parenteral or intraarticular corticosteroids within 6 weeks

          9. Allergy to gadolinium contrast dye

         10. Any contraindication to receiving a MRI

         11. Pregnant women

         12. Allergy to febuxostat (Uloric) or colchicine [substudy subjects only]
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
Condition: Constipation
MeSH terms: Constipation
Intervention: Lubiprostone; Lubiprostone; Lubiprostone
Intervention description: 12 mcg capsule once daily (QD); 12 mcg capsule twice daily (BID); 24 mcg capsule twice daily (BID)
Intervention MeSH terms: Lubiprostone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a
      pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a
      subset of patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Less than 18 years of age

          -  Weight of at least 12 kg and capable of swallowing a capsule

          -  Able to refrain from use of medications known to treat or associated with constipation
             symptoms

          -  Stable fiber therapy or ADHD therapy if using such medications

          -  Patient/Caregiver able to complete daily diary

          -  Patient able to use recommended rectal and/or oral rescue medications if needed

        Exclusion Criteria:

          -  Constipation is associated with some medical, anatomic, physical, organic, or other
             condition

          -  Hirschsprung's Disease or Nonretentive Fecal Incontinence

          -  Untreated fecal impactions or impactions requiring digital manipulation

          -  Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator
             discretion

          -  Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or
             unexplained weight loss

          -  Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric
             disorder, other systemic disease, or abnormal laboratory tests at the investigator
             discretion

          -  If female, is currently pregnant or nursing, or plans to become pregnant or nurse
             during the clinical study

          -  Sexually active males and females must utilize acceptable birth control methods

          -  Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211
Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification
Condition: Cataracts
MeSH terms: Cataract
Intervention: Moxifloxacin; besifloxacin
Intervention description: One drop 4 times daily for 3 days and one drop the day of sample collection; One drop 4 times daily for 3 days and one drop on day of sample collection
Intervention MeSH terms: Moxifloxacin; Besifloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare drug concentrations in aqueous humor following ocular
      instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man or woman 18 years of age or older.

          -  Physically capable of instilling eye drop or have an appropriate person available to
             assist in administration of eye drops 4 times a day.

          -  Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the
             treatment of cataract.

          -  Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be
             medically cleared for surgery.

          -  Willing to adhere to the prohibitions and restrictions specified in this protocol.

          -  Subjects must have signed an informed consent document indicating that they understand
             the purpose of and procedures required for the study and are willing to participate in
             the study.

        Exclusion Criteria:

          -  Known allergy or contraindication to the test article(s) or their components.

          -  Presence of any abnormality or significant illness in the eye that in the
             investigator's opinion could affect the subject's health or the study parameters.

          -  Presence of an active ocular infection (bacterial, viral or fungal), or positive
             history of ocular herpetic infection.

          -  History of any significant illness that could be expected to interfere with the study
             parameters. Any condition that, in the opinion of the investigator, would compromise
             the well-being of the subject or the study.

          -  Use of disallowed therapies (systemic or topical):

               -  Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of
                  Visit 1 or anytime after Visit 1 for the duration of the study.

          -  Use of contact lenses for one week prior to the study and for the duration of the
             study.

          -  Received an experimental drug or used an experimental medical device within 10 days
             before the planned start of treatment.

          -  Breast-feeding
Comparison of Bacteriostatic Saline to Buffered Lidocaine for Ultrasound Guided Hip Joint Injection Local Anesthesia
Condition: Hip Pain
Intervention: bacteriostatic saline; buffered lidocaine
Intervention MeSH terms: Lidocaine; Benzyl Alcohol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare infiltration pain and anesthetic efficacy between
      lidocaine and Bacteriostatic saline (BS) for ultrasound (US) guided intraarticular hip
      injections.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  age 18-75 years

          -  referred for US-guided intraarticular hip injections in the Mayo Clinic Sports
             Medicine Center, Physical Medicine & Rehabilitation Clinic, or Musculoskeletal Clinic

        EXCLUSION CRITERIA:

          -  chronic opioid use

          -  opioid use on day of procedure

          -  history of fibromyalgia or other diffuse chronic pain syndrome

          -  pain behavior during the clinical encounter as judged by the injectionist

          -  anesthetic administration time outside the designated 5-15 second time frame
Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Risedronate/Cholecalciferol combination; Risedronate
Intervention description: Risendronate/Cholecalciferol combination once a week; Risedronate once a week
Intervention MeSH terms: Cholecalciferol; Vitamin D; Risedronic Acid; Etidronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1053.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Risedronate, cholecalciferol, BMD

Summary:

      The purpose of this study is to evaluate the efficacy and the safety of Risedronate,
      cholecalciferol combination tablet in patients with Osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male osteoporosis patients over 19 years of age

          2. Female osteoporosis patients with menopause

               -  Definition of osteoporosis

                    -  They had a BMD T-score -2.5 or less at mean Lumbar spine(L1-L4), Femoral
                       neck or total. Or evidence of at least one vertebral fracture

               -  Definition of menopause(can be one of three condition)

                    -  For 12months spontaneous amenorrhea

                    -  For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating
                       hormone) is 40mlU/mL and over

                    -  6weeks after bilateral ovariectomy whether hysterectomy or not.

        Exclusion Criteria:

          1. Patients with esophagus disorder (i.e:esophagostenosis)

          2. Patients administered with osteoporosis therapy(except calcium, Vit.D
             medication)within the previous 3 Months

          3. Patients with serum calcium concentrations 8.0mg under

          4. Patients with severe nephropathy (CCr 30mL/min less)

          5. Patients with unable to sit upright or stand for 30minutes
Azithromycin in Bronchiolitis Obliterans Syndrome
Condition: Bronchiolitis Obliterans Syndrome; Graft Rejection; Lymphocytic Bronchiolitis; Respiratory Infection
MeSH terms: Bronchiolitis; Respiratory Tract Infections; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome; Syndrome
Intervention: Azithromycin; Placebo
Intervention description: Azithromycin 250 mg daily during 5 days followed by 250 mg three times a week on Mon., Wed. and Fri. during study-period.; Placebo once daily during 5 days, followed by one placebo three times a week on Mon., Wed. and Fri during rest of study-period.
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bronchiolitis Obliterans Syndrome; Acute allograft Rejection; Lymphocytic bronchiolitis; Respiratory infection; Survival; Mortality; Pulmonary function; FEV1; Broncho-alveolar lavage; Neutrophils; Interleukin; Culture; Azithromycin

Summary:

      Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans
      Syndrome after lung transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable LTx recipients at discharge after transplantation.

          -  Signed informed consent

          -  Adult (age at least 18 years old at moment of transplantation)

          -  Able to take oral medication

        Exclusion Criteria:

          -  Prolonged and/or complicated ICU-course after transplantation.

          -  Early (<30 days post-transplant) post-operative death

          -  Major suture problems (airway stenosis or stent)

          -  Retransplantation (lung)

          -  Previous transplantation (solid organ)

          -  Multi-organ transplantation (lung+ other solid organ)
Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers
Condition: Bleeding Peptic Ulcer
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Intervention: argon plasma coagulation; hemoclipping
Intervention description: Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan); clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention device: argon plasma coagulation ( (PSD-60/Endoplasma, Olympus Corp., Tokyo,Japan) ; hemoclipping (Olympus HX 110/610) Intervention drug: distilled water design setting: argon plasma coagulation plus distilled water injection vs hemoclipping plus distilled water
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: argon plasma coagulation; hemoclipping; distilled water injection

Summary:

      Endoscopic treatment is recommended for initial hemostasis in nonvariceal upper
      gastrointestinal bleeding. However, the additional hemostatic efficacy of argon plasma
      coagulation (APC) has not been widely investigated. We designed a randomized trial comparing
      APC plus injection therapy vs hemoclipping plus injection therapy for peptic ulcer bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

        ． high-risk peptic ulcer bleeding. High-risk bleeding ulcers were defined as participants
        with stigmata of a bleeding visible vessels (eg, spurting, oozing), a non-bleeding visible
        vessels (NBVV) or adherent clot.4 A NBVV at endoscopy was defined as a raised red, red-blue
        or pale hemispheric vessel protruding from the ulcer bed, without active bleeding. An
        adherent clot was defined as an overlying blood clot that was resistant to vigorous
        irrigation.

        Exclusion Criteria:

          -  the presence of another possible bleeding site (eg, gastroesophageal varix, gastric
             cancer, reflux esophagitis)

          -  coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial
             infarction, surgical abdomen)

          -  treatment with an anticoagulant (eg, warfarin)

          -  pregnancy

          -  the presence of operated stomach

          -  refusal to participate in the study
Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa
Condition: HIV; Impaired Cognition
MeSH terms: Cognitive Dysfunction
Intervention: standard care; novel treatment
Intervention description: atazanavir 300 mg daily
ritonavir 100 mg daily
tenofovir 245 mg daily*
emtricitabine 200 mg daily*; darunavir 800 mg daily
ritonavir 100 mg daily
lamivudine 300 mg daily** and abacavir 600mgs daily**
maraviroc 150 mg once daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV

Summary:

      The purpose of this study is to compare two different combination anti-HIV therapies over 48
      weeks and to assess if differences in improvement in the function of the brain are observed
      over this period.

      The study will compare anti-HIV therapy combinations which are currently in use.

      The patients will not have had any previous treatment for their HIV infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected males or females

          -  signed informed consent

          -  no previous antiretroviral treatment since HIV diagnosis

          -  screening CD4+ lymphocyte count <= 350 cells/ųL

          -  susceptible to all currently licensed (Nucleoside Reverse Transcriptase Inhibitors)
             NRTIs, (Non-Nucleoside Reverse Transcriptase Inhibitors) NNRTIs and PIs based on HIV-1
             genotypic resistance report

          -  CCR5-tropic HIV based on genotypic resistance testing*

        Exclusion Criteria:

          -  • existing neurological disease

               -  hepatitis B or hepatitis C co-infection

               -  age under 18 years

               -  screening laboratory parameters > grade 2 (with the exception of cholesterol and
                  triglycerides)

               -  current history of major depression or psychosis

               -  recent head injury (past three months)

               -  current alcohol abuse or drug dependence

               -  active opportunistic infection or significant co-morbidities

               -  patients who are receiving other concomitant medication which are not permitted,
                  as listed in appendix 2

               -  female patients of child-bearing potential who:

                    -  have a positive serum pregnancy test at screening or during the study

                    -  are breast feeding

                    -  are planning to become pregnant

               -  all participants unwilling to use a barrier method of contraception

               -  patients who in the opinion of the investigator are not candidates for inclusion
                  in the study
Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
Condition: Obesity
Intervention: Tigecycline
Intervention description: 100 mg IV as a single infusion over 30 minutes
Intervention MeSH terms: Tigecycline
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      If tigecycline clearance increases with body size then serum exposure values will be lower in
      obese class III compared to normal weight subjects because exposure changes inversely with
      clearance when the dose is fixed without regard to weight.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects fulfilling the following criteria will be eligible:

          1. males and females, 18 to 50 years of age;

          2. non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers;

          3. Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III);

          4. female subjects of childbearing potential (self-reported) either surgically
             sterilized, using an effective method of contraception (diaphragm, cervical cap,
             condom) or agree to abstain from sex from time of prestudy screening, during entire
             study period and 1 month following the study period

        Exclusion Criteria:

          1. history of significant hypersensitivity reaction to any components of Tygacil®;

          2. history of significant clinical illness requiring pharmacological management;

          3. history of blood donation in the past eight week period;

          4. abnormal serum electrolyte or complete blood count requiring further clinical work-up;

          5. transaminases (AST or ALT) > 2.5 x upper limit of normal;

          6. subjects with stage 4 or 5 chronic kidney disease;

          7. positive serum pregnancy test (if female);

          8. abnormal electrocardiogram (ECG) as judged by study physician;

          9. unable to tolerate venipuncture and multiple blood draws;

         10. clinically significant abnormal physical examination defined as a physical finding
             requiring further clinical work-up;

         11. unable to independently provide a written informed consent.