bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease
Condition: Chronic Kidney Disease; High Cholesterol
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypercholesterolemia
Intervention: Atorvastatin
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic kidney disease; High cholesterol

Summary:

      The purpose of this study is to see if patients with chronic kidney disease have endothelial
      cells that don't function properly, which is thought to be a marker for cardiovascular risk.
      Endothelial cells line the heart and blood vessels. The investigators will treat your high
      cholesterol with a cholesterol-lowering drug (atorvastatin, or Lipitor). They will determine
      if this cholesterol lowering drug improves subjects' cholesterol as well as the function of
      endothelial cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage 3, 4 and 5 chronic kidney disease (not on dialysis)

          -  Hyperlipidemia requiring cholesterol lowering therapy

          -  Aged 18 to 80 years old

          -  Ability to provide informed consent

        Exclusion Criteria:

          -  Patients requiring multiple cholesterol reducing agents

          -  Patients with neovascularization present, such as neoplasm, active wounds, or
             significant retinopathy

          -  Patients with contraindications or allergy to statins
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
Condition: Preterm Birth; Child Development; Child Behavior
MeSH terms: Premature Birth
Intervention: LCPUFA oil supplement; Canola Oil Placebo
Intervention description: 2.5mL per day for 90 days
Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg); 2.5mL per day for 90 days
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Months
Maximum age: 39 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to examine whether supplementation with certain polyunsaturated
      fatty acids can help development and behavior of children born preterm.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Child born at less than or equal to 29 completed weeks' gestation;

          2. Child between 18 months, 0 days and 38 months, 30 days old chronological age;

          3. Child admitted to NICU and/or had a Neonatology Clinic follow up visit scheduled.

          4. Child showing some autistic symptoms;

          5. Child between the 5th and 95th percentiles (per WHO growth chart) for weight at
             his/her most recent hospital visit;

          6. English spoken in the home, demonstrate ability to communicate in English well-enough
             to understand study, informed consent, and study questionnaires; and

          7. Have informed consent on file.

        Exclusion Criteria:

          1. Consume LCPUFA supplement drops, chews, powders, Pediasure, or fatty fish more than 2x
             per week;

          2. Unable to tolerate venipuncture;

          3. Any major malformation that would preclude participation;

          4. Cerebral Palsy (quadriparesis only);

          5. Deafness;

          6. Blindness;

          7. Bleeding disorder;

          8. Type I diabetes;

          9. Fragile X Syndrome, Rett Syndrome, Angelman Syndrome, Tuberous Sclerosis;

         10. Non febrile seizure in the last month without a clear and resolved etiology;

         11. Feeding problem that may inhibit full participation;

         12. Known fish allergy;

         13. Known canola/rapeseed allergy or sensitivity; or

         14. Recorded score of <70 on Bayley Cognitive Section within the past year.
Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin
Condition: Skin Manifestations
MeSH terms: Skin Manifestations
Intervention: metronidazole 1% gel; azelaic acid 15% gel
Intervention description: Apply topically on one side of the face once daily for three weeks; Apply topically on the opposite side of the face twice daily for three weeks
Intervention MeSH terms: Metronidazole; Azelaic acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1%
      to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product
      labeling for three weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female adults (ages 18 years or older)

          -  Subjects with healthy skin as determined by the clinical grader

        Exclusion Criteria:

          -  Subjects with a degree of skin pigmentation that interferes with the reading of skin
             reactions

          -  Subjects with known allergy to one of the components of the study drugs (refer to the
             package inserts for MetroGel® 1% and Finacea® Gel 15%)

          -  Subjects who have participated in another investigational drug or device research
             study within 30 days of enrollment

          -  Subjects with a washout period for topical treatment on the treated area less than 1
             week for corticosteroids and/or 4 weeks for retinoids

          -  Subjects with a washout period for systemic treatment less than 1 week for medications
             that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months
             for retinoids

          -  Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis,
             rosacea, or other topical conditions on the area to be treated

          -  Subjects who foresee unprotected and intense UV exposure during the study (mountain
             sports, UV radiation, sunbathing, etc.)
Assessment of Patients Treated With JETREA® for Vitreomacular Traction
Condition: Vitreomacular Traction; Vitreomacular Adhesion
MeSH terms: Tissue Adhesions
Intervention: Ocriplasmin
Intervention description: 0.5 mg/0.2 mL solution for injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 628.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitreomacular traction; Symptomatic vitreomacular adhesion; Ocriplasmin; JETREA

Summary:

      The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin
      (JETREA®) over a 6-month follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (VMT/sVMA),
             with evidence of focal VMA visible on Spectral Domain Optical Coherence Tomography
             (SD-OCT).

          -  Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed
             consent form.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential if pregnant, breastfeeding, or not in agreement to use
             adequate birth control methods to prevent pregnancy throughout the study.

          -  Hypersensitivity to ocriplasmin or any of the JETREA® excipients.

          -  Active or suspected intraocular or periocular infection.

          -  Presence of Epiretinal Membrane (ERM) over the macula at baseline.

          -  Broad VMT/VMA >1500 microns at baseline.

          -  History of vitrectomy in the study eye.

          -  History of laser photocoagulation to the macula in the study eye.

          -  Any relevant concomitant ocular condition that, in the opinion of the investigator,
             could be expected to worsen or require surgical intervention during the study period.

          -  Macular hole of >400µm diameter in the study eye.

          -  High myopia in the study eye.

          -  Pseudo-exfoliation, Marfan's syndrome, phacodonesis or any other finding in the
             Investigator's opinion suggesting lens/zonular instability.

          -  Aphakia.

          -  History of retinal detachment.

          -  Diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions.

          -  Recent ocular surgery or ocular injection.

          -  Vitreous hemorrhage.

          -  Exudative age-related macular degeneration (AMD).

          -  Therapy with another investigational agent within 30 days prior to Visit 1.

          -  Active, simultaneous enrollment in another ophthalmology clinical study.

          -  Other protocol-defined exclusion criteria may apply.
Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR)
Condition: Aortic Stenosis; Inflammation; Thrombosis
MeSH terms: Thrombosis; Aortic Valve Stenosis; Inflammation; Constriction, Pathologic
Intervention: Clopidogrel; Ticagrelor
Intervention description: Standard ADP receptor blockade; High potency ADP receptor blockade
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The central hypothesis of this study is that TAVR leads to platelet deposition and
      inflammatory cell activation that can be attenuated by the potent anti-platelet and/or
      pleiotropic effects of ticagrelor.

      This single center, prospective randomized trial addresses the following specific aims:

        1. To determine whether high-potency ADP receptor blockade reduces measures of platelet
           activation in patients after TAVR.

        2. To determine whether high-potency ADP receptor blockade mitigates the pro-thrombotic
           inflammatory response observed after TAVR.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Valvular heart disease and a clinical indication for TAVR

          2. Age of 18 years or older

          3. Capable of informed consent

          4. Planned transfemoral TAVR

        Exclusion Criteria:

          1. Prior history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage

          2. Established bleeding diathesis or thrombocytopenia (<150k/dl)

          3. End-stage renal disease

          4. Severe hepatic impairment or liver cirrhosis

          5. Pregnancy

          6. Current infection

          7. History of autoimmune disease

          8. Established allergy to contrast agents, thienopyridines, aspirin, or ticagrelor

          9. History of solid organ transplantation

         10. Atrial Fibrillation, DVT, PE or other indication for long term anti-coagulation

         11. Plan for direct aortic access or trans-apical TAVR

         12. Enrollment in another clinical trial

         13. Recent (< 12 months) or active excessive bleeding
A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.
Condition: Echocardiography
Intervention: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)
Intervention description: The recommended dose of Optison is 0.5mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed.
The injection rate should not exceed 1mL per second. Follow the Optison injection with a flush of 0.9% sodium chloride injection, USP or 5% dextrose in water injection, United States Pharmacopeia (USP) .
The maximum total dose should not exceed 5.0mL in any 10 minutes period. The maximum total dose should not exceed 8.7mL in any one patient study.
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1039.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Surveillance; Optison; Perflutren; Echocardiography; Subjects receive Optison during enhanced echocardiography

Summary:

      This prospective surveillance trial will gather safety information for Optison when it is
      used in routine practice.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is over 18 years old.

          -  The subject has been scheduled for an Optison-enhanced echocardiography exam.

          -  The subject has provided signed and dated informed consent.

        Exclusion Criteria:

          -  Known hypersensitivity to perflutren, blood, blood products or albumin.
Ketamine Effect After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
Condition: Pain; Obesity; Hypoxia
MeSH terms: Hypoxia
Intervention: Ketamine; placebo
Intervention description: Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).; Group P (placebo) will receive the same amount of saline.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Quality of Recovery 40 Questionaire; Pain; Hypoxia; Gastric Surgery; Obesity; Ketamine

Summary:

      Laparoscopic surgery for gastric reduction is frequently associated with high levels of
      postoperative pain. Postoperative pain is very often treated with opioids. However large
      doses of opioids can result in respiratory depression with hypoxemia especially in high risk
      patients with obstructive sleep apnea. since a large group of patients undergoing surgery for
      gastric reduction surgery also have obstructive sleep apnea, it is expected that these
      patients are also at high risk for postoperative respiratory depression and hypoxemia.

      Intraoperative ketamine has been used as an effective multimodal agent to reduce
      postoperative pain. However, ketamine alone has not been examined to improve postoperative
      pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is
      unknown if the use of intraoperative ketamine can lead to better overall quality of recovery
      in the same patient population. In addition, ketamine has been shown to improve ventilation
      but it remains to be determined if the intraoperative use of ketamine will result in less
      postoperative hypoxemic events.

      The main objective of the current investigation is to examine the effect of intraoperative
      ketamine on postoperative quality of recovery after gastric reduction surgery. The
      investigators hypothesize that subjects receiving ketamine will have a greater global quality
      of recovery score than the ones receiving saline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-64

          -  surgery: laparoscopic gastric reduction (gastric sleeve or gastric bypass)

          -  ASA physical status classification I, II, III

          -  Body Mass Index >35kg/m2

          -  Fluent in English

        Exclusion Criteria:

          -  History of allergy to protocol medications

          -  History of chronic opioid use

          -  Pregnant patients

          -  Drop out: Conversion to an open surgical route, patient or surgeon request.
Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Placebo; Milnacipran
Intervention description: Placebo tablets administered orally twice daily; Milnacipran tablets administered orally twice daily
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 340.0
Sex: All
Healthy volunteers: No
Keywords: Milnacipran; Pain; Durability of Effect; Loss of Therapeutic Response; Fatigue; Forest Research Institute; Savella ®

Summary:

      The purpose of this study is to evaluate the durability of effect of milnacipran for the
      treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to
      characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated
      by changes in symptoms following the discontinuation of milnacipran.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently participating in Study MLN-MD-06

          -  Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit
             1)

        Exclusion Criteria:

          -  Significant risk of suicide

          -  History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current
             episode of major depressive disorder

          -  Myocardial infarction and/or stroke within the prior 12 months

          -  Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg
             at Screening (Visit 1)

          -  Active liver disease

          -  Severe renal impairment

          -  Platelet and bleeding disorders

          -  Female patients who are pregnant or breastfeeding
Cryptococcal Optimal ART Timing Trial
Condition: Cryptococcal Meningitis; HIV Infections; AIDS
MeSH terms: Meningitis, Cryptococcal; Meningitis
Intervention: efavirenz; nucleoside
Intervention description: Treatment strategy of when to initiate first line HIV therapy after cryptococcal meningitis diagnosis.; Treatment strategy of when to initiate first line HIV therapy after cryptococcal meningitis diagnosis.
Intervention MeSH terms: Lamivudine; Zidovudine; Efavirenz; Stavudine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 14 Years
Healthy volunteers: No
Keywords: cryptococcal meningitis; cryptococcus; cryptococcosis; HIV; AIDS; strategy

Summary:

      The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal
      meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital
      discharge results in superior survival compared to standard initiation of ART started as an
      outpatient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-infection, documented by ELISA

          -  Antiretroviral medication naïve (excluding mother-to-child transmission therapy)

          -  Age >14 years

          -  Cryptococcal meningitis diagnosed by either culture or CSF cryptococcal antigen (CRAG)

          -  Ability and willingness of the participant or legal guardian/representative to give
             informed consent.

          -  Receiving amphotericin-based anti-fungal therapy

        Exclusion Criteria:

          -  Study entry prior to receipt of <7 days or >11 days of amphotericin therapy

          -  History of prior, known cryptococcal meningitis

          -  Inability to take enteral medication

          -  Receiving chemotherapy or other immunosuppressant medications

          -  Cannot or unlikely to attend regular clinic visits

          -  Contraindication to immediate or delayed HIV therapy based on serious co-morbidities
             or co-infections, or laboratory values

          -  Pregnancy or Breastfeeding

          -  Female participants of childbearing potential who are participating in sexual activity
             that could lead to pregnancy must agree to use two reliable methods of contraception
Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Venlafaxine ER; Dialogues Time to Talk Program
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 537.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Depression; Anxiety

Summary:

      The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in
      subjects treated with Venlafaxine Extended Release (ER). Dialogues Time to Talk Program is a
      patient management program, which aims to help patients achieve successful outcomes by
      reinforcing physician treatment efforts, providing feedback to treating physicians, and
      encouraging better physician-patient communications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently experiencing a major depressive episode, which requires the initiation of
             antidepressant drug treatment or a change in current antidepressant drug treatment

          -  At least 18 years of age

        Exclusion Criteria:

          -  History or presence of bipolar disorder

          -  Current treatment with venlafaxine
A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
Condition: Colorectal Cancer
MeSH terms: Colonic Neoplasms
Intervention: capecitabine [Xeloda]
Intervention description: 1250mg/m2 po bid on days 1-14 of each 3 week cycle
Intervention MeSH terms: Capecitabine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 228.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant
      treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as
      intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week
      without treatment). The anticipated time on study treatment is 3-12 months, and the target
      sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  colon cancer (Dukes stage C);

          -  surgery, with no evidence of remaining tumor;

          -  ECOG performance status of <=1.

        Exclusion Criteria:

          -  previous therapy for currently treated colon cancer;

          -  any evidence of metastatic disease;

          -  history of other malignancy within last 5 years;

          -  clinically significant cardiac disease.