bioihbjkbjnl/mcl2 huggingface dataset:
The Jetstream G3™ Calcium Study
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Intervention: Jetstream Atherectomy System
Intervention description: to perform atherectomy on calcified lesions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: PAD, Peripheral Arterial Disease, Calcium, Atherectomy, Jetstream

Summary:

      To investigate the treatment effects with the Jetstream G3 System in moderate to severely
      calcified peripheral artery disease in the common femoral, superficial femoral or popliteal
      arteries using intravascular ultrasound (IVUS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient is ≥ 18 years of age.

          2. Patient has claudication determined to be due to femoropopliteal lesion(s) requiring
             revascularization.

          3. The target lesion(s) is/are located in the common femoral, superficial femoral or
             popliteal arteries.

          4. The reference vessel lumen (proximal to target lesion) is ≥ 3.0mm.

          5. The patient is an acceptable candidate for percutaneous intervention using the
             Jetstream G3 System in accordance with its labeled indications and instructions for
             use.

          6. The patient has signed approved informed consent.

          7. Moderate or severe vessel obstructive intraluminal calcification as demonstrated by
             IVUS and angiography.

        Exclusion Criteria:

          1. Patient has an uncontrollable allergy to nitinol, stainless steel or other stent
             materials or to contrast agent.

          2. Patient is unable to take appropriate anti-platelet therapy.

          3. Patient has no distal runoff vessels.

          4. Deep wall calcium.

          5. Interventional treatment is intended for in-stent restenosis at the peripheral
             vascular site.

          6. Patient has target vessel with moderate or severe angulation (e.g., >30 degrees) or
             tortuosity at the treatment segment.

          7. Patient has a history of coagulopathy or hypercoagulable bleeding disorder.

          8. Patient is receiving hemodialysis or has impaired renal function (creatinine is > 2.5
             mg/dl) at the time of treatment.

          9. Patient has evidence of intracranial or gastrointestinal bleeding within the past 3
             months.

         10. Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal
             organ within the past 14 days.

         11. Patient is pregnant or nursing a child.

         12. Intended interventional treatment includes planned laser, brachytherapy or atherectomy
             procedure other than the Jetstream G3 System.

             -
A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
Intervention description: Open-label Antara (fenofibrate) + open-label Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Intervention MeSH terms: Fenofibrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: omega-3-acid ethyl esters; Very high triglycerides; Lovaza; fenofibrate

Summary:

      This was a 24-month, open-label extension study that followed an 8-week double-blind study
      (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study
      LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid
      ethyl esters) and Antara (fenofibrate) would result in a greater reduction in serum
      triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone.
      This second extension of 24 months was to assess the continued efficacy of adjunctive Lovaza
      (omega-3-acid ethyl esters) [formerly known as Omacor] therapy in hypertriglyceridemic
      subjects treated with Antara (fenofibrate) in lowering serum triglyceride (TG) levels.
    

Eligibility criteria:

        Subjects were men and women who had successfully completed the previous open-label
        extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the
        original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a
        renewed waiver of a previously approved protocol deviation.

        Eligibility for entry into this study was based on the inclusion/exclusion criteria
        described of the double-blind LOV111859/OM5 protocol.

        Subjects were men and women who had successfully completed the previous open-label
        extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the
        original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a
        renewed waiver of a previously approved protocol deviation. The main eligibility criteria
        for LOV111859/OM5 were,

          -  18 to79 years of age (inclusive) at screening

          -  fasting serum TG levels ≥500 mg/dL and <1300 mg/dL

          -  BMI ≥ 25 kg/m2 and ≤43 kg/m2.

        Subjects enrolled directly from the end of LOV111860/OM5X into LOV111821/OM5XX.
Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Eslicarbazepine; Carbamazepine
Intervention description: Healthy adults will be titrated onto Eslicarbazepine Acetate (800mg daily) . After four weeks maintenance they will be tapered off and enter washout period, then crossed over to 2nd drug.; Healthy adults will be titrated onto Carbamazepine (400 mg bid). After four weeks maintenance they will be tapered off and enter washout period, then crossed over to 2nd drug.
Intervention MeSH terms: Carbamazepine; Eslicarbazepine acetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Eslicarbazepine; Carbamazepine; cognition

Summary:

      Double-blind, randomized, two period crossover comparison of the cognitive and behavioral
      effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adults between the ages of 18 and 55 years old.

          2. Male or female

        Exclusion Criteria:

          1. Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic,
             neurologic, psychiatric, or renal disease or pregnancy.

          2. Presence or history of drug or alcohol abuse.

          3. The use of concomitant medications, which are known to affect ESL or Carbamazepine or
             the use of any concomitant medications that may alter cognitive function (see Section
             VII.E for a partial list).

          4. Use of oral contraceptive hormones or other medications that could be affected by ESL
             or Carbamazepine.

          5. Prior adverse reaction to or prior hypersensitivity to either study medication or to
             related compounds.

          6. Prior participation in studies involving anticonvulsant medications.

          7. Subjects who have received any investigational drug within the previous thirty days.

          8. Subjects with IQ < 70 as determined by the Peabody Picture Vocabulary Test.

          9. Presence of HLA B*1502 in subjects of Asian descent; this will be obtained at
             screening in subjects of Asian descent.
Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
Condition: Dental Implant; Immediate Dental Implant; Soft Tissue Augmentation
Intervention: Immediate implant; SCTG; ADM
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the esthetic outcomes following immediate implant
      combined with the autogenous tissue graft or acellular dermal matrix compared to immediate
      implant alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who are in need of a tooth extraction at the maxillary premolar, canine and
             incisor region, and subsequent single implant placement.

          -  The reasons for extraction will include poor endodontic prognosis and/or unrestorable
             teeth (extensive caries, traumatic fractures, fractures of endodontically treated
             teeth, root perforation, root resorption with or without radiographic periapical
             lesion up to 3 mm in diameter). patients who are systemically healthy or with
             controlled common systemic conditions (controlled hypertension, controlled diabetes
             HbA1c up to 7 %).

          -  adjacent teeth have to be present and the eligible tooth has esthetically acceptable
             buccal gingival margin position prior to surgery, compared to neighboring teeth and
             contralateral tooth, and adequate width of buccal keratinized gingiva(≥3mm).

          -  level of radiographic bone level has the distance from CEJ to interproximal crest up
             to 4 mm.

          -  Location of buccal alveolar crest has to be generally within 4 mm from the free
             gingival margin, verified after the extraction, before randomization; and
             fenestration, if present, up to 3mm in diameter at the apical part of the root and
             affecting less than 30% of the buccal socket wall.

        Exclusion Criteria:

          -  currently smoke exceeding 10 cigarettes/ day

          -  severe parafunctional habits, malocclusion or intent of orthodontic therapy in the
             future and are pregnant.

          -  teeth in the surgical site will be excluded if there is advanced periodontal disease
             or periapical lesion causing significant bony defects that are beyond the criteria
             mentioned at Section 3.3.

          -  allergy to antibiotics contained in the ADM (Gentimicin, Cefoxitin, Lincomcin,
             polymixin B and Vancomycin) will not be included in the immediate implant combined
             with ADM group.
Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
Condition: Transplant Glomerulopathy
Intervention: Acthar gel
Intervention description: Administration of the study drug in addition to the current maintenance immunosuppressive agents
Intervention MeSH terms: Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is an open label safety and feasibility trial using Acthar® in addition to the
      investigators center-specific standard therapy, which could include increase in maintenance
      immunosuppression, high dose IVIG (intravenous immunoglobulin) (2 g/Kg), and/or Rituximab, in
      patients with chronic antibody-mediated rejection (CAMR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18 years

          -  Morphologic diagnosis of CAMR, by light &/or electron microscopy any time after
             transplantation

          -  Current or previously documented donor-specific antibody (DSA) and/or focal or diffuse
             peritubular capillary C4d staining by immunohistochemistry

          -  eGFR>25 ml/min

        Exclusion Criteria:

          -  Diagnosis of malignancy within a year prior to enrollment (except cured cutaneous
             basal cell or squamous cell carcinoma).

          -  Lack of evidence of antibody involvement

          -  Pregnancy, lactation, or refusal to use birth control in women of child bearing
             potential

          -  Active infection, or history of HIV

          -  History of liver or thoracic transplant
The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease
Condition: Hypertension; Coronary Artery Disease
MeSH terms: Hypertension; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Nebivolol; Carvedilol
Intervention description: Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily; Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily
Intervention MeSH terms: Carvedilol; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: carvedilol; Coreg (TM); hypertension; blood pressure; coronary artery disease; Nebivolol; BYSTOLIC (TM)

Summary:

      This study is being done to see if the blood pressure lowering effect of an approved drug
      nebivolol is comparable to that of another approved drug carvedilol for the treatment of
      hypertension in patients who have coronary artery disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ambulatory outpatients 18 to 85 of age at screening

          -  Coronary artery disease as defined by: status post myocardial infarction (heart
             attack) greater than 14 days post event with no upper time limit (and followed by
             stress testing with additional imaging (echocardiographic or nuclear) within the 12
             months prior to enrollment) and/or angiographic evidence of one or more major coronary
             arteries narrowing of greater than 50% and/or a history of percutaneous or surgical
             coronary revascularization greater than 4 months after that procedure at the time of
             enrollment.

          -  Qualifying blood pressure criteria for study entry and for randomization

          -  Willing to adhere to exercise stress (treadmill) tests

        Exclusion Criteria:

          -  Unstable angina within 7 days of screening

          -  Potential coronary surgical/intervention within the next 6 months

          -  Have any form of secondary hypertension

          -  Have a history of hypersensitivity to nebivolol, metoprolol, carvedilol, or any beta
             blocker
Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: N1539
Intervention description: Once daily
Intervention MeSH terms: Meloxicam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: meloxicam; pediatric

Summary:

      This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539
      in postoperative Pediatric subjects aged 2 to <17 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 2 to <17 years of age before dosing on Day 1

          -  Eligible for elective surgery that will be performed according to standard surgical
             technique under appropriate anesthesia

          -  Be premenarche or have confirmed negative urine pregnancy testing before surgery on
             Day 1, if an adolescent female of childbearing potential

          -  Willing and able to cooperate with all the requirements of the study; including
             providing appropriate informed consent/assent

        Exclusion Criteria:

          -  Have a known allergy or hypersensitivity to meloxicam, aspirin, other non-steroidal
             anti-inflammatory drugs (NSAIDs), or any excipient of N1539

          -  Have a known bleeding disorder that may be worsened with the administration of an
             NSAID

          -  Be undergoing cardiothoracic surgery

          -  Has used meloxicam within 7 days before the surgical procedure on Day 1

          -  Has any clinically significant medical history or clinical manifestations of
             significant disease or any other condition that increases the risk associated with the
             subject's participation in the study or compromises the scientific objectives of the
             study.
The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon
Condition: Raynaud Phenomenon
MeSH terms: Raynaud Disease
Intervention: AbobotulinumtoxinA; Saline solution
Intervention description: AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution; Non-bacteriostatic saline solution
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a two-arm parallel assignment involves two groups of participants. One group/hand receives the abobotulinum toxin A, and the other group/hand receives a saline solution (control).
Masking: Double (Participant, Investigator)
Masking description: This is a double-blind placebo-controlled trial.
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Raynaud Phenomenon; AbobotulinumtoxinA

Summary:

      This study aims to investigate the effect of abobotulinum toxin A on the symptoms of
      Raynaud's phenomenon.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adult between 18 and 80 years of age

          -  Must have health insurance

          -  Must have a current diagnosis of Raynaud's phenomenon

        Exclusion Criteria:

          -  Allergy to abobotulinum toxin A or its components

          -  Diagnosis of myasthenia gravis

          -  Previously received abobotulinum toxin vaccine

          -  Previously undergone upper extremity vascular surgery (including surgical
             sympathectomy)

          -  Currently receiving aminoglycoside antibiotics

          -  Received abobotulinum toxin A treatment in either hand in the past 6 months

          -  Pregnant women

          -  Women currently breastfeeding

          -  Current tobacco smoker (use in the past 12 months)

          -  Unable to read and speak English

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Prisoners
Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)
Condition: Atrial Flutter
MeSH terms: Atrial Flutter
Intervention: Gold tip catheter; Platinum-iridium tip catheter
Intervention description: Radiofrquency ablation using gold tip catheter; Radiofrequency ablation using platinum-iridium tip catheter
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Transvenous Catheter Ablation; Radiofrequency Catheter Ablation; Atrial flutter; Catheter Ablation

Summary:

      The purpose of this study is to demonstrate the advantage of using a gold alloy tip electrode
      over a platinum/iridium alloy tip electrode in ablation of the cavotricuspid isthmus in
      patients with atrial flutter.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least one electrocardiogram (ECG)-documented (can be older than 3 months),
             symptomatic, typical atrial flutter episode with either negative, sawtooth-shaped
             P-waves in leads II, III, and augmented voltage foot (aVF), or positive P-waves in
             leads II, III, and aVF

          -  At least one persistent, typical atrial flutter episode of over 2 hours that has been
             documented in the history in the patient file and/or ECG

          -  Signed informed consent form

        Exclusion Criteria:

          -  Patient has recently undergone isthmus ablation

          -  Acute coronary syndrome or myocardial infarction within the last 3 months

          -  Acute reversible causes for atrial flutter (e.g. acute myocarditis)

          -  Severe cardiac valvular defects

          -  Tricuspid valve replacement

          -  Atrial septum defect

          -  Cardiovascular surgery scheduled within the next 6 months

          -  Unstable medication in the last 7 days before study inclusion

          -  New York Heart Association (NYHA) class IV

          -  Women who are breastfeeding

          -  Pregnancy

          -  Abuse of drugs or alcohol

          -  Patient is unable to participate in follow-up examinations

          -  The patient has only partial legal competence

          -  Participation in another clinical study

          -  The ablation procedure presents an above average risk to the patient as compared to
             the normal patient group (must be noted by the physician on the appropriate form).

          -  Right atrial thrombus

        Late Exclusion Criteria:

          -  Patient included by accident

          -  Premature termination of the ablation procedure

          -  Atrial flutter not dependent on the posterior isthmus

          -  No conduction at the posterior isthmus before ablation