bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Arctic Front® Cryoablation Catheter; Flecainide or Sotalol or Propafenone
Intervention description: Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system.; Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day
Intervention MeSH terms: Flecainide; Sotalol; Propafenone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation

Summary:

      This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical
      investigation conducted at 26 investigational sites in the United States and Canada. Subjects
      with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy
      failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or
      sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a
      Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and
      symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic
      electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated
      trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90
      days after study therapy was initiated was considered a blanked period for all subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented Paroxysmal Atrial Fibrillation (PAF): PAF diagnosis, 2 episodes of PAF
             within the last 2 months, at least 1 episode of PAF must be documented

          -  Age 18-75

          -  Documented Effectiveness Failure of one (1) AF drug

          -  Willing to be randomized to either group and do full 12 month follow-up

          -  Able to follow standardized AF drug protocol

        Exclusion Criteria:

          -  Any cardioversion within 3 months or more than 2 within 2 years

          -  Amiodarone within 6 months

          -  LA size > 5.0cm

          -  Previous LA ablation/surgery, structural heart disease, heart failure class III or IV

          -  Hypertrophic cardiomyopathy, Mitral prosthesis

          -  Unstable angina, uncontrolled hyperthyroidism

          -  Stroke or TIA within 6 months, MI within 2 months, cardiac surgery within 3 months

          -  Thrombocytosis, thrombocytopenia

          -  Any condition contraindicating chronic anticoagulation

          -  EF <40%

          -  Pregnancy

          -  Life expectancy <1year
Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular Insulin
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Intervention: Human regular insulin; Insulin lispro; Insulin glargine
Intervention description: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization); Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization); Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperglycemia; Diabetes; Hospital; Diabetic

Summary:

      The purpose of this study is to compare the use of insulin glargine plus insulin lispro to
      human regular insulin for treatment of hyperglycemia in the hospital setting in patients
      without known prior history of diabetes.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  No known history of diabetes

          -  Admission or pre-entry plasma glucose (PG) level between 140 and 400 mg/dL

          -  Non-critically ill and admitted to acute care medical services

          -  Have a body mass index greater than or equal to 18.5 kg/m^2 and less than or equal to
             45 kilograms per square meter (kg/m^2)

        Major Exclusion Criteria:

          -  Received any insulin/analog therapy for longer than 108 hours prior to study entry or
             intermediate- or long-acting insulin/analogs (neutral protamine Hagedorn, detemir, or
             glargine) in the 24 hours prior to randomization or any intravenous insulin therapy
             prior to randomization

          -  Laboratory evidence of diabetic ketoacidosis for patients with pre-randomization PG
             greater than 250 mg/dL

          -  Have taken any oral or injectable antihyperglycemic medications other than insulin
             within 3 months prior to study entry

          -  Have acute critical illness or are expected to require admission to an ICU or
             equivalent or be treated with glucocorticoid therapy during the hospital study period

          -  Expected hospitalization less than 24 hours post-randomization
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Intervention: Evolocumab
Intervention description: Administered by subcutaneous injection
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Hypercholesterolemia; Elevated Cholesterol; High Cholesterol; PCSK9 mutations; Severe Familial Hypercholesterolemia; evolocumab; Repatha; Heterozygous Familial Hypercholesterolemia; Homozygous Familial Hypercholesterolemia; Pediatric; Paediatric

Summary:

      The main purpose of this study is to describe the safety and tolerability of 80 weeks of
      subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age
      with familial hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

        Heterozygous Familial Hypercholesterolemia (HeFH):

        -Completed Study 20120123 (NCT02392559) while still on assigned investigational product and
        did not experience a treatment-related serious adverse event

        Homozygous Familial Hypercholesterolemia (HoFH):

          -  Male or female, ≥ 10 to ≤ 17 years of age at time of enrollment

          -  Diagnosis of HoFH

          -  On a low-fat diet and receiving background lipid-lowering therapy

          -  Lipid-lowering therapy unchanged for ≥ 4 weeks prior to LDL-C screening; fibrates must
             be stable for at least 6 weeks prior to screening.

          -  Fasting LDL-C at screening ≥ 130 mg/dL (3.4 mmol/L)

          -  Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

        Exclusion Criteria:

        -Currently receiving treatment in another investigational device or drug study, or less
        than 30 days since ending treatment on another investigational device or drug study(s);
        except Study 20120123

        HoFH:

          -  Moderate to severe renal dysfunction

          -  Active liver disease or hepatic dysfunction,

          -  Creatine kinase > 3 times the upper limit of normal (ULN) at screening
Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease
Condition: Hepatitis C Virus (HCV)
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Kidney Diseases
Intervention: ombitasvir/paritaprevir/ritonavir and dasabuvir; ombitasvir/paritaprevir/ritonavir
Intervention description: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet; Tablet; ombitasvir coformulated with paritaprevir and ritonavir
Intervention MeSH terms: Ritonavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatitis C infection; hepatitis C; severe kidney disease; chronic kidney disease; Genotype 1a; Genotype 4; treatment experienced; interferon; IFN; pegIFN

Summary:

      This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or
      without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4
      (GT4) infection and with severe kidney impairment or end-stage kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis C virus (HCV) genotype 1a (GT1a) infection or genotype 4 (GT4)
             infection (HCV RNA level greater than 1,000 IU/mL at Screening).

          -  Females must be post-menopausal, of non-child bearing potential or practicing specific
             forms of birth control.

          -  Chronic kidney disease stage 4 or stage 5.

        Exclusion Criteria:

          -  Females who are pregnant or breastfeeding

          -  Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human
             immunodeficiency virus antibody (HIV Ab)

          -  HCV genotype performed during screening unable to genotype or co-infection with any
             other HCV genotype, no mixed genotypes.

          -  Abnormal laboratory tests

          -  Current enrollment in another investigational study

          -  Prior treatment with a direct acting antiviral agent (DAA) containing regimen with the
             exception of interferon or pegylated interferon with or without ribavirin

          -  Current treatment with a direct acting antiviral agent (DAA) containing regimen

          -  Any evidence of liver cirrhosis or liver cancer
Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: C1 esterase inhibitor [human] liquid; Placebo
Intervention description: C1 Esterase Inhibitor [Human] Liquid administered Subcutaneously as specified on specified days; Placebo
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of subcutaneous administration
      of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in
      adolescent and adult subjects with hereditary angioedema.
    

Eligibility criteria:

        The maximum duration of participation is approximately 9 months. Patients will complete a
        screening period of up to 21 days. Following screening, eligible patients will be randomly
        assigned to 1 of 3 treatment sequences. Each patient will undergo 2 14-week treatment
        periods for a total of 28 weeks (Treatment Period 1 and Treatment Period 2). After
        completing the 2 treatment periods, patients will enter a 1-month follow-up period.
Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery
Condition: Dysphagia After Anterior Cervical Decompression and Fusion of the Spine
MeSH terms: Deglutition Disorders
Intervention: Dexamethasone; Saline
Intervention description: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.; The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose.
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled study to examine the effect of local
      intravenous steroids following anterior cervical spine surgery on the development of
      dysphagia in patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subjects included in the study are patients undergoing an anterior cervical spine
             procedure.

        Exclusion Criteria:

          -  Patients with greater than ASA grade II will be excluded. Patients with
             non-degenerative conditions, such as trauma, tumors, infection, radiation, and
             diabetes will be excluded. Patients with posterior procedures will be excluded.
             Patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on
             the EAT-10 questionnaire,19 will also be excluded. Patients who are pregnant will be
             excluded from this study.
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
Condition: Acute Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Intervention: Diclofenac Sodium; Placebo
Intervention description: Topical gel 1%-4 times daily; Topical gel-4 times daily
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankle Sprain, soft tissue injury

Summary:

      The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied
      four times a day in subjects with acute ankle sprains under 'in-use' conditions, in
      particular with regard to pain relief.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 years and over.Acute sprain of the lateral ankle, Grade I-II,
             meeting baseline pain intensity level. Injury within past 12 hours.

        Exclusion Criteria:

          -  Pain medication was taken within the 6 hours that precede randomization.During the
             past 3 months: Grade I-III sprain of the same ankle.During the past 6 months: Grade
             II-III sprain, any other significant injury (such as fracture or torn ligament), or
             surgery (except for skin or nails) of the same ankle or foot.Pain or instability in
             the same ankle attributable to previous ankle sprain or any other trauma.Ankle sprain
             attributable to a known disease affecting the ligaments, such as ligament hyperlaxity
             due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome,
             Ehlers-Danlos syndrome).
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain; Low Back Pain
Intervention: Buprenorphine; Buprenorphine; Oxycodone Immediate-Release
Intervention description: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.; Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear; Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
Intervention MeSH terms: Oxycodone; Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 660.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Low back pain; opioid; transdermal; Butrans

Summary:

      The objective of this study is to demonstrate the effectiveness and tolerability of the
      buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal
      system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back
      pain currently treated with oral opioids. The double-blind treatment intervention duration is
      12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will
      be provided to all subjects in addition to study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  low back pain for 3 months or longer, confirmed by radiographic evidence.

          -  receiving a stable dose of an opioid analgesic for low back pain.

        Exclusion Criteria:

          -  taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days
             of enrollment.

          -  requiring frequent analgesic therapy for chronic condition(s), in addition to low back
             pain.

        Other protocol-specific exclusion/inclusion criteria may apply.
ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial
Condition: Vascular Disease
MeSH terms: Vascular Diseases
Intervention: ArterX Surgical Sealant; Gelfoam and Thrombin
Intervention description: Apply at the suture site.; Apply at the suture site.
Intervention MeSH terms: Thrombin; Gelatin Sponge, Absorbable
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arterial Surgery; Open vascular Surgery; Sealant

Summary:

      This is a prospective, multi-center randomized, controlled study. The study is designed to
      assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group
      in the open surgical repair of large vessels using synthetic vascular grafts or patches.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject must meet all of the following criteria to be eligible for treatment in the Study:

          1. The subject must be equal or greater than 18 years old.

          2. The subject must be scheduled for the surgical placement of a synthetic (i.e.,
             PTFE/Dacron) vascular graft or patch for large vessel repair/arterial
             reconstruction/hemodialysis access/arteriotomy.

          3. The subject has no child bearing potential or has a negative serum or urine pregnancy
             test within 7 days of the index procedure.

          4. The subject is willing and able to be contacted for the follow up visits at 6 weeks (±
             7 days) and 3 months (± 7 days).

          5. The subject or guardian must provide written informed consent using a form that is
             reviewed and approved by the IRB.

        Exclusion Criteria:

        Subjects will be excluded from the Study if any of the following criteria are met:

          1. The subject has a known hypersensitivity or contraindication to heparin, bovine or
             seafood products.

          2. The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood
             transfusions.

          3. The subject is currently enrolled in this, or another investigational device or drug
             trial (IDE or IND) that has not completed the required follow-up period. Note:
             Extended follow-up trials for products that were investigational but are currently
             commercially available are not considered investigational trials.
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
Condition: Post Partum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Brexanolone
Intervention description: Administered as IV infusion.
Intervention MeSH terms: Brexanolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 15 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of
      brexanolone in the treatment of adolescent female participants with postpartum depression
      (PPD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Participant has had a major depressive episode that began no earlier than the third
             trimester and no later than the first 4 weeks following delivery, as diagnosed by
             Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
             Disorders (DSM-5) Axis I Disorders (SCID-5).

          2. Participant is ≤6 months postpartum at screening.

        Key Exclusion Criteria:

          1. Active psychosis

          2. Attempted suicide during current episode of PPD

          3. Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

        Note: Other protocol-defined inclusion/exclusion criteria may apply.
The Influence of a Warmed Surgical Bandage System on Subcutaneous Tissue Oxygen Tension After Cardiac Surgery
Condition: Cardiac Surgery
Intervention: conventional bandage; warming bandage
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: wound infection; tissue oxygen tension; local warming

Summary:

      Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound
      infections
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥18 years of age scheduled for elective cardiac surgery on normothermic
             cardio-pulmonary bypass will be invited to participate

        Exclusion Criteria:

          -  Emergency surgery

          -  Pre - or postoperative on intraaortic balloon pump

          -  Preoperative mechanical ventilation

          -  Postoperative respiratory failure

          -  Postoperative extracorporal membrane oxygenation

          -  Left ventricular function < 40%

          -  Fever (core temperature > 38 °C) or current infection

          -  No anticipated or no definitive primary closure of surgical wound.