bioihbjkbjnl/mcl2 huggingface dataset:
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
Condition: Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: THERMOCOOL® SMARTTOUCH™ Catheter
Intervention description: AF Ablation
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This study had a single arm: catheter ablation for PAF
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug refractory; Atrial fibrillation; Antiarrhythmic drug failure; Atrial tachyarrhythmias

Summary:

      This is a prospective, multicenter, non-randomized continued access clinical evaluation
      utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had at least 3 atrial fibrillation episodes within 6 months of this study

          -  Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation
             episodes

          -  18 years of age or older

        Exclusion Criteria including, but not limited to:

          -  Have had previous ablation for atrial fibrillation

          -  Have take amiodarone within 6 months of this study

          -  Have had any heart surgery within the last 60 days

          -  Have had a heart attack within the last 60 days

          -  Females who are pregnant or breast feeding
Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: abatacept
Intervention description: 125 mg once a week up to 12 months.
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Subcutaneous Abatacept; Ultrasound

Summary:

      Rheumatoid arthritis (RA) is a chronic inflammatory disease (a long-lasting disease causing
      pain and swelling) associated with significant health problems. It is a difficult disease to
      manage as the disease is often unpredictable. RA causes inflammation (swelling) of the joints
      that can cause joint damage, deformity, and progressive disability and impairment. It is
      estimated that 1% of the world's population suffers from this disease.

      The purpose of this research study is to determine if a change in inflammation seen on the
      ultrasound is a good indicator of how subjects' rheumatoid arthritis is responding to
      treatment of subcutaneous abatacept at 3 weeks, 3 months, 6 months, and 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Over 18 years old

          2. Has a diagnosis of rheumatoid arthritis

          3. Stable DMARDs for at least 1 month (methotrexate, leflunomide, hydroxychloroquine, or
             sulfasalazine)

          4. Disease activity score DAS28/ESR > 3.2 or all must be met: TJC (tender joint
             count)>=4, SJC (swollen joint count)>=4

          5. Must be able to understand information in the Informed Consent and comply with study
             requirements

          6. Total ultrasound synovitis (inflammation of joint-lining membrane) power Doppler score
             >=1 for at least 2 joints and total synovitis score >=1 for at least 1 joint

        Exclusion Criteria:

          1. Current or prior use of biologic drugs (TNF inhibitors, IL-6 inhibitors, CD20
             inhibitors, IL-1 inhibitors, etc.)

          2. Pregnancy or breast feeding

          3. Daily prednisone > 10mg (stable dose for at least 1 month)

          4. Intra-articular steroid injection of the wrist or joints within last 2 months

          5. History of a concomitant autoimmune disease such as lupus, psoriatic arthritis

          6. History of cancer

          7. Previous exposure to abatacept
Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 150 μg; Tiotropium 18 μg; Placebo
Intervention description: Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.; Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.; Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; indacaterol; tiotropium

Summary:

      This study compared the effects of a single dose of indacaterol with that of a single dose of
      tiotropium on inspiratory capacity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive
             Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD)
             and:

               1. Smoking history of at least 10 pack-years.

               2. Forced expiratory volume in 1 second (FEV1) < 80% and ≥ 50% of the predicted
                  normal value.

               3. Post-bronchodilator FEV1/Force vital capacity (FVC) < 0.7.

        Exclusion Criteria:

          -  Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid
             treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening.

          -  Patients who have had a respiratory tract infection within 6 weeks prior to screening.

          -  Patients with concomitant pulmonary disease.

          -  Patients with alpha-1-antitrypsin deficiency.

          -  Patients with contraindications for tiotropium treatment.

          -  Patients with a history of hypersensitivity to any of the study drugs or to drugs from
             similar drug classes.

        Other protocol-defined inclusion/exclusion criteria applied to the study.
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
Condition: Epilepsy; Generalized Tonic-clonic Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Levetiracetam
Intervention description: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 4 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Levetiracetam; Epilepsy; Generalized tonic-clonic seizures

Summary:

      To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or
      3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years
      with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2
      Anti-Epileptic Drugs (AEDs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  An epileptic patient with generalized tonic-clonic seizures that are classifiable
             according to the International League Against Epilepsy classification of epileptic
             seizures (Epilepsia, 1981)

          -  A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks
             (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined
             Baseline Period and during the Combined Baseline Period

        Exclusion Criteria:

          -  Presence of any sign (clinical or imaging procedures) suggesting a progressive brain
             lesion/disease, in particular, progressive disorder with epileptic seizures

          -  Diagnosis of Lennox-Gastaut Syndrome

          -  Confirmed focal epilepsy based on clinical signs (seizure types), with consistent
             electroencephalogram and magnetic resonance imaging features

          -  A history of convulsive or nonconvulsive status epilepticus while taking concomitant
             anti-epileptic drugs for the last 3 months prior to Visit 1
The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome
Condition: Familial Chylomicronemia Syndrome
MeSH terms: Hyperlipoproteinemia Type I; Syndrome
Intervention: Volanesorsen; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52
      weeks in participants with Familial Chylomicronemia Syndrome
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of chylomicronemia

          -  A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia)

          -  Fasting triglycerides (TG) ≥ 750 mg/dL (8.4 mmol/L) at Screening

        Exclusion Criteria:

          -  Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%

          -  Other types of severe hypertriglyceridemia

          -  Active pancreatitis within 4 weeks of screening

          -  Acute Coronary Syndrome within 6 months of screening

          -  Major surgery within 3 months of screening

          -  Treatment with Glybera therapy within 2 years of screening

          -  Previous treatment with IONIS-APOCIIIRx

          -  Have any other conditions in the opinion of the investigator which could interfere
             with the participant participating in or completing the study
Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
Condition: Hematological Malignancies; Acute Lymphoblastic Leukemia (ALL); Acute Myelogenous Leukemia (AML); Chronic Myelogenous Leukemia (CML); Myelodysplastic Syndrome (MDS); Lymphoma; Acute Leukemia
MeSH terms: Lymphoma; Leukemia; Neoplasms; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Hematologic Neoplasms; Myelodysplastic Syndromes
Intervention: NiCord® (omidubicel); Cord Blood Unit
Intervention description: Cord blood unit
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is an open-label, controlled, multicenter, international, Phase III, randomized
      study of transplantation of NiCord® versus transplantation of one or two unmanipulated,
      unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid
      leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required
      disease features rendering them eligible for allogeneic transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Applicable disease criteria

          -  Patients must have one or two partially HLA-matched CBUs

          -  Back-up stem cell source

          -  Adequate Karnofsky/Lansky Performance score

          -  Sufficient physiological reserves

          -  Signed written informed consent

        Exclusion Criteria:

          -  HLA-matched donor able to donate

          -  Prior allogeneic HSCT

          -  Other active malignancy

          -  Active or uncontrolled infection

          -  Active/symptoms of central nervous system (CNS) disease

          -  Pregnancy or lactation
Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Condition: Obesity; Diabetes; Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: Exercise; Reduced Calorie Diet; Weight Maintenance Diet
Intervention description: Participants will participate in supervised exercise sessions; Participants will follow a reduced calorie diet; Participants will follow a weight maintenance diet
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: glucose; insulin; lipids; C-reactive protein; adiponectin; leptin; TNF alpha; IL-6; Quality of Life; functional status

Summary:

      The investigators want to determine if the benefits of weight loss outweigh the potential
      risk in a group of older adults. The investigators will test the hypothesis that changes in
      diet composition alone or in conjunction with weight loss will have a significant effect on
      fat stores, and as a result, improve cardiometabolic risk factors and functional status in
      adults 65 and older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 65 years of age

          -  BMI 27 - 42 kg/m2 - at increased health risk (taking at least 1 medication for
             hypertension, hyperlipidemia, or type 2 diabetes)

        Exclusion Criteria:

          -  difficulties chewing or swallowing food

          -  digestive diseases that may affect the ability to follow a high fiber diet

          -  cognitive impairment

          -  depression

          -  recent weight change (+/- 10 lbs in the last 12 months)

          -  poorly controlled blood pressure

          -  history of non-skin cancer in last 5 years

          -  cardiovascular disease event in past 6 months or severe pulmonary disease or renal
             failure

          -  major liver dysfunction

          -  current smoker or quit less than months prior

          -  history of prior surgical procedures for weight control or liposuction

          -  use of estrogen or testosterone replacement therapy

          -  current use of insulin or sulfonylurea agents

          -  current use of corticosteroids > 5 days/month on average

          -  current use of medications for treatment of psychosis or manic-depressive illness

          -  use of weight-loss medications in previous 3 months

          -  dependence on others for food procurement or preparation

          -  ischemic changes on exercise treadmill test
A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Intervention: Fremanezumab
Intervention description: Fremanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 275.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in
      participants with cluster headache (CH). Participants who complete the pivotal studies
      TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338) and enroll into the
      current study will visit the investigational center for investigational medicinal product
      (IMP) administration, safety and efficacy assessments, and blood and urine collections for
      pharmacokinetics, immunogenicity (anti-drug antibodies [ADAs]), and biomarker analyses.
      Participants will return to the investigational center for a follow-up visit to evaluate
      ADAs, fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant
      medications) approximately 7.5 months after the last dose of IMP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant completes either the Phase 3 pivotal study for ECH (Study
             TV48125-CNS-30056) or the Phase 3 pivotal study for CCH (Study TV48125-CNS-30057)
             without important protocol deviations related to participant safety and participant
             compliance.

          -  Prior to 15 June 2018, participants from the ECH study and the CCH study were
             enrolled. After 15 June 2018, only participants who participated in the ECH study
             (Study TV48125-CNS-30056) will be enrolled for active treatment.

          -  In addition, participants who do not complete the pivotal efficacy studies, and
             participants who complete the pivotal efficacy studies but will not continue treatment
             during this long-term safety study, will be offered to enroll in this study for the
             purpose of evaluating ADAs, and safety (adverse events and concomitant medications)
             approximately 7.5 months after administration of the last dose of the IMP.

               -  Additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  Any finding that, in the judgment of the investigator, is a clinically significant
             abnormality, including serum chemistry, hematology, coagulation, and urinalysis test
             values (abnormal tests may be repeated for confirmation)

               -  Additional criteria apply, please contact the investigator for more information
Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Evolocumab; Low-density Lipoprotein Cholesterol (LDL-C) Apheresis
Intervention description: Administered by subcutaneous injection once every 2 weeks; Participants received apheresis for LDL-C according the their physician's prescription and local custom.
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LDL-C Apheresis; Hypercholesterolemia; Elevated Cholesterol; High Cholesterol; PCSK9 mutations; Severe Familial Hypercholesterolemia; evolocumab; Repatha

Summary:

      To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled
      low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future
      apheresis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ≥ 18 years of age

          -  Subject has been receiving regular apheresis for LDL-C lowering for at least 3 months
             immediately prior to lipid screening and has a treatment goal of LDL-C < 100 mg/dL
             (2.6 mmol/L), and has been receiving LDL-C apheresis during the last ≥ 4 weeks prior
             to lipid screening at regular QW or Q2W schedule and with no changes in apheresis type

          -  Subject is receiving lipid-lowering pharmacological background therapy which includes
             a high-intensity statin dose (moderate-intensity statin dose with attestation that a
             higher dose is not appropriate for the subject) unless the subject has a history of
             statin intolerance

          -  Lipid-lowering therapy status (ie, any therapy for lowering lipids, including
             apheresis type and frequency) must be unchanged for ≥ 4 weeks prior to LDL-C screening

          -  Pre-apheresis LDL-C is ≥ 100 mg/dL (≥ 2.6 mmol/L) and ≤ 190 mg/dL (≤ 4.9 mmol/L) at
             screening

          -  Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) at screening.

        Exclusion criteria:

          -  Known homozygous familial hypercholesterolemia

          -  Missing any apheresis session is medically contraindicated or inappropriate

          -  Stopping apheresis would be inappropriate in the opinion of the investigator even if
             LDL-C is controlled to < 100 mg/dL with other therapies

          -  Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI),
             coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization.

          -  Uncontrolled hypertension
Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury
Condition: Spinal Cord Injury; Muscle Spasticity
MeSH terms: Muscle Spasticity; Spinal Cord Injuries; Wounds and Injuries
Intervention: Fampridine-SR; Placebo
Intervention description: 25mg bid (twice daily); Placebo
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: spinal cord injury; muscle spasticity

Summary:

      Normally, nerve fibers carry electrical impulses through the spinal cord, providing
      communication between the brain and the arms and legs. In people with spinal cord injury,
      some fibers may be destroyed at the site of injury, while others remain connected but do not
      work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal
      cord injury may have spasticity which is muscle spasms or muscle stiffness that makes
      movement difficult. Fampridine-SR is an experimental drug that increases the ability of the
      nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on
      moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as
      bladder control, bowel function and sexual function. The study will also examine the possible
      risks of taking Fampridine-SR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6
             months)

          -  Moderate to severe lower-limb spasticity

          -  Able to give informed consent and willing to comply with protocol

        Exclusion Criteria:

          -  Pregnancy

          -  History of seizures

          -  Existing or history of frequent Urinary Tract Infections

          -  History of drug or alcohol abuse

          -  Allergy to pyridine-containing substances

          -  Received a botox injection 4 months prior to study

          -  Received an investigational drug within 30 days

          -  Previously treated with 4-aminopyridine (4-AP)

          -  Not on stable medication dosing in 3 weeks prior to study

          -  Abnormal ECG or laboratory value at screening