bioihbjkbjnl/mcl2 huggingface dataset:
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
Condition: Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Evolocumab; Placebo
Intervention description: Dose of subcutaneous evolocumab every 4 weeks; Dose of subcutaneous placebo treatment every 4 weeks
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 158.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Hypercholesterolemia; Elevated Cholesterol; High Cholesterol; Heterozygous Familial Hypercholesterolemia; PCSK9 mutations; Paediatric; pediatric; Childhood Familial Hypercholesterolemia

Summary:

      A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged
      10-17 years diagnosed with heterozygous familial hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 10 to ≤ 17 years of age (before 18th birthday)

          -  Diagnosis of heterozygous familial hypercholesterolemia

          -  On an approved statin with stable optimized dose for ≥ 4 weeks

          -  Other lipid-lowering therapy stable for ≥ 4 weeks (fibrates must be stable for ≥ 6
             weeks)

          -  Fasting LDL-C ≥ 130 mg/dL (3.4 mmol/L)

          -  Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

        Exclusion Criteria:

          -  Type 1 diabetes, or type 2 diabetes that is or poorly controlled

          -  Uncontrolled hyperthyroidism or hypothyroidism

          -  Cholesterylester transfer protein (CETP) inhibitor in the last 12 months, or
             mipomersen or lomitapide in the last 5 months

          -  Previously received evolocumab or any other investigational therapy to inhibit
             proprotein convertase subtilisin/kexin type 9 (PCSK9).

          -  Lipid apheresis within the last 12 weeks prior to screening.

          -  Homozygous familial hypercholesterolemia
Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab pegol (CZP); Placebo
Intervention description: 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.; Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1648.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab pegol; Cimzia; Rheumatoid Arthritis; Joint Disease; Chronic Arthritis

Summary:

      This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab
      pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patient with established moderate to severe rheumatoid arthritis

        Exclusion Criteria:

          -  All concomitant diseases or pathological conditions that could interfere and impact
             the assessment of the study treatment

          -  Previous clinical trials and previous biological therapy that could interfere with the
             results in the present clinical trials
Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.
Condition: Epilepsy, Tonic-clonic
MeSH terms: Epilepsy; Epilepsy, Generalized; Epilepsy, Tonic-Clonic
Intervention: Levetiracetam
Intervention description: Pharmaceutical form: oral tablets Route of administration: Oral use
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Monotherapy; Epilepsy; Keppra; Levetiracetam

Summary:

      An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse
      events reporting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a confirmed diagnosis of epilepsy.

          -  Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with
             clear focal origin),or generalized tonic-clonic seizures (without clear focal origin),
             that are classifiable according to the International Classification of Epileptic
             Seizures

          -  Subjects having participated in the previous double-blind monotherapy trial (N01061
             [NCT00150735] or N01093 [NCT00150787]).

          -  Male/female subjects (>= 16 years).

        Exclusion Criteria:

        - Need for an additional Antiepileptic Drug (AED).
Multicentre Randomised Clinical Trial Comparing Fixed vs Pro re Nata (PRN) Dosing of 700 μg Dexamethasone
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Ozurdex
Intervention description: Dexamethasone implant (Ozurdex)
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic macular edema, Ozurdex

Summary:

      Multicentre randomized controlled trial to evaluate whether 5 monthly fixed dosing of 700 µg
      Dexamethasone Posterior Segment Drug Delivery System (Ozurdex) is as efficacious as Optical
      coherence tomography (OCT)-guided PRN dosing in patients with refractory diabetic macular
      edema.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects of either sex aged 18 years or over

          2. Diagnosis of diabetes mellitus (type 1 or type 2).

          3. Best corrected visual acuity in the study eye between ≥34 and ≤73 ETDRS letters at 1m
             at baseline attributable to diabetic macular edema (DME)

          4. On clinical exam at baseline in the study eye, retinal thickening due to diabetic
             macular oedema involving the centre of the macula and OCT central subfield > 300
             microns despite previous therapy.

          5. Media clarity, pupillary dilation, and subject cooperation sufficient for adequate
             fundus photographs.

          6. Ability to return for study visits

          7. Visual acuity in fellow eye ≥ 2/60

          8. Ability to give informed consent throughout the duration of the study

        Main Exclusion Criteria:

          1. Macular ischaemia

          2. Macular oedema is considered to be due to a cause other than diabetic macular oedema.

          3. Co-existent ocular disease

          4. An ocular condition is present (other than diabetes) that, in the opinion of the
             investigator, might affect macular oedema or alter visual acuity during the course of
             the study.

          5. A substantial cataract that, in the opinion of the investigator, is likely to be
             decreasing visual acuity by 3 lines or more.
Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
Condition: Pain
MeSH terms: Toothache
Intervention: Novel Ibuprofen; Acetaminophen; Placebo
Intervention description: Single-dose of novel ibuprofen (equal to 400 mg ibuprofen); Single-dose of acetaminophen (1000mg); Single-dose of placebo
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 218.0
Sex: All
Minimum age: 16 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Pain following third molar extraction (wisdom tooth)

Summary:

      This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen
      formulation to placebo and acetaminophen in the treatment of post-surgical dental pain
      following "wisdom" tooth (third molar) removal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal, healthy males and females 16 to 40 years of age

          -  Outpatients who have moderate to severe post-operative pain (confirmed by a Visual
             Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS
             PSR) following surgical extraction of two or more third molars, at least one of which
             must be a partial or complete bony mandibular impaction

          -  Use of only the following pre-operative medication(s)/anesthetic(s): topical
             benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine)
             with or without vasoconstrictor and/or nitrous oxide

        Exclusion Criteria:

          -  Pregnancy or breast-feeding

          -  Alcohol or substance abuse

          -  Any serious medical or psychiatric disorder

          -  History of stomach ulcers, stomach bleed, or other bleeding disorders

          -  Use of a prescription or over-the-counter (OTC) drug with which administration of
             ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID); acetaminophen
             (APAP); or codeine or any other opioid is contraindicated (including: opioids,
             antipsychotics, antianxiety agents, or other central nervous system depressants
             [including alcohol])
PGL4001 Versus GnRH-agonist in Uterine Myomas
Condition: Uterine Myomas
MeSH terms: Myoma; Leiomyoma; Myofibroma
Intervention: PGL4001; leuprorelin
Intervention description: tablets; solution for injection
Intervention MeSH terms: Leuprolide; Ulipristal acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 301.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Uterine Myomas

Summary:

      This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month
      period for the pre-operative treatment of pre-menopausal women suffering from excessive
      uterine bleeding due to uterine myoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a pre-menopausal woman between 18 and 50 years inclusive.

          -  Have excessive uterine bleeding due to myoma

          -  Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size

          -  Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.

          -  If of childbearing potential the subject must be practicing a non-hormonal method of
             contraception.

          -  Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

        Exclusion Criteria:

          -  Has a history of or current uterine, cervical, ovarian or breast cancer.

          -  Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.

          -  Has a known severe coagulation disorder.

          -  Has a history of or current treatment for myoma with a Selective Progesterone Receptor
             Modulator (SPRM) or a GnRH-agonist.

          -  Has a history of or known current osteoporosis.

          -  Has abnormal hepatic function at study entry.

          -  Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during
             the course of the study.

          -  Has a current (within twelve months) problem with alcohol or drug abuse.

          -  Is currently enrolled in an investigational drug or device study or has participated
             in such a study within the last 30 days.
CRESTOR Athero Imaging Head to Head IVUS Study
Condition: Coronary Atherosclerosis
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia
Intervention: Rosuvastatin; Atorvastatin
Intervention description: capsule, oral, once daily; capsule, oral, one daily
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2333.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Coronary artery disease

Summary:

      A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing
      the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic
      disease burden as measured by intravascular ultrasound in patients with coronary artery
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical indication for coronary angiography

          -  Angiographic evidence of Coronary Artery Disease (CAD), as defined by at least 1
             lesion in a native coronary artery that has >20% reduction in lumen diameter by visual
             estimation

          -  Left main coronary artery must have <=50% reduction in lumen diameter by visual
             estimation

          -  LDL-C >100 mg/dL (2.6 mmol/L) for patients with no statin therapy in the past 4 weeks;
             LDL-C >80mg/dL (2.08mmol/L) for patients on therapy in the past 4 weeks

        Exclusion Criteria:

          -  Use of certain lipid-lowering medication for more than 3 months within the previous 12
             months. Longer periods of treatment are not permitted because of the potential effects
             of such therapy on coronary atherosclerosis.

          -  Patients who have symptoms consistent with moderate or greater severity of Congestive
             Heart Failure (CHF).

          -  Clinically significant heart disease which, in the opinion of the Principal
             Investigator (or designee), is likely to require coronary bypass surgery, cardiac
             transplantation, surgical repair and/or replacement during the course of the study
Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection
Condition: Cystic Fibrosis
MeSH terms: Infections; Cystic Fibrosis; Fibrosis
Intervention: Liposomal amikacin for inhalation
Intervention description: Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.
590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.
Administration time is approximately 13 minutes.
Liposomal amikacin for inhalation will be administered in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment followed by 28 days off-treatment.
Intervention MeSH terms: Amikacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; Respiratory Infections; Pulmonary Cystic Fibrosis; cystic fibrosis transmembrane conductance regulator (CFTR); Anti-bacterial Agent; Arikayce; ALIS; LAI

Summary:

      The purpose of this study is to evaluate the long term safety and tolerability of Liposomal
      Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic
      infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension
      study enrolled subjects who had successfully completed study TR02-108, were compliant with
      the study protocol, and did not meet any of the listed study discontinuation criteria. The
      safety and tolerability of LAI were evaluated for up to approximately 2 years.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Written informed consent or assent

          -  Subject has completed study TR02-108, and has been compliant with the study protocol

          -  Women of childbearing potential must agree to use reliable methods of contraception
             for the duration of the study

        Key Exclusion Criteria:

          -  Subject met any of the listed criteria for study drug discontinuation in protocol
             TR02-108.

          -  Abnormal laboratory assessments including LFT (≥ 3× upper limit of normal [ULN]),
             serum creatinine (> 2× ULN) and absolute neutrophil count [ANC] (< 1000).

          -  Psychotic, addictive or other disorder limiting the ability to provide informed
             consent or to comply with study requirements.

          -  History of alcohol, medication or illicit drug abuse within the 6 months prior to
             consent.

          -  Smoking tobacco or any substance within 6 months prior to consent or anticipated
             inability to refrain from smoking throughout the study
Long Term Safety of Naldemedine
Condition: Opioid-induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: Naldemedine; Placebo
Intervention description: Naldemedine 0.2 mg tablet taken orally once a day; Placebo tablet taken orally once a day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1246.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Opioid Induced Constipation

Summary:

      The purpose of this study is to evaluate the long-term safety of naldemedine for the
      treatment of constipation due to opioid therapy.
    

Eligibility criteria:

        Inclusion Criteria

          1. Subjects aged 18 to 80 years inclusive at the time of informed consent

          2. Subjects must have non-malignant chronic pain treated and must have opioid induced
             constipation (OIC)

          3. Subjects must be treated with a stable opioid regimen at a total daily dose on average
             of ≥ 30 mg equivalents of oral morphine sulfate

          4. Subjects may or may not be on a routine laxative regimen at the time of Screening

        Exclusion Criteria

          1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract

          2. Evidence of active medical diseases affecting bowel transit

          3. History of pelvic disorders that may be a cause of constipation

          4. Surgery (except for minor procedures) within 60 days of Screening

          5. History of chronic constipation prior to starting analgesic medication or any
             potential non-opioid cause of bowel dysfunction that may be a major contributor to the
             constipation (e.g. mechanical GI obstruction)

          6. Subjects who have never taken laxatives for the treatment of OIC

          7. Current use of any prohibited medication including opioid antagonists, partial or
             mixed agonists/antagonists
Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC); Saline; Influenza vaccine
Intervention description: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC); Normal saline for injection; Seasonal inactivated influenza vaccine (SIIV)
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1796.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the
      same visit or separately
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants ≥65 years of age at the time of consent

          -  Adults determined by clinical assessment, including medical history and clinical
             judgment, to be eligible for the study, including adults with preexisting stable
             disease

          -  Adults who have no history of ever receiving a pneumococcal vaccine, or have a history
             of receiving a licensed pneumococcal vaccination ≥6 months prior to first study
             vaccination.

        Exclusion Criteria:

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis)

          -  Previous vaccination with any investigational pneumococcal vaccine, or planned receipt
             of any licensed or investigational pneumococcal vaccine through study participation.

          -  Vaccination with any influenza or pneumococcal vaccine <6 months before
             investigational product administration, or planned receipt of any licensed or
             investigational non-study influenza vaccine during study participation.

             -- Serious chronic disorder, that in the investigator's opinion would make the
             participant inappropriate for entry into the study

          -  Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results
Greater Occipital Nerve Block With Bupivacaine for Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Greater occipital nerve block; Bupivacaine
Intervention description: Bilateral greater occipital nerve block; 0.5 cc of 0.5% bupivacaine injected intradermally
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, sham-controlled study of greater occipital nerve block (GONB) using
      bupivacaine 0.5% for emergency department patients with acute migraine. Patients are only
      enrolled if they fail first line therapy with metoclopramide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ED patient with acute migraine or probable migraine

          -  Fail first line therapy with metoclopramide

        Exclusion Criteria:

          -  Can't obtain consent

          -  Concern for secondary headache

          -  Skull defect

          -  Propensity for bleeding

          -  Overlying infection

          -  Pregnancy

          -  Allergy, intolerance study medication