bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy
Condition: Pregnancy Prevention
Intervention: DR-103
Intervention description: One tablet daily.
Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days of 10 mcg EE.
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3597.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception; Oral contraceptives

Summary:

      This is an open-label, single-treatment study. All subjects will receive 12 months of oral
      contraceptive therapy with DR-103. Study participants will receive physical and gynecological
      exams, including Pap smear. During the study, all participants will be required to complete a
      diary.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sexually active at risk for pregnancy

          -  Agreement to use study OC therapy as their only method of birth control during the
             study

          -  history of regular spontaneous menstrual cycles or withdrawal bleeding episodes

          -  Others as dictated by FDA-approved protocol

        Exclusion Criteria:

          -  Any contraindication to the use of oral contraceptives

          -  Pregnancy or plans to become pregnant in the next 14 months

          -  Smoker and age ≥ 35 years

          -  Others as dictated by FDA-approved protocol
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Condition: Acute Gouty Arthritis
MeSH terms: Arthritis; Arthritis, Gouty
Intervention: Canakinumab 150mg in prefilled syringe
Intervention description: Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Uncontrolled
Masking: None (Open Label)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Gout; arthritis; gout flare; acute gout; gouty; rheumatic disease; uric acid; podagra

Summary:

      This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety
      and tolerability in patients who have frequent flares of acute gouty arthritis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Compliance and completion of the canakinumab PFS core study

          -  Unchanged significant clinical medical history from entry into core study

        Exclusion criteria:

          -  Physician judgment of unsuitability for the study

          -  Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may
             apply
SONOlysis in Risk REduction of Symptomatic and Silent Brain infarCtions dUring Cardiac surgEry
Condition: Coronary Artery Bypass Graft Redo; Heart Valve Diseases
MeSH terms: Brain Infarction; Heart Valve Diseases; Infarction
Intervention: sonolysis; cardiac surgery
Intervention description: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes; coronary artery bypass graft (CABG) heart valve replacement
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 40 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: sonolysis, brain infarction, prevention, cardiac surgery

Summary:

      The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual
      transcranial Doppler monitoring) using 2 MHz diagnostic probe on the reduction of risk of
      brain infarctions due to the activation of endogenous fibrinolytic system during cardiac
      surgery (CS). 120 patients indicated for CS (CABG or valve replacement) will be enrolled into
      the study in order to demonstrate a twenty-percent risk reduction of number and volume of
      brain infarctions detected using MRI examination 24 hours after CEA or CS in 5% level of
      significance. Patients will be randomized - subgroup 1 will undergo a 40-240minute
      non-diagnostic TCD monitoring during CS, subgroup 2 will undergo interventions without TCD
      monitoring.

      The aim of the project is a concordance with the aim No 1 of the Resort Program of a Research
      and Development: "Improvement of quality of life of patients using the modern therapeutic
      methods but with relative small positive effect of quality of life". The aim of the project
      is in concordance with a priority of announced public grant competition: "Development of the
      new therapeutic methods of cardiovascular disorders, especially coronary heart disease and
      stroke". Confirmation of our hypothesis that sonothrombolysis is able to activate endogenous
      fibrinolytic system during CS with consecutive reduction of the number and volume of brain
      infarcts, can lead to the increase of the safety of CS in patients. We can presume that up to
      50% of patients indicated for CS can be treated using these methods in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 40-90 years,

          -  sufficient temporal bone window for TCD with detectable blood flow in MCA,

          -  independent patient (modified Rankin score 0-2),

          -  informed consent signed by the patient,

          -  CS will be performed as an elective surgery with an extracorporeal circulation

        Exclusion Criteria:

          -  contra-indication for MRI examination (pace-maker, implanted metal material,
             claustrophobia),

          -  emergent surgery,

          -  acute myocardial infarction,

          -  combined cardiac surgery,

          -  combined cardiac and carotid surgery
Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
Condition: COPD; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Roflumilast; Placebo
Intervention description: 500 μg tablet, once daily, oral administration in the morning after breakfast; tablet, once daily, oral administration in the morning after breakfast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 158.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Roflumilast; Chronic Obstructive Pulmonary Disease; COPD

Summary:

      The objective of the Biopsy trial is to investigate the effect of roflumilast 500 µg tablets
      once daily versus placebo on inflammation parameters in bronchial biopsy tissue specimen and
      additional in sputum and blood serum. Also data on safety status will be obtained.

      Patients to be included required to have moderate to severe COPD associated with chronic
      bronchitis. The total duration of this randomized, multicentre, phase III trial is 24 weeks
      maximum.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  Giving written informed consent

          -  History of COPD (according to GOLD 2009) for at least 12 months prior to baseline
             visit V0 associated with chronic productive cough for at least three months in each of
             the two years prior to baseline visit V0 (with other causes of productive cough
             excluded)

          -  Outpatients 40-80 years of age

          -  Post-bronchodilator 30% ≤FEV1 ≤80% predicted

          -  Post-bronchodilator FEV1/FVC ratio ≤70%

          -  Current or former smokers with smoking history ≥20 pack years

        Main Exclusion Criteria:

        • Criteria affecting the read-out parameters of the trial:

          -  Clinical instability, defined as experiencing a COPD exacerbation six months prior to
             V0

          -  An upper/lower respiratory tract infection which has not resolved four weeks prior to
             V0

          -  Diagnosis of asthma and/or other relevant lung disease

          -  Known alpha-1-antitrypsin deficiency

          -  Suspicion or diagnosis of a bleeding disorders irrespective of its pathophysiological
             mechanism

          -  Other protocol-defined exclusion criteria may apply
Study of Safety and Efficacy of an Oral Contraceptive
Condition: Contraception
Intervention: Norethindrone/ethinyl estradiol
Intervention description: 1 tablet per day
Intervention MeSH terms: Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1700.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception

Summary:

      This is a non-comparative study. the primary objective of the study is to assess the efficacy
      of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are
      to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of
      the product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Women

          -  Age 18-45

          -  At risk for pregnancy

          -  History of regular cycles

        Exclusion Criteria:

          -  Contraindications for use of hormonal contraception

          -  Conditions which affect the absorption or metabolism of steroid hormones

          -  BMI>35
A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis
Condition: End Stage Renal Disease; Kidney Failure; Renal Failure; Hyperphosphatemia; ESRD
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Hyperphosphatemia
Intervention: ferric citrate
Intervention description: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Participation Limited; Long Term; Safety Extension

Summary:

      A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have
      completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may
      participate in this trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or non-pregnant, non-breast-feeding females who participated in the Safety
             Assessment Period (SAP), and if eligible, the Efficacy Assessment Period (EAP) of
             Study KRX-0502-304

          2. Willing and able to give informed consent

        Exclusion Criteria:

          1. Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in
             first period

          2. Any subject in Study KRX-0502-304 SAP who early terminated from the trial

          3. Any subject who participated in Study KRX-0502-304 but declined EAP

          4. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease

          5. History of malignancy in the last five years

          6. Previous intolerance to KRX-0502 (ferric citrate)

          7. Intolerance to oral iron-containing products

          8. Absolute requirement for oral iron therapy

          9. Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.]
             allowed)

         10. Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals

         11. Inability to tolerate oral drug intake

         12. Any other medical condition that rendered the subject unable to or unlikely to
             complete the trial or that would interfere with optimal participation in the trial or
             produce significant risk to the subject

         13. Inability to cooperate with study personnel or history of noncompliance

         14. Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
Condition: Facial Rhytides; Crow's Feet Lines; Glabellar Lines
Intervention: normal saline; onabotulinumtoxinA 44 U; onabotulinumtoxinA 24 U
Intervention description: Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.; 44 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.; 24 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 684.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of botulinum toxin type A compared to
      placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients
      who successfully completed Study 191622-099.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successfully completed Study 191622-099

        Exclusion Criteria:

          -  Known immunization or hypersensitivity to botulinum toxin of any serotype

          -  Anticipated need for treatment with botulinum toxin of any serotype during the study
             (except for study treatment)

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral
             sclerosis

          -  Anticipated need for surgery or hospitalization during the study
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
Condition: Chronic Kidney Disease Requiring Chronic Dialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: PA21 (2.5 g tablet containing 500 mg iron); Sevelamer carbonate; PA21-1 (1.25 g tablet containing 250 mg iron)
Intervention description: Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).; Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day); Low dose comparator (1.25 g/day)
Intervention MeSH terms: Iron; Sevelamer
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1059.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PA21; Phosphate Binder

Summary:

      This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety
      and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis
      patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate
      levels in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)

          -  Stable dose of phosphate binder

          -  Written informed consent

        Exclusion Criteria:

          -  Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)

          -  Other significant medical conditions

          -  Pregnancy
Opioid Use in Single Shot Nerve Block vs Continuous Peripheral Nerve Infusion in Anterior Cruciate Ligament (ACL) Repair
Condition: Injury of Anterior Cruciate Ligament
MeSH terms: Anterior Cruciate Ligament Injuries
Intervention: bupivacaine; bupivacaine; continuous perineural infusion catheter; continuous perineural infusion catheter
Intervention description: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Males Single shot peripheral nerve block; Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Females Single shot peripheral nerve block; Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair.; Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair.
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 14 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: anterior cruciate ligament reconstruction; transplantation allografts; adolescent; nerve block; pain

Summary:

      Anterior cruciate ligament repair using hamstring autograft in children is a painful
      orthopedic procedure. The current practice to provide analgesia for this procedure include
      femoral continuous perineural infusion and femoral single shot peripheral nerve block, along
      with perioperative opioids and NSAIDS both IV and orally. Since the use of opioids can be
      associated with adverse side effects, which include, but are not limited to nausea, vomiting,
      constipation, pruritus and respiratory depression, comparing the amount of opioid used with
      either analgesia delivery method is needed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiology (ASA) physical status 1 or 2

          -  Male or female subjects ages 14 to 18 years old at time of procedure

          -  Patients who undergo an ACL repair using the hamstring autograft at The Children's
             Hospital of Philadelphia

          -  Parental/guardian permission (informed consent) and if appropriate, child assent

        Exclusion Criteria:

          -  Parents/patients refusal to the placement of a femoral and/or sciatic nerve block

          -  Contraindications to femoral and/or sciatic nerve block:

               1. Infection

               2. Neurologic deficits, including motor and/or sensory deficit of the femoral and
                  sciatic nerves.

          -  Patients' inability to participate in pain scoring because of developmental delay.

          -  Performance of an all-epiphyseal ACL repair.

          -  Allergy to any of the medications used in the study.

          -  Presence of a coagulopathy
A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole 2%; Vehicle
Intervention description: Crisaborole ointment 2%; Vehicle ointment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 620.0
Sex: All
Minimum age: 3 Months
Healthy volunteers: No
Keywords: Eczema; Crisaborole

Summary:

      This study will evaluate crisaborole therapy once daily (QD) as a long-term topical
      maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID)
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  3 months of age and older

          -  Confirmed diagnosis of atopic dermatitis according to Hanifin and Rajka criteria

          -  Minimum of 5% BSA affected by atopic dermatitis

          -  ISGA score of Mild (2) or Moderate (3)

        Exclusion Criteria:

        - Has any clinically significant medical disorder, condition, or disease (including active
        or potentially recurrent non AD dermatological conditions and known genetic dermatological
        conditions that overlap with AD, such as Netherton syndrome).
A Study of Ceftobiprole in Patients With Fever and Neutropenia.
Condition: Fever; Neutropenia; Gram-positive Bacterial Infections; Pseudomonas Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Pseudomonas Infections; Gram-Positive Bacterial Infections; Neutropenia; Fever
Intervention: Ceftobiprole Medocaril; Cefepime with or without vancomycin
Intervention description: 500 mg every 8 hours; 120-minute infusion [250 mL]
Intervention MeSH terms: Vancomycin; Cefepime; Ceftobiprole; Ceftobiprole medocaril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Low numbers of neutrophils in the blood; increased body temperature; cancer chemotherapy; ceftobiprole; pseudomonas infections

Summary:

      The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a
      comparator in patients with fever and neutropenia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with neutropenia and fever associated with administration of chemotherapy for
             cancer that requires intravenous therapy with antibiotics.

        Exclusion Criteria:

          -  Patients who have received antibacterial (oral or intravenous ) treatment for more
             than 24 hours for fever and neutropenia or have received systemic antibacterial
             therapy in the previous 72 hours for a defined infectious disease

          -  Patients with known or suspected hypersensitivity to any related anti-infective

          -  patients with hepatic impairment

          -  Patients with severe renal impairment

          -  Patients who are pregnant or lactating

          -  Patients who are likely to require major surgical intervention for infection.