bioihbjkbjnl/mcl2 huggingface dataset:
C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: C1 esterase inhibitor [human] (C1INH-nf); Placebo (saline)
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Hereditary angioedema; HAE; C1 esterase inhibitor (human); C1INH-nf

Summary:

      The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of
      acute HAE attacks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HAE

          -  Normal C1q level

        Exclusion Criteria:

          -  Low C1q level

          -  B-cell malignancy

          -  Presence of anti-C1INH autoantibody

          -  History of allergic reaction to C1INH or other blood products

          -  Narcotic addiction

          -  Current participation in any other investigational drug study or within the past 30
             days

          -  Participation in a C1 esterase inhibitor trial, or received blood or a blood product
             in the past 90 days

          -  Pregnancy or lactation

          -  Any clinically significant medical condition, such as renal failure, that in the
             opinion of the investigator would interfere with the subject's ability to participate
             in the study
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin (MK0431); Comparator: glipizide
Intervention description: Sitagliptin 100 mg oral tablets of sitagliptin once daily.; Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
Intervention MeSH terms: Sitagliptin Phosphate; Glipizide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1172.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      The purpose of this investigational study is to determine the safety and effectiveness of an
      investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are at least 18 years of age and not older than 78 with type 2 diabetes
             mellitus
Dysport® Adult Upper Limb Spasticity Extension Study
Condition: Nervous System Disorders
MeSH terms: Nervous System Diseases
Intervention: Botulinum toxin type A
Intervention description: Dysport® was supplied to the study centres in vials containing 500 U of botulinum toxin type A (BTX-A). Depending on the dose administered up to 3 vials were required for the injection.
Each vial was reconstituted with sodium chloride for injection (0.9%). A total volume of 5.0 mL of the reconstituted product was injected for Dysport® 500 U and 1000 U, and 7.5 mL was injected for Dysport® 1500 U.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to assess the long term safety of Dysport® in
      hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over
      repeated treatment cycles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of the double blind study, Y-52-52120-145

        Exclusion Criteria:

          -  Major limitation in the passive range of motion in upper limb
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: Evolocumab; Placebo to Evolocumab; Ezetimibe; Placebo to Ezetimibe
Intervention description: Subcutaneous injection; Subcutaneous injection; Tablet for oral administration; Tablet for oral administration
Intervention MeSH terms: Ezetimibe; Evolocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: High Cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia

Summary:

      The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab
      every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from
      baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable
      to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A)
      reductase inhibitors).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 to ≤ 80 years of age

          -  Not on a statin or on a low dose statin with stable dose for at least 4 weeks

          -  History of intolerance to at least 2 statins

          -  Subject not at LDL-C goal

          -  Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks.

          -  Fasting triglycerides ≤ 400 mg/dL

        Exclusion Criteria:

          -  New York Heart Association (NYHA) III or IV heart failure

          -  Uncontrolled cardiac arrhythmia

          -  Uncontrolled hypertension

          -  Type 1 diabetes, poorly controlled type 2 diabetes

          -  Uncontrolled hypothyroidism or hyperthyroidism
Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Rabeprazole ER; Ranitidine
Intervention description: 50 mg capsule, taken orally, once daily for 26 weeks.; 150 mg capsule, taken orally, twice daily for 26 weeks.
Intervention MeSH terms: Rabeprazole; Ranitidine; Ranitidine bismuth citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Gastroesophageal; Reflux; Disease; GERD

Summary:

      The purpose of this study is to compare the efficacy of rabeprazole extended release (ER) 50
      mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing
      in subjects with healed erosive gastroesophageal reflux disease (eGERD).
    

Eligibility criteria:

        Inclusion Criteria:

        1. Prior completion of Study E3810-G000-301 or -303. Subjects will need to have healed
        erosive esophagitis (absence of esophageal mucosal breaks or erosions) confirmed by EGD and
        sustained resolution of heartburn at Visit 4 or 5 of Study E3810-G000-301 or -303.

        Exclusion Criteria:

          1. Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm).

          2. Barrett's esophagus or esophageal stricture.

          3. Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine
             receptor antagonists (H2RA), antacids, sucralfate, misoprostol, prokinetics or drugs
             with significant anticholinergic effects throughout the study.

          4. Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs),
             oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day).

          5. Significant hepatic, renal, respiratory, endocrine, hematologic, neurologic,
             psychiatric, or cardiovascular system abnormalities that would be likely to interfere
             with the conduct of the study, the interpretation of study results, or the health of
             the subject during the study.

          6. Any condition that would make the subject, in the opinion of the investigator or
             sponsor, unsuitable for the study.
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
Condition: Metabolic Acidosis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acidosis
Intervention: TRC101; Placebo
Intervention description: Oral suspension; Oral suspension
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: blood bicarbonate, kidney disease

Summary:

      This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study
      will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney
      disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12
      weeks once daily.

      The maximum study duration is anticipated to be up to 16 weeks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Blood bicarbonate level of 12 to 20 mEq/L.

          -  Estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.73m2.

          -  Stable kidney function defined as <=20% variability in eGFR during screening period.

        Key Exclusion Criteria:

          -  Any level of low blood bicarbonate during the screening period that in the opinion of
             the Investigator, requires emergency intervention or evaluation for an acute acidotic
             process.

          -  Anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within
             3 months prior to screening.

          -  Heart failure with maximum New York Heart Association (NYHA) Class IV symptoms or that
             required hospitalization during the preceding 6 months.

          -  Heart or kidney transplant.

          -  Chronic obstructive pulmonary disease (COPD) that is treated with chronic oral
             steroids, that requires the subject to be on oxygen, or that required hospitalization
             within the previous 6 months.

          -  Change in doses to alkali therapy in the 4 weeks prior to screening.

          -  History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing
             disorders, inflammatory bowel disease, major gastrointestinal surgery, frequent
             diarrhea or active gastric/duodenal ulcers.

          -  Serum calcium <= 8.0 mg/dL at screening.

          -  Planned initiation of renal replacement therapy within 12 weeks following
             randomization.

          -  Use of polymeric binder drugs within 14 days prior to screening.
Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium Bromide 200 µg; Aclidinium Bromide 400 µg
Intervention description: aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment; aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
Intervention MeSH terms: Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 605.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; COPD; Chronic Bronchitis; Emphysema; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease

Summary:

      The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled
      aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic
      obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in
      period, a 52-week treatment period and a 2-week follow up phone call. All patients will be
      randomized to one of two doses of aclidinium bromide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for
             Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC
             < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted

          -  Current or former cigarette smokers

        Exclusion Criteria:

          -  Patients who have been hospitalized for an acute COPD exacerbation within 3 months
             before the first visit

          -  Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1

          -  Patient with any clinically significant respiratory conditions other than COPD,
             cardiovascular conditions or mental illness

          -  History or presence of asthma verified from medical records

          -  Chronic use of oxygen therapy greater than or equal to 15 hours per day

          -  Patient with uncontrolled infection due to HIV and/or active hepatitis

          -  Patients with a history of hypersensitivity reaction to inhaled anticholinergics

          -  Patients with clinically significant cardiovascular conditions, including myocardial
             infarction during the previous 6 months, newly diagnosed arrhythmia within the
             previous 3 months, unstable angina, unstable arrhythmia that had required changes in
             pharmacological therapy or other intervention.
A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals); Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray; Placebo
Intervention description: Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.; Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.; Placebo nasal spray administered once daily (4 actuations) for 14 days.
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 727.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Rhinitis; Seasonal Allergic Rhinitis; Fluticasone furoate; Equivalence; Hay fever

Summary:

      This study compared the safety and efficacy of a generic fluticasone furoate (Lek
      Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal
      allergic rhinitis. Additionally both the test and the reference formulations were tested for
      superiority against a placebo nasal spray.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of
             2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in
             season at the time the study is being conducted.

          -  Signed informed consent (assent) form.

          -  Documented positive allergic skin test to local pollen.

          -  An average score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS)
             with a minimum score of at least 2 for "nasal congestion" and at least 4 on the
             reflective Total Ocular Symptom Score (rTOSS).

        Exclusion Criteria:

          -  History of asthma that required chronic therapy (with the exception of occasional
             acute or mild exercise induced asthma).

          -  Some other past and concomitant medical conditions, prohibited medications.

          -  Upper respiratory tract infection or any untreated infections.

          -  Patient has started immunotherapy/changed the dose.

          -  Any known allergy to any of the components of the study nasal spray.
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: C1 esterase inhibitor [human] (C1INH-nf)
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: Hereditary angioedema; C1 esterase inhibitor (human)

Summary:

      The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf
      for the prevention of acute HAE attacks.
    

Eligibility criteria:

        Inclusion Criteria:

        - History of at least 1 HAE attack per month or any history of laryngeal edema

        In addition, this study was open to all subjects who:

          -  Completed participation in LEVP2005-1/B (NCT01005888) any time after the final
             prophylactic therapy in Part B

          -  Were enrolled but not randomized in LEVP2005-1/A (NCT00289211) after Part A was closed

          -  Were enrolled and randomized in LEVP2005-1/A after LEVP2005-1/B was closed to
             enrollment, any time after the 3-day telephone follow-up

          -  Were excluded from LEVP2005-1 for any of the following reasons:

               -  Pregnancy or lactation

               -  Age less than 6 years

               -  Narcotic addiction

               -  Presence of anti-C1 inhibitor (C1INH) autoantibodies

          -  Were not enrolled in LEVP2005-1 after enrollment in LEVP2005-1 was closed, under the
             following circumstances:

               -  Had a diagnosis of HAE: evidence of a low C4 level plus either a low C1INH
                  antigenic level or a low C1INH functional level, or

               -  Had a known HAE-causing C1INH mutation, or

               -  Had a diagnosis of HAE based on a strong family history of HAE as determined by
                  the principal investigator

        Exclusion Criteria:

          -  History of allergic reaction to C1INH or other blood products

          -  Participated in any other investigational drug study within the past 30 days other
             than those sponsored by Lev Pharmaceuticals

          -  Received blood or a blood product in the past 60 days other than C1INH-nf
Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol; Placebo Nasal Aerosol
Intervention description: Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol; HFA Vehicle Aerosol
Intervention MeSH terms: Beclomethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 474.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the efficacy and safety of an investigational nasal
      aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent

          -  Documented history of perennial allergic rhinitis

          -  A demonstrated sensitivity to at least one allergen known to induce PAR through a
             standard skin prick test.

          -  Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6
             (out of a possible 12)

          -  Other criteria apply

        Exclusion Criteria:

          -  History of physical findings of nasal pathology (within 60 days prior to screening
             visit)

          -  Participation in any investigational drug study 30 days preceding screening visit

          -  History of respiratory infection/disorder with 14 days preceding screening visit or
             during the run-in period

          -  Use of any prohibited concomitant medications
Confirmatory Study of DSP-5423P in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: DSP-5423P Placebo; DSP-5423P 40mg; DSP-5423P 80mg; DSP-5423P Placebo-to-Flex; DSP-5423P Active-to-Flex
Intervention description: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily; DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily; DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily; DSP-5423P Placebo:
DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Flex:
DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily; DSP-5423P Active:
DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Flex:
DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 580.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with
      placebo in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria

          -  Patients who are aged 18 years or older at informed consent

          -  Patient understands the objectives and procedures of the study and who provide written
             voluntarily consent to participate in the study, etc.

        Exclusion Criteria:

          -  Patients who fall under a contraindication listed in the blonanserin (LONASEN) package
             insert

          -  Patients with Parkinson disease

          -  Patients who previously received blonanserin, etc.