bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
Condition: Hypoxic-Ischemic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypothermia; Hypoxia
Intervention: Cooling cap (YJW608-04B)
Intervention description: A semiconductor water circulation cooling device (YJW608-04B, Henyang Radio Manufactory, Hunan, China) was used to conduct head cooling. The hypothermia group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C. All infants were nursed under a servo-controlled radiant warmer and the rectal temperature was maintained at 34.5 to 35 degree C. Head cooling was started within 6 hours after birth for 72 hours followed by spontaneous re-warming and the average time to reach the target temperature was 2 hours.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 256.0
Sex: All
Maximum age: 6 Hours
Healthy volunteers: No
Keywords: hypothermia; neonate; hypoxic-ischemic encephalopathy; efficacy; safety

Summary:

      The purpose of this study is to investigate the effectiveness and safety of selective head
      cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age up to 6 hours

          -  Gestational age ≥ 36 weeks and birth weight ≥ 2500 g

          -  Apgar score ≤ 3 at 1 minute and ≤ 5 at 5 minutes, and/or cord blood gas pH < 7.0 or
             base deficit ≤ 16 mmol/L, and/or need for resuscitation or ventilation at 5 minutes of
             age

          -  Clinical signs of encephalopathy (seizures, coma, abnormal muscle tone and irregular
             breathing, etc)

        Exclusion Criteria:

          -  Major congenital abnormalities

          -  Infection

          -  Other etiology of induced brain injury

          -  Severe anemia (Hb < 120 g/L)

        Eligible infants assessed for the severity of HIE according to criteria of the Neonatal
        Association of Chinese Academy of Pediatrics 25 modified from Sarnat and Sarnat 26 in 1986
Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin 50 mg; Metformin 500 mg; Sitagliptin 100 mg; Placebo; Metformin 850 mg
Intervention description: Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.; Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.; Sitagliptin 100 mg once daily for 24 weeks.; Matching placebo tablets to sitagliptin or metformin for 24 weeks.; Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 744.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of initial treatment with sitagliptin and
      metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that
      after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided
      greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin
      alone and with metformin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  has type 2 diabetes mellitus

          -  is male, a female who cannot have children, or a female who agrees to use birth
             control during the study

          -  is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral
             single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

        Exclusion Criteria:

          -  Patient has type 1 diabetes mellitus or ketoacidosis

          -  Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)

          -  Patient is on a weight loss program not in the maintenance phase or on a weight loss
             medication

          -  Patient has a history of liver disease, heart failure, heart disease, stroke, high
             blood pressure, blood disorders, or cancer

          -  Patient is HIV positive

          -  Patient is pregnant
A Study of Monthly Risedronate for Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: risedronate; risedronate
Intervention description: tablet, 5 mg risedronate, once a day for 2 years; oral, 150 mg risedronate, once a month for 2 years
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1294.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No
Keywords: randomized controlled trial, osteoporosis, risedronate

Summary:

      The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as
      compared to the standard daily dosing regimen of risedronate 5 mg daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female: 50 years of age or older

          -  >5 years since last menses natural or surgical

          -  have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD)
             below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult
             female mean value and also have at least one prevalent vertebral body fracture

        Exclusion Criteria:

          -  history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia

          -  BMI (body mass index) >32 kg/m^2

          -  use of medications within 3 months of starting study drug that impact bone metabolism
             such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and
             parathyroid hormone

          -  hypocalcemia or hypercalcemia of any cause

          -  markedly abnormal clinical laboratory measurements that are assessed as clinically
             significant by the investigator
BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases; Fibrosis
Intervention: c13 methacetin solution with breath analyzer
Intervention description: Carbon 13 methacetin 75mg dissolved in 150 ml is given to the subject and metabolism is measured by a breath analyzer after decomposed by the liver
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 414.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Methacetin; Breath; Test; Cirrhosis

Summary:

      This trial is a pivotal trial to validate the use of a 13 C labeled substrate called
      methacetin and the BreathID automatic breath testing system, for determination of cirrhosis
      in patients with chronic liver disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18 with chronic liver disease

        Exclusion Criteria:

          -  Patients that are taking hepatotoxin drug.

          -  Patient with severe congestive heart failure

          -  Patient with severe pulmonary hypertension

          -  Patient with uncontrolled diabetes mellitus

          -  Patient with previous surgical bypass surgery for morbid obesity

          -  Patient with extensive small bowel resection

          -  Patient currently receiving total parenteral nutrition

          -  Patient is a recipients of any organ transplant

          -  Patients that received any anti-viral treatment within the past year

          -  Women who are pregnant

          -  Patient allergic to acetaminophen (such as Tylenol or any other related medications)

          -  Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial
             asthma

          -  Patients unable to sign informed consent

          -  Patients that based on the opinion of the investigator should not be enrolled into
             this study

          -  Patients that are participating in other clinical trials evaluating experimental
             treatments or procedures
A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.
Condition: Anemia
MeSH terms: Anemia
Intervention: epoetin alfa or beta; methoxy polyethylene glycol-epoetin beta (Mircera); methoxy polyethylene glycol-epoetin beta (Mircera)
Intervention description: iv 3 times weekly, as prescribed; 60, 100 or 180 micrograms sc (starting dose) every 2 weeks; 60, 100 or 180 micrograms sc (starting dose) every 4 weeks
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 572.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as
      maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who
      were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years
      and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  chronic renal anemia;

          -  on dialysis therapy for at least 12 weeks before screening;

          -  receiving sc epoetin for at least 8 weeks before screening.

        Exclusion Criteria:

          -  women who are pregnant, breastfeeding or using unreliable birth control methods;

          -  administration of another investigational drug within 4 weeks before screening, or
             during the study period.
Open-Label 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)
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 113.0
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 repeat use of C1INH-nf for the
      treatment of acute HAE attacks.
    

Eligibility criteria:

        Inclusion Criteria:

        This study was open to all subjects who:

          -  Completed participation in LEVP2005-1/A (NCT00289211) and were not participating in
             LEVP2005-1/B (NCT01005888), any time after the 3-day telephone follow-up

          -  Completed participation in LEVP2005-1/B any time after the final prophylactic therapy
             in Part B

          -  Were enrolled but not randomized in LEVP2005-1/A after Part A was closed

          -  Were excluded from LEVP2005-1 for any of the following reasons:

               -  Pregnancy or lactation

               -  Age less than 6 years

               -  Narcotic addiction

               -  Presence of anti-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

          -  Received blood or a blood product in the past 60 days other than C1INH-nf
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
Condition: Central Precocious Puberty (CPP)
MeSH terms: Puberty, Precocious
Intervention: Leuprolide Acetate (LA)
Intervention description: Administered intramuscularly as an injection
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Central Precocious Puberty (CPP); Leuprolide Acetate (LA)

Summary:

      The primary objective of the study is to assess the safety and efficacy of a leuprolide
      acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are
      either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have
      been previously treated with a GnRHa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone
             agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have
             been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or
             males 2 - 11 years of age).

          -  No history of clinically significant medical conditions or any other reason that the
             investigator determines would make the participant an unsuitable candidate to receive
             study drug.
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly Patients
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Placebo; Vortioxetine (Lu AA21004); Duloxetine
Intervention description: capsules; daily; orally; encapsulated tablets; daily; orally; encapsulated tablets; daily; orally
Intervention MeSH terms: Duloxetine Hydrochloride; Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 453.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Depression; Elderly; Acute treatment

Summary:

      To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of
      depression by means of the change from baseline in the 24-item Hamilton Depression Scale
      (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.
    

Eligibility criteria:

        Inclusion Criteria:

        Clinical Diagnosis of recurrent Major Depressive Episode (MDE) according the Diagnostic and
        Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria
        with:

          -  Reported duration of the current episode of at least 4 weeks

          -  MADRS total score >=26

          -  At least one previous MDE before the age of 60 years

        Exclusion Criteria:

          -  Mini Mental State Exam (MMSE) <24

          -  Any current anxiety disorder as defined in the DSM-IV-TR

          -  Current or past history of manic or hypomanic episode, schizophrenia, or any other
             psychotic disorder, including major depression with psychotic features, mental
             retardation, organic mental disorders, or mental disorders due to a general medical
             condition as defined in the DSM-IV-TR

          -  Any substance disorder (except nicotine and caffeine) within the previous 6 months as
             defined in the DSM-IV-TR

          -  Presence or history of a clinically significant neurological disorder (including
             epilepsy)

          -  Neurodegenerative disorder (Alzheimer's disease, Parkinson disease, multiple
             sclerosis, Huntington disease, etc)

          -  Any Axis II disorder that might compromise the study

          -  Significant risk of suicide according to the investigator's opinion, or has a score
             >=5 on item 10 of the MADRS or has made a suicide attempt in the previous 6 months

        Other inclusion and exclusion criteria may apply.
Management of Recurrent Croup
Condition: Croup
MeSH terms: Laryngitis; Croup
Intervention: Fluticasone; Prednisolone IF needed
Intervention description: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
Intervention MeSH terms: Fluticasone; Prednisolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 6 Months
Maximum age: 15 Years
Healthy volunteers: No
Keywords: croup; recurrent croup; barky cough

Summary:

      Presently children who experience recurring croup symptoms receive a variety of treatments.
      This is because it is not clear which treatments may be best. Some children are given inhaled
      steroids (similar to what children with asthma use). Others are carefully watched and
      cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and
      should episodes of croup recur they are treated with a short course of oral steroids. The
      purpose of this study is to compare two safe and clinically appropriate methods for treating
      recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed
      basis, to see if either is useful in preventing future episodes of croup.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric population: 6 months to 15 years of age

          -  2 or more episodes of croup in 12 month period

               -  croup defined as acute onset inspiratory stridor, barking cough, with respiratory
                  distress.

        Exclusion Criteria:

          -  Grade 3 or 4 subglottic stenosis

          -  Subglottic hemangioma

          -  Posterior laryngeal cleft

          -  Recurrent respiratory papillomatosis

          -  External compression (Innominate artery compression, mediastinal mass, (double aortic
             arch, etc)

          -  Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial
             tracheitis, or supraglottic foreign body

          -  Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress

          -  Current steroid therapy for previously diagnosed condition, i.e. reactive airway
             disease.

          -  Other medical conditions necessitating chronic steroid utilization
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Placebo; Risankizumab
Intervention description: Placebo for risankizumab administered by subcutaneous injection; Risankizumab administered by subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 964.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the safety and efficacy of risankizumab versus
      placebo in participants with moderately to severely active psoriatic arthritis (PsA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening
             Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening
             Visit.

          -  Participant has active disease at Baseline defined as ≥ 5 tender joints (based on 68
             joint counts) and ≥ 5 swollen joints (based on 66 joint counts)

          -  Diagnosis of active plaque psoriasis with at least one psoriatic plaque of ≥ 2 cm
             diameter or nail changes consistent with psoriasis at Screening Visit.

          -  Participant has demonstrated an inadequate response or intolerance to or
             contraindication for conventional synthetic disease modifying anti-rheumatic drugs
             (csDMARD) therapy(ies).

          -  Presence of either at Screening:

               -  ≥ 1 erosion on radiograph as determined by central imaging review or;

               -  High sensitivity C-reactive protein (hsCRP) ≥ 3.0 mg/L.

        Exclusion Criteria:

          -  Participant is considered by investigator, for any reason, to be an unsuitable
             candidate for the study.

          -  Participant has a known hypersensitivity to risankizumab.

          -  Participant has previous treatment with biologic agent.
Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Intervention: Dopamine; Norepinephrine
Intervention description: Dopamine 5-20 mcg/kg/min to pre-determined max of 20; Norepinephrine 5-20 mcg/min, to a pre-determined max of 20
Intervention MeSH terms: Dopamine; Norepinephrine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 252.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sepsis; septic shock

Summary:

      We are performing a prospective, randomized, controlled trial of dopamine versus
      norepinephrine for septic shock. The trial will enroll patients with suspected or documented
      site of infection and having 2 out of the three SIRS criteria. Patients will also be
      receiving standard of care, early-goal directed therapy including but not limited to fluid
      resuscitation, appropriate and early antibiotics, source control and evaluation for
      drotrecogin alpha where deemed appropriate, while being supported for septic shock.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients are transferred to our medical intensive care unit from the emergency room
             (ER), general medical floors, and from outside hospitals.

          -  Patients were eligible if they were greater than 18 years of age

          -  Presented with a diagnosis of SIRS plus a suspected or documented source of infection.

        Exclusion Criteria:

          -  Patients were not eligible if they were found to have hypovolemic and/or hemorrhagic
             etiologies of their vasodilatory shock or another etiology of their SIRS.