bioihbjkbjnl/mcl2 huggingface dataset:
IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium.
Condition: Angina, Unstable; Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Infarction; Heart Failure, Congestive
MeSH terms: Heart Failure; Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Angina, Unstable; Infarction
Intervention: GIK; Placebo
Intervention description: Intravenous solution, 1.5ml/kg/hour, continuous infusion for total of 12 hours.; Intravenous solution of Dextrose 5 percent at 1.5 ml/kg/hour for a total of 12 hours.
Intervention MeSH terms: Insulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 911.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Acute Coronary Syndrome

Summary:

      The purpose of this study is to test the impact of pharmacological myocardial metabolic
      support, in the form of intravenous (IV) glucose, insulin and potassium (GIK), for the
      treatment of patients with threatened or established acute myocardial infarction (AMI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms of threatened or established AMI including but not limited to:

               1. Chest pain, discomfort, or tightness

               2. Arm or shoulder pain

               3. Jaw pain

               4. Epigastric discomfort

               5. Shortness of breath

          -  12-lead electrocardiogram (ECG) with two or more contiguous leads with ST elevation
             greater than 1 mm, ST depression greater than 0.5 mm, T wave inversion or other T wave
             abnormalities (hyperacute T waves), or left bundle branch block (not known to be old).
             Identification aided by the acute cardiac ischemia time-insensitive predictive
             instrument (ACI-TIPI)and thrombolytic predictive instrument (TPI) decision support
             software (ACI-TIPI >= 75% and TPI detection of suspected STEMI).

        Exclusion Criteria:

          -  End-stage kidney failure requiring dialysis

          -  Rales present more than halfway up the back

          -  Unable to comply with the requirements of the study

          -  Incarcerated

          -  Known to be pregnant
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Lumateperone (ITI-007); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 529.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate
      in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in
      patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis
             of Bipolar I or Bipolar II disorder

          -  experiencing a current major depressive episode

          -  treatment with either lithium or valproate and inadequate therapeutic response of
             depressive symptoms

        Exclusion Criteria:

          -  any subject unable to provide informed consent

          -  any female subject who is pregnant or breastfeeding

          -  any subject judged to be medically inappropriate for study participation
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Twinrix™ adult
Intervention description: Intramuscular administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Combined Hepatitis A and B vaccine; Hepatitis A; Hepatitis B

Summary:

      The aim of this study is to evaluate the long-term persistence of hepatitis A and B
      antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a
      3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting
      has been updated in order to comply with the FDA Amendment Act, Sep 2007.

      This protocol posting deals with objectives & outcome measures of the extension phase at year
      11 to 15.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects participating in this study should have received three-dose primary
             vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.

          -  Written informed consent will be obtained from each subject before the blood sampling
             visit of each year
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
Condition: Vascular Diseases
MeSH terms: Vascular Diseases
Intervention: Gadobutrol (Gadavist, Gadovist, BAY86-4875); Gadopentate dimeglumine (Magnevist, BAY86-4882)
Intervention description: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Gadovist; Gadavist; MRI Imaging; vascular diseases; Chinese

Summary:

      The purpose of this study is to determine if the contrast agent is effective and safe in the
      Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chinese origin

          -  Known or suspected blood vessel diseases

        Exclusion Criteria:

          -  Pregnancy

          -  Lactation

          -  Conditions interfering with MRI

          -  Allergy to any contrast agent or any drugs

          -  Participation in other trial

          -  Require emergency treatment

          -  Severely impaired liver and kidney functions
An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan.
Condition: Heart Failure With Preserved Ejection Fraction (HFpEF)
MeSH terms: Heart Failure
Intervention: LCZ696
Intervention description: Starting dose was either 50 mg b.i.d. or 100 mg b.i.d. largely depending on the last dose level taken by the patient at the time of completing PARAGON-HF and patient condition. The dose level was gradually up-titrated with the goal of reaching the target dose of 200 mg b.i.d. as soon as tolerated by the patient
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: heart failure with preserved ejection fraction, Japanese patients, extension study, long-term safety and tolerability, open-label

Summary:

      This study evaluated the safety and tolerability of LCZ696 treatment in Japanese heart
      failure patients (NYHA Class II-IV) with preserved ejection fraction after CLCZ696D2301
      (PARAGON-HF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent must be obtained before any assessment is performed.

          -  Patients who have completed LCZ696D2301 and are able to be safely enrolled into this
             study as judged by the investigator.

        Exclusion Criteria:

          -  Patients who discontinued study drug treatment during LCZ696D2301 due to an event or
             intercurrent illness. Eligibility can be re-considered if the event has resolved and
             no longer represents a risk to the patient and the patient can safely tolerate the
             administration of LCZ696 per the investigator's assessment.

          -  Any medical condition that in the opinion of the investigator is likely to prevent the
             patient from safely tolerating LCZ696 or complying with the requirements of the study.

          -  Patients who have experience of angioedema event(s) which occurred and reported by the
             investigator during LCZ696D2301.

          -  Pregnant or nursing (lactating) women.

          -  Women of childbearing potential unless they are using highly effective methods of
             contraception.

        Other protocol-defined inclusion/exclusion may apply.
Virtual Continuity and Its Impact on Complex Hospitalized Patients' Care
Condition: Automated Communication Tools; Complex Medical Patients
Intervention: Automated communication tools
Intervention description: Automated communication tools will include:
PCP notification of patient admission and location
Data on medications begun on admission
Automated alerts on changes in patient status and location while the patient is hospitalized
Links to the EMR and to hospital physician contact information on all email alerts
Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP
Automatic reporting to PCPs of test results pending at discharge
Electronic delivery of final discharge summaries
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 835.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Automated Communication Tools; Medication errors; PCP communication

Summary:

      Communication between physicians caring for a patient in the hospital and that patient's
      primary care provider is less than optimal, and can lead to diminished health care quality
      and safety. This project will lead to better communication between physicians and could
      decrease medication errors that tend to occur as the patient goes from hospital to home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are admitted to UPMC Presbyterian General Medicine, Geriatrics, Cardiology, or Surgery
             inpatient services;

          -  Are 18 years of age or older;

          -  Are currently receiving 5 or more medications;

          -  Have 2 or more comorbid conditions present, defined using the Elixhauser comorbidity
             system (Med Care 1998;36:8-27 and Med Care. 2005 Nov; 43(11): 1130-9 ). These
             comorbidities are: congestive heart failure, cardiac arrhythmias, valvular disease,
             pulmonary circulation disorders, peripheral vascular disorders, hypertension,
             paralysis, other neurologic disorders, chronic pulmonary disease, diabetes
             uncomplicated, diabetes complicated, hypothyroidism, renal failure, liver disease,
             peptic ulcer disease excluding bleeding, AIDS/HIV disease, lymphoma, metastatic
             cancer, solid tumor without metastasis, rheumatoid arthritis/collagen vascular
             diseases, coagulopathy, obesity, weight loss, fluid and electrolyte disorders, blood
             loss anemia, deficiency anemias, alcohol abuse, drug abuse, psychoses, and depression

          -  Have a Primary Care Physician who has outpatient data included on EPIC electronic
             health record.

        Exclusion Criteria:

          -  Are admitted to critical care units;

          -  Are admitted from skilled nursing facilities;

          -  Have dementia;

          -  Were previously enrolled in the study

          -  Are organ transplant recipients
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Intervention: Metoclopramide Nasal Spray; Placebo Nasal Spray
Intervention description: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID); One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
Intervention MeSH terms: Metoclopramide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes; Gastroparesis; Delayed gastric emptying; Nausea; Vomiting; Bloating; Abdominal pain; Early Satiety; Gastric stasis; Gastropathy

Summary:

      The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray
      compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects between the ages of 18 and 75 years

          -  Willingness and ability to give written informed consent

          -  The ability to read, understand and speak English

          -  Prior diagnosis of Type 1 or Type 2 diabetes

          -  Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying

          -  A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization

          -  Willingness to discontinue current treatment for diabetic gastroparesis and to avoid
             all proscribed (excluded) medications, as specified by the protocol, for the duration
             of the study

        Exclusion Criteria:

          -  Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of
             gastroparesis and disorders known to be associated with abnormal gastrointestinal
             motility

          -  A history of allergic or adverse responses, including, but not limited to, acute
             dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or
             similar product

          -  A history of, or physical findings suggestive of, tardive dyskinesia

          -  A history of epilepsy or currently using and unwilling or unable stop other drugs
             known to be associated with extrapyramidal reactions at screening

          -  Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the
             skin) currently present, initially diagnosed or recurring within five (5) years of
             screening

          -  Renal dysfunction calculated as creatinine clearance (CrCl) <40 mL/min at screening

          -  Hemoglobin A1c >11.5% at screening
Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Teneligliptin 20mg; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed as a prospective, multi-centre, parallel group, double-blind
      randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of
      MP-513 (Teneligliptin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed and dated informed consent form has been obtained from the subject, in
             accordance with International Conference on Harmonisation guidelines on Good Clinical
             Practice (ICH GCP), before any screening or study related procedures take place.

          -  The subject is aged ≥18 years at signature of the informed consent form.

          -  Hospitalization status: outpatient.

          -  The subject has had a documented diagnosis of type 2 diabetes mellitus for at least 3
             months at the screening visit (Day -28).

          -  The subject is undergoing diet and exercise therapy, and diet and exercise regimen has
             not been changed for at least 8 consecutive weeks at the screening visit (Day -28).
             Subjects who cannot do exercise due to complication are not limited to this criteria.

          -  The subject's glycosylated fraction of haemoglobin(HbA1c) is ≥ 7.0% and < 10.0% at the
             screening visit (Day -28) and on Day -14.

        Exclusion Criteria:

          -  The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.

          -  The subject has received insulin within 1 year prior to the screening visit (Day -28),
             with the exception of insulin therapy during hospitalization or insulin therapy for
             medical conditions not requiring hospitalization (< 2 weeks' duration).

          -  The subject has received an anti-diabetic drug within 8 weeks prior to the screening
             visit (Day -28).
Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair
Condition: Heart Valve Diseases
MeSH terms: Heart Valve Diseases
Intervention: Atorvastatin
Intervention MeSH terms: Atorvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No

Summary:

      The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory
      agent can be effective in preventing from atrial fibrillation incidence in patients whom
      undergone open cardiac surgery for their heart valve repair.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than 25 y/o

          -  No occurrence of intra- or post-operative cardiopulmonary arrest

          -  Not consuming drugs affecting atrial rhythm

          -  Having sinus rhythm before surgery

          -  Lack of paroxysmal atrial fibrillation history

          -  Only undergo heart valve surgery

          -  Lack of considerable heart ischemia needed atorvastatin use

          -  Routine cares in ward, post-operative ward, and intensive care unit were done

        Exclusion Criteria:

          -  Lesser than 25 y/o

          -  History of atrial fibrillation

          -  History of taking anti-arrhythmic drugs

          -  History of implementing pacemakers

          -  Severe heart failure

          -  Renal failure

          -  Hepatic failure

          -  Severe pulmonary diseases

          -  Heart block or bradyarrhythmia

          -  Routine cares in ward, post-operative ward, and intensive care unit were not done

          -  Performing concomitant cardiac surgery except valve repair

          -  Having considerable heart ischemia needed atorvastatin use
A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: S5G4T-1; S5G4T-2
Intervention description: Once a day topical cream; Once a day topical cream
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 361.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: papulopustular rosacea

Summary:

      To assess the efficacy and safety of S5G4T-1 compared to its vehicle when applied once daily
      for 12 weeks in participants with papulopustular rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must sign an Institutional Review Board (IRB) approved written informed
             consent for this study.

          2. Male and female 18 years of age and older.

          3. Participants must have clinical diagnosis of moderate to severe rosacea.

          4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules
             and/or pustules) including those present on the nose.

          5. Have 2 nodules or less.

        Exclusion Criteria:

          1. Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of
             their study participation or were found to have positive pregnancy test at Baseline or
             screening visits.

          2. Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).

          3. Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or
             keratitis) of sufficient severity to require topical or systemic antibiotics.