bioihbjkbjnl/mcl2 huggingface dataset:
Esmolol for Treatment of Perioperative Tachycardia
Condition: High-risk, Non-cardiovascular Surgeries
MeSH terms: Tachycardia
Intervention: Esmolol
Intervention description: Infusion will be started at 50 mcg/kg/min for 4 minutes and titrated in increments of 50 mcg/kg/min up to a maximum of 300mcg/kg/min (maintenance dose) to maintain a heart rate between 60 and 80 beats per minute (bpm) while maintaining a minimum systolic blood pressure (SBP) of 95 mmHg during the length of surgery and up to 12 hours post-operatively.
Intervention MeSH terms: Esmolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 76.0
Sex: All
Minimum age: 41 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out if Esmolol is a safe and effective alternative
      treatment compared to standard treatment using a long acting beta blocker drug, in
      controlling abnormal heart rate before, during and immediately after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or Females

          2. Age > 40y/o

          3. Scheduled high risk (ASA II-IV) non-cardiac surgery with anticipated 12 hour
             post-operative ICU care

          4. Written informed consent

          5. Patients on a stable chronic oral beta-blocker therapy

          6. Revised Cardiac Risk Index 1(below) Cardiac Risk Index 1 or greater (below)

               -  a history of coronary disease

               -  a history of congestive heart failure

               -  a history of treated diabetes

               -  a history of cerebrovascular disease

               -  a history of chronic renal failure

        Exclusion Criteria:

          1. Active bleeding

          2. Untreated left main disease

          3. Active cardiac condition (eg unstable angina pectoris, acute exacerbation of CHF,
             serious arrhythmias, symptomatic valve disease)

          4. Preoperative positive troponin T

          5. Contraindication for esmolol use

          6. Previous allergy or intolerance to esmolol

          7. Cancer with an expected life expectancy < 6 months

          8. Pregnancy or lactating or planning to become pregnant

          9. Failure to provide informed consent, unable to understand or follow instructions.

         10. History of drug allergy or idiosyncrasy to beta-adrenergic drugs

         11. Recent history (within 1 year) of drug or alcohol abuse

         12. Patients with a Pacemaker

         13. Abnormal liver function Child-Pugh - B

         14. Body Mass Index > 45

         15. Reactive airway disease (defined as a history of hospitalization with status
             asthmaticus within the past one year)

         16. Surgery scheduled to begin after 2pm
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo; Belimumab 1 mg/kg; Belimumab 10 mg/kg
Intervention description: Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.; Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.; Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 819.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies; Autoimmune Diseases; Systemic Lupus Erythematosus; SLE; Belimumab; Lupus

Summary:

      The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on
      quality of life of two different doses of belimumab administered in addition to standard
      therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE)
      disease.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of SLE by ACR criteria.

          -  Active SLE disease.

          -  Autoantibody-positive.

          -  On stable SLE treatment regimen.

        Key Exclusion Criteria:

          -  Pregnant or nursing

          -  Have received treatment with any B cell targeted therapy.

          -  Have received treatment with a biological investigational agent in the past year.

          -  Have received IV cyclophosphamide within 180 days of Day 0.

          -  Have severe lupus kidney disease.

          -  Have active central nervous system (CNS) lupus.

          -  Have required management of acute or chronic infections within the past 60 days.

          -  Have current drug or alcohol abuse or dependence.

          -  Have a historically positive test or test positive at screening for HIV, hepatitis B,
             or hepatitis C.
Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
Condition: Hyponatremia
MeSH terms: Hyponatremia
Intervention: 0.3% Saline in 3.3% dextrose; 0.45% Saline in 5% dextrose; 0.9% Saline in 5% dextrose
Intervention description: Hypotonic Solutions: 0.3% Saline in 3.3% dextrose; Hypotonic Solutions: 0.45% Saline in 5% dextrose; Isotonic Solutions 0.9% Saline in 5% dextrose
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 161.0
Sex: All
Minimum age: 3 Months
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine if isotonic solutions reduce the risk of hospital
      acquired hyponatremia compared with hypotonic solutions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children between 3 months to 15 years.

          -  Need for intravenous fluids for 8 hours or more.

          -  Normal serum sodium at the beginning of the study of the study (135-145 mEQ/L).

          -  Acute respiratory problems (acute asthma attack, bronchiolitis or pneumonia).

          -  Acute gastrointestinal disorders (viral o bacterial gastroenteritis).

          -  Elective surgical procedures.

          -  Pre, peri o post operative patients (acute appendicitis, intussusception, intestinal
             perforation, ileus).

        Exclusion Criteria:

          -  Severe hyponatremia (serum sodium < 125 mEq/L).

          -  Severe hypernatremia (serum sodium >155 mEq/L).

          -  Need for intravenous fluids for less than 8 hours according with their treating
             physician.

          -  Severe dehydration or Shock.

          -  Preexisting chronic diseases (renal diseases, heart diseases or endocrine disorders).

          -  Neurologic diseases.

          -  Head trauma.

          -  Cerebral edema or Intracranial hypertension.

          -  Diabetic ketoacidosis.

          -  Use of diuretics one week or less before the study.

          -  Need for admission to the pediatric critical intensive care unit
Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: Topical Herbal Solution; Topical Minoxidil 5%
Intervention description: Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.; Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.
Intervention MeSH terms: Minoxidil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Androgenic Alopecia; Hair Diseases; Skin Diseases; Baldness; Alopecia; Hair Loss

Summary:

      The purpose of this study is evaluating the efficacy and safety of a topical herbal solution
      in males for the treatment of Androgenetic alopecia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men 18 to 50 years old

          -  Written consent

          -  Normal general health status

          -  Men who have a presentation of androgenetic alopecia (Norwood II - V).

        Exclusion Criteria:

          -  Use of any topical product in the target region interfering with the study product in
             the last three months

          -  Within the past 6 months receiving of chemotherapy/cytotoxic agents

          -  Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia

          -  Uncontrolled hypertension

          -  Any dermatological disorders in the scalp, such as fungal or bacterial infections,
             eczema, atopic dermatitis, seborrheic dermatitis, psoriasis, sun damage, skin cancer

          -  Hormonal diseases such as thyroid disorders, diabetes and, ...

          -  Smokers

          -  Liver and kidney disease

          -  History of hair transplants

          -  History of surgical correction of hair loss on the scalp

          -  Subject having dyed, bleached hair or, with a permanent wave prior to study start.

          -  No written consent
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
Condition: Bipolar I Disorder
Intervention: Cariprazine
Intervention description: Cariprazine was supplied in capsules.
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 403.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Mania; Acute mania; Bipolar I disorder

Summary:

      The objective of this study is to evaluate the long-term safety, tolerability, and
      pharmacokinetics of cariprazine in patients with bipolar I disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have provided informed consent prior to any study specific procedures.

          -  Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed
             by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (SCID).

          -  Patients who experienced a manic or mixed episode that required treatment within the
             past 12 months.

          -  Patients with normal physical examination, laboratory, vital signs, and
             electrocardiogram (ECG).

        Exclusion Criteria:

          -  Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I
             disorder.
Remission and Joint Damage Progression in Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; placebo; methotrexate
Intervention description: abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months; placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months; Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24
Intervention MeSH terms: Methotrexate; Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1052.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: abatacept, methotrexate, erosive RA

Summary:

      This is a world wide study to evaluate the remission and joint damage in subjects treated
      with abatacept in addition to methotrexate versus subjects who receive methotrexate along
      with a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis (RA) <=2 years; MTX naive or <=10 mg/wk for <=3
             weeks. No dose within 3 months prior to informed consent.

          -  C-Reactive Protein (CRP) >= 4.5 mg/L (after amendment)

          -  Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive

          -  Tender joints >=12 and swollen joints >=10

        Exclusion Criteria:

          -  Women and men who are not willing to use birth control

          -  Diagnosed with other rheumatic disease

          -  History of cancer within 5 years

          -  Active tuberculosis

          -  Treatment with another investigation drug within 28 days

          -  Active bacterial or viral infection
Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia
Condition: Smoking Cessation; Schizophrenia
MeSH terms: Schizophrenia
Intervention: Tropisetron; Placebo; Risperidone
Intervention description: 10 mg/day; placebo; 6mg/day
Intervention MeSH terms: Tropisetron; Risperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This study will determine the effectiveness of tropisetron plus risperidone in improving
      cognitive symptoms in Chinese people with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently resides in Beijing, China

          -  Diagnosis of schizophrenia or schizophreniform disorder

          -  Duration of symptoms is no longer than 60 months

          -  No history of treatment with antipsychotic medication or, if previously treated, a
             total lifetime usage of less than 14 days

          -  Current psychotic symptoms are of moderate severity or greater as measured by one of
             the five psychotic items in the Brief Psychiatric Rating Scale (BPRS)

        Exclusion Criteria:

          -  Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV Axis I diagnosis other
             than schizophrenia or schizophreniform psychosis

          -  Documented disease of the central nervous system that might interfere with the trial
             assessments (e.g., stroke, tumor, Parkinson's disease, Huntington's disease, seizure
             disorder, history of brain trauma resulting in significant impairment, chronic
             infection)

          -  Acute, unstable, and/or significant and untreated medical illness (e.g., infection,
             unstable diabetes, uncontrolled hypertension)

          -  A clinically significant echocardiogram (ECG) abnormality in the opinion of the
             investigator

          -  Pregnant or breastfeeding

          -  Use of prohibited concomitant therapy

          -  History of severe allergy or hypersensitivity

          -  Dependence on alcohol or illegal drugs

          -  Use of any of the following medications during the trial: antipsychotic medications
             other than risperidone; psychostimulants; or antidepressants
Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Flublok Quadrivalent Influenza Vaccine; Inactivated Influenza Vaccine
Intervention description: Intramuscular injection of vaccine; Intramuscular injection of vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9003.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully
      licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in
      protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ambulatory adults aged 50 and older.

          2. Medically stable, as determined by medical history and targeted physical examination.
             "Medically stable" is defined as no change in diagnoses or chronic medications (dose
             or class) for medical reasons in the 3 months prior to study.

          3. Absence of underlying conditions that make participation in the study contrary to the
             subject's best interest.

          4. Able to understand and comply with planned study procedures.

          5. Provides written informed consent prior to initiation of any study procedure.

        Exclusion Criteria:

          1. Known contraindication to either study vaccine (see product package inserts)

          2. Receipt of any other influenza vaccine within 180 days prior to enrollment in this
             study.

          3. Underlying disease or ongoing therapy that might cause immunocompromise, e.g.
             cytotoxic agents or supraphysiologic doses of corticosteroids, such that response to
             vaccination might be sub-optimal.
Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 338.0
Sex: All
Minimum age: 66 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD

Summary:

      The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR)
      quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve
      depressive symptoms in elderly patients with major depressive disorder.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients, 66 years or older, with a documented clinical diagnosis of
             MDD.

        Exclusion Criteria:

          -  The presence of dementia or mental disorder other than MDD within 6 months of
             enrolment,

          -  Uncontrolled hypertension, substance or alcohol abuse

          -  A current diagnosis of cancer or a current or past diagnosis of stroke
The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; placebo; liraglutide
Intervention description: Administered s.c. (under the skin) once daily. Dose individually adjusted.; Administered s.c. (under the skin) once daily. Dose individually adjusted.; Administered s.c. (under the skin) once daily. Dose: 1.8 mg.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 346.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial
      is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide
      (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type
      2 diabetes qualifying for treatment intensification.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Insulin naïve

          -  Ongoing treatment with metformin or metformin in combination with either sulphonylurea
             (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice
             daily (BID))

          -  Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both
             inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for
             subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or
             exenatide (only BID)

        Exclusion Criteria:

          -  Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria
             within 12 weeks

          -  Calcitonin equal to or above 50 pg/mL

          -  Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial
             infarction; unstable angina pectoris; or coronary arterial bypass graft or
             angioplasty; all within 24 weeks

          -  Current or past (within the last 5 years) malignant neoplasms (except basal cell and
             squamous cell carcinoma)