bioihbjkbjnl/mcl2 huggingface dataset:
Escitalopram in Patients With Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: Escitalopram
Intervention description: Flexible-dosed (5 to 20 mg Oral Tablets Daily)
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Social Anxiety Disorder; SAD; Antidepressant; Anxiolytic

Summary:

      The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of
      treatment in patients with Social Anxiety Disorder (SAD), to evaluate proportion of patients
      who respond to escitalopram during the treatment period, and to evaluate safety of
      escitalopram.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient suffers from SAD, diagnosed according to ICD-10 (International
             Classification of Diseases)

          -  The patient meets criteria set in the national SPC for escitalopram

          -  The patient is, in the opinion of the investigator, otherwise healthy on the basis of
             a physical examination, medical history and vital signs

        Exclusion Criteria:

          -  The patient has/has had an alcohol or drug abuse-related disorder, as defined in
             ICD-10

          -  The patient has contraindications to escitalopram

          -  The patient has a history of severe drug allergy or hypersensitivity, or known
             hypersensitivity to escitalopram

          -  The patient has a serious illness and/or serious sequelae thereof, including liver or
             renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine,
             neurological, infectious, neoplastic, or metabolic disturbance

          -  The patient is pregnant or breast-feeding

          -  The patient, if a woman of childbearing potential, is not using adequate contraception
Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery
Condition: Type 2 Diabetes Mellitus; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Placebo
Intervention description: one 5-mg saxagliptin tablet daily; 5mg placebo tablet daily
Intervention MeSH terms: Saxagliptin
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes; Diabetes Mellitus; Type 2 Diabetes; Cardiovascular Disease; Coronary Artery Bypass Surgery

Summary:

      Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular
      events (for example, heart attack) and the risk is related to one's overall control of blood
      glucose levels. In this study the investigators will measure the effects of saxagliptin,
      compared to placebo, before, during, and after coronary artery bypass graft (CABG) surgery.
      The investigators will use samples of the patients' blood and tissue to measure and evaluate
      indicators of the body's response to the treatment. This study is being done to evaluate the
      effect of saxagliptin on biomarkers of the heart to help us understand whether reducing or
      controlling a person's blood glucose levels during and after CABG surgery will produce better
      clinical outcomes (for example, better heart health).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Known diagnosis of type 2 diabetes mellitus (T2DM) with glycosylated hemoglobin
             (HbA1c) between 6.5% and 10%, inclusive.

               -  Stable doses of oral antihyperglycemic agents for at least 2 months

               -  Stable dose of chronic insulin therapy for at least 2 months

               -  HbA1c documented within 3 months before study enrollment

          -  Planned first elective coronary artery bypass graft (CABG) surgery

        Exclusion Criteria:

          -  Elevated Creatine Kinase-Myocardial Bands (CK-MB) or troponin level above the 99th
             percentile at screening

          -  Receiving incretin therapy or having received incretin therapy within the previous 2
             months

          -  Type 1 DM or a history of ketoacidosis

          -  Women who are pregnant or breastfeeding

          -  Known end-stage Kidney disease

          -  Known sensitivity or intolerance to saxagliptin or dipeptidyl peptidase-4 (DPP-4)
             inhibitor

          -  Clinically apparent liver disease

          -  History of pancreatitis
Recovery Profile Comparison Between Remifentanil-propofol or Desflurane Anesthesia Monitored With Bispectral Index.
Condition: Delayed Emergence From Anesthesia
MeSH terms: Delayed Emergence from Anesthesia
Intervention: Desflurane; Propofol
Intervention description: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring; Total intravenous anesthesia based on propofol
Intervention MeSH terms: Propofol; Desflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Airway extubation; Anesthesia Recovery Period; Desflurane; Propofol; Intravenous anesthesia; Balanced Anesthesia

Summary:

      Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative
      recovery than remifentanil-propofol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients over 18 years old classified by the American Society of
             Anesthesiologists as physical status I or II, undergoing elective breast surgery with
             general anesthesia.

        Exclusion Criteria:

          -  History of: illegal drug and alcohol abuse

          -  Pregnancy on course or suspicion of

          -  Neuromuscular disorders

          -  Cerebral vascular disease

          -  Dysphagia

          -  Dysphonia

          -  Gastroesophageal reflux disease

          -  Previous larynx and/or upper gastrointestinal tract surgery

          -  Allergy to any drug to be used and malignant hyperthermia.

          -  Patients who develop hemodynamic instability in the surgery and need blood transfusion
             were excluded from the study.

          -  Patients unable to swallow 20 ml of water in an upright position were also excluded.
TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
Condition: Patient Indicated for an ICD
Intervention: Home Monitoring; In-Office Conventional Follow-up
Intervention description: Home Monitoring programmed on. In-office and Home Monitoring evaluation at 3 and 15 months post ICD implant. Home Monitoring evaluation only at 6, 9, and 12 months post ICD implant.; Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1450.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Telemonitoring; ICD; Reduction of office follow-ups

Summary:

      This study is a multi-center, prospective and randomized trial. The primary objective of this
      study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely
      reduce the number of regularly scheduled office follow-up visits, compared to the
      conventional method of implantable cardioverter defibrillator (ICD) follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Implanted within the last 45 days or being considered for implant with a BIOTRONIK ICD
             with Home Monitoring (HM)/Intracardiac Electrogram (IEGM)-Online technology, or
             legally marketed future generation device with HM/IEGM Online.

          -  Able to utilize the HM system throughout the study

          -  Ability to give informed consent

          -  Geographically stable and able to return for regular follow-ups for fifteen (15)
             months

          -  At least 18 years old

        Exclusion Criteria:

          -  Patients who do not fulfill all inclusion criteria

          -  Pacemaker dependent

          -  Currently enrolled in any other cardiac clinical investigation
A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inflexal V
Intervention description: Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2008-2009 season, containing per 0.5 mL dose:
15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
15 µg HA antigen of B/Florida/4/2006-like virus
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Virus; Vaccination; Immunisation

Summary:

      A study to assess whether the Northern Hemisphere 2008/2009 season influenza vaccine Inflexal
      V fulfills the EMEA requirements for re-registration of influenza vaccines
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy female and male adults

          -  Aged ≥18 to ≤60 years or >60 years on Day 1

          -  Written informed consent

        Exclusion criteria:

          -  Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or
             other acute disease

          -  Acute febrile illness (≥38.0 °C)

          -  Prior vaccination with an influenza vaccine in the past 330 days

          -  Known hypersensitivity to any vaccine component

          -  Previous history of a serious adverse reaction to influenza vaccine

          -  History of egg protein allergy or severe atopy

          -  Known blood coagulation disorder

          -  Chronic (longer than 14 days) administration of immunosuppressants or other
             immune-modifying drugs within 6 months before the first dose of study vaccine; oral
             corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded;
             inhaled or topical steroids are allowed

          -  Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)

          -  Investigational medicinal product received in the past 3 months (90 days)

          -  Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months
             (90 days)

          -  Pregnancy or lactation

          -  Participation in another clinical trial

          -  Employee at the investigational site, or relative or spouse of the investigator

          -  Suspected non-compliance
Labetalol and Esmolol: Vital Signs and Post Operative Pain Management
Condition: Laparoscopic Surgery
Intervention: Fentanyl; Labetalol; Esmolol
Intervention description: Fentanyl 50 micrograms/ml boluses will be given:
at the induction time
at the time before surgical incision, and
as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm); Labetalol 5 mg/ml boluses will be given:
at the induction time
at the time before surgical incision, and
as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm); Esmolol 10 mg/ml boluses will be given:
at the induction time
at the time before surgical incision, and
as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
Intervention MeSH terms: Labetalol; Fentanyl; Esmolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Labetalol; Esmolol; Fentanyl; Anesthetic adjuvant; Ambulatory surgery; Outpatient surgery; Pain management; Hemodynamic stability; Perioperative outcomes

Summary:

      This study proposes to investigate the effects of labetalol or esmolol on managing the vital
      signs (like blood pressure and heart rate) during surgery, on pain management, and on the
      later recovery after surgery.

      It will also assess the cost-effectiveness of Labetalol and esmolol for outpatient surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled to undergo outpatient surgery procedures

          -  Willingness and ability to sign an informed consent document

          -  No allergies to anesthetic or analgesic medications

          -  18 - 80 years of age

          -  American Society of Anesthesiologists (ASA) physical status classification I - III
             adults of either sex

          -  Women of childbearing potential must be currently practicing an acceptable form of
             birth control, and have a negative urine pregnancy test

        Exclusion Criteria:

          -  Patients with known allergy, hypersensitivity or contraindications to anesthetic or
             analgesic medications

          -  Patients with clinically-significant medical conditions, such as brain, heart, kidney,
             endocrine, or liver diseases, peptic ulcer disease or bleeding disorders

          -  Pregnant or lactating women

          -  Subjects with a history of alcohol or drug abuse within the past 3 months

          -  Any other conditions or use of any medication which may interfere with the conduct of
             the study
Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol; Salmeterol
Intervention description: Indacaterol is delivered via a SDDPI.; Salmeterol/fluticasone is delivered via a MDDPI
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 581.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; Indacaterol; Salmeterol/fluticasone propionate

Summary:

      The purpose of this study is to compare the effectiveness and safety of indacaterol with
      salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive
      pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone
      propionate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with moderate COPD (Stage II)

          -  Able to perform spirometry assessments

          -  Current or ex-smokers

          -  On treatment with the fixed-dose combination of salmeterol 50 µg/fluticasone
             propionate 500 µg MDDPI b.i.d. for the treatment of COPD for ≥ 3 months directly
             preceding Visit 1.

        Exclusion Criteria:

          -  Having had a COPD exacerbation that required treatment with antibiotics and/or oral
             corticosteroids and/or hospitalization in the past year.

          -  Having a history of, or current ECG abnormality

          -  Asthma

        Other protocol-defined inclusion/exclusion criteria may apply.
Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
Condition: Blepharospasm
MeSH terms: Blepharospasm
Intervention: Botulinum Toxin Type A 900kDa; Botulinum Toxin Type A 150kDa
Intervention description: 6 to 16 injections, with maximum of 21, at a dose of ≥20U/eye (≥40U total dose); 6 to 16 injections, with a maximum of 21, at a dose of ≥20U/eye (≥40U total dose)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot study estimates the treatment effects of two different types of botulinum toxin
      type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive
      contraction of the muscles around the eye and can lead to repetitive blinking or sustained
      closure of the eyelids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with benign essential blepharospasm

          -  Received ≥20U/eye of BOTOX® for at least one visit prior to study entry and required,
             in the investigators opinion, the same dose at the study injection visit.

          -  Combined Jankovic Rating Score of >2

        Exclusion Criteria:

          -  Female subjects who were pregnant, breastfeeding, or who were of childbirth potential
             and not practicing birth control.

          -  Profound atrophy of the muscles in the target area(s) of injection.

          -  Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis or any other
             disease that might interfere with neuromuscular function.

          -  Known significantly impaired renal and/or hepatic function
Can Dexmedetomidine For Procedural Sedation In Knee Arthroplasty Reduce Postoperative Pain? A Randomized Control Study
Condition: Total Knee Arthroplasty
MeSH terms: Pain, Postoperative
Intervention: Dexmedetomidine; Normal Saline Placebo
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Dexmedetomidine has been often used for procedural sedation. It has also has been shown to
      have a pain sparing effect. Therefore the investigators propose that if Dexmedetomidine is
      used for sedation in total knee replacements done under spinal anesthetic, the patients will
      have less pain up to 24 hours after the procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Total Knee arthroplasty American Society of Anesthesiologist score of 1-3 Age 18-85
             Elective total knee arthroplasty under spinal anesthetic.

        Exclusion Criteria:

          -  Contraindication to Dexmedetomidine. (second or third degree heart block, renal or
             hepatic dysfunction) Contraindication to Spinal Anesthetic Pain being treated by
             opioids prior to operation Contraindication to premedication Previous total knee
             arthroplasty
Gastric Acid Suppression and Probiotic Colonization
Condition: Probiotics
Intervention: Omeprazole; VSL #3; Placebo
Intervention description: Proton pump inhibitor (PPI) that suppresses gastric acid secretion; Probiotics; Placebo to match omeprazole
Intervention MeSH terms: Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Probiotics are over-the-counter dietary products with microorganisms that are generally
      consumed for health benefit. However, the durability of these microorganisms is unclear,
      particularly when they pass through the highly acidic environment of the stomach. We will
      test the colonization of these microorganisms among individuals who consume probiotics with
      and without acid suppression therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers ages 18 years and ≤ 75 years.

          -  Able to visit the study Doctor's office 3 times, answer 3 questionnaires, and provide
             stools and blood samples.

        Exclusion Criteria:

          -  Gastric cancer, Barrett's esophagus cancer, any gastrointestinal condition, or soy or
             gluten sensitivity

          -  Previous abdominal surgery

          -  Currently pregnant or nursing

          -  Had H. Pylori Infection

          -  Diagnosed with any chronic medical condition other than hypertension or hyperlipidemia

          -  Currently consuming herbs or probiotics
Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Acamprosate
Intervention description: Subjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence
Intervention MeSH terms: Acamprosate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol dependence; Acamprosate(drug); Drug Court; Probation; Parole; Criminal justice

Summary:

      The purpose of this study is to test how tolerable and effective acamprosate is when used to
      prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in
      drug court).
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of alcohol dependence in the year before entering criminal justice supervision

          -  Currently under criminal justice supervision (drug court, probation, or parole) in
             central Virginia

        Exclusion Criteria:

          -  Pregnant or nursing a baby

          -  Known sensitivity to acamprosate

          -  Elevated serum creatinine level or other evidence of kidney problems

          -  Symptoms of severe depression or suicidal ideation

          -  Non-English speaking such that they cannot provide informed consent

          -  Cognitive impairment such that they cannot provide informed consent