bioihbjkbjnl/mcl2 huggingface dataset:
Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Exenatide; Placebo
Intervention description: Exenatide SQ 2mg/week for 24 weeks.; Placebo SQ 1x/week for 24 weeks.
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a 24-week, randomized, double-blind, placebo-controlled trial of exenatide weekly
      injection (2mg per dose) as an adjunctive therapy in 70 schizophrenia subjects to examine
      exenatide's effects on negative symptoms and cognition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-65 years

          -  diagnosis of schizophrenia or schizoaffective disorder

          -  stable dose of the current antipsychotic drug for at least one month

          -  well established compliance with outpatient treatment per treating clinician's
             judgment

          -  able to complete the cognitive assessment battery (must be English speaking)

          -  Female subjects will be eligible to participate in the study if they are of
             non-childbearing potential or of child-bearing potential and willing to practice
             appropriate birth control methods during the study

        Exclusion Criteria:

          -  inability to provide informed consent

          -  current substance abuse

          -  psychiatrically unstable per treating clinician's judgment

          -  significant medical illnesses including uncontrolled hypertension, diabetes, seizure
             disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases

          -  currently on anti-inflammatory or immunosuppressant medication including oral steroids

          -  currently on sulfonylurea drugs (e.g. glyburide)

          -  history of chronic infection (including tuberculosis, HIV and hepatitis), malignancy,
             organ transplantation, blood dyscrasia, central nervous system demyelinating disorder,
             and any other known autoimmune or inflammatory condition

          -  pregnant or breastfeeding

          -  prisoners
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Blood sampling
Intervention description: A blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-B™ vaccine.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 16 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B

Summary:

      This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs)
      antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the
      study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up
      study.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who had participated in the primary study.

          -  Written informed consent obtained from the subject.
Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension
Condition: Hypertension in Pregnancy; Postpartum Preeclampsia
MeSH terms: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Intervention: ACE Inhibitors and Diuretics; NIFEdipine ER
Intervention description: Hctz/Lisinopril (brand name: Zestoretic); Extended release nifedipine
Intervention MeSH terms: Nifedipine; Diuretics; Angiotensin-Converting Enzyme Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized control trial
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if a combined pill of Angiotensin-converting enzyme (ACE)
      inhibitors (a medication that helps relax your veins and arteries to lower your blood
      pressure) with diuretics (sometimes called water pills, help rid your body of salt and water)
      will control blood pressure better than a different blood pressure medication of calcium
      channel blocker (lower your blood pressure by preventing calcium from entering the cells of
      your heart and arteries). Both medications are part of our usual care for high blood pressure
      after delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postpartum women at ≥ 18 years of age

          -  Postpartum diagnosis of persistent hypertension (2 measurements of Systolic BP ≥150
             and/or diastolic BP ≥ 100 or systolic BP ≥140 and/or diastolic BP ≥ 90 for people with
             diabetes) requiring an oral medication based on the ACOG criteria or

          -  Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum requiring blood
             pressure medication in the postpartum

          -  Chronic hypertension requiring blood pressure medication postpartum

        Exclusion Criteria:

          -  Urine output < 30 cc/h prior to screening for eligibility

          -  Creatinine > 1.4 during current admission

          -  End-stage renal disease

          -  Hypersensitivity to ACE inhibitors or sulfa drugs

          -  Idiopathic/hereditary angioedema

          -  Hyperkalemia (serum potassium >5 mEq/L) during current admission

          -  Pulmonary edema
An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib
Intervention description: Erlotinib will be given orally as 150 milligrams (mg) once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6586.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will provide treatment with erlotinib to participants with advanced NSCLC who have
      received at least one course of standard chemotherapy or radiation therapy, or who are not
      medically suitable for either. Efficacy and safety will be monitored throughout the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater than or equal to (≥) 18 years of age

          -  Histologically or cytologically documented inoperable, locally advanced, metastatic,
             or recurrent NSCLC

          -  Previous treatment with no more than 2 prior chemotherapy regimens

        Exclusion Criteria:

          -  Previous systemic anti-cancer therapy with human epidermal growth factor receptor 1
             (HER1)/epidermal growth factor receptor (EGFR) inhibitors

          -  Inability to take oral medication

          -  Any other malignancies within 5 years
Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins
Condition: Varicose Veins
MeSH terms: Varicose Veins
Intervention: Polidocanol with Glucose; Glucose
Intervention description: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects; An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects
Intervention MeSH terms: Polidocanol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: Female
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Sclerotherapy; varicose veins; veins

Summary:

      It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75%
      hypertonic glucose of sclerotherapy in lower limbs´ reticular veins. It will be included only
      adult women with reticular veins on the side of the thighs and mild venous insufficiency
      (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  females

          -  with at least 10 cm from the lateral reticular veins of the leg or thigh of the leg

          -  clinical classification of chronic venous disease C1(mild venous disease),

          -  minimum age of 18 year-old and maximum age 69 year-old

          -  agreement with the study

          -  signing the free and informed consent ( IC)

          -  not use anticoagulant drugs .

        Exclusion Criteria:

          -  male

          -  varicose disease in any quantity or location with clinical classification of chronic
             venous disease different of C1(mild venous disease)

          -  restrict mobility

          -  arterial insufficiency

          -  be allergic to any substance that may be related to the study drugs

          -  any cause of dermatitis on application site

          -  free of comorbidities clinically serious as diabetes mellitus, heart failure,
             respiratory failure, uncontrolled hypertension with medication, and uncontrolled
             hypothyroidism

          -  pregnancy

          -  previous deep vein thrombosis (DVT)

          -  family history of DVT

          -  thrombophilia

          -  do not agree with the search terms
Pharmacokinetics of Preoperative Vancomycin
Condition: Surgical Site Infection; Vancomycin
MeSH terms: Surgical Wound Infection
Intervention: Administration of Vancomycin
Intervention description: Intravenous Vancomycin Administration
Intervention MeSH terms: Vancomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 31 Days
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Neurosurgery patients between the ages of 31 days up to 18 years

          2. Receiving a single dose of vancomycin administered prior to surgery for cerebrospinal
             fluid (CSF) shunt placement or revision.

          3. Orthopedic surgical patients between the ages of 31 days up to 18 years

          4. Receiving a single dose of vancomycin administered prior to surgery for definitive
             spinal fusion.

        Exclusion Criteria:

          1. Patients already receiving vancomycin for treatment of an active infection,

          2. Patients who have a Creatinine ≥1.2,

          3. Patients who's creatinine clearance less than 50,

          4. Known chronic renal failure and are on dialysis,

          5. Patients with a known allergy to vancomycin, not including Red Man Syndrome.
Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Paroxetine; Placebo
Intervention description: Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.; Placebo: same as paroxetine (active comparator)
Intervention MeSH terms: Paroxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: PTSD; Paroxetine; Subthreshold

Summary:

      The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine
      for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the
      early post-deployment period; and 2) To determine the potential efficacy of paroxetine in
      preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and
      improving overall veteran function.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Veterans 18-55 years of age

          2. Diagnosis of subthreshold PTSD (at least one symptom in PTSD symptom clusters B, C,
             and D by structured interview; with or without functional impairment exposure to war
             zone stressors)

          3. Written informed consent; and

          4. A negative serum pregnancy test for women of childbearing potential.

        Exclusion Criteria:

          1. Lifetime history of DSM-IV diagnosis of bipolar disorder, schizophrenia or other
             psychotic disorder, or cognitive disorder due to a general medical condition

          2. History of substance dependence within the last 3 months

          3. Significant suicide risk or serious suicide attempt within the last year

          4. Clinically significant medical condition or laboratory or EKG abnormality

          5. Women of childbearing potential who are unwilling to practice an acceptable method of
             contraception

          6. Subjects needing concurrent use of psychiatric medications

          7. History of hypersensitivity to paroxetine

          8. HADS depression subscale score > 12

          9. Failure to respond to an adequate trial of paroxetine (20 mg/day x 8 wks).
Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
Condition: Hypotension; Kidney Injury
MeSH terms: Hypotension
Intervention: Plasmalyte 3ml/kg/hr group; Plasmalyte 6ml/kg/hr group
Intervention description: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them; This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
Intervention MeSH terms: Plasma-lyte 148
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Hypotension; Kidney injury

Summary:

      The purpose of this study is to conduct a prospective, randomized, controlled trial comparing
      a restrictive vs. conservative fluid strategy in thoracic surgery patients. Excessive
      perioperative fluid has been retrospectively implicated in the development postoperative
      acute lung injury (PALI) and pulmonary edema following lung resection. However, fluid
      restriction in these patients is not without risk and may compromise end organ perfusion
      (i.e. acute kidney injury). The hypothesis is that a conservative fluid approach in thoracic
      surgery patients will result in better end organ perfusion with fewer occasions of acute
      kidney injury (AKI) without causing an increase in postoperative acute lung injury or
      pulmonary edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  between 18-89 years of age

          -  undergoing pulmonary lobectomy with open or video assisted thoracotomy

        Exclusion Criteria:

          -  patient refusal

          -  pregnancy

          -  cardiac arrhythmia

          -  pacemaker dependency

          -  severe aortic insufficiency

          -  idiopathic hypertrophic subaortic stenosis

          -  prisoners

          -  decisionally challenged

          -  patients that refuse to receive intravenous fluid products made from human plasma
             (Albumin 5%)

          -  patients with skin infection or breakdown on their fingers

          -  severe peripheral vascular disease

          -  evidence of compromised finger perfusion will be excluded
Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: Combigan Two Times Daily (BID); Simbrinza Three Times Daily (TID)
Intervention MeSH terms: Brimonidine Tartrate, Timolol Maleate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Open-Angle Glaucoma; Ocular Hypertension

Summary:

      To compare Combigan Two Times Daily (BID) vs Simbrinza Three Times Daily (TID) in subjects
      currently being treated with Latanoprost for Open-Angle Glaucoma or Ocular Hypertension. Both
      of these drugs are currently FDA approved as combination therapy for patients with Open-Angle
      Glaucoma or Ocular Hypertension. The purpose of this clinical trial would be to assess which
      treatment, if either, is superior in lowering intraocular pressure (IOP). A secondary
      objective is to assess the tolerability of each drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open-angle glaucoma or ocular Hypertension

          -  Currently treated with Latanoprost for min of 6 weeks

          -  Male or Female 18 yrs and older

          -  Best Corrected Visual Acuity 20/100 or better in both eyes

          -  Pachymetry >470 and < 640

          -  Women of childbearing potential must have a negative urine pregnancy test at the
             screening/baseline visit

          -  Patient willing and capable of providing informed consent

        Exclusion Criteria:

          -  C/D > 0.8

          -  Visual field loss, which in the opinion of the investigator is functionally
             significant

          -  Current use of ocular steroids

          -  Concurrent significant active ocular disease History (within 3 months prior to
             Screening) of ocular laser, intraocular, filtering or refractive surgery or planned
             ocular surgery of any kind during study participation

          -  Change within prior 30 days or anticipated change in any systemic medication that is
             known to affect IOP

          -  Uncontrolled systemic disease

          -  Significant ocular hyperemia at baseline

          -  Prior glaucoma procedure within 3 months

          -  Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing
             potential and not using a reliable method of contraception

          -  Known allergy or sensitivity to any study medication

          -  Asthma or any other known medical condition that the investigator feels would put
             patient at increased risk from any of the study medications

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days prior to Screening
Computerized Cognitive Training for Diabetic Elderly Veterans
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: computerized cognitive training; control games
Intervention description: A variety of computer games tailored to address their personal cognitive deficits.; A variety of computer games that are engaging but not designed to enhance cognitive skills
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 199.0
Sex: All
Minimum age: 55 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: computerize cognitive training; dementia; cognitive decline; Diabetes Mellitus, Type 2

Summary:

      Computerized cognitive training (CCT) is an intervention has improved cognitive functioning
      in the elderly with and without cognitive impairment. The investigators will study the effect
      of a CCT program over an active control, "classic" computerized games. The outcomes will be
      memory and executive functions/attention, diabetes elf-management and adherence to
      medications, and glycemic and blood pressure control. Non-demented elderly Veterans with
      diabetes mellitus, who are at high risk for cognitive impairment, will be from the James J.
      Peters, Bronx, NY and Ann Arbor, MI VAMCs. This novel potential service fits the portfolio of
      the Quality Enhancement Research Initiative for Diabetes Mellitus (QUERI-DM) for which the
      Ann Arbor VAMC is a primary center. If successful, the VA National Center for Prevention and
      MyHeatheVet will collaborate in disseminating results to encourage implementation throughout
      the VA
    

Eligibility criteria:

        Inclusion Criteria:

          -  55 years old or above

          -  A diagnosis of type 2 diabetes

          -  Access to computer and internet

          -  Has an informant

          -  Self-management score 18 or below

        Exclusion Criteria:

          -  Dementia or prescribed AD medications

          -  Major medical, psychiatric, or neurological conditions that affect cognitive
             performance

          -  Severe impairment of vision, hearing or fine motor control necessary for computer
             operation