bioihbjkbjnl/mcl2 huggingface dataset:
ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
Condition: Shingles
MeSH terms: Herpes Zoster
Intervention: ZOSTAVAX
Intervention description: Shingles vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: solid tumor; chemotherapy; vaccine

Summary:

      This study evaluates if the shingles vaccine works in those persons that receive it before
      they receive chemotherapy for solid organ tumors. Half of the participants will receive the
      ZOSTAVAX shingle vaccine and half of the participants will not received anything.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Solid organ tumor patients that have at least 14 days between entry into the study
             with ZOSTAVAX vaccination and initial therapy for their malignancy that will include
             chemotherapy alone or surgery with subsequent chemotherapy plus or minus radiation
             therapy

          -  A plan for chemotherapy that at the onset at least an anticipated stop date within 3-6
             months of our sample collection phase of the study

        Exclusion Criteria:

          -  Prior history of HZ or shingles vaccine

          -  Systemic chemotherapy < 3 months prior to enrollment

          -  Any history of hematologic malignancy, HIV/AIDS, hematopoietic stem cell transplant,
             or other cellular immunodeficiency state

          -  Those receiving immunomodulating drugs at the time of vaccination such as prednisone
             methotrexate, azathioprine, mercaptopurine, or other biologics including TNF-alpha
             inhibitors

          -  Widespread metastatic tumor with bone marrow involvement

          -  Indefinite duration palliative chemotherapy subjects

               -  Inability to communicate with the study staff or bring unable to consent for
                  themselves

               -  History of anaphylactic/anaphylactiod reaction to gelatin, neomycin, or other
                  components of the vaccine
Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Brexpiprazole
Intervention description: Oral brexpiprazole tablets as adjunctive therapy to ADT
Intervention MeSH terms: Brexpiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MDD; Depression; Brexpiprazole

Summary:

      The clinical trial will investigate the effect of brexpiprazole on the concept of life
      engagement in participants with Major Depressive Disorder (MDD) with a current depressive
      episode.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants (outpatients) between the regional age of majority (18 or
             19 years of age) to 65 years of age, inclusive, at the time of informed consent.

          -  Primary diagnosis of MDD and in a current non-psychotic major depressive episode (MDE)
             as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
             (DSM-5) criteria, who have been outpatients for at least 4 weeks, and have an
             inadequate response, per investigator judgment, to 1 or 2 adequate treatments of ADTs
             in their current MDE, including current ADT.

          -  Participants with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the
             screening and baseline visits, if separate.

        Exclusion Criteria:

          -  Participants currently or previously treated with brexpiprazole including participants
             who received brexpiprazole in any prior clinical trial.

          -  Participants with a concurrent DSM-5 diagnosis of the following will be excluded:

               -  Schizophrenia or schizoaffective disorder

               -  Bipolar I or bipolar II disorder

               -  Post-traumatic stress disorder

               -  Dementia

               -  Eating disorder

               -  Borderline personality disorder

               -  Antisocial personality disorder

          -  Participants with a suicidality score of 3 based on Inventory of Depressive
             Symptomatology Self-Report (IDS-SR) suicidality item 18 or participants who, in the
             opinion of the investigator, presents a serious risk of suicide.
Coronary Artery Revascularization in Diabetes
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Percutaneous coronary intervention (PCI); Coronary artery bypass graft (CABG)
Intervention description: percutaneous coronary stenting with drug eluding stents; coronary bypass
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CABG; Coronary Disease; Diabetes; PCI

Summary:

      This is a randomized, multi-site, clinical trial comparing percutaneous coronary stenting
      (PCI) with drug eluding stents to coronary bypass for angiographically significant coronary
      artery disease in diabetes. The hypothesis being tested is that a strategy of surgical
      revascularization is superior to percutaneous intervention in preventing death or myocardial
      infarction in diabetics with severe ischemic heart disease.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with diabetes with severe coronary artery disease General Inclusion Criteria

          1. Age at least 18 years old

          2. Patients with either Type I or Type II diabetes with a documented HbA1c greater than
             site ULN (If not on diabetic medication must be confirmed by a blood glucose of >126
             mg/dL fasting, or >200mg/dL non-fasting); OR on diabetic medication with a documented
             physician diagnosis of diabetes mellitus.

          3. No child bearing potential (if female)

          4. Patient competent to provide consent

             Exclusion Criteria:

             General Exclusion Criteria

          5. Congenital heart disease

          6. Coronary bypass surgery within the preceding one year

          7. Need for concomitant cardiac surgery

          8. AHA Class III decompensated heart failure or AHA Class IV heart failure

          9. Undergoing PCI for hemodynamic instability related to acute STEMI

         10. History of a hemorrhagic stroke

         11. Severe bleeding diathesis

         12. History of chronic pancreatitis

         13. A severe co-morbid condition that is expected to limit life to less than two years

         14. Embolic stroke in the past six months

         15. Significant GI bleed within the last one month

         16. Lack of adequate surgical conduit

         17. Sensitivity to clopidogrel (Plavix)

         18. Sensitivity to glycoprotein IIb/IIIa inhibitors

         19. Chronic systemic steroid use

         20. Participation in another trial with active intervention

         21. Patient unable to be adequately followed
Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents
Condition: Coronary Heart Disease; Coronary Restenosis
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Coronary Restenosis
Intervention: Oral sirolimus; Drug Eluting stent
Intervention description: Oral sirolimus given orally during 14 days plus bare metal stent implantation was compared with DES.Oral sirolimus was given as bolus of 10 mg started day before intervention followed by 3mg per day during 13 days after PCI. 180 mg of Diltiazem was added during oral administration of sirolimus .; Any Drug eluting stent
Intervention MeSH terms: Sirolimus; Paclitaxel; Temsirolimus; MTOR Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Eluting Stents; Stents Bare Metal; Stent Thrombosis; Coronary revascularization; Survival

Summary:

      In a previous randomized comparison oral sirolimus plus bare metal stent compared to bare
      metal stent implantation alone demonstrated at one year of follow up a significant reduction
      of angiographic and clinical parameters of restenosis (ANMAT resolution number 3366 from June
      2004 and Rodriguez A et al JACC,2006,47,1522-1529). In addition previous reported registries
      from our group with Drug Eluting Stents showed similar amount of reduction in clinical
      parameters (not angiographic)of restenosis (ERACI III, Rodriguez A et al EuroIntervention
      2006,2:53-60). Taking in account that 8.3% of patients treated with oral rapamycin plus Bare
      Metal Stents(ORAR II Trial JACC 2006)and 8.8% of patients treated with DES developed clinical
      restenosis (ERACI III Registry, EuroIntervention 2006) the investigators sought to compare
      differences in overall cost with both revascularization strategies at 1, 2, 3 and 5 years of
      follow up assuming that safety and efficacy clinical end points would be similar.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Indication of revascularization

          -  De novo lesions

          -  Native vessels

          -  Suitable for stent placement

        Exclusion Criteria:

          -  Acute myocardial infarction within the last 24 hours

          -  In stent restenosis

          -  Previous percutaneous coronary intervention within the last 6 months
L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer
Condition: Breast Cancer; Chemotherapeutic Agent Toxicity; Neurotoxicity
MeSH terms: Breast Neoplasms; Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Intervention: L-carnitine L-tartrate; placebo
Intervention description: Given orally; Given orally
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: neurotoxicity; chemotherapeutic agent toxicity; stage IV breast cancer; recurrent breast cancer

Summary:

      RATIONALE: L-carnitine L-tartrate may prevent peripheral neuropathy caused by chemotherapy.

      PURPOSE: This randomized clinical trial is studying how well L-carnitine L-tartrate works in
      preventing peripheral neuropathy caused by chemotherapy in women with metastatic breast
      cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of breast cancer

               -  Metastatic disease

          -  Scheduled to receive ≥ 1 of the following chemotherapy drugs:

               -  Paclitaxel

               -  Docetaxel

               -  Capecitabine

               -  Gemcitabine hydrochloride

                    -  Concurrent enrollment in the University of Minnesota study "Population
                       Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with
                       Solid Tumors" (Human Subjects Code 0508M72989) required

               -  Albumin-bound paclitaxel (Abraxane)

               -  Doxorubicin hydrochloride

        PATIENT CHARACTERISTICS:

          -  Life expectancy ≥ 6 months

          -  Serum creatinine < 2.0 mg/dL

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No history of seizures

          -  No uncontrolled hypertension

          -  No history of stroke

          -  No malabsorption syndrome

          -  No cognitive impairment

          -  No history of psychiatric disability affecting informed consent or compliance with
             drug intake

          -  Able to take oral medication

          -  Able to complete questionnaire(s) alone or with assistance

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No concurrent warfarin

          -  No concurrent radiotherapy
Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
Condition: Pre-eclampsia Aggravated
MeSH terms: Eclampsia; Pre-Eclampsia
Intervention: placebo; Magnesium Sulphate; sugammadex
Intervention description: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion; Experimental :
50 mg/kg bolus plus 15 mg/kg continuous infusion; 4 mg/kg iv bolus at the end of the surgery
Intervention MeSH terms: Magnesium Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: sugammadex; rocuronium; magnesium; female

Summary:

      Background: The aim of this prospective study was to evaluate the effect of magnesium on the
      reversal of rocuronium-induced neuromuscular block by sugammadex.

      Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II,
      undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with
      propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane.
      The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a
      bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo
      group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium
      was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more
      during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv
      was administered. Patients were observed until a TOF ratio of 0.9 was achieved.
      Patient-controlled analgesia with intravenous morphine was used postoperatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients

          -  American Society of Anesthesiologists (ASA) physical status I or II

          -  18-60 years of age who were undergoing elective gynecological surgery

          -  requiring endotracheal intubation were enrolled in this prospective study.

        Exclusion Criteria:

          -  Patients who had body mass index > 35

          -  gastroesophageal reflux

          -  a history of allergy

          -  used medication known to interact with the drugs being used in this trial

          -  who experienced expected or unexpected difficulty during intubation or ventilation

          -  had neuromuscular disease

          -  hepatic or renal insufficiency

          -  were pregnant

          -  had a family history of malignant hyperthermia

          -  detection if low or high control plasma magnesium levels
A Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Ranibizumab 0.5 mg; Aflibercept 2.0 mg
Intervention description: Administered as an intravitreal injection; Administered as an intravitreal injection
Intervention MeSH terms: Ranibizumab; Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Investigators were not masked. The patients, the BCVA assessors, and the Central Reading Center (who set the treatment intervals) were masked.
Enrollment: 281.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Age-related macular degeneration; AMD; wet AMD; ranibizumab; aflibercept; geographic atrophy; inject and extend

Summary:

      The purpose of this study was to compare the development of new geographic atrophy in
      patients with wet Age-related Macular Degeneration (AMD) when treated with either ranibizumab
      or aflibercept over 24 months. Geographic atrophy is an advanced form of AMD that can result
      in the progressive and irreversible loss of visual function over time.
    

Eligibility criteria:

        Inclusion criteria:

        - Written informed consent.

        Inclusion criteria specific to the study eye:

          -  Diagnosis of active subfoveal Choroidal Neovascularisation (CNV) secondary to wet
             Age-related Macular Degeneration (AMD);

          -  Best Corrected Visual Acuity (BCVA) score of 23 letters or more as measured by 3-metre
             Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts.

        Exclusion criteria:

          -  Pregnant, nursing, or at risk of becoming pregnant during the study;

          -  Inability to comply with the study or follow-up procedures;

          -  Recent (3 months) stroke or myocardial infarction; uncontrolled hypertension;
             hypersensitivity to the study treatments or to fluorescein;

          -  In either eye: active periocular or ocular infection or inflammation; iris
             neovascularisation; uncontrolled or neovascular glaucoma; or one or more patch of
             geographic atrophy (GA) as specified in the protocol.

        Exclusion criteria specific to the study eye:

          -  Prior or current treatment with anti-angiogenic drugs or corticosteroids;

          -  Other eye conditions as specified in the protocol;

          -  Any intraocular procedure carried out within 2 months before baseline or anticipated
             within 6 months following baseline.
Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity
Condition: Attention Deficit Hyperactivity Disorder; Glucose Intolerance; Obesity
MeSH terms: Hyperkinesis; Obesity; Glucose Intolerance; Attention Deficit Disorder with Hyperactivity
Intervention: Lis-dexamphetamine
Intervention description: Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Dextroamphetamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ADHD; Glucose Intolerance; Obesity; Vyvanse

Summary:

      The purpose of this study to assess the effects of chronic administration of Vyvanse
      (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with
      Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are
      obese.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female, ages between 8 and 17

          -  Body Mass Index > 30

          -  fasting blood sugar between 90-100 mg/dl

          -  2 hour post prandial >140 <180 mg/dl

          -  meets criteria for a diagnosis of ADHD, any subtype

        Exclusion Criteria:

          -  known cardiovascular disease or diabetes

          -  structural cardiac abnormalities, abnormal ECGs, family history of sudden death

          -  positive urine drug screen

          -  fasting blood sugar level > 126 mg/dl

          -  HbA1c > 6.5 %

          -  Weight > 300 lbs
A Low Dose Remifentanil Infusion During Tracheal Extubation in Surgical Intensive Care Unit Patients
Condition: Tracheal Extubation
Intervention: Remifentanil
Intervention description: Control group : stopping of propofol and remifentanil infusion Remifentanil group : stopping of propofol and maintenance of remifentanil infusion
Intervention MeSH terms: Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 50.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: safety and efficacy of maintaining a remifentanil infusion during extubation in propofol-remifentanil sedated patients after surgery

Summary:

      Tracheal extubation can be associated with hyperdynamic circulatory response. The
      investigators examined the effect of maintaining a remifentanil infusion on the
      cardiovascular response during extubation in propofol-remifentanil sedated patients after
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 20

          2. Short term ventilator care after surgery in intensive care unit

        Exclusion Criteria:

          1. pneumonia

          2. chronic obstructive lung disease

          3. asthma

          4. end stage renal disease

          5. risk factors for aspiration