bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Indices of SNAP vs VISTA on Surgical Patients Undergoing General Anesthesia
Condition: Anesthesia, General
Study type: Interventional

Summary: 
      Establish the range of index values for the SNAP II corresponding to each anesthetic state
      studied.
    

Detailed description: 
      Index values for the SNAP II monitor will be identified with each corresponding anesthetic
      state studied.
    

Intervention name(s): SNAP monitor; Bispectral Index Monitor (BIS Monitor)
Intervention type(s): Device
Intervention description(s): Intended to monitor the state of the brain by data acquisition of EEG signals.
Other intervention name(s): SNAP II monitor; BIS Monitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: To acquire developmental data to prospectively support SNAP; II index ranges at the studied anesthetic states.
Study of the Effect of omega3 on Biomarkers of Cardiac Necrosis (CKMB and Troponin I) and Inflammation Marker (CRP) After Elective Percutaneous Coronary Intervention (PCI)
Condition: Coronary Arteriosclerosis
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Inflammation; Necrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the effect of omega 3 on biomarkers of cardiac
      necrosis(CKMB and troponin I) and inflammation marker CRP.
    

Detailed description: 
      Percutaneous coronary intervention (PCI) has become the most common form of coronary
      revascularization worldwide. Although PCI is a safe procedure, it may have multiple risks
      including bleeding, coronary dissection, abrupt vessel closure, and myocardial necrosis. It
      is estimated that approximately 25% of patients undergoing PCI have significant
      postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations
      and approximately 50% of patients have significant post-procedural troponin elevations.
      Initially, it was felt these elevations were simple enzyme leaks with no long-term
      implications.

      Now, several studies have demonstrated that periprocedural infarction is associated with
      short-, intermediate-, and long-term adverse outcomes, most notably mortality. Pretreatment
      with antiplatelets such as aspirin and clopidogrel play an important role in reducing
      cardiovascular events (CV events) following PCI.

      Omega -3 polyunsaturated fatty acids (PUFAs) have antiplatelet effect. It may also improve
      response to aspirin and clopidogrel in low-response patients.

      This study is a randomized clinical trial (RCT) evaluating the effect of omega 3 supplement
      [with 400mg Eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA)] on biomarkers of
      cardiac necrosis (CKMB and troponin I) in patients undergoing elective PCI. Eighty patients
      planed to do elective PCI will be categorized into two groups. The first group will be
      received standard regimen for PCI (aspirin, clopidogrel, and heparin) and the second group
      will be treated with standard regimen in addition to 3 gram omega 3 (12 hours before PCI).
      Blood samples will be drawn in all patients before and 8 and 24 h after intervention for
      cardiac biomarkers assessment (CK-MB, troponin I)and inflammation marker C-reactive protein
      (CRP). Major adverse cardiac events (MACE) will be evaluated as a second endpoint.
    

Intervention name(s): omega 3
Intervention type(s): Drug
Intervention description(s): 3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
Other intervention name(s): fish oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: elective percutaneous coronary intervention; hs-CRP; CKMB and troponin I
Phase 1 Study Accessing the Safety and Tolerability of CBP-307
Condition: Autoimmune Diseases
MeSH terms: Autoimmune Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      CBP-307 following oral single and multiple escalating dose administration in healthy
      subjects.
    

Detailed description: 
      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      CBP-307 following oral single and multiple escalating dose administration in healthy
      subjects. The study will have two parts: Part 1 will assess 5 dose levels of the drug in
      single dosing; and Part 2 will evaluate 3 dose levels in 28-day repeat dosing. The effect of
      food will also be evaluated in a single dosing study.
    

Intervention name(s): CBP-307; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Caffeine on Heart Function
Condition: Fatigue; Tachycardia
MeSH terms: Tachycardia
Study type: Interventional

Summary: 
      -  The primary objective of this study is to assess the effect of an energy drink on
           ventricular repolarization as measured by the interval between the cardiac Q wave and
           the cardiac T wave (QT interval)obtained from the body surface ECG.

        -  The secondary objective is to assess the effects of an energy drink on heart rate and
           blood pressure (hemodynamic effects).

      To place the observed changes in context, comparison will be made to a commonly consumed
      drink, coffee: Starbuck's K-cup Breakfast Blend.
    

Detailed description: 
      This study will assess cardiac repolarization before and after three conditions each of which
      will involve the subject drinking beverages of varying caffeine content.
    

Intervention name(s): Monster Energy Drink; Monster energy drink; Monster Energy Drink; Coffee
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Small Dose of Monster energy drink. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 16 ounce can of monster energy drink for a person weighing 75 kg).; Medium Dose of Monster Energy Drink. This will be given at a dose of 3 mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg).; Monster energy drink. This will be given at a dose of 3mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg).; Coffee. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 8 ounce cup of coffee drink for a person weighing 75 kg).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: heart rate; blood pressure; caffeine; energy drink
Vorinostat in Treating Women With Ductal Carcinoma in Situ of the Breast
Condition: Breast Cancer
MeSH terms: Carcinoma; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This clinical trial is studying how well vorinostat works in treating women with
      ductal carcinoma in situ of the breast.
    

Detailed description: 
      OBJECTIVES:

        -  To evaluate the in vivo molecular and biological effects of vorinostat by analyzing
           changes in proliferation and apoptosis, histone acetylation, and HDAC protein expression
           in women with ductal carcinoma in situ of the breast.

      OUTLINE: Patients receive oral vorinostat twice a day for 3 days in the absence of
      unacceptable toxicity. Patients then undergo lumpectomy or mastectomy 2 hours after the last
      dose of vorinostat.

      Blood and tissue samples are collected at baseline and during surgery for biomarker
      laboratory studies. Samples are analyzed by immunohistochemistry for Ki-67, HDAC1 and HDAC6
      protein expression, and histone H4 and α-tubulin acetylation.

      After completion of study therapy, patients are followed for 1 month and then every 6 months
      for 5 years.
    

Intervention name(s): vorinostat; protein expression analysis; immunohistochemistry staining method; laboratory biomarker analysis; neoadjuvant therapy; therapeutic conventional surgery
Intervention type(s): Drug; Genetic; Other; Other; Procedure; Procedure
Intervention MeSH terms: Vorinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ductal breast carcinoma in situ
West Virginia WISEWOMAN Project
Condition: Risk Reduction Behavior
Study type: Interventional

Summary: 
      To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge,
      skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors
      to prevent, delay and control cardiovascular and other chronic diseases.
    


Intervention name(s): West Virginia WISEWOMAN
Intervention type(s): Behavioral
Intervention description(s): Print-based tailored health communications and computer-based interactive nutrition program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Endoscopy With Short Fasting
Condition: Upper Gastrointestinal Symptoms
Study type: Interventional

Summary: 
      Upper gastrointestinal (GI) endoscopy is widely used in the clinical practice. An empty
      stomach is required to ensure quality and safety. For this reason, endoscopy is
      conventionally performed after 8 or more hours of fasting, which is potentially related to
      discomfort to the patients. In recent studies, surgical cholecystectomy has been described to
      be safe after two hours of fasting on liquids. The aim of this study is to assess safety,
      quality and comfort of upper GI endoscopy after two hours of fasting.
    


Intervention name(s): endoscopy after short fasting; conventional fasting
Intervention type(s): Procedure; Procedure
Intervention description(s): patients were evaluated with endoscopy after fasting for two hours; patients were evaluated after fasting for 8 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarkers of Asthma
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the role of versican and hyaluronan measurements in
      induced sputum as biomarkers of asthma. Enroll 10 subjects with mild persistent asthma who
      are not receiving treatment with a controller therapy.
    

Detailed description: 
      We will compare spirometry, eNO and sputum measurements of versican and hyaluronan before and
      after treatment with fluticasone 220 ug/bid.
    

Intervention name(s): Inhaled corticosteroid (fluticasone)
Intervention type(s): Drug
Intervention description(s): inhaled fluticasone 220 ug/bid
Other intervention name(s): fluticasone
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: versican; hyaluronan; sputum
Colloid Osmotic Pressure During Heart Surgery in Children
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Observational

Summary: 
      Clinical oedema is seen after open heart surgery with the use of cardiopulmonary bypass and
      hypothermia in children. The oedema formation is due to increased fluid transport from blood
      to tissue. This transcapillary fluid transport is dependent on differences in interstitial
      and plasma colloid osmotic pressure. The purpose of this investigation is to evaluate changes
      in interstitial colloid osmotic pressure before, under and after the use of cardiopulmonary
      bypass in children. The study hypothesis is that oedema developed during cardiopulmonary
      bypass and hypothermia is caused by increased micro vascular protein leakage and reduced
      colloid osmotic pressure gradient through the capillary membrane.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children scheduled for open heart surgery with the use of Cardiopulmonary Bypass at Oslo
        University Hospital
      
Biospecimen description: 
      Interstitial fluid Serum
    
Keywords: Congenital heart disease; Cardiopulmonary bypass; Capillary leak; Colloid osmotic pressure; Children
A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Mulberry Fruit Extract
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after
      administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma
      concentration of C3G and the antioxidative markers such as total antioxidative capacity and
      attack of free oxygen radical will be measured.

      Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg
      Mulberry fruit extract.

      This study, as an exploratory trial, does not required statistical hypothesis.
    


Intervention name(s): Mulberry fruit extract
Intervention type(s): Other
Intervention description(s): 1000 mg oral daily dose for 2 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: C3G; Oxidative stress; Antioxidant; Mulberry
Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This protocol represents the second in human study of TUTI-16, and is being conducted to
      continue to gather safety and human immunogenicity (anti-HIV-1 Tat titers) data of
      subcutaneously administered TUTI-16.
    

Detailed description: 
      HIV-1 Tat protein, a virally encoded toxin, is secreted by HIV-1 infected cells and acts on
      uninfected cells, rendering them permissive for HIV-1 replication. HIV-1 Tat enhances chronic
      viral replication and induces immune suppression. Antibodies to Tat inhibit this Tat-mediated
      transcellular activation in vitro and minimize chronic plasma viremia. HIV-1 Tat activities
      can be blocked in vitro and in vivo by anti-Tat antibodies.

      The Thymon Universal Tat Immunogen (TUTI-16) is a fully synthetic, self-adjuvanting
      lipopeptide vaccine that is water soluble and administered by subcutaneous injection. In
      preclinical studies, a priming dose and a three week boost in rats induced a high titer
      antibody response to the eight known distinct epitope variants of HIV-1 Tat protein. These
      antibodies block the function of the HIV-1 Tat protein (toxin), which is essential to the
      maintenance of chronic HIV-1 viremia. Therefore, TUTI-16 has potential as a therapeutic
      vaccine for HIV-1 in humans.
    

Intervention name(s): TUTI-16 (0.2mg); TUTI-16 (1.0 mg)
Intervention type(s): Biological; Biological
Intervention description(s): Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.; Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; vaccine; lipopeptide; Tat; TUTI-16; THYMON
Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear
      cells in acute ischemic stroke patients is safe and improves neurological outcomes.
    

Detailed description: 
      This is a study in which the patients will be included diagnosed of ischemic stroke sharply
      in the territory of the cerebral average artery that there fulfill criteria of incorporation
      and none of those of exclusion and that they have signed the informed assent. 76 patients
      will randomize in proportion 2:1:1 in a group control that will receive only medical
      conventional treatment and in two groups of intervention that will receive an unique
      intra-arterial infusion of mononuclear autologous bone marrow stem cells (one group of dose
      of 2 millions of BMSC for kilogram of weight and another group of dose of 5 millions of BMSC
      for kilogram of weight). The three groups of patients will be followed for 24 months. The
      randomization will be stratified depending on the NHSS score. This clinical trial has a
      voluntary substudy to obtain information on plasma biomarkers.
    

Intervention name(s): Autologous bone marrow mononuclear cell intra-arterial injection
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Cell therapy; Bone marrow
Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety and efficacy of memantine extended
      release, as well as its extent of absorption in pediatric patients with autism.
    

Detailed description: 
      This is a multicenter, two-part study in pediatric (ages 6 to 18 years) patients diagnosed
      with autism.

      Patients participating in Part One will receive a single open-label dose of memantine. Blood
      samples for pharmacokinetic analysis will be collected.

      Part Two is a randomized, double-blind, placebo-controlled 12-week efficacy and safety study
      evaluating change in all core domains (social interactions, communication, and restricted
      interests and repetitive behaviors) of autism.

      In the Forest autism trials conducted in children ages 6-12, dosing with an extended release
      formulation of memantine was weight-based. These weight based dose limits were selected to
      ensure exposure in terms of area under the curve (AUC) was less than the predefined limit of
      2100 ng∙h/mL that represented a 10-fold lower exposure than observed at the NOAEL (No
      observed adverse effect level) of 15 mg/kg/day in juvenile rats.

      The weight-based dose limits in these studies were as follows:

        -  Group A: ≥ 60 kg; max 15 mg/day

        -  Group B: 40-59 kg; max 9 mg/day

        -  Group C: 20-39 kg; max 6 mg/day

        -  Group D: < 20 kg; max 3 mg/day
    

Intervention name(s): Memantine - Extended Release (ER); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.; Placebo capsules, once daily, oral administration.
Other intervention name(s): Namenda ER
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: autism; memantine; pediatric; Forest Laboratories; Autism in pediatric patients
A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      1323495 in healthy subjects following bid oral administration of multiple rising doses, each
      over an 11 day treatment period.

      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose
      proportionality (only for Part 1) as well as attainment of steady state. This includes
      exploration of a therapeutic exposure range, a range not adequately achieved in the
      single-rising dose trial 1405-0001.
    


Intervention name(s): BI 1323495; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Oral administration
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Significance of Alveolar Recruitment Maneuver During Bariatric Surgery
Condition: Obesity
Study type: Interventional

Summary: 
      The ventilation of the patient under general anesthesia is an old problem and extensively
      studied, especially in visceral surgery, higher risk of postoperative complications. Studies
      have recently shown the impact of a lung-protective ventilation in visceral surgery, however
      obese patients are often excluded, and alveolar recruitment maneuver has never been studied
      independently.

      The investigators are conducting a randomized controlled prospective study to investigate the
      clinical value to achieve alveolar recruitment maneuver routinely in patients undergoing
      bariatric surgery.

      The objective is to show the reduction in dyspnea, oxygen dependency: reflection of
      atelectasis and the incidence of postoperative complications.
    


Intervention name(s): Anesthesia: alveolar recruitment maneuver; Anesthesia: standardized
Intervention type(s): Procedure; Procedure
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of the Effectiveness and Safety of SugarDown vs. Placebo in Type 2 Diabetic Subjects Treated With Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To assess the safety and effectiveness of two doses of SugarDown in two different doses vs.
      placebo on serum glucose levels after meals in subjects with Type 2 Diabetes treated with
      metformin alone. There will be five visits, a screening visit, baseline visit, and 3
      treatment visits. The study duration will be five weeks. Subjects will all receive placebo
      tablets at the baseline visit, eat a standard rice meal, and then serum glucose levels will
      be measured in frequent intervals over four hours immediately following the meal. Subjects
      will be randomized to one of the six treatment sequences. Patients will take in an unknown
      order one week of placebo, one week of 4 g dose and one week of 8 g dose of SugarDown
      immediately before breakfast, lunch and dinner meals. Patients will continue their usual
      metformin regimen during the trial period.
    


Intervention name(s): SugarDown; Placebo Oral Tablet
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 4 or 8 gram dose in tablet form, before meals, daily for one week; Placebo comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment