bioihbjkbjnl/mcl2 huggingface dataset:
Opioid Free Anesthesia in Bariatric Surgery
Condition: Opioid Use; Postoperative Pain; Postoperative Nausea and Vomiting; Bariatric Surgery Candidate
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      This study compares the intraoperative opioid free anesthesia approach in laparoscopic
      bariatric surgery to a conventional opioid- based anesthesia. Half of participants will
      receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other
      half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine
    

Detailed description: 
      Since optimal analgesia for the obese patients undergoing bariatric surgeries has always been
      challenging, and knowing the comorbidities and physiological changes in this population, use
      of opioid-sparing agents during anesthesia has attracted substantial research.the use of
      opioids in the perioperative period in obese patients is associated with an increased risk of
      complications . They are especially more sensitive to the respiratory depressant effect of
      opioids , thus any analgesic alternative without further compromising airway tone would be a
      desirable choice.

      Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has
      antinociceptive, analgesic and sedative properties, without compromising airway tone and
      reflexes .

      Lidocaine, a local anesthetic that has been shown to be an effective multimodal strategy to
      minimize postoperative pain was evaluated in one study involving obese patients undergoing
      bariatric surgery. Its usage was associated with an improved quality of recovery compared to
      placebo .
    

Intervention name(s): Opioid free Anesthesia dexmedetomidine and lidocaine; Opioid based anesthesia Fentanyl and Remifentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Opioid free anesthesia with dexmedetomidine and lidocaine; Opioid based anesthesia with Fentanyl and Remifentanyl
Intervention MeSH terms: Lidocaine; Fentanyl; Dexmedetomidine; Remifentanil; Analgesics, Opioid; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lidocaine; Dexmedetomidine; Opioid Free; Bariatric surgery
Urodynamics of Suprasacral Spinal Cord Injury Patients
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      The medical records of 215 patients with spinal cord injury(SCI) at the Department of
      Rehabilitation Medicine of the 2nd Affiliated Hospital of Wenzhou Medical University,
      Wenzhou, China were evaluated between January 1, 2016 and December 20, 2019. According to the
      inclusion criteria and exclusion criteria, 101 patients were included. The patients were
      dichotomized into two groups: complete SCI group and incomplete SCI group, based on the
      American Spinal Injury Association Guidelines Impairment Scale (AIS) .The investigators
      retrospectively collected records of urodynamic evaluations of this patients and then analyze
      the urodynamic parameters,including detrusor overactivity (DO), bladder compliance (BC),
      bladder-filling sensation, maximum cystometric capacity (MCC), detrusor external sphincter
      dyssynergia (DESD), maximum urinary flow rate (Qmax), detrusor pressure at a maximum urinary
      flow rate(PdetQmax).
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Traumatic spinal cord injury patients with voiding dysfunction and had urodynamic
        examination.
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be the first evaluation of exenatide in adolescent subjects with type 2
      diabetes mellitus and is designed to evaluate the blood levels of the drug
      (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and
      tolerability of exenatide in these subjects.
    


Intervention name(s): Exenatide - Exenatide - Placebo; Exenatide - Placebo - Exenatide; Placebo - Exenatide - Exenatide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose, followed by placebo 0.02 mL, single dose. All are subcutaneous injections.; Exenatide 2.5 mcg, single dose, followed by placebo 0.02 mL, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections.; Placebo 0.02 mL, single dose, followed by Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections.
Other intervention name(s): Byetta; Byetta; Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: diabetes; adolescents; exenatide; Amylin; Lilly
Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Diabetes; Weight Gain
MeSH terms: Body Weight; Weight Gain; Weight Loss; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To test the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight
      gain in persons with schizophrenia who are currently taking either drug; measures of the
      metabolic syndrome will be evaluated as well.
    

Detailed description: 
      This study is a sixteen week placebo-controlled, double-blind investigation of the effect of
      pramlintide on body weight in clozapine- and olanzapine-induced weight gain. We will recruit
      approximately 72 volunteers with the plan of having a final N = 25 in each of the 2 treatment
      groups. (This number is to allow for normal attrition in this patient population. If needed,
      we will recruit more than 72 volunteers in order to achieve the appropriate number of
      completed subjects.) Patients will be recruited from the local Dallas public and VA mental
      health systems as volunteers for this study. This study is anticipated to last 20 weeks (2
      weeks lead-in [approximately 2-3 visits], 1 week training [4 visits], 16 weeks active
      drug/placebo [one visit per week for the first 4 weeks, then one visit every 2 weeks for the
      remainder], and one week follow-up [one visit]. Please see attached chart for more details
      about each visit.) Volunteers will have to have a history of significant weight gain
      accompanying olanzapine or clozapine treatment and have a BMI=>27 and =<40. Each volunteer
      will be maintained on their optimal dose of clozapine or olanzapine and be randomized blindly
      to pramlintide or placebo. Pramlintide will be administered by the patients in a
      self-injectable form and dosing will begin at 180 mcg bid for 2 weeks and then increase to
      360 mcg bid for the remainder of the study. The randomization to pramlintide/placebo will be
      preceded by a week-long self-administration training program using placebo for pramlintide
      (with additional information regarding nutrition, exercise, general self-care, and risk
      factors for diabetes being provided to the patients during this training program).
    

Intervention name(s): Pramlintide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 180mg subcutaneous injections, twice daily; 180mg subcutaneous injections, twice daily
Other intervention name(s): Amylin; sterile saline
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Schizophrenia; Schizoaffective; Olanzapine; Zyprexa; Clozapine; Clozaril; Pramlintide; Diabetes; Weight Gain; Obesity; Metabolic Syndrome
18572 - Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987521)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: Y49-103)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose of PF-06835919 Escalation Study in Healthy Adult Subjects
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a
      single dose of PF-06835919 in healthy adult subjects.
    


Intervention name(s): PF-06835919; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single or repeated, escalating dose; Single or repeated, escalating dose
Allocation: Randomized
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
PET Imaging of Endotoxin-induced iNOS Activation
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall purpose of this research is to gain understanding of the basic responses of the
      lung to inflammation. Inflammation is the way our bodies react to irritation or injury, and
      involves red, warm, and often painful swelling of the affected tissue. "Acute lung injury"
      involves a generalized inflammation to the lung that is activated by any of several
      conditions: infection, trauma, inhalation of toxic substances, etc. When lung injury is
      severe, not enough oxygen can get into the body; this can lead to the need for mechanical
      support of breathing (mechanical ventilation), problems with brain, heart or other organ
      function, and in some cases, death. Inducible nitric oxide synthase (iNOS) contributes to the
      development of lung inflammation.
    

Detailed description: 
      The investigators plan to use [18F](+/-)NOS (the F stands for fluorine and NOS stands for
      Nitric Oxide Synthase, the name for the investigational radioactive drug that targets iNOS)
      and positron emission tomography (PET) imaging as a measure of lung inflammation. PET is a
      machine that detects radiation and generates pictures using a donut shaped scanner similar in
      appearance to an x-ray "CAT" scan.

      In order to show that [18F](+/-)NOS-PET is related to the amount of inflammation, the
      investigators first need to create a state of controlled lung inflammation that can be
      measured and quantified. "Controlled lung inflammation" means a reaction in the lungs that is
      similar to that which occurs during lung infection (increased respiratory secretions, and
      cough). It is "controlled" because the investigators will not be using anything alive or
      contagious (it will not spread from one part of your body to another, and cannot spread to
      another person) and a small area in only one lung will be affected. In order to create this
      state of controlled lung inflammation, the investigators plan to put a small amount of
      endotoxin into a single small section of the lung using a bronchoscope (a long, flexible,
      narrow tube that is passed through the nose or the mouth into the airways of the lung). This
      use of endotoxin is considered investigational. The investigators have received permission
      from the FDA to use endotoxin in this research study.
    

Intervention name(s): Endotoxin (E. coli O:113, Reference Endotoxin); [18F](+/-)NOS
Intervention type(s): Drug; Drug
Other intervention name(s): Lipopolysaccharide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lung inflammation; positron emission tomography (PET); fluorodeoxyglucose (FDG); inducible nitric oxide synthase (iNOS); lung anti-inflammatory therapy
Neoadjuvant Chemotherapy Versus Surgery Alone for Esophageal Squamous Cell Carcinoma
Condition: Esophageal Neoplasm
MeSH terms: Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal
      squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for
      esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy
      with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total
      2-field lymph node dissection improves the overall survival of thoracic esophageal cancer
      patients.
    

Detailed description: 
      The effect of Neo-adjuvant chemotherapy on survival of patients with thoracic esophageal
      squamous cell carcinomas remains the most controversial part of Neo-adjuvant therapy for
      esophageal carcinomas. Therefore, the optimal management of resectable esophageal squamous
      cell carcinomas differs widely among different areas based on local randomized controlled
      trials.

      The neo-adjuvant chemotherapy might be a good strategy if sufficient local control is
      achieved by surgical treatment. This study defined the detail of surgery procedure and the
      region of lymphadenectomy and adopted cisplatin and paclitaxel as neoadjuvant chemotherapy
      regimens. We try to evaluate the efficacy and safety of this neo-adjuvant strategy.
    

Intervention name(s): cisplatin and paclitaxel
Intervention type(s): Drug
Intervention description(s): Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.
Other intervention name(s): TP
Intervention MeSH terms: Paclitaxel; Cisplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Residual Allergenicity of Tree (Birch, Hazel, and Alder) Pollen Allergoid Using Skin Prick Testing
Condition: Type I Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the residual allergenicity of Tree MATA (modified
      pollen allergen tyrosine adsorbate) by skin prick testing. This is done by a comparison of
      the wheal response after skin prick testing with aqueous native and modified allergen,
      modified tyrosine adsorbed allergen and Tree MATA MPL (modified tyrosine adsorbed + MPL
      [Monophosphoryl Lipid A]).
    

Detailed description: 
      Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients
      with proven type I hypersensitivity to cross reacting tree pollens. MPL (Monophosphoryl Lipid
      A), a purified, detoxified glycolipid derived from the cell wall of Salmonella minnesota, is
      included in the product formulation as an adjuvant to increase the immunogenic effect of the
      product and to enhance the switch from an allergen-specific TH2 to a TH1-like profile.

      The tree pollen extract is modified with glutaraldehyde to produce the active ingredient, an
      allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus
      reducing the risk of side effects. However, a simultaneous reduction in other important
      immunological properties, such as IgG and T cell reactivities is not seen.

      The purpose of this study is to assess residual allergenicity of the modified tree pollen in
      Tree MATA MPL using skin prick testing.
    

Intervention name(s): Tree MATA MPL
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: allergy; skin prick test; allergoid; allergenicity; specific immunotherapy
Specialty Mental Health Probation in North Carolina
Condition: Mental Illness; Substance Use; Criminal Behavior
MeSH terms: Substance-Related Disorders; Mental Disorders
Study type: Interventional

Summary: 
      Specialty mental health probation for offenders with severe mental illness has been widely
      disseminated; however, randomized studies are needed to determine its effectiveness. The
      purpose of the study is to test the feasibility and efficacy of specialty mental health
      probation (SMHP) for probationers with mental illness in North Carolina. 320 adult
      probationers with mental illness in will be randomly assigned to specialty mental health
      probation (experimental condition) or usual probation (control condition). Probationers
      assigned to the experimental condition will be supervised by specialty mental health
      probation officers, who will have reduced caseloads and advanced training in mental health
      and other topics. Probationers assigned to the control condition will receive standard
      probation. Criminal justice and mental health outcomes will be examined.
    

Detailed description: 
      Specialty mental health probation for offenders with severe mental illness has been widely
      disseminated; however, randomized studies are needed to determine its effectiveness. The
      purpose of the study is to test the feasibility and efficacy of specialty mental health
      probation (SMHP) for probationers with mental illness in North Carolina. 320 adult
      probationers with severe mental illness in will be randomly assigned to receive specialty
      mental health probation (experimental condition) or standard probation (control condition).
      Probationers assigned to the experimental condition will be supervised by specialty mental
      health probation officers, who will have reduced caseloads and advanced training in mental
      health and other topics. Probationers assigned to the control condition will receive standard
      probation. Criminal justice and mental health outcomes will be examined.
    

Intervention name(s): Specialty Mental Health Probation
Intervention type(s): Behavioral
Intervention description(s): Specialty mental health probation includes the following components: (1) exclusively mentally ill caseload of probationers; (2) reduced caseload of 40-45 probationers; (3) problem-solving supervision orientation; (4) ongoing training and consultation; and (5) greater connection with local mental health services
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of a Study Product on Quality of Life and Mood
Condition: Quality of Life; Mood
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase II randomized, placebo controlled study evaluating the efficacy of
      Eurycomalongifoliawater extract (Physta®)+Multivitamin on quality of life and mood on 86
      healthy adults over a 24 week supplementation period.
    


Intervention name(s): Eurycomalongifoliawater extract (Physta®); Placebo; Multivitamin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Multivitamin; Eurycomalongifoliawater extract; Quality of Life; Mood
Hepatic and Cardiac Metabolic Flexibility in Obese With NAFLD.
Condition: NAFLD - Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from reversible hepatic steatosis
      to inflammation and fibrosis termed steatohepatitis (NASH) and cirrhosis. New evidence
      indicates that NAFLD is associated with development of heart failure, abnormal ventricular
      glucose and fatty acid (FA) utilisation and cardiosteatosis. The mechanisms behind cardiac
      involvement and the progression from NAFLD to NASH are poorly understood but must include
      altered cardiac and intrahepatic lipid handling. In collaboration with renowned research
      groups from Oxford, Mayo Clinic and Copenhagen investigators plan comprehensive kinetic
      studies of heart and liver FA uptake and oxidation, ventricular function and substrate
      utilisation, and hepatic triglyceride (TG) secretion in order to assess mechanisms governing
      cardiac and hepatic lipid and glucose trafficking in subjects with NAFLD and NASH and the
      relationship with heart function. In addition, the investigators will assess skeletal muscle
      and adipose tissue enzyme activities, gene expression and protein concentrations in these
      subjects to define mechanisms involved in the cross-talk between heart, liver, muscle and
      adipose tissues. Investigators will address these questions using innovative tracer
      techniques (11Cpalmitate, 11C acetate, 18FDG glucose PET tracers and TG tracers) in
      combination with hepatic vein catherisation to study cardiac and liver substrate trafficking,
      as well as NMR spectroscopy, echocardiography, muscle and fat biopsies in combination with
      state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression.
      Effects of acute exercise will be assessed. The overarching goals are to define abnormalities
      and differences between NAFLD and NASH in hepatic lipid (FA and TG) metabolism and to assess
      the effect of exercise on both hepatic, cardiac and adipose and skeletal muscle lipid and
      substrate utilisation.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Moderate Intensity Exercise (50 % af VO2max) for 90 minutes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental: 1 Healthy male volunteers Behavioral: Exercise Moderate Intensity Exercise (50 % af VO2max) for 90 minutes before and after PET scanning, Experimental: 2 Healthy female volunteers Moderate Intensity Exercise (50 % af VO2max) for 90 minutes before and after a PET scanning.
Masking: None (Open Label)
Primary purpose: Health Services Research
Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma
Condition: Stage IV Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this
      study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with
      nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.
    


Intervention name(s): cisplatin and 5-Fu combined with nimotuzumab
Intervention type(s): Drug
Intervention description(s): DDP+5-Fu DDP 100 mg/m2 intravenous infusion in day1, 5-Fu 1000mg/m2/d continuous intravenous infusion on days 1 through 4, both drugs are given every 3 weeks.
Nimotuzumab 200mg/d, intravenous infusion every week
Intervention MeSH terms: Nimotuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment