bioihbjkbjnl/mcl2 huggingface dataset:
Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children
Condition: Spinal Puncture
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare intraoperative and recovery parameters in patients
      who receive two different dose combinations of propofol and remifentanil in patients
      undergoing a lumbar puncture.
    

Detailed description: 
      Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year
      at the Hospital for Sick Children. In a previous study, we determined the optimal dose of
      remifentanil which provides effective anesthesia with little or no movement during LP in
      children. The present study will determine the optimal dose combination of propofol and
      remifentanil to keep patients comfortable and still during the procedure while decreasing the
      incidence of side effects and allows for shorter recovery times and earlier discharge from
      the recovery room.
    

Intervention name(s): Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg; Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.; Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lumbar Puncture; Pediatrics; Propofol; Remifentanil; sedation; Oncology
An Observational/Non-interventional, Study of NS3/4a Protease and NS5A Protein of Hepatitis C Virus in Brazilian Participants With Chronic HCV Infection
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      The purpose of this study is to describe the genetic diversity of Hepatitis C virus (HCV)
      NS3/4a protease and NS5A protein of HCV in participants with chronic disease naive-drug or
      previously failed to double therapy (Peg-interferon and Ribavirin) and to identify the
      frequency of natural polymorphisms in HCV NS3/4a protease and NS5A protein that are
      associated with direct-acting antivirals (DAAs)-resistance.
    

Detailed description: 
      This is a multicenter, observational/non-interventional, cross-sectional study to describe
      the genetic diversity of and to identify the natural polymorphisms in HCV NS3/4a protease and
      NS5A protein of hepatitis C virus in Brazilian participants with chronic HCV infection.
      Brazilian participants with Genotype 1 HCV infection treatment naive participants or
      previously failed to double therapy (Peg-interferon-α and Ribavirin) will be included in the
      trial and will constitute the trial population.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Brazilian participants with Genotype 1 HCV infection treatment naive patients or previously
        failed to double therapy (Peg-interferon-α and Ribavirin) will be included in the trial.
      
Biospecimen description: 
      The total blood volume to be collected will be approximately 15 milliliters (mL) (3 tubes,
      5mL each). Fasting is not required. The blood sample collection scheme was designed to
      collect the minimum number of blood samples that is necessary to accomplish the study
      objective. Blood samples will be frozen and incinerated 30 days after blood collection at the
      national central laboratory.
    
Keywords: Hepatitis C virus
Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate
      vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.
    


Intervention name(s): MenACWY-CRM; MenC-CRM; DTaP-Hib-IPV; PC7; MMR; Varicella
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Subjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh.; One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region.; One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh.
Other intervention name(s): Meningococcal ACWY conjugate vaccine; Meningococcal C conjugate vaccine; Combined vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type B and inactivated polio virus; Pentacel; Heptavalent conjugate pneumococcal; Prevnar; Measles, mumps and rubella
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: meningitis; children; vaccine
Immune Response Following Seasonal Influenza Vaccination
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, single administration dose study in adult healthy male and female
      subjects. After qualifying for the study, subjects will receive a single intramuscular
      injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.
    

Detailed description: 
      Subjects will be screened within 28 days prior to enrollment into the study. After qualifying
      for the study subjects will visit the clinical unit on Day l and will have pre-dose blood
      samples taken for humoral (serum) and cellular(peripheral blood mononuclear cells PBMCs)
      immunity testing and nasopharyngeal swabs for assessment of mucosa! immunity, and will then
      be given the vaccine.

      Over the next 6 months, I 0-mL blood samples will be collected on Days 4, 8, 15, 29, 91 and
      181 for HAI testing. Peripheral blood mononuclear cells will be collected on Day 8 to assess
      cellular responses. A nasopharyngeal swab will also be done on Day 29. Screening assessments
      will include clinical laboratory tests (hematology, chemistry, urinalysis (UA), drug and
      alcohol testing), vital signs, 12-lead electrocardiogram and physical examination.

      Adverse events (AEs) will be monitored throughout the study.
    

Intervention name(s): Licensed seasonal influenza vaccine
Intervention type(s): Biological
Intervention description(s): 20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Seasonal
Cognitive Behavior Therapy for Adolescents With Bulimia
Condition: Bulimia Nervosa
MeSH terms: Bulimia; Bulimia Nervosa
Study type: Interventional

Summary: 
      We are interested in studying two different psychological treatments for eating disorders for
      adolescents (ages 12-18). The study is designed to help adolescents who are having problems
      with binge eating and/or purging. The treatment consists of 14 sessions of approximately
      one-hour each over about three months.
    

Detailed description: 
      Interested adolescents will have a phone screen and then come in for an in-person psychiatric
      evaluation. If eligible and interested, they will be randomly assigned to 4 months of
      outpatient treatment (free of charge) that is either 1) cognitive-behavioral therapy or 2)
      supportive psychotherapy.
    

Intervention name(s): psychotherapy
Intervention type(s): Behavioral
Intervention description(s): 1) cognitive-behavioral therapy or 2) supportive psychotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bulimia Nervosa, EDNOS, Adolescents
Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the current study is to investigate the efficacy, safety and tolerability of
      several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of
      treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition,
      there will be an open-label treatment arm with metformin for sensitivity measurement with
      this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in
      this study.
    


Intervention name(s): Placebo; BI 1356 dose 3 once daily; BI 1356 dose 2 once daily; BI 1356 dose 1 once daily; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo matching BI 1356; BI 1356 dose 3 once daily; BI 1356 dose 2 once daily; BI 1356 dose 1 once daily; Metformin
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg
      three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine
      and placebo group with similar pills, also PCA morphine. The goal is to measure morphine
      usage and incidence of morphine side effects (pruritis, days foley, days to first stool,
      sedation, pain scores, PCA use).
    

Detailed description: 
      Healthy, American Society of Anesthesia (ASA) 1-2 Idiopathic Scoliosis patients for spinal
      fusion.

      Blinded, drug only known by hospital pharmacist. Study group 1- Gabapentin 15mg/kg with
      premed, 5/kg TID for 5 days of discharge, standard PCA morphine with dose and basal Study
      Group 2- Capsules resembling neurontin, with standard PCA morphine

      No remifentanil, clonidine, ketamine

      N=60 First patient enrolled 6/06 Last patient enrolled 7/15/08
    

Intervention name(s): Gabapentin; Placebo; Morphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge; Administered as needed
Other intervention name(s): Neurontin
Intervention MeSH terms: Morphine; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gabapentin; Pediatric Spinal Fusion; Narcotic Use
Value of Target-controlled Intravenous Anaesthesia (TCIVA) in Spinal Cord Stimulation
Condition: Failed Back Surgery Syndrome
MeSH terms: Failed Back Surgery Syndrome
Study type: Interventional

Summary: 
      Study design 60 patients Monocenter prospective study Randomized in 2 groups 36 months
      Objectives Demonstrate the superiority of target controlled intravenous anesthesia versus
      total anesthesia with the low back paresthesia mapping in at least 95% of patients implanted
      with a multicolumn lead.
    


Intervention name(s): Target-controlled intravenous anaesthesia; Total anaesthesia
Intervention type(s): Procedure; Procedure
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Diabetic Ketoacidosis: Brain Morphology and Cognition
Condition: Diabetic Ketoacidosis
MeSH terms: Ketosis; Acidosis; Diabetic Ketoacidosis
Study type: Observational

Summary: 
      The purpose of this study is to assess brain and memory changes in patients with uncontrolled
      diabetes (a condition called diabetic ketoacidosis (DKA))
    

Detailed description: 
      Diabetic ketoacidosis (DKA) is a common and serious medical problem. Most cases occur when
      patients forget or stop insulin injections. Some patients require frequent admissions to the
      hospital with DKA after stopping insulin. Many patients do not know why they stop insulin
      therapy. The investigators will test if patients with one or more episodes of DKA have poor
      memory and brain changes that may lead to poor management.

      In this study, the investigators will perform memory testing and brain images in subjects
      with initial DKA episode and subjects with more than 3 episodes of DKA. The results will be
      compared to subjects with diabetes and no history of DKA and healthy (non-diabetic) subjects.
      Each subject with DKA will have an MRI and cognitive testing done shortly after hospital
      discharge, 1 month, and 3 months after hospital discharge. Diabetic subjects without DKA and
      healthy controls will only come in for a single baseline visit and have a MRI and cognitive
      testing done.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with diabetic ketoacidosis (DKA) will be recruited from Emory University Hospital
        and Grady Memorial Hospital patients when DKA is treated. Diabetic subjects and age-matched
        controls will be recruited from physician referrals.
NBA G-League Sweat Testing Study: Validity of the Gx Sweat Patch in Measuring Sweating Rate and Sweat Chloride Concentration During On-court Training With Basketball Players
Condition: Sweat Analysis
Study type: Interventional

Summary: 
      To determine the validity of the Gx Sweat Patch in measuring sweating rate and sweat chloride
      concentration during moderate-high intensity practice against well-established reference
      methods in field conditions with basketball athletes
    


Intervention name(s): Gx sweat patch; Reference sweat patch
Intervention type(s): Other; Other
Intervention description(s): Adhesive-backed flexible epidermal wearable regional sweat patch to collect and analyze sweat via microfluidics and colorimetric assay; Adhesive Tegaderm with absorbent pad regional sweat patch to collect sweat, followed by standard benchtop gravimetry and ion chromatography methods to analyze sweat
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Each subject serves as their own control. Both devices are worn during the same exercise session.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sweating rate; sweat electrolytes; sweat electrolyte concentration; sweat patch; wearable; epidermal; Gx patch
Autologous Bone Marrow Transplantation in Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission
Condition: Leukemia, Myelocytic, Acute; Leukemia; Blood and Marrow Transplant (BMT)
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the role of high dose chemotherapy with autologous hematopoietic cell
      transplantation for AML.
    

Detailed description: 
      To use high dose chemotherapy with autologous stem cell rescue to try to increase the chance
      of long term control and cure of the disease.
    

Intervention name(s): high dose chemotherapy then autologous hematopoietic cell transplant
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of Wearable Artificial Kidney
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study of a wearable type of kidney dialysis machine to treat patients with
      chronic kidney disease.
    

Detailed description: 
      This is a pilot study to evaluate the clearances, tolerability and safety of a wearable
      artificial kidney device for treating patients with chronic kidney failure.
    

Intervention name(s): Wearable artificial kidney
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: end stage renal failure; dialysis; wearable artificial kidney
Protein Need and Interest of " Quick Proteins " to the Obese Subject Operated by Bariatric Surgery (BIBOP)
Condition: Obesity; Bariatric Surgery
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The main objective of the study is to evaluate the protein requirement associated with
      postoperative weight loss caused by by-pass (shunt which leads to a certain degree of
      malabsorption) or sleeve gastrectomy (more technically conservative with less malabsorption),
      through the study of nitrogen balance. The benefit of protein supply easily absorbed and with
      high essential amino acids content (proteins "fast" soluble milk) on protein metabolism and
      muscle function will also be studied. Endotoxemia and intestinal flora variations were
      measured before and after bariatric surgery.
    

Detailed description: 
      This is a prospective longitudinal study of the effect of bariatric surgery on protein
      requirements and protein metabolism, and protein supplementation interest, appropriate to the
      digestive tract changes, for the mass and muscle function. Three groups of patients will be
      studied: One group undergoing sleeve gastrectomy in Clermont-Ferrand (group 1: n = 20) will
      be followed by current recommendations. A second group undergoing sleeve gastrectomy in
      Clermont-Ferrand (group 2: n = 20) will receive during three months, protein supplement
      (powder whey protein ("fast")) at dose of 40g / day. 10 patients in group 1 and 10 patients
      in group 2 will participate in protein metabolism study. The third group undergoing gastric
      bypass in Lyon (group 3: n = 20) will be followed by the current recommendations and will
      participate in study of endotoxemia.
    

Intervention name(s): bariatric surgery
Intervention type(s): Other
Intervention description(s): This is a prospective longitudinal study of the effect of bariatric surgery on protein requirements and protein metabolism, and protein supplementation interest, appropriate to the digestive tract changes, for the mass and muscle function
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Morbid obesity,; Bariatric surgery, by-pass, sleeve gastrectomy,; Nitrogen balance,; Protein requirement,; Weight loss; Muscle wasting, muscle disability
Misoprostol in Termination of First Trimester Missed Abortion
Condition: Miscarriage
MeSH terms: Abortion, Spontaneous; Abortion, Missed
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether oral versus vaginal misoprostol is
      effective in termination of first trimester missed abortion and to compare between two
      different routes.
    

Detailed description: 
      Objective: To compare the effectiveness of oral versus vaginal misoprostol prior to surgical
      termination of first trimester missed abortion as cervical priming agent , the difference of
      cervical dilatation immediately prior to operation , the duration of operation and side
      effects between two treatment groups.

      Design: This study was conducted as randomised study.

      Setting: Maternity Teaching Hospital in Hawler/ Kurdistan/ Iraq.

      Population: Over a period of six months from the first of January to the thirtieth of June,
      2008, one hundred women were included in this study. They were cases of first trimester
      abortion (6-12 weeks).

      Method: Patients were randomly selected for the type of treatment they received. The first
      group (oral) were assigned to receive 400 micrograms of misoprostol orally as preoperative
      cervical priming agent, where as the second group (vaginal) were allocated to have treatment
      either with vaginal misoprostol to receive 400 micrograms vaginally.

      Main outcome measure: Oral versus vaginal misoprostol as cervical ripening agent prior to
      termination of first trimester missed abortion.

      Keywords: First trimester, missed abortion, misoprostol, cervical ripening, oral, vaginal.
    

Intervention name(s): Misoprostol ( Cytotec) 200 microgram a tablet
Intervention type(s): Drug
Intervention description(s): In this study, two arms we put under study ... and to find how far a single drug, Misoprostol, is effective to have changes on the cervix.
Other intervention name(s): PHARMACIA CORPORATION - Istanbul, serial number 022-00; 200 microgram a tablet
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: First trimester; missed abortion; misoprostol; cervical ripening; oral; vaginal; first trimester missed abortion
Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults
Condition: Nociceptive Pain; Monitoring, Intraoperative
MeSH terms: Mydriasis; Nociceptive Pain
Study type: Interventional

Summary: 
      After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to
      nociceptive stimulation perioperatively.
    

Detailed description: 
      An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in
      response to incremental nociceptive stimuli. The PDR is a robust reflex, even in patients
      under general anesthesia, and may provide a potential evaluation of the autonomous
      nociceptive circuit. American Society of Anesthesiologists (ASA) classification I or II
      patients undergoing elective surgery under general anesthesia are recruited. Enrolled
      patients perioperative undergo PDR measurement at 2 different standardized times (before and
      after opioid administration) generated by an inbuilt pupillary pain index (PPI) protocol.
      PPI, as a surrogate for nociception includes noxious stimulations from 10 up to 60 milli
      ampere (mA) until pupil dilation is larger than 13% from baseline diameter. Therefore, no
      inappropriate high stimulation is executed.
    

Intervention name(s): PDR measurement
Intervention type(s): Procedure
Intervention description(s): PDR measurement at two standardized times perioperatively:
: anesthetized subject by propofol sedation until sedation depth monitor NeuroSense® (NeuroWave Systems Inc, Cleveland, OH) between 40-50
: administration of remifentanil via effect site target concentration (Minto-model) at 5 ng/ml, in the absence of adjustments in sedation depth
Other intervention name(s): PPI assessment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic