bioihbjkbjnl/mcl2 huggingface dataset:
Electrical Impedance Tomography for Endotracheal Tube Placement
Condition: Endotracheal Tube Placement
Study type: Interventional

Summary: 
      Endobronchial tube misplacement is serious complication during general anesthesia in
      pediatric patients. Correct placement of the endotracheal tube (ETT) in the trachea is
      crucial. Several methods have been suggested for determination of correct ETT placement.
      However, to date, auscultation of the left and right lung is the standard of care and the
      only ubiquitary available method with an error rate of up to 12%. Electrical impedance
      tomography (EIT) is a new non-invasive method for evaluation of left and right lung
      ventilation. In this study the investigators investigate the potential role of EIT for proper
      placement of pediatric endotracheal tubes.
    

Detailed description: 
      Several methods have been suggested for determination of correct ETT placement. These include
      for example the marker method, the mainstem method or the formula method. However, to date,
      auscultation of the left and right lung is the standard of care and the only ubiquitary
      available method with an error rate of up to 12%. Electrical impedance tomography (EIT) is a
      new non-invasive method for evaluation of left and right lung ventilation. In this study the
      investigators investigate the potential role of EIT for proper placement of pediatric
      endotracheal tubes. For this purpose, pediatric patients are routinely intubated for cardiac
      catheterization using the mainstem method or 3xETT size method. Placement of the ETT is then
      verified by intraoperative fluoroscopy and lung ventilation is verified by EIT.
    

Intervention name(s): measurement of left and right lung ventilation
Intervention type(s): Device
Intervention description(s): Patients are ventilated after endotracheal tube placement and left and right lung ventilation if determined using electrical impedance tomography
Other intervention name(s): EIT, Draeger
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Primary purpose: Diagnostic
Keywords: pediatric anesthesia; endotracheal tube; electrical impedance tomography; misplacement; endobronchial
Functional Lipids and Appetite Regulation
Condition: Obesity
Study type: Interventional

Summary: 
      To evaluate the short-term effects of structured lipids on appetite regulation.
    

Detailed description: 
      Background Obesity is a major health problem worldwide, and it is a risk factor for several
      chronic disorders. Even small changes in energy intake, leading to a positive balance may
      lead to weight gain over time. Thus, slight modifications in food intake, such as the
      inclusion of foods that effect energy balance, may prevent weight gain and even facilitate
      weight loss. Replacing dietary fat with low-calorie fat (LCF), such as modified triglycerides
      with medium and long chained PUFA.may be an efficient way to reduce body fat.

      Bray et al. (2002) has shown a sustained weight loss of ~6 kg over a 9 month period where
      one-third of a fat-reduced diet (25% fat) was replaced by olestra. This weight loss can not
      solely be explained by the decreased caloric content of olestra. Thus, inhibition of appetite
      leading to lower food intake, may be a potential mechanism of the observed weight loss.

      A reduced absorption of LCF leaves undigested fatty acids in the middle and lower intestine,
      which may generate increased feelings of satiety and decrease caloric intake due to
      regulating peptides and hormones such (CCK, GLP-1, etc.). In addition, intraduodenal fatty
      acids may also promote distension of the stomach and distension of the intestine, which are
      well-known gastrointestinal signals controlling mechanisms for food intake.

      Taken together, in addition to the acute reduction in caloric intake, LCF may encourage a
      gastrointestinal hormone response promoting beneficial effects on appetite regulation and
      energy balance.

      Aims To evaluate the short-term effects of LCF on

      Primary:

        -  Appetite sensations after a meal (VAS)

        -  Postprandiel secretion of appetite regulating hormones

        -  Ad libitum caloric intake 4,5-h subsequent to a fixed meal

      Secondary:

      • Palatability of the test meal
    

Intervention name(s): SALATRIM
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Appetite regulation; Hormones; Energy intake
A Study of Different Injectable Formulations of LY3375880 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purposes of this study are: 1. To learn more about the safety and side effects of
      different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood
      stream and how long it takes to get out of the body. The study will last about 85 days.
      Screening may occur up to 28 days prior to enrollment.
    


Intervention name(s): LY3375880; Buffer Matrix (No LY3375880); Autoinjector (AI); Manual Syringe
Intervention type(s): Drug; Drug; Device; Device
Intervention description(s): Administered SC; Administered SC; AI used to administer LY3375880 or Buffer Matrix; Manual syringe used to inject LY3375880
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part A is a crossover design. Part B is a parallel design.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Apidra Children & Adolescents Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      Evaluate the percentage of patients achieving glycosylated hemoglobin (HbA1c) level < 8% (in
      patients of 6-12 years old) and HbA1c level < 7.5% (in patients of 13-17 year old) at 6 and
      12 months of treatment

      Secondary Objectives:

      Change in HbA1c level at 6 and 12 months of treatment Monthly rate of hypoglycaemia/per
      patient from the baseline to the end of the study Change in daily dose of glargine and
      glulisine at 6 and 12 months of treatment.
    


Intervention name(s): INSULIN GLULISINE; INSULIN GLARGINE
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day; Pharmaceutical form:solution for injection Route of administration: subcutaneous Dose regimen: 0-15 minutes before meal or within 20 minutes from the start of meal according to prandial plasma glucose values
Other intervention name(s): Apidra; Lantus
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Risk Prediction of Carotid Endarterectomy by Vascular Ultrasound Evaluation
Condition: Stroke
Study type: Observational [Patient Registry]

Summary: 
      Carotid endarterectomy (CEA) is one of the surgical treatment methods for the reconstruction
      of arterial stenosis or occlusion. Perioperative stroke, cerebral hemorrhage,hyperperfusion
      syndrome and death are main complications of CEA. Investigator have established a risk
      prediction model of the procedure based on vascular characteristics and hemodynamic
      parameters retrospectively. This prospective study was aimed to verify the predictive ability
      of CEA comprehensive prediction model through the analysis of patients receiving CEA
      procedure in the investigator's center in the next two years.
    

Detailed description: 
      Subjects: In this study, a total of 600-800 patients with severe carotid artery stenosis or
      occlusion who scheduled for CEA are recruited.

      Data collection:

        1. The plaque characteristics, stenosis degrees of carotid artery and intracranial
           arteries, and collateral circulation are evaluated by ultrasound prior to the procedure.

        2. CT, MRI and digital subtraction angiography (DSA) were applied pre- and post-procedure
           to identify the clinical events.

      Endpoint: The combination endpoints events of death, cerebral hemorrhage , newly cerebral
      infarction, hyperperfusion syndrome within 30-day after the procedure.

      Statistical analysis plans: The Statistical Package of Social Sciences (SPSS version 22.0)
      software are used for statistical analysis. The area under the receiver operating
      characteristic (ROC) curve and hosmer-lemeshow test were used to evaluate the discrimination
      and calibration of the risk prediction model.
    

Intervention name(s): CEA surgery
Intervention type(s): Procedure
Intervention description(s): patients with carotid artery severe (70-99%) stenosis or occlusion received CEA surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with carotid artery severe (70-99%) stenosis or occlusion who are scheduled for
        CEA.
      
Keywords: Ultrasound; Carotid Endarterectomy; Risk Prediction Model
Antimicrobial Resistance Rate In Escherichia Coli And Klebsiella Pneumonia : A Retrospective Study
Condition: Antibiotic Reaction
MeSH terms: Pneumonia; Escherichia coli Infections
Study type: Observational

Summary: 
      Antibiotics are medicines used to avoid and treat bacterial infections. Antibiotic resistance
      is increasing to dangerous level globally.
    

Detailed description: 
      Antibiotics resistance is a global health problem.
    

Intervention name(s): urine culture
Intervention type(s): Diagnostic Test
Intervention description(s): urine culture and antibiotic susceptibility test
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with dysurea
      
Keywords: antibiotics, urine, resistance
The Effect of Mindfulness-Based Cognitive Therapy Program Applied to Nursing Students
Condition: Mindfulness; Depression, Anxiety; Stress; Nursing Students
MeSH terms: Depression
Study type: Interventional

Summary: 
      Among the stress factors of nursing students are traumatic experiences such as death and
      encountering a dying patient from the first moments of their education years, fear of making
      mistakes in the clinic, patient care, not getting enough support from the instructor or
      clinic staff, and communication problems. Exposure to long-term and uncontrollable stress
      negatively affects students' professional identity development and health. Students who
      cannot cope with their stress feel stress at a higher level and as a result they may
      experience anxiety and depression.It is important for nurse candidates to graduate by being
      supported in all aspects, both in terms of individual and professional development. For this
      reason, nursing educators should use effective and innovative interventions to help students
      recognize the stress they experience and help them reduce stress. Mindfulness-Based Cognitive
      Therapy Program (MBCT) is one of these programs. Although studies with MBCT are found in the
      literature, our country In the literature, no randomized controlled studies were found with
      nursing students. In line with this information, it was thought that mindfulness-based
      studies were needed. This study was planned to determine the effect of MBCT program on
      depression, anxiety, stress and cognitive flexibility of nursing students.
    

Detailed description: 
      Inclusion criteria for research

        -  to be nursing students

        -  to have a score of 4 or more (General Health Questionnaire)

        -  Internet access to participate in online sessions

        -  Individuals who voluntarily agree to participate in the research will be included.

      Exclusion criteria from the research

        -  Those who are in the acute depression period

        -  Risk of suicidal

        -  Having participated in MBSR-MBCT programs before

      Application Protocol Principles

        -  to consider students individuality, to provide correct information/education,

        -  Guiding to increase motivation,

        -  Giving feedback and supporting individuals,

        -  to provide accessibility for individuals' concerns and questions,
    

Intervention name(s): Mindfulness Based Cognitive Therapy Group
Intervention type(s): Behavioral
Intervention description(s): Mindfulness Based Cognitive Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Effects of Reiki on Painful Neuropathy and Cardiovascular Risk Factors
Condition: Coronary Disease; Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Coronary Disease; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The object of this study is to determine if Reiki will improve glycemic control and cardiac
      autonomic function diabetic patients with painful neuropathy.
    

Detailed description: 
      The incidence of coronary heart disease(CHD) in type II diabetes is currently at least 20% in
      subjects 65 years and older. Numerous data suggest that hyperglycemia may be an independent
      risk factor for macrovascular complications. Diabetic painful neuropathy (DPN) affects 5-50%
      of patients with diabetes and is exacerbated by poor glycemic control. DPN is characterized
      by acute functional abnormalities in nerve fibers followed by chronic nerve fiber loss and
      blunted nerve fiber regeneration. Symptoms include tingling and burning sensations in the
      calves, ankles and feet. Pharmacological treatment of diabetic autonomic neuropathy (DAN) and
      DPN include tricyclic antidepressants, which are cardiotoxic and have a low efficacy rate.
      The ADA recommends the utilization of diet and exercise as the primary means of glycemic
      control, and therefore of DPN. Because of the increased levels of extremity pain, patients
      with DPN are less likely to include exercise as a part of their health regimen. Diabetic
      autonomic neuropathy (DAN) commonly complicates diabetes and has been invoked as a cause of
      sudden death in diabetic patients. The excess cardiac mortality in diabetics appears to be
      augmented by the presence of DAN in patients with advanced deficits in sympathetic
      cardiovascular enervation which may augment cardiac arrhythmogenesis. An bio-energy modality
      known as Reiki is an energy manipulation technique similar to Therapeutic Touch, a hands-on
      modality familiar in nursing for the relief of chronic pain, as well as accelerate healing in
      full thickness dermal wounds. The study approach is to apply Reiki to patients with DPN +/-
      DAN in a semi-double blind, randomized, crossover study to ascertain if glycemic control and
      cardiac autonomic function are improved in these patients. Outcome measures will include
      HBA1c values, the McGill-Melzack Pain Questionnaire, and a quality of life questionnaire.
      Participants will also be tested as to their ability to tolerate exercise by a 6 minute walk
      test. This study will help elucidate whether an bio-energy technique can reduce pain levels,
      improve glycemic control by increasing exercise tolerance and improve cardiac autonomic
      function, both major contributors to CHD mortality.
    

Intervention name(s): Reiki
Intervention type(s): Procedure
Allocation: Randomized
Masking: Single
Primary purpose: Treatment
A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate
      the effects of lebrikizumab on airway eosinophilic inflammation in participants with
      uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second
      controller medication. Enrolled participants will undergo a 3-week screening period during
      which assessments, including a bronchoscopy procedure, will be made. Participants will
      subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection
      on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care
      therapy throughout the study. End of treatment assessments will be taken at Week 12. Total
      study period, including screening and follow-up, is expected to last 23 weeks.
    


Intervention name(s): Lebrikizumab; Placebo; Inhaled corticposteroids (ICS); Second Asthma Controller Medication
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lebrikizumab will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.; Lebrikizumab matching placebo will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.; Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS.; Participants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study.
Other intervention name(s): RO5490255
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of Part I of this study is to evaluate the safety and tolerability of intravenous
      (IV) doses of MK-2640 in healthy participants and to obtain preliminary plasma
      pharmacokinetic profiles of MK-2640. The purpose of Parts II and III of this study is to
      evaluate the safety and tolerability of IV doses of MK-2640 and regular human insulin (RHI),
      and to evaluate the pharmacokinetic and pharmacodynamic profile of MK-2640 and RHI in
      participants with type 1 diabetes mellitus (T1DM). Part II will be initiated only if Part I
      general safety, tolerability and other observed data are supportive of progression to Part
      II. Part III will be initiated only if Parts I and II general safety, tolerability and other
      observed data are supportive of progression to Part III.
    


Intervention name(s): MK-2640; Regular Human Insulin (RHI); Dextrose; Insulin aspart; Rescue medication
Intervention type(s): Drug; Biological; Drug; Biological; Drug
Intervention description(s): MK-2640 intravenous infusion administered to participant in a fasted state; RHI 100 units/mL intravenous infusion to maintain target glycemic level; Dextrose 20% or 50% intravenous infusion for approximately 9 or 7 hours, as appropriate to attain a target glycemic level; Insulin aspart subcutaneous injection or intravenous infusion the evening before each period in Parts II and III to achieve/maintain glycemic target.; Rescue medication may be administered for hypotension or mild to moderate infusion reaction. Rescue medication may include epinephrine, antihistamines, steroids, or acetaminophen/paracetamol.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; MK-2640
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacodynamic Evaluation of Intranasal Nalmefene
Condition: Pharmacodynamic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to determine the pharmacodynamics (the effects of the drug and mechanisms of
      their action within the body) of Nalmefene when given intranasally (IN; into the nose)
      compared to intranasal naloxone when given to healthy volunteers under steady state opioid
      agonism.
    

Detailed description: 
      Open-label, 2-part study. Part 1 is a pilot study to determine the relationship between
      opioid agonism and suppression of carbon dioxide induced increases in minute ventilation
      prior to opioid exposure. Part 2 will be a randomized, 2 period, 2 treatment, crossover study
      to evaluate the pharmacodynamic effects of intranasal (IN) nalmefene compared to IN naloxone
      to reverse opioid-induced suppression of carbon dioxide induced increases in minute
      ventilation, in healthy volunteers with prior opioid exposure.

      Both Part 1 and Part 2 of the study will consist of an outpatient Screening Visit taking
      place 28 days prior to admission, an in-clinic Treatment Phase consisting of a 6 or 7 day
      inpatient stay, and a Follow-Up Phone Call conducted 3 to 7 days after discharge.
    

Intervention name(s): Nalmefene hydrochloride; Naloxone hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 3mg Nasal spray; 4mg Nasal Spray
Intervention MeSH terms: Naloxone; Nalmefene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science